MONUROL fosfomycin (as trometamol) 3 g granules for oral solution sachet

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

fosfomycin trometamol, Quantity: 5.631 g

Pieejams no:

Mayne Pharma International Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

fosfomycin trometamol

Zāļu forma:

Granules

Kompozīcija:

Excipient Ingredients: saccharin; sucrose; Flavour

Ievadīšanas:

Oral

Vienības iepakojumā:

1

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

MONUROL is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Escherichia coli or, Enterococcus faecalis.,MONUROL is not indicated for the treatment of pyelonephritis or perinephric abscess or where resistance is likely (previous treatment failure, infection due to non-susceptible organism).,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to MONUROL. However, therapy may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Consideration should be given to the relevant clinical guidelines on the appropriate use of antibacterial agents.

Produktu pārskats:

Visual Identification: White granules for oral solution; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2017-09-04

Lietošanas instrukcija

MONUROL
®
1
MONUROL
®
_Fosfomycin trometamol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MONUROL. 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 taking MONUROL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MONUROL IS
USED FOR
MONUROL contains the active
ingredient fosfomycin trometamol
and it belongs to a group of
medicines called antibiotics.
MONUROL 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 THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
MONUROL is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
MONUROL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MONUROL IF YOU:
•
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 disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTO

Produkta apraksts

v 2.0
1
AUSTRALIAN PRODUCT INFORMATION
MONUROL (FOSFOMYCIN) GRANULES FOR ORAL SOLUTION
1.
NAME OF THE MEDICINE
Fosfomycin trometamol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of MONUROL granules for oral solution contains 5.631 g of
fosfomycin
trometamol equivalent to 3.0 g fosfomycin.
Fosfomycin trometamol is a white or nearly white crystalline powder.
It is very soluble
in water, slightly soluble in 95% methanol and ethanol, almost
insoluble in anhydrous
acetone, in ether and in chlorinated solvents.
Excipients with known effect: MONUROL contains sugars (as sucrose) and
saccharin.
For the full list of excipients, see
_ section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
MONUROL contains 3 g fosfomycin (as fosfomycin trometamol), presented
as white
granules for oral solution in single use sachet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MONUROL is indicated only for the treatment of acute uncomplicated
lower urinary
tract infections (acute cystitis) in females above 12 years of age
caused by the following
susceptible pathogens: Enterobacteriaceae (including
_Escherichia coli_
),
_Enterococcus _
_faecalis_
.
MONUROL is not indicated for the treatment of pyelonephritis or
perinephric abscess or
where resistance is likely (previous treatment failure, infection due
to non-susceptible
organism).
Appropriate culture and susceptibility studies should be performed to
identify the
causative organism(s) and determine its (their) susceptibility to
MONUROL. However,
therapy may be initiated before results of these tests are known; once
results become
available, appropriate therapy should be continued. Consideration
should be given to the
relevant clinical guidelines on the appropriate use of antibacterial
agents.
v 2.0
2
4.2.
DOSE AND METHOD OF ADMINISTRATION
The recommended dose for the treatment of acute uncomplicated lower
urinary tract
infections (acute cystitis) is a single MONUROL 3 g sachet in women
above 12 years of
age.
MONUROL is for oral administration.
It should be taken on an empty