VETMULIN 162 mg/ml Solution for Injection for pigs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Tiamulin

Sẵn có từ:

Huvepharma NV

Mã ATC:

QJ01XQ01

INN (Tên quốc tế):

Tiamulin

Liều dùng:

162 milligram(s)/millilitre

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Porcine

Khu trị liệu:

tiamulin

Chỉ dẫn điều trị:

Antibacterial

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2009-10-30

Đặc tính sản phẩm

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