HEPARIN SODIUM B.BRAUN 5000 IUML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HEPARIN SODIUM

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

B01AB01

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

HEPARIN SODIUM 5000 IU

Administration route:

I.V, S.C

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG., GERMANY

Therapeutic area:

HEPARIN

Therapeutic indications:

- Prevention of thromboembolic disorders. - As part of the treatment of venous and arterial thromboembolic disorders (including early treatment of heart attacks as well as unstable angina pectoris). - For the anticoagulation in case of treatment or operation with extracorporeal circulation (e.g. heart-lung machine, hemodialysis).

Authorization date:

2023-03-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_HEPARIN SODIUM B.BRAUN 5000 IU/ML _
Solution for injection or infusion.
For subcutaneous and intravenous injection or intravenous infusion
after dilution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 5 ml solution for injection or infusion contains 25,000
IU of heparin sodium (from
porcine intestinal mucosa).
Excipient with known effect:
This medicine contains 62.5 mg benzyl alcohol in each vial which is
equivalent to 62.5 mg
per 5 ml.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection and infusion
Clear, colourless up to faintly straw-coloured solution, practically
free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prevention of thromboembolic disorders
-
As part of the treatment of venous or arterial thromboembolic
disorders (including the early
treatment of heart attacks as well as unstable angina pectoris)
-
For anticoagulation during treatment or operation with an
extracorporeal circulation (e.g.
heart/lung machine, haemodialysis)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage _
Heparin sodium must be individually dosed.
The dosage depends on the coagulation parameters (see section 4.4),
the nature and course of
the disease, the patient's response, adverse reactions, and the
patient's weight and age.
Differences in sensitivity to heparin and a possible change in heparin
tolerance during the
course of treatment need to be considered.
PROPHYLAXIS OF THROMBOEMBOLISM (LOW-DOSE TREATMENT)
Subcutaneous injection is recommended for the prophylaxis of
thromboembolism. Pre-filled
syringes with an appropriate dosage are available for this.
General dosage recommendation for the prophylaxis of thromboembolism:
_-_
_ _
_Pre- and postoperative prophylaxis of thromboembolism _
Preoperatively 5000-7500 IU subcutaneously approximately 2 hours
before the operation.
Postoperatively, depending on the risk of thrombosis, usually 5000 IU
subcutaneously every
8-12 hours or 7500 IU