ENROFLOX 40% PREMIX

COMPOSITION

Each gram of product contains Enrofloxacin 400 mg.

TARGET SPECIES

Pigs and broilers

INDICATIONS

Broilers - In populations where diagnosis has been confirmed, in the prevention and treatment of gastrointestinal disorders caused by Escherichia coli.

Pigs - In the treatment of respiratory diseases caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae, susceptible to enrofloxacin.

CONTRAINDICATIONS

Do not use in cases of known hypersensitivity to enrofloxacine or to the excipient. Do not use in known cases of resistance to quinolones. Do not use the product in the case of cartilage growth disorders and/or during injury to the locomotor system, especially at joints.

ADVERSE REACTIONS

Adverse reactions are mild. Vomiting and anorexia are the most common effects.

DOSAGE, METHOD AND ROUTE(S) OF ADMINISTRATION

The treatment shall be administered orally (by incorporation in fodder), for 5 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. 

For mass treatment, we recommend the correct calculation of the total body weight and the amount of product to be administered, as well as the preparation of premixes, for proper homogenisation. 

Pigs - Administer a dose of 5 mg active substance/kg body weight/day, for 5 consecutive days. The amount of Enroflox 40% Premix (CEP) 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: CEP (L) = [5xTBW (kg)]/[400xTFC (L)] per 1000 L tank water 5 = dose (mg)/kg bw, 400 = mg enrofloxacin/1 g Enroflox 40% Premix. 

In broilers, administer a dose of 10 mg active substance/kg body weight/day, for 5 consecutive days. The amount of Enroflox 40% Premix (CEP) 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: CEP (L) = [10xTBW (kg)]/[400xTFC (L)] per 1000 L tank water 10 = dose (mg)/kg bw, 400 = mg enrofloxacin/1 g Enroflox 40% Premix. 

The consumption of medicated fodder depends on the clinical condition of the animals. In order to obtain a correct dose, the enrofloxacin concentration should be adjusted accordingly.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure a proper dose, the exact body weight will be determined to avoid underdosing or overdosing. Fodder consumption should be monitored to ensure adequate dose.

If the fodder consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the ENROFLOX 40% Premix concentration should be adjusted so that the animals assimilate the recommended dose. Otherwise another medication should be considered.

WITHDRAWAL PERIOD(S)

Meat and offal 

Broilers - 7 days 

Pigs - 7 days 

Do not use in poultry laying eggs for human consumption.

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 original packaging: 28 days. Shelf-life of the veterinary medicinal product after incorporation into fodder: 28 days

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

Throughout treatment, animals should consume only medicated fodder. The product must be thoroughly homogenised with concentrated fodder to ensure uniform dispersion throughout its mass.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on the results of susceptibility testing of isolated bacteria. 

Fluoroquinolones will be kept as a back-up for treatments that respond poorly to other classes of antimicrobial substances under clinical conditions. If this is not possible, therapy will be based on epidemiological information on the susceptibility of isolated bacteria. Using the product in violation of the instructions in the SmPC may increase the prevalence of enrofloxacin resistance and may decrease the effectiveness of antimicrobial treatments in the quinolone group as a result of cross-resistance.

The ingestion of medicated fodder by the animal may be affected by the disease.

 In case of insufficient medicated fodder ingestion, the treatment schedule will be reviewed.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Those with known sensitivity to enrofloxacin will avoid contact with the product. To avoid exposure during preparation of medicated fodder, wear suitable protective equipment (overalls, goggles and waterproof gloves). Do not eat, drink or smoke while handling the product. Wash hands after use. In case of accidental ingestion, immediately wash mouth with water and seek medical attention. In case of accidental contact with the skin, wash the area with soap and water. In case of accidental contact with the eyes, rinse thoroughly with clean tap water. If irritation occurs on the skin after exposure, you should seek medical attention and show this leaflet to your doctor. Swelling of the face, lips and eyes or difficulty breathing are severe symptoms and require urgent medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

In pigs, the product can be use during gestation and lactation. Do not use in poultry laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

In combination with tetracycline and macrolide antibiotics, enrofloxacin has an antagonistic effect. The absorption of enrofloxacin may be reduced if the product is taken with substances containing magnesium and aluminium.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Do not exceed the recommended dose. In case of accidental overdose, the treatment is symptomatic. There is NO specific antidote.

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.

PRESENTATION/PACKAGE 

50g, 100g, 1kg laminated terephthalate polyethylene foil/low-density polyethylene bags.

Glass-shape 5kg bag, made of laminated terephthalate polyethylene foil/aluminium foil/low-density polyethylene.

10 kg, 20 kg laminated terephthalate polyethylene foil/aluminium/low-density polyethylene bags sealed by heat-sealing.