FrancophonIA/ELRC3.0 huggingface dataset:
English: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (or any combination with hydrochlorothiazide) - anticholinergics (substances generally used to treat movement disorders or intestinal cramps) - anticonvulsants (substances used to prevent and relieve seizures) - barbiturates (substances generally used to induce sleep) - dopaminergic agonists (substances such as L-dopa, bromocriptine) - neuroleptics (substances used in the treatment of mental disorders) - oral anticoagulants
Danish: (vanddrivende medicin) - antikolinergika (stoffer, der generelt bruges til behandling af lidelser i bevægeapparatet eller tarmkramper) - antikonvulsiva (stoffer, der bruges til at forebygge og afhjælpe krampeanfald) - barbiturater (stoffer, der generelt bruges som sovemidler) - dopaminerge agonister (stoffer såsom L-dopa, bromocriptin) - neuroleptika (stoffer, der bruges til behandling af sindslidelser) - orale antikoagulantia (blodfortyndende medicin)
English: EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) EU/1/02/218/015 980 film-coated tablets (10 packs of 98) EU/1/02/218/030 840 film-coated tablets (20 packs of 42)
Danish: EU/1/02/218/010 1000 filmovertrukne tabletter (20 x 50) EU/1/02/218/015 980 filmovertrukne tabletter (10 x 98) EU/1/02/218/030 840 filmovertrukne tabletter (20 x 42)
English: Psychotic reactions
Danish: Psykiske forstyrrelser
English: Axura 5 mg/pump actuation, oral solution
Danish: Axura 5 mg/pumpetryk, oral opløsning
English: EU/1/02/218/012 14 film-coated tablets EU/1/02/218/007 28 film-coated tablets EU/1/02/218/001 30 film-coated tablets EU/1/02/218/013 42 film-coated tablets EU/1/02/218/002 50 film-coated tablets EU/1/02/218/008 56 film-coated tablets EU/1/02/218/014 98 film-coated tablets EU/1/02/218/003 100 film-coated tablets EU/1/02/218/009 112 film-coated tablets
Danish: EU/1/02/218/012 14 filmovertrukne tabletter EU/1/02/218/007 28 filmovertrukne tabletter EU/1/02/218/001 30 filmovertrukne tabletter EU/1/02/218/013 42 filmovertrukne tabletter EU/1/02/218/002 50 filmovertrukne tabletter EU/1/02/218/008 56 filmovertrukne tabletter EU/1/02/218/014 98 filmovertrukne tabletter EU/1/02/218/003 100 filmovertrukne tabletter EU/1/02/218/009 112 filmovertrukne tabletter
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatinin-clearance 30-49 ml/min) er daglig dosis 10 mg (1 ml opløsning, hvilket svarer til to tryk på pumpen).
English: Continue to take Axura as long as it is of benefit to you.
Danish: Bliv ved med at tage Axura, så længe De har gavn af det. Deres læge bør regelmæssigt vurdere Deres behandling.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Danish: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter
English: Do not pass it on to others.
Danish: Lad derfor være med at give Axura til andre.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Danish: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter Axura 20 mg filmovertrukne tabletter
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Danish: Hos patienter med svært nedsat nyrefunktion (kreatinin-clearance 5-29 ml/min) er daglig dosis 10 mg (1 ml opløsning, hvilket svarer til to tryk på pumpen).
English: What Axura looks like and contents of the pack
Danish: Axuras udseende og pakningsstørrelse
English: Axura 20 mg film-coated tablets Memantine hydrochloride
Danish: Axura 20 mg filmovertrukne tabletter Memantinhydrochlorid
English: Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Danish: Axura 5 mg, 10 mg, 15 mg, 20 mg filmovertrukne tabletter Memantinhydrochlorid
English: Axura 20 mg film-coated tablets
Danish: Axura 20 mg filmovertrukne tabletter
English: Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Danish: Axura 5 mg/pumpetryk, oral opløsning memantinhydrochlorid
English: Axura 10 mg film-coated tablets Memantine hydrochloride
Danish: Axura 10 mg filmovertrukne tabletter Memantinhydrochlorid
English: Axura 10 mg film-coated tablets Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: Axura 10 mg filmovertrukne tabletter Hver tablet indeholder 10 mg memantinhydrochlorid (svarende til 8,31 mg memantin).
English: Axura 15 mg 7 film-coated tablets.
Danish: Axura 15 mg 7 filmovertrukne tabletter.
English: Axura 20 mg film-coated tablets Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: Axura 20 mg filmovertrukne tabletter Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
English: Axura 10 mg film-coated tablets
Danish: Axura 10 mg filmovertrukne tabletter
English: Axura 5 mg 7 film-coated tablets.
Danish: Axura 5 mg 7 filmovertrukne tabletter.
English: Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Danish: 3. uge (dag 15-21): Patienten bør indtage én filmovertrukket 15 mg-tablet dagligt (grålig orange, oval-aflang) i 7 dage.
English: Axura 10 mg 7 film-coated tablets.
Danish: Axura 10 mg 7 filmovertrukne tabletter.
English: Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Danish: Axura 15 mg filmovertrukne tabletter er orange til gråligt orange, ovale-aflange tabletter præget med ”15” på den ene side og ”MEM” på den anden side.
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Danish: Axura 5 mg, filmovertrukne tabletter Axura 10 mg, filmovertrukne tabletter Axura 15 mg, filmovertrukne tabletter Axura 20 mg, filmovertrukne tabletter Memantinhydrochlorid
English: The dosing pump must only be used with the Axura solution in the bottle provided, not for other substances or containers.
Danish: De må ikke anvende doseringspumpen til andre væsker eller med andre beholdere.
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets
Danish: Axura 5 mg, filmovertrukne tabletter Axura 10 mg, filmovertrukne tabletter Axura 15 mg, filmovertrukne tabletter Axura 20 mg, filmovertrukne tabletter
English: What Axura is and what it is used for What you need to know before you take Axura How to take Axura
Danish: Det skal De vide, før De begynder at tage Axura Sådan skal De tage Axura Bivirkninger
English: Axura 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Danish: Axura 5 mg filmovertrukne tabletter er hvide til grålighvide, ovale-aflange tabletter præget med ”5” på den ene side og ”MEM” på den anden side.
English: Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Danish: Axura filmovertrukne tabletter er bleggule til gule, ovale, filmovertrukne tabletter med delekærv og præget ”1-0” på den ene side og ”M M” på den anden side.
English: The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Danish: Axura 20 mg filmovertrukne tabletter er svagt røde til gråligrøde, ovale-aflange tabletter præget med ”20” på den ene side og ”MEM” på den anden sidet.
English: The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Danish: De bleggule til gule filmovertrukne tabletter på 10 mg er ovale tabletter med delekærv og præget med ”1-0” på den ene side og ”M M” på den anden side.
English: If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Axura.
Danish: Kontakt lægen eller apoteketspersonalet, før De tager Axura.
English: Axura 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Danish: Axura 10 mg filmovertrukne tabletter er bleggule til gule, ovale tabletter med delekærv og præget ”1-0” på den ene side og ”M M” på den anden side.
English: The use of memantine in pregnant women is not recommended.
Danish: Axura bør normalt ikke bruges til gravide kvinder.
English: If you take more Axura than you should
Danish: Hvis De har taget for meget Axura
English: Tablet coating
Danish: Filmovertrukne tabletter
English: Sími.
Danish: poteket.
English: EMEA Number Invented Name Strength Pharmaceutical Form
Danish: EMEA nummer Særnavn
English: Packaging Content Package size Withdraw al period
Danish: Indhold Pakningsstørrelse
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje og indehavere af markedsføringstilladelser i medlemsstaterne
English: AstraZeneca A/S Arne Jacobsens Allé 13 2300 København S Denmark
Danish: AstraZeneca A/S Arne Jacobsens Allé 13 2300 København S Danmark
English: AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway
Danish: AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norge
English: AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble.
Danish: AstraZeneca Farmacéutica Spanien, S.A. Parque Norte.Edificio Roble.
English: Spain.
Danish: Spanien.
English: Palazzo Galileo, Via F. Sforza, 20080 Basiglio (MI), Italy
Danish: Palazzo Galileo, Via F. Sforza, 20080 Basiglio (MI), Italien
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi, Athens Greece
Danish: Grækenland AstraZeneca SA 4 Theotokopoulou & Astronafton str 151 25 Maroussi, Athens Greece
English: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom
Danish: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, Storbritannien
English: AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italy
Danish: Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italien
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgien
English: AstraZeneca AB, S-151 85 Södertälje Sweden
Danish: AstraZeneca AB, S-151 85 Södertälje Sverige
English: AstraZeneca AB, S-151 85 Södertälje, Sweden
Danish: AstraZeneca AB, S-151 85 Södertälje, Sverige
English: AstraZeneca Pharmaceuticals AB, S-151 85 Södertälje, Sweden
Danish: Bulgarien AstraZeneca Pharmaceuticals AB, S-151 85 Södertälje, Sverige
English: AstraZeneca UK Ltd 2 Kingdom Street London, W2 6BD, United Kingdom
Danish: AstraZeneca UK Ltd 2 Kingdom Street London, W2 6BD, Storbritannien
English: AstraZeneca UK Ltd. 2 Kingdom Street, London W2 6BD, United Kingdom
Danish: AstraZeneca UK Ltd. 2 Kingdom Street, London W2 6BD, Storbritannien
English: 4 days (including the day of administration)
Danish: 4 dage (inklusive dagen for administration)
English: Control, N = 10
Danish: Kontrol, N = 10
English: Followed by 5 days
Danish: Efterfulgt af 5 dage
English: Study 301 was an open-label, randomised, controlled study.
Danish: Studie 301 var et åbent, randomiseret, kontrolleret studie.
English: Phase 3 study
Danish: Fase 3-studie
English: It is important that you take this medicine according to the instructions given.
Danish: Det er vigtigt, at du tager denne medicin efter anvisningerne.
English: Do not stop taking the medicine without first talking to your doctor.
Danish: Hold ikke op med at tage denne medicin uden først at tale med lægen.
English: System organ class / Frequency
Danish: Systemorganklasse / hyppighed
English: Vertical dotted lines represent additional 25% above and below the box.
Danish: Lodrette stiplede linjer repræsenterer yderligere 25 % over og under kassen.
English: The effects of this medicine on pregnancy and the unborn child are not known.
Danish: Virkningen af dette lægemiddel på graviditet og det ufødte barn er ukendt.
English: The virus used to deliver the gene does not cause disease in humans.
Danish: Den virus, der anvendes til at indføre genet, medfører ikke sygdom hos mennesker.
English: Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Danish: Din læge kan måske gøre noget for at reducere eventuelt ubehag, der er forårsaget af disse midlertidige forstyrrelser.
English: Table 1 Pre- and post-operative immunomodulatory regimen for each eye
Danish: Tabel 1 Præ- og post-operativt immunmodulerende regime for hvert øje
English: Followed by 5 days of one dose every other day
Danish: Efterfulgt af 5 dage med én dosis hver anden dag
English: There are no known clinically significant interactions.
Danish: Der er ingen kendte klinisk signifikante interaktioner.
English: 30 June 2030
Danish: 30. juni 2030
English: Criteria for Study sites/treatment centres should include:
Danish: Kriterier for studiecentre/behandlingscentre bør inkludere:
English: 31 subjects were enrolled, 13 males and 18 females.
Danish: 31 forsøgsdeltagere blev inkluderet: 13 mænd og 18 kvinder.
English: Your doctor will talk to you about the anaesthesia and how it will be given to you.
Danish: Din læge vil tale med dig om bedøvelsen, og hvordan den gives.
English: Accidental exposure must be avoided.
Danish: Utilsigtet eksponering skal undgås.
English: This medicine contains genetically modified organisms.
Danish: Dette lægemiddel indeholder genmodificerede organismer.
English: This will be repeated on your other eye at least 6 days afterwards.
Danish: Dette vil blive gentaget for dit andet øje efter et mellemrum på mindst 6 dage.
English: Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Danish: Din læge vil muligvis udsætte behandlingen, indtil infektionen har fortaget sig, da dette lægemiddel kan gøre det sværere for dig at bekæmpe en infektion.
English: Each box represents the middle 50% of distribution of MLMT score change.
Danish: De enkelte kasser repræsenterer de midterste 50 % af fordelingen af ændring i MLMT-score.
English: As a precaution, you should not receive Luxturna while you are pregnant.
Danish: For en sikkerheds skyld bør du ikke få Luxturna, mens du er gravid.
English: The interval between injection to the eyes for each subject was from 6 to 18 days.
Danish: Intervallet mellem injektion i øjnene for de enkelte forsøgsdeltagere var mellem 6 og 18 dage.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af voretigen neparvovec til gravide kvinder.
English: • Change of the electrical activity of the heart
Danish: • Ændring i hjertets elektriske aktivitet
English: 3 days prior to Luxturna administration
Danish: 3 dage før administration af Luxturna
English: It is unknown whether voretigene neparvovec is excreted in human milk.
Danish: Det er ukendt, om voretigen neparvovec udskilles i human mælk.
English: Table 5 Full-field light sensitivity testing
Danish: Tabel 5 Test af fuldfeltslysfølsomhed
English: Spark Therapeutics Inc. 3737 Market Street, Suite 1300 Philadelphia
Danish: Spark Therapeutics Inc. 3737 Market Street, Suite 1300 Philaldelphia
English: The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Danish: Gennemsnitsalderen var 15 år (interval 4 til 44 år), inklusive 64 % pædiatriske patienter (n = 20, i alderen fra 4 til 17 år) og 36 % voksne (n = 11).
English: The testing of each subject was videotaped and assessed by independent graders.
Danish: De enkelte forsøgsdeltageres test blev optaget på video og vurderet af uafhængige bedømmere.
English: Tell your doctor about any visual disturbances that you experience.
Danish: Fortæl lægen om alle synsforstyrrelser, du oplever.
English: Voretigene neparvovec has minor influence on the ability to drive and use machines.
Danish: Voretigen neparvovec påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Information on how to obtain the special formats will be provided in the patient card.
Danish: Information om, hvordan de alternative formater tilgås, vil være angivet på patientkortet.
English: Improvement in full-field light sensitivity was maintained for up to 3 years after exposure to voretigene neparvovec.
Danish: Forbedringen i fuldfeltslysfølsomhed blev opretholdt i op til 3 år efter eksponering for voretigen neparvovec.
English: 10 subjects were randomised to the control (non-intervention) group.
Danish: 10 forsøgsdeltagere blev randomiseret til kontrolgruppen (uden intervention).
English: Precaution to be taken before manipulating or administering the medicinal product This medicinal product contains genetically modified organisms.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering eller administration af lægemidlet Dette lægemiddel indeholder genmodificerede organismer.
English: One subject in the control group withdrew consent and was discontinued from the study.
Danish: Én forsøgsdeltager i kontrolgruppen trak sit samtykke tilbage og blev ekskluderet fra studiet.
English: Talk to your doctor before resuming these activities.
Danish: Tal med lægen, inden du genoptager disse aktiviteter.
English: You will not be given Luxturna if you are allergic to voretigene neparvovec or any of the other ingredients of this medicine (listed in section 6) if you have an eye infection if you have eye inflammation
Danish: Du vil ikke få Luxturna hvis du er allergisk over for voretigen neparvovec eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) hvis du har en øjeninfektion hvis du har øjenbetændelse
English: This medicinal product must not be administered by intravitreal injection.
Danish: Dette lægemiddel må ikke administreres ved intravitreal injektion.
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common ≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed med følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
Danish: I fase 3-studiet anvendte MLMT syv niveauer af belysning i intervallet 400 lux til 1 lux (svarende til for eksempel et godt oplyst kontor ned til en måneløs sommernat).
English: Patients and their caregivers should be provided with the patient information pack, including:
Danish: Patienter og deres omsorgspersoner bør modtage patientinformationspakken indeholdende:
English: Change in MLMT score
Danish: Ændringer i MLMT-score
English: Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Danish: Resultaterne af testen af fuldfeltslysfølsomhed efter første studieår: hvidt lys [Log10(cd.s/m2)] er vist i tabel 5 nedenfor.
English: Patients treated with Luxturna should not donate blood, organs, tissues and cells for transplantation.
Danish: Patienter, der er blevet behandlet med Luxturna, må ikke donere blod, organer, væv og celler til transplantation.
English: Damage to the tissues of the eye may be accompanied by bleeding and swelling and an increased risk of infection.
Danish: Beskadigelse af vævet i øjet kan være ledsaget af blødning og hævelser samt øget risiko for infektion.
English: • Tell your doctor if you have an active infection of any sort.
Danish: • Fortæl det til lægen, hvis du har en aktiv infektion uanset type.
English: This is because Luxturna is a gene therapy product.
Danish: Det er fordi Luxturna er et genterapiprodukt.
English: During treatment with this medicine, the doctor inserts an air bubble in the eye, which is slowly absorbed by your body.
Danish: Under behandlingen med dette lægemiddel indfører lægen en luftboble i øjet, som langsomt optages af kroppen.
English: The following side effects may happen with the injection procedure:
Danish: Følgende bivirkninger kan forekomme med indsprøjtningsproceduren:
English: Children and adolescents Luxturna has not been studied in children under four years of age.
Danish: Børn og unge Luxturna er ikke undersøgt hos børn i alderen under fire år.
English: Warnings and precautions Before receiving treatment with Luxturna:
Danish: Advarsler og forsigtighedsregler Inden du får behandling med Luxturna:
English: These mutations prevent the body from producing a protein needed for vision and so lead to loss of sight and eventual blindness.
Danish: Disse mutationer forhindrer kroppen i at danne et protein, der er nødvendigt for synet, og derfor opstår synstab og i sidste ende blindhed.
English: A total of 41 subjects (81 eyes injected [one Phase 1 subject did not meet eligibility criteria for a second injection]) participated in the clinical programme.
Danish: I alt 41 forsøgsdeltagere (81 injicerede øjne [én fase 1-forsøgsdeltager opfyldte ikke inklusionskriterierne for en sekundær injektion]) deltog i det kliniske program.
English: One subject discontinued from the study prior to treatment.
Danish: Én forsøgsdeltager udgik af studiet inden behandlingen.
English: The back-up syringe may not be retained.
Danish: Reservesprøjten må ikke beholdes.
English: • You will not be able to donate blood, organs, tissues and cells for transplantation after you have been treated with Luxturna.
Danish: • Du må ikke donere blod, organer, væv og celler til transplantation, når du er blevet behandlet med Luxturna.
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity.
Danish: Det må ikke administreres i umiddelbar nærhed af fovea for at opretholde foveal integritet.
English: If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before being treated with Luxturna.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sygeplejerske til råds, før du får behandling med Luxturna.
English: All participants had a clinical diagnosis of Leber congenital amaurosis, and some may have also had prior or additional clinical diagnoses, including retinitis pigmentosa.
Danish: Alle deltagere havde den kliniske diagnose Lebers kongenitte amaurose, og nogle kan også have haft tidligere eller yderligere kliniske diagnoser, herunder retinitis pigmentosa.
English: Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
Danish: Alvorlige bivirkninger relateret til administrationsproceduren blev rapporteret for tre forsøgsdeltagere i det kliniske program.
English: Any exposed wounds should be covered before handling.
Danish: Eventuelle blotlagte sår skal tildækkes inden håndtering.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Danish: Symptomatisk og understøttende behandling efter den behandlende læges skøn anbefales i tilfælde af overdosering.
English: Solvent for Luxturna
Danish: Solvens til Luxturna