NEO-CYTAMEN Solution for injection Ref.[49889] Active ingredients: Vitamin B12a

Precautions

The dosage schemes given above are usually satisfactory, but regular examination of the blood is advisable. If megaloblastic anaemia fails to respond to hydroxocobalamin, folate metabolism should be investigated. Doses in excess of 10mcg daily may produce a haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. The haematological and neurological state should be monitored regularly to ensure adequacy of therapy. Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period. Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrence of reactive thrombocytosis.

Chloramphenicol-treated patients may respond poorly to Neo-Cytamen. Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives but this interaction is unlikely to have clinical significance. Antimetabolites and most antibiotics invalidate vitamin B₁₂ assays by microbiological techniques.

Neo-Cytamen should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B₁₂ deficiency has been demonstrated.

Neo-Cytamen is secreted into breast milk but this is unlikely to harm the infant, and may be beneficial if the mother and infant are vitamin B₁₂ deficient.

None stated.

The following effects have been reported and are listed below by body system:

Blood and lymphatic system disorders:

Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.

Cardiovascular disorders:

Arrhythmias secondary to hypokalaemia.

Disorders of the immune system:

Hypersensitivity reactions including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis.

Gastro intestinal disorders:

Nausea, vomiting, diarrhoea.

General disorders:

Fever, chills, hot flushing, dizziness, malaise, pain. Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site induration, and injection site swelling.

Neurological disorders:

Headache, sensory abnormalities such as paraesthesiae.

Tremor.

Renal and unrinary disorders:

Chromaturia

Skin and subcutaneous tissue disorders:

Acneiform and bullous eruptions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None.