SELECTAN ORAL 23 mg/ml solution for use in drinking water for pigs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Florfenicol

MAH:

Laboratorios Hipra S.A.

ATC_code:

QJ01BA90

INN:

Florfenicol

dosage:

23 milligram(s)/millilitre

pharmaceutical_form:

Solution for use in drinking water

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Pigs

therapeutic_area:

florfenicol

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

2011-04-15

SPC

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 cases 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.
Animals showing a decreased water intake and/or a poor general
condition should be treated by the parenteral route.
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