FrancophonIA/ELRC3.0 huggingface dataset:
English: or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle).
Croatian: ili - intravenski docetaksel - 75 mg/m² u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 6
English: or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Croatian: 12 tjedana ili - intravenski paklitaksel - 175 mg/m² u kontinuiranoj intravenskoj infuziji svaka 3 tjedna u 4
English: Brain oedema
Croatian: Učestalost malaksalost edem
English: Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
Croatian: Parenteralnu otopinu prije davanja treba pregledati kako bi se isključila prisutnost čestica ili promjena boje.
English: Acute pulmonary oedema
Croatian: +dispneja kašalj epistaksa rinoreja
English: NAME OF THE MEDICINAL PRODUCT Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Croatian: Ogivri 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: Respiratory distress
Croatian: • plućni poremećaji
English: Haemorrhoids
Croatian: pvrijednost
English: NAME OF THE MEDICINAL PRODUCT Ogivri 150 mg powder for concentrate for solution for infusion trastuzumab
Croatian: Ogivri 150 mg prašak za koncentrat za otopinu za infuziju
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Croatian: Vrijednosti farmakokinetičkih parametara u stanju dinamičke ravnoteže predviđene za populaciju uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: Ogivri vial
Croatian: Ogivri bočica
English: Sinusitis
Croatian: • mučnina
English: Neck Pain
Croatian: np np np
English: Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Croatian: Ogivri je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim rakom dojke:
English: Early breast cancer
Croatian: Rak dojke
English: Acute respiratory distress syndrome
Croatian: Krvožilni poremećaji navale vrućine
English: p = 0.014**
Croatian: Broj bolesnica s događajem p = 0,014**
English: 4 mg/kg + 2 mg/kg qw
Croatian: 4 mg/kg + 2 mg/kg jedanput na tjedan metastatski rak dojke 805 37,4
English: Retinal haemorrhage
Croatian: • upala dojke
English: Therefore, you should tell your doctor, pharmacist or nurse that you have had Ogivri if you start any new medicine in the 7 months after stopping treatment.
Croatian: Ako započnete uzimanje bilo kojeg novog lijeka tijekom 7 mjeseci nakon prestanka terapije lijekom Ogivri, recite svom liječniku, ljekarniku ili medicinskoj sestri da ste primali Ogivri.
English: Renal failure
Croatian: Nepouzdan rezultat
English: Laryngeal oedema
Croatian: Učestalost tkiva osip
English: which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles.
Croatian: ciklusa (2. dan 1. ciklusa, a potom 1. dan svakog sljedećeg ciklusa) nakon čega je slijedio: - karboplatin - s ciljnom AUC 6 mg/ml/min, primijenjen u intravenskoj infuziji tijekom 30
English: Lacrimation increased
Croatian: • uzdignuti osip
English: - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) The efficacy results from Study MO16432 are summarized in Table 12.
Croatian: - doksorubicin 60 mg/m² plus paklitaksel 150 mg/m², svaka 3 tjedna u 3 ciklusa, a zatim - paklitaksel 175 mg/m², svaka 3 tjedna u 4 ciklusa, a zatim - CMF 1. i 8. dana svaka 4 tjedna u 3 ciklusa, a zatim nakon kirurškog zahvata - dodatni ciklusi adjuvantnog trastuzumaba (do dovršetka 1 godine liječenja).
English: Ogivri is given as an infusion into a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Croatian: Ogivri se daje infuzijom u venu (intravenskom infuzijom, „dripom“).
English: + 7.2 mL
Croatian: Konačna koncentracija bočica od 150 mg + 7,2 mL
English: ATC vet code: QI07AD08.
Croatian: ATCvet kod: QI07AD08.
English: Overdose(symptoms, emergency procedures, antidotes):
Croatian: Predoziranje (simptomi, hitni postupci, antidoti):
English: Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Croatian: Dobro promućkati i odmah primijeniti cijelu količinu (1 ml) rekonstituiranog proizvoda.
English: At least one year following the primary vaccination course.
Croatian: Najmanje godinu dana nakon osnovnog cijepljenja.
English: 3 weeks after completion of the primary course.
Croatian: 3 tjedna nakon prvog cijepljenja.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against disease caused by canine parainfluenza virus.
Croatian: Cjepivo je namijenjeno aktivnoj imunizaciji zdrave štenadi i zdravih pasa protiv bolesti koje uzrokuje pseći virus parainfluence.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4.
Croatian: Ne postoje dostupni podaci o neškodljivosti i učinkovitosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim s Versiguard Rabies i Versican Plus L4.
English: However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Croatian: Budući da je patogenost tog soja niska, nije potrebno odvojeno držati cijepljene od necijepljenih pasa.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)), - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/168/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/14/168/001
English: Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 8 weeks can be vaccinated with Versican Plus Pi mixed with Versiguard Rabies as the safety of this association has been demonstrated in 6 week old dogs.
Croatian: Iako je učinkovitost frakcije bjesnoće dokazana 12 tjedana nakon primjene, po vlastitom nahođenju veterinara, a u slučaju potrebe, može se cijepiti pse mlađe od 8 tjedana, s Versican Plus Pi pomiješanim s Versiguard Rabies, jer je dokazana neškodljivost navedenog načina primjene u pasa u dobi od 6 tjedana.
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Croatian: Pseći parainfluenca virus tip 2, soj CPiV-2-Bio 15 10
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Croatian: - sprječavanje kliničkih znakova (iscjedak iz nosa i očiju) i smanjivanje izlučivanja virusa uzrokovanog virusom parainfluence.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene deseterostruke propisane doze nisu zapažene druge nuspojave osim onih navedenih u odjeljku 4.6. Međutim, kod manjeg broja pasa uočena je bolnost na mjestu aplikacije odmah po primjeni deseterostruke doze.
English: Incompatibilities: Do not mix with any other veterinary medicinal product other than those mentioned above.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onima navedenim u gornjem tekstu.
English: Do not mix with any veterinary medicinal product except those mentioned in section 4.8.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim onima navedenim u odjeljku 4.8. 6.3 Rok valjanosti
English: First dose: Versican Plus Pi from 8-9 weeks of age.
Croatian: Prva doza: Versican Plus Pi nakon navršenih 8 - 9 tjedna starosti.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Croatian: Farmakoterapijska grupa: imunološki pripravci za pse, živa virusna i inaktivirana bakterijska cjepiva.
English: The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination.
Croatian: Živi atenuirani cjepni soj CPiV životinje mogu nakon cijepljenja izlučivati u okoliš.
English: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Croatian: Sadržaj jedne bočice Versican Plus Pi treba rekonstituirati sa sadržajem jedne bočice Versiguard Rabies umjesto s otapalom.
English: Re-vaccination scheme: A single dose of Versican Plus Pi to be given annually.
Croatian: Jedna doza Versican Plus Pi godišnje.
English: Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Croatian: Druga doza: Versican Plus Pi pomiješan s Versiguard Rabies 3 - 4 tjedna kasnije, ali ne prije navršenih 12 tjedana života.
English: PACKAGE LEAFLET: Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Croatian: UPUTA O VMP: Versican Plus Pi liofilizat i otapalo za suspenziju za injekciju za pse
English: WITHDRAWAL PERIOD(S) Not applicable.
Croatian: 4.11 Karencija(e) Nije primjenjivo.
English: Primary vaccination scheme: Two doses of Versican Plus Pi 3-4 weeks apart from 6 weeks of age.
Croatian: Osnovno cijepljenje (primovakcinacija): Dvije doze Versican Plus Pi u razmaku od 3 - 4 tjedna nakon navršenih 6 tjedana starosti.
English: Type 1 glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Croatian: I sadržavaju 1 dozu liofilizata, zatvorene brombutilnim gumenim čepom i aluminijskom kapicom.
English: If protection against Leptospira is required, dogs can be vaccinated with two doses of Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Croatian: Ako je potrebna zaštita od Leptospire pse se može cijepiti s dvije doze Versican Plus Pi pomiješane sa
English: First dose: Versican Plus Pi from 8-9 weeks of age Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Croatian: Druga doza: Versican Plus Pi pomiješan s Versiguard Rabies 3 - 4 tjedna kasnije, ali ne prije navršenih
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi lyophilisate for dogs
Croatian: Versican Plus Pi liofilizat za pse
English: No other adverse reactions other than those mentioned under “Adverse reactions” were observed after administration of a 10-fold overdose of the vaccine.
Croatian: Nakon primjene deseterostruke propisane doze nisu zapažene druge nuspojave osim onih navedenih u odjeljku 6 (Nuspojave).
English: 4.2 Indications for use, specifying the target species Active immunisation of dogs from 6 weeks of age:
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: Rezolsta contains two active substances.
Croatian: Rezolsta sadrži dvije djelatne tvari.
English: The full EPAR and risk management plan summary for Rezolsta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Rezolsta nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Rezolsta and what is it used for?
Croatian: Što je Rezolsta i za što se koristi?
English: Overall, 258 patients (82%) achieved this response after 24 weeks of treatment, and 253 patients (81%) at 48 weeks, which was comparable to results previously seen with darunavir plus ritonavir.
Croatian: Načelno, 258 bolesnika (82%) postio je ovaj odgovor nakon 24 tjedana liječenja, a 253 bolesnika (81%) nakon 48 tjedana, što je usporedivo s rezultatima koji su prethodno uočeni s darunavirom i ritonavirom.
English: Rezolsta darunavir / cobicistat
Croatian: Rezolsta darunavir / kobicistat
English: Other information about Rezolsta
Croatian: Ostale informacije o lijeku Rezolsta
English: Darunavir is a protease inhibitor.
Croatian: Darunavir je inhibitor proteaze.
English: What measures are being taken to ensure the safe and effective use of Rezolsta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rezolsta?
English: Rezolsta is available as tablets that contain 800 mg of darunavir and 150 mg of cobicistat.
Croatian: Rezolsta je dostupan kao tablete koje sadrže 800 mg darunavira i 150 mg kobicistata.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 virus in the blood) to less than 50 copies/ml.
Croatian: Djelotvornost je izmjerena smanjenjem virusnog opterećenja (količina virusa HIV-1 u krvi) na manje od 50 kopija/ml.
English: In addition there was no evidence of unexpected safety concerns.
Croatian: Nadalje, nema dokaza o neočekivanim problemima vezanima uz sigurnu primjenu.
English: Rezolsta must not be taken by patients who have severely reduced liver function.
Croatian: Rezolsta ne smiju uzimati bolesnici s ozbiljnim smanjenjem funkcije jetre.
English: This is a summary of the European public assessment report (EPAR) for Rezolsta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rezolsta.
English: It is not intended to provide practical advice on how to use Rezolsta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Rezolsta.
English: Both active substances have already been shown to be effective, and combining them into a single tablet was considered to be more convenient than taking them separately, reducing the risk of errors.
Croatian: Dokazano je da su obje djelatne tvari učinkovite, a njihova kombinacija u jednoj tableti smatra se praktičnijom nego da se uzimaju zasebno, čime se smanjuje rizik od pogrešaka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rezolsta on 19/11/2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Rezolsta na snazi u Europskoj uniji od 19.11.2014.
English: When the enzyme is blocked, the virus does not reproduce normally and its increase and spread slows down.
Croatian: Kad je enzim blokiran, virus se ne razmnožava na normalan način, a njegova stopa replikacije se smanjuje.
English: What are the risks associated with Rezolsta?
Croatian: Koji su rizici povezani s lijekom Rezolsta?
English: Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection.
Croatian: Sindrom imunosne rekonstitucije nastupa kad bolesnikov imunosni sustav počinje opet funkcionirati i boriti se protiv postojećih infekcija, što uzrokuje upalu na mjestu infekcije.
English: Rezolsta does not cure HIV infection or AIDS, but it can delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Rezolsta ne liječi infekciju HIV-a ili SIDA-e, ali može odgoditi ili obrnuti oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: The most serious side effects were rash, diabetes, hypersensitivity (allergic) reactions, vomiting, and ‘immune reconstitution syndrome'.
Croatian: Najozbiljnije nuspojave su osip, dijabetes, preosjetljivost (alergijske) reakcije, povraćanje i „sindrom imunosne rekonstitucije”.
English: Darunavir is currently authorised as Prezista and cobicistat as Tybost.
Croatian: Darunavir je trenutno odobren kao Prezista, a kobicistat kao Tybost.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rezolsta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Rezolsta nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: It must also not be used together with certain other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Croatian: Ne smije se koristiti zajedno s drugim lijekovima jer može doći do interakcije s istima te tako smanjiti djelotvornost terapije ili povećati rizik od nuspojava.
English: A risk management plan has been developed to ensure that Rezolsta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rezolsta.
English: Cobicistat acts as a ‘booster' to enhance the effects of darunavir, by prolonging the time in which it acts in the body.
Croatian: Kobicistat djeluje kao „booster“ kako bi pojačao djelovanje darunavira, produljujući vrijeme djelovanja u tijelu.
English: Rezolsta is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Rezolsta je antivirotik koji se u kombinaciji s drugim lijekovima koristi za liječenje odraslih osoba s virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje stečeni sindrom imunodeficijencije (AIDS).
English: Why is Rezolsta approved?
Croatian: Zašto je lijek Rezolsta odobren?
English: The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), and rash.
Croatian: Najčešće nuspojave Rezolsta (mogu se javiti u više od 1 na 10 osoba) su proljev, mučnina (osjećaj slabosti) i osip.
English: Rezolsta, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Rezolsta, se uzima u kombinaciji s drugim HIV lijekovima, smanjuje koncentraciju HIV-a u krvi i održava ga na niskim razinama.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rezolsta, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Rezolsta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Rezolsta can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Croatian: Rezolsta se izdaje samo na liječnički recept, a terapiju treba započeti zdravstveni djelatnik koji ima iskustva u liječenju HIV infekcija.
English: Because darunavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Rezolsta produced similar effects and levels of darunavir in the blood to the two active substances given separately, and to darunavir given with a different booster medicine, ritonavir (an established combination).
Croatian: Budući da je već utvrđena djelotvornost darunavira i kobicistata, te da su odobreni za primjenu za liječenje HIV-a, ispitivanja su uglavnom provedena kako bi se dokazalo da lijek Rezolsta djeluje i rezultira koncentracijama darunavira u krvi koje su slične dvjema djelatnim tvarima primijenjenima zasebno, i darunaviru koji se primjenjuje zajedno s drugim booster lijekom, ritonavirom (dokazana kombinacija).
English: For more information about treatment with Rezolsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rezolsta pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In addition, one main study was carried out to examine the safety and effectiveness of darunavir and cobicistat given with other HIV medicines, in 313 adult patients with HIV who had not been previously treated or who had been previously treated and whose infection was not expected to be resistant to darunavir.
Croatian: Nadalje, provedeno je jedno glavno ispitivanje kako bi se ispitala sigurna primjena i djelotvornost darunavira i kobicistata primijenjenih zajedno s drugim lijekovima protiv HIV-a, u 313 odraslih bolesnika s HIV-om koji nisu prethodno liječeni ili koji su prethodno liječeni, a za čiju se infekciju ne očekuje na je rezistentna na darunavir.
English: The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
Croatian: Lijek je predviđen za uporabu samo u bolesnika koji nisu ranije primili liječenje protiv HIV-a ili ranije liječenih bolesnika za čiju se bolest ne očekuje da je rezistentna na darunavir te koji su dovoljno zdravi i imaju razine virusa HIV-a niže od određenih graničnih vrijednosti.
English: What benefits of Rezolsta have been shown in studies?
Croatian: Koje su koristi lijeka Rezolsta utvrđene u ispitivanjima?
English: Rezolsta contains the active substances darunavir and cobicistat.
Croatian: Rezolsta sadrži djelatne tvari darunavir i kobicistat.
English: For practical information about using Rezolsta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Rezolsta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Rezolsta used?
Croatian: Kako se Rezolsta koristi?
English: It blocks an enzyme called protease, which the HIV virus needs to make new copies of itself.
Croatian: Inhibira enzime naziva proteaza, koji je potreban virusu HIV-a za razmnožavanje.
English: How does Rezolsta work?
Croatian: Kako djeluje Rezolsta?
English: For the full list of all side effects reported with Rezolsta, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Rezolsta potražite u uputi o lijeku.
English: This summary was last updated in 06-2018.
Croatian: Sažetak je posljednji put ažuriran u 06. 2018.
English: Further information on Zebinix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Zebinix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: At the start of the study, patients had around 13 seizures per month.
Croatian: Na početku ispitivanja bolesnici su imali oko 13 napadaja mjesečno.