AUGMENTIN SUSPENSION 228MG5ML

Država: Malezija

Jezik: engleski

Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivni sastojci:

AMOXYCILLIN; POTASSIUM CLAVULANATE

Dostupno od:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International ime):

AMOXYCILLIN; POTASSIUM CLAVULANATE

Jedinice u paketu:

70 mL; 70 mL BOTTLE

Proizveden od:

GLAXO WELLCOME PRODUCTION

Uputa o lijeku

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_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AUGMENTIN SUSPENSION
_ _
_ _
Amoxicillin/ Potassium clavulanate (228 mg/5 ml, 457 mg/5 ml)
1
WHAT IS IN THIS LEAFLET
1.
What Augmentin is used for
2.
How Augmentin works
3.
Before you use Augmentin
4.
How to use Augmentin
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Augmentin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT AUGMENTIN IS USED FOR
Augmentin is an antibiotic used
in children to treat infections in
different parts of the body caused
by bacteria in respiratory tract,
urinary tract, skin and soft tissue
and dental infections.
HOW AUGMENTIN WORKS
Augmentin contains two
different medicines called
amoxicillin and clavulanic acid.
Amoxicillin is a penicillin
antibiotic. Amoxicillin can
sometimes be stopped from
working (made inactive). The
other active medicine, clavulanic
acid, stops this from
happening.
BEFORE YOU USE AUGMENTIN
_When you must not use it _
Do not use this medicine if:
•
Your child is allergic
(hypersensitive) to
amoxicillin, clavulanic acid,
other penicillin based
antibiotics, or similar
antibiotics called
cephalosporins
Your child has ever had liver
problems or jaundice
(yellowing of the skin and/or
whites of the eyes) when
taking an antibiotic.
•
If you think any of these
apply to your child, check
with your doctor before you
take Augmentin.
_Before you start to use it _
Take special care and get advice
from your doctor if:
•
Your child has ever had an
allergic reaction
to any other
antibiotics or medicines.
This might include a skin
rash or swelling of the face
or neck.
•
Your child has glandular
fever (mononucleosis)
•
Your child is taking
medicines, such as warfarin,
that are used to prevent
blood clots
•
Your child has liver
problems
•
Your child has kidney
disease
•
Your child is not urinating
regularly or not able to drink
very much
•
Your child has a genetic
condition called
phenylketonuria
Check with your doctor if you
think any of

Svojstava lijeka

CONFIDENTIAL
[GSK logo]
AUGMENTIN
SUSPENSION 228 MG/5 ML AND 457 MG/5 ML –
MIXED FRUIT FLAVOUR
AMOXICILLIN TRIHYDRATE – POTASSIUM CLAVULANATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
A white to off-white dry powder for reconstitution in water to form an
off-white mixed-
fruit flavoured suspension.
_AUGMENTIN_
suspension 228 mg/5 mL: When reconstituted, each 5 mL contains 200 mg
amoxicillin (as amoxicillin trihydrate) and 28.5 mg clavulanic acid
(as potassium
clavulanate).
_AUGMENTIN_
suspension 457 mg/5 mL: When reconstituted, each 5 mL contains 400 mg
amoxicillin (as amoxicillin trihydrate) and 57 mg clavulanic acid (as
potassium
clavulanate).
CLINICAL INFORMATION
INDICATIONS
_AUGMENTIN _
should be used in accordance with local official
antibiotic-prescribing
guidelines and local susceptibility data.
_AUGMENTIN_
suspension (228 mg/5 mL and 457mg/5 mL), for twice daily oral dosing,
is indicated for short term treatment of bacterial infections at the
following sites when
amoxicillin resistant beta-lactamase producing strains are suspected
as the cause. In other
situations, amoxicillin alone should be considered.
_Upper respiratory tract infections (including ENT)_
e.g. recurrent tonsillitis, sinusitis,
otitis media.
_Lower respiratory tract infections _
e.g. acute exacerbations of chronic bronchitis, lobar
and bronchopneumonia.
_Urinary tract infections_
e.g. cystitis, urethritis, pyelonephritis
_Skin and soft tissue infections_
e.g. cellulitis, animal bites.
_Dental infections_
e.g. severe dental abscess with spreading cellulitis.
Susceptibility to
_AUGMENTIN_
will vary with geography and time (see
_Pharmacological _
_Properties, Pharmacodynamics_
for further information). Local susceptibility data should
be consulted where available, and microbiological sampling and
susceptibility testing
performed where necessary.
CONFIDENTIAL
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with
_AUGMENTIN_
susceptible beta-lactamase-producing organisms may be treated with
_AUGMENTIN_
suspension