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

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Tulathromycin

Beschikbaar vanaf:

Dopharma Research B.V.

ATC-code:

QJ01FA94

INN (Algemene Internationale Benaming):

Tulathromycin

farmaceutische vorm:

Solution for injection

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Cattle, Pigs, Sheep

Therapeutisch gebied:

Antimicrobial

Autorisatie-status:

Authorized

Autorisatie datum:

2021-06-25

Productkenmerken

Amended Pages
AN: 02185/2019
Page 1 of 8
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.
Amended Pages
AN: 02185/2019
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 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