HEPARIN SODIUM 20000UNIT/500ML IN DEXT 5% INJ SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

HEPARIN SODIUM

Commercializzato da:

HOSPIRA HEALTHCARE ULC

Codice ATC:

B01AB01

INN (Nome Internazionale):

HEPARIN

Dosaggio:

40UNIT

Forma farmaceutica:

SOLUTION

Composizione:

HEPARIN SODIUM 40UNIT

Via di somministrazione:

INTRAVENOUS

Confezione:

500ML

Tipo di ricetta:

Ethical

Area terapeutica:

HEPARINS

Dettagli prodotto:

Active ingredient group (AIG) number: 0104596010; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-11-22

Scheda tecnica

PRESCRIBING INFORMATION
HEPARIN SODIUM 20 000 UNITS/500 ML IN DEXTROSE 5% INJECTION
HEPARIN SODIUM 25 000 UNITS/500 ML IN 5% DEXTROSE INJECTION
Heparin Sodium in 5% Dextrose
20 000 or 25 000 USP Units in Flexible Plastic Container
Anticoagulant
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Approval:
May 09, 2017
Submission Control No: 203541
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_Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection _
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_Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection_
HEPARIN SODIUM 20 000 UNITS/500 ML IN DEXTROSE 5% INJECTION
HEPARIN SODIUM 25 000 UNITS/500 ML IN 5% DEXTROSE INJECTION
20 000 or 25 000 USP Units in Flexible Plastic Container
THERAPEUTIC CLASSIFICATION
Anticoagulant
CLINICAL PHARMACOLOGY
Heparin inhibits reactions that lead to the clotting of blood and the
formation of fibrin clots both
_in vitro _and _in vivo. _Heparin acts at multiple sites in the normal
coagulation system. Small
amounts of heparin in combination with antithrombin III (heparin
cofactor) can inhibit
thrombosis by inactivating activated Factor X and inhibiting the
conversion of prothrombin to
thrombin. Once active thrombosis has developed, larger amounts of
heparin can inhibit further
coagulation by inactivating thrombin and preventing the conversion of
fibrinogen to fibrin.
Heparin also prevents the formation of a stable fibrin clot in
inhibiting the activation of the fibrin
stabilizing factor.
Bleeding time is usually unaffected by heparin. Clotting time is
prolonged by full therapeutic
doses of heparin; in most cases, it is not measurably affected by low
doses of heparin.
Peak plasma levels of heparin are achieved 2 to 4 hours following
subcutaneous administration,
although there are considerable individual variations. Log linear
plots of heparin plasma
concentrations, with time for a wide range of dose levels, are linear,
which suggests the absence
of zero order processes. The liver a