MONURIL

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

FOSFOMYCIN TROMETAMOL

Tilgængelig fra:

TUNGGAL IDAMAN ABDI - Indonesia

INN (International Name):

FOSFOMYCIN TROMETAMOL

Dosering:

5.631 G

Lægemiddelform:

GRANULA

Enheder i pakken:

DUS, 1 SACHET @ 3 G

Fremstillet af:

ZAMBON SWITZERLAND LTD. - Switzerland

Autorisation dato:

2020-03-15

Produktets egenskaber

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