natgillin/translations-raw huggingface dataset:
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
BESEDILO ”SAMO ZA ŽIVALI” Samo za živali.
SPECIAL STORAGE CONDITIONS Do not store above 25 °C. 
POSEBNA OPOZORILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25˚C.
Meat and offal (chicken and turkeys): 24 hours. 
Meso in organi (piščancev in puranov): 24 ur
2 OJ No. L 172 of 02.07.02 
2 OJ št. L 172 z dne 02.07.02
Difloxacin (as hydrochloride) 
Difloksacin (v obliki klorida)
METHOD AND ROUTE OF ADMINISTRATION Subcutaneous use. 
NAČIN UPORABE IN DAJANJA Subkutano dajanje.
For oral administration in drinking water. 
Zdravilo se daje peroralno v vodo za pitje.
9 OJ No. L 45 of 15.02.97 
9 OJ št. L 45 z dne 15.02.97
[MA Number recommended, but not required on the immediate label] EU/2/97/003/016 
/Številka dovoljenja je priporočljiva, ni pa obvezna na stični ovojnini/ EU/2/97/003/016
Shelf life of the veterinary medicinal product as packaged for sale: 2 years 
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
TARGET SPECIES Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 kg body weight). 
CILJNA ŽIVALSKA VRSTA Piščanci (brojlerji in piščanci za matično jato) in purani (mladi purani, težki do 2 kg)
Mycoplasma spp. 
Mycoplasm spp.
Not for use in animals from which milk is produced for human consumption 
Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
Turkeys only - for the treatment of infections caused by Pasteurella multocida. 
Pri puranih: Za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
It is well distributed in the body (Vd = 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours. 
Dobro se distribuira po organizmu (Vd = 4,7 l/kg).
• Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp. 
• akutnih nekompliciranih infekcij urinarnega trakta, ki jih povzročata Escherichia coli ali Staphylococcus spp.,
Dicural Coated Tablets should only be used based on susceptibility testing. 
Dicural filmsko obložene tablete uporabljajte le na osnovi predhodnih testiranj občutljivosti povzročiteljev.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/016-018 
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/016-018
After subcutaneous administration of difloxacin peak plasma levels of 1.7 g/ml are achieved at 6 hours post dosing. 
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,7 μg/ml v 6 urah po dajanju.
Cattle: Cardboard box with one glass vial of 50ml, 100ml or 250 ml with a rubber stopper and aluminium cap. 
Kartonska škatla s stekleno vialo po 50, 100 ali 250 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
METHOD AND ROUTE OF ADMINISTRATION Oral use. 
NAČIN UPORABE IN DAJANJA Peroralna uporaba.
TARGET SPECIES Cattle (calves and young cattle) 
CILJNA ŽIVALSKA VRSTA Govedo (teleta in mlado govedo)
• Superficial pyoderma caused by Staphylococcus intermedius. 
• površinske pioderme, ki jo povzroča Staphylococcus intermedius.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
The recommended dose is 2.5 mg difloxacin/kg bodyweight/day for 3 days (that is, 5ml/100 kg bodyweight/day). 
Priporočljiv dnevni odmerek difloksacina znaša 2,5 mg/kg telesne mase v obdobju 3 dni ( to ustreza 5 ml/100 kg/dan).
The following organisms were tested and found to be susceptible to difloxacin in vitro: 
Študije in vitro so pokazale, da so na difloksacin občutljivi naslednji mikroorganizmi:
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 
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
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. 
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).
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. 
Dicural peroralna raztopina je rumenkasta bistra vodna raztopina, pakirana v plastenke po 250 ali 1000 ml, zaprte z navojno zaporko.
Difloxacin Bovine2 
Difloksacin Difloksacin Govedo 2
DATE OF RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE /PODALJŠANJA DOVOLJENJA ZA PROMET
Chickens and turkeys - for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum. 
Piščanci in purani: zdravljenje kroničnih respiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
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. 
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.
Marketing authorisation holder: Pfizer Limited 
Imetnik dovoljenja za promet z zdravilom: Pfizer Limited
In target animal safety studies, subcutaneous administration was generally well tolerated. 
Ciljne živali zdravilo na splošno dobro prenašajo.
WITHDRAWAL PERIOD Cattle: Meat and offal: 46 days 
KARENCA Govedo:Meso in organi: 46 dni
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each ml contains: 
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsak ml peroralne raztopine vsebuje:
Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking water at 30 mg/kg (chickens) or 22 mg/kg (turkeys) for three times the recommended duration (15 consecutive days), difloxacin hydrochloride appeared to be safe for the birds. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Poskusi pri ciljnih živalskih vrstah so pokazali, da je difloksacinijev klorid v dnevnih predpisanih odmerkih (30 mg/kg pri piščancih in 22 mg/kg pri puranih) tudi pri trikrat daljšem dajanju (15 dni) varen za ptice.
Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma. 
Z dajanjem difloksacina prenehamo, če po 5 dneh zdravljenja ni učinka, oziroma po 10 dneh pri zdravljenju pioderme.
Shelf-life after first use of the product: 28 days. 
Rok uporabnosti zdravila po prvem odprtju vsebnika:28 dni.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/004-015 
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/004-015
Do not store above 25°C. 
Shranjujte pri temperaturi do 25˚ C.
For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight/ day. 
Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg telesne mase/dan.
If filled to the brim the measuring device provides 50ml. 
Napolnjen do roba znaša 50 ml.
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Limited 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pfizer Limited
Chickens: 
Karenca:
The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended. 
Uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.
PACKAGE LEAFLET FOR Dicural 100 mg/ml oral solution for chickens and turkeys 
Dicural 100 mg/ml, peroralna raztopina za piščance in purane
It is very well distributed in the body (Vd = 9.9 l/kg) and has a plasma elimination half-life of approximately 7 hours. 
Po organizmu se dobro distribuira (Vd = 9,9 l/kg).
Following continuous oral dosing with Dicural oral solution at 10 mg/kg/day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 200 ng/ml. 
Pri pet dnevnem dajanju peroralne raztopine Dicural v odmerku 10 mg/kg/dan znašajo plezemske koncentracije difloksacina približno 200 μg/ml.
Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract infections. 
Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično, posebno pri zdravljenju urinarnih infekcij.
PACKAGE LEAFLET FOR Dicural coated tablets for dogs 
Dicural filmsko obložene tablete za pse
300 µg/kg 400 µg/kg 1900 µg/kg 600 µg/kg 
300 μg/kg 400 μg/kg
Oral use. 
NAČIN UPORABE
Difloxacin acts primarily through inhibition of bacterial DNA gyrase. 
Difloksacin učinkuje tako, da inhibira DNA girazo mikroorganizmov.
The main metabolites are hydrolysable conjugates of difloxacin, the other metabolites are proportionally minor ones. 
Glavni metabolit je hidroliziran konjugat difloksacina.
TARGET SPECIES Cattle (calves and young cattle)\ Dogs 
CILJNE ŽIVALSKE VRSTE Govedo (teleta in mlado govedo) Psi
PACKAGE SIZE 10 tablets 20 tablets 100 tablets 
VELIKOST PAKIRANJA 10 tablet
Do not use after the expiry date stated on the label after EXP 
Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na nalepki.
Benzyl alcohol Propylene glycol Arginine 
Benzilalkohol Propilenglikol Arginin
Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase. 
Difloksacinijev klorid učinkuje bakteriocidno tako, da inhibira DNA girazo mikroorganizmov.
TARGET SPECIES Cattle (calves and young cattle) and dogs 
CILJNA ŽIVALSKA VRSTA Govedo (teleta, mlado govedo) in psi
The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating micro-organisms. 
Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ne glede na to, ali so v fazi replikacije ali ne.
Do not use after the expiry date stated on the carton after EXP. 
Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na ovojnini.
MARKETING AUTHORISATION NUMBERS EU/2/97/003/001-003 
ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/001-3
For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day. 
Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg/dan.
Medium Large 
Srednji psi
Dicural oral solution should only be used based on susceptibility testing 
Dicural peroralna raztopina se uporablja samo po predhodnih testih na občutljivost povzročitelja.
In turkeys difloxacin has a moderate oral bioavailability (approx. 58%). 
Pri puranih je biološka uporabnost peroralno apliciranega difloksacina približno 58 %.
6.2 Incompatibilities 
6.2 Glavne inkopatibilnosti
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 antibiotics. 
Zato fluorokinolonskih pripravkov ne uporabljati za zdravljenje infekcij, kjer ni učinka ali pa je slabši od pričakovanega, ampak uporabite druge, ustrezne antibiotike.
White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution. 
Bela steklenica (HDPE) za 250 ml ali 1 liter, zaprta z navojno zaporko.
Muscle Skin + fat Liver Kidney 
Mišičnina Koža in maščoba Jetra
A new injection site should be used each day. 
Zdravilo aplicirajte vsaki dan na drugo mesto.
Active substance: 
Preveliki odmerki:
After subcutaneous administration the bioavailability is 88% and the volume of distribution is 2.5 l/kg. 
Po subkutanem dajanju je njegova biološka razpoložljivost 88%.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
BESEDILO ”ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight). 
CILJNE ŽIVALSKE VRSTE Piščanci (brojlerji in piščanci namenjeni za matično jato Purani (mladi purani, težki do 2 kg).
No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product. 
Vodi, v kateri je primešano zdravilo, ne dodajajte klorovih pripravkov (za kloriranje vode) ali vodikovega peroksida.
7 OJ No. L 143 of 27.06.95 
7 OJ št. L 143 z dne 27.06.95
Dogs treated orally with difloxacin (as hydrochloride) at 10 times the recommended dose for 10 days occasionally showed mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation. 
Psi, ki so dobivali 10 dni zapovrstjo difloksacinijev klorid v 10 krat večjem odmerku od predpisanega, so pokazali rahle znake neželenih učinkov, kot so: rumeno-oranžno obarvanost blata, slabost in povečano slinjenje.
Marketing authorisation holder Pfizer Limited 
Imetnik dovoljenja za promet z zdravilom Pfizer Limited
For the 250 ml bottle a separate measuring device is placed on the screw cap. 
Pri 250 ml steklenici je merica priložena.
Name and address of the manufacturers responsible for batch release: 
Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije: Za vse tri farmacevtske oblike:
6 OJ No. L 143 of 27.06.95 
6 OJ št. L 143 z dne 27.06.95
ACTIVE SUBSTANCES Difloxacin (as hydrochloride) 50 mg/ml 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Difloksacin (v obliki klorida) 50 mg/ml
In turkeys: Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida. 
Pri puranih tudi za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
• Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp. 
• Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
Difloxacin is well distributed throughout the animal body, as was demonstrated by the tissue to plasma ratios. 
Difloksacin se dobro distribuira po organizmu v različne organe.
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg/ml oral solution for chickens and turkeys 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg/ml peroralna raztopina za piščance in purane
Muscle Fat Liver Kidney 
Mišičnina Maščoba Jetra
Official and local antimicrobial policies should be taken into account when the product is used. 
Zdravilo je treba uporabiti v skladu z lokalnimi predpisi s področja protimikrobnega zdravljenja.
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/016 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/016
To be supplied only on veterinary prescription. 
Oskrba le na podlagi veterinarskega recepta.
Antagonism may be observed with nitrofurantoin. 
Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično.
In cattle: Dicural 50 mg/ml solution for injection is indicated for the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp. 
Dicural 50mg/ml raztopino za injiciranje uporabljamo za zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajo-samostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver). 
Pri pet dnevnem dajanju Dicurala v odmerku 10 mg/kg/dan znašajo plezemske koncentracije približno 60 μg/ml.Koncentracija difloksacina v organih pa so različne in znašajo od 2,5 v abdominalni maščobi, do 3,7 v mišicah in 36,5 v jetrih.
A fraction of difloxacin is eliminated by the urine. 
Največ difloksacina se izloči z blatom, manj pa z urinom.
In chickens and turkeys: Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum. 
Dicural - peroralna raztopina se uporablja za zdravljenje kroničnih repsiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
8 OJ No. L 143 of 26.06.95 
8 OJ št. L 143 z dne 27.06.95
Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp. 
Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
For animal treatment only - to be supplied only on veterinary prescription.. 
Samo za živali - oskrba le na podlagi veterinarskega recepta.
In another study dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation. 
Pri desetkrat večjih odmerkih, danih peroralno v obdobju 10 dni, pa so se pokazali blagi neželeni učinki, kot je rumeno-oranžno obarvano blato, emezija in povečano slinjenje
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/001 - 1 x 250 ml EU/2/97/003/002 - 1 x 1000 ml EU/2/97/003/003 - 6 x 1000 ml 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/001 - 1 x 250 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs CARTON for 50 ml vial 
PODATKI NA ZUNANJI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse Kartonska škatla za 50 ml steklenico
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance 
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Zdravilne učinkovine
No other source of drinking water should be available during the medication period. 
V času zdravljenja naj bo to edina voda za pitje.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 100 mg 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 100 mg
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling this product. 
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic in zaščitne obrazne maske in očal.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 
NAČIN(I) UPORABE ZDRAVILA Subkutano dajanje.
B. PACKAGE LEAFLET 
DODATEK II
Cattle: Meat and offal: 46 days 
Meso in organi: 46 dni Psi:
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 150 mg 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 150 mg
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs Difloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse Difloksacin
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION 
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 15 mg 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 15 mg
The medicated drinking water should be prepared freshly each day. 
Dnevno naj se pripravi sveža voda za pitje, kateri je primešano zdravilo.
Antacids may interfere with gastro-intestinal absorption. 
Istočasna uporaba antacidov lahko zmanjša enteralno resorbcijo difloksacina.
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 150 mg filmsko obložene tablete za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle and dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda in pse
Dicural 100 mg difloxacin (as hydrochloride) 
Dicural 100 mg difloksacin (v obliki klorida)
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs Difloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse Difloksacin
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 50 mg 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 50 mg
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs Difloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse Difloksacin
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse
Dicural 150 mg difloxacin (as hydrochloride) 
Dicural 150 mg difloksacin (v obliki klorida)
For animal treatment only -to be supplied only on veterinary prescription. 
Samo za živali-oskrba le na podlagi veterinarskega recepta.
In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device, when handling this product. 
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic, zaščitne maske in očal.
Dicural 15 mg difloxacin (as hydrochloride) 
Dicural 15 mg difloksacin (v obliki klorida)
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/013 - 10 tablets EU/2/97/003/014 - 20 tablets EU/2/97/003/015 - 100 tablets 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/013 - 10 tablet
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse
Dicural 50 mg difloxacin (as hydrochloride) 
Dicural 50 mg difloksacin (v obliki klorida)
PACKAGE LEAFLET FOR: Dicural 50 mg/ml solution for injection for cattle and dogs 
Dicural 50 mg/ml, raztopina za injiciranje za goveda in pse
Coated tablets 
100 tablet
Dogs: Not applicable 
NEŽELENI UČINKI
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/004 - 10 tablets EU/2/97/003/005 - 20 tablets EU/2/97/003/006 - 100 tablets 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/004 - 10 tablet
Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin. 
Na učinkovanje difloksacina so občutljivi naslednji mikroorganizmi, izolirani iz piščancev in puranov: Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum.
The fluoroquinolones exert their antibacterial effect against both replicating and dormant microorganisms. 
Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ki so v fazi replikacije, kot tistim, ki so v fazi transkripcije pri delitvi celic.
WITHDRAWAL PERIOD Withdrawal period: Cattle - meat and offal 46 days 
KARENCA Karenca: Govedo-meso in organi 46 dni
MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/010 - 10 tablets EU/2/97/003/011 - 20 tablets EU/2/97/003/012 - 100 tablets 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/010 - 10 tablet
Turkeys: 
Purani
Cattle (calves and young cattle) Dogs. 
Govedo (teleta in mlado govedo) Psi
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs 50 ml vial label 
PODATKI NA STIČNI, OZ.PRIMARNI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse 50 ml steklenica
Active substance 
Zdravilne učinkovine