Pulmotil G200 Premix for medicated feedingstuff

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tilmicosin phosphate

Available from:

Elanco GmbH

ATC code:

QJ01FA91

INN (International Name):

Tilmicosin phosphate

Dosage:

200 gram(s)/kilogram(s)

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tilmicosin

Authorization status:

Authorised

Authorization date:

1997-01-24

Summary of Product characteristics

Health Products Regulatory Authority
24 July 2018
CRN000YKH
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil G200 Premix for medicated feedingstuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tilmicosin (as phosphate)
200
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
Health Products Regulatory Authority
24 July 2018
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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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
tilmicosin and may decrease the effectiveness of treatment with
tilmicosin related
substances.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Due to the likely variability (time, geographical) in the occurrence
of the resistance of
bacteria for tilmi