HEPARIN SODIUM injection solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
14-01-2018

Aktīvā sastāvdaļa:

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

Pieejams no:

Cardinal Health

SNN (starptautisko nepatentēto nosaukumu):

HEPARIN SODIUM

Kompozīcija:

HEPARIN 1000 [USP'U] in 1 mL

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

New Drug Application

Produkta apraksts

                                HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
CARDINAL HEALTH
----------
HEPARIN SODIUM INJECTION USP
Rx only
DERIVED FROM PORCINE INTESTINAL MUCOSA.
Available as: Preservative Free OR Contains Benzyl Alcohol OR Parabens
DESCRIPTION
Heparin is a heterogeneous 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) ß-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.
Heparin Sodium Injection, USP is a sterile solution of heparin sodium
derived from porcine intestinal
mucosa, standardized for anticoagulant activity, in water for
injection. 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.
Structure of Heparin Sodium (representative subunits):
Heparin Sodium Injection, USP (porcine), preservative free, is
available as follows:
Each mL of the 1,000 units per mL preparation contains: 1,000 USP
Heparin units (porcine); 9 mg
sodium chloride; Water for Injection q.s. Made isotonic with sodium
chloride. Hydrochloric acid
and/or sodium hydroxide may have been added for pH adjustment (5.0 to
7.5).
Each 0.5 mL of the 5,000 units per 0.5 mL preparation contains: 5,000
USP Heparin units (porcine);
Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may
have been added for pH
adjustment (5.0 to 7.5).
Heparin Sodium Injection, USP (porcine), preserved
                                
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