Tulissin 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tulathromycin

Available from:

Virbac

ATC code:

QJ01FA94

INN (International Name):

Tulathromycin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2020-04-24

Summary of Product characteristics

Revised: February 2022
AN: 01799/2021
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulissin 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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 coloured 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.
Revised: February 2022
AN: 01799/2021
Page 2 of 8
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
The efficacy of an