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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Tulathromycin

Tillgänglig från:

Dopharma Research B.V.

ATC-kod:

QJ01FA94

INN (International namn):

Tulathromycin

Dos:

100 milligram(s)/millilitre

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

tulathromycin

Bemyndigande status:

Authorised

Tillstånd datum:

2021-06-25

Produktens egenskaper

Health Products Regulatory Authority
25 June 2021
CRN009P90
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DORAXX 100 mg/ml solution for injection for cattle, pigs and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Tulathromycin
​
100 mg
​
​
​
EXCIPIENT:
​
​
Monothioglycerol
​
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
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 veterinary medicinal 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
veterinary medicinal 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
acti