FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage symptomatic treatment should be given.
Danish: Der findes ingen kendt modgift for ibafloxacin (eller andre quinoloner), derfor bør der, i tilfælde af overdosering, behandles symptomatisk.
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Danish: Ensidig anvendelse af en enkelt type antibiotika kan resultere i udvikling af resistens i en bakteriepopulation.
English: In dogs, this period depends on the breed.
Danish: Hos hunde er denne periode raceafhængig.
English: The overall absorption was higher in dogs and cats when administered with food.
Danish: Den samlede absorption er højere hos hunde og katte, når det gives sammen med mad.
English: PHARMACEUTICAL FORM Oral gel
Danish: LÆGEMIDDELFORM Oral gel
English: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Danish: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Østrig
English: Therefore, ibafloxacin should not be used in cats aged less than 8 months.
Danish: Derfor bør ibafloxacin ikke anvendes til katte, der er yngre end 8 måneder.
English: 6.5 Nature and contents of container
Danish: 6.5 Den indre emballages art og indhold
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: TEKSTEN " KUN TIL DYR" SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: 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.
Danish: Det er af største vigtighed at reservere fluorquinoloner til behandling af kliniske infektioner, som har responderet dårligt eller forventes at respondere dårligt på behandling med andre typer af antibiotika.
English: IBAFLIN TABLETS 30, 150, 300 AND 900 MG
Danish: IBAFLIN TABLETTER 30, 150, 300 OG 900 MG
English: Read the package insert before use.
Danish: Læs indlægssedlen inden brug.
English: mg administered
Danish: mg indgivet
English: and Salmonella spp.
Danish: og Salmonella spp.
English: Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Sodium hydroxide solution Water for injections
Danish: Methylparahydroxybenzoat (0,125%) Kaliumdihydrogenphosphat Dinatriumhydrogenphosphatdihydrat Carbomer (carbopol 974 PNF) Natriumhydroxid opløsning Vand til injektionsvæske
English: 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.
Danish: Ved administration til raske katte over en periode på 30 dage forårsagede Ibaflin oral gel opkast/regurgitation og savlen ved doser af 15 til 75 mg/kg.
English: However, it is preferred to administer the tablet at feeding time to ensure maximal bioavailability.
Danish: Det anbefales dog at give tabletten ved fodringstid for at opnå maksimal biotilgængelighed.
English: The gel should therefore be administered at feeding time to ensure maximal bioavailability.
Danish: Gelen bør derfor gives ved fodringstid for at opnå maksimal biotilgængelighed.
English: It is advisable to determine the underlying cause and also treat the animal accordingly.
Danish: Det tilrådes at fastslå den tilgrundliggende årsag og også behandle dyret for denne.
English: Shelf-life after first opening: 8 weeks
Danish: Opbevaringstid efter første åbning af den indre emballage: 8 uger
English: Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
Danish: Ved utilsigtet indtagelse bør man søge lægehjælp, især hvis det drejer sig om et barn.
English: Name and address of the Marketing Authorisation Holder Intervet International B.V.
Danish: Indehaver af markedsføringstilladelsen: Intervet International B.V.
English: Once a syringe is opened it should only be used to continue the treatment course in the same animal.
Danish: Når en sprøjte én gang er taget i brug, bør den kun anvendes i forbindelse med fortsat behandling af det samme dyr.
English: In order to avoid any cross contamination, the same syringe should not be used for different animals.
Danish: For at undgå mulig krydskontaminering bør den samme sprøjte ikke anvendes til mere end ét dyr.
English: EXPIRY DATE (Month/year)
Danish: EXP (måned/år)
English: Its action results from inhibition of bacterial DNA gyrase.
Danish: Dets virkning er opnået ved hæmning af bakteriel DNA-gyrase.
English: Ibaflin 7.5% Oral Gel should not be used in cats.
Danish: Ibaflin 7,5% oral gel må ikke anvendes til katte.
English: If necessary and depending on the clinical response, treatment can be continued until the response is considered to be adequate.
Danish: Hvis nødvendigt, og afhængigt af den kliniske respons, kan behandling fortsættes indtil tilfredsstillende respons er opnået.
English: EXPIRY DATE EXP {month/year}>
Danish: UDLØBSDATO EXP {måned/år)
English: Ibaflin can be administered at any time of the day without consequences for efficacy.
Danish: Ibaflin kan gives på ethvert tidspunkt af dagen, uden at det påvirker virkningen.
English: 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.
Danish: Der foreligger ingen information om ibafloxacins påvirkning af ledbruskens udvikling hos katte i løbet af perioden med hurtig vækst, hvor ledbrusken kunne blive påvirket.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Danish: En stamme, der er resistent overfor èt flourquinolon, vil også være resistent overfor andre medlemmer af gruppen af flourquinoloner.
English: White adjustable multidose pre-filled syringe consisting of high density polyethylene (HDPE, barrel, plunger and ring) and low density polyethylene (LDPE, cap and seal).
Danish: Hvid justérbar præfyldt multidosissprøjte af high density polyethylen (HDPE, cylinder, stempel og ring) og low density polyethylen (LDPE, hætte og forsegling).
English: 20 or 100 tablets 10, 20 or 100 tablets 8, 16 or 80 tablets 5, 25 or 50 tablets
Danish: 20 eller 100 tabletter 10, 20 eller 100 tabletter 8, 16 eller 80 tabletter 5, 25 eller 50 tabletter
English: Can be used during pregnancy in dogs.
Danish: Kan anvendes under drægtighed hos hunde.
English: ADVICE ON CORRECT ADMINISTRATION Ibaflin can be administered at any time of the day without consequences for efficacy.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Ibaflin kan indgives på hvilket som helst tidspunkt på dagen, uden at det påvirker virkningen.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ibafloxacin
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Ibafloxacin
English: Methyl parahydroxybenzoate (0.125%)
Danish: Methylparahydroxybenzoat (0,125%)
English: C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Danish: C. FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant
English: The main excretory route is via urine and faeces.
Danish: Den vigtigste udskillelsesvej er via urin og afføring.
English: In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.
Danish: Hos hunde nås maksimal plasmakoncentration efter 2 timer, når det gives med eller uden mad.
English: TARGET SPECIES Dogs and cats
Danish: DYREARTER Hunde og katte
English: Prohibition of sale, supply and/or use Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant
English: This period depends on the breed.
Danish: Denne periode er raceafhængig.
English: and Klebsiella spp.
Danish: og Klebsiella spp.
English: Ibaflin contains ibafloxacin as active ingredient.
Danish: Ibaflin indeholder ibafloxacin som aktivt stof.
English: - 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)
Danish: - æske med 1 x 15 ml (0,5 ml trin) præfyldt sprøjte (Ibaflin 3% oral gel) - æske med 5 x 15 ml (0,5 ml trin) præfyldte sprøjter (Ibaflin 3% oral gel) - æske med 1 x 30 ml (1 ml trin) præfyldt sprøjte (Ibaflin 7,5% oral gel ) - æske med 5 x 30 ml (1 ml trin) præfyldte sprøjter (Ibaflin 7,5% oral gel)
English: Persons with known hypersensitivity to quinolones should avoid contact with the product.
Danish: Personer med kendt overfølsomhed over for quinoloner bør undgå kontakt med produktet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver (præfyldt sprøjte med) Ibaflin oral gel indeholder: Aktivt stof (Aktive stoffer):
English: and Pasteurella spp.
Danish: og Pasteurella spp.
English: Any syringes containing unused product should be disposed of once a course of treatment has been completed.
Danish: Alle sprøjter der indeholder rester af produktet, skal destrueres straks behandlingen er færdiggjort
English: After multiple oral administration, steady state is reached after the first or second dosing and no accumulation or induction of biotransformation enzymes occurs.
Danish: Ved gentagen oral indgift opnås steady state efter første eller anden dosering, og der forekommer ikke akkumulering eller induktion af biotransformations-enzym.
English: RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: BEGRÆNSNINGER FOR UDLEVERING OG BRUG Veterinærlægemidlet må kun udleveres efter recept.
English: 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.
Danish: Må ikke anvendes til katte, der er yngre end 8 måneder, da der ikke foreligger information om ibafloxacins påvirkning af ledbruskens udvikling hos katte i løbet af opvækstperioden.
English: 20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
Danish: 20 tabletter / 100 tabletter 10 tabletter/ 20 tabletter/ 100 tabletter 8 tabletter/ 16 tabletter/ 80 tabletter 5 tabletter/ 25 tabletter/ 50 tabletter
English: Do not use in dogs during the period of growth as articular cartilage may be affected.
Danish: Må ikke anvendes til hunde i løbet af opvækstperioden, da ledbrusken kan blive påvirket.
English: Ibaflin 30 mg tablets for dogs Ibaflin 150 mg tablets for dogs Ibaflin 300 mg tablets for dogs Ibaflin 900 mg tablets for dogs
Danish: Ibaflin 30 mg tabletter til hund Ibaflin 150 mg tabletter til hund Ibaflin 300 mg tabletter til hund Ibaflin 900 mg tabletter til hund
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE.
English: These effects are mild and transient.
Danish: Disse bivirkninger er milde og kortvarige.
English: These effects were mild and transient.
Danish: Disse bivirkninger var milde og kortvarige.
English: For ibafloxacin (parent compound), MIC values ranging from 0.032 - 0.5 µg/ml are observed for canine isolates of E. coli, Staphylococcus spp.
Danish: For ibafloxacin (modersubstansen) er der fundet MIC-værdier i området 0,032 - 0,5 µg/ml for isolater fra hund af E. coli, Staphylococcus spp.
English: 4.4 Special warnings for each target species
Danish: 4.4 Særlige advarsler for hver dyreart, som lægemidlet er beregnet til
English: Ibaflin can be used during pregnancy.
Danish: Ibaflin kan anvendes under drægtighed.
English: Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Danish: Pyodermi (overfladisk og dyb), sår, bylder, akutte ukomplicerede urinvejsinfektioner og infektion i de øvre luftveje.
English: Ibaflin gel can be used during pregnancy in dogs.
Danish: Ibaflin oral gel kan anvendes under drægtighed hos hunde.
English: Terminal plasma halflife is approximately 4-5 hours.
Danish: Terminal plasma halveringstid er ca. 4-5 timer.
English: The safety of the veterinary medicinal product has not been established during lactation.
Danish: Sikkerheden ved brugen af det veterinære lægemiddel under diegivning er ikke fastlagt.
English: If you notice any other side effect, please inform your veterinary surgeon.
Danish: Hvis De bemærker andre bivirkninger, bedes De venligst informere dyrlægen herom.
English: After oral administration in dogs, ibafloxacin is rapidly absorbed with maximum plasma levels of microbiologically active compounds obtained at 1-2 hours after administration.
Danish: Efter oral indgift til hunde absorberes ibafloxacin hurtigt med maksimal plasma koncentration af mikrobiologiske aktive forbindelser 1-2 timer efter indgift.
English: The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active .
Danish: Den hyppigst forekommende metabolit er 8-hydroxy-ibafloxacin, der også er mikrobiologisk aktiv.
English: Terminal plasma halflife is approximately 3-5 hours.
Danish: Den terminale plasma halveringstid er ca. 3-5 timer.
English: Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase.
Danish: Ibafloxacin er et bredspektret antibiotikum med baktericid virkning grundet hæmning af bakteriel DNA-gyrase.
English: The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
Danish: Sikkerheden ved brugen af det veterinære lægemiddel er ikke fastlagt for drægtige katte og for diegivende hunde og katte.
English: Antacids can interfere with gastro-intestinal absorption of quinolones.
Danish: Antacida kan forstyrre den gastrointestinale absorption af quinoloner.
English: It is recommended that the gel is administered at the time of feeding.
Danish: Det anbefales at give gelen ved fodringstid.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Kun til dyr
English: IBAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Danish: IBAFLIN 3% ORAL GEL, JUSTÉRBAR MULTIDOSISSPRØJTE
English: The treatment should be reconsidered if after 5 days no improvement in the clinical condition is observed.
Danish: Behandlingen bør revurderes, hvis der efter 5 dage ikke ses en bedring af den kliniske tilstand.
English: 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.
Danish: Ved gentagen oral indgift opnås steady state efter første dosering, og der forekommer ikke akkumulering hos hunde, hvorimod moderat akkumulering er set hos katte.
English: 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
Danish: Ibaflin 3% oral gel: 30 mg ibafloxacin pr. g gel (svarende til 30,9 mg/ml); Ibaflin 7,5% oral gel: 75 mg ibafloxacin pr. g gel (svarende til 78,8 mg/ml) Hjælpestoffer:
English: 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.
Danish: Efter oral administration til katte absorberes ibafloxacin hurtigt, og maksimal plasmakoncentration nås efter 1 time, når det gives uden mad, og efter 2 timer når det gives sammen med mad.
English: In cats, relevant susceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
Danish: Relevante og følsomme mikroorganismer hos kat er E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
English: Starch
Danish: Batch
English: 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.
Danish: MIC værdier for ibafloxacin (modersubstans) i området 0,032 - 0,5 µg/ml ses hos isolater fra hund af E. coli, Staphylococcus spp., Proteus mirabilis, stammer af Pasteurella spp.
English: Ibaflin is indicated for the treatment of the following conditions in dogs:
Danish: Ibaflin er indikeret til behandling af følgende tilstande hos hunde:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ibaflin contains:
Danish: Hver Ibaflin tablet indeholder:
English: The safety of the veterinary medicinal product has not been established in lactating dogs and in pregnant and lactating cats.
Danish: Sikkerheden ved brugen af det veterinære lægemiddel er ikke fastlagt for diegivende hunde og for drægtige og diegivende katte.
English: Ibaflin should only be used based on susceptibility testing.
Danish: Ibaflin bør kun anvendes på basis af en resistensbestemmelse.
English: Do not use in dogs and cats with known quinolone hypersensitivity.
Danish: Må ikke anvendes til hunde og katte med kendt overfølsomhed over for quinoloner.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 75 mg of ibafloxacin per ml of gel
Danish: MÆNGDE AF AKTIVT STOF (AKTIVE STOFFER) 75 mg ibafloxacin pr. ml gel
English: 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.
Danish: Ved oral administration af en dosis på 75 mg/kg/dag (fem gange den anbefalede dosis) i en periode på 90 dage til hunde, blev ibafloxacin tolereret godt.
English: 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).
Danish: Sprøjten indstilles til den beregnede dosering ved at placere ringen på det korrekte sted på stemplet (trin af 0,5 ml for 15 ml sprøjten og 1,0 ml for 30 ml sprøjten).
English: 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).
Danish: Sprøjten indstilles til den beregnede dosering ved at placere ringen på det korrekte sted på stemplet (trin af 1 ml for 30 ml sprøjten).
English: The influence on fertility in male breeding animals has not been investigated.
Danish: Påvirkning af fertiliteten hos avls hanhunde er ikke undersøgt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: Navn og adresse på indehaveren af markedsføringstilladelsen
English: Name and address of the Marketing Authorisation Holder
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUME ELLER ANTAL DOSER
English: PACKAGE INSERT FOR INCLUSION WITH THE IBAFLIN TABLETS
Danish: INDLÆGSSEDDEL TIL PAKNINGER MED IBAFLIN TABLETTER Ibaflin tabletter, til hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Danish: VETERINÆRLÆGEMIDLETS NAVN Ibaflin 3% oral gel
English: 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.
Danish: Hvis der ved dyb pyodermi ikke kan ses en tilstrækkelig bedring af tilstanden efter en behandlingsperiode på 21 dage, anbefales det at genoverveje behandlingen.
English: For a full list of excipients, see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestofferne
English: B. PACKAGE INSERT
Danish: BILAG II
English: 6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte lægemidler eller affald fra sådanne
English: 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).
Danish: Sprøjten indstilles til den beregnede dosering ved at placere ringen på det korrekte sted på stemplet (trin af 0,5 ml for 15 ml sprøjten).
English: 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.
Danish: Hvis der ved profund pyodermi ikke kan ses en tilstrækkelig bedring af tilstanden efter en behandlingsperiode på 21 dage, anbefales det at genoverveje behandlingen.
English: Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Danish: Ibafloxacin og 8-hydroxy-ibafloxacin virker synergistisk.
English: 30 mg of ibafloxacin per tablet 150 mg of ibafloxacin per tablet 300 mg of ibafloxacin per tablet 900 mg of ibafloxacin per tablet
Danish: 30 mg ibafloxacin pr tablet 150 mg ibafloxacin pr tablet 300 mg ibafloxacin pr tablet 900 mg ibafloxacin pr tablet
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINIMUMS OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE PAKNING.
English: 0.5 ml of gel per kg body weight
Danish: 0,5 ml gel pr. kg legemsvægt
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 1 SPRØJTE IBAFLIN 3% ORAL GEL / ÆSKE TIL 5 SPRØJTER IBAFLIN 3% ORAL GEL
English: After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs.
Danish: Ved gentagen oral indgift opnås steady state efter første dosering, og der forekommer ikke akkumulering hos hunde.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Ibaflin 3% oral gel til hunde og katte
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats Ibaflin 7.5% oral gel for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Ibaflin 3% oral gel til hunde og katte Ibaflin 7,5% oral gel til hunde
English: 4.1 Target species
Danish: 4.1 Dyrearter som lægemidlet er beregnet til
English: Oral use, 15 mg ibafloxacin/kg once daily.
Danish: Oral anvendelse, 15 mg ibafloxacin/kg én gang dagligt.
English: UNDESIRABLE EFFECTS
Danish: BIVIRKNINGER
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Danish: Farmakoterapeutisk gruppe: antibakterielt quinolon, ATCvet kode: QJ 01 MA Ibaflin indeholder ibafloxacin som aktiv substans.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg of ibafloxacin per ml of gel
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 30 mg ibafloxacin pr. ml oral gel
English: 4.9 Posology and method of administration
Danish: 4.9 Dosering og indgivelsesvej
English: The safety of the veterinary medicinal product has not been established in lactating dog.
Danish: Sikkerheden ved brugen af det veterinære lægemiddel er ikke fastlagt for diegivende hunde.
English: The treatment should be reconsidered if at 5 days no improvement in the clinical condition is observed.
Danish: Behandlingen bør revurderes, hvis der ikke ses en bedring af den kliniske tilstand på femtedagen.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 1 SPRØJTE IBAFLIN 7,5% ORAL GEL / ÆSKE TIL 5 SPRØJTER IBAFLIN 7,5% ORAL GEL
English: 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.
Danish: Sikkerhedsstudier udført på 8 måneder gamle beagle hunde viste, at ved oral indgift af 45 mg/kg/dag (tre gange den anbefalede dosis) i 90 dage, gav ibafloxacin ikke anledning til erkendelige uønskede reaktioner.
English: Ibaflin gel should only be used based on susceptibility testing.
Danish: Ibaflin oral gel bør kun anvendes på basis af en resistensbestemmelse.