Biomutin 200 mgml Solution for Injection

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

TIAMULIN HYDROGEN FUMARATE

Inapatikana kutoka:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (Jina la Kimataifa):

TIAMULIN HYDROGEN FUMARATE

Vitengo katika mfuko:

100ml mL

Viwandani na:

Biowet Drwalew S.A

Tabia za bidhaa

BIOMUTIN 200 MG/ML
SOLUTION FOR INJECTION
INGREDIENTS:
Each ml contains:
Tiamulin Hydrogen Fumarate
…………............................................................……..
200 mg
PRODUCT DESCRIPTION:
Colourless, clear solution, acceptable slightly yellow tint. Solution
for Injection.
PHARMACODYNAMICS
The following organisms show sensitivity to tiamulin in vitro:
Brachyspira: _Brachyspira hyodysenteriae, Brachyspira pilosicoli_
Mycoplasmas: _ Mycoplasma hyopneumoniae, M. hyorhinis, M. hyosynoviae,
M. dispar, Ureaplasma spp, _
Gram-positive: _Staphylococcus spp., Streptococcus spp.,
Corynebacterium pyogenes._
Gram-negative: _ Pasteurella spp., Klebsiela pneumoniae,
Actinobacillus (Haemophilus)spp., Fusobacterium _
_necrophorum, Bacteroides spp., Campylobacter coli, Lawsonia
intracellularis._
PHARMACOKINETICS
Following oral administration the active ingredient, tiamulin, is
rapidly absorbed, peak serum levels being
achieved within two hours. Tiamulin distributes widely in tissues,
including the colon. High tiamulin
concentrations are found in the lung of up to approximately 20 times
the value found in the serum. Two hours
post-injection, tiamulin lung levels of 14.5 – 16.7 mg/g have been
found.
INDICATION(S):
Swine dysentery: For the treatment of swine dysentery caused by _
Brachyspira hyodysenteriae_ and
complicated by _Bacteroides spp_ and _Fusobacterium spp._
Enzootic pneumonia complex of pigs: For the treatment of enzootic
pneumonia complex, caused by _ M. _
_hyopneumoniae_ and where the secondary bacteria are sensitive to
tiamulin.
Mycoplasmal arthritis: For the treatment of arthritis caused by
_Mycoplasma hyosynoviae_, to reduce lameness
and restore growth performance.
RECOMMENDED DOSAGE AND MODE OF ADMINISTRATION
Solution for injections, intramuscular administration.
Swine dysentery Treatment: The dose is 1 ml/20 kg bodyweight
(equivalent to 10 mg tiamulin hydrogen
fumarate/kg body weight) intramuscularly administered as a single
treatment to pigs showing clinical signs of
the disease.
Enzootic Pne