Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
LIOTHYRONINE SODIUM
Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom
H03AA02
LIOTHYRONINE SODIUM 20 µg
POWDER FOR SOLUTION FOR INJECTION
LIOTHYRONINE SODIUM 20 µg
POM
THYROID THERAPY
Withdrawn
2006-03-20
PACKAGE LEAFLET: INFORMATION FOR THE USER TRIIODOTHYRONINE 20 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION Liothyronine Sodium 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, pharmacist or nurse. 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 Triiodothyronine injection is and what it is used for 2 What you need to know before you use Triiodothyronine injection 3. How to use Triiodothyronine injection 4. Possible side effects 5. How to store Triiodothyronine injection 6. Contents of the pack and other information 1. WHAT TRIIODOTHYRONINE INJECTION IS AND WHAT IT IS USED FOR Triiodothyronine injection contains liothyronine sodium which is a quick acting, naturally occurring form of the hormone thyroxine. Thyroxine is normally produced by the thyroid gland in the neck. It controls many bodily functions, mainly to do with growth and energy. Triiodothyronine injection is used to treat severe under activity of the thyroid gland (myxoedema) when it is not possible to give thyroid treatment by mouth. It may be used with other medicines such as steroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRIIODOTHYRONINE INJECTION DO NOT USE TRIIODOTHYRONINE INJECTION IF: • you know that you are allergic to liothyronine sodium or any of the other ingredients of Triiodothyronine injection (see section 6 of this leaflet) • you have a disease involving the heart or blood vessels. • you have pain in the chest (angina pectoris) • you have an overactive thyroid gland with raised levels of thyroid hormones (thyrotoxicosis). Please tell your doctor before you are given this injection if any of the above applies to you. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Triiodothyronine injection if y Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triiodothyronine 20 micrograms Powder for Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20mcg liothyronine sodium BP Excipient(s) with known effect: Dextran 110 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sterile Intravenous injection, packed as a freeze-dried white plug, in a neutral glass ampoule for reconstitution with 1 or 2ml water for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is indicated for the treatment of myxoedema coma, usually in conjunction with other measures including the intravenous injection of a corticosteroid. For the treatment of less severe forms of myxoedema and for maintenance therapy, orally administered liothyronine should be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 5 to 20 micrograms given by slow intravenous injection and repeated at intervals of 12 hours or less if required. The minimal interval between dosing is 4 hours. An initial dose of 50 micrograms intravenously is used by some physicians, followed by further intravenous injections of 25 micrograms every 8 hours until improvement occurs. The dosage may then be reduced to 25 micrograms intravenously twice daily. Method of administration: Usually given by intravenous injection, as the alkalinity of the solution may cause irritation of the tissues if given by deep intramuscular injection. The solution is prepared by adding 1 or 2ml water for injection to the ampoule and shaking gently until the solution has dissolved. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Liothyronine sodium is contraindicated in patients with cardiovascular disorders or angina of effort and thyrotoxicosis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Liothyronine must be given with extreme caution in myxoedema coma because too large a dose can precipitate heart failure, especially in the elderly patients and those w Prečítajte si celý dokument