natgillin/translations-raw huggingface dataset:
Your doctor may prescribe a different dose of Viraferon alone or in combination with other medicines (e.g. ribavirin). 
Zdravnik vam lahko predpiše tudi drugačen odmerek zdravila Viraferon, samostojno ali skupaj z drugimi zdravili (npr. s ribavirinom).
Insert the needle into the pinched skin at an angle of approximately 45°. 
Vbodite iglo v kožno gubo pod kotom približno 45°.
Skin laceration 
laceracije na koži
Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon. 
Z uporabo sterilizirane injekcijske brizge in injekcijske igle injicirajte 1 ml vode za injekcije v vialo zdravila Viraferon.
if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor. 
- če se pri vas pojavijo simptomi prehlada ali druge okužbe dihal, npr. zvišana telesna temperatura, kašelj ali kakršnekoli težave z dihanjem, obvestite svojega zdravnika.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. 
Med standardne ukrepe za preprečevanje okužb kot posledica uporabe zdravil, izdelanih iz človeške krvi ali plazme, sodijo selekcija darovalcev, presejalno testiranje posameznih darovanih enot in skupne količine zbrane plazme na specifične markerje okužbe in uporaba učinkovitih proizvodnih postopkov za inaktivacijo oz. odstranjevanje virusov.
PHARMACEUTICAL FORM Powder and solvent for solution for injection White to cream coloured powder. 
FARMACEVTSKA OBLIKA Prašek in vehikel za raztopino za injiciranje Prašek bele do krem barve.
WHAT VIRAFERON IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO VIRAFERON IN ZA KAJ GA UPORABLJAMO
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits. 
Po injiciranju človeškega rekombinantnega interferona alfa-2b do 3 mesece niso opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
These undesirable effects have also been reported with Viraferon alone. 
O teh neželenih učinkih so poročali tudi pri monoterapiji z zdravilom Viraferon.
Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons. 
Rekombinantni interferon alfa-2b je vodotopna beljakovina z molekulsko maso približno 19.300 daltonov.
Growth rate decrease (height and/or weight decrease for age)§ 
zmanjšana rast (premajhna telesna višina in/ali masa glede na starost)§
If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours. 
Če raztopine ne uporabite takoj, jo morate shraniti v hladilniku pri temperaturi 2°C - 8°C in jo uporabiti v 24 urah.
The increased response rate to the combination of Viraferon + ribavirin, compared with Viraferon alone, is maintained across all subgroups. 
Povečana pogostnost odziva na kombinacijo zdravila Viraferon in ribavirina, v primerjavi s samim zdravilom Viraferon, se ohrani v vseh podskupinah.
Viraferon (3 MIU 3 times a week) I/R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day) 
Viraferon (3 mio i.e. trikrat na teden) I/R Viraferon (3 mio i.e. trikrat na teden) + ribavirin (1.000/1.200 mg/dan)
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection. 
Preliminarni podatki kažejo, da je lahko zdravljenje z interferonom alfa povezano z večjo pogostnostjo zavrnitve ledvičnega presadka.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism. 
Četudi natančen mehanizem delovanja rekombinantnega interferona alfa-2b proti virusom ni znan, kaže, da spremeni presnovo celice gostiteljice.
Cleanse and disinfect the skin where the injection is to be made. 
Očistite in dezinficirajte si kožo na mestu, kjer boste injicirali zdravilo.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate. 
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Viraferon in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels. 
Vaš zdravnik bo opravil preiskave krvi, da zagotovi, da je vaše število levkocitov (celice, ki se bojujejo proti okužbi), število eritrocitov (celice z železom za prenos kisika), število trombocitov (celice za strjevanje krvi), pa tudi drugi vaši laboratorijski izvidi sprejemljivi.
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV. 
Študija 2 pa (P02080) je bila randomizirana enocentrična študija, v katero je bilo vključenih 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe. 
Počasi povlecite bat nazaj, da posesate ustrezen odmerek zdravila, kot ga je predpisal vaš zdravnik, v brizgo.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing. 
Neželeni učinki, podani v Preglednici 1, so povzeti iz kliničnih preskušanj in iz postmarketinških izkušenj.
Virological response in previously untreated paediatric patients Viraferon 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day 
Virološki odziv pri predhodno nezdravljenih pediatričnih bolnikih Viraferon 3 mio i.e./m2 3 - krat na teden ribavirin 15 mg/kg/dan
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition. 
Če ocenite, da je potrebno zdravljenje z interferonom alfa-2b pri odraslih bolnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100 %. 
Tako pri subkutani uporabi kot pri intramuskularni uporabi je bila biološka uporabnost zdravila večja od 100 %.
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored. 
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom Viraferon, morate skrbno spremljati.
Caution must be observed also in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression. 
Previdnost je potrebna tudi pri bolnikih z motnjami koagulacije (npr. tromboflebitisom, pljučno embolijo) ali hudo mielosupresijo.
After each complete turn make sure that the triangle is opposite the dosage indicator (see Diagram O). 
Po vsakem polnem obratu mora biti trikotnik nasproti kazalnika odmerkov (glejte sliko O).
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. 
Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin.
Combination therapy with ribavirin: Ribavirin causes serious birth defects when administered during pregnancy. 
Kombinirana terapija z ribavirinom: Ribavirin lahko povzroči hude poškodbe plodu, če se uporablja med nosečnostjo.
In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes. 
V veliko študijo so vključili skupaj 1.071 bolnikov, ki so bili predhodno vključeni v študijo z nepegiliranim interferonom alfa-2b ali z nepegiliranim interferonom alfa-2b in ribavirinom, da bi ovrednotili trajanje stalnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV. 
Študija 1 (RIBAVIC; P01017) je bila randomizirana, multicentrična študija, v katero je bilo vključenih 412 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor. 
Snemite zaščitni pokrovček igle, ne da bi se dotaknili igle, in napolnite brizgo z zrakom, tako da potegnete bat nazaj do črte, ki predstavlja odmerek zdravila, ki vam ga je predpisal zdravnik.
Sodium chloride, 
Natrijev klorid
Do not exceed the recommended dosage, and take Viraferon for as long as prescribed. 
Ne prekoračite priporočenega odmerka in zdravilo jemljite tako dolgo, kot je bilo predpisano.
3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment. 
trikrat na teden skupaj z ribavirinom v odmerku 15 mg/kg na dan v času enega leta, čemur je sledilo 6mesečno spremljanje po zdravljenju.
For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy. 
Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotavljate nobenega izboljšanja serumske vrednosti HBV-DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom Viraferon ukiniti.
Pharmacotherapeutic group: Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code: L03A B05 
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, citokini in imunomodulatorji, interferoni, interferon alfa-2b, oznaka ATC: L03A B05
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive treatment. 
Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija.
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell. 
Tako zavira replikacijo virusov, če pa do replikacije kljub temu pride, potomski virioni ne morejo zapustiti celice.
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon. 
Standardne hematološke preiskave in biokemične preiskave krvi (celotna krvna slika in diferencialna krvna slika, število trombocitov, določanje elektrolitov, jetrnih encimov, serumskih beljakovin, bilirubina v serumu in serumskega kreatinina) morate opraviti pri vseh bolnikih, in sicer pred terapijo z zdravilom Viraferon in redno med sistemsko terapijo z njim.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates. 
HCV genotip in virusna obremenitev na začetku zdravljenja sta znana prognostične dejavnika, ki vplivata na pogostnost odziva.
The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3). 
Relativna koristnost kombinirane terapije z zdravilom Viraferon in ribavirinom je še posebej pomembna za podskupino bolnikov, ki jih je najtežje zdraviti (genotip 1 in velika virusna obremenitev) (Preglednica 3).
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. 
Pri izdelavi zdravil iz človeške krvi ali plazme upoštevamo določene ukrepe za preprečevanje prenosa okužb na bolnike.
Viraferon is used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver. 
Viraferon se uporablja za zdravljenje odraslih bolnikov kroničnega hepatitisa B ali C, ki sta virusni okužbi jeter.
if you have had a severe nervous or mental disorder. 
- če ste imeli kdaj v preteklosti hudo bolezen živčevja ali duševno bolezen.
Other side effects not listed above may also occur in some patients. 
Pri nekaterih bolnikih se lahko pojavijo tudi drugi neželeni učinki, ki niso navedeni zgoraj.
Toxicity was demonstrated in monkeys given 100 x 106 IU/kg/day for 3 months. 
Raziskave pa so pokazale toksičnost interferona pri opicah, ki so prejemale 100 x 106 i.e./kg na dan 3 mesece.
Enuresis, micturition disorder, urinary incontinence 
enureza, motnje uriniranja, urinska inkontinenca
if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection. 
če ste prejeli presadek organa, bodisi ledvice ali jeter, bi lahko zdravljenje z interferonom povečalo tveganje za njegovo zavrnitev.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards. 
Če pride do te reakcije, naj si potem temeljito sperejo usta.
Psychiatric and central nervous system (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period. 
Psihiatrične motnje in centralni živčni sistem (CŽS): Med terapijo z zdravilom Viraferon so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6-mesečnem obdobju spremljanja.
For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings. 
Za odmerke, ki ustrezajo polnim obratom, se mora lestvica poravnati s pravilno oznako odmerka, za tiste odmerke, ki ustrezajo klikom med polnimi obrati, pa se mora poravnati med dvema ustreznima oznakama odmerka za polni obrat.
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8). 
Če sumite na sindrom VKH, morate bolniku ukiniti protivirusno zdravljenje in se posvetovati glede uvedbe kortikosteroidne terapije (glejte poglavje 4.8).
Overall, in both studies, patients who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin. 
Na splošno so v obeh študijah opazili, da je bila pri bolnikih, ki so prejemali zdravilo Viraferon z ribavirinom, manjša verjetnost za odziv kot pri tistih, ki so prejemali pegiliran interferon alfa-2b z ribavirinom.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered. 
Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih učinkov in mora po potrebi uvesti ustrezno terapijo.
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4). 
V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte poglavje 4.4).
All Genotypes 
Vsi genotipi
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in combination with ribavirin (from two studies) are shown in Table 3. 
Pogostnosti ohranjenega virološkega odziva za terapevtske skupine, zdravljene eno leto z zdravilom Viraferon v monoterapiji ali v kombinaciji z ribavirinom (iz dveh raziskav) so podane v preglednici 3.
After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C). 
Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v 24 urah, če jo shranjujete v hladilniku (2°C - 8°C).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10); rarely (≥1/10,000, <1/1,000); very rarely (<1/10,000); not known. 
V okviru razvrstitve po organskih sistemih so neželeni učinki dodatno navedeni po pogostnosti v naslednje kategorije: zelo pogosti (≥1/10), pogosti (≥1/100, <1/10), redki (≥1/10.000, <1/1.000), zelo redki (<1/10.000) oziroma pogostnost ni znana.
Paediatric Use: Children are particularly prone to develop depression when being treated with Viraferon and ribavirin. 
Uporaba pri otrocih: Otrocih so še bolj nagnjeni k depresiji kadar so zdravljeni z zdarvilom Viraferon in ribavirinom.
Do not use Viraferon after the expiry date which is stated on the package. 
Zdravila Viraferon ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes. 
Pridobiva se iz klona E. coli, v katerega je vgrajen plasmidni hibrid izdelan z genetskim inženiringom, ki vsebuje gen za interferon alfa-2b iz človeških levkocitov.
Милко Бичев" № 7, ет.3 
Милко Бичев" № 7, ет.3 BG-София 1504
Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. 
Kronični hepatitis B: Zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki imajo znake replikacije virusa hepatitisa B (prisotnost HBV-DNA in HBeAg), povečano vrednost alanin-aminotransferaze (ALT) in histološko dokazano aktivno vnetje in/ali fibrozo jeter.
Viraferon has been classified as recombinant interferon alfa-2b. 
Viraferon je opredeljen kot rekombinantni interferon alfa2b.
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary. 
Med sočasno terapijo s ksantinskimi snovmi morate spremljati serumsko koncentracijo teofilina in po potrebi prilagoditi odmerek zdravila.
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset. 
Dodatek terapije z alfa interferoni, in sicer v monoterapiji ali v kombinaciji z ribavirinom, lahko poveča tveganje pri tej podskupini bolnikov.
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. 
Viraferon je sterilna, stabilna formulacija visokoprečiščenega interferona alfa-2b, ki ga izdelujemo s tehnikami rekombinantne DNA.
Patients predisposed to the development of autoimmune disorders may be at increased risk. 
Bolniki, ki so nagnjeni k nastanku avtoimunskih bolezni, so lahko bolj ogroženi zaradi tega.
• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting. 
• otekanje dlani, stopal, gležnjev, obraza, ustnic, ust ali žrela, ki lahko povzroči težave s požiranjem ali dihanjem, koprivnica, izguba zavesti.
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCVRNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment). 
V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCVRNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV-RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha. 
Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so ga opažali tudi pri tistih z malignimi boleznimi, zdravljenimi z interferonom alfa.
The aetiology has not been defined. 
Etiologija teh motenj ni bila ugotovljena.
Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the injection needle (Diagram I). 
Potrkajte po rezervoarju s prstom, da bodo morebitni zračni mehurčki splavali na vrh rezervoarja, tik pod injekcijsko iglo (slika I).
High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus monkeys. 
Tudi za velike odmerke drugih oblik interferonov alfa in beta je znano, da povzročijo od odmerka odvisne učinke v smislu izgube ovulacije ali splava pri opicah rhesus.
Relapse patients (adults): Viraferon is given in combination with ribavirin. 
Bolniki z relapsom bolezni (odrasli): Viraferon se uporablja v kombinaciji z ribavirinom.
The appropriate dose can then be withdrawn with a sterile injection syringe and injected. 
Potem lahko posesate ustrezni odmerek v sterilno injekcijsko brizgo in ga injicirate.
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination. 
Vsi bolniki, ki tožijo o spremembah ostrine vida ali vidnega polja ali ki imajo druge oftalmološke simptome med zdravljenjem z zdravilom Viraferon, morajo biti takoj poslani na celoten oftalmološki pregled.
In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia. 
V kliničnih raziskavah, opravljenih pri širokem razponu indikacij in širokem razponu odmerkov (od 6 mio i.e./m2 na teden pri dlakastocelični levkemiji do največ 100 mio i.e./m2 na teden pri melanomu), so bili najpogosteje opaženi neželeni učinki zvišana telesna temperatura, utrujenost, glavobol in mialgija.
Driving and using machines Do not drive or use machinery if you become drowsy, tired, or confused from this medicine. 
Vpliv na sposobnost upravljanja vozil in strojev Če postanete zaradi tega zdravila zaspani, utrujeni ali zmedeni, ne vozite in ne upravljajte strojev.
Chronic hepatitis B: 
Kronični hepatitis B:
Pull off the cap of the pen and disinfect the rubber membrane (see Diagram C) with one cleansing swab. 
Snemite pokrovček peresnika in dezinficirajte gumijasto opno (slika C) z enim čistilnim tamponom.
If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual. 
Če si sami injicirate zdravilo Viraferon ali ga dajete otroku v kombinaciji z ribavirinom, injicirajte priporočeni odmerek takoj, ko se spomnite, in nadaljujte z zdravljenjem kot običajno.
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year. 
V Preglednici 1 je podana pogostnost z zdravljenjem povezanih neželenih učinkov, o katerih so poročali predhodno nezdravljeni bolniki v kliničnih preskušanjih, v katerih so se zdravili eno leto.