HEPARIN SODIUM ROVI 5000 IUML

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

HEPARIN SODIUM

Saadav alates:

KAMADA LTD, ISRAEL

ATC kood:

B01AB01

Ravimvorm:

SOLUTION FOR INJECTION

Koostis:

HEPARIN SODIUM 5000 IU / 1 ML

Manustamisviis:

S.C, I.V

Retsepti tüüp:

Required

Valmistatud:

LABORATORIOS FARMACÉUTICOS ROVI, S.A , SPAIN

Terapeutiline ala:

HEPARIN

Näidustused:

• 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)

Loa andmise kuupäev:

2019-10-07

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
HEPARIN SODIUM ROVI 5,000 IU/ML
,
Solution for Injection
1.
NAME OF THE MEDICINAL PRODUCT
HEPARIN SODIUM ROVI 5,000 IU/ML
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the product contains 5,000 IU of heparin sodium.
Each vial of 5 ml solution for injection contains 25,000 IU of heparin
sodium (from porcine
intestinal mucosa).
Excipient with known effect:
This medicine contains 10 mg benzyl alcohol in each ml, which is
equivalent to 50 mg per
vial of 5 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless or slightly yellowish, clear solution, free of 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 5,000-7,500 IU subcutaneously approximately 2 hours
before the operation.
Postoperatively, depending on the risk of thrombosis, usually 5,000 IU
subcutaneously every
8-12 hours or 7,500 IU subcutaneously ever