LORICAN (25% Tilmicosin Oral Solution)

Država: Malezija

Jezik: angleščina

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

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Prenos Lastnosti izdelka (SPC)
29-01-2024

Aktivna sestavina:

TILMICOSIN

Dostopno od:

Rural Chemical Industries Sdn Bhd

INN (mednarodno ime):

TILMICOSIN

Enote v paketu:

1000.00 mcg/mL

Izdeluje:

Qilu Animal Health Products Co., Ltd

Lastnosti izdelka

                                I) BRAND OR PRODUCT NAME
LORICAN (25% Tilmicosin Oral Solution)
II) NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Tilmicosin, 25% w/v
III) PRODUCT DESCRIPTION
A clear solution with the color of light yellow to yellow.
IV) PHARMACODYNAMICS/PHARMACOKINETICS/ENVIRONMENTAL
PROPERTIES
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 
                                
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