Chanaxin 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:

Chanelle Pharmaceuticals Manufacturing Ltd

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:

2022-05-20

Summary of Product characteristics

Issued: April 2022
AN: 01155/2020
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Chanaxin 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 yellow solution for injection.
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
Issued: April 2022
AN: 01155/2020
Page 2 of 8
the product is used. The veterinary medicinal product should only be
used if pigs are
expected to develop the disease within 2–3 days.
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 the active substance, other
macrolide
antibiotics or 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
lincosa