ENROFLOX INJ. 100 mg/ml

COMPOSITION

Active substance:

Enrofloxacin            100 mg/ml

Excipients:

N-butyl alcohol         30 mg/ml

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CONTRAINDICATIONS

Do not use in cases of known resistance against quinolones. 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.

Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.

Do not use in growing horses because of possible deleterious damage on articular cartilage.

ADVERSE REACTIONS

Local tissue reactions may occasionally occur at the injection site.  

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be given at different injection sites.

Cattle

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5 days.

- Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous administration.

- Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.

The second dose may be administered by the subcutaneous route. In this case, the withdrawal period following subcutaneous injection applies.

Not more than 10 ml should be administered at one subcutaneous injection site.

Pigs

2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.

- Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days. In pigs, the injection should be made in the neck at the ear base.

Not more than 3 ml should be administered at one intramuscular injection site. If in the first 2-3 days no improvement in clinical signs is observed, additional susceptibility testing and the possibility of changing antimicrobial therapy should be considered.

ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIODS

Cattle

Following intravenous injection:

Meat and offal: 5 days.

Milk: 3 days.

Following subcutaneous injection:

Meat and offal: 12 days.

Milk: 4 days.

Pigs

Meat and offal: 13 days

SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C.

Store in the original package.

Store in a dry place.

Protect from direct sunlight.

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.

SPECIAL WARNINGS

Special precautions for use in animals

Official and local antimicrobial policies should be taken into account when the product is used.

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. Whenever possible fluoroquinolones should only be used based on susceptibility testing.

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

Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.

The use of enrofloxacin in growing lambs at the recommended dose for 15 days, caused histological changes in the articular cartilage, which are not associated with clinical signs.

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

This product is an alkaline solution. In case of accidental skin or eye contact, rinse immediately with plenty of water. Seek medical advice immediately and show the package leaflet or the label to the physician.

Do not eat, drink or smoke when handling the product.

Care should be taken to avoid accidental self-injection. If accidental self-injection occurs seek medical advice immediately. Avoid skin and eye contact. Wash any splashes from skin or eyes immediately with water. Wash hands after use. Wear protective gloves.

People with known hypersensitivity to fluoroquinolones should avoid any contact with the product.

Use during pregnancy, lactation or lay

Enrofloxacin can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Antagonistic effects due to concurrent administration of macrolides and tetracyclines may occur.

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

Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.

Incompatibilities

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

PRESENTATION/PACKAGE

Vials of 50 ml, 100 ml, 250 ml and 500 ml.