Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TADALAFIL
ABBOTT INDONESIA - Indonesia
TADALAFIL
10.00 MG
ORODISPERSIBLE FILM
DUS, 4 SACHET @ 1 ORODISPERSIBLE FILM
CTCBIO INC - Republic Of Korea
2019-12-31
CALIBERI ® TADALAFIL 1. NAME OF THE MEDICINAL PRODUCT CALIBERI ® 5 mg, 10 mg and 20 mg orodispersible films. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible film contains 5 mg, 10 mg or 20 mg tadalafil. Excipients: Each orodispersible film contains 0,2; 0,4 or 0,8 mg sucralose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible film. The 5 mg, 10 mg and 20 mg orodispersible films are light yellow orodispersible films. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of erectile dysfunction in adult men (ED). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: CALIBERI ® is available as 5 mg, 10 mg and 20 mg orodispersible films for oral use. POSOLOGY: USE IN ADULT MEN ERECTILE DYSFUNCTION The recommended dose is 10 mg taken prior to anticipated sexual activity and without regard to food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dosing frequency is once per day. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. In patients who anticipate a frequent use of CALIBERI ® (i.e., at least twice weekly) a once daily regimen with the lowest doses of CALIBERI ® might be considered suitable, based on patient choice and the physician's judgment. In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The appropriateness of continued use of the daily regimen should be reassessed periodically. DISETUJUI OLEH BPOM : 21/11/2019 EREG10034611800025 EREG10034611800026 EREG10034611800027 EREG10034611800028 EREG10034611800029 EREG10034611800030 EREG10034611800031 EREG10034611800032 EREG10034611800033 USE IN ELDERLY MEN Dosage adjustments are not required in elderly patients. USE IN MEN WITH IMPAIRED RENAL FUNCTION Dosage adjustments are not required in patients with mild to moderate renal im Lugege kogu dokumenti