PULMOTIL AC CONCENTRATE FOR ORAL SOLUTION FOR USE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-12-2014
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Active ingredient:
TILMICOSIN
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QJ01FA91
INN (International Name):
TILMICOSIN
Dosage:
250 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 28/11/2014_
_CRN 7019438_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET
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