FrancophonIA/ELRC3.0 huggingface dataset:
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Estonian: Euroopa Ravimiameti esitatud kokkuvõte: • Tingimuslik müügiluba
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and presented by the European Medicines Agency
Estonian: IV LISA Euroopa ravimiameti esitatud kokkuvõte tingimusliku müügiloa andmise kohta
English: Do not use during the period of growth.
Estonian: Mitte kasutada kasvuperioodil.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Estonian: TEKSTI ÜLEVAATAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti (EMA) koduleheküljelt aadressil http://www.ema.europa.eu/.
English: Not applicable.
Estonian: Ei ole rakendatav.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: MÄRGE ”AINULT VETERINAARSEKS KASUTAMISEKS” NING TINGIMUSED VÕI PIIRANGUD TARNIMISE JA KASUTAMISE OSAS, kui need on kohaldatavad
English: Shelf-life after first opening: 8 weeks
Estonian: 3 aastat Kõlblikkusaeg pärast esmast avamist: 8 nädalat
English: mg administered
Estonian: mg manustada
English: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Estonian: Intervet GesmbH Siemensstrasse 107 A-1210 Viin Austria
English: A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Estonian: Tüved, mis omavad resistentsust fluorokinoloonile, on samuti resistentsed teistele fluorokinoloonide klassi liikmetele.
English: Do not use in dogs with a weight of less than 3 kg. Ibaflin should only be used based on susceptibility testing.
Estonian: Mitte kasutada koertel kehakaaluga alla 3 kg. Ibaflin`i tuleks kasutada ainult tuginedes tundlikkustestile.
English: Date of first authorisation/renewal of the authorisation
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Estonian: Intervet International bv Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Estonian: Korrektseks doseerimiseks peab kehakaalu määrama võimalikult täpselt, et vältida aladoseerimist.
English: Methyl parahydroxybenzoate (0.125%)
Estonian: Metüülparahüdroksübensoaat (0,125%)
English: Once a syringe is opened it should only be used to continue the treatment course in the same animal.
Estonian: Olles süstla avanud, tuleks seda kasutada vaid sama looma ravimisel.
English: If necessary and depending on the clinical response, treatment can be continued until the response is considered to be adequate.
Estonian: Vajadusel ja sõltuvalt kliinilisest tulemusest võib ravikuuri pikendada adekvaatsete tulemuste saavutamiseni.
English: If you notice any other side effects, please inform your veterinary surgeon.
Estonian: Kui täheldate teisi kõrvaltoimeid, palun teavitage sellest oma veterinaararsti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga Ibaflin Oral Gel eeltäidetud süstal sisaldab:
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Estonian: Ühe antibiootikumirühma pidev kasutamine võib viia resistentsuse tekkimiseni bakterite populatsioonis.
English: Prohibition of sale, supply and/or use Not applicable.
Estonian: MÜÜGI, TARNIMISE JA/VÕI KASUTAMISE KEELD Ei rakendata.
English: In most cases, a 10-day treatment course will be sufficient.
Estonian: Enamikul juhtudel piisab 10-päevasest ravikuurist.
English: Dosage (number of tablets)
Estonian: Doseerimine (tablettide arv)
English: In order to avoid any cross contamination, the same syringe should not be used for different animals.
Estonian: Hoidmaks ära nakkuse levikut ei tohiks sama süstalt kasutada erinevatel loomadel.
English: Name and address of the Marketing Authorisation Holder Intervet International B.V.
Estonian: Müügiloa hoidja nimi ja aadress Intervet International B.V.
English: In most cases, a 10 day-treatment course will be sufficient.
Estonian: Enamikul juhtudel piisab 10päevasest ravikuurist.
English: IBAFLIN TABLETS 30, 150, 300 AND 900 MG
Estonian: IBAFLIN TABLETID 30, 150, 300 ja 900 mg
English: (MIC ≤ 0.5 µg ibafloxacin/ml).
Estonian: (MIK ≤ 0,5 µg ibafloksatsiini/ml).
English: Antagonism may be observed with nitrofurantoin.
Estonian: Nitrofurantoiiniga koosmanustamisel võib täheldada antagonismi.
English: Pyoderma is mostly secondary to an underlying disease.
Estonian: Püoderma on enamasti sekundaarne haigus.
English: These effects are mild and transient.
Estonian: Need tunnused on nõrgad ja mööduva iseloomuga.
English: No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage symptomatic treatment should be given.
Estonian: Spetsiifilised antidoodid ibafloksatsiinile (samuti teistele kinoloonidele) on teadmata ja seetõttu rakendatakse üledoseerimisel sümptomaatilist ravi.
English: The duration of treatment depends on the nature and severity of the infection and on the response.
Estonian: Ravikuuri kestus sõltub nakkuse iseloomust ja raskusest ning ravi tulemuslikkusest.
English: ADVICE ON CORRECT ADMINISTRATION Ibaflin can be administered at any time of the day without consequences for efficacy.
Estonian: SOOVITUSED ÕIGE MANUSTAMISVIISI OSAS Ibaflin'i võib manustada suvalisel ajal päeva jooksul kaotamata efektiivsuses.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Estonian: MÄRGE “AINULT VETERINAARSEKS KASUTAMISEKS” Ainult veterinaarseks kasutamiseks.
English: Dogs and cats
Estonian: Kass ja koer
English: This period depends on the breed.
Estonian: Kasvuperioodi pikkus sõltub tõust.
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.
Estonian: Mitte kasutada kassidel, kes on nooremad kui 8 kuud, kuna puudub informatsioon ibafloksatsiini kahjuliku toime kohta liigeskõhrede arengule kassidel kiire kasvamise perioodil, kuid liigesekõhred võivad saada kahjustatud.
English: 20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
Estonian: 20 tabletti / 100 tabletti 10 tabletti / 20 tabletti / 100 tabletti 8 tabletti /16 tabletti / 80 tabletti 5 tabletti /25 tabletti / 50 tabletti
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Estonian: SÄILITAMISE ERITINGIMUSED Mitte hoida temperatuuril üle 25°C.
English: and Pasteurella spp.
Estonian: ja Pasteurella spp.
English: PACKAGE INSERT FOR INCLUSION WITH THE IBAFLIN TABLETS
Estonian: PAKENDI INFOLEHT IBAFLIN TABLETTIDE PAKENDILE
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Estonian: Farmakoterapeutiline grupp: antibakteriaalne kinoloon, ATC-vet kood: QJ 01 MA
English: and Klebsiella spp.
Estonian: ja Klebvsiella spp.
English: The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active .
Estonian: Kõige sagedasim metaboliit on 8-hüdroksü-ibafloksatsiin, mis on samuti mikrobioloogiliselt aktiivne.
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)
Estonian: - kartongkarp 1 x 15 ml (0,5 ml gradueering) eeltäidetud süstal (Ibaflin 3% Oral Gel) - kartongkarp 5 x 15 ml (0,5 ml gradueering) eeltäidetud süstlad (Ibaflin 3% Oral Gel) - kartongkarp 1 x 30 ml (1 ml gradueering) eeltäidetud süstal (Ibaflin 7,5% Oral Gel) - kartongkarp 5 x 30 ml (1 ml gradueering) eeltäidetud süstlad (Ibaflin 7,5% Oral Gel)
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96
Estonian: Farmakoterapeutiline grupp: antibakteriaalne kinoloon, ATC-vet kood: QJ 01 MA 96.
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.
Estonian: Pärast peroraalset manustamist koerale imendub ibafloksatsiin kiiresti ja mikrobioloogiliselt aktiivse aine maksimaalne plasmakontsentratsioon saavutatakse 1...2 tunni jooksul pärast manustamist.
English: and Salmonella spp.
Estonian: tüvede ja Salmonella spp.
English: Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Estonian: Ibafloksatsiin on fluorokinoloonide klassi kuuluv sünteetiline antimikroobne aine.
English: Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Sodium hydroxide solution Water for injections
Estonian: Metüülparahüdroksübensoaat (0,125%) Kaaliumdivesinikfosfaat Dinaatriumvesinikfosfaatdihüdraat Karbomeer (carbopol 974 PNF) Naatriumhüdroksiidilahus Süstevesi
English: In dogs, this period depends on the breed.
Estonian: Koertel sõltub kasvuperioodi pikkus looma tõust.
English: The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
Estonian: Veterinaarravimi ohutust tiinetele kassidele ja kasside ning koerte laktatsiooni ajal ei ole uuritud.
English: 1 adjustable pre-filled multidose syringe, containing 15 ml.
Estonian: 1 reguleeritav mitmedoosiline eeltäidetud süstal sisaldusega 15 ml.
English: Ibaflin 30 mg: ibafloxacin 30 mg Ibaflin 150 mg: ibafloxacin 150 mg Ibaflin 300 mg: ibafloxacin 300 mg Ibaflin 900 mg: ibafloxacin 900 mg
Estonian: Ibaflin 30 mg: ibafloksatsiin 30 mg Ibaflin 150 mg: ibafloksatsiin 150 mg Ibaflin 300 mg: ibafloksatsiin 300 mg Ibaflin 900 mg: ibafloksatsiin 900 mg
English: Ibaflin gel can be used during pregnancy in dogs.
Estonian: Ibaflin geeli on lubatud kasutada koertel tiinuse ajal.
English: Ibaflin should only be used based on susceptibility testing.
Estonian: Ibaflin`i tuleks kasutada ainult tuginedes tundlikkustestile.
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
Estonian: Ibaflin 30 mg tabletid koertele Ibaflin 150 mg tabletid koertele Ibaflin 300 mg tabletid koertele Ibaflin 900 mg tabletid koertele
English: In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.
Estonian: Koertel saavutatakse maksimaalne plasma kontsentratsioon 2 tundi pärast manustamist ja seda nii koos toiduga kui ilma manustamisel.
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).
Estonian: Valge reguleeritav mitmedoosiline eeltäidetud süstal koosneb kõrge tihedusega polüetüleenist (HDPE: hülss, kolb, rõngas) ja madala tihedusega polüetüleenist (LDPE:otsik ja kapsel).
English: Ibaflin 7.5% Oral Gel should not be used in cats.
Estonian: Ibaflin 7,5% peroraalset geeli ei tohi kasutada kassidel.
English: C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Estonian: C. MÜÜGI-, HANKE- JA/VÕI KASUTUSKEELD Pole kohaldatav.
English: Once opened use within 8 weeks.
Estonian: KÕLBLIKKUSAEG Kõlblik kuni {kuu/aasta} Avatud preparaat kasutada 8 nädala jooksul.
English: Do not use in dogs during the period of growth as articular cartilage may be affected.
Estonian: Mitte kasutada koertel kasvuperioodil, sest liigeskõhred võivad saada kahjustatud.
English: Do not use after the expiry date stated on the label.
Estonian: Peale etiketil märgitud kõlblikkusaja lõppu mitte kasutada.
English: D. STATEMENT OF THE MRLs Not applicable
Estonian: D. RAVIMJÄÄKIDE PIIRNORMID Pole kohaldatav.
English: Ibaflin 30 mg Ibaflin 150 mg
Estonian: Ibaflin 30 mg Ibaflin 150 mg Ibaflin 300 mg
English: The safety of the veterinary medicinal product has not been established during lactation.
Estonian: Veterinaarravimi ohutust laktatsiooni ajal ei ole uuritud.
English: Can be used during pregnancy in dogs.
Estonian: Lubatud kasutada koertel tiinuse ajal.
English: Ibaflin contains ibafloxacin as active ingredient.
Estonian: Ibaflin sisaldab toimeainena ibafloksatsiini.
English: The main excretory routes are via urine and faeces.
Estonian: Väljutamine toimub peamiselt uriini ja väljaheidetega.
English: Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Estonian: Püoderma (pindmine ja sügav), haavad, abstsessid, kuseteede ägedad komplitseerumata nakkused, ülemiste hingamisteede nakkused.
English: Terminal plasma halflife is approximately 4-5 hours.
Estonian: Poolestusaeg plasmas on ligikaudu 4…5 tundi.
English: Therefore, ibafloxacin should not be used in cats aged less than 8 months.
Estonian: Seetõttu tuleks hoiduda ibafloksatsiini andmisest kassidele, kes on nooremad kui 8 kuud, sest liigesekõhred võivad saada kahjustatud.
English: Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase.
Estonian: Ibafloksatsiin on laia toimespektriga bakteritsiidne antibiootikum, mis inhibeerib bakteri DNA güraasi.
English: Name and address of the Marketing Authorisation Holder
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: Ibaflin gel contains ibafloxacin as active ingredient.
Estonian: Ibaflin geel sisaldab toimeainena ibafloksatsiini.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Estonian: KARTONGKARP 1 SÜSTLAGA IBAFLIN 7,5% PERORAALNE GEEL / KARTONGKARP 5 SÜSTLAGA IBAFLIN 7,5% PERORAALNE GEEL
English: Cellulose
Estonian: Tselluloos
English: Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
Estonian: Juhuslikul ravimi alla neelamisel, eriti laste puhul, pöörduda arsti poole.
English: In cats, relevant susceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
Estonian: Kassidel on tähtsamad ibafloksatsiinile tundlikud mikroorganismid E. coli, Staphylococcus spp.,Pasteurella spp., Proteus spp.
English: Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Estonian: Ibafloksatsiini ja 8-hüdroksü-ibafloksatsiini toime on sünergiline.
English: The influence on fertility in male breeding animals has not been investigated.
Estonian: Mõju isaste aretuskoerte viljakusele ei ole uuritud.
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.
Estonian: Puudub informatsioon ibafloksatsiini kahjuliku toime kohta liigeskõhrede arengule kassidel kiire kasvamise perioodil.
English: Terminal plasma halflife is approximately 3-5 hours.
Estonian: Poolestusaeg plasmas on ligikaudu 3…5 tundi.
English: Ibaflin is indicated for the treatment of the following conditions in dogs:
Estonian: Ibaflin on näidustatud järgmiste haiguslike seisundite raviks koertel:
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
Estonian: Ibaflin 3% Oral Gel: 30 mg ibafloksatsiini ühe grammi geeli kohta (ekvivalentne 30,9 mg/ml) Ibaflin 7,5% Oral Gel: 75 mg ibafloksatsiini ühe grammi geeli kohta (ekvivalentne 78,8 mg/ml) Abiaine(d):
English: The following dosage scheme is advised:
Estonian: Soovitatavad on järgmised raviskeemid:
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.
Estonian: Kui sügava püoderma puhul ei ole ravi andnud tulemusi 21 päeva jooksul, tuleb raviskeem ümber hinnata.
English: TARGET SPECIES Dogs and cats
Estonian: LOOMALIIGID Koer ja kass.
English: The gel should be administered at the time of feeding.
Estonian: Geeli tuleks manustada söötmise ajal.
English: Do not use in dogs and cats with known quinolone hypersensitivity.
Estonian: Mitte kasutada koertel ja kassidel, kellel esineb ülitundlikkus kinoloonide suhtes.
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.
Estonian: Kui süvamise püoderma ravil ei ole rahuldavat tulemust saavutatud 21 päeva jooksul, tuleb raviskeem ümber hinnata.
English: The overall absorption was higher when administered with food.
Estonian: Imendumine oli parem ravimi manustamisel koos toiduga.
English: 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
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS Ibaflin 3% Oral Gel: 30 mg ibafloksatsiini ühe grammi geeli kohta (ekvivalentne 30,9 mg/ml) Abiained
English: 4.9 Posology and method of administration
Estonian: Annustamine ja manustamisviis
English: 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
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS Ibaflin 7,5% Oral Gel: 75 mg ibafloksatsiini ühe grammi geeli kohta (ekvivalentne 78,8 mg/ml) Abiained
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ibafloxacin
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS
English: 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.
Estonian: Mõistlik on jätta fluorokinoloonid viimase valiku ravimiks, kui ravi teiste klasside antibiootikumidega annab nõrga tulemuse või ei toimi üldse.
English: Siemensstraße 107 1210 Vienna Austria
Estonian: Siemensstraße 107
English: 150mg and 300mg tablets: 4 years 30mg and 900mg tablets: 3 years 6.4 Special precautions for storage Do not store above 25°C.
Estonian: 150 mg ja 300 mg tabletid: 4 aastat 30 mg ja 900 mg tabletid: 3 aastat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats Ibaflin 7.5% oral gel for dogs
Estonian: VETERINAARRAVIMI NIMETUS Ibaflin 3% peroraalne geel koertele ja kassidele Ibaflin 7,5% peroraalne geel koertele
English: However, it is preferred to administer the tablet at feeding time to ensure maximal bioavailability.
Estonian: Maksimaalse biosaadavuse tagamiseks tuleks eelistada tableti manustamist söötmise ajal.
English: Persons with known hypersensitivity to quinolones should avoid contact with the product.
Estonian: Inimesed, kes on kinoloonide suhtes ülitundlikud, peaksid kokkupuudet veterinaarravimiga vältima.
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.
Estonian: Soovitatav on jätta fluorokinoloonid viimase valiku ravimiks, kui ravi teiste klasside antibiootikumidega annab nõrga tulemuse või ei toimi üldse.
English: PHARMACEUTICAL FORM Oral gel
Estonian: RAVIMVORM Peroraalne geel
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Estonian: VETERINAARRAVIMI NIMETUS Ibaflin 3% peroraalne geel
English: - 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.
Estonian: - kartongkarp 8, 16 või 80 tabletti PVC/PVDC/alumiinium blisteris 900 mg tabletid: - kartongkarp 5, 25 või 50 tabletti PVC/alumiinium kuumsuletud blisteris
English: PACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES
Estonian: PAKENDI INFOLEHT 3% PERORAALSE GEELI PAKENDILE
English: 6.5 Nature and contents of container
Estonian: Vahetu pakendi iseloomustus ja koostis
English: - 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
Estonian: 30 mg tabletid: - kartongkarp 20 või 100 tabletti PVC/alumiinium kuumsuletud blisteris 150 mg tabletid: - kartongkarp 10, 20 või 100 tabletti PVC/alumiinium kuumsuletud blisteris
English: / Carton box containing 5 adjustable pre-filled multidose syringes, each containing 15 ml Ibaflin 3% oral gel.
Estonian: / kartongkarp sisaldab 5 reguleeritavat mitmedoosilist süstalt sisaldusega 15 ml Ibaflin 3% peroraalset geeli.
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).
Estonian: Süstal tuleb tuleb reguleerida vastavalt arvestatud doosile, keerates doseerimisrõngas kolvil sobivasse asendisse (üks aste 15 ml süstlal võrdub 0,5 ml-ga ja 30 ml süstlal 1 ml-ga).
English: Any syringes containing unused product should be disposed of once a course of treatment has been completed.
Estonian: Süstlad, mis sisaldavad ravikuurist üle jäänud ravimit, tuleb hävitada.
English: 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.
Estonian: 8-kuu vanustel koertel läbi viidud ohutusalased uuringud, kus manustati 90 päeva jooksul peroraalselt 45 mg/kg/päevas (soovituslikust doosist 3 korda suurem doos) ei põhjustanud ibafloksatsiin kõrvaltoimeid.
English: It is advisable to determine the underlying cause and to treat the animal accordingly.
Estonian: On soovitatav teha kindlaks esmane haiguspõhjus ja teostada ravi vastavalt sellele.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI VÕI NENDE JÄÄTMETE , KUI NEID TEKIB, HÄVITAMISEL
English: 15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight Read the package insert before use.
Estonian: 15 mg kg kehamassi kohta = 0,5 ml geeli kg kehamassi kohta Enne kasutamist lugege pakendi infolehte.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats.
Estonian: VETERINAARRAVIMI NIMETUS Ibaflin 3% peroraalne geel koertele ja kassidele.
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).
Estonian: Süstal tuleb tuleb reguleerida vastavalt arvestatud doosile, keerates doseerimisrõngas kolvil sobivasse asendisse (üks aste võrdub 30 ml süstlal 1 ml-ga).
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.
Estonian: 8-kuu vanustel beagle tõugu koertel läbi viidud ohutusalased uuringud, kus manustati 90 päeva jooksul peroraalselt 45 mg/kg/päevas (soovituslikust doosist 3 korda suurem doos) ei põhjustanud ibafloksatsiin kõrvaltoimeid.
English: Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency.
Estonian: Harvadel juhtudel on täheldatud kõhulahtisust, pehmeid väljaheiteid, oksendust, uimasust ja anoreksiat.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Estonian: MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VÄLJASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: The treatment should be re-considered if at 5 days no improvement in the clinical condition is observed.
Estonian: Kui 5 päeva jooksul ei ole ravi andnud tulemusi, tuleb raviskeem ümber hinnata.