FrancophonIA/ELRC3.0 huggingface dataset:
English: When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Danish: Når Lyxumia blev givet sammen med et sulfonylurinstof og basalinsulin, forekom der symptomatisk hypoglykæmi hos 47,2 % af de lixisenatidbehandlede patienter sammenlignet med 21,6 % ved placebo (25,6 % absolut forskel).
English: What you need to know before you use Lyxumia
Danish: Det skal du vide, før du begynder at tage Lyxumia Tag ikke Lyxumia
English: Frequency of occurrence
Danish: Hyppighed af bivirkning
English: Rubber seal
Danish: Ydre nålehylster
English: Each pre-filled pen contains 14 doses, each dose contains 10 micrograms in 0.2 ml.
Danish: Hver fyldt pen indeholder 14 doser; hver dosis indeholder 10 mikrogram i 0,2 ml.
English: Mean HbA1c (%) Baseline
Danish: Gennemsnitlig HbA1c (%)
English: Pack size of 1 pre-filled pen.
Danish: Pakningsstørrelse på 1 fyldt pen.
English: Lixisenatide 20 mcg (N= 154)
Danish: Lixisenatid 20 µg (N= 154)
English: Step 3 Pull the injection button out
Danish: Trin 3 Træk injektionsknappen ud
English: Lixisenatide 20 mcg (N= 327)
Danish: Lixisenatid 20 µg (N= 327)
English: EU/1/12/811/003 - 2 pens
Danish: EU/1/12/811/005 - 2 penne
English: Each pre-filled pen contains 14 doses, each dose contains 20 micrograms in 0.2 ml.
Danish: Hver fyldt pen indeholder 14 doser; hver dosis indeholder 20 mikrogram i 0,2 ml.
English: 1 pre-filled pen of 3 ml (14 doses)
Danish: 3 ml (14 doser)
English: Lixisenatide 20 mcg (N= 570)
Danish: Lixisenatid 20 µg (N= 570)
English: • The green pen contains 14 pre-set doses; each dose contains 10 micrograms of Lyxumia.
Danish: • Den grønne pen indeholder 14 forudindstillede doser; hver dosis indeholder 10 mikrogram
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.
Danish: Behandlingsopstartspakningen indeholder en grøn pen af Lyxumia 10 mikrogram injektionsvæske, opløsning, og en lilla pen af Lyxumia 20 mikrogram injektionsvæske, opløsning.
English: You must start your treatment with the green 10 micrograms Lyxumia pen.
Danish: Du skal starte din behandling med den grønne 10 mikrogram Lyxumia-pen.
English: Contact your doctor, pharmacist or nurse for help.
Danish: Kontakt din læge, apotekspersonalet eller sundhedspersonalet for at få hjælp.
English: Use is not recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Danish: Brug kan ikke anbefales til patienter med svært nedsat nyrefunktion eller terminal nyresygdom (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 (1 pre-filled pen + 1 pre-filled pen)
Danish: EU/1/12/811/005 (1 fyldt pen + 1 fyldt pen)
English: Contact your doctor, pharmacist or nurse.
Danish: Kontakt din læge, apotekspersonalet eller sundhedspersonalet.
English: One green 10 microgram pen (Lyxumia 10 micrograms solution for injection), each dose contains 10 micrograms in 0.2 ml.
Danish: En grøn 10 mikrogram pen (Lyxumia 10 microgram injektionsvæske, opløsning), hver dosis indeholder 10 mikrogram i 0,2 ml.
English: Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly.
Danish: Lyxumia skal injiceres subkutant i låret, abdomen eller overarmen.
English: Step C. Pull the injection button out
Danish: Trin C Træk injektionsknappen ud
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.
Danish: Din læge kan reducere din dosis af disse lægemidler, før du begynder at tage Lyxumia.
English: Guide the needle into the outer needle cap.
Danish: Før nålen ind i det ydre nålehylster.
English: Click secs
Danish: Klik sek
English: Front
Danish: Foran
English: Pen ready for injections (white window)
Danish: Pen klar til injektion
English: During the entire treatment period, when Lyxumia was given with a sulphonylurea alone, symptomatic hypoglycaemia occurred in 22.7% of lixisenatide treated patients versus 15.2% with placebo (7.5% absolute difference).
Danish: Når Lyxumia blev givet i kombination med et sulfonylurinstof alene, forekom der symptomatisk hypoglykæmi hos 22,7 % af de lixisenatidbehandlede patienter versus 15,2 % ved placebo (7,5 % absolut forskel) under hele behandlingsperioden.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl så spørg lægen eller apotekspersonalet.
English: • Replace the pen cap after each use in order to protect from light.
Danish: • Sæt hætten på pennen efter brug for at beskytte produktet mod lys.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 or 20 micrograms lixisenatide.
Danish: Hver dosis (0,2 ml) indeholder 10 eller 20 mikrogram lixisenatid.
English: One purple 20 microgram pen (Lyxumia 20 micrograms solution for injection), each dose contains 20 micrograms in 0.2 ml.
Danish: En lilla 20 mikrogram pen (Lyxumia 20 microgram injektionsvæske, opløsning), hver dosis indeholder 20 mikrogram i 0,2 ml.
English: For the maintenance dose Lyxumia 20 micrograms solution for injection is available.
Danish: Lyxumia 20 mikrogram injektionsvæske er tilgængelig som vedligeholdelsesdosis.
English: Injection button
Danish: Injektionsknap
English: Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 10 micrograms.
Danish: En grøn pen af Lyxumia 10 microgram injektionsvæske, opløsning indeholder 3 ml opløsning, der giver 14 doser af 10 mikrogram.
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.
Danish: Pakning indeholdende 1 grøn, fyldt Lyxumia-pen 10 mikrogram injektionsvæske, opløsning og 1 lilla, fyldt Lyxumia-pen 20 mikrogram injektionsvæske, opløsning.
English: For the starting dose Lyxumia 10 micrograms solution for injection is available.
Danish: Lyxumia 10 mikrogram injektionsvæske er tilgængelig som startdosis.
English: How to use Lyxumia Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • Beta cell function
Danish: • Betacelle-funktion
English: • The purple pen contains 14 pre-set doses; each dose contains 20 micrograms of Lyxumia.
Danish: • Den lilla pen indeholder 14 forudindstillede doser; hver dosis indeholder 20 mikrogram
English: - Lyxumia 20 micrograms solution for injection: Each dose contains 20 micrograms of lixisenatide (100 micrograms per ml).
Danish: - Lyxumia 20 microgram injektionsvæske, opløsning: Hver dosis indeholder 20 mikrogram lixisenatid (100 mikrogram per ml).
English: • Keep your Lyxumia pens in a safe place out of the reach and sight of children.
Danish: • Opbevar dine Lyxumia-penne sikkert og utilgængeligt for børn.
English: Mean body weight (kg) Baseline
Danish: Gennemsnitlig legemsvægt (kg)
English: How to use Lyxumia
Danish: Sådan skal du tage Lyxumia
English: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg.
Danish: Hver enkelt grøn, fyldt pen indeholder 3 ml injektionsvæske, og doserer 14 doser af 10 µg.
English: Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 20 micrograms.
Danish: En lilla pen af Lyxumia 20 microgram injektionsvæske, opløsning indeholder 3 ml opløsning, der giver 14 doser af 20 mikrogram.
English: Preferably inject Lyxumia before the same meal every day, when you have chosen the most convenient meal for your injection.
Danish: Når du har valgt det måltid, der passer bedst til din injektion, er det bedst at injicere Lyxumia før det samme måltid hver dag.
English: - Lyxumia 10 micrograms solution for injection: Each dose contains 10 micrograms of lixisenatide (50 micrograms per ml).
Danish: - Lyxumia 10 microgram injektionsvæske, opløsning: Hver dosis indeholder 10 mikrogram lixisenatid (50 mikrogram per ml).
English: • Activate the pen on the same day as your first injection
Danish: Afsnit 2 - KOM GODT I GANG Aktiver pennen samme dag som du får din første injektion Aktiver først din nye pen
English: Pen cap
Danish: Ny pen
English: Mean body weight
Danish: Gennemsnitlig legemsvægt
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 micrograms lixisenatide (50 micrograms per ml).
Danish: Hver dosis (0,2 ml) indeholder 10 mikrogram lixisenatid (50 mikrogram pr. ml).
English: Lyxumia 20 micrograms solution for injection Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml).
Danish: Lyxumia 20 mikrogram injektionsvæske, opløsning Hver dosis (0,2 ml) indeholder 20 mikrogram (µg) lixisenatid (100 µg per ml).
English: Read the Instructions for Use carefully before using your Lyxumia pen.
Danish: Afsnit 1 - VIGTIGE OPLYSNINGER Læs omhyggeligt denne vejledning, før du bruger din Lyxumia-pen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 20 micrograms lixisenatide (100 micrograms per ml).
Danish: Hver dosis (0,2 ml) indeholder 20 mikrogram lixisenatid (100 mikrogram pr. ml).
English: INSTRUCTIONS FOR USE
Danish: BRUGSANVISNING
English: Lyxumia 20 micrograms solution for injection Lixisenatide
Danish: Lyxumia 20 mikrog injektion Lixisenatid
English: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg.
Danish: Hver enkelt lilla, fyldt pen indeholder 3 ml injektionsvæske, og doserer 14 doser af 20 µg.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonaletet eller sundhedsspersonalet, hvis der er noget, du er i tvivl om.
English: If you use more Lyxumia than you should
Danish: Hvis du har taget for meget Lyxumia
English: Methionine
Danish: Baseline
English: - you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lyxumia, hvis: - du har type 1-diabetes eller ”diabetisk ketoacidose” (en komplikation ved diabetes der sker, når kroppen ikke kan nedbryde glucose på grund af for lidt insulin), idet denne medicin i så fald ikke er velegnet for dig - du har eller har haft betændelse i bugspytkirtlen (pancreatitis) - du har et alvorligt mave- eller tarmproblem, såsom en sygdom i mavens muskler kaldet ”gastroparese”, som resulterer i forsinket mavetømning - du har en alvorlig nyresygdom eller du er i dialyse, idet brugen af denne medicin i så fald ikke anbefales
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 ml (14 doses)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection lixisenatide
Danish: Lyxumia 10 mikrogram injektionsvæske, opløsning Lyxumia 20 mikrogram injektionsvæske, opløsning lixisenatid
English: Click
Danish: sek klik
English: Add-on combination therapy with a basal insulin
Danish: Tillægsbehandling til basalinsulin
English: Each dose contains 540 micrograms of metacresol.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver dosis indeholder 540 mikrogram metacresol.
English: Lyxumia 10 micrograms solution for injection
Danish: Lyxumia 10 mikrog injektion Lixisenatid
English: Lyxumia should not be used during breast-feeding.
Danish: Lyxumia må ikke anvendes under amning.
English: Cystitis
Danish: Dosering
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lyxumia 10 micrograms solution for injection Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).
Danish: Lyxumia 10 mikrogram injektionsvæske, opløsning Hver dosis (0,2 ml) indeholder 10 mikrogram (µg (mikrog)) lixisenatid (50 µg per ml).
English: Questions and answers
Danish: Advarsler og forsigtighedsregler
English: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use lixisenatide in these populations (see section 5.2).
Danish: eller terminal nyresygdom, og derfor anbefales det ikke at anvende lixisenatid til disse populationer (se pkt.
English: Pen needles are not included.
Danish: Pennåle medfølger ikke.
English: Black plunger
Danish: Sort stempel
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 1530 ml/min) AUC was increased by 46%, 51% and 87%, respectively.
Danish: Hos forsøgspersoner med let (kreatinin-clearance beregnet efter Cockcroft-Gault formlen 60-90 mL/min.
English: Needle Protective seal
Danish: Mave-tarm-kanalen
English: • Cystitis
Danish: • Rygsmerter
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
Danish: Tabel 4: Placebokontrollerede studier i kombination med basalinsulin (24-ugers resultater)
English: NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection Lixisenatide
Danish: Lyxumia 10 mikrogram injektionsvæske, opløsning Lyxumia 20 mikrogram injektionsvæske, opløsning Lixisenatid
English: Put the outer needle cap back on.
Danish: Sæt det ydre nålehylster fast igen.
English: INFORMATION IN BRAILLE Lyxumia 10
Danish: Lyxumia 10
English: After first use
Danish: Efter anbrud
English: Lyxumia 20 micrograms solution for injection
Danish: Lyxumia 20 mikrogram injektionsvæske, opløsning
English: INFORMATION IN BRAILLE Lyxumia 20
Danish: Lyxumia 20
English: Section 3 - DAILY USE OF PEN
Danish: Andre vigtige oplysninger om brug af fyldte penne
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/001 - 1 pen
Danish: EU/1/12/811/001 - 1 pen
English: • Feeling dizzy
Danish: • Følelse af svimmelhed
English: Posology
Danish: Kasser
English: NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection
Danish: Lyxumia 10 mikrogram injektionsvæske, opløsning Lyxumia 20 mikrogram injektionsvæske, opløsning
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.
Danish: Den fuldstændige EPAR for Darunavir Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg).
Danish: Darunavir Mylan fås som tabletter (75 mg, 150 mg, 300 mg, 400 mg, 600 mg og 800 mg).
English: Darunavir Mylan may be given to adults or children from 3 years of age and weighing at least 15 kg.
Danish: Darunavir Mylan kan gives til voksne eller børn på tre år og derover, som vejer mindst 15 kg.
English: Therefore, the CHMP's view was that, as for Prezista, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Prezista.
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.
Danish: Tidligere behandlede patienter kan også tage en dosis på 800 mg en gang dagligt, forudsat at deres hivinfektion er velkontrolleret og sandsynligvis ikke er resistent over for darunavir.
English: As for every medicine, the company provided studies on the quality of Darunavir Mylan.
Danish: Som for alle lægemidler, fremlagde virksomheden undersøgelser af kvaliteten af Darunavir Mylan.
English: This is a summary of the European public assessment report (EPAR) for Darunavir Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for 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.
Danish: Det betyder, at Darunavir Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Prezista.
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.
Danish: Lægemidlet tages altid med enten cobicistat (hos voksne) eller lavdosis ritonavir (hos voksne og børn) og andre hivlægemidler og bør tages sammen med mad.
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.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Darunavir Mylan er af sammenlignelig kvalitet og er bioækvivalent med Prezista.
English: The Committee recommended that Darunavir Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Darunavir Mylan godkendes til anvendelse i EU.
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.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Prezista, og det er ikke nødvendigt at gentage disse med Darunavir Mylan.
English: Ritonavir and cobicistat reduce the breakdown of darunavir, increasing the levels of darunavir in the blood.
Danish: Ritonavir og cobicistat nedsætter nedbrydningen af darunavir og øger dermed koncentrationen af darunavir i blodet.
English: What measures are being taken to ensure the safe and effective use of Darunavir Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Darunavir Mylan?
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.
Danish: Darunavir Mylan kurerer ikke hivinfektion eller aids, men hivbehandling kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: It is given with low-dose ritonavir or, in adults, with cobicistat.
Danish: Det gives sammen med lavdosis ritonavir eller, hos voksne, sammen med cobicistat.
English: Darunavir Mylan is always given with ritonavir or cobicistat.
Danish: Darunavir Mylan gives altid med ritonavir eller cobicistat.
English: For more information about treatment with Darunavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Darunavir Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Darunavir Mylan is a ‘generic medicine'.
Danish: Darunavir Mylan er et "generisk lægemiddel".
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.
Danish: Når Darunavir Mylan tages i kombination med andre hivlægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
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.
Danish: Da Darunavir Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What is Darunavir Mylan and what is it used for?
Danish: Hvad er Darunavir Mylan, og hvad anvendes det til?
English: Other information about Darunavir Mylan
Danish: Andre oplysninger om Darunavir Mylan
English: The active substance in Darunavir Mylan, darunavir, is a protease inhibitor.
Danish: Det aktive stof i Darunavir Mylan, darunavir, er en proteasehæmmer.
English: What are the benefits and risks of Darunavir Mylan?
Danish: Hvilken fordel og risiko er der forbundet med Darunavir Mylan?
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.
Danish: Darunavir Mylan udleveres kun efter recept, og behandlingen bør iværksættes af en sundhedsperson med erfaring i behandling af hivinfektion.
English: It is not intended to provide practical advice on how to use Darunavir Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Darunavir Mylan bør anvendes.
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.
Danish: Til børn på mellem tre og 17 år, som vejer mindst 15 kg, og som ikke tidligere er blevet behandlet, varierer den anbefalede dosis fra 600 mg til 800 mg en gang dagligt, afhængigt af deres vægt.
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).
Danish: Darunavir Mylan er et antiviralt lægemiddel, der anvendes sammen med andre hivlægemidler til behandling af patienter med hiv-1 (humant immundefektvirus type 1).
English: For previously treated children the usually recommended dose varies between 375 and 600 mg twice a day depending on their weight.
Danish: Til tidligere behandlede børn varierer den normale anbefalede dosis fra 375 mg til 600 mg to gange dagligt, afhængigt af deres vægt.
English: For practical information about using Darunavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Darunavir Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Darunavir Mylan approved?
Danish: Hvorfor blev Darunavir Mylan godkendt?
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.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Darunavir Mylan.
English: How has Darunavir Mylan been studied?
Danish: Hvordan blev Darunavir Mylan undersøgt?
English: How is Darunavir Mylan used?
Danish: Hvordan anvendes Darunavir Mylan?
English: How does Darunavir Mylan work?
Danish: Hvordan virker Darunavir Mylan?
English: Adopted at the 10-13 May 2016 PRAC
Danish: Vedtaget på PRAC's møde 10.-13. maj 2016
English: Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including:
Danish: Tal omgående med din læge eller sygeplejerske, hvis du bemærker nogen af følgende Symptomer på alvorlige infektioner, herunder:
English: • An unexplained fever
Danish: • Feber af ukendt årsag
English: Serious cases of ARN, either affecting one or both eyes, led to blindness in some patients.
Danish: Alvorlige tilfælde af ARN i ét eller begge øjne medførte blindhed hos nogle patienter.
English: • Severe diarrhoea
Danish: • Voldsom diarré
English: Warfarin - Calciphylaxis (EPITT no 18545)
Danish: Warfarin - Kalcifylaksi (EPITT nr. 18545)