SELECTAN 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND SWINE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-08-2015
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Active ingredient:
FLORFENICOL
Available from:
Laboratorios Hipra S.A.
ATC code:
QJ01BA90
INN (International Name):
FLORFENICOL
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Florfenicol
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2008-02-15
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SELECTAN
300 mg/ml solution for injection for cattle and swine.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Florfenicol …………………………………………………………………………… 300 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A slightly yellowish and clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and swine.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by florfenicol susceptible bacteria:
Cattle:
Therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella multocida, _and
_Histophilus somni._
Swine:
Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus pleuropneumoniae _and
_Pasteurella multocida_.
4.3 CONTRAINDICATIONS
Do not administer to adult bulls or boars intended for breeding purposes.
Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 10/08/2015_
_CRN 7020043_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use in piglets of less than 2 kg.
Swab the septum before removing each dose.
Use a dry, sterile syringe and needle.
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and
local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistan
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