FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop Kyprolis for grade 3 or 4 cardiac events until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment (see section 4.2).
Danish: Stop behandling med Kyprolis ved kardielle hændelser grad 3 eller 4, indtil patienten er restitueret, og overvej at genstarte Kyprolis med 1 dosisniveaureduktion baseret på en vurdering af fordele/risici (se pkt.
English: Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion carfilzomib
Danish: Kyprolis 10 mg pulver til infusionsvæske, opløsning Kyprolis 30 mg pulver til infusionsvæske, opløsning Kyprolis 60 mg pulver til infusionsvæske, opløsning carfilzomib
English: Second Kyprolis dose reduction
Danish: Anden reduktion af Kyprolis-dosis
English: What Kyprolis is and what it is used for What you need to know before you use Kyprolis How to use Kyprolis
Danish: Det skal du vide, før du begynder at bruge Kyprolis Sådan skal du bruge Kyprolis Bivirkninger
English: The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.
Danish: Kyprolis-behandlingen skal afbrydes ved mistanke om PRES. Sikkerheden ved reinitiering af Kyprolis hos patienter, der tidligere har haft PRES, kendes ikke.
English: Kyprolis in combination with dexamethasone alonea
Danish: Kyprolis i kombination med dexamethason alenea
English: Antiviral prophylaxis should be considered in patients being treated with Kyprolis to decrease the risk of herpes zoster reactivation (see section 4.8).
Danish: For at reducere risikoen for reaktivering af herpes zoster skal antiviral profylakse overvejes hos patienter, der behandles med Kyprolis (se pkt.
English: • Fluid in the lungs
Danish: • Væske i lungerne
English: Kyprolis in combination with dexamethasone
Danish: Kyprolis i kombination med dexamethason
English: The demographics and baseline characteristics for study 2011-003 were well-balanced between the two arms, including prior treatment with bortezomib (54%), prior treatment with lenalidomide (38%), lenalidomide refractory (25%), age (65 years, range 30-89 years), gender (51% male), ECOG performance status (45% with performance status 1), high risk genetic mutations, consisting of the genetic subtypes t(4;14) or t(14;16) in 10% or more of screened plasma cells, or deletion 17p in ≥ 20%
Danish: Demografiske karakteristika og baseline-karakteristika for studie 2011-003 var velafbalancerede mellem de to behandlingsarme, herunder tidligere behandling med bortezomib (54 %), tidligere behandling med lenalidomid (38 %), refraktær for lenalidomid (25 %), alder (65 år, interval 30-89 år),
English: Dizziness Peripheral neuropathy Headache
Danish: Nervesystemet Svimmelhed Perifer neuropati Hovedpine
English: • Bone pain, muscle pain, chest pain
Danish: • Knoglesmerter, muskelsmerter, brystsmerter
English: For clinical management of dyspnoea during Kyprolis treatment, see section 4.4.
Danish: 4.4 vedrørende den kliniske håndtering af dyspnø under behandling med Kyprolis.
English: No starting dose adjustment is recommended in patients with mild or moderate hepatic impairment based on available pharmacokinetic data.
Danish: Baseret på de tilgængelige farmakokinetiske data anbefales justering af initialdosis ikke til patienter med let eller moderat nedsat leverfunktion.
English: • Flu-like symptoms (influenza)
Danish: • Influenzalignende symptomer
English: Evaluate and stop Kyprolis until resolved and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Danish: Evaluér og stop behandling med Kyprolis, indtil hændelsen er svundet, og overvej, om Kyprolis skal genstartes, baseret på en vurdering af fordele/risici (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Danish: LÆGEMIDLETS NAVN Kyprolis 10 mg pulver til infusionsvæske, opløsning carfilzomib
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 60 mg powder for solution for infusion carfilzomib
Danish: LÆGEMIDLETS NAVN Kyprolis 60 mg pulver til infusionsvæske, opløsning carfilzomib
English: LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER Betadexsulfobutylethernatrium, vandfri citronsyre (E 330), natriumhydroxid.
English: 30 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with an orange plastic flip off cap.
Danish: Kyprolis 30 mg pulver til infusionsvæske, opløsning 30 ml klart hætteglas (type I-glas), der lukkes med en prop af fluorpolymer-belagt elastomer og en aluminiumsforsegling med orange vippelåg.
English: 10 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a light blue plastic flip off cap.
Danish: Kyprolis 10 mg pulver til infusionsvæske, opløsning 10 ml klart hætteglas (type I-glas), der lukkes med en prop af fluorpolymer-belagt elastomer og en aluminiumsforsegling med blåt vippelåg.
English: Pneumonia Respiratory tract infection
Danish: Pneumoni Luftvejsinfektion
English: • Runny nose, nasal congestion or sneezing
Danish: • Næse, der løber, stoppet næse eller nysen
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 30 mg powder for solution for infusion carfilzomib
Danish: LÆGEMIDLETS NAVN Kyprolis 30 mg pulver til infusionsvæske, opløsning carfilzomib
English: Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Danish: Hjælpestoffer: Betadexsulfobutylethernatrium, vandfri citronsyre (E 330), natriumhydroxid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of carfilzomib.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 10 mg carfilzomib.
English: OS months median (95% CI) HR (95% CI); 1-sided p-valueb
Danish: (95 % CI) HR (95 % CI); 1-sidet p-værdib
English: The safety and efficacy of Kyprolis were evaluated in a randomised, open-label, multicentre study of 792 patients with relapsed multiple myeloma, which evaluated the combination of Kyprolis with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone, randomised 1:1.
Danish: Kyprolis' sikkerhed og virkning blev undersøgt i et randomiseret, åbent multicenterstudie med 792 patienter med recidiveret myelomatose.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 60 mg carfilzomib.
English: Death, n (%) Median OS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Danish: HR (Kd/Vd) (95 % CI) p-værdi (1-sidet)
English: Kyprolis in combination with lenalidomide and dexamethasonea
Danish: Kyprolis i kombination med lenalidomid og dexamethason
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 30 mg carfilzomib.
English: • Tiredness (fatigue)
Danish: • Grå stær (katarakt)
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion
Danish: Kyprolis 10 mg pulver til infusionsvæske, opløsning Kyprolis 30 mg pulver til infusionsvæske, opløsning Kyprolis 60 mg pulver til infusionsvæske, opløsning
English: This should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning, hvis du er på en natriumfattig diæt.
English: • Shortness of breath
Danish: • Hvæsende vejrtrækning
English: Kyprolis, lenalidomide, and dexamethasone
Danish: Kyprolis, lenalidomid og dexamethason
English: This is to check that you have enough blood cells and your liver and kidneys are working properly.
Danish: Du vil få taget blodprøver inden behandlingen med Kyprolis starter og under behandlingen for at kontrollere, at niveauet af dine blodceller er tilstrækkeligt, og at din lever og dine nyrer fungerer tilfredsstillende.
English: 50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap.
Danish: Kyprolis 60 mg pulver til infusionsvæske, opløsning 50 ml klart hætteglas (type I-glas), der lukkes med en prop af fluorpolymer-belagt elastomer og en aluminiumsforsegling med lilla vippelåg.
English: Pulmonary haemorrhage Interstitial lung disease
Danish: Akut respirationsinsufficiens Pulmonal blødning Interstitiel lungesygdom Pneumonitis
English: For clinical management of hypertension during Kyprolis treatment, see section 4.4.
Danish: 4.4 vedrørende den kliniske håndtering af hypertension under behandling med Kyprolis.
English: For clinical management of thrombocytopenia during Kyprolis treatment, see section 4.4.
Danish: 4.4 vedrørende den kliniske håndtering af trombocytopeni under behandling med Kyprolis.
English: - The active substance is carfilzomib.
Danish: Kyprolis indeholder: - Aktivt stof: carfilzomib.
English: Pulmonary embolism Pulmonary oedema Epistaxis
Danish: Lungeemboli Lungeødem Epistaxis Orofaryngeale smerter Dysfoni Hvæsende vejrtrækning Pulmonal hypertension
English: Stop Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Danish: Stop behandling med Kyprolis i tilfælde af hypertension, indtil hændelsen er svundet eller vendt tilbage til baseline-niveau, og overvej, om Kyprolis skal genstartes, baseret på en vurdering af fordele/risici (se pkt.
English: Death, n (%) Median OS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Danish: HR (KRd/Rd) (95 % CI) p-værdi (1-sidet)
English: For men taking Kyprolis
Danish: Mænd, der bruger Kyprolis
English: Pneumonitis
Danish: Levertoksicitet
English: Stop Kyprolis for grade 3 and 4 dyspnoea until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see sections 4.2 and 4.8).
Danish: Stop behandling med Kyprolis i tilfælde af dyspnø grad 3 og 4, indtil hændelsen er svundet eller vendt tilbage til baseline-niveau, og overvej, om Kyprolis skal genstartes, baseret på en vurdering af fordele/risici (se pkt.
English: For clinical management of cardiac disorders during Kyprolis treatment, see section 4.4.
Danish: 4.4 vedrørende den kliniske håndtering af hjertesygdomme under behandling med Kyprolis.
English: In case of hypertensive crises, stop Kyprolis until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Danish: Stop behandling med Kyprolis i tilfælde af hypertensiv krise, indtil hændelsen er svundet eller vendt tilbage til baseline-niveau, og overvej, om Kyprolis skal genstartes, baseret på en vurdering af fordele/risici (se pkt.
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; OS = overall survival; HR = hazard ratio; CI = confidence interval; mo = months a. Study PX-171-009
Danish: KRd = Kyprolis, lenalidomid og dexamethason; Rd = lenalidomid og dexamethason; OS = samlet overlevelse; HR = hazard ratio; CI = konfidensinterval; mdr.
English: Evidence of TLS during treatment should be monitored for, including regular measurement of serum electrolytes, and managed promptly.
Danish: blandt andet med regelmæssig måling af serumelektrolytter.
English: GRH0219EN v1
Danish: GRH0558DA v1
English: • Toothache
Danish: • Hudkløe
English: NL-4817 ZK Breda The Netherlands
Danish: NL-4817 ZK Breda
English: Day
Danish: Hjerte
English: Days
Danish: Øjne
English: For clinical management of hepatic toxicity during Kyprolis treatment, see section 4.4.
Danish: 4.4 vedrørende den kliniske håndtering af levertoksicitet under behandling med Kyprolis.
English: • Fluid build-up in the lining of the heart (pericardial effusion), symptoms include chest pain or pressure and shortness of breath
Danish: Symptomerne omfatter brystsmerter eller trykken for brystet samt stakåndethed
English: Progression/Death, n (%) Median PFS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Danish: Progression/Dødsfald, n (%) Median-PFS, mdr.
English: • Dehydration
Danish: • Dehydrering (væskemangel)
English: • Women who are breast-feeding (see section 4.6).
Danish: • Amning (se pkt.
English: Musculoskeletal and connective tissue disorders
Danish: Blødning og trombocytopeni
English: PFS months median (95% CI)a
Danish: (95 % CI)a
English: EU (MA) number
Danish: EU (MT) nummer
English: Packaging Content Package size
Danish: Emballage Indhold Pakningsstørr else
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter
English: Quality of the product is considered satisfactory.
Danish: Produktets kvalitet anses for at være tilfredsstillende.
English: This has now been harmonised.
Danish: Dette er nu harmoniseret.
English: Generally the infant dose stays below 0.5% of the maternal dose, often even lower.
Danish: Sædvanligvis er dosis til spædbarnet under 0,5 % af den maternelle dosis, og ofte endnu lavere.
English: Please see Annex III.
Danish: Der henvises til bilag III.
English: It is known that excretion in milk is low.
Danish: Det vides, at udskillelsen i mælk er lav.
English: • treatment of schizophrenia
Danish: • behandling af skizofreni
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF,
English: The treatment of acute and chronic psychosis is a broader indication than schizophrenia and as such should be substantiated adequately.
Danish: Behandling af akut og kronisk psykose er en bredere indikation end skizofreni og bør som sådan underbygges tilstrækkeligt.
English: Discussions held were mainly around the amount of data currently available for the first trimester.
Danish: Drøftelserne vedrørte hovedsagelig de nuværende foreliggende data for første trimester.
English: No literature review to underpin that conclusion was provided.
Danish: Der blev ikke forelagt en litteraturgennemgang til underbygning af denne konklusion.
English: Common sources (Briggs et al., 2011; Reprotox Database) reviewed several case reports and some publications reporting on a limited series of pregnancies.
Danish: Fælles kilder (Briggs et al., 2011, Reprotox Database) gennemgik en række case-rapporter og nogle publikationer om et begrænset antal graviditeter.
English: Further amendments were introduced in this section consequently to the modifications made in section 4.6.
Danish: Der blev indført yderligere ændringer i dette afsnit som konsekvens af ændringerne i afsnit 4.6.
English: The CHMP considered all available data which concerned more than 300 cases of exposure during pregnancy.
Danish: CHMP gennemgik alle foreliggende data vedrørende mere end 300 tilfælde med eksponering under graviditet.
English: The fact that quetiapine has not been studied on human fertility is now harmonised under this subheading.
Danish: Det forhold, at quetiapin ikke er blevet undersøgt hvad angår fertilitet hos mennesker, er nu angivet harmoniseret under denne underoverskrift.
English: The limited available data on treatment of mixed episodes was not designed to investigate the efficacy/safety of quetiapine in mixed episodes and showed only a positive non-significant trend in this subgroup.
Danish: De begrænsede foreliggende data om behandling af blandede episoder var ikke bestemt til at undersøge quetiapins virkning/sikkerhed ved blandede episoder og viste kun en ikke-signifikant positiv tendens hos denne undergruppe.
English: Several clinical studies have been published during recent years (e.g. Haberman et al 2013) indicating that there is no major teratogenic risk due to the use of atypical antipsychotics.
Danish: I de senere år er der publiceret flere kliniske undersøgelser (f.eks. Haberman et al., 2013), som tyder på, at der ikke er større teratogen risiko ved anvendelse af atypiske antipsykotika.
English: Severe neutropenia and agranulocytosis
Danish: Svær neutropeni og agranulocytose
English: In several MSs there were discrepancies in section 4.2 due to the differences in the indications.
Danish: I flere medlemsstater var der afvigelser i punkt 4.2 på grund af forskelle i indikationerne.
English: The content was therefore reworded and harmonised across all MSs.
Danish: Indholdet blev derfor omformuleret og harmoniseret i alle medlemsstater.
English: The CHMP agreed that no definitive conclusion on the risk during pregnancy can be drawn based on the data available.
Danish: CHMP fandt, at der ikke kan drages en endelig konklusion om risikoen under graviditet på grundlag af de foreliggende data.
English: Section 4.4 - Special warnings and precautions for use Metabolic risk
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Metabolisk risiko
English: As a result of this harmonisation procedure, Module 3 was updated to harmonise the information between the Member States.
Danish: Som resultat af denne harmoniseringsprocedure blev modul 3 ajourført, så oplysningerne i medlemsstaterne blev harmoniseret.
English: The MAH proposal for harmonisation did not support this warning.
Danish: Markedsføringstilladelsesindehaverens forslag til harmonisering støttede ikke denne advarsel.
English: Grounds for the variation to the terms of the marketing authorisation(s)
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen (tilladelserne)
English: Only one MS had a warning regarding the hepatic effects.
Danish: Kun én medlemsstat havde en advarsel om leverpåvirkning.
English: Lastly, an administrative change has been made to the section heading, and the frequency of severe neutropenia has been changed to maintain consistency with the information currently contained in Section 5.1 of the SmPC.
Danish: Endelig er der foretaget en administrativ ændring af overskriften til afsnittet, og hyppigheden af svær neutropeni er ændret, så der er overensstemmelse med de oplysninger, som nu er indeholdt i punkt 5.1 i produktresuméet.
English: The manufacture and control of both the active substance and the finished product comply with CHMP/ICH guidelines.
Danish: Fremstilling og kontrol af både lægemiddelstoffet og det færdige præparat er i overensstemmelse med retningslinjerne fra CHMP/ICH.
English: In two MSs the heading read “Somnolence” instead of “Somnolence and dizziness”.
Danish: I to medlemsstater havde denne overskrift ordlyden “somnolens” i stedet for “somnolens og svimmelhed”.
English: In four MSs the wording “moderate to severe” was missing in the therapeutic indication.
Danish: I fire medlemsstater var ordene “moderat til svær” udeladt i den terapeutiske indikation.
English: However, divergent wording has been identified in seven MSs in which “major” was missing in the indication.
Danish: Der er imidlertid konstateret en divergerende ordlyd i syv medlemsstater, hvor ordet “svær” var udeladt i indikationen.
English: However, part of the information in this section has been moved from the heading “Somnolence” as explained above.
Danish: En del af oplysningerne i dette afsnit er dog som nævnt flyttet fra overskriften “somnolens”.
English: The final harmonised wording addresses all the identified discrepancies e.g. differences in frequency of reported adverse events like rhinitis.
Danish: Den endelige harmoniserede ordlyd ophæver alle de fundne afvigelser, f.eks. forskelle i hyppigheden af indberettede bivirkninger såsom rhinitis.
English: The final text was agreed within this harmonisation procedure and took into account the guidance provided in the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005), which mentions the available data and lack of teratogenic effects up to now, but also states that no conclusions on risk can be drawn.
Danish: Den endelige tekst blev vedtaget under denne harmoniseringsprocedure og tog hensyn til retningslinjerne for vurdering af lægemiddelforårsaget risiko i forbindelse med reproduktion og laktation hos mennesker: “From data to labelling” (EMEA/CHMP/203927/2005), som henviser til de foreliggende data og det hidtidige fravær af teratogene effekter, men også nævner, at der ikke kan drages konklusioner om risikoen.
English: The proposed wording was in line with the current guidance and a clear distinction could be made between the data relevant for the first trimester (potential for congenital abnormalities) and the third trimester (neonatal withdrawal effects).
Danish: Den foreslåede ordlyd var på linje med den nuværende vejledning, og der kunne klart skelnes mellem data med relevans for første trimester (potentiale for kongenitte anormaliteter) og tredje trimester (abstinenser hos nyfødte).
English: The limited available data does not indicate a risk for congenital abnormalities.
Danish: De begrænsede foreliggende data tyder ikke på risiko for kongenitte anormaliteter.
English: A simple extrapolation from schizophrenia trials to other psychosis is not encouraged by the Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia (EMA/CHMP/40072/2010 Rev. 1).
Danish: Simpel ekstrapolering fra skizofreniundersøgelser til andre psykoser frarådes i vejledningen om klinisk undersøgelse af lægemidler, herunder depotpræparater, til behandling af skizofreni (EMA/CHMP/40072/2010 Rev. 1).
English: The warning on cardiomyopathy and myocarditis was included through a type II variation, which was finalised during the assessment of this referral procedure under Article 30 from Directive 2001/83/EC started.
Danish: Advarslen om kardiomyopati og myokarditis blev tilføjet ved en type II-ændring, som blev færdigbehandlet under vurderingen af denne indbringelsesprocedure i henhold til artikel 30 i direktiv 2001/83/EF.
English: However, and since there were fatal post-marketing reports of agranulocytosis the harmonised wording reflects this information.
Danish: Da der imidlertid efter markedsføring var indberetninger om fatale tilfælde af agranulocytose, fremgår dette af den harmoniserede ordlyd.
English: It is approved via national, mutual recognition (MRP) or decentralised procedures (DCP).
Danish: Det er godkendt ved den nationale procedure, den gensidige anerkendelsesprocedure og den decentrale procedure.
English: The CHMP commented on the wording namely on the affinity for serotonin 5HT1A and for norepinephrine transporter (NET) due to the current limited available data in this regard.
Danish: CHMP kommenterede ordlyden vedrørende affiniteten for serotonin-5HT1A og noradrenalintransporteren (NET) på grund af de begrænsede foreliggende data herom.
English: The proposal presented by the MAH reflected the latest scientific information.
Danish: Forslaget fra indehaveren af markedsføringstilladelsen afspejlede den nyeste videnskabelige viden.
English: The wording on “Constipation and intestinal obstruction” was already harmonised.
Danish: Ordlyden “konstipation og tarmobstruktion” var allerede harmoniseret.
English: The proposed wording was fully endorsed by the CHMP.
Danish: Den foreslåede ordlyd blev godkendt i sin helhed af CHMP.
English: Due to the divergent national decisions taken by MS concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised PIs and thus to harmonise its divergent PIs across the EU.
Danish: På grund af de divergerende nationale afgørelser, der var truffet af medlemsstaterne ved godkendelsen af ovenstående produkter (og relaterede navne), indgav EuropaKommissionen en officiel henvisning til CHMP/EMA's sekretariat i medfør af artikel 30 i direktiv 2001/83/EF med henblik på at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed få dem harmoniseret i EU.