Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone sodium succinate
Pfizer Ltd
H02AB09
Hydrocortisone sodium succinate
100mg
Powder and solvent for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5012882006051
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOLU-CORTEF ® 100 MG hydrocortisone sodium succinate PFIZER 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, nurse or pharmacist. 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. WHAT IS IN THIS LEAFLET 1. WHAT SOLU-CORTEF IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-CORTEF 3. HOW SOLU-CORTEF IS GIVEN TO YOU 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SOLU-CORTEF 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SOLU-CORTEF IS AND WHAT IT IS USED FOR Solu-Cortef contains hydrocortisone sodium succinate. Hydrocortisone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid such as Solu-Cortef can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your ADRENAL GLANDS (e.g. adrenal insufficiency). Corticosteroids can also help treat SHOCK following surgery, injuries, hypersensitivity (ANAPHYLACTIC) reactions or other stressful conditions. These include inflammatory or allergic conditions affecting the: BOWEL and GUT e.g. Crohn’s disease (inflammation of the gut) or ulcerative colitis (inflammation of the lower bowel) LUNGS e.g. bronchial asthma or inflammation caused by breathing in (aspirating) vomit or stomach contents SKIN e.g. Stevens-Johnson syndrome (an autoimmune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus) Solu-Cortef may be prescribed to treat conditions other than those listed above, such as adrenal insufficiency and other medical Lesen Sie das vollständige Dokument
OBJECT 1 SOLU-CORTEF Summary of Product Characteristics Updated 08-May-2018 | Pfizer Limited 1. Name of the medicinal product Solu-Cortef 100 mg 2. Qualitative and quantitative composition Each vial contains hydrocortisone sodium succinate 133.7 mg equivalent to hydrocortisone 100 mg. Excipient with known effect: Each vial contains 10.14 mg of sodium For the full list of excipients, see section 6.1 3. Pharmaceutical form White, freeze dried powder for parenteral use. 4. Clinical particulars 4.1 Therapeutic indications Anti-inflammatory agent. Solu-Cortef is indicated for any condition in which rapid and intense corticosteroid effect is required such as: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency 2. Collagen diseases Systemic lupus erythematosus 3. Dermatological diseases Severe erythema multiforme (Stevens-Johnson syndrome) 4. Allergic states Bronchial asthma, anaphylactic reactions 5. Gastro-intestinal diseases Ulcerative colitis, Crohn's disease 6. Respiratory diseases Aspiration of gastric contents 7. Medical emergencies Solu-Cortef is indicated in the treatment of shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present. 4.2 Posology and method of administration Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation. Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. In general high-dose corticosteroid therapy should be continued only until the patient's condition has stabilised - usually not Lesen Sie das vollständige Dokument