HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

HEPARIN SODIUM

Dostupné z:

PFIZER CANADA ULC

ATC kód:

B01AB51

INN (Medzinárodný Name):

HEPARIN, COMBINATIONS

Dávkovanie:

2UNIT

Forma lieku:

SOLUTION

Zloženie:

HEPARIN SODIUM 2UNIT

Spôsob podávania:

INTRAVENOUS

Počet v balení:

500ML/1000ML

Typ predpisu:

Ethical

Terapeutické oblasti:

HEPARINS

Prehľad produktov:

Active ingredient group (AIG) number: 0104596011; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2017-06-13

Súhrn charakteristických

PRESCRIBING INFORMATION
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION
Heparin Sodium in 0.9% Sodium Chloride
2 USP Heparin Units/mL in Flexible Plastic (PVC) Containers
Anticoagulant
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Approval:
March 8, 2019
Submission Control No: 222931
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_Heparin Sodium in 0.9% Sodium Chloride Injection _
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HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION
2 USP Heparin Units/mL in Flexible Plastic (PVC) Containers
THERAPEUTIC CLASSIFICATION
Anticoagulant
ACTION AND CLINICAL PHARMACOLOGY
Heparin inhibits reactions which lead to the clotting of blood and the
formation of fibrin clots _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 preventing the conversion of
prothrombin to thrombin. Once
active thrombosis has developed, larger amounts of heparin, in
combination with antithrombin
III, can inhibit further coagulation by inactivating thrombin and
earlier clotting intermediates,
thus preventing the conversion of fibrinogen to fibrin. Heparin also
prevents the formation of
stable fibrin clot by inhibiting the activation of the fibrin
stabilizing factor.
Bleeding time is usually unaffected by heparin. Clotting time is
usually not measurably affected
by low doses, but is prolonged by full therapeutic doses of heparin.
Heparin is only active parenterally. In doses less than 5 000 units,
heparin is primarily eliminated
by hepatic metabolism. In larger doses, up to 50% is excreted
unchanged in the urine.
The plasma half-life is approximately 1.5 hours; however, the
half-life increases with increasing
doses, ranging from approximately 1 hour with a dose of 100 units/kg
to approximately 2.5 hours
with a dose of 400 units/kg. The plasma half-life may be prolonged in
patients wi