VETMULIN 100mgg Premix for Medicated feeding Stuff

Riik: Malaisia

keel: inglise

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

Toimeaine:

TIAMULIN HYDROGEN FUMARATE

Saadav alates:

PAHANG PHARMACY SDN. BHD.

INN (Rahvusvaheline Nimetus):

TIAMULIN HYDROGEN FUMARATE

Ühikuid pakis:

1 kg; 5 kg; 20 kg

Valmistatud:

Biovet Joint Stock Company

Toote omadused

VETMULIN 100 G/KG PREMIX FOR MEDICATED FEEDING STUFF
STATEMENT OF ACTIVE SUBSTANCE:
Each kg contains Tiamulin hydrogen fumarate 100g (equivalent to
tiamulin 81g)
PRODUCT DESCRIPTION:
Vetmulin 100 g/kg premix for medicated feeding stuff represents a
yellowish free-flowing granular material.
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 in-vitro activity against a wide range of bacteria
including _ 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:
Pigs: Following oral administration, tiamulin hydrogen fumarate is
rapidly
absorbed from the gastrointestinal tract of pigs (85-90%) and appears
in
the blood within 30 minutes. 2-4 hours (tmax) after the oral
administration
of 10 mg tiamulin/kg BW in the form of an oral solution, a Cmax of 1
μg/ml
was measured; an oral administration of 25 mg/kg gave a Cmax of 1.82
μg/ml. There is very good distribution in the tissues with
accumulation in
lungs and in the colon. 30-50% of tiamulin is bound to serum proteins.
Tiamulin is rapidly metabolised in the liver (hydroxylation,
de-