Florkem 300 mg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active substance:

Florfenicol..................................................300 mg

Excipients:

Colourless to yellow clear solution.

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Pharmacological properties

4.1 ATCvet code:

QJ01BA90

4.2 Pharmacodynamics

Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram positive and Gram negative bacteria isolated from domestic animals.

Florfenicol acts by inhibiting bacteria proteins synthesis at the ribosomal level, thus is bacteriostatic. However, in vitro tests have shown that florfenicol has a bactericidal activity against the most commonly isolated bacterial pathogens involved in respiratory diseases:

- Histophilus somni, Mannheimia haemolytica and Pasteurella multocida isolated from cattle

- Actinobacillus pleuropneumonia, and Pasteurella multocida isolated from pigs.

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. Cross resistance with chloramphenicol can occur. Resistance to florfenicol and other antimicrobials has been identified in the food-born pathogen Salmonella typhimurium and co-resistance with the third-generation cephalosporins has been observed in respiratory and digestive Escherichia coli. 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.

In bovine, 99% of P. multocida isolates (n=156) and 98% of M. haemolytica isolates (n=109) were susceptible to florfenicol (strains isolated in France in 2012). In swine, 99% of P. multocida isolates (n=150) were susceptible to florfenicol (strains isolated in France in 2012).

The following Minimum Inhibitory Concentrations (MIC) have been determined for florfenicol in European isolates collected from diseased animals between 2009 to 2012:

4.3 Pharmacokinetics

In cattle Intramuscular administration of the formulation at the recommended dose of 20 mg/kg maintains efficacious blood levels for 48 hours. Maximum mean serum concentration (Cmax) of 3.8 µg/ml occurred 5.7 hours (Tmax) after dosing. The mean serum concentration 24 hours after dosing was 1.95 µg/ml. The mean elimination half life was 15.3 hours.

In pigs After intramuscular administration of florfenicol, maximum serum concentration of 4.7 µg/ml is reached after 1.8 hours and the concentrations deplete with a terminal mean half-life of 14.8 hours. Serum concentrations drop below 1 µg/ml, the MIC90 for the target porcine pathogens, 12-24 hours following IM administration.

Florfenicol concentrations achieved in lung tissue reflect plasma concentration, 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.

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Target species

Cattle and pigs.

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Indications

Cattle:

Treatment of respiratory tract infections due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.

Pigs:

Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.

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Dosage

Intramuscular use. The injection should be given in the neck.

Cattle :

20 mg florfenicol per kg bodyweight, i.e. 1 ml of solution per 15 kg bodyweight, twice 48 hours apart.

Pigs :

15 mg florfenicol per kg bodyweight, i.e. 1 ml of solution per 20 kg bodyweight, twice 48 hours apart.

The dose volume given at any one injection site should not exceed 10 ml in cattle and 3 ml in pigs.

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

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.

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Contraindications

Do not use in adult bulls or boars intended for breeding purposes.

Do not administer in cases of hypersensitivity to the active ingredient or any of the excipients.

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Adverse reactions

Cattle:

Very rare (< 1 animal / 10,000 animals treated, including isolated reports): Reduced food intake1, Soft stool1,2, Injection site reaction2,3 (e.g inflammation, lesion)

1 Treated animals recover quickly and completely upon termination of treatment. 2 Transient.

3 May persist for up to 28 days.

Pigs:

Common (1 to 10 animals / 100 animals treated): Anal and rectal disorder (e.g. erythema, oedema) 1, Diarrhoea1,2

Very Rare (< 1 animal / 10,000 animals treated, including isolated reports): Injection site reaction2,3 (e.g inflammation, lesion)

1 May affect 50% of the animals and be observed for up to one week.

2 Transient.

3 Disappear within 28 days.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Wipe the stopper before removing each dose. Use a dry, sterile needle and syringe. Do not use in piglets of less than 2 kg.

Under field conditions, approximately 30% of treated pigs presented with pyrexia (40°C) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose.

Use of 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 product is used.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other antimicrobials, due to the potential for cross- resistance. Particular attention should be paid to improving farming practices to avoid any stress condition (improving management practices and by cleaning and disinfection).

Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken when handling the product to avoid accidental self-injection. In case of accidental self-injection, seek medical advice, and show the package leaflet or the label to the physician.

People with known hypersensitivity to the components of the formulation should avoid contact with the product.

Wash hands after handling the product.

Special precautions for the protection of the environment:

Not applicable

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable

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Use during pregnancy, lactation or lay

Studies in laboratory animals have not revealed any evidence of embryo- or foeto- toxic potential for florfenicol. However, the safety of florfenicol on bovine and porcine reproductive performance and pregnancy has not been assessed. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

None known.

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Overdose

In swine after intramuscular 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.

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Special warnings

None

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Withdrawal period

Cattle:

Meat and offal: 37 days Milk: Not permitted for use in lactating animals producing milk for human consumption.

Pigs:

Meat and offal: 18 days

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Incompatibilities

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

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Immediate packaging

Material of the primary container Colourless glass vial type II (20 – 50 – 100 – 250 - 500 ml).

Translucent multi-layer plastic vials (50 – 100 – 250 – 500 ml).

Chlorobutyl stopper type II.

Pack size Box containing one vial of 20, 50, 100, 250 or 500 ml.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3years

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

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 14966/5082 Vm 14966/3081

8 DATE OF FIRST AUTHORISATION

25 August 2009

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

November 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 11 November 2025

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Registration holder

Ceva Sante Animale

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