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
NORETHISTERONE
BAYER INDONESIA - Indonesia
NORETHISTERONE
5 Mg
TABLET
DUS, 2 BLISTER @ 15 TABLET
BAYER WEIMAR GMBH UND CO. KG - Federal Republic of Germany
2019-04-17
COMPOSITION AND DESCRIPTION COMPOSITION Each tablet of PLETAAL Tablets 50 contains 50 mg of cilostazol. Each tablet of PLETAAL Tablets 100 contains 100 mg of cilostazol. Each capsule of PLETAAL SR Capsules 100 mg contains 100 mg of cilostazol PRODUCT DESCRIPTION BRAND NAME DESCRIP TION APPEARANCE DIAM ETER (MM) THICKNE SS (MM) WEIGHT (MG) CODE PLETAAL TABLETS 50 White compres sed Tablets 7 2.5 Ca 115 OG31 PLETAAL TABLETS 100 White compres sed Tablets 8 3.0 Ca 170 OG30 PLETAAL SR CAPSULES 100 mg White capsules filled with white granules, imprinted “OG29” in black ink. Approx . 18 Approx. 6 Approx. 206.8 OG29 INDICATIONS • Treatment of ischemic symptoms, including ulceration, pain, and coldness of the extremities, in chronic arterial occlusion • Prevention of recurrence of cerebral infarction (excluding cardiogenic cerebral embolism) CONTRAINDICATIONS (CILOSTAZOL IS CONTRAINDICATED IN THE FOLLOWING PATIENTS.) 1. Patients with hemorrhage (e.g.,hemophilia, increased capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body) (Bleeding tendency may be increased.) 2. Patients with congestive heart failure (Condition may be worsened.) (See item (5) under 2. IMPORTANT PRECAUTIONS.). 3. Patients with a history of hypersensitivity to any ingredient of the drug. 4. Women who are pregnant or may possibly become pregnant (See 4. USE DURING PREGNANCY, DELIVERY, OR LACTATION.) DOSAGE AND ADMINISTRATION PLETAAL TABLET The usual adult dose of PLETAAL Tablets is 100 mg of Cilostazol, twice daily by the oral route. The dosage may be adjusted according to the age of the patients and the severity of symptoms. PLETAAL SR CAPSULES 100 MG The usual adult dose of PLETAAL SR Capsules 100 mg is 200 mg of cilostazol, once daily, by the oral route. This drug is taken on an empty stomach without food. PHARMACOLOGY 1. ANTIPLATELET ACTION (1) _In vitro_ studies • Cilostazol inhibited platelet aggregati 阅读完整的文件