Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
LEVOTHYROXINE SODIUM
MERCK SERONO LTD
H03AA01
TABLETS
LEVOTHYROXINE SODIUM 100 MCG
PER OS
Required
MERCK HEALTHCARE KGAA, GERMANY
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM
Euthyrox 25 - 200 microgram :- Treatment of benign euthyroid goitre.- Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post - operative hormone status.- Substitution therapy in hypothyroidism.- Suppression therapy in thyroid cancer.Euthyrox 25 - 100 microgram :- Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism.Euthyrox 100/150/200 microgram :- Diagnostic use for thyroid suppression testing.
2017-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Euthyrox ® 25 microgram Euthyrox ® 50 microgram Euthyrox ® 100 microgram Tablets The active ingredient: Each tablet contains levothyroxine sodium 25, 50 or 100 mcg. Inactive ingredients and allergens in the medicine: see section 2 under “Important information regarding some of the ingredients of the medicine” and section 6 “Further information”. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR Euthyrox, in various dosages, is used to treat the following conditions: • benign enlargement of the thyroid gland (benign goitre - swelling of the neck due to enlargement of the thyroid gland) in patients with normal thyroid function • prevention of recurrence of goitre after surgery • as a substitute for the natural hormone produced by the thyroid gland, if your thyroid gland does not produce enough thyroxine • suppression of tumor regrowth in patients with thyroid cancer • to balance the levels of the hormone produced by the thyroid gland, when hyperthyroidism is treated with medicines that inhibit thyroid gland activity At a dosage of 100 mcg and above, Euthyrox is used to test thyroid function. Therapeutic group: Thyroid gland hormone. Levothyroxine, the active substance in Euthyrox, is a synthetic substitute for the natural hormone produced by the thyroid gland and is used to treat diseases or dysfunction of the thyroid gland. Levothyroxine has the same activity as the natural hormone produced by the thyroid gland. 2. BEFORE USING THE MEDICINE In order to ensure the continuity o Soma hati kamili
Prescribing information 1. NAME OF THE MEDICINAL PRODUCT Euthyrox ® 25 microgram tablets Euthyrox ® 50 microgram tablets Euthyrox ® 100 microgram tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet Euthyrox 25 microgram contains 25 microgram levothyroxine sodium. 1 tablet Euthyrox 50 microgram contains 50 microgram levothyroxine sodium. 1 tablet Euthyrox 100 microgram contains 100 microgram levothyroxine sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription on one side: Euthyrox 25 microgram EM 25 Euthyrox 50 microgram EM 50 Euthyrox 100 microgram EM 100 The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Euthyrox 25 - 200 microgram: - Treatment of benign euthyroid goitre - Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post-operative hormone status - Substitution therapy in hypothyroidism - Suppression therapy in thyroid cancer Euthyrox 25 – 100 microgram: - Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism Euthyrox 100/150/200 microgram: - Diagnostic use for thyroid suppression testing 4.2 Posology and method of administration Posology 2 The dosage recommendations given are only for guidance. The individual daily dose should be determined on the basis of laboratory tests and clinical examinations. As a number of patients show elevated concentrations of T 4 and fT 4, basal serum concentration of thyroid- stimulating hormone provides a more reliable basis for following treatment course. Thyroid hormone therapy should be started at low dose and increased gradually every 2 to 4 weeks until the full replacement dose is reached. _Paediatric population _ For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15 micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be ad Soma hati kamili