Amogen Suspension for Injection

Land: Malaysia

Språk: engelsk

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

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Preparatomtale Preparatomtale (SPC)
17-03-2020

Aktiv ingrediens:

AMOXICILLIN TRIHYDRATE; Gentamicin sulfate

Tilgjengelig fra:

Vemedim Sdn Bhd

INN (International Name):

AMOXICILLIN TRIHYDRATE; Gentamicin sulfate

Enheter i pakken:

100 ml

Produsert av:

VEMEDIM VETERINARY DRUGS AND PROBIOTICS CO., LTD (VEMEDIM ANIMAL HEALTH)

Preparatomtale

                                Manufactured by:
VEMEDIM VETERINARY DRUGS AND PROBIOTICS CO., LTD
(Vemedim Animal Health)
Song Hau Industrial Zone, Chau Thanh District,
Hau Giang Province, Vietnam
Product Registration Holder:
VEMEDIM SDN. BHD.
15, Jalan USJ 1/31, 47600 Subang Jaya
Selangor, Darul Ehsan, Malaysia
COMPOSITION: Each ml contains:
Amoxicillin trihydrate ……………..…… 150 mg
Gentamicin
Sulfate …...…....…….… 40,000 IU
Benzyl alcohol (as preservative) …..… 0.03 ml
DESCRIPTION
The
finished
product
is
ivory
cream
suspension.
PHARMACODYNAMICS
Amoxicillin
is
a
bactericidal
antibiotic
that
belongs to the penicillin group. It inhibits the
synthesis
of
the
mucopeptide,
one
of
the
components of the bacterial rigid cell wall that
gives
the
bacteria
mechanical
stability,
destroying the bacteria in its growth phase.
Gentamicin
is
an
aminoglycoside
antibiotic
that acts directly on the ribosome, where it
inhibits
protein
biosynthesis
and
decreases
the fidelity of interpretation of the genetic code.
The penetration of gentamicin in the cell is
increased
when
the
permeability
of
the
bacterial cell wall is altered by amoxicillin. This
fact allows the use of smaller amounts of the
aminoglycoside.
The bound amoxicillin and gentamicin have a
broad
antibacterial
spectrum
that
includes
Gram
positive
bacteria
(_corinebacteria_)
and
Gram negative bacteria (_E. coli, Pasteurella_
_spp_, and _ Salmonella_ _ spp_). Their association
improves the therapeutic properties of each of
these antibiotics administered alone.
PHARMACOKINETICS
Amoxicillin is well absorbed after parenteral
administration.
17-20%
of
the
active
substance
binds
to
plasma
proteins.
It
is
excreted mainly by unaltered urine and to a
lesser extent by milk and bile.
Gentamicin
is
poorly
absorbed
from
the
gastrointestinal
tract,
however,
it
is
well
absorbed after parenteral administration. It is
rapidly distributed reaching the kidney, liver,
lung, endometrium and breast parenchyma. Its
elimination takes place in a biphasic manner,
a
first
rapid
phase
corresponding
to
the
di
                                
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