Pulmotil G200 Premix for Medicated Feedingstuff

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Tilmicosin

MAH:

Elanco Europe Ltd

ATC_code:

QJ01FA91

INN:

Tilmicosin

pharmaceutical_form:

Premix for medicated feeding stuff

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Pigs, Rabbits

therapeutic_area:

Antimicrobial

authorization_status:

Authorized

authorization_date:

1995-11-17

SPC

Amended Pages: August 2022
Page 1 of 7
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.
Amended Pages: August 2022
Page 2 of 7
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
susceptibility
te