Mediflox 10%

Composition

1 ml of solution for injection contains:

Active substance:

Enrofloxacin 100 mg

Excipients:

Potassium hydroxide; benzyl alcohol; citric acid, monohydrate, Water for injections.

Target species:

Cattle (calves), pigs, sheep, goats, dogs and cats.

Indications for use, specifying the target species

Treatment of infections of the digestive, respiratory and urogenital tracts and other infections caused by enrofloxacin susceptible strains.

If the clinical improvement is not observed in 3 days after treatment has started, a change of therapeutic has to be considered.

Contraindications

Administration of this product is contraindicated in prevention of diseases.

Do not use when the resistance to the other quinolone drugs occurred in order to avoid the cross resistance.

Do not use in cases of diagnosed disturbances of cartilage development and/or during the injuries of locomotor system which resulted in cartilage damages.

Do not use in cases of known sensitivity to fluoroqunolone drugs or on the excipients of this VMP.

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. Do not use in cats less than 8 weeks of age.

Amounts to be administered and administration route

Subcutaneous or intramuscular use.

Cattle (calves): 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: 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 subcutaneous administration. Not more than 10 ml should be administered at one subcutaneous injection site.

Pigs: 2.5 mg 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 site.

Sheep and goats: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days. Not more than 6 ml should be administered at one subcutaneous injection site.

Dogs and cats: 5 mg enrofloxacin/kg bw corresponding to 1 ml/20 kg bw once daily by subcutaneous injection for up to 5 days.

Withdrawal period(s)

Cattle:

Meat and offal: 14 days, milk 4 days

Pigs:

Meat and offal: 10 days

Sheep:

Meat and offal: 4 days, milk: 72 hours

Goats:

Meat and offal: 6 days, milk: 96 hours

Incompatibilities

Enrofloxacin is not to be mixed with tetracyclines, chloramphenicol analogues (tiamphenicol and florfenicol) and macrolide antibiotics.

Special precautions for storage

Store at temperature of 25ºC, in original package

Do not keep in refrigerator; do not freeze

Keep out from the reach of children

Packaging

100 ml glass vials, in cardboard box