SELECTAN ORAL 23 mg/ml Solution for Use in Drinking Water for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Florfenicol

Available from:

Laboratorios Hipra SA

ATC code:

QJ01BA90

INN (International Name):

Florfenicol

Pharmaceutical form:

Concentrate for oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2011-04-28

Summary of Product characteristics

AN: 00907/2015
Revised: April 2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SELECTAN ORAL 23 mg/ml solution for use in drinking water for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE:
Florfenicol
……………………………………………………………………………
23 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
A slightly yellowish and clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: Treatment and metaphylaxis 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 use in case of known hypersensitivity to the active substance
or to the excipient.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The treated pigs should be placed under special observation. On each
of the five days of
treatment, unmedicated drinking water should not be given until the
full daily amount of
medicated drinking water has been ingested by pigs.
If there are no signs of improvement after three days of treatment,
the diagnosis should be
reviewed and, if necessary, the treatment changed.
AN: 00907/2015
Revised: April 2016
Page 2 of 6
Animals showing a decreased water intake and/or a poor general
condition should be
treated by the parenteral route.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The veterinary medicinal product should be used in conjunction with
susceptibility testing.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to the florfenicol.
Official and local antimicrobi