FrancophonIA/ELRC3.0 huggingface dataset:
English: Defitelio contains the active substance defibrotide.
Slovenian: Vsebuje učinkovino defibrotid.
English: In addition, defibrotide may protect the cells that line blood vessels.
Slovenian: Poleg tega utegne ščititi celice, ki tvorijo notranjo plast stene krvnih žil.
English: The dose depends on the patient's bodyweight.
Slovenian: Daje se z dvourno (kapalno) infuzijo v veno štirikrat na dan. Odmerek je odvisen od bolnikove telesne mase.
English: VOD is a condition in which the veins in the liver become blocked and stop the liver working properly.
Slovenian: Huda venookluzivna bolezen je bolezen, pri kateri se vene v jetrih zamašijo, to pa povzroči jetrno okvaro.
English: This summary was last updated in 02-2008.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2008.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Slovenian: To pomaga pri zaščiti pred boleznimi, ki jih te bakterije in virusi povzročajo.
English: for PROCOMVAX on 7 May 1999.
Slovenian: dne 7. maja 1999.
English: In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age.
Slovenian: V obeh skupinah so bili dojenčki cepljeni pri dveh, štirih ter 12 do 15 mesecih starosti.
English: This document is a summary of the European Public Assessment Report (EPAR).
Slovenian: Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
English: PROCOMVAX has been studied in one main study involving 882 infants.
Slovenian: Zdravilo PROCOMVAX so preučevali v eni glavni klinični študiji, v katero je bilo vključenih 882 dojenčkov.
English: If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
English: However, the company provided further information from other studies to show that three doses of PROCOMVAX produced adequate levels of protection.
Slovenian: Vendar pa je podjetje priskrbelo dodatne informacije iz drugih študij, s katerimi so pokazali, da trije odmerki zdravila PROCOMVAX zagotovijo ustrezno stopnjo
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Slovenian: Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROCOMVAX
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PROCOMVAX
English: The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S.N.C.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom PROCOMVAX, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD S.N.C.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznimi.
English: Vaccination with PROCOMVAX should be postponed in infants with moderate or severe sudden fever until they have recovered.
Slovenian: Cepljenje s cepivom PROCOMVAX je treba pri dojenčkih z zmernim ali hudim nenadnim povišanjem telesne temperature odložiti, dokler ne okrevajo.
English: Their breathing should be monitored for up to three days after vaccination.
Slovenian: Njihovo dihanje je potrebno nadzorovati do tri
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko dojenček prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot „tujke“ in proti njim razvije protitelesa.
English: The active substances are ‘adsorbed', meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Slovenian: Zdravilni učinkovini sta „adsorbirani“, kar pomeni, da sta vezani na površino aluminijeve spojine, cepivo pa vsebuje „adjuvans“ (spojino, ki vsebuje aluminij), ki spodbudi boljši odziv.
English: Other information about PROCOMVAX:
Slovenian: Druge informacije o zdravilu PROCOMVAX:
English: Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual highpitched crying and prolonged crying) and otitis media (infection of the middle ear).
Slovenian: Drugi pogosti neželeni učinki so povišana telesna temperatura, anoreksija (izguba teka), bruhanje, driska, razdražljivost, zaspanost, jok (vključno z jokom z nenavadno visokim glasom in dolgotrajnim jokom) in otitis media (vnetje srednjega ušesa).
English: Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine.
Slovenian: Dojenčki, pri katerih se po injiciranju pojavijo simptomi, ki nakazujejo na preobčutljivost (alergijsko reakcijo), ne smejo več dobiti nadaljnjih injekcij tega cepiva.
English: PROCOMVAX is a vaccine, which is available as a suspension for injection.
Slovenian: Zdravilo PROCOMVAX je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
English: PROCOMVAX is a vaccine.
Slovenian: Zdravilo PROCOMVAX je cepivo.
English: The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling.
Slovenian: Najpogostejši neželeni učinki, opaženi pri uporabi zdravila PROCOMVAX, so reakcije na mestu injiciranja, vključno z bolečino, občutljivostjo, eritemi (rdečino) in otekanjem.
English: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of
Slovenian: • iz Hib prečiščene beljakovine, vezane na nosilec (beljakovino, prečiščeno iz zunanje ovojnice
English: PROCOMVAX should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Slovenian: Zdravilo PROCOMVAX se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) katero izmed zdravilnih učinkovin ali katero koli drugo sestavino zdravila.
English: The study compared the effects of PROCOMVAX with those of separate vaccines containing the same active substances.
Slovenian: V študiji so primerjali učinke zdravila PROCOMVAX z učinki ločenih cepiv, ki sta vsebovali isti zdravilni učinkovini.
English: It contains proteins from Haemophilus influenzae type b (‘Hib', a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Slovenian: Kot zdravilno učinkovino vsebuje beljakovine Haemophilus influenzae tipa b („Hib“ je bakterija, ki lahko povzroči meningitis) in dele virusa hepatitisa B.
English: The vaccine must only be given by injection into a muscle.
Slovenian: Cepivo se sme dajati le z injiciranjem
English: What benefit has PROCOMVAX shown during the studies?
Slovenian: Kakšne koristi je zdravilo PROCOMVAX izkazalo med raziskavami?
English: The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age.
Slovenian: Shema cepljenja predvideva tri odmerke zdravila PROCOMVAX, ki bi jih naj otrok idealno prejel pri starosti dveh, štirih ter 12 do 15 mesecev.
English: The main measure of effectiveness whether protective levels of antibodies to Hib and hepatitis B virus had developed at one and two months after vaccination.
Slovenian: Glavni pokazatelj učinkovitosti je bil, ali se je razvila zaščitna koncentracija protiteles proti Hib ter virusu hepatitisa B en oziroma dva meseca po cepljenju.
English: In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib.
Slovenian: V glavni študiji sta bila odziva tako na zdravilo PROCOMVAX kot na ločeni cepivi z vidika koncentracije protiteles proti Hib šibka.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX's benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila PROCOMVAX pri cepljenju proti invazivni bolezni, ki jo povzroča Hib, ter proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, pri otrocih, starih od 6 tednov do 15 mesecev, večje od z njim povezanih tveganj.
English: For the full list of all side effects reported with PROCOMVAX, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PROCOMVAX, glejte Navodilo za uporabo.
English: Why has PROCOMVAX been approved?
Slovenian: Zakaj je bilo zdravilo PROCOMVAX odobreno?
English: The Committee recommended that PROCOMVAX be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo PROCOMVAX odobri dovoljenje
English: PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘invasive' disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
Slovenian: Zdravilo PROCOMVAX se uporablja za cepljenje dojenčkov, starih od šest tednov do 15 mesecev, proti invazivni bolezni, ki jo povzroča Hib (npr. bakterijski meningitis), in proti okužbi z virusom
English: PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
Slovenian: Zdravilo PROCOMVAX je kombinacija komponent, ki so v raznih cepivih v Evropski uniji (EU) na voljo že vrsto let.Kako je bilo zdravilo PROCOMVAX raziskano?
English: What is the risk associated with PROCOMVAX?
Slovenian: Kakšna tveganja so povezana z zdravilom PROCOMVAX?
English: Children who receive one dose of a hepatitis B vaccine at or shortly after birth can be given PROCOMVAX.
Slovenian: Otroci, ki ob rojstvu ali kmalu zatem prejmejo odmerek cepiva proti hepatitisu B, lahko dobijo zdravilo PROCOMVAX.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Slovenian: Posledično bo imunski sistem ob ponovni izpostavitvi bakterijam ali virusom sposoben hitreje tvoriti protitelesa.
English: The results of further studies were used to support the use of PROCOMVAX, both in infants who had and who had not received hepatitis B vaccination in the past.
Slovenian: Rezultati nadaljnjih študij so bili uporabljeni v podporo uporabi zdravila PROCOMVAX, in sicer tako pri dojenčkih, ki so bili predhodno cepljeni proti hepatitisu B, kot tudi pri tistih, ki tega celjenja predhodno niso prejeli.
English: As for all vaccines, if PROCOMVAX is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Slovenian: Kot pri vseh cepivih, obstaja tudi pri zdravilu PROCOMVAX, če se uporablja pri nedonošenčkih, tveganje za pojav apneje (krajših prekinitev dihanja).
English: The full EPAR for PROCOMVAX can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PROCOMVAX je na voljo tukaj.
English: The additional studies showed that protection against hepatitis B from PROCOMVAX was adequate in infants who had and who had not received hepatitis B vaccination in the past.
Slovenian: Dodatne študije so pokazale, da je zaščita, ki jo proti hepatitisu B nudi zdravilo PROCOMVAX, ustrezna tako pri dojenčkih, ki so bili predhodno cepljeni proti hepatitisu B, kot tudi pri tistih, ki tega
English: The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
Slovenian: Z glavno študijo so pokazali tudi, da zdravilo PROCOMVAX zagotavlja ustrezno stopnjo zaščite proti virusu hepatitisa B. Ta zaključek so potrdili tudi rezultati sedmih dodatnih študij, ki jih je predložilo
English: What is PROCOMVAX used for?
Slovenian: Za kaj se zdravilo PROCOMVAX uporablja?
English: PROCOMVAX contains small amounts of:
Slovenian: Zdravilo PROCOMVAX vsebuje
English: These are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Slovenian: • površinski antigen (beljakovine s površine) virusa hepatitisa B. Te beljakovine so pridobljene z metodo, imenovano „tehnologija rekombinantne DNA“, pri kateri kvasovka prejeme gen (DNA), s
English: The marketing authorisation was renewed on 7 May 2004.
Slovenian: Dovoljenje za promet je bilo
English: PROCOMVAX is not recommended for infants younger than six weeks of age, because of a risk of a reduced protective response to Hib.
Slovenian: Zaradi tveganja za zmanjšanje imunskega odziva na Hib uporaba zdravila PROCOMVAX pri dojenčkih, mlajših od šest tednov, ni priporočljiva.
English: The tmax was delayed by two hours.
Slovenian: Tmax je bil zakasnjen za dve uri.
English: Frequencies are defined as very common (≥ 1/10),
Slovenian: Pogostnost je definirana kot zelo pogosti (≥ 1/10),
English: Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008
Slovenian: Datum prve odobritve: 6. marec 2003 Datum zadnjega podaljšanja: 6. marec 2008
English: 4.8 Undesirable effects a. Summary of the safety profile
Slovenian: 4.8 Neželeni učinki a. Povzetek varnostnega profila
English: Clinical efficacy and safety:
Slovenian: Klinična učinkovitost in varnost:
English: • Take care not to infect other people.
Slovenian: • Pazite, da ne okužite drugih.
English: If you do get any of them, it is unlikely to be serious, but you need to check.
Slovenian: Če jih imate, ni verjetno, da so resni, vendar je treba preveriti.
English: Wait and take the next dose at the regular time.
Slovenian: Počakajte in vzemite naslednji odmerek ob običajnem času.
English: • If you are over 65 years of age your doctor may monitor your health more closely.
Slovenian: • Če ste starejši od 65 let, bo morda zdravnik bolj pozorno nadzoroval vaše zdravje.
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za dojene novorojence/otroke ne moremo izključiti.
English: The optimum duration of treatment is unknown.
Slovenian: Optimalna dolžina zdravljenja ni znana.
English: As data becomes available
Slovenian: Ko bodo podatki na voljo
English: County Cork, T45 DP77 Ireland
Slovenian: County Cork, T45 DP77 Irska
English: Do not take a double dose (two doses close together).
Slovenian: Ne vzemite dvojnega odmerka (dveh odmerkov enega za drugim).
English: • Tell your doctor immediately if you are pregnant or planning to become pregnant.
Slovenian: • Nemudoma povejte zdravniku, če ste noseči ali če načrtujete nosečnost.
English: • If you are HIV positive this medicine will not control your HIV infection.
Slovenian: • Če ste HIV pozitivni, to zdravilo ne bo nadzorovalo vaše okužbe s HIV.
English: What it is used for
Slovenian: Za kaj ga uporabljamo
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data):
Slovenian: Pogostnost naslednjih neželenih učinkov ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: • Do not use Hepsera in children or adolescents under 18 years of age.
Slovenian: • Zdravila Hepsera ne uporabljajte pri otrocih ali mladostnikih, mlajših od 18 let.
English: Exacerbation of hepatitis:
Slovenian: Poslabšanje hepatitisa:
English: Tablet.
Slovenian: Tableta.
English: Magnesium stearate
Slovenian: Magnezijev stearat
English: 30 tablets.
Slovenian: 30 tablet.
English: People with liver disease may also be at risk.
Slovenian: Tudi osebe z boleznijo jeter so izpostavljene tveganju.
English: You may need blood tests for several months after treatment.
Slovenian: Krvne preiskave bodo morda potrebne tudi nekaj mesecev po prenehanju zdravljenja.
English: Elderly: The clinical experience in patients > 65 years of age is very limited.
Slovenian: Starejši: Klinične izkušnje zdravljenja bolnikov starejših od 65 let so zelo omejene.
English: This is to make sure that your medicine is fully effective and to reduce the development of resistance to the treatment.
Slovenian: S tem zagotovite popolno učinkovitost zdravila in zmanjšate možnost razvoja odpornosti na zdravljenje.
English: The risk of this occurring is increased with long-term use of Hepsera.
Slovenian: Tveganje, da do tega pride, se z dolgotrajno uporabo zdravila Hepsera poveča.
English: The safety data derived from 5 pivotal randomized controlled studies, including a total of 1,174 patients, were reviewed.
Slovenian: Pregledani so bili podatki o varnosti, ki izhajajo iz 5 ključnih randomiziranih, nadzorovanih študij, v katere je bilo skupno vključenih 1.174 bolnikov.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: You must continue to take precautions to avoid this.
Slovenian: Zato morate nadaljevati zaščitne ukrepe, ki to preprečujejo.
English: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100) or not known (identified through postmarketing safety surveillance and the frequency cannot be estimated from the available data).
Slovenian: pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1000, < 1/100) ali pogostnost neznana (neželeni učinki opaženi pri spremljanju varnosti po pridobitvi dovoljenja za promet in trženju zdravila in njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Lactic acidosis occurs more often in women, particularly if they are very overweight.
Slovenian: Laktacidoza se pogosteje pojavlja pri ženskah, zlasti če imajo zelo povečano telesno maso.
English: • Do not take Hepsera if you are taking any medicines containing tenofovir.
Slovenian: • Ne jemljite zdravila Hepsera, če jemljete katero koli zdravilo, ki vsebuje tenofovir.
English: As adefovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Slovenian: Ker je adefovir strukturno soroden analogom nukleozidov, tega tveganja ne moremo izključiti.
English: Increases in creatinine
Slovenian: povišanje kreatinina
English: It can cause too much lactic acid in the blood and enlargement of the liver.
Slovenian: Lahko povzroči preveliko količino mlečne kisline v krvi in povečanje jeter.
English: Pharmacokinetic studies have not been conducted in the elderly.
Slovenian: Farmakokinetične raziskave niso bile izvedene pri starejših.
English: • Kidney problems, as shown by blood tests
Slovenian: • težave z ledvicami, ki se pokažejo pri krvnih preiskavah
English: Some of the signs of lactic acidosis are:
Slovenian: Nekateri znaki laktacidoze so:
English: Five patients achieved and maintained HBsAg seroconversion (HBsAg negative/HBsAb positive).
Slovenian: Pet bolnikov je doseglo in ohranilo HBsAg serokonverzijo (HBsAg negativni/anti-HBs pozitivni).
English: • pentamidine, for other types of infection.
Slovenian: • pentamidin proti drugim vrstam okužb.
English: Hepsera with food and drink
Slovenian: Zdravilo Hepsera skupaj s hrano in pijačo
English: • Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
Slovenian: • Povejte zdravniku, če imate bolezen ledvic ali če so preiskave pokazale, da imate težave z ledvicami.
English: Gender, age and ethnicity: The pharmacokinetics of adefovir were similar in male and female patients.
Slovenian: Spol, starost in pripadnost etnični skupini: Farmakokinetične lastnosti adefovirja so bile podobne pri moških in ženskih bolnikih.
English: Improvement in liver function was also seen after one year of therapy.
Slovenian: Prav tako so po enem letu zdravljenja opazili izboljšanje jetrne funkcije.
English: • If it is nearly time for your next dose, skip the missed dose.
Slovenian: • Če je že skoraj čas za naslednji odmerek, pozabljenega odmerka ne vzemite.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Slovenian: Če je zdravljenje podaljšano na več kakor 2 leti, je priporočljivo redno ponovno ocenjevanje zdravljenja za potrditev, da nadaljevanje z izbranim načinom zdravljenja za bolnika ostaja primerno.
English: The use of adefovir dipivoxil must be accompanied by the use of effective contraception.
Slovenian: Uporabo dipivoksiladefovirata mora spremljati uporaba učinkovite kontracepcije.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake {EXP}.
English: It's best for your doctor to monitor your health after stopping treatment with Hepsera.
Slovenian: Zato je najbolje, da zdravnik nadzoruje vaše zdravje po prekinitvi zdravljenja z zdravilom Hepsera.
English: In case of emergence of resistance, treatment should be modified.
Slovenian: Če se pojavi odpornost, je treba zdravljenje prilagoditi.
English: It is not known whether the active substance in this medicine passes into breast milk.
Slovenian: Ni znano, ali učinkovina v tem zdravilu prehaja v materino mleko.
English: • Digestive problems including wind or discomfort after eating meals
Slovenian: • prebavne težave, vključno z vetrovi ali neprijetnim občutkom po obroku
English: • look out for possible signs of lactic acidosis - see section 4, Possible side effects.
Slovenian: • bodite pozorni na morebitne znake laktacidoze - glejte poglavje 4 Možni neželeni učinki;
English: On the basis of these data, the frequency of these adverse drug reactions is calculated to be 0.4% corresponding to the frequency category uncommon.
Slovenian: Na osnovi teh podatkov je bila preračunana pogostnost teh neželenih učinkov zdravila 0,4 %, kar ustreza kategoriji pogostnosti “občasni”.
English: Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.
Slovenian: Vsakih šest mesecev je potrebno pri bolnikih nadzorovati biokemične, virološke in serološke označevalce hepatitisa B.
English: It is not known whether Hepsera is safe to use during human pregnancy.
Slovenian: Ni znano, ali je pri človeku uporaba zdravila Hepsera med nosečnostjo varna.
English: Treatment with 10 mg adefovir dipivoxil has not been shown to be effective against HIV replication and therefore should not be used to control HIV infection.
Slovenian: Zdravljenje s 10 mg dipivoksiladefovirata se ni pokazalo kot učinkovito proti replikaciji HIV in se zato naj ne bi uporabljalo za nadzorovanje okužbe s HIV.
English: A vaccine is available to protect those at risk from becoming infected with HBV.
Slovenian: Za zaščito oseb s tveganjem za okužbo s HBV je na voljo cepivo.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines and herbal products obtained without a prescription.
Slovenian: • Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili in izdelki rastlinskega izvora, ki ste jih dobili brez recepta.
English: Return any left over tablets to your pharmacist.
Slovenian: Preostale tablete vrnite farmacevtu.
English: The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and frequency (see Table 1).
Slovenian: Neželeni učinki za katere se smatra, da so bili vsaj možno povezani z zdravljenjem, so navedeni spodaj po organskih sistemih in pogostnosti (glejte preglednico 1).
English: The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.
Slovenian: Povezava odgovora na zdravljenje z dolgoročnimi posledicami kot so hepatocelularni karcinom ali dekompenzirana ciroza ni poznana.