Florfenikel 300 mg/ml Solution for Injection for Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Florfenicol

Available from:

Kela – Kempisch Laboratorium – Kela Laboratoria NV

ATC code:

QJ01BA90

INN (International Name):

Florfenicol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2012-02-27

Summary of Product characteristics

Revised: October 2023
AN: 00425/2023 & 00624/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
FLORFENIKEL 300 mg/ml solution for injection for cattle and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Florfenicol 300 mg
EXCIPIENT:
N-methyl pyrrolidone 200 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear, light yellow to yellow solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Treatment
of
respiratory
tract
infections
due
to
strains
of
_Mannheimia _
_haemolytica, Pasteurella multocida _and _Histophilus somni_
susceptible to florfenicol_. _
Pigs: Treatment of acute outbreaks of swine respiratory disease caused
by strains of
_Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_
susceptible to florfenicol.
4.3 CONTRAINDICATIONS
Do not use in adult bulls and boars intended for breeding purposes.
Do not use in piglets of less than 2 kg.
Do not use in case of hypersensitivity to florfenicol or to any of the
excipients.
Do not use in case of resistance to the active substance.
Do not administer intravenously.
Revised: October 2023
AN: 00425/2023 & 00624/2023
Page 2 of 7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The stopper must be cleaned before removing each dose. Use a dry,
sterile syringe and
needle.
Use of product should be based on susceptibility testing of the
bacteria isolated from the
animal. If this is not possible, therapy should be based on local
(regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Official national and regional antimicrobial policies should be taken
into account when
the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to florfenicol and may decrease the
effectiv