Flordofen 300 mg/ml Solution for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Florfenicol

Available from:

Dopharma Research B.V.

ATC code:

QJ01BA90

INN (International Name):

Florfenicol

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

florfenicol

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2014-03-28

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:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
N-methyl pyrrolidone
250 mg
Propylene glycol
Macrogol 300
Clear, slightly yellowish solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and pigs
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
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.
3.4
SPECIAL WARNINGS
This veterinary medicinal product does not contain an antimicrobial
preservative.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Do not administer to piglets of less than 2 kg.
Use of the veterinary medicinal 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 veterinary
medicinal product is used.
Use of the veterinary medicinal product deviating from the
instructions given in the SPC may increase
the prevalence of bacteria resistant to florfenicol and may de