DORAXX 25 mg/ml solution for injection for pigs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Tulathromycin

제공처:

Dopharma Research B.V.

ATC 코드:

QJ01FA94

INN (국제 이름):

Tulathromycin

약제 형태:

Solution for injection

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 영역:

tulathromycin

승인 상태:

Authorised

승인 날짜:

2022-01-07

제품 특성 요약

Health Products Regulatory Authority
11 January 2022
CRN009YR1
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DORAXX 25 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
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ACTIVE SUBSTANCE:
​
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Tulathromycin
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25 mg
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EXCIPIENT:
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Monothioglycerol
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5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow solution, free from visible
particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of swine respiratory disease (SRD)
associated with _Actinobacillus pleuropneumoniae_, _Pasteurella _
_multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis _and
_Bordetella bronchiseptica _susceptible to tulathromycin. The
presence of the disease in the group must be established before the
product is used. The veterinary medicinal product should
only be used if pigs are expected to develop the disease within 2–3
days.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance occurs with other macrolides. Do not administer
simultaneously with antimicrobials with a similar mode of
action such as other macrolides or lincosamides.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to
tulathromycin and may decrease the effectiveness of tre