Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FOSFOMYCIN TROMETAMOL
TUNGGAL IDAMAN ABDI - Indonesia
FOSFOMYCIN TROMETAMOL
5.631 G
GRANULA
DUS, 1 SACHET @ 3 G
ZAMBON SWITZERLAND LTD. - Switzerland
2020-03-15
MONURIL ® 3G FOSFOMYCIN TROMETAMOL COMPOSITION : MONURIL 3 g granules for oral solution: Each sachet contains: Fosfomycin Trometamol 5.631 g (equivalent to 3 g fosfomycin). Each sachet contains white granular powder with a characteristic odour of mandarin flavour. Monuril also contain mandarin flavour, orange flavour, saccharin and.sucrose. CLINICAL PARTICULARS INDICATION : - The treatment of acute, uncomplicated cystitis in women and female adolescents - Perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult man Consideration should be given to official guidance on the appropriate use of antibacterial agents POSOLOGY AND METHOD OF ADMINISTRATION : ACUTE, UNCOMPLICATED CYSTITIS IN WOMEN AND FEMALE ADOLESCENTS (>12 YEARS OF AGE): 3 g Fosfomycin once PERIOPERATIVE ANTIBIOTIC PROPHYLAXIS FOR TRANSRECTAL PROSTATE BIOPSY: 3 g Fosfomycin 3 hours prior to the procedure. Method of administration For oral use. For the indication of acute, uncomplicated cystitis in women and female adolescents it should be taken on an empty stomach (about 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after emptying the bladder. The dose should be dissolved into a glass of water, and taken immediately after its preparation CONTRAINDICATIONS : Hypersensitivity to the active substance or to any of the excipients. Use of Monuril is not recommended in patients with renal impairment (creatinin clearance < 80 ml/min) SPECIAL WARNINGS AND PRECAUTIONS FOR USE : Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during Fosfomycin treatment (see sections 4.3 and 4.8). If such reaction occurs, treatment with Fosfomycin must be discontinued immediately and adequate emergency measures must be initiated. Clostridioides difficile-associated diarrhea Clostridioides difficile-associated colitis and pseudo-membranous colitis have been reported with Fosfomycin and may range in severity from mild to life-threatening (s Baca dokumen lengkap