FrancophonIA/ELRC3.0 huggingface dataset:
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Slovenian: Zaključki, ki jih je predstavila Evropska agencija za zdravila, o: • pogojnem dovoljenju za promet z zdravilom
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and presented by the European Medicines Agency
Slovenian: Zaključki o odobritvi pogojnega dovoljenja za promet z zdravilom, ki jih je predstavila evropska agencija za zdravila
English: Date of revision of the text
Slovenian: Datum revizije besedila
English: UNDESIRABLE EFFECTS
Slovenian: NEŽELENI UČINKI
English: These effects were mild and transient.
Slovenian: Ti učinki so bili blagi in prehodni.
English: If necessary and depending on the clinical response, treatment can be continued until the response is considered to be adequate.
Slovenian: Če je potrebno in glede na klinično odzivanje, lahko z zdravljenjem nadaljujemo, dokler menimo, da je odzivanje nanj ustrezno.
English: The following dosage scheme is advised:
Slovenian: Priporočena je naslednja shema odmerjanja:
English: In most cases, a 10 day-treatment course will be sufficient.
Slovenian: Večinoma zadošča 10-dnevno zdravljenje.
English: Methyl parahydroxybenzoate (0.125%)
Slovenian: Metilparahidroksibenzoat (0,125 %)
English: Dosage (number of tablets)
Slovenian: Odmerek (število tablet)
English: Do not use during the period of growth.
Slovenian: Zdravila ne uporabljajte v obdobju rasti.
English: Intervet Productions S.A. Rue de Lyons 27460 Igoville France
Slovenian: Peroralni gel Intervet Productions S.A. Rue de Lyons 27460 Igoville Francija
English: In order to avoid any cross contamination, the same syringe should not be used for different animals.
Slovenian: Da ne bi prišlo do navzkrižne okužbe, iste brizge ne smemo uporabljati za različne živali.
English: Shelf-life after first opening: 8 weeks
Slovenian: 3 leta Rok uporabnosti po prvem odpiranju: 8 tednov
English: However, it is preferred to administer the tablet at feeding time to ensure maximal bioavailability.
Slovenian: Vendar pa je tableto najbolje dajati v času hranjenja, da bi zagotovili največjo biološko uporabnost.
English: Antagonism may be observed with nitrofurantoin.
Slovenian: Do antagonizma lahko pride z nitrofurantoinom.
English: The duration of treatment depends on the nature and severity of the infection and on the response.
Slovenian: Trajanje zdravljenja je odvisno od oblike in resnosti okužbe ter od odzivnosti na zdravljenje.
English: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Slovenian: Intervet GesmbH Siemensstrasse 107 A-1210 Dunaj Avstrija
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
English: The overall absorption was higher when administered with food.
Slovenian: Skupna absorpcija je bila večja, kadar so zdravilo dajali s hrano.
English: Do not use in dogs with a weight of less than 3 kg. Ibaflin should only be used based on susceptibility testing.
Slovenian: Ne uporabite pri psih, ki so lažji od 3 kg. Ibaflin uporabljajte samo na podlagi izvidov testiranja občutljivosti povzročitelja.
English: Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25 ºC.
English: Ibaflin can be administered at any time of the day without consequences for efficacy.
Slovenian: Ibaflin lahko dajemo ob katerem koli času dneva, ne da bi se spremenila učinkovitost.
English: Read the package insert before use.
Slovenian: Pred uporabo preberite navodilo za uporabo.
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.
Slovenian: Če pri globoki piodermi ni zadovoljivega izboljšanja po 21 dneh zdravljenja, je treba o njem ponovno presoditi.
English: ADVICE ON CORRECT ADMINISTRATION Ibaflin can be administered at any time of the day without consequences for efficacy.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Ibaflin lahko dajemo ob kateremkoli času dneva, ne da bi se spremenila njegova učinkovitost.
English: PHARMACEUTICAL FORM Oral gel
Slovenian: FARMACEVTSKA OBLIKA Peroralni gel
English: It is advisable to determine the underlying cause and to treat the animal accordingly.
Slovenian: Priporočljivo je poiskati osnovni vzrok in žival ustrezno zdraviti.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ibafloxacin
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Ibafloksacin
English: The treatment should be reconsidered if after 5 days no improvement in the clinical condition is observed.
Slovenian: O zdravljenju moramo ponovno presoditi, če se po 5 dneh klinično stanje ne izboljša.
English: Once opened use within 8 weeks.
Slovenian: Odprto zdravilo uporabite v 8 tednih.
English: IBAFLIN TABLETS 30, 150, 300 AND 900 MG
Slovenian: IBAFLIN, TABLETE 30, 150, 300 in 900 mg
English: The overall absorption was higher in dogs and cats when administered with food.
Slovenian: Skupna absorpcija je bila pri psih in mačkah večja, kadar so jim zdravilo dajali s hrano.
English: Pyoderma is mostly secondary to an underlying disease.
Slovenian: Pioderma se večinoma pojavlja kot sekundarno obolenje ob osnovni bolezni.
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.
Slovenian: Zdravila ne uporabljajte pri mačkah do 8 mesecev starosti, ker ni na voljo podatkov o učinku ibafloksacina na razvoj sklepnega hrustanca v obdobju hitre rasti; možne so okvare sklepnega hrustanca.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 (napolnjena brizga) Ibaflin peroralnega gela vsebuje:
English: A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Slovenian: Sev, ki je odporen proti enemu fluorokinolonu, je odporen tudi proti drugim zdravilom iz skupine fluorokinolonov.
English: Therefore, ibafloxacin should not be used in cats aged less than 8 months.
Slovenian: Zato ibafloksacina ne smemo dajati mačkam, mlajšim od 8 mesecev.
English: In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.
Slovenian: Pri psih doseže največjo raven v plazmi v 2 urah pri dajanju s hrano ali brez nje.
English: Once a syringe is opened it should only be used to continue the treatment course in the same animal.
Slovenian: Načeto brizgo smemo uporabiti samo za nadaljevanje zdravljenja iste živali.
English: Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Sodium hydroxide solution Water for injections
Slovenian: 6.1 Seznam pomožnih snovi metilparahidroksibenzoat (0,125 %) kalijev dihidrogenfosfat dinatrijev hidrogenfosfat dihidrat karbomer (karbopol 974 PNF) raztopina natrijevega hidroksida voda za injekcije
English: 20 or 100 tablets 10, 20 or 100 tablets 8, 16 or 80 tablets 5, 25 or 50 tablets
Slovenian: 20 ali 100 tablet 10, 20 ali 100 tablet 8, 16 ali 80 tablet 5, 25 ali 50 tablet
English: After multiple oral administration, steady state is reached after the first or second dosing and no accumulation or induction of biotransformation enzymes occurs.
Slovenian: Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem ali drugem odmerku in se ne akumulira in ne inducira encimov biotransformacije.
English: 6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
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.
Slovenian: Preudarno je prihraniti uporabo fluorokinolonov za zdravljenje kliničnih stanj, ki se slabo odzivajo ali za katera pričakujemo, da so bodo slabo odzivala na druge skupine antibiotikov.
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Slovenian: Preveliko zanašanje na eno skupino antibiotikov lahko privede do odpornosti bakterijske populacije.
English: Name and address of the Marketing Authorisation Holder Intervet International B.V.
Slovenian: Ime in naslov imetnika dovoljenja za promet Intervet International B.V.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ºC.
English: and Klebsiella spp.
Slovenian: in Klebsiella spp.
English: and Pasteurella spp.
Slovenian: in Pasteurella spp.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: and Proteus mirabilis.
Slovenian: in Proteus mirabilis v vzorcih, izoliranih pri psih.
English: Ibaflin gel is indicated in dogs for the treatment of the following conditions:
Slovenian: Ibaflin gel je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj:
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zdravilo pravilno odmerili in da ne bi bil odmerek premajhen, je treba telesno maso določiti, kolikor je možno natančno.
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.
Slovenian: Ibafloksacin se po peroralnem dajanju pri psih hitro absorbira in doseže največje ravni mikrobiološko aktivnih spojin v plazmi 1 do 2 uri po dajanju.
English: PACKAGE INSERT FOR INCLUSION WITH THE IBAFLIN TABLETS
Slovenian: NAVODILO ZA UPORABO ZA TABLETE IBAFLIN
English: No specific antidotes for ibafloxacin (or other quinolones) are known, therefore, in case of overdosage symptomatic treatment should be given.
Slovenian: Za ibafloksacin (in druge fluorokinolone) ni znanih antidotov, zato je treba pri vnosu prevelikega odmerka uvesti simptomatsko zdravljenje.
English: Its action results from inhibition of bacterial DNA gyrase.
Slovenian: Njegovo delovanje temelji na zaviranju bakterijske DNA-giraze.
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Slovenian: Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA
English: 300 mg tablets:
Slovenian: Tablete 30 mg:
English: Any syringes containing unused product should be disposed of once a course of treatment has been completed.
Slovenian: Brizge z neporabljenim gelom je treba po končanem zdravljenju zavreči.
English: EXPIRY DATE EXP {month/year}>
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI EXP {mesec/leto}
English: The gel should therefore be administered at feeding time to ensure maximal bioavailability.
Slovenian: Gel dajemo zato ob času hranjenja, da bi zagotovili optimalno biološko uporabnost.
English: Prohibition of sale, supply and/or use Not applicable.
Slovenian: C. PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
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
Slovenian: Ibaflin 30 mg: ibafloksacin 30 mg Ibaflin 150 mg: ibafloksacin 150 mg Ibaflin 300 mg: ibafloksacin 300 mg Ibaflin 900 mg: ibafloksacin 900 mg
English: The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active .
Slovenian: Presnovek, ki nastaja v največji količini, je 8-hidroksi-ibafloksacin, ki je tudi mikrobiološko aktiven.
English: EXPIRY DATE (Month/year)
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA (Mesec/leto)
English: 20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
Slovenian: 20 tablet / 100 tablet 10 tablet / 20 tablet / 100 tablet 8 tablet / 16 tablet / 80 tablet 5 tablet / 25 tablet / 50 tablet
English: Ibaflin 7.5% Oral Gel should not be used in cats.
Slovenian: Ibaflin 7,5 % peroralnega gela ne smemo uporabljati pri mačkah.
English: It is recommended that the gel is administered at the time of feeding.
Slovenian: Gel je priporočljivo dajati ob času hranjenja.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA
English: Cats and dogs Ibaflin 3% Oral Gel
Slovenian: Psi in mačke Ibaflin 3 % peroralni gel
English: Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Slovenian: Pioderma (površinska in globoka), rane, abscesi, akutne nezapletene okužbe sečil in zgornjih dihalnih poti
English: Date of first authorisation/renewal of the authorisation
Slovenian: Datum pridobitve/podaljšanja dovoljenja za promet
English: 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.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Peroralno dajanje odmerkov ibafloksacina po 75 mg/kg na dan (petkratni priporočeni odmerek) v obdobju 90 dni, so psi dobro prenašali.
English: Ibafloxacin is a broad spectrum, bactericidal antibiotic.
Slovenian: Ibafloksacin je širokospektralen, baktericidni antibiotik.
English: The influence on fertility in male breeding animals has not been investigated.
Slovenian: Učinek na plodnost pri plemenskih samcih ni raziskan.
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).
Slovenian: Bela, nastavljiva večodmerna napolnjena brizga iz polietilena visoke gostote (HDPE, telo, bat in objemka) in polietilena majhne gostote (LDPE, zaporka in tesnilo)
English: Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
Slovenian: V primeru nenamernega zaužitja zdravila, zlasti pri otroku, se je treba posvetovati z zdravnikom.
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.
Slovenian: MIK ibafloksacina (matične spojine) so v razponu 0,032 do 0,5 µg/ml za E. coli, Staphylococcus spp.
English: Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Slovenian: Ibafloksacin in 8-hidroksi-ibafloksacin delujeta sinergistično.
English: Persons with known hypersensitivity to quinolones should avoid contact with the product.
Slovenian: Osebe z znano preobčutljivostjo za kinolone se morajo izogibati stiku z izdelkom.
English: In cats, relevant susceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
Slovenian: Pri mačkah so občutljivi mikroorganizmi E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
English: Terminal plasma halflife is approximately 4-5 hours.
Slovenian: Končna razpolovna doba izločanja iz plazme je približno 4 do 5 ur.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Slovenian: BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali.
English: Terminal plasma halflife is approximately 3-5 hours.
Slovenian: Končna razpolovna doba izločanja iz plazme je približno 3 do 5 ur.
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.
Slovenian: Pri zdravih mačkah je 30-dnevno dajanje Ibaflin peroralnega gela v odmerkih po 15 do 75 mg/kg povzročilo bruhanje oz. regurgitacijo in slinjenje.
English: (MIC ≤ 0.5 µg ibafloxacin/ml).
Slovenian: (MIK ≤ 0,5 µg/ml ibafloksacina).
English: C. PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
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)
Slovenian: - zloženka z 1 napolnjeno brizgo s 15 ml (za nastavitev po 0,5 ml) (Ibaflin 3 % peroralni gel) - zloženka s 5 napolnjenimi brizgami s 15 ml (za nastavitev po 0,5 ml) (Ibaflin 3 % peroralni gel) - zloženka z 1 napolnjeno brizgo s 30 ml (za nastavitev po 1 ml) (Ibaflin 7,5 % peroralni gel) - zloženka s 5 napolnjenimi brizgami s 30 ml (za nastavitev po 1 ml) (Ibaflin 7,5 % peroralni gel)
English: 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.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo za kinolone naj se izogibajo stiku z zdravilom.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
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.
Slovenian: MIK ibafloksacina (matične spojine) so v razponu 0,032 do 0,5 µg/ml za E. coli, Staphylococcus spp., Proteus mirabilis, seve Pasteurella spp.
English: Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Slovenian: Ibafloksacin je sintetična protimikrobna snov iz skupine fluorokinolonov.
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.
Slovenian: - zloženka z 20 ali s 100 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija Tablete 150 mg: - zloženka z 10, 20 ali s 100 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija - zloženka z 10, 20 ali s 100 tabletami v pretisnih omotih iz pvc, pvdc in aluminija Tablete 300 mg: - zloženka z 8, s 16 ali z 80 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija - zloženka z 8, s 16 ali z 80 tabletami v pretisnih omotih iz pvc, pvdc in aluminija Tablete 900 mg: - zloženka s 5, 25 ali 50 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija
English: Antacids can interfere with gastro-intestinal absorption of quinolones.
Slovenian: Antacidi lahko vplivajo na absorpcijo kinolonov iz prebavil.
English: 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.
Slovenian: Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči, pri mačkah pa so zasledili zmerno kopičenje.
English: Name and address of the Marketing Authorisation Holder
Slovenian: Ime in naslov imetnika dovoljenja za promet
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.
Slovenian: Ibafloksacin se po peroralnem dajanju pri mačkah hitro absorbira in doseže največjo raven v plazmi v 1 uri, kadar ga dajemo brez hrane, in v 2 urah, kadar ga dajemo s hrano.
English: mg administered
Slovenian: Odmerek v mg
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
Slovenian: Ibaflin 30 mg, tablete za pse Ibaflin150 mg, tablete za pse Ibaflin 300 mg, tablete za pse Ibaflin 900 mg, tablete za pse
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
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Ibaflin 3 %, peroralni gel: 30 mg ibafloksacina v 1 g gela (ustreza 30,9 mg/ml) Pomožne snovi
English: PHARMACEUTICAL FORM
Slovenian: FARMACEVTSKA OBLIKA Tableta
English: Do not use in dogs during the period of growth as articular cartilage may be affected.
Slovenian: Zdravila ne uporabljajte pri psih v obdobju rasti, ker ima lahko škodljiv učinek na sklepni hrustanec.
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
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Ibaflin 7,5 %, peroralni gel: 75 mg ibafloksacina v 1 g gela (ustreza 78,8 mg/ml) Pomožne snovi
English: Do not use in dogs with known quinolone hypersensitivity.
Slovenian: Ne uporabite pri psih z znano preobčutljivostjo za kinolone.
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
Slovenian: Ibaflin 3 %, peroralni gel: 30 mg ibafloksacina v 1 g gela (ustreza 30,9 mg/ml) Ibaflin 7,5 %, peroralni gel: 75 mg ibafloksacina v 1 g gela (ustreza 78,8 mg/ml) Pomožne snovi
English: After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs.
Slovenian: Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči.
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.
Slovenian: O učinku ibafloksacina na razvoj sklepnega hrustanca pri mačkah v obdobju hitre rasti ni podatkov.
English: Siemensstraße 107 1210 Vienna Austria
Slovenian: Siemensstraße 107
English: In dogs, this period depends on the breed.
Slovenian: Pri psih je obdobje rasti pri različnih pasmah različno.
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.
Slovenian: Študije varnosti za ciljno živalsko vrsto, izvedene pri psih, starih 8 mesecev, so pokazale, da ibafloksacin po peroralnem dajanju v odmerkih po 45 mg/kg telesne mase na dan (trikratni priporočeni odmerek) v obdobju 90 dni nima zaznavnih neželenih učinkov.
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.
Slovenian: Študije varnosti za ciljno živalsko vrsto, izvedene pri psih, pasme beagle, starih 8 mesecev, so pokazale, da ibafloksacin po peroralnem dajanju v odmerkih po 45 mg/kg telesne mase na dan (trikratni priporočeni odmerek) v obdobju 90 dni nima zaznavnih neželenih učinkov.
English: 15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
Slovenian: 15 mg/kg telesne mase = 1 ml gela/5 kg telesne mase
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.
Slovenian: Peroralno dajanje odmerkov ibafloksacina po 75 mg/kg na dan (petkratni priporočeni odmerek) v obdobju 90 dni, so psi dobro prenašali.
English: Do not use in dogs and cats with known quinolone hypersensitivity.
Slovenian: Ne smemo ga uporabljati pri psih in mačkah z znano preobčutljivostjo za kinolone.
English: Ibaflin can be used during pregnancy.
Slovenian: Ibaflin lahko dajemo med brejostjo.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
Slovenian: ZLOŽENKA Z 1 BRIZGO IBAFLIN 3 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 3 % PERORALNEGA GELA