Pulmotil AC 250 mg/ml Concentrate for Oral Solution for Use in Drinking Water or Milk Replacer

Summary of Product characteristics

                                Revised: January 2019
AN: 00874/2018
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
0.2 mg/ml
Disodium edetate
2.0 mg/ml
For the 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 consumption),
Turkeys
Pigs
Calves (non ruminant)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment and metaphylaxis 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 metaphylaxis of respiratory disease in
chicken
flocks, associated with _Mycoplasma gallisepticum _and _M. synoviae. _
Turkeys: For the treatment and metaphylaxis of respiratory disease in
turkey
flocks, associated with _Mycoplasma gallisepticum _and _M. synoviae. _
Calves: For the treatment and metaphylaxis of bovine respiratory
disease,
associated with _Mannheimia haemolytica, Pasteurella multocida,
Mycoplasma _
_bovis, M. dispar _and other organisms susceptible to tilmicosin.
The presence of the disease in the group/flock must be established
before the
product is used.
4.3
CONTRAINDICATIONS
Page 1 of 7
Revised: January 2019
AN: 00874/2018
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: Water consumption should be monitored in
order to
guarantee adequate dosing. In cas
                                
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