HEPARIN BICHSEL 1000 IUML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HEPARIN SODIUM

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

B01AB01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HEPARIN SODIUM 1000 IU / 1 ML

Administration route:

I.V, S.C

Prescription type:

Required

Manufactured by:

LABORATORIUM DR. G. BICHSEL AG

Therapeutic area:

HEPARIN

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, hemodialysis)

Authorization date:

2020-10-11

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Heparin Bichsel 1000 IU/ml
_ _
Heparin Bichsel 5000 IU/ml
_ _
_ _
Solution for injection.
For subcutaneous and intravenous injection. or intravenous infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ampoule of 1 ml
Heparin Bichsel 1000 IU/ml
_ _contains 1,000 I.U. heparin
sodium.
1 ampoule of 1 ml
Heparin Bichsel 5000 IU/ml
_ _contains 5,000 I.U. heparin
sodium.
1 ampoule of 5 ml
Heparin Bichsel 5000 IU/ml
_ _contains 25,000 I.U. heparin
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
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, nature and course of
the
disease, 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- 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 subcutaneously every
12 hours until the patient is mobilised or until vitamin K antagonists
have an
adequate effect. Laboratory monitoring (coagulation parameters) for
dose
adjustment may be required in individual cases.
_- Prophylaxis in non-surgical medicine _
(e.g. prolonged bed rest, increased t