FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Samtidig administration af carbamazepin, en potent CYP3A-inducer, kan reducere plasmakoncentrationerne af cobicistat og elvitegravir signifikant, hvilket kan medføre manglende terapeutisk virkning og resistensudvikling.
English: • and you notice within 18 hours of the time you usually take Stribild, you must take the tablet as soon as possible.
Danish: • og De kommer i tanker om det inden for 18 timer efter det tidspunkt, De normalt tager
English: Percentage of subjects with CD4+ cell counts ≤ 200 cells/mm3
Danish: Gennemsnitlig CD4+ celletal ved baseline (interval), x 106 celler/l Procentdel af personer med CD4+ celletal ≤ 200 celler/mm3
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Danish: Ved overdosering, skal patienten monitoreres for tegn på toksicitet (se pkt.
English: Patients who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety.
Danish: Patienter, der oplever en bekræftet forhøjelse i serum-kreatinin på over 26,5 µmol/l (0,3 mg/dl) fra baseline, bør overvåges tæt for renale bivirkninger.
English: 4 See section 4.8, Description of selected adverse reactions for more details.
Danish: Beskrivelse af udvalgte bivirkninger for flere detaljer.
English: Norgestimate: AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
Danish: AUC: ↑ 126 % Cmin: ↑ 167 % Cmax: ↑ 108 %
English: ANTIARRHYTHMICS Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Danish: Digoxin (0,5 mg enkeltdosis)/Cobicistat (150 mg flerdosis)
English: Atorvastatin (10 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)
Danish: Atorvastatin (10 mg enkeltdosis)/ Elvitegravir (150 mg én gang daglig)/ Cobicistat (150 mg én gang daglig)/ Emtricitabin (200 mg én gang daglig)/ Tenofoviralafenamid (10 mg én gang daglig)
English: (may affect at least 1 in every 10 patients treated)
Danish: (kan opstå hos mindst 1 ud af 10 behandlede patienter)
English: Recommendation concerning co-administration with Stribild
Danish: samtidig administration af Stribild
English: Mean baseline plasma HIV-1 RNA (range) log10 copies/mL Percentage of subjects with viral load > 100,000 copies/mL Mean baseline CD4+ cell count (range), x 106 cells/L
Danish: Gennemsnitlig plasma hiv 1-rna ved baseline (interval) log10 kopier/ml Procentdel af personer med viral load > 100.000 kopier/ml
English: (may affect up to 1 in every 1,000 patients treated)
Danish: (kan opstå hos op til 1 ud af 1.000 behandlede patienter)
English: Clinical monitoring should be made upon co-administration with Stribild.
Danish: Der skal udføres klinisk overvågning ved samtidig administration med Stribild.
English: That Stribild is not recommended for use in adolescent patients with renal impairment.
Danish: 10. At det frarådes at anvende Stribild hos unge patienter med nedsat nyrefunktion.
English: Monitoring of renal function is recommended for patients receiving Stribild (see section 4.4).
Danish: Nyrefunktionen bør monitoreres hos patienter, som får Stribild (se pkt.
English: Ketoconazole (200 mg twice daily)/Elvitegravir (150 mg once daily)2
Danish: Ketoconazol (200 mg to gange daglig)/Elvitegravir (150 mg én gang daglig)2
English: How to take Stribild
Danish: Sådan skal De tage Stribild
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Danish: De gennemsnitlige forandringer ved uge 48 (afslutningen af den randomiserede fase) i gruppen, der fik tenofovirdisoproxil, og i gruppen, der fik enten stavudin eller zidovudin, var hhv. 0,032 og 0,087 i BMD Z-scoren for columna lumbalis og -0,184 og -0,027 i BMD Z-scoren for hele kroppen.
English: The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Danish: Aktive stoffer: elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil.
English: The safety and efficacy of Stribild in children under the age of 12 years have not been established (see section 4.2 for information on paediatric use).
Danish: Sikkerheden og virkningen af Stribild hos børn under 12 år er ikke klarlagt (se pkt.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily) + Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil (150 mg/150 mg/200 mg/245 mg once daily)
Danish: Sofosbuvir/Velpatasvir (400 mg/100 mg én gang daglig) + Elvitegravir/Cobicistat/ Emtricitabin/Tenofovirdisoproxil (150 mg/150 mg/200 mg/245 mg én gang daglig)
English: That patients who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety.
Danish: At patienter, der oplever en bekræftet forhøjelse i serum-kreatinin på over 26,5 µmol/l (0,3 mg/dl) fra baseline, bør overvåges tæt for renale bivirkninger.
English: In Study GS-US-236-0102 HIV-1 infected antiretroviral treatment-naïve adult patients received oncedaily treatment of Stribild or once-daily treatment of fixed-dose combination of EFV/FTC/tenofovir disoproxil.
Danish: Behandlingsnaive hiv 1-inficerede voksne patienter I studie GS-US-236-0102, modtog hiv 1-inficerede antiretroviral-naive voksne patienter behandling med Stribild én gang daglig eller fastdosiskombination af EFV/FTC/tenofovirdisoproxil én gang daglig.
English: Clinical monitoring is recommended upon co-administration of Stribild.
Danish: Klinisk overvågning anbefales ved samtidig administration af Stribild.
English: Co-administration of rifabutin, potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Samtidig administration af rifabutin, en kraftig CYP3Ainducer, kan reducere plasmakoncentrationerne af cobicistat og elvitegravir signifikant, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
English: Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)4
Danish: Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)4
English: • decreased levels of potassium in the blood
Danish: • fald i niveauet af blodets kaliumniveau
English: That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any adolescent patient receiving Stribild, renal function should be re-evaluated within one week.
Danish: At nyrefunktionen bør evalueres igen i løbet af en uge, hvis serumphosphat bekræftes at være < 3,0 mg/dl (0,96 mmol/l) hos en ung patient, der får Stribild.
English: Use of Stribild is not recommended in paediatric patients under the age of 18 years with renal impairment (see section 4.4).
Danish: Pædiatriske patienter med nedsat nyrefunktion Stribild bør ikke anvendes til pædiatriske patienter under 18 år med nedsat nyrefunktion (se pkt.
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Danish: ANTIKONVULSIVA Carbamazepin (200 mg to gange daglig)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)
English: What Stribild looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: 25-O-desacetyl-rifabutin AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
Danish: AUC: ↑ 525 % Cmin: ↑ 394 % Cmax: ↑ 384 %
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for elvitegravir eller cobicistat hos personer med moderat nedsat leverfunktion og hos raske personer.
English: In Study GS-US-236-0102, the mean increase from baseline in CD4+ cell count at Week 48 was 239 cells/mm3 in the Stribild-treated patients and 206 cells/mm3 in the EFV/FTC/tenofovir disoproxiltreated patients.
Danish: I studie GS-US-236-0102 var den gennemsnitlige stigning i CD4+ celletal fra baseline ved uge 48 239 celler/mm3 hos patienter behandlet med Stribild, og 206 celler/mm3 hos patienter behandlet med EFV/FTC/tenofovirdisoproxil.
English: Voxilaprevir: AUC: ↑ 171% Cmax:↑ 92% Cmin: ↑ 350%
Danish: AUC: ↑ 171% Cmax: ↑ 92% Cmin: ↑ 350%
English: Cmin1
Danish: asteni1
English: EFV/FTC/ tenofovir disoproxil n = 352
Danish: EFV/FTC/tenofovirdisoproxil n = 352
English: Mean changes from baseline BMD Z-scores (height-age adjusted) were −0.09 for lumbar spine and
Danish: De gennemsnitlige ændringer i BMD Z-scorer (justeret for højde og alder) ved uge 48 i forhold til baseline var -0,09 for columna lumbalis og -0,12 for hele kroppen minus hovedet.
English: Increased plasma concentrations of tenofovir resulting from co-administration of Stribild and sofosbuvir/velpatasvir/voxilaprevir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af Stribild og sofosbuvir/velpatasvir/voxilaprevir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Danish: Antimykobakterielle lægemidler Rifabutin (150 mg hver anden dag)/Elvitegravir (150 mg én gang daglig)/Cobicistat (150 mg én gang daglig)
English: Increased plasma concentrations of tenofovir resulting from co-administration of Stribild and sofosbuvir/velpatasvir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af Stribild og sofosbuvir/velpatasvir kan øge risikoen for bivirkninger relateret til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: In Study GS-US-236-0103, the mean increase from baseline in CD4+ cell count at Week 48 was 207 cells/mm3 in the Stribild-treated patients and 211 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Danish: I studie GS-US-236-0103 var den gennemsnitlige stigning fra baseline i CD4+ celletal ved uge 48 207 celler/mm3 hos patienter behandlet med Stribild, og 211 celler/mm3 hos patienter behandlet med ATV/r + FTC/tenofovirdisoproxil.
English: Concentrations of trazodone may increase upon co-administration with cobicistat.
Danish: Koncentrationer af trazodon kan øges ved samtidig administration af cobicistat.
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for elvitegravir eller cobicistat hos personer med svært nedsat nyrefunktion og hos raske personer.
English: Discontinuation of Stribild therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Danish: Seponering af behandlingen med Stribild hos hiv-inficerede patienter, der samtidig er inficeret med HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis (se pkt.
English: Therapeutic monitoring is recommended upon co-administration with Stribild.
Danish: Der anbefales terapeutisk overvågning ved samtidig administration af Stribild.
English: At Week 144, the mean increase from baseline in CD4+ cell count was 280 cells/mm3 in the Stribild-treated patients and 293 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Danish: Ved uge 144 var den gennemsnitlige stigning fra baseline i CD4+ celletal 280 celler/mm3 hos patienter behandlet med Stribild, og 293 celler/mm3 hos patienter behandlet med ATV/r + FTC/tenofovirdisoproxil.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 56 cells/mm3 in the Stribild-treated patients and 58 cells/mm3 in the NNRTI+FTC/tenofovir disoproxil-treated patients.
Danish: Ved uge 48 var den gennemsnitlige stigning i CD4+ celletal fra baseline 56 celler/mm3 hos Stribild-behandlede patienter og 58 celler/mm3 hos NNRTI+FTC/TDF/tenofovirdisoproxil-behandlede patienter.
English: Hepatic impairment
Danish: hovedpine, svimmelhed
English: The mean increase from baseline in CD4+ cell count at Week 48 was 40 cells/mm3 in the Stribild-treated patients and 32 cells/mm3 in the PI+RTV+FTC/tenofovir disoproxil-treated patients.
Danish: Ved uge 48 var den gennemsnitlige stigning i CD4+ celletal fra baseline 40 celler/mm3 hos Stribild-behandlede patienter og 32 celler/mm3 hos PI+RTV+FTC/tenofovirdisoproxil-behandlede patienter.
English: The use of Stribild is not recommended in paediatric patients with renal impairment (see section 4.2).
Danish: Stribild bør ikke anvendes hos pædiatriske patienter med nedsat nyrefunktion (se pkt.
English: At Week 144, the mean increase from baseline in CD4+ cell count was 321 cells/mm3 in the Stribild-treated patients and 300 cells/mm3 in the EFV/FTC/tenofovir disoproxil-treated patients.
Danish: Ved uge 144 var den gennemsnitlige stigning i CD4+ celletal fra baseline 321 celler/mm3 hos patienter behandlet med Stribild, og 300 celler/mm3 hos patienter behandlet med EFV/FTC/tenofovirdisoproxil.
English: Digoxin:
Danish: Rifabutin:
English: Cmin: ↑ 250%
Danish: Cmax: ↔ Cmin: ↑ 250%
English: Recommended dose for adults and adolescents aged 12 to less than 18 years who weigh at least 35 kg:
Danish: Den anbefalede dosis for voksne og unge i alderen 12 til under 18 år, som vejer mindst 35 kg, er: • En tablet om dagen gennem munden sammen med mad.
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. cobicistat) er ikke klarlagt.
English: Therefore, Stribild is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Derfor frarådes det at bruge Stribild hos patienter med svært nedsat leverfunktion (se pkt.
English: Virologically-suppressed HIV-1 infected patients
Danish: HCV-inficerede patienter.
English: The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Danish: Den gennemsnitlige knogleøgningsrate i columna spinalis ved uge 48 var ensartet de to behandlingsgrupper imellem.
English: Caution is warranted and clinical monitoring is recommended upon co-administration with Stribild.
Danish: Der rådes til forsigtighed og klinisk overvågning ved samtidig administration af Stribild.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir og en farmakokinetisk booster (f.eks. cobicistat) er ikke klarlagt.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir/voxilaprevir og en farmakokinetisk booster (f.eks. cobicistat) er ikke klarlagt.
English: AUC: ↓ 21% Cmin: ↓ 67%
Danish: AUC: ↓ 21 % Cmin: ↓ 67 % Cmax: ↔
English: AUC: ↑ 48% Cmin: ↑ 67%
Danish: AUC: ↑ 48 % Cmin: ↑ 67 % Cmax: ↔
English: Atorvastatin:
Danish: Rosuvastatin:
English: Renal and urinary disorders: Common:
Danish: Nyrer og urinveje:
English: That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained.
Danish: At der bør søges rådgivning hos en endokrinolog og/eller nefrolog i tilfælde af påvisning af eller mistanke om knogleabnormiteter.
English: • Children commonly experienced low red blood cell count (anaemia).
Danish: • En almindelig bivirkning hos børn er et lavt antal røde blodlegemer (blodmangel) - dette kan forårsage træthed eller stakåndethed hos barnet
English: If you take more Stribild than you should
Danish: Hvis De har taget for mange Stribild
English: alfuzosin (used to treat an enlarged prostate gland) amiodarone, quinidine (used to correct irregular heartbeats)
Danish: alfuzosin (anvendes til at behandle en forstørret blærehalskirtel) amiodaron, quinidin (anvendes til at korrigere uregelmæssige hjerteslag) dabigatran (anvendes til at forebygge og behandle blodpropper) carbamazepin, phenobarbital, phenytoin (anvendes til at forebygge krampeanfald) rifampicin (anvendes til at forebygge og behandle tuberkulose og andre infektioner)
English: Adverse reaction
Danish: ANTIARYTMIKA
English: Rosuvastatin: AUC: ↑ 38% Cmin: N/A Cmax: ↑ 89%
Danish: Atorvastatin: AUC: ↑160 % Cmin: NC Cmax: ↑132 %
English: Suspension and emulsion for emulsion for injection
Danish: suspension og emulsion til injektionsvæske, emulsion
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Danish: Intramuskulær anvendelse suspension (H5N1): hætteglas (glas) emulsion (adjuvant): hætteglas (glas)
English: 2.5 ml (emulsion)
Danish: 2.5 ml (suspension) 2.5 ml (emulsion)
English: 2 x 25 vials (emulsion)
Danish: hætteglas (suspension) 2 x 25 hætteglas (emulsion)
English: Strength Pharmaceutical form Route of administration
Danish: Stärke Darreichungsform Art der Anwendung
English: Pack size
Danish: Packungsgröße
English: MA (EU) number (Invented) name
Danish: Name (Phantasiebe zeichnung)
English: Veralipride was authorised in 6 European Member States: Belgium, France, Italy, Luxembourg and Portugal.
Danish: Veraliprid blev godkendt i 6 EU-medlemsstater: Belgien, Frankrig, Italien, Luxembourg og Portugal.
English: The final opinion was converted into a Decision by the European Commission on 1 October 2007.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 1 oktober 2007.
English: London, 1 October 2007 EMEA/CHMP/432352/2007
Danish: London, 1 oktober 2007 EMEA/CHMP/432352/2007
English: Until June 2005, veralipride was also marketed in Spain.
Danish: Indtil juni 2005 var veraliprid også markedsført i Spanien.
English: The Rapporteur and Co-Rapporteur appointed were: Eric Abadie and Barbara van Zwieten-Boot, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis Eric Abadie og Barbara van Zwieten-Boot.
English: * Note: The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
Danish: * Bemærkning: Oplysningerne i dette dokument og bilagene afspejler CHMP's udtalelse af 19. juli 2007.
English: On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC.
Danish: Den 7. september 2006, efter tilbagetrækning af veraliprid fra det spanske marked som følge af indberetninger af alvorlige bivirkninger i nervesystemet, henviste Europa-Kommissionen sagen til EMEA i henhold til artikel 31 i direktiv 2001/83/EF.
English: The list of product names concerned is given in Annex I.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I.
English: COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I) International Non-Proprietary Name (INN): Veralipride
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31 OM Agreal og tilknyttede navne (se bilag I) Internationalt fællesnavn (INN): Veraliprid
English: The referral procedure started on 21 September 2006.
Danish: Indbringelsesproceduren blev indledt den 21. september 2006.
English: Veralipride was approved since 1979 for the indication of treatment of vasomotor symptoms (hot flushes) associated with the menopause.
Danish: Veraliprid har været godkendt siden 1979 til indikationen behandling af vasomotoriske symptomer (hedestigninger) i forbindelse med menopausen.
English: Oral explanations were given on 20 June
Danish: Der blev afgivet mundtlige redegørelser den 20. juni 2007.
English: Written explanations were provided by the Marketing Authorisation Holder on 4 January 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 4. januar 2007.
English: On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Danish: På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporterne fra rapportørerne var CHMP af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende veraliprid er negativt, og vedtog således en udtalelse den 19. juli 2007, hvori det anbefaledes at tilbagekalde markedsføringstilladelsen for samtlige lægemidler indeholdende veraliprid.
English: An extra drop should be given 30 to 120 minutes before the operation begins.
Danish: En ekstra dråbe skal gives 30 til 120 minutter, før operationen starter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nevanac den 11. december 2007.
English: If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.
Danish: Hvis patienten samtidig anvender anden øjenmedicin, bør der gå mindst fem minutter mellem anvendelsen af hvert lægemiddel.
English: The full EPAR for Nevanac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Nevanac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Nevanac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nevanac.
English: Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.
Danish: Derfor skal patienter rådes til ikke at anvende kontaktlinser under behandlingen med Nevanac.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nevanac.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Nevanac.
English: Treatment should begin one day before the cataract operation.
Danish: Behandlingen skal begynde en dag før operationen for grå stær.
English: These were measured two weeks after surgery.
Danish: Tidspunktet for målingen var to uger efter operationen.
English: What measures are being taken to ensure the safe and effective use of Nevanac?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nevanac?
English: For more information about treatment with Nevanac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nevanac, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.