FrancophonIA/ELRC3.0 huggingface dataset:
English: If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Danish: Hvis den initiale støddosis er veltolereret, kan de efterfølgende doser administreres som en 30 minutters infusion.
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Danish: I dette punkt er følgende kategorier for hyppighed blevet anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Each vial contains either:
Danish: Hvert hætteglas indeholder enten:
English: Monoclonal antibodies attach to specific proteins or antigens.
Danish: Monoklonale antistoffer binder til specifikke proteiner eller antigener.
English: The efficacy results from the BCIRG 006 are summarised in Tables 9 and 10.
Danish: Effektresultaterne fra BCIRG 006-studiet er sammenfattet i tabel 9 og 10.
English: Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
Danish: Efterfølgende vedligeholdelsesdoser bør administreres 7 eller 21 dage senere i henhold til henholdvis ugentlige eller 3-ugers doseringsregimer.
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with KANJINTI.
Danish: Derfor skal din hjertefunktion kontrolleres før, under (hver tredje måned) og efter (op til to til fem år) behandlingen med KANJINTI.
English: Median follow-up 12 months*
Danish: Median opfølgning 12 måneder*
English: The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm.
Danish: Hyppigheden af symptomatisk kardiel dysfunktion var 1,7 % i trastuzumab-armen.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Danish: Opbevar altid dette lægemiddel i den lukkede originalpakning i køleskab ved 2 °C - 8 °C.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Danish: Størstedelen af infusionsrelaterede reaktioner er dog milde til moderate i styrke (NCI-CTC klassificeringssystem) og plejer at opstå tidligt i behandlingen, det vil sige under infusion nummer et, to og tre og formindskes i hyppighed ved efterfølgende infusioner.
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Danish: 1 Angiver bivirkninger, som er rapporteret i stor udstrækning i forbindelse med infusionsrelaterede reaktioner.
English: If you experience any of the above symptoms when your treatment with KANJINTI has finished, you should see your doctor and tell them that you have previously been treated with KANJINTI.
Danish: Hvis du får nogle af ovenstående symptomer, når behandlingen med KANJINTI er stoppet, skal du kontakte din læge og fortælle, at du tidligere er blevet behandlet med KANJINTI.
English: For instructions on reconstitution of KANJINTI intravenous formulation before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af KANJINTI intravenøs formulering før administration, se pkt.
English: Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
Danish: Formel kardiologisk vurdering bør overvejes hos patienter, hos hvem der er mistanke om kardiologisk sygdom efter baseline screening.
English: These events have occasionally been fatal.
Danish: Disse bivirkninger har nogle gange haft letal udgang.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Danish: Trastuzumab kan dog øge den samlede eksponering for en af doxorubicins metabolitter (7-deoxy-13-dihydro-doxorubicinon, D7D).
English: • You have early breast cancer, with high levels of a protein called HER2.
Danish: • Du har tidlig brystkræft med høje koncentrationer af et protein, som kaldes HER2.
English: This translates into an absolute benefit in terms of an 8 year disease-free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
Danish: Dette overføres til en absolut gavnlig effekt udtrykt i en 8 års sygdomsfri overlevelsesrate på 6,4 procentpoint til fordel for 1 års trastuzumab-behandling.
English: Treatment with KANJINTI alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Danish: Behandling med KANJINTI alene eller sammen med et taxan kan påvirke hjertet, især hvis du tidligere har fået antracykliner (taxaner og antracykliner er to andre slags lægemidler, der anvendes til at behandle kræft).
English: This helps your medicine work as well as it can.
Danish: Dette får lægemidlet til at virke bedst muligt.
English: p-value versus AC→P
Danish: p-værdi versus AC→P
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Danish: • udføres i et laminært flow eller biologisk sikkerhedsskab ved brug af standard forholdsregler til sikker håndtering af intravenøse midler.
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6.
Danish: Dette lægemiddel må ikke blandes eller fortyndes med andre lægemidler end dem, der er anført under pkt.
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Danish: I dette studie havde 87 % af de inkluderede patienter sygdom, som var IHC3+ og 95 % af de inkluderede patienter havde sygdom, der var IHC3+ og/eller FISH-positiv.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Danish: Støddosen af KANJINTI bør administreres som en 90 minutters intravenøs infusion.
English: • The active substance is trastuzumab.
Danish: • Aktivt stof: trastuzumab.
English: Hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Danish: Hormon-receptor-positive patienter må heller ikke have responderet på hormonbehandling, medmindre patienterne er uegnede til behandlingen.
English: Therefore you should tell your doctor, pharmacist or nurse that you have had KANJINTI if you start any new medicine in the 7 months after stopping treatment.
Danish: Du bør derfor fortælle din læge, apotekspersonalet eller sundhedspersonalet, at du har fået KANJINTI, hvis du begynder at anvende enhver form for nyt lægemiddel indenfor 7 måneder efter ophør med KANJINTI-behandlingen.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop KANJINTI treatment.
Danish: Hvis du udvikler tegn på hjertesvigt (dårlig pumpefunktion af hjertet), kan det være, at din hjertefunktion skal kontrolleres oftere (hver 6. til 8. uge), du vil muligvis få behandling af hjertesvigt, eller du må stoppe behandlingen med KANJINTI.
English: Glomerulonephritis membranous Not known Glomerulonephropathy
Danish: Membranøs glomerulonephritis Ikke kendt Glomerulonefropati
English: There is no fertility data available.
Danish: Der foreligger ingen data vedrørerende fertilitet.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstiderne og opbevaringsbetingelserne inden ibrugtagen brugerens ansvar og vil normalt ikke overstige 24 timer ved 2 °C - 8 °C.
English: The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied.
Danish: Sikkerheden ved fortsættelse eller genoptagelse af trastuzumab-behandling hos patienter, som oplever kardiel dysfunktion, er ikke undersøgt prospektivt.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given trastuzumab.
Danish: I meget sjældne tilfælde er det sket, at patienter, som havde alvorlige vejrtrækningsproblemer inden behandlingsstart, døde, da de fik trastuzumab.
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Danish: Disse symptomer kan behandles med et analgetikum/antipyretikum såsom meperidin eller paracetamol eller et antihistamin såsom diphenhydramin.
English: Tell a doctor or nurse straight away, if you notice any of the following side effects:
Danish: Fortæl øjeblikkeligt din læge eller sygeplejerske, hvis du oplever en af følgende bivirkninger:
English: Gallop rhythm present
Danish: Galloperende rytme til stede
English: Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments.
Danish: Tidligere kemoterapi skal have omfattet mindst et antracyklin og et taxan, medmindre patienterne er uegnede til disse behandlinger.
English: However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates are unlikely to have a clinically meaningful effect on trastuzumab concentrations.
Danish: På grund af størrelsen af disse kovarianters effekt på trastuzumabs eksponering er det dog ikke sandsynligt, at disse kovarianter har nogen klinisk relevant effekt på koncentrationen af trastuzumab.
English: Care must be taken to ensure the sterility of prepared solutions.
Danish: Der skal udvises forsigtighed for at sikre steriliteten af den klargjorte opløsning.
English: Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class II-IV) or asymptomatic cardiac dysfunction.
Danish: Patienter, som behandles med KANJINTI, har en øget risiko for at udvikle kongestiv hjerteinsufficiens (New York Heart Association [NYHA] klasse II-IV) eller asymptomatisk kardiel dysfunktion.
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Danish: FP+H: Fluoropyrimidin/cisplatin + trastuzumab FP: Fluoropyrimidin/cisplatin a Sandsynslighedsratio
English: Neutropenic sepsis
Danish: Neutropenisk sepsis
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including cross-over of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Danish: *Co-primære endepunkt for sygdomsfri overlevelse på 1 år versus observation overholdt de prædefinerede statistiske grænser ** Endelig analyse (inkluderende overgang af 52 % af patienterne fra observations-armen til trastuzumab) ***Der er diskrepans i den samlede prøvestørrelse grundet et lille antal patienter, der blev randomiseret efter skæringsdatoen for analysen for 12 måneders median opfølgning.
English: Your doctor may prescribe KANJINTI for the treatment of breast and gastric cancer when:
Danish: Din læge kan ordinere KANJINTI til behandling af bryst- og mavekræft, hvis:
English: At the time of a safety update after a median of 3.5-3.8 years follow-up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Danish: På tidspunktet for en sikkerhedsopdatering efter en median opfølgningstid på 3,5-3,8 år genbekræfter en analyse af sygdomsfri overlevelse størrelsen af den gavnlige effekt vist i den endelige analyse af sygdomsfri overlevelse.
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥ 50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Danish: Reversibiliteten af svær kongestiv hjerteinsufficiens (defineret som en sekvens på mindst to på hinanden følgende LVEF-værdier ≥ 50 % efter hændelsen) var evident hos 71,4 % af de trastuzumab-behandlede patienter.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Danish: Patienter, som tidligere har fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m2 infunderet over 3 timer) med eller uden trastuzumab.
English: • You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
Danish: • Du har metastatisk brystkræft (brystkræft, som har spredt sig ud over den oprindelige tumor) med høje koncentrationer af HER2.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in table 6:
Danish: Effektresultaterne fra studie BO16348 efter 12 måneders* og 8 års** median opfølgning er sammenfattet i tabel 6:
English: Febrile neutropenia
Danish: Febril neutropenia
English: KANJINTI may affect your ability to drive a car or use machines.
Danish: KANJINTI kan påvirke din evne til at køre bil, motorcykel, cykle eller betjene maskiner.
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Danish: Erfaring med samtidig administration af trastuzumab og regimer med lavdosis-antracyklin er på nuværende tidspunkt begrænset til to studier (MO16432 og BO22227).
English: +Cardiac failure (congestive)
Danish: +Hjerteinsufficiens (kongestiv)
English: The reconstituted KANJINTI results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Danish: Det rekonstituerede KANJINTI resulterer i en farveløs til svagt gul, klar opløsning, som hovedsaglig skal være fri for synlige partikler.
English: Do not use with glucose-containing solutions.
Danish: Der må ikke anvendes glucoseopløsninger.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstiderne og opbevaringsbetingelserne inden ibrugtagen brugerens ansvar og vil normalt ikke overstige 24 timer ved 2 °C - 8 °C, medmindre rekonstituering og fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: KANJINTI should be carefully handled during reconstitution.
Danish: KANJINTI skal behandles forsigtigt under rekonstitueringen.
English: If a pregnant woman is treated with KANJINTI, or if a patient becomes pregnant while receiving KANJINTI or within 7 months following the last dose of KANJINTI, close monitoring by a multidisciplinary team is desirable.
Danish: Hvis en gravid kvinde behandles med KANJINTI, eller hvis en patient bliver gravid under behandlingen med KANJINTI eller indenfor 7 måneder efter den sidste dosis KANJINTI, anbefales tæt monitorering af et tværfagligt hold.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Danish: Generelt anses CISH for at være positiv, hvis der er mere end 5 kopier af HER2-genet per cellekerne i mere end 50 % af tumorcellerne.
English: From a microbiological point of view, the reconstituted solution and KANJINTI infusion solution should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og infusionsopløsningen med KANJINTI anvendes med det samme.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping KANJINTI treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Danish: Trastuzumab kan fortsat være i cirkulationen i op til 7 måneder efter ophør af KANJINTIbehandlingen, baseret på populationsfarmakokinetiske analyser af alle tilgængelige data (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Danish: Dato for første markedsføringstilladelse: 16. maj 2018
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during KANJINTI therapy and for 7 months after the last dose.
Danish: Da humant IgG1 udskilles i human mælk, og da den potentielle skade på spædbørn er ukendt, må kvinder ikke amme under behandling med KANJINTI og i de første 7 måneder efter sidste dosis.
English: Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Danish: Der er ikke observeret klinisk signifikante interaktioner mellem trastuzumab og de andre lægemidler, der blev anvendt samtidigt i de kliniske studier.
English: Do not use KANJINTI if:
Danish: Du må ikke få KANJINTI, hvis:
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Danish: Denne tilstand kan være skadelig for dit foster og er blevet forbundet med ufuldstændig udvikling af lungerne, hvilket kan resultere i fosterdød.
English: • swelling or bleeding at the back of the eyes
Danish: • hævelse eller blødning bagest i øjnene
English: Table 6 Efficacy results from study BO16348
Danish: Effektresultater fra studie BO16348
English: Breast inflammation/mastitis
Danish: Brystinflammation/mastitis
English: Duration of response, median months
Danish: Responsvarighed, median måneder
English: At the time of the analysis a total of 349 randomised patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Danish: På det tidspunkt, analysen blev foretaget, var i alt 349 randomiserede patienter døde: 182 patienter (62,8 %) i kontrolarmen og 167 patienter (56,8 %) i behandlingsarmen.
English: In the final population PK model, in addition to primary tumour type, body weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Danish: I den endelige populationsfarmakokinetiske model blev udover primær tumortype også kropsvægt, serum-aspartat-aminotransferase og -albumin identificeret som statistisk signifikante kovarianter med indvirkning på trastuzumabs eksponering.
English: During a KANJINTI infusion, chills, fever and other flu like symptoms may occur.
Danish: Under en KANJINTI-infusion kan der forekomme kulderystelser, feber og andre influenzalignende symptomer.
English: Occasionally, symptoms start later than six hours after the infusion begins.
Danish: Lejlighedsvis kan symptomerne indtræffe senere end 6 timer efter, infusionen er påbegyndt.
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
Danish: I meget sjældne tilfælde har patienter oplevet frembrud af infusionssymptomer og pulmonale symptomer mere end 6 timer efter påbegyndelse af trastuzumab-infusionen.
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Danish: Hjertefunktionen bør monitoreres under behandlingen (f.eks. hver 12. uge) hos alle patienter.
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Danish: Hyppigheden var højest hos patienter, der fik administreret trastuzumab samtidig med et taxan (2,0 %).
English: • You should use effective contraception during treatment with KANJINTI and for at least 7 months after KANJINTI treatment has ended.
Danish: • Du skal bruge effektiv prævention under behandlingen med KANJINTI og i mindst 7 måneder efter, at behandlingen med KANJINTI er stoppet.
English: Trastuzumab was administered weekly with chemotherapy and 3-weekly thereafter for a total of 52 weeks.
Danish: Trastuzumab blev administreret ugentligt med kemoterapi og derefter hver 3. uge i ialt 52 uger.
English: The reconstituted solution should not be frozen.
Danish: Den rekonstituerede opløsning må ikke nedfryses.
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Danish: Der var ikke tegn på akut eller multipel dosis-relateret toksicitet i studier på op til 6 måneder og heller ikke tegn på reproduktionstoksicitet i studier vedrørende teratologi, fertilitet hos hunner eller sen gestationstoksicitet hhv. placentaoverførsel.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC03
English: Chemo + trastuzumab (n = 115)
Danish: Kemo + trastuzumab (n = 115)
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Danish: Trastuzumab er desuden en potent mediator af antistofafhængig cellemedieret cytotoksicitet (ADCC).
English: The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Danish: Hyppigheden af infusionsrelaterede reaktioner af alle grader varierede mellem studierne afhængigt af indikation og metode til dataindsamling og afhængigt af, om trastuzumab blev givet samtidig med kemoterapi eller som monoterapi.
English: Trastuzumab 1 Year N = 1,702***
Danish: Trastuzumab 1 år N = 1.702***
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Danish: Monitorering kan være en hjælp til at identificere patienter, som udvikler kardiel dysfunktion.
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler bør handelsnavnet og batchnummeret af det administrerede præparat tydeligt registreres.
English: 2) Swirl the vial gently to aid reconstitution.
Danish: 2) Sving hætteglasset forsigtigt for at understøtte rekonstitueringen.
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Danish: Et fåtal af patienterne blev testet under anvendelse af fluorescens in situ-hybridisering (FISH).
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Danish: Trastuzumab blev undersøgt som adjuverende behandling i 4 store multicenter, randomiserede studier.
English: To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Danish: For at sikre nøjagtige og reproducerbare resultater skal testningen udføres af et speciallaboratorium, som kan sikre validering af testprocedurerne.
English: There is no experience with overdose in human clinical trials.
Danish: Der er ikke rapporteret tilfælde af overdosering i humane kliniske studier.
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, KANJINTI is given every 3 weeks.
Danish: Ved tidlig brystkræft, metastatisk brystkræft og metastatisk mavekræft gives KANJINTI hver 3. uge.