Tilmicosol 250 mg/ml concentrate for oral solution
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
14-09-2012
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Active ingredient:
tilmicosin 250 mg/ml
Available from:
Lavet Pharmaceuticals Ltd.
ATC code:
QJ01FA91
Pharmaceutical form:
Oral solution
Therapeutic group:
tilmicosin
Therapeutic area:
Cattle Young, Chicken, Pigs, Turkeys
Authorization date:
2010-11-24
Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tilmicosol
_(in Cyprus, Czech Republic, Greece, Hungary, Spain, Lithuania,
Portugal and United Kingdom) _
Tilmic
_(in Denmark) _
TylmiScan
_(in Poland) _
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 (E 310) 0.2 mg/ml
Disodium edetate 2.0 mg/ml
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 eggs 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_. _
2
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, M
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