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CYTAMEN

Information leaflet

                                                   Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Cytamen 1000 micrograms/ml Solution for Injection

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each ml contains cyanocobalamin 1000 micrograms (1.0 mg)

 Excipients: Each ml contains 3.5mg (0.154 mmol) of sodium.

 For a full list of excipients, see section 6.1

 3 PHARMACEUTICAL FORM

 Solution for injection.

 A clear red solution.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Addisonian pernicious anaemia.
 Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency and the Schilling test.

 Investigational use in the Schilling test.

 4.2 Posology and method of administration

 The following dosage schemes are suitable for adults and children.

 Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:
 Initially: 250 to 1,000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms
 weekly until the blood count is normal.
 Maintenance: 1,000 micrograms monthly.

 Addisonian pernicious anaemia and other macrocytic anaemias, anaemia with neurological complications:
 Initially: 1,000 micrograms intramuscularly on alternate days as long as improvement is occurring.
 Maintenance: 1,000 micrograms monthly.

 Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some
 malabsorption syndromes and strict vegetarianism:
 250 to 1,000 micrograms monthly.

 Schilling test:
 An intramuscular injection of 1,000 micrograms cyanocobalamin is an essential part of this test.




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Date Printed 21/03/2011                               CRN 2095747                                         page number: 1
                                                   Irish Medicines Board




 4.3 Contraindications

 Hypersensitivity to cyanocobalamin or any other constituents.

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

 Not indicated for treatment of toxic amblyopias - use Neo-Cytamen.

 4.4 Special warnings and precautions for use

 The dosage schemes given above are usually satisfactory, but regular examination of the blood is advisable. If
 megaloblastic anaemia fails to respond to cyanocobalamin, folate metabolism should be investigated.

 Doses in excess of 10 micrograms daily may produce an incomplete 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.

 This medicinal product contains less than 1mmol sodium (23 mg) per dose, i.e. essentially 'sodium free'.

 4.5 Interaction with other medicinal products and other forms of interaction

 Chloramphenicol treated patients may respond poorly to Cytamen. Serum concentrations of cyanocobalamin may be
 lowered by oral contraceptives. Antimetabolites and most antibiotics invalidate vitamin B12 assays by microbial
 techniques.

 4.6 Fertility, pregnancy and lactation

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

 4.7 Effects on ability to drive and use machines

 None stated.

 4.8 Undesirable effects

 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.

 Disorders of the immune system:
 Hypersensitivity reactions including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis.

 Gastro intestinal disorders:
 Nausea




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Date Printed 21/03/2011                               CRN 2095747                                         page number: 2
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