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Ibaflin

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Summary for the public


What is Ibaflin?

Ibaflin contains ibafloxacin, which belongs to a class of medicines having an antibiotic action.

Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).


What is Ibaflin used for?

Ibaflin is used to treat the infections in dogs and cats:

  • skin infections, including shallow and deep ‘pyoderma’, infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species,
  • upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.

It is also used in dogs to treat acute (short-lived), uncomplicated infections of the urinary tract caused by Staphylococci, Proteus species, Enterobacter species, E. coli and Klebsiella species.
Ibaflin is given by mouth. Dogs are treated using the tablets, except for skin infection, where in addition to the tablets either strengths of the oral gel may be used. Cats are treated using the 3% oral gel. The dose and duration of treatment depend on the nature and severity of the infection, the weight and species of the animal being treated, and the animal’s response to treatment. The standard dose is 15 mg per kilogram body weight once a day for the length of time determined by your veterinarian. For more information, see the Package Leaflet.


How does Ibaflin work?

Ibafloxacin, is an antibiotic belonging to the class ‘fluoroquinolones’. It works by blocking an enzyme called ‘DNA gyrase’, which is important in allowing bacteria to make copies of their DNA. This enzyme is only found in bacterial cells, and does not have a similar function in animal cells. By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death. A strain which is resistant to one type of fluoroquinolone will also be resistant to other members of the class of fluoroquinolones. The use of ibafloxacin may result in an increase in the prevalence of resistant strains in the target species although this risk is likely to be less of a concern due to the treatment of individual animals with this product.


How has Ibaflin been studied?

Ibaflin tablets have been studied in dogs, looking at their effectiveness in treating skin, urinary tract and respiratory tract infections. The oral gel has been studied in cats looking at skin, respiratory tract and urinary tract infections. In these studies, the effects of Ibaflin were compared with those of other antibiotics (marbofloxacin, enrofloxacin or amoxicillin/clavulanic acid).

From data of two different clinical trials, comparable efficacy was shown between the Ibaflin gel formulations and a positive control to support the claims for skin (soft tissue infections – wounds, abscesses) and upper respiratory tract infections in cats for the oral gel formulations. The indication for treatment of urinary infections in cats was not accepted. Ibaflin oral gel is indicated in dogs for the treatment of skin infections (pyoderma – superficial and deep, wounds, abscesses).

Comparable efficacy of the gel formulation to the tablet formulation was shown for dogs in a clinical trial.


What benefit has Ibaflin shown during the studies?

Ibaflin tablets were at least as effective as the comparator antibiotics in treating skin, urinary tract and upper tract respiratory infections in dogs. The tablets and oral gel were of comparable effectiveness in treating skin infections in dogs.

The oral gel was also at least as effective as the comparator antibiotic (amoxicillin/clavulanic acid) in treating skin and upper respiratory tract infections in cats. However, the results were insufficient to support the use of Ibaflin in the treatment of urinary tract infections in cats.


What are the side-effects associated with Ibaflin?

Diarrhoea, soft faeces, vomiting, dullness (lack of responsiveness) and anorexia (loss of appetite) occur with low frequency in dogs and cats given Ibaflin. Salivation can also occur with the oral gel. These effects are mild and temporary.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

People who are hypersensitive (allergic) to quinolones should avoid any contact with Ibaflin.

Medical advice should be sought if the tablets are swallowed accidentally, particularly by a child.


Why has Ibaflin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Ibaflin:

The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B.V. on 13 June 2000. The marketing authorisation was renewed on 13 June 2005. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Ibaflin
EMEA Product number: EMEA/V/C/000052
Active substance: ibafloxacin
INN or common name: Ibafloxacin
Species: DogsCats
ATCvet Code: QJ01MA96
Marketing Authorisation Holder: Intervet International BV
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 13/06/2000
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE 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:
    Active substance(s)
    Ibafloxacin 30 mg
    Ibafloxacin 150 mg
    Ibafloxacin 300 mg
    Ibafloxacin 900 mg
    Excipients
    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 treatment of the following conditions in dogs:
    Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible strains
    of Staphylococci, E. coli, and Proteus mirabilis .
    Acute, uncomplicated urinary tract infections , caused by susceptible strains of Staphylococci, Proteus
    spp., Enterobacter spp., E. coli and Klebsiella spp.
    Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and
    Klebsiella spp .
    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.
    4.4 Special warnings for each target species
    Do not use in dogs with known quinolone hypersensitivity.
    2/35
    4.5 Special precautions for use
    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 which
    have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin should
    only be used based on susceptibility testing.
    Special precautions for use in animals
    Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying
    cause and to treat the animal accordingly.
    Special precautions to be taken by the person administering the product
    Persons with known hypersensitivity to quinolones should avoid any contact with the product.
    Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
    4.6 Adverse reactions (frequency and seriousness)
    Diarrhoea, soft faeces, vomiting, dullness and anorexia have been observed with low frequency. These
    effects were mild and transient.
    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
    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.
    4.9 Posology and method of administration
    Oral use, 15 mg ibafloxacin/kg once daily. The duration of treatment depends on the nature and
    severity of the infection and on the response. 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 at 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.
    To ensure a correct dosage body weight should be determined as accurately as possible to avoid
    underdosing. The following dosage scheme is advised:
    Body weight
    (kg)
    Dosage (number of tablets)
    mg
    administered
    Ibaflin 30 mg Ibaflin 150
    mg
    Ibaflin
    300mg
    Ibaflin 900
    mg
    1
    0.5
    15
    2
    1
    30
    3
    1.5
    45
    4
    2
    60
    5
    0.5
    75
    6-10
    1
    150
    11-15
    1.5
    225
    3/35
     
    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 administered orally at
    45 mg/kg/day (three times the recommended dose) for a period of 90 days, ibafloxacin produced no
    observable adverse effects.
    No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage
    symptomatic treatment should be given.
    4.11 Withdrawalperiods
    Not applicable.
    5. PHARMACOLOGICAL PARTICULARS
    Pharmacodynamic properties
    Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
    Ibaflin contains ibafloxacin as active ingredient. Ibafloxacin is a synthetic antimicrobial substance of
    the fluoroquinolone class.
    Ibafloxacin is a broad spectrum, bactericidal antibiotic. Its action 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 µg/ml are observed 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.
    Pharmacokinetic particulars
    After oral administration in dogs, ibafloxacin is rapidly absorbed with maximum plasma levels of
    microbiologically active compounds obtained at 1-2 hours after administration. Terminal plasma half-
    life is approximately 4-5 hours. Ibaflin can be administered at any time of the day without
    consequences for efficacy. However, it is preferred to administer the tablet at feeding time to ensure
    maximal bioavailability.
    The main excretory route is via urine and faeces. After multiple oral administration, steady state is
    reached after the first or second dosing and no accumulation or induction of biotransformation
    enzymes occurs.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Yeast
    Starch
    Cellulose
    Lactose
    Sodium laurylsulphate
    Silica
    Magnesium stearate
    4/35
    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: - Carton box with 20 or 100 tablets in PVC/aluminium heat sealed blisters
    150 mg tablets: - Carton box with 10, 20 or 100 tablets in PVC/aluminium heat sealed blisters
    - Carton box with 10, 20 or 100 tablets in PVC/PVDC/aluminium blisters
    300 mg tablets: - Carton box with 8, 16 or 80 tablets in PVC/aluminium heat sealed blisters
    - Carton box with 8, 16 or 80 tablets in PVC/PVDC/aluminium blisters
    900 mg tablets: - 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 HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(s)
    EU/2/00/022/001-008
    EU/2/00/022/013-017
    9.
    DATE OF FIRST AUTHORISATION/renewal of the authorisation
    08.07.2005 / 26.05.2010
    10. Date of revision of the text
    26.05.2010
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMA) http://www.ema.europa.eu/ .
    Prohibition of sale, supply and/or use
    Not applicable.
    5/35
    1. NAME OF VETERINARY THE 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)
    Excipients
    Methyl parahydroxybenzoate (0.125%)
    For a full list of excipients, see section 6.1.
    3. PHARMACEUTICAL FORM
    Oral gel
    4. CLINICAL PARTICULARS
    Target species
    Dogs and cats
    4.2 Indications for use
    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 .
    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
    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.
    Ibaflin 7.5% Oral Gel should not be used in cats.
    6/35
    4.4 Special warnings for each target species
    Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause
    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 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.
    Special precautions for use in animals
    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.
    Special precautions to be taken by the person administering the product
    Persons with known hypersensitivity to quinolones should avoid contact with the veterinary medicinal
    product.
    4.6 Adverse reactions (frequency and seriousness)
    Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency.
    These effects were mild and transient.
    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.
    4.8 Interaction with other medicinal products 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 ibafloxacin/kg bodyweight once daily.
    Cats and dogs
    Ibaflin 3% Oral Gel
    0.5 ml of gel per kg body weight
    Dogs
    Ibaflin 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.
    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.
    7/35
     
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    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.
    4.11 Withdrawalperiods
    Not applicable.
    5. PHARMACOLOGICAL PARTICULARS
    Ibaflin gel contains ibafloxacin as active ingredient. Ibafloxacin is a synthetic antimicrobial substance
    of the fluoroquinolone class.
    Pharmacodynamic properties
    Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96
    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
    µ
    Pharmacokinetic particulars
    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 repeated oral administration, steady state is reached after the first dosing and no accumulation
    occurs in dogs whereas modest accumulation is observed in cats.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Methyl parahydroxybenzoate (0.125%)
    Potassium dihydrogen phophate
    Disodium hydrogen phosphate dihydrate
    Carbomer (carbopol 974 PNF)
    Sodium hydroxide solution
    Water for injections
    6.2 Incompatibilities
    Not applicable.
    6.3 Shelf-life
    3 years
    Shelf-life after first opening: 8 weeks
    8/35
    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 Klebsiella spp. (MIC ≤ 0.5 µg ibafloxacin/ml).
    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 (HDPE, barrel,
    plunger and ring) and low density polyethylene (LDPE, cap and seal).
    - carton box with 1 x 15 ml (0.5 ml steps) pre-filled syringe (Ibaflin 3% Oral Gel)
    - carton box with 5 x 15 ml (0.5 ml steps) pre-filled syringes (Ibaflin 3% Oral Gel)
    - carton box with 1 x 30 ml (1 ml steps) pre-filled syringe (Ibaflin 7.5% Oral Gel)
    - carton box with 5 x 30 ml (1 ml steps) pre-filled syringes (Ibaflin 7.5% Oral Gel)
    6.6 Special precautions for the disposal of unused medicinal product or waste 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
    8.
    MARKETING AUTHORISATION NUMBER(s)
    EU/2/00/022/09-12
    9.
    DATE OF FIRST AUTHORISATION/renewal of the authorisation
    08.07.2005 / 26.05.2010
    10. Date of revision of the text
    26.05.2010
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMA) http://www.ema.europa.eu/ .
    Prohibition of sale, supply and/or use
    Not applicable.
    9/35
    ANNEX II
    A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    D. STATEMENT OF THE MRLs
    10/35
    B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
    RESTRICTIONS REGARDING SUPPLY AND USE
    C. PROHIBITION OF SALE, SUPPLY AND/OR USE
    A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Tablets
    Intervet GesmbH
    Siemensstrasse 107
    A-1210 Wien
    Austria
    Oral Gel
    Intervet Productions S.A.
    Rue de Lyons
    27460 Igoville
    France
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
    RESTRICTIONS REGARDING SUPPLY AND USE
    Veterinary medicinal product subject to prescription.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    C. PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable
    D. STATEMENT OF THE MRLs
    Not applicable
    11/35
    ANNEX III
    LABELLING AND PACKAGE INSERT
    12/35
    A. LABELLING
    13/35
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    I BAFLIN T ABLETS 30, 150, 300 AND 900 MG
    1. NAME OF VETERINARY THE 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. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Ibafloxacin
    3. PHARMACEUTICAL FORM
    Tablet
    4. PACKAGE SIZE
    20 tablets / 100 tablets
    10 tablets / 20 tablets / 100 tablets
    8 tablets /16 tablets / 80 tablets
    5 tablets /25 tablets / 50 tablets
    5. TARGET SPECIES
    Dogs
    6. INDICATIONS
    Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and
    upper respiratory tract infections.
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily.
    Read the package insert before use.
    8. WITHDRAWAL PERIOD
    Not applicable.
    14/35
     
    9. SPECIAL WARNING(S), IF NECESSARY
    Do not use during the period of growth or in combination with nonsteroidal anti-inflammatory drugs
    (NSAIDs) in dogs with a history of seizures. Do not use in dogs with a weight of less than 3 kg. Ibaflin
    should only be used based on susceptibility testing. Do not use in dogs with known quinolone
    hypersensitivity.
    Read the package insert before use.
    10. EXPIRY DATE
    (Month/year)
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 25°C.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary product or waste material derived from such veterinary medicinal products should
    be disposed of in accordance with local requirements.
    13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE
    For animal treatment only. Veterinary medicinal product subject to prescription.
    14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/022/001-008
    EU/2/00/022/013-017
    17. MANUFACTURER'S BATCH NUMBER
    15/35
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    C ARTON B OX FOR 1 SYRINGE I BAFLIN 3% ORAL GEL / C ARTON B OX FOR 5 SYRINGES I BAFLIN 3%
    ORAL GEL
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 3% oral gel for dogs and cats.
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Ibafloxacin
    3. PHARMACEUTICAL FORM
    Oral gel
    4. PACKAGE SIZE
    1 adjustable pre-filled multidose syringe, containing 15 ml. / Carton box containing 5 adjustable pre-filled
    multidose syringes, each containing 15 ml Ibaflin 3% oral gel.
    5. TARGET SPECIES
    Dogs and cats
    6. INDICATIONS
    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 .
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily.
    15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
    Read the package insert before use.
    16/35
     
    8. WITHDRAWAL PERIOD
    Not applicable.
    9. SPECIAL WARNING(S), IF NECESSARY
    Do not use during the period of growth. Ibaflin gel should be used based on susceptibility testing. Do not
    use in dogs and cats with known quinolone hypersensitivity.
    Read the package insert before use.
    10. EXPIRY DATE
    (Month/year)
    Once opened use within 8 weeks
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 25°C.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary product or waste material derived from such veterinary medicinal products should
    be disposed of in accordance with local requirements.
    13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE
    For animal treatment only. Veterinary medicinal product subject to prescription.
    14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/022/09
    EU/2/00/022/10
    17/35
     
    17. MANUFACTURER'S BATCH NUMBER
    18/35
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    C ARTON B OX FOR 1 SYRINGE I BAFLIN 7.5% ORAL GEL / C ARTON BOX FOR 5 SYRINGES I BAFLIN
    7.5% ORAL GEL
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 7.5% oral gel for dogs.
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Ibafloxacin
    3. PHARMACEUTICAL FORM
    Oral gel
    4. PACKAGE SIZE
    Carton box containing 1 adjustable pre-filled multidose syringe, containing 30 ml Ibaflin 7.5% oral gel. /
    Carton box containing 5 adjustable pre-filled multidose syringes, containing 30 ml Ibaflin 7.5% oral gel.
    5. TARGET SPECIES
    Dogs
    6. INDICATIONS
    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.
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily.
    15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
    Read the package insert before use.
    8. WITHDRAWAL PERIOD
    Not applicable.
    19/35
     
    9. SPECIAL WARNING(S), IF NECESSARY
    Do not use in cats.
    Do not use during the period of growth. Ibaflin gel should be used based on susceptibility testing. Do not
    use in dogs with known quinolone hypersensitivity.
    Read the package insert before use.
    10. EXPIRY DATE
    (Month/year)
    Once opened use within 8 weeks.
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 25°C.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary product or waste material derived from such veterinary medicinal products should
    be disposed of in accordance with local requirements.
    13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE
    For animal treatment only. Veterinary medicinal product subject to prescription.
    14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/022/11
    EU/2/00/022/12
    20/35
     
    17. MANUFACTURER'S BATCH NUMBER
    21/35
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    I BAFLIN T ABLETS 30, 150, 300 AND 900 MG
    1. NAME OF VETERINARY THE 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. QUANTITY OF THE ACTIVE SUBSTANCE(S)
    30 mg of ibafloxacin per tablet
    150 mg of ibafloxacin per tablet
    300 mg of ibafloxacin per tablet
    900 mg of ibafloxacin per tablet
    3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    20 or 100 tablets
    10, 20 or 100 tablets
    8, 16 or 80 tablets
    5, 25 or 50 tablets
    4. ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily.
    Read the package insert before use.
    5. WITHDRAWALPERIOD
    Not applicable.
    6. BATCH NUMBER
    Batch
    7. EXPIRY DATE
    EXP {month/year}>
    8. THE WORDS "FOR ANIMAL TREATMENT ONLY"
    For animal treatment only.
    22/35
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    I BAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 3% oral gel for dogs and cats
    2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
    30 mg of ibafloxacin per ml of gel
    3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    15 ml
    4. ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily (i.e. 0.5 ml of gel per kg body weight).
    Read the package insert before use.
    5. WITHDRAWALPERIOD
    Not applicable.
    6. BATCH NUMBER
    Batch
    7. EXPIRY DATE
    EXP {month/year}>
    Once opened use within 8 weeks.
    8. THE WORDS "FOR ANIMAL TREATMENT ONLY"
    For animal treatment only.
    23/35
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    I BAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
    1. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 7.5% oral gel for dogs
    2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
    75 mg of ibafloxacin per ml of gel
    3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    30 ml
    4. ROUTE(S) OF ADMINISTRATION
    Oral use, 15 mg per kg bodyweight once daily (i.e. 1 ml of gel per 5 kg body weight).
    Read the package insert before use.
    5. WITHDRAWALPERIOD
    Not applicable.
    6. BATCHNUMBER
    Batch
    7. EXPIRY DATE
    EXP {month/year}>
    Once opened use within 8 weeks.
    8. THE WORDS "FOR ANIMAL TREATMENT ONLY"
    For animal treatment only.
    24/35
     
    B. PACKAGE INSERT
    25/35
    P ACKAGE INSERT FOR INCLUSION WITH THE I BAFLIN T ABLETS
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Name and address of the Manufacturing Authorisation Holder responsible for batch release
    Intervet GesmbH.
    Siemensstraße 107
    1210 Vienna
    Austria
    2. NAME OF VETERINARY THE 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
    3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
    Ibaflin 30 mg: ibafloxacin 30 mg
    Ibaflin 150 mg: ibafloxacin 150 mg
    Ibaflin 300 mg: ibafloxacin 300 mg
    Ibaflin 900 mg: ibafloxacin 900 mg
    4. INDICATIONS
    Ibaflin is indicated for the treatment of the following conditions in dogs:
    Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible strains
    such as S taphylococci, E. coli, Proteus mirabilis .
    Acute, uncomplicated urinary tract infections , caused by susceptible strains such as S taphylococci,
    Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
    Respiratory tract infections (upper tract) caused by susceptible strains of S taphylococci, E. coli, and
    Klebsiella spp .
    5. 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 nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of
    seizures.
    26/35
    6. UNDESIRABLE EFFECTS
    Diarrhoea, soft faeces, vomiting, dullness and anorexia have been observed with low frequency. These
    effects are mild and transient.
    If you notice any other side effects, please inform your veterinary surgeon.
    7. TARGET SPECIES
    Dog
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Oral use, 15 mg ibafloxacin/kg once daily. The duration of treatment depends on the nature and severity
    of the infection and on the response. 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 re-considered if at 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.
    To ensure a correct dosage body weight should be determined as accurately as possible to avoid
    underdosing. The following dosage scheme is advised:
    Body weight
    (kg)
    Dosage (number of tablets)
    mg.
    administered
    Ibaflin
    30 mg
    Ibaflin
    150 mg
    Ibaflin
    300mg
    Ibaflin
    900 mg
    1
    0.5
    15
    2
    1
    30
    3
    1.5
    45
    4
    2
    60
    5
    0.5
    75
    6-10
    1
    150
    11-15
    1.5
    225
    16-20
    1
    300
    21-30
    0.5
    450
    31-40
    2
    600
    41-60
    1
    900
    9. ADVICE ON CORRECT ADMINISTRATION
    Ibaflin can be administered at any time of the day without consequences for efficacy. However, it is
    preferred to administer the tablet at feeding time to ensure maximal bioavailability.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE CONDITIONS
    Do not store above 25°C.
    Keep out of the reach and sight of children.
    27/35
     
    12. SPECIAL WARNING(S)
    Persons with known hypersensitivity to quinolones should avoid any contact with the product. The
    influence on fertility in male breeding dogs has not been studied.
    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 which
    have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin should
    only be used based on susceptibility testing.
    Do not use in dogs with known quinolone hypersensitivity.
    Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause
    and to treat the animal accordingly.
    Antiacids can interfere with gastro-intestinal absorption of quinolones. Antagonism may be observed with
    nitrofurantoin.
    The safety of the veterinary medicinal product has not been established during lactation. Ibaflin can be
    used during pregnancy.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
    26.05.2010
    15. OTHER INFORMATION
    Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
    Ibafloxacin is a broad spectrum bactericidal antibiotic from the quinolone group. Its action results from
    inhibition of bacterial DNA gyrase.
    After oral administration in dogs, ibafloxacin is rapidly absorbed with maximum plasma levels of
    microbiologically active compounds obtained at 1-2 hours after administration. Terminal plasma half-life
    is approximately 4 - 5 hours. The main excretory route is via urine and faeces. After multiple oral
    administration, steady state is reached after the first or second dosing and no accumulation or induction of
    biotransformation enzymes occurs.
    Target animal safety studies in beagle dogs of 8 months of age demonstrated that, when administered
    orally at 45 mg/kg/day (three times the recommended dose) for a period of 90 days, ibafloxacin
    produced no observable adverse effects.
    28/35
    P ACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Name and address of the Manufacturing Authorisation Holder responsible for batch release
    Intervet Productions S.A.
    Rue de Lyons
    27460 Igoville
    France
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 3% oral gel
    3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
    Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml);
    Excipients
    Methyl parahydroxybenzoate (0.125%)
    4. INDICATIONS
    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 .
    29/35
     
    5. CONTRAINDICATIONS
    Do not use in cats up to 8 months of age as 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. 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.
    6. UNDESIRABLE EFFECTS
    Diarrhoea, soft faeces, vomiting, dullness, and anorexia were observed with low frequency. These effects
    were mild and transient.
    If you notice any other side effect, please inform your veterinary surgeon.
    7. TARGETSPECIES
    Dogs and cats
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Oral use, 15 mg ibafloxacin/kg once daily.
    15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
    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).
    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 at 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.
    It is recommended that the gel is administered at the time of feeding.
    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.
    9. ADVICE ON CORRECT ADMINISTRATION
    Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause
    and also treat the animal accordingly.
    Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in
    dogs with a history of seizures. Anti-acids can interfere with gastro-intestinal absorption of quinolones.
    Antagonism may be observed with nitrofurantoin.
    Ibaflin gel can be used during pregnancy in dogs. The safety of the veterinary medicinal product has not
    been established in lactating dogs and in pregnant and lactating cats. The influence on fertility in male
    breeding animals has not been investigated.
    30/35
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE CONDITIONS
    Keep out of the reach and sight of children.
    Do not store above 25°C.
    Do not use after the expiry date stated on the label.
    Any syringes containing unused product should be disposed of once a course of treatment has been
    completed.
    12. SPECIAL WARNING(S)
    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 which have
    responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin gel should only
    be used based on susceptibility testing.
    Persons with known hypersensitivity to quinolones should avoid contact with the product.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
    26.05.2010
    15. OTHER INFORMATION
    For animal treatment only.
    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
    µ
    After oral administration in cats, ibafloxacin is rapidly absorbed with maximum 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 gel should therefore be administered at feeding time to ensure maximal bioavailability.
    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.
    31/35
    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 Klebsiella spp . (MIC ≤ 0.5 µg ibafloxacin/ml).
    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.
    32/35
    P ACKAGE INSERT FOR INCLUSION WITH THE 7.5 % ORAL GEL SYRINGE PACKAGES
    1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Name and address of the Marketing Authorisation Holder
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Name and address of the Manufacturing Authorisation Holder responsible for batch release
    Intervet Productions S.A.
    Rue de Lyons
    27460 Igoville
    France
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2. NAME OF VETERINARY THE MEDICINAL PRODUCT
    Ibaflin 7.5% oral gel
    3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
    Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml)
    Excipients
    Methyl parahydroxybenzoate (0.125%)
    4. INDICATIONS
    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 staphylococci, E. coli and Proteus mirabilis
    5. CONTRAINDICATIONS
    Ibaflin 7.5% Oral Gel should not be used in cats.
    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.
    33/35
     
    6. ADVERSE REACTIONS
    Diarrhoea, soft faeces, vomiting, dullness, and anorexia were observed with low frequency. These effects
    were mild and transient.
    If you notice any other side effect, please inform your veterinary surgeon.
    7. TARGET SPECIES
    Dogs
    8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Oral use, 15 mg ibafloxacin/kg once daily.
    15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
    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 1 ml for the 30 ml syringe).
    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 at 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.
    It is recommended that the gel is administered at the time of feeding.
    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.
    9. ADVICE ON CORRECT ADMINISTRATION
    Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause
    and also treat the animal accordingly.
    Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in
    dogs with a history of seizures. Anti-acids can interfere with gastro-intestinal absorption of quinolones.
    Antagonism may be observed with nitrofurantoin.
    Ibaflin gel can be used during pregnancy in dogs. The safety of the veterinary medicinal product has not
    been established in lactating dog. The influence on fertility in male breeding animals has not been
    investigated.
    10. WITHDRAWAL PERIOD
    Not applicable.
    34/35
    11. SPECIAL STORAGE CONDITIONS
    Keep out of the reach and sight of children.
    Do not store above 25°C.
    Do not use after the expiry date stated on the label.
    Any syringes containing unused product should be disposed of once a course of treatment has been
    completed.
    12. SPECIAL WARNING(S)
    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 which have
    responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin gel should only
    be used based on susceptibility testing.
    Persons with known hypersensitivity to quinolones should avoid contact with the product.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIAL, IF ANY
    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
    26.05.2010
    15. OTHER INFORMATION
    For animal treatment only.
    g/ml are observed for canine isolates of E. coli, Staphylococcus spp. and Proteus mirabilis.
    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 when
    administered with food. The gel should therefore be administered at feeding time to ensure maximal
    bioavailability. 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.
    µ
    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.
    35/35
    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


    Source: European Medicines Agency


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