FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential of cross resistance.
Slovenian: Pri uporabi zdravila brez upoštevanja podatkov, ki so navedeni v povzetku glavnih značilnosti zdravila (SPC) lahko pride do zmanjšanja prevalence bakterijske rezistence na fluorokinolone in zmanjšanja učinkovitosti zdravljenja z drugimi kinoloni zaradi možne navskrižne rezistence.
English: Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.
Slovenian: Ne uporabite pri pticah v obdobju nesnosti in/ali 4 tedne pred začetkom obdobja nesnosti.
English: The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Slovenian: Tablete se dajejo vsaj še dva dni po prenehanju kliničnih znakov bolezni.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
English: In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%).
Slovenian: Pri piščancih se difloksacin po peroralnem dajanju skoraj v celoti resorbira (približno 96 %).
English: Annex II of Council Regulation (EEC) No 2377/90 Oral solution:
Slovenian: Dodatek II Uredbe Sveta (EGS) št. 2377/90 Peroralna raztopina
English: The elimination half-life averaged 9.3 hours.
Slovenian: Razpolovni čas izločanja znaša približno 9,3 ur.
English: 4.2 Indications for use, specifying the target species For the treatment of:
Slovenian: 4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste Za zdravljenje:
English: The administration must be continued for 5 days.
Slovenian: Zdravljenje traja 5 dni.
English: EXPIRY DATE EXP {month/year}
Slovenian: DATUM IZTEKA UPORABNOSTI EXP{ mesec/leto}
English: A half-life time of 5.8 hours has been observed.
Slovenian: Razpolovni čas izločanja je 5,8 ur.
English: Annex I of Council Regulation (EEC) No 2377/90 Pharmacologically active substance residue
Slovenian: Dodatek I Uredbe Sveta (EGS) št. 2377/90 Farmakološko aktivna snov zaostanek dovoljene količine zaostankov (MRL)
English: Solution for injection: Pharmacologically active substance
Slovenian: Raztopina za injiciranje: Farmakološko aktivna snov Živalska vrsta
English: Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
Slovenian: Difloksacin je aril-fluorokinolon s širokim spektrom protimikrobnega učinkovanja.
English: Blister label
Slovenian: Etiketa na blistru
English: Propylene glycol 9 Benzyl alcohol 10 Arginine 11
Slovenian: Propilenglikol 9 Benzilakohol 10 Arginin 11
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli druge neželene učinke, obvestite svojega veterinarja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine
English: Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
Slovenian: Farmakoterapevtska skupina: splošni antbiotik za sistemsko uporabo; antibakterik za sistemsko uporabo; kinolonski antibakterik
English: Adverse reactions were rare in dogs treated with difloxacin.
Slovenian: Neželeni učinki so pri psih, zdravljenih z difloksacinom, redki.
English: For oral use.
Slovenian: Za peroralno dajanje.
English: The reproductive safety of the veterinary medicinal product has only been evaluated in laboratory animals, the use of difloxacin in pregnant or lactating bitches or male stud dogs is therefore not recommended.
Slovenian: Varnost zdravila v obdobju brejosti je bila raziskana samo pri laboratorijskih živalih, zato uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste
English: The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg.
Slovenian: Hitrost distribuiranja difloksacina po subkutanem dajanju je 229 ml/h/kg.
English: Dicural 15 mg coated tablets for dogs Dicural 50 mg coated tablets for dogs Dicural 100 mg coated tablets for dogs Dicural 150 mg coated tablets for dogs
Slovenian: Dicural 15 mg filmsko obložene tablete za pse Dicural 50 mg filmsko obložene tablete za pse Dicural 100 mg filmsko obložene tablete za pse Dicural 150 mg filmsko obložene tablete za pse
English: Benzyl alcohol6
Slovenian: Benzilalkohol 6
English: Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
Slovenian: Za pripravo ustrezne koncentracije difloksacina v vodi za pitje (10 %V/V) izračunajte količino ml zdravila za 1000 litrov vode:
English: 3 OJ No. L 290 of 5.12.95
Slovenian: 3 OJ št. L 290 z dne 5.12.95
English: Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Slovenian: Tudi dolgotrajno dajanje zdravila (nad 180 dni) v odmerku 5 mg/kg telesne mase ni imelo vpliva na kinetiko difloksacina - ne na njegovo akumulacijo in ne na povečanje njegovega metabolizma.
English: PHARMACEUTICAL FORM Coated tablets
Slovenian: FARMACEVTSKA OBLIKA Filmsko obložena tableta
English: Superficial pyoderma may require treatment for up to a maximum of 21 days.
Slovenian: Zdravljenje traja najmanj 5 dni; zdravljenje površinske pioderme pa do največ 21 dni.
English: Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Slovenian: Če je le mogoče, se zdravljenje s fluorokinoloni izvaja po predhodnem testiranju občutljivosti povzročiteljev.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains:
Slovenian: NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsaka tableta vsebuje:
English: Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in a few hours after initiation of medication.
Slovenian: Difloksacin se po peroralnem dajanju hitro absorbira in doseže ustrezno koncentracijo v plazmi v nekaj urah po dajanju.
English: Edetic acid3
Slovenian: Edetična kislina 3
English: Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive microorganisms.
Slovenian: Difloksacin učinkuje bakteriocidno na številne po Gramu negativne mikroorganizme in selektivno na po Gramu pozitivne mikroorganizme.
English: Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
Slovenian: Koncentracija difloksacina v različnih tkivih je enaka ali večja kot je MIC za relevantne mikroorganizme in traja toliko časa, kot traja zdravljenje.
English: PACKAGE SIZE 100 ml
Slovenian: VELIKOST PAKIRANJA 100 ml
English: The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
Slovenian: Kažejo se v zmanjšanju apetita, pojavu slabosti, driske in iritacije anusa.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:{številka}:
English: Potassium Hydroxide4 Propylene glycol5
Slovenian: Kalijev hidroksid 4 Propilenglikol 5
English: Manufacturer for the batch release Pfizer Olot, S.L.U.
Slovenian: Izdelovalec, odgovoren za sproščanje serije Pfizer Olot, S.L.U.
English: 4.11 Withdrawal period Not applicable.
Slovenian: 4.11 Karenca(e) Navedba ni smiselna.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC ZDRAVILA IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE UPORABE
English: CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
Slovenian: KARTONSKA OVOJNINA 1 X 250 ml STEKLENICA /1 X 1000 ML STEKLENICA / 6 X 1000 ML STEKLENICA
English: 10 OJ No L 143 of 26.06.95 11 OJ No. L 240 of 10.09.99
Slovenian: 10 OJ št. L 143 z dne 26.06.95 11 OJ št. L 240 z dne 10.09.99
English: Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations: Dogs: 50 ml vial.
Slovenian: Dicural 50 mg/ml, raztopina za injiciranje za govedo in pse je na razpolago v naslednjih pakiranjih: Za pse: 50 ml viala
English: DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Slovenian: ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA Dicural peroralna raztopina se daje dnevno v vodo za pitje v koncentraciji, ki zagotavlja odmerek 10 mg/kg.
English: Pharmacologically active substance
Slovenian: Farmakološko aktivna snov Živalska vrsta
English: People with a known hypersensitivity to quinolones should avoid any contact with the product.
Slovenian: Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
English: Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Sodium lauryl sulphate
Slovenian: Natrijev karboksimetilškrob Mikrokristalna celuloza Magnezijev stearat Silikondioksid, koloidni Natrijev laurilsulfat
English: Shelf-life after first opening the container: 1 month.
Slovenian: Rok uporabnosti po prvem odpiranju neposredne ovojnice: 1 mesec.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o produktu so na voljo na spletni strani Evropske agencije za zdravila http:/www.ema.europa.eu/
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http:www.ema.europa.eu/
English: After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 g/ml are achieved in 3.1 hours post dosing.
Slovenian: Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,4-1,9 μg/ml v 3,1 urah po dajanju.
English: Dogs: Cardboard box with one glass vial of 50ml with a rubber stopper and aluminium cap.
Slovenian: Psi: Kartonska škatla s stekleno vialo za 50 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
English: The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
Slovenian: Kombinacija fluorokinolonov in nesteroidnih antiinflamatorikov (NSAID) lahko pri epilepsiji sproži napad.
English: Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5 months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/kg/day (as the hydrochloride) for 90 days.
Slovenian: Opažene so histopatološke spremembe sklepnega hrustanca pri psih pasme beagle, ki so pri starosti 3,5 mesecev dobivali peroralno večji odmerek od 5 mg/kg 90 dni zapovrstjo.
English: These adverse reactions were self-limiting within one or two days and did not require additional treatment.
Slovenian: Ti neželeni učinki izginejo brez posebnega zdravljenja v enem do dveh dneh.
English: 400 µg/kg 100 µg/kg 1400 µg/kg 800 µg/kg
Slovenian: 400 μg/kg 100 μg/kg 1400 μg/kg 800 μg/kg
English: Animal Species
Slovenian: CILJNE ŽIVALSKE VRSTE
English: Cattle: None.
Slovenian: Govedo: Niso znane.
English: No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage symptomatic treatment should be given.
Slovenian: Ni specifičnega antidota za difloksacin (in druge kinolone), zato je zdravljenje pri prevelikem odmerjanju simptomatsko.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml peroralne raztopine vsebuje:
English: A fraction of difloxacin (i.e. 7 - 18%) is eliminated via the urine.
Slovenian: Največ difloksacina (68-82%) se izloči z blatom, manjša količina (7-18%) pa z urinom.
English: Excipients: Benzyl alcohol
Slovenian: Nosilci: Benzilalkohol
English: Since no studies were performed in clinically lame birds, Dicural should not be used in birds with existing leg-weakness or in birds suffering from osteoporosis.
Slovenian: Pri klinično šepavih pticah niso bile opravljene študije, zato zdravila ne uporabljati pri pticah, ki šepajo ali imajo ugotovljeno osteoporozo.
English: In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin.
Slovenian: Pri obeh vrstah se difloksacin metabolizira v sarafloksacin (desmetil difloksacin) ali pa oksidira v Noksid-difloksacin.
English: Edetic acid Potassium hydroxide Propylene glycol Benzyl alcohol Purified water
Slovenian: Edetična kislina Kalijev hidroksid Propilenglikol Benzilakohol Prečiščena voda
English: Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
Slovenian: Mutacija gena giraze v bakterijski celici in sprememba v prepustnosti celične membrane na kinolone lahko pripelje do nastanka rezistence proti kinolonskim pripravkom.
English: Difloxacin Poultry1
Slovenian: Difloksacin Difloksacin Perutnina 1
English: All food-producing species
Slovenian: Vse živalske vrste, namenjene prehrani ljudi
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Slovenian: Ni dokazana varnost zdravila v obdobju brejosti in laktacije.
English: 5 OJ No. L 45 of 15.02.97
Slovenian: 5 OJ št. L 45 z dne 15.02.97
English: BATCH NUMBER Lot {number}
Slovenian: ŠTEVILKA SERIJE Serija: { številka}
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
English: MARKETING AUTHORISATION NUMBER(S) [Recommended, but not required on the immediate label] EU/2/97/003/017 - 100 ml
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL /Priporočeno, vendar ni obvezno na stični ovojnini/ EU/2/97/003/17 - 100 ml
English: Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
Slovenian: Koncentracije difloksacina v organih so različne in znašajo od 0,6 v abdominalni maščobi do 2,4 v pljučih in 14,1 v jetrih.
English: Following an oral dose (a plain tablet) in dogs of 5 mg/kg bodyweight, difloxacin reached its average peak plasma concentration of 1.8 µg/ml in approximately 3 hours.
Slovenian: Difloksacin po peroralnem dajanju (tableta) v odmerku 5 mg/kg telesne mase pri psih doseže najvišjo koncentracijo v plazmi 1,8 μg v 3 urah.
English: At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle.
Slovenian: Pri zelo velikih odmerkih se pokažejo učinki na živčni sistem (ataksija, zanašanje, drgetanje, krči in drugo).
English: SPECIAL WARNING(S), IF NECESSARY People with a known hypersensitivity to quinolones should avoid any contact with the product.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Osebe z znano preobčutljivostjo na kinolone naj se izogibajo direktnemu stiku z zdravilom.
English: Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
Slovenian: Stalna uporaba iste vrste antibiotikov ima lahko za posledico rezistenco mikroorganizmov.
English: The recommended dose of difloxacin is 5 mg/kg bodyweight per day.
Slovenian: Priporočljiv dnevni odmerek difloksacina znaša 5 mg/kg telesne mase.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
English: 4 OJ No. L 272 of 25.10.96
Slovenian: 4 OJ št. L 172 z dne 25.10.96
English: The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Slovenian: Peroralno dajanju petkrat večjih odmerkov difloksacina v obdobju 30 dni ni povzročilo nastanka neželenih učinkov.
English: 1 OJ No. L 172 of 02.07.02
Slovenian: 1 OJ št. L 172 z dne 02.07.02
English: Not permitted for use in laying birds producing eggs for human consumption.
Slovenian: Ni dovoljena uporaba pri pticah v obdobju valjenja, katerih jajca so namenjena za prehrano ljudi..
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: BESEDILO ”SAMO ZA ŽIVALI” Samo za živali.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Slovenian: POSEBNA OPOZORILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25˚C.
English: Meat and offal (chicken and turkeys): 24 hours.
Slovenian: Meso in organi (piščancev in puranov): 24 ur
English: 2 OJ No. L 172 of 02.07.02
Slovenian: 2 OJ št. L 172 z dne 02.07.02
English: Difloxacin (as hydrochloride)
Slovenian: Difloksacin (v obliki klorida)
English: METHOD AND ROUTE OF ADMINISTRATION Subcutaneous use.
Slovenian: NAČIN UPORABE IN DAJANJA Subkutano dajanje.
English: For oral administration in drinking water.
Slovenian: Zdravilo se daje peroralno v vodo za pitje.
English: 9 OJ No. L 45 of 15.02.97
Slovenian: 9 OJ št. L 45 z dne 15.02.97
English: [MA Number recommended, but not required on the immediate label] EU/2/97/003/016
Slovenian: /Številka dovoljenja je priporočljiva, ni pa obvezna na stični ovojnini/ EU/2/97/003/016
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
English: TARGET SPECIES Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 kg body weight).
Slovenian: CILJNA ŽIVALSKA VRSTA Piščanci (brojlerji in piščanci za matično jato) in purani (mladi purani, težki do 2 kg)
English: Mycoplasma spp.
Slovenian: Mycoplasm spp.
English: Not for use in animals from which milk is produced for human consumption
Slovenian: Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
English: Turkeys only - for the treatment of infections caused by Pasteurella multocida.
Slovenian: Pri puranih: Za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
English: It is well distributed in the body (Vd = 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Slovenian: Dobro se distribuira po organizmu (Vd = 4,7 l/kg).
English: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp.
Slovenian: • akutnih nekompliciranih infekcij urinarnega trakta, ki jih povzročata Escherichia coli ali Staphylococcus spp.,
English: Dicural Coated Tablets should only be used based on susceptibility testing.
Slovenian: Dicural filmsko obložene tablete uporabljajte le na osnovi predhodnih testiranj občutljivosti povzročiteljev.
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/016-018
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/016-018
English: After subcutaneous administration of difloxacin peak plasma levels of 1.7 g/ml are achieved at 6 hours post dosing.
Slovenian: Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,7 μg/ml v 6 urah po dajanju.
English: Cattle: Cardboard box with one glass vial of 50ml, 100ml or 250 ml with a rubber stopper and aluminium cap.
Slovenian: Kartonska škatla s stekleno vialo po 50, 100 ali 250 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
English: METHOD AND ROUTE OF ADMINISTRATION Oral use.
Slovenian: NAČIN UPORABE IN DAJANJA Peroralna uporaba.
English: TARGET SPECIES Cattle (calves and young cattle)
Slovenian: CILJNA ŽIVALSKA VRSTA Govedo (teleta in mlado govedo)
English: • Superficial pyoderma caused by Staphylococcus intermedius.
Slovenian: • površinske pioderme, ki jo povzroča Staphylococcus intermedius.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: The recommended dose is 2.5 mg difloxacin/kg bodyweight/day for 3 days (that is, 5ml/100 kg bodyweight/day).
Slovenian: Priporočljiv dnevni odmerek difloksacina znaša 2,5 mg/kg telesne mase v obdobju 3 dni ( to ustreza 5 ml/100 kg/dan).
English: The following organisms were tested and found to be susceptible to difloxacin in vitro:
Slovenian: Študije in vitro so pokazale, da so na difloksacin občutljivi naslednji mikroorganizmi:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE Dicural 50 mg/ml solution for injection for cattle OUTER CARTON for 100 ml vial / 250 ml vial / VIAL LABEL 100 ml vial / 250 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN NA STIČNI, OZ.PRIMARNI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda KARTONSKA ŠKATLA za 100 ml steklenico / 250 ml steklenico/ STIČNA OVOJNINA ZA 100 ml steklenico/ 250 ml steklenico
English: In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Slovenian: Največ difloksacina je v nespremenjeni obliki v blatu, urinu in v tkivih-jetrih, maščobi in ledvicah, manj pa v obliki metabolitov (desmetil difloksacina in difloksacin-N-oksida).
English: Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution.
Slovenian: Dicural peroralna raztopina je rumenkasta bistra vodna raztopina, pakirana v plastenke po 250 ali 1000 ml, zaprte z navojno zaporko.
English: Difloxacin Bovine2
Slovenian: Difloksacin Difloksacin Govedo 2
English: DATE OF RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE /PODALJŠANJA DOVOLJENJA ZA PROMET
English: Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Slovenian: Piščanci in purani: zdravljenje kroničnih respiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
English: As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Slovenian: Tako kot drugi fluorokinoloni tudi difloksacin učinkuje zaviralno na rast in obnavljanje sklepnega hrustanca, zato ga ne uporabite pri psih v fazi hitre rasti, ki je pri majhnih in srednje velikih pasmah psov do 8. meseca starosti, pri večjih pasmah do 1 leta, pri izredno velikih pasmah psov pa do 18.meseca starosti.
English: Marketing authorisation holder: Pfizer Limited
Slovenian: Imetnik dovoljenja za promet z zdravilom: Pfizer Limited
English: In target animal safety studies, subcutaneous administration was generally well tolerated.
Slovenian: Ciljne živali zdravilo na splošno dobro prenašajo.