natgillin/translations-raw huggingface dataset:
This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart). 
Sem spadajo bolniki, pri katerih naj bi se izvedla perkutana transluminalna koronarna angioplastika (PTCA, tj. vrsta kirurškega posega za čiščenje arterij, ki oskrbujejo srce).
What are the benefits and risks of Eptifibatide Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Eptifibatide Accord?
• patients who have unstable angina (chest pain caused by poor blood flow to the heart, that may occur at rest or without an obvious trigger); 
• bolnikih, ki imajo nestabilno angino pektoris (bolečine v prsnem košu zaradi slabega pretoka krvi v srce, ki se lahko pojavijo med počitkom ali brez očitnega sprožila);
Eptifibatide Accord is a ‘generic medicine'. 
Zdravilo Eptifibatide Accord je „generično zdravilo“.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eptifibatide Accord, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Eptifibatide Accord in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• patients who have already had a non-Q-wave myocardial infarction (a type of heart attack), with chest pain in the last 24 hours and with abnormalities on the electrocardiogram (ECG) or signs of heart problems in the blood. 
• bolnikih, ki so imeli miokardni infarkt brez zobca Q (vrsta srčnega napada), pri katerih so v zadnjih 24 urah bile prisotne bolečine v prsnem košu ter kažejo odstopanja od normalnega elektrokardiograma (EKG) ali znake v krvi, ki nakazujejo na težave s srcem.
For more information about treatment with Eptifibatide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Eptifibatide Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), infusion of Eptifibatide Accord can be continued for up to 24 hours after the procedure, with a maximum treatment duration of 96 hours. 
Kadar se pri bolniku opravi perkutani koronarni poseg (PCI ali angioplastika, tj. kirurški poseg za odmašitev zoženih koronarnih arterij), se lahko zdravljenje nadaljuje še največ 24 ur po kirurškem posegu, najdaljše skupno trajanje zdravljenja pa je 96 ur.
Other information about Eptifibatide Accord 
Druge informacije o zdravilu Eptifibatide Accord
Eptifibatide Accord is a medicine used to prevent a heart attack in adults. 
Zdravilo Eptifibatide Accord se uporablja za preprečevanje srčnih napadov pri odraslih.
For practical information about using Eptifibatide Accord, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Eptifibatide Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Eptifibatide Accord. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Eptifibatide Accord and what is it used for? 
Kaj je zdravilo Eptifibatide Accord in za kaj se uporablja?
This means that it helps to prevent cells in the blood called platelets sticking together (aggregating). 
To pomeni, da pomaga preprečevati zlepljanje krvnih celic, imenovanih trombociti.
Therefore, the CHMP's view was that, as for Integrilin, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Integrilin, odtehtajo znana tveganja.
Eptifibatide Accord is an inhibitor of platelet aggregation. 
Zdravilo Eptifibatide Accord je zaviralec agregacije trombocitov.
Why is Eptifibatide Accord approved? 
Zakaj je bilo zdravilo Eptifibatide Accord odobreno?
No additional studies were needed as Eptifibatide Accord is a generic medicine that is given by injection and infusion into a vein and contains the same active substance as the reference medicine, Integrilin. 
Ker je zdravilo Eptifibatide Accord generično zdravilo, ki se daje z injiciranjem in infundiranjem v veno in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Integrilin, niso bile potrebne nobene dodatne študije.
The medicine contains the active substance eptifibatide. 
Zdravilo Eptifibatide Accord vsebuje zdravilno učinkovino eptifibatid.
How has Eptifibatide Accord been studied? 
Kako je bilo zdravilo Eptifibatide Accord raziskano?
How is Eptifibatide Accord used? 
Kako se zdravilo Eptifibatide Accord uporablja?
How does Eptifibatide Accord work? 
Kako zdravilo Eptifibatide Accord deluje?
Each tablet contains: 
Vsaka tableta vsebuje:
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
Approximately 95 % of the oral dose was absorbed. 
Približno 95 % peroralnega odmerka se absorbira.
Cardboard boxes of 1, 2 or 10 blisters. 
Kartonska škatla z 1, 2 ali 10 blistri.
Do not use in epileptic dogs. 
Ne uporabite pri psih, ki imajo epilepsijo.
ATC vet code: QJ01MA94 
ATC vet oznaka: QJ01MA94
D. STATEMENT OF THE MRLs which are accepted in accordance with Council Regulation (EEC) No 2377/90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/93 of 22 July 1993, as amended. 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) ki so sprejete v skladu z Uredbo Sveta (EGS) št. 2377/90 in v skladu s členom 31 (3b) Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, kot sledi.
4.8 Interaction with other veterinary medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In general the pruritis disappears within a few minutes and the local swelling within a few days. 
Pruritis preneha v nekaj minutah, oteklina pa izgine v nekaj dneh.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
BESEDILO ”SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days. 
Če po treh dneh zdravljenja ni bistvenega izboljšanja, nadaljujte z zdravljenjem še dva dni.
The volume of distribution is 2.6 l/kg. 
Distribucijski volumen znaša 2,6 l/kg.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. 
Imetnik tega dovoljenja mora obvestiti evropsko komisijo o načrtih trženja tega zdravila.
Ethanol 8 
Etanol 8
After subcutaneous administration the bioavailability is 96%. 
Po subkutanem dajanju je njegova biološka razpoložljivost 96%.
For a full list of excipients, see section 6.1 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1
4.10 Overdose (symptoms, emergency procedures, antidotes) 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
Keep the container in the outer carton. 
Vsebnik shranjujte v zunanji ovojnini.
number of animals in the house X mean weight of individual animal(kg) X 100 
število živali v hlevu X povprečna masa posamezne živali (kg) X 100
PVC/aluminium blisters with 10 tablets per blister. 
PVC/aluminijast blister z 10 filmsko obloženimi tabletami.
Treatment of: 
Zdravljenje:
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected. 
Uporaba 0,03 % koncentracije vodne raztopine (= 300 ml v 1000 litrov) ali večje pri puranih ni smiselna.
The screw cap on the 1 litre bottle can be used as measuring device. 
Zamašek pri litrski steklenici se lahko uporabi kot merica.
Cattle: 50, 100 and 250 ml vials. 
Za goveda: 100 in 250 ml viala
Difloxacin 
Difloksacin
CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS 
KARTONSKA ŠKATLA Z 10 TABLETAMI / 20 TABLETAMI / 100 TABLETAMI
Each strength of the product is available in packs of 10, 20 and 100 tablets. 
Vse navedene koncentracije tablet so na razpolago v pakiranju po 10, 20 ali 100 tablet.
Special precautions for use in animals 
Posebni previdnosti ukrepi za uporabo pri živalih
Medicated water must be freshly prepared daily. 
Medicirano vodo pripravite vsak dan svežo.
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. 
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.
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period. 
Ne uporabite pri pticah v obdobju nesnosti in/ali 4 tedne pred začetkom obdobja nesnosti.
The tablets should be administered for at least 2 days beyond the cessation of clinical signs. 
Tablete se dajejo vsaj še dva dni po prenehanju kliničnih znakov bolezni.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products 
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%). 
Pri piščancih se difloksacin po peroralnem dajanju skoraj v celoti resorbira (približno 96 %).
Annex II of Council Regulation (EEC) No 2377/90 Oral solution: 
Dodatek II Uredbe Sveta (EGS) št. 2377/90 Peroralna raztopina
The elimination half-life averaged 9.3 hours. 
Razpolovni čas izločanja znaša približno 9,3 ur.
4.2 Indications for use, specifying the target species For the treatment of: 
4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste Za zdravljenje:
The administration must be continued for 5 days. 
Zdravljenje traja 5 dni.
EXPIRY DATE EXP {month/year} 
DATUM IZTEKA UPORABNOSTI EXP{ mesec/leto}
A half-life time of 5.8 hours has been observed. 
Razpolovni čas izločanja je 5,8 ur.
Annex I of Council Regulation (EEC) No 2377/90 Pharmacologically active substance residue 
Dodatek I Uredbe Sveta (EGS) št. 2377/90 Farmakološko aktivna snov zaostanek dovoljene količine zaostankov (MRL)
Solution for injection: Pharmacologically active substance 
Raztopina za injiciranje: Farmakološko aktivna snov Živalska vrsta
Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity. 
Difloksacin je aril-fluorokinolon s širokim spektrom protimikrobnega učinkovanja.
Blister label 
Etiketa na blistru
Propylene glycol 9 Benzyl alcohol 10 Arginine 11 
Propilenglikol 9 Benzilakohol 10 Arginin 11
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 
Če opazite kakršne koli druge neželene učinke, obvestite svojega veterinarja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilne učinkovine
Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials. 
Farmakoterapevtska skupina: splošni antbiotik za sistemsko uporabo; antibakterik za sistemsko uporabo; kinolonski antibakterik
Adverse reactions were rare in dogs treated with difloxacin. 
Neželeni učinki so pri psih, zdravljenih z difloksacinom, redki.
For oral use. 
Za peroralno dajanje.
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. 
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.
4.2 Indications for use, specifying the target species 
4.2 Indikacije za uporabo, opredelitev ciljne živalske vrste
The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg. 
Hitrost distribuiranja difloksacina po subkutanem dajanju je 229 ml/h/kg.
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 
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
Benzyl alcohol6 
Benzilalkohol 6
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: 
Za pripravo ustrezne koncentracije difloksacina v vodi za pitje (10 %V/V) izračunajte količino ml zdravila za 1000 litrov vode:
3 OJ No. L 290 of 5.12.95 
3 OJ št. L 290 z dne 5.12.95
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. 
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.
PHARMACEUTICAL FORM Coated tablets 
FARMACEVTSKA OBLIKA Filmsko obložena tableta
Superficial pyoderma may require treatment for up to a maximum of 21 days. 
Zdravljenje traja najmanj 5 dni; zdravljenje površinske pioderme pa do največ 21 dni.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing. 
Če je le mogoče, se zdravljenje s fluorokinoloni izvaja po predhodnem testiranju občutljivosti povzročiteljev.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains: 
NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsaka tableta vsebuje:
Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in a few hours after initiation of medication. 
Difloksacin se po peroralnem dajanju hitro absorbira in doseže ustrezno koncentracijo v plazmi v nekaj urah po dajanju.
Edetic acid3 
Edetična kislina 3
Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive microorganisms. 
Difloksacin učinkuje bakteriocidno na številne po Gramu negativne mikroorganizme in selektivno na po Gramu pozitivne mikroorganizme.
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. 
Koncentracija difloksacina v različnih tkivih je enaka ali večja kot je MIC za relevantne mikroorganizme in traja toliko časa, kot traja zdravljenje.
PACKAGE SIZE 100 ml 
VELIKOST PAKIRANJA 100 ml
The observed reactions were inappetence, emesis, diarrhoea, and anal irritation. 
Kažejo se v zmanjšanju apetita, pojavu slabosti, driske in iritacije anusa.
MANUFACTURER'S BATCH NUMBER Lot {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija:{številka}:
Potassium Hydroxide4 Propylene glycol5 
Kalijev hidroksid 4 Propilenglikol 5
Manufacturer for the batch release Pfizer Olot, S.L.U. 
Izdelovalec, odgovoren za sproščanje serije Pfizer Olot, S.L.U.
4.11 Withdrawal period Not applicable. 
4.11 Karenca(e) Navedba ni smiselna.
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC ZDRAVILA IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
PHARMACEUTICAL FORM Solution for injection. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE 
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE UPORABE
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 
KARTONSKA OVOJNINA 1 X 250 ml STEKLENICA /1 X 1000 ML STEKLENICA / 6 X 1000 ML STEKLENICA
10 OJ No L 143 of 26.06.95 11 OJ No. L 240 of 10.09.99 
10 OJ št. L 143 z dne 26.06.95 11 OJ št. L 240 z dne 10.09.99
Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations: Dogs: 50 ml vial. 
Dicural 50 mg/ml, raztopina za injiciranje za govedo in pse je na razpolago v naslednjih pakiranjih: Za pse: 50 ml viala
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. 
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.
Pharmacologically active substance 
Farmakološko aktivna snov Živalska vrsta
People with a known hypersensitivity to quinolones should avoid any contact with the product. 
Osebe z znano preobčutljivostjo na kinolone naj se izogibajo stiku z zdravilom.
Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Sodium lauryl sulphate 
Natrijev karboksimetilškrob Mikrokristalna celuloza Magnezijev stearat Silikondioksid, koloidni Natrijev laurilsulfat
Shelf-life after first opening the container: 1 month. 
Rok uporabnosti po prvem odpiranju neposredne ovojnice: 1 mesec.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Podrobne informacije o produktu so na voljo na spletni strani Evropske agencije za zdravila http:/www.ema.europa.eu/
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
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/
After subcutaneous administration of difloxacin peak plasma levels of 1.4 -1.9 g/ml are achieved in 3.1 hours post dosing. 
Po subkutanem dajanju doseže difloksacin največjo koncentracijo v plazmi 1,4-1,9 μg/ml v 3,1 urah po dajanju.
Dogs: Cardboard box with one glass vial of 50ml with a rubber stopper and aluminium cap. 
Psi: Kartonska škatla s stekleno vialo za 50 ml, zaprto z gumijastim zamaškom in aluminijastim pokrovom.
The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures. 
Kombinacija fluorokinolonov in nesteroidnih antiinflamatorikov (NSAID) lahko pri epilepsiji sproži napad.
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. 
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.
These adverse reactions were self-limiting within one or two days and did not require additional treatment. 
Ti neželeni učinki izginejo brez posebnega zdravljenja v enem do dveh dneh.
400 µg/kg 100 µg/kg 1400 µg/kg 800 µg/kg 
400 μg/kg 100 μg/kg 1400 μg/kg 800 μg/kg
Animal Species 
CILJNE ŽIVALSKE VRSTE
Cattle: None. 
Govedo: Niso znane.
No specific antidotes for difloxacin (or other quinolones) are known, therefore in case of overdosage symptomatic treatment should be given. 
Ni specifičnega antidota za difloksacin (in druge kinolone), zato je zdravljenje pri prevelikem odmerjanju simptomatsko.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml peroralne raztopine vsebuje:
A fraction of difloxacin (i.e. 7 - 18%) is eliminated via the urine. 
Največ difloksacina (68-82%) se izloči z blatom, manjša količina (7-18%) pa z urinom.
Excipients: Benzyl alcohol 
Nosilci: Benzilalkohol
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. 
Pri klinično šepavih pticah niso bile opravljene študije, zato zdravila ne uporabljati pri pticah, ki šepajo ali imajo ugotovljeno osteoporozo.
In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin. 
Pri obeh vrstah se difloksacin metabolizira v sarafloksacin (desmetil difloksacin) ali pa oksidira v Noksid-difloksacin.
Edetic acid Potassium hydroxide Propylene glycol Benzyl alcohol Purified water 
Edetična kislina Kalijev hidroksid Propilenglikol Benzilakohol Prečiščena voda
Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones 
Mutacija gena giraze v bakterijski celici in sprememba v prepustnosti celične membrane na kinolone lahko pripelje do nastanka rezistence proti kinolonskim pripravkom.
Difloxacin Poultry1 
Difloksacin Difloksacin Perutnina 1
All food-producing species 
Vse živalske vrste, namenjene prehrani ljudi
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 
Ni dokazana varnost zdravila v obdobju brejosti in laktacije.
5 OJ No. L 45 of 15.02.97 
5 OJ št. L 45 z dne 15.02.97
BATCH NUMBER Lot {number} 
ŠTEVILKA SERIJE Serija: { številka}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
MARKETING AUTHORISATION NUMBER(S) [Recommended, but not required on the immediate label] EU/2/97/003/017 - 100 ml 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL /Priporočeno, vendar ni obvezno na stični ovojnini/ EU/2/97/003/17 - 100 ml
Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver). 
Koncentracije difloksacina v organih so različne in znašajo od 0,6 v abdominalni maščobi do 2,4 v pljučih in 14,1 v jetrih.
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. 
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.
At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle. 
Pri zelo velikih odmerkih se pokažejo učinki na živčni sistem (ataksija, zanašanje, drgetanje, krči in drugo).
SPECIAL WARNING(S), IF NECESSARY People with a known hypersensitivity to quinolones should avoid any contact with the product. 
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Osebe z znano preobčutljivostjo na kinolone naj se izogibajo direktnemu stiku z zdravilom.
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population. 
Stalna uporaba iste vrste antibiotikov ima lahko za posledico rezistenco mikroorganizmov.
The recommended dose of difloxacin is 5 mg/kg bodyweight per day. 
Priporočljiv dnevni odmerek difloksacina znaša 5 mg/kg telesne mase.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
4 OJ No. L 272 of 25.10.96 
4 OJ št. L 172 z dne 25.10.96
The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions. 
Peroralno dajanju petkrat večjih odmerkov difloksacina v obdobju 30 dni ni povzročilo nastanka neželenih učinkov.
1 OJ No. L 172 of 02.07.02 
1 OJ št. L 172 z dne 02.07.02
Not permitted for use in laying birds producing eggs for human consumption. 
Ni dovoljena uporaba pri pticah v obdobju valjenja, katerih jajca so namenjena za prehrano ljudi..