País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Methotrexate
IMED Healthcare Ltd.
L01BA; L01BA01
Methotrexate
25 milligram(s)
Solution for injection in pre-filled pen
Folic acid analogues; methotrexate
2021-09-10
PACKAGE LEAFLET: INFORMATION FOR THE USER METOJECT 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN methotrexate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Metoject is and what it is used for 2. What you need to know before you use Metoject 3. How to use Metoject 4. Possible side effects 5. How to store Metoject 6. Contents of the pack and other information 1. WHAT METOJECT IS AND WHAT IT IS USED FOR Metoject is indicated for the treatment of active rheumatoid arthritis in adult patients. severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. RHEUMATOID ARTHRITIS (RA) is a chronic collagen disease, characterised by inflammation of the synovial membranes (joint membranes). These membranes produce a fluid which acts as a lubricant for many joints. The inflammation causes thickening of the membrane and swelling of the joint. PSORIASIS is a common chronic skin disease, characterised by red patches covered by thick, dry, silvery, adherent scales. PSORIATIC ARTHRITIS is a kind of arthritis with psoriatic lesions of the skin and nails, especially at the joints of fingers and toes. Metoject modifies and slows down the progressi Leer el documento completo
Health Products Regulatory Authority 10 September 2021 CRN00C8N1 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoject 25 mg solution for injection in pre-filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pre-filled pen with 0.50 ml solution contains methotrexate disodium equivalent to 25 mg methotrexate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Product imported from _Germany._ Clear, yellow-brown solution. 4 CLINICAL PARTICULARS As per PA0623/014/006 5 PHARMACOLOGICAL PROPERTIES As per PA0623/014/006 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Sodium hydroxide Water for injections 6.2 INCOMPATIBILITIES In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the pre-filled pen and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25 °C. Keep the pre-filled pens in the outer carton in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Pre-filled pen containing 0.50 ml (25 mg) solution. Pack size 1 pre-filled pen. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING The manner of handling and disposal must be in accordance with local requirements. Pregnant health care personnel should not handle and/or administer Metoject. Health Products Regulatory Authority 10 September 2021 CRN00C8N1 Page 2 of 2 Methotrexate should not come into contact with the skin or mucosa. In the event of contamination, the affected area must be rinsed immediately with ample amount of water. For single use only. Any unused medicinal product or waste should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/172/005 Leer el documento completo