Pulmotil G40 Premix for medicated feeding stuff

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:

40 gram(s)/kilogram(s)

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Porcine, Rabbits

Therapeutic area:

tilmicosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1997-01-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil G40 Premix for medicated feedingstuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tilmicosin (as phosphate) 40 g/kg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feedingstuff.
A yellowish tan to reddish tan free flowing granular material.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and rabbits
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: Prevention and treatment of respiratory disease caused by_
Actinobacillus pleuropneumoniae, Mycoplasma_
_hyopneumoniae, Pasteurella multocida_ and other organisms sensitive
to tilmicosin.
Rabbits: Prevention and treatment of respiratory disease caused by_
Pasteurella multocida_ and_ Bordetella_
_bronchiseptica,_ susceptible to tilmicosin.
4.3 CONTRAINDICATIONS
Horses or other E_quidae_, must not be allowed access to feeds
containing tilmicosin. Horses fed with tilmicosin medicated
feeds may present signs of toxicity with lethargy, anorexia, reduction
of feed consumption, loose stools, colic, distension of
the abdomen and death.
Do not use in case of hypersensitivity to tilmicosin or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Under practical conditions, the management of respiratory disease
outbreaks recognises that acutely ill animals are
inappetant and require parenteral therapy.
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