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

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Tulathromycin

Verfügbar ab:

Vetoquinol SA

ATC-Code:

QJ01FA94

INN (Internationale Bezeichnung):

Tulathromycin

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cattle, Pigs, Sheep

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2020-05-18

Fachinformation

Revised: February 2023
AN: 03065/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LYDAXX 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 yellow 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 2023
AN: 03065/2022
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