ENROFLOX INJ. 50 mg/ml

COMPOSITION

Active substance:

Enrofloxacin         50 mg/ml

Excipients:

N-butyl alcohol     30 mg/ml

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 young dogs during their growth, i.e. in small breeds of dogs less than 8 months of age, in big breeds of dogs less than 12 months of age, in giant breeds of dogs less than 18 months of age, as articular cartilage may be affected during the period of growth. 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.

During the period of rapid growth, enrofloxacin may affect the development of articular cartilage.     

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Intravenous, subcutaneous or intramuscular use. Repeated injections should be given at different injection sites.

Calves

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 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/10 kg bw, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous administration.

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

Sheep and goats

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, by subcutaneous injection, once daily for 3 days. Not more than 6 ml should be administered at one subcutaneous injection site.

Pigs

2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/10 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/10 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.

Dogs

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, daily by subcutaneous injection for up to 5 days.

Treatment may be initiated with injectable product and maintained with enrofloxacin tablets. Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the literature of the tablet product. If there is no clinical improvement within two to three days, further susceptibility testing and possibly a change in antimicrobial therapy should be considered. Do not exceed the recommended dose.

ADVICE ON CORRECT ADMINISTRATION

Not more than 10 ml (calves) 5 ml (sheep and goats) and 2.5 ml (lambs and kids) should be administered at one intramuscular injection site.

Do not overdose. To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIODS

Calves

Following intravenous injection:

Meat and offal: 5 days.

Following subcutaneous injection:

Meat and offal: 12 days.

Not authorised for use in animals producing milk for human consumption.

Sheep (meat and offal): 4 days.

Milk: 3 days.

Goats (meat and offal): 6 days.

Milk: 4 days.

Pigs (meat and offal): 13 days.

SPECIAL STORAGE PRECAUTIONS

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.

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 medicinal products to animals

The product is an alkaline solution. Wash any splashes from skin or eyes immediately with water, seek medical advice immediately and show the package leaflet or the label to the physician. Do not eat, drink or smoke whilst using the product. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs seek medical advice immediately. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves. People with known hypersensitivity to (fluoro) quinolone should avoid contact with the veterinary medicinal product.

Use during pregnancy, lactation or lay

The product may be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions. The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. Thus, in dogs, the co-administration of enrofloxacin and flunixin increased the AUC and the elimination half-life of flunixin and increased the elimination half-life and reduced the C_max of enrofloxacin.

Antagonistic effects due to concurrent administration of macrolides, tetracyclines or amphenicols 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 and 250 ml.