AUGMENTIN FOR ORAL SUSPENSION 228 mg5 ml

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

AMOXYCILLIN TRIHYDRATE 229.58mg/5ml EQV AMOXYCILLIN; POTASSIUM CLAVULANATE 33.95mg/5ml EQV CLAVULANIC ACID

Disponibil de la:

GLAXOSMITHKLINE PTE LTD

Codul ATC:

J01CR02

Dozare:

200 mg/5 ml

Forma farmaceutică:

POWDER, FOR SUSPENSION

Compoziție:

AMOXYCILLIN TRIHYDRATE 229.58mg/5ml EQV AMOXYCILLIN 200 mg/5 ml; POTASSIUM CLAVULANATE 33.95mg/5ml EQV CLAVULANIC ACID 28.5 mg/5 ml

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

SmithKline Beecham Limited trading as SmithKline Beecham Pharmaceuticals

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1998-06-19

Prospect

1 
AUGMENTIN
TM

SUSPENSION 228 MG/5 ML AND 457 MG/5 ML – 
MIXED FRUIT FLAVOUR 
AMOXICILLIN TRIHYDRATE – POTASSIUM CLAVULANATE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_AUGMENTIN_ suspension 228 mg/5 ml contains 200 mg amoxicillin
(as amoxicillin 
trihydrate) and 28.5 mg clavulanic acid
(as potassium clavulanate) per 5 ml. 
_AUGMENTIN_ suspension 457 mg/5 ml contains 400 mg amoxicillin
(as amoxicillin 
trihydrate) and 57 mg clavulanic acid
(as potassium clavulanate) per 5 ml. 
PHARMACEUTICAL FORM 
Dry powder for reconstitution in water, at time of dispensing,
to form an oral sugar free 
suspension.

CLINICAL PARTICULARS 
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 _t_issue infections_ e.g. cellulitis, animal
bites. 
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. 

2 
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with 
_AUGMENTIN_ suscep

Caracteristicilor produsului

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 457 mg/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.
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.
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with
_AUGMENTIN_ susceptible beta-lactamase producing organisms may be
treated with
_AUGMENTIN_ suspension 228 mg/5 mL and 457 mg/5 mL. These infections
should not
require the addition of another antibiotic resistant t