国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
CYANOCOBALAMIN
RPH Pharmaceuticals AB
1000 Microgram/ML
Solution for Injection
2011-03-21
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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/03/2011_ _CRN 2095747_ _page number: 1_ 4.3 CONTRAINDICATIONS Hypersensitivity to cyanocobalamin or any other constituents 阅读完整的文件