1.Product name:Vitamin B 12 injection
2.Specification:1 mg/2ml
3.Package:5 ampoules/tray,2 trays/box
4.Shelf life:36 months
5.Registration dossiers are available.
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PROPRIETARY NAME
 
VITAMIN B12 Injection 1mg/2ml.
 
COMPOSITION
 
Ampoules each 2ml contains: 1000 micrograms (1mg) Cyanocobalamin. The main constitute of this product is Cyanocobalamin, and its chemical structure is
 
INDICATIONS
 
Vitamin B12 is used to treat vitamin B12 deficiency, cyanide poisoning, and hereditary deficiency of transcobalamin ll. It is also given as part of the Schilling test for detecting pernicious anemia. For cyanide poisoning, a large amount may be given intravenously, and sometimes in combination with sodium thiosulfate.
 
High vitamin B12 level in elderly individuals may protect against brain atrophy or shrinkage associated with Alzheimer's disease and impaired cognitive function.
 
High-dose administration of Vitamin B12 has been additionally validated to stimulate the activity of the body's TH1 suppressor T-Cells, which then down-regulates the over-production of the allergen antibody lg E in allergic individuals.
 
DOSAGE AND ADMINISTRATION
 
Administered intramuscularly.
 
In the absence of neurological involvement, cyanocobalamin may be administered in doses of 250 to 1000 micrograms intramuscularly on alternate days for 1 to 2 weeks, then 250 micrograms weekly until the blood count returns to normal. Maintenance doses of 1000 micrograms are administered monthly.
 
If there is neurological involvement, cyanocobalamin may be given in doses of 1000 micrograms on alternate days and continued for as long as improvement occurs.
 
For the prophylaxis of anaemia associated with vitamin B12 deficiency resulting from gastrectomy or malabsorption syndromes cyanocobalamin may be given in doses of 250 to 1000 micrograms intramuscularly each month.
 
CONTRA-INDICATIONS
 
Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin should not be used to treat megaloblastic anaemia of pregnancy. Cyanocobalamin should not be administered before pernicious anaemia or folic acid deficiency has been ruled out.
 
WARNING
 
Must not be administered intravenously.
 
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
 
Allergic reactions have been reported after Injection.
 
Vitamin B12 should be given prophylactically only when there is a reasonable indication. Dietary deficiency in the strict vegetarian, the predictable malabsorption of vitamin B12 in patients who have had a gastrectomy, and certain diseases of the small intestine constitute such indications. Administration of cyanocobalamine doses greater than 10 micrograms daily, may produce a haematological response in patients with folate deficiency.
 
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTUCULARS OF ITS 
 
IDENTIFICATION:
 
A dark red solution in ampoules.
 
PRESENTATION:
 
5 ampoules packing in white hard tray, 2 trays packed in one box.
 
STORAGE INSTRUCTIONS:
 
Protect from light. Store below 25.
 
Keep out of reach of children.