TYLOSIN-100 Water Soluble Powder

Land: Maleisië

Taal: Engels

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

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18-10-2022

Werkstoffen:

TYLOSIN TARTRATE

Beschikbaar vanaf:

GENPHARMA SDN. BHD

INN (Algemene Internationale Benaming):

TYLOSIN TARTRATE

Eenheden in pakket:

120.00 mcg/mL

Geproduceerd door:

PAHANG PHARMACY SDN. BHD.

Productkenmerken

                                [Draft of Package Insert]
FOR ANIMAL USE ONLY
TYLOSIN-100
WATER SOLUBLE POWDER
CONTENT: Each sachet (120 g) contains,
Tylosin (as tartrate) ……………………………….100 g
PRODUCT DESCRIPTION: A light yellow powder.
PHARMACODYNAMICS:
Tylosin is a macrolide antibiotic produced by a strain of_
Streptomyces fradiae._ It exerts its
antimicrobial effect by inhibiting protein synthesis of susceptible
micro-organisms.
The tylosin spectrum of activity includes amongst others Gram-positive
bacteria, some Gram –
negative strains such as_ Pasteurella_, and_ Mycoplasma spp_.
PHARMACOKINETICS:
In most species peak plasma concentrations have been attained 1 to 2
hours after administration
of tylosin. Compared to plasma levels clearly higher tissue
concentrations have been observed.
Tylosin was extensively metabolised.
Most of the residues are excreted in faeces predominantly consisting
of tylosin (factor A),
relomycin (factor D) and dihydrodesmycosin.
INDICATION:
Calves
-
Treatment and prevention of pneumonia caused by_ Mycoplasma spp_ when
the disease has
been established in the herd.
Pigs
-
Treatment and prevention of enzootic pneumonia caused by_ Mycoplasma
hyopneumoniae_ and
_Mycoplasma hyorhinis_ when the disease has been established in the
herd.
Chickens
-
Treatment and prevention of chronic respiratory diseases (CRD) caused
by_ Mycoplasma_
_gallisepticum_ and_ Mycoplasma synoviae_ when the disease has been
established in the flock.
-
Treatment and prevention of necrotic enteritis caused by_ Clostridium
perfringens_ when the
disease has been established in the flock.
Turkeys
-
Treatment and prevention of infectious sinusitis caused by_ Mycoplasma
gallisepticum._ When
the disease has been established in the flock.
DOSAGE & ADMINISTRATION:
Oral administration through the drinking water.
In calves the product can also be administered through milk or milk
replacer.
1 gram of the veterinary medicinal product corresponds to 0.833 gram
of tylosin. The dosages are
as follows:
Calves:
10 – 20 mg tylosin per kg BW (
                                
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