Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methylprednisolone sodium succinate
Kent Pharma (UK) Ltd
H02AB04
Methylprednisolone sodium succinate
500mg
Powder and solvent for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5060061160667
481384_1216 PIL METILPREDNISOLONA 22/12/16 08:30 página 1 481384/1216 148 x 560 mm Black P.273 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METHYLPREDNISOLONE 500 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION METHYLPREDNISOLONE 1000 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION Methylprednisolone sodium succinate 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 please ask your doctor or pharmacist • This medicine has been prescribed for you. 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 side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Methylprednisolone is and what it is used for 2. What you need to know before you are given Methylprednisolone 3. How Methylprednisolone is given to you 4. Possible side effects 5. How to store Methylprednisolone 6. Contents of the pack and other information. 1. W HAT M ETHYLPREDNISOLONE IS AND WHAT IT IS USED FOR Methylprednisolone contains methylprednisolone sodium succinate. Methylprednisolone belongs to a group of medicines called corticosteroids (steroids). Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Methylprednisolone can help following surgery (e.g. organ transplants), flare- ups of the symptoms of multiple sclerosis or other stressful conditions. These include inflammatory or allergic conditions affecting the: • BRAIN caused by a tumour or meningitis • BOWEL and GUT e.g. ‘Crohn’s disease’ and ‘ulcerative colitis’ • LUNGS caused by asthma, severe allergy or hypersensitivity, tuberculos Læs hele dokumentet
OBJECT 1 METHYLPREDNISOLONE 500 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 25-Jan-2017 | Beacon Pharmaceuticals 1. Name of the medicinal product Methylprednisolone 500 mg powder and solvent for solution for injection/infusion 2. Qualitative and quantitative composition Each vial of powder contains methylprednisolone sodium succinate 663.0 mg equivalent to 500 mg of methylprednisolone. After reconstitution in water for injections, each ml of solution contains the equivalent of 59.6 mg of methylprednisolone. Each ampoule of solvent contains 7.8 ml of water for injections. Sodium content: the 500 mg methylprednisolone vials contain the equivalent of 37.4 mg (1.6 mmol) of sodium. For a full list of excipients, see section 6.1 3. Pharmaceutical form Powder and solvent for solution for injection/infusion. Each vial of methylprednisolone sodium succinate contains a white or almost white amorphous powder. Each ampoule of solvent contains water for injections. 4. Clinical particulars 4.1 Therapeutic indications Methylprednisolone powder and solvent for injection/infusion is indicated to treat any condition in which rapid and intense corticosteroid effect is required such as: 1. Dermatological disease Severe erythema multiforme (Stevens Johnson syndrome) 2. Allergic states Bronchial asthma Severe seasonal and perennial allergic rhinitis Angioneurotic oedema Anaphylaxis 3. Gastro intestinal diseases Ulcerative colitis Crohn's disease 4. Respiratory diseases Aspiration of gastric contents Fulminating or disseminated tuberculosis (with appropriate antituberculous chemotherapy) 5. Neurological disorders Cerebral oedema secondary to cerebral tumour Acute exacerbations of multiple sclerosis superimposed on a relapsing/remitting background. 6. Miscellaneous T.B. meningitis (with appropriate antituberculous chemotherapy) Transplantation 4.2 Posology and method of administration Posology Methylprednisolone powder for injection/infusion may be administered intravenously or in Læs hele dokumentet