البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BOSENTAN AS MONOHYDRATE
J-C HEALTH CARE LTD
C02KX01
FILM COATED TABLETS
BOSENTAN AS MONOHYDRATE 62.5 MG
PER OS
Required
ACTELION PHARMACEUTICALS LTD., SWITZERLAND
BOSENTAN
BOSENTAN
Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV.Reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease.
2022-05-31
1 Tracleer 62.5 mg and Tracleer 125 mg_PI_ December-2023 TRACLEER ® PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate). Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate). Excipient with known effect This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to sayessentially ‘sodium-free’ . For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablets): Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62.5” on one side. Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side. Patient Alert Card The marketing of Tracleer is subject to a risk management plan (RMP) including 'Patient Alert Card'. The 'Patient Alert Card' emphasizes important safety information that the patient should be aware of before and during treatment. The Patient Alert Card is included in the pack, please explain to the patient the need to review the card before starting treatment. WARNING: EMBRYO-FETAL TOXICITY Do not administer Tracleer to a pregnant female because it may cause fetal harm [see Contraindications (4.3) and Fertility, pregnancy and lactation (4.6)]. Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception [see Fertility, pregnancy and lactation (4.6)]. 2 Tracleer 62.5 mg and Tracleer 125 mg_PI_ December-2023 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV. Reductio اقرأ الوثيقة كاملة