DODEX INJECTABLE- cyanocobalamin injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Accord Healthcare, Inc.

Uygulama yolu:

SUBCUTANEOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Cyanocobalamin is indicated for vitamin B 12 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 B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B 12 absorption test ( Schilling test). Sensitivity to cobalt and/or vitamin B 12 is a contraindication.

Ürün özeti:

Dodex ® Injectable (Cyanocobalamin Injection, USP 1,000 mcg/mL) is supplied as follows: NDC 16729-533-63           1 mL Multiple Dose Vial            Boxes of 1 NDC 16729-533-08           1 mL Multiple Dose Vial            Boxes of 25 NDC 16729-533-03           10 mL Multiple Dose Vial          Boxes of 1 NDC 16729-533-10           30 mL Multiple Dose Vial          Boxes of 1 NDC 16729-605-63           1 mL Single dose Pre-filled syringe              Boxes of 1 NDC 16729-605-43            1 mL Single dose Pre-filled syringe             Boxes of 10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Manufactured by: Accord Healthcare, Inc., 1009 Slater Road. Suite-210-B, Durham, NC 27703, USA. Manufactured for: Intas Pharmaceuticals Limited, Ahmedabad – 380 054. India Issued : September 2022 10 4292 3 6019309

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DODEX INJECTABLE- CYANOCOBALAMIN INJECTION
ACCORD HEALTHCARE, INC.
----------
DODEX INJECTABLE
CCYANOCOBALAMIN INJECTION, USP
RX ONLY
DESCRIPTION:
Dodex
Injectable (Cyanocobalamin Injection, USP) is a sterile solution of
cyanocobalamin for intramuscular or subcutaneous injection. Each mL
contains 1000
mcg cyanocobalamin.
Each vial and pre-filled syringe also contains Sodium Chloride, 0.4%
and Sodium Acetate,
0.04%. Benzyl Alcohol, 1.5%, is present as a preservative and Water
for Injection q.s.
Glacial acetic acid may has 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 B
coenzymes
are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the
molecular formula
is C
H
CoN
O
P. The cobalt content is 4.34%. The molecular weight is 1355.39.
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
®
®
12
63
88
14
14
12
12
12
the main organ for vitamin B
storage.
Within 48 hours after injection of 100 or 1000 mcg of vitamin B
, 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 B
depends on the presence of sufficient
intrinsic factor and calcium ions. Intrinsic factor deficiency