ENROFLOX LICH. 10 %

COMPOSITION

Enrofloxacin       100 mg/ml

CONTRAINDICATIONS

Do not use for prophylaxis. Do not use when resistance /cross-resistance to (fluoro)quinolones is known to occur.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of disturbances in growth of cartilages and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints.

ADVERSE REACTIONS

Minor adverse reactions. Vomiting and anorexia are the most common effects.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Oral administration in drinking water.

To avoid under-dosing and to ensure a correct dosage, bodyweight should be determined as accurately as possible.

Chickens: 10 mg enrofloxacin/kg body weight per day, for 5 consecutive days.

Treatment for 3–5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. If no clinical improvement is achieved within 2–3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.

Pigs: 5 mg enrofloxacin/kg body weight per day, for 5 consecutive days.

The amount of Enroflox Lich 10% solution (AES) will be calculated based on the Total Body Weight (TBW) of the herd to be treated and the Total Water Consumption (TWC) of the herd in 24 hours using the formula:

‍

5 = dose/kg b.w.

100 = mg  enrofloxacin/1 ml Enroflox Lich 10% oral solution.

The uptake of medicated water depends on the clinical condition of the animals. Ingestion of the medicated water may be affected by the disease.

ADVICE ON CORRECT ADMINISTRATION

Water intake should be monitored to ensure proper dosing. In order to obtain the correct dosage, the concentration of ENROFLOX LICH 10% should be adjusted accordingly otherwise the treatment schedule will be reviewed.

Medicated drinking water should be prepared fresh every 24 hours.

WITHDRAWAL PERIODS

Chickens (meat and offal): 7 days.

Pigs (meat and offal): 7 days.

Not authorised for use in laying birds producing eggs for human consumption.

Do not administer to layer replacement birds within 14 days of coming into lay.

SPECIAL STORAGE PRECAUTIONS

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.

Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

SHELF-LIFE

Shelf life after first opening the immediate packaging: 28 days.

Shelf life after reconstitution into drinking water: 24 hours.             

SPECIAL WARNINGS

Special warnings for each target species

Treatment of Mycoplasma spp. infections may not eradicate the organism.

Special precautions for use in animals

Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in Mycoplasma synoviae in the EU.

Official and local antimicrobial policies should be taken into account when the product is used. Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Use of the product deviating from the instructions given by in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.             

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Those with known hypersensitivity to enrofloxacin should avoid contact with this product.

To avoid exposure during the preparation of the medicated water wear appropriate protective clothing, safety glasses and waterproof gloves.

Do not eat, drink or smoke while handling this product. Wash hands after use.

In case of accidental ingestion, wash your mouth immediately with water and seek medical attention. In case of accidental skin contact, wash the area with soap and water. In case of accidental contact with eyes, rinse thoroughly with clean tap water.

If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the physician this warning.

Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.                  

Use during pregnancy, lactation or lay

Minor adverse reactions. Vomiting and anorexia are the most common effects.

Interaction with other medicinal products and other forms of interactions

When combined with tetracyclines and macrolide antibiotics, enrofloxacin may produce an antagonistic effect.

Absorption of enrofloxacin may be reduced when it is combined with substances containing magnesium or aluminum.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Do not exceed the recommended dose. There is no antidote in accidental overdose and the treatment is symptomatic.

Major incompatibilities

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

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

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

PRESENTATION/PACKAGE

HDPE white vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml and HDPE canisters of 5 L, 10 L, 20 L closed with a cap of the same material.