natgillin/translations-raw huggingface dataset:
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).
Two months after completion of INCIVO treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control.
Dva meseca po zaključku zdravljenja z zdravilom INCIVO so hormonski kontraceptivi spet primerni kot ena od dveh zahtevanih učinkovitih kontracepcijskih metod.
When co-administration is required, high doses of itraconazole (> 200 mg/day) or ketoconazole (> 200 mg/day) are not recommended.
Kadar je potrebna sočasna uporaba teh zdravil, veliki odmerki itrakonazola (> 200 mg/dan) ali ketokonazola (> 200 mg/dan), niso priporočljivi.
There are no data from the use of INCIVO in pregnant women.
Ni podatkov o uporabi zdravila INCIVO pri nosečnicah.
However, when fed via milk from telaprevir-treated dams, body weight gain of rat pups was lower than normal (likely due to taste aversion).
Če pa so jih hranili z mlekom samic, ki so prejemale telaprevir, je bilo pridobivanje telesne mase mladičev počasnejše kot je normalno (verjetno zaradi neprijetnega okusa mleka).
If you have both hepatitis C virus infection and human immunodeficiency virus infection, and are taking efavirenz, the recommended dose regimen is 3 tablets of INCIVO every 8 hours with food.
Če imate okužbo z virusom hepatitisa C in virusom imunske pomankljivosti pri človeku in jemljete efavirenz, je priporočljivi odmerek zdravila INCIVO 3 tablete na vsakih 8 ur, s hrano.
Replicon variants generated from patient-derived sequences showed similar results.
Tudi variante replikonov, dobljene iz sekvenc, odvzetih od bolnikov, so dale podobne rezultate.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use INCIVO are provided with a healthcare professional educational pack containing the following:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravniki, ki bodo predpisovali ali uporabljali zdravilo INCIVO prejeli izobraževalno gradivo, ki bo vsebovalo:
What INCIVO looks like and contents of the pack Film-coated tablet.
Izgled zdravila INCIVO in vsebina pakiranja Filmsko obložena tableta.
These may be symptoms of anaemia (decrease in your red blood cells);
To so lahko znaki anemije (zmanjšanja števila rdečih krvnih celic).
Patients should be instructed to swallow the tablets whole (e.g. patients should not chew, break or
Bolnike je treba poučiti, naj tablete pogoltnejo cele (ne smejo jih žvečiti, zlomiti ali raztopiti).
Do not use INCIVO in combination with any of the following medicines as they may increase the risk of severe side effects, and/or affect the way INCIVO or the other medicine works:
Ne jemljite zdravila INCIVO skupaj z naslednjimi zdravili, ker lahko povečajo tveganje za pojav hudih neželenih učinkov in/ali vplivajo na delovanje zdravila INCIVO ali drugih zdravil:
The effect of subject gender on telaprevir pharmacokinetics was evaluated using population pharmacokinetics of data from Phase 2 and 3 studies of INCIVO.
Vpliv spola preiskovanca na farmakokinetiko telaprevirja so ovrednotili s pomočjo podatkov populacijske farmakokinetike iz študij zdravila INCIVO faze II in III.
Other enzymes are also involved in the metabolism such as aldo-ketoreductases and other proteolytic enzymes.
V presnovo so lahko vključeni tudi drugi encimi, kot so aldo-ketoreduktaze in drugi proteolitični encimi.
Patients Co-infected with HIV-1
Bolniki, sočasno okuženi z virusom HIV-1
INCIVO tablets should be stored in the original bottle.
Tablete INCIVO shranjujte v originalni plastenki.
Transfusion rates over the whole study period were 4.6% and 1.6%, respectively.
Stopnja transfuzije je bila 4,6% in 1,6% za vsako skupino v celotnem času trajanja študij.
Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO
Povejte svojemu zdravniku, če imate okužbo z virusom hepatitisa B, da se bo lahko odločil ali je zdravilo INCIVO primerno za vas.
The SVR rate for Black patients was 62% (45/73).
Stopnja trajnega virološkega odziva pri bolnikih iz skupine črncev je bila 62% (45/73).
In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme.
In vitro študije z rekombinantnim UGT1A3 kažejo na možnost, da telaprevir zavira ta encim.
The safety and efficacy of INCIVO in children aged < 18 years have not yet been established.
Varnost in učinkovitost zdravila INCIVO pri otrocih, starih < 18 let, še nista ugotovljeni.
In clinical trials, the majority of patients were administered antihistamines and topical corticosteroids.
V kliničnih preskušanjih so večini bolnikov predpisali antihistaminike in lokalne kortikosteroide.
An effect of telaprevir on UDP-glucuronyltransferases cannot be ruled out and may affect the plasma concentrations of abacavir or zidovudine.
Učinka telaprevirja na UDP-glukuroniltransferaze ne moremo izključiti in lahko vpliva na plazemske koncentracije abakavirja ali zidovudina.
However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
Kljub temu pa je priporočljivo klinično spremljanje, ker bo lahko pri nekaterih bolnikih potrebna prilagoditev odmerka metadona v času vzdrževalnega zdravljenja z njim.
The total treatment duration was determined based on the patients' individual on-treatment viral response.
Celokupen čas zdravljenja je bil določen glede na virološki odziv posameznega bolnika.
Your doctor will decide on the appropriate dose regimen for you.
Zdravnik vam bo predpisal režim jemanja zdravila, ki je primeren za vas.
This difference is likely due to the higher genetic barrier for the V36M and R155K substitutions for genotype 1b than genotype 1a.
Ta razlika je bila verjetno posledica večje genetske ovire substituciji V36M in R155K pri genotipu 1b kot pri genotipu 1a.
The lower limit of the 95% CI (-4.9%) was greater than the pre-determined noninferiority margin of -11% and therefore the non inferiority of T12(b.i.d.
Vrednost spodnje meje 95% IZ (-4,9%) je bila višja od vnaprej določene meje primerljivosti, ki je bila -11%, in zato je bila dokazana primerljivost režimov T12(b.i.d.
If you are taking INCIVO twice daily (morning and evening) If you notice the missed dose within 6 hours, you must take three tablets immediately.
Če jemljete zdravilo INCIVO dvakrat na dan (zjutraj in zvečer) Če se na pozabljeni odmerek spomnite v roku 6 ur, morate takoj zaužiti tri tablete.
Clinical relevance unknown.
Klinični pomen ni znan.
Caution should be used and dose reduction for amlodipine should be considered.
Potrebna je previdnost in po potrebi tudi zmanjšanje odmerka amlodipina.
Voriconazole should not be administered to patients receiving telaprevir unless an assessment of the benefit/risk ratio justifies its use.
Vorikonazola ne smete predpisovati bolnikom, ki prejemajo telaprevir, razen če njegovo uporabo opravičuje ocena razmerja med tveganjem in koristjo.
Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
O smrtnih primerih so poročali pri bolnikih z napredujočim izpuščajem in sistemskimi simptomi, ki so prejemali kombinirano terapijo z zdravilom INCIVO tudi po pojavu hude kožne reakcije.
The rash reported during INCIVO combination treatment was assessed as a typically pruritic, eczematous rash, and involved less than 30% of body surface area.
Izpuščaj, o katerem so poročali pri kombiniranem zdravljenju z zdravilom INCIVO, so ocenili kot značilno pruritičen, ekcematozen izpuščaj, ki je zajemal manj kot 30% telesne površine.
Plasma HCV RNA values were measured using the COBAS
Plazemske vrednosti HCV RNK so merili s pomočjo testa COBAS
Signs and symptoms of dehydration include increased thirst, dry mouth, decreased urine frequency or volume, and dark coloured urine.
Znaki in simptomi dehidracije obsegajo povečano žejo, suha usta, zmanjšano pogostnost uriniranja ali zmanjšano količino urina in temno obarvan urin.
Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia and hypocalcaemia) should be monitored and corrected, if necessary, prior to initiation and during INCIVO therapy.
Motnje elektrolitov (npr. hipokaliemija, hipomagneziemija in hipokalcemija) je treba spremljati in jih po potrebi odpraviti še pred uvedbo zdravila INCIVO oziroma med zdravljenjem.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Refer to sections 4.4 and 4.6.
Glejte poglavji 4.4 in 4.6.
In INCIVO clinical experience, less than 0.1% of patients had Stevens-Johnson Syndrome (SJS).
V okviru kliničnih izkušenj z zdravilom INCIVO se je Stevens-Johnsonov sindrom (SJS) pojavil pri manj kot 0,1% bolnikov.
Tell your doctor if you have had other problems with your liver such as liver failure.
Povejte zdravniku, če ste imeli kdaj kakšne druge težave z jetri, kot je jetrna odpoved.
P < 0.001, T12/PR compared to Pbo/PR48.
P < 0,001, T12/PR za primerjavo s Pbo/PR48.
A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing.
Do zmanjšanja koncentracije hemoglobina pride v prvih 4 tednih zdravljenja, najnižje vrednosti pa so dosežene ob koncu jemanja zdravila INCIVO.
T12/PR All Patients
T12/PR Vsi bolniki
Dosing of the animals did not result in any exposure-margin when compared to human exposure.
Odmerki pri živalih niso dosegali meje izpostavljenosti v primerjavi z ljudmi.
Drug interactions need to be carefully taken into account, see sections 4.4 and 4.5.
Skrbno je treba upoštevati interakcije z drugimi zdravili, glejte poglavji 4.4 in 4.5.
Atazanavir/ritonavir: this combination is associated with a high frequency of hyperbilirubinaemia/icterus.
Atazanavir/ritonavir: to kombinacijo povezujejo z veliko pogostnostjo hiperbilirubinemije/zlatenice.
Important information about some of the ingredients of INCIVO This medicinal product contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet.
Pomembne informacije o nekaterih sestavinah zdravila INCIVO To zdravilo vsebuje 2,3 mg natrija na tableto, kar je treba upoštevati pri bolnikih na dieti z
In case of overdose you may experience nausea, headache, diarrhoea, decreased appetite, abnormal
V primeru prevelikega odmerka se lahko pojavi slabost, glavobol, driska, zmanjšan apetit, nenormalen
atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir to treat HIV infections (HIV-protease inhibitors)
atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir za zdravljenje okužbe s HIV (zaviralci proteaze HIV)
It is not known whether telaprevir is excreted in human breast milk.
Ni znano, ali se telaprevir pri človeku izloča v materino mleko.
Prescribers should ensure that patients are fully informed about the risk of severe rashes, and to consult with their prescriber immediately if they develop a new rash or worsening of an existing rash.
Zdravnik mora zagotoviti, da so bolniki natančno poučeni o tveganju za pojav hudih izpuščajev in o tem, da se morajo ob pojavu izpuščaja ali ob poslabšanju obstoječega izpuščaja takoj posvetovati s svojim zdravnikom.
If you notice the missed dose within 4 hours, you must take two tablets immediately.
Če se na pozabljeni odmerek spomnite v roku 4 ur, morate takoj zaužiti dve tableti.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Bolnice, ki jemljejo estrogene v okviru hormonske nadomestne terapije, je treba klinično spremljati, da ugotovite znake pomanjkanja estrogena.
CYP3A4 is partly responsible for the metabolism of telaprevir.
izoencim CYP3A4 je delno odgovoren za presnovo telaprevirja.
Telaprevir and its major metabolite are excreted in rat milk (see section 5.3).
Telaprevir in njegov glavni presnovek se izločata v mleko pri podganah (glejte poglavje 5.3).
Syncope and retinopathy have been reported in some patients taking INCIVO and should be considered when assessing a patient's ability to drive or operate machines.
Pri nekaterih bolnikih, ki so jemali zdravilo INCIVO, so poročali o sinkopi in retinopatiji, kar je treba upoštevati pri oceni bolnikove sposobnosti za vožnjo in upravljanje s stroji.
Marked immunosuppressant dose reductions with or without prolongation of the dosing intervals will be required.
Potrebno bo bistveno zmanjšanje odmerka z ali brez podaljšanje razmika med odmerki imunosupresiva.
If you or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section 'Pregnancy precautions for men and women' below).
Če zanosite (oziroma če zanosi vaša partnerka) med zdravljenjem z zdravilom INCIVO ali v mesecih, ki sledijo temu zdravljenju, se nemudoma obrnite na svojega zdravnika (glejte poglavje Preprečevanje nosečnosti v nadaljevanju).
Co-administration with inducers may lead to lower exposure of telaprevir with risk of lower efficacy.
Sočasna uporaba z induktorji lahko vodi do zmanjšanja izpostavljenosti telaprevirju in nevarnosti za manjšo učinkovitost.
ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole
ANTIMIKOTIKI ketokonazol* itrakonazol posakonazol vorikonazol
The contribution of unchanged
Prispevek nespremenjenega, s C
• Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components.
• merila za oceno in zdravljenje izpuščaja in hudih kožnih reakcij, še posebno kriterije za nadaljevanje ali prekinitev zdravljenja s telaprevirjem in drugimi zdravili
Telaprevir is primarily metabolised in the liver.
Telaprevir se presnavlja predvsem v jetrih.
The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours.
Srednja vrednost razpolovne dobe izločanja po peroralnem jemanju enkratnega 750 mg odmerka telaprevirja se je značilno gibala med približno 4,0 in 4,7 ure.
Table 4: Selected laboratory abnormalities (DAIDS
Preglednica 4: izbrane laboratorijske nenormalnosti (stopnje ≥ 2 po DAIDS
Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d.
Preglednica 6: stopnje SVR po podskupinah bolnikov: študija C211 T12(b.i.d.
Pregnancy precautions for men and women
Kontracepcija pri moških in ženskah
Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called 'long QT syndrome', or a family history of a heart condition called 'congenital QT syndrome'.
Povejte svojemu zdravniku, če imate srčno popuščanje, nereden srčni utrip, počasen srčni utrip, motnjo, ki se kaže na elektrokardiogramu (EKG) in se imenuje “sindrom dolgega intervala QT” ali imate v družini srčno bolezen, imenovano “kongenitalni sindrom QT”.
The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Smer puščice (↑ = povečanje, ↓ = zmanjšanje, ↔ = ni spremembe) za vsak farmakokinetični parameter temelji na 90% intervalu zaupanja za razmerje geometrične sredine, ki je v okviru razpona 80-125% (↔), ali pod (↓) oziroma nad (↑) njim.
Table 2: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Preglednica 2: INTERAKCIJE IN PRIPOROČILA ZA ODMERJANJE Z DRUGIMI ZDRAVILI Zdravila po terapevtskih področjih
In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
V dveh dvojno slepih, randomiziranih in s placebom ter aktivno učinkovino nadzorovanih študijah, ki sta bili opravljeni za ovrednotenje vpliva zdravila na interval QT, monoterapija s telaprevirjem v odmerku 750 mg na vsakih 8 ur ni bila povezana s klinično pomembnimi učinki na interval QTcF.
Hormonal contraceptives may be continued but may not be reliable during INCIVO dosing and for up to two months following cessation of INCIVO (see section 4.5).
Med jemanjem zdravila INCIVO se uporaba hormonskih kontraceptivov lahko nadaljuje, vendar le-ti morda ne bodo zanesljivi še do dva meseca po ukinitvi zdravila INCIVO (glejte poglavje 4.5).
The Marketing Authorisation Holder shall agree to the format and content of the healthcare professional educational pack with the National Competent Authority prior to launch in the Member State.
Imetnik dovoljenja za promet z zdravilom se bo za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce pred dajanjem zdravila na trg dogovoril s pristojnim nacionalnim organom države
All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system.
Vse preučevane variante, ki so bile rezistentne za telaprevir, so ostale popolnoma občutljive za interferon-alfa, ribavirin in reprezentativne nukleozidne in nenukleozidne zaviralce polimeraze HCV v sistemu replikonov.