1. Name of the medicinal product

Heparin Sodium Injection USP 1000 Units/1ml Taj Pharma
Heparin Sodium Injection USP 5000 Units/5ml Taj Pharma
Heparin Sodium Injection USP 25000 Units/5ml Taj Pharma

  1. Qualitative and quantitative composition

a) Heparin Sodium Injection USP 1000 Units/1ml
Each ml contains:
Heparin Sodium                         1000 Units
Sodium Chloride                        8.6mg
Benzyl alcohol                         0.001ml

b) Heparin Sodium Injection USP 5000 Units/5ml
Each ml contains:
Heparin Sodium                         1000 Units
Sodium Chloride                         8.6mg
Benzyl alcohol                             0.001ml

c) Heparin Sodium Injection USP 25000 Units/5ml
Each ml contains:
Heparin Sodium                         5000 Units
Sodium Chloride                         8.6mg
Benzyl alcohol                             0.001ml

  1. Pharmaceutical form

Solution for Injection.

  1. Clinical particulars

4.1 Therapeutic indications

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

4.2 Posology and method of administration

Method of administration

For routine use, 2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the other excipients listed in section 6.1Current or history of heparin induced thrombocytopenia.

Heparin Sodium 100 IU/ml i.v. flush solution contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

4.4 Special warnings and precautions for use

Heparin Sodium 100 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Rigorous aseptic technique should be observed at all times in its use.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days (or earlier in patients with previous exposure to heparin) treatment should be stopped immediately in those who develop thrombocytopenia or paradoxical thrombosis, heparin should immediately be eliminated from all flushes and ports.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis 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 and HITT.

Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect.

Heparin Sodium 100 IU/ml i.v. flush solution contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic and allergic reactions (anaphylactoid) in this age group (see also section 4.3 for premature babies or neonates).

Heparin Sodium 100 IU/ml i.v. flush solution contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

4.5 Interaction with other medicinal products and other forms of interaction

For incompatibilities with other medicinal products see Section 6.2.

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter the results of the tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken.

4.6 Fertility, preganancy and lactation

The safety of Heparin Sodium 100 I.U./ml Flushing Solution in pregnancy is not established but the dose of heparin used would not be expected to constitute a hazard. However, as benzyl alcohol may cross the placenta, the use of Heparin Sodium 100 IU/ml i.v. flush solution containing benzyl alcohol should be avoided during pregnancy.

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects on ability to drive and use machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

When used as recommended, the low dose of heparin reaching the blood is extremely unlikely to have any systemic effects. However, there have been rare reports of immune-mediated thrombocytopenia and , thrombosis in patients receiving heparin flushes (see also Section 4.4, Special Warnings and Precautions for Use)..

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

Local irritation may occur if inadvertently injected subcutaneously.

Reporting of suspected adverse reactions

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

4.9 Overdose

An overdose is unlikely to occur. Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine sulphate itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine sulphate may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary Product Characteristics.

  1. Pharmaceutical particulars

6.1 List of excipients

Benzyl alcohol,

Methylparahydroxybenzoate,

Propylparahydroxybenzoate,

Sodium citrate,

Sodium chloride,

Water for Injections.

6.2 Incompatibilities

This product is compatible with normal saline. Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

10 x 2 ml ampoules.

6.6 Special precautions for disposal and other handling

None

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 Injection USP 1000 Units/1ml Taj Pharma
Heparin Sodium Injection USP 5000 units/5ml Taj Pharma
Heparin Sodium Injection USP 25000 units/5ml Taj Pharma

Package leaflet: information for the user

heparin sodium

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

  1. What Heparin Sodium Injection is and what it is used for

Heparin Sodium Injection belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting.

Heparin Sodium Injection 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.

  1. What you need to know before you have Heparin Sodium Injection

Do not have Heparin Sodium Injection

  • 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

Before you have Heparin Sodium Injection , 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 “.

If you have Heparin Sodium Injection 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 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 “. If you are pregnant or might be pregnant, tell your doctor before you are given Heparin Sodium Injection .

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 .

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

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.

  1. How to use Heparin Sodium Injection

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

The recommended dose of Heparin Sodium Injection 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 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.

  1. 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.

  1. How to store Heparin Sodium Injection
  • Keep out of the sight and reach of children.
  • Do not use Heparin Sodium Injection 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.

  1. Contents of the pack and other information

What Heparin Sodium Injection 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 looks like and contents of the pack

Heparin Sodium Injection 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