Vime Tylovet 50 mgml Solution for Injection

País: Malasia

Idioma: inglés

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

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03-07-2020

Ingredientes activos:

TYLOSIN

Disponible desde:

Vemedim Sdn Bhd

Designación común internacional (DCI):

TYLOSIN

Unidades en paquete:

100 ml

Fabricado por:

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

Ficha técnica

                                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:
Tylosin …………………….….…..…… 50 mg
With 4.0% (v/v) Benzyl Alcohol as a preservative
DESCRIPTION
The
finished
product
is
yellow
transparent
solution.
TARGET SPECIES
Cattle
(Beef,
calves,
dairy,
non-lactating),
swine
PHARMACODYNAMICS
Tylosin is a macrolide antibiotic and exerts its
antibiotic activity by a similar mechanism to
other
macrolides
i.e.
binding
to
the
50S
fraction
of
the
ribosomes
resulting
in
an
inhibition of the synthesis of proteins. Tylosin
has mainly a bacteriostatic activity.
Tylosin has an antibiotic effect against Gram
positive
cocci
(Staphylococci,
Streptococci),
Gram
positive
bacilli
(_Erysipelothrix_
spp.),
some Gram-negative bacilli (_Pasteurella_ spp.,
_Mannheimia_ spp.) and _Mycoplasma_ spp.
Resistance to macrolides is usually plasmid-
mediated but modification of ribosomes may
occur
through
chromosomal
mutation.
Resistance can occur by i) decreased entry
into bacteria (most common with the gram-
negative
bacteria),
ii) synthesis
of
bacterial
enzymes
that
hydrolyse
the
drug
and,
iii)
modification of the target (the ribosome).
This latter resistance type may also lead to
cross-resistance
with
other
antibiotics
that
preferentially
bind
to
bacterial
ribosome.
Gram-negative anaerobic bacteria are often
resistant.
Resistance of _ Brachyspira hyodysenteriae _ to
tylosin has been reported.
PHARMACOKINETICS
Absorption: Following intramuscular injection,
tylosin
blood
levels
peak
1-2
hours
post-
injection. Duration of activity is approximately
12 hours.
Distribution, Biotransformation and Elimination:
Tylosin levels of 1.4 to 1.6 and 2.2 to 6.7μg/ml
were
recorded
in
serum
and
lung
tissue
respectively following intramuscular injection
of 8.8 mg/kg bodyweight in pigs. Measur
                                
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