Plant derived API
Plant extract ointments
Vitamin B12 ampoule 1000 gamma 1 ml # 10126 PB(10,20)
Код АТХ: B03BA 1
One ampoule of 1 ml contains 100 mcg; 250 mcg; 500 mcg or 1000 mcg cyanocobalamin.
For treatment of megaloblastic anemia; for prophylaxis and treatment of Vitamin B12 deficiency (macrocytic and megaloblastic anemia, incomplete nutrition and intestinal malabsorption, post gastric resection state and surgical removal of glands). As additional therapy in the treatment of: chronic alcoholism; fish tapeworm disease; in chronic atrophic gastritis; in genetic diseases (homocystinuria, methylmalonic aciduria); chronic hepatic diseases – hepatic steatosis, hepatitis, cirrhosis, etc.; hyperthyroidism; chronic enterocolitis with steatorrhea, tropical sprue, regional enteritis, persistent diarrhea, after ileum resection; neurasthenia (fatigue syndrome); diseases of the peripheral nervous system (neuritis, radiculitis, plexitis, etc.).
Dosage and administration:
It is applied intramuscularly.
Adults: in megaloblastic anemia 500 to 1000 mcg daily for 10 to 12 days, maintenance dose of 250 mcg once per month during the first 3-6 months, then 250 mcg every 2-3 months.
In hepatic diseases, Vitamin B12 is applied every other day at a maximum daily dose of 500 mcg in a therapeutic course of 20 applications.
In mild vitamin B12 deficiency states, 100 mcg (0.1 mg) daily during the first week, followed by 100 mcg (0.1 mg) every other day during the second and third weeks, then the same dose every 3-4 days for the next 2-3 weeks. The treatment with these doses continues until clinical remission is obtained.
As maintenance therapy, it is applied intramuscularly at a dose of 100 to 200 mcg (0.1 to 0.2 mg) once per month.
In children, it is applied intramuscularly at a dose of 30-50 mcg (0.03-0.05 mg) daily over a period of 2 or more weeks (the total dose ranges from 1 to 5 mg).
For maintenance treatment: intramuscularly 100 mcg (0.1 mg) once per month.
Hypersensitivity to the product; acute thromboembolism; erythremia; Leber’s disease; malignant diseases.
Some medicinal agents, such as phenobarbital, phenytoin and aminophenazone, potentiate vitamin B12 metabolism and lead to hypovitaminosis. In concomitant administration with alcohol, aminosalicylates, colchicine, aminoglycosides, chloramphenicol, vitamin B12 resorption is considerably suppressed. Serum concentrations of the product may be reduced in concomitant administration with oral contraceptives, high doses or long-term treatment with folic acid.
Rarely observed. Allergic reactions (predominantly skin reactions – acneform rash), itching, accelerated cardiac action, pain in the cardiac region, insomnia, painfulness at the site of injection, diarrhea, pink colouring of the urine.
10 or 100 ampoules of 1 ml (100 mcg; 250 mcg; 500 mcg or 1000 mcg) solution for injections.
On doctor’s prescription.
Manufactured by Sopharma AD: www.sopharma.com
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