ENROFLOX 10%

COMPOSITION

Each mL of product contains Enrofloxacin 100 mg.

TARGET SPECIES

Chickens and pigs

INDICATIONS

Treatment of infections caused by the following enrofloxacin-susceptible bacteria:

Chickens - Mycoplasma gallisepticum, Mycoplasma synoviae, Avibacterium paragallinarum, Pasteurella multocida, 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 for prophylaxis.

Do not use when it is known that resistance/cross-resistance to (fluoro)quinolone occurs in the populations for which treatment is intended. Do not use in cases of known hypersensitivity to enrofloxacin or to any of the product excipients. 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 FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Administration: oral, in drinking water.

To ensure a proper dose, the exact body weight will be determined to avoid underdosing or overdosing.

Chickens - Administer a dose of 10 mg active substance/kg body weight/day, for 3-5 consecutive days. For 5 consecutive days in mixed infections and in chronic progression forms. If no clinical improvement is observed within 2 to 3 days, an alternative antimicrobial therapy based on susceptibility testing should be used. 

The amount of Enroflox Lich 10% (CSE) 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: CSE (L) =[10xTBW(kg)]/[100xTWC(L)]

per 1000 L of medicated tank water, 10 = dose/kg bw, 100 = mg enrofloxacin/1 mL Enroflox Liquid 10% oral solution.

Pigs - Administer a dose of 5 mg active substance/kg body weight/day, for 5 consecutive days. 

The Enroflox Lich 10% Solution Amount (CSE) 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 formula CSE (L) = [5xTBW (kg)/100xTWC (L)] per 1000 L medicated tank water, 5 = dose/kg bw, 100 = mg enrofloxacin/1 mL Enroflox Liquid 10% oral solution

WARNINGS/ADVICE ON CORRECT ADMINISTRATION 

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

WITHDRAWAL PERIOD(S)

Chickens Meat and offal: 7 days

Pigs Meat and offal: 7 days

Use in poultry laying eggs for human consumption is not authorised. Do not administer to replacement poultry 14 days before the beginning of the laying period.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and 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)

It is possible that the treatment of Mycoplasma spp. infections not to eradicate the disease. The product should be diluted before use in animals.

Water consumption should be monitored to ensure adequate dose. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the ENROFLOX LICH 10% concentration should be adjusted so that the animals assimilate the recommended dose. Otherwise another medication should be considered.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Since enrofloxacin was originally authorised for use in poultry, a reduction in E. coli susceptibility to fluoroquinolones and an increase in resistant organisms was widely spread. The resistance to Mycoplasma synoviae has also been reported in the EU. Official, national and regional policies on antimicrobials shall be respected when using the product. 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. 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 drinking water should be freshly prepared every 24 hours. 

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

Those with known sensitivity to enrofloxacin or excipients will avoid contact with the product. To avoid exposure during medicated solution preparation, wear suitable protective equipment (overalls, goggles and waterproof gloves). Do not eat, drink or smoke during product handling. Wash hands after use. In case of accidental ingestion, immediately wash mouth with water and seek medical attention. In case of accidental contact with skin, wash the area with water and soap. In case of accidental contact with eyes, rinse abundantly with clean tap water. If irritation occurs on the skin after exposure, you should seek medical attention and show the package 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 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. There is no antidote in accidental overdose, and therapy is symptomatic.

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 products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste. The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and 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.