FLORCRID 4% PREMIX

COMPOSITION

1 g of product contains Florfenicol 40 mg.

TARGET SPECIES

Pigs

INDICATIONS

For the treatment and prevention (in populations where the diagnosis has been confirmed) of diseases caused by florfenicol-susceptible germs and those associated with Actinobacillus pleuropneumoniae, Pasteurella multocida.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use in hogs for reproduction.

ADVERSE REACTIONS

In pigs, during treatment, 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 ​​administered orally by incorporation into fodder. 

Pigs - Administer a dose of 15 mg active substance/kg body weight/day (equivalent 0.35 Florcrid 40 mg/g premix/kg body weight/day), for 5 consecutive days. The amount of Florcrid 40 mg/g premix (CF) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Fodder Consumption (TFC) of the population in 24 hours using the following formula: CF (Kg/T) = [15xTBW(kg)]/[40xTFC(kg)] per 1000 kg of fodder. 15 = dose (mg)/kg bw; 40 = mg florfenicol/1 g Florcrid 40 mg/g premix. The maximum incorporation rate is 12.5 kg/tonne (500 ppm florfenicol). Higher incorporation rates may reduce the palatability of the fodder and lower fodder consumption. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The consumption of medicated fodder depends on the clinical condition of the animals. Medicated fodder must be the only source of feed. If no improvement in clinical signs is observed during treatment, the diagnosis should be reviewed and the treatment changed.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Do not use the product if you notice any visible signs of damage to the immediate packaging.

WITHDRAWAL PERIOD(S)

Meat and offal - 17 days.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Keep in the original package. Store in a dry place. Keep away from direct light.

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 incorporation into fodder: 28 days.

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the veterinary medicinal product should be based on the results of susceptibility testing of isolated bacteria from animals. If this is not possible, therapy should be based locally on epidemiological information (regional, farm) on the target bacteria’s susceptibility. 

When using the product, official and local regulations regarding antimicrobial substances shall be observed.

Using the product in violation of the instructions in the SmPC may increase the prevalence of florfenicol resistance and may decrease the effectiveness of antimicrobial treatments in the amfenicol group as a result of cross-resistance.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT 

Do not smoke, drink or eat while handling 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. Adequate protective equipment shall be used when handling the product. Those with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product.

USE DURING PREGNANCY AND LACTATION.

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 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. Treated animals will be kept in shelters throughout the treatment period, and the manure collected shall not be used for soil fertilisation. 

PRESENTATION/PACKAGING

50g, 100g, 1kg, 5kg laminated terephthalate polyethylene foil/aluminium/low-density polyethylene bags. 25kg, 50kg laminated terephthalate polyethylene foil/aluminiu/low-density polyethylene heat-sealed bags.