Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
METHOTREXATE SODIUM
Cyanamid of Great Britain
1g/40 ml Mg/Ml
Solution for Injection
1983-12-13
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0037/023/015 Case No: 2025577 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CYANAMID OF GREAT BRITAIN FAREHAM ROAD, GOSPORT, HANTS, PO13 0AS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product METHOTREXATE INJECTION 1G/40ML The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 10/11/2006 until 12/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/11/2006_ _CRN 2025577_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate Injection 1 g / 40 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains methotrexate sodium equivalent to 1 g methotrexate, which is equivalent to 25 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. A clear, yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methotrexate is indicated in the treatment of neoplastic disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Routes of administration: _Methotrexate Injection may be given by intramuscular, intravenous (bolus injection or infusion), intrathecal, and intra-arterial r Pročitajte cijeli dokument