Nuflor Drinking Water Concentrate for Swine, 23 mg/mL, Concentrate for Oral Solution

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Florfenicol

Disponible depuis:

Schering-Plough Ltd

Code ATC:

QJO1BA

DCI (Dénomination commune internationale):

Florfenicol

Statut de autorisation:

Expired

Résumé des caractéristiques du produit

Revised: 30 April 2010
AN: 01567/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NUFLOR Drinking Water Concentrate for Swine, 23 mg/mL, Concentrate for
Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Florfenicol
23 mg/mL
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear, colourless to yellow, slightly viscous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Swine
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In swine:
Treatment and prevention at the group level where clinical signs are
present
of swine respiratory disease associated with _Actinobacillus
pleuropneumoniae_
and _Pasteurella multocida_ susceptible to florfenicol. The presence
of the
disease should be established in the herd before initiating preventive
treatment.
4.3
CONTRAINDICATIONS
Do not use in boars intended for breeding purposes.
Do not administer in cases of previous allergic reactions to
florfenicol.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Page 1 of 7
Revised: 30 April 2010
AN: 01567/2009
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
The veterinary medicinal product should be used in conjunction with
susceptibility testing.
Inappropriate use of the veterinary medicinal product may increase the
prevalence of bacteria resistant to florfenicol.
Treatment should not exceed 5 days.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
People with known hypersensitivity to polyethylene glycols should
avoid
contact with the veterinary medicinal product.
In case of accidental spillage onto skin rinse with water.
ii.
Other precautions
Manure from treated pigs should be stored for one month prior to
spreading and incorporating into land
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A slight reduction of water consumption by the animals, dark brown
faeces
and constipation may be observed during treatment.
Commonly observed ad