International generic name
Drug form and composition
One ampoule of 1 ml contains 100 mcg; 250 mcg; 500 mcg or 1000 mcg
For treatment of pernicious anemia; for prophylaxis and treatment of Vitamin
B12 deficiency, observed in macrocytic and megaloblastic anemia, incomplete nutrition
and intestinal malabsorption. In the complex therapy of: alcoholism; hemolytic anemia;
chronic febrile states; fish tapeworm; in anemia after stomach resection; in gastritis
accompanied with achlorhydria; in genetic diseases; hyperthyroidism; steatorrhoea,
tropic sprue, regional enteritis; persisting diarrhea; after ileum resection; malabsorption
syndrome with pancreas insufficiency; malignant diseases of pancreas or intestines;
in renal diseases and in prolonged stress.
Dosage and administration
The most frequent scheme of administration for adults in pernicious anemia is
500-1000 mcg daily for 10-20 days. The maintenance dose is 250 mcg, once monthly
in the first 3-6 months, then 250 mcg each 2-3 months. The treatment with these
doses continues to obtain clinical remission. As maintenance therapy it is applied
intramuscularly, 100 mcg to 200 mcg once monthly in total gastrectomy and wide ileum
resection. In children it is applied intramuscularly or deeply subcutaneous, 30-50
mcg daily for two or more weeks. Maintenance therapy in children: 100 mcg intramuscularly,
Supersensitivity to the preparation; acute thromboembolism; Osler’s disease;
Special warnings and precautions
A pain in the injection spot is likely to occur. The preparation should be applied
with caution and in lower doses in patients with stenocardia and to thrombogenic
persons. The blood picture should be controlled regularly and in a trend to erythrocytosis
and leucocytosis, the dose should be reduced or the therapy should be stopped temporary.
In pregnant and nursing women it should be applied after assessment of the ratio
benefit/risk of the therapy for the mother and the child.
The combined therapy with phenobarbital, phenythoine and aminophenazone potentiates
metabolism of vitamin B12, which is risky for hypovitaminosis. The simultaneous
administration with alcohol, amino-salicylates, colchicin, aminoglycosides, chloramphenicol,
the resorption of vitamin B12 is inhibited significantly, and high doses of folic
acid and oral contraceptives may decrease the serum concentrations of vitamin B12.
In predisposed patient are observed allergic reactions; rashes; increased heart
activity; pains in cardiac area; insomnia; diarrhea; pink colouration of urine.
Vitamin B12 (cyanocobalamin) catalyzes protein metabolism and promotes synthesis
of proteins. Affects the metabolism of carbohydrates and lipids. Stimulates erythropoesis,
promoting synthesis of hemoglobin and accumulation of compounds of sulfhydryl groups
in erythrocytes. Exerts a favourable effect on the function of liver and nervous
system. Participates in synthesis of nucleic acids, choline, meteonine, creatinine,
purines and pyramidines. B12 deficiency in organism leads to disturbance of chromosome
replication of DNA in cells.
10 or 100 ampoules of 1 ml (100 mcg; 250 mcg; 500 mcg and 1000 mcg).