FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
Bulgarian: 20 tablet / 100 tablet 10 tablet / 20 tablet / 100 tablet 8 tablet / 16 tablet / 80 tablet 5 tablet / 25 tablet / 50 tablet
English: Prohibition of sale, supply and/or use Not applicable.
Bulgarian: C. PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
English: The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active.
Bulgarian: Presnovek, ki nastaja v največji količini, je 8-hidroksi-ibafloksacin, ki je tudi mikrobiološko aktiven.
English: EXPIRY DATE (Month/year)
Bulgarian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA (Mesec/leto)
English: Ibaflin 7.5% Oral Gel should not be used in cats.
Bulgarian: Ibaflin 7,5 % peroralnega gela ne smemo uporabljati pri mačkah.
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96
Bulgarian: Farmakodinamične lastnosti Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA 96
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Bulgarian: Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA
English: If you notice any other side effects, please inform your veterinary surgeon.
Bulgarian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: It is recommended that the gel is administered at the time of feeding.
Bulgarian: Gel je priporočljivo dajati ob času hranjenja.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bulgarian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Bulgarian: BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Bulgarian: 1 (napolnjena brizga) Ibaflin peroralnega gela vsebuje:
English: Cats and dogs Ibaflin 3% Oral Gel
Bulgarian: Psi in mačke Ibaflin 3 % peroralni gel
English: The influence on fertility in male breeding animals has not been investigated.
Bulgarian: Učinek na plodnost pri plemenskih samcih ni raziskan.
English: Date of first authorisation/renewal of the authorisation
Bulgarian: Datum pridobitve/podaljšanja dovoljenja za promet
English: and Pasteurella spp.
Bulgarian: in Pasteurella spp.
English: and Klebsiella spp.
Bulgarian: Klebsiella spp.
English: Target species
Bulgarian: CILJNE ŽIVALSKE VRSTE
English: Ibafloxacin is a broad spectrum, bactericidal antibiotic.
Bulgarian: Ibafloksacin je širokospektralen, baktericidni antibiotik.
English: Medicinal advice should be sought in the event of accidental ingestion, particularly by a child.
Bulgarian: V primeru nenamernega zaužitja zdravila, zlasti pri otroku, se je treba posvetovati z zdravnikom.
English: Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Bulgarian: Pioderma (površinska in globoka), rane, abscesi, akutne nezapletene okužbe sečil in zgornjih dihalnih poti
English: Magnesium stearate
Bulgarian: silicijev dioksid magnezijev stearat
English: Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Bulgarian: Ibafloksacin in 8-hidroksi-ibafloksacin delujeta sinergistično.
English: 4.2 Indications for use
Bulgarian: Indikacije za uporabo
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Bulgarian: ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ºC.
English: Name and address of the Marketing Authorisation Holder
Bulgarian: Ime in naslov imetnika dovoljenja za promet
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Bulgarian: Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
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
Bulgarian: Ibaflin 30 mg, tablete za pse Ibaflin150 mg, tablete za pse Ibaflin 300 mg, tablete za pse Ibaflin 900 mg, tablete za pse
English: Special precautions to be taken by the person administering the product
Bulgarian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Bulgarian: Ibafloksacin je sintetična protimikrobna snov iz skupine fluorokinolonov.
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.
Bulgarian: 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: 4.5 Special precautions for use
Bulgarian: 4.5 Posebni previdnostni ukrepi
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.
Bulgarian: 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:
English: Antacids can interfere with gastro-intestinal absorption of quinolones.
Bulgarian: 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.
Bulgarian: Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči, pri mačkah pa so zasledili zmerno kopičenje.
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.
Bulgarian: Pri zdravih mačkah je 30-dnevno dajanje Ibaflin peroralnega gela v odmerkih po 15 do 75 mg/kg povzročilo bruhanje oz.
English: Sodium laurylsulphate Silica
Bulgarian: 6.1 Seznam pomožnih snovi kvas škrob celuloza laktoza natrijev lavrilsulfat
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.
Bulgarian: Peroralno dajanje odmerkov ibafloksacina po 75 mg/kg na dan (petkratni priporočeni odmerek) v obdobju 90 dni, so psi dobro prenašali.
English: In dogs, this period depends on the breed.
Bulgarian: Pri psih je obdobje rasti pri različnih pasmah različno.
English: PHARMACEUTICAL FORM
Bulgarian: FARMACEVTSKA OBLIKA Tableta
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.
Bulgarian: in doseže največje ravni mikrobiološko aktivnih spojin v plazmi 1 do 2 uri po dajanju.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING
Bulgarian: B. POGOJI DOVOLJENJA
English: Do not use in dogs with known quinolone hypersensitivity.
Bulgarian: Ne uporabite pri psih z znano preobčutljivostjo za kinolone.
English: Do not use in dogs during the period of growth as articular cartilage may be affected.
Bulgarian: Zdravila ne uporabljajte pri psih v dobi rasti, ker lahko okvari
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Bulgarian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs.
Bulgarian: Po večkratnem peroralnem dajanju doseže stabilno stanje po prvem odmerku in se pri psih ne kopiči.
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
Bulgarian: 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: Siemensstraße 107 1210 Vienna Austria
Bulgarian: Siemensstraße 107
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.
Bulgarian: Zdravila ne uporabljajte pri mačkah do 8 mesecev starosti, ker ni na voljo podatkov o učinku
English: ANNEX III LABELLING AND PACKAGE INSERT
Bulgarian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
Bulgarian: Z 1 BRIZGO IBAFLIN 3 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 3 % PERORALNEGA GELA
English: The main excretory routes are via urine and faeces.
Bulgarian: Zdravilo se pretežno izloča z urinom in blatom.
English: Ibaflin can be used during pregnancy.
Bulgarian: Ibaflin lahko dajemo med brejostjo.
English: 4.7 Use during pregnancy, lactation or lay
Bulgarian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti.
English: mg administered
Bulgarian: Odmerek v mg
English: Do not use in dogs and cats with known quinolone hypersensitivity.
Bulgarian: Ne smemo ga uporabljati pri psih in mačkah z znano preobčutljivostjo za kinolone.
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.
Bulgarian: Tablete po 150 mg in 300 mg: 4 leta Tablete po 30 mg in 900 mg: 3 leta
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
Bulgarian: Ibafloksacin 30 mg Ibafloksacin 150 mg Ibafloksacin 300 mg Ibafloksacin 900 mg
English: 4.9 Posology and method of administration
Bulgarian: 4.9 Odmerjanje in pot uporabe
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.
Bulgarian: MIK ibafloksacina (matične spojine) so v razponu 0,032 do 0,5 µg/ml za E. coli, Staphylococcus spp.
English: The safety of the veterinary medicinal product has not been established in lactating dogs and in pregnant and lactating cats.
Bulgarian: Varnost zdravila ni raziskana pri psicah v obdobju laktacije in pri brejih mačkah in mačkah v obdobju laktacije.
English: and Proteus mirabilis.
Bulgarian: in Proteus mirabilis v vzorcih, izoliranih pri psih.
English: Do not use during the period of growth or in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Bulgarian: Zdravila ne uporabljajte v obdobju rasti ali v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Bulgarian: Z 1 BRIZGO IBAFLIN 7,5 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 7,5 % PERORALNEGA GELA
English: Oral use, 15 mg ibafloxacin/kg once daily.
Bulgarian: ZDRAVILA Peroralno, 15 mg ibafloksacina/kg 1-krat na dan.
English: In dogs the maximum plasma levels were observed at 2 hours when administered with or without food.
Bulgarian: Pri psih doseže največjo raven v plazmi v 2 urah pri dajanju
English: The safety of the veterinary medicinal product has not been established during lactation.
Bulgarian: Varnost zdravila ni raziskana med laktacijo.
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
Bulgarian: Ibaflin 7,5 %, peroralni gel: 75 mg ibafloksacina v 1 g gela (ustreza 78,8 mg/ml) Pomožne snovi
English: Ibafloxacin is a broad spectrum bactericidal antibiotic from the quinolone group.
Bulgarian: Ibafloksacin je širokospektralen, baktericidni antibiotik iz skupine kinolonov.
English: The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
Bulgarian: Varnost zdravila ni raziskana pri brejih mačkah ter pri psicah in mačkah v obdobju laktacije.
English: MARKETING AUTHORISATION HOLDER
Bulgarian: trženja za zdravilo, odobreno
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).
Bulgarian: s pomikom objemke na ustrezno mesto na batu (brizga s 30 ml - stopnje po 1,0 ml).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats
Bulgarian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel za pse in mačke
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Bulgarian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel
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
Bulgarian: Ibaflin 3 %, peroralni gel: 30 mg ibafloksacina v 1 g gela (ustreza 30,9 mg/ml) Pomožne snovi
English: 0.5 ml of gel per kg body weight
Bulgarian: 0,5 ml gela na kg telesne mase
English: Pharmacokinetic particulars
Bulgarian: Farmakokinetični podatki
English: Persons with known hypersensitivity to quinolones should avoid contact with the product.
Bulgarian: Osebe z znano preobčutljivostjo za kinolone se morajo izogibati stiku z izdelkom.
English: Veterinary medicinal product subject to prescription.
Bulgarian: Na veterinarski recept.
English: Marketing Authorisation number(s) EU/2/00/022/09-12
Bulgarian: Številka dovoljenja za promet EU/2/00/022/09-12
English: Keep out of the reach and sight of children.
Bulgarian: Shranjujte nedosegljivo otrokom.
English: Terminal plasma halflife is approximately 4-5 hours.
Bulgarian: Končna razpolovna doba izločanja iz plazme je približno 4 do 5 ur. Izloča se pretežno z urinom
English: Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in dogs with a history of seizures.
Bulgarian: Kinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
English: The safety of the veterinary medicinal product has not been established in lactating dog.
Bulgarian: Varnost zdravila ni raziskana pri psicah v obdobju laktacije.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Bulgarian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
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).
Bulgarian: Bela, nastavljiva večodmerna napolnjena brizga iz polietilena visoke gostote (HDPE, telo, bat in objemka)
English: RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Bulgarian: Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: B. PACKAGE INSERT
Bulgarian: DODATEK III
English: and Salmonella spp.
Bulgarian: in Salmonella spp., izolirane pri psih.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel for dogs
Bulgarian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel za pse
English: Marketing Authorisation number(s) EU/2/00/022/001-008
Bulgarian: Številke dovoljenja za promet EU/2/00/022/001-008
English: (MIC ≤ 0.5 µg ibafloxacin/ml).
Bulgarian: in Klebsiella spp. (MIK ≤ 0,5 µg/ml ibafloksacina).
English: Ibaflin is indicated for the treatment of the following conditions in dogs:
Bulgarian: Ibaflin je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj:
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.
Bulgarian: ibafloksacina (matične spojine) so v razponu 0,032 do 0,5 µg/ml za E. coli, Staphylococcus spp.,
English: Ibaflin gel is indicated in cats for treatment of the following conditions:
Bulgarian: Ibaflin gel je pri mačkah indiciran za zdravljenje naslednjih bolezenskih stanj:
English: 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.
Bulgarian: Pri večini pasem je uporaba ibafloksacina kontraindicirana za pse, mlajše od 8 mesecev, pri zelo velikih pasmah pa za pse, mlajše od 18 mesecev.
English: Active substance(s)
Bulgarian: ŠTEVILKA(E) DOVOLJENJ(A)
English: Ibaflin should only be used based on susceptibility testing.
Bulgarian: Ibaflin smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
English: Ibaflin gel should only be used based on susceptibility testing.
Bulgarian: Ibaflin gel smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
English: Cellulose
Bulgarian: Ibafloksacin
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ibafloxacin
Bulgarian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: Terminal plasma halflife is approximately 3-5 hours.
Bulgarian: Končna razpolovna doba izločanja iz plazme je približno 3 do 5 ur. Skupna absorpcija je bila večja, kadar
English: Pharmacodynamic properties
Bulgarian: Farmakodinamične lastnosti
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.
Bulgarian: sklepnega hrustanca pri mačkah v obdobju hitre rasti ni podatkov.
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.
Bulgarian: in doseže največjo raven v plazmi v 1 uri, kadar ga dajemo brez hrane, in v 2 urah, kadar ga dajemo s hrano.
English: INDICATIONS Ibaflin gel is indicated in dogs for the treatment of the following conditions: - Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as staphylococci, E. coli and Proteus mirabilis
Bulgarian: INDIKACIJE Ibaflin gel je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj: - dermalne okužbe (pioderma - površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
English: SPECIAL WARNING(S)
Bulgarian: POSEBNA OPOZORILA
English: In cats, relevant susceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
Bulgarian: Pri mačkah so občutljivi mikroorganizmi E. coli, Staphylococcus spp.,
English: Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Bulgarian: in druge oblike interakcij Fluorokinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
English: Ibaflin 30 mg Ibaflin 150 mg
Bulgarian: Ibaflin 30 mg: ibafloksacin 30 mg Ibaflin 150 mg:
English: Name and address of the Manufacturing Authorisation Holder responsible for batch release
Bulgarian: Ime in naslov imetnika dovoljenja za izdelavo zdravila, odgovornega za sprostitev serije Intervet GesmbH.
English: Lactose
Bulgarian: ZLOŽENKA
English: Starch
Bulgarian: MIK
English: Ibaflin gel should be used based on susceptibility testing.
Bulgarian: Ibaflin gel uporabljamo na podlagi izvidov testiranja občutljivosti povzročitelja.
English: Ibaflin gel is indicated in dogs for the treatment of the following conditions:
Bulgarian: Indikacije za uporabo Ibaflin gel je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Bulgarian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
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
Bulgarian: s 100 tabletami v zavarjenih pretisnih omotih iz pvc in aluminija - zloženka z 10, 20 ali
English: 15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
Bulgarian: Peroralno, 15 mg ibafloksacina/kg, 1-krat na dan 15 mg/kg telesne mase = 1 ml gela/5 kg telesne mase
English: - Dermal infections (soft tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp, E. coli, Proteus spp.
Bulgarian: - dermalne okužbe (okužbe mehkega tkiva - rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp.
English: Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.
Bulgarian: Okužbe dihalnih poti (zgornjih dihal), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children.
Bulgarian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: 1 adjustable pre-filled multidose syringe, containing 15 ml.
Bulgarian: 1 nastavljiva, napolnjena večodmerna brizga
English: Do not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Bulgarian: Zdravila ne uporabljajte v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ibaflin contains:
Bulgarian: Ena tableta Ibaflina vsebuje:
English: ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily.
Bulgarian: POT(I) UPORABE ZDRAVILA Peroralno 15 mg/kg telesne mase, 1-krat na dan.
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
Bulgarian: tableti 300 mg ibafloksacina v 1 tableti 900 mg ibafloksacina v 1 tableti
English: Oral use, 15 mg ibafloxacin/kg bodyweight once daily.
Bulgarian: Peroralno, 15 mg ibafloksacina/kg telesne mase, 1-krat na dan.
English: Do not use in dogs with a weight of less than 3 kg. Ibaflin should only be used based on susceptibility testing.
Bulgarian: Ne uporabite pri psih, ki so lažji od 3 kg.
English: Ibaflin gel can be used during pregnancy in dogs.
Bulgarian: Ibaflin gel lahko dajemo brejim psicam.
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.
Bulgarian: 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
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel
Bulgarian: Z AUPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel
English: Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency.
Bulgarian: UČINKI Driska, mehko blato, bruhanje, otopelost in anoreksija se pojavljajo redko. Ti učinki so bili blagi in prehodni.
English: 15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
Bulgarian: Peroralno, 15 mg ibafloksacina/kg, 1-krat na dan 15 mg /kg telesne mase = 0,5 ml gela/kg telesne mase
English: Yeast
Bulgarian: OVOJNINAH
English: PACKAGE INSERT FOR INCLUSION WITH THE 7.5 % ORAL GEL SYRINGE PACKAGES
Bulgarian: UPORABO ZA BRIZGE S PERORALNIM GELOM 7,5 %