Tulaxa 25 mg/ml solution for injection for pigs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Tulathromycin

Disponible des:

Krka, d.d., Novo mesto

Codi ATC:

QJ01FA94

Designació comuna internacional (DCI):

Tulathromycin

Dosis:

25 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

tulathromycin

Estat d'Autorització:

Authorised

Data d'autorització:

2020-10-09

Fitxa tècnica

Health Products Regulatory Authority
23 November 2021
CRN00CDJ3
Page 1 of 4
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
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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.
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 effe