FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant rituximab is associated with increased antibody conjugated MMAE (acMMAE) plasma AUC by 24% and decreased unconjugated MMAE plasma AUC by 37%, based on population PK analysis.
Danish: Det er vist i en farmakokinetisk populationsundersøgelse, at samtidig behandling med rituximab øger det antistofkonjugerede MMAE (acMMAE)-plasma-AUC med 24% og mindsker det ukonjugerede MMAE-plasma-AUC med 37%.
English: No adjustment in the starting dose is required when administering Polivy to patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or aspartate transaminase [AST] greater than ULN).
Danish: Justering af startdosis Polivy er ikke nødvendig hos patienter med let nedsat leverfunktion (bilirubin værdier >øvre normalgrænse til bilirubin værdier ≤1,5 × øvre normalgrænse eller aspartat transaminase [ASAT] >øvre normalgrænse).
English: After reconstitution each mL contains 20 mg of polatuzumab vedotin.
Danish: Efter rekonstitution indeholder hver ml 20 mg polatuzumab vedotin.
English: Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Danish: Op til 72 timer i køleskab (2°C - 8°C) eller op til 8 timer ved stuetemperatur (9°C - 25°C)
English: Intravenous use
Danish: polatuzumab vedotin Intravenøs anvendelse
English: What you need to know before you are given Polivy You must not be given Polivy
Danish: Det skal du vide, før du begynder at bruge Polivy Sådan skal du bruge Polivy Bivirkninger
English: Tél/Tel: +32 (0) 2 525 82 11
Danish: Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
English: There are insufficient data to assess the impact of severe renal impairment (CrCL 15-29 mL/min, n = 3) on PK. No data are available in patients with end-stage renal disease and/or who are on dialysis.
Danish: Der er ikke tilstrækkelige data til at vurdere betydningen af svær nedsat nyrefunktion (CrCL 15-29 ml/min, n = 3) i forhold til farmakokinetik.
English: Table 6 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Danish: Tabel 6 Påvist varighed af kemisk og fysisk stabilitet af den tilberedte infusionsopløsning Fortynder anvendt til tilberedning af infusionsopløsningen
English: After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
Danish: Efter rekonstitution indeholder hver milliliter (ml) 20 mg polatuzumab vedotin.
English: What Polivy is and what it is used for
Danish: Virkning og anvendelse Hvad er Polivy?
English: • burning pain when passing urine
Danish: • brændende fornemmelse når du tisser
English: Tel: +46 (0) 8 726 1200
Danish: Roche AB Tel: +46 (0) 8 726 1200
English: In patients with mild hepatic impairment [AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN], n = 54], acMMAE exposures are similar whereas unconjugated MMAE AUC are 40% higher compared to patients with normal hepatic function (n = 399), based on a population PK analysis.
Danish: Det vurderes, på baggrund af den farmakokinetiske populationsanalyse, at patienter med let nedsat leverfunktion (ASAT eller ALAT >1,0 til 2,5 × øvre normalgrænse eller total bilirubin >1,0 til 1,5 × øvre normalgrænse, n = 54) har en optagelse af acMMAE svarende til patienter med normal leverfunktion, mens AUC for ukonjugeret MMAE er 40% højere end hos patienter med normal leverfunktion (n = 399).
English: Based on the population PK analysis, Cycle 3 acMMAE AUC increased by approximately 30% over Cycle 1
Danish: Baseret på den farmakokinetiske populationsanalyse øges acMMAE AUC i behandlingsserie 3 med ca. 30% i forhold til AUC i behandlingsserie 1 og med mere end 90% i behandlingsserie 6.
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 6.
Danish: Kemisk og fysisk holdbarhed af den tilberedte infusionsopløsning præsenteres i tabel 6.
English: Primary endpoint Complete Response Rate* (IRC-assessed) at End of treatment** Responders (%) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Key secondary and exploratory endpoints Duration of response (INV-assessed) Number of patients included in analysis Number (%) of patients with event Median DOR (95% CI), months HR [95% CI]
Danish: Varighed af respons (INV-vurderet) Antal patienter inkluderet i analyse Antal patienter (%) med hændelse Median responsvarighed (95% KI), måneder HR (95% KI)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 140 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: • look pale
Danish: • ser bleg ud
English: PML is a very rare and life threatening infection in the brain, that has occured in one patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.
Danish: Progressiv multifokal leukoencefalopati (PML) er en meget sjælden og livsfarlig infektion i hjernen, der er set hos én patient, behandlet med Polivy sammen med bendamustin og et tredje lægemiddel, obinutuzumab.
English: Common pancytopenia
Danish: INFORMATION I BRAILLESKRIFT
English: No dedicated clinical drug-drug interaction studies with polatuzumab vedotin in humans have been conducted.
Danish: Der er ikke udført dedikerede kliniske, undersøgelser af interaktionen mellem lægemidler med polatuzumab vedotin til mennesker.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Danish: Polivy indeholder en cytotoksisk komponent og skal administreres under opsyn af en læge med erfaring inden for brug af cytotoksiske lægemidler.
English: Respiratory, thoracic and mediastinal disorders Very common cough Common pneumonitis
Danish: Meget almindelig hoste Almindelig pneumonitis
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose (see section 4.6).
Danish: Mandlige patienter med kvindelige partnere, der kan blive gravide, skal tilrådes at anvende sikker prævention under behandling med Polivy og i mindst 6 måneder efter sidste dosis (se pkt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours refrigerated (2 °C − 8 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -forhold inden anvendelse brugerens ansvar og bør sædvanligvis ikke overstige 24 timer i køleskab (2°C - 8°C), med mindre fortyndingen har fundet sted under kontrollerede og aseptiske forhold.
English: There are insufficient data to assess the impact of moderate hepatic impairment (total bilirubin > 1.5-3×ULN, n = 2) on PK. No data are available in patients with severe hepatic impairment or liver transplantation.
Danish: Der er ikke tilstrækkelige data til at vurdere betydningen af moderat nedsat leverfunktion (total bilirubin >1,5-3×øvre normalgrænse, n = 2) i forhold til farmakokinetik.
English: Polivy contains a cytotoxic component which is covalently attached to the monoclonal antibody.
Danish: Forsigtighed i forbindelse med håndtering eller administration af produktet Polivy indeholder en cytotoksisk komponent som er kovalent forbundet med det monoklonale antistof.
English: Instructions for reconstitution
Danish: Fortyndingsvejledning
English: Age did not have an effect on the pharmacokinetics of acMMAE and unconjugated MMAE based on a population PK analysis with patients aged 20-89 years.
Danish: Baseret på en farmakokinetisk populationsanalyse af patienter i aldersgruppen 20-89 år, påvirkede alder ikke farmakokinetikken for acMMAE og ukonjugeret MMAE.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours refrigerated (2 °C − 8 °C), unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -forhold inden anvendelse brugerens ansvar og bør sædvanligvis ikke overstige 24 timer i køleskab (2°C - 8°C), med mindre rekonstituering har fundet sted under kontrollerede og aseptiske forhold.
English: If you are a woman of childbearing age, you must use effective contraception during treatment and for 9 months after the last dose of Polivy.
Danish: Kvinder, der kan blive gravide skal bruge sikker prævention under hele behandlingen og i 9 måneder efter sidste dosis af Polivy.
English: Suomi/Finland Roche Oy
Danish: Suomi/Finland
English: How Polivy works
Danish: Hvordan virker Polivy?
English: Do not use if the reconstituted solution is discoloured, is cloudy, or contains visible particulates.
Danish: Kontrollér, at den rekonstituerede opløsning ikke er misfarvet eller indeholder partikler.
English: • inflammation of the lungs
Danish: • betændelsestilstand i lungerne
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 1.
Danish: Dokumenteret kemisk og fysisk holdbarhed af fortyndet opløsning til infusion vises i tabel 1.
English: No Grade 3-5 PN events were reported in either the Polivy plus BR arm or BR arm. 2.2% of patients discontinued Polivy treatment due to PN and 4.4% of patients had Polivy dose reduction due to PN. No patients in the BR arm discontinued treatment or had dose reductions due to PN.
Danish: 2,2% af patienterne fik seponeret behandling med Polivy på grund af PN, og 4,4% af patienterne fik reduceret dosis af Polivy på grund af PN. Ingen patienter i BR-armen fik seponeret behandlingen eller reduceret dosis på grund af PN. I Polivy plus BR-armen var median for debut af første PN-hændelse 1,8 måneder, og hos 61,1% af patienterne med PN-hændelser rapporteredes det, at hændelsen svandt.
English: Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Danish: Trombocytopeni-hændelser medførte seponering af behandling hos 11,1% af patienterne i Polivy plus BR-armen og 5,1% af patienterne i BR-armen.
English: No dedicated mutagenicity studies have been performed with polatuzumab vedotin.
Danish: Der er ikke udført dedikerede mutagenicitetsstudier med polatuzumab vedotin.
English: Women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose.
Danish: Kvinder, der kan blive gravide, bør tilrådes at anvende sikker prævention under behandling med polatuzumab vedotin og i mindst 9 måneder efter sidste dosis.
English: Discontinue Polivy.
Danish: Brug ikke Polivy
English: Τηλ: +30 210 61 66 100
Danish: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
English: Succinic acid
Danish: Succinsyre
English: Women of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 9 months after the last dose (see section 4.6).
Danish: Kvindelige patienter, der kan blive gravide, skal tilrådes at bruge sikker prævention under behandling med Polivy og i mindst 9 måneder efter sidste dosis (se pkt.
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 6 months after the last dose.
Danish: Mænd med kvindelige partnere, der kan blive gravide, bør tilrådes at anvende sikker prævention under behandling med polatuzumab vedotin og i mindst 6 måneder efter sidste dosis.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: • numbness
Danish: • vægttab
English: PML has been reported with Polivy treatment (see section 4.8).
Danish: Der er rapporteret progressiv multifokal leukoencefalopati (PML) i forbindelse med Polivy-behandling (se pkt.
English: Eye disorders Common vision blurred
Danish: Almindelig sløret syn
English: Tel: +44 (0) 1707 366000
Danish: Roche Products Ltd. Tel: +44 (0) 1707 366000
English: • painful rash
Danish: • smertefuldt udslæt
English: What Polivy is used for
Danish: Hvordan anvendes Polivy?
English: For dose modifications for peripheral neuropathy (section 4.4) see Table 1 below.
Danish: 4.4), se tabel 1 nedenfor.
English: Table 1 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Danish: Tabel 1 Dokumenteret kemisk og fysisk holdbarhed af fortyndet opløsning til infusion Solvens til fortynding af opløsning til infusion
English: Talk to your doctor or nurse before you are given Polivy if any of the following apply to you (or you are not sure):
Danish: Hvis ét eller flere af følgende udsagn er relevant for dig eller du er usikker, skal du kontakte lægen eller sygeplejersken inden du får Polivy:
English: • feel dizzy
Danish: • føler dig svimmel
English: No dedicated teratogenicity studies in animals have been performed with polatuzumab vedotin.
Danish: Der er ikke udført dedikerede teratogenicitetsstudier med dyr og polatuzumab vedotin.
English: Very common weight decreased Common transaminase elevation, lipase increase, hypophosphataemia Injury, poisoning and procedural complications Very Common infusion-related reactionsb a
Danish: Meget almindelig vægttab Almindelig stigning i transaminaser, stigning i lipase, hypofosfatæmi
English: IRRs, PN, fatigue, and dizziness may occur during treatment with Polivy (see sections 4.4 and 4.8).
Danish: Infusionsrelaterede reaktioner, perifer neuropati, træthed og svimmelhed kan forekomme under behandling med Polivy (se pkt.
English: • develop chills or shivering
Danish: • får kulderystelser eller kuldegysninger
English: Men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Danish: Mænd der bruger dette lægemiddel bør få gemt sæd i sæddepot inden behandlingen påbegyndes.
English: Discard diluted Polivy solution if storage time exceeds the limits specified in Table 1.
Danish: Hvis opbevaringen overstiger de i tabel 1 angivne holdbarhedsfrister, skal den fortyndede Polivy-opløsning smides ud.
English: Polivy should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
Danish: Hvis patienten oplever en livstruende reaktion, skal behandling med Polivy straks stoppes og seponeres permanent.
English: General disorders and administration site conditions Very common fatigue, pyrexia, asthenia, chills Investigations
Danish: Meget almindelig træthed, pyreksi, asteni, kulderystelser
English: In most cases you will not have any symptoms but tell your doctor or nurse straight away if you get: • yellowing of your skin and of the whites of your eyes (jaundice).
Danish: De fleste har ingen symptomer, men kontakt straks lægen eller sygeplejersken, hvis:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 140 mg of polatuzumab vedotin.
Danish: Hvert hætteglas med pulver til koncentrat til infusionsvæske, opløsning indeholder 140 mg polatuzumab vedotin.
English: Pack size of one vial.
Danish: Der er ét hætteglas i pakken.
English: • unusual sensations
Danish: • følelsesløshed
English: Table 4 Summary of ADRs occurring in relapsed or refractory DLBCL patients treated with Polivy in combination with BR Infections and infestations Very common pneumoniaa, herpes virus infectiona, upper respiratory tract infection Common sepsis, cytomegalovirus infection Blood and lymphatic system disorders Very common febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia
Danish: Meget almindelig febril neutropeni, neutropeni, trombocytopeni, anæmi, leukopeni, lymfopeni Almindelig pancytopeni
English: • pneumonia (lung infection)
Danish: • lungebetændelse
English: E.
Danish: N.V.
English: No dedicated fertility studies in animals have been performed with polatuzumab vedotin.
Danish: Der er ikke gennemført dedikerede dyrefertilitetsstudier med polatuzumab vedotin.
English: If possible, the first dose should be given before this season starts.
Danish: Om muligt bør den første dosis gives, inden denne sæson begynder.
English: This was a reduction of 55%.
Danish: Det svarer til en reduktion på 55 %.
English: It is used in the following groups of children, who are at high risk for this disease:
Danish: Det anvendes hos følgende grupper af børn, der har høj risiko for at få sygdommen:
English: This helps to prevent RSV infection.
Danish: Dette medvirker til at forebygge infektion med RSV.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Synagis den 13. august 1999.
English: This is a summary of the European public assessment report (EPAR) for Synagis.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Synagis.
English: In children born with heart disease, there was a reduction of 45%.
Danish: Hos børn med medfødte hjertelidelser var reduktionen 45 %.
English: The full EPAR for Synagis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Synagis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance palivizumab.
Danish: Det indeholder det aktive stof palivizumab.
English: • children who are less than six months old and were born five or more weeks prematurely (at 35
Danish: • børn, der er under seks måneder og er født fem uger for tidligt eller mere (i 35. svangerskabsuge eller før)
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 Synagis.
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 Synagis.
English: The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Danish: De hyppigste bivirkninger ved Synagis (som ses hos mellem 1 og 10 patienter ud af 100) er feber og udslæt.
English: Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Danish: Synagis gives en gang om måneden, når der er risiko for RSV-infektion i området: På den nordlige halvkugle er dette fra november til april.
English: • children who are less than two years of age and were born with a serious heart disease.
Danish: • børn under to år med medfødt alvorlig hjertesygdom.
English: When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs.
Danish: Når palivizumab bindes til fusionsproteinet, bliver viruset ude af stand til at trænge ind i kroppens celler, specielt cellerne i lungerne.
English: For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Synagis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Synagis
Danish: Andre oplysninger om Synagis
English: Patients generally receive a total of five monthly injections into the thigh muscle.
Danish: Patienten får sædvanligvis i alt fem månedlige indsprøjtninger, der gives i lårmusklen
English: • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
Danish: • børn under to år, der inden for de seneste seks måneder er blevet behandlet for bronkopulmonal dysplasi (abnormt lungevæv, der sædvanligvis findes hos for tidligt fødte børn),
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur, der kaldes et antigen.
English: Synagis is a powder and solvent that are made up into a solution for injection.
Danish: Synagis er et pulver og en solvens, der blandes til en opløsning til injektion.
English: Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Danish: Palivizumab er udformet, så det bindes til et protein, der kaldes fusionsprotein A, på overfladen af RSV.
English: The active substance in Synagis, palivizumab, is a monoclonal antibody.
Danish: Det aktive stof i Synagis, palivizumab, er et monoklonalt antistof.
English: The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Synagis opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Synagis.
English: Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
Danish: I en anden undersøgelse blev Synagis sammenlignet med placebo hos 1 287 børn med medført hjertesygdom.
English: Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Danish: Synagis må ikke anvendes af patienter, der er overfølsomme (allergiske) over for palivizumab eller andre af indholdsstofferne eller over for andre humaniserede monoklonale antistoffer.
English: What is the risk associated with Synagis?
Danish: Hvilken risiko er der forbundet med Synagis?
English: For the full list of all side effects reported with Synagis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Synagis fremgår af indlægssedlen.
English: Why has Synagis been approved?
Danish: Hvorfor blev Synagis godkendt?
English: Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Danish: Synagis var mere effektivt end placebo til at nedbringe antallet af indlæggelser på grund af RSV: Af de børn, der fik Synagis, blev 5 % indlagt for RSV-infektion i løbet af undersøgelsen.
English: Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Danish: Synagis anvendes til forebyggelse af indlæggelseskrævende alvorlige nedre luftvejsinfektioner (i lungerne) med respiratorisk syncytialvirus (RSV).
English: What is Synagis?
Danish: Hvad er Synagis?
English: What is Synagis used for?
Danish: Hvad anvendes Synagis til?
English: What benefit has Synagis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Synagis?
English: How has Synagis been studied?
Danish: Hvordan blev Synagis undersøgt?
English: How is Synagis used?
Danish: Hvordan anvendes Synagis?
English: In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.
Danish: I begge undersøgelser blev behandlingens virkning hovedsagelig bedømt på det antal børn, der måtte indlægges på grund af RSV-infektion.
English: The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
Danish: Hovedundersøgelsen af Synagis blev udført hos 1 502 børn i højrisikogruppen.
English: How does Synagis work?
Danish: Hvordan virker Synagis?