FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with GEP-NETs is low, they are considered ‘rare', and Lutathera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 January 2008.
Slovenian: Ker je bolnikov z gastroenteropankreatičnimi nevroendokrinimi tumorji malo, velja ta bolezen za redko, zato je bilo zdravilo Lutathera 31. januarja 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih).
English: For more information about treatment with Lutathera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lutathera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Lutathera?
Slovenian: Kakšna tveganja so povezana z zdravilom Lutathera?
English: Lutathera can help slow the worsening of the condition and its side effects are considered manageable.
Slovenian: Zdravilo Lutathera lahko pomaga upočasniti poslabšanje stanja, njegovi neželeni učinki pa veljajo za obvladljive.
English: Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients.
Slovenian: Le manjši delež bolnikov z gastroenteropankreatičnimi nevroendokrinimi tumorji se lahko zdravi kirurško, pri večini bolnikov pa so tumorji v času diagnoze že razširjeni.
English: The full EPAR for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lutathera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Lutathera approved?
Slovenian: Zakaj je bilo zdravilo Lutathera odobreno?
English: For practical information about using Lutathera, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lutathera naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Slovenian: Lutathera je zdravilo proti raku, ki se uporablja za zdravljenje tumorjev v prebavilih, znanih kot gastroenteropankreatični nevroendokrini tumorji (GEP-NET).
English: For the full list of all side effects reported with Lutathera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lutathera, glejte navodilo za uporabo.
English: This compares with around 9 months for patients treated with octreotide, a medicine already approved for treating the condition.
Slovenian: Pri bolnikih, ki so se zdravili z oktreotidom, zdravilom, ki je že odobreno za zdravljenje te bolezni, je bilo to obdobje dolgo približno 9 mesecev.
English: Lutathera contains the active substance lutetium (177Lu) oxodotreotide.
Slovenian: Zdravilo Lutathera vsebuje zdravilno učinkovino lutecijev (177Lu) oksodotreotid.
English: The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da koristi zdravila Lutathera odtehtajo z njim povezano tveganje, in priporočila, da se zanj izda dovoljenje za promet.
English: The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs.
Slovenian: Zdravilna učinkovina v zdravilu Lutathera, lutecijev (177Lu) oksodotreotid, deluje z vezavo na somatostatinske receptorje, ki so v velikem številu prisotni na nekaterih gastroenteropankreatičnih nevroendokrinih tumorjih.
English: How does Lutathera work?
Slovenian: Kako zdravilo Lutathera deluje?
English: Lutathera is given by infusion (drip) into a vein.
Slovenian: Zdravilo Lutathera se daje z infundiranjem (kapalno infuzijo) v veno.
English: The medicine is only for GEP-NETs that have receptors called somatostatin receptors on their cell surfaces.
Slovenian: Zdravilo je namenjeno samo za gastroenteropankreatične nevroendokrine tumorje, ki imajo na celični površini receptorje, imenovane somatostatinski receptorji.
English: How is Lutathera used?
Slovenian: Kako se zdravilo Lutathera uporablja?
English: Lutathera can help slow down the worsening of GEP-NETs.
Slovenian: Zdravilo lahko pomaga upočasniti poslabšanje gastroenteropankreatičnih nevroendokrinih tumorjev.
English: They are taken once a day.
Slovenian: Jemljejo se enkrat na dan.
English: The European Commission issued a decision on this opinion on 20 December 2010.
Slovenian: Evropska komisija je odločbo v zvezi s tem mnenjem izdala dne 20. decembra 2010.
English: It is used to treat severe pain.
Slovenian: Uporablja se za zdravljenje hude bolečine.
English: Ethirfin was authorised in the European Union (EU) under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 15 July 2005.
Slovenian: Zdravilo Ethirfin je bilo odobreno v Evropski uniji (EU) s postopkom medsebojnega priznavanja na podlagi prvotnega dovoljenja za promet, odobrenega na Danskem dne 15. julija 2005.
English: This renewal was to be recognised in Germany, Ireland, Italy and the United Kingdom (the ‘concerned Member States').
Slovenian: Podaljšanje dovoljenja za promet z zdravilom naj bi priznali v Nemčiji, na Irskem, v Italiji in Združenem kraljestvu („zadevne države članice“).
English: Why was Ethirfin reviewed?
Slovenian: Zakaj je bilo zdravilo Ethirfin pregledano?
English: Because these Member States were not able to reach an agreement, the German and United Kingdom medicines regulatory agencies referred the matter to the CHMP for arbitration on 30 October 2009.
Slovenian: Ker navedene države članice niso mogle doseči soglasja, sta regulativni agenciji za zdravila v Nemčiji in Združenem kraljestvu dne 30. oktobra 2009 zadevo napotili na CHMP v arbitražo.
English: Ethirfin is a medicine that contains the active substance morphine sulphate.
Slovenian: Ethirfin je zdravilo, ki vsebuje zdravilno učinkovino morfinijev sulfat.
English: The European Medicines Agency has completed an arbitration procedure for Ethirfin and associated names.
Slovenian: Evropska agencija za zdravila je zaključila arbitražni postopek za zdravilo Ethirfin in povezana imena.
English: Therefore the benefits of Ethirfin do not outweigh its risks, and the marketing authorisation for Ethirfin should not be renewed in all concerned Member States.
Slovenian: Koristi zdravila Ethirfin tako ne odtehtajo z njim povezanih tveganj, zato se dovoljenje za promet z zdravilom Ethirfin ne sme podaljšati v vseh zadevnih državah članicah.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there is a significant interaction between Ethirfin and alcohol, and that patients taking Ethirfin and alcohol are at risk of developing serious side effects.
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP sklenil, da obstaja pomembno medsebojno delovanje med zdravilom Ethirfin in alkoholom ter da se lahko pri bolnikih, ki jemljejo zdravilo Ethirfin z alkoholom, pojavijo hudi neželeni učinki.
English: Questions and answers on Ethirfin and associated names (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Ethirfin in povezanimi imeni (morfinijev sulfat, kapsule s podaljšanim sproščanjem, 20, 60, 120 in 200 mg)
English: What is Ethirfin?
Slovenian: Kaj je zdravilo Ethirfin?
English: The grounds for the referral were concerns that the active substance in the capsules could be released too quickly if the capsules are taken with alcohol, because they contain a ‘polymethacrylatetriethylcitrate' coating to control the release of morphine and this coating is soluble in alcohol.
Slovenian: Podlaga za napotitev so bili zadržki, da se lahko zdravilna učinkovina iz kapsul sprosti prehitro, če se kapsule jemljejo z alkoholom, saj so kapsule obložene s „polimetakrilat-trietilcitratom“, ki uravnava sproščanje morfina, ta obloga pa je v alkoholu topljiva.
English: The company applied for the marketing authorisation to be renewed in Denmark (the ‘reference Member State').
Slovenian: Družba je vlogo za podaljšanje prometa z zdravilom predložila na Danskem („referenčna država članica“).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on the renewal of the marketing authorisation for Ethirfin.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji so zaprosili, da sprejme odločitev o podaljšanju dovoljenja za promet z zdravilom Ethirfin.
English: Questions and answers on Ethirfin and associated names (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg) EMA/297829/2011
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Ethirfin in povezanimi imeni (morfinijev sulfat, kapsule s podaljšanim sproščanjem, 20, 60, 120 in 200 mg) EMA/276994/2011
English: The Committee concluded that the marketing authorisation should not be renewed, as patients taking Ethirfin and alcohol are at risk of developing serious side effects.
Slovenian: Odbor je sklenil, da se dovoljenje za promet z zdravilom ne sme podaljšati, saj pri bolnikih, ki jemljejo zdravilo Ethirfin in alkohol, obstaja tveganje za pojav hudih neželenih učinkov.
English: Ethirfin is available as ‘prolonged-release' capsules that release the active substance slowly.
Slovenian: Zdravilo Ethirfin je na voljo v obliki kapsul s podaljšanim sproščanjem, ki počasi sproščajo zdravilno učinkovino.
English: The rapid release of the active substance is called ‘dose dumping' and could put patients at risk of exposure to large doses of morphine, leading to side effects such as respiratory depression (an inhibition of breathing).
Slovenian: odmerkov morfina, kar lahko povzroči neželene učinke, na primer respiratorno depresijo (zmanjšanje dihanja).
English: Annex IV Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant
Slovenian: Znanstveni zaključki in podlaga za ohranitev dovoljenj za promet z zdravilom ali spremembo pogojev dovoljenj za promet z zdravilom, kot je ustrezno
English: This finding was maintained after 96 weeks.
Slovenian: Ti rezultati so ostali enaki tudi po 96 tednih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz on 2 March 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Reyataz, veljavno po vsej Evropski uniji, izdala 2. marca 2004.
English: What measures are being taken to ensure the safe and effective use of Reyataz?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Reyataz?
English: It is available as capsules (100 mg, 150 mg, 200 mg and 300 mg) and oral powder (50 mg).
Slovenian: Na voljo je v obliki kapsul (100 mg, 150 mg, 200 mg in 300 mg) in peroralnega praška (50 mg).
English: The full EPAR for Reyataz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Reyataz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: More than half of these patients had taken HIV treatment in the past.
Slovenian: Približno polovica teh bolnikov je predhodno že prejemala zdravila proti virusu HIV.
English: What benefit has Reyataz shown during the studies?
Slovenian: Kakšne koristi je zdravilo Reyataz izkazalo med študijami?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reyataz have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Reyataz, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about treatment with Reyataz, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Reyataz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In patients who had been treated before, the results of the first study could not be interpreted, as a large number of patients left the study before its planned end.
Slovenian: Pri predhodno zdravljenih bolnikih rezultatov prve študije ni bilo možno ovrednotiti, ker je veliko število bolnikov sodelovanje v študiji prekinilo še pred njenim načrtovanim zaključkom.
English: This document is a summary of the European Public Assessment Report (EPAR) for Reyataz.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Reyataz.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Reyataz.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Reyataz, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For adults (aged 18 years or over), the recommended dose is 300 mg once a day.
Slovenian: Priporočeni odmerek zdravila za odrasle (starejše od 18 let) je 300 mg enkrat na dan.
English: The patients also had improvements in their immune systems.
Slovenian: Pri bolnikih se je izboljšal tudi imunski sistem.
English: Reyataz is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Slovenian: Zdravilo Reyataz se običajno daje z ritonavirjem za okrepitev njegovega delovanja, zdravniki pa lahko v nekaterih posebnih primerih razmislijo o prenehanju dajanja ritonavirja pri odraslih.
English: In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Slovenian: V vseh študijah so bolniki jemali tudi dva nukleozidna ali nukleotidna zaviralca reverzne transkriptaze (NRTI, vrsta protivirusnega zdravila).
English: Reyataz does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Reyataz ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Reyataz v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: A measure of effectiveness was the viral load after treatment for 48 weeks.
Slovenian: Merilo učinkovitosti je bilo virusno breme po 48-tedenskem zdravljenju.
English: The main measure of effectiveness was the change in the levels of HIV in the patients' blood (viral load).
Slovenian: Glavno merilo učinkovitosti je bila sprememba koncentracije virusa HIV (virusnega bremena) v bolnikovi krvi.
English: In younger patients, the dose of Reyataz depends on body weight.
Slovenian: Pri mlajših bolnikih je odmerek zdravila Reyataz odvisen od njihove telesne mase.
English: In studies, side effects were similar in younger patients.
Slovenian: V študijah so bili pri mlajših bolnikih ugotovljeni podobni neželeni učinki.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work.
Slovenian: Ni pričakovati, da bi zdravilo učinkovalo pri bolnikih, pri katerih številna zdravila istega razreda kot zdravilo Reyataz (zaviralci proteaze) ne učinkujejo.
English: The study looked at the effect of the medicine on viral load and on the immune system, among other measures.
Slovenian: V študiji so med drugim proučevali učinek zdravila na virusno breme in imunski sistem.
English: In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John's wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood.
Slovenian: Prav tako se ga ne sme dajati bolnikom, ki jemljejo rifampicin (zdravilo za zdravljenje tuberkoloze), sildenafil (kadar se uporablja za zdravljenje pljučne arterijske hipertenzije), šentjanževko (zeliščni pripravek za zdravljenje depresije) ali zdravila, ki se v telesu presnavljajo enako kot zdravilo Reyataz in so v velikih količinah v krvi škodljiva.
English: In adults, the most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), rash, fatigue (tiredness) and jaundice (yellowing of the skin and eyes because of liver problems).
Slovenian: Pri odraslih so najpogostejši neželeni učinki zdravila Reyataz (opaženi pri 1 do 10 bolnikov od 100) glavobol, očesni ikterus (rumeno obarvanje oči), bruhanje, driska, bolečine v trebuhu, navzeja (slabost), dispepsija (zgaga), izpuščaji, utrujenost in zlatenica (porumenitev kože in oči zaradi okvare jeter).
English: What is the risk associated with Reyataz?
Slovenian: Kakšna tveganja so povezana z zdravilom Reyataz?
English: Reyataz is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged 3 months and over and weighing at least 5 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Reyataz se uporablja v kombinaciji z nizkim odmerkom ritonavirja in drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, starejših od treh mesecev s telesno maso najmanj pet kg, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Reyataz must not be used in patients who have severe reductions in their liver function; if given with ritonavir it must not be used in patients with moderate reduction in liver function.
Slovenian: Zdravila Reyataz ne smejo uporabljati bolniki z resnim zmanjšanjem delovanja jeter, če se daje skupaj z ritonavirjem pa ga ne smejo uporabljati bolniki z zmernim zmanjšanjem delovanja jeter.
English: Reyataz is an antiviral medicine that contains the active substance atazanavir.
Slovenian: Zdravilo Reyataz je protivirusno zdravilo, ki vsebuje zdravilno učinkovino atazanavir.
English: Reyataz oral powder can be used for children aged at least 3 months and weighing at least 5 kg, and for patients who cannot swallow capsules.
Slovenian: Reyataz se lahko uporablja pri otrocih, starih najmanj tri mesece in s telesno maso najmanj pet kg ter pri bolnikih, ki ne morejo pogoltniti kapsul.
English: It compared continued treatment with either a higher dose of Reyataz without ritonavir or the boosted combination.
Slovenian: Neprekinjeno zdravljenje so primerjali bodisi z zdravilom Reyataz brez ritonavirja bodisi z okrepljeno kombinacijo.
English: In the two studies in children aged from 3 months up to 11 years taking boosted Reyataz oral powder, the viral load was undetectable in about half the children after treatment for 48 weeks.
Slovenian: V dveh študijah pri otrocih, starih od 3 mesece do 11 let; ki so jemali okrepljeni peroralni prašek zdravila Reyataz, je bilo virusno breme nezaznavno pri približno polovici otrok po 48-tedenskem zdravljenju.
English: Reyataz capsules boosted with ritonavir have also been studied in 41 patients aged between 6 and 18 years.
Slovenian: Zdravilo Reyataz v kapsulah, okrepljeno z ritonavirjem, so proučevali tudi pri 41 bolnikih, starih od 6 do 18 let.
English: Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection.
Slovenian: Zdravljenje z zdravilom Reyataz lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: In the study in patients who already had undetectable viral loads with ritonavir-boosted Reyataz capsules, these were maintained in 68 of 87 patients (78%) who continued treatment with a higher dose of Reyataz without ritonavir, and in 64 of 85 (75%) who continued with the boosted combination.
Slovenian: V študiji pri bolnikih, ki so že imeli nezaznavno raven virusnega bremena z zdravilom Reyataz v kapsulah, okrepljenim z ritonavirjem, se je ta ohranila pri 78 % (68 od 87) bolnikov, ki so nadaljevali zdravljenje z večjim odmerkom zdravila Reyataz brez ritonavirja, in pri 75 % (64 od 85) tistih, ki so nadaljevali z zdravljenjem z okrepljeno kombinacijo.
English: The active substance in Reyataz, atazanavir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Reyataz, atazanavir, je zaviralec proteaze.
English: Other information about Reyataz:
Slovenian: Druge informacije o zdravilu Reyataz:
English: Why has Reyataz been approved?
Slovenian: Zakaj je bilo zdravilo Reyataz odobreno?
English: Reyataz oral powder with ritonavir has been assessed in two main studies involving 155 children aged from 3 months up to 11 years.
Slovenian: Peroralni prašek zdravila Reyataz z ritonavirjem so ocenjevali v dveh glavnih študijah pri 155 otrocih starih od 3 mesece do 11 let.
English: For patients who have received HIV medicines before, doctors should prescribe Reyataz only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Reyataz.
Slovenian: Zdravniki lahko predpišejo zdravilo Reyataz bolnikom, ki so že jemali druga zdravila za zdravljenje okužbe z virusom HIV šele po tem, ko preverijo, katera zdravila je bolnik jemal prej in ko opravijo preiskave za ugotovitev verjetnosti, da se bo virus odzval na to zdravilo.
English: In the patients aged between 6 and 18 years, 81% of those who had not taken HIV treatment in the past (13 out of 16) and 24% of those who had taken it in the past (6 out of 25) had viral loads below 50 copies/ml after 48 weeks.
Slovenian: Pri bolnikih, starih od 6 do 18 let, je 81 % (13 od 16) tistih, ki se še niso zdravili zaradi okužbe z virusom HIV, in 24 % (6 od 25) tistih, ki so se proti njej že zdravili, po 48 tednih imelo virusno breme pod 50 kopij/ml.
English: In patients who had not been treated before, ritonavir-boosted Reyataz capsules were as effective as ritonavir-boosted lopinavir.
Slovenian: Pri bolnikih, ki predhodno še niso bili zdravljeni, je bilo z ritonavirjem okrepljeno zdravilo Reyataz v kapsulah enako učinkovito kot z ritonavirjem okrepljen lopinavir.
English: At the start of the study, the patients' viral loads were around 88,100 copies/ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ml, compared with 76% of those taking lopinavir (338 out of 443).
Slovenian: Na začetku študije je bilo virusno breme pri bolnikih okoli 88 100 kopij/ml, po 48 tednih pa je bilo pri 78 % (343 od 400) bolnikov, ki so jemali zdravilo Reyataz nižje od 50 kopij/ml v primerjavi s 76 % (338 od 443) tistih, ki so jemali lopinavir.
English: Reyataz capsules have been assessed in four main studies involving patients aged 16 years and over.
Slovenian: Zdravilo Reyataz so proučevali v štirih glavnih študijah, v katere so bili vključeni bolniki, starejši od 16 let.