Tuloxxin 25 mg/ml solution for injection for pigs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Tulathromycin

Tilgængelig fra:

Krka, d.d., Novo mesto

ATC-kode:

QJ01FA94

INN (International Name):

Tulathromycin

Dosering:

25 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

tulathromycin

Autorisation status:

Authorised

Autorisation dato:

2020-11-13

Produktets egenskaber

Health Products Regulatory Authority
23 November 2021
CRN00CDJ6
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tuloxxin 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.
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