FrancophonIA/ELRC3.0 huggingface dataset:
English: This can indicate you have low numbers of platelets (cells that help the blood to clot)
Danish: Det kan være tegn på, at du har et lavt antal blodplader (celler, der får blodet til at størkne)
English: * Frequency is calculated based on data from clinical trials in which most patients used prophylaxis
Danish: * Hyppigheden er beregnet på baggrund af data fra kliniske studier, hvori de fleste patienter fik profylakse
English: The PL is updated accordingly.
Danish: Indlægssedlen opdateres i overensstemmelse med dette.
English: Kyprolis will be given to you by a doctor or nurse.
Danish: Du vil få Kyprolis af en læge eller sygeplejerske.
English: The risk of cardiac failure is also increased in Asian patients.
Danish: Risikoen for hjerteinsufficiens er ligeledes øget hos asiatiske patienter.
English: A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended.
Danish: Det anbefales at foretage en grundig vurdering af kardiovaskulære risikofaktorer før behandlingsstart.
English: It is recommended to control hypertension prior to starting and during treatment.
Danish: Det anbefales at kontrollere hypertension inden behandlingens start og under behandlingen.
English: It is not known if Kyprolis passes into breast milk in humans.
Danish: Det vides ikke, om Kyprolis passerer over i mælken hos mennesker.
English: PML is known safety issue of bortezomib, which belongs to the same class as carfilzomib.
Danish: PML er et kendt sikkerhedsproblem ved bortezomib, som tilhører den samme klasse som carfilzomib.
English: Therefore, caution should be used during handling and preparation of Kyprolis.
Danish: Derfor skal der udvises forsigtighed under håndtering og klargøring af Kyprolis.
English: Adverse reactions are presented below by system organ class and frequency category (table 5).
Danish: Bivirkningerne vises nedenfor inddelt efter systemorganklasse og frekvens (tabel 5).
English: Kyprolis is for single use only.
Danish: Kyprolis er kun til engangsbrug.
English: Special attention should be paid to patients with moderate and severe hepatic impairment in view of the very limited efficacy and safety data on this population.
Danish: Patienter med moderat og svært nedsat leverfunktion skal have særlig bevågenhed set i lyset af de meget begrænsede data vedrørende virkning og sikkerhed i denne population.
English: Do not use Kyprolis if you are allergic to carfilzomib or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Kyprolis, hvis du er allergisk over for carfilzomib eller et af de øvrige indholdsstoffer i Kyprolis (angivet i afsnit 6).
English: Each 28-day period is considered one treatment cycle.
Danish: Hver periode på 28 dage anses for at være en behandlingscyklus.
English: The overall incidence of venous thromboembolic events was higher in the Kyprolis arms of two phase 3 studies.
Danish: Den samlede forekomst af venøse tromboemboliske hændelser var højere i Kyprolis-armene i to fase 3-studier.
English: • For patients on dialysis receiving Kyprolis, the dose is to be administered after the dialysis procedure
Danish: • For patienter i dialyse, der får Kyprolis, skal dosen administreres efter dialysen
English: Do not take Kyprolis if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: Du må ikke bruge Kyprolis, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: There have been cases of QT interval prolongation reported in clinical studies.
Danish: Der er indberettet tilfælde af forlænget QT-interval i kliniske studier.
English: • Low white blood cell count, which may decrease your ability to fight infection and may be associated with fever
Danish: • Lavt antal hvide blodlegemer, som kan nedsætte din evne til at bekæmpe infektioner og muligvis vil være forbundet med feber
English: • Inflammation of the colon caused by a bacteria called Clostridium difficile
Danish: • Betændelse i tyktarmen, der skyldes en bakterie, som hedder Clostridium difficile
English: Kd (black) Vd (grey)
Danish: Kd (sort) Vd (grå)
English: Non-haematologic toxicity (renal)
Danish: Ikke-hæmatologisk toksicitet (renal)
English: Dose level reductions are presented in table 4.
Danish: Dosisreduktioner vises i tabel 4.
English: There are no data from the use of carfilzomib in pregnant women.
Danish: Der er ingen data fra anvendelse af carfilzomib til gravide kvinder.
English: All patients should be routinely evaluated for hypertension while on Kyprolis and treated as needed.
Danish: Alle patienter bør undersøges rutinemæssigt for hypertension, mens de får Kyprolis, og behandles efter behov.
English: You may need extra tests to check that your heart, kidneys and liver are working properly.
Danish: Du vil muligvis have brug for at få lavet flere test for at sikre, at dit hjerte, dine nyrer og din lever fungerer tilfredsstillende.
English: These events typically occurred early in the course of Kyprolis therapy (< 5 cycles).
Danish: Disse hændelser opstod typisk tidligt i behandlingsforløbet med Kyprolis (< 5 cyklusser).
English: • Reduced blood flow to the heart
Danish: • Nedsat blodtilførsel til hjertet
English: Results from both studies show that renal function status had no marked effect on the exposure of carfilzomib following single or repeat-dose administration.
Danish: Resultater fra begge studier viser, at status for nyrefunktion ikke har nogen udtalt indvirkning på eksponeringen for carfilzomib efter administration af enkeltdoser eller gentagne doser.
English: Treatment with Kyprolis has not been evaluated in pregnant women.
Danish: Behandling med Kyprolis er ikke blevet undersøgt hos gravide kvinder.
English: However, Kyprolis treatment may also be stopped if you experience side effects that cannot be managed.
Danish: Behandlingen med Kyprolis kan dog blive afbrudt, hvis du får bivirkninger, som ikke kan behandles.
English: Tell your doctor or nurse if you are taking medicines used to prevent pregnancy such as oral contraceptives or other hormonal contraceptives, as these may not be suitable for use with Kyprolis.
Danish: Fortæl lægen eller sundhedspersonalet, hvis du bruger medicin til forebyggelse af graviditet, for eksempel p-piller eller andre former for hormonel prævention, da de muligvis ikke er egnede sammen med Kyprolis.
English: Kyprolis is supplied in a glass vial as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use.
Danish: Kyprolis leveres i et hætteglas som et hvidt til offwhite pulver til infusionsvæske, opløsning, der opløses (rekonstitueres) inden brug.
English: A pre-planned overall survival (OS) analysis was performed after 246 deaths in the KRd arm and 267 deaths in the Rd arm.
Danish: Der blev udarbejdet en planlagt analyse af samlet overlevelse (OS) efter 246 dødsfald i KRd-armen og 267 dødsfald i Rd-armen.
English: Cytochrome P450 mediated mechanisms played a minor role in overall carfilzomib metabolism.
Danish: Cytochrom P450-medierede mekanismer spiller en mindre rolle i carfilzomibs overordnede metabolisme.
English: The results of study PX-171-009 are summarised in table 6 and in figure 1 and figure 2.
Danish: Resultaterne af studie PX-171-009 er opsummeret i tabel 6 samt figur 1 og figur 2.
English: Treatment may be continued until disease progression or until unacceptable toxicity occurs.
Danish: Behandlingen kan fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Enrolled subjects were defined as refractory to a therapy if they met any of the following 3 criteria: nonresponsive (< minimal response) to any regimen; progression during any regimen; or progression within 60 days of completion of any regimen.
Danish: De inkluderede patienter blev defineret som værende refraktære over for en behandling, hvis et af følgende tre kriterier var opfyldt: ikke responderende (< minimal respons) på et vilkårligt regimen; progression i løbet af et vilkårligt regimen eller progression inden for 60 dage efter gennemførelse af et vilkårligt regimen.
English: Frequency categories were determined from the crude incidence rate reported for each adverse reaction in a dataset of pooled clinical studies (n = 2,944).
Danish: Frekvensgrupperne blev fastlagt ud fra den rå incidensrate, der er indberettet for hver bivirkning i et datasæt af puljede kliniske studier (n = 2.944).
English: 6.6 Special precautions for disposal and other handling General precautions
Danish: 6.6 Regler for bortskaffelse og anden håndtering Generelle forholdsregler
English: Based on its mechanism of action and findings in animals, Kyprolis can cause foetal harm when administered to a pregnant woman.
Danish: Ud fra dets virkningsmekanisme og fund i dyreforsøg kan Kyprolis beskadige fosteret, hvis det administreres til gravide kvinder.
English: The safety of resuming carfilzomib, after HBV reactivation is adequately controlled, is not known.
Danish: Sikkerheden i forbindelse med genoptagelse af behandling med carfilzomib, når HBV-reaktivering er tilstrækkeligt kontrolleret, kendes ikke.
English: Electrocardiographic changes
Danish: Elektrokardiografiske ændringer
English: A statistically significant advantage in OS was observed in patients in the KRd arm compared to patients in the Rd arm.
Danish: Der blev observeret en statistisk signifikant fordel i OS hos patienterne i KRd-armen sammenlignet med patienterne i Rd-armen.
English: Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse og frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: It is unknown whether carfilzomib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om carfilzomib eller dets metabolitter udskilles i human mælk.
English: Caution should be observed when carfilzomib is combined with medicinal products that are substrates of these enzymes, such as oral contraceptives.
Danish: Der skal udvises forsigtighed, hvis carfilzomib kombineres med lægemidler, der er substrater for disse enzymer, for eksempel orale kontraceptiva.
English: All patients should be screened for HBV before initiation of treatment with carfilzomib.
Danish: Alle patienter skal screenes for HBV, før der iværksættes behandling med carfilzomib.
English: Appropriate dose modifications based on toxicity should be made (see table 3).
Danish: Dosis bør justeres på passende vis på baggrund af toksicitet (se tabel 3).
English: Experts in the treatment of HBV infection should be consulted, as necessary.
Danish: Eksperter i behandling af HBV-infektion skal konsulteres efter behov.
English: Dosing should be modified based on Kyprolis toxicity.
Danish: Dosis skal ændres på baggrund af Kyprolis' toksicitet.
English: This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
Danish: Det gælder også medicin, du har fået uden recept, for eksempel vitaminer eller naturlægemidler.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for carfilzomib, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for carfilzomib er CHMP nået frem til følgende videnskabelige konklusioner:
English: This metabolite has no known biological activities.
Danish: Denne metabolit har ingen kendt biologisk aktivitet.
English: The reconstituted product should be a clear, colourless to slightly yellow solution and should not be administered if any discolouration or particulate matter is observed.
Danish: Det rekonstituerede præparat skal være en klar, farveløs til lys gullig opløsning og må ikke administreres, hvis der ses misfarvning eller partikler.
English: Note: Kyprolis infusion times remain unchanged during dose reduction(s) a. If symptoms do not resolve, discontinue Kyprolis treatment
Danish: Bemærk: Infusionstiden for Kyprolis forbliver uændret i forbindelse med dosisreduktion(er) a. Kyprolis skal seponeres, hvis symptomerne ikke svinder
English: Carfilzomib is a P-glycoprotein (P-gp) but not a BCRP substrate.
Danish: Carfilzomib er et P-glykoprotein (P-gp), men ikke et BCRP-substrat.
English: Carfilzomib is eliminated primarily via metabolism with subsequent excretion of its metabolites in urine.
Danish: Carfilzomib elimineres primært gennem metabolisme med efterfølgende udskillelse af dets metabolitter i urinen.
English: Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2.
Danish: Patienter med BSA over 2,2 m2 skal have en dosis, der er baseret på et BSA på 2,2 m2.
English: Population pharmacokinetic analyses indicate there are no effects of age, gender or race on the pharmacokinetics of carfilzomib.
Danish: Farmakokinetiske populationsanalyser indikerer, at alder, køn eller race ikke har nogen indvirkninger på carfilzomibs farmakokinetik.
English: There is biological plausibility for carfilzomib induced PML (lymphopenia and opportunistic infections are expected ADRs).
Danish: Der er en biologisk plausibilitet for carfilzomib-induceret PML (lymfopeni og opportunistiske infektioner er forventede bivirkninger).
English: Patients receiving carfilzomib should be monitored for any new or worsening neurologic, cognitive or behavioural signs and symptoms that may be suggestive of PML as part of the differential diagnosis of CNS disorders.
Danish: Patienter i behandling med carfilzomib skal monitoreres for eventuelle nye eller forværrede neurologiske, kognitive eller adfærdsmæssige tegn og symptomer, der kan tyde på PML, som en del af differentialdiagnosticering af CNS-sygdomme.
English: Patients with a high tumour burden should be considered to be at greater risk for TLS.
Danish: Patienter med en stor tumorbyrde bør anses for at have en øget risiko for TLS.
English: Hydration, fluid and electrolyte monitoring
Danish: Hydrering, væske- og elektrolytmonitorering
English: Multiple myeloma is a cancer of plasma cells (a type of white blood cell).
Danish: Myelomatose er kræft i plasmaceller (en slags hvide blodlegemer).
English: An effect of Kyprolis on QT interval cannot be excluded (see section 5.1).
Danish: En effekt af Kyprolis på QT-intervallet kan ikke udelukkes (se pkt.
English: Kyprolis has minor influence on the ability to drive and use machines.
Danish: Kyprolis påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder
English: Ensure that patients are well hydrated before administration of Kyprolis in cycle 1, and in subsequent cycles as needed (see section 4.2).
Danish: Det skal sikres, at patienterne er velhydrerede inden administration af Kyprolis i cyklus 1 og i de efterfølgende cyklusser efter behov (se pkt.
English: • Absolute neutrophil count < 0.5 x 109/L and an oral temperature > 38.5°C or two consecutive readings of > 38.0°C for 2 hours
Danish: • Absolut neutrofiltal < 0,5 x 109/l og en oral temperatur > 38,5 °C eller to målinger i træk på > 38,0 °C i løbet af 2 timer
English: In vitro, carfilzomib was found to have minimal neurotoxicity and minimal reaction to non-proteasomal proteases.
Danish: In vitro havde carfilzomib minimal neurotoksicitet og minimal reaktion på non-proteasomale proteaser.
English: Recommended dose modifications
Danish: Anbefalede dosisændringer
English: The metabolites have no known biologic activity.
Danish: Metabolitterne har ingen kendt biologisk aktivitet.
English: Based on the number of relevant cases reported cumulatively, including 16 events with a fatal outcome during the reporting period, the existing warning on cardiac disorders should be updated to recommend that patients should be evaluated for cardiovascular risk factors before treatment with carfilzomib, that a comprehensive cardiological assessment should be considered for patients at high-risk for cardiovascular disease and that hypertension should be controlled during treatment, as a history of hypertension was frequently reported in patients presenting with cardiac disorders.
Danish: På baggrund af det antal af relevante tilfælde, der samlet set er rapporteret, herunder 16 hændelser med dødeligt udfald i rapporteringsperioden, skal den eksisterende advarsel om hjertesygdom opdateres, så den anbefaler, at patienterne evalueres for kardiovaskulære risikofaktorer inden behandling med carfilzomib, at det overvejes at udføre en omfattende kardiologisk vurdering af patienter med høj risiko for kardiovaskulær sygdom, samt at hypertension er kontrolleret under behandlingen, da hypertension i anamnesen ofte blev rapporteret for patienter, der fik hjertesygdom.
English: Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Danish: Behandling med Kyprolis skal superviseres af en læge med erfaring i kræftbehandling.
English: Recommended actions and dose modifications are presented in table 3.
Danish: Den anbefalede håndtering og dosisændringer vises i tabel 3.
English: • Change in voice or hoarseness
Danish: • Ændret stemme eller hæshed
English: • Heart failure and heart problems including rapid, strong or irregular heartbeat
Danish: • Hjertesvigt og hjerteproblemer, herunder hurtige, kraftige eller uregelmæssige hjerteslag
English: Carfilzomib caused embryo-foetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose.
Danish: Carfilzomib forårsagede embryoføtal toksicitet hos drægtige kaniner ved doser, der var lavere end den anbefalede dosis til patienter.
English: Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Danish: Patienter med kendte risikofaktorer for tromboemboli, herunder tidligere trombose, skal monitoreres nøje.
English: Consequently, as a precautionary measure, breast-feeding is contra-indicated during and for at least 2 days after treatment with Kyprolis.
Danish: Som en sikkerhedsforanstaltning er amning derfor kontraindiceret under behandling med Kyprolis og i mindst 2 dage efter behandlingen.
English: Each 28-day period is one treatment cycle.
Danish: Hver periode på 28 dage anses for at være én behandlingscyklus.
English: 25 mg daily Cycles 2-12
Danish: 25 mg dagligt Cyklus 2-12
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XX45 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, ATC-kode: L01XX45
English: All patients should be monitored for evidence of volume overload and fluid requirements should be tailored to individual patient needs.
Danish: Alle patienter skal monitoreres for tegn på volumenoverbelastning, og væskebehovet skal tilpasses den enkelte patient.
English: Signs and symptoms of TTP/HUS should be monitored for.
Danish: Der skal monitoreres for tegn og symptomer på TTP/HUS.
English: Carfilzomib works by blocking the proteasome.
Danish: Carfilzomib virker ved at blokere proteasomer.
English: Kyprolis is used to treat adult patients with multiple myeloma who have had at least one previous treatment for this disease.
Danish: Kyprolis bruges til behandling af voksne patienter med myelomatose, som har fået mindst én tidligere behandling for denne sygdom.
English: Carfilzomib does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19 and 2D6 in vitro and is therefore not expected to influence exposure of medicinal products that are substrates of these enzymes as a result of inhibition.
Danish: Carfilzomib hæmmer ikke CYP1A2, 2B6, 2C8, 2C9, 2C19 og 2D6 in vitro og forventes derfor ikke at påvirke eksponeringen af lægemidler, som er substrater for disse enzymer, som følge af hæmning.
English: The risk of cardiac failure is increased in elderly patients (≥ 75 years).
Danish: Risikoen for hjerteinsufficiens er øget hos ældre patienter (≥ 75 år).
English: For patients with positive HBV serology, prophylaxis with antivirals should be considered.
Danish: For patienter med positiv HBV-serologi bør antiviral profylakse overvejes.
English: You should talk to your doctor or nurse about suitable methods of contraception.
Danish: Tal med lægen eller sundhedspersonalet om egnede præventionsformer.
English: If a patient is currently using oral contraceptives or a hormonal method of contraception that is associated with a risk of thrombosis, the patient should switch to an alternative method of effective contraception.
Danish: Hvis patienten aktuelt bruger et oralt kontraceptivum eller en hormonel kontraceptionsmetode, der er forbundet med risiko for trombose, skal hun skifte til anden sikker kontraception.
English: No effects on reproductive tissues were noted during 28-day repeat-dose rat and monkey toxicity studies or in 6-month rat and 9-month monkey chronic toxicity studies.
Danish: Der blev ikke observeret nogen negative virkninger på reproduktivt væv i toksicitetsstudier med 28 dages gentagen dosering til rotter og aber eller i 6 måneders kroniske toksicitetsstudier hos rotter og 9-måneders kroniske toksicitetsstudier hos aber.
English: Lenalidomide and dexamethasone are other medicines used to treat multiple myeloma.
Danish: Lenalidomid og dexamethason er andre lægemidler, der bruges til behandling af myelomatose.
English: If foaming occurs, allow the solution to settle in the vial until foaming subsides (approximately 5 minutes) and the solution is clear.
Danish: Hvis der dannes skum, skal opløsningen have lov at sætte sig i hætteglasset, indtil skummet synker til bunds (ca. 5 minutter), og opløsningen er klar.
English: • Serious infection including infection in the blood (sepsis)
Danish: • Alvorlige infektioner, for eksempel blodforgiftning (sepsis)
English: Some of these events have been fatal (see section 4.8).
Danish: Nogle af disse hændelser har været dødelige (se pkt.
English: Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
Danish: Det er ikke nødvendigt at justere dosis ved vægtændringer mindre end eller lig med 20 %.
English: The majority of dyspnoea adverse reactions were non-serious (< 5% of subjects had grade ≥ 3 events), resolved, rarely resulted in treatment discontinuation, and had an onset early in the course of study (< 3 cycles).
Danish: Størstedelen af tilfældene af dyspnø var ikke alvorlige (< 5 % af patienterne havde hændelser grad ≥ 3), forsvandt, medførte sjældent seponering af behandlingen og indtrådte tidligt i studiet (< 3 cyklusser).
English: Store refrigerated (2°C to 8°C).
Danish: Opbevares i køleskab (2 °C til 8 °C).
English: This is because this medicine could cause hepatitis B virus to become active again.
Danish: Dette skyldes, at dette lægemiddel kan reaktivere hepatitis B-virus.
English: Pruritus Erythema Hyperhidrosis
Danish: Udslæt Pruritus Erytem Hyperhidrose
English: • All other grade 3 or 4 non-haematologic toxicities (see section 4.4)
Danish: • Alle andre ikke-hæmatologiske toksiciteter grad 3 eller 4 (se pkt.
English: Chemical and physical in-use stability of reconstituted solutions in the vial, syringe or intravenous bag has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at 25°C.
Danish: Den kemiske og fysiske stabilitet af rekonstitueret infusionsvæske i hætteglas, sprøjte eller infusionspose er blevet påvist i 24 timer ved 2 °C - 8 °C eller i 4 timer ved 25 °C.
English: Intravenous carfilzomib administration resulted in suppression of proteasome chymotrypsin-like (CT-L) activity when measured in blood 1 hour after the first dose.
Danish: Intravenøs administration af carfilzomib medførte suppression af proteasom-kymotrypsin-lignende (CT-L) aktivitet, når det blev målt i blodet 1 time efter første dosis.
English: No fertility studies have been performed in animals (see section 5.3).
Danish: Der er ikke udført fertilitetsstudier på dyr (se pkt.
English: Evaluate dyspnoea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes.
Danish: Evaluér dyspnøen for at udelukke kardiopulmonale tilstande, herunder hjerteinsufficiens og lungesyndromer.