FrancophonIA/ELRC3.0 huggingface dataset:
English: Median (months) (95% CI)
Danish: Mediantid til hændelser (måneder) 95% konfidensinterval
English: Atezolizumab (1,200 mg)a + nab-paclitaxel (100 mg/m2)b,c
Danish: A Atezolizumab (1.200 mg)a + nab-paclitaxel (100 mg/m2)b,c + carboplatin (AUC 6)c
English: Adrenal insufficiency occurred in 0.4% (12/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set binyrebarkinsufficiens hos 0,4% (12/3.178)) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: • 840 mg administered intravenously every two weeks, or
Danish: Anbefalet dosis af Tecentriq er: · 840 mg administreret intravenøst hver 2. uge, eller · 1680 mg administreret intravenøst hver 4. uge.
English: polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE) or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Træk 20 ml Tecentriq koncentrat fra hætteglasset, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 or grade 3 recurrent myositis, or when unable to reduce the corticosteroid dose to the equivalent of ≤ 10 mg prednisone per day within 12 weeks after onset.
Danish: recidiverende myositis, eller når det ikke er muligt at reducere kortikosteroiddosis til ≤10 mg/dag prednison eller ækvivalent produkt inden for 12 uger efter indtræden af hændelsen.
English: b etoposide (100 mg/m2)b,c atezolizumab (1,200 mg)
Danish: + etoposid (100 mg/m2)b,c
English: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles.
Danish: Førstelinjebehandling af ikke-planocellulært, ikke-småcellet lungekræft Tecentriq i kombination med bevacizumab, paclitaxel og carboplatin I induktionsfasen er den anbefalede dosis 1200 mg Tecentriq administreret som intravenøs infusion efterfulgt af bevacizumab, paclitaxel og derefter carboplatin hver 3. uge i fire eller seks serier.
English: Baseline ECOG performance status was 0 (58.4%)
Danish: Baseline ECOG-performance status var 0 (58,4%) eller 1 (41,3%).
English: No reproductive or teratogenicity studies in animals have been conducted with atezolizumab.
Danish: Der er ikke gennemført reproduktionsstudier eller teratogenicitetsstudier med dyr medatezolizumab.
English: 9.3, 40.0) in patients with PD-L1 expression ≥ 5%, 18.8% (95% CI: 10.9, 29.0) in patients with PD-L1 expression ≥ 1%, and 19.3% (95% CI: 12.7, 27.6) in all comers.
Danish: Den bekræftede objektive responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 21,9% (95% konfidensinterval: 9,3; 40,0) hos patienter med PD-L1-ekspression ≥5%, 18,8% (95% konfidensinterval: 10,9; 29,0) hos patienter med PD-L1-ekspression ≥1% og 19,3% (95% konfidensinterval: 12,7; 27,6) i alle grupper.
English: Figure 11: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Danish: Figur 11: Forest-plot over samlet overlevelse fordelt på PD-L1-ekspression i den primære analysepopulation (OAK)a a Statificeret hazardratio for ITT og TC eller IC≥1%.
English: Treatment may be resumed when serum amylase and lipase levels improve to Grade 0 or Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Danish: Behandlingen kan genoptages, når bivirkningen er forbedret til grad 0 eller grad 1 inden for 12 uger, eller symptomer på pancreatitis er forsvundet, og kortikosteroiddosis er reduceret til ≤10 mg prednison dagligt eller ækvivalent produkt.
English: Immune-related adverse reactions
Danish: Infusionsrelaterede reaktioner
English: MARKETING AUTHORISATION NUMBER(S)
Danish: Indehaver af markedsføringstilladelsen
English: corticosteroids should be tapered over ≥ 1 month.
Danish: ≤grad 1, skal kortikosteroidbehandlingen nedtrappes over ≥1 måned.
English: The median time to onset was 7 months (range: 18 days to
Danish: Mediantid til hændelsen var 7 måneder (interval: 18 dage til 8,1 måneder).
English: The median time to onset was 5.0 months (range: 9 days to
Danish: Mediantid til hændelse var 5,0 måneder (interval: 9 dage til 16,9 måneder).
English: Median time to events (months)
Danish: Medianvarighed af progressionsfri overlevelse (måneder)
English: 79639 Grenzach-Whylen
Danish: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Tyskland
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Danish: Behandling med atezolizumab kan genoptages hvis hændelsen er forbedret til ≤ grad 1 inden for 12 uger og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt.
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg oral prednisone or equivalent per day.
Danish: Behandling med atezolizumab kan genoptages hvis bivirkningen er forbedret til ≤ grad 1 inden for 12 uger og kortikosteroiddosis er reduceret til ≤10 mg/dag oral prednison eller ækvivalent produkt.
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Danish: Figur 3: Forest-plot over samlet overlevelse fordelt på PD-L1-ekspression i den primære analysepopulation (OAK)a a Statificeret hazardratio for ITT og TC eller IC≥1%.
English: CI = confidence interval; DOR = duration of response; NE = not estimable; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Danish: Median (måneder) (95% konfidenseinterval) 12,3 (6,0 ; NE) 14,1 (9,2 ; NE) 15,9 (10,4 ; NE) Samlet overlevelses-rate ved 1 år (%) IC=tumorinfiltrerende immunceller; NE=kan ikke estimeres; RECIST=Response Evaluation Criteria in Solid Tumours v1.1.
English: Meningoencephalitis occurred in 0.4% (13/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set meningoencefalitis hos 0,4% (13/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: 12-month OS (%)*** 18-month OS (%)***
Danish: 12-måneder progressionsfri overlevelse (%) Interimanalyse af samlet overlevelse*
English: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er i kliniske forsøg med atezolizumab observeret tilfælde af pneumonitis, også dødelige (se pkt.
English: Method of administration
Danish: Behandlings -regime
English: • numbness or paralysis, which may be signs of Guillain-Barré syndrome
Danish: · betændelse i bugspytkirtlen · følelsesløshed eller lammelse, som kan være tegn på Guillain Barré-syndrom · betændelse i hinden rundt om rygmarven og hjernen · lavt niveau af binyrebarkhormon · forhøjet funktion af skjoldbruskkirtlen (hyperthyrodisme) · type 1 diabetes · muskelbetændelse (myositis)
English: Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Danish: Behandlingen kan genoptages, når symptomerne er forbedret til grad 0 eller grad 1 inden for 12 uger og kortikosteroiddosis er reduceret til
English: The confirmed ORRs per IRF-RECIST v1.1 were 21.9% (95% CI:
Danish: Den bekræftede objektiv responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 28,0% (95% konfidensinterval: 19,5; 37,9) hos patienter med PD-L1
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Danish: Behandling med atezolizumab kan genoptages hvis bivirkningen er forbedret til ≤ Grad 1 inden for 12 uger, og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt.
English: No. of responders (%) 95% CI
Danish: Antal bekræftede respondere (%) 95% konfidensinterval
English: Tel: +49 (0) 7624 140
Danish: Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
English: • inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): symptoms may include neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness
Danish: · type 1 diabetes, inklusive syre i blodet på grund af diabetes (diabetisk ketoacidose): symptomer kan omfatte større sult og tørst end sædvanligt, øget vandladningstrang, vægttab og træthed · hjernebetændelse (encefalitis) eller betændelse i hinden rundt om rygmarven og hjernen (meningitis): symptomer kan omfatte nakkestivhed, hovedpine, feber, kulderystelser, opkastning, lysfølsomhed i øjnene, forvirring og søvnighed · nervebetændelse eller nerveproblemer (neuropati): symptomer kan omfatte muskelsvaghed ogfølelsesløshed, prikken og stikken i hænder og fødder · betændelse i bugspytkirtlen (pancreatitis): symptomer kan omfatte mavesmerter, kvalme og opkastning · Hjertemuskelbetændelse (myocarditis): symptomer kan omfatte stakåndethed, nedsat træningstolerance, træthedsfølelse, brystsmerter, hævelse af ankler eller ben, uregelmæssig hjerterytme og besvimelse · nyrebetændelse (nefritis); symptomer kan omfatte ændringer i urinmængden og farve, smerter i bækkenet og hævelse i kroppen og kan føre til nyresvigt.
English: For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC),
Danish: Til den anbefalede dosis på 1680 mg: Træk 28 ml Tecentriq koncentrat fra to Tecentriq 840 mg hætteglas, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
English: 12-month OS (%)
Danish: 12 måneders progressionsfri overlevelse (%) Andre endepunkter
English: How to store Tecentriq
Danish: Sådan skal du bruge Tecentriq
English: ORR (IRF-assessed; RECIST v1.1)
Danish: Objektiv responsrate (ved uafhængigt panel; RECIST v1.1)
English: Tecentriq monotherapy
Danish: Trombocytopenic
English: No. of responders (%) 95% CI No. of complete response (%) No. of partial response (%)
Danish: Antal responderende patienter (%) 95% konfidensinterval Anal fuldstændigt respons (%) Antal delvist respons (%) Investigatorvurderet varighed af respons* (RECIST v1.1)
English: f
Danish: m
English: For ≥ Grade 3 hyperglycaemia
Danish: Hypokaliæmi, hyponatriæmi, hyperglykæmi
English: DATE OF REVISION OF THE TEXT
Danish: Dosisændringer under behandling
English: Cases of hepatitis, some leading to fatal outcomes have been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er i kliniske forsøg med atezolizumab observeret tilfælde af hepatitis, nogle dødelige (se pkt.
English: Furthermore, it is important for you to know that:
Danish: Desuden er det vigtigt for dig at vide, at:
English: Therefore, its use in this age group is not relevant.
Danish: Dets brug er derfor ikke relevant til denne aldersgruppe.
English: No special considerations are needed.
Danish: Ingen særlige overvejelser.
English: Hypersensitivity***
Danish: Overfølsomhed***
English: These may be serious and require that you contact your doctor immediately.
Danish: Disse kan være alvorlige og kræve, at du kontakter lægen øjeblikkeligt.
English: Absorption / Distribution
Danish: Absorption/fordeling
English: It is important to have any symptoms diagnosed and treated as soon as possible.
Danish: Det er vigtigt, at få alle symptomer diagnosticeret og behandlet hurtigst muligt.
English: • Use of antibiotics according to national guidelines
Danish: • Anvendelse af antibiotika i henhold til nationale guidelines
English: Populations with limited data
Danish: Populationer med begrænsede data
English: The majority of patients in both studies had Type II diabetes.
Danish: Størstedelen af patienterne i begge studier havde type 2-diabetes.
English: Recurrences should be treated as a new manifestation of the disease.
Danish: Gentagne episoder skal behandles som nye manifestationer af sygdommen.
English: This benefit was maintained through week 100.
Danish: Denne fordel blev opretholdt til uge 100.
English: If required, sterile equipment for paracentesis should be available.
Danish: Om nødvendigt bør sterilt udstyr til paracentese være disponibelt.
English: The treatment interval is then extended to two months.
Danish: Behandlingsintervallet forlænges herefter til to måneder.
English: From this timepoint all patients were treated if prespecified criteria were met.
Danish: Fra dette tidspunkt fik alle patienter behandling, hvis de opfyldte de forudspecificerede kriterier.
English: A developmental NOAEL was not identified.
Danish: Der blev ikke identificeret noget NOAEL for udvikling.
English: Therefore, systemic pharmacodynamic effects such as blood pressure changes are unlikely.
Danish: Systemisk farmakodynamiske virkninger som f.eks. ændringer i blodtrykket er derfor usandsynlig.
English: These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies.
Danish: Disse alvorlige bivirkninger, der påvirker øjnene, forekom ved færre end 1 ud af 1.900 injektioner i kliniske studier.
English: The statistically significant difference was maintained through week 52.
Danish: Den statistisk signifikante forskel blev bevaret til uge 52.
English: 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)
Danish: 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)
English: The adverse reactions are listed by system organ class and frequency using the following convention:
Danish: Bivirkninger er anført efter systemorganklasse og frekvens med anvendelse af følgende konvention:
English: No studies have been conducted on the mutagenic or carcinogenic potential of aflibercept.
Danish: Der er ikke udført studier om aflibercepts mutagene eller karcinogene potentiale.
English: The following is a list of the side effects reported to be possibly related to the injection procedure or to the medicine.
Danish: Følgende er en liste over de bivirkninger, der er indberettet som værende muligvis relaterede til injektionsproceduren eller medicinen.
English: Among those, 2,501 patients were treated with the recommended dose of 2 mg.
Danish: Af disse blev 2.501 patienter behandlet med den anbefalede dosis på 2 mg.
English: Eylea is indicated for adults for the treatment of
Danish: Eylea er indiceret til voksne til behandling af
English: - diabetics with very high average blood sugar values (HbA1c over 12%).
Danish: - sukkersygepatienter med meget højt gennemsnitligt blodsukker (HbA1c over 12 %).
English: • The dose should be withheld within the previous or next 28 days in the event of a performed or planned intraocular surgery.
Danish: • Dosis skal seponeres inden for de foregående eller næste 28 dage ved udført eller planlagt intraoculær kirurgi.
English: F) Nominal p-value
Danish: F) Nominel p-værdi
English: As with other large proteins, both free and bound aflibercept are expected to be cleared by proteolytic catabolism.
Danish: På samme måde som andre store proteiner forventes det, at både frit og bundet aflibercept elimineres gennem proteolytisk katabolisme.
English: There is no requirement for monitoring between injections.
Danish: Der er intet krav til overvågning mellem injektionerne.
English: If you are pregnant or planning to become pregnant, discuss this with your doctor before treatment with Eylea.
Danish: Hvis du er gravid eller planlægger at blive gravid, skal du diskutere dette med din øjenlæge inden behandlingen med Eylea.
English: Make a new appointment for an examination and injection.
Danish: Aftal et nyt besøg for undersøgelse og injektion.
English: Following this, patients in both groups continued to be eligible for additional injections in case of disease persistence or recurrence.
Danish: Derefter var patienterne i begge grupper fortsat berettigede til yderligere injektioner i tilfælde af vedvarende sygdom eller sygdomstilbagefald.
English: - if you have a severe form of CRVO or BRVO (ischaemic CRVO or BRVO), treatment with Eylea is not recommended.
Danish: - Hvis du har en alvorlig form for CRVO eller BRVO (iskæmisk CRVO eller BRVO), anbefales behandling med Eylea ikke.
English: Such effects are not expected after ocular administration with very low systemic exposure.
Danish: Denne virkning forventes ikke efter okulær administration med meget lav systemisk eksponering.
English: There are no data on the use of aflibercept in pregnant women.
Danish: Der er ingen data fra anvendelse af aflibercept til gravide kvinder.
English: Proper aseptic injection techniques must always be used when administering Eylea.
Danish: Korrekte aseptiske injektionsteknikker skal altid anvendes ved administration af Eylea.
English: Caution should be exercised when treating such patients.
Danish: Der bør udvises forsigtighed, når sådanne patienter bliver behandlet.
English: Active severe intraocular inflammation.
Danish: Aktiv svær intraokulær inflammation.
English: Your doctor will monitor this after each injection.
Danish: Dette vil blive kontrolleret efter hver injektion.
English: It is unknown whether aflibercept is excreted in human milk.
Danish: Det er ukendt, om aflibercept udskilles i human mælk.
English: - diabetics with uncontrolled high blood pressure.
Danish: - sukkersygepatienter med ukontrolleret højt blodtryk.
English: Aflibercept does not accumulate in the plasma when administered intravitreally every 4 weeks.
Danish: Aflibercept akkumulerer ikke i plasmaet, når det administreres intravitrealt hver 4. uge.
English: There is limited experience in patients older than 75 years with DME.
Danish: Der er begrænset erfaring hos patienter over 75 år med DME.
English: Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
Danish: Inden for alle indikationer sås der ikke nogen væsentlig forskel mellem de grupper, der blev behandlet med aflibercept og de tilsvarende sammenligningsgrupper.
English: Allergic reactions (hypersensitivity) could potentially occur.
Danish: Der kan muligvis forekomme allergiske reaktioner (overfølsomhed).
English: At week 24 these proportions were 80% and 67%, respectively.
Danish: Ved uge 24 var disse andele henholdsvis 80 % og 67 %.
English: Prior to launch and during the product's lifecycle in each Member State the Marketing Authorisation Holder (MAH) will agree the final educational material with the National Competent Authority.
Danish: Før lancering og gennem produktets livscyklus vil indehaveren af markedsføringstilladelsen i hvert medlemsland aftale det endelige uddannelsesmateriale med den nationale kompetente myndighed.
English: - if surgery was performed or is planned on your eye within the previous or next four weeks.
Danish: - Hvis du er blevet opereret, eller der planlægges operation i dit øje i de sidste eller næste fire uger.
English: A positive value favours Eylea.
Danish: En positiv værdi bestyrker Eylea.
English: Patients should not drive or use machines until their visual function has recovered sufficiently.
Danish: Patienten bør ikke føre motorkøretøj eller betjene maskiner, før synsfunktionen er genvundet i tilstrækkelig grad.
English: Additionally, region (Europe/Australia vs. Japan) had been included as factor for VIVIDDME, and history of MI and/or CVA as a factor for VISTADME.
Danish: Desuden var region (Europa/Australien vs. Japan) blevet inkluderet som faktor for VIVIDDME, og tidligere MI og/eller CVA som en faktor for VISTADME.
English: Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity.
Danish: Den månedlige behandling fortsætter, til maksimal visus er opnået, og/eller der ikke er tegn på sygdomsaktivitet.
English: Patients with myopic CNV will be treated with one single injection.
Danish: Patienter med myopisk CNV vil blive behandlet med en enkelt injektion.
English: If a dose of Eylea is missed
Danish: Hvis en dosis af Eylea springes over
English: The physician information in the educational material contains the following key elements:
Danish: Informationen i uddannelsesmaterialet til lægen indeholder følgende nøgleelementer:
English: * Conditions known to be associated with wet AMD.
Danish: * Tilstande, der vides at være forbundet med våd AMD.
English: The safety and efficacy of Eylea have not been established in children and adolescents.
Danish: Sikkerhed og virkning ved Eylea er ikke klarlagt hos børn og unge.
English: Treatment intervals greater than four months between injections have not been studied (see Section
Danish: Behandlingsintervaller på længere end fire måneder mellem injektionerne er ikke blevet undersøgt (se pkt.
English: Differences for both endpoints were maintained through week 48.
Danish: Forskellene for begge endepunkter blev opretholdt til og med uge 48.
English: • Sterile techniques, including periocular and ocular disinfection to minimise the risk of infection
Danish: • Sterile teknikker, inklusive periokulær og okulær desinfektion til minimering af risiko for infektion
English: Over the 2 year treatment period patients received an average of 10.4 injections.
Danish: I løbet af den 2-årige behandlingsperiode modtog patienterne gennemsnitlig 10,4 injektioner.
English: Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Danish: Supplerende anvendelse af fotodynamisk terapi med verteporfin (PDT) og Eylea er ikke blevet undersøgt, og der er derfor ikke fastsat en sikkerhedsprofil.
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Danish: Desuden skal patienten overvåges i ugen efter injektionen for at kunne igangsætte tidlig behandling, hvis der opstår en infektion.
English: What Eylea contains - The active substance is: aflibercept.
Danish: Eylea indeholder: - Aktivt stof: aflibercept.
English: SD: Standard deviation
Danish: SD: Standardafvigelse
English: If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Danish: Hvis behandling foretages i begge øjne samtidigt, kan dette føre til øget systemisk eksponering, hvilket kunne øge risikoen for systemiske bivirkninger.
English: The patient information pack of the educational material includes a patient information booklet and an audio-CD that contain following key elements:
Danish: Patientinformationspakken af uddannelsesmaterialet indeholder patientinformationsfolder og en lydCD, som indeholder følgende nøgleelementer:
English: There is no experience in the treatment of - patients with acute infections.
Danish: Der er ingen erfaring ved behandling af - patienter med akutte infektioner.
English: Observed in the wet AMD studies only.
Danish: Kun observeret i studier af våd AMD.
English: Remove the filter needle and properly dispose of it.
Danish: Fjern filterkanylen og bortskaf den på korrekt vis.
English: Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.
Danish: Passende overvågning kan bestå af kontrol af perfusion af det optiske nervehoved eller tonometri.
English: Date of latest renewal: 13 July 2017
Danish: Dato for første markedsføringstilladelse: 22. november 2012 Dato for seneste fornyelse: 13. juli 2017
English: • Who should be treated with Eylea
Danish: • Hvem bør behandles med Eylea
English: - There is no experience of using Eylea in pregnant women.
Danish: - Der er ingen erfaring med at bruge Eylea til gravide kvinder.
English: • Confirmation that the vial is for single use only
Danish: • Bekræftelse af, at hætteglasset kun er til engangsbrug