Presentation

Ibaflin 3% Oral Gel containing 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml).

Uses

Ibaflin gel is indicated in dogs for the treatment of the following conditions:

- Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis.

Ibaflin gel is indicated in cats for treatment of the following conditions:

- Dermal infections (soft tissue infections – wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.

- Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. and Pasteurella spp.

Dosage and administration

Oral use, 15 mg ibafloxacin/kg bodyweight once daily.

15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight.

The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 0.5 ml for the 15 ml syringe).

The gel should be administered at the time of feeding.

The duration of treatment depends on the nature and severity of the infection and on the response seen. In most cases, a 10-day treatment course will be sufficient. If necessary, and depending on the clinical response, treatment can be continued until the response is considered to be adequate. The treatment should be reconsidered if, after 5 days, no improvement in the clinical condition is observed.

If in cases of deep pyoderma, sufficient improvement is not seen after a treatment course of 21 days, it is recommended that the treatment is reconsidered.

Contra-indications, warnings, etc

No information is available on the influence of ibafloxacin on developing articular cartilage in young cats.  As articular cartilage may be affected during this period of rapid growth, ibafloxacin should not be used in cats aged less than 8 months.  In dogs, this period depends on the breed. 

For the majority of breeds, the use of ibafloxacin is contra-indicated in dogs less than 8 months of age and in giant breeds less than 18 months old.

Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency. These effects were mild and transient.

Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin gel should only be used based on susceptibility testing. Do not use in dogs and cats with known quinolone hypersensitivity.

In order to avoid any cross contamination, the same syringe should not be used for different animals. Once a syringe is opened it should only be used to continue the treatment course in the same animal.

The product can  be used during pregnancy in dogs. The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.

Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.  Antacids can interfere with gastro-intestinal absorption of quinolones. Antagonism may be observed with nitrofurantoin.

Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause and treat the animal accordingly.

User warning

Persons with known hypersensitivity to quinolones should avoid contact with the veterinary medicinal product.

For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions

Do not store above 25°C.

Once opened use within 8 weeks.  Syringes containing unused product should be disposed of once a course of treatment has been completed.

Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM

Package quantities

Cartons with 1 x 15 ml (0.5 ml steps) or  5 x 15 ml (0.5 ml steps) pre-filled syringes.

Further information

Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.

Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase. The most abundant metabolite is 8‑hydroxy‑ibafloxacin, which is also microbiologically active. lbafloxacin and 8-hydroxy-ibafloxacin act synergistically.  For ibafloxacin (parent compound), MIC values ranging from 0.032 – 0.5 µg/ml are observed for canine isolates of E. coli, Staphylococcus spp. and Proteus mirabilis. In cats, relevant susceptible micro-organisms are E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp. and Klebsiella spp. (MIC ≤ 0.5 µg ibafloxacin/ml).

After oral administration to cats, ibafloxacin is rapidly absorbed with maximal plasma levels observed at 1 hour when administered without food and 2 hours when administered with food.  In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.  Terminal plasma half-life is approximately 3-5 hours. The overall absorption was higher in dogs and cats when administered with food.  The main excretory routes are via urine and faeces.

After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs, whereas modest accumulation is observed in cats.

When administered orally at 75 mg/kg/day (five times the recommended dose) for a period of 90 days in dogs, ibafloxacin was well tolerated. When administered over a period of 30 days to healthy cats, Ibaflin oral gel produced vomiting/regurgitation and salivation at doses of 15 to 75 mg/kg.  Among the 6 animals dosed at 15 mg/kg/day, no effects were observed except vomiting and salivation in one male and one female cat, on one day only, during the 30 days course of treatment.

Marketing authorisation number

EU/2/00/002/009 (carton with 1 syringe)

EU/2/00/002/010 (carton with 5 syringes)

Marketing Authorisation Holder

Intervet International bv

Wim de Körverstraat 35

PO Box 31

5830 AA Boxmeer

The Netherlands