Helium Oxygen Mixture

Dosage Form: gas
Helium/Oxygen Mixture 70/30

COMPRESSED GAS, OXIDIZING, N.O.S.    (     % OXYGEN USP    %HELIUM USP) UN3156

NON-FLAMMABLE GAS 2     OXIDIZER 5.1   34499 (11/05)

OXYGEN CONTENT OVER 23.5 %

Rx only. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. CAUTION: HIGH PRESSURE OXDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED,  remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. CAS: OXYGEN  7782-44-7    HELIUM 7440-59-7    DO NOT REMOVE THIS PRODUCT LABEL.   

FILLED and INPSECTED BY GENERAL AIR SERVICE and SUPPLY DENVER, CO 80204

HELIUM/OXYGEN MIXTURE 70/30  helium/oxygen mixture 70/30  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 21220-128 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (Helium) Helium 700 mL  in 1 L Oxygen (Oxygen) Oxygen 300 mL  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 21220-128-01 7108 L In 1 CYLINDER None 2 21220-128-02 708 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1975

Labeler - General Air Service & Supply Co (151227338)

Establishment
Name	Address	ID/FEI	Operations
General Air Service & Supply Co		006686091	manufacture

Revised: 12/2010General Air Service & Supply Co

Lercanidipine Hydrochloride 20 mg film-coated tablets

1. Name Of The Medicinal Product

Lercanidipine Hydrochloride 20 mg film-coated tablets

2. Qualitative And Quantitative Composition

One film-coated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.8 mg lercanidipine.

Excipient:

Lercanidipine Hydrochloride 20 mg film-coated tablets: Lactose monohydrate 60 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets

Lercanidipine Hydrochloride 20 mg film-coated tablets: Pink, round, biconvex 8.5 mm film-coated tablets, scored on one side, marked 'L' on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1 Therapeutic Indications

Lercanidipine is indicated for the treatment of mild to moderate essential hypertension.

4.2 Posology And Method Of Administration

The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response.

Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent.

Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of lercandipine to therapy with a beta-adrenoreceptor blocking drug, a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor.

Since the dose-response curve is steep with a plateau at doses between 20-30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase.

Elderly

Although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly.

Children and adolescents

Lercanidipine is not recommended for use in children and adolescents below the age of 18 years as there is no clinical experience.

Renal insufficiency

Special care should be exercised when treatment is commenced in patients with mild to moderate renal impairment. Although the usually recommended dose schedule may be tolerated, an increase in dose to 20mg daily must be approached with caution.

Lercanidipine is not recommended for use in patients with severe renal impairment (GFR < 30 ml/min).

Hepatic insufficiency

Special care should be exercised when treatment is commenced in patients with mild to moderate hepatic dysfunction. Although the usually recommended dose schedule may be tolerated, an increase in dose to 20 mg daily must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered.

Administration

The tablets should be taken with some water before a meal.

4.3 Contraindications

- Hypersensitivity to lercanidipine, to any dihydropyridine or to any of the excipients.

- Left ventricular outflow tract obstruction.

- Untreated congestive cardiac failure.

- Unstable angina pectoris.

- Within 1 month of a myocardial infarction.

- Severe renal or hepatic impairment.

- Pregnancy and lactation (see section 4.6).

- Women of child-bearing potential unless effective contraception is used.

- Strong inhibitors of CYP3A4 (see section 4.5).

- Cyclosporin (see section 4.5).

- Grapefruit juice (see section 4.5).

-

4.4 Special Warnings And Precautions For Use

Sick sinus syndrome

Special care should be exercised when lercanidipine is used in patients with sick sinus syndrome (if a pacemaker is not in situ). Although hemodynamic controlled studies revealed no impairment of ventricular function, care is also required in patients with LV dysfunction. It has been suggested that some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease. Although lercanidipine is long-acting caution is required in such patients.

Angina pectoris

Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks.

Isolated cases of myocardial infarction may be observed (see 4.8).

Use in renal or hepatic dysfunction:

Special care should be exercised when treatment is commenced in patients with mild to moderate renal or hepatic dysfunction. Although the usually recommended dose schedule may be tolerated by these subgroups, an increase in dose to 20 mg daily must be approached with caution. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered.

Lercanidipine is not recommended for use in patients with severe hepatic impairment or in patients with severe renal impairment (GFR < 30 ml/min) (see 4.2).

Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs (see 4.5).

CYP3A4 inducers

Inducers of CYP3A4 like anticonvulsants (e.g. phenytoin, carbamazepine) and rifampicin may reduce lercanidipine's plasma levels and therefore the efficacy of lercanidipine may be less than expected (see section 4.5).

This medicinal product contains lactose monohydrate and therefore should not be administered to patients with Lapp lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Metabolic interactions

Lercanidipine is known to be metabolised by the CYP3A4 enzyme and, therefore, inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination of lercanidipine.

CYP3A4 inhibitors

Co-administration of lercanidipine with inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, erythromycin, troleandomycin) should be avoided (see 4.3).

An interaction study with a strong CYP3A4 inhibitor, ketoconazole, has shown a considerable increase in plasma levels of lercanidipine (a 15-fold increase of the AUC and an 8-fold increase of the C_max for the eutomer S-lercanidipine).

Increased plasma levels of both lercanidipine and ciclosporin have been observed following concomitant administration. A study in young healthy volunteers has shown that when ciclosporin was administered 3 hours after the lercanidipine intake, the plasma levels of lercanidipine did not change, while the AUC of ciclosporin increased by 27%. However, the co-administration of lercanidipine with ciclosporin has caused a 3-fold increase of the plasma levels of lercanidipine and a 21% increase of the ciclosporin AUC. Ciclosporin and lercanidipine should not be administered together.

As for other dihydropyridines, lercanidipine is sensitive to inhibition of metabolism by grapefruit juice, with a consequent rise in its systemic availability and increased hypotensive effect. Lercanidipine should not be taken with grapefruit juice.

When concomitantly administered at a dose of 20 mg with midazolam p.o. to elderly volunteers, lercanidipine's absorption was increased (by approximately 40%) and the rate of absorption was decreased (t_max was delayed from 1.75 to 3 hours). Midazolam concentrations were not modified.

CYP3A4 inducers

Co-administration of lercanidipine with CYP3A4 inducers like anticonvulsants (e.g. phenytoin, carbamazepine), rifampicin should be approached with caution since the antihypertensive effect may be reduced and blood pressure should be monitored more frequently than usual.

CYP3A4 substrates

Healthy volunteers treated with digoxin following dosing with 20 mg lercanidipine given fasted showed a mean increase of 33% in digoxin C_max , while AUC and renal clearance were not significantly modified. Patients on concomitant digoxin treatment should be closely monitored clinically for signs of digoxin toxicity.

Co-administration of 20 mg lercanidipine in patients chronically treated with b-methyldigoxin showed no evidence of pharmacokinetic interaction.

Concomitant administration of cimetidine 800 mg daily does not cause significant modifications in plasma levels of lercanidipine, but at higher doses caution is required since the bioavailability and the hypotensive effect of lercanidipine may be increased.

An interaction study with fluoxetine (an inhibitor of CYP2D6 and CYP3A4), conducted in volunteers of an age of 65 ± 7 years (mean ± s.d.), has shown no clinically relevant modification of the pharmacokinetics of lercanidipine.

The co-administration of 20 mg lercanidipine to healthy volunteers given fasted did not alter the pharmacokinetics of warfarin.

Caution should be exercised when lercanidipine is co-prescribed with other substrates of CYP3A4, like terfenadine, astemizole, class III antiarrhythmic drugs such as amiodarone, quinidine.

Alcohol

Alcohol should be avoided since it may potentiate the effect of vasodilating antihypertensive drugs.

Other interactions

When lercanidipine was co-administered with metoprolol, β-blocker eliminated mainly by the liver, the bioavailability of metoprolol was not changed while that of lercanidipine was reduced by 50%. This effect may be due to the reduction in the hepatic blood flow caused by β-blockers and may therefore occur with other drugs of this class. Consequently, lercanidipine may be safely administered with beta-adrenoceptor blocking drugs, but dose adjustment may be required.

When a dose of 20 mg of lercanidipine was repeatedly co-administered with 40 mg of simvastatin, the AUC of lercanidipine was not significantly modified, while simvastatin's AUC increased by 56% and that of its active metabolite β-hydroxyacid by 28%. It is unlikely that such changes are of clinical relevance. No interaction is expected when lercanidipine is administered in the morning and simvastatin in the evening, as indicated for such drug.

Lercanidipine has been safely administered with diuretics and ACE inhibitors.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of lercanidipine in pregnant women. Non-clinical data provide no evidence of a teratogenic effect in the rat and the rabbit and reproductive performance in the rat was unimpaired. Since other dihydropyridine compounds have been found teratogenic in animals, lercanidipine should not be administered during pregnancy or to women with child-bearing potential unless effective contraception is used.

Lactation

Because of high lipophilicity of lercanidipine, distribution in milk may be expected. Therefore, it should not be administered to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Lercanidipine has no or negligible influence on the ability to drive and use machines. However, caution should be exercised because dizziness, asthenia, fatigue and rarely somnolence may occur.

4.8 Undesirable Effects

The following undesirable effects have been reported in clinical studies and in the post-marketing phase:

Assessment of frequencies:

Very common:
Common:
Uncommon:
Rare:
Very rare:	< 1/10,000, cannot be estimated from the available data

Investigations

Very rare: reversible increases in serum levels of hepatic transaminases

Cardiac disorders

Uncommon: tachycardia; palpitations, peripheral oedema

Rare: angina pectoris

Very rare: chest pain, myocardial infarction, hypotension

Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks.

Nervous system disorders

Uncommon: headache; dizziness

Gastrointestinal disorders

Rare: nausea; dyspepsia; diarrhoea; abdominal pain; vomiting

Very rare: gingival hypertrophy

Renal and urinary disorders

Rare: polyuria

Very rare: urinary frequency

Skin and subcutaneous tissue disorders

Rare: rash

Musculoskeletal and connective tissue disorders

Rare: myalgia

Vascular disorders

Uncommon: flushing

General disorders and administration site conditions

Rare: asthenia; fatigue

Immune system disorders

Very rare: hypersensitivity

Psychiatric disorders

Rare: somnolence

Lercanidipine does not appear to influence adversely blood sugar or serum lipid levels.

4.9 Overdose

In the post-marketing experience, three cases of overdose were reported (150 mg, 280 mg and 800 mg of lercanidipine, respectively, ingested in an attempt to commit suicide).

Dose level	Signs/Symptoms	Management	Outcome
150 mg + undefined amount of alcohol	Sleepiness	Gastric lavage Active charcoal	Recovered
280 mg + 5.6 mg moxonidine	Cardiogenic shock Severe myocardial ischaemia Mild renal failure	High-dose catecholamines Furosemide Digitalis Parenteral plasma expanders	Recovered
800 mg	Emesis Hypotention	Active charcoal Cathartics Dopamine i.v.	Recovered

As with other dihydropyridines, overdosage might be expected to cause excessive peripheral vasodilatation with marked hypotension and reflex tachycardia. In case of severe hypotension, bradycardia and unconsciousness, cardiovascular support could be helpful, with intravenous atropine for bradycardia.

In view of the prolonged pharmacological effect of lercanidipine, it is essential that the cardiovascular status of patients who take an overdose is monitored for 24 hours at least. There is no information on the value of dialysis. Since the drug is highly lipophilic, it is most probable that plasma levels are no guide to the duration of the period of risk and dialysis may not be effective.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Selective calcium channel blockers with mainly vascular effects

ATC Code: C08CA13

Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance. Despite its short pharmacokinetic plasma half-life, lercanidipine is endowed with a prolonged antihypertensive activity because of its high membrane partition coefficient, and is devoid of negative inotropic effects due to its high vascular selectivity.

Since the vasodilatation induced by lercanidipine is gradual in onset, acute hypotension with reflex tachycardia has rarely been observed in hypertensive patients.

As for other asymmetric 1,4-dihydropyridines, the antihypertensive activity of lercanidipine is mainly due to its (S)-enantiomer.

In addition to the clinical studies conducted to support the therapeutic indications, a further small uncontrolled but randomised study of patients with severe hypertension (mean ± SD diastolic blood pressure of 114.5 ± 3.7 mmHg) showed that blood pressure was normalised in 40% of the 25 patients on 20 mg once daily dose and in 56% of 25 patients on 10 mg twice daily doses of lercanidipine. In a double-blind, randomized, controlled study versus placebo in patients with isolated systolic hypertension lercanidipine was efficacious in lowering systolic blood pressure from mean initial values of 172.6 ± 5.6 mmHg to 140.2 ± 8.7 mmHg.

5.2 Pharmacokinetic Properties

Absorption

Lercanidipine is completely absorbed after 10-20 mg oral administration and peak plasma levels, 3.30 ng/ml ± 2.09 s.d. and 7.66 ng/ml ± 5.90 s.d. respectively, occur about 1.5-3 hours after dosing.

The two enantiomers of lercanidipine show a similar plasma level profile: the time to peak plasma concentration is the same, the peak plasma concentration and AUC are, on average, 1.2-fold higher for the (S) enantiomer and the elimination half-lives of the two enantiomers are essentially the same. No "in vivo" interconversion of enantiomers is observed.

Due to the high first pass metabolism, the absolute bioavailability of lercanidipine orally administered to patients under fed conditions is around 10%, although it is reduced to 1/3 when administered to healthy volunteers under fasting conditions.

Oral administration of lercanidipine leads to plasma levels of lercanidipine not directly proportional to dosage (non-linear kinetics). After 10, 20 or 40 mg, peak plasma concentrations observed were in the ratio 1:3:8 and areas under plasma concentration-time curves in the ratio 1:4:18, suggesting a progressive saturation of first pass metabolism. Accordingly, availability increases with dosage elevation.

Oral availability of lercanidipine increases 4-fold when lercanidipine is ingested up to 2 hours after a high fat meal. Accordingly, lercanidipine should be taken before meals.

Distribution

Distribution from plasma to tissues and organs is rapid and extensive.

The degree of serum protein binding of lercanidipine exceeds 98%. Since plasma protein levels are reduced in patients with severe renal or hepatic dysfunction, the free fraction of the drug may be increased.

Metabolism

Lercanidipine is extensively metabolised by CYP3A4; no parent drug is found in the urine or the faeces. It is predominantly converted to inactive metabolites and about 50% of the dose is excreted in the urine.

In vitro-experiments with human liver microsomes have demonstrated that lercanidipine shows some degree of inhibition of CYP3A4 and CYP2D6, at concentrations 160- and 40-fold, respectively, higher than those reached at peak in the plasma after the dose of 20 mg.

Moreover, interaction studies in humans have shown that lercanidipine did not modify the plasma levels of midazolam, a typical substrate of CYP3A4, or of metoprolol, a typical substrate of CYP2D6. Therefore, inhibition of biotransformation of drugs metabolised by CYP3A4 and CYP2D6 by lercanidipine is not expected at therapeutic doses.

Elimination

Elimination occurs essentially by biotransformation.

A mean terminal elimination half life of 8-10 hours was calculated and the therapeutical activity lasts for 24 hours because of its high binding to lipid membrane. No accumulation was seen upon repeated administration.

Elderly, renal and hepatic insufficiency

In elderly patients and in patients with mild to moderate renal dysfunction or mild to moderate hepatic impairment the pharmacokinetic behaviour of lercanidipine was shown to be similar to that observed in the general patient population; patients with severe renal dysfunction or dialysis-dependent patients showed higher levels (about 70%) of the drug. In patients with moderate to severe hepatic impairment, the systemic bioavailability of lercanidipine is likely to be increased since the drug is normally metabolised extensively in the liver.

5.3 Preclinical Safety Data

Safety pharmacological studies in animals have shown no effects on the autonomic nervous system, the central nervous system or on gastrointestinal function at antihypertensive doses.

The relevant effects which have been observed in long-term studies in rats and dogs were related, directly or indirectly, to the known effects of high doses of Ca-antagonists, predominantly reflecting exaggerated pharmacodynamic activity.

Lercanidipine was not genotoxic and showed no evidence of carcinogenic hazard.

Fertility and general reproductive performance in rats were unaffected by treatment with lercanidipine.

There was no evidence of any teratogenic effect in rats and rabbits; however, in rats, lercanidipine at high dose levels induced pre- and post- implantation losses and delay in foetal development.

Lercanidipine hydrochloride, when administered at high dose (12 mg/kg/day) during labour, induced dystocia.

The distribution of lercanidipine and/or its metabolites in pregnant animals and their excretion in breast milk have not been investigated.

Metabolites have not been evaluated separately in toxicity studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Magnesium stearate

Povidone

Sodium starch glycolate (Type A)

Lactose monohydrate

Cellulose, microcrystalline

Film-coating:

Macrogol

Polyvinyl alcohol

Talc

Titanium dioxide (E 171)

Iron oxide, yellow (E 172)

Iron oxide, red (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Al/PVC blister:

Do not store above 25°C. Store in the original package in order to protect from moisture.

Al/PVDC blister:

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5 Nature And Contents Of Container

Blister pack (Aluminium/PVC) with push-through foil.

Blister pack (Aluminium/PVDC) with push-through foil.

Pack sizes: 7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Caduceus Pharma Ltd

6^th Floor

94 Wigmore Street

London

W1U 3RF

UK

8. Marketing Authorisation Number(S)

PL 24668/0176

9. Date Of First Authorisation/Renewal Of The Authorisation

22 December 2009

10. Date Of Revision Of The Text

22 December 2009

Sterile Water for Injection

Sterile Water for Injection, USP

Glass Vial

Plastic Vial

Rx only

Sterile Water for Injection Description

This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For I.V. injection, add sufficient solute to make an approximately isotonic solution.

Water for Injection, USP is chemically designated H2O.

The glass vial is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.

Sterile Water for Injection - Clinical Pharmacology

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.

Indications and Usage for Sterile Water for Injection

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Contraindications

Sterile Water for Injection, USP must be made approximately isotonic prior to use.

Warnings

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.

Precautions

Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Drug Interactions

Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

Use aseptic technique for single or multiple entry and withdrawal from all containers.

When diluting or dissolving drugs, mix thoroughly and use promptly.

Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.

Adverse Reactions

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Overdosage

Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re‑evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Sterile Water for Injection Dosage and Administration

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Sterile Water for Injection Supplied

Sterile Water for Injection, USP is supplied in the following:

NDC No.	Container	Size
0409-4887-05	Glass Fliptop Vial	1 mL
0409-4887-10	Plastic Fliptop Vial	10 mL
0409-4887-34	Plastic Fliptop Vial	10 mL
0409-4887-20	Plastic Fliptop Vial	20 mL
0409-4887-50	Plastic Fliptop Vial	50 mL

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]

Revised: October, 2009

Printed in USA                                                    EN - 2272

Hospira, Inc., Lake Forest, IL 60045 USA

RL-2906

RL-2762

STERILE WATER  water  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-4887 Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (WATER) WATER 1 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-4887-05 25 VIAL In 1 TRAY contains a VIAL 1 1 mL In 1 VIAL This package is contained within the TRAY (0409-4887-05) 2 0409-4887-10 25 VIAL In 1 TRAY contains a VIAL 2 10 mL In 1 VIAL This package is contained within the TRAY (0409-4887-10) 3 0409-4887-50 25 VIAL In 1 TRAY contains a VIAL 3 50 mL In 1 VIAL This package is contained within the TRAY (0409-4887-50) 4 0409-4887-20 25 VIAL In 1 TRAY contains a VIAL 4 20 mL In 1 VIAL This package is contained within the TRAY (0409-4887-20) 5 0409-4887-34 30 VIAL In 1 TRAY contains a VIAL 5 10 mL In 1 VIAL This package is contained within the TRAY (0409-4887-34)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018801	09/15/2011

Labeler - Hospira, Inc. (141588017)

Revised: 09/2011Hospira, Inc.

More Sterile Water for Injection resources

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Jetmonal

Jetmonal may be available in the countries listed below.

Ingredient matches for Jetmonal

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Jetmonal in the following countries:

• Turkey

International Drug Name Search

Gammagard

Pronunciation: i-MUNE GLOB-ue-lin
Generic Name: Immune Globulin (Human)
Brand Name: Examples include Gammagard and Gamunex-C

Gammagard may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or a condition called paraproteinemia. You may also be at increased risk if you are over 65 years old or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Serious kidney problems occur more commonly in patients who receive immune globulin intravenous (IGIV) products that contain sucrose. Gammagard does not contain sucrose.

Discuss any questions or concerns with your doctor.

Gammagard is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. Some brands of Gammagard are also used to treat patients with idiopathic thrombocytopenic purpura (ITP) or chronic inflammatory demyelinating polyneuropathy (CIDP). It may also be used for other conditions as determined by your doctor.

Gammagard is an immune globulin. It works by providing antibodies that fight infection.

Do NOT use Gammagard if:

• you are allergic to any ingredient in Gammagard or to another immune globulin


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood


• you have immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of allergic reaction to IgA

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gammagard:

Some medical conditions may interact with Gammagard. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have antibodies to IgA


• if you have recently received any vaccines, will be receiving a live vaccine (eg, measles, mumps, rubella), have been exposed to measles, or are at risk of measles exposure (eg, traveling to an area where measles is common)


• if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, or a blood clotting disorder; a history of a stroke, a heart attack, or blood clots; or if you are at risk of any of these problems


• if you have diabetes, dehydration or low blood volume, a blood infection, a weakened immune system, a condition called paraproteinemia, high protein levels in the blood, high blood triglyceride levels, asthma, kidney problems, or are at risk of kidney problems


• if you have a history of migraine headaches


• if you are very overweight or will be confined to a bed or a chair for a long period of time


• if you have recently used another immune globulin product

Some MEDICINES MAY INTERACT with Gammagard. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs, eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney


• Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur


• Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Gammagard

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gammagard may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gammagard:

Use Gammagard as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• If you will be using Gammagard at home as an injection under the skin (subcutaneous injection), an extra patient leaflet is available with Gammagard. Talk to your pharmacist if you have questions about this information.


• Gammagard is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Gammagard at home, a health care provider will teach you how to use it. Be sure you understand how to use Gammagard. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• If you will be using Gammagard as an injection under the skin, be sure NOT to inject it into a muscle or vein. Be sure you know how and where to inject Gammagard (eg, into the abdomen, thigh, upper arm).


• Do not use Gammagard if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not use Gammagard if it has ever been frozen.


• Do not shake Gammagard.


• Do not mix Gammagard with any other medicine.


• Do NOT use Gammagard as an injection under the skin for ITP or CIDP. If you have ITP or CIDP, it should only be given as an injection in your vein at your doctor's office, hospital, or clinic. Discuss any questions or concerns with your doctor.


• Throw away any medicine that is left in the vial after you use a dose of Gammagard.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Gammagard, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Gammagard.

Important safety information:

• Gammagard may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gammagard with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with immunoglobulin medicines. This syndrome usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.


• Gammagard may cause live vaccines to be less effective. Talk with your doctor before you receive any vaccine while you are using Gammagard.


• Gammagard is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Gammagard. Discuss any questions or concerns with your doctor.


• Gammagard may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Gammagard.


• Lab tests, including antibody and immune globulin levels, blood thickness, urine output, and kidney function, may be performed while you use Gammagard. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Gammagard with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems and blood clots.


• Caution is advised when using Gammagard in CHILDREN; they may be more sensitive to its effects, especially fever or vomiting.


• Gammagard should be used with extreme caution in CHILDREN with CIDP. It should also be used with extreme caution if given as an injection under the skin in CHILDREN. Safety and effectiveness have not been established.


• PREGNANCY and BREAST-FEEDING: It is not known if Gammagard can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gammagard while you are pregnant. It is not known if Gammagard is found in breast milk. If you are or will be breast-feeding while you use Gammagard, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gammagard:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; cough; diarrhea; dizziness; flushing; headache; joint or back pain; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); blue lips, arms, hands, legs, or feet; calf pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; dark urine; fainting; fast or irregular heartbeat; fever; mental or mood changes; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe stomach or back pain; shortness of breath or trouble breathing; slurred speech; swelling; symptoms of aseptic meningitis (eg, severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, severe nausea and vomiting); symptoms of kidney problems (eg, decreased urination, lower back or flank pain, shortness of breath, swelling or bloating, sudden weight gain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gammagard:

Store Gammagard in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Gammagard may be stored at room temperature under 77 degrees F (25 degrees C) for a period of time. Check with your pharmacist about how long your brand of Gammagard may be stored at room temperature. Follow the storage instructions for Gammagard very closely. Do not use it if the expiration date on the container has passed. Store away from heat and light. Do not store in the bathroom. Keep Gammagard out of the reach of children and away from pets.

General information:

• If you have any questions about Gammagard, please talk with your doctor, pharmacist, or other health care provider.


• Gammagard is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gammagard. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gammagard resources

• Gammagard Use in Pregnancy & Breastfeeding
• Gammagard Drug Interactions
• Gammagard Support Group
• 0 Reviews for Gammagard - Add your own review/rating

Compare Gammagard with other medications

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Idiopathic Thrombocytopenic Purpura
• Primary Immunodeficiency Syndrome

Homeopathic Analgesic Ointment

Pronunciation: hoh-mee-o-PATH-ik AN-al-JE-zik
Generic Name: Homeopathic Analgesic
Brand Name: Traumeel

Homeopathic Analgesic Ointment is used for:

Temporary relief of minor muscle and joint aches and pains caused by strains, sprains, and bruising. Homeopathic Analgesic Ointment is a topical homeopathic analgesic. It works by reducing inflammation to temporarily relieve pain.

Do NOT use Homeopathic Analgesic Ointment if:

• you are allergic to any ingredient in Homeopathic Analgesic Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Homeopathic Analgesic Ointment:

Some medical conditions may interact with Homeopathic Analgesic Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a burn or open wound at the affected area or if your skin is damaged, broken, or irritated in any way

Some MEDICINES MAY INTERACT with Homeopathic Analgesic Ointment. Because little, if any, of Homeopathic Analgesic Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Do not start, stop, or change the dose of any medicine without approval from your doctor or health care provider.

How to use Homeopathic Analgesic Ointment:

Use Homeopathic Analgesic Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply generously to the affected area. Gently massage the medicine into the skin until it disappears.


• Wash your hands immediately after using Homeopathic Analgesic Ointment.


• Do not apply to burns, open wounds, or damaged, broken, or irritated skin.


• A bandage or wrap may be applied over Homeopathic Analgesic Ointment.


• If you miss a dose of Homeopathic Analgesic Ointment, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Homeopathic Analgesic Ointment.

Important safety information:

• Homeopathic Analgesic Ointment is for external use only. Do not get it in your eyes, nose, or mouth. If you get it any of these areas, rinse right away with cool tap water.


• Do NOT use more than the recommended dose or use more often than directed without checking with your doctor.


• Do not use Homeopathic Analgesic Ointment over large areas of the body without checking with your doctor.


• If your symptoms do not get better, if they get worse, or if you develop a rash, check with your doctor.


• Homeopathic Analgesic Ointment may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Homeopathic Analgesic Ointment while you are pregnant. It is not known if Homeopathic Analgesic Ointment is found in breast milk after topical use. If you are or will be breast-feeding while you use Homeopathic Analgesic Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Homeopathic Analgesic Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Homeopathic Analgesic Ointment. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Homeopathic Analgesic Ointment:

Store Homeopathic Analgesic Ointment at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Homeopathic Analgesic Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Homeopathic Analgesic Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Homeopathic Analgesic Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Homeopathic Analgesic Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

granisetron transdermal

Generic Name: granisetron (transdermal) (gra NIS e tron)

Brand Names: Sancuso

What is transdermal granisetron?

Granisetron blocks the actions of chemicals in the body that may cause nausea and vomiting.

Granisetron transdermal (skin patch) is used to prevent nausea and vomiting caused by cancer chemotherapy.

Granisetron may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about transdermal granisetron?

You should not use this medication if you are allergic to granisetron.

Before using granisetron, tell your doctor if you have a stomach or intestinal disorder, if you have recently had stomach or intestinal surgery, or if you have ever had an allergic reaction to any type of medicated skin patch. You may need a dose adjustment or special tests to safely use granisetron.

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the granisetron skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch. Do not use granisetron during a time when you are not having chemotherapy, unless your doctor has told you to.

What should I discuss with my healthcare provider before using granisetron?

You should not use this medication if you are allergic to granisetron.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using transdermal granisetron, tell your doctor if you have:

• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  if you have recently had stomach or intestinal surgery; or

  
  


• 
  

  if you have ever had an allergic reaction to any type of medicated skin patch.

  
  

FDA pregnancy category B. Granisetron is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use transdermal granisetron on anyone younger than 18 years old.

How should I use transdermal granisetron?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Apply the granisetron skin patch 24 to 48 hours before your chemotherapy is scheduled to start. To use the patch, open the sealed pouch and remove the protective liner. Apply the transdermal patch to a clean, dry area on the outer side of your upper arm. Avoid placing the patch on skin that is red, irritated or damaged.

Press the patch onto the skin and press it down firmly with your fingers. Make sure the patch is well sealed around the edges.

Leave the patch in place and wear it for at least 24 hours after your chemotherapy ends. You may continue wearing the skin patch for up to 7 days if needed, depending on your chemotherapy schedule. Follow your doctor's instructions.

Do not cut or trim the granisetron skin patch.

If the patch falls off, try sticking it back on. If it does not stay on, replace it with a new one and wear it for the rest of your patch-wearing time. Do not change your schedule, even if you apply a new patch to replace one that has fallen off.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Do not use granisetron during a time when you are not having chemotherapy, unless your doctor has told you to. Keep each granisetron skin patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions if you forget to apply a granisetron skin patch at least 24 hours before your chemotherapy is scheduled to start. Do not use extra patches to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of transdermal granisetron is not expected to produce life-threatening side effects.

What should I avoid while using transdermal granisetron?

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the granisetron skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.

Transdermal granisetron side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Remove the skin patch and call your doctor at once if you have a serious side effect such as:

• 
  

  severe redness, itching, swelling, or other irritation where the patch is worn;

  
  


• 
  

  uneven heart rate;

  
  


• 
  

  fever, pale skin, easy bruising or bleeding; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  diarrhea, constipation;

  
  


• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  loss of appetite;

  
  


• 
  

  headache;

  
  


• 
  

  mild itching or skin irritation where the patch is worn;

  
  


• 
  

  dizziness, drowsiness, anxiety;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  temporary hair loss.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Granisetron Dosing Information

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

IV: 10 mcg/kg over 5 minutes, beginning 30 minutes before initiation of chemotherapy.

Orally: 2 mg, given up to 1 hour before chemotherapy, or 1 mg twice a day (the first dose is given up to 1 hour before chemotherapy, and the second dose is given 12 hours later).

Granisetron transdermal system: Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. Granisetron transdermal system is a 52 cm2 patch containing 34.3 mg of granisetron. The patch releases 3.1 mg of granisetron per 24 hours for up to 7 days.

The transdermal system (patch) should be applied to clean, dry, intact healthy skin on the upper outer arm. Granisetron transdermal system should not be placed on skin that is red, irritated or damaged. Each patch is packed in a pouch and should be applied directly after the pouch has been opened. The patch should not be cut into pieces.

Usual Adult Dose for Nausea/Vomiting--Radiation Induced:

2 mg orally given within 1 hour of radiotherapy.

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

Prevention and Treatment
IV: 1 mg undiluted over 30 seconds, given before induction of anesthesia, or immediately before reversal of anesthesia; or give after surgery.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

Greater than or equal to 2 to 16 years: 10 mcg/kg IV 30 minutes before start of chemotherapy.

Study (n=80)
Randomized double-blind clinical studies have used granisetron injection in the range of 10 to 40 mcg/kg.

What other drugs will affect transdermal granisetron?

There may be other drugs that can interact with transdermal granisetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More granisetron resources

• Granisetron Side Effects (in more detail)
• Granisetron Dosage
• Granisetron Use in Pregnancy & Breastfeeding
• Drug Images
• Granisetron Drug Interactions
• Granisetron Support Group
• 6 Reviews for Granisetron - Add your own review/rating

Compare granisetron with other medications

• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced

Where can I get more information?

• Your pharmacist can provide more information about transdermal granisetron.

See also: granisetron side effects (in more detail)

Boots Cold and Flu Relief Tablets

1. Name Of The Medicinal Product

Cold Relief Tablets or Cold and Flu Relief Tablets

2. Qualitative And Quantitative Composition

Active ingredients	Per Tablet
Paracetamol Ph Eur	400mg
Phenylephrine Hydrochloride BP	5mg
Anhydrous Caffeine Ph Eur	30mg
Ascorbic Acid Ph Eur	50mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of colds, influenza and sinus congestion.

4.2 Posology And Method Of Administration

Adults and Children over 12 years: 2 tablets with water followed by 1 or 2 tablets every four hours, if needed, up to a maximum of 8 tablets in 24 hours.

Not to be taken more frequently than every four hours.

Children under 12 years: Not recommended.

Elderly: The normal adult dose is appropriate in the elderly.

For oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, diabetes, hyperthyroidism, phaeochromocytoma, closed angle glaucoma, prostatic enlargement and liver failure.

Patients being treated with monoamine oxidase inhibitors, or within 14 days of ceasing such treatment. (See section 4.5.)

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not take with any other paracetamol-containing products.

Contains paracetamol.

This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Keep all medicines out of the reach of children.

If symptoms persist for more than 7 days, consult your doctor.

Do not exceed the stated dose.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined label/leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestryramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May also interfere with the hypotensive effects of antihypertensive drugs. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. The product may increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants).

4.6 Pregnancy And Lactation

Pregnancy

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, there is a potential promotion of uterine contractility and vasoconstriction, with the possibility of foetal hypoxia.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Lactation

Paracetamol is excreted in breast milk but not in a clinically significant amount.

In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Side effects are usually mild and may include hypertension, reflex bradycardia, palpitations, headache, difficulty in micturition and urinary retention, anxiety, restlessness, dizziness, nausea, vomiting, irritability, anorexia, tachycardia, tremors, skin rashes and other allergic reactions occasionally.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thromboctopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol.

Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

or

b) Regularly consume ethanol in excess of recommended amounts.

Or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Phenylephrine

Symptoms

Other symptoms of overdosage include an increase in blood pressure and associated reflex bradycardia, hypertension and arrhythmias.

Management

Raised blood pressure should be treated with an alpha receptor antagonist such as intravenous phentolamine. Reduction of blood pressure should by reflex mechanism increase the heart rate but if necessary this can be facilitated by the administration of atropine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgestic with antipyretic properties.

Ascorbic Acid is a source of Vitamin C which may be beneficial during infection when Vitamin C levels are believed to fall.

Caffeine acts on the central nervous system producing a condition of wakefulness and increased mental activity.

Phenylephrine is a sympathomimetic agent with predominantly alpha adrenergic activity. It has decongestant and weak bronchodilator activity.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10-60 minutes after oral adminstration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations.

Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates.

Less than 5% is excreted as unchanged paracetamol. Elimination half life varies from about 1 to 3 hours.

Phenylephrine has low oral bioavailability owing to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver. Peak plasma concentrations are achieved within 1-2 hours. The mean plasma half life is in the range 2-3 hours.

Caffeine is readily absorbed after oral administration and is widely distributed throughout the body. Caffeine passes readily into the central nervous system and into saliva. In adults caffeine is metabolised almost completely via oxidation, demethylation and acetylation with only about 1% excreted unchanged. Elimination half life is about 3-6 hours in adults.

Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. Ascorbic acid is reversibly oxidised to dehydroascorbic acid; some is metabolised to ascorbate-2-sulphate, which is inactive and oxalic acid which are excreted in the urine. Ascorbic acid in excess of the body's needs is also rapidly eliminated unchanged in the urine. Ascorbic acid crosses the placenta and is distributed into breast milk.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize Starch

Riboflavin-5-phoshphate Sodium

Pregelatinised Maize Starch

Magnesium Stearate

Stearic Acid PDR

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None stated.

6.5 Nature And Contents Of Container

A child resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9micron soft temper aluminium foil.

Pack sizes: 6, 7, 8, 10, 12, 14, 16, 18, 20, 21, 24, 25, 30, 32, 36, 48, 96.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/5234R

9. Date Of First Authorisation/Renewal Of The Authorisation

25 July 1989/31 July 1995

10. Date Of Revision Of The Text

March 2009