Fenflor 300 mg/ml Solution for Injection for Pigs

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Florfenicol

Disponível em:

Krka d.d., Novo Mesto

Código ATC:

QJ01BA90

DCI (Denominação Comum Internacional):

Florfenicol

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Pigs

Área terapêutica:

Antimicrobial

Status de autorização:

Authorized

Data de autorização:

2007-07-04

Características técnicas

Revised November 2023
AN: 03904/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenflor 300 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS
Dimethyl sulfoxide
Propylene glycol
Macrogol 400
A light yellow to yellow, clear, viscous liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of acute outbreaks of respiratory disease caused by strains
of _Actinobacillus _
_pleuropneumoniae_ and _Pasteurella multocida_ susceptible to
florfenicol.
3.3
CONTRAINDICATIONS
Do not use in boars intended for breeding.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in cases of known resistance to the active substance.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Wipe the stopper before removing each dose. Use a dry, sterile syringe
and needle.
Do not use in piglets of less than 2 kg.
Revised November 2023
AN: 03904/2022
Page 2 of 5
The product should be used in conjunction with susceptibility testing
and take into
account official and local antimicrobial policies.
Use a suitable draw-off needle or automatic dosing syringe to avoid
excessive
puncturing of the closure.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals:
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label to the physician.
People with known hypersensitivity to florfenicol, propylene glycol
and polyethylene
glycols should avoid contact with the veterinary medicinal product.
In case of accidental contact with eyes, rinse immediately with plenty
of water.
Special precautions for the protection of the environment:
N