natgillin/translations-raw huggingface dataset:
If a hypersensitivity reaction is suspected, Janumet should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8). 
Pri sumu na preobčutljivostne reakcije morate zdravljenje z zdravilom Janumet prekiniti, oceniti druge morebitne vzroke za ta neželeni učinek in začeti zdraviti sladkorno bolezen z drugimi zdravili (glejte poglavje 4.8).
What Janumet contains 
Kaj vsebuje zdravilo Janumet
How to take Janumet 
Kako jemati zdravilo Janumet
Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes. 
Sitagliptinijev fosfat je peroralno aktiven, močan in zelo selektiven zaviralec encima dipeptidilpeptidaze 4 (DPP-4) in se uporablja za zdravljenje sladkorne bolezni tipa 2.
Janumet has no or negligible influence on the ability to drive and use machines. 
Zdravilo Janumet nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Janumet must therefore not be used in women who are breast-feeding (see section 4.3). 
Zato ženske, ki dojijo, zdravila Janumet ne smejo jemati (glejte poglavje 4.3).
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Janumet (see section 4). 
Pri bolnikih, ki so prejemali zdravilo Janumet, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. 
Zdravilo Janumet je indicirano kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka samega metformina, ki ga prenašajo, ali pri bolnikih, ki že prejemajo kombinacijo sitagliptina in metformina.
Tablet core microcrystalline cellulose (E460) povidone K29/32 (E1201) sodium lauril sulfate sodium stearyl fumarate 
Jedro tablete mikrokristalna celuloza (E460) povidon K29/32 (E1201) natrijev lavrilsulfat natrijev stearilfumarat
- if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. 
- če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
Janumet must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4). 
Zdravilo Janumet je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.3 in 4.4).
You will need to stop taking Janumet at the time of the X-ray and for 2 or more days after as directed by your doctor, 
Zdravilo Janumet morate prenehati jemati na dan rentgenskega pregleda in ga ne smete jemati še 2 ali več dni po njem, kot vam je naročil zdravnik, odvisno od delovanja vaših ledvic.
Do not take Janumet if any of the above apply to you and talk with your doctor about other ways of managing your diabetes. 
Zdravila Janumet ne jemljite in se z zdravnikom posvetujte o drugih možnostih za nadzor sladkorne bolezni, če kar koli od navedenega velja za vas.
Janumet is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. 
Zdravilo Janumet je indicirano za trojno kombinirano zdravljenje z agonistom receptorja gama, aktiviranega s peroksisomskim proliferatorjem (PPAR - peroxisome proliferator-activated receptor gamma) (tj. s tiazolidindionom) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in agonista PPAR.
The level of digoxin in your blood may need to be checked if taking with Janumet. 
Med sočasnim jemanjem z zdravilom Janumet vam bodo morda morali preveriti vrednosti digoksina v krvi.
For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride. 
Za različne odmerke metformina je zdravilo Janumet na voljo v jakostih po 50 mg sitagliptina in 850 mg metforminijevega klorida ali 1.000 mg metforminijevega klorida.
Janumet is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. 
Zdravilo Janumet je indicirano tudi kot dodatno zdravljenje k insulinu (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
Talk to your doctor or pharmacist before taking Janumet: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. 
Pred začetkom jemanja zdravila Janumet se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste kdaj imeli bolezen trebušne slinavke (kot je pankreatitis).
If you are not sure, talk to your doctor, pharmacist or nurse before taking Janumet. 
Če niste prepričani, se pred začetkom jemanja zdravila Janumet, posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. 
Zdravilo Janumet je indicirano v kombinaciji s sulfonilsečnino (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in sulfonilsečnine.
Janumet 50 mg/1,000 mg film-coated tablets 
Janumet 50 mg/1.000 mg filmsko obložene tablete
Janumet 50 mg/850 mg film-coated tablets 
Janumet 50 mg/850 mg filmsko obložene tablete
If pancreatitis is suspected, Janumet and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Janumet should not be restarted. 
V primeru potrjenega akutnega pankreatitisa se zdravila Janumet ne sme ponovno uvesti.
EU/1/08/455/009 EU/1/08/455/010 EU/1/08/455/011 EU/1/08/455/012 EU/1/08/455/013 EU/1/08/455/014 EU/1/08/455/016 EU/1/08/455/018 EU/1/08/455/021 EU/1/08/455/022 
EU/1/08/455/008 EU/1/08/455/009 EU/1/08/455/010 EU/1/08/455/011 EU/1/08/455/012 EU/1/08/455/013 EU/1/08/455/014 EU/1/08/455/016
How to store Janumet 
Shranjevanje zdravila Janumet
EU/1/08/455/008 14 film-coated tablets EU/1/08/455/009 28 film-coated tablets EU/1/08/455/010 56 film-coated tablets EU/1/08/455/021 60 film-coated tablets EU/1/08/455/011 112 film-coated tablets EU/1/08/455/012 168 film-coated tablets EU/1/08/455/022 180 film-coated tablets EU/1/08/455/013 196 film-coated tablets EU/1/08/455/014 50 x 1 film-coated tablets EU/1/08/455/016 196 (2 x 98) film-coated tablets EU/1/08/455/018 168 (2 x 84) film-coated tablets 
EU/1/08/455/008 14 filmsko obloženih tablet EU/1/08/455/009 28 filmsko obloženih tablet EU/1/08/455/010 56 filmsko obloženih tablet EU/1/08/455/021 60 filmsko obloženih tablet EU/1/08/455/011 112 filmsko obloženih tablet EU/1/08/455/012 168 filmsko obloženih tablet EU/1/08/455/022 180 filmsko obloženih tablet EU/1/08/455/013 196 filmsko obloženih tablet EU/1/08/455/014 50 x 1 filmsko obložena tableta EU/1/08/455/016 196 (2 x 98) filmsko obloženih tablet EU/1/08/455/018 168 (2 x 84) filmsko obloženih tablet
EU/1/08/455/001 14 film-coated tablets EU/1/08/455/002 28 film-coated tablets EU/1/08/455/003 56 film-coated tablets EU/1/08/455/019 60 film-coated tablets EU/1/08/455/004 112 film-coated tablets EU/1/08/455/005 168 film-coated tablets EU/1/08/455/020 180 film-coated tablets EU/1/08/455/006 196 film-coated tablets EU/1/08/455/007 50 x 1 film-coated tablets EU/1/08/455/015 196 (2 x 98) film-coated tablets EU/1/08/455/017 168 (2 x 84) film-coated tablets 
EU/1/08/455/001 14 filmsko obloženih tablet EU/1/08/455/002 28 filmsko obloženih tablet EU/1/08/455/003 56 filmsko obloženih tablet EU/1/08/455/019 60 filmsko obloženih tablet EU/1/08/455/004 112 filmsko obloženih tablet EU/1/08/455/005 168 filmsko obloženih tablet EU/1/08/455/020 180 filmsko obloženih tablet EU/1/08/455/006 196 filmsko obloženih tablet EU/1/08/455/007 50 x 1 filmsko obložena tableta EU/1/08/455/015 196 (2 x 98) filmsko obloženih tablet EU/1/08/455/017 168 (2 x 84) filmsko obloženih tablet
Janumet 50 mg/1,000 mg tablets sitagliptin/metformin HCl 
Janumet 50 mg/1.000 mg tablete sitagliptin/metformin HCl
Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. 
multidrug and toxin extrusion], kot so ranolazin, vandetanib, dolutegravir in cimetidin), bi lahkozvečala sistemsko izpostavljenost metforminu in tveganje za laktacidozo.
Janumet 50 mg/850 mg tablets sitagliptin/metformin HCl 
Janumet 50 mg/850 mg tablete sitagliptin/metformin HCl
If bullous pemphigoid is suspected, Janumet should be discontinued. 
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Janumet prekiniti.
depending on how your kidneys are working - if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties - if you have liver problems - if you drink alcohol to excess (either every day or only from time to time) - if you are breast-feeding 
- če ste pred nedavnim imeli srčni napad ali imate hude težave s krvnim obtokom, kot so "šok" ali težave pri dihanju.
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Janumet (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Janumet, as you may experience low blood sugar levels (hypoglycaemia). 
- če imate ali ste imeli alergijsko reakcijo na sitagliptin, metformin ali zdravilo Janumet (glejte poglavje 4).
In addition, patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with a sulphonylurea or with insulin. 
Poleg tega je treba bolnike, ki jemljejo zdravilo Janumet skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
Janumet 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride 
Janumet 50 mg/1.000 mg filmsko obložene tablete sitagliptin/metforminijev klorid
Janumet 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride 
Janumet 50 mg/850 mg filmsko obložene tablete sitagliptin/metforminijev klorid
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Janumet) or during post-approval use of Janumet or sitagliptin alone or with other diabetes medicines: 
Pri nekaterih bolnikih, ki so v kliničnih študijah jemali samo sitagliptin (eno od učinkovin v zdravilu Janumet) ali so v obdobju trženja jemali zdravilo Janumet ali sitagliptin, sam ali z drugimi zdravili za zdravljenje sladkorne bolezni, so se pojavili naslednji neželeni učinki: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
Janumet combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. 
Vsebuje sitagliptinijev fosfat, ki je zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, ki spada med bigvanide.
Date of first authorisation: 19 September 2011 
Datum prve odobritve: 19. september 2011
95% confidence interval 
95% interval zaupanja
Study 108 (ADVANCE) 
Študija 108 (ADVANCE)
45 to ≤ 65 years of age Black 
Starost od 45 do ≤ 65 let Črnci
No new safety findings were identified. 
Novih varnostnih dogodkov niso opazili.
Tell your doctor if you take any of the following medicines: 
Povejte svojemu zdravniku, če jemljete katero od naslednjih zdravil:
Your doctor will monitor your early response to treatment and how much virus is in your blood. 
Zdravnik bo spremljal tudi vaš zgodnji odziv na zdravljenje in koliko virusa je v vaši krvi.
Ribavirin can damage your unborn baby. 
Ribavirin bi lahko povzročil okvare pri vašem nerojenem otroku.
Among HIV regimens that can be used (not limited to those below) the following should be taken into account: 
Pri načinih zdravljenja HIV, ki so na voljo (niso pa omejeni na spodnje) je treba upoštevati naslednje:
Pregnancy and contraception requirements 
Zahteve glede nosečnosti in kontracepcije
The total dose is 6 tablets per day. 
Celokupni odmerek je 6 tablet na dan.
These may be symptoms of anaemia. 
To so lahko simptomi anemije.
Always take the tablets with food. 
Tablete vedno jemljite s hrano.
Otherwise, the total treatment duration was 48 weeks. 
Drugače je zdravljenje trajalo 48 tednov.
It is therefore absolutely essential that you take all precautions not to get pregnant during this therapy. 
Zato je nujno, da uvedete vse previdnostne ukrepe, da med tem zdravljenjem ne zanosite.
- 3 tablets of INCIVO twice daily (morning and evening) with food. 
- 3 tablete zdravila INCIVO dvakrat na dan (zjutraj in zvečer) s hrano.
amlodipine, diltiazem, felodipine, nicardipine, 
amlodipin, diltiazem, felodipin, nikardipin,
Data in the paediatric population are currently not available. 
Podatki za pediatrično populacijo niso na voljo.
Hispanic Latino 
Španskega oziroma latinskoameriškega rodu
The incidence was calculated by the number of patients for each parameter. 
Pogostnost je bila izračunana glede na število bolnikov za vsak parameter posebej.
More than 90% of rashes were of mild or moderate severity. 
V več kot 90% primerov je bil izpuščaj blag ali zmeren.
The rash may take several weeks to resolve. 
To lahko traja tudi več tednov.
At steady-state, the effective half-life is about 9-11 hours. 
V stanju dinamičnega ravnovesja je učinkoviti razpolovni čas približno 9-11 ur.
INCIVO is not for use in children or adolescents, because it has not been sufficiently studied in 
Zdravilo INCIVO ni namenjeno uporabi pri otrocih ali mladostnikih, ker ni bilo zadostno preučeno pri
- to check for changes in some values of your blood cells or chemistry. 
- preveril spremembe nekaterih vrednosti vaših krvnih celic in biokemičnih lastnosti krvi.
Simvastatin is contraindicated due to the predicted marked increase in exposure caused by multiple mechanisms. 
Sočasna uporaba s simvastatinom je kontraindicirana zaradi predvidenega izrazitega povečanja izpostavljenosti, ki je posledica več mehanizmov.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
Effect on concentration of INCIVO or concomitant medicinal product and possible mechanism 
Vpliv na koncentracijo zdravila INCIVO oziroma drugega sočasno uporabljenega zdravila in verjetni mehanizem delovanja
Do not take INCIVO if you are allergic to telaprevir or any of the other ingredients of this medicine 
Ne jemljite zdravila INCIVO, če ste alergični na telaprevir ali katerokoli sestavino tega zdravila
Make sure that you check the following points and tell your doctor treating your hepatitis C virus (HCV) if any of these apply to you. 
Preveriti morate naslednje navedbe in povedati zdravniku, ki zdravi okužbo z virusom hepatitisa C (HCV), če katera od njih velja za vas.
The Physician Leaflet should contain the following key elements: 
Navodilo za uporabo za zdravnike mora vsebovati naslednje ključne elemente:
What INCIVO is and what it is used for 
Kaj je zdravilo INCIVO in za kaj ga uporabljamo
Treatment of overdose with INCIVO consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. 
Zdravljenje prevelikega odmerjanja zdravila INCIVO je sestavljeno iz splošnih podpornih ukrepov, vključno s spremljanjem vitalnih znakov in opazovanjem bolnikovega kliničnega stanja.
Refer to section 4.4, Laboratory tests. 
Glejte poglavje 4.4 Laboratorijske preiskave.
What INCIVO is and what it is used for What you need to know before you take INCIVO 
Kaj je zdravilo INCIVO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo INCIVO
Increased plasma concentrations of quetiapine may lead to coma. 
Povečane koncentracije kvetiapina lahko vodijo v komo.
Maximum plasma concentrations after a single dose of telaprevir are generally achieved after 4 - 5 hours. 
Največje plazemske koncentracije po zaužitju enkratnega odmerka telaprevirja so običajno dosežene po 4 do 5 urah.
In rats and dogs, telaprevir was associated with a reversible reduction of red blood cell parameters accompanied by a regenerative response. 
Pri podganah in psih je bila uporaba telaprevirja povezana z reverzibilnim zmanjšanjem parametrov rdečih krvničk, ki ga je spremljal regenerativni odziv.
The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body. 
Zaviralci NS3-4A proteaze zmanjšajo količino virusa hepatitisa C v telesu.
After ending treatment, approximately one week may be needed for the inhibition to completely disappear. 
Po zaključku zdravljenja je potreben približno en teden, da zaviranje popolnoma izzveni.
The clinical implications of this finding are currently unknown. 
Klinični pomen teh izsledkov trenutno ni znan.
Extent and features of Cutaneous Reactions 
Obseg in značilnosti kožne reakcije
Co-administration should be done in a setting which ensures clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation. 
Sočasno uporabo je treba izvajati v okolju, ki zagotavlja klinično spremljanje in ustrezno medicinsko zdravljenje v primeru depresije dihanja in/ali podaljšane sedacije.
to decrease blood pressure (calcium channel blockers) to treat HIV infections (CCR5 antagonist) 
za znižanje krvnega tlaka (zaviralci kalcijevih kanalčkov) za zdravljenje okužbe s HIV (antagonist CCR5)
In rats (but not in dogs), telaprevir caused degenerative changes in testes which were reversible and did not affect fertility. 
Pri podganah (pri psih pa ne) je telaprevir povzročil degenerativne spremembe v modih, ki so bile reverzibilne in niso vplivale na plodnost.
No clinical studies have been performed in paediatric patients. 
Pri pediatričnih bolnikih niso opravili nobenih kliničnih študij.
The time dependency indicates that inhibition of CYP3A4 may be intensified during the first 2 weeks of treatment. 
Spremljanje časovne odvisnosti kaže, da se zaviranje CYP3A v prvih dveh tednih zdravljenja lahko stopnjuje.
INCIVO has only been used in a limited number of patients of 65 years or older. 
Zdravilo INCIVO je bilo doslej uporabljeno le pri omejenem številu bolnikov, starih 65 let ali več.
Please see section ‘Other medicines and INCIVO'. 
Glejte poglavje ‘Druga zdravila in zdravilo INCIVO'.
However, sufficiently high concentrations were not tested for intestinal inhibition to be excluded. 
Vendar niso preskušali dovolj velikih koncentracij, da bi lahko izključili zaaviranje v črevesju.
It may appear at any time after start of treatment, although the majority of cases appeared between six and ten weeks after the start of treatment with INCIVO. 
Pojavi se lahko kadarkoli po začetku zdravljenja, v večini primerov se je pojavil v obdobju med šestim in desetim tednom zdravljenja z zdravilom INCIVO.
- to check if you have anaemia (decrease in your red blood cells). 
- preveril, ali ste anemični (imate zmanjšano število rdečih krvničk).
Telaprevir is extensively metabolised in the liver, involving hydrolysis, oxidation, and reduction. 
Telaprevir se obsežno presnovi v jetrih s hidrolizo, oksidacijo in redukcijo.
The food is important to get the right levels of medicine in your body. 
To je pomembno, da dosežete primerne koncentracije zdravila v vašem telesu.
The median recovery of the administered radioactive dose was approximately 82% in the faeces, 9% in exhaled air and 1% in urine. 
Mediane vrednosti izmerjenega radioaktivnega odmerka so bile približno 82% v blatu, 9% v izdihanem zraku in 1% v seču.
These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy. 
Ta priporočila temeljijo na študijah njegovih interakcij z drugimi zdravili (kar je označeno z *) ali na napovedanih interakcijah glede pričakovane stopnje interakcij in nevarnosti za pojav resnih neželenih učinkov ali neučinkovitost zdravljenja.
For additional information on mild to moderate rash, see section 4.8. 
Za dodatne informacije o blagih do zmernih izpuščajih glejte poglavje 4.8.
INCIVO is not recommended for use in children and adolescents younger than 18 years of age because the safety and efficacy has not been established in this population. 
Uporaba zdravila INCIVO pri otrocih in mladostnikih, mlajših od 18 let ni priporočena, ker njegova varnost in učinkovitost pri tej populaciji še ni bila ugotovljena.
Usually the rash is mild or moderate, but the rash may be, or may become, severe and/or life-threatening. 
Običajno je ta izpuščaj blag ali zmeren, lahko pa je ali postane tudi hud in/ali življenju nevaren.
For outcomes obtained in HIV co-infected patients, see section 5.1. 
Za izide pri bolnikih s sočasno okužbo s HIV glejte poglavje 5.1.
ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000). 
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in redki (≥ 1/10.000 do < 1/1.000).
Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AE11. 
Farmakoterapevtska skupina: Protivirusna zdravila z neposrednim delovanjem, oznaka ATC: J05AE11
What you need to know before you take INCIVO 
Kaj morate vedeti, preden boste vzeli zdravilo INCIVO
However, patients treated with peginterferon alfa-2b experienced more frequent viral breakthrough, and were less likely to meet the criteria for shortened total treatment duration (see section 5.1). 
Vendar je pri bolnikih, ki so prejemali peginterferon alfa-2b pogosteje prišlo do virološkga preboja in so imeli manjšo verjetnost, da bodo ustrezali kriterijem za skrajšanje celokupnega trajanja zdravljenja (glejte poglavje 5.1).