FrancophonIA/ELRC3.0 huggingface dataset:
English: In boceprevir-treated subjects who did not attain sustained virologic response (SVR) for whom samples were analysed, 53% had post
Croatian: Sustained Virologic Response, SVR), a čiji su uzorci analizirani, ustanovljeni su RAV-ovi nakon početka
English: boceprevir AUC ↓ 8%** boceprevir Cmax ↓ 6% boceprevir Cmin ↑ 17%
Croatian: boceprevir Cmax ↓ 6% boceprevir Cmin ↑ 17%
English: 5.1 Pharmacodynamic properties
Croatian: Podaci o farmakokinetičkim interakcijama
English: Adverse Reactions
Croatian: Rezistencija
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja lijekom Victrelis.
English: Table 9 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and Relapse
Croatian: Tablica 9 Stope trajnog virološkog odgovora (SVR)*, odgovora na kraju liječenja (EOT) i relapsa za ispitanike koji nisu odgovorili na prethodno liječenje
English: Victrelis in combination with peginterferon alfa and ribavirin is not recommended in patients who
Croatian: Primjena lijeka Victrelis u kombinaciji s peginterferonom alfa i ribavirinom ne preporučuje se u bolesnika koji na početku liječenja imaju broj trombocita < 100 000/mm
English: General disorders and administration site conditions Asthenia*, chills, fatigue*, pyrexia*, influenza-like
Croatian: astenija*, zimica, umor*, pireksija*, bolest nalik gripi
English: escitalopram AUC ↓ 21% escitalopram Cmax ↓ 19%
Croatian: (escitalopram pojedinačna doza od 10 mg + Victrelis 800 mg triput na escitalopram Cmax ↓ 19%
English: Reminder: Please also read the “Possible side effects” in the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Croatian: Podsjetnik: Prije nego počnete uzimati Victrelis, molimo pročitajte i dio "Moguće nuspojave" u Uputama o lijeku za peginterferon alfa i ribavirin.
English: Hypotension*, hypertension Deep vein thrombosis*, flushing, pallor, peripheral
Croatian: duboka venska tromboza*, crvenilo praćeno osjećajem užarenosti, bljedilo, hladnoća perifernih dijelova tijela
English: Breast-feeding
Croatian: hipertireoza
English: Stomach and gut: pain in stomach and in the upper right side of the stomach or back; a burning feeling in the stomach, upset stomach; feeling bloated, burping (belching) Anus: wind (flatulence); piles (haemorrhoids); difficulty passing stools (constipation) Urinary: going to the toilet to urinate more often than usual Sexual: a decrease in sex drive; difficulty getting or keeping an erection Mental illness: changes in mood, feeling agitated; memory loss, trouble concentrating Chest: difficulty breathing; chest discomfort, chest pain; heavy feeling in the chest, with
Croatian: Želudac i crijeva: bol u trbuhu i na gornjoj desnoj strani trbuha ili leđa; osjećaj žarenja u želucu, nelagoda u želucu; nadutost, podrigivanje Anus: vjetrovi; hemoroidi; otežana stolica (zatvor)
English: Vistor hf.
Croatian: Ελλάδα MSD Α.Φ.Β.Ε.Ε.
English: In particular, do not take Victrelis if you are taking any of the following medicines: • alfuzosin and silodosin - used to treat symptoms of an enlarged prostate
Croatian: • alfuzozin i silodozin - za liječenje simptoma povećane prostate
English: Dermatitis, eczema, erythema, hyperhidrosis, night sweats, oedema peripheral, psoriasis, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, skin lesion
Croatian: Poremećaji kože i potkožnog tkiva alopecija, suha koža, svrbež, osip dermatitis, ekcem, eritem, hiperhidroza, noćno znojenje, periferni edem, psorijaza, eritematozni osip, makularni osip, makulopapularni osip, papularni osip, osip koji svrbi,
English: Erectile dysfunction Amenorrhoea, menorrhagia, metrorrhagia
Croatian: amenoreja, menoragija, metroragija
English: ‡ % (n/N) 95% CI EOT(Undetectable HCV-RNA) % (n/N) 95% CI
Croatian: EOT (nemjerljiva HCV-RNK) % (n/N)
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotypes other than genotype 1 have not been established.
Croatian: Nisu ustanovljene sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C drugog genotipa
English: Hypokalaemia*¸ appetite disorder, diabetes mellitus, gout, hypercalcaemia
Croatian: hipokalijemija*, poremećaj teka, šećerna bolest, giht,
English: HCV Relapse Rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable
Croatian: Stopa relapsa HCV-a je udio ispitanika s nemjerljivom HCV-RNK na kraju liječenja (EOT), ali mjerljivom HCV-RNK na kraju razdoblja praćenja (EOF) među ispitanicima s nemjerljivom razinom na EOT za koje su postojali podaci na EOF.
English: Lead-In Response (Viral Load Reduction)
Croatian: Triazolam (peroralna primjena)
English: Rates for subjects who failed previous therapy
Croatian: Ispitanici s prethodnim relapsom
English: Epistaxis, nasal congestion, oropharyngeal pain, respiratory tract congestion, sinus congestion, wheezing Pleuritic pain*, pulmonary embolism*, dry throat, dysphonia, increased upper airway secretion, oropharyngeal blistering
Croatian: epistaksa, kongestija nosa, bol u uhu i ždrijelu, kongestija dišnih puteva, kongestija sinusa, piskanje
English: • If you get any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Rates for patients who
Croatian: Čuvanje kod bolesnika
English: The SVR rates in subjects randomized to receive ribavirin dose reduction and randomized to receive
Croatian: Stope SVR-a u bolesnika randomiziranih da primaju sniženu dozu ribavirina bile su slične onima u bolesnika randomiziranih da primaju eritropoetin.
English: Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Croatian: Tablica 6 Trajan virološki odgovor (SVR)*, odgovor na kraju liječenja (EOT) i stope relapsa † u bolesnika s istodobnom HIV infekcijom koji prethodno nisu bili liječeni
English: Since Victrelis is prescribed with peginterferon alfa and ribavirin, please also refer to the respective Summary of Product Characteristics of peginterferon alfa and ribavirin.
Croatian: Prije započinjanja liječenja lijekom Victrelis moraju se pročitati Sažeci opisa svojstava lijeka za peginterferon alfa i
English: *, End of Treatment (EOT) and Relapse
Croatian: *, odgovora na kraju liječenja (engl.
English: Eye disorders Common:
Croatian: Srčani poremećaji Često:
English: Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin.
Croatian: U bolesnika koji su primali Victrelis u kombinaciji s peginterferonom alfa i ribavirinom prijavljeni su slučajevi pancitopenije.
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
Croatian: Tel.: +421 2 58282010 dpoc_czechslovak@merck.com
English: (CYP3A inhibition - effect on quetiapine)
Croatian: (drospirenon - inhibicija CYP3A)
English: Use of gloves and other protective equipment is recommended.
Croatian: Preporučuje se nošenje rukavica i druge zaštitne opreme.
English: You may also be given other medicines.
Croatian: Također možete primati i druge lijekove.
English: Do not drive a car or operate machines if you have these symptoms.
Croatian: Nemojte voziti automobil ili upravljati strojevima ako imate ove simptome.
English: The infusion may last up to 30 minutes.
Croatian: Infuzija može trajati do 30 minuta.
English: Your doctor will examine you and review your full medical history.
Croatian: Vaš će Vas liječnik pregledati i razmotriti Vašu potpunu povijest bolesti.
English: Some of these events have been fatal.
Croatian: Neki od tih događaja imali su smrtan ishod.
English: • Any other major disease for which you were hospitalised or received any medicine.
Croatian: • Bilo koja druga teška bolest zbog koje ste bili hospitalizirani ili ste primali bilo koje lijekove.
English: Proper aseptic technique must be observed.
Croatian: Nužno je pridržavati se odgovarajuće aseptičke tehnike.
English: Tell your doctor straight away if you get notice any of the following symptoms:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma:
English: You should talk to your doctor or nurse about suitable methods of contraception.
Croatian: Trebate razgovarati sa svojim liječnikom ili medicinskom sestrom o odgovarajućim metodama kontracepcije.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog gledišta, lijek se treba primijeniti odmah.
English: There is currently insufficient information to draw conclusions about the safety of doses higher than those evaluated in clinical studies.
Croatian: Trenutno nema dovoljno informacija za donošenje zaključaka o sigurnosti doza viših od onih procijenjenih u kliničkim ispitivanjima.
English: Do not take Kyprolis if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: Ne uzimajte Kyprolis ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: As this medicine is being given by a doctor or nurse, it is unlikely that you will be given too much.
Croatian: S obzirom da će Vam ovaj lijek dati liječnik ili medicinska sestra, nije vjerojatno da ćete primiti previše lijeka.
English: Most patients will receive treatment for as long as their disease improves or remains stable.
Croatian: Većina bolesnika primat će liječenje toliko dugo dok se njihovo stanje poboljšava ili ostaje stabilno.
English: The median follow-up was approximately 37 months.
Croatian: Medijan praćenja je približno bio 37 mjeseci.
English: Tell your doctor if you have ever had or might now have a hepatitis B infection.
Croatian: Obavijestite svog liječnika ako ste ikada imali ili možda sada imate infekciju hepatitisom B.
English: • Ringing in the ears (tinnitus)
Croatian: • Zvonjava u ušima (tinitus)
English: Each pack contains 1 vial.
Croatian: Svako pakiranje sadrži 1 bočicu.
English: The proteasome is a system within the cells that breaks down proteins when they are damaged or no longer needed.
Croatian: Proteasom je sustav unutar stanice koji razgrađuje proteine kada su oštećeni ili više nisu potrebni.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, otrovanje i komplikacije u proceduri
English: You will be monitored closely during treatment.
Croatian: Tijekom liječenja bit ćete pomno praćeni.
English: • Allergic reaction to Kyprolis
Croatian: • Alergijska reakcija na Kyprolis
English: Your doctor or nurse will check if you are getting enough fluids.
Croatian: Vaš liječnik ili medicinska sestra provjerit će dobivate li dovoljno tekućine.
English: In addition and according to the agreed case definition by Mentzer et al., two cases of level 1, one case of level 2 and one case of level 3 were identified.
Croatian: Osim toga i prema dogovorenoj definiciji slučaja prema Mentzeru i sur. identificirana su dva slučaja razine 1, jedan slučaj razine 2 i jedan slučaj razine 3.
English: The median follow-up was approximately 67 months.
Croatian: Medijan praćenja bio je oko 67 mjeseci.
English: • Difficulty sleeping (insomnia)
Croatian: • Problemi sa spavanjem (nesanica)
English: Recommended action
Croatian: Preporučeni postupci
English: If you had these symptoms prior to treatment with carfilzomib, tell your doctor about any change in these symptoms.
Croatian: Ako ste imali ove simptome prije liječenja karfilzomibom, obavijestite svog liječnika o svakoj promjeni ovih simptoma.
English: Your doctor will check you for signs of this infection before, during and for some time after treatment with this medicine.
Croatian: Vaš će liječnik provjeriti imate li znakove ove infekcije prije, za vrijeme i određeno vrijeme nakon liječenja ovim lijekom.
English: • Reduced blood flow to the heart
Croatian: • Smanjen dotok krvi u srce
English: This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
Croatian: To uključuje i bilo koje lijekove dobivene bez recepta, poput vitamina ili biljnih lijekova.
English: This assessment should optimise the patient's status, with particular attention to blood pressure control and fluid management.
Croatian: Ta procjena bi trebala optimizirati status bolesnika, uz posebnu pozornost usmjerenu na kontrolu krvnog tlaka i tjelesne tekućine.
English: Elderly patients (≥ 75 years)
Croatian: Stariji bolesnici (u dobi od ≥ 75 godina)
English: Gently swirl and/or invert the vial slowly for approximately 1 minute, or until complete dissolution.
Croatian: Nježno vrtite i/ili sporo preokrećite bočicu otprilike 1 minutu ili do potpunog otapanja.
English: These reactions can occur immediately following or up to 24 hours after administration of Kyprolis.
Croatian: Ove reakcije se mogu pojaviti neposredno nakon ili do 24 sata nakon primjene lijeka Kyprolis.
English: Increased c-reactive protein
Croatian: Povišena razina c-reaktivnog proteina
English: These may all be symptoms of a serious and potentially fatal brain condition known as Progressive Multifocal Leukoencephalopathy (PML).
Croatian: Sve ovo mogu biti simptomi ozbiljne i potencijalno smrtonosne bolesti mozga poznate kao progresivna multifokalna leukoencefalopatija (PML).
English: They should be monitored for clinical and laboratory signs of HBV reactivation during and after the end of treatment.
Croatian: Potrebno ih je pratiti radi kliničkih i laboratorijskih znakova reaktivacije HBV-a tijekom i nakon završetka liječenja.
English: Some of these events have been fatal (see section 4.8).
Croatian: Neki od tih događaja imali su smrtan ishod (vidjeti dio 4.8).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Croatian: Datum prvog odobrenja: 19. studenog 2015.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka za primjenu odgovornost su korisnika i ne bi smjeli prelaziti 24 sata pri 2°C - 8°C.
English: Kyprolis is given 2 days in a row each week, for 3 weeks, followed by one week without treatment.
Croatian: Kyprolis se primjenjuje 2 dana zaredom svaki tjedan, kroz 3 tjedna, nakon čega će slijediti jedan tjedan bez liječenja.
English: If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Croatian: Ako se lenalidomid primjenjuje tijekom trudnoće, očekuje se teratogeni učinak lenalidomida u ljudi.
English: * Frequency is calculated based on data from clinical trials in which most patients used prophylaxis
Croatian: * Učestalost je izračunata na temelju podataka iz kliničkih ispitivanja u kojima je većina bolesnika koristila profilaksu
English: It is recommended to control hypertension prior to starting and during treatment.
Croatian: Preporučeno je kontrolirati hipertenziju prije početka i tijekom liječenja.
English: Your doctor or nurse will determine the dose of Kyprolis that you receive.
Croatian: Vaš liječnik ili medicinska sestra će odrediti dozu lijeka Kyprolis koju ćete primiti.
English: By preventing the breakdown of proteins in cancer cells, which are more likely to contain more abnormal proteins, Kyprolis causes the death of cancer cells.
Croatian: Sprječavanjem razgradnje proteina unutar stanica raka, koje će vjerojatnije sadržavati više abnormalnih proteina, Kyprolis uzrokuje smrt stanica raka.
English: Kyprolis will be given to you by a doctor or nurse.
Croatian: Kyprolis će Vam dati liječnik ili medicinska sestra.
English: These patients may be at greater risk for cardiac complications.
Croatian: U ovih bolesnika može biti povećan rizik od srčanih komplikacija.
English: 47.6 (42.5, NE)
Croatian: 47,6 (42,5, NP)
English: You may need extra tests to check that your heart, kidneys and liver are working properly.
Croatian: Možda će biti potrebne dodatne pretrage kako bi se provjerilo rade li Vaše srce, bubrezi i jetra pravilno.
English: Each 28-day period is considered one treatment cycle.
Croatian: Svaki period od 28 dana smatra se jednim terapijskim ciklusom.
English: Lenalidomide is structurally related to thalidomide.
Croatian: Lenalidomid je strukturno povezan s talidomidom.
English: You must read the package leaflet of all medicines that you take in combination with Kyprolis so that you understand the information related to those medicines.
Croatian: Morate pročitati Uputu o lijeku za sve lijekove koje uzimate u kombinaciji s lijekom Kyprolis kako biste razumjeli informacije povezane s tim lijekovima.
English: This metabolite has no known biological activities.
Croatian: Ovaj metabolit nema poznate biološke aktivnosti.
English: Enrolled subjects were defined as refractory to a therapy if they met any of the following 3 criteria: nonresponsive (< minimal response) to any regimen; progression during any regimen; or progression within 60 days of completion of any regimen.
Croatian: Uključeni ispitanici bili su definirani kao otporni na liječenje ako su ispunjavali jedan od sljedeća tri kriterija: izostanak odgovora (< minimalni odgovor) na bilo koji režim; progresija bolesti tijekom bilo kojeg režima; ili progresija bolesti unutar 60 dana od završetka bilo kojeg režima.
English: Do not use Kyprolis if you are allergic to carfilzomib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Kyprolis ako ste alergični na karfilzomib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: This can indicate you have low numbers of platelets (cells that help the blood to clot)
Croatian: To može ukazivati da imate nizak broj trombocita (stanice koje pomažu u zgrušavanju krvi)
English: Kd (black) Vd (grey)
Croatian: Kd (crna) Vd (siva)
English: What Kyprolis is and what it is used for
Croatian: Što je Kyprolis i za što se koristi
English: • Serum creatinine equal to or greater than 2 × baseline; or
Croatian: • Kreatinin u serumu jednak ili veći od 2 x početne vrijednosti; ili
English: The results of study 2011-003 are summarised in table 7.
Croatian: Rezultati ispitivanja 2011-003 sažeti su u tablici 7.
English: Appropriate dose modifications based on toxicity should be made (see table 3).
Croatian: Potrebno je provesti odgovarajuće prilagodbe doze na temelju toksičnosti (vidjeti Tablicu 3).
English: Read the complete preparation instructions prior to reconstitution.
Croatian: Prije rekonstitucije pročitajte cijele upute za pripremu.
English: Population pharmacokinetic analyses indicate there are no effects of age, gender or race on the pharmacokinetics of carfilzomib.
Croatian: Analize populacijske farmakokinetike ukazuju da ne postoji utjecaj dobi, spola ili rase na farmakokinetiku karfilzomiba.
English: Kyprolis will be stored in the pharmacy.
Croatian: Kyprolis će se čuvati u ljekarni.
English: Tell your doctor or nurse if you are taking medicines used to prevent pregnancy such as oral contraceptives or other hormonal contraceptives, as these may not be suitable for use with Kyprolis.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate lijekove za sprečavanje trudnoće, kao što su oralni kontraceptivi ili drugi hormonski kontraceptivi, jer ti lijekovi možda nisu primjereni za istodobnu primjenu s lijekom Kyprolis.
English: Number of subjects at risk:
Croatian: Broj ispitanika izloženih riziku:
English: Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia).
Croatian: Potrebno je poduzeti mjere kako bi se svi promjenjivi čimbenici rizika (npr. pušenje, hipertenzija i hiperlipidemija) sveli na najmanju moguću razinu.
English: A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended.
Croatian: Preporučuje se temeljita procjena čimbenika kardiovaskularnog rizika prije početka liječenja.
English: What Kyprolis is and what it is used for What you need to know before you use Kyprolis How to use Kyprolis
Croatian: Što je Kyprolis i za što se koristi Što morate znati prije nego počnete uzimati Kyprolis Kako uzimati Kyprolis
English: This study did not evaluate the benefit/risk ratio in the broader refractory population.
Croatian: Ovim ispitivanjem se nije procijenio omjer koristi i rizika u široj refraktornoj populaciji.
English: Carfilzomib caused embryo-foetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose.
Croatian: Karfilzomib je uzrokovao embrio-fetalnu toksičnost u gravidnih ženki zečeva pri dozama koje su bile niže nego u bolesnika koji su primali preporučenu dozu.
English: Kyprolis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Croatian: Kyprolis se ne smije primjenjivati tijekom trudnoće osim ako potencijalna korist nadilazi potencijalni rizik za fetus.
English: Consequently, as a precautionary measure, breast-feeding is contra-indicated during and for at least 2 days after treatment with Kyprolis.
Croatian: Stoga je, kao mjera predostrožnosti, dojenje kontraindicirano tijekom i najmanje 2 dana nakon liječenja lijekom Kyprolis.
English: The elapsed time from reconstitution to administration should not exceed 24 hours.
Croatian: Vrijeme proteklo između rekonstitucije i primjene ne smije biti duže od 24 h.
English: These events typically occurred early in the course of Kyprolis therapy (< 5 cycles).
Croatian: Ovi su se događaji obično javljali rano u tijeku liječenja lijekom Kyprolis (< 5 ciklusa).
English: • Liver problems including an increase in liver enzymes in the blood
Croatian: • Problemi s jetrom, uključujući povećanje razine jetrenih enzima u krvi
English: What Kyprolis looks like and contents of the pack
Croatian: Kako Kyprolis izgleda i sadržaj pakiranja
English: PML is known safety issue of bortezomib, which belongs to the same class as carfilzomib.
Croatian: PML je poznato sigurnosno pitanje vezano uz bortezomib, koji pripada istoj skupini kao i karfilzomib.
English: 18.7 (15.6, NE)
Croatian: 18,7 (15,6; NP)
English: • Change in voice or hoarseness
Croatian: • Promjena glasa ili promuklost
English: Dexamethasone should be administered 30 minutes to 4 hours before Kyprolis.
Croatian: Deksametazon se treba primijeniti 30 minuta do 4 sata prije lijeka Kyprolis.
English: • A general feeling of illness or discomfort
Croatian: • Općenit osjećaj bolesti ili nelagode
English: Each 28-day period is one treatment cycle.
Croatian: Svaki period od 28 dana čini jedan terapijski ciklus.
English: What you need to know before you use Kyprolis
Croatian: Što morate znati prije nego počnete uzimati Kyprolis
English: Talk to your doctor or nurse before using Kyprolis if you have any of the conditions listed below.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije primjene lijeka Kyprolis ako imate bilo koje od dolje navedenih stanja.
English: If the hypertension cannot be controlled, the Kyprolis dose should be reduced.
Croatian: Ako se hipertenzija ne može kontrolirati, dozu lijeka Kyprolis treba smanjiti.
English: No clinical trial was conducted with a dose of 56 mg/m2.
Croatian: Nije provedeno kliničko ispitivanje s dozom od 56 mg/m2.
English: Combination dosing with lenalidomide and dexamethasone did not affect proteasome inhibition.
Croatian: Kombinirana primjena s lenalidomidom i deksametazonom nije utjecala na inhibiciju proteasoma.
English: Special attention should be paid to patients with moderate and severe hepatic impairment in view of the very limited efficacy and safety data on this population.
Croatian: Bolesnicima s umjerenim i teškim oštećenjem jetre treba posvetiti posebnu pozornost, zbog toga što su podaci o djelotvornosti i sigurnosti u ovoj populaciji vrlo ograničeni.