VETMULIN 162 mg/ml Solution for Injection for pigs

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Tiamulin

可用日期:

Huvepharma NV

ATC代码:

QJ01XQ01

INN（国际名称）:

Tiamulin

剂量:

162 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Porcine

治疗领域:

tiamulin

疗效迹象:

Antibacterial

授权状态:

Authorised

授权日期:

2009-10-30

产品特点

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.
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the likely variability (time, geographical) in the