Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate sodium
Rosemont Pharmaceuticals Ltd
L04AX03
Methotrexate sodium
2mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5016119270697 5016119270093
Methotrexate 2mg/ml Oral Solution JOB INFORMATION COLOURS Product Name: Print Colours: 9pt Font Size: 1 ARTWORK VERSION: Pharmacode: N/A 403 1 EAN Code: No. of Colours: THIRD PARTY APPROVAL REQUIRED Name: Signature: Date: YES TICK APPLICABLE BOX Tabbed: Keyline Ref: 300 x 400mm UKL472 150 x 37.5mm Yes Dimensions: Folded Size: E3RG3RBJ1 New Item Code: P0799 Previous Item Code: N/A Supplier Code: 35ml / 65ml Pack Size: 45ml / 75ml Bottle Size: 2mg/ml Strength: N/A 1 of 2 Design Icon: Page Number: Univers Roman UNIVERS BOLD Font Type: JOB SPECIFICATION MAIN BODY TEXT Non-print Colours: BLACK 7474 265 BLACK 877 PANTONE 485 PANTONE KEYLINE BRAILLE BRAILLE SUBSTRATE APPROVALS 100 90 80 70 60 50 40 30 20 10 0 28/02/18 Date: DH Operator: - PREFLIGHT VERSION: - Date: - Operator: NO AUTHORITY APPROVAL SUPPLIED YES TICK APPLICABLE BOX N/A REGULATORY SIGN-OFF Name: Signature: Date: _Continued overleaf_ E3RG3RBJ1 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 2MG/ML ORAL SOLUTION METHOTREXATE FOR THE TREATMENT OF PSORIASIS AND RHEUMATOID ARTHRITIS SHOULD ONLY BE ADMINISTERED 1X/WEEK. METHOTREXATE ADMINISTERED FOR THE TREATMENT OF ONCOLOGICAL DISEASES SHOULD BE ADMINISTERED CAUTIOUSLY TAKING INTO ACCOUNT THE BODY SURFACE AREA. PLEASE NOTE THAT THIS ORAL SOLUTION CONTAINS 2MG METHOTREXATE IN 1ML SOLUTION AND THAT THE SCALING OF THE DOSING SYRINGE IS IN ML AND NOT MG. INCORRECT DOSING OF METHOTREXATE CAN RESULT IN SERIOUS POTENTIALLY FATAL ADVERSE DRUG REACTIONS. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. ■ 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Прочетете целия документ
OBJECT 1 METHOTREXATE 2MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 11-May-2018 | Rosemont Pharmaceuticals Limited 1. Name of the medicinal product METHOTREXATE FOR THE TREATMENT OF PSORIASIS AND RHEUMATOID ARTHRITIS SHOULD ONLY BE ADMINISTERED 1X/WEEK. METHOTREXATE ADMINISTERED FOR THE TREATMENT OF ONCOLOGICAL DISEASES SHOULD BE ADMINISTERED CAUTIOUSLY TAKING INTO ACCOUNT THE BODY SURFACE AREA. INCORRECT DOSING OF METHOTREXATE CAN RESULT IN SERIOUS POTENTIALLY FATAL ADVERSE DRUG REACTIONS. HEALTH CARE PROFESSIONALS AND THE PATIENTS SHOULD BE ADVISED ACCORDINGLY Methotrexate 2mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of oral solution contains 2.19mg Methotrexate disodium equivalent to 2mg Methotrexate. Excipients with known effect Sodium Methyl Parahydroxybenzoate Sodium Ethyl Parahydroxybenzoate Sulphites (from the flavour) For the full list of excipients, see section 6.1. 3. Pharmaceutical form A clear yellow oral solution. 4. Clinical particulars 4.1 Therapeutic indications Methotrexate 2mg/ml Oral Solution is indicated in the following oncological indications: • The maintenance treatment of Acute Lymphocytic Leukaemia (ALL) in children and adults. • The treatment of malignant trophoblastic tumours Methotrexate 2mg/ml Oral Solution is indicated in: • The treatment of severe active rheumatoid arthritis in adults. • The treatment of severe forms of psoriasis vulgaris including chronic plaque psoriasis, erythrodermic psoriasis, psoriatic arthritis and pustular psoriasis which are not responsive to other conventional therapies such as phototherapy, PUVA and retinoids. 4.2 Posology and method of administration Treatment with 'Methotrexate 2 mg/ml oral should be initiated and supervised by physicians with experience in antimetabolite chemotherapy and the management of the approved indications. The treatment regimen should be decided on an individual patient basis, with reference to current treatment protocols. During treatment with methotrexate patients require Прочетете целия документ