NUFLOR 300 mg/ml solution for injection for cattle and sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Florfenicol

Available from:

Intervet Ireland Limited

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, Sheep

Therapeutic area:

florfenicol

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2012-11-23

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NUFLOR 300 mg/ml solution for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
EXCIPIENTS:
N-methyl-2-pyrollidone
250 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, light yellow to straw-coloured, somewhat viscous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Diseases caused by florfenicol susceptible bacteria.
Metaphylactic and therapeutic treatment of respiratory tract
infections in cattle due to
_ Mannheimia _
_haemolytica_
,
_ Pasteurella multocida_
and
_ Histophilus somni_
. The presence of the disease in the herd
should be established before metaphylactic treatment.
Sheep:
Treatment of ovine respiratory tract infections due to
_Mannheimia haemolytica _
and
_ Pasteurella _
_multocida _
susceptible to florfenicol.
4.3
CONTRAINDICATIONS
Do not use in adult bulls and rams intended for breeding purposes.
Do not use in the case of known hypersensitivity to the active
substance or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should be used in conjunction with susceptibility testing
and take into account official
and local antimicrobial policies.
The safety of the product has not been established in sheep younger
than 7 weeks of age.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
People with known hypersensitivity to propylene glycol and
polyethylene glycols should avoid contact
with the veterinary medicinal product. In case of accidental contact
with skin or eyes, rinse
immediately with plenty of water.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
Laboratory studies in rabbits and rats with the