MONUROL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FOSFOMYCIN AS TROMETAMOL

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

J01XX01

الشكل الصيدلاني:

POWDER FOR ORAL SOLUTION

تركيب:

FOSFOMYCIN AS TROMETAMOL 3 G/SACHET

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ZAMBON SWITZERLAND LTD., SWITZERLAND

المجموعة العلاجية:

FOSFOMYCIN

المجال العلاجي:

FOSFOMYCIN

الخصائص العلاجية:

A single-dose treatment for acute, uncomplicated urinary tract infection and as prophylaxis in diagnostic and surgical transurethral procedures.

تاريخ الترخيص:

2022-11-30

نشرة المعلومات

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
MONUROL
POWDER FOR ORAL SOLUTION
SACHET
ACTIVE INGREDIENT:
Each sachet contains: Fosfomycin (as trometamol) 3 g
For the list of the additional ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients’ in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
•
For single-dose treatment of acute uncomplicated urinary tract
infection .
•
For preventive treatment of infections subsequent to surgical or
diagnostic procedures of
the lower urinary tract.
THERAPEUTIC GROUP: antibiotic medicine.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients
the medicine contains (for the list of the additional ingredients, see
section 6).
•
You suffer from severe kidney failure (creatinine clearance of less
than 10 ml/min).
•
•
You are a dialysis patient.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TREATMENT WITH MONUROL TELL THE DOCTOR IF:
•
You suffer from persistent bladder infections.
•
You previously suffered from diarrhea after taking any antibiotic
medicine.
•
You suffer or have suffered in the past from impaired kidney function.
ADDITIONAL WARNINGS:
Conditions you need to pay attention to:
The medicine may cause serious side effects. These effects include
allergic reactions and
inflammation of the large intestine. You must pay attention to
symptoms while you are taking the
medicine, to reduce the risk of any problems. See 'Serious side
effects' i

خصائص المنتج

MONUROL-DL-Nov 2022-02
1. NAME OF THE MEDICINAL PRODUCT
Monurol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains 5.631 gram of fosfomycin trometamol equivalent to
3 gram fosfomycin
Excipient(s) with known effect:
One sachet contains 2.213 g of sucrose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A single-dose treatment for acute, uncomplicated urinary tract
infection and as prophylaxis in
diagnostic and surgical transurethral procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for the treatment of acute uncomplicated lower
urinary tract infections is a single 3 g sachet in adults.
The recommended regimen for the prophylaxis of urinary tract
infections in surgery and diagnostic procedure involving lower
urinary tract in adult males and females is one Monurol 3 g sachet 3
hours before surgery and one 3 g sachet 24 hours after
surgery.
Children and young people weighing less than 50 kg and/ or below 12
years old (see Special warnings and precautions for
use).
Method of administration
Monurol is for oral administration. It should be taken on an empty
stomach, about 2-3 hours before or after eating, preferably
before bedtime, after emptying the bladder. The dose should be
dissolved into a glass of water and taken immediately after its
preparation.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with severe renal failure (creatinine clearance < 10mL/min).
Patients undergoing haemodialysis.
4.4
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 reactions
occur, treatment with fosfomycin must be discontinued
immediately and adequate emergency measures must be initiated.
_Clostridioides d