FrancophonIA/ELRC3.0 huggingface dataset:
English: WITHDRAWAL PERIOD Cattle: Meat and offal: 46 days
Slovenian: KARENCA Govedo:Meso in organi: 46 dni
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each ml contains:
Slovenian: NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Vsak ml peroralne raztopine vsebuje:
English: 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.
Slovenian: 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.
English: Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
Slovenian: Z dajanjem difloksacina prenehamo, če po 5 dneh zdravljenja ni učinka, oziroma po 10 dneh pri zdravljenju pioderme.
English: Shelf-life after first use of the product: 28 days.
Slovenian: Rok uporabnosti zdravila po prvem odprtju vsebnika:28 dni.
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/004-015
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/004-015
English: Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25˚ C.
English: For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight/ day.
Slovenian: Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg telesne mase/dan.
English: If filled to the brim the measuring device provides 50ml.
Slovenian: Napolnjen do roba znaša 50 ml.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Limited
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pfizer Limited
English: Chickens:
Slovenian: Karenca:
English: The use of difloxacin in pregnant or lactating bitches or male stud dogs is not recommended.
Slovenian: Uporaba ni priporočljiva pri samicah, ki so breje ali v obdobju laktacije ter pri samcih za razplod.
English: PACKAGE LEAFLET FOR Dicural 100 mg/ml oral solution for chickens and turkeys
Slovenian: Dicural 100 mg/ml, peroralna raztopina za piščance in purane
English: It is very well distributed in the body (Vd = 9.9 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Slovenian: Po organizmu se dobro distribuira (Vd = 9,9 l/kg).
English: 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.
Slovenian: Pri pet dnevnem dajanju peroralne raztopine Dicural v odmerku 10 mg/kg/dan znašajo plezemske koncentracije difloksacina približno 200 μg/ml.
English: Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract infections.
Slovenian: Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično, posebno pri zdravljenju urinarnih infekcij.
English: PACKAGE LEAFLET FOR Dicural coated tablets for dogs
Slovenian: Dicural filmsko obložene tablete za pse
English: 300 µg/kg 400 µg/kg 1900 µg/kg 600 µg/kg
Slovenian: 300 μg/kg 400 μg/kg
English: Oral use.
Slovenian: NAČIN UPORABE
English: Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
Slovenian: Difloksacin učinkuje tako, da inhibira DNA girazo mikroorganizmov.
English: The main metabolites are hydrolysable conjugates of difloxacin, the other metabolites are proportionally minor ones.
Slovenian: Glavni metabolit je hidroliziran konjugat difloksacina.
English: TARGET SPECIES Cattle (calves and young cattle)\ Dogs
Slovenian: CILJNE ŽIVALSKE VRSTE Govedo (teleta in mlado govedo) Psi
English: PACKAGE SIZE 10 tablets 20 tablets 100 tablets
Slovenian: VELIKOST PAKIRANJA 10 tablet
English: Do not use after the expiry date stated on the label after EXP
Slovenian: Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na nalepki.
English: Benzyl alcohol Propylene glycol Arginine
Slovenian: Benzilalkohol Propilenglikol Arginin
English: Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Slovenian: Difloksacinijev klorid učinkuje bakteriocidno tako, da inhibira DNA girazo mikroorganizmov.
English: TARGET SPECIES Cattle (calves and young cattle) and dogs
Slovenian: CILJNA ŽIVALSKA VRSTA Govedo (teleta, mlado govedo) in psi
English: The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating micro-organisms.
Slovenian: Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ne glede na to, ali so v fazi replikacije ali ne.
English: Do not use after the expiry date stated on the carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka uporabnosti, navedenega na ovojnini.
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/001-003
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU2/97/003/001-3
English: For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day.
Slovenian: Pri hudih respiratornih obolenjih odmerek povečajte na 5 mg/kg/dan.
English: Medium Large
Slovenian: Srednji psi
English: Dicural oral solution should only be used based on susceptibility testing
Slovenian: Dicural peroralna raztopina se uporablja samo po predhodnih testih na občutljivost povzročitelja.
English: In turkeys difloxacin has a moderate oral bioavailability (approx. 58%).
Slovenian: Pri puranih je biološka uporabnost peroralno apliciranega difloksacina približno 58 %.
English: 6.2 Incompatibilities
Slovenian: 6.2 Glavne inkopatibilnosti
English: It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Slovenian: Zato fluorokinolonskih pripravkov ne uporabljati za zdravljenje infekcij, kjer ni učinka ali pa je slabši od pričakovanega, ampak uporabite druge, ustrezne antibiotike.
English: White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution.
Slovenian: Bela steklenica (HDPE) za 250 ml ali 1 liter, zaprta z navojno zaporko.
English: Muscle Skin + fat Liver Kidney
Slovenian: Mišičnina Koža in maščoba Jetra
English: A new injection site should be used each day.
Slovenian: Zdravilo aplicirajte vsaki dan na drugo mesto.
English: Active substance:
Slovenian: Preveliki odmerki:
English: After subcutaneous administration the bioavailability is 88% and the volume of distribution is 2.5 l/kg.
Slovenian: Po subkutanem dajanju je njegova biološka razpoložljivost 88%.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Slovenian: BESEDILO ”ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
English: Chickens (broilers and future breeders) Turkeys (young turkeys up to 2 kg body weight).
Slovenian: CILJNE ŽIVALSKE VRSTE Piščanci (brojlerji in piščanci namenjeni za matično jato Purani (mladi purani, težki do 2 kg).
English: 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.
Slovenian: Vodi, v kateri je primešano zdravilo, ne dodajajte klorovih pripravkov (za kloriranje vode) ali vodikovega peroksida.
English: 7 OJ No. L 143 of 27.06.95
Slovenian: 7 OJ št. L 143 z dne 27.06.95
English: 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.
Slovenian: 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.
English: Marketing authorisation holder Pfizer Limited
Slovenian: Imetnik dovoljenja za promet z zdravilom Pfizer Limited
English: For the 250 ml bottle a separate measuring device is placed on the screw cap.
Slovenian: Pri 250 ml steklenici je merica priložena.
English: Name and address of the manufacturers responsible for batch release:
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije: Za vse tri farmacevtske oblike:
English: 6 OJ No. L 143 of 27.06.95
Slovenian: 6 OJ št. L 143 z dne 27.06.95
English: ACTIVE SUBSTANCES Difloxacin (as hydrochloride) 50 mg/ml
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Difloksacin (v obliki klorida) 50 mg/ml
English: In turkeys: Dicural oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.
Slovenian: Pri puranih tudi za zdravljenje infekcij, ki jih povzroča Pasteurella multocida.
English: • Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Slovenian: • Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
English: Difloxacin is well distributed throughout the animal body, as was demonstrated by the tissue to plasma ratios.
Slovenian: Difloksacin se dobro distribuira po organizmu v različne organe.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg/ml oral solution for chickens and turkeys
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg/ml peroralna raztopina za piščance in purane
English: Muscle Fat Liver Kidney
Slovenian: Mišičnina Maščoba Jetra
English: Official and local antimicrobial policies should be taken into account when the product is used.
Slovenian: Zdravilo je treba uporabiti v skladu z lokalnimi predpisi s področja protimikrobnega zdravljenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/016
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/016
English: To be supplied only on veterinary prescription.
Slovenian: Oskrba le na podlagi veterinarskega recepta.
English: Antagonism may be observed with nitrofurantoin.
Slovenian: Fluorokinoloni in nitrofurani učinkujejo medsebojno antagonistično.
English: 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.
Slovenian: 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.
English: Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
Slovenian: 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.
English: A fraction of difloxacin is eliminated by the urine.
Slovenian: Največ difloksacina se izloči z blatom, manj pa z urinom.
English: 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.
Slovenian: Dicural - peroralna raztopina se uporablja za zdravljenje kroničnih repsiratornih infekcij, ki jih povzročajo na difloksacin občutljivi mikroorganizmi: Escherichia coli in Mycoplasma gallisepticum.
English: 8 OJ No. L 143 of 26.06.95
Slovenian: 8 OJ št. L 143 z dne 27.06.95
English: Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Slovenian: Zdravljenje respiratornih obolenj (transportna mrzlica, pljučnice pri teletih), ki jih povzročajosamostojno ali v kombinaciji naslednji mikroorganizmi: Pasteurella haemolytica, Pasteurella multocida in/ali Mycoplasma spp.
English: For animal treatment only - to be supplied only on veterinary prescription..
Slovenian: Samo za živali - oskrba le na podlagi veterinarskega recepta.
English: 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.
Slovenian: 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
English: 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
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/001 - 1 x 250 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs CARTON for 50 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse Kartonska škatla za 50 ml steklenico
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance
Slovenian: NAVEDBA ZDRAVILNE IČINKOVIN(E) IN DRUGE(IH) SESTAVINE(E) Zdravilne učinkovine
English: No other source of drinking water should be available during the medication period.
Slovenian: V času zdravljenja naj bo to edina voda za pitje.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 100 mg
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 100 mg
English: In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling this product.
Slovenian: Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic in zaščitne obrazne maske in očal.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Slovenian: NAČIN(I) UPORABE ZDRAVILA Subkutano dajanje.
English: B. PACKAGE LEAFLET
Slovenian: DODATEK II
English: Cattle: Meat and offal: 46 days
Slovenian: Meso in organi: 46 dni Psi:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 150 mg
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 150 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs Difloxacin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse Difloksacin
English: DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 15 mg
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 15 mg
English: The medicated drinking water should be prepared freshly each day.
Slovenian: Dnevno naj se pripravi sveža voda za pitje, kateri je primešano zdravilo.
English: Antacids may interfere with gastro-intestinal absorption.
Slovenian: Istočasna uporaba antacidov lahko zmanjša enteralno resorbcijo difloksacina.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 150 mg filmsko obložene tablete za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle and dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg/ml raztopina za injiciranje za goveda in pse
English: Dicural 100 mg difloxacin (as hydrochloride)
Slovenian: Dicural 100 mg difloksacin (v obliki klorida)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs Difloxacin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse Difloksacin
English: Sodium croscarmellose
Slovenian: Escherichia coli
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 50 mg
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Difloksacin (v obliki klorida) 50 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs Difloxacin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse Difloksacin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 100 mg filmsko obložene tablete za pse
English: Dicural 150 mg difloxacin (as hydrochloride)
Slovenian: Dicural 150 mg difloksacin (v obliki klorida)
English: For animal treatment only -to be supplied only on veterinary prescription.
Slovenian: Samo za živali-oskrba le na podlagi veterinarskega recepta.
English: In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device, when handling this product.
Slovenian: Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz gumijastih rokavic, zaščitne maske in očal.
English: Dicural 15 mg difloxacin (as hydrochloride)
Slovenian: Dicural 15 mg difloksacin (v obliki klorida)
English: 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
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/013 - 10 tablet
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 50 mg filmsko obložene tablete za pse
English: PACKAGE SIZE 1 x 250 ml 1 x 1000 ml 6 x 1000 ml
Slovenian: 6 x 1000 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dicural 15 mg filmsko obložene tablete za pse
English: Dicural 50 mg difloxacin (as hydrochloride)
Slovenian: Dicural 50 mg difloksacin (v obliki klorida)
English: PACKAGE LEAFLET FOR: Dicural 50 mg/ml solution for injection for cattle and dogs
Slovenian: Dicural 50 mg/ml, raztopina za injiciranje za goveda in pse
English: Coated tablets
Slovenian: 100 tablet
English: Dogs: Not applicable
Slovenian: NEŽELENI UČINKI
English: 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
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/004 - 10 tablet
English: Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin.
Slovenian: Na učinkovanje difloksacina so občutljivi naslednji mikroorganizmi, izolirani iz piščancev in puranov: Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum.
English: The fluoroquinolones exert their antibacterial effect against both replicating and dormant microorganisms.
Slovenian: Fluorokinoloni imajo protimikrobno učinkovanje tako proti mikroorganizmom, ki so v fazi replikacije, kot tistim, ki so v fazi transkripcije pri delitvi celic.
English: Tel: + 0040 21 207 28 93
Slovenian: Pfizer Romania SRL Tel: + 0040 21 207 28 93
English: WITHDRAWAL PERIOD Withdrawal period: Cattle - meat and offal 46 days
Slovenian: KARENCA Karenca: Govedo-meso in organi 46 dni
English: 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
Slovenian: ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/97/003/010 - 10 tablet
English: Turkeys:
Slovenian: Purani
English: Cattle (calves and young cattle) Dogs.
Slovenian: Govedo (teleta in mlado govedo) Psi
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs 50 ml vial label
Slovenian: PODATKI NA STIČNI, OZ.PRIMARNI OVOJNINI Dicural 50mg/ml raztopina za injiciranje za goveda in pse 50 ml steklenica
English: Active substance
Slovenian: Zdravilne učinkovine
English: Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating.
Slovenian: Dicural filmsko obložene tablete vsbujejo difloksacinijev klorid.
English: Measuring lines indicate the volume supplied.
Slovenian: Na njej so oznake za določanje volumna.
English: Skilarence is available as tablets (30 and 120 mg).
Slovenian: Zdravilo Skilarence je na voljo v obliki tablet (30 mg in 120 mg).
English: The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so dosegli 75-odstotno zmanjšanje rezultata resnosti bolezni.
English: What measures are being taken to ensure the safe and effective use of Skilarence?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Skilarence?
English: The full EPAR for Skilarence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Skilarence je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Psoriasis results from over-activity of the body's immune (defence) system.
Slovenian: Psoriaza je posledica čezmerne aktivnosti telesnega imunskega (obrambnega) sistema.
English: Tablets should be swallowed whole during or immediately after a meal.
Slovenian: Tablete je treba pogoltniti cele med obrokom ali takoj po njem.
English: This is a summary of the European public assessment report (EPAR) for Skilarence.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Skilarence.
English: Most side effects are mild or moderate.
Slovenian: Večina neželenih učinkov je bila blaga ali zmerna.
English: Other information about Skilarence
Slovenian: Druge informacije o zdravilu Skilarence
English: The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day.
Slovenian: Začetni odmerek je 30 mg enkrat dnevno, odmerek pa se povečuje vsak teden po urniku, prikazanem v navodilu za uporabo, dokler se stanje psoriaze ne začne izboljševati oziroma dokler bolnik ne prejema največjega odmerka 240 mg trikrat dnevno.
English: Skilarence dimethyl fumarate
Slovenian: Skilarence dimetilfumarat
English: It must also not be used by women during pregnancy or if breast-feeding.
Slovenian: Prav tako ga ne smejo uporabljati nosečnice ali doječe matere.
English: It is not intended to provide practical advice on how to use Skilarence.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm .
Slovenian: Po 16 tednih zdravljenja je takšno zmanjšanje doseglo 37 % bolnikov, ki so jemali zdravilo Skilarence, v primerjavi s 15 % bolnikov, ki so jemali placebo, in 40 % bolnikov, ki so jemali zdravilo Fumaderm.
English: The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use.
Slovenian: Odbor CHMP je presodil, da je glavna študija dokazala kratkotrajno učinkovitost zdravila Skilarence, objavljene študije s podobnimi zdravili pa kažejo, da se učinkovitost z nadaljnjo uporabo ohranja.