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

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Tulathromycin

Dostopno od:

Krka d.d., Novo Mesto

Koda artikla:

QJ01FA94

INN (mednarodno ime):

Tulathromycin

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle, Pigs, Sheep

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2019-02-07

Lastnosti izdelka

Unlimited renewal: July 2023
AN: 00701/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tuloxxin 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 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 or slightly brown 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.
Unlimited renewal: July 2023
AN: 00701/2023
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.