Cyanocobalamin-BP (Vit B12)

Cyanocobalamin

1 ampoule (1 ml) of solution for injection contains cyanocobalamin 0.5 mg. Excipient with known effect: sodium.

Indication: Indicated for anaemias caused by vitamin B12 deficiency (regardless of cause: gastrectomy, helminth infestation, intestinal malabsorption, pregnancy), megaloblastic, post-haemorrhagic and iron-deficiency anaemias, aplastic anaemia in children, hepatitis and liver cirrhosis, polyneuritis and other neurological conditions, and other clinical states listed in the SmPC.

Contraindications (SmPC sec. 4.3): 4.3. Contraindications
Hypersensitivity to cyanocobalamin or to any of the excipients listed in section 6.1; erythraemia, erythrocytosis. Neoplasms, except cases accompanied by megaloblastic anaemia and vitamin B12 deficiency. Acute thromboembolic disease. High functional class angina pectoris on exertion. Children under 3 years of age.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4. Special warnings and precautions for use
Anaphylactic shock and death have been reported after parenteral administration of vitamin B12. Before starting treatment, intradermal testing is recommended for patients suspected of being sensitive to this medicinal product. Patients diagnosed with early-stage Leber's disease (hereditary optic neuropathy) have been found to experience severe and rapid optic nerve atrophy when treated with vitamin B12. Cyanocobalamin-BP must not be used for Leber's hereditary optic neuropathy. Caution is recommended during treatment in patients predisposed to thrombosis and in patients with angina pectoris, and coagulation parameters should be monitored. Cyanocobalamin should not be used concomitantly with medicinal products that increase blood coagulation.
Laboratory tests
Haematocrit, reticulocyte count, vitamin B12, […]