SUMMARY OF PRODUCT CHARACTERISTICS

FLORINJECT 300 mg/ml solution for injection for cattle and pigs

CALFLOR 300 mg/ml solution for injection for cattle and pigs (FR)

Each ml contains

Active substance:

Florfenicol 300 mg

Excipients:

For a full list of excipients, see section 6.1.

Solution for injection.

Clear slightly yellowish solution.

4. CLINICAL PARTICULARS:

Cattle and pigs.

4.2 Indications for use, specifying target species:

Cattle:

Diseases caused by florfenicol susceptible bacteria.

Prevention and treatment of respiratory tract infections in cattle due toMannheimia haemolytica, Pasteurella multocidaandHistophilus somni.

The presence of the disease in the herd should be established before preventive treatment.

Pigs:

Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae andPasteurella multocidasusceptible to florfenicol.

Do not administer to adult bulls and boars intended for breeding purposes.

Do not use in case of hypersensitivity or previous allergic reactions to florfenicol or to any of the excipients.

4.4 Special warnings for each target species

None.

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.

The veterinary medicinal product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.

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

Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice taking the label or package leaflet with you to showthe physician.

Avoid skin or eye contact with the product. In case of contact with the skin or eyes, rinse the affected area immediately with plenty of water. Wash the hands after use.

Do not use the product if you know you are sensitive to propylene glycol or polyethylene glycols.

In cattle, 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.

Administration of the product by the intramuscular and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days.

On very rare occasions, anaphylactic reactions have been reported in cattle.

In pigs, commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals. These effects can be observed for one week. Under field conditions approximately 30% of treated pigs presented with pyrexia (40C) associated with either moderate depression or moderate dyspnea a week or more after administration of the second dose.

Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.

Laboratory studies have not produced any evidence of teratogenic or foetotoxic effects.

Cattle

The safety of the veterinary medicinal product has not been established during pregnancy.

Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Pig

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

It is not recommended to use the veterinary medicinal product in pigs during pregnancy and lactation.

None known.

4.9 Amounts to be administered and administration route:

Route of administration: intramuscular and subcutaneous for cattle; intramuscular for pig.

Cattle:

For treatment

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

SC route: 40 mg/kg bodyweight (2ml/15kg) to be administered once only using a 16 gauge needle.

The dose volume given at any one injection site should not exceed 10ml for both routes of administration (intramuscular and subcutaneous).

The injection should only be given in the neck.

For prevention

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

The injection should only be given in the neck.

Swab septum before removing each dose. Use a dry sterile needle and syringe.

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

Pigs:

15 mg/kg bodyweight (1 ml per 20 kg) by intramuscular injection into the neck muscle twice at 48 hour intervals using a 16-gauge needle.

The volume administered per injection site should not exceed 3 ml.

It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection.If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.

Wipe the stopper before removing each dose. Use a dry, sterile syringe and needle.

Do not broach the vial more than 25 times.

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

In swine after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed.

After administration of 5 times the recommended dose or more, vomiting has also been noted.

4. 11 Withdrawal period:

Cattle:

Meat and offal: by IM (at 20 mg/kg bodyweight, twice): 30 days

by SC (at 40 mg/kg bodyweight, once): 44 days

Milk: Not authorised for use in cattle producing milk for human consumption, including during the dry period

Pigs:

Meat and offal: 18 days

Pharmacotherapeutic group: Antibacterial for systemic use

ATCVet code: QJ01BA90

5.1 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. 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, Histophilus somni and in swine respiratory disease include Actinobacillus pleuropneumoniaeandPasteurella multocida.

Florfenicol is considered to be a bacteriostatic agent, but in vitro studies of florfenicol demonstrate bactericidal activity againstMannheimia haemolytica, Pasteurella multocida, Histophilus somniand Actinobacillus pleuropneumoniae.

Acquired resistance to florfenicol is mediated by efflux pump resistance associated with a floR gene. Such resistance has not yet been identified in the target pathogens except for Pasteurella multocida and Actinobacillus pleuropneumoniae.

Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium and co-resistance with the third-generation cephalosporins has been observed in respiratory and digestive Escherichia coli

5.2. Pharmacokinetic properties

In cattle,intramuscular administration at the recommended dose of 20mg/kg maintains efficacious blood levels in cattle for 48 hours. Maximum mean serum concentration (C_max) of 3.37µg/ml occurs at 3.3 hours (T_max) after dosing.

The mean serum concentration 24 hours after dosing was 0.77µg/ml.

The administration of the product by subcutaneous route at the recommended dosage of 40mg/kg maintains bovine efficacious blood levels in cattle (ie above the MIC₉₀of the main respiratory pathogens) for 63 hours. Maximum serum concentration (C_max) of approximately 5 µg/ml occurs approximately 5.3 hours (T_max) after dosing. The mean serum concentration 24 hours after dosing is approximately 2 µg/ml.

The elimination half life was 18.3 hours.

In pigs intravenously administered florfenicol had a mean plasma clearance rate of 5.2 ml/min/kg and a mean volume of distribution at equilibrium of 948 ml/kg. The mean terminal half-life is 2.2 hours.

After initial intramuscular administration of florfenicol, maximum plasma concentrations of between 3.8 and 13.6 g/ml are reached after 1.4 hours and the concentrations deplete with a terminal mean half-life of 3.6 hours. After a second intramuscular administration, maximum plasma concentrations of between 3.7 and 3.8 g/ml are reached after 1.8 hours. Plasma concentrations drop below 1 g/mL, the MIC₉₀for the target porcine pathogens, 12 to 24 hours following IM administration. Florfenicol concentrations achieved in lung tissue reflect plasma concentrations, with a lung:plasma concentration ratio of approximately 1.

After administration to pigs by the intramuscular route, florfenicol is rapidly excreted, primarily in urine. The florfenicol is extensively metabolised.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

N-methyl-pyrrolidone

Propylene glycol

Macrogol 300

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf-Life

Shelf-life of the veterinary product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage:

Keep the vial in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging:

Polypropylene vials of 250 ml, closed with pink bromobutyl stopper secured with flip-off aluminium collar.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Laboratorios Calier, S.A.

C/ Barcelonès, 26 (El Ramassar)

08520 Les Franqueses del Vallès

Barcelona

Spain

8. MARKETING AUTHORISATION NUMBER

Vm 20634/4007

9. DATE OF THE FIRST AUTHORISATION

27 September 2013

10. PROHIBITION OF SALE, SUPPLY AND / OR USE

Under veterinary prescription.

Approved: 27/09/2013