CYTAMEN 1000 Microgram/ML Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
CYANOCOBALAMIN
Available from:
RPH Pharmaceuticals AB
INN (International Name):
CYANOCOBALAMIN
Dosage:
1000 Microgram/ML
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-08-07
Summary of Product characteristics
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
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