ISOTYL-250 Oral Solution

País: Malàisia

Idioma: anglès

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

ingredients actius:

TILMICOSIN PHOSPHATE

Disponible des:

GENPHARMA SDN. BHD

Designació comuna internacional (DCI):

TILMICOSIN PHOSPHATE

Unidades en paquete:

1.00 mcg/mL

Fabricat per:

PAHANG PHARMACY SDN. BHD.

Fitxa tècnica

Revised: 26 February 2010
AN: 01572/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil AC 250 mg/ml Concentrate for Oral Solution for use in
drinking water
or milk replacer
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tilmicosin (as phosphate) 250 mg/ml
EXCIPIENTS:
Propyl gallate
Disodium edetate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Oral Solution for use in drinking water or milk
replacer.
Clear yellow to amber coloured solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (except hens producing egges for human comsumption),
Turkeys,
Pigs,
Calves (non ruminant)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment and prevention of respiratory disease in pig
herds,
associated with_ Mycoplasma hyopneumoniae, Pasteurella multocida,_
_Actinobacillus pleuropneumoniae_ and other organisms susceptible to
tilmicosin_._
Chickens: For the treatment and prevention of respiratory disease in
chicken
flocks, associated with_ Mycoplasma gallisepticum_ and_ M. synoviae._
Turkeys: For the treatment and prevention of respiratory disease in
turkey
locks, associated with_ Mycoplasma gallisepticum_ and_ M. synoviae._
Calves: For the treatment and prevention of bovine respiratory
disease,
associated with_ Mannheimia haemolytica, Pasteurella multocida,
Mycoplasma_
_bovis, M. dispar_ and other organisms susceptible to tilmicosin_._
Revised: 26 February 2010
AN: 01572/2009
4.3
CONTRAINDICATIONS
Do not allow horses and other equines access to drinking water
containing
tilmicosin.
Do not use in case of hypersensitivity to tilmicosin or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Important: must be diluted before administration to animals
Pigs, chickens and turkeys: Wtaer consumption should be monitored in
order to
guarantee adequate dosing. In case water consumption does not match
quantities for which recommended concentrations were calculated, the
concentration of Pulmoti