Heparin Sodium 25, 000 I. U. /Ml Solution for Injection or Concentrate for Solution (without preservative)

• Customization: Available
• Application: Surgery
• Usage Mode: For external use
• Model NO.: Heparin sodium 25,000 I.U./ml (5,000 I.U. in 0.2ml
• Suitable for: Elderly, Adult
• State: Solid
• Shape: Powder
• Type: Biological Products
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: One Vial One Box
• Specification: 25000IU/5ml
• Trademark: None
• Origin: China
• HS Code: 3004909099
• Production Capacity: 500, 000vials

Product Description

Heparin sodium injection BP 25000 IU/5ml
Each ml contains BP Heparin sodium 5000IU
For I.V./S.C.Use

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

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.
 

Route of administration

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

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 1,000-5,000 units,

Maintenance: 1,000-2,000 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. 

Shelf life

Unopened - 3 years

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

Special precautions for storage

Do not store above 25°C

Store in the original package

Nature and contents of container

Neutral glass ampoules (Type I Ph Eur) of 1ml capacity containing 0.2ml, 0.5ml and 1ml of solution respectively and 5ml ampoules containing 5ml of solution. Cartons contain 10, 15 or 50 ampoules.