Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METHOTREXATE
PFIZER (MALAYSIA) SDN. BHD.
METHOTREXATE
30 Tablets
Excella GmbH
Pfizer Confidential _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PFZ METHOTREXATE ® TABLET Methotrexate (2.5 mg) PLD Title : Methotrexate (PFZ METHOTREXATE ® )Tablet PLD Date : 2114 June May 20193082305 FebruarJanuaryyAprilAugust 202210 Country : Malaysia Reference Ddocument : METHOTREXATE Tablet Malaysia LPD, dated 010 21 FebruaryMayJanuary 2021018 Reason for cCchange : PfLEET Numbero: 2020-0061147 (O), To remove product owner informationTo develop PLD based on effective Malaysia LPD (10 January 2018) and new template : :To update label as per BOH commentsTo amend serial number and MAL number : PfLEET Number 2020-0061675 (D) - To include rheumatoid arthritis (RA) indication : To update serial number : To amend as per BOH recommendation :To update serial number as per BOH request Pfizer Confidential _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PFZ METHOTREXATE ® TABLET Methotrexate (2.5 mg) 1 WHAT IS IN THIS LEAFLET 1. What METHOTREXATE is used for 2. How METHOTREXATE works 3. Before you use METHOTREXATE 4. How to use METHOTREXATE 5. While you are using it 6. Side effects 7. Storage and Disposal of METHOTREXATE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Rerevision 10.11. Serial Number WHAT METHOTREXATE IS USED FOR METHOTREXATE is used alone or in combination with other anticancer agents to treat various cancers. METHOTREXATE is also indicated in the symptomatic control of severe psoriasis when other treatments are not responsive. METHOTREXATE can also be usedis now the most popular drug for the treatment of can be used in Rheumatoid arthritis (RA) in adutsadults. that is joint pain. HOW METHOTREXATE WORKS METHOTREXATE works by blocking an enzyme process in cells that is required for cell growth. This interferes with the growth of some cells that are growing rapidly in psoriasis or ,rheumatoid arthritis and cancer. The precise mechanism of METHOTREXATE in treating rheumatoid arthritis is uncertain. METHOTREXATE either taken alone or with other medicines Leggi il documento completo
1 METHOTREXATE TABLETS 1. NAME OF THE MEDICINAL PRODUCT PFZ Methotrexate Tablet 2.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Methotrexate Tablets contain 2.5 mg of Methotrexate 3. PHARMACEUTICAL FORM Round, convex, yellow in colour, approximately 6.35 ± 0.1 mm in diameter, engraved with ‘2.5’ on one side and scored in half on the other side and engraved with a block letter ‘M’ above the score and ‘I’ below. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The following are representative indications. Locally approved indications may differ. Methotrexate is a cytotoxic drug used for antineoplastic chemotherapy and in certain nonmalignant conditions. ANTI-NEOPLASTIC CHEMOTHERAPY Methotrexate is indicated for the treatment of gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Methotrexate is indicated for the palliation of acute lymphocytic leukemia. It is also indicated in the treatment and prophylaxis of meningeal leukemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem-cell) leukemias in children. In combination with other anticancer drugs or suitable agents Methotrexate may be used for induction of remission, but it is most commonly used, as described in the literature, in the maintenance of induced remissions. Methotrexate may be used alone or in combination with other anticancer agents in the management of breast cancer, epidermoid cancers of the head and neck, and lung cancer, particularly squamous cells and small cell types. Methotrexate is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in those cases in children; and in advanced cases of mycosis fungoides. PSORIASIS CHEMOTHERAPY (SEE SECTION 4.4) Because of high risk attending its use, Methotrexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been est Leggi il documento completo