HYDROXOCOBALAMIN injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

HYDROXOCOBALAMIN ACETATE (UNII: S535M27N3Q) (HYDROXOCOBALAMIN - UNII:Q40X8H422O)

Disponible des:

Actavis Pharma, Inc.

Designació comuna internacional (DCI):

HYDROXOCOBALAMIN ACETATE

Composición:

HYDROXOCOBALAMIN 1000 ug in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

- Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. Pernicious anemia, both uncomplicated and accompanied by nervous system involvement. - Dietary deficiency of Vitamin B12 , occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B12 deficiency is very rare). Dietary deficiency of Vitamin B12 , occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B12 deficiency is very rare). - Malabsorption of vitamin B12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency. Malabsorption of vitamin B12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency. - Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc. - Competition for Vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind-loop syndrome may produce deficiency of Vitamin B12 or folate. Competition for Vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind-loop syndrome may produce deficiency of Vitamin B12 or folate. - Inadequate utilization of vitamin B12 . This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia. Inadequate utilization of vitamin B12 . This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia. - For the Schilling Test. For the Schilling Test.

Resumen del producto:

Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PROTECT FROM LIGHT. Literature revised: January 2017 Manufactured by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA PIN229-WAT/2

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROXOCOBALAMIN- HYDROXOCOBALAMIN INJECTION, SOLUTION
ACTAVIS PHARMA, INC.
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HYDROXOCOBALAMIN INJECTION USP
RX ONLY
DESCRIPTION
Hydroxocobalamin injection is a sterile solution of hydroxocobalamin
for intramuscular administration.
Each mL contains: Hydroxocobalamin Acetate equivalent to 1000 mcg
Hydroxocobalamin, Sodium
Acetate Anhydrous 0.2 mg, Glacial Acetic Acid 0.442 mg, Sodium
Chloride 8.2 mg, with
Methylparaben 1.5 mg and Propylparaben 0.2 mg as preservatives, in
Water for Injection q.s. Additional
Glacial Acetic Acid and/or Sodium Acetate may have been used to adjust
pH. pH range is 3.5 to 5.0.
Hydroxocobalamin appears as dark red orthorhombic needles or as an
amorphous or crystalline red
powder. It is very hygroscopic in the anhydrous form, and moderately
soluble in water. It has a
molecular weight of 1346.37. The vitamin B
coenzymes are very unstable in light. Hydroxocobalamin
shares the cobalamin molecular structure with cyanocobalamin.
The chemical name is α-(5,6-dimethylbenzimidazoly) hydroxocobamide.
The empirical formula is
C
H CoN O P and its structural formula is:
The cobalt content is 4.34%.
CLINICAL PHARMACOLOGY
Vitamin B
is essential to growth, cell reproduction, hematopoiesis,
nucleoprotein and myelin
synthesis.
Fifty percent of the administered dose of hydroxocobalamin disappears
from the injection site in 2.5
hours. Hydroxocobalamin is bound to plasma proteins and stored in the
liver. It is excreted in the bile
and undergoes some enterohepatic recycling. Within 72 hours after
injection of 500 to 1000 mcg of
hydroxocobalamin, 16 to 66 percent of the injected dose may appear in
the urine. The major portion is
excreted within the first 24 hours.
12
62
89
13
15
12
INDICATIONS AND USAGE
I. Pernicious anemia, both uncomplicated and accompanied by nervous
system involvement.
II. Dietary deficiency of Vitamin B
, occurring in strict vegetarians and in their breast-fed infants.
(Isolated vitamin B
deficiency is very rare).
III. Malabsorption of vitamin B
, resulting from structural or func