CYANOCOBALAMIN- cyanocobalamin injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)

Доступно од:

General Injectables & Vaccines, Inc

INN (Међународно име):

Cyanocobalamin

Састав:

Cyanocobalamin 1000 ug in 1 mL

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:       Addisonian (pernicious) anemia     Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy     Fish tapeworm infestation     Malignancy of pancreas or bowel     Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with

Резиме производа:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT THE PRODUCT FROM LIGHT. IN0031 Rev. 11/05 MG #10565 AMERICAN REGENT, INC. SHIRLEY, NY 11967

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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CYANOCOBALAMIN 1000MCG/ML INJECTION, USP 30 ML MULTI-DOSE VIAL
DES CRIPTION
RX ONLY
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular or
subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin.
Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%,
is present as a preservative.
Hydrochloric acid and/or sodium hydroxide may have been added during
manufacture to adjust the pH
(range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an
amorphous or crystalline red
powder. It is very hygroscopic in the anhydrous form, and sparingly
soluble in water (1:80). It is stable
to autoclaving for short periods at 121°C. The vitamin B12 coenzymes
are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the
molecular formula is
C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is
1355.39.
The structural formula is represented below.
CLINICAL PHARMACOLOGY
Vitamin B12 is essential to growth, cell reproduction, hematopoiesis,
and nucleoprotein and myelin
synthesis. Cyanocobalamin is quantitatively and rapidly absorbed from
intramuscular and subcutaneous
sites of injection; the plasma level of the compound reaches its peak
within 1 hour after intramuscular
injection. Absorbed vitamin B12 is transported via specific B12
binding proteins, transcobalamin I and II
to the various tissues. The liver is the main organ for vitamin B12
storage. Within 48 hours after
injection of 100 or 1000 mcg of vitamin B12, 50 to 98% of the injected
dose may appear in the urine.
The major portion is excreted within the first eight hours.
Intravenous administration results in even
more rapid excretion with little opportunity for liver storage.
Gastrointestinal absorption of vitamin B12
depends on the presence of sufficient intrinsic factor and calcium
ions. Intrinsic factor deficiency
causes pernicious anemia, which may be associated wit