Vetmulin 162 mg/ml Solution for Injection for Pigs

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Tiamulin

제공처:

Huvepharma N.V.

ATC 코드:

QJ01XQ01

INN (International Name):

Tiamulin

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Pigs

치료 영역:

Antimicrobial

승인 상태:

Authorized

승인 날짜:

2009-10-21

제품 특성 요약

Issued: August 2014
AN. 01241/2013
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 162 mg/ml Solution for Injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Tiamulin
162 mg/ml
EXCIPIENTS
Butyl parahydroxybenzoate 0.324 mg/ml
Propyl gallate (E310) 0.163 mg/ml
For a full list of excipients: see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Pale yellow oily solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For treatment and metaphylaxis of swine dysentery caused by _
Brachyspira _
_hyodysenteriae_.
For the treatment of enzootic pneumonia caused by tiamulin-susceptible
_Mycoplasma hyopneumoniae_ and mycoplasmal arthritis caused by
tiamulin-
susceptible _Mycoplasma hyosynoviae._
Issued: August 2014
AN. 01241/2013
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to
any of the excipients Do not use in cases of known resistance to
tiamulin.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
Inflammation/scarring may occur at the site of injection. For this
reason, it is
recommended that the product should be administered into the muscle of
the
neck.
4.5
SPECIAL PRECAUTIONS FOR USE
I)SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the likely variability (time, geographical) in the occurrence
of
resistance of bacteria for tiamulin, the use of the product should be
based on bacteriological sampling and susceptibility testing taking
into
account official and local antimicrobial policies. Use of the product
deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to tiamulin and may decrease the
effectiveness of treatment with other pleuromutilins due to the
potential
for cross-resistance.
Long
term
or
repeated
use
should
be
avoided
by
improving
management practice and thorough cleansing and disinfection.
In the absence of a satisfactory response to treatment