Pulmotil G200 Premix for Medicated Feedingstuff

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Tilmicosin

Inapatikana kutoka:

Eli Lilly and Company Limited

ATC kanuni:

QJ01FA91

INN (Jina la Kimataifa):

Tilmicosin

Dawa fomu:

Premix for medicated feeding stuff

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Pigs, Rabbits

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

1995-11-17

Tabia za bidhaa

Revised: October 2013
AN: 00506/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmotil G200 Premix for medicated feeding stuff
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 feeding stuff.
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 Equidae, 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.
Page 1 of 7
Revised: October 2013
AN: 00506/2013
4.5
SPECIAL PRECAUTIONS FOR USE
i)
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
tilmicosin, bacteriological
sampling and suscept