VETMULIN 162 MG/ML SOLUTION FOR INJECTION FOR PIGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

TIAMULIN

제공처:

Huvepharma NV

ATC 코드:

QJ01XQ01

INN (International Name):

TIAMULIN

복용량:

162 Mg/Ml

약제 형태:

Solution for Injection

처방전 유형:

POM

치료 그룹:

Porcine

치료 영역:

Tiamulin

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2009-10-30

제품 특성 요약

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
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._
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active ingredient or 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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/08/2014_
_CRN 7016586_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the likely variability (time, geographical) in the occurance 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