URIZONE 3 g GRANULES

Ország: Dél-afrikai Köztársaság

Nyelv: angol

Forrás: South African Health Products Regulatory Authority (SAHPRA)

Beszerezhető a:

Adcock Ingram Limited

Adagolás:

See ingredients

Gyógyszerészeti forma:

GRANULES

Összetétel:

EACH SACHET CONTAINS FOSFOMYCIN TROMETAMOL EQUIVALENT TO 3 g FOSFOMYCIN

Engedélyezési státusz:

Registered

Engedély dátuma:

1994-01-09

Betegtájékoztató

1
LABELLING - PATIENT INFORMATION LEAFLET
The under-mentioned information with regard to this medicine shall
appear on the patient
information leaflet. The information shall be presented in the format
stipulated, provided that
the Council may authorise any deviation from such information or such
format (Refer to
Regulation 10 of the Act).
1. Scheduling status
2. Proprietary name and dosage form
3. Composition of the medicine, that is, what this medicine contains
4. Approved indication and use, that is, what this medicine is used
for
5. Instruction before taking the medicine (refer to the Guidelines)
6. Instructions on how to take this medicine (refer to Guidelines)
7. Side effects {refer to Guidelines)
8. Storage and disposal information (refer to Guidelines)
9. Presentation
10. Identification
11. Registration number
12. Name and business address of the holder of the certificate of
registration
13. Date of publication of the Patient Information Leaflet
Please note that the proposed Patient Information Leaflet is based on
the proposed
Package Insert. A separate submission of the proposed Patient
Information Leaflet has been
made to the Clinical Unit for evaluation of the clinical aspects. The
proposed patient
information leaflet has been included in this MRF1 update for
assessment of the
pharmaceutical aspects thereof.
2
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD
NOT SHARE YOUR
MEDICINE WITH OTHER PEOPLE. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS
ARE THE SAME
AS YOURS.
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM: URIZONE 2G AND 3G (GRANULES)
Fosfomycin trometamol equivalent to 2g or 3g of Fosfomycin base.
1. WHAT URIZONE CONTAINS:
This medicine contains the active ingredient fosfomycin trometamol.
URIZONE 2G:
Each sachet contains 3,754g fosfomycin trometamol equivalent to
fosfomycin 2g.
C

Termékjellemzők

1
SCHEDULING STATUS:
PROPRIETARY NAME:
URIZONE 2 G
and 3 G GRANULES
(AND DOSAGE FORM): GRANULES
COMPOSITION:
URIZONE 2 G:
Each sachet contains 3,754 g fosfomycin trometamol equivalent to
fosfomycin 2 g.
Contains sugar: 2,100 g sucrose per sachet.
URIZONE 3 G:
Each sachet contains 5,631 g fosfomycin trometamol equivalent to
fosfomycin 3 g.
Contains sugar: 2,213 g sucrose per sachet.
PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad & Medium Spectrum Antibiotics
PHARMACOLOGICAL ACTION:
Fosfomycin trometamol is a broad-spectrum bactericidal antibiotic,
derived from
phosphonic acid with activity in the lower urinary tract.
The antibacterial activity of fosfomycin is due to an inhibition of
bacterial cell wall
synthesis. Its particular mechanism of action is inhibition of enol
pyruvyl transferase.
Fosfomycin is active
_in vitro_
against species of Gram-positive and Gram-negative bacteria
most frequently isolated in urinary tract infections (E. Coli,
Proteus, Klebsiella,
Enterobacter, Staphylococcus, Streptococcus). In vitro sensitivity
does not necessarily
imply
_in vivo_
efficacy.
2
Fosfomycin trometamol is an orally well-absorbed salt of fosfomycin.
It usually provides
therapeutic concentrations of the active moiety in the urine for
periods of thirty-six hours
or more from a single dose.
Fosfomycin is eliminated mainly unchanged through the kidneys and this
results in very
high peak urinary concentrations (approx. 3000 mg/I) within two to
four hours.
Therapeutic concentrations in urine are usually maintained for at
least thirty-six hours.
Food delays and reduces absorption of fosfomycin trometamol, resulting
in reduced blood
and urinary concentrations.
In patients with moderately reduced renal function (creatinine
clearance> 80 ml/min).
including the physiological reduction in the elderly, the half-life of
fosfomycin is
prolonged but urinary concentration remains therapeutically adequate.
INDICATIONS:
URIZONE
is indicated as a single dose in the treatment of acute uncomplicated
lower
urinary tract infections caused by