TILMICOSIN 100 mgml Oral Solution

Country: Malaysia

Language: English

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

Active ingredient:

TILMICOSIN PHOSPHATE

Available from:

Fijiliam Enterprise Sdn. Bhd.

INN (International Name):

TILMICOSIN PHOSPHATE

Units in package:

1000.00 mcg/mL

Manufactured by:

Osmosis Nutrition Sdn Bhd

Summary of Product characteristics

TILMICOSIN 100MG / ML ORAL SOLUTION
ACTIVE INGREDIENT
Each ml contains:
Tilmicosin
phosphate...……………………………………...………..
111.28 mg
_(equivalent to 100.00 mg of Tilmicosin) _
DESCRIPTION
A yellow to ambered coloured solution containing 100 mg per ml of
Tilmicosin (phosphate). 1.00 mg per
mL of methylparaben is added as preservative and propylene glycol is
added as vehicle to make up the
volume to 1.00 mL. The product is available in 1L white HDPE plastic
bottle.
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
miroorganism with activity against
certain gram-negative ones and Mycoplasma of a bovine, porcine, ovine
and avian origin. In particular, its
activity has been demonstarted 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, M. dispar _
Scientific evidence suggests that macrolides act synergistically with
the host immune system. Macrolides
appear to enhance phagocyte killing bacteria. Tilmicosin has been
shown to inhabit 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 tissue.
Pigs: After oral administration of 200 mg tilmicosin/1 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