Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Methotrexate disodium eqv to methotrexate
ACCORD HEALTHCARE PRIVATE LIMITED
L01BA01
TABLET
Methotrexate disodium eqv to methotrexate 2.5 mg
ORAL
Prescription Only
Intas Pharmaceuticals Limited
ACTIVE
2023-03-13
PACKAGE INSERT (For the use of a Registered Medical Practitioner or a Hospital) NAME OF THE MEDICINAL PRODUCT MEREX 2.5 (Methotrexate Tablets USP 2.5 mg) QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablets contains: Methotrexate disodium equivalent to Methotrexate.....2.5 mg For a full list of excipients, see Pharmaceutical particulars section PHARMACEUTICAL FORM Uncoated tablets Pale yellow to yellow, round shaped, biconvex, uncoated tablets, debossed on one side “HZ” and “1” on either side of the score line and plain on other side. Scoreline is provided in order to facilitate tablet breaking. WARNING Methotrexate must only be used by physicians experienced in anti-metabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Patients should be fully informed of the risk of fatal or severe toxic reactions involved with the administration of methotrexate and should be under constant supervision of the physician. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy and only when the diagnosis has been established, by biopsy and/or after consultation. 1. Methotrexate may produce depression of the bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. 2. At high or prolonged doses, methotrexate may be hepatotoxic. Liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis have been reported. Since changes may occur without previous signs of gastro-intestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. Special caution is indicated in the presence of liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential and alcohol should be avoided. 3. Malignant lymphomas, Lees het volledige document