AMULIN 10% Injection

Country: Malaysia

Language: English

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

Active ingredient:

TIAMULIN HYDROGEN FUMARATE

Available from:

RANGE PHARMA SDN. BHD.

INN (International Name):

TIAMULIN HYDROGEN FUMARATE

Units in package:

100.00 ml

Manufactured by:

RANGE PHARMA SDN. BHD.

Summary of Product characteristics

AMULIN 10% INJECTION
DESCRIPTION AND COMPOSITION
AMULIN 10% Injection is a colourless to yellow clear oily solution.
100mg Tiamulin Hydrogen Fumarate as its active ingredient and 1m g
Chlorocresol as a preservative per ml.
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., Klebsiella 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 achived 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 in the
serum. Two hours post- injection, tiamulin lung levels of 14.5- 16.7
mg/g have been found.
INDICATION
Swine dysentery: For the treatment of swine dysentery caused by
Brachyspira hyodysenteriae and complicated by Bacteriodes 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 DOSE
Swine Dysentery Treatment
The dose is 0.1 ml/kg body weight (equivalent to 10 mg tiamulin
hydrogen fumarate/kg body weight) intramuscularly administered as a
single
treatment to pigs showing clinical signs of the disease. Mycoplasmal
Arthritis Treatment and Enzootic Pneumonia Complex of Pigs Treatment
The dose is 0.15 ml/ kg body weight (equivalent to 15 mg tiamulin
hydrogen fumarate/kg body weight) daily, adminis