Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
LIOTHYRONINE SODIUM
Mercury Pharma Group Limited
H03AA02
LIOTHYRONINE SODIUM
POWDER FOR SOLUTION FOR INJECTION
LIOTHYRONINE SODIUM 20 microgram(s)
POM
THYROID THERAPY
Authorised
2006-03-20
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU HAVE THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Triiodothyronine injection is and what it is used for 2. Before you are given Triiodothyronine injection 3. How Triiodothyronine injection is given 4. Possible side effects 5. How to store Triiodothyronine injection 6. Further 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. BEFORE YOU ARE GIVEN TRIIODOTHYRONINE INJECTION YOU SHOULD NOT RECEIVE 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. TAKE SPECIAL CARE WITH TRIIODOTHYRONI সম্পূর্ণ নথি পড়ুন
Page 1 of 6 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 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 Dosage: 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 any components of the preparation. Liothyronine sodium is contraindicated in patients with cardiovascular disorders or angina of effort and thyrotoxicosis. Page 2 of 6 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 with ischaemic heart disease. ECG monitoring can give a useful indication of impending ischemia, however, cha সম্পূর্ণ নথি পড়ুন