Flordofen 300 mg/ml Solution for Injection for Cattle and Pigs

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Florfenicol

Dostępny od:

Dopharma Research B.V.

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:

2014-02-10

Charakterystyka produktu

Revised: October 2018
AN: 02455/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flordofen 300 mg/ml solution for injection for cattle and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
_EXCIPIENTS_:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
Treatment and metaphylaxis of respiratory tract infections in cattle
due to_ _
_Mannheimia haemolytica, Pasteurella multocida_ and_ Histophilus
somni_,
susceptible to florfenicol.
The presence of the disease in the herd should be established before
methaphylaxis.
PIGS:
Treatment of acute outbreaks of respiratory disease caused by strains
of
_Actinobacillus pleuropneumoniae _and_ Pasteurella multocida_
susceptible to
florfenicol.
4.3
CONTRAINDICATIONS
Do not use in adult bulls and boars intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Revised: October 2018
AN: 02455/2017
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
This veterinary medicinal product does not contain an antimicrobial
preservative.
Special precautions for use in animals
Do not administer to piglets of less than 2 kg.
Use of product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local
(regional, farm level) epidemiological information about
susceptibility of the
target bacteria.
Official national and regional antimicrobial policies should be taken
into account
when the product is used.
Use of the product deviating from the instructions given in the SPC
may
increase the prevalence of bacteria resistant to florfenicol and may
decrease
the effectiveness of treatment with other antimicrobials d