FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler bortset fra dem, der er nævnt i pkt.
English: - Fever or infection: You may develop a temperature of 38 ºC or greater during treatment (since you might have fewer white blood cells than normal which is very common).
Danish: - Feber eller infektion: Du kan få en temperatur på 38 ºC eller højere under behandlingen (da du kan have færre hvide blodlegemer end normalt, hvilket er meget almindeligt).
English: Progression free survival, months
Danish: Progressionsfri overlevelse, måneder
English: - have severe kidney problems.
Danish: - har alvorlige nyreproblemer.
English: Symptomatic treatment should be instituted promptly if stomatitis occurs.
Danish: Symptomatisk behandling skal påbegyndes omgående, hvis stomatitis opstår.
English: The correct amount of Cyramza needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
Danish: Den rette mængde Cyramza, som er nødvendig for at behandle din sygdom, vil blive beregnet af din læge eller sygehusapotekets farmaceut afhængigt af din legemsvægt.
English: REACH-2 efficacy results are shown in Table 12 and Figure 8.
Danish: REACH-2-effektresultater er vist i tabel 12 og figur 8.
English: Cyramza should only be used if the potential benefit to the mother justifies the potential risk during pregnancy.
Danish: Cyramza bør kun anvendes, hvis den potentielle fordel for moderen retfærdiggør den potentielle risiko under graviditeten.
English: Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis.
Danish: Vaskulær endotelial vækstfaktor (VEGF)-receptor 2 er den vigtigste mediator for VEGF-induceret angiogenese.
English: If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can't use these medicines.
Danish: Hvis du er i tvivl, skal du spørge din læge eller sundhedspersonalet, om der kan være nogle grunde til, at du ikke kan få disse lægemidler.
English: - have high blood pressure.
Danish: - har forhøjet blodtryk.
English: Your doctor or hospital pharmacist will calculate your body surface area by measuring your height and weight and will work out the right dose for you.
Danish: Din læge eller sygehusapotekets farmaceut beregner din legemsoverflade ved at måle højde og vægt og beregner herefter den rette dosis til dig.
English: ADRs of aneurysms and artery dissections have a frequency of ‘not known'.
Danish: Bivirkningerne aneurismer og arterielle dissektioner har hyppigheden ”Ikke kendt”.
English: This is equivalent to approximately 4% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til ca. 4 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Cyramza has been administered in a Phase 1 study up to 10 mg/kg every two weeks without reaching a maximum tolerated dose.
Danish: Cyramza er givet i et fase 1-studie med op til 10 mg/kg hver anden uge uden, at der blev nået en maksimal tolereret dosis.
English: The majority of patients (76%) had experienced disease progression within 6 months from the start of first-line therapy.
Danish: Størstedelen af patienterne (76 %) havde oplevet sygdomsprogression inden for 6 måneder fra påbegyndelse af førstelinjebehandlingen.
English: In both treatment arms, patients who experienced neutropenia had a longer median OS compared to patients who did not experience neutropenia.
Danish: I begge behandlingsarme havde de patienter, som fik neutropeni, en længere median OS sammenlignet med de patienter, som ikke fik neutropeni.
English: This is equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette svarer til ca. 4 % af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: You should not receive Cyramza for at least 4 weeks before you undergo planned surgery and your doctor will decide when to re-start treatment.
Danish: Du bør ikke få Cyramza i mindst 4 uger inden en planlagt operation, og lægen beslutter, hvornår behandlingen skal genoptages.
English: Also tell your doctor if you are taking any medicines which may increase the risk of bleeding or which affect blood clotting ability.
Danish: Du skal også fortælle lægen, hvis du tager medicin, som kan øge risikoen for blødning, eller som påvirker blodets evne til at størkne.
English: ADRs are listed below by MedDRA body system organ class.
Danish: Bivirkningerne er anført nedenfor i henhold til MedDRA-systemorganklasse.
English: Patients in two Phase 3 studies, RAINBOW and REGARD were tested at multiple time-points for anti-drug antibodies (ADAs).
Danish: Patienter i to fase 3-studier, RAINBOW og REGARD, blev testet på flere forskellige tidspunkter for anti-drug antistoffer (ADA'er).
English: Dose modifications of each component of FOLFIRI should be made independently and are provided in Table 4.
Danish: Dosisjustering af de enkelte komponenter i FOLFIRI skal foretages uafhængigt og er angivet i tabel 4.
English: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim France
Danish: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim Frankrig
English: Intestinal obstructiona
Danish: Intestinal obstruktiona
English: Patients who are treated with ramucirumab should have their blood pressure monitored.
Danish: Patienter, som behandles med ramucirumab, skal have deres blodtryk monitoreret.
English: Severe bleeding
Danish: Svær blødning
English: The safety and efficacy of Cyramza in children and adolescents (<18 years) has not been established.
Danish: Cyramzas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Before initiating Cyramza, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Cyramza bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: None of the patients with ADAs experienced an IRR.
Danish: Ingen af patienterne med ADA'er oplevede en infusionsrelateret reaktion (IRR).
English: Your doctor will discuss with you if the potential benefits of treatment are judged to outweigh the potential risks for you.
Danish: Lægen vil tale med dig om, hvorvidt de potentielle fordele ved behandlingen skønnes at opveje de potentielle risici for dig.
English: Rare side effects (may affect up to 1 in 1000 people): - abnormal blood clotting in small blood vessels
Danish: Sjældne bivirkninger (kan ramme op til 1 ud af 1.000 personer): - unormal blodkoagulation i små blodkar
English: Table 4: FOLFIRI dose reductions FOLFIRI componenta
Danish: Tabel 4: FOLFIRI dosisreduktioner FOLFIRI komponenta
English: Two-thirds of the patients experienced disease progression while still on first-line therapy (66.8%).
Danish: 2/3 af patienterne havde oplevet sygdomsprogression, mens de stadig fik førstelinjebehandling (66,8 %).
English: Patients were required to have adequate hepatic, renal and coagulation function.
Danish: Patienterne skulle have tilstrækkelig lever-, nyre- og koagulationsfunktion.
English: The primary endpoint was overall survival.
Danish: Det primære endepunkt var samlet overlevelse.
English: Samples were tested from 956 patients: 527 ramucirumab treated patients and 429 control treated patients.
Danish: Prøver fra 956 patienter blev undersøgt: 527 patienter, som fik ramucirumab, og 429 kontrolpatienter blev testet.
English: Criteria to be met prior to each paclitaxel infusion are provided in Table 1.
Danish: De kriterier, som skal opfyldes inden hver infusion af paclitaxel, er anført i tabel 1.
English: h Includes cases of nephrotic syndrome.
Danish: h Inklusive tilfælde af nefrotisk syndrom.
English: Eligible patients were Child Pugh A (score < 7), had creatinine clearance ≥ 60 ml/min, and ECOG PS of 0 or 1.
Danish: Egnede patienter havde Child Pugh A (score <7), kreatinclearance ≥ 60ml/min og ECOG PS på 0 eller 1.
English: Cyramza is a concentrate for solution for infusion (also called “sterile concentrate”).
Danish: Cyramza er et koncentrat til fremstilling af en infusionsvæske (også kaldet "sterilt koncentrat").
English: If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
Danish: Hvis du bliver gravid under behandlingen med Cyramza, vil din læge tale med dig om, hvorvidt fordelen for dig ved behandlingen er større end en mulig risiko for dig eller det ufødte barn.
English: This is a specialised protein that can recognise and attach to another protein found on blood vessels called ‘VEGF receptor 2'.
Danish: Dette er specielt protein, som kan genkende og binde sig til et andet protein, der findes i blodårerne - dette protein kaldes ”VEGF receptor 2”.
English: In the pivotal studies there is limited evidence that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Danish: I de pivotale studier har begrænsede data vist tegn på, at patienter over 65 år har en øget risiko for bivirkninger i forhold til patienter under 65 år.
English: Prior to being given any paclitaxel infusion, you will have blood tests to check that your blood counts are high enough and that your liver is functioning well.
Danish: Inden du får en infusion med paclitaxel, vil du få taget blodprøver for at kontrollere, at dine blodværdier er høje nok, og at din lever fungerer tilfredsstillende.
English: Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Danish: Klargør infusionsopløsningen ved anvendelse af aseptisk teknik for at sikre steriliteten af den klargjorte opløsning.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer ATC-kode: L01XC21.
English: As Cyramza inhibits the development of new blood vessels, it may decrease the likelihood of you becoming pregnant or maintaining a pregnancy.
Danish: Da Cyramza hæmmer udviklingen af nye blodkar, kan det nedsætte din mulighed for at blive gravid eller opretholde en graviditet.
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Danish: Parenterale lægemiddelprodukter skal kontrolleres visuelt for partikler før indgivelse.
English: The infusion rate of ramucirumab should be reduced by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a grade 1 or 2 IRR.
Danish: Infusionshastigheden for ramucirumab skal reduceres med 50 % under hele infusionen og ved alle efterfølgende infusioner, hvis patienten oplever en IRR af grad 1 eller 2.
English: No liver metastases: ALT/AST ≤3 x ULN Liver metastases: ALT/AST ≤5 x ULN
Danish: Ingen levermetastaser: ALT/AST ≤ 3 x ULN Levermetastaser: ALT/AST ≤ 5 x ULN
English: You may be given another medicine to reduce the risk of an infusion-related reaction before you receive Cyramza.
Danish: Du vil muligvis få anden medicin for at nedsætte risikoen for en infusionsrelateret reaktion, inden du får Cyramza.
English: Cyramza should not be administered or mixed with dextrose solutions.
Danish: Cyramza bør ikke administreres eller blandes med glucoseopløsninger.
English: Cyramza may cause changes in laboratory tests.
Danish: Cyramza kan være årsag til ændrede laboratorieprøver.
English: Depending on the protein level measured, Cyramza may be temporarily discontinued.
Danish: Afhængig af det målte proteinindhold kan behandlingen med Cyramza blive stoppet midlertidigt.
English: Based on PopPK, there was no difference in ramucirumab exposure in patients ≥65 years of age compared to patients <65 years old.
Danish: Baseret på PopPK var der ingen forskel i eksponering for ramucirumab hos patienter ≥ 65 år sammenlignet med patienter < 65 år.
English: Cyramza):
Danish: Cyramza indeholder:
English: Patients who discontinued one or more components of treatment because of an adverse event were permitted to continue therapy with the other treatment component(s) until disease progression or unacceptable toxicity.
Danish: De patienter, som seponerede en eller flere af komponenterne på grund af en bivirkning, fik lov til at fortsætte behandlingen med den eller de andre behandlingskomponenter indtil sygdomsprogression eller uacceptabel toksicitet.
English: To achieve the required infusion duration of approximately 60 minutes, the maximum infusion rate of 25 mg/minute should not be exceeded, instead the infusion duration should be increased.
Danish: For at opnå den påkrævede infusionsvarighed på ca. 60 minutter må den maksimale infusionshastighed på 25 mg/minut ikke overskrides.
English: - Infusion-related reaction: Infusion-related reactions may happen during treatment because Cyramza is given as an intravenous infusion via a drip (see section 3).
Danish: - Infusionsrelaterede reaktioner: Infusionsrelaterede reaktioner kan opstå under behandling med Cyramza, fordi Cyramza gives som en intravenøs infusion via et drop (se afsnit 3).
English: Common side effects (may affect up to 1 in 10 people): - hole in the wall of your gut: this is a hole that develops in the stomach, gut or bowel.
Danish: Almindelige bivirkninger (kan ramme op til 1 ud af 10 personer): - hul i tarmvæggen: dette er et hul, som udvikler sig i mavesækken eller tarmen.
English: Tell your doctor immediately if you experience any of the following serious side effects that have been observed during Cyramza treatment (see also What you need to know before you are given
Danish: Fortæl straks din læge, hvis du oplever en eller flere af de følgende alvorlige bivirkninger, som er observeret under behandling med Cyramza (se også Det skal du vide, før du får Cyramza):
English: To grow, cancer needs new blood vessels to develop.
Danish: For at kræft kan vokse skal der dannes nye blodårer.
English: Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Danish: Hvert 10 ml hætteglas indeholder mindre end 1 mmol (23 mg) natrium, dvs. det er i det væsentlige natrium-frit.
English: It is unknown whether ramucirumab is excreted in human milk.
Danish: Det er ukendt, om ramucirumab udskilles i human mælk.
English: The amount of paclitaxel or docetaxel needed depends on the surface area of your body.
Danish: Den nødvendige mængde paclitaxel eller docetaxel afhænger af din legemsoverflade.
English: The primary QoL analysis showed similar time to deterioration for all Lung Cancer Symptom Scale (LCSS) scores between treatment arms.
Danish: Den primære QoL-analyse viste samme tid til forværring for alle Lung Cancer Symptom Scale (LCSS)-parametre i de 2 behandlingsarme.
English: Elderly patients with NSCLC
Danish: Ældre patienter med NSCLC
English: Your doctor will monitor your blood pressure and adjust your blood pressure medicine as needed during treatment with Cyramza.
Danish: Lægen vil overvåge dit blodtryk og justere din blodtryksmedicin efter behov under behandlingen med Cyramza.
English: Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Danish: Ramucirumab er et humant IgG1-monoklonalt antistof, der produceres i murine (NS0) celler ved rekombinant DNA-teknologi.
English: Alpha fetoprotein (AFP) testing in HCC
Danish: Test for alfaføtoprotein (AFP) ved HCC
English: Your doctor or nurse will check for side effects during your infusion.
Danish: Din læge eller sygeplejerske vil holde øje med bivirkninger under infusionen.
English: Women of childbearing potential should use effective contraception during and up to 3 months after the last dose of ramucirumab treatment.
Danish: Reproduktionsdygtige kvinder skal anvende sikker kontraception under og i op til 3 måneder efter sidste dosis af ramucirumab.
English: The primary endpoint was OS and the secondary endpoints included PFS, objective response rate (ORR) and quality of life (QoL) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
Danish: Det primære endepunkt var OS, og de sekundære endepunkter inkluderede PFS, objektiv responsrate (ORR) og livskvalitet (Quality of life (QoL)) bedømt ved the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
English: Dose reductions for individual components of FOLFIRI may be made for specific toxicities.
Danish: Dosis af de individuelle komponenter i FOLFIRI kan reduceres ved specifikke toksiciteter.
English: Cyramza is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Cyramza anbefales ikke under graviditet og til reproduktionsdygtige kvinder, som ikke bruger kontraception.
English: Patients should be monitored for clinical signs and symptoms of hepatic encephalopathy.
Danish: Patienterne skal overvåges for kliniske tegn og symptomer på hepatisk encefalopati.
English: Table 5 provides details of dose delays or dose reductions of components of FOLFIRI at the next cycle based on maximum grade of specific adverse drug reactions.
Danish: Tabel 5 angiver detaljer for dosisudsættelse eller dosisreduktion af FOLFIRI-komponenterne ved den næste serie baseret på maksimal grad af specifikke bivirkninger.
English: The primary endpoint was overall survival (OS) and the secondary endpoints included progression free survival (PFS) and overall response rate (ORR).
Danish: Det primære endepunkt var samlet overlevelse (OS), og de sekundære endepunkter omfattede progressionsfri overlevelse (PFS) og total responsrate (ORR).
English: There was no clear deviation from dose proportionality in pharmacokinetics of ramucirumab from 6 mg/kg to 20 mg/kg.
Danish: Der var ingen klar afvigelse fra dosisproportionaliteten i farmakokinetikken for ramucirumab fra 6 mg/kg til 20 mg/kg.
English: - are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
Danish: - skal gennemgå en planlagt operation, hvis du for nyligt har gennemgået en operation, eller hvis du har ringe sårheling efter operation.
English: If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Danish: Hvis patienterne oplever symptomer, som påvirker deres evne til at koncentrere sig og reagere, anbefales det, at de ikke fører motorkøretøj eller betjener maskiner, før virkningen har fortaget sig.
English: Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.
Danish: Præmedicinering anbefales med en histamin H1-antagonist (f.eks. diphenhydramin) inden infusion af ramucirumab.
English: In REACH-2, baseline patient demographics and disease characteristics were generally balanced between arms, except for AFP, which was lower in the placebo arm.
Danish: I REACH-2 var patienternes demografi og sygdomskarakteristika ved baseline generelt balanceret mellem armene, bortset fra AFP, som var lavere i placeboarmen.
English: d Includes: blood pressure increased and hypertension.
Danish: d Dette omfatter: blodtryksstigning og hypertension.
English: If you are receiving Cyramza in combination with either paclitaxel or docetaxel on the same day, Cyramza will be given first.
Danish: Hvis du får Cyramza i kombination med enten paclitaxel eller docetaxel på den samme dag, vil du få Cyramza først.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges straks, er brugeren ansvarlig for opbevaringstiden i brug og betingelserne inden brug, som normalt ikke vil være mere end 24 timer ved 2 ºC til 8 ºC, medmindre der er foretaget fortynding under kontrollerede og validerede aseptiske forhold.
English: No animal studies have been performed to test ramucirumab for potential of carcinogenicity or genotoxicity.
Danish: Der er ikke udført dyreforsøg for at teste ramucirumab for potentiale for karcinogenicitet eller genotoksicitet.
English: Patients may be at increased risk for the development of fistula when treated with Cyramza.
Danish: Patienterne kan have en øget risiko for udvikling af fistler i forbindelse med behandling med Cyramza.
English: Based on PopPK, the following covariates were found to have no impact on ramucirumab disposition: age, sex, race, albumin levels.
Danish: Baseret på PopPK har følgende kovarianter ingen indvirkning på ramucirumabs fordeling: alder, køn, race, albuminniveau.
English: If you experience an infusion-related reaction during treatment, the time taken to give your infusion will be increased for the rest of that infusion and for all future infusions.
Danish: Hvis du oplever en infusionsrelateret reaktion under behandlingen, øges den tid, det tager at indgive infusionen, under resten af den pågældende infusion og ved alle efterfølgende infusioner.
English: Your doctor may prescribe treatment to help with the symptoms.
Danish: Din læge kan udskrive medicin, som kan afhjælpe symptomerne.
English: An improvement in PFS was also associated with increasing ramucirumab exposure for advanced gastric cancer, NSCLC, and mCRC.
Danish: En forbedring i PFS var også forbundet med øget ramucirumab-eksponering ved fremskreden gastrisk cancer, NSCLC og mCRC.
English: This medicine is given by infusion via a drip over a period of approximately 60 minutes.
Danish: Lægemidlet gives som en infusion via et drop over et tidsrum på ca. 60 minutter.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.
Danish: Hvis det ikke anvendes straks, er brugeren ansvarlig for opbevaringstiden i brug og betingelserne inden brug, som normalt ikke vil være mere end 24 timer ved 2 ºC til 8 ºC.
English: This receptor is needed in the development of new blood vessels.
Danish: Denne receptor bruges, når der dannes nye blodårer.
English: Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus < 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
Danish: Randomiseringen blev stratificeret i henhold til vægttab i løbet af de sidste 3 måneder (≥ 10 % versus < 10 %), geografisk region og placeringen af den primære tumor (mavesæk versus den gastroøsofagale overgang).
English: f Includes one case of nephrotic syndrome
Danish: f Dette omfatter et tilfælde af nefrotisk syndrom.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har været utilstrækkelige med hensyn til reproduktionstoksicitet (se pkt.
English: The container should be gently inverted to ensure adequate mixing.
Danish: Beholderen skal forsigtigt vendes op og ned for at sikre, at væsken blandes tilstrækkeligt.
English: Includes hepatic encephalopathy and hepatic coma.
Danish: Dette omfatter hepatisk encefalopati og hepatisk koma.
English: There are no data from the use of ramucirumab in pregnant women.
Danish: Der foreligger ingen data om brug af ramucirumab til gravide kvinder.
English: The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.
Danish: Beslutningen om at genoptage behandlingen med ramucirumab efter et kirurgisk indgreb skal baseres på et klinisk skøn med hensyn til tilstrækkelig sårheling.
English: Papendorpseweg 83 3528 BJ Utrecht
Danish: Papendorpseweg 83 3528 BJ Utrecht Holland
English: If the patient becomes pregnant while being treated with ramucirumab, she should be informed of the potential risk to the maintenance of pregnancy and the risk to the foetus.
Danish: Hvis patienten bliver gravid under behandlingen med ramucirumab, skal hun informeres om den potentielle risiko ved opretholdelse af graviditeten og risikoen for fostret.