Heparin Sodium Solution for injection 1000 IU/1ml | 5000IU/0.5ml | 5000IU/1ml |10,000IU/1ml |25,000 IU/1ml(5ml) USP in Pre-filled Syringe Taj Pharma

1. Name of the medicinal product

Heparin Sodium solution for injection 1000 IU/1ml | 5000IU/0.5ml | 5000IU/1ml |10,000IU/1ml |25,000 IU/1ml(5ml) | in Pre-filled Syringe Taj Pharma

2. Qualitative and quantitative composition

a) Heparin Sodium solution for injection 1000 IU/1ml USP in Pre-filled Syringe Taj Pharma
Each 1ml of Prefilled Syringe Contains:
Heparin sodium 1000IU

b) Heparin Sodium solution for injection 5000 IU/0.5ml USP in Pre-filled Syringe Taj Pharma
Each 0.5ml of Prefilled Syringe Contains:
Heparin sodium                       5000IU

c) Heparin Sodium solution for injection 5000 IU/1ml USP in Pre-filled Syringe Taj Pharma
Each 1ml of Prefilled Syringe Contains:
Heparin sodium                       5000IU

d) Heparin Sodium solution for injection 10,000 IU/1ml USP in Pre-filled Syringe Taj Pharma
Each 1ml of Prefilled Syringe Contains:

Heparin sodium                       10,000IU

e) Heparin Sodium solution for injection 25000 IU/1ml (5ml) USP in Pre-filled Syringe Taj Pharma
Each 1ml of Prefilled Syringe Contains:
Heparin sodium 25,000IU
(1,25,000 IU in 5ml)

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection or concentrate for solution for infusion

A colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing.

4. Clinical particulars

4.1 Therapeutic indications

Prophylaxis of deep vein thrombosis and pulmonary embolism

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

Prophylaxis of mural thrombosis following myocardial infarction.

In extracorporeal circulation and haemodialysis.

4.2 Posology and method of administration

Route of administration

By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection.

The intravenous injection volume of heparin injection should not exceed 15ml.

As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.

Recommended dosage

Prophylaxis of deep vein thrombosis and pulmonary embolism:

Adults:

2 hours pre-operatively:

followed by:

5,000 units subcutaneously

5,000 units subcutaneously every 8-12 hours, for 7-10 days or until the patient is fully ambulant.

No laboratory monitoring should be necessary during low dose heparin prophylaxis. If monitoring is considered desirable, anti-Xa assays should be used as the activated partial thromboplastin time (APTT) is not significantly prolonged.

During pregnancy: 5,000 – 10,000 units every 12 hours, subcutaneously, adjusted according to APTT or anti-Xa assay.

Elderly:

Dosage reduction and monitoring of APTT may be advisable.

Children:

No dosage recommendations.

Treatment of deep vein thrombosis and pulmonary embolism:

Adults:

Loading dose: 5,000 units intravenously (10,000 units may be required in severe pulmonary embolism)
Maintenance: 1,000-2,000 units/hour by intravenous infusion,

or 10,000-20,000 units 12 hourly subcutaneously,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously
Maintenance: 15-25 units/kg/hour by intravenous infusion,

or 250 units/kg 12 hourly subcutaneously

or 100 units/kg 4-hourly by intravenous injection

Treatment of unstable angina pectoris and acute peripheral arterial occlusion:

Adults:

Loading dose: 5,000 units intravenously
Maintenance: 1,000-2,000 units/hour by intravenous infusion,

or 5,000-10,000 units 4-hourly by intravenous injection.

Elderly:

Dosage reduction may be advisable.

Children and small adults:

Loading dose: 50 units/kg intravenously
Maintenance: 15-25 units/kg/hour by intravenous infusion,

or 100 units/kg 4-hourly by intravenous injection

Daily laboratory monitoring (ideally at the same time each day, starting 4-6 hours after initiation of treatment) is essential during full-dose heparin treatment, with adjustment of dosage to maintain an APTT value 1.5-2.5 x midpoint of normal range or control value.

Prophylaxis of mural thrombosis following myocardial infarction

Adults:

12,500 units 12 hourly subcutaneously for at least 10 days.

Elderly:

Dosage reduction may be advisable

In extracorporeal circulation and haemodialysis

Adults:

Cardiopulmonary bypass:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the activated clotting time (ACT) in the range 400-500 seconds.

Haemodialysis and haemofiltration:

Initially 1-5,000 units,

Maintenance: 1-2,000 units/hour, adjusted to maintain clotting time >40 minutes.

Heparin resistance

Patients with altered heparin responsiveness or heparin resistance may require disproportionately higher doses of heparin to achieve the desired effect. Also refer to section 4.4, Special warnings and precautions for use.

4.3 Contraindications

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

Must not be given to premature babies or neonates (contains benzyl alcohol).

Heparin should not be administered by intramuscular injection or after major trauma.

Patients who consume large amounts of alcohol, who are sensitive to the drug, who are actively bleeding or who have haemophilia or other bleeding disorders, severe liver disease (including oesophageal varices), purpura, severe hypertension, active tuberculosis or increased capillary permeability.

Patients with present or previous thrombocytopenia. The rare occurrence of skin necrosis in patients receiving heparin contra-indicates the further use of heparin either by subcutaneous or intravenous routes because of the risk of thrombocytopenia. Because of the special hazard of post-operative haemorrhage heparin is contra-indicated during surgery of the brain, spinal cord and eye, in procedures at sites where there is a risk of bleeding, in patients that have had recent surgery, and in patients undergoing lumbar puncture or regional anaesthetic block.

The relative risks and benefits of heparin should be carefully assessed in patients with a bleeding tendency or those patients with an actual or potential bleeding site eg. hiatus hernia, peptic ulcer, neoplasm, bacterial endocarditis, retinopathy, bleeding haemorrhoids, suspected intracranial haemorrhage, cerebral thrombosis or threatened abortion.

In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contraindicated because use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. If such a procedure is planned the heparin should be stopped and the procedure should be delayed until the aPTT has returned to normal. Epidural anaesthesia use during birth in pregnant women treated with heparin is contraindicated (see section 4.6).

Menstruation is not a contra-indication.

Concomitant use of intravenous diclofenac with heparin (including low dose heparin) is contraindicated.

4.4 Special warnings and precautions for use

Platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia (HIT) and heparin induced thrombocytopenia with thrombosis (HITT) can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT or HITT.

In patients with advanced renal or hepatic disease, a reduction in dosage may be necessary. The risk of bleeding is increased with severe renal impairment and in the elderly (particularly elderly women).

Although heparin hypersensitivity is rare, it is advisable to give a trial dose of 1,000 I.U. in patients with a history of allergy. Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins.

In most patients, the recommended low-dose regimen produces no alteration in clotting time. However, patients show an individual response to heparin, and it is therefore essential that the effect of therapy on coagulation time should be monitored in patients undergoing major surgery.

Caution is recommended in patients receiving heparin prophylactically and undergoing spinal or epidural anaesthesia or spinal puncture (risk of spinal or epidural haematoma resulting in prolonged or permanent paralysis). The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anticoagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform a nurse or clinician immediately if they experience any of these.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium, or taking potassium sparing drugs. The risk of hyperkalemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and in all patients treated for more than 7 days.

Heparin resistance

There is considerable variation in individual anticoagulant responses to heparin.

Heparin resistance, defined as an inadequate response to heparin at a standard dose for achieving a therapeutic goal occurs in approximately 5 to 30% of patients.

Factors predisposing to the development of heparin resistance, include:

  • Antithrombin III activity less than 60% of normal (antithrombin III-dependent heparin resistance):

Reduced antithrombin III activity may be hereditary or more commonly, acquired (secondary to preoperative heparin therapy in the main, chronic liver disease, nephrotic syndrome, cardiopulmonary bypass, low grade disseminated intravascular coagulation or drug induced, e.g. by aprotinin, oestrogen or possibly nitroglycerin)

  • Patients with normal or supranormal antithrombin III levels (antithrombin III-independent heparin resistance)
• Thromboembolic disorders

• Increased heparin clearance

  • Elevated levels of heparin binding proteins, factor VIII, von Willebrand factor, fibrinogen, platelet factor 4 or histidine-rich glycoprotein
• Active infection (sepsis or endocarditis)

• Preoperative intra-aortic balloon counter-

-pulsation

• Thrombocytopenia

• Thrombocytosis

• Advanced age

• Plasma albumin concentration ≤ 35g/dl

• Relative hypovolaemia

Heparin resistance is also often encountered in acutely ill patients, in patients with malignancy and during pregnancy or the post-partum period.

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with heparin (see section 4.5).

Heparin Injection contain Benzyl alcohol and Methyl parahydroxybenzoate

Benzyl alcohol

This medicine contains 10mg/ml benzyl alcohol. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called ”gasping syndrome”) in young children.

Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor.

Large amounts of benzyl alcohol can build up in pregnant or breast feeding women which may cause side effects (called ”metabolic acidosis”). This side effect can also be seen in people with liver or kidney disease.

Methyl parahydroxybenzoate

The methyl parahydroxybenzoate in heparin injection may cause allergic reactions (possibly delayed) and exceptionally bronchospasm

4.5 Interaction with other medicinal products and other forms of interaction

Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and other NSAIDs should be used with care. Increased risk of haemorrhage with;

– Ketorolac

– Intravenous diclofenac (refer to section 4.3)

Avoid concomitant use of either ketorolac or intravenous diclofenac, even with low-dose heparin.

Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase, dipyridamole, dextran solutions, abciximab, eptifibatide or any other drug which may interfere with coagulation.

Cephalosporins: Some cephalosporins, e.g. cefaclor, cefixime and ceftriaxone, can affect the coagulation process and may therefore increase the risk of haemorrhage when used concurrently with heparin.

ACE inhibitors, angiotensin-II receptor antagonists or the renin inhibitor aliskiren: Hyperkalaemia may occur with concomitant use.

Nitrates: Reduced activity of heparin has been reported with simultaneous intravenous glyceryl trinitrate infusion.

Probenecid: May increase the anticoagulant effects of heparin.

Tobacco smoke: Nicotine may partially counteract the anticoagulant effect of heparin. Increased heparin dosage may be required in smokers.

Interference with diagnostic tests may be associated with pseudo-hypocalcaemia (in haemodialysis patients), artefactual increases in total thyroxine and triiodothyronine, simulated metabolic acidosis and inhibition of the chromogenic lysate assay for endotoxin. Heparin may interfere with the determination of aminoglycosides by immunoassays.

4.6 Fertility, pregnancy and lactation

Heparin is not contraindicated in pregnancy. Heparin does not cross the placenta or appear in breast milk. The decision to use heparin in pregnancy should be taken after evaluation of the risk/benefit in any particular circumstances.

Osteoporosis has been reported with prolonged heparin treatment during pregnancy.

Particular caution is required at the time of delivery. Due to the risk of uteroplacental haemorrhage, heparin treatment should be stopped at the onset of labour.

If epidural anaesthesia is envisaged, heparin treatment should be suspended whenever possible.

Use in women with threatened abortion is contraindicated (refer to section 4.3).

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Blood disorders:

Haemorrhage (see also Special Warnings and Precautions and Overdosage Information).

Thrombocytopenia has been observed occasionally (see also Special Precautions and Warnings). It has been reported that thrombocytopenia occurs more frequently with bovine-derived heparin than porcine-derived heparin. Two types of heparin-induced thrombocytopenia have been defined. Type I is frequent, mild (usually >50 x 109/L) and transient, occurring within 1-5 days of heparin administration. Type II is less frequent but often associated with severe thrombocytopenia (usually <50 x 109/L). It is immune-mediated and occurs after a week or more (earlier in patients previously exposed to heparin). It is associated with the production of a platelet-aggregating antibody and thromboembolic complications, due to platelet-rich thrombi (the ‘white clot syndrome’), which may precede the onset of thrombocytopenia. Pulmonary embolism has been reported as thromboembolic complications of heparin-induced thrombocytopenia. Heparin should be discontinued immediately in patients who develop thrombocytopenia.

Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Endocrine disorders:

Adrenal insufficiency secondary to adrenal haemorrhage has been associated with heparin (rarely). Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. Rarely, clinically significant hyperkalemia may occur particularly in patients with chronic renal failure and diabetes mellitus (see Warnings and Precautions).

Hepatic disorders:

Increased serum transaminase values may occur but usually resolve on discontinuation of heparin.

Immune system disorders:

Hypersensitivity reactions to heparin are rare. They include urticaria, conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression, fever, chills, angioneurotic oedema and anaphylactic shock.

In some instances the precipitating agent will prove to be the preservative rather than the heparin itself.

Metabolic disorders:

Heparin administration is associated with release of lipoprotein lipase into the plasma; rebound hyperlipidaemia may follow heparin withdrawal.

Muscle and tissue disorders:

There is some evidence that prolonged dosing with heparin (i.e. over many months) may cause osteoporosis and fractures in the vertebra and ribs. Significant bone demineralisation has been reported in women taking more than 10,000 I.U. per day of heparin for three months or longer.

Reproductive and breast disorders:

Priapism has been reported.

Skin and subcutaneous tissue disorders:

Local irritation and skin necrosis may occur but are rare. There is some evidence that prolonged dosing with heparin (i.e. over many months) may cause alopecia.

Erythematous nodules, or infiltrated and sometimes eczema-like plaques, at the site of subcutaneous injections are common, occurring 3-21 days after starting heparin treatment.

Pruritus

Rash (including erythematous and maculopapular)

Vascular disorders:

Haematoma. Very rare cases of epidural and spinal haematoma have been reported in patients receiving heparin for prophylaxis undergoing spinal or epidural anaesthesia or spinal puncture.

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

A potential hazard of heparin therapy is haemorrhage, but this is usually due to overdosage and the risk is minimised by strict laboratory control. Slight haemorrhage can usually be treated by withdrawing the drug. If bleeding is more severe, clotting time and platelet count should be determined. Prolonged clotting time will indicate the presence of an excessive anticoagulant effect requiring neutralisation by intravenous protamine sulfate, at a dosage of 1 mg for every 100 I.U. of heparin to be neutralised. The bolus dose of protamine sulfate should be given slowly over about 10 minutes and not exceed 50 mg. If more than 15 minutes have elapsed since the injection of heparin, lower doses of protamine will be necessary.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Heparin is an anticoagulant and acts by inhibiting thrombin and by potentiating the naturally occurring inhibitors of activated Factor X (Xa).

5.2 Pharmacokinetic properties

As heparin is not absorbed from the gastrointestinal tract and sublingual sites it is administered by injection. After injection heparin extensively binds to plasma proteins.

Heparin is metabolised in the liver and the inactive metabolic products are excreted in the urine.

The half life of heparin is dependent on the dose.

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.

6. Pharmaceutical particulars

6.1 List of excipients

Benzyl alcohol, Methyl parahydroxybenzoate, Water for injections, Sodium hydroxide solution, Hydrochloric acid

6.2 Incompatibilities

Heparin is incompatible with many injectable preparations e.g. some antibiotics, opioid analgesics and antihistamines.

The following drugs are incompatible with heparin;

Alteplase, amikacin sulfate, amiodarone hydrochloride, ampicillin sodium, aprotinin, benzylpenicillin potassium or sodium, cefalotin sodium, chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulfate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulfate, labetolol hydrochloride, levofloxacin, meticillin sodium, methotrimeprazine, netilmicin sulfate, nicardipine hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride, polymyxin B sulfate, promethazine hydrochloride, streptomycin sulfate, tobramycin sulfate, triflupromazine hydrochloride, vancomycin hydrochloride, vinblastine sulfate and vinorelbine tartrate.

Dobutamine hydrochloride and heparin should not be mixed or infused through the same intravenous line, as this causes precipitation.

Heparin and reteplase are incompatible when combined in solution.

If reteplase and heparin are to be given through the same line this, together with any Y-lines, must be thoroughly flushed with a 0.9% saline or a 5% glucose solution prior to and following the reteplase injection.

6.3 Shelf life

3 years

Following the withdrawal of the first dose the remainder should be used within 28 days. After this period, any unused material should be discarded.

6.4 Special precautions for storage

Do not store above 25°C

Store in the original package

Chemical and physical in use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 25°C. Other in use storage times and conditions are the responsibility of the user.

6.5 Nature and contents of container

Prefilled Syringe containing Heparin sodium. Carton containing 10 Prefilled Syringes

6.6 Special precautions for disposal and other handling

Each Prefilled Syringe should be restricted to use in a single patient.

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

Heparin Sodium Solution for injection 1000 IU/1ml | 5000IU/0.5ml | 5000IU/1ml |10,000IU/1ml |25,000 IU/1ml(5ml) USP in Pre-filled Syringe Taj Pharma

Package leaflet: information for the user

Heparin sodium injection in prefilled syringes

Read all of this leaflet carefully before you start taking 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 any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  • 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 this leaflet

  1. What Heparin Sodium injection in Prefilled Syringe is and what it is used for
    2. What you need to know before you use Heparin Sodium injection in Prefilled Syringe
    3. How to use Heparin Sodium injection in Prefilled Syringe
    4. Possible side effects
    5. How to store Heparin Sodium injection in Prefilled Syringe
    6. Contents of the pack and other information

1.What Heparin Sodium injection in Prefilled Syringe is and what it is used for

Heparin Sodium injection in Prefilled Syringe belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting.

Heparin Sodium injection in Prefilled Syringe is given into an intravenous (I.V.) line. This means it is injected into the tube connected to a vein to keep it clear by preventing the blood from clotting in it.

It is not recommended for treatment of harmful blood clots in your body.

2. What you need to know before you have Heparin Sodium injection in Prefilled Syringe

Do not have Heparin Sodium injection in Prefilled Syringe

  • If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
  • If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction called heparin-induced thrombocytopenia).

Do not give this medicine to a premature baby, a newborn baby, or a baby up to a month old.

Take special care with Heparin Sodium injection in Prefilled Syringe

Before you have Heparin Sodium injection in Prefilled Syringe, tell your doctor:

  • If you are pregnant or think you are pregnant. Read the section “Pregnancy and breast-feeding”.
  • If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin.
  • If this medicine is for a child who is between one month and three years old.
  • If you know that you are sensitive to methylparahydroxybenzoate or propylparahydroxybenzoate. Read the information in the section “Important information about some of the ingredients of Heparin Sodium injection in Prefilled Syringe “.

If you have Heparin Sodium injection in Prefilled Syringe regularly for more than five days, your doctor may take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your medicine.

Depending on the result the doctor may tell you to stop having this medicine straight away.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Unless your doctor has told you it is essential, you must not have Heparin Sodium injection in Prefilled Syringe if you are pregnant, or think you are pregnant.

Read the information about benzyl alcohol in the section “Important information about some of the ingredients of Heparin Sodium injection in Prefilled Syringe “. If you are pregnant or might be pregnant, tell your doctor before you are given Heparin Sodium injection in Prefilled Syringe .

If you become pregnant while having this medicine, tell your doctor.

If you are breast-feeding, ask your doctor for advice before having Heparin Sodium injection in Prefilled Syringe .

Driving and using machines

Usually your medicine may have little effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Heparin Sodium injection in Prefilled Syringe

This medicine contains:

  • Benzyl alcohol. This is a preservative. It may harm a newborn baby. It must not be used in premature babies or babies under one month old.
  • Methylparahydroxybenzoate and propylparahydroxybenzoate. These are preservatives. They may give you an allergic reaction. This may happen at any time after you have your medicine. Please read section 4 so you can spot any signs this may be happening to you.
  • This medicine is nearly “sodium free”. Your medicine contains less than 23 milligrams (mg) of sodium in each 100 international Units (IU) dose.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3. How to use Heparin Sodium injection in Prefilled Syringe

Heparin Sodium injection in Prefilled Syringe will be given to you by a doctor or nurse. Heparin Sodium injection in Prefilled Syringe should not be mixed with any other injection.

The recommended dose of Heparin Sodium injection in Prefilled Syringe is

2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required. Your doctor will prescribe the right dose for you.

If you take more Heparin Sodium injection in Prefilled Syringe than you should:

You may start to haemorrhage (bleed severely). Please read section 4 so you can spot any signs this may be happening to you. You may be given another injection of a medicine called protamine sulphate.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. Possible side effects

When used as recommended the low dose of heparin reaching the blood is unlikely to have any effects on the body. However, information is given here on possible side effects.

Important side effects to look out for

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

  • You have difficulty breathing, wheezing
  • Your face or throat swell
  • Your skin develops a severe rash
  • Hives
  • Fever, chills
  • Swelling of eyes and lips
  • You develop blue tinge to the lips

You should tell your doctor straight away if you spot any of the following signs which mean you may be starting to bleed severely:

  • Red or brown urine
  • Black tarry stools
  • Unusual bruising
  • Bleeding from your nose, mouth or any operation wound that will not stop.

Other possible side effects

  • Bruising or bleeding more easily. Your blood may also form harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms.
    Your doctor can explain this more.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet.

5. How to store Heparin Sodium injection in Prefilled Syringe

  • Keep out of the sight and reach of children.
  • Do not use Heparin Sodium injection in Prefilled Syringe after the expiry date on the label. The expiry date is the last day of that month.
  • Store below 25°C.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Contents of the pack and other information

What Heparin Sodium injection in Prefilled Syringe contains

  • The active ingredient is heparin sodium.
    This product contains 100 IU of heparin sodium in each millilitre (ml).
  • The other ingredients are benzyl alcohol, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium chloride, sodium citrate and water for injections.

You can find important information about some of the ingredients near the end of section 2, just before section 3.

What Heparin Sodium injection in Prefilled Syringe looks like and contents of the pack

Heparin Sodium injection in Prefilled Syringe is a clear, colourless or pale yellow liquid. This medicine comes in glass ampoules containing 2 ml. There are 10 ampoules 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