CYANOCOBALAMIN injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

şimdi satın al

Indir Ürün özellikleri (SPC)
15-12-2022

Aktif bileşen:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Mevcut itibaren:

General Injectables and Vaccines, Inc.

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 oral supplement

Ürün özeti:

Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows: 10 mL Multiple Dose Vial, NDC 67457-399-10  Box of 1 vial. 10 mL Multiple Dose Vial, NDC 67457-399-25  Box of 25 vials. 30 mL Multiple Dose Vial, NDC 67457-400-31  Box of 1 vial. 30 mL Multiple Dose Vial, NDC 67457-400-05  Box of 5 vials. Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

                                CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
CYANOCOBALAMIN INJECTION, USP
(1,000 MCG/ML)
RX ONLY
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous injection.
Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%.
Benzyl Alcohol
1.5% is present as a preservative. Sodium acetate and Glacial acetic
acid are present as
buffer. Hydrochloric acid and/or sodium hydroxide may have been added
during
manufacture to adjust the pH (range 4.5 to 7.0).
Cyanocobalamin appears as dark red crystals or as an amorphous or
crystalline red
powder or purplish crystalline powder. Sparingly soluble in water and
soluble in alcohol,
practically insoluble in acetone, in chloroform and in either. It is
stable to autoclaving for
short periods at 121°C. The vitamin B12coenzymes 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 1355.4.
The structural formula is represented below.
CLINICAL PHARMACOLOGY
Vitamin B
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 B
is transported via
specific B
binding proteins, transcobalamin I and II to the various tissues. The
liver is
the main organ for vitamin B
storage.
Within 48 hours after injection of 100 or 1,000 mcg of vitamin B
, 50 to 98% of the
12
12
12
12
12
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 B
depends on the presence of sufficient intrinsic
factor and calcium ions. Intri
                                
                                Belgenin tamamını okuyun
                                
                            

Bu ürünle ilgili arama uyarıları

Belge geçmişini görüntüleyin