Country: Egypt
Language: English
Source: EDA (Egyptian Drug Authority)
NOVARTIS PHARMA EGYPT
1 mg/ml
injection
1 ampoule
NOVARTIS PHARMA-SWITZERLAND
1998-06-02
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 015 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 medicines like prednisolone or cor Read the complete document
SAFETY DATA SEEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Identification number Name of the substance Synacthen Depot - - Registration number ACTH (1-24) * α1-24-Corticotropin * Tetracosactrin * Cosyntropin * ACTH (adrenocorticotropic hormone fragment) * Tetracosactide hexaacetate * .alpha.1-24-Corticotropin, acetate (salt) Synonyms SYNAM SDS number SYNAM Item Code 18-January-2018 Issue date 02 Version number 01-October-2019 Revision date 18-January-2018 Supersedes date 1.2. Relevant identified uses of the substance or mixture and uses advised against Drug product (pharmaceutical bulk, primary packed, finished product, pharmaceutical intermediate. Identified uses None known. Uses advised against 1.3. Details of the supplier of the safety data sheet Mallinckrodt Pharmaceuticals Company name College Business and Technology Park Address Cruiserath Road Blanchardstown, Dublin 15, Ireland Customer Service 353 1 696 0000 (Worldwide) Brands.SDS@mnk.com e-mail 0 800 680 0425/ GB)+44 20 35147487 (Access Code: 335277) Emergency telephone number 1.4. Emergency telephone number 112 (Available 24 hours a day. SDS/Product information may not be available for the Emergency Service.) General in EU SECTION 2: Eazards identification 2.1. Classification of the substance or mixture The substance has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Regulation (EC) No 1272/2008 as amended H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. Category 1 Respiratory sensitisation Eealth hazards H317 - May cause an allergic skin reaction. Category 1 Skin sensitisation Eazard summary Harmful if inhaled. May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. 2.2. Label elements Label according to Regulation (EC) No. 1272/2008 as amended Contains: Sodium chloride, Ttetracosactide hexaacetate E Read the complete document