FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide.
Slovenian: Po uporabi antagonistov muskarinskih receptorjev, vključno z umeklidinijevim bromidom, se lahko pojavijo učinki na srce in ožilje, npr. motnje srčnega ritma, kakršni sta atrijska fibrilacija in tahikardija.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Other special populations
Slovenian: Druge posebne skupine bolnikov
English: • cough
Slovenian: • kašelj,
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: If you stop using Rolufta Ellipta
Slovenian: Če ste pozabili uporabiti zdravilo Rolufta Ellipta
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p<0.001) in the 24-week study.
Slovenian: V 24-tedenski študiji so z zdravilom Rolufta Ellipta v primerjavi s placebom ugotovili statistično značilno izboljšanje fokalnega seštevka TDI po 24 tednih (1,0 enota, p < 0,001).
English: Desiccant
Slovenian: Dojenje
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Slovenian: Rolufta Ellipta 55 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij (umeklidinijev bromid)
English: Similarly, a greater proportion of patients achieved at least the MCID for Rolufta Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Slovenian: Podobno je v 24-tedenskih študiji po 24 tednih vsaj minimalno klinično pomembno razliko s 55 mikrogrami zdravila Rolufta Ellipta dosegel večji delež bolnikov (44 %) kot s placebom (34 %).
English: In use shelf-life: 6 weeks.
Slovenian: Rok uporabnosti po prvem odprtju: 6 tednov.
English: Wait to open the cover until you are ready to inhale your dose.
Slovenian: Pokrovček odprite šele, ko ste pripravljeni, da vdihnete odmerek.
English: Keep this medicine out of the sight and reach of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom!
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Slovenian: Rolufta Ellipta 55 µg prašek za inhaliranje umeklidinij (umeklidinijev bromid)
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Slovenian: Ko bolnik inhalator prvič vzame iz embalaže, je v položaju ˝zaprto˝.
English: Hypersensitivity reactions including: Rash, urticaria and pruritus
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije, ki vključujejo: izpuščaj, urtikarijo in pruritus občasni
English: Effects on lung function
Slovenian: Ključne študije učinkovitosti: Učinki na delovanje pljuč
English: Rolufta Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Slovenian: Zdravilo Rolufta Ellipta je tudi statistično značilno izboljšalo zdravstveno kakovost življenja, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
English: Carton
Slovenian: TRAKU
English: No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose.
Slovenian: Pri odmerku, 4-krat višjem od terapevtskega odmerka, niso opazili vpliva na AUC ali Cmax umeklidinija.
English: Renal and urinary disorders Urinary retention Dysuria
Slovenian: Bolezni sečil zastoj urina dizurija neznana pogostnost neznana pogostnost
English: Do not shake the inhaler.
Slovenian: Inhalatorja ne stresajte.
English: Check with your doctor if you think any of these may apply to you.
Slovenian: Če menite, da kaj od tega velja za vas, se posvetujte z zdravnikom.
English: Write the date the inhaler should be thrown away on the label in the space provided.
Slovenian: V predvideni prostor na nalepki inhalatorja vpišite datum, do katerega morate inhalator zavreči.
English: Use this medicine for as long as your doctor recommends.
Slovenian: Če ste prenehali uporabljati zdravilo Rolufta Ellipta To zdravilo uporabljajte toliko časa, kot vam svetuje zdravnik.
English: • sore throat
Slovenian: • vnetje žrela,
English: Your Rolufta Ellipta inhaler carton contains
Slovenian: Škatla vašega zdravila Rolufta Ellipta vsebuje
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant packet.
Slovenian: Inhalator Ellipta sestavljajo sivo ohišje, svetlo zelen pokrovček ustnika in števec odmerkov.
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide) Inhalation use
Slovenian: Rolufta Ellipta 55 µg prašek za inhaliranje umeklidinij (umeklidinijev bromid) za inhaliranje
English: 1 inhaler of 7 doses.
Slovenian: 1 inhalator s 7 odmerki 1 inhalator s 30 odmerki
English: Method of administration
Slovenian: POSTOPEK UPORABE
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Slovenian: To ustreza odmerjenemu odmerku 62,5 mikrograma umeklidinija (kar ustreza 74,2 mikrograma umeklidinijevega bromida).
English: Ireland.
Slovenian: Irska
English: Nasopharyngitis Upper respiratory tract infection Urinary tract infection Sinusitis
Slovenian: Infekcijske in parazitske bolezni nazofaringitis okužba zgornjih dihal okužba sečil sinuzitis faringitis pogosti pogosti pogosti pogosti občasni
English: COPD exacerbations
Slovenian: Poslabšanja KOPB
English: Symptomatic outcomes
Slovenian: KLINIČNI PODATKI
English: • Increase of the measured eye pressure
Slovenian: • zamegljen vid,
English: Similarly, a greater proportion of patients achieved ≥1 unit TDI focal score for Rolufta Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Slovenian: 1 enoto fokalnega seštevka TDI večji delež bolnikov z zdravilom Rolufta Ellipta (53 %) kot s placebom
English: If you forget to use Rolufta Ellipta Don't inhale an extra dose to make up for a forgotten dose.
Slovenian: Ne vdihnite dodatnega odmerka, da bi nadomestili pozabljenega.
English: Driving and using machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The “Discard by” date should be written on the inhaler label in the space provided.
Slovenian: V predvideni prostor na nalepki inhalatorja naj vpiše datum "Zavrzite do".
English: Annex A
Slovenian: DODATEK A
English: 28 patches (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
Slovenian: Transdermalni obliž transdermalnih obližev (7 x 2 mg/24 h, 7 x 4 mg/24 h, 7 x 6 mg/24 h, 7 x 8 mg/24 h)
English: Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ET copolymer/paper)
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja transdermalnih obližev (večkratno
English: Page 2/2
Slovenian: Stran 2/2
English: Questions and answers
Slovenian: Vprašanja in odgovori
English: EMA/23377/2010 EMEA/H/C/1108
Slovenian: 20. januar 2010 EMA/285618/2010 EMEA/H/C/1108
English: What was the recommendation of the CHMP at that time?
Slovenian: Kakšno je bilo takrat priporočilo CHMP?
English: The application was withdrawn at ‘day 180'.
Slovenian: Družba je vlogo umaknila na 180. dan postopka.
English: The company presented the results of three main studies involving around 900 adults with pain.
Slovenian: Družba je predstavila rezultate treh glavnih študij, ki so vključevale skupno 900 odraslih z bolečinami.
English: The main studies involved relatively young patients and therefore no conclusion could be drawn on how the medicine would work in other age groups.
Slovenian: Glavne študije so vključevale razmeroma mlade bolnike, zato ni bilo mogoče sklepati, kako bi zdravilo delovalo na bolnike v drugih starostnih skupinah.
English: There was also insufficient information on the safety of the medicine compared with medicines containing only one of the active substances.
Slovenian: Prav tako ni bilo zadostnih informacij o varnosti zdravila v primerjavi z zdravili, ki vsebujejo le eno od obeh zdravilnih učinkovin.
English: It was expected to be used without prescription.
Slovenian: Zdravilo naj bi bilo na voljo brez recepta.
English: What are the consequences 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: It was to be available as capsules.
Slovenian: Naj voljo naj bi bilo v kapsulah.
English: The main measures of effectiveness were based on the level of pain relief after two hours, the number of patients who were asleep after one hour and how long the patients slept.
Slovenian: Glavna merila učinkovitosti so bila stopnja zmanjšanja bolečine po dveh urah, število bolnikov, ki so zaspali po eni uri, in dolžina njihovega spanca.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Slovenian: To pomeni, da je CHMP takrat ocenjeval dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
English: What documentation did the company present to support its application?
Slovenian: Katero dokumentacijo je družba predložila v podporo svoji vlogi?
English: How far into the evaluation was the application when it was withdrawn?
Slovenian: Kako daleč je bil postopek ocenjevanja vloge ob njenem umiku?
English: Summary of the application at the time of withdrawal
Slovenian: Povzetek vloge ob njenem umiku
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Slovenian: Dopis, s katerim družba CHMP obvešča o umiku vloge, je na voljo tukaj.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na seznam vprašanj, so nekatera izmed njih še vedno ostala nerešena.
English: What were the reasons given by the company for withdrawing the application?
Slovenian: Kakšni so bili razlogi družbe za umik vloge?
English: Its main action is to block receptors for histamine, which is involved in inflammation and allergic reactions, but it also leads to drowsiness which helps to improve sleep.
Slovenian: Deluje predvsem tako, da zavira receptorje za histamine, ki sodelujejo pri vnetnih in alergijskih reakcijah, vendar povzroča tudi zaspanost, kar pripomore k lažjemu spancu.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation and pain.
Slovenian: Deluje tako, da zavira encim, imenovan ciklooksigenaza, ki proizvaja prostaglandine, snovi, ki sodelujejo pri vnetju in bolečinah.
English: The studies compared the medicine with placebo (a dummy treatment) and a medicine containing ibuprofen alone.
Slovenian: V študijah so zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine) in z zdravilom, ki vsebuje samo ibuprofen.
English: When taken together, the two active substances were expected to provide benefits for patients with pain who have difficulty sleeping because of the pain.
Slovenian: Kadar se obe zdravilni učinkovini jemljeta skupaj, naj bi pomagala bolnikom z bolečinami, ki zaradi njih ne morejo spati.
English: Ibuprofen is a painkiller that belongs to the class non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Ibuprofen je zdravilo proti bolečinam, ki spada v razred nesteroidnih protivnetnih zdravil (NSAID).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ibuprofen/Diphenhydramine Hydrochloride Wyeth could not have been approved.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih zastavil CHMP, je Odbor v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Ibuprofen/Diphenhydramine Hydrochloride Wyeth ni mogoče odobriti.
English: Because Ibuprofen/Diphenhydramine Hydrochloride Wyeth was intended to be available without a prescription, the Committee requested more information on how it would interact with other medicines.
Slovenian: Ker naj bi bilo zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth na voljo brez recepta, je Odbor zahteval več informacij o medsebojnih vplivih z drugimi zdravili.
English: The effects of Ibuprofen/Diphenhydramine Hydrochloride Wyeth were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Ibuprofen/Diphenhydramine Hydrochloride Wyeth so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Diphenhydramine hydrochloride is found in medicines used to treat allergies, cough and sleep problems.
Slovenian: Difenhidraminijev klorid je možno najti v zdravilih za zdravljenje alergij, kašlja in težav s spanjem.
English: On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Slovenian: Družba Wyeth Consumer Healthcare je dne 7. januarja 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ibuprofen/Diphenhydramine Hydrochloride Wyeth, namenjenim zdravljenju bolnikov z blagimi do zmernimi bolečinami, ki zaradi njih težko spijo.
English: Diphenhydramine hydrochloride is an antihistamine.
Slovenian: Difenhidraminijev klorid je antihistaminik.
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth contains two active substances that have been available in the European Union for many years in commonly used non-prescription medicines.
Slovenian: Zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth vsebuje dve zdravilni učinkovini, ki sta v Evropski uniji že vrsto let na voljo v pogosto uporabljenih zdravilih, ki se izdajajo brez recepta.
English: Ibuprofen is found in medicines used to treat pain, inflammation and fever.
Slovenian: Ibuprofen je mogoče najti v zdravilih za zdravljenje bolečin, vnetij in povišane telesne temperature.
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth was expected to be used for the short-term treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Slovenian: Zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth naj bi se uporabljalo za kratkotrajno zdravljenje blagih do zmernih bolečin pri odraslih, ki zaradi njih težko spijo.
English: The company informed the CHMP that at present there are no ongoing clinical trials or compassionate use programmes with Ibuprofen/Diphenhydramine Hydrochloride Wyeth.
Slovenian: Družba je obvestila CHMP, da klinična preskušanja ali programi sočasne uporabe z zdravilom Ibuprofen/Diphenhydramine Hydrochloride Wyeth ne potekajo.
English: The CHMP noted that the applicant had not shown enough evidence that there was a relevant advantage of using Ibuprofen/Diphenhydramine Hydrochloride Wyeth over using ibuprofen alone.
Slovenian: CHMP je menil, da predlagatelj ni zadostno dokazal pomembnih prednosti uporabe zdravila Ibuprofen/Diphenhydramine Hydrochloride Wyeth v primerjavi z zdravilom, ki vsebuje le ibuprofen.
English: Withdrawal of marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (ibuprofen and diphenhydramine hydrochloride) EMA/23377/2010
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Ibuprofen/Diphenhydramine Hydrochloride Wyeth (ibuprofen in difenhidraminijev klorid) EMA/285618/2010
English: Withdrawal of marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (ibuprofen and diphenhydramine hydrochloride)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Ibuprofen/Diphenhydramine Hydrochloride Wyeth (ibuprofen in difenhidraminijev klorid)
English: Ibuprofen/Diphenhydramine Hydrochloride Wyeth is a medicine that contains the active substances ibuprofen and diphenhydramine hydrochloride.
Slovenian: Zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth vsebuje zdravilni učinkovini ibuprofen in difenhidraminijev klorid.
English: What is Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
Slovenian: Kaj je zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth?
English: How was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to work?
Slovenian: Kako naj bi zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth delovalo?
English: What was Ibuprofen/Diphenhydramine Hydrochloride Wyeth expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ibuprofen/Diphenhydramine Hydrochloride Wyeth uporabljalo?
English: The recommended dose is one tablet once daily with a meal.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan, zaužita z obrokom.
English: Further information on Juluca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Juluca je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Juluca?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Juluca?
English: Both active substances are already available in the European Union: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.
Slovenian: Obe zdravilni učinkovini sta že na voljo v Evropski uniji: dolutegravir je odobren od leta 2014 in rilpivirin od leta 2011.
English: Juluca (dolutegravir / rilpivirine)
Slovenian: Juluca (dolutegravir/rilpivirin)
English: Juluca must not be used with the following medicines because they may reduce its effectiveness:
Slovenian: Zdravilo Juluca se ne sme jemati skupaj z naslednjimi zdravili, ki lahko zmanjšajo njegovo učinkovitost:
English: The Agency decided that Juluca's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Zato je agencija zaključila, da so koristi zdravila Juluca večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Juluca are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Juluca stalno spremljajo.
English: The most serious side effects (which may affect up to 1 in 100) include allergic reactions that include rash or liver damage.
Slovenian: Najresnejši neželeni učinki (ki lahko prizadenejo do 1 bolnika od 100) so alergične reakcije, ki vključujejo izpuščaj ali okvaro jeter.
English: • rifampicin, rifapentine (antibiotics);
Slovenian: • rifampicinom in rifapentinom (antibiotikoma);
English: Why is Juluca authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Juluca odobreno v EU?
English: An overview of Juluca and why it is authorised in the EU
Slovenian: Pregled zdravila Juluca in zakaj je odobreno v EU
English: In this way, Juluca helps to prevent the spread of HIV-1 and keep the amount of the virus in the blood at a low level.
Slovenian: Zdravilo Juluca tako pomaga preprečiti širjenje virusa HIV-1 in ohranjati količino virusa v krvi na nizki ravni.
English: Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs.
Slovenian: Ker zdravilo Juluca ne vsebuje NRTI, pri njem ni dolgoročnih neželenih učinkov, ki jih povzročajo NRTI.
English: Other information about Juluca
Slovenian: Druge informacije o zdravilu Juluca
English: What benefits of Juluca have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Juluca izkazalo v študijah?
English: Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Juluca, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Juluca and what is it used for?
Slovenian: Kaj je zdravilo Juluca in za kaj se uporablja?
English: It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.
Slovenian: Ni primerno za bolnike, pri katerih je katero koli zdravilo za zdravljenje okužbe z virusom HIV prenehalo delovati, ali za bolnike, ki so okuženi z virusom HIV, odpornim proti zdravilom, ki delujejo enako kot zdravilni učinkovini zdravila Juluca.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Juluca have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Juluca upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Juluca?
Slovenian: Kakšna tveganja so povezana z zdravilom Juluca?
English: For more information about using Juluca, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Juluca glejte priloženo navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Juluca se uporablja za zdravljenje odraslih oseb, okuženih z virusom humane imunske pomanjkljivosti (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: The side effects of Juluca are well known and manageable.
Slovenian: Neželeni učinki zdravila Juluca so dobro znani in obvladljivi.
English: The proportion of patients whose viral load was below 50 copies/ml after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).
Slovenian: Delež bolnikov, pri katerih je bilo virusno breme po 48 tednih nižje od 50 kopij/ml, je bil pri bolnikih, ki so prešli na jemanje kombinacije dolutegravirja in rilpivirina, enak v primerjavi s tistimi, ki so še naprej uporabljali trenutna zdravila (95 % v obeh primerih).
English: The European Medicines Agency considered that Juluca's effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs.
Slovenian: Evropska agencija za zdravila je menila, da je učinkovitost zdravila Juluca primerljiva z učinkovitostjo kombiniranega zdravljenja s tremi zdravili za zdravljenje okužbe z virusom HIV, ki vključujejo NRTI.