HEPARIN SODIUM TEVA 25000 IU 5 ML

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

HEPARIN SODIUM

Fáanlegur frá:

TEVA ISRAEL LTD

ATC númer:

C05BA03

Lyfjaform:

SOLUTION FOR INJECTION / INFUSION

Samsetning:

HEPARIN SODIUM 25000 IU / 5 ML

Stjórnsýsluleið:

S.C, I.V

Gerð lyfseðils:

Required

Framleitt af:

MERCKLE GMBH, GERMANY

Lækningarsvæði:

HEPARIN

Ábendingar:

- 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)

Leyfisdagur:

2022-02-28

Vara einkenni

Heparin‐Sodium 25 000 IU‐5ml sol for inj/inf SPC Notification
08‐2021 AH
SUMMARY OF PRODUCT CHARACTERISTICS
Heparin Sodium Teva 25,000 IU/5 ml,
Solution for Injection or Infusion
1.
NAME OF THE MEDICINAL PRODUCT
_HEPARIN SODIUM TEVA 25,000 IU/5 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 50 mg benzyl alcohol in each vial which is
equivalent to 50 mg per 5
ml.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection and infusion
Clear, colourless to slightly yellowish solution.
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.
Heparin‐Sodium 25 000 IU‐5ml sol for inj/inf SPC Notification
08‐2021 AH
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-