Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Methotrexate
PCO Manufacturing Ltd.
L04AX03
Methotrexate
50 milligram(s)/millilitre
Solution for injection in pre-filled syringe
methotrexate
2019-03-08
PACKAGE LEAFLET: INFORMATION FOR THE USER METOJECT ® 50 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE 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 50 mg/ml is and what it is used for 2. What you need to know before you use Metoject 50 mg/ml 3. How to use Metoject 50 mg/ml 4. Possible side effects 5. How to store Metoject 50 mg/ml 6. Contents of the pack and other information 1. WHAT METOJECT 50 MG/ML IS AND WHAT IT IS USED FOR Metoject 50 mg/ml contains methotrexate as active substance. Methotrexate is a substance with the following properties: • it interferes with the growth of certain cells in the body that reproduce quickly. • it reduces the activity of the immune system (body’s own defence mechanism). • it has anti-inflammatory effects. Metoject 50 mg/ml 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. Psoriatic arthritis is a kind of arthritis with psoriatic lesions of the skin and nails, especially at the joints of fingers and toes. Pso Perskaitykite visą dokumentą
Health Products Regulatory Authority 07 November 2023 CRN00DX54 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoject 50 mg/ml Solution for Injection, pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 50 mg methotrexate (as methotrexate disodium). 1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate. 1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate. 1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection, pre-filled syringe. _Product imported from Greece _ Clear, yellow-brown solution 4 CLINICAL PARTICULARS As per PA0623/014/001 5 PHARMACOLOGICAL PROPERTIES As per PA0623/014/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Sodium hydroxide for pH adjustment 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 container 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 syringes in the outer carton in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Nature of container Pre-filled syringes of colourless glass of 1 ml capacity with embedded injection needle. Plunger stoppers and rods inserted on the stopper to form the syringe plunger. Health Products Regulatory Authority 07 November 2023 CRN00DX54 Page 2 of 2 Pack size Pre-filled syringes containing 0.30 ml, 0.40 ml, or 0.50 ml solution are available in packs of 1 syringe with embedded s.c. injection needle and alcohol pads. Pre-filled syringes containing 0.30 ml, 0.40 ml, or 0.50 ml solution are available in packs of 1 syringe with embedded s.c. injection needle. All pack sizes are available with graduation marks. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND Perskaitykite visą dokumentą