CAVUMOX (625MG TABLETS)

Land: Maleisië

Taal: Engels

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

Werkstoffen:

CLAVULANIC ACID; AMOXYCILLIN TRIHYDRATE

Beschikbaar vanaf:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Algemene Internationale Benaming):

CLAVULANIC ACID; AMOXYCILLIN TRIHYDRATE

Eenheden in pakket:

5 x 3s Tablets

Geproduceerd door:

SIAM BHEASACH CO LTD

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CAVUMOX 625 MG TABLET
AMOXICILLIN / CLAVULANIC ACID (500 MG / 125 MG)
1
WHAT IS IN THIS LEAFLET.
1.
What CAVUMOX is used for
2.
How CAVUMOX works
3.
Before you use CAVUMOX
4.
How to use CAVUMOX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
1.
WHAT CAVUMOX IS USED FOR.
Contains 500 mg amoxicillin and 125
mg clavulanic acid per tablet.
It is an antibiotic agent with a notably
broad spectrum of activity against the
commonly occurring bacterial
pathogens in general practice and
hospital. The beta-lactamase inhibitory
action of clavulanate extends the
spectrum of amoxicillin to embrace a
wider range of organisms, including
many resistant to other beta-lactam
antibiotics. CAVUMOX should be
used in accordance with local official
antibiotic-prescribing guidelines and
local susceptibility data. CAVUMOX
oral presentations for twice daily
dosing, are indicated for short-term
treatment of bacterial infections at the
following sites:

Upper respiratory tract infections,
including ENT (e.g., tonsillitis,
sinusitis, otitis media)

Lower respiratory tract infections
(e.g., acute exacerbation of chronic
bronchitis, lobar and
bronchopneumonia)

Genito-urinary tract infections
(e.g., cystitis, urethritis,
pyelonephritis)

Skin and soft tissue infections
(e.g., boils, abscesses, cellulitis,
wound infections)

Bone and joint infections (e.g.,
osteomyelitis)

Dental infections (e.g.,
dentoalveolar abscess)

Other infections (e.g., septic
abortion, puerperal sepsis, intra-
abdominal sepsis)
Susceptibility to CAVUMOX will
vary with geography and time. Local
susceptibility data should be consulted
where available, and microbiological
sampling and susceptibility testing
performed where necessary.
2.
HOW CAVUMOX WORKS
The beta-lactamase inhibitory action
of clavulanate extends the spectrum of
amoxicillin to embrace a wider range
of organisms

Productkenmerken

_ _
_ _
_ _
PRODUCT NAME
CAVUMOX 625 MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate)
and 125 mg clavulanic acid (as
potassium clavulanate)
PRODUCT DESCRIPTION
White, oblong, biconvex film coated tablet
PHARMACODYNAMICS
CAVUMOX is a combination of amoxicillin (as trihydrate), a
broad-spectrum antibiotic and clavulanic
acid (as potassium salt), a progressive and irreversible inhibitor of
β-Lactamase enzymes produced
by many Gram-positive and Gram-negative bacteria.
The combination of amoxicillin/clavulanic acid extends the antibiotic
spectrum of amoxicillin to include
bacteria normally resistant to amoxicillin and β-lactam antibiotic.
CAVUMOX is bactericidal to a wide range of Gram-positive and
Gram-negative bacteria includes β-
lactamase penicillin resistant organisms.
PHARMACOKINETICS
The pharmacokinetics of the two components of CAVUMOX are closely
matched. Peak serum levels
of both occur about 1 hour after oral administration. Absorption of
CAVUMOX is optimized at the start
of a meal. Doubling the dosage of CAVUMOX approximately doubles the
serum levels achieved. Both
amoxicillin and clavulanate have low levels of serum binding; about
70% remains free in the serum.
INDICATION
CAVUMOX is an antibiotic agent with a notably broad spectrum of
activity against the commonly
occurring bacterial pathogens in general practice and hospital. The
beta-lactamase inhibitory action of
clavulanate extends the spectrum of amoxicillin to embrace a wider
range of organisms, including
many resistant to other beta-lactam antibiotics.
CAVUMOX should be used in accordance with local official
antibiotic-prescribing guidelines and local
susceptibility data.
CAVUMOX oral presentations for twice daily dosing, are indicated for
short-term treatment of bacterial
infections at the following sites:
▪
Upper respiratory tract infections, including ENT (e.g. tonsillitis,
sinusitis, otitis media)
▪
Lower
respiratory
tract
infections
(e.g.
acute
exacerbation
of
chronic
bro