Ibaflin - patient leaflet, side effects, dosage

Ibafloxacin 150 mg

Ibafloxacin 300 mg

Ibafloxacin 900 mg

4. CLINICAL PARTICULARS

Dogs

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.

roduct. a child.

ith low frequency. These

Oral use, 15 mg ibafloxacin severity of the infection and sufficient. If necessary and de

response is considered t improvement in the clini improvement is not seen af reconsidered.

To ensure a correct dosag underdosing. The following

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

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. PHAR

UTICAL PARTICULARS

Yeast

Starch

30 mg tablets:

150 mg tablets:

300 mg tablets:

900 mg tablets:

• – Carton box with 20 or 100 tablets in PVC/aluminium heat sealed blisters

• – 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

• – 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

• – Carton box with 5, 25 or 50 tablets in PVC/aluminium heat sealed blisters.

8. Marketing Authorisati

08.07.2005 /

ot applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ibaflin 3% oral gel for dogs and cats

Ibaflin 7.5% oral gel for dogs

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

Methyl parahydroxybenzoate (0.125%)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral gel

4. CLINICAL PARTICULARS

Dogs and cats

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.

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.

were observed with low frequency.

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.

Not applicable.

Ibaflin gel contains ibafloxacin as active ingredient. Ibafloxacin is a of the fluoroquinolo­ne class.

Pharmacodynamic properties

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.

• 6. PHARMACEUTICAL

ate dihydrate

Not

Shelf-life

aste materials, if any

EU/2/00/022/09–12

08.07.2005 / 26.05.2010

26.05.2010

Detailed information on this product is available on the website of the European Medicines Agency (EMA)

A.

MANUFACTURING AUTHORISATIO RELEASE

B.

ANNEX II

LDER RESPONSIBLE FOR BATCH

CONDITIONS OF THE MARKET UTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE

PROHIBITION OF SALE, SUPPLY AND/OR USE

C.

STATEMENT OF THE

D.

Commission about the marketing

Not applicable

Not applicable

D. STATEMENT OF TH

20 tablets / 100 tablets

10 tablets / 20 tablets / 100 tablets

8 tablets /16 tablets / 80 tablets

5 tablets /25 tablets / 50 tablets

Dogs

Pyoderma (superficial an upper respiratory tract i

6. INDICATIONS

5. TARGET SPECIES

ounds, abscesses, acute uncomplicated urinary tract infections and

UTE(S) OF ADMINISTRATION

cable.

DRAWAL PERIOD

Do not use during the period of growth or in combination with nonsteroidal anti-inflammatory d (NSAIDs) in dogs with a history of seizures. Do not use in dogs with a weight of less than 3 kg. Ib should only be used based on susceptibility testing. Do not use in dogs with known quinolone hypersensitivity.

Read the package insert before use.

(Month/year)

Do not store above 25°C.

PRODUCT OR WASTE

Any unused veterinary product or waste material derived fro be disposed of in accordance with local requirements.

veterinary medicinal products should

For animal treatment only. Veterinary medicinal pr

NLY" AND CONDITIONS OR USE

uct subject to prescription.

14. THE WORDS "KEEP OUT OF TH E REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of ildren.

15. NAME AND ADD

Name and address of the

Intervet International B.V.

Wim de Korverstraat

5831 AN Boxmeer

The Netherl

THE MARKETING AUTHORISATION HOLDER

eting Authorisation Holder

EU/2/00

EU/2/00

G AUTHORISATION NUMBER(S)

001–008

2/013–017

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

box containing 5 adjustable pre-filled

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 THE VETERINARY MEDICINAL PRODUCT

Ibaflin 3% oral gel for dogs and cats.

• 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Ibafloxacin

Oral gel

• 4. PACKAGE SIZE

1 adjustable pre-filled multidose syringe, containing 15 multidose syringes, each containing 15 ml Ibaflin 3% oral gel.

Dogs and cats

Ibaflin gel is indicated in dogs

ent of the following conditions:

Ibaflin gel is indicated i

or treatment of the following conditions:

Not applicable.

Do not use during the period of growth. Ibaflin gel should be used based on susceptibility use in dogs and cats with known quinolone hypersensitivity.

Read the package insert before use.

m such veterinary medicinal products should

Any unused veterinary product or waste material be disposed of in accordance with local requirem

Keep out of the reach an

children.

For animal treatment only. Veterinary

icinal product subject to prescription.

F THE REACH AND SIGHT OF CHILDREN

15. NAME AND

5831 AN The Neth

eer

2/00/022/09

U/2/00/022/10

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

ntaining 30 ml Ibaflin 7.5% oral gel. /

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 THE VETERINARY MEDICINAL PRODUCT

Ibaflin 7.5% oral gel for dogs.

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Ibafloxacin

Oral gel

4. PACKAGE SIZE

Carton box containing 1 adjustable pre-filled multidose s

Carton box containing 5 adjustable pre-filled multidose syringes, containing 30 ml Ibaflin 7.5% oral gel.

Dogs

Ibaflin gel is indicated in dogs

ment of the following conditions:

Dermal infections (pyodermO ^jUperficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis.

7. METHOD A

TE(S) OF ADMINISTRATION

8.

No

DRAWAL PERIOD

able.

Do not use in cats.

USED PRODUCT OR WASTE

Do not use during the period of growth. Ibaflin gel should be used based on susceptibility testing. use in dogs with known quinolone hypersensitivity.

Read the package insert before use.

(Month/year)

Once opened use within 8 weeks.

Do not store above 25°C.

Any unused veterinary product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Keep out of the reach and sight

Intervet Internat

Wim de Ko 5831 AN Bo

The Net

For animal treatment only. Veterinary

Name and address

15. NAME AND A

14. THE WORDS "KEEP

product subject to prescription.

Marketing Authorisation Holder

5

HE REACH AND SIGHT OF CHILDREN

SS OF THE MARKETING AUTHORISATION HOLDER

16.

e

s

0/022/11

0/022/12

Batch

4. ROUTE(S) OF ADMINISTRATI

5. WITHDRAWAL PERIO

Oral use, 15 mg per kg bodyweight on Read the package insert before use.

Not applicable.

6. BATCH NUM

r animal treatment only.

kg body weight).

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

I BAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE

1. NAME OF THE VETERINARY 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 D

15 ml

4. ROUTE(S) OF ADMINISTRATION

Oral use, 15 mg per kg bodyweight once daily (i.e. 0.5 Read the package insert before use.

5. WITHDRAWAL PERIOD

Batch

Not applicable.

6. BATCH NUMBER

7. EXPIRY DATE

EXP {month/ Once opened

eks.

FOR ANIMAL TREATMENT ONLY

8. THE WO

For animal t

nt only.

I BAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE

1. NAME OF THE VETERINARY 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 DO

30 ml

4. ROUTE(S) OF ADMINISTRATION

5. WITHDRAWAL PERIOD

Not applicable.

6. BATCH NUMBER

Batch

7. EXPIRY DATE

8. THE W

For animal t

EXP {month/year}> Once opened use withi

kg body weight).

NIMAL TREATMENT ONLY

Oral use, 15 mg per kg bodyweight once daily (i.e. 1 ml of g Read the package insert before use.

2. NAME OF THE VETERINARY MEDICINAL PROD

SUBSTANCE(S)

Ibaflin is indicated for the t Dermal infections (py such as Staphylococci, Acute, uncomplicat Proteus spp., Entero

tment of the following conditions in dogs:

^Superficial and deep, wounds, abscesses) caused by susceptible strains Proteus mirabilis.

ary tract infections, caused by susceptible strains such as Staphylococci, spp., E. coli and Klebsiella spp.

Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.

Do on

5. CO

NDICATIONS

not use in dogs during the period of growth as articular cartilage may be affected. This period depends the breed. For the majority of breeds the use of ibafloxacin is contra-indicated in dogs less than 8 nths of age, and in giant breeds less than 18 months.

not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of ures.

9. ADVICE ON CO

Ibaflin can be adminis

Persons with known hypersensitivity to quinolones should avoid any contact with the product. Th 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 ba population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditio have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibafl only be used based on susceptibility testing.

Do not use in dogs with known quinolone hypersensitivity.

should

rial

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

Antiacids can interfere with gastro-intestinal absorption of quinolones. Antagonism nitrofurantoin.

The safety of the veterinary medicinal product has not been established used during pregnancy.

derlying cause

Any unused veterinary medicinal product or waste materials derived products should be disposed of in accordance with the local requirem

bserved with

. Ibaflin can be

h veterinary medicinal

T REVISED

Ibafloxacin is a broad spectrum bacterici

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 Korverstraat 35

5831 AN Boxmeer

The Netherlands

Intervet Productions S.A.

Rue de Lyons 27460 Igoville France

Intervet International B.V.

Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands

ODUCT

2. NAME OF THE VETERINARY MEDICIN

Ibaflin 3% oral gel

Ibaflin 3% Oral Gel: 30 mg of ibafloxac

Methyl parahydroxybenzoate (

4. INDICATIONS

to 30.9 mg/ml);

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:

Dermhinfections (soft tissue infections – wounds, abscesses) caused by susceptible pathogens such lococcus spp., E. coli, Proteus spp. and Pasteurella spp.

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

5. CONTRAINDI­CATIONS

Do not use in cats up to 8 months of age as no information is available on the influence of ibafloxac developing articular cartilage in the cat during the period of rapid growth as articular cartilage ma affected. In dogs, this period depends on the breed. For the majority of breeds, the use of ibafloxac 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 freque were mild and transient.

e effects

If you notice any other side effect, please inform your veterinary surgeon.

Dogs and cats

Oral use, 15 mg ibafloxacin/kg once daily.

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

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.

Pyoderma is and also treat

underlying disease. It is advisable to determine the underlying cause

Quinolo

dog Ant

s should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in a history of seizures. Anti-acids can interfere with gastro-intestinal absorption of quinolones.

onism may be observed with nitrofurantoin.

lin gel can be used during pregnancy in dogs. The safety of the veterinary medicinal product has not established in lactating dogs and in pregnant and lactating cats. The influence on fertility in male ding animals has not been investigated.

Not applicable.

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 t completed.

has been

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 cal conditions which have

responded poorly, or are expected to respond poorly, to other classes o ic. Ibaflin gel should only

be used based on susceptibility testing.

Persons with known hypersensitivity to quinolones should avoid

t with the product.

USED PRODUCT OR WASTE

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

Ibafloxacin is a synthet spectrum antibiotic with abundant metabolite i hydroxy-ibafloxacin a

15. OTHER INFORMATI

For animal treatment only.

0.032 – 0.5 p g/m In cats, relevant spp. and Klebsie

l are o

robial substance of the fluoroquinolone class. Ibafloxacin is a broad cidal action resulting from inhibition of bacterial DNA gyrase. The most y-ibafloxacin, which is also microbiologically active. lbafloxacin and 8-ergistically. For ibafloxacin (parent compound), MIC values ranging from ved for canine isolates of E. coli, Staphylococcus spp. and Proteus mirabilis.

sceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus p.. (MIC < 0.5 ^g ibafloxacin/ml).

After o 1 hour plasma

P ackage insert for inclusion with the 7.5 % oral gel syringe packages

• 1. NAME AND ADDREss oF THE MARKETiNG AUTHoRisATioN HoLDER AND THE MANUFAcTURiNG AUTHRoisATioN HoLDER REsPoNsiBLE FoR BAT RELEAsE, iF DiFFERENT

Name and address of the Marketing Authorisation Holder Intervet International B.V.

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

Intervet Productions S.A.

Rue de Lyons 27460 Igoville France

Intervet International B.V.

Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands

PRODUCT

Ibaflin 7.5% oral gel

Ibaflin 7.5% Oral Gel: 75 mg of ibaflox

Methyl parahydroxybenzoate (

4. INDICATIONS

to 78.8 mg/ml)

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

Iba

5.

INDICATIONS

Oral Gel should not be used in cats.

9. ADVICE ON CORRE

ISTRATION

cable.

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 completed.

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.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local req

14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED

26.05.2010

For animal treatment only.

15. OTHER 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 syner cally. For ibafloxacin (parent compound), MIC values ranging from

0.032 – 0.5 p g/ml are obse In dogs the maximum pl Terminal plasma halfadministered with fo bioavailability. The steady state is reached a

d

canine isolates of E. coli, Staphylococcus spp. and Proteus mirabilis. els were observed at 2 hours when administered with or without food.

is approximately 3–5 hours. The overall absorption was higher when gel should therefore be administered at feeding time to ensure maximal xcretory routes are via urine and faeces. After multiple oral administration, the first dosing and no accumulation occurs in dogs.

When admi dogs, ibaflo

orally at 75 mg/kg/day (five times the recommended dose) for a period of 90 days in as well tolerated.