natgillin/translations-raw huggingface dataset:
QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 2 ml: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
En 2 ml odmerek vsebuje: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
Zoetis Österreich GmbH Tel: +43 1 2701100 110
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na viali 100 ml
Each dose of 2 ml of the vaccine contains:
En 2 ml odmerek:
Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
En 2 ml odmerek: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
Ìsland
Eesti
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Simptomatsko zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih motenj pri starejših osebah (razen Alzheimerjeve bolezni in drugih demenc)
• Ancillary treatment of Raynaud's syndrome
Pomožno zdravljenje Raynaudovega sindroma
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Priloga III Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Vsa sklicevanja na zgoraj navedene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Vsa sklicevanja na zgoraj navedene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.
Bolniki lahko nadaljujejo z zdravljenjem, razen če se bolezen poslabša ali če zdravljenja ne prenašajo več.
The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Evropska komisija je dovoljenje za promet z zdravilom Kadcyla, veljavno po vsej Evropski uniji, izdala dne 15. novembra 2013.
The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Kadcyla je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Kadcyla.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kadcyla.
What measures are being taken to ensure the safe and effective use of Kadcyla?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kadcyla?
Other information about Kadcyla
Druge informacije o zdravilu Kadcyla
The dose to be given depends on the patient's bodyweight and the infusion is repeated every 3 weeks.
Odmerek, ki ga prejme bolnik, je odvisen od njegove telesne mase, infundiranje pa je treba ponoviti vsake 3 tedne.
Kadcyla trastuzumab emtansine
Kadcyla trastuzumab emtanzin
In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
V eni glavni študiji, v katero je bilo vključenih 991 takih bolnikov, so tisti, ki so bili zdravljeni z zdravilom Kadcyla, v povprečju živeli 9,6 meseca brez poslabšanja bolezni, bolniki, ki so jih zdravili z dvema drugima zdraviloma proti raku, kapecitabinom in lapatanibom, pa 6,4 meseca.
A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Kadcyla je bil pripravljen načrt obvladovanja tveganj.
What benefits of Kadcyla have been shown in studies?
Kakšne koristi je zdravilo Kadcyla izkazalo v študijah?
It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Veže se na beljakovino v celicah, imenovano „tubulin“, ki ima pomembno vlogo pri tvorjenju notranjega „ogrodja“, ki ga morajo celice zgraditi, da se lahko delijo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Kadcyla večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What is Kadcyla and what is it used for?
Kaj je zdravilo Kadcyla in za kaj se uporablja?
The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Najpogostejši neželeni učinki zdravila Kadcyla (ki lahko prizadenejo več kot 25 % bolnikov) so navzeja (slabost), utrujenost in glavobol.
What are the risks associated with Kadcyla?
Kakšna tveganja so povezana z zdravilom Kadcyla?
Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Ker obstaja nevarnost, da bi zaradi podobno zvenečih zdravilnih učinkovin (trastuzumab emtanzin in trastuzumab) zdravilo Kadcyla zamenjali za zdravilo Herceptin, bo družba zagotovila izobraževalno gradivo za vse zdravstvene delavce, ki naj bi uporabljali zdravilo Kadcyla ali Herceptin, da se jih opozori na to, da zdravili med seboj nista zamenljivi, in da se jih seznani z ukrepi, ki jih morajo upoštevati, da preprečijo uporabo napačnega zdravila.
Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Uporablja se lahko samo, kadar se ugotovi, da rak „čezmerno izraža HER2“: to pomeni, da na površini rakave celice nastajajo velike količine beljakovine, ki spodbuja rast rakave celice, in se imenuje HER2 (humani epidermalni rastni dejavnik).
For more information about treatment with Kadcyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Kadcyla preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).
Uporablja se za zdravljenje napredovalega ali metastatskega (ki se je razširil na druge dele telesa) raka dojk pri odraslih, ki so že prejemali trastuzumab in taksan (vrsta zdravila za zdravljenje raka).
Why is Kadcyla approved?
Zakaj je bilo zdravilo Kadcyla odobreno?
It is not intended to provide practical advice on how to use Kadcyla.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Najpogostejši resni neželeni učinki so hemoragija (krvavitev), pireksija (povišana telesna temperatura), dispneja (težave z dihanjem), kostno-mišične bolečine (bolečine v mišicah in kosteh), trombocitopenija (nizko število trombocitov), bolečine v trebuhu in bruhanje.
In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.
pri katerih se pojavijo alergijske reakcije ali neželeni učinki, bo lečeči zdravnik morda moral zmanjšati odmerek ali prekiniti zdravljenje z zdravilom Kadcyla.
Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Zdravilo Kadcyla je znatno upočasnilo poslabšanje bolezni in podaljšalo čas preživetja pri bolnikih z napredovalim in metastatskim rakom dojk, ki so imeli izražen HER2 in so že bili zdravljeni s trastuzumabom in taksanom.
Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever.
Bolnike je treba med infundiranjem in po njem opazovati zaradi morebitnih reakcij, povezanih z infundiranjem, kot so na primer rdečica, napadi mrazenja in poišana telesna temperatura.
Regarding Kadcyla's safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.
Glede varnosti zdravila Kadcyla je zaključil, da so njegovi neželeni učinki na splošno obvladljivi in da ima v primerjavi z drugimi zdravili, ki so trenutno na voljo, ugoden splošni varnostni profil.
• Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
• trastuzumaba, ki je monoklonsko protitelo (vrsta beljakovine), ki deluje tako, da prepozna beljakovino HER2, ki je v velikih količinah prisotna na površini nekaterih rakavih celic, in se veže nanjo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.
Zdravilo mora predpisati zdravnik, daje pa se lahko samo pod nadzorom zdravstvenega delavca, ki ima izkušnje z zdravljenjem bolnikov z rakom.
The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Zdravilna učinkovina v zdravilu Kadcyla, trastuzumab emtanzin, je sestavljena iz dveh med seboj povezanih zdravilnih sestavin:
Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
Kadcyla je zdravilo za zadravljenje raka, ki vsebuje zdravilno učinkovino trastuzumab emtanzin.
Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Poleg tega je bil pri bolnikih, ki so jih zdravili z zdravilom Kadcyla, čas preživetja 31 mesecev, pri bolnikih, zdravljenih s kapecitabinom in lapatinibom, pa 25 mesecev.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells.
Ob vezavi na HER2 trastuzumab aktivira celice imunskega sistema, ki nato uničijo rakave celice.
About a quarter of breast cancers overexpress HER2.
HER2 je čezmerno izražena pri približno četrtini primerov raka dojke;
For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Kadcyla naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Kadcyla, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kadcyla, glejte navodilo za uporabo.
By attaching to tubulin in cancer cells, DM1 stops the formation of this skeleton, preventing the division and growth of the cancer cells.
Ko se DM1 veže na tubulin v rakavih celicah, zaustavi tvorbo tega ogrodja in s tem prepreči delitev in rast rakavih celic.
The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy.
CHMP je menil, da je zdravilo Kadcyla znatno podaljšalo čas preživetja bolnikov v primerjavi s standardnim zdravljenjem.
Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo Kadcyla je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
How does Kadcyla work?
Kako zdravilo Kadcyla deluje?
How is Kadcyla used?
Kako se zdravilo Kadcyla uporablja?
Trastuzumab also stops HER2 from stimulating the growth of the cancer cells.
Poleg tega trastuzumab prepreči, da bi beljakovina HER2 še naprej spodbujala rast rakavih celic.
• DM1, a toxic substance that kills cells when they attempt to divide and grow.
• DM1, tj. toksična snov, ki uniči celice pri poskusu delitve ali rasti, postane aktivna, ko zdravilo Kadcyla vstopi v rakavo celico.
The recommended dose is two tablets taken once a day with food for 8, 12 or 24 weeks.
Priporočeni odmerek sta dve tableti, ki se jemljeta enkrat na dan skupaj s hrano v obdobju 8, 12 ali 24 tednov.
Further information on Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Viekirax so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.
Tako se upočasni izločanje paritaprevirja iz telesa in paritaprevirju omogoči dlje trajajoče delovanje proti virusu.
The Agency therefore decided that Viekirax's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Viekirax večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Viekirax?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Viekirax?
It must also not be used together with medicines that can raise or lower the levels of Viekirax's active substances in the blood.
Prav tako se ne sme uporabljati skupaj z zdravili, ki lahko zvišajo ali znižajo ravni učinkovin zdravila Viekirax v krvi.
Viekirax received a marketing authorisation valid throughout the EU on 15 January 2015.
Za zdravilo Viekirax je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
Zdravilo Viekirax je na voljo v obliki tablet, ki vsebujejo 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
Almost all the patients with these genotypes treated in studies had the virus cleared from their blood.
Pri skoraj vseh bolnikih s temi genotipi, zdravljenih v študijah, je bil virus odstranjen iz krvi.
As for all medicines, data on the use of Viekirax are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Viekirax stalno spremljajo.
Other information about Viekirax
Druge informacije o zdravilu Viekirax
By blocking these proteins, the medicine prevents the hepatitis C virus from multiplying and infecting new cells.
Z zaviranjem teh beljakovin zdravilo virusu hepatitisa C prepreči, da bi se razmnoževal in okužil nove celice.
What is Viekirax and what is it used for?
Kaj je zdravilo Viekirax in za kaj se uporablja?
An overview of Viekirax and why it is authorised in the EU
Pregled zdravila Viekirax in zakaj je odobreno v EU
Side effects reported with Viekirax are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Viekirax, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The clearance rate was particularly high in patients infected with genotypes 1b and 4.
Odstranjevanje je bilo še zlasti uspešno pri bolnikih, okuženih z genotipoma 1b in 4.
It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
Vsebuje tri učinkovine: ombitasvir, paritaprevir in ritonavir.
What benefits of Viekirax have been shown in studies?
Kakšne koristi zdravila Viekirax so se pokazale v študijah?
For more information about using Viekirax, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Viekirax glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Viekirax authorised in the EU?
Zakaj je bilo zdravilo Viekirax odobreno v EU?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viekirax have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Viekirax upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus infecting the patient, the nature of the patient's liver problems, for example if they have liver cirrhosis (scarring) or their liver is not working properly, and whether they have received previous treatment.
Kombinacija uporabljenih zdravil in trajanje zdravljenja sta odvisna od genotipa virusa hepatitisa C, s katerim je bolnik okužen, od vrste težav z jetri, ki jih ima bolnik, na primer od tega, ali ima cirozo (brazgotinjenje) jeter ali pa njegova jetra ne delujejo pravilno, in od tega, ali je bolnik že bil zdravljen.
The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir.
Tretja učinkovina, ritonavir, ne deluje neposredno proti virusu hepatitisa C, temveč zavira delovanje encima, imenovanega CYP3A, ki razgrajuje paritaprevir.
What are the risks associated with Viekirax?
Kakšna tveganja so povezana z zdravilom Viekirax?
Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.
Zdravilo Viekirax se vedno uporablja v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C, kot sta dasabuvir in ribavirin.
Several varieties (genotypes) of hepatitis C virus exist, and Viekirax is recommended for patients with virus of genotypes 1a, 1b and 4.
Obstaja več vrst (genotipov) virusa hepatitisa C, zdravilo Viekirax pa se priporoča za zdravljenje bolnikov z virusom genotipov 1a, 1b in 4.
In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Viekirax in combination with dasabuvir was effective in clearing the virus from the blood.
V šestih glavnih študijah, v katere je bilo vključenih približno 2 300 bolnikov, okuženih z genotipoma 1a ali 1b virusa hepatitisa C, je bilo zdravilo Viekirax v kombinaciji z dasabuvirjem učinkovito pri odstranjevanju virusa iz krvi.
Viekirax must not be used in patients with moderate to severe liver impairment and in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Zdravilo Viekirax se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro jeter in ženskah, ki jemljejo etinilestradiol, tj. vrsto estrogena v hormonskih kontracepcijskih sredstvih.
The 3 active substances in Viekirax work in different ways: ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Tri učinkovine v zdravilu Viekirax delujejo na različne načine: ombitasvir zavira delovanje beljakovine v virusu hepatitisa C, imenovane „NS5A“, paritaprevir pa zavira delovanje druge beljakovine, imenovane „NS3/4A“.
Viekirax can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Predpisovanje in izdaja zdravila Viekirax je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Zdravilo Viekirax je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo jeter, ki jo povzroča virus hepatitisa C.
In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
V sedmi študiji so bolnike s cirozo jeter in stabilnim delovanjem jeter (kompenzirano cirozo), okužene z genotipom 1b, zdravili z zdraviloma Exviera in Viekirax brez ribavirina in pri 100 % bolnikov (60 od 60) je bil virus odstranjen iz krvi.
The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 5 people) are tiredness and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Viekirax, kadar se uporablja skupaj z dasabuvirjem in ribavirinom (ki se lahko pojavijo pri več kot 1 od 5 bolnikov), so utrujenost in navzea (siljenje na bruhanje).
An additional study showed Viekirax to be effective against genotype 4: when given with ribavirin, Viekirax cleared this genotype from the blood of all the 91 patients infected with it after 12 weeks.
V dodatni študiji se je zdravilo Viekirax pokazalo kot učinkovito proti genotipu 4, saj je v kombinaciji z ribavirinom po 12 tednih ta genotip odstranilo iz krvi vseh 91 bolnikov, okuženih z njim.
For the full list of side effects and restrictions of Viekirax, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Viekirax glejte navodilo za uporabo.
The European Medicines Agency noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Evropska agencija za zdravila je ugotovila, da zdravilo Viekirax v kombinaciji z drugimi zdravili učinkovito odstranjuje genotipe 1a, 1b in 4 virusa hepatitisa C iz krvi, tudi pri bolnikih s cirozo jeter.
The company that markets Viekirax will carry out a study in patients who have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Viekirax.
Podjetje, ki trži zdravilo Viekirax, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Viekirax, izvedlo študijo pri bolnikih, ki so preboleli raka jeter.
Although there were some cases of raised liver enzymes in patients treated with Viekirax in combination with dasabuvir and ribavirin, side effects with this combination were generally well tolerated.
Čeprav je bilo pri bolnikih, zdravljenih z zdravilom Viekirax v kombinaciji z dasabuvirjem in ribavirinom, zabeleženih nekaj primerov zvišanih jetrnih encimov, so bolniki neželene učinke pri tej kombinaciji na splošno dobro prenašali.