natgillin/translations-raw huggingface dataset:
Administration of Dukoral should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness. 
Uporabo cepiva Dukoral je treba prestaviti pri bolnikih z akutno boleznijo prebavnega trakta ali akutno povišano telesno temperaturo.
The suspension is a whitish suspension supplied in a vial. 
Suspenzija je belkasta suspenzija, ki je na voljo v viali.
Children of 2 to below 6 years of age: The primary vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart. 
Otroci, stari od 2 do 6 let: Primarno cepljenje obsega 3 odmerke, ki se vzamejo peroralno (skozi usta) s presledkom najmanj 1 tedna (do 6 tednov).
In the longitudinal cohort-analysis conducted during the mass-vaccination campaign in Zanzibar, protective effectiveness after 2 doses of Dukoral was 79% (95% CI, 47, 92) for a follow-up period of 15 months. 
V vzdolžni kohortni analizi, opravljeni med kampanjo množičnega cepljenja v Zanzibarju, je bila učinkovitost zaščite po 2 odmerkih cepiva Dukoral 79 % (95 % interval zaupanja, 47, 92) v 15 mesecih spremljanja.
Study location 
Kraj raziskave
Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial. 
Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale s cepivom.
Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vial. 
Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale.
Skin and subcutaneous tissue disorders: Urticaria, angioedema, pruritus General disorders and administration site conditions: Pain, flu-like syndrome, asthenia, chills 
Bolezni kože in podkožja: urtikarija, angioedem, pruritus Splošne težave in spremembe na mestu aplikacije: bolečine, gripi podoben sindrom, astenija, mrzlica
Follow up 
Sledenje
Shake the Dukoral® suspension vial (1 vial = 1 dose). 
Pretresite vialo z zdravilom Dukoral® suspenzija (1 viala = 1 odmerek).
The effervescent granules are white with a raspberry flavour and are supplied in a sachet. 
Šumeča zrnca so bela, z okusom po malinah in pakirana v vrečici.
The safety of Dukoral was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT). 
Varnost cepiva Dukoral so ocenili v kliničnih preskušanjih, v katerih so sodelovali odrasli in otroci, starejši od 2 let, opravljenih v državah, endemičnih in neendemičnih za kolero in enterotoksigeno
No established immunological correlates of protection against cholera after oral vaccination have been identified. 
Imunološke korelacije zaščite proti koleri po peroralnem cepljenju niso opredelili.
If more than 6 months have passed since the last vaccination, the primary vaccination (3 doses) should be repeated. 
Če je od zadnjega cepljenja preteklo več kot 6 mesecev, je treba ponoviti primarno cepljenje (3 odmerki).
What Dukoral looks like and contents of the pack 
Izgled zdravila Dukoral in vsebina pakiranja
If less than 6 months have passed since the last vaccination a single dose will renew the protection. 
Če je od zadnjega cepljenja preteklo manj kot 6 mesecev, bo en odmerek zadostoval za obnovo zaščite.
• The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour. 
• Šumeča zrnca vsebujejo natrijev hidrogenkarbonat, citronsko kislino, natrijev karbonat, natrij saharinat, natrijev citrat in aromo maline.
If you had your last dose of vaccine less than 2 years ago a single dose will renew your protection. 
Če je od zadnjega odmerka cepiva preteklo manj kot 2 leti, vam bo en odmerek zadostoval za obnovo zaščite.
The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap. 
Suspenzija za cepljenje je polnjena v 3-mililitrskih vialah (steklo tipa I) z gumijastim zamaškom
However, immunological and duration of protection data suggest that if up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2 to below 6 years a single booster dose should be given. 
Vendar imunološki podatki in podatki o trajanju zaščite kažejo, da je treba odraslim, če sta od zadnjega cepljenja pretekli do 2 leti, in otrokom, starim od 2 do
Very rare side effects (may affect up to 1 in a 10,000 people) 
Zelo redki neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 10.000):
Dukoral is presented as a suspension and effervescent granules for oral suspension. 
Zdravilo Dukoral je na voljo kot suspenzija in šumeča zrnca za peroralno suspenzijo.
For children of 2 to below6 years: pour away half of the buffer solution. 
Za otroke od 2 do 6 let: odlijte stran pol pufrske raztopine 2.
The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms. 
Protitelesa proti toksinu preprečujejo toksinu kolere, da bi se vezal na sluznico črevesa, in tako preprečijo simptome driske, ki jih ta toksin povzroča.
• Flu -like symptoms, chestiness, chills, general pain, weakness 
• gripi podobni simptomi, respiratorni simptomi, mrazenje, splošne bolečine, oslabelost,
• Diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort 
• driska, bolečine v trebuhu, krči v trebuhu, klokotanje v trebuhu, napenjanje v trebuhu, vetrovi in splošen neprijeten občutek v trebuhu,
No animal data on reproduction toxicity are available. 
Na voljo ni podatkov o vplivu zdravila na sposobnost razmoževanja pri živalih.
• Give the 2nd dose to the child at least 1 week after the 1st dose. 
• Otroku dajte drugi odmerek najmanj 1 teden po prvem odmerku.
In the case-control study conducted during the mass vaccination campaign in Mozambique, protective effectiveness of 2 doses of Dukoral was 84% (95% CI: 43, 95, per-protocol analysis; p=0.005) for the initial 5 months of follow-up. 
V študiji primerov, opravljeni med kampanjo množičnega cepljenja v Mozambiku, je bila učinkovitost zaščite 2 odmerkov cepiva Dukoral v prvih 5 mesecih spremljanja 84 % (95 % interval zaupanja: 43, 95, analiza po protokolih, p = 0,005).
To be used with DUKORAL. 
Za uporabo s cepivom DUKORAL.
− Recombinant cholera toxin B subunit (rCTB) 1 mg 
− rekombinantno podenoto toksina kolera B (rCTB) 1 mg
Protective efficacy of Dukoral against cholera has not been studied following repeated booster vaccination. 
Učinkovitosti zaščite cepiva Dukoral po večkratnih poživitvenih cepljenjih niso raziskovali.
- granules for oral suspension in a sachet :: 
- zrnca za peroralno suspenzijo v vrečici:
In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy against cholera after 2 vaccine doses was 85% (95%CI: 36, 97, per-protocol analysis). 
V drugem preskušanju, ki so ga opravili pri vojaških nabornikih v Peruju, je bila kratkoročna učinkovitost zaščite proti koleri po dveh odmerkih cepiva 85-odstotna (interval zaupanja 95 %: 36, 97,
In subjects infected with HIV, limited data are available on immunogenicity and safety of the vaccine. 
Na voljo je le malo podatkov o imunogenosti in varnosti cepiva pri bolnikih, okuženih z virusom HIV.
• Give the 1st dose to the child no later than 3 weeks before you leave for your trip. 
• Otroku dajte prvi odmerek najpozneje 3 tedne pred odhodom na potovanje.
The vaccine acts by inducing antibodies against both the bacterial components and CTB. 
Cepivo deluje tako, da sproži nastanek protiteles proti bakterijski komponenti in podenoti B toksina kolere (CTB).
Additional adverse reactions reported during post-marketing surveillance are listed below. 
Neželeni učinki iz nadzora po prihodu cepiva na trg Drugi neželeni učinki, o katerih so poročali med nadzorom po prihodu cepiva na trg, so našteti spodaj:
The vaccine is acid labile. 
Cepivo je nestabilno v kislinah.
Active substances: 1 dose contains 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Učinkovine: 1 odmerek vsebuje
Dukoral contains sodium 
Zdravilo Dukoral vsebuje natrij
(produced in V. cholerae O1 Inaba, classical biotype strain 213.) 
(pridobljen s pomočjo bakterije V. cholerae O1 Inaba, klasičnem biotipu, sev 213)
• Take the 2nd dose at least 1 week after the 1st dose and at least 1 week before your trip. 
• Vzemite drugi odmerek najmanj 1 teden po prvem in najmanj 1 teden pred potovanjem.
2x1 dose 
2 x 1 odmerek
Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 
Vibrio cholerae O1 Inaba, klasični biotip (inaktiviran s toploto)
Do not use Dukoral after the expiry date which is stated on the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
No clinical data on protective efficacy of Dukoral against cholera after administration of booster doses are available. 
Na voljo ni nobenih kliničnih podatkov o učinkovitosti zaščite cepiva Dukoral proti koleri po dajanju poživitvenega odmerka.
20x1 dose 
20 x 1 odmerek
• Take the 1st dose no later than 2 weeks before you leave for your trip. 
• Vzemite prvi odmerek najpozneje 2 tedna pred odhodom na potovanje.
If more than 2 years have passed since you had the last vaccine dose, the primary vaccination (2 doses) should be repeated. 
Če je od zadnjega odmerka cepiva preteklo več kot 2 leti, morate ponoviti primarno cepljenje (2 odmerka).
Valneva Sweden AB, 105 21 Stockholm, Sweden. 
Valneva Sweden AB, 105 21 Stockholm, Švedska.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING DUKORAL - 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve) 
DUKORAL - pakiranje po 1 odmerek, pakiranje 2 x 1 odmerek, pakiranje 20 x 1 odmerek (zunanji ovoj)
Do not take other medicine starting 1 hour before until 1 hour after taking the vaccine. 
Eno uro pred jemanjem cepiva in eno uro po tem ne jemljite drugih zdravil.
Vomiting, nausea Very rare Sore throat, dyspepsia 
Zelo redki bolečine v grlu, dispepsija
Other side effects: Uncommon side effects (may affect up to 1 in a 100 people) 
Občasni neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 100):
An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults. 
odmerka cepiva enako učinkovita kot 3 odmerki.
Nervous system disorders Uncommon Headache Rare 
Bolezni živčevja Občasni glavobol
Mix suspension with buffer solution before drinking. 
Pred pitjem suspenzijo zmešajte s pufrsko raztopino.
- Granules for oral suspension in a sachet. 
- zrnca za peroralno suspenzijo v vrečici
In the Bangladesh field trial, protective efficacy of Dukoral in the overall population was 85% (95%CI: 56, 95, per-protocol analysis) for the initial 6 months of follow-up. 
Dukoral v celotni populaciji 85-odstotna (interval zaupanja 95 %: 56, 95, analiza po protokolih).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets) 
DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vrečic z natrijevim hidrogenkarbonatom)
If you have taken more than one dose at one time, please contact your doctor, pharmacist or nurse. 
Če ste vzeli več kot en odmerek naenkrat, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
Pour the content of the Dukoral® suspension vial into the glass of buffer solution (see 1). 
Prelijte vsebino viale z zdravilom Dukoral® suspenzija v kozarec pufrske raztopine (glejte
If you take the doses less than one week apart, contact your doctor, pharmacist or nurse. 
Če ste vzeli odmerke z manj kot enim tednom presledka, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
The suspensionsupplied in a single-dose glass vial is a whitish suspension.. Each vial comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate. 
Vsaki viali je priložena ena vrečica z belimi šumečimi zrnci natrijevega hidrogenkarbonata.
The immune responses to Dukoral were not studied. 
Imunskega odziva na cepivo Dukoral niso raziskovali.
No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with Dukoral in clinical studies. 
V kliničnih študijah niso skupaj s cepivom Dukoral dajali nobenega drugega cepiva ali zdravila, vključno s cepivom proti otroški paralizi in z antimalariki.
Sodium hydrogen carbonate 
Natrijev hidrogenkarbonat šumeča zrnca
Consequently, food and drink should be avoided 1 hour before and 1 hour after vaccination. 
Zato se je uro pred cepljenjem in uro po njem treba izogibati hrani in pijači.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 vaccine vials) 
PODATKI NA PRIMARNI OVOJNINI DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vial s cepivom)
Dukoral suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral) 
Dukoral suspenzija in šumeča zrnca za peroralno suspenzijo cepivo proti koleri (inaktivirano, peroralno)
• Generally feeling unwell, feeling dizzy 
• splošno slabo počutje, omotica,
• Nausea (feeling sick), vomiting, loss of /or poor appetite 
• navzea (siljenje na bruhanje), bruhanje, izguba ali poslabšanje apetita, • otekla in razdražena notranjost nosu, kašelj.
• Numbness or pins and needles 
• otrplost ali mravljinčenje,
Adverse reactions reported are consistent with those seen after the recommended dosing. 
Neželeni učinki, o katerih so poročali, so skladni s tistimi,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sodium hydrogen carbonate 5.6 g, sachet 
OVOJNINAH natrijev hidrogenkarbonat 5,6 g, vrečica
Sodium carbonate, anhydrous Saccharin sodium Sodium citrate 
natrijev hidrogenkarbonat citronska kislina brezvodni natrijev karbonat natrijev saharinat natrijev citrat aroma maline
Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1 hour after administration of Dukoral. 
Uro pred uporabo cepiva Dukoral in uro po njej se je treba izogibati tudi peroralnemu jemanju drugih cepiv in zdravil.
Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity. 
Zaščitno imunost verjetno povzročajo lokalno nastala sekretorna protitelesa IgA v črevesu.
Fever, malaise Very rare Fatigue, shivers 
Zelo redki utrujenost, drhtenje
Respiratory, thoracic and mediastinal disorders: Dyspnoea, increased sputum Gastrointestinal disorders: Flatulence 
Bolezni dihal, prsnega koša in mediastinalnega prostora: dispneja, povečano izločanje sluzi Bolezni prebavil: vetrovi
• Give the 3rd dose at least one week after the 2nd dose and at least one week before your trip. 
• Dajte otroku tretji odmerek najmanj 1 teden po drugem in najmanj 1 teden pred potovanjem.
Food and drink should be avoided 1 hour before and 1 hour after vaccination. 
Uro pred cepljenjem in uro po njem se je treba izogibati hrani in pijači.
How to store Dukoral 
Shranjevanje zdravila Dukoral
DUKORAL suspension Cholera vaccine (inactivated, oral) 
DUKORAL supenzija cepivo proti koleri (inaktivirano, peroralno)
− A total of 1.25x1011 bacteria of the following strains: 
Vsak odmerek suspenzije za cepljenje (3 ml) vsebuje: − skupaj 1,25 x 1011 bakterij naslednjih sevov:
Oral administration of other medicinal products should be avoided within 1 hour before and 1 hour after administration of Dukoral. 
Uro pred jemanjem Dukorala in uro po njem se je treba izogibati peroralnemu jemanju drugih zdravil.
Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria* 
31,25 x 109 bakterij* Vibrio cholerae O1 Inaba, biotip El Tor (inaktiviran s formalinom) 31,25 x 109 bakterij*
To prepare the buffer solution,dissolve the effervescent granules in a glass of cool water (approx. 150 ml) by gently stirring. 
Pripravite pufrsko raztopino tako, da raztopite šumeča zrnca v kozarcu hladne vode (približno
Talk to your doctor before taking Dukoral 
Pred začetkom uporabe zdravila Dukoral se posvetujte z zdravnikom:
Name and address of the manufacturers of the biological active substances 
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin Valneva Sweden AB
Booster dose 
Poživitveni odmerek
Sodium hydrogen carbonate effervescent granules Oral use. 
Šumeča zrnca natrijevega hidrogenkarbonata peroralna uporaba
No preclinical safety testing with the vaccine has been conducted. 
5.3 Predklinični podatki o varnosti S tem cepivom niso opravili nikakršnih predkliničnih študij varnosti.
Vascular disorders: Hypertension 
Žilne bolezni: povišan krvni tlak
Musculoskeletal and connective tissue disorders Very rare Joint pain 
Bolezni mišično-skeletnega sistema in vezivnega tkiva
If more than 6 weeks have passed, contact your doctor, pharmacist or nurse. 
Če je preteklo več kot 6 tednov, se obrnite na svojega zdravnika,
Rare side effects (may affect up to 1 in a 1,000 people) 
Redki neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 1.000): • povišana telesna temperatura,
• Sweating, shivering 
• koprivnica, srbenje,
No clinical efficacy data has been generated on repeat booster dosing. 
O učinkovitosti večkratnih poživitvenih odmerkov ni kliničnih podatkov.
− 31.25x109 bacteria* of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated). 
− 31,25 x 109 bakterij* vsake od naslednjih sevov bakterije V. cholerae O1: klasični biotip Inaba
Children less than 2 years 
Odrasli in otroci >6 let
31.25x109 bacteria* of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated). 
(inaktiviran s toploto), biotip Inaba El Tor (inaktiviran s formalinom), klasični biotip Ogawa (inaktiviran s toploto), klasični biotip Ogawa (inaktiviran s formalinom).
• Difficulty in sleeping 
• otekanje bezgavk,
Avoid food and drink starting 1 hour before until 1 hour after the vaccination. 
Eno uro pred cepljenjem do ene ure po njem ne uživajte hrane in pijače.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DUKORAL, vial label 1 dose 
OVOJNINAH DUKORAL, nalepka za vialo - 1 odmerek
Respiratory symptoms (including rhinitis and cough) Gastrointestinal disorders Uncommon Diarrhoea, abdominal cramps, abdominal pain, stomach/abdominal gurgling (gas), abdominal discomfort 
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki dihalni simptomi (vključno z rinitisom in kašljem)
The usual dose of Zepatier is one tablet taken once a day for 12 weeks. 
Običajni odmerek zdravila Zepatier je ena tableta enkrat dnevno v obdobju 12 tednov.
The full EPAR for Zepatier 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 (EPAR) za zdravilo Zepatier je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Zepatier? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zepatier?
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zepatier'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 zato zaključil, da so koristi zdravila Zepatier večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Zepatier 
Druge informacije o zdravilu Zepatier
This is a summary of the European public assessment report (EPAR) for Zepatier. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zepatier.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zepatier have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Zepatier, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Elbasvir blocks the action of a protein called ‘NS5A', while grazoprevir blocks an enzyme called ‘NS3/4A protease'. 
Elbasvir zavira delovanje beljakovine, imenovane „NS5A“, medtem ko grazoprevir zavira delovanje encima, imenovanega „proteaza NS3/4A“.
The available data in patients with genotype 3 virus were not sufficient to support the use of Zepatier for this genotype. 
Razpoložljivi podatki pri bolnikih z virusom genotipa 3 niso bili zadostni, da bi podprli uporabo zdravila Zepatier pri tem genotipu.
The most common side effects with Zepatier (which may affect more than 1 in 10 people) are tiredness and headache. 
Najpogostejša neželena učinka zdravila Zepatier (ki lahko prizadeneta več kot 1 osebo od 10) sta utrujenost in glavobol.
In some cases, treatment may be longer and Zepatier may be used together with another medicine called ribavirin. 
V nekaterih primerih je zdravljenje lahko daljše, zdravilo Zepatier pa se lahko uporablja skupaj z drugim zdravilom, ribavirinom.
This was considered acceptable because chronic hepatitis C virus is very rarely cured without treatment and, at the time the studies started, other antiviral medications such as Zepatier were not available. 
To je bilo sprejemljivo, ker se kronični virus hepatitisa C zelo redko ozdravi brez zdravljenja in ker v času začetka študij druga protivirusna zdravila, kot je zdravilo Zepatier, še niso bila na voljo.
Zepatier is available as tablets which contain 50 mg elbasvir and 100 mg grazoprevir. 
Zdravilo Zepatier je na voljo v obliki tablet, ki vsebujejo 50 mg elbasvirja in 100 mg grazoprevirja.
In most of the studies, treatment with Zepatier was not compared with another treatment or no treatment. 
V večini študij zdravljenja z zdravilom Zepatier niso primerjali z drugim zdravilom ali odsotnostjo zdravljenja.
Zepatier was well tolerated with a favourable safety profile. 
Zdravilo Zepatier so bolniki dobro prenašali in ima ugoden varnostni profil.
What are the risks associated with Zepatier? 
Kakšna tveganja so povezana z zdravilom Zepatier?
What is Zepatier and what is it used for? 
Kaj je zdravilo Zepatier in za kaj se uporablja?
What benefits of Zepatier have been shown in studies? 
Kakšne koristi je zdravilo Zepatier izkazalo v študijah?
It is not intended to provide practical advice on how to use Zepatier. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Zepatier approved? 
Zakaj je bilo zdravilo Zepatier odobreno?
Benefit was also seen in patients also infected with HIV or who had chronic (long-term) kidney disease. 
Koristne učinke so opazili tudi pri bolnikih, okuženih z virusom HIV, in bolnikih s kronično (dolgotrajno) ledvično boleznijo.
Zepatier with or without ribavirin has been investigated in eight main studies involving around 2,000 patients infected with hepatitis C virus of various genotypes whose liver was working normally or adequately. 
Zdravilo Zepatier z ribavirinom ali brez njega so preučevali v osmih glavnih študijah, ki so vključevale okrog 2 000 bolnikov, okuženih z virusom hepatitisa C različnih genotipov, pri katerih so jetra delovala normalno ali ustrezno.
For more information about treatment with Zepatier, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Zepatier preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.