Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METHOTREXAAT
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L01BA01
METHOTREXATE
Oplossing voor injectie
NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,
Intraveneus gebruik, Intramusculair gebruik, Subcutaan gebruik
Methotrexate
Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;
2010-02-22
Sandoz B.V. Page 1/18 Methotrexaat Sandoz ® 10 mg=1 ml RVG 117408-11 1313-V12 1.3.1.3 Bijsluiter Augustus 2019 PIL for Lantarel FS® 7,5 mg/10 mg/15 mg/20 mg/25 mg Fertigspritze; Injektionslösung i.m./i.v./s.c. (methotrexate), Pfizer Pharma GmbH, Germany, dated September 2019 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXAAT SANDOZ ® 7,5 MG = 0,75 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT 10 MG/ML METHOTREXAAT SANDOZ ® 10 MG = 1 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT 10 MG/ML METHOTREXAAT SANDOZ ® 15 MG = 1,5 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT 10 MG/ML METHOTREXAAT SANDOZ ® 20 MG = 2 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT 10 MG/ML methotrexaat 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 your 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 [Nationally completed name] is and what it is used for 2. What you need to know before you use [Nationally completed name] 3. How to use [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] is a medicine containing methotrexate. Methotrexate is a substance with the following properties: it interferes with the growth of certain cells in the body that reproduce quickly (anti-tumour agent) it reduces undesired reactions of the body’s own defence mechanism (immunosuppressant), and it has anti-inflammatory effects _ _ [Nationally comple Prečítajte si celý dokument
Sandoz B.V. Page 1/22 Methotrexaat Sandoz 10 mg=1 ml RVG 117408-11 1311-V11 1.3.1.1 Samenvatting van de Productkenmerken Augustus 2020 SmPC for Lantarel FS® 7,5 mg/10 mg/15 mg/20 mg/25 mg Fertigspritze; Injektionslösung i.m./i.v./s.c. (methotrexate), Pfizer Pharma GmbH, Germany, dated September 2019 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methotrexaat Sandoz 7,5 mg = 0,75 ml, oplossing voor injectie in voorgevulde injectiespuit 10 mg/ml Methotrexaat Sandoz 10 mg = 1 ml, oplossing voor injectie in voorgevulde injectiespuit 10 mg/ml Methotrexaat Sandoz 15 mg = 1,5 ml, oplossing voor injectie in voorgevulde injectiespuit 10 mg/ml Methotrexaat Sandoz 20 mg = 2 ml, oplossing voor injectie in voorgevulde injectiespuit 10 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 10 mg of methotrexate (as 10.97 mg of methotrexate disodium). Each pre-filled syringe of 0.75 ml contains 7.5 mg of methotrexate. Each pre-filled syringe of 1 ml contains 10 mg of methotrexate. Each pre-filled syringe of 1.5 ml contains 15 mg of methotrexate. Each pre-filled syringe of 2 ml contains 20 mg of methotrexate. Excipient(s) with known effect Each ml solution for injection contains 0.16 mmol (3.8 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, yellow solution, free of particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Active rheumatoid arthritis in adult patients - Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA) (children > 3 years) when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate. - 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IMPORTANT WARNING ABOUT THE DOSAGE OF [NATIONALLY COMPLETED NAME]: In the treatment of rheumatoid arthriti Prečítajte si celý dokument