HEPARIN SODIUM IN 0.9 % SODIUM CHLORIDE INJECTION (2UML HEPARIN SOD.)

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

HEPARIN SODIUM

Disponible des:

TEVA MEDICAL LTD

Codi ATC:

B01AB01

formulario farmacéutico:

SOLUTION FOR INFUSION

Composición:

HEPARIN SODIUM 2 U/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

TEVA MEDICAL LTD, ISRAEL

Grupo terapéutico:

HEPARIN

Área terapéutica:

HEPARIN

indicaciones terapéuticas:

Anticoagulant in extracorporeal circulation, dialysis procedures, an aid in the maintenance of catheter patency.

Data d'autorització:

2011-07-31

Fitxa tècnica

"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
יאמ
2014
.
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: May 2014.
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION (2U/ML
HEPARIN SODIUM)
SOLUTION FOR INFUSION
IN NON PVC BAGS
DESCRIPTION
Heparin Sodium in 0.9% Sodium Chloride Injection is a sterile
nonpyrogenic solution
of Heparin Sodium, USP derived from porcine intestinal mucosa,
standardized for
use as an anticoagulant, in 0.9% Sodium Chloride (NaCl) Injection with
400 mcg
Citric Acid Monohydrate (C
6
H
8
O
7

H
2
O) USP and 4.34 mg Dibasic Sodium Phosphate
Heptahydrate, USP (Na
2
HPO
4

7H
2
O) per milliliter as buffers supplied in single dose
containers for vascular administration. The potency is determined by
biological assay
using USP reference standard based upon units of heparin activity per
milligram. The
osmolarity is approximately 358-mOsmol/L. The pH of the solution is
approximately
7.0. For further information see Table 1.
Postulated repeating unit of heparin
The bags are composed of polyolefin/polyamide co-extruded plastic
(PL-2442).
The
bags
are
overwrapped
with
a
protective
plastic
pouch
composed
of
polyamide/polypropylene.
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 co-
factor) can prevent the development of a hypercoagulable state by
inactivating
activated Factor X, preventing the conversion of prothrombin to
thrombin. Once a
hypercoagulable
state
exists,
larger
amounts
of
heparin
in
combination
with
antithrombin III can inhibit the coagulation process by inactivating
thrombin and
earlier clotting intermediates, thus preventing the conversion of
fibrinogen to fibrin.
Heparin a