国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
THIAMAZOLE
MERCK TBK - Indonesia
THIAMAZOLE
5 Mg
TABLET SALUT SELAPUT
DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT
MERCK KGAA - Federal Republic of Germany
2019-11-15
_Page 1 of 9 _ THYROZOL® THIAMAZOLE ANTITHYROID 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Thyrozol 5 mg film-coated tablet contains 5 mg Thiamazole. Each Thyrozol 10 mg film-coated tablet contains 10 mg Thiamazole. Excipient(s): Contains 200 mg Lactose monohydrate per tablet (Thyrozol 5 mg), see section 3.4 Special Warnings and Special Precautions for Use. Contains 195 mg Lactose monohydrate per tablet (Thyrozol 10 mg), see section 3.4 Special Warnings and Special Precautions for Use. For a full list of excipients, see section 5.1 List of Excipient. 2. PHARMACEUTICAL FORM Film-coated tablet. 3. CLINICAL PARTICULARS 3.1 INDICATIONS Drug treatment of hyperthyroidism, especially in slight or absent thyroid enlargement (goitre) as well as in younger patients. Preparation for surgery in all forms of hyperthyroidism. Preparation of patients with hyperthyroidism for planned radioiodine treatment to prevent the risk of a thyrotoxic crisis after therapy. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION CONSERVATIVE TREATMENT OF HYPERTHYROIDISM Two different dosage regimens are recommended: a) Complete blocking of thyroid hormone production is achieved with daily doses of 25 to at the most 40 mg Thiamazole. Initial therapy (to achieve normal metabolic activity of the thyroid gland): Maximum daily dose: 40 mg Thiamazole in single doses of maximally 20 mg Thiamazole, depending on the severity of the disease. 2 times 1 tablet Thyrozol 10 mg (20 mg) - mild cases 2 times 1 tablet Thyrozol 20 mg (40 mg) - severe cases. After normalization of the thyroid function (generally between weeks 3 and 8) the dose is stepwise reduced in long-term treatment to a maintenance dose of 5 to 20 mg daily. This dosage usually requires the additional administration of thyroid hormones. b) In therapy with Thyrozol alone the dose depends on metabolic activity which must be checked individually in each patient, paying particular attention to the TSH (= Thyroid Stimulating Hormone) DISETUJUI OLEH BPOM: 31/12/2021 EREG100149VR12100180 EREG 阅读完整的文件