Karifloxx 100 Mg Oral Solution

Target species

Chickens (broilers) and rabbits.

Indications for use, specifying the target species

Treatment of infections caused by the following bacterial susceptible to enrofloxacin:

• Chickens
• Mycoplasma gallisepticum
• Mycoplasma synoviae
• Avibacterium paragallinarum
• Pasteurella multocida
• Rabbits
• For the treatment infectious diseases due to Pasteurella multocida.

Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.

For oral administration via the drinking water.

Chickens

KARIFLOXX 100 mg/mL is applied via the drinking water. The basic dosage is 1 mL per 10 kg (10 mg per kg) live mass given in a 6 to 8 hour water supply over 3 consecutive days. Diseases such as colibacillosis, fowl cholera, infectious coryza and mycoplasmosis (MG/MS) should be treated continuously for 3 consecutive days. In mycoplasmosis, treat whenever symptoms occur or positive seroconversion is diagnosed. Salmonellosis should be treated for 5 consecutive days.

Average live mass (g) mg AI/ 1 000 birds mL KARIFLOXX 100 mg/mL / 1 000 birds Total KARIFLOXX 100 mg/mL volume (mL) for 1 000 birds for 3 treatment days

• 140 1 400 14 42
• 340 3 400 34 102
• 650 6 500 65 195
• 1 000 10 000 100 300
• 1 400 14 000 140 420
• 1 800 18 000 180 540
• 2 200 22 000 220 660

Rabbits

10 mg/kg body mass per day for 5 consecutive days. To ensure a correct dosage body mass should be determined as accurately as possible to avoid underdosing. The intake of medicated water depends on the clinical condition of the animals and the time of year. In order to obtain the correct dosage, the concentration of enrofloxacin has to be adjusted accordingly. According to the recommended dose, the number and mass of the animals which should be treated, the exact daily dose of KARIFLOXX 100 mg/mL should be calculated using the following formula:

mL of product/L water = 10 mg/kg/day x average body mass of the animals / 100 mg/mL x average water consumption (L/day)

The medicated water should be made up fresh each day just before it is offered to the animals. Sufficient access to the system of supply should be available for the animals to be treated to ensure adequate water consumption. The drinking water must be medicated throughout the treatment period, and no other water source should be available. Use appropriate and properly calibrated dosing equipment.

• Do not use in the case of known hypersensitivity to enrofloxacin, other (fluoro)quinolones or to any of the excipients of KARIFLOXX 100 mg/mL.
• Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment.
• Do not use for prophylaxis.

Special warnings for each target species

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

Withdrawal period: Meat and offal: Chickens (broilers): 7 days Rabbits: 3 days

• In vitro, an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial medicines such as macrolides or tetracyclines and phenicols.
• The simultaneous application of medicines containing aluminium or magnesium can impair the absorption of enrofloxacin.

• Do not use in laying hens producing eggs for human consumption.
• Do not administer to layer replacement birds within 14 days of coming into lay.

Side effects

None known. If you notice any serious effects or other effects, please inform your veterinarian.

Special precautions for use in animals

Official and local antimicrobial policies should be taken into account when the KARIFLOXX 100 mg/mL 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 this Package Insert may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. 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 synovia in the EU.

Known signs of overdose and particulars of its treatment

At the dosage of 20 mg/kg body mass (twice the recommended dosage) administered for 15 days (3 times the recommended duration of treatment) adverse reactions were not observed. In case of overdosage, the symptoms would be a weak stimulation of the spontaneous motility, so the treatment should be ceased. Overdose by fluoroquinolones may cause sickness, vomiting and diarrhoea. The use of fluoroquinolones during the growth phase combined with a marked and prolonged increase in the intake of drinking water, and hence active ingredient, possibly due to high temperatures, may potentially be associated with damage of the articular cartilage.