Selectan 300 mg/ml Solution for Injection for Cattle and Swine

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Florfenicol

Dostępny od:

Laboratorios Hipra SA

Kod ATC:

QJ01BA90

INN (International Nazwa):

Florfenicol

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cattle, Pigs

Dziedzina terapeutyczna:

Antimicrobial

Status autoryzacji:

Authorized

Data autoryzacji:

2007-12-19

Charakterystyka produktu

Revised: October 2023
AN: 00750/2023 & 00776/2023
Page 1 of 5
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
Excipients
N-methyl pyrrolidone
……………………………………………...…………………308
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.
Revised: October 2023
AN: 00750/2023 & 00776/2023
Page 2 of 5
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 resistant to the florfenicol and may decrease
the effectiveness
of treatment with other amfenicols, due to the potential for
crossresistance.
SPECIAL PRECAUTION TO