TILMICOSIN 25 wv Oral Solution

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

TILMICOSIN PHOSPHATE

Verfügbar ab:

PAHANG PHARMACY SDN. BHD.

INN (Internationale Bezeichnung):

TILMICOSIN PHOSPHATE

Einheiten im Paket:

1l kg

Hergestellt von:

PAHANG PHARMACY SDN. BHD.

Fachinformation

[Draft of Package Insert]
FOR ANIMAL USE ONLY
TILMICOSIN-25 W/V
ORAL SOLUTION
CONTENT: Tilmicosin…….………………………………..250
mg/ml
PRODUCT DESCRIPTION: Clear, light yellowish liquid.
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