FLORCRID 10%

COMPOSITION

1 mL of product contains Florfenicol 100 mg.

TARGET SPECIES

Pigs and chickens (broilers)

INDICATIONS

Pigs Treatment and prevention (in populations where the diagnosis has been confirmed) at group level, when there are clinical signs of chronic respiratory disease (pleuropneumonia) caused by Actinobacillus pleuropneumoniae, Pasteurella multocida.

Chickens (broilers) - The treatment and prevention (in populations where the diagnosis has been confirmed) at group level, when clinical signs of the following are present:

enteritis (colibacillosis) caused by E. coli.

respiratory diseases (mycoplasma) caused by Mycoplasma gallisepticum.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to product excipients. Do not use in poultry laying eggs for human consumption. Do not use in hogs for reproduction.

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

Administration: oral, in drinking water.

Pigs - Administer a dose of 15 mg active substance/kg body weight/day, i.e., 0.15 mL of product 0.15%/kg body weight/day, for 5 consecutive days. The amount of Florcrid 100 mg/mL 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)]/[100xTWC (L))] per 1000 L medicated tank water.

Chickens (broilers) - Administer a dose of 30 mg active substance/kg body weight/day, i.e., 0.3 mL of product/kg body weight/day, for 3 consecutive days. The amount of Florcrid 100 mg/mL 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)]/[100xTWC (L))] per 1000 L medicated tank water. CAUTION! When using a dosing device, to avoid precipitation, do not use more than 5L of product per 100L of water. Do not set the dosing device below 2%.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. Ingestion of medicated water depends on the clinical condition of the animals. 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. 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.

WITHDRAWAL PERIOD(S)

Meat and offal: 

Pigs 17 days

Chickens (broilers) 3 days

Use in poultry laying eggs for human consumption is not authorised.

SPECIAL PRECAUTIONS FOR STORAGE 

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.

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 dilution in drinking water: 24 hours.

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:

Those with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal 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. Do not eat, drink or smoke while handling or administering the product to animals.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Studies in laboratory animals have revealed no embryotoxic or foetotoxic of florfenicol. However, product safety in the target species has not been demonstrated regarding reproduction, gestation and lactation. Administer the product after the risk-benefit ratio has been assessed by a veterinarian.

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

PRESENTATION/PACKAGE

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