FrancophonIA/ELRC3.0 huggingface dataset:
English: At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the hazard ratio comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Danish: Ved den endelige OS-analyse (skæringsdato for data (DCO) 9. maj 2016) ved 79 % modenhed var hazard ratio ved sammenligning af olaparib med placebo 0,73 (95 % CI 0,55-0,95; p=0,02138 (opnåede ikke det præspecificerede signifikansniveau på < 0,0095); median 29,8 måneder for olaparib versus 27,8 måneder for placebo).
English: Table 5 Summary of primary objective outcome for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Danish: Tabel 5 Sammenfatning af de primære objektive resultater for alle patienter og patienter med BRCA1/2-muteret og BRCA1/2 wt/VUS PSR-ovariecancer i SStudy 19
English: PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind placebo-controlled multicentre study.
Danish: PAES: For yderligere at bekræfte virkningen af olaparib hos patienter med platinsensitiv recidiverende BRCA-muteret high-grade serøs ovariecancer, skal indehaveren af markedsføringstilladelsen indsende resultaterne af studie D0816C00002, et randomiseret, dobbeltblindet, placebokontrolleret, fase III-multicenterstudie.
English: Contraception in males
Danish: Antikonception hos mænd
English: In the olaparib arm 55% of the patients had only 2 prior lines of treatment with 45% receiving 3 or more prior lines of treatment.
Danish: I olaparib-armen havde 55 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 45 % havde modtaget 3 eller flere tidligere behandlingslinjer.
English: At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the HR comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Danish: Ved den sidste OS-analyse (skæringsdato for data (DCO) 9. maj 2016) ved 79 % modenhed var HR ved sammenligning af olaparib og placebo 0,73 (95 % CI 0,55-0,95; p=0,02138 (opnåede ikke det præspecificerede signifikansniveau på < 0,0095); median 29,8 måneder for olaparib versus 27,8 måneder for placebo).
English: Most patients were ECOG performance status 0 (81%), there are no data in patients with performance status 2 to 4.
Danish: De fleste patienter havde en ECOG performance status på 0 (81 %); der er ingen data for patienter med funktionsstatus 2 til 4.
English: Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Danish: Figur 1 Study 19: Kaplan-Meier-plot af PFS for BRCA-muterede patienter (53 % modenhedinvestigators vurdering)
English: Median time (months) (95% CI) HR (95% CI)
Danish: Mediantid (måneder) (95 % CI) HR (95% CI)
English: The recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a strong CYP3A inhibitor or 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Danish: Det anbefales, at Lynparza-dosis reduceres til 150 mg to gange dagligt (svarende til en samlet daglig dosis på 300 mg) sammen med en potent CYP3A-inhibitor og til 200 mg to gange dagligt (svarende til en samlet daglig dosis på 400 mg) sammen med en moderat CYP3A-inhibitor (se pkt.
English: In the placebo arm 61% of patients had received only 2 prior lines with 39% receiving 3 or more prior lines of treatment.
Danish: I placebo-armen havde 61 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 39 % havde modtaget 3 eller flere tidligere behandlingslinjer.
English: Placebo Olaparib 400 mg capsule bd
Danish: Placebo Olaparib 400 mg kapsel bd
English: If a further dose reduction is required, then reduction to 100 mg twice daily (equivalent to a total daily dose of 200 mg) is recommended.
Danish: Hvis der er brug for endnu en dosisreduktion, så anbefales en reduktion til 100 mg to gange dagligt (svarende til en samlet daglig dosis på 200 mg).
English: The primary endpoint was PFS based on investigator assessment using RECIST 1.0.
Danish: Det primære endepunkt var PFS baseret på investigatorvurdering under anvendelse af RECIST 1.0.
English: Film-coated tablets
Danish: Tabletkerne Copovidon
English: In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
Danish: bd To gange dagligt; CI konfidensinterval; DOR Varighed af respons, DCO data cut off; HR hazard ratio; HR+ hormonreceptor positiv, ORR objektiv responsrate; OS samlet overlevelse; PFS progressionfri overlevelse; PFS2 Tid til anden progression eller død, TNBC tripel negativ brystcancer.
English: The safety and efficacy of olaparib as a maintenance therapy in the treatment of PSR ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a large Phase II randomised, double-blind, placebo-controlled trial (Study 19).
Danish: Sikkerhed og effekt af olaparib som vedligeholdelsesbehandling i behandlingen af patienter med PSR ovariecancer, herunder patienter med tubacancer eller med primær peritoneal cancer, efter behandling med to eller flere platinholdige regimer, blev undersøgt i et stort randomiseret, dobbeltblindet, placebokontrolleret fase II-studie (SStudy 19).
English: • Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
Danish: • Hver Lynparza 150 mg filmovertrukket tablet indeholder 150 mg olaparib.
English: Confirmed ORR - DCO 09 December 2016
Danish: Bekræftet ORR - DCO 9. december
English: 51.3%; including 20 patients identified with a somatic tumour BRCA1/2 mutation) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Danish: En planlagt sub-gruppeanalyse identificerede patienter med BRCA1/2-muteret ovariecancer (n=136, 51,3 %; heraf 20 patienter, som havde en somatisk tumor-BRCA1/2-mutation) som den sub-gruppe, der opnåede den største kliniske fordel af vedligeholdelsesbehandling med olaparib monoterapi.
English: • colchicine - used to treat gout
Danish: • colchicin - anvendes til behandling af urinsyregigt
English: PFS2 (40% maturity) Number of events: Total number of patients (%)
Danish: PFS2 (31 % modenhed) Antal hændelser: Samlet antal patienter (%) Mediantid (måneder)
English: In the olaparib arm 44% of the patients had only 2 prior lines of treatment with 56% receiving 3 or more prior lines of treatment.
Danish: I olaparib-armen havde 44 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 56 % havde modtaget 3 eller flere tidligere behandlingslinjer.
English: Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150' on one side and plain on the other side.
Danish: Grøn til grågrøn, oval, bikonveks tablet, præget med "OP150" på den ene side og ingenting på den anden side.
English: In the placebo arm 49% of patients had received only 2 prior lines with 51% receiving 3 or more prior lines of treatment.
Danish: I placebo-armen havde 49 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 51 % havde modtaget 3 eller flere tidligere behandlingslinjer.
English: Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100' on one side and plain on the other side.
Danish: Gul til mørkegul, oval, bikonveks tablet, præget med "OP100" på den ene side og ingenting på den anden side.
English: • Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
Danish: • Hver Lynparza 100 mg filmovertrukket tablet indeholder 100 mg olaparib.
English: Most patients were ECOG performance status 0 (77%), there are no data in patients with performance status 2 to 4.
Danish: De fleste patienter havde en ECOG performance status på 0 (77 %); der er ingen data for patienter med performance status 2 til 4.
English: Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib.
Danish: Lynparza 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg olaparib.
English: Most patients were ECOG performance status 0 (78%), there are no data in patients with performance status 2 to 4.
Danish: De fleste patienter havde en ECOG performance status på 0 (78 %); der er ingen data for patienter med performance status på 2 til 4.
English: Olaparib 400 mg capsule bd
Danish: Olaparib 400 mg kapsel bd
English: The study met its primary objective demonstrating a statistically significant improvement in investigator assessed PFS for olaparib compared with placebo with a HR of 0.30 (95% CI 0.22-0.41; p<0.0001; median 19.1 months olaparib vs 5.5 months placebo).
Danish: Studiet opfyldte sit primære mål og demonstrerede en statistisk signifikant forbedring i investigatorvurderet PFS for olaparib sammenlignet med placebo med en HR på 0,30 (95 % CI 0,220,41; p<0,0001; median 19,1 måneder for olaparib vs 5,5 måneder for placebo).
English: For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) (see section 5.2).
Danish: Den anbefalede dosis af Lynparza til patienter med moderat nedsat nyrefunktion (kreatininclearance 31 til 50 ml/min) er 200 mg (to 100 mg tabletter) to gange dagligt (svarende til en samlet daglig dosis på 400 mg) (se pkt.
English: The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Danish: Sikkerhed og virkning af olaparib som vedligeholdelsesterapi i behandlingen af patienter med platinsensitiv recidiverende (PSR) high-grade serøs ovarie-, tuba- eller primær peritoneal cancer efter behandling med to eller flere platinholdige regimer blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret fase II-studie (Study 19).
English: • looking for faulty DNA repair genes, such as BRCA (BReast CAncer) genes.
Danish: Disse specifikke kræftceller kan identificeres ved: at de reagerer på platinbaseret kemoterapi, eller at de har beskadigede DNA-reparationsgener, såsom BRCA-gener (brystcancergener).
English: Each film-coated tablet contains 150 mg of olaparib.
Danish: Hver filmovertrukket tablet indeholder 150 mg olaparib.
English: Lynparza co-administration with strong or moderate CYP3A inhibitors is not recommended (see section 4.5).
Danish: Samtidig administration af Lynparza og stærke eller moderate CYP3A-inhibitorer frarådes (se pkt.
English: No Lynparza dose adjustment is required for patients with mild or moderate hepatic impairment (see section 4.2).
Danish: Dosisjustering af Lynparza er ikke nødvendig til patienter med let eller moderat nedsat leverfunktion (se pkt.
English: The primary endpoint was PFS determined by investigator assessment using RECIST 1.1.
Danish: Det primære endepunkt var PFS baseret på investigators vurdering under anvendelse af RECIST 1.1.
English: Lynparza 100 mg tablets olaparib
Danish: Lynparza 100 mg tabletter olaparib
English: For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Danish: Den anbefalede dosis af Lynparza til patienter med moderat nedsat nyrefunktion (kreatininclearance 31 til 50 ml/min) er 300 mg to gange dagligt (svarende til en samlet daglig dosis på 600 mg) (se pkt.
English: Lynparza 150 mg tablets olaparib
Danish: Lynparza 150 mg tabletter olaparib
English: The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a hazard ratio (HR) of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib versus 4.8 months placebo).
Danish: Studiet opfyldte sit primære mål og demonstrerede en statistisk signifikant forbedring af PFS for olaparib sammenlignet med placebo i den samlede population med en hazard ratio (HR) på 0,35 (95 % CI 0,25-0,49; p<0,00001; median 8,4 måneder for olaparib versus 4.8 måneder for placebo).
English: In vitro, olaparib has been shown to be an inhibitor of BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K.
Danish: Det er vist, at olaparib hæmmer BCPR, OATP1B1, OCT1, OCT2, OAT3, MATE1 og MATE2K in vitro.
English: Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib.
Danish: Lynparza 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg olaparib.
English: The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a HR of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib vs 4.8 months placebo).
Danish: Studiet opfyldte sit primære mål og påviste en statistisk signifikant forbedring af PFS for olaparib i sammenligning med placebo i den samlede population med en HR på 0,35 (95 % CI 0,25-0,49; p<0,00001; median 8,4 måneder for olaparib vs 4,8 måneder for placebo).
English: If strong or moderate CYP3A inhibitors must be co-administered, the dose of Lynparza should be reduced.
Danish: Hvis samtidig administration af stærke eller moderate CYP3A-inhibitorer er nødvendig, bør dosis af Lynparza reduceres.
English: Table 3 Summary of primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Danish: Tabel 3 Sammenfatning af de primære, objektive resultater for patienter med gBRCA1/2 m PSR-ovariecancer i SOLO2
English: Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decrease and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased;
Danish: Anæmi omfatter de foretrukne termer for anæmi, makrocytisk anæmi, erytropeni, nedsat hæmatokrit, nedsat hæmoglobin, normokrom anæmi, normokrom normocytisk anæmi, normocytisk anæmi og nedsat antal røde blodlegemer; Neutropeni omfatter de foretrukne termer for agranulocytose, febril neutropeni, nedsat granulocyttal,
English: In BRCA-mutated patients (n=136) there was a statistically significant improvement in PFS, TFST and TSST.
Danish: Der var en statistisk signifikant forbedring af PFS, TFST og TSST hos BRCA-muterede patienter (n=136).
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 100 mg (one 100 mg tablet) taken twice daily (equivalent to a total daily dose of 200 mg).
Danish: Hvis en stærk CYP3A-inhibitor skal gives samtidig, anbefales det at reducere dosis af Lynparza til 100 mg (én 100 mg tablet) to gange dagligt (svarende til en samlet daglig dosis på 200 mg).
English: Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende to typer pålidelig antikonception før initiering af Lynparza-behandling, under behandlingen og i 1 måned efter sidste dosis med Lynparza (se pkt.
English: The recommended dose of Lynparza is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg.
Danish: Den anbefalede dosis Lynparza er 300 mg (to 150 mg tabletter) indtaget to gange dagligt, svarende til en samlet daglig dosis på 600 mg. 100 mg tabletten er tilgængelig til dosisreduktion.
English: All patients comprises of the following subgroups: BRCA1/2-mutated, BRCA1/2 wt/VUS and BRCA1/2 status unknown
Danish: Alle patienter består af følgende sub-grupper: BRCA1/2-muteret, BRCA1/2 wt/VUS og BRCA1/2-status ukendt (11 patienter med ukendt status, ikke vist som en separat undertype i tabellen).
English: Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets olaparib
Danish: Lynparza 100 mg filmovertrukne tabletter Lynparza 150 mg filmovertrukne tabletter olaparib
English: o A test is used to find out whether you have BRCA-mutated ovarian cancer.
Danish: o Der bruges en test til at bestemme, om du har BRCA-muteret kræft i æggestokkene.
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg).
Danish: Hvis en stærk CYP3A-inhibitor skal gives samtidig, anbefales det at reducere dosis af Lynparza til 150 mg to gange dagligt (svarende til en samlet daglig dosis på 300 mg).
English: Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
Danish: granulocytopeni, idiopatisk neutropeni,neutropeni, neutropenisk infektion, neutropenisk sepsis og nedsat neutrofiltal; Trombocytopeni omfatter de foretrukne termer for nedsat antal trombocytter, nedsat trombocytproduktion, nedsat trombokrit og trombocytopeni; Leukopeni omfatter de foretrukne termer for leukopeni og nedsat antal hvide blodlegemer; Lymfopeni omfatter de foretrukne termer for nedsat antal B-lymfocytter, nedsat antal lymfocytter, lymfopeni, og nedsat antal T-lymfocytter; Hoste omfatter de foretrukne termer for hoste og produktiv hoste; Udslæt omfatter de foretrukne termer for eksfoliativt udslæt, generaliseret erytem, udslæt, erytematøst udslæt, generaliseret udslæt, makulært udslæt, makulo-papuløst udslæt, papuløst udslæt og kløende udslæt; Hypersensitivitet omfatter de foretrukne termer for lægemiddelhypersensitivitet og hypersensitivitet; Dermatitis omfatter de foretrukne termer for dermatitis, allergisk dermatitis og eksfoliativ dermatitis.
English: You will be asked to take 200 mg (2 x 100 mg tablets)
Danish: Du vil blive bedt om at tage 200 mg (2 x 100 mg tabletter) to gange dagligt - i alt 4 tabletter hver dag.
English: If you take more Lynparza than you should
Danish: Hvis du har taget for meget Lynparza
English: Median time (months) (95% CI)
Danish: Mediantid (måneder) (95% CI)
English: What you need to know before you take Lynparza 3.
Danish: Det skal du vide, før du begynder at tage Lynparza Sådan skal du tage Lynparza Bivirkninger
English: The safety and efficacy of olaparib as maintenance therapy were studied in a Phase III randomised, double-blind, placebo-controlled trial in patients with germline BRCA1/2-mutated PSR ovarian, fallopian tube or primary peritoneal cancer.
Danish: Sikkerhed og virkning af olaparib som vedligeholdelsesbehandling af PSR ovariecancer, tubacancer eller primær peritoneal cancer blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret fase III-studie med patienter med germline BRCA1/2-muteret sygdom.
English: If you think any of these may apply to you, talk to your doctor, pharmacist or nurse before or during treatment with Lynparza.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du tror, at noget af dette gælder for dig, før eller under behandling med Lynparza.
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) (see sections 4.4 and 4.5).
Danish: Hvis en moderat CYP3A-inhibitor skal gives samtidig, anbefales det at reducere dosis af Lynparza til 200 mg to gange dagligt (svarende til en samlet daglig dosis på 400 mg) (se pkt.
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg) (see sections 4.4 and 4.5).
Danish: Hvis en moderat CYP3A-inhibitor skal gives samtidig, anbefales det at reducere dosis af Lynparza til 150 mg (én 150 mg tablet) to gange dagligt (svarende til en samlet daglig dosis på 300 mg) (se pkt.
English: Olaparib 300 mg tablet bd Placebo
Danish: Olaparib 300 mg tablet bd
English: bd Twice daily; NR not reached; CI confidence interval; PFS2 time from randomisation to second progression or death;
Danish: bd To gange dagligt; NR ikke nået; CI konfidensinterval; PFS2 tid fra randomisering til anden progression eller død; TFST Tid fra randomisering til start af første, efterfølgende behandling eller død.
English: Olaparib 400 mg bd 53/74 (72) Placebo OS (73% maturity) (DCO 09 May 2016)
Danish: Olaparib 400 mg bd 53/74 (72) Placebo
English: Common Dyspnoea Uncommon Cough
Danish: Almindelig Dyspnø
English: Stomatitis a, Upper abdominal pain
Danish: Opkastning, diarré, kvalme Ikke almindelig Stomatitis a, øvre abdominalsmerter
English: If a strong or moderate CYP3A inhibitor must be co-administered, the dose of Lynparza should be reduced (see sections 4.2 and 4.5).
Danish: Hvis det er nødvendigt samtidig at tage en stærk eller moderat CYP3A-inhibitor, bør dosis af Lynparza reduceres (se pkt.
English: Lynparza 100 mg film-coated tablets
Danish: Lynparza 100 mg filmovertrukne tabletter
English: Lynparza 150 mg film-coated tablets
Danish: Lynparza 150 mg filmovertrukne tabletter
English: Thrombocytopenia a, Leukopenia
Danish: Almindelig Neutropeni a, trombocytopeni a,
English: If you notice any side effects not listed in this leaflet, please contact your doctor straight away.
Danish: Kontakt straks lægen, hvis du får bivirkninger, som ikke er nævnt her.
English: Lynparza 100 mg film-coated tablets olaparib
Danish: Lynparza 100 mg filmovertrukne tabletter olaparib
English: Lynparza 150 mg film-coated tablets olaparib
Danish: Lynparza 150 mg filmovertrukne tabletter olaparib
English: twice a day - a total of 4 tablets each day.
Danish: - i alt 12 kapsler hver dag.
English: 14 Capsules
Danish: 14 kapsler
English: Blister(Alu/Alu)
Danish: Oral anvendelse Blister (alu/alu)
English: 200 mg Powder for concentrate for solution for infusion
Danish: 200 mg Pulver til koncentrat til infusionsvæske, opløsning
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse hætteglas (glas) 10 ml
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spedra on 21 June 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Spedra den 21. juni 2013.
English: If it is taken with food, it may take longer to work.
Danish: Hvis det tages med et måltid, kan der gå længere tid, før det virker.
English: This is a summary of the European public assessment report (EPAR) for Spedra.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Spedra.