MSD NUFLOR MINIDOSE 250 ml VET ONLY (S4)

PHARMACOLOGICAL ACTION

Pharmacodynamic properties

Florfenicol is a synthetic broad-spectrum antibiotic effective against most gram-positive and gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic and time dependent. Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

Florfenicol is considered to be a bacteriostatic agent, but in vitro studies of florfenicol demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following breakpoints have been determined for florfenicol in bovine respiratory disease: susceptible: ≤ 2 µg/mℓ, intermediate: 4 µg/mℓ, resistant: ≥ 8 µg/mℓ.

Pharmacokinetic properties

After parenteral application, florfenicol is mainly excreted via urine and to a small extent via faeces, mainly as parent compound, but also followed by florfenicol amine and florfenicol oxamic acid. After intramuscular (IM) administration of florfenicol at the recommended dose of 20 mg/kg body weight, maximum mean concentration in serum of 3,02 µg/mℓ occurred in 6 hours after dosing. The administration of Nuflor® Minidose by the subcutaneous (SC) route at the recommended dose of 40 mg/kg, maintained efficacious plasma levels of florfenicol in cattle above the MIC90 of 0,5 µg/mℓ and 1,0 µg/mℓ for 90,7 hours and 33,8 hours, respectively. Maximum mean serum concentration (Cmax) of 1,8 µg/mℓ occurred 7 hours (Tmax) after dosing.

INDICATIONS

Preventive and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, that issusceptible to florfenicol. The presence of the disease in the herd should be confirmed before administering preventive treatment.

CONTRAINDICATIONS

Not for use in adult bulls intended for breeding purposes.

WARNINGS

Withdrawal period:

Meat and offal: By IM route (at 20 mg/kg body weight, twice): 30 days.

By SC route (at 40 mg/kg body weight, once): 53 days.

Milk: Not permitted for use in lactating animals producing milk for human consumption.

SAFETY IN PREGNANCY AND LACTATION

The safety of Nuflor® Minidose has not been established in cattle, pigs and sheep during pregnancy, lactation, lay or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

DOSAGE AND DIRECTIONS FOR USE

For treatment

IM route: 20 mg/kg body weight (2 mℓ/45 kg) to be administered twice, 48 hours apart.

SC route: 40 mg/kg body weight (4 mℓ/45 kg) to be administered once only.

For prevention

SC route: 40 mg/kg body weight (4 mℓ/45 kg) to be administered once only.

The injection should only be given in the neck. The dose volume given at any one injection site should not exceed 10 mℓ.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Swab rubber stopper before withdrawing each dose. Use a dry, sterile needle and syringe.

For 250 mℓ vials, do not broach the vial more than 25 times.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.

SPECIAL PRECAUTIONS FOR USE

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection. In case of self-injection, seek medical advice immediately and show this package leaflet to the physician. Avoid direct contact with skin, mouth and eyes. Wash hands after treatment. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use Nuflor® Minidose with serious caution to avoid accidental self-injection.

Special precautions for use in animals

Nuflor® Minidose should be used in conjunction with susceptibility testing and official and local antimicrobial policies should be considered.

Subcutaneous injection of Nuflor® Minidose at the maximum recommended volume of

10 mℓ per injection site, may cause transient local algesia and clinically obvious swelling at the injection site. Local algesia may persist for some days. Injection site swellings decrease over time but may persist for up to 61 days.

INTERACTIONS

None known.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

None known.

IDENTIFICATION

Clear, colourless to yellow solution for injection. Practically free from visible particles.

PRESENTATION

Carton containing one 50 mℓ, 100 mℓ or 250 mℓ colourless, Type II glass, multi-dose vial, sealed with a grey bromobutyl rubber stopper and blue aluminium seal.

Not all pack sizes may necessarily be marketed.

STORAGE

Store at or below 25 °C. Keep the vial in the outer carton in order to protect it from light.

After opening the vial, use Nuflor® Minidose within 28 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the container label.

KEEP OUT OF REACH AND SIGHT OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.

REGISTRATION NUMBER

10/17.1/05 (Act 101/1965)