Augmentin ES powder for oral suspension with strawberry flavour

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Verfügbar ab:

Glaxo Wellcome Production

ATC-Code:

J01C R02

INN (Internationale Bezeichnung):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosierung:

600mg/5ml+ 42.9mg/5ml

Darreichungsform:

powder for oral suspension with strawberry flavour

Einheiten im Paket:

glass bottle 100ml and measuring spoon 5ml

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2015-09-04

Gebrauchsinformation

Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
Mycoplasma spp.
Pharmacokinetics
Pharmacokinetic parameters are given below for AUGMENTIN ES
administered at 45mg/kg every 12 hours to paediatric patients
Formulation
C max
(mg/L)
T max
(hours)
AUC
(mg.h/L)
T ½
(hours)
AUGMENTIN ES
600/42.9 mg/5ml
Dosed at 45 mg/kg
amoxicillin 12-hourly
Amoxicillin
15.7
2.0
59.8
1.4
Clavulanate
1.7
1.1
4.0
1.1
The pharmacokinetics of the two components of AUGMENTIN ES are closely
matched. Both clavulanate and amoxicillin have low levels
of serum binding; about 70% remains free in the serum.
Pre-clinical Safety Data
No further information of relevance.
PHARMACEUTICAL PARTICULARS
List of Excipients
Orange flavour
Powder for oral suspension: colloidal silicon dioxide, orange flavour,
golden syrup flavour, xanthan gum, aspartame,
hydroxypropylmethylcellulose and silicon dioxide.
Strawberry cream flavour
Powder for oral suspension: colloidal silicon dioxide, sodium
carboxymethylcellulose-12, strawberry cream flavour, xanthan gum,
aspartame, and silicon dioxide.
Incompatibilities
None known.
Shelf Life
The expiry date is indicated on the packaging.
Special Precautions for Storage
The powder for oral suspension should be stored in a well sealed
container, in a dry place at or below 25
°
C. Reconstituted suspensions
should be stored in a refrigerator (2-8
°
C) and used within 10 days.
Nature and Contents of Container
AUGMENTIN ES powder for oral suspension, will be supplied as a dry
powder suitable for reconstitution.
Orange flavour
The dry powder is filled into glass bottles with polypropylene caps.
Strawberry cream flavour
The dry powder is filled into glass bottles with aluminium caps with a
PVC liner.
Instructions for Use/Handling
At time of dispensing, the dry powder should be reconstituted to form
an oral suspension, as detailed below:
•
Check cap seal is intact before use.
•
Invert and shake bottle to loosen powder.
•
Add volume of water (indicated below). Invert and shake well.
•
Alternati

Fachinformation

SUMMARY
OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Augmentin
ES
600 mg'42.9 mgz S ml powder
for oral
suspension
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
(E95
I)
per m!.
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 is indicated for the treatment
of the following infections
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):
•
Acute otitis media
Community
acquired pneumonia.
•
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 amoxiciII inlclavulanic
acid content
except
when doses are
stated in terms of an individual
component.
The dose of Augmentin
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).
2
dults and children>
40 kg:
There is no experience
with Augmentin suspension
in adults and children ~ 40 kg,
and therefore
no
dose recommendation
can be given.
Children
<
40 kg Caged> 3 months)
The recommended
dose of Augmentin
suspension
is
_90/6.4_
rug/kg/day in two divided doses.
There are no clinical
data on Augmentin
in children under
3 months of age.
Renal
impairment
No dose adjustment
i