Pulmotil AC Concentrate for oral solution for use in drinking water or milk replacer

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin

Dosage:

250 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Fowl - Chicken, Fowl - Turkey, Porcine

Therapeutic area:

tilmicosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1999-02-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil AC 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 eggs for human consumption)
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 flocks, 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.
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.
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