HEPARIN SODIUM- heparin sodium injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)

Fáanlegur frá:

Cardinal Health

Stjórnsýsluleið:

SUBCUTANEOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Heparin Sodium Injection, USP is indicated for: Heparin sodium should NOT be used in patients with the following conditions:

Vörulýsing:

(derived from porcine intestinal mucosa) Heparin Sodium Injection, USP Overbagged with 5 x 10 mL Multi-Dose vials per bag, NDC 55154-4749-5 10,000 USP Units/10 mL (1,000 USP Units/mL) 10 mL Multi-dose Vials Store at 20 to 25˚C (68 to 77˚F). [See USP Controlled Room Temperature.] To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or electronically at [e-mail] , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information go to www.hospira.com or call 1-800-615-0187.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
CARDINAL HEALTH
----------
HEPARIN SODIUM
Injection, USP
Rx only
DESCRIPTION
Heparin is a heterogenous group of straight-chain anionic
mucopolysaccharides, called
glycosaminoglycans, having anticoagulant properties. Although others
may be present, the main sugars
occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2)
2-deoxy-2-sulfamino-α-D-glucose 6-
sulfate, (3) β-D-glucuronic acid, (4)
2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid.
These sugars are present in decreasing amounts, usually in the order
(2)> (1)> (4)> (3)> (5), and are
joined by glycosidic linkages, forming polymers of varying sizes.
Heparin is strongly acidic because
of its content of covalently linked sulfate and carboxylic acid
groups. In heparin sodium, the acidic
protons of the sulfate units are partially replaced by sodium ions.
Structural formula of Heparin Sodium (representative subunits):
Heparin Sodium Injection, USP is a sterile solution of heparin sodium
derived from porcine intestinal
mucosa, standardized for anticoagulant activity. It is to be
administered by intravenous or deep
subcutaneous routes. The potency is determined by a biological assay
using a USP reference standard
based on units of heparin activity per milligram.
Heparin Sodium Injection, USP is available in the following
concentrations/mL:
HEPARIN SODIUM
SODIUM CHLORIDE
BENZYL ALCOHOL
1,000 USP units
8.6 mg
0.01 mL
5,000 USP units
7 mg
0.01 mL
10,000 USP units
5 mg
0.01 mL
pH 5.0-7.5; sodium hydroxide and/or hydrochloric acid added, if
needed, for pH adjustment.
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
de