AUGMENTIN ES 600 MG5 ML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

Tillgänglig från:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kod:

J01CR02

Läkemedelsform:

POWDER FOR SUSPENSION

Sammansättning:

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

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

SMITHKLINE BEECHAM PHARMACEUTICALS, UK

Terapiområde:

AMOXICILLIN AND ENZYME INHIBITOR

Terapeutiska indikationer:

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.

Tillstånd datum:

2016-05-30

Bipacksedel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
AUGMENTIN ES 600 MG/5 ML
POWDER FOR PREPARATION OF ORAL SUSPENSION
Each 5 ml of suspension contains:
600 mg amoxicillin (as trihydrate)
42.9 mg clavulanic acid (as potassium salt)
Each 1 ml of suspension contains:
120 mg amoxicillin (as trihydrate)
8.58 mg clavulanic acid (as potassium salt)
A list of the additional ingredients is detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains
concise
information
about
the
medicine.
If
you
have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
AUGMENTIN ES 600 MG/5 ML is a medicine for treatment of middle ear
infections caused by drug-sensitive bacteria in children from the age
of 3
months and weighing less than 40 kg.
Augmentin is an antibiotic that works by killing bacteria that cause
infections.
It contains two different medicines called amoxicillin and clavulanic
acid.
Amoxicillin belongs to a group of medicines called “penicillins”
whose action
can sometimes be stopped (become inactive). The other active component
(clavulanic acid) prevents this from happening.
THERAPEUTIC GROUP
Amoxicillin: Penicillin antibiotic group
Clavulanic acid: Beta-lactamase enzyme inhibitors
2.
BEFORE USING THE MEDICINE
DO NOT GIVE YOUR CHILD AUGMENTIN IF:
∙
they are sensitive (allergic) to amoxicillin, clavulanic acid,
penicillin or any
of the additional ingredients contained in the medicine (listed in
section 6)
∙
they have ever had a severe allergic reaction to any other antibiotic.
This
can include a skin rash or swelling of the face or throat
∙
they have ever had liver problems or jaundice (yellowing of the skin)
when taking an antibiotic.
→ DO NOT GIVE AUGMENTIN

Produktens egenskaper

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
Excipient: Contains 2.72 mg of aspartame (E951) per ml.
Contains maltodextrin (glucose).
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/5 ml in children under 3 months of age.
Renal impairment
No dose ad