Aviax 50 gramkg Powder

Country: Malaysia

Language: English

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

Active ingredient:

SEMDURAMICIN

Available from:

Phibro Corporation (m) Sdn Bhd

INN (International Name):

SEMDURAMICIN

Units in package:

25.00 mcg/mL

Manufactured by:

Phibro Saude Animal Internacional LTDA

Summary of Product characteristics

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.SAFETY
AND TOXICITY
Overview:
Safety
Aviax is well tolerated in broilers, causing no increase in mortality
or toxic symptoms even at
i
three times the recommended dose.
A VIAX
does not affect the moisture content of litter in
broiler
houses.
A VIAX
is non-toxic in non-target species such as turkeys, cattle, swine and
horses.
Overview:
Toxicity
The manufacture and use of semduramicin have no adverse effect on the
environment.
The use
of litter as fertilizer
from birds receiving 25 ppm semduramicin likewise had no demonstrable
long-term adverse effect on the environment.
Toxicological evaluation of semduramicin sodium
identified no mutagens or carcinogens.
There was no evidence of toxic potential from topical
administration, or of adverse effects on reproduction or fetal
parameters.
Metabolism
and distribution
Semduramicin is metabolized primarily
in the broiler liver.
Carbon-14 tracer studies in broilers
fed 25 ppm semduramicin for
7 or 11 days demonstrated that over the first
48 hours of
withdrawal,
the liver contained at least three times the residue concentration
found in kidney,
muscle, fat and skin with adhering fat.
Unchanged semduramicin was the only major residue found in the liver
after 6- and 48-hour
-withdrawal
periods, respectively. Of the remaining residues, approximately 9 %
was bound and
'W
the rest consisted of numerous low-level fragments more polar than
semduramicin.
None of the
latter exceeded 10% of the total residue or a concentration of 100
ppb.
Liver metabolism studies
in rats and dogs show a similar metabolite profile,
with unchanged semduramicin as the major
residue.
Further
studies demonstrate that total residues (in
ppb) of
semduramicin
sodium and its
metabolites are well below safe concentrations in all edible tissues
after a withdrawal period of
six hours.
Elimination
Residue concentrations were determined in plasma, bile and excreta
following the administration
of radiolabeled semduramicin.
Bile represents a major pathway of drug elimination.
Levels of
plasma resi