国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tetracosactide acetate
Atnahs Pharma UK Ltd
H01AA02
Tetracosactide acetate
1mg/1ml
Suspension for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100; GTIN: 5036631851945 5391525930077
Synacthen Depot PIL UK 016 PACKAGE LEAFLET : INFORMATION FOR THE PATIENT SYNACTHEN ® DEPOT AMPOULES 1MG/ML TETRACOSACTIDE ACETATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. WHAT SYNACTHEN DEPOT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SYNACTHEN DEPOT 3. HOW TO USE SYNACTHEN DEPOT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SYNACTHEN DEPOT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SYNACTHEN DEPOT IS AND WHAT IT IS USED FOR Synacthen Depot belongs to a group of medicines called pituitary hormones and analogues. The pituitary gland is a small gland inside the brain which controls many other glands in the body, including the thyroid and adrenal glands. The pituitary gland produces hormones which send chemical messages to various parts of the body and affect many bodily functions such as blood pressure, blood sugar levels, growth and menstrual cycle. The adrenal glands are found on top of the kidneys and make the body’s natural steroids which can affect blood pressure and the way the body handles the sugars, protein and fats absorbed from food. They also make adrenaline which controls the body’s response to different types of stress. Synacthen Depot is similar to the hormone that the pituitary gland normally produces (called ACTH) to make the adrenal glands produce certain steroids. Synacthen Depot PIL UK 016 When Synacthen Depot is injected it works on the adrenal glands by ‘telling’ them to produce more steroids. Synacthen Depot is used in place of medicin 完全なドキュメントを読む
OBJECT 1 SYNACTHEN DEPOT AMPOULES 1MG/ML Summary of Product Characteristics Updated 19-Oct-2017 | Mallinckrodt Specialty Pharmaceuticals Ireland Limited 1. Name of the medicinal product Synacthen Depot Ampoules 1mg/ml 2. Qualitative and quantitative composition Tetracosactide acetate 1mg/ml Excipient(s) with known effect Contains benzyl alcohol (10mg/ml). Each ampoule contains a total of 3.32 mg of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Suspension for injection. Tetracosactide acetate is absorbed on to zinc phosphate. A sterile, milky white suspension, which settles on standing, in a clear glass ampoule. 4. Clinical particulars 4.1 Therapeutic indications _Therapeutic use_: Synacthen Depot should normally only be used for short-term therapy in conditions for which glucocorticoids are indicated in principle, for example, in ulcerative colitis and Crohn's disease, juvenile rheumatoid arthritis, or as adjunct therapy in patients with rheumatoid arthritis and osteoarthrosis. Synacthen Depot may be particularly useful in patients unable to tolerate oral glucocorticoid therapy or in patients where normal therapeutic doses of glucocorticoids have been ineffective. _Diagnostic use_: As a diagnostic aid for the investigation of adrenocortical insufficiency. 4.2 Posology and method of administration Posology THERAPEUTIC USE: Initially, daily doses of Synacthen Depot should be given but after approximately 3 days, intermittent doses may be given. _Adults_: Initially 1mg intramuscularly daily or 1mg every 12 hours in acute cases. After the acute symptoms of the disease have disappeared, treatment may be continued at a dose of 1mg every 2 to 3 days; in patients who respond well, the dosage may be reduced to 0.5mg every 2 to 3 days or 1mg per week. _Paediatric population:_ Due to the presence of benzyl alcohol, Synacthen Depot is contraindicated in premature babies and in neonates (less than one month). (See section 4.3 Contraindications). _Children aged 3 to 5 years_: Initially 0.25 t 完全なドキュメントを読む