Summary of medicine characteristics - Ibaflin
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Ibaflin 30 mg tablets for dogs
Ibaflin 150 mg tablets for dogs
Ibaflin 300 mg tablets for dogs
Ibaflin 900 mg tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Ibaflin contains:
Ibafloxacin 30 mg
Ibafloxacin 150 mg
Ibafloxacin 300 mg
Ibafloxacin 900 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
4.1 Target species
Dogs
4.2 Indications for use
Ibaflin is indicated for the treat Dermal infections (pyoderma
of Staphylococci, E. coli, Acute, uncomplicated uri spp., Enterobacter spp., E Respiratory tract infectio Klebsiella spp.
ent of the following conditions in dogs:
uperficial and deep, wounds, abscesses) caused by susceptible strains teus mirabilis.
ct infections, caused by susceptible strains of Staphylococci, Proteus
oli and Klebsiella spp.
(upper tract) caused by susceptible strains of Staphylococci, E. coli, and
4.3 Contraindications
Do not use in dogs during the period of growth as articular cartilage may be affected. 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.
Do not use in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
ecial warnings for each target species
not use in dogs with known quinolone hypersensitivity.
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4.5 Special precautions for use
uld
erlying
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bac population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions w have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin only be used based on susceptibility testing.
Pyoderma is mostly secondary to an underlying disease. It is advisable to determi cause and to treat the animal accordingly.
Persons with known hypersensitivity to quinolones should avoid any contact wi Medicinal advice should be sought in the event of accidental ingestion, particul
roduct. a child.
4.6 Adverse reactions (frequency and seriousness)
Diarrhoea, soft faeces, vomiting, dullness and anorexia have been obse effects were mild and transient.
ith low frequency. These
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy. The safety of the veterinary medicinal product has not been established during lactation.
The influence on fertility in male breeding dogs has not been studied.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Posology and method of admini
dequate. The treatment should be reconsidered if at 5 days no
ondition is observed. If in cases of deep pyoderma, sufficient er a treatment course of 21 days, it is recommended that the treatment is
e body weight should be determined as accurately as possible to avoid dosage scheme is advised:
| Body weight (kg)" | posage (number of tablets) | mg administered | |||
| Ibaflin 30 mg | Ibaflin 150 mg | Ibaflin 300mg | Ibaflin 900 mg | ||
| 1 | 0.5 | 15 | |||
| Jb2 C > | 1 | 30 | |||
| 1.5 | 45 | ||||
| 2 | 60 | ||||
| b^f | 0.5 | 75 | |||
| 1/6–10 | 1 | 150 | |||
| I 11–15 | 1.5 | 225 | |||
| 16–20 | 1 | 300 | |||
| 21–30 | 0.5 | 450 | |||
| 31–40 | 2 | 600 « | |||
| 41–60 | 1 | 900 £ |
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Target animal safety studies in dogs of 8 months of age demonstrated that, when administ 45 mg/kg/day (three times the recommended dose) for a period of 90 days, ibafloxaci observable adverse effects.
No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage symptomatic treatment should be given.
ally at duced no
4.11 Withdrawal periods
Not applicable.
5. PHARMACOLOGICAL PARTICULARS
Pharmacotherapeutic group: antibacterial quinolone ATCvet co Ibaflin contains ibafloxacin as active ingredient. Ibafloxacin i the fluoroquinolone class.
Ibafloxacin is a broad spectrum, bactericidal antibiotic. Its ac
QJ 01 MA
synthetic antimicrobial substance of
tion results from inhibition of bacterial
DNA gyrase. The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active. Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically. For ibafloxacin (parent compound), MIC values ranging from 0.032 – 0.5 ^g/ml are^bserved for canine isolates of E. coli, Staphylococcus spp., Proteus mirabilis, strains of Pasteurella spp. and Salmonella spp.
A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
After oral administration in dog microbiologically active comp life is approximately 4–5 hours.
consequences for efficacy. maximal bioavailability. The main excretory route reached after the first or
enzymes occurs.
ibafloxacin is rapidly absorbed with maximum plasma levels of btained at 1–2 hours after administration. Terminal plasma half-aflin can be administered at any time of the day without , it is preferred to administer the tablet at feeding time to ensure
ia urine and faeces. After multiple oral administration, steady state is econd dosing and no accumulation or induction of biotransformation
6.1 Lis
6. PHAR
UTICAL PARTICULARS
Yeast
Starch
laurylsulphate
Silica
agnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf-life
150mg and 300mg tablets: 4 years
30mg and 900mg tablets: 3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
30 mg tablets:
150 mg tablets:
300 mg tablets:
900 mg tablets:
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– Carton box with 20 or 100 tablets in PVC/aluminium heat sealed blisters
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– Carton box with 10, 20 or 100 tablets in PVC/aluminium heat sealed blisters
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– Carton box with 10, 20 or 100 tablets in PVC/PVDC/aluminium blisters
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– Carton box with 8, 16 or 80 tablets in PVC/aluminium heat sealed blisters
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– Carton box with 8, 16 or 80 tablets in PVC/PVDC/aluminium blisters
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– Carton box with 5, 25 or 50 tablets in PVC/aluminium heat sealed blisters.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HO
Intervet International B.V.
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
8. Marketing Authorisati
EU/2/00/022/001–008
EU/2/00/022/013–017
9. Date of first a
08.07.2005 /
10. Date of revision of the text
ot applicable.
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Ibaflin 3% oral gel for dogs and cats
Ibaflin 7.5% oral gel for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Active substance(s)
Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml);
Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml
3. PHARMACEUTICAL FORM
Oral gel
4. CLINICAL PARTICULARS
Dogs and cats
4.2 Indications for use
Ibaflin gel is indicated in dogs for the treatment of the following conditions:
Dermal infections (pyoderm pathogens such as Staphylo
perficial and deep, wounds, abscesses) caused by susceptible spp, E. coli and Proteus mirabilis.
Ibaflin gel is indicated in cats for treatment of the following conditions:
Dermal infectio as Staphylococc
: tissue infections – wounds, abscesses) caused by susceptible pathogens such 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.
4.3 Contraindications
No information is available on the influence of ibafloxacin on developing articular cartilage in the cat during the period of rapid growth as articular cartilage may be affected. Therefore, ibafloxacin should used in cats aged less than 8 months. In dogs, this period depends on the breed. For the majority ds, the use of ibafloxacin is contra-indicated in dogs less than 8 months of age and in giant s less than 18 months old.
aflin 7.5% Oral Gel should not be used in cats.
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4.4 Special warnings for each target species
terial
Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying ca and treat the animal accordingly.
The influence on fertility in male breeding animals has not been investigated.
4.5 Special precautions for use
Heavy reliance on a single class of antibiotic may result in the induction of resistanc population. It is prudent to reserve the fluoroquinolones for the treatment of clinical ons 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.
Persons with known hypersensitivity to quinolones should avoid contact with the veterinary medicinal product.
were observed with low frequency.
4.6 Adverse reactions (frequency and seriousness)
Diarrhoea, soft faeces, vomiting, dullness, anorexia an These effects were mild and transient.
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4.7 Use during pregnancy, lactation or lay
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.
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4.8 Interaction with other me
cts and other forms of interaction
Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures. Anti-acids can interfere with gastro-intestinal absorption of quinolones. Antagonism may be observed with nitrofurantoin.
4.9 Posology and method of administration
Oral use, 15 mg ibafloxaci
dyweight once daily.
| Cats and dogs | jlfn^/o Oral Gel | 0.5 ml of gel per kg body weight |
| Dogs | 4baf]]n 7.5% Oral Gel | 1 ml of gel per 5 kg body weight. |
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. 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 and 1.0 ml for the 30 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.
f in cases of deep pyoderma, sufficient improvement is not seen after a treatment course of 21 days, it s recommended that the treatment is reconsidered.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
bial substance
When administered orally at 75 mg/kg/day (five times the recommended dose) for a period of 90 d in dogs, ibafloxacin was well tolerated. When administered over a period of 30 days to healthy cat Ibaflin oral gel produced vomiting/regurgitation and salivation at doses of 15 to 75 mg/kg.
4.11 Withdrawal periods
Not applicable.
5. PHARMACOLOGICAL PARTICULARS
Ibaflin gel contains ibafloxacin as active ingredient. Ibafloxacin is a of the fluoroquinolone class.
Pharmacotherapeutic group: antibacterial quinolone ATCvet code:
Ibafloxacin is a broad spectrum antibiotic with bactericidal action ing from inhibition of bacterial DNA gyrase. The most abundant metabolite is 8-hydroxy-ibafloxac ch is also microbiologically
active. lbafloxacin and 8-hydroxy-ibafloxacin act synergistically. r ibafloxacin (parent compound), MIC values ranging from 0.032 – 0.5 p g/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 llg ibafloxacin/ml).
After oral administration to cats, ibafloxacin is rap sorbed 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 ho administered with food. The main excret After repeated oral administration, steady occurs in dogs whereas-modest accumulai
The overall absorption was higher in dogs and cats when outes are via urine and faeces.
e is reached after the first dosing and no accumulation is observed in cats.
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6. PHARMACEUTICAL
6.1 List of excipients
Methyl parahydroxybenzoate (0.12 Potassium dihydrogen phophate
Disodium hydrogen phosph Carbomer (carbopol 974 PN Sodium hydroxide solution Water for injections
ate dihydrate
6.2
tibilities
Not
Shelf-life
s
helf-life after first opening: 8 weeks
6.4 Special precautions for storage
Do not store above 25°C.
Any syringes containing unused product should be disposed of once a course of treatment has been completed.
6.5 Nature and contents of container
White adjustable multidose pre-filled syringe consisting of high density polyethylene ( plunger and ring) and low density polyethylene (LDPE, cap and seal).
carton box with 1 × 15 ml (0.5 ml steps) pre-filled syringe (Ibaflin 3% Oral Gel carton box with 5 × 15 ml (0.5 ml steps) pre-filled syringes (Ibaflin 3% Oral Ge carton box with 1 × 30 ml (1 ml steps) pre-filled syringe (Ibaflin 7.5% Oral Gel carton box with 5 × 30 ml (1 ml steps) pre-filled syringes (Ibaflin 7.5% Oral Ge
6.6 Special precautions for the disposal of unused medicinal pro
aste materials, if any
Any unused veterinary product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands