FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil sezname vprašanj.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
English: This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin.
Slovenian: To pomeni, da stimulira receptor TRPV1, ki ga najdemo v nociceptorjih (receptorjih za bolečino) v koži.
English: The analysis included data on 2,073 diabetic and non-diabetic patients from six studies.
Slovenian: V analizo so bili vključeni podatki iz šestih študij z 2 073 bolniki s sladkorno boleznijo ali brez nje.
English: It contains the active substance capsaicin (8%).
Slovenian: Vsebuje zdravilno učinkovino kapsaicin (8
English: In patients with diabetes, Qutenza is expected to work in the same way as it does in its existing indication.
Slovenian: Pri bolnikih s sladkorno boleznijo naj bi zdravilo Qutenza delovalo enako kot pri obstoječi indikaciji.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Potem ko je ocenil odgovore družbe na seznam vprašanj, so nekatera izmed njih še vedno ostala nerešena.
English: Qutenza contains high doses of capsaicin that are released quickly and overstimulate the TRPV1 receptors.
Slovenian: Zdravilo Qutenza vsebuje visoke odmerke kapsaicina, ki se hitro sproščajo in prekomerno stimulirajo receptorje TRPV1.
English: Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain.
Slovenian: Receptorji s prekomernim stimuliranjem postanejo „desenzitirani“ in se ne morejo več odzivati na dražljaje, ki običajno povzročajo bolečino pri bolnikih s periferno nevropatsko bolečino.
English: Patients with diabetes, but especially those with diabetic neuropathic pain, could be put at risk as Qutenza may increase their chances of developing ulcers in the foot, which could lead to serious complications.
Slovenian: Bolniki s sladkorno boleznijo, zlasti tisti z nevropatskimi bolečinami zaradi sladkorne bolezni, so lahko ogroženi, saj lahko zdravilo Qutenza poveča možnost, da se pri njih pojavijo razjede na stopalih, kar bi lahko pripeljalo do hudih zapletov.
English: What is Qutenza?
Slovenian: Kaj je zdravilo Qutenza?
English: There are no consequences on the use of Qutenza in its authorised indication.
Slovenian: Umik nima posledic za uporabo zdravila Qutenza pri odobreni indikaciji.
English: Qutenza has been authorised in the EU since May 2009 and is already used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves in the extremities) in adults who do not have diabetes.
Slovenian: Zdravilo Qutenza je v EU odobreno od maja 2009 in se že uporablja za zdravljenje periferne nevropatske bolečine (bolečine, ki jo povzroča poškodba živcev v okončinah) pri odraslih, ki nimajo sladkorne bolezni.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Slovenian: Družba je v uradnem dopisu navedla, da je podlaga za odločitev o umiku vloge mnenje odbora CHMP, da predloženi podatki ne omogočajo, da bi Odbor lahko sprejel pozitivno mnenje o razmerju med koristmi in tveganji.
English: It is used either alone or together with other painkillers.
Slovenian: Uporablja se lahko kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ‘selective agonist' of the ‘transient receptor potential vanilloid 1' (TRPV1) receptor.
Slovenian: Zdravilna učinkovina v zdravilu Qutenza, kapsaicin, je snov, ki jo običajno najdemo v papriki čili in je selektivni agonist vaniloidnega receptorja 1 (TRPV1).
English: At the time of the initial approval, the evidence supporting the medicine's use in patients with diabetic neuropathic pain was considered insufficient and the CHMP excluded its use in all patients with diabetes.
Slovenian: Ob prvi odobritvi se je štelo, da so dokazi, ki podpirajo uporabo zdravila pri bolnikih z nevropatsko bolečino, ki je posledica sladkorne bolezni, nezadostni, zato je CHMP izključil njegovo uporabo pri bolnikih s sladkorno boleznijo.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qutenza could not have been approved to treat diabetic patients with non-diabetic peripheral neuropathic pain.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Qutenza ni mogoče odobriti za zdravljenje sladkornih bolnikov s periferno nevropatsko bolečino, ki ni posledica sladkorne bolezni.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qutenza in diabetic patients did not outweigh its risks.
Slovenian: Zato je CHMP v času umika vloge menil, da koristi zdravila Qutenza pri sladkornih bolnikih ne odtehtajo z njim povezanih tveganj.
English: What was Qutenza expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Qutenza uporabljalo?
English: On 14 March 2012, Astellas Pharma Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Qutenza, which would have extended its use to patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
Slovenian: je 14. marca 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Qutenza, s katerim je želela njegovo uporabo razširiti na bolnike s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
English: The Committee was concerned that it would not be possible in clinical practice to distinguish patients with non-diabetic neuropathic pain from those with diabetic neuropathic pain.
Slovenian: Odbor je bil zaskrbljen, da v klinični praksi morda ne bi bilo mogoče razlikovati med bolniki z nevropatsko bolečino, ki ni posledica sladkorne bolezni, in tistimi z nevropatsko bolečino, ki je posledica sladkorne bolezni.
English: The company's analysis was intended to show that diabetic patients with peripheral neuropathic pain not caused by diabetes have as good outcomes with Qutenza as non-diabetic patients.
Slovenian: Namen analize, ki jo je opravila družba, je bil dokazati, da imajo sladkorni bolniki s periferno nevropatsko boleznijo, ki ni posledica sladkorne bolezni, enako dobre rezultate z zdravilom Qutenza kot bolniki brez sladkorne bolezni.
English: What is happening with Qutenza for the treatment of neuropathic pain in patients who do not have diabetes?
Slovenian: Kakšne so posledice za zdravilo Qutenza, indicirano za zdravljenje nevropatske bolečine pri bolnikih, ki nimajo sladkorne bolezni?
English: How is Qutenza expected to work?
Slovenian: Kako naj bi zdravilo Qutenza delovalo?
English: Qutenza was also expected to be used in patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
Slovenian: Zdravilo Qutenza naj bi se uporabljalo tudi za zdravljenje bolnikov s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
English: Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin).
Slovenian: Qutenza je dermalni obliž (obliž, ki dovaja zdravilo na kožo).
English: The frequency of these events is unknown.
Slovenian: Pogostnost teh dogodkov je neznana.
English: • Anaemia (low number of red blood cells).
Slovenian: • anemija (majhno število rdečih krvnih celic).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15.01.2015
English: Main demographics in TURQUOISE-III Characteristics
Slovenian: Glavne demografske značilnosti v TURQUOISE-III
English: Component of a multipack, can't be sold separately.
Slovenian: Komponenta večkratnega pakiranja, ni za ločeno prodajo.
English: (administered 12 hours apart)
Slovenian: (uporabljena v razmaku 12 ur)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/982/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/982/001
English: Table 15 shows SVR rates for these subjects.
Slovenian: Preglednica 15 prikazuje deleže SVR za te preiskovance.
English: Hepatitis B Virus Reactivation
Slovenian: Reaktivacija virusa hepatitisa B
English: Limited data in patients with endstage renal disease indicate no clinically significant changes in exposure also in this patient group.
Slovenian: Omejeni podatki pri bolnikih z ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet
English: • Feeling weak or lack of energy (asthenia).
Slovenian: • občutek šibkosti ali pomanjkanja energije (astenija).
English: Arm B 24 Weeks N = 32
Slovenian: Skupina B 24 tednov N = 32
English: Treatment-emergent variants and their prevalence in these virologic failure populations are shown in Table 5.
Slovenian: Med zdravljenjem nastale variante in njihova prevalenca v teh populacijah z virološkim neuspehom so prikazane v preglednici 5.
English: See section 5.1 for additional information.
Slovenian: Za dodatne informacije glejte poglavje 5.1.
English: If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Slovenian: Če ste pomotoma vzeli večji odmerek od priporočenega, takoj obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico.
English: Genotype 1a N=67
Slovenian: Genotip 1a N = 67
English: • Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Slovenian: • kontrola glede kliničnih znakov in simptomov dekompenzacije jeter (kot so ascites, jetrna encefalopatija, krvavitev iz varic),
English: ↑ ergot derivatives
Slovenian: ↑ ergot derivati
English: The combined action of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Slovenian: Kombinirano delovanje treh zdravilnih učinkovin ustavi razmnoževanje virusa hepatitisa C in okužbo novih celic ter v določenem časovnem obdobju odstrani virus iz krvi.
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Slovenian: Sprememba telesne mase za10 kg od 76 kg (mediana telesna masa v študijah 3. faze) bi imela za posledico < 10 % spremembo izpostavljenosti ombitasvirju in nobene spremembe izpostavljenosti paritaprevirju.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljenje na spletni strain Evropske agencije za zdravila: http://www.ema.europa.eu.
English: • If you have severe liver problems other than hepatitis C.
Slovenian: • Če imate hudo bolezen jeter, ki ni hepatitis C.
English: Effect of baseline HCV substitutions/polymorphisms on treatment outcome
Slovenian: Vpliv izhodiščnih substitucij/polimorfizmov HCV na izid zdravljenja
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX67
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX67
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • Discontinue treatment in patients who develop evidence of hepatic decompensation.
Slovenian: • prekiniti zdravljenje pri bolnikih, pri katerih so se pojavili znaki dekompenzacije jeter.
English: 25 mg once daily administered in the morning, with food
Slovenian: 25 mg enkrat na dan, zjutraj s hrano
English: • amiodarone
Slovenian: • amiodaron
English: AbbVie Ltd Maidenhead SL6 4UB United Kingdom
Slovenian: AbbVie Ltd Maidenhead SL6 4UB Velika Britanija
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Viekirax.
Slovenian: Če kar koli od zgoraj navedenega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdraviloViekirax.
English: Contraceptive medicines that contain ethinyl estradiol cannot be used in combination with Viekirax.
Slovenian: Zdravila za kontracepcijo, ki vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Viekirax.
English: If you take more Viekirax than you should
Slovenian: Če ste vzeli večji odmerek zdravila Viekirax, kot bi smeli
English: Coadministration of Viekirax with other antivirals has not been studied and therefore cannot be recommended.
Slovenian: Sočasna uporaba zdravila Viekirax z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
English: Purpose of the medicine
Slovenian: Namen uporabe zdravila
English: HIV-1 Co-infection
Slovenian: Sočasna okužba s HIV-1
English: If you forget to take Viekirax
Slovenian: Če ste pozabili vzeti zdravilo Viekirax
English: Follow the dosing recommendations in Table 1.
Slovenian: Upoštevajte navodila za odmerjanje v preglednici 1.
English: NA Clinical monitoring of patients is recommended.
Slovenian: NA Bolnike je priporočljivo klinično nadzirati.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Slovenian: Preizkus je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e. na ml.
English: Viekirax is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Slovenian: Zdravilo Viekirax je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (nalezljiva bolezen, ki prizadane jetra in jo povzroča virus hepatitisa C).
English: How much to take The recommended dose is two tablets taken together in the morning.
Slovenian: Priporočeni odmerek je dve tableti, ki ju vzamete zjutraj.
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended.
Slovenian: Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno poveča, zato takšna uporaba ni priporočljiva.
English: Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Slovenian: Ta zvišanja ALT so bila bistveno pogostejša v podskupini preiskovank, ki so uporabljale zdravila z etinilestradiolom, na primer kombinirane peroralne kontraceptive ali kontracepcijske vaginalne obročke (6 od 25 oseb); (glejte poglavje 4.3).
English: It is important not to miss a dose of this medicine.
Slovenian: Pomembno je, da ne pozabite vzeti tega zdravila.
English: The dose of ribavirin was left to the discretion of the investigator, with most patients receiving 600 to 800 mg per day as a starting dose, and most patients also receiving 600 to 800 mg per day at the end of treatment.
Slovenian: Odmerek ribavirina je bil prepuščen raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg na dan in večina bolnikov je tudi na koncu zdravljenja prejemala od 600 do
English: Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein
Slovenian: Ne (za kateri koli zgoraj našteti parameter) *AFP= alfa fetoprotein v serumu
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine.
Slovenian: Preiskovanci so prejemali stabilno shemo antiretrovirusne terapije (ART) za HIV-1, ki je vključevala z ritonavirjem okrepljen atazanavir ali raltegravir, uporabljen z osnovno shemo tenofovirja ter emtricitabina ali lamivudina.
English: SVR12, n/N (%) [95% CI] Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse
Slovenian: SVR12, n/N (%) [95 % IZ] Izid pri preiskovancih brez SVR12 Virološki neuspeh med zdravljenjem Recidiv po zdravljenju a
English: In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogencontaining products (approximately 1% in each group).
Slovenian: V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršni se običajno uporabljajo pri hormonskem nadomestnem zdravljenju (tj. peroralni in lokalni estradiol in konjugirani estrogeni), podobna deležu, opaženem med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
English: The interactions between pitavastatin and fluvastatin and Viekirax have not been investigated.
Slovenian: Medsebojna delovanja med pitavastatinom in fluvastatinom ter zdravilom Viekirax niso raziskana.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol.
Slovenian: Tri osebe so jemanje zdravila Viekirax in dasabuvirja prekinile za obdobje od enega do sedmih dni; ena od njih je dobivala etinilestradiol.
English: (see sections 4.2, 4.4, and
Slovenian: (glejte poglavje 4.4).
English: INFORMATION IN BRAILLE viekirax
Slovenian: PODATKI V BRAILLOVI PISAVI viekirax
English: Concerning genotypespecific virological and clinical activity, see section 5.1.
Slovenian: Za virološko in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
English: Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Slovenian: AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l, IN albumin ≥ 35 g/l pred zdravljenjem
English: As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Slovenian: Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravila z etinilestradiolom, 26 %, so takšna zdravila kontraindicirana med uporabo zdravila Viekirax z dasabuvirjem ali brez njega.
English: Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Slovenian: Ombitasvir je zaviralec beljakovine NS5A HCV, ki je nujna za replikacijo virusov.
English: In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Slovenian: V prisotnosti paritaprevirja/ritonavirja se je izpostavljenost dasabuvirju zmanjšala za približno 50 do 60 %, izpostavljenost ombitasvirju pa se je povečala za 31 do 47 %.
English: b. Other includes early drug discontinuation not due to virologic failure missing HCV RNA values in the
Slovenian: b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virološkega neuspeha in manjkajoče vrednosti HCV RNA znotraj okna SVR12.
English: Phenobarbital
Slovenian: fenobarbital
English: Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.
Slovenian: Glede na majhen delež neuspešnega zdravljenja, zabeležen ob uporabi priporočenih shem zdravljenja pri bolnikih, okuženih s HCV genotipa 1a in 1b, prisotnost izhodiščnih variant le malo vpliva na verjetnost za doseganje trajnega virološkega odziva (SVR).
English: Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Slovenian: Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo
English: TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
Slovenian: TURQUOISE-II: Deleži recidivov glede na izhodiščne laboratorijske vrednosti, po 12 in 24 tednih zdravljenja, pri preiskovancih s kompenzirano cirozo, okuženih z genotipom 1a
English: Thirty four subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Slovenian: Vključenih je bilo štiriintrideset preiskovancev (29 z okužbo s HCV genotipa 1a in 5 z okužbo s HCV genotipa 1b), ki po presaditvi niso bili zdravljeni zaradi okužbe s HCV in so imeli oceno fibroze po METAVIR F2 ali manj.
English: Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Slovenian: Bolniki s hudo okvaro jeter (Child-Pugh C) (glejte poglavje 5.2).
English: Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Slovenian: Vpliv dasabuvirja na paritaprevir/ritonavir in ombitasvir V prisotnosti dasabuvirja se je izpostavljenost paritaprevirju povečala za 50 do 65 %, izpostavljenost ombitasvirju pa se ni spremenila.
English: The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Slovenian: Učinkovitost in varnost zdravila Viekirax v kombinaciji z dasabuvirjem (z ribavirinom ali brez njega) so preučili v sedmih kliničnih preskušanjih 3. faze (vključno z dvema preskušanjema izključno pri bolnikih s cirozo (Child-Pugh A)) pri več kot 2.360 preiskovancih s kronično okužbo s hepatitisom C genotipa 1, kot povzema preglednica 6.
English: It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.
Slovenian: Ni znano, ali zdravilne učinkovine v zdravilu Viekirax (ombitasvir, paritaprevir in ritonavir) prehajajo v materino mleko.
English: Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Slovenian: Namen uporabe zdravila alfuzosin pri povečani prostati amiodaron, dronedaron za uravnavanje nerednega srčnega utripa astemizol, terfenadin pri simptomih alergije.
English: 33 out of the 34 subjects (97.1%) achieved SVR12 (96.6% in subjects with genotype 1a infection and 100% in subjects with genotype 1b infection).
Slovenian: SVR 12 je doseglo 33 od 34 preiskovancev (97,1 %) (96,6 % okuženih z genotipom 1a in 100 % okuženih z genotipom 1b).
English: 5 mg single dose and other vitamin K antagonists
Slovenian: Klinične opombe enkraten odmerek 5 mg in drugi antagonisti vitamina K