FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives.
Danish: Ved klargøring som anvist indeholder infusionsopløsninger af Cyramza ingen antimikrobielle konserveringsmidler.
English: Discard any unused portion of ramucirumab left in a vial, as the product contains no antimicrobial preservatives.
Danish: Eventuelt ubrugt ramucirumab, som er tilbage i et hætteglas, skal bortskaffes, da produktet ikke indeholder antimikrobielle konserveringsmidler.
English: The one sub-group with HR > 1 was for patients with disease progression from start of first-line bevacizumab treatment of <3 months (HR 1.02 [95% CI: 0.68 to 1.55]).
Danish: Den eneste subgruppe med HR > 1 var patienter med sygdomsprogression < 3 måneder efter påbegyndelse af førstelinjebehandling med bevacizumab (HR 1,02 [95 % KI: 0,68-1,55]).
English: The recommended dose of Cyramza for the treatment of gastric cancer, for the treatment of advanced cancer of the colon or rectum and for the treatment of liver cancer is 8 mg per kilogram of your body weight once every 2 weeks.
Danish: Den anbefalede dosis af Cyramza til behandling af mavekræft, til behandling af fremskreden kræft i tyktarmen eller endetarmen og til behandling af leverkræft er 8 mg pr. kilogram legemsvægt én gang hver anden uge.
English: If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
Danish: Hvis du oplever en infusionsrelateret reaktion under behandlingen med Cyramza, vil du få medicin inden alle efterfølgende infusioner.
English: Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Danish: Tabel 12: Resumé af effektdata i REACH-2 - Intent to treat (ITT) population Cyramza N=197
English: Based on PopPK, ramucirumab exposure was similar in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 to <90 ml/min), moderate renal impairment (CrCl ≥30 to <60 ml/min) or severe renal impairment (CrCl 15 to 29 ml/min) as compared to patients with normal renal function (CrCl ≥90 ml/min).
Danish: Baseret på PopPK var eksponeringen for ramucirumab den samme hos patienter med let nedsat nyrefunktion (kreatininclearance [CrCl] ≥ 60 til < 90 ml/min), moderat nedsat nyrefunktion (CrCl ≥ 30 til <60 ml/min) og svært nedsat nyrefunktion (CrCl < 15-29 ml/min) som hos patienter med normal nyrefunktion (CrCl ≥ 90 ml/min).
English: Table 7: ADRs reported in patients treated with ramucirumab in combination with chemotherapy in phase 3 clinical trials (RAINBOW, REVEL and RAISE)
Danish: Tabel 7: Bivirkninger rapporteret hos patienter behandlet med ramucirumab i kombination med kemoterapi i kliniske fase 3-studier (RAINBOW, REVEL og RAISE)
English: Febrile neutropeniad
Danish: Febril neutropenid
English: Prior to chemotherapy, patients should have a complete blood count.
Danish: Før kemoterapien skal der foretages komplet blodtælling.
English: - severe bleeding in your gut: symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Danish: - alvorlig blødning i tarmen: symptomerne kan omfatte ekstrem træthed, svaghed, svimmelhed eller ændring i farven af afføringen.
English: Patients with squamous histology are at higher risk of developing serious pulmonary bleeding, however, no excess of Grade 5 pulmonary haemorrhage was observed in ramucirumab treated patients with squamous histology in REVEL.
Danish: Patienter med planocellulær histologi har en højere risiko for at udvikle alvorlig pulmonal blødning, dog blev der ikke observeret en øget hyppighed af grad 5 pulmonal blødning hos ramucirumabbehandlede patienter med planocellulær histologi i REVEL-studiet.
English: Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level (see Table 3).
Danish: Når urinproteinniveauet er faldet til <2 g/24 timer, skal behandlingen genoptages ved et reduceret dosisniveau (se tabel 3).
English: Table 6: ADRs reported in patients treated with ramucirumab as monotherapy in phase 3 clinical trials (REGARD, REACH-2 and REACH patients with alpha fetoprotein ≥ 400 ng/ml)
Danish: Tabel 6: Bivirkninger rapporteret hos patienter behandlet med ramucirumab som monoterapi i kliniske fase 3-studier (REGARD, REACH-2 og REACH patienter med alfaføtoprotein ≥400 ng/ml)
English: EU/1/14/957/002 - 2 vials of 10 ml.
Danish: EU/1/14/957/002 - 2 hætteglas med 10 ml 13.
English: Symptoms may include a burning sensation in the mouth, ulceration, blisters or swelling.
Danish: Symptomer på dette kan omfatte en brændende følelse i munden, sår, blister eller hævelse.
English: e Includes: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
Danish: e Dette omfatter: abdominale smerter, nedre abdominale smerter, øvre abdominale smerter og leversmerter.
English: Based on PopPK, ramucirumab exposure in patients with mild hepatic impairment (total bilirubin >1.0-1.5 upper limit of normal (ULN) and any AST or total bilirubin ≤1.0 ULN and AST >ULN) or moderate hepatic impairment (total bilirubin > 1.5-3.0 ULN and any AST) was similar to patients with normal hepatic function (total bilirubin and AST ≤ ULN).
Danish: Baseret på PopPK var eksponeringen for ramucirumab den samme hos patienter med let nedsat leverfunktion (total-bilirubin > 1,0-1,5 gange øvre normalgrænse (ULN) og enhver ASAT eller total-bilirubin ≤ 1,0 ULN og ASAT > ULN) og moderat nedsat leverfunktion (total bilirubin > 1,5-3,0 ULN og enhver AST) som hos patienter med normal leverfunktion (total-bilirubin og ASAT ≤ ULN).
English: Tables 6 and 7 below list the adverse drug reactions (ADRs) from placebo controlled phase III clinical trials associated with ramucirumab used either as a monotherapy treatment for gastric cancer and HCC or in combination with different chemotherapy regimens for the treatment of gastric cancer, mCRC and NSCLC.
Danish: Tabel 6 og 7 viser bivirkninger fra kliniske placebokontrollerede fase 3-studier relateret til ramucirumab anvendt enten som monoterapi ved gastrisk cancer og HCC eller i kombination med forskellige kemoterapiregimer ved behandling af gastrisk cancer, mCRC og NSCLC.
English: Other medicines and Cyramza
Danish: Brug af anden medicin sammen med Cyramza
English: Cyramza will be permanently stopped if you experience a severe infusion-related reaction.
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du oplever en alvorlig infusionsrelateret reaktion.
English: How you are given Cyramza
Danish: Sådan får du Cyramza
English: Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml.
Danish: Tilsæt en tilstrækkelig mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske til beholderen, så den samlede mængde bliver 250 ml.
English: Ramucirumab therapy should be temporarily discontinued if there are wound healing complications, until the wound is fully healed (see section 4.4).
Danish: Behandling med ramucirumab skal seponeres midlertidigt, hvis der er sårhelingskomplikationer, indtil såret er komplet helet (se pkt 4.4).
English: Patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL NSCLC clinical trial.
Danish: Patienter, som fik en eller anden form for terapeutisk antikoagulationsbehandling og/eller kronisk behandling med nonsteroide anti-inflammatoriske lægemidler eller trombocytfunktionshæmmere, blev ekskluderet fra det kliniske NSCLC-studie REVEL.
English: To be included in the study, patients were required to have total bilirubin of ≤1.5 mg/dl and AST and ALT ≤3 times ULN, or ≤5 times ULN if liver metastases were present.
Danish: For at blive inkluderet i studiet skulle patienterne have total bilirubin på ≤ 1,5 mg/dl og AST og ALT ≤ 3 gange
English: - Inflammation of the mouth (‘stomatitis'): Cyramza, when given in combination with chemotherapy may increase the risk of developing inflammation of the mouth.
Danish: - Betændelse i munden (stomatitis): Når Cyramza gives i kombination med kemoterapi, kan det øge risikoen for, at du får betændelse i munden.
English: Cyramza may increase the risk of problems with wound healing.
Danish: Cyramza kan øge risikoen for problemer med sårheling.
English: EORTC QLQ-C30, patients in the ramucirumab plus FOLFIRI treatment arm reported a transient decrease in QoL compared to the patients in the placebo plus FOLFIRI treatment arm in most of the scales.
Danish: For EORTC QLQ-C30 rapporterede patienter i ramucirumab plus FOLFIRI-armen om et forbigående fald i QoL på de fleste af skalaerne sammenlignet med patienter i placebo plus FOLFIRI-armen.
English: Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Danish: Gastrointestinal blødninga,f Gastrointestinal perforationa
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cyramza in all subsets of the paediatric population in gastric adenocarcinoma, in adenocarcinoma of the colon and rectum, in lung carcinoma, and liver cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Cyramza i alle undergrupper af den pædiatriske population med gastrisk cancer, adenokarcinom i kolon og rektum, lungecancer og levercancer (se pkt.
English: - have lung cancer and have had recent bleeding in the lung (coughing up bright red blood) or you are regularly taking non-steroidal anti-inflammatory medicines, or medicines which affect blood clotting ability.
Danish: - har lungekræft og for nyligt har haft blødning i lungerne (ophostning af lyst rødt blød), eller hvis du regelmæssigt tager visse typer gigtmedicin eller smertestillende medicin (nonsteroid anti-inflammatorisk medicin) eller medicin, som påvirker blodets størkningsevne.
English: Table 5: Dose modification of FOLFIRI components due to specific ADRs
Danish: Tabel 5: Dosisjustering af FOLFIRI-komponenter på grund af specifikke bivirkninger BIVIRKNING NCI
English: If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued (see section 4.4).
Danish: Hvis der forekommer medicinsk signifikant hypertension, som ikke kan kontrolleres forsvarligt med antihypertensiv behandling, skal behandling med ramucirumab seponeres permanent (se pkt.
English: A total of 1072 patients were randomised (1:1) to receive either Cyramza (n=536) at 8 mg/kg or placebo (n=536), in combination with FOLFIRI.
Danish: I alt 1.072 patienter blev randomiseret (1:1) til enten Cyramza (n=536) 8 mg/kg eller placebo (n=536) i kombination med FOLFIRI.
English: Cyramza at 8 mg/kg or placebo was administered by intravenous infusion every 2 weeks (on days 1 and 15) of a 28-day cycle.
Danish: Cyramza 8 mg/kg eller placebo blev administreret ved intravenøs infusion hver anden uge (på dag 1 og 15) i en 28-dages serie.
English: During each infusion, your doctor or nurse will check for side effects.
Danish: Dosisjusteringer Din læge eller sygeplejerske vil holde øje med bivirkninger under hver infusion.
English: you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Danish: Derfor bør du ikke amme dit barn under behandlingen med Cyramza og i mindst 3 måneder efter sidste dosis.
English: Palmar-plantar erthyrodysaesthesia syndromeg
Danish: Palmoplantar erytrodysæstesi syndromg
English: Cyramza is used to treat liver cancer that is advanced or cannot be taken out by surgery, in adults who have been previously treated with another anticancer medicine (sorafenib) and who have an elevated level of a particular protein in the blood (alpha fetoprotein).
Danish: Cyramza bruges til behandling af leverkræft, der er fremskreden eller ikke kan fjernes ved operation, hos voksne, som tidligere har været behandlet med et andet lægemiddel mod kræft (sorafenib) og som har forhøjet niveau af et bestemt protein i blodet (alfaføtoprotein).
English: Patients were required to have ECOG PS 0 or 1 and to have disease progression within 6 months of the last dose of first-line therapy.
Danish: Patienterne skulle have ECOG- performancestatus (PS) 0 eller 1 og sygdomsprogression indenfor 6 måneder efter den sidste dosis af førstelinjebehandlingen.
English: Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
Danish: På centre i den østlige del af Asien blev der administreret en reduceret docetaxeldosis på 60 mg/m2 hver 21. dag.
English: In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%).
Danish: Hos mCRC-patienter, som blev behandlet med ramucirumab plus FOLFIRI i RAISE-studiet, var proteinuri (1,5 %) den hyppigste bivirkning (≥1 %), som medførte seponering af ramucirumab.
English: In case of pre-filled intravenous infusion container usage Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the pre-filled 250 ml intravenous container.
Danish: Ved anvendelse af fyldt intravenøs infusionsbeholder Ud fra den beregnede mængde ramucirumab fjernes den tilsvarende mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske fra den fyldte 250 ml intravenøse beholder.
English: Reproductive toxicity studies with ramucirumab have not been performed, however, animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryo-foetal development, and postnatal development.
Danish: Dyremodeller knytter imidlertid angiogenese, VEGF og VEGF-receptor 2 til kritiske elementer i den kvindelige reproduktion, den embryoføtale udvikling og den postnatale udvikling.
English: Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du fortælle det til din læge inden påbegyndelse af behandlingen.
English: Patients with recent serious pulmonary, gastrointestinal, or postoperative bleeding, evidence of CNS haemorrhage, tumour involvement of major airway or blood vessel, intra-tumour cavitation, and history of significant bleeding or uncontrolled thrombotic disorders were excluded.
Danish: Patienter med nylig alvorlig pulmonal, gastrointestinal eller postoperativ blødning, tegn på CNS-blødning, tumor involverende de større luftveje eller blodårer, intratumorkavitation og tidligere signifikant blødning eller ukontrollerede trombotiske sygdomme blev ekskluderet.
English: After dilution, Cyramza is administered as an intravenous infusion over approximately 60 minutes.
Danish: Cyramza administreres efter fortynding som en intravenøs infusion over ca. 60 minutter.
English: Patients were required to have experienced disease progression during, or within 4 months after the last dose of, first-line therapy for metastatic disease, or during adjuvant treatment or within 6 months after the last dose of adjuvant therapy, and had ECOG PS 0-1.
Danish: Patienterne skulle have oplevet sygdomsprogression inden for 4 måneder efter sidste dosis af førstelinjebehandlingen for metastatisk sygdom, eller under adjuverende behandling eller inden for 6 måneder efter sidste dosis af den adjuverende behandling, og have ECOG PS på 0-1.
English: Docetaxel dose adjustments
Danish: Justering af docetaxeldosis
English: Efficacy results are shown in Table 8.
Danish: Effektresultaterne er vist i tabel 8.
English: Symptoms may include: extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Danish: Symptomerne kan være: ekstrem træthed, svaghed, svimmelhed eller ændring i farven af afføringen.
English: Median age was 62 years and 40% of patients were ≥65 years; 57% of patients were male; 76% were White and 20% Asian; 49% had ECOG PS 0; 49% of patients had KRAS mutant tumours; and 24% of patients had TTP <6 months after commencing first-line treatment.
Danish: Median-alderen var 62 år, og 40 % af patienterne var ≥ 65 år, 57 % af patienterne var mænd, 76 % var kaukasiere og 20 % asiater, 49 % havde ECOG-PS 0, 49 % af patienterne havde KRAS-muterende tumorer, og 24 % af patienterne havde TTP < 6 måneder efter påbegyndelse af førstelinjebehandling.
English: For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered.
Danish: For østasiatiske patienter skal en reduceret startdosis af docetaxel på 60 mg/m2 på dag 1 i en serie på 21 dage overvejes.
English: The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body's surface area once every 3 weeks.
Danish: Den anbefalede dosis af docetaxel er 75 mg for hver kvadratmeter (m²) kropsoverflade én gang hver 3. uge.
English: Post discontinuation systemic anticancer therapy was given to 54% of patients receiving Cyramza plus FOLFIRI and 56% of patients receiving placebo plus FOLFIRI.
Danish: Der blev givet systemisk anti-cancerbehandling efter afslutning af studiet til 54 % af de patienter, der fik Cyramza plus FOLFIRI, og til 56 % af de patienter, der fik placebo plus FOLFIRI.
English: If particulate matter or discolouration is identified, discard the vial.
Danish: Hvis der observeres partikler eller misfarvning, skal hætteglasset bortskaffes.
English: If a patient develops wound healing complications during therapy, ramucirumab should be discontinued until the wound is fully healed (see section 4.2).
Danish: Hvis en patient udvikler sårhelingskomplikationer under behandlingen, skal ramucirumab seponeres, indtil såret er komplet helet (se pkt.
English: Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusionrelated reactions and proteinuria (see sections 4.2 and 4.4).
Danish: Klinisk relevante reaktioner (herunder grad ≥ 3) forbundet med antiangiogen behanding observeret hos patienter behandlet med ramucirumab i kliniske studier omfattede: gastrointestinale perforationer, infusionsrelaterede reaktioner og proteinuri (se pkt.
English: In this case, East Asian patients with a starting dose of 60 mg/m² should have docetaxel treatment discontinued (see Posology).
Danish: Hvis dette sker for øst-asiatiske patienter ved en startdosis på 60 mg/m², skal docetaxel seponeres (se Dosering).
English: If you have liver cancer your doctor will monitor you for signs and symptoms of confusion and/or disorientation associated with chronic liver problems and will stop treatment with Cyramza if you develop these signs and symptoms.
Danish: Hvis du har leverkræft, vil din læge overvåge dig for tegn og symptomer på forvirring og/eller desorientering forbundet med kroniske leverproblemer.
English: It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Danish: Det gives sammen med en medicinkombination kaldet ”FOLFIRI-kemoterapi”, som indeholder fluoruracil, folinsyre og irinotecan.
English: See docetaxel prescribing information for specific dosing advice.
Danish: Se produktresumeet for docetaxel for specifik doseringsvejledning.
English: There is no relevant use of ramucirumab in the paediatric population for the indications of advanced gastric cancer or gastro-oesophageal adenocarcinoma, adenocarcinoma of the colon and rectum, lung carcinoma, and hepatocellular carcinoma.
Danish: Det er ikke relevant at anvende ramucirumab hos den pædiatriske population til indikationerne fremskreden gastrisk cancer, adenokarcinom i den gastroøsofagale overgang, adenokarcinom i kolon og rektum, lungecancer eller hepatocellulært karcinom.
English: Cyramza contains sodium
Danish: Cyramza indeholder natrium
English: Hepatic encephalopathyc
Danish: Hepatisk encefalopatic
English: Efficacy results are shown in Table 9.
Danish: Effektresultaterne er vist i tabel 9.
English: - develop high blood pressure, until it is controlled with anti-hypertensive medicine - develop wound healing problems, until the wound is healed - will undergo planned surgery, four weeks prior to surgery
Danish: Behandlingen med Cyramza vil blive stoppet midlertidigt, hvis du: - udvikler forhøjet blodtryk, indtil det er bragt under kontrol med blodtrykssænkende medicin - udvikler problemer med sårheling, indtil såret er helet, eller inden en planlagt operation - skal have en planlagt operation, 4 uger før operationen
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus paclitaxel (n=330) or placebo plus paclitaxel (n=335).
Danish: Patienterne blev randomiseret i forholdet 1:1 til at få Cyramza plus paclitaxel (n=330) eller placebo plus paclitaxel (n=335).
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus docetaxel (n=628) or placebo plus docetaxel (n=625).
Danish: Patienterne blev randomiseret i forholdet 1:1 til Cyramza plus docetaxel (n=628) eller placebo plus docetaxel (n=625).
English: The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.
Danish: Farmakokinetikken for paclitaxel blev ikke påvirket ved samtidig administration af ramucirumab, og farmakokinetikken for ramucirumab blev ikke påvirket ved samtidig administration af paclitaxel.
English: Hypoalbuminaemiaa Hyponatraemiaa
Danish: Hypoalbuminæmia Hyponatriæmia
English: Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Danish: Ramucirumab skal seponeres permanent, hvis medicinsk signifikant hypertension ikke kan kontrolleres med antihypertensiv behandling (se pkt.
English: Ramucirumab in combination with FOLFIRI
Danish: Ramucirumab i kombination med FOLFIRI
English: Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%.
Danish: ORR i Cyramza plus paclitaxel-gruppen var 27,9 % og 16,1 % i placebo plus paclitaxel-gruppen.
English: The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab.
Danish: Farmakoinetikken for docetaxel blev ikke påvirket ved samtidig administration af ramucirumab.
English: Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy.
Danish: Proteinuri Patienterne skal monitoreres for udvikling eller forværring af proteinuri under behandlingen med ramucirumab.
English: Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab.
Danish: Hætteglas indeholder enten 100 mg eller 500 mg som en 10 mg/ml opløsning ramucirumab.
English: In the REACH-2 study for HCC, a relevant exposure-efficacy association was observed for ramucirumab which showed that only patients with above-median exposure experienced an improvement in OS, compared to placebo, and these exposure-efficacy relationships remained after attempts to adjust for other prognostic factors.
Danish: I REACH-2-studiet blev der for HCC observeret en relevant sammenhæng mellem eksponering og effekt for ramucirumab, hvilket viste, at kun patienter med en eksponering over medianen oplevede en forbedring i OS sammenlignet med placebo.