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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tulathromycin

Available from:

Laboratorios SYVA, S.A.U

ATC code:

QJ01FA94

INN (International Name):

Tulathromycin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tulathromycin

Authorization status:

Authorised

Authorization date:

2021-05-14

Summary of Product characteristics

Health Products Regulatory Authority
14 May 2021
CRN009P2P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TROXXAN 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
action s