FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment No formal studies of rucaparib in patients with hepatic impairment have been conducted.
Croatian: Nisu provedena formalna ispitivanja rukapariba u bolesnica s oštećenjem funkcije jetre.
English: The risk for a clinically relevant effect of concomitant administration of proton pump inhibitors (PPIs) is likely small (see section 5.2).
Croatian: Rizik za klinički relevantni učinak istodobne primjene inhibitora protonske pumpe
English: During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8-10 weeks of treatment with rucaparib.
Croatian: trombocitopenija), a uobičajeno se prvi put opažaju nakon 8 - 10 tjedana liječenja rukaparibom.
English: Common
Croatian: Središnje
English: 600 mg twice daily (two 300 mg tablets twice daily)
Croatian: 600 mg dva puta dnevno (dvije tablete od 300 mg dva puta dnevno)
English: Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 250 mg of rucaparib.
Croatian: Rubraca 250 mg filmom obložene tablete: Jedna filmom obložena tableta sadrži 250 mg rukapariba u obliku rukaparibkamsilata.
English: Nausea, Vomiting, Diarrhoea, Abdominal pain
Croatian: proljev, bol u abdomenu
English: a The median duration of response is determined from the patients who had an objective tumour response according to RECIST guidelines, following treatment with rucaparib.
Croatian: NP (NP-NP) b Medijan trajanja odgovora određen je kod bolesnica koje su imale objektivni odgovor prema RECIST
English: Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 300 mg of rucaparib.
Croatian: Rubraca 300 mg filmom obložene tablete: Jedna filmom obložena tableta sadrži 300 mg rukapariba u obliku rukaparibkamsilata.
English: Hepatobiliary disorders Very common
Croatian: Vrlo često anemijab
English: Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Croatian: Rubraca 200 mg filmom obložena tableta Plava, 11 mm, okrugla, filmom obložena tableta s utisnutom oznakom „C2”.
English: • sunburn
Croatian: • proljev
English: Management of Treatment-emergent AST/ ALT Elevations Grade of AST/ALT Elevation
Croatian: Tablica 2. Zbrinjavanje povišenih vrijednosti AST-a/ALT-a nastalih tijekom liječenja Stupanj povišenih vrijednosti AST-a/ALT-a Zbrinjavanje 3. stupanj bez drugih znakova disfunkcije jetre
English: How to store Rubraca
Croatian: Kako čuvati lijek Rubraca
English: Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 200 mg of rucaparib.
Croatian: Rubraca 200 mg filmom obložene tablete: Jedna filmom obložena tableta sadrži 200 mg rukapariba u obliku rukaparibkamsilata.
English: Rucaparib increased omeprazole Cmax by 1.09 fold (90% CI: 0.93 to 1.27) and AUCinf by 1.55 fold (90% CI: 1.32 to 1.83).
Croatian: Supstrati CYP2C19 Rukaparib je povećao Cmax omeprazola za 1,09 puta (90% CI: 0,93; 1,27) i AUCinf za 1,55 puta (90%
English: PHARMACEUTICAL FORM
Croatian: 14. NAČIN IZDAVANJA LIJEKA
English: - Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Croatian: - Rubraca 300 mg filmom obložene tablete: Poli(vinilni) alkohol (E1203), titanijev dioksid (E171), makrogol 4000 (E1521), talk
English: Dyspepsia
Croatian: Doziranje
English: Figure 1.
Croatian: PRILOG I.
English: Fatiguec
Croatian: • žgaravica
English: Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Croatian: Rubraca je indicirana kao monoterapijsko liječenje u odraslih bolesnica s relapsnim ili progresivnim, na platinu osjetljivim, epitelnim rakom jajnika, jajovoda ili primarnim peritonealnim rakom, visokog gradusa i s BRCA mutacijom (germinativnom i/ili somatskom), a koje su liječene s dvije ili više prethodnih linija kemoterapije na bazi platine i koje ne podnose daljnju kemoterapiju na bazi platine.
English: Rubraca 300 mg film-coated tablets
Croatian: Rubraca 300 mg filmom obložene tablete
English: Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.
Croatian: Jedna tableta sadrži 250 mg rukapariba u obliku rukaparibkamsilata.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Rubraca 300 mg film-coated tablets rucaparib
Croatian: Rubraca 300 mg filmom obložene tablete rukaparib
English: Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.
Croatian: Jedna tableta sadrži 300 mg rukapariba u obliku rukaparibkamsilata.
English: Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.
Croatian: Jedna tableta sadrži 200 mg rukapariba u obliku rukaparibkamsilata.
English: Efficacy results are summarised in Table 4 and Figure 1.
Croatian: Rezultati djelotvornosti sažeti su u tablici 4. te na slici 1. Tablica 4. Rezultati za djelotvornost u ispitivanju ARIEL3 Parametar
English: Rubraca 250 mg film-coated tablets
Croatian: Rubraca 250 mg filmom obložene tablete
English: Rubraca 200 mg film-coated tablets
Croatian: Rubraca 200 mg filmom obložene tablete
English: Anaemiab
Croatian: • mučnina
English: Rubraca 250 mg film-coated tablets rucaparib
Croatian: Rubraca 250 mg filmom obložene tablete rukaparib
English: Clovis Oncology France SAS Tel: +31 (0)8000227859
Croatian: Clovis Oncology Italy IT S.r.l. Tel: +39 800194716
English: Rubraca 200 mg film-coated tablets rucaparib
Croatian: Rubraca 200 mg filmom obložene tablete rukaparib
English: • a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Croatian: „mijelodisplastičnog sindroma”(MDS) ili „akutne mijeloične leukemije” (AML).
English: Dose adjustments for adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Dyspnoea
Croatian: Doza
English: Package leaflet: Information for the patient Rubraca 200 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za bolesnika Rubraca 200 mg filmom obložene tablete Rubraca 250 mg filmom obložene tablete Rubraca 300 mg filmom obložene tablete rukaparib
English: Hepatic impairment
Croatian: • loša probava
English: Continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 x ULN
Croatian: Tjedno praćenje testova funkcije jetre dok se vrijednosti ne poboljšaju na ≤ 2. stupanj Nastavak primjene rukapariba pod uvjetom da je bilirubin < GGN i da je alkalna fosfataza < 3 x GGN
English: EU/1/17/1250/001 EU/1/17/1250/002 EU/1/17/1250/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1250/003
English: Due date
Croatian: drugo tromjesečje
English: • diarrhoea
Croatian: • povraćanje
English: It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Croatian: Daje se u preporučenoj dozi od 60 mg na dan (3 tablete od 20 mg).
English: Further information can be found in the summary of the risk management plan.
Croatian: Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom..
English: The full EPAR and risk management plan summary for Cotellic 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 Cotellic nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Cotellic
Croatian: Ostale informacije o lijeku Cotellic
English: Cotellic cobimetinib
Croatian: Cotellic kobimetinib
English: Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Croatian: Terapija lijekom Cotellic primjenjuje se u ciklusima od 28 dana: tablete se uzimaju 21 uzastopan dan, nakon čega slijedi sedmodnevna pauza.
English: In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.
Croatian: U smislu sigurnosti, nuspojave se smatraju prihvatljivima i moguće ih je kontrolirati uz odgovarajuće mjere.
English: This is a summary of the European public assessment report (EPAR) for Cotellic.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Cotellic.
English: It is not intended to provide practical advice on how to use Cotellic.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Cotellic.
English: What measures are being taken to ensure the safe and effective use of Cotellic?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cotellic?
English: Cotellic is available as tablets (20 mg).
Croatian: Cotellic je dostupan u obliku tableta (20 mg).
English: This encourages the cancer to develop by allowing uncontrolled division of the cancer cells.
Croatian: To potiče razvoj raka time što dopušta nekontroliranu diobu stanica raka.
English: A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Cotellic.
English: The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhoea, rash, nausea (feeling sick), vomiting, pyrexia (fever), photosensitivity (light sensitivity) reaction, abnormal results for certain liver function tests (increased levels of alanine aminotransferase, aspartate aminotransferase) and abnormal results for an enzyme related to muscle breakdown (creatine phosphokinase).
Croatian: Najčešće nuspojave s lijekom Cotellic (koje se mogu javiti u više od 1 na 5 osoba) su proljev, osip, mučnina (osjećaj slabosti), povraćanje, pireksija (vrućica), fotoosjetljive reakcije (preosjetljivost na svjetlo), abnormalni rezultati za određene jetrene testove (povišene razine alanin aminotransferaze, aspartat aminotransferaze) i abnormalni rezultati za enzime povezane s mišićnom razgradnjom (kreatin fosfokinaze).
English: Treatment with Cotellic must be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Liječenje lijekom Cotellic mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Why is Cotellic approved?
Croatian: Zašto je Cotellic odobren?
English: What is Cotellic and what is it used for?
Croatian: Što je Cotellic i za što se koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic'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 Cotellic nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Before starting treatment, patients must be tested for the BRAF V600 mutation.
Croatian: Prije početka terapije bolesnike treba testirati na mutaciju BRAF V600.
English: What are the risks associated with Cotellic?
Croatian: Koji su rizici povezani s lijekom Cotellic?
English: Cotellic works by blocking MEK directly and by preventing its activation by the abnormal form of BRAF, thereby slowing down the growth and spread of the cancer.
Croatian: Cotellic djeluje inhibirajući MEK izravno i sprječavajući njegovu aktivaciju abnormalnim oblikom BRAF-a, te stoga usporava rast i širenje raka.
English: In this study, adding Cotellic to vemurafenib was more effective than adding placebo to vemurafenib: it took on average 12.3 months before the disease got worse in patients given Cotellic, compared with 7.2 months in patients given placebo.
Croatian: U tom je ispitivanju dodavanje lijeka Cotellic vemurafenibu bilo je djelotvornije od dodavanja placeba vemurafenibu: do pogoršanja bolesti u prosjeku je prošlo 12,3 mjeseci kod bolesnika koji su primali Cotellic u usporedbi s 7,2 mjeseca kod bolesnika koji su primali placebo.
English: Although a supportive study showed that patients who were not previously treated with BRAF or MEK inhibitor medicines (such as vemurafenib) seemed to benefit the most from the therapy, the Committee considered that patients who previously received BRAF inhibitors may still benefit from treatment with Cotellic and vemurafenib.
Croatian: Iako je dodatno ispitivanje pokazalo da su bolesnici koji prethodno nisu liječeni lijekovima koji inhibiraju BRAF ili MEK (poput vemurafeniba) imali najviše koristi od terapije, Odbor je zaključio kako bolesnici koji su prethodno primili inhibitore BRAF-a mogu i dalje imati koristi od terapije lijekom Cotellic i vemurafenibom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cotellic, 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 Cotellic nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Cotellic is used in combination with another medicine called vemurafenib.
Croatian: Cotellic se koristi u kombinaciji s drugim lijekom naziva vemurafenib.
English: Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Croatian: Cotellic je citostatik koji se koristi za liječenje odraslih osoba s melanomom (tipom raka kože) koji se proširio na druge dijelove tijela ili se ne može ukloniti kirurškim putem.
English: For the full list of all side effects and restrictions reported with Cotellic, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja prijavljenih s lijekom Cotellic potražite u uputi o lijeku.
English: Because Cotellic and vemurafenib work by blocking different proteins important for cancer growth, combining them results in a better response and could delay cancer cells becoming resistant to vemurafenib.
Croatian: Budući da su Cotellic i vemurafenib djelovali inhibirajući različite bjelančevine važne za rast raka, njihovo kombiniranje rezultiralo je boljim odgovorom i moglo je odgoditi rezistenciju stanica raka na vemurafenib.
English: Patients had not been previously treated and were given either Cotellic with vemurafenib or placebo (a dummy treatment) with vemurafenib; the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
Croatian: Bolesnici prethodno nisu bili liječeni, a primili su bilo Cotellic s vemurafenibom ili placebo (prividno liječenje) s vemurafenibom; glavna mjera djelotvornosti bilo je razdoblje preživljenja bolesnika, a da im se pritom bolest nije pogoršala (preživljenje bez progresije).
English: For more information about treatment with Cotellic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Cotellic pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: For practical information about using Cotellic, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Cotellic bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: It is only for patients whose melanoma tumour cells have been shown to have a specific mutation (change) in the BRAF gene called ‘BRAF V600'.
Croatian: Predviđen je samo za bolesnike čije su stanice melanoma testirane i pokazale su specifičnu mutaciju (promjenu) u svojem genu naziva „BRAF V600”.
English: The doctor may need to interrupt or stop treatment, or reduce the dose, if the patient experiences certain side effects.Treatment should continue for as long as the disease improves or remains stable and side effects are tolerable.
Croatian: Liječnik će možda trebati prekinuti ili zaustaviti terapiju, odnosno smanjiti dozu, ako bolesnik iskusi određene nuspojave.
English: What benefits of Cotellic have been shown in studies?
Croatian: Koje su koristi lijeka Cotellic utvrđene u ispitivanjima?
English: Cotellic is only given to patients whose melanoma is caused by the BRAF V600 mutation and must be used in combination with vemurafenib, which is a BRAF inhibitor.
Croatian: Cotellic se primjenjuje samo u bolesnika čiji je melanom uzrokovan mutacijom BRAF V600 i treba se koristiti u kombinaciji s vemurafenibom, koji je inhibitor BRAF-a.
English: How does Cotellic work?
Croatian: Kako djeluje Cotellic?
English: Cotellic has been studied in one main study involving 495 patients with melanoma that had spread or that could not be surgically removed, and whose melanoma had a BRAF V600 mutation.
Croatian: Cotellic je ispitivan u jednom glavnom ispitivanju koje je uključivalo 495 bolesnika s melanomom koji se proširio na druge dijelove tijela ili koji se nije mogao kirurški ukloniti i čiji je melanom imao mutaciju BRAF V600.
English: The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein involved in stimulating normal cell division.
Croatian: Djelatna tvar lijeka Cotellic, kobimetinib, je inhibitor MEK-a, bjelančevine uključene u stimulaciju diobe normalnih stanica.
English: How is Cotellic used?
Croatian: Kako se Cotellic koristi?
English: The Committee noted that Cotellic in combination with vemurafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation, when compared with vemurafenib alone.
Croatian: Odbor je zaključilo da je Cotellic pokazao klinički relevantne koristi u bolesnika čiji je melanom imao mutaciju BRAF V600, ako se koristio kao monoterapija, u usporedbi s monoterapijom vemurafenibom.
English: In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on the protein MEK.
Croatian: U slučaju melanoma s mutacijom BRAF V600 prisutan je abnormalni oblik bjelančevine BRAF, koja aktivira drugu bjelančevinu naziva MEK.
English: Cotellic contains the active substance cobimetinib.
Croatian: Sadrži djelatnu tvar kobimetinib.
English: Some side effects could be or could become serious
Croatian: Određene nuspojave mogu biti ili postati ozbiljne
English: Gastrointestinal disorders
Croatian: Gastrointestinalni poremećaji
English: Section 4:
Croatian: Dio 4:
English: Adopted at the 4-7 May 2015 PRAC
Croatian: Usvojeno na sjednici PRAC-a 4. - 7. svibnja 2015.
English: Section 2: What you need to know before you take Arava Warning and precautions
Croatian: Dio 2.: Što morate znati prije nego počnete uzimati lijek Arava Upozorenja i mjere opreza
English: A targeted questionnaire should be implemented to maximise the information obtained from future cases.
Croatian: Potrebno je uvesti ciljani upitnik kako bi se prikupilo što više informacija iz budućih slučajeva.
English: You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
Croatian: Možda će se vaša terapija morati ponovno procijeniti kako biste nastavili primati odgovarajuću terapiju za svoje stanje.
English: Symptoms may include new or worsening weakness on one side of the body: clumsiness, changes in vision, speech, thinking, or memory; or confusion or personality changes lasting for more than several days.
Croatian: Simptomi mogu uključivati novu ili pogoršanu slabost jedne strane tijela: nespretnost, promjene u vidu, govoru, razmišljanju ili pamćenju; ili smetenost ili promjene osobnosti koje traju više od nekoliko dana.
English: Section 4.4 - Special warning and precautions for use:
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi:
English: PML is an opportunistic infection caused by JohnCunningham virus (JCV) which may be fatal or result in severe disability.
Croatian: PML je oportunistička infekcija koju uzrokuje John-Cunningham virus (JCV) koja može biti smrtonosna ili rezultirati teškim invaliditetom.
English: Frequency ‘common': colitis
Croatian: Učestalost "često": kolitis
English: • Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
Croatian: • Nadraženost oka (osjećaj peckanja, osjećaj pijeska u očima, svrbeži, žarenja ili osjećaj stranog tijela u oku).
English: PRAC recommendations on signals for update of product information
Croatian: Preporuke PRAC-a vezane uz signale za ažuriranje informacija o lijeku
English: The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Croatian: Vodič za propisivače treba ažurirati s obzirom na taj rizik, a PML treba pažljivo pratiti i u budućim PSUR-ovima.
English: Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Croatian: Nije poznato (učestalost se ne može procijeniti na temelju dostupnih podataka) Rizik od rijetke infekcije mozga koja se naziva progresivna multifokalna leukoencefalopatija (PML).
English: Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Croatian: Latanoprost (Xalatan) - povećani broj prijava poremećaja oka, posebice nadraženosti oka, nakon promjene formulacije (EPITT br. 18068)
English: In case of PML is suspected, treatment with fingolimod should be discontinued.
Croatian: U slučaju sumnje na PML, liječenje fingolimodom treba prekinuti.
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Croatian: Progresivna multifokalna leukoencefalopatija (PML) prijavljena je tijekom liječenja fingolimodom nakon dobivanja odobrenja za stavljanje lijeka u promet (vidjeti dio 4.8).
English: The frequency may be calculated by considering the frequency of anaemia and haemolytic anaemia in studies.
Croatian: Učestalost se može izračunati razmatrajući učestalost anemije i hemolitičke anemije u ispitivanjima.
English: If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week).
Croatian: Ako osjetite nadraženost oka dovoljno jaku da oko prekomjerno suzi ili da počnete razmatrati prekid uzimanja lijeka, neodloživo (unutar tjedan dana) se savjetujte s liječnikom, ljekarnikom ili medicinskom sestrom.
English: The symptoms of PML may be similar to an MS relapse.
Croatian: Simptomi PML-a mogu biti slični onima relapsa multiple skleroze.
English: Summary of Product Characteristics (SmPC): Section 4.4 - Special warnings and precautions for use Infections
Croatian: Sažetak opisa svojstava lijeka (SPC): Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi Infekcije
English: During routine MRI, physicians should pay attention to PML suggestive lesions.
Croatian: Tijekom rutinskog oslikavanja MR-om, liječnici trebaju obratiti pozornost na lezije koje upućuju na PML.