ALCLAV 642.9MG5ML POWDER FOR ORAL SUSPENSION

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

Amoxicilin Trihydrate; POTASSIUM CLAVULANATE

Διαθέσιμο από:

Ascend Laboratories Sdn Bhd

INN (Διεθνής Όνομα):

Amoxicilin Trihydrate; POTASSIUM CLAVULANATE

Μονάδες σε πακέτο:

1 BOTTLE

Κατασκευάζεται από:

ALKEM LABORATORIES LIMITED

Φύλλο οδηγιών χρήσης

2
ALCLAV 642.9MG/5ML POWDER FOR ORAL
SUSPENSION
(AMOXICILLIN 600MG/5ML AND CLAVULANIC ACID 42.9MG/5ML POWDER FOR ORAL
SUSPENSION)
_Consumer Medication Information Leaflet (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Alclav is used for
2.
How Alclav works
3.
Before you use Alclav
4.
How to use Alclav
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Alclav
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
11.
Serial number
WHAT ALCLAV_ _IS USED FOR
Alclav
_ _
is
used
to
treat
recurrent
or
persistent infections in the ears (acute otitis
media)
of
pediatrics.
This
infection
is
caused
by
the
bacterias
(
_Streptococcus _
_pneumoniae,_
_Haemophilus influenzae and _
_Moraxella catarrhalis_
).
HOW ALCLAV_ _WORKS_ _
Alclav
_ _
is an antibiotic and 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”
that
can
sometimes
be
stopped
from
working (made inactive). The other active
component (clavulanic acid) stops this from
happening.
BEFORE YOU USE ALCLAV_ _
-
_When you must not use it _
•
If your child is allergic (hypersensitive) to
Amoxicillin,
Clavulanic
acid,
Penicillin,
Cephalosporin
or
any
of
the
other
ingredients of Alclav
_ _
•
If your child has ever had a severe allergic
(hypersensitive)
reaction
to
any
other
antibiotic. This can include a skin rash or
swelling of the face or neck.
•
If your child has ever had liver problems
or jaundice (yellowing of the skin) when
taking an antibiotic.
•
If your child has has Clostridium difficile
associated
diarrhea
(CDAD)
after
taking
antibiotic
•
If you are not sure, talk to the doctor or
pharmacist before giving Alclav
_Pregnancy and lactation _
Do not use Alclav if you are pregnant,
trying to get pregnant or think you may be
pregnant.
Do not use Alclav if you are breast-
feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to us

Αρχείο Π.Χ.Π.

1
ALCLAV 642.9MG/5ML
POWDER FOR ORAL SUSPENSION
NAME AND STRENGTH OF ACTIVE INGREDIENTS
Amoxicillin 600 mg, Clavulanic acid 42.9 mg per 5 ml
COMPOSITION
Amoxicillin USP as a Trihydrate equivalent to
Amoxicillin
600 mg
Potassium Clavulanate diluted Ph.Eur
equivalent to Clavulanic Acid
42.9 mg
PRODUCT DESCRIPTION
Description as is: White to off-white free flowing powder filled in
HDPE bottle.
Reconstituted: On reconstitution with water, gives white to off-white
homogeneous suspension having
characteristic of orange odour
PHARMACODYNAMICS
ATC CODE: J01CR02 AMOXICILLIN AND ENZYME INHIBITOR
Mechanism of Action
Amoxicillin binds to penicillin-binding proteins within the bacterial
cell wall and inhibits bacterial
cell wall synthesis. Clavulanic acid is a beta-lactam, structurally
related to penicillin, which may
inactivate certain beta-lactamase enzymes.
PK/PD relationship
The time above the minimum inhibitory concentration (T>MIC) is
considered to be the major
determinant of efficacy for amoxicillin.
Mechanism of Resistance
Resistance to penicillins may be mediated by destruction of the
beta-lactam ring by a betalactamase,
altered affinity of penicillin for target, or decreased penetration of
the antimicrobial drug to reach the
target site. Amoxicillin alone is susceptible to degradation by
beta-lactamases, and therefore its
spectrum of activity does not include bacteria that produce these
enzymes.
WARNING: UNSUITABLE FOR PHENYLKETONURICS
NOT TO BE USED IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO PENICILLIN
2
Spectrum of Activity
Amoxicillin/clavulanic acid has been shown to be active against most
isolates of the following
microorganisms, both in vitro and in clinical infections as described
in the INDICATIONS section.
_Gram-positive bacteria:_
_Streptococcus pneumoniae _
(including isolates with penicillin MICs ≤ 2 mcg/mL)
_Gram-negative bacteria:_
_Haemophilus influenzae _
(including beta-lactamase-producing isolates)
_Moraxella catarrhalis _
(including beta-lactamase-producing isolates)
The following in vitro data