AUGMENTIN ES 600 MG5 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J01CR02

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

AMOXICILLIN AS TRIHYDRATE 600 MG / 5 ML; CLAVULANIC ACID AS POTASSIUM SALT 42.9 MG / 5 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO WELLCOME PRODUCTION, FRANCE

Therapeutic group:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic area:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic indications:

Augmentin ES is indicated for the treatment of acute otitis media in children aged at least 3 months and less than 40 kg body weight, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae:Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Authorization date:

2016-04-30

Patient Information leaflet

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AugES PT v10B

Summary of Product characteristics

1
Augmentin ES 600 mg/5 ml
1.
NAME OF THE MEDICINAL PRODUCT
Augmentin ES 600 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every ml of oral suspension contains amoxicillin
trihydrate equivalent to 120 mg
amoxicillin and potassium clavulanate equivalent to 8.58 mg of
clavulanic acid.
Excipient with known effect
Every ml of oral suspension contains 2.72 mg aspartame (E951). The
flavouring in Augmentin ES 600 mg/5
ml contains maltodextrin (glucose) (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
Off-white powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Augmentin
_ES_
600 mg/5 ml is indicated for the treatment of acute otitis media in
children aged at least 3
months and less than 40 kg body weight, caused or thought likely to be
caused by penicillin-resistant
_Streptococcus pneumoniae_
(see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
Posology and method of administration
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are stated
in terms of an individual component.
The dose of Augmentin
_ES_
600 mg/5 ml that is selected to treat an individual infection should
take into account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient as shown below.
Treatment should not be extended beyond 14 days without review (see
section 4.4 regarding prolonged
therapy).
Adults and children
≥
40 kg:
There is no experience with Augmentin ES 600 mg/5 ml suspension in
adults and children
≥
40 kg, and
therefore no dose recommendation can be given.
2
Children < 40 kg (aged
≥
3 months)
The recommended dose of Augmentin
_ES_
600 mg/5 ml suspension is 90/6.4 mg/kg/day in two divided doses.
There are no clinical data on Augmentin
_ES_
600 mg