Tulaxa 100 mg/ml solution for injection for cattle, pigs and sheep

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Tulathromycin

Disponibil de la:

Krka, d.d., Novo mesto

Codul ATC:

QJ01FA94

INN (nume internaţional):

Tulathromycin

Dozare:

100 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

tulathromycin

Statutul autorizaţiei:

Authorised

Data de autorizare:

2019-02-08

Caracteristicilor produsului

Health Products Regulatory Authority
23 November 2021
CRN00CDJ3
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulaxa 100 mg/ml solution for injection for cattle, pigs and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
ACTIVE SUBSTANCE:
Tulathromycin 100 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
Cattle, pigs and sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with _Mannheimia haemolytica_, _Pasteurella _
_multocida, Histophilus somni _and _Mycoplasma bovis _susceptible to
tulathromycin. The presence of the disease in the group
must be established before the product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated
with _Moraxella bovis _susceptible to tulathromycin.
Pigs
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.
Sheep
Treatment of the early stages of infectious pododermatitis (foot rot)
associated with virulent _Dichelobacter nodosus _requiring
systemic treatment.
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.
Sheep:
Health Products Regulatory Authority
23 N