Yen-AnMulin 10% WW Powder

Land: Malasía

Tungumál: enska

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

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05-05-2022

Virkt innihaldsefni:

TIAMULIN HYDROGEN FUMARATE

Fáanlegur frá:

Yenher Agro-products Sdn. Bhd.

INN (Alþjóðlegt nafn):

TIAMULIN HYDROGEN FUMARATE

Einingar í pakka:

100 gm; 1 kg; 25 kg

Framleitt af:

Dexchem Industries Sdn Bhd

Vara einkenni

                                PRODUCT NAME:
YEN-ANMULIN 10% W/W POWDER
ACTIVE INGREDIENTS:
Tiamulin Hydrogen Fumarate: 100 mg
PRODUCT DESCRIPTION:
White and odourless powder.
TARGET SPECIES:
Swine, Poultry, Others: Pig, Chicken (broiler, replacement pullet,
layer/breeder), Turkey (poult (grower) and breeder), Rabbit
PHARMACODYNAMICS:
Tiamulin is a bacteriostatic semi-synthetic antibiotic belonging to
the pleuromutilin group of antibiotics and acts at the ribosomal level
to inhibit
bacterial protein synthesis.
Tiamulin has shown a in-vitro activity against a wide range of
bacteria such as _Brachyspira hyodysenteriae_, _Brachyspira
pilosicoli_, _Lawsonia _
_intracellularis_ and Mycoplasma spp.
Tiamulin is bacteriostatic at therapeutic concentrations and has been
shown to act at the 70S ribosome level and the primary binding site is
on the 50S subunit and possibly a secondary site where the 50S and 30S
subunits join. It appears to inhibit microbial protein production by
producing biochemical inactive initiation complexes, which prevent
elongation of the polypeptide chain.
Mechanisms responsible for resistance development in Brachyspira spp
to the pleuromutilin class of antibiotics are considered to be based
on
mutations at the ribosomal target site. Clinically relevant resistance
to tiamulin requires combinations of mutations around the tiamulin
binding
site.
Resistance to tiamulin may be associated with decreased susceptibility
to other pleuromutilins.
PHARMACOKINETICS:
Pig
Tiamulin is well absorbed in the pig (over 90%) following oral
administration and widely distributed through the body. Following a
single oral
dose of 10 mg and 25 mg tiamulin/kg bodyweight, the Cmax was 1.03
µg/ml and 1.82 µg/ml respectively by microbiological assay and the
Tmax was 2 hours for both. Tiamulin has been shown to concentrate in
the lung, a target tissue, and also in liver, where it is metabolised
and
excreted (70-85%) in the bile, the remainder is excreted via the
kidney (15-30%). Tiamulin which has not been absorbed or metabolised,
passes down the intestine
                                
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