Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of Injection contains:
Methyl Ergometrine Maleate equivalent to
Ergometrine…………………………0.2mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Sterile Injection.

4. Clinical particulars

4.1 Therapeutic indications

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection is used in the active management of the third stage of labour and in the treatment of post-partum haemorrhage. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection may be given by intramuscular or intravenous injection.

4.2 Posology and method of administration

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection should be used under medical supervision only

Adults:

Active Management of the Third Stage of Labour

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection is administered (often in combination with synthetic oxytocin 5 units) intramuscularly as a dose of 500 micrograms following the delivery of the anterior shoulder of the infant or at the latest immediately after delivery of the baby.

Prevention and Treatment of Postpartum Haemorrhage

Doses of 200 micrograms to 500 micrograms of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma are given intramuscularly, following expulsion of the placenta or when bleeding occurs. In emergencies, Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection may be given intravenously at a dose of 250 micrograms to 500 micrograms.

Use in special populations

Patients with renal impairment or hepatic impairment

No studies have been performed in patients with renal or hepatic impairment. However, considering the metabolic pathway of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma, use is contraindicated in severe hepatic and renal impairment and caution is required in mild or moderate hepatic and renal impairment (see sections 4.3 Contraindications, 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties).

Paediatric population

No data are available.

Elderly

Not applicable.

Method of administration

Intramuscular injection is the recommended route.

Intravenous administration of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection at a dose of 250 micrograms to 500 micrograms (by slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Pregnancy and labour (induction of labour, first stage labour and second stage labour prior to the delivery of the anterior shoulder) due to the risk of uterine hypertonus and associated foetal complications (see section 4.6 Fertility, pregnancy and lactation).
• Primary or secondary uterine inertia.
• Severe hypertension, pre-eclampsia, eclampsia.
• Severe cardiac disorders.
• Severe hepatic or renal impairment.
• Occlusive vascular disease e.g. Raynaud’s disease / phenomenon
• Sepsis

4.4 Special warnings and precautions for use

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma may give rise to widespread vasoconstriction and rarely acute pulmonary oedema.

Active management of the third stage of labour requires expert obstetric supervision.

In breech presentations and other abnormal presentations, Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection, should not be given until after delivery of the child, and in multiple births not until the last child has been delivered (see section 4.6 Fertility, pregnancy and lactation).

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma derivatives are excreted in breast milk but in unknown amounts. It can also suppress lactation, so repeated use should be avoided (see section 4.6 Fertility, pregnancy and lactation).

Caution is required in patients with mild or moderate hypertension, or with mild or moderate degrees of cardiac, liver or kidney disease. Severe forms are contraindications (see section 4.3 Contraindications).

Patients with coronary artery disease may be more susceptible to angina or myocardial ischaemia and infarction caused by Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma-induced vasospasm.

If in the treatment of postpartum haemorrhage, bleeding is not arrested by the injection, the possibility of a retained placental fragment, or soft tissue injury (cervical or vaginal laceration), or of a clotting defect should be considered and appropriate measures taken before a further injection is given.

Ergot alkaloids are substrates of CYP3A4. The concomitant use of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection with strong CYP3A4 inhibitors such as macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine), or azole antifungals (e.g. ketoconazole, itraconazole, voriconazole) should be avoided, since this can result in an elevated exposure to methylMethyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma and ergot toxicity (vasospasm and ischaemia of the extremities and other tissues).Caution should be exercised when Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection is used concurrently with other vasoconstrictors or other ergot alkaloids. Concurrent use of vasoconstrictors and Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection after delivery during anaesthesia may lead to severe postpartum hypertension. MethylMethyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma may enhance the vasoconstrictor/vasopressor effects of other drugs such as triptans (5HT_1B/1D receptor agonists), sympathomimetics (including those in local anaesthetics), beta-blockers or other ergot alkaloids (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Caution is required when using Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection alone or in combination with prostaglandins and their analogues in the treatment of postpartum atonic uterine haemorrhage (see section 4.5 Interaction with other medicinal products and other forms of interaction).

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection with the following medicinal products is not recommended:

Vasoconstrictors/Sympathomimetics

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection may enhance the vasopressor effects of vasoconstrictors and sympathomimetics, even those contained in local anaesthetics.

Prostaglandins and their analogues

Prostaglandins and their analogues facilitate contraction of the myometrium hence Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection can potentiate the uterine action of prostaglandins and analogues and vice versa.

CYP3A4 inhibitors

Strong CYP3A4 inhibitors such as protease inhibitors, macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine), azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), quinolones might raise the levels of ergot derivatives, which may lead to ergotism. Combined use with Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma should be avoided. Other weaker CYP3A4 inhibitors (e.g cimetidine, delavirdine, grapefruit juice, quinupristin, dalfopristin) might interact similarly, although possibly to a lesser extent.

Ergot alkaloids/ergot derivatives

Concurrent use of other ergot alkaloids (e.g methysergide) and other ergot derivatives can increase the risk of severe and persistent spasm of major arteries in some patients.

Triptans

Additive vasoconstriction may occur when Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is concomitantly given with triptans (e.g. sumatriptan, zolmitriptan, rizatriptan, almotriptan, eletriptan).

Beta-blockers

Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.

Glyceryl trinitrate and other antianginal drugs

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs.

Consideration should be given to the concomitant use of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection with the following medicinal products:

Inhalation anaesthetics

Inhalation anaesthetics (e.g. halothane, cyclopropane, sevoflurane, desflurane, isoflurane) have a relaxing effect on uterus and produce a notable inhibition of uterine tone and thereby, may diminish the uterotonic effect of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma.

CYP3A4 inducers

CYP3A4 inducers (e.g nevirapine, rifampicin) may reduce the clinical effect of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma.

4.6 Fertility, pregnancy and lactation

Pregnancy

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma has potent uterotonic activity. Therefore, Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection is contraindicated during pregnancy, during induction of labour, and during first and second stage labour prior to the delivery of the anterior shoulder (see section 4.3 Contraindications).

In breech presentation and other abnormal presentations, Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection should not be given before delivery of the child is completed, and in multiple births not before the last child has been delivered (see section 4.4 Special warnings and precautions for use).

Breast-feeding

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma derivatives are excreted in breast milk but in unknown amounts. There is no specific data available for elimination of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma partitioned in breast-milk. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma can inhibit prolactin secretion and in turn can suppress lactation, so its repeated use should be avoided.

4.7 Effects on ability to drive and use machines

Receiving Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection can start labour. Women with contractions should not drive or use machines. Patients should be warned of the possibility of dizziness and hypotension (see section 4.8 Undesirable effects).

4.8 Undesirable effects

Immune system disorders

Anaphylactic/Anaphylactoid reactions with associated symptoms of dyspnoea, hypotension, collapse or shock

Nervous system disorders

Headache, dizziness

Ear & labyrinth disorders

Tinnitus

Cardiac disorders

Cardiac arrhythmias, palpitations, bradycardia, chest pain, coronary arteriospasm with very rare reports of myocardial infarction (see section 4.4 Special warnings and precautions for use)

Vascular disorders

Hypertension, vasoconstriction

Respiratory disorders

Dyspnoea, pulmonary oedema

Gastrointestinal disorders

Nausea, vomiting, abdominal pain

Skin & subcutaneous tissue disorders

Skin rashes

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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms of acute poisoning include nausea, vomiting, diarrhoea, extreme thirst, coldness, tingling and itching of the skin, tachycardia, vasospastic reactions, respiratory depression, confusion, convulsions and coma. Angina, hypertension or hypotension may also occur.

In cases of oral ingestion, although the benefit of gastric decontamination is uncertain, activated charcoal may be given to patients who present within 1 hour of ingesting a toxic dose (more than 125 micrograms/kg in adults) or any amount in a child or in adults with peripheral vascular disease, ischaemic heart disease, severe infection, or hepatic or renal impairment. Alternatively, gastric lavage may be considered in adults within 1 hour of ingesting a potentially life-threatening overdose.

In both acute and chronic poisoning by all routes, attempts must be made to maintain an adequate circulation to the affected parts of the body in order to prevent the onset of gangrene. In severe arterial vasospasm, vasodilators such as sodium nitroprusside by intravenous infusion have been given; heparin and dextran 40 have also been advocated to minimise the risk of thrombosis. Analgesics may be required for severe ischaemic pain.

Accidental administration of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma-containing medicinal products to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms such as respiratory depression, convulsions, cyanosis, oliguria, hypertonia and heart arrhythmia have been reported. Treatment has been symptomatic in most cases; respiratory and cardiovascular support have been required.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ergot alkaloids

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma produces sustained tonic uterine contraction via agonist or partial agonist effects at myometrial 5-HT2 receptors and alpha-adrenergic receptors. Both upper and lower uterine segments are stimulated to contract in a tetanic manner. Unlike oxytocin Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma has an effect on the non-pregnant uterus. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma inhibits prolactin secretion and in turn can reduce lactation. Uterine stimulation occurs within 7 minutes of intramuscular injection and almost immediately following intravenous injection. The sustained uterine contractions produced by Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma are effective in controlling uterine haemorrhage.

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma has weak antagonist actions at dopaminergic receptors in certain blood vessels. Compared with other ergot alkaloids, effects of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma on cardiovascular and central nervous system are less pronounced. It has a partial agonist action in blood vessels (less than ergotamine) and has little or no antagonist action at α adrenergic receptors.

5.2 Pharmacokinetic properties

Absorption

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is rapidly absorbed after administration by mouth or by intramuscular injection. Uterotonic effect can be observed within 10 minutes following oral administration and within 7 minutes of intramuscular injection.

Distribution

The average steady state volume of distribution of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma in healthy man is reported to be 1.04 L/kg. The plasma protein binding of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is unknown. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is known to cross the placenta and its clearance from the foetus is slow. Concentrations of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma achieved in foetus are not known. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is also expected to be excreted in the breast milk and to reduce milk secretion.

Metabolism/Biotransformation

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is mainly metabolised in the liver by hydroxylation and glucuronic acid conjugation and possibly N-demethylation. Like other ergot alkaloids it is a substrate for CYP3A4 enzymes.

Elimination

The plasma half life of Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma is reported to be in the range of 30-120 min. When administered orally, the drug is mainly eliminated with the bile into the faeces as 12-hydroxyMethyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma glucuronide. It is eliminated unchanged in the urine and can be detected up to 8 h after injection.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maleic Acid BP QS

Water for Injections EP to 100%

6.2 Incompatibilities

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma Injection is incompatible with various drugs according to resulting Ph, temperature and concentration of drugs. Mixing with other drugs in the same syringe should therefore be avoided. Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma may, however, be diluted to a volume of 5mls with 0.9% Sodium Chloride Injection prior to IV administration.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Methyl Ergometrine Maleate Injection USP 0.2mg/1ml Taj Pharma should be stored between 2°C and 8°C and protected from light.

6.5 Nature and contents of container

1ml clear type I glass ampoules. Packed in cartons to contain 10 ampoules.

6.6 Special precautions for disposal and other handling

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

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

METHYL ERGOMETRINE MALEATE INJECTION USP
0.2MG/1ML
TAJ PHARMA

ergometrine maleate

Read all of this leaflet carefully before you start receiving 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THE LEAFLET

1. What Ergometrine Injection is and what it is used for
2. What you need to know before you are given Ergometrine Injection
3. How Ergometrine Injection is given
4. Possible side effects
5. How to store Ergometrine Injection
6. Contents of the pack and other information

   1. WHAT ERGOMETRINE INJECTION IS AND WHAT IT IS USED FOR

Ergometrine Injection is a medicine that causes contraction of the muscles of the womb and is used:

• in the active management of the third stage of labor to control bleeding after the birth.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ERGOMETRINE INJECTION

You must NOT be given Ergometrine Injection:

• if you are allergic to ergometrine maleate or any of the other ingredients in this injection (listed in section 6)
• if you have severe or very high blood pressure
• if you have heart disease
• if you suffer from severe liver, kidney, heart or circulation problems
• if you are suffering from eclampsia or pre- eclampsia (which causes high blood pressure, protein in the urine, swelling)
• if your womb is not contracting properly
• if you are pregnant or if you are in labour but the baby’s shoulder still cannot be seen
• if you have a serious infection
• if you have Raynaud’s disease or phenomenon (poor circulation which makes the toes and fingers numb and pale)

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before being given the injection:

• if you have raised blood pressure
• if you have liver or kidney problems
• if you have an infection
• if you have any heart problems
• if you are going to have an operation under general anaesthetic
• if your baby is in a breech position (or any other abnormal position) before birth, Ergometrine Injection will not be given until after your baby has been born.
• if you have a multiple pregnancy (e.g. twins, triplets), Ergometrine Injection will not be given until after the last baby has been born.

If any of the above applies to you, or you are not sure, speak to your doctor or nurse before you receive Ergometrine Injection.

Other medicines and Ergometrine Injection:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Ergometrine Injection:

• anaesthetics which you breathe in to put you to sleep during surgery as they could decrease the effect of ergometrine (e.g. halothane, cyclopropane, sevoflurane, desflurane, isoflurane)
• prostaglandins (used to start labour or to treat stomach ulcers) and similar drugs as the effects of both drugs may be increased
• vasoconstrictors (used to narrow the blood vessels and decrease the flow of blood) and sympathomimetics (used in the   treatment of asthma, nasal congestion and low blood pressure in emergency situations) as the effect of the drug may be increased. This includes where these types of medicines are part of a local anaesthetic or cough or cold remedy
• antiviral drugs used to treat HIV, AIDS or hepatitis (e.g. ritonavir, indinavir, nelfinavir, delavirdine, nevirapine)
• antifungal drugs (e.g. ketoconazole, itraconazole, voriconazole)
• quinolones (antibacterial drugs, e.g.
• ciprofloxacin, levofloxacin, ofloxacin)
• certain types of antibiotics (including troleandomycin, erythromycin, clarithromycin, quinupristin, dalfopristin, rifampicin)
• cimetidine used to treat ulcers and heartburn
• ergot alkaloids or ergot derivatives, used to treat headaches and migraines (e.g. methysergide)
• triptans used to treat headaches and migraines (e.g. sumatriptan, zolmitriptan, rizatriptan, almotriptan, eletriptan)
• beta-blockers used to treat certain heart or eye problems, anxiety or prevent migraines
• anti-anginal medicines including glyceryl trinitrate
• any medicines that can cause an irregular heartbeat

Ergometrine Injection with food and drink:

Tell your doctor or midwife if you have recently had any grapefruit juice. It is recommended that you do not drink grapefruit juice around the same time as your treatment with Ergometrine Injection as these may interact.

Pregnancy and breast feeding: Pregnancy:

You must not receive Ergometrine Injection if you are pregnant or if you are in labour but the baby’s shoulder still cannot be seen.

If your baby is in a breech position (or any other abnormal position) before birth, Ergometrine Injection will not be given until after your baby has been born.

If you have a multiple pregnancy (e.g. twins, triplets), Ergometrine Injection will not be given until after the last baby has been born.

Breast-feeding:

Ergometrine may reduce milk production, therefore repeated use should be avoided.

Driving and using machines:

Ergometrine can start labour. Women with contractions should not drive or use machines.

Ergometrine can cause the side effects of dizziness and low blood pressure (symptoms of which are light-headedness and blurred vision) in some people. If affected you should not drive or use machinery.

3. HOW ERGOMETRINE INJECTION IS GIVEN

Your nurse or doctor will give you the injection. Your doctor will decide the correct dosage for you

and how and when the injection will be given.

If you are given more Ergometrine Injection than you should:

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much.

If you think you have been given too much or if you experience any of the following affects you must tell the person giving you the injection immediately.

• feeling or being sick
• a fall or rise in blood pressure (dizziness, light headedness, feeling faint)
• vasospastic reactions (pain or discomfort of your fingers caused by a lack of blood reaching the fingertips)
• difficulty in breathing
• fits
• coma

Ergometrine Injection is not recommended for elderly patients and children.

4. POSSIBLE SIDE EFFECTS

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

Tell your doctor or contact your nearest hospital straight away if you notice or suspect any of the following symptoms. You may need urgent medical treatment.

• signs of a severe allergic reaction, such as:
• swelling of the face, tongue or throat
• difficulty breathing
• low blood pressure (which can cause fainting or dizziness and lightheadedness)
• severe irritation, reddening or blistering of your skin
• collapse
• shock
• heart attack (which can cause chest pain or pain down left arm)

Other possible side effects of Ergometrine Injection include:

• nausea
• vomiting
• abdominal pains
• headache
• dizziness
• ringing in the ears
• skin rashes
• irregular or slowed heart beat
• palpitations (an awareness of your heart beating)
• chest pains
• high blood pressure

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.

5.HOW TO STORE ERGOMETRINE INJECTION

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

Your injection will be stored in a refrigerator

between 2 °C to 8 °C and protected from light. 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ergometrine Injection contains:

Each ml of Injection contains:
Methyl Ergometrine Maleate equivalent to
Ergometrine…………………………0.2mg

The other ingredients are maleic acid and sterile water for injections.

What Ergometrine Injection looks like and contents of the pack:

Ergometrine Injection is supplied in a 1 ml clear glass ampoule, 10 ampoules are supplied in a carton.

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