Fenflor 300 mg/ml solution for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Florfenicol

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01BA90

INN (International Name):

Florfenicol

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

florfenicol

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-09-26

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.
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:
Not applicable.
3.6
ADVERSE EVENTS
Pigs:
Common
(1 to 10 animals / 100 animals
treated):
Diarrhoea
1
Peri-anal and rectal erythema/o