FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack containing 1 green pre-filled pen of Lyxumia 10 micrograms solution for injection and 1 purple pre-filled pen of Lyxumia 20 micrograms solution for injection.
Slovenian: Pakiranje vsebuje 1 zelen napolnjeni injekcijski peresnik z zdravilom Lyxumia 10 mikrogramov raztopina za injiciranje in 1 škrlaten napolnjen injekcijski peresnik z zdravilom Lyxumia 20 mikrogramov raztopina za injiciranje.
English: Restoration of first phase insulin secretion and improved second phase insulin secretion in response to an intravenous bolus of glucose were demonstrated in patients with type 2 diabetes (n=20) after a single dose of Lyxumia.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 (n = 20) sta bila po enem samem odmerku zdravila Lyxumia ugotovljena obnovitev prve faze in izboljšanje druge faze izločanja insulina v odziv na intravenski bolus glukoze.
English: Put the outer needle cap back on.
Slovenian: Zunanji pokrovček igle znova namestite.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 - 2 pens
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/811/005 - 2 peresnika
English: The reductions in fasting plasma glucose obtained with Lyxumia treatment ranged from 0.42 mmol/L to 1.19 mmol/L (7.6 to 21.4 mg/dl) from baseline at the end of the main 24-week treatment period in placebo-controlled studies.
Slovenian: V študijah, kontroliranih s placebom, je bilo na koncu glavnega 24-tedenskega obdobja zdravljenja z zdravilom Lyxumia doseženo znižanje glukoze v plazmi na tešče od 0,42 mmol/L do 1,19 mmol/L (7,6 do 21,4 mg/dl) v primerjavi z izhodiščem.
English: It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen.
Slovenian: Izbrati je treba obrok, pri katerem je injiciranje zdravila Lyxumia za bolnika najbolj praktično; potem je treba prandialno injekcijo zdravila Lyxumia po možnosti uporabljati vsak dan pred istim obrokom.
English: The treatment initiation pack contains one green pen of Lyxumia 10 micrograms solution for injection and one purple pen of Lyxumia 20 micrograms solution for injection.
Slovenian: Pakiranje za uvedbo zdravljenja vsebuje en zelen peresnik z zdravilom Lyxumia 10 mikrogramov raztopina za injiciranje in en škrlaten peresnik z zdravilom Lyxumia 20 mikrogramov raztopina za injiciranje.
English: Do not freeze Lyxumia once it has been activated.
Slovenian: Ko je zdravilo Lyxumia aktivirano, ga ne zamrzujte.
English: Read the Instructions for Use carefully before using your Lyxumia pen.
Slovenian: Pred uporabo natančno preberite navodila za ravnanje z peresnikom Lyxumia.
English: - Lyxumia 10 micrograms solution for injection: Each dose contains 10 micrograms of lixisenatide (50 micrograms per ml).
Slovenian: - Lyxumia 10 mikrogramov raztopina za injiciranje: En odmerek vsebuje 10 mikrogramov liksisenatida (50 mcg/ml).
English: Preferably inject Lyxumia before the same meal every day, when you have chosen the most convenient meal for your injection.
Slovenian: Potem, ko ste izbrali obrok, pri katerem je injiciranje zdravila za vas najbolj praktično, si zdravilo Lyxumia po možnosti injicirajte vsak dan pred istim obrokom.
English: Use of purple 20 micrograms pen
Slovenian: Uporaba škrlatnega peresnika 20 mikrogramov
English: No effects on paracetamol Cmax and tmax were observed when paracetamol was administered 1 hour before lixisenatide.
Slovenian: Če je bil paracetamol uporabljen 1 uro pred liksisenatidom, niso opazili nobenega vpliva na Cmax in tmax paracetamola.
English: Lyxumia comes as a pre-filled pen for injection.
Slovenian: Zdravilo Lyxumia je na voljo v obliki napolnjenega injekcijskega peresnika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lyxumia 20 mcg injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Lyxumia 20 mcg injekcija liksisenatid subkutana uporaba
English: - Lyxumia 20 micrograms solution for injection: Each dose contains 20 micrograms of lixisenatide (100 micrograms per ml).
Slovenian: - Lyxumia 20 mikrogramov raztopina za injiciranje: En odmerek vsebuje 20 mikrogramov liksisenatida (100 mcg/ml).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Lyxumia if:
Slovenian: Pred začetkom uporabe zdravila Lyxumia se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro:
English: Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly.
Slovenian: Zdravila Lyxumia se ne sme dajati intravensko ali intramuskularno.
English: About Your Lyxumia pens Green 10 microgram Lyxumia pen
Slovenian: O peresnikih Lyxumia Zeleni peresnik Lyxumia 10 mikrogramov
English: Based on these results, no dose adjustment for ramipril is required when co-administered with lixisenatide.
Slovenian: Na podlagi teh rezultatov odmerka ramiprila med sočasno uporabo z liksisenatidom ni treba prilagoditi.
English: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg.
Slovenian: En zelen napolnjen injekcijski peresnik vsebuje 3 ml raztopine in vsebuje 14 odmerkov po 10 mcg.
English: LS change from baseline LS mean difference (SE) of lixisenatide versus 95% CI
Slovenian: Povprečna razlika (standardna napaka) (po metodi NK) med liksisenatidom in 95 % IZ
English: Read these instructions carefully before using your Lyxumia pens.
Slovenian: Pred uporabo peresnikov Lyxumia skrbno preberite ta navodila.
English: Begin with the green 10 microgram Lyxumia pen.
Slovenian: Začnite z zelenim peresnikom Lyxumia 10 mikrogramov.
English: • oral antidiabetics (such as metformin, pioglitazone, sulphonylurea medicines) and/ or ,
Slovenian: Ta zdravila so: peroralni antidiabetiki (npr. metformin, pioglitazon, sulfonilsečninska zdravila) in/ali, bazalni insulin; to je vrsta insulina, ki deluje ves dan.
English: About your needle (supplied separately)
Slovenian: O igli (igle dobite posebej)
English: • Replace the pen cap before you throw away your Lyxumia pen.
Slovenian: • Preden peresnik Lyxumia zavržete, nanj namestite pokrovček peresnika.
English: Reduction from baseline in the AUC0:30-4:30 h of plasma glucose after a test-meal was: -12.61 h*mmol/L (-227.25 h*mg/dl) in the lixisenatide group and -4.04 h*mmol/L (-72.83 h*mg/dl) in the liraglutide group.
Slovenian: (-227,25 h*mg/dl) in v skupini z liraglutidom -4,04 h*mmol/l (-72,83 h*mg/dl).
English: At the end of the study, 43.6% (main meal group) and 42.8% (breakfast group) of patients achieved an HbA1c less than 7%.
Slovenian: Na koncu študije je HbA1c pod 7 % doseglo 43,6 % bolnikov v skupini, ki je zdravilo uporabljala pri glavnem dnevnem obroku, in 42,8 % bolnikov v skupini, ki je zdravilo uporabljala pri zajtrku.
English: Use 29 to 32 gauge disposable pen needles with your Lyxumia pen.
Slovenian: S peresnikom Lyxumia uporabljajte igle za peresa za enkratno uporabo številke od 29 do 32.
English: This is more likely to happen if you also take a sulphonylurea or a basal insulin.Your doctor may reduce your dose of these medicines before you start using Lyxumia.
Slovenian: Zdravnik vam bo morda zmanjšal odmerek teh zdravil, preden začnete uporabljati zdravilo Lyxumia.
English: How to store Lyxumia
Slovenian: Shranjevanje zdravila Lyxumia
English: Black plunger
Slovenian: Črni bat
English: Contact your doctor, pharmacist or nurse.
Slovenian: Posvetujte se s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Arrow window
Slovenian: Okence s puščico
English: Lyxumia pen Information
Slovenian: Lyxumia container
English: Stop taking Lyxumia and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, nehajte uporabljati zdravilo Lyxumia in se nemudoma posvetujte z zdravnikom:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/002 - 1 pen
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/811/002 - 1 peresnik
English: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg.
Slovenian: En škrlaten napolnjen injekcijski peresnik vsebuje 3 ml razopine in vsebuje 14 odmerkov po 20 mcg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INITIATION PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJE ZA UVEDBO ZDRAVLJENJA)
English: Adverse reactions reported from placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Slovenian: V preglednici 1 so prikazani neželeni učinki, ki so jih zabeležili med celotnim obdobjem zdravljenja v študijah III. faze, kontroliranih s placebom ali zdravilno učinkovino.
English: Primary composite endpoint CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina
Slovenian: Primarni sestavljeni opazovani dogodek Srčno-žilna smrt, MI brez 406 (13,4 %) 399 (13,2 %) smrtnega izida, možganska kap brez smrtnega izida ali sprejem v bolnišnico zaradi nestabilne angine pektoris Sekundarna sestavljena opazovana dogodka Primarni + SP
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/001 - 1 pen
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/12/811/001- 1 peresnik
English: Lyxumia 20 micrograms solution for injection
Slovenian: Lyxumia 20 mikrogramov raztopina za injiciranje
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 ali farmacevtom ali medicinsko sestro.
English: Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection lixisenatide
Slovenian: Lyxumia 10 mikrogramov raztopina za injiciranje Lyxumia 20 mikrogramov raztopina za injiciranje liksisenatid
English: Contact your doctor, pharmacist or nurse for help.
Slovenian: Za pomoč se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
English: Patients (%) achieving HbA1c
Slovenian: Izhodišče Povprečna sprememba od izhodišča Bolniki (%), ki so dosegli HbA1c
English: Purple 20 microgram Lyxumia pen
Slovenian: Škrlatni peresnik Lyxumia 20 mikrogramov
English: NAME OF THE MEDICINAL PRODUCT Treatment initiation pack Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection
Slovenian: Pakiranje za uvedbo zdravljenja Lyxumia 10 mikrogramov raztopina za injiciranje Lyxumia 20 mikrogramov raztopina za injiciranje
English: Evening (N= 255)
Slovenian: Zvečer (N =
English: Lyxumia 20 micrograms solution for injection Lixisenatide
Slovenian: Lyxumia 20 mikrogramov raztopina za injiciranje liksisenatid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 20 micrograms lixisenatide (100 micrograms per ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En odmerek (0,2 ml) vsebuje 20 mikrogramov liksisenatida (100 mikrogramov na ml).
English: Lyxumia should not be used if breast-feeding.
Slovenian: Zdravila Lyxumia ne smete uporabljati, če dojite.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 micrograms lixisenatide (50 micrograms per ml).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En odmerek (0,2 ml) vsebuje 10 mikrogramov liksisenatida (50 mikrogramov na ml).
English: No increase in mean heart rate in patients with type 2 diabetes was seen in all placebo controlled phase III studies.
Slovenian: V nobeni kontrolirani študiji III. faze niso opazili povečanja povprečne srčne frekvence pri bolnikih s sladkorno boleznijo tipa II.
English: Each cartridge is assembled into a disposable pen.
Slovenian: Vsak vložek je vgrajen v peresnik za injiciranje za enkratno uporabo.
English: • Glycaemic control
Slovenian: • Urejenost glikemije
English: Table 4: Placebo-controlled studies in combination with a basal insulin (24-week results) Basal insulin as background therapy Alone or in combination with metformin
Slovenian: Preglednica 4: S placebom kontrolirane študije v kombinaciji z bazalnim insulinom (24-tedenski rezultati)
English: in case of vomiting, nausea and diarrhoea.
Slovenian: - če izgubite telesno tekočino/ste dehidrirani, npr. v primeru bruhanja, slabosti v želodcu in driske.
English: The use of insulin is recommended instead.
Slovenian: Zdravila Lyxumia se med nosečnostjo ne sme uporabljati; namesto tega je priporočljiva uporaba insulina.
English: Vomiting Diarrhoea
Slovenian: O peresniku Lyxumia
English: During use of the pen
Slovenian: Med uporabo injekcijskega peresnika
English: Lyxumia 10 micrograms solution for injection
Slovenian: Lyxumia 10 mikrogramov raztopina za injiciranje liksisenatid
English: Needle Protective seal
Slovenian: Zunanji pokrovček igle
English: The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period.
Slovenian: Med glavnim 24-tedenskim obdobjem zdravljenja je bila incidenca prenehanj zdravljenja zaradi neželenih učinkov med prejemniki zdravila Lyxumia 7,4 % in med prejemniki placeba 3,2 %.
English: Ask your pharmacist how to throw away the needle you no longer use.
Slovenian: Iglo, ki jo ne potrebujete več zavrzite, kot vam je svetoval farmacevt.
English: Stroke
Slovenian: Metionin
English: • Activate the pen on the same day as your first injection
Slovenian: 2. poglavje - KAKO ZAČETI • Aktivirajte peresnik na dan, ko boste zdravilo prvič injicirali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 (1 pre-filled pen + 1 pre-filled pen)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/12/811/005 (1 napolnjen injekcijski peresnik + 1 napolnjen injekcijski peresnik) DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve : 01 Februar 2013 Datum zadnjega podaljšanja:
English: Dizziness Somnolence
Slovenian: Pomožne snovi
English: Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg).
Slovenian: Na voljo je v obliki tablet (75, 150, 300, 400, 600 in 800 mg).
English: Darunavir Mylan may be given to adults or children from 3 years of age and weighing at least 15 kg.
Slovenian: Zdravilo Darunavir Mylan se lahko daje odraslim ali otrokom, starejšim od treh let, ki tehtajo najmanj 15 kg.
English: The full EPAR for Darunavir Mylan 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 Darunavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Darunavir Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Darunavir Mylan.
English: Previously treated patients can also take a dose of 800 mg once a day provided that their HIV infection is well controlled and is not likely to be resistant to darunavir.
Slovenian: Predhodno zdravljeni bolniki lahko jemljejo tudi 800-miligramski odmerek enkrat na dan, če je njihova okužba z virusom HIV dobro nadzorovana in je verjetnost odpornosti na darunavir majhna.
English: Because Darunavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Darunavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Darunavir Mylan has been shown to have comparable quality and to be bioequivalent to Prezista.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Darunavir Mylan primerljivo raven kakovosti kot zdravilo Prezista ter da mu je biološko enakovredno.
English: As for every medicine, the company provided studies on the quality of Darunavir Mylan.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Darunavir Mylan.
English: The Committee recommended that Darunavir Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Darunavir Mylan odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Mylan 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 Darunavir Mylan, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Mylan.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Prezista, zato jih ni treba ponoviti za zdravilo Darunavir Mylan.
English: What measures are being taken to ensure the safe and effective use of Darunavir Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Darunavir Mylan?
English: This means that Darunavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Prezista, ki je že odobreno v Evropski uniji (EU).
English: Darunavir Mylan, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Darunavir Mylan v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: Darunavir Mylan is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Darunavir Mylan je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, okuženih z virusom človeške imunske pomanjkljivosti tipa 1 (HIV1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: What are the benefits and risks of Darunavir Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Darunavir Mylan?
English: The medicine is always taken either with cobicistat (in adults) or with low-dose ritonavir (in adults and children) and with other HIV medicines, and should be taken with food.
Slovenian: Zdravilo Darunavir Mylan se vedno jemlje bodisi v kombinaciji s kobicistatom (pri odraslih) bodisi v kombinaciji z nizkimi odmerki ritonavirja (pri odraslih in otrocih) in z drugimi zdravili za zdravljenje okužbe s HIV, pri čemer ga je treba jemati sočasno s hrano.
English: For more information about treatment with Darunavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Darunavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For children aged 3 to 17 years and weighing at least 15 kg who have not be treated before, the recommended dose varies between 600 and 800 mg once daily depending on their weight.
Slovenian: Pri otrocih, starih od tri do 17 let, ki tehtajo vsaj 15 kg in niso bili predhodno zdravljeni, je priporočeni odmerek med 600 in 800 mg enkrat na dan, odvisno od njihove telesne mase.
English: Darunavir Mylan does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Darunavir Mylan ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: Therefore, the CHMP's view was that, as for Prezista, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Prezista odtehtajo znana tveganja.
English: It is not intended to provide practical advice on how to use Darunavir Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For previously treated children the usually recommended dose varies between 375 and 600 mg twice a day depending on their weight.
Slovenian: Pri predhodno zdravljenih otrocih znaša običajni priporočeni odmerek med 375 in 600 mg dvakrat na dan, odvisno od njihove telesne mase.
English: Ritonavir and cobicistat reduce the breakdown of darunavir, increasing the levels of darunavir in the blood.
Slovenian: Ritonavir in kobicistat upočasnjujeta hitrost razgradnje darunavirja in s tem povečujeta njegove ravni v krvi.
English: Other information about Darunavir Mylan
Slovenian: Druge informacije o zdravilu Darunavir Mylan
English: What is Darunavir Mylan and what is it used for?
Slovenian: Kaj je zdravilo Darunavir Mylan in za kaj se uporablja?
English: For practical information about using Darunavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Darunavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Darunavir Mylan is a ‘generic medicine'.
Slovenian: Zdravilo Darunavir Mylan je „generično zdravilo“.
English: Darunavir Mylan can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Darunavir Mylan je le na recept, zdravljenje z njim pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: The active substance in Darunavir Mylan, darunavir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Darunavir Mylan, darunavir, je zaviralec proteaze.
English: Darunavir Mylan is always given with ritonavir or cobicistat.
Slovenian: Zdravilo Darunavir Mylan se vedno daje v kombinaciji z ritonavirjem ali kobicistatom.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Opravila je tudi študije, ki so pokazale, da je zdravilo Darunavir Mylan biološko enakovredno referenčnemu zdravilu.
English: Why is Darunavir Mylan approved?
Slovenian: Zakaj je bilo zdravilo Darunavir Mylan odobreno?
English: For adults who have not been treated before, the recommended dose is 800 mg once a day.
Slovenian: Priporočeni odmerek zdravila za odrasle, ki predhodno še niso bili zdravljeni, je 800 mg enkrat na dan. Priporočeni odmerek zdravila za odrasle, ki so že bili predhodno zdravljeni, je 600 mg dvakrat na dan.
English: Darunavir Mylan contains the active substance darunavir.
Slovenian: Zdravilo Darunavir Mylan vsebuje zdravilno učinkovino darunavir.
English: How is Darunavir Mylan used?
Slovenian: Kako se zdravilo Darunavir Mylan uporablja?
English: How has Darunavir Mylan been studied?
Slovenian: Kako je bilo zdravilo Darunavir Mylan raziskano?
English: How does Darunavir Mylan work?
Slovenian: Kako zdravilo Darunavir Mylan deluje?
English: Adopted at the 10-13 May 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 10. in 13. majem 2016
English: • Severe diarrhoea
Slovenian: • hudo drisko
English: Tell your doctor straight away if you have any of the following side effects…:
Slovenian: Nemudoma obvestite svojega zdravnika, če opazite katerega od naslednjih neželenih učinkov:
English: Warfarin - Calciphylaxis (EPITT no 18545)
Slovenian: Varfarin - kalcifilaksija (EPITT št. 18545)
English: Serious cases of ARN, either affecting one or both eyes, led to blindness in some patients.
Slovenian: Resni primeri ARN, ki so prizadeli eno ali obe očesi, so pri nekaterih bolnikih povzročili slepoto.