Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methylprednisolone sodium succinate
Pfizer 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: 5012882001070
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PFIZER SOLU-MEDRONE ® 40 MG, 125 MG, 500 MG, 1 GRAM 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, ask your doctor or pharmacist. 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 SOLU-MEDRONE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-MEDRONE 3. HOW SOLU-MEDRONE IS GIVEN TO YOU 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SOLU-MEDRONE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SOLU-MEDRONE IS AND WHAT IT IS USED FOR Solu-Medrone 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 Solu-Medrone 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 tuberculosis meningitis BOWEL and GUT e.g. ‘Crohn’s disease’ and ‘ulcerative colitis’ LUNGS caused by asthma, severe allergy or hypersensitivity, tuberculosis or breathing in (aspirating) vomit or stomach contents SKIN e.g. Stevens-Johnson Syndrome. Solu-Medrone may be prescribed to treat conditions other than those listed above. Talk to your doctor if you are unsure why you have been given this medicine, if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-MEDRONE DO NOT USE SOLU-MEDRONE: If you think you have ever suffered an ALLERGIC REACTION, or any other type of reacti Read the complete document
OBJECT 1 SOLU-MEDRONE 500MG Summary of Product Characteristics Updated 14-Jun-2017 | Pfizer Limited 1. Name of the medicinal product Solu-Medrone 500 mg or methylprednisolone sodium succinate for injection. 2. Qualitative and quantitative composition Solu-Medrone 500 mg: Methylprednisolone sodium succinate 663.0 mg equivalent to 500 mg of methylprednisolone. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for injection. 4. Clinical particulars 4.1 Therapeutic indications Solu-Medrone 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 anti-tuberculous 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 Solu-Medrone may be administered intravenously or intramuscularly, the preferred method for emergency use being intravenous injection given over a suitable time interval. When administering Solu- Medrone in high doses intravenously it should be given over a period of at least 30 minutes. Doses up to 250 mg should be given intravenously over a period of at least five minutes. For intravenous infusion the initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. To avoid compatibility problems with other drugs Solu-Medrone should be administered separately, only in the solutions mentioned. Undesirable effects may be minimised Read the complete document