FrancophonIA/ELRC3.0 huggingface dataset:
English: Ambrisentan Mylan is effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Slovenian: Učinkovitost zdravila Ambrisentan Mylan je bila dokazana pri pljučni arterijski hipertenziji brez znanega vzroka in pljučni arterijski hipertenziji, povezani z boleznijo vezivnega tkiva.
English: The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow.
Slovenian: Učinkovina v zdravilu Ambrisentan Mylan, ambrisentan, zavira receptorje za hormon, imenovan endotelin, ki povzroča zožitev žil.
English: How has Ambrisentan Mylan been studied?
Slovenian: Kako je bilo zdravilo Ambrisentan Mylan raziskano?
English: Therefore, the Agency's view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Ambrisentan Mylan enako kot pri zdravilu Volibris odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Slovenian: Zdravljenje se uvede v odmerku 5 mg enkrat na dan, zdravnik pa lahko glede na odziv in neželene učinke, ki jih občuti bolnik, odmerek poveča na največ 10 mg na dan. Na 10 miligramov povečani odmerek se priporoča, kadar se zdravilo uporablja v kombinaciji s tadalafilom (drugim zdravilom za zdravljenje pljučne arterijske hipertenzije).
English: How is Ambrisentan Mylan used?
Slovenian: Kako se zdravilo Ambrisentan Mylan uporablja?
English: How does Ambrisentan Mylan work?
Slovenian: Kako zdravilo Ambrisentan Mylan deluje?
English: 11 October 2019
Slovenian: 11. oktober 2019
English: What is paromomycin?
Slovenian: Kaj je paromomicin?
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/129)
Slovenian: Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/129)
English: The European Commission issued a decision on 11 October 2019.
Slovenian: Evropska komisija je sklep izdala 11. oktobra 2019.
English: These included data from companies and published literature.
Slovenian: Vključeni so bili podatki, ki so jih priskrbela podjetja, in podatki iz objavljene literature.
English: Why were veterinary medicines containing paromomycin reviewed?
Slovenian: Zakaj so bila zdravila za uporabo v veterinarski medicini, ki vsebujejo paromomicin, pregledana?
English: The Committee also noted the possibility that inappropriate doses could lead to bacterial resistance.
Slovenian: Odbor je opozoril tudi na možnost, da bi lahko neustrezni odmerki povzročili razvoj bakterijske odpornosti.
English: Therefore, the CVMP recommended suspending the marketing authorisations for these veterinary medicines until adequate data are available.
Slovenian: Odbor CVMP je zato priporočil, da se dovoljenja za promet s temi zdravili za uporabo v veterinarski medicini začasno umaknejo, dokler ne bodo na voljo ustrezni podatki.
English: On 25 September 2018, the Belgian medicines authority requested that the CVMP review all available data on paromomycin's effectiveness and residue depletion (how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body).
Slovenian: Belgijski organ za zdravila je 25. septembra 2018 zahteval, da odbor CVMP ponovno pregleda vse razpoložljive podatke o učinkovitosti paromomicina in izločanju ostankov (kako dolgo traja, da ostanki zdravila v telesu živali padejo pod mejno vrednost najvišjih dovoljenih količin ostankov (MRL)).
English: Paromomycin is an aminoglycoside antibiotic used to treat a wide range of bacterial infections and is given to pigs by injection into a muscle.
Slovenian: Paromomicin je aminoglikozidni antibiotik, ki se uporablja za zdravljenje številnih bakterijskih okužb in se daje prašičem z injiciranjem v mišico.
English: The CVMP reviewed available data on effectiveness and residue depletion.
Slovenian: Odbor CVMP je pregledal razpoložljive podatke o učinkovitosti in izločanju ostankov.
English: The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.
Slovenian: Karenca je najkrajši čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter se lahko meso in drugi živalski proizvodi uporabijo za prehrano ljudi.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of these medicines do not outweigh their risks because of inadequate data supporting their use in pigs and the possibility of bacterial resistance.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da koristi teh zdravil ne odtehtajo z njimi povezanih tveganj zaradi nezadostnih podatkov o njihovi uporabi pri prašičih in možnosti razvoja bakterijske odpornosti.
English: The Belgian authority noted that there were different approved uses, dose schedules and withdrawal periods across the EU.
Slovenian: Opozoril je, da so po EU odobrene različne uporabe, časovni razporedi odmerjanja in obdobja karence.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of veterinary medicines containing paromomycin given to pigs by injection into the muscle do not outweigh their risks.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je odbor CVMP zaključil, da koristi zdravil za uporabo v veterinarski medicini, ki vsebujejo paromomicin in se dajejo prašičem z injiciranjem v mišico, ne odtehtajo z njimi povezanih tveganj.
English: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs
Slovenian: Vprašanja in odgovori o začasnem umiku dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo paromomicin za injiciranje in se uporabljajo za prašiče
English: On 18 July 2019, the European Medicines Agency recommended suspending the marketing authorisations for paromomycin antibiotics given to pigs by injection into a muscle.
Slovenian: Evropska agencija za zdravila je 18. julija 2019 priporočila, da se dovoljenja za promet z antibiotiki, ki se dajejo prašičem z injiciranjem v mišico, začasno umaknejo.
English: The Committee based its opinion on the lack of adequate data on how effective these medicines are and residue depletion data.
Slovenian: Svoje mnenje je utemeljil na pomanjkanju ustreznih podatkov o njihovi učinkovitosti in izločanju njihovih ostankov.
English: 08019 - Barcelona Spain
Slovenian: 08019 - Barcelona Španija
English: Evropská 846/176a 160 00 Praha 6
Slovenian: Evropská 846/176a 160 00 Praha 6 Češka
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: GR-Greece
Slovenian: GR-Grčija
English: Empreendimento Lagoas Park Edifício 7 - 3º Piso 2740-244 Porto Salvo
Slovenian: Edifício 7 - 3º Piso 2740-244 Porto Salvo
English: 65926 Frankfurt am Main, Deutschland
Slovenian: 65926 Frankfurt am Main, Nemčija
English: Sweden sanofi-aventis AB Box 141 42
Slovenian: Švedska sanofi-aventis AB Box 141 42
English: United Kingdom Aventis Pharma Limited,
Slovenian: Aventis Pharma Limited,
English: Greece sanofi-aventis AEBE 348 Syngrou avenueBuilding A
Slovenian: Grčija sanofi-aventis AEBE 348 Syngrou avenueBuilding A
English: Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia
Slovenian: Estonija sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonija
English: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom)
Slovenian: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, Velika Britanija)
English: UAB “SANOFIAVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania
Slovenian: UAB “SANOFIAVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Litva
English: West Malling
Slovenian: West Malling Kent
English: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Cyprus
Slovenian: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Ciper
English: Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland
Slovenian: Irska sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Irska
English: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE
Slovenian: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris Francija
English: United Kingdom Aventis Pharma Limited, 50 Kings Hill Avenue
Slovenian: Aventis Pharma Limited, 50 Kings Hill Avenue
English: Slovenia sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenia
Slovenian: Slovenija sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenija
English: Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8
Slovenian: Sanofi-Avenstis Bulgaria EOOD, Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8
English: Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, The Netherlands
Slovenian: Nizozemska sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, Nizozemska
English: Hungary sanofi-aventis Zrt.
Slovenian: Madžarska sanofi-aventis Zrt.
English: Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finland
Slovenian: Finska sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finska
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65 926 Frankfurt am Main, Germany
Slovenian: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65 926 Frankfurt am Main, Nemčija
English: SANOFI-AVENTISProdutos
Slovenian: Portugalska SANOFI-AVENTISProdutos
English: Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy
Slovenian: Viale Luigi Bodio 37/B 20158 Milan Italija
English: Luxembourg Sanofi-aventis Belgium
Slovenian: Luksemburg Sanofi-aventis Belgium
English: Belgium Sanofi-aventis Belgium
Slovenian: Sanofi-aventis Belgium
English: Tavanic 250 250 mg Film-coated tablets
Slovenian: Tavanic 250 250 mg Filmsko obložene tablete
English: Tavanic 500 500 mg Film-coated tablets
Slovenian: Tavanic 500 500 mg Filmsko obložene tablete
English: Tavanic 500mg 500 mg Film-coated tablets
Slovenian: Tavanic 500mg 500 mg Filmsko obložene tablete
English: This summary was last updated in 02-2016.
Slovenian: Povzetek je bil nazadnje posodobljen MM-2016.
English: What measures are being taken to ensure the safe and effective use of Zurampic?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zurampic?
English: Patients should drink plenty of fluids throughout the day.
Slovenian: Bolniki morajo čez dan popiti dovolj tekočine.
English: What is Zurampic and what is it used for?
Slovenian: Kaj je zdravilo Zurampic in za kaj se uporablja?
English: The full EPAR and risk management plan summary for Zurampic 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) in povzetek načrta obvladovanja tveganj za zdravilo Zurampic sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Risks such as kidney damage or heart problems are addressed in the product information.
Slovenian: Tveganja, kot so poškodbe ledvic in težave s srcem, se obravnavajo v informacijah o zdravilu.
English: It is not intended to provide practical advice on how to use Zurampic.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Zurampic is available as 200-mg tablets.
Slovenian: Zdravilo Zurampic je na voljo v obliki 200-miligramskih tablet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zurampic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Zurampic večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What benefits of Zurampic have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zurampic izkazalo v študijah?
English: This is a summary of the European public assessment report (EPAR) for Zurampic.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zurampic.
English: A risk management plan has been developed to ensure that Zurampic is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Zurampic je bil pripravljen načrt obvladovanja tveganj.
English: Other information about Zurampic
Slovenian: Druge informacije o zdravilu Zurampic
English: What are the risks associated with Zurampic?
Slovenian: Kakšna tveganja so povezana z zdravilom Zurampic?
English: Zurampic was studied in two main studies involving over 1,200 adults with gout who were previously treated with allopurinol.
Slovenian: Zdravilo Zurampic so proučevali v dveh glavnih študijah, ki sta vključevali več kot 1 200 odraslih s protinom, ki so se predhodno zdravili z alopurinolom.
English: Why is Zurampic approved?
Slovenian: Zakaj je bilo zdravilo Zurampic odobreno?
English: Adding Zurampic 200 mg once daily was effective in 55% (222 of 405) patients.
Slovenian: Dodajanje zdravila Zurampic 200 mg enkrat na dan je bilo učinkovito pri 55 % (222 od 405) bolnikov.
English: Looking just at patients whose blood uric acid level did not fall sufficiently on treatment with febuxostat alone, the level dropped to less than 50 mg/litre in 44% (26 of 59) patients taking Zurampic compared to 24% (12 of 51) patients taking placebo.
Slovenian: Med bolniki, pri katerih se koncentracija sečne kisline v krvi ob zdravljenju samo s febuksostatom ni dovolj znižala, se je njena koncentracija znižala na manj kot 50 mg/liter pri 44 % (26 od 59) bolnikov, ki so prejemali zdravilo Zurampic, v primerjavi s 24 % (12 od 51) bolnikov, ki so prejemali placebo.
English: A third main study involved 324 adults who had at least one measurable tophus (large deposit of uric acid in or around a joint or under the skin) and with high blood levels of uric acid (over 80 mg/litre without gout medicines or above 60 mg/litre despite treatment with allopurinol or febuxostat).
Slovenian: Tretja glavna študija je vključevala 324 odraslih, ki so imeli vsaj en merljiv tof (velika zaloga sečne kisline v sklepu ali okoli njega ali pod kožo) in visoko koncentracijo sečne kisline (nad 80 mg/liter brez zdravila za protin ali nad 60 mg/liter kljub zdravljenju z alopurinolom ali febuksostatom).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zurampic, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The company that markets Zurampic will carry out a study on the risk of heart, circulation or kidney disorders in patients treated with Zurampic, particularly in those who have previously suffered from such disorders.
Slovenian: Družba, ki trži zdravilo Zurampic, bo izvedla študijo o tveganjih za nastanek bolezni srca, ožilja ali ledvic pri bolnikih, ki se zdravijo z zdravilom Zurampic, zlasti pri tistih, ki so že imeli te bolezni.
English: Overall, Zurampic 200 mg once daily was effective in 57% (60 of 106) patients.
Slovenian: Skupno je bilo zdravilo Zurampic 200 mg enkrat na dan učinkovito pri 57 % (60 od 106) bolnikov.
English: The most common side effects with Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastro-oesophageal reflux disease) stomach acid coming back to the mouth, and blood tests showing increased blood creatinine levels (a marker of kidney function).
Slovenian: Najpogostejši neželeni učinki zdravila Zurampic (ki lahko prizadenejo največ 1 osebo od 10) so gripa, glavobol, zgaga in (gastroezofagealna refluksna bolezen) vračanje želodčne kisline nazaj v usta ter izvidi krvnih preiskav, ki kažejo na zvišano koncentracijo kreatinina v krvi (označevalec delovanja ledvic).
English: For more information about treatment with Zurampic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zurampic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Slovenian: Najresnejši neželeni učinki so bili ledvična odpoved, okvarjeno delovanje ledvic in ledvični kamni, prizadeli pa so manj kot 1 osebo od 100.
English: Patients must not take Zurampic if they suffer from tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or a rare hereditary disease called LeschNyhan syndrome, both of which raise uric acid levels in the blood.
Slovenian: Bolniki ne smejo jemati zdravila Zurampic, če imajo sindrom lize tumorja (zaplet zaradi hitre razgradnje rakavih celic med zdravljenjem zaradi raka) ali redko dedno bolezen, imenovano Lesch-Nyhanov sindrom; oba sindroma namreč dvigneta koncentracijo sečne kisline v krvi.
English: It does this by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Slovenian: To doseže tako, da blokira beljakovino, imenovano prenašalec sečne kisline 1 (URAT1), v ledvicah.
English: These studies compared the effect of adding Zurampic or placebo (a dummy treatment) to patients' allopurinol treatment.
Slovenian: V teh študijah so primerjali učinek dodajanja zdravila Zurampic ali placeba (zdravila brez zdravilne učinkovine) zdravljenju z alopurinolom.
English: This compared with 47% (51 of 109) patients given placebo.
Slovenian: Ta delež je pri bolnikih, ki so prejemali placebo, znašal 47 % (51 od 109).
English: Patients were first treated with febuxostat alone for three weeks and then with febuxostat plus either Zurampic or placebo.
Slovenian: Bolnike so najprej tri tedne zdravili samo s febuksostatom, nato pa s febuksostatom v kombinaciji bodisi z zdravilom Zurampic bodisi s placebom.
English: The recommended dose is 200 mg once daily, taken in the morning at the same time as a xanthine oxidase inhibitor medicine such as allopurinol or febuxostat.
Slovenian: Priporočeni odmerek je 200 mg enkrat na dan, ki ga je treba vzeti zjutraj hkrati z zaviralcem ksantin-oksidaze, kot sta alopurinol ali febuksostat.
English: This prevents the build-up of uric acid in joints where it can cause pain, swelling and joint damage.
Slovenian: Tako se prepreči kopičenje sečne kisline v sklepih, kjer povzroča bolečino, otekanje in poškodbe.
English: The patient's kidney function will be monitored regularly during treatment with Zurampic and the doctor will advise the patient to take sufficient fluid during the day and always take Zurampic with either allopurinol or febuxostat, which helps to prevent kidney damage from Zurampic.
Slovenian: Med zdravljenjem z zdravilom Zurampic bo zdravnik spremljal delovanje bolnikovih ledvic in mu svetoval, naj podnevi popije dovolj tekočine in naj vedno vzame zdravilo Zurampic bodisi z alopurinolom bodisi s febuksostatom, kar preprečuje poškodbe ledvic zaradi zdravila Zurampic.
English: This is because these disorders have occurred during treatment with Zurampic.
Slovenian: Študijo bodo izvedli zato, ker so se te bolezni že pojavile med zdravljenjem z zdravilom Zurampic.
English: For practical information about using Zurampic, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zurampic naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Slovenian: Z zaviranjem beljakovine URAT1 se več sečne kisline izloča z urinom in je manj ostaja v krvi.
English: Patients with very poor kidney function or who have had a kidney transplant must also not take Zurampic.
Slovenian: Tudi bolniki z zelo okvarjenim delovanjem ledvic ali bolniki s presajenimi ledvicami zdravila Zurampic ne smejo jemati.
English: If treatment with the xanthine oxidase inhibitor is interrupted, then treatment with Zurampic must also be interrupted at the same time.
Slovenian: Če se zdravljenje z zaviralcem ksantin-oksidaze prekine, je treba takrat prekiniti tudi zdravljenje z zdravilom Zurampic.
English: Over time, visible deposits of uric acid disappeared in increasing number of patients continuing Zurampic and febuxostat treatment, and fewer patients had recurrence of gout attacks.
Slovenian: Sčasoma so pri čedalje večjem številu bolnikov, ki so nadaljevali zdravljenje z zdravilom Zurampic, vidne zaloge sečne kisline izginile, število bolnikov s ponavljajočimi se napadi protina pa je bilo manjše.
English: How is Zurampic used?
Slovenian: Kako se zdravilo Zurampic uporablja?
English: Zurampic is used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat.
Slovenian: Zdravilo Zurampic se uporablja v kombinaciji z zaviralcem ksantin-oksidaze, kot sta alopurinol ali febuksostat.
English: Xanthine oxidase inhibitors reduce the production of uric acid in the body.
Slovenian: Zaviralci ksantin-oksidaze zmanjšajo tvorbo sečne kisline v telesu.
English: For the full list of all side effects reported with Zurampic, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri zdravilu Zurampic, glejte navodilo za uporabo.
English: The active substance in Zurampic, lesinurad, helps to remove uric acid from the body.
Slovenian: Zdravilna učinkovina zdravila Zurampic, lesinurad, pripomore k odstranjevanju sečne kisline iz telesa.
English: Their blood level of uric acid was not sufficiently controlled with allopurinol alone and was above 60 mg/litre at the start of the study.
Slovenian: Alopurinol ni v zadostni meri nadzoroval koncentracije sečne kisline v njihovi krvi, ki je bila na začetku študije nad 60 mg/liter.
English: It is used in combination with a xanthine oxidase inhibitor, another type of gout medicine, when the xanthine oxidase inhibitor on its own is not able to control uric acid levels sufficiently.
Slovenian: Uporablja se v kombinaciji z zaviralcem ksantin-oksidaze, drugo vrsto zdravila proti protinu, kadar sam zaviralec ksantin-oksidaze ne more v zadostni meri nadzorovati koncentracije sečne kisline.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 60 mg/litre after 6 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je koncentracija sečne kisline v krvi po 6 mesecih zdravljenja znižala pod 60 mg/liter.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 50 mg/litre after 6 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je koncentracija sečne kisline v krvi po 6 mesecih zdravljenja znižala pod 50 mg/liter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zurampic on 18 February 2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zurampic, veljavno po vsej Evropski uniji, izdala <datum izdaje dovoljenja za promet z zdravilom>.