Tulaxa 25 mg/ml Solution for Injection for Pigs

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Tulathromycin

제공처:

Krka d.d., Novo Mesto

ATC 코드:

QJ01FA94

INN (국제 이름):

Tulathromycin

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Pigs

치료 영역:

Antimicrobial

승인 상태:

Authorized

승인 날짜:

2020-08-14

제품 특성 요약

Unlimited renewal: July 2023
AN: 00707/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulaxa 25 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
ACTIVE SUBSTANCE:
Tulathromycin
25 mg
EXCIPIENTS:
Monothioglycerol
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly yellow or slightly brown solution.
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.
Unlimited renewal: July 2023
AN: 00707/2023
Page 2 of 5
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 treatment with o