GENTRAN 40 (DEXTRAN 40 INTRAVENOUS INFUSION BP 10%
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
DEXTRAN 40 SODIUM CHLORIDE
Available from:
Baxter Healthcare Limited
Dosage:
10/0.9 %w/v %w/v
Pharmaceutical form:
Solution for Infusion
Authorization date:
1983-04-01
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentran 40 (Dextran 40 Intravenous Infusion BP 10% w/v in Sodium Chloride Intravenous Infusion BP 0.9% w/v).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 ml contains:
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
A clear, colourless, sterile, aqueous solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the treatment of hypovolaemic shock.
Prophylaxis of thromboembolic episodes in surgery.
As a diluent in the pump oxygenator during extra-corporeal circulation.
To improve blood flow and tissue function in burns and conditions associated with local ischaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
The dosage is dependent upon the age, weight and clinical condition of the patient.
HYPOVOLAEMIC SHOCK
_Adults_
Usual dose is 500 to 1500ml, depending on individual response. This dose should not be exceeded except in unusual
circumstances.
_Paediatric Patients_
Children 10ml/kg - Babies 5ml/kg.
PROPHYLAXIS OF THROMBOEMBOLIC EPISODES
500 -1000ml daily commencing on day of surgery and continuing for 2-5 days post operatively.
AS DILUENT IN PUMP OXYGENATOR
10 to 20ml/kg. The dextran concentration should never exceed 3%.
Dextran 40 (Dextran 40 for Injection) 100 g
Sodium Chloride
9 g
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/11/2007_
_CRN 2043478_
_page number: 1_
TO IMPROVE BLOOD FLOW AND TISSUE FUNCTION IN BURNS/ISCHAEMIA
Usual dose is 500ml prior to surgery and 500ml during surgery. Dosage depends on individual patient’s circumstances
and response.
ADMINISTRATION
Intravenous.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to dextrans.
Use in
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