Nuflor

1 x 100 ml

Liquid for injection, solution

Active substance

Florfenicol : 300 mg/ml

ATC code

QJ01BA90 Florfenicol

QJ01BA Amphenicols

QJ01B Amphenicols

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle and sheep.

Indications

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.

Dose to be administered and administration route

Swab septum before removing each dose. Use a dry sterile needle and syringe. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

The vials should not be broached more than 20 times. User should therefore select the most appropriate vial size according to the target species to be treated. When treating groups of animals at the same time, use of a draw-off needle in the vial stopper is recommended to avoid excess stopper broaching. The draw-off needle should be removed after treatment.

For treatment

Cattle:

Intramuscular use: 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart using a 16 gauge needle.

Subcutaneous use: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.

The injection should only be given in the neck.

Sheep:

Intramuscular use: 20 mg florfenicol/kg bodyweight (1 ml/15 kg) to be administered daily for three consecutive days. The volume administered per injection site should not exceed 4 ml.

Pharmacokinetic studies showed that mean plasma concentrations remain above MIC₉₀ (1 μg/ml) for up to 18 hours after administration of the veterinary medicinal product at the recommended treatment dose. The pre-clinical data supported the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml.

For metaphylaxis

Cattle:

Subcutaneous use: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.

The injection should only be given in the neck.

Adverse reactions

Cattle:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Reduced food intake^¹;

Loose stool¹;

Injection site inflammation^², Injection site lesion²; Anaphylaxis.

Sheep:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Reduced food intake¹;

Injection site inflammation², Injection site lesion².

¹ Quick and complete recovery upon termination of treatment.

² Mild and may persist up to 28 days after intramuscular administration.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.