FrancophonIA/ELRC3.0 huggingface dataset:
English: What Zonegran looks like and contents of the pack - Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are printed with a logo and “ZONEGRAN 25” in black.
Croatian: Kako Zonegran izgleda i sadržaj pakiranja - Zonegran 25 mg tvrde kapsule imaju bijelo neprozirno tijelo i bijelu neprozirnu kapicu s otisnutim logom i oznakom “ZONEGRAN 25” u crnoj boji.
English: When a child is taking Zonegran:
Croatian: Kada se dijete liječi Zonegranom:
English: Zonegran 25 mg, 50 mg, and 100 mg hard capsules zonisamide
Croatian: Zonegran 25 mg, 50 mg i 100 mg tvrde kapsule zonisamid
English: Women of childbearing potential must use effective contraception during treatment with Zonegran, and for one month after discontinuation.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja Zonegranom i još mjesec dana nakon prestanka liječenja.
English: How to store Zonegran
Croatian: Kako čuvati Zonegran
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heatstroke (see section 4.4: Paediatric population).
Croatian: Liječnici moraju upozoriti pedijatrijske bolesnike i njihove roditelje/njegovatelje, na uokvireni tekst (u Uputi o lijeku) sa savjetima za sprječavanje toplinskog udara (vidjeti dio 4.4, Pedijatrijska populacija).
English: • The starting dose is 100 mg taken once a day.
Croatian: • Početna doza je 100 mg jedanput na dan.
English: • Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonegran, which may require an adjustment of your dose of Zonegran.
Croatian: • Drugi lijekovi kao što su fenitoin, karbamazepin, fenobarbiton i rifampicin mogu smanjiti razine
English: Zonegran may be used:
Croatian: Zonegran se može primjenjivati:
English: Age ( 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Croatian: Nakon prilagodbe za utjecaj tjelesne težine u bolesnika s epilepsijom, dob ( 12 godina) i spol nisu primjetno utjecali na izloženost zonisamidu tijekom doziranja u stanju dinamičke ravnoteže.
English: Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Croatian: Zabilježeni su slučajevi agranulocitoze, trombocitopenije, leukopenije, aplastične anemije, pancitopenije i leukocitoze.
English: Zonegran contains sunset yellow FCF (E110) and allura red AC (E129) Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110) and a red colour called allura red AC (E129), which may cause allergic reactions.
Croatian: Zonegran sadrži boje sunset yellow FCF (E110) i allura red AC (E129) Zonegran 100 mg tvrde kapsule sadrže žutu boju pod nazivom sunset yellow FCF (E110) i crvenu boju pod nazivom allura red AC (E129), koje mogu prouzročiti alergijske reakcije.
English: • are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems.
Croatian: • mlađi od 12 godina jer kod Vas može postojati veći rizik od smanjenog znojenja, toplinskog udara, upale pluća i tegoba s jetrom; ako ste mlađi od 6 godina, Zonegran se za Vas ne preporučuje.
English: • This may be increased by up to 100 mg at intervals of two weeks.
Croatian: • Ta se doza može povećavati za do 100 mg u razmacima od dva tjedna.
English: PP-population* ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Croatian: ITT populacija < 4 napadaja tijekom početnog razdoblja od 3 mjeseca > 4 napadaja tijekom početnog razdoblja od 3 mjeseca
English: Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Croatian: Nuspojave povezane s primjenom Zonegrana iz kliničkih ispitivanja i nakon stavljanja lijeka u promet tablično su prikazane niže.
English: Paediatric population (aged 6 years and above) - recommended down-titration schedule
Croatian: Tablica 3 Pedijatrijska populacija (u dobi od 6 i više godina) - preporučeni režim postupnog smanjivanja doze
English: Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate
Croatian: Sadržaj kapsule celuloza, mikrokristalična hidrogenirano biljno ulje (sojino) natrijev laurilsulfat
English: • This may be increased by up to 100 mg at intervals of one to two weeks.
Croatian: • Ta se doza može povećavati za do 100 mg u razmacima od jednog do dva tjedna.
English: See Section 2 for important information about the ingredients: sunset yellow FCF (E110) and allura red AC (E129) and hydrogenated vegetable oil (from soyabean).
Croatian: Vidjeti dio 2 za važne podatke o sastojcima: boje sunset yellow FCF (E110) i allura red AC (E129) i hidrogenirano biljno ulje (sojino).
English: Zonegran should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Croatian: Zonegran treba primjenjivati oprezno u odraslih bolesnika istodobno liječenih inhibitorima karboanhidraze kao što su topiramat i acetazolamid, jer nema dovoljno podataka koji bi isključili moguću farmakodinamičku interakciju (vidjeti dio 4.4).
English: There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
Croatian: Nema dovoljno podataka o ukidanju drugih antiepileptičkih lijekova kada su, uz Zonegran kao dodatni lijek, napadaji stavljeni pod nadzor, a čime bi se omogućila monoterapija Zonegranom.
English: • low blood potassium levels, convulsions/seizures.
Croatian: • niske razine kalija u krvi, konvulzije / napadaji
English: Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), and a red colour called allura red AC (E129), which may cause allergic reactions.
Croatian: Zonegran 100 mg tvrde kapsule sadrže žutu boju pod nazivom sunset yellow FCF (E110) i crvenu boju pod nazivom allura red AC (E129), koje mogu uzrokovati alergijsku reakciju.
English: Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Croatian: Pretrage sniženi bikarbonati smanjena težina povišena kreatin fosfokinaza u krvi, povišen kreatinin u krvi, povišena urea u krvi, poremećeni nalazi pretraga funkcije jetre
English: Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see section 4.4).
Croatian: Ozbiljne nuspojave imunološke naravi povezane s lijekovima koji sadrže sulfonamidnu skupinu uključuju osip, alergijsku reakciju i velike hematološke poremećaje, uključujući aplastičnu anemiju koja vrlo rijetko može imati smrtni ishod (vidjeti dio 4.4).
English: • suffer from kidney problems as your dose of Zonegran may need adjusting.
Croatian: • patite od tegoba s bubrezima jer Vam možda treba prilagoditi dozu Zonegrana
English: Increase at two-weekly intervals in increments of 1 mg/kg
Croatian: Povećavati u razmacima od dva tjedna s povećanjem doze za 1 mg/kg
English: Contains also hydrogenated vegetable oil (from soyabean), sunset yellow FCF (E110) and allura red AC (E129).
Croatian: Također sadrži hidrogenirano biljno ulje (sojino), boju sunset yellow FCF (E110) i boju allura red AC (E129).
English: Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances, including aplastic anaemia, which very rarely can be fatal.
Croatian: Ozbiljne nuspojave imunološke naravi povezane s lijekovima koji sadrže sulfonamidnu skupinu uključuju osip, alergijsku reakciju i velike hematološke poremećaje, uključujući aplastičnu anemiju koja vrlo rijetko može imati smrtni ishod.
English: Oral use Read the package leaflet before use.
Croatian: Kroz usta Prije uporabe pročitajte uputu o lijeku.
English: • loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
Croatian: • gubitak težine, mučnina, probavne tegobe, bolovi u želucu, proljev, zatvor
English: • hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating,
Croatian: • halucinacije, gubitak pamćenja, koma, maligni neuroleptički sindrom (nemogućnost kretanja, znojenje, vrućica, nemogućnost zadržavanja mokraće), epileptički status (produljeni ili ponavljani napadaji)
English: Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean)
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 0,75 mg hidrogeniranog biljnog ulja (sojinog).
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population)
Croatian: Zonisamid Karbamazepin n (ITT populacija)
English: Zonegran should be used with caution in adult patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate or acetazolamide, as there are insufficient data to rule out a pharmacodynamic interaction (see also section 4.4 Paediatric population and section 4.5).
Croatian: Zonegran treba primjenjivati oprezno u odraslih bolesnika koji se istodobno liječe inhibitorima karboanhidraze, kao što je topiramat ili acetazolamid, jer nema dovoljno podataka koji bi isključili farmakodinamičku interakciju (vidjeti također dio 4.4, Pedijatrijska populacija i dio 4.5).
English: Zonegran belongs to a group of medicines (sulphonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Croatian: Zonegran pripada skupini lijekova (sulfonamida) koji mogu uzrokovati teške alergijske reakcije, teške osipe na koži i poremećaje krvi, vrlo rijetko sa smrtnim ishodom.
English: • slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes.
Croatian: • usporene misli, gubitak koncentracije, smetnje govora, neuobičajeni osjeti vezani uz kožu (trnci),
English: Be especially careful while driving or operating machinery, if Zonegran affects you in this way.
Croatian: Ako Zonegran na Vas tako djeluje, budite posebno oprezni kada upravljate vozilima ili rukujete strojevima.
English: Respiratory disorder
Croatian: Poremećaj funkcije jetre
English: A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Croatian: Osim toga ovojnica kapsule od 100 mg sadrži boju sunset yellow FCF (E110) i boju allura red (E129).
English: 300 - 500 mg/day (once a day)
Croatian: 300 do 500 mg na dan (jedanput na dan)
English: • live in a place or are on holiday in a place where the weather is warm.
Croatian: • ako živite u podneblju gdje je toplo vrijeme ili ste na odmoru u području s takvim vremenom; od Zonegrana se možete manje znojiti što može prouzročiti povišenje Vaše tjelesne temperature.
English: Increase at two-weekly intervals in increments of up to 100 mg
Croatian: povećavati u razmacima od dva tjedna s povećanjem doze do 100 mg
English: - Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed with a logo and “ZONEGRAN 100” in black.
Croatian: - Zonegran 100 mg tvrde kapsule imaju bijelo neprozirno tijelo i crvenu neprozirnu kapicu s otisnutim logom i oznakom “ZONEGRAN 100” u crnoj boji.
English: Excipient with known effect: Each hard capsule contains 1.5 mg hydrogenated vegetable oil (from soyabean)
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 1,5 mg hidrogeniranog biljnog ulja (sojinog).
English: Very Common Common
Croatian: vrlo često često
English: Potential medicinal product interactions affecting Zonegran
Croatian: Moguće interakcije drugih lijekova i Zonegrana
English: - Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed with a logo and “ZONEGRAN 50” in black.
Croatian: - Zonegran 50 mg tvrde kapsule imaju bijelo neprozirno tijelo i sivu neprozirnu kapicu s otisnutim logom i oznakom “ZONEGRAN 50” u crnoj boji.
English: A dietary supplement or increased food intake should be considered if the patient is failing to gain weight in accordance with growth charts, otherwise Zonegran should be discontinued.
Croatian: Ako bolesnik ne uspijeva dobivati na težini u skladu s krivuljom rasta, može se razmotriti upotreba dodataka prehrani ili povećanje unosa hrane; u protivnom liječenje Zonegranom treba prekinuti.
English: Zonegran belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4.
Croatian: Zonegran pripada skupini lijekova (sulfonamida) koji mogu uzrokovati teške alergijske reakcije, teške osipe na koži i poremećaje krvi, vrlo rijetko sa smrtnim ishodom (vidjeti dio 4, Moguće nuspojave).
English: Excipient with known effect: Each hard capsule contains 3 mg hydrogenated vegetable oil (from soyabean)
Croatian: Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 3 mg hidrogeniranog biljnog ulja (sojinog).
English: • lung infection / inflammation, urinary tract infections.
Croatian: • infekcija / upala pluća, infekcije mokraćnog sustava
English: 100 mg / day (in two divided doses)
Croatian: 100 mg na dan (podijeljeno u dvije doze)
English: Zonegran should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.5).
Croatian: U pedijatrijskih bolesnika Zonegran se ne smije primjenjivati s drugim inhibitorima karboanhidraze kao što su topiramat i acetazolamid (vidjeti dio 4.5).
English: Hydrogenated vegetable oil (from soyabean)
Croatian: Hidrogenirano biljno ulje (sojino).
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) šelak propilenglikol kalijev hidroksid željezov oksid, crni (E172)
English: Zonegran 100 mg hard capsules contain 100 mg zonisamide.
Croatian: Zonegran 100 mg tvrde kapsule sadrže 100 mg zonisamida.
English: Adverse reactions associated with Zonegran obtained from adjunctive use clinical studies and post-marketing surveillance
Croatian: Tablica 4 Nuspojave povezane sa Zonegranom iz kliničkih ispitivanja dodatne primjene i praćenja nakon stavljanja lijeka u promet
English: A white opaque body and a white opaque cap printed with a logo and “ZONEGRAN 25” in black.
Croatian: Bijelo neprozirno tijelo i bijela neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 25” u crnoj boji.
English: Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) bojilo allura red AC (E129) bojilo sunset yellow FCF (E110) šelak propilenglikol kalijev hidroksid željezov oksid, crni (E172)
English: Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
Croatian: Analiza podataka nakon stavljanja lijeka u promet pokazuje da je u bolesnika u dobi od 65 godina ili starijih, u usporedbi s općom populacijom, zabilježena veća učestalost sljedećih događaja:
English: When you take Zonegran on its own:
Croatian: Kada uzimate samo Zonegran:
English: thiazide diuretics, and sulfonylurea antidiabetes medicines,
Croatian: tiazidne diuretike i lijekove protiv šećerne bolesti iz skupine sulfonilureje,
English: Zonegran 50 mg hard capsules contain 50 mg zonisamide.
Croatian: Zonegran 50 mg tvrde kapsule sadrže 50 mg zonisamida.
English: Zonegran 25 mg hard capsules contain 25 mg of zonisamide.
Croatian: Zonegran 25 mg tvrde kapsule sadrže 25 mg zonisamida.
English: Zonegran 100 mg hard capsules
Croatian: Zonegran 100 mg tvrde kapsule
English: A white opaque body and a red opaque cap printed with a logo and “ZONEGRAN 100” in black.
Croatian: Bijelo neprozirno tijelo i crvena neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 100” u crnoj boji.
English: Zonegran should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.4 Paediatric population).
Croatian: Zonegran se u pedijatrijskih bolesnika ne smije primjenjivati istodobno s drugim inhibitorima karboanhidraze kao što su topiramat i acetazolamid (vidjeti dio 4.4, Pedijatrijska populacija).
English: Zonegran must be added to existing therapy for paediatric patients aged 6 years and above.
Croatian: Pedijatrijskim bolesnicima u dobi od 6 i više godina, Zonegran se mora dodati već postojećoj terapiji.
English: Zonegran 100 mg hard capsules zonisamide
Croatian: Zonegran 100 mg tvrde kapsule zonisamid
English: Zonegran 25 mg hard capsules zonisamide
Croatian: Zonegran 25 mg tvrde kapsule zonisamid
English: EU/1/04/307/006 28 capsules EU/1/04/307/004 56 capsules EU/1/04/307/011 84 capsules EU/1/04/307/007 98 capsules EU/1/04/307/008 196 capsules
Croatian: EU/1/04/307/006 28 kapsula EU/1/04/307/004 56 kapsula EU/1/04/307/011 84 kapsule EU/1/04/307/007 98 kapsula EU/1/04/307/008 196 kapsula
English: Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis
Croatian: Stevens-Johnsonov sindrom (SJS) i lijekom izazvani sindrom preosjetljivosti (DIHS).
English: These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Croatian: Zonegrana uz održanu djelotvornost pri dozama od 300 do 500 mg na dan.
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Croatian: Psihijatrijski poremećaji agitacija, razdražljivost stanje konfuzije, depresija afektivna labilnost, anksioznost, nesanica, psihotični poremećaj ljutnja, agresija, suicidalna ideacija, pokušaj samoubojstva halucinacije
English: A white opaque body and a grey opaque cap printed with a logo and “ZONEGRAN 50” in black.
Croatian: Bijelo neprozirno tijelo i siva neprozirna kapica s otisnutim logom i oznakom “ZONEGRAN 50” u crnoj boji.
English: Zonegran Capules:
Croatian: Zonegran tvrde kapsule:
English: Zonegran 25 mg hard capsules
Croatian: Zonegran 25 mg tvrde kapsule
English: Zonegran 50 mg hard capsules
Croatian: Zonegran 50 mg tvrde kapsule
English: EU/1/04/307/010 14 capsules EU/1/04/307/009 28 capsules EU/1/04/307/003 56 capsules EU/1/04/307/012 84 capsules
Croatian: EU/1/04/307/010 14 kapsula EU/1/04/307/009 28 kapsula EU/1/04/307/003 56 kapsula EU/1/04/307/012 84 kapsule
English: EU/1/04/307/001 14 capsules EU/1/04/307/005 28 capsules EU/1/04/307/002 56 capsules EU/1/04/307/013 84 capsules
Croatian: EU/1/04/307/001 14 kapsula EU/1/04/307/005 28 kapsula EU/1/04/307/002 56 kapsula EU/1/04/307/013 84 kapsule
English: 200 mg /day (once a day)
Croatian: 200 mg na dan (jedanput na dan)
English: Adjunctive therapy - with CYP3A4inducing agents
Croatian: - bez lijekova induktora CYP3A4
English: Zonegran 50 mg hard capsules zonisamide
Croatian: Zonegran 50 mg tvrde kapsule zonisamid
English: Pneumonia Urinary tract infection
Croatian: Infekcije i infestacije pneumonija, infekcija mokraćnog sustava
English: Six months seizure freedom
Croatian: 6.3 Rok valjanosti
English: 100 mg/day (once a day)
Croatian: 100 mg na dan (jedanput na dan)
English: Very Common
Croatian: manje često
English: • urinary stones.
Croatian: • mokraćni kamenci
English: • feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
Croatian: • osjećate se neobično umorno ili kao da imate temperaturu, boli Vas grlo, imate otečene žlijezde ili
English: Leukopenia Thrombocytopenia
Croatian: • bubrežni kamenci
English: You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Croatian: Istraživanja su pokazala povećan rizik od prirođenih mana u djece majki koje uzimaju lijekove protiv epilepsije.
English: • gall bladder inflammation, gallstones.
Croatian: • upala žučnog mjehura, žučni kamenci
English: It is available as tablets (25 mg).
Croatian: Dostupan je u obliku tableta (od 25 mg).
English: The full EPAR for Edurant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Edurant nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Edurant rilpivirine
Croatian: Edurant rilpivirin
English: Edurant must be taken with a meal.
Croatian: Edurant se mora uzimati uz obrok.
English: In all studies, the main measure of effectiveness was based on the reduction in viral load.
Croatian: U svim ispitivanjima glavno mjerilo djelotvornosti temeljilo se na smanjenju virusnog opterećenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Edurant na snazi u Europskoj uniji od 28. studenoga 2011.
English: Edurant does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Edurant ne liječi infekciju HIV-om niti AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: The recommended dose of Edurant is one tablet once a day.
Croatian: Preporučena doza lijeka Edurant je jedna tableta jedanput na dan.
English: What measures are being taken to ensure the safe and effective use of Edurant?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Edurant?
English: Edurant was also effective in adolescents, with around 72% of patients responding to treatment after 48 weeks.
Croatian: Edurant je bio učinkovit i u adolescenata, pri čemu je oko 72 % bolesnika odgovorilo na terapiju nakon 48 tjedana.
English: • rifampicin, rifapentine (antibiotics);
Croatian: • rifampicin, rifapentin (antibiotici)
English: Other information about Edurant
Croatian: Ostale informacije o lijeku Edurant
English: Edurant is an antiviral medicine.
Croatian: Edurant je protuvirusni lijek.
English: Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.
Croatian: Uzimajući u obzir oba ispitivanja, 84 % bolesnika koji su primali Edurant odgovorilo je na terapiju nakon godine dana, u usporedbi s 82 % bolesnika koji su primali efavirenz.
English: For more information about treatment with Edurant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Edurant pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: This is a summary of the European public assessment report (EPAR) for Edurant.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Edurant.
English: If Edurant is given together with rifabutin, the doctor should increase the dose of Edurant to two tablets once a day during rifabutin treatment.
Croatian: Ako se Edurant primjenjuje zajedno s rifabutinom, liječnik treba povećati dozu lijeka Edurant na dvije tablete jedanput na dan tijekom terapije rifabutinom.