Tulissin 25 mg/ml Solution for Injection for Pigs

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Tulathromycin

Verfügbar ab:

Virbac

ATC-Code:

QJ01FA94

INN (Internationale Bezeichnung):

Tulathromycin

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Pigs

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2020-04-24

Fachinformation

Revised: February 2022
AN: 01799/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulissin 25 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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 coloured 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
Revised: February 2022
AN: 01799/2021
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal 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 effectiveness of treatment with
oth