Cadorex 300 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Florfenicol

Available from:

Livisto Int'l S.L.

ATC code:

QJ01BA90

INN (International Name):

Florfenicol

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:

2017-05-16

Summary of Product characteristics

Revised: July 2023
AN: 00480/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERSTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol 300 mg
EXCIPIENTS:
N-methyl pyrrolidone 250 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, light yellow to straw-coloured, somewhat viscous solution, free
from foreign
matter.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Diseases caused by florfenicol susceptible bacteria: Treatment of
respiratory
tract infections in cattle due to _Mannheimia haemolytica, Pasteurella
multocida _
and_ Histophilus somni. _
Sheep:
Treatment of ovine respiratory tract infections due to _Mannheimia
haemolytica _
and _Pasteurella multocida_.
Pigs:
Treatment of acute outbreaks of swine respiratory disease caused by
strains of
_Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_.
4.3 CONTRAINDICATIONS
Do not use in adult bulls and rams intended for breeding purposes.
Do not administer to boars intended for breeding.
Revised: July 2023
AN: 00480/2023
Page 2 of 8
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This medicinal product does not contain any antimicrobial
preservative.
The safety of the product has not been established in sheep under 7
weeks of
age.
Do not use in piglets of less than 2 kg.
Use of the product should be based on identification and
susceptibility testing of
the target pathogens. Use of the product should be in accordance with
official,
national and regional antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase
the prevalence of bacteria resistant to the florfenicol and m