Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
FOLIC ACID
Mercury Pharmaceuticals (Ireland) Ltd
5 Milligram
Tablets
1980-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Folic Acid Tablets BP 5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of Folic Acid Ph. Eur. 3 PHARMACEUTICAL FORM Tablet. Yellow, circular compressed tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of megaloblastic anaemia associated with folic acid deficiency. To reduce the risk of recurrence of neural tube defect (NTD) in women who have already had a baby affected by NTD. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Folic Acid Tablets BP are for oral administration. Megaloblastic Anaemia associated with folic acid deficiency. _Adults:_ Initial dose: 5 to 20mg daily. Maintenance: 2.5 to 10 mg daily. _Children:_ Aged up to 1 year may be given a maintenance dose of 250 micrograms per kg body-weight daily; 1 to 5 years 2.5 mg daily; 6 to 12 years 5 mg daily. An initial dosage of twice the maintenance dose may be given for 2 days. To reduce risk of recurrence of NTD. Women who have already had a baby affected by NTD and who may become pregnant again should take one 5 mg tablet daily, commencing before conception and continuing until the twelfth week of pregnancy. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to folic acid. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In the treatment of pernicious anaemia, folic acid should never be given alone or in conjunction with in adequate amounts of Vitamin B 12 (cyanocobalamin or hydroxocobalamin). Before treatment a megaloblastic anaemia with folic acid, the diagnosis must be fully established and other possible causes outruled. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2010_ _C Lugege kogu dokumenti