Tilmiseen 25% wv Oral Solution

Country: Malaysia

Language: English

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

Active ingredient:

TILMICOSIN PHOSPHATE

Available from:

Taseen Trading Sdn Bhd

INN (International Name):

TILMICOSIN PHOSPHATE

Units in package:

500ml mL

Manufactured by:

Samyang Anipharm Co., Ltd

Summary of Product characteristics

PACKAGE INSERT
TILMISEEN 25% W/V ORAL SOLUTION
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Tilmicosin Phosphate 25%w/v
PRODUCT DESCRIPTION
Yellowish brown solution.
PHARMACODYNAMICS
Tilmicosin is a semi-synthetic antibiotic of the macrolide group and
is believed to affect protein synthesis.
It has bacteriostatic action but at high concentrations it may be
bactericidal.
This antibacterial activity is predominantly against Gram-positive
microorganism with activity against
certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine
and avian origin. In particular, its
activity has been demonstrated against the following microorganism:

_Pigs: Mycoplasma hyopneumoniae, Pasteurella multocida and
Actinobacillus _
_pleuropneumoniae _
_ _

_Chickens and turkeys: Mycoplasma gallisepticum and Mycoplasma
synoviae _
_ _

_Calves: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma
bovis and M. dispar. _
Scientific evidence suggests that macrolides act synergistically with
the host immune system. Macrolides
appear to enhance phagocyte killing of bacteria. Tilmicosin has been
shown to inhibit _in vitro _the
replication of the Porcine Reproductive and Respiratory Syndrome virus
in alveolar macrophages in a
dose dependent fashion.
Cross-resistance between tilmicosin and other macrolides and
lincomycin has been observed.
PHARMACOKINETICS
Whilst blood concentrations of tilmicosin are low, there is
pH-dependent macrophage accumulation of
tilmicosin in inflamed tissues.
Pigs: After oral administration of 200 mg tilmicosin/l drinking water,
the average active substance
concentrations detected in lung tissue, alveolar macrophages and
bronchial epithelium 5 days after the
start of treatment were 1.44 μg/ml, 3.8 μg/ml and 7.4 μg/g
respectively.
Poultry: As early as 6 hours after oral administration of 75 mg
tilmicosin/l drinking water, the average
active substance concentrations detected in lung and alveolar tissue
were 0.63 μg/g and 0.30 μg/g
respectively. 48 hours after the start of treatment, the tilmicosin