SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Florfenicol 300 mg

Excipients:

Qualitative composition of excipients and other constituents

Glycerol formal

Pyrrolidone

A light yellow to straw coloured solution.

3. CLINICAL INFORMATION

3.1 Target species

Cattle and pigs.

3.2 Indications for use for each target species

Cattle:

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

Pigs:

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

3.3 Contraindications

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

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of known resistance to florfenicol.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Do not use in piglets of less than 2 kg.

Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure.

Florfenicol should be used for treatment of severe infections only.

Use of the veterinary medicinal 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 veterinary medicinal product is used.

Use of the veterinary medicinal 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 (e.g. ceftiofur) due to the potential for cross resistance.

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

This veterinary medicinal product may cause allergic reactions in those that are sensitive.

People with known hypersensitivity to florfenicol or any of the excipients should avoid contact with the veterinary medicinal product.

Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The veterinary medicinal product may cause irritation if it comes into contact with the skin, mucous membranes or eyes. Avoid direct contact with skin, mouth and eyes. In case of contact with the skin or eyes, rinse the affected area immediately with plenty of clean water. If accidental ingestion occurs, rinse the mouth with plenty of water and seek medical advice immediately. Wash hands after use.

Special precautions for the protection of the environment:

The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.

3.6 Adverse events

Cattle.

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

Reduced food intake1 Loose stool 1, 2 Injection site inflammation, Injection site lesion3, Anaphylactiv shock.

¹ Quick and complete recovery upon termination of treatment.

² Transient.

³ Swelling and hardness, may persist for 31 days after intramuscular or subcutaneous administration.

Pigs.

Common (1 to 10 animals / 100 animals treated):	Diarrhoea1, 2 Anal oedema2, Rectal oedema2 Local erythema2, 3
Very rare (<1 animal / 10 000 animals treated, including isolated reports):	Pyrexia4 Depression4, 5 Dyspnoea4, 5

¹ Transient.

² Can be observed for one week.

³ Perianal and rectal.

⁴ Under field conditions and occurs one week or more after administration of the second dose.

⁵ Moderate.

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.

3.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic effects for florfenicol. However, safety during pregnancy and lactation has not been investigated in the target species. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

Cattle: Intramuscular or subcutaneous use. Pigs: Intramuscular use.

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

Swab septum before removing each dose.

Use a dry sterile needle and syringe.

Do not broach the vial more than 25 times.

Cattle:

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

Subcutaneous Injection: 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.

Pigs:

Intramuscular Injection: 15 mg/kg bodyweight (1 ml per 20 kg) 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 cattle and pigs 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.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Cattle: None.

Pigs:

After administration of three times the recommended dose or more, a reduction in feeding, hydration and weight gain has been observed. After administration of five times the recommended dose or more, vomiting has also been noted.

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.

3.12 Withdrawal periods

Cattle

Meat and offal:

By intramuscular injection (at 20 mg/kg, twice): 39 days.

By subcutaneous injection (at 40 mg/kg, once): 44 days.

Not authorised for use in animals producing milk for human consumption.

Pigs

Meat and offal: 22 days.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code:

QJ01BA90

4.2 Pharmacodynamics

Florfenicol is a synthetic broad spectrum antibiotic effective against most Grampositive and Gram-negative bacteria isolated from domestic animals. It acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. However, in vitro studies of florfenicol demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida, Actinobacillus pleuropneumoniae and Histophilus somni.

In vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in cattle (including Pasteurella multocida, Mannheimia haemolytica, and Histophilus somni) and in pigs (including Actinobacillus pleuropneumoniae and Pasteurella multicida). 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. Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium and co-resistance to florfenicol and other antimicrobials (e.g. ceftiofur) has been identified in the microorganisms from the family Enterobacteriaceae.

4.3 Pharmacokinetics

In Cattle:

The administration of the veterinary medicinal product by the subcutaneous route at the recommended dosage of 40 mg/kg maintains bovine efficacious blood levels (i.e. above the MIC₉₀ of the main respiratory pathogens) for 63 hours. Maximum serum concentration (C_max) of approximately 5µg/ml, occurs at approximately 5.3 hours (T_max) after dosing. The mean serum concentration 24 hours after dosing is 2 µg/ml.

Intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels in cattle for 48 hours. Maximum mean serum concentration (C_max) of 3.37 µg/ml occurs at 3.3 hours (T_max) after dosing. The mean serum concentration 24 hours after dosing is 0.77 µg/ml.

The harmonic mean elimination half life was 18.3 hours.

In Pigs:

In pigs intravenously administered florfenicol has 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 mean serum concentrations of between 3.8 and 13.6 µg/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 serum concentrations of between 3.7 and 3.8 µg/ml are reached after 1.8 hours. Serum concentrations drop below 1 µg/ml, the MIC₉₀ for the target porcine pathogens, 12 to 24 hours following intramuscular 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 rapidly metabolised.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

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

5.2 Shelf life

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

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

5.3 Special precautions for storage

Keep the container in the protective sleeve/outer carton.

Protect from light.

5.4 Nature and composition of immediate packaging

50 ml, 100 ml, 250 ml and 500 ml clear type I glass vials and HDPE plastic vials with bromobutyl rubber bungs and aluminium seal.

50 ml clear type I glass vials as well as the 50 ml, 100ml, 250 ml and 500 ml HDPE plastic vials are presented in a cardboard box.

100 ml, 250 ml and 500 ml glass vials are accompanied by a protective sleeve.

Not all pack sizes may be marketed.

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

Medicines should not be disposed of via wastewater or household waste.

The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.

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.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

7. MARKETING AUTHORISATION NUMBER

Vm 02000/4316

8. DATE OF FIRST AUTHORISATION

11 May 2012

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

July 2026

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.

Approved 10 August 2026