Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
thyrotropin alfa
Sanofi B.V.
H01AB01
thyrotropin alfa
Anterior pituitary lobe hormones and analogues, Pituitary and hypothalamic hormones and analogues
Thyroid Neoplasms
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST).Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
Revision: 29
Authorised
2000-03-09
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER THYROGEN 0.9 MG POWDER FOR SOLUTION FOR INJECTION Thyrotropin alfa _ _ 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 . - If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Thyrogen is and what it is used for 2. What you need to know before you use Thyrogen 3. How to use Thyrogen 4. Possible side effects 5. How to store Thyrogen 6. Contents of the pack and other information 1. WHAT THYROGEN IS AND WHAT IT IS USED FOR Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes. Thyrogen is used to detect certain types of thyroid cancer in patients who have had their thyroid gland removed and who are taking thyroid hormones. One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging. It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left. These hormones can be measured in your blood. Thyrogen is also used with radioiodine treatment to eliminate (ablate) the thyroid tissue left over after surgical removal of the thyroid gland (remnant) in patients who do not have secondary cancer growths (metastases) and who are taking thyroid hormone. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE THYROGEN DO NOT USE THYROGEN: • if you are allergic to bovine or human thyroid stimulating hormone (TSH) or any of the other ingredients of this medicine (listed in section 6). • if you are pregnant. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Thyrogen • if you have kidney disease that requires dialysis and Прочетете целия документ
1 ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Thyrogen 0.9 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa. Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rhTSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be supervised by physicians with expertise in thyroid cancer. Posology The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only. _Paediatric population _ Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances. 3 _Elderly _ Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic Прочетете целия документ