FLORCRID 2.5%

COMPOSITION

100 mL of product contain Florfenicol 2.5 g.

TARGET SPECIES

Pigs and chickens (broilers).

INDICATIONS

In the treatment of diseases caused by Florfenicol-susceptible germs, as follows:

Chickens (broilers) - the treatment and prevention (in populations where the diagnosis has been confirmed) of enteritis caused by E. coli, chronic respiratory diseases caused by Mycoplasma gallisepticum.

Pigs - the treatment and prevention (in populations where the diagnosis has been confirmed) of respiratory diseases associated with Actinobacillus pleuropneumoniae, Pasteurella multocida.

CONTRAINDICATIONS

Do not administer to hogs used for breeding.

Do not administer in cases of hypersensitivity to the active substance or to the excipient. Do not use in piglets of less than 2kg. Do not use in poultry laying eggs for human consumption.

ADVERSE REACTIONS

In pigs, during treatment, a reduction in water consumption and the occurrence of the following side effects can occur: erythema/perianal and rectal oedema, transient diarrhoea, constipation and dark brown faeces.

These reactions are transient and reversible. 

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

The product is orally administered in drinking water. 

Pigs - Administer a dose of 15 mg florfenicol/kg body weight/day, i.e., 0.6 mL Florcrid 2.5%/kg body weight/day, for 5 consecutive days. The amount of Florcrid 2.5% solution (CSF) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the following formula: CSF (L) = [15xTBW (kg)]/[25xTWC (L))] per 1000 L medicated tank water. If a dispenser set to P% is used, the following formula applies: CSF (L) = [15xTBW (kg)]/[25xTWC (L))] x 1/P% per 10 L medicated, pre-diluted tank water.

Chicken (broilers) - Administer a dose of 30 mg florfenicol/kg body weight/day, i.e., 1.2 mL Florcrid 2.5%/kg body weight/day, for 3 consecutive days. The amount of Florcrid 2.5% solution (CSF) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the following formula:

CSF (L) = [30xTBW (kg)]/[25xTWC (L))] per 1000 L medicated tank water. If a dispenser set to P% is used, the following formula applies: CSF (L) = [30xTBW (kg)]/[25xTWC (L))] x 1/P% per 10 L medicated, pre-diluted tank water.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

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

Medicated water intake depends on the clinical condition of the animals. Medicated water should be the only source of drinking water.

Medicated water can only be used for 24 hours and should be freshly prepared every day. 

If no improvement in clinical signs is observed during treatment, the diagnosis should be reviewed and the treatment changed.

CAUTION!!! SOLUTIONS WITH FLORFENICOL CONCENTRATION FROM 1.2 g/L TO 12 g/L PRECIPITATE IN THE CASE OF USING A DISPENSER. IF THE CSF FROM CALCULATIONS IS FROM 0.48 TO 4.8, THE DOSE PERCENTAGE P% SHALL BE CHANGED.

WITHDRAWAL PERIOD(S)

Meat and offal

Pigs - 17 days

Chickens (broilers) - 3 days

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

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. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Because of the variability (time, geographical area) in the susceptibility of bacteria when using the product, bacteriological sampling and susceptibility testing for isolated microorganisms from sick animals is recommended. If this is not possible, the treatment should be based on local epidemiological information (region, farm) concerning the target bacteria’s susceptibility. Using the product in violation of the instructions in the SmPC may increase the prevalence of active substance resistance and may decrease the effectiveness of treatment because of their potential cross-resistance. When using the product, official and local policies regarding antimicrobial substances shall be observed. Ingestion of medicated water by animals may be impaired by the disease. In case of insufficient medicated water ingestion, the treatment schedule will be reviewed.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT

Do not smoke, drink or eat while handling the product. Those with hypersensitivity to florfenicol or polyethylene glycol should avoid contact with the product. In case of accidental contact with the eyes, rinse with plenty of water. In case of accidental contact with skin, wash the area with water and soap. In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician. 

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Studies in laboratory animals have revealed no embryotoxic or foetotoxic of florfenicol. The effect of florfenicol on reproduction, gestation and lactation has not been established.

The product must not be administered during gestation and lactation.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

No data are available.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

In case of overdose, decrease in water consumption, decrease in weight gain, dehydration, anal/perianal oedema, rectal prolapse, changes in the haematological and biochemical parameters are observed.

INCOMPATIBILITIES

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

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

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

Animals or poultry treated are kept in shelters throughout the treatment period and the resulting manure shall not be used for soil fertilisation.

PRESENTATION

The product is packaged in while 50mL, 100mL, 250mL, 500mL, 1L HDPE vials and 5L, 10L, 20L HDPE cans.