Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Tetracosactide acetate
Alfasigma S.p.A
H01AA; H01AA02
Tetracosactide acetate
250 mcg/ml microgram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
ACTH; tetracosactide
Not marketed
1978-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SYNACTHEN 250 MICROGRAMS/ML, SOLUTION FOR INJECTION (TETRACOSACTIDE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET : 1. What Synacthen 250 micrograms/ml is and what it is used for 2. What you need to know before you use Synacthen 250 micrograms/ml 3. How to use Synacthen 250 micrograms/ml 4. Possible side effects 5. How to store Synacthen 250 micrograms/ml 6. Contents of the pack and other information 1. WHAT SYNACTHEN 250 MICROGRAMS/ML IS AND WHAT IT IS USED FOR Synacthen ampoules contains tetracosactide. This is a substance which stimulates the adrenal glands to produce certain hormones. Synacthen (tetracosactide) is used as a test to find out the cause of certain hormonal problems e.g., low levels of the hormone cortisol as in Addison’s disease. Two blood samples will be taken, one before the injection of Synacthen and the other 30 minutes after injection. These blood samples will show whether your adrenal glands are functioning as well as they should by measuring the hormone levels. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE SYNACTHEN 250 MICROGRAMS/ML DO NOT TAKE SYNACTHEN: if you are allergic (hypersensitive) to tetracosactide and/or ACTH (Adrenocorticotropic hormone) or any of the other ingredients of this medicine (listed in section 6). If you have allergic disorders (e.g. asthma). 2 WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Synacthen if you have previously experienced adverse reactions to ACTH, Synacthen or other drugs. TA Read the complete document
Health Products Regulatory Authority 09 March 2022 CRN009PDJ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Synacthen 250 micrograms/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE One ampoule of 1 ml contains 250 micrograms of Tetracosactide (as tetracosactide acetate). EXCIPIENT WITH KNOWN EFFECT: One ampoule of 1 ml contains 3.33 mg of sodium (as sodium acetate and sodium chloride). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. As a diagnostic test for the investigation of adrenocortical insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS This preparation of Synacthen is intended for administration for diagnostic purposes only as a single intramuscular or intravenous dose; it is not to be used for repeated therapeutic administration. _ _ _The 30-minute Synacthen diagnostic test_ This test is based on measurement of the plasma cortisol concentration immediately before and exactly 30 minutes after an intramuscular or intravenous injection of 250mcg (1ml) Synacthen. Adrenocortical function can be regarded as normal if the post-injection rise in plasma cortisol concentration amounts to at least 200nmol/litre (70mcg/litre). All plasma samples should be stored in a refrigerator until plasma cortisol level estimation. SPECIAL POPULATIONS RENAL IMPAIRMENT No studies have been performed in patients with renal impairment. HEPATIC IMPAIRMENT No studies have been performed in patients with hepatic impairment ELDERLY POPULATION (AGED 65 YEARS AND ABOVE) There is no evidence to suggest that dosage should be different in the elderly. USE IN CHILDREN An intravenous dose of 250mcg/1.73 m 2 body surface area has been suggested. Thus for children aged 5-7 years, approximately half the adult dose will be adequate. For more accurate dosing of other ages, standard body Read the complete document