Monural granules for oral solution

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

fosfomycin (fosfomycin trometamol)

Disponible des:

Zambon Switzerland Ltd.

Codi ATC:

J01XX01

Designació comuna internacional (DCI):

fosfomycin (fosfomycin trometamol)

Dosis:

3g

formulario farmacéutico:

granules for oral solution

Unidades en paquete:

(1) sachet 8g, (2) sachets 8g

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2020-06-30

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MONURAL 3 g granules for oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_MONURAL 3 g granules for oral solution _
Each sachet contains:
Active substance: fosfomycin 3.0 g (as fosfomycin trometamol 5.631 g)
Excipients: mandarine flavoring 0.07 g, orange flavoring 0.07 g,
saccharin 0.016 g, sucrose 2.213 g (corresponding to
37 kJ or 0,088 carbohydrate exchange).
Composition of orange flavouring: Flavouring 8%, maize maltodextrin
72%, modified waxy maize starch E1450 10%
Composition of mandarin flavouring: Flavouring 7,4%, sugar 70%, arabic
gum E414 22%, calcium phosphate E341 0.6%,
butylated hydroxyanisole (BHA) E320 <0,01%
3. PHARMACEUTICAL FORM
Granules for oral solution.
White to off‐white granules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Monural is indicated for the treatment of the following infections,
caused by fosfomycin‐sensitive pathogens:
•
acute, uncomplicated urinary tract infections
•
asymptomatic bacteriuria
•
prophylaxis in surgical or diagnostic procedures involving lower
urinary tract (e.g. TUR)
Should take into account the recommendations given to official
guidance on the appropriate use of antibiotics; in
particular in order to avoid the increase in antibiotic resistance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
USUAL DOSE
Adults: 1 sachet of Monural 3 g as single dose.
Prophylaxis: 1 sachet of Monural 3 g approximately 3 hours before and
24 hours after surgery.
Children and adolescents below 50 kg body weight: As the experience in
children is limited and Monural 3 g, due to its
dosage strength, is not suitable for children and adolescents under 50
kg body weight, Monural should not be used in
this age group.
CORRECT METHOD OF ADMINISTRATION
Monural should be taken on an empty stomach, i.e. 2‐3 hours before
or after meals, preferably in the evening before
bedtime, after emptying the bladder.
Monural should be dissolved in a glass of water or in another
non‐alcoholic drink and taken immediate