Glycopyrronium Bromide 200micrograms/1ml Solution for Injection in Prefilled Syringe Taj Pharma

Glycopyrronium Bromide 200micrograms/1ml & 400micrograms/2ml Solution for Injection in Prefilled Syringe Taj Pharma.

1. Name of the medicinal product

Glycopyrronium Bromide 200micrograms/1ml & 400micrograms/2ml Solution for Injection in Prefilled Syringe Taj Pharma.

2. Qualitative and quantitative composition

a) Glycopyrronium Bromide 200micrograms/1ml
Each 1ml of injection contains
Glycopyrronium bromide
(glycopyrrolate) 200 micrograms (0.2mg).

b) Glycopyrronium Bromide 400micrograms/2ml
Each 2ml of injection contains Glycopyrronium bromide
(glycopyrrolate) 400 micrograms (0.4mg).

Excipient(s) with known effect:

Sodium Chloride: contains 9 mg per ml

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Solution for injection in Prefilled Syringe.

Clear, colourless, sterile solution.

4. Clinical particulars

4.1 Therapeutic indications

1. To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants.
2. As a pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions and to reduce the acidity of the gastric contents.
3. As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.

4.2 Posology and method of administration

Posology

Premedication:

Adults and Elderly: 200 to 400 micrograms (0.2mg to 0.4mg) intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. Larger doses may result in profound and prolonged antisialagogue effect which may be unpleasant for the patient.

Paediatric population: 4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) intravenously or intramuscularly before the induction of anaesthesia. Larger doses may result in profound and prolonged antisialagogue effect which may be unpleasant for the patient.

Intra-operative use:

Adults and Elderly: A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. This dose may be repeated if necessary.

Paediatric population: A single dose of 200 micrograms (0.2mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) may be used. This dose may be repeated if necessary.

Reversal of residual non-depolarising neuromuscular block:

Adults and Elderly: 200 micrograms (0.2mg) intravenously per 1000 micrograms (1mg) neostigmine or the equivalent dose of pyridostigmine. Alternatively, a dose of 10 to 15 micrograms/kg (0.01 to 0.015mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or equivalent dose of pyridostigmine. Glycopyrrolate Injection may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.

Paediatric population: 10 micrograms/kg (0.01mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or the equivalent dose of pyridostigmine. Glycopyrrolate Injection may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.

Method of administration:

Glycopyrrolate Injection is for intravenous or intramuscular injection.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.

In common with other antimuscarinic drugs caution is advised in patients with prostatic hypertrophy, paralytic ileus, pyloric stenosis and closed angle glaucoma. Quaternary ammonium compounds in large dose have been shown to block the nicotinic muscle end plate receptors. This must be evaluated prior to its administration in patients with myasthenia gravis.

Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval.

4.4 Special warnings and precautions for use

Antimuscarinics should be used with caution (due to increased risk of side effects) in Down’s syndrome, in children and in the elderly.

Extreme caution is advised in patients with gastro-oesophageal reflux disease, diarrhoea, ulcerative colitis, acute myocardial infarction, thyrotoxicosis, coronary artery disease, cardiac dysarythmias, hypertension, congestive heart failure conditions characterised by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery) because of the increase in heart rate produced by their administration, coronary artery disease and cardiac arrhythmias, pyrexia (due to inhibition of sweating), pregnancy and breast feeding.. As glycopyrrolate inhibits sweating, patients with increased temperature (especially children) should be observed closely.

Because of prolongation of renal elimination, repeated or large doses of Glycopyrronium Bromide should be avoided in patients with uraemia.

Anticholinergic drugs can cause ventricular arrhythmias when administered during inhalation anaesthesia especially in association with the halogenated hydrocarbons.

Unlike atropine, glycopyrrolate is a quaternary ammonium compound and does not cross the blood-brain barrier. It is therefore less likely to cause postoperative confusion which is a particular concern in the elderly patients. Compared to atropine, glycopyrrolate has reduced cardiovascular and ocular effects.

4.5 Interaction with other medicinal products and other forms of interaction

Many drugs have antimuscarinic effects; concomitant use of two or more of such drugs can increase side-effects such as dry mouth, urine retention and constipation. Concomitant use can also lead to confusion in the elderly.

Anticholinergic agents may delay absorption of other medication given concomitantly.

Concurrent administration of anticholingergics and corticosteroids may result in increased intraocular pressure.

Concurrent use of antocholinergic agents with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.

Ritodrine: tachycardia

There is increased risk of antimuscarinic side effects in patients taking drugs with antimuscarinic effects such as MAOIs, amantadine, clozapine, tricyclic antidepressants, disopyramaide, antihistamines, pethidine, phenothiazines (increased antimuscarinic side effects of phenothiazines but reduced plasma concentrations) and nefopam.

Domperidone/Metoclopramide: antagonism of effect on gastro-intestinal activity Ketoconazole: reduced absorption of ketoconazole

Levodopa: absorption of levodopa possibly reduced

Memantine: effects possibly enhanced by memantine

Nitrates: possibly reduced effect of sublingual nitrates (failure to dissolve under the tongue owing to dry mouth)

Parasympathomimetics: antagonism of effect

4.6 Fertility, pregnancy and lactation

Pregnancy:

For use as indicated, animal studies are of very limited relevance (see section 5.3). Use in human pregnancy has not been systematically evaluated. This product should only be used in pregnancy if considered essential.

Breast-feeding:

May reach breast milk but in amounts probably too small to be harmful.

Caution is advised when considering administration to a nursing mother.

4.7 Effects on ability to drive and use machines

Glycopyrrolate has moderate influence on the ability to drive and use machines. However, systemic administration of antimuscarinics may cause blurred vision, dizziness and other effects that may impair a patient’s ability to perform skilled tasks such as driving. These activities should not be undertaken until any disturbance of visual accommodation or balance has resolved. Do not operate or drive heavy machinery unless the drug has been shown not to interfere with mental or physical ability.

4.8 Undesirable effects

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data

Tabulated list of adverse reactions:

Other side effects of anti-muscarinics include-

* Followed by tachycardia, palpitation and arrhythmias

**Particularly in elderly

However the use of Glycopyrronium Injection as a preoperative anticholinergic is associated with less effect on the cardiovascular system compared to atropine.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

Symptoms:

Since glycopyrrolate is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature.

Management:

To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulphate may be given in a dose of 1000 micrograms (1.0mg) for each 1000 micrograms (1.0mg) of glycopyrrolate known to have been administered by the parenteral route.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Quaternary ammonium antimuscarinic

Mechanism of action:

Glycopyrrolate is a quaternary ammonium antimuscarinic agent and like other anticholinergic agents, it inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and to a limited degree in the autonomic ganglia. Thus it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g. bronchorrhea, bronchospasm, bradycardia and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.

The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulphate and scopolamine hydrobromide, which are non-polar tertiary amines which penetrate lipid barriers easily.

Glycopyrronium Injection has been used successfully as an adjunct to reversal by neostigmine when atropine has been used as the preoperative anticholinergic. The use of Glycopyrronium Injection as an adjunct to reversal by neostigmine of non-depolarising muscle relaxants is associated with less initial tachycardia and better protection against the cholinergic effects of neostigmine compared to reversal with a mixture of neostigmine and atropine.

5.2 Pharmacokinetic properties

Absorption:

With intravenous injection, the onset of action is generally evident within one minute. Peak effects occur approximately 30 to 45 minutes after intramuscular administration. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine.

Elimination:

Glycopyrrolate is rapidly diminished and/or excreted after intravenous administration. The terminal elimination phase is relatively slow with quantifiable levels remaining up to 8 hours after administration.

5.3 Preclinical safety data

Safety Pharmacology:

Acute toxicity of glycopyrrolate was studied in mice and rats. Following intraperitoneal administration, the LD50 was estimated to be 107 mg/kg in mice and 196 mg/kg in rats. Following oral dosing, the LD50 was estimated to be 1150 mg/kg in rats. Chronic oral administration doses of 4, 16, and 64 mg/kg for up to 27 weeks in dogs produced mydriasis, cycloplegia, xerostomia, emesis, occasional lacrimation, injection of sclera and rhinorrhea. There were no changes in organ weight and histopathology showed no drug-related changes. Safety in human pregnancy and lactation has not been established.

Teratogenicty:

Although reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate.

Toxicity to reproduction and development:

Diminished rates of conception and of survival at weaning were observed in rats, in a dose-related manner. Studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Chloride

Dilute Hydrochloric Acid

Water for Injections

6.2 Incompatibilities

Glycopyrronium Injection has been shown to be physically compatible with the following agents commonly used in anaesthetic practice: Butorphanol, Lorazepam, Droperidol and Fentanyl Citrate, Levorphanol Tartrate, Pethidine Hydrochloride, Morphine Sulphate, Neostigmine, Promethazine and Pyridostigmine.

Glycopyrronium Injection has been shown to be physically incompatible with the following agents commonly used in anaesthetic practice: Diazepam, Dimenhydrinate, Methohexitone Sodium, Pentazocine, Pentobarbitone Sodium, Thiopentone Sodium.

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Glycopyrronium Injection 1ml and 2ml is presented as Solution for injection in Prefilled Syringe, packed in cardboard cartons to contain 10 x 1ml; 10 x 2ml and 3 x 2ml Prefilled Syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Keep this medicine out of the sight and reach of children.

If only part of Solution for injection in Prefilled Syringe is not used, discard the remaining solution.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Glycopyrronium Bromide 200micrograms/1ml & 400micrograms/2ml Solution for Injection in Prefilled Syringe Taj Pharma

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. (see section 4).

This product will be referred to as Glycopyrronium Injection in Prefilled Syringe from here on.

What is in this leaflet

1. What Glycopyrronium Injection in Prefilled Syringe is and what it is used for
   2. What you need to know before you use Glycopyrronium Injection in Prefilled Syringe
   3. How to use Glycopyrronium Injection in Prefilled Syringe
   4. Possible side effects
   5. How to store Glycopyrronium Injection in Prefilled Syringe
   6. Contents of the pack and other information
2. WHAT GLYCOPYRRONIUM INJECTION IN PREFILLED SYRINGE IS AND WHAT IT IS USED FOR

Glycopyrronium bromide belongs to a group of medicines called anticholinergic drugs.

Glycopyrrolate Injection in Prefilled Syringe may be used

• to protect against some of the unwanted effects of drugs such as neostigmine or pyridostigmine, which are used to reverse the effects of certain types of muscle- relaxing drugs (called non-depolarising muscle relaxants)
• before an operation, to reduce saliva and other secretions and to make the stomach contents less acid
• before or during an operation, to reduce or prevent slowness of the heart beat during surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYCOPYRRONIUM INJECTION IN PREFILLED SYRINGE

Do not use Glycopyrronium Injection in Prefilled Syringe:

• if you are allergic to Glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6).
• if you have glaucoma.
• if you suffer from myasthenia gravis (a disorder that causes extreme muscle weakness and fatigue).
• if you have an enlarged prostate.
• if you have stomach or bowel problems.
• if you are taking Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval (irregular heart rhythm).

Warnings and precautions

Talk to your doctor or nurse before using Glycopyrronium Injection in Prefilled Syringe:

• if you have Down’s Syndrome.
• if you are over 60 years of age.
• if you are a child.
• if you have history of heart disease, heart attack, coronary heart disease or irregular heart beats or high blood pressure.
• if you have a condition characterised by rapid heartbeat (including over-active thyroid, heart failure or heart surgery).
• if you have gastric reflux (a condition in which the liquid stomach contents backs up (regurgitates) into the gullet.
• if you have diarrhea.
• if you have ulcerative colitis (an inflammation of the large intestine).
• if you have kidney disease you need to avoid repeated or large doses.
• if you have an overactive thyroid gland.
• if you have a high temperature (fever) (as the drug will inhibit sweating).
• if you have been administered inhalation anesthesia (to put you asleep before an operation) as it may cause a change in your normal heart rhythm.
• if you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing vomiting abdominal pain and swelling (paralytic ileus)
• if you are pregnant or are breast feeding (see section Pregnancy and breast-feeding and fertility below).

Other medicines and Glycopyrronium Injection in Prefilled Syringe

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. A number of drugs can interact with Glycopyrronium Injection in Prefilled Syringe which can significantly alter their effects. These drugs include:

• Drugs for depression known as Tricyclic Antidepressants (for example amitriptyline or imipramine) and Monoamine Oxidase Inhibitors (MAOIs) (for example phenelzine, tranylcypramine).
• Clozapine which is used to treat severe mental disorders.
• Strong pain relievers such as Nefopam
• Amantadine, levodopa which is used to treat Parkinson’s disease or viral infection.
• Phenothiazines used to treat severe mental problems or nausea, vomiting or vertigo (for example chlorpromazine, fluphenazine, prochlorperazine, trifluoperazine).
• Antihistamines used to treat allergies (for example promethazine).
• Pethidine (used to treat moderate to severe pain).
• Domperidone or metoclopramide (used to treat nausea and vomiting).
• Ketoconazole (used to treat fungal infections).
• Memantine (used to treat Alzheimer’s disease).
• Parasympathomimetics (these are drugs that affect chemicals in the body which are involved in transmission of nerve impulses to a muscle) (for example carbachol, neostigmine, physostigmine).
• Ritodrine (used to prevent uncomplicated premature labour).
• Corticosteroids used to treat various conditions including asthma and inflammatory disease (for example prednisolone).
• Slow-dissolving digoxin tablets, disopyramide (used to treat heart problems).

Glyceryl trinitrate tablets (used to treat angina) may not dissolve under the tongue as well as usual owing to the dry mouth which glycopyrronium bromide causes.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nursefor advice before using this medicine.

Driving and using machines

You should not drive or use machines after being given this medicine until the doctor advises you that you are safe to do so.

Glycopyrronium Injection in Prefilled Syringe contains sodium

Glycopyrronium Injection in Prefilled Syringe contains less than 1mmol (23mg) of sodium per 2 ml (essentially ‘sodium-free’).

3. HOW TO USE GLYCOPYRRONIUM INJECTION IN PREFILLED SYRINGE

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is:

Dosage when used before an operation

Adults and elderly

200 to 400 micrograms (0.2 to 0.4mg) may be injected into a vein or into a muscle before the anaesthetic is given. Alternatively, a dose of 4 to 5 micrograms per kilogram of body weight (0.004 to 0.005mg per kg) may be used, up to a maximum dose of 400 micrograms (0.4mg).

Use in children and adolescents:

4 to 8 micrograms per kilogram of body weight (0.004 to 0.008mg per kg) up to a maximum of 200 micrograms (0.2mg) may be injected into a vein or into a muscle before the anaesthetic is given.

Dosage when used during an operation

Adults and elderly

A single dose of 200 to 400 micrograms (0.2 to 0.4mg) should be given by Injection in Prefilled Syringe into a vein. Alternatively, a single dose of 4 to 5 micrograms per kilogram of body weight (0.004 to 0.005mg per kg) may be used, up to a maximum of 400 micrograms (0.4mg). This dose may be repeated if necessary.

Use in children and adolescents

A single dose of 200 micrograms (0.2mg) should be given by Injection in Prefilled Syringe into a vein. Alternatively, a single dose of 4 to 8 micrograms per kilogram of body weight (0.004 to 0.008mg per kg) may be used, up to a maximum of 200 micrograms (0.2mg). This dose may be repeated if necessary.

Dosage when reversing the effects of non-depolarising muscle relaxants

Adults and elderly:

200 micrograms (0.2mg) per 1,000 micrograms (lmg) of neostigmine or the equivalent dose of pyridostigmine, by Injection in Prefilled Syringe into a vein.

Alternatively, a dose of 10 to 15 micrograms per kilogram of body weight (0.01 to 0.015mg per kg) may be injected into a vein with 50 micrograms per kg (0.05mg per kg) of neostigmine or equivalent dose of pyridostigmine. Glycopyrrolate Injection in Prefilled Syringe may be administered at the same time and from the same syringe with the neostigmine or pyridostigmine.

Use in children and adolescents

10 micrograms per kg of body weight (0.0lmg per kg) may be injected into a vein with 50 micrograms per kg (0.05mg per kg) of neostigmine or the equivalent dose of pyridostigmine. Glycopyrrolate Injection in Prefilled Syringe  may be administered at the same time and from the same syringe with the neostigmine or pyridostigmine.

Method of administration:

Glycopyrronium Injection in Prefilled Syringe is administered by Injection in Prefilled Syringe  into a vein or muscle.

Your doctor will decide the correct dose for you depending on your circumstances. Your dose may be calculated according to your weight.

The Injection in Prefilled Syringe may need to be repeated depending on your response.

If you use more Glycopyrronium Injection in Prefilled Syringe than you should

This is unlikely because the dose will be administered by a health professional.

If you have any further questions on the use of this medicine ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side-effects, although not everybody gets them.

Consult a doctor straight away if you notice any of the following symptoms – you may need urgent medical treatment:

Swelling mainly of the face, lips or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from the available data).

All medicines can cause allergic reactions although serious allergic reactions are very rare.

Other side effects have also been reported under the following frequency

Very rare (may affect up to 1 in 10,000 people)

glaucoma (increased pressure in the eyes).

Not known (frequency cannot be estimated from the available data)

• a dry mouth
• blurred vision or reduced ability to sweat
• palpitations (an awareness of strong, thumping heart beats)
• fear of bright light
• confusion
• vomiting
• feeling sick (nausea)
• difficulty in passing water (urinating)
• a faster heart rate than normal
• difficulty in passing stools (constipation)
• reduced lung secretion
• redness and dryness of the skin
• feeling unwell
• feeling giddy

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLYCOPYRRONIUM INJECTION IN PREFILLED SYRINGE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

If only part used, discard the remaining solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Glycopyrronium Injection in Prefilled Syringe contains

The active substance is glycopyrronium bromide.

The other ingredients are sodium chloride, dilute hydrochloric acid and water for Injection in Prefilled Syringe s.

What Glycopyrronium Injection in Prefilled Syringe looks like and contents of the pack

Glycopyrronium Injection in Prefilled Syringe is a clear, colourless, sterile solution for Injection in Prefilled Syringe.

Each 1ml glass Injection in Prefilled Syringe contains 200 micrograms (0.2mg) of glycopyrronium bromide.

Each 2ml glass Injection in Prefilled Syringe contains 400 micrograms (0.6mg) of glycopyrronium bromide.

Each carton contains ten 1ml Injection in Prefilled Syringe s, or three or ten 2ml Injection in Prefilled Syringe s of Glycopyrronium Injection in Prefilled Syringe.

Not all pack sizes may be marketed.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com