UroFos

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g;  

متاح من:

Te Arai BioFarma Limited

جرعة:

3 g

الشكل الصيدلاني:

Oral granules

تركيب:

Active: Fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g   Excipient: Orange flv pdr FA-01142 (20375254) Saccharin sodium Sucrose Tangerine flv pdr FA-00898 (20375218)

نوع الوصفة الطبية :

Prescription

الخصائص العلاجية:

Treatment of uncomplicated actue cystitis caused by pathogens susceptible to fosfomycin in adult women and adolescents aged over 12.

ملخص المنتج:

Package - Contents - Shelf Life: Sachet, surlyn/aluminium/LDPE/paper - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Sachet, surlyn/aluminium/LDPE/paper - 2 dose units - 36 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2018-02-26

نشرة المعلومات

New Zealand Consumer Medicine Information
UROFOS
_FOSFOMYCIN (AS FOSFOMYCIN TROMETAMOL)_
3 g granules for oral solution
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using UROFOS.
This leaflet answers some common questions about UROFOS. It does not
contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
UROFOS against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT UROFOS IS USED FOR
UROFOS contains the active ingredient fosfomycin trometamol and it
belongs to a
group of medicines called antibiotics.
UROFOS is only used to treat uncomplicated infections of the bladder
in females. It
works by killing bacteria which can cause infections.
Ask your doctor if you have any questions about why UROFOS has been
prescribed
for you.
This medicine is available only with a doctor's prescription.
UROFOS is not addictive.
1
BEFORE YOU USE UROFOS
_ _
_ _
_WHEN YOU MUST NOT USE IT _
Do not use UROFOS if:
•
are allergic to fosfomycin trometamol or any of the other ingredients
listed at
the end of this leaflet
•
have severe kidney problems (creatinine clearance below 10 ml/min)
•
are undergoing haemodialysis.
Some of the symptoms of an allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives on the skin.
Do not give this medicine to a child under the age of 12 years.
Safety and effectiveness in children younger than 12 years have not
been
established.
Do not take this medicine after the expiry date printed on the pack or
if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for
disposa
If you are not sure whether you should

خصائص المنتج

NEW ZEALAND DATA SHEET
New Zealand Data Sheet UroFos v1.0 June 2020
Page 1 of 7
1 PRODUCT NAME
UroFos 3 g granules for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 3 g of fosfomycin (as fosfomycin trometamol)
Excipient(s) with known effect: each sachet contains 2.216 g of
sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral solution.
White or almost white granules.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of uncomplicated acute cystitis caused by pathogens
susceptible to fosfomycin in adult
women and adolescents aged over 12.
Prophylaxis of urinary tract infections during surgery and
trans-urethral diagnostic maneuvers.
4.2
Dose and method of administration
-
Treatment of uncomplicated acute cystitis in adult women and
adolescents (aged over 12): 1
sachet of 3 g (single dose).
-
Prophylaxis
of
urinary
tract
infections
during
surgery
and
trans-urethral
diagnostic
maneuvers: 1 sachet of 3 g administered 3 hours before surgery and a
second sachet
administered 24 hours after the surgery.
_Renal impairment_
This medicine is not to be used in patients with severe renal failure,
nor haemodialyzed patients (see
section 4.3.).
For patients with mild to moderate renal impairment, dose adjustments
within recommended dose
range are not needed, as its therapeutic concentration in urine
remains unchanged (see section 5.2.).
_Paediatric population _
Uncomplicated acute cystitis:
This medicine should not be used in children under the age of 12 (see
section 4.3.).
Prophylaxis of urinary tract infections:
Not recommended in this population.
Method of administration:
Route of administration: oral use
The contents of each sachet should be dissolved and in half a glass of
water and taken
immediately after (see section 6.6.). The reconstituted solution is a
uniform opalescent solution. It is
recommended to administer this medicine on an empty stomach,
preferably before the night
resting, and after voiding the bladder.
NEW ZEALAND DATA SHEE