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:

HF Acquisition Co LLC, DBA HealthFirst

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE & ADMINISTRATION); Prophylaxis and treatment of pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin sodium should NOT be used in patients with the following conditions: Severe thrombocytopenia; When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin); An uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.

Vörulýsing:

HEPARIN SODIUM INJECTION, USP 50,000 USP is supplied in the following dosage forms. NDC 51662-1409-1 HEPARIN SODIUM INJECTION, USP 50,000 USP UNITS PER 5mL (10,000 USP UNITS per mL) 5mL VIAL NDC 51662-1409-2 HEPARIN SODIUM INJECTION, USP 50,000 USP UNITS PER 5mL (10,000 USP UNITS per mL) 5mL VIAL, 1 VIAL PER POUCH NDC 51662-1409-3 HEPARIN SODIUM INJECTION, USP 50,000 USP UNITS PER 5mL (10,000 USP UNITS per mL) 5mL VIAL, 1 VIAL PER POUCH, 25 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Discard unused portion. This container closure is not made from natural rubber latex.

Leyfisstaða:

New Drug Application

Vara einkenni

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
HEPARIN SODIUM INJECTION, USP 50,000 USP UNITS PER 5ML (10,000 USP
UNITS PER ML) 5ML VIAL
SPL UNCLASSIFIED
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