FrancophonIA/ELRC3.0 huggingface dataset:
English: The addition of Avastin to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Danish: Tillæg af Avastin til FOLFOX-4 gav en statistisk signifikant forlængelse af overlevelse.
English: The results of these analyses were very similar to the primary PFS results.
Danish: Resultaterne af disse analyser var meget lig de primære resultater for PFS.
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Danish: Alvorlige bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra tilgængelige data) omfatter:
English: 6 - 12 months (n=202) Median
Danish: 6 - 12 måneder (n=202) Median
English: ● you may develop a severe migraine.
Danish: • Du kan få svær migræne.
English: If you are considering having children you should discuss this with your doctor before your treatment starts.
Danish: Hvis du overvejer at få børn, skal du rådføre dig med din læge, før behandlingen påbegyndes.
English: Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
Danish: Nogle af disse bivirkninger resulterede i varierende grader af synstab, herunder permanent blindhed.
English: With or without gross residual disease.
Danish: Med eller uden makroskopisk residualsygdom.
English: If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.
Danish: Hvis der opstår en reaktion, skal infusionen ophøre og passende medicinsk behandling iværksættes.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Table 6 Treatment regimens in trial NO16966 (mCRC) Treatment
Danish: Behandlingsregimer i studie NO16966 (mCRC) Behandling
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Danish: Progressionen af metastatisk sygdom blev hæmmet, og den mikrovaskulære permeabilitet blev nedsat.
English: Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry.
Danish: Adjuvant taxanbehandling var kun tilladt, hvis den var afsluttet mindst 12 måneder før inklusion i studiet.
English: According to the two-compartmental model, the elimination half-life is 18 days for a typical female patient and 20 days for a typical male patient.
Danish: Ifølge to-kompartmentmodellen er halveringstiden for en typisk kvindelig patient 18 dage og 20 dage for en typisk mandlig patient.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Danish: Hvis det er påkrævet skal behandlingen enten seponeres permanent eller afbrydes midlertidigt, som beskrevet i pkt.
English: In Part II, treatment assignment was double-blind with respect to Avastin.
Danish: I del 2 var tildeling af behandling dobbeltblindet i forhold til Avastin.
English: Statistically significant improvements in progression-free survival were also observed.
Danish: Der blev også observeret statistisk signifikante forbedringer i progressionsfri overlevelse.
English: However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR= 0.91).
Danish: Stigningen i det primære endepunkt, samlet overlevelse på 2 måneder, var ikke signifikant (HR = 0,91).
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og på hætteglasset efter forkortelsen ”EXP”.
English: Effects on wound healing were shown to be fully reversible.
Danish: Det blev vist, at effekten på sårheling var helt reversibel.
English: Binding of the IgG to the FcRn receptor results in protection from cellular metabolism and the long terminal half-life.
Danish: Binding af IgG til FcRn-receptoren medfører beskyttelse fra cellulær metabolisme og den lange terminale halveringstid.
English: ● your doctor will decide when you should be given your next dose of Avastin.
Danish: • Din læge beslutter, hvornår du skal have den næste Avastindosis.
English: Efficacy Results for Study ML18147 (ITT population)
Danish: Effektresultater for studie ML18147 (ITT population)
English: Do not stop treatment with Avastin unless you have discussed this with your doctor.
Danish: Stop ikke behandlingen med Avastin før, du har diskuteret det med din læge.
English: Prespecified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Danish: Præspecificerede PFS-analyser blev udført, alle med en cut-off den 29. september 2009.
English: Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Danish: Avastin kan skade det ufødte barn, da det kan standse dannelsen af nye blodkar.
English: a Interferon alfa-2a 9 MIU 3x/week b
Danish: Interferon alfa-2a 9 MIE 3x/ugentlig b
English: (See section 4.2 for information on paediatric use).
Danish: 4.2 for information om pædiatrisk anvendelse).
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Danish: Langtidsvirkningerne af bevacizumab-behandling på fertiliteten er ukendt.
English: Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
Danish: Kvinder i den fertile alder skal anvende effektiv kontraception under og i op til 6 måneder efter behandling.
English: The dose of Avastin needed depends on your body weight and the kind of cancer to be treated.
Danish: Dosis af Avastin afhænger af din legemsvægt og af den type kræft, der skal behandles.
English: Reactions (frequency*)
Danish: Bivirkninger (frekvens*)
English: Overall Survival (final analysis)***
Danish: Samlet overlevelse (endelig analyse)***
English: ● if you undergo surgery.
Danish: • hvis du skal opereres.
English: There were no grade 4 or 5 hypertension events.
Danish: Der var ingen tilfælde af hypertension af grad 4 eller 5.
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly-diagnosed high-grade glioma.
Danish: Der er utilstrækkelig information til at fastslå sikkerhed og effekt af bevacizumab hos børn med nylig diagnosticeret høj-grads-gliom.
English: It is not known whether bevacizumab is excreted in human milk.
Danish: Det vides ikke, om bevacizumab udskilles i human mælk.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes øjeblikkelig, er holdbarheden under anvendelse og opbevaringsbetingelserne før anvendelsen brugerens ansvar, og de er normalt ikke længere end 24 timer ved 2 ºC - 8 ºC, medmindre opløsningen har fundet sted under kontrollerede og validerede aseptiske omstændigheder.
English: Prior hormonal therapy for the treatment of metastatic disease was allowed.
Danish: Tidligere hormonbehandling af metastisk sygdom var tilladt.
English: ***The final analysis of overall survival was performed when 266 deaths, which account for 73.7 % of enrolled patients, were observed.
Danish: ***Den endelige analyse af samlet overlevelse er udført efter registrering af 266 dødsfald, hvilket udgør 73,7 % af de inkluderede patienter.
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Danish: • abnormt højt blodtryk i lungernes blodårer, som forårsager, at højre side af hjertet arbejder hårdere end normalt,
English: Overall Survival (OS)
Danish: Samlet overlevelse (OS)
English: A total of 820 patients were randomised.
Danish: I alt blev 820 patienter randomiseret.
English: This study included a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase.
Danish: Dette studie indeholdt en blindet behandlingsfase, en valgfri åben post-progressionsfase og en opfølgningsfase for overlevelse.
English: The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Danish: Populationsfarmakokinetiske data hos voksne og pædiatriske patienter blev analyseret for at evaluere virkningen af demografiske karakteristika.
English: Objective Response Rate (ORR) Patients included in analysis Rate
Danish: Objektiv responsrate (ORR) Patienter inkluderet i analysen
English: * Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Danish: * Samlet overlevelsesanalyse ved klinisk cut-off 31. januar 2007 ** Primær analyse ved klinisk cut-off 31. januar 2006 a I forhold til kontrolarmen
English: Avastin was combined with two chemotherapy regimens:
Danish: Avastin blev kombineret med to kemoterapiregimer:
English: Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Caution should be exercised when Avastin and intravenous bisphosphonates are administered simultaneously or sequentially.
Danish: Der bør udvises forsigtighed, når Avastin og intravenøse bisfosfonater administreres samtidigt eller sekventielt.
English: • post-authorisation safety studies,
Danish: ● sikkerhedsstudier efter markedsføringstilladelse,
English: The value for clearance is, on average, equal to 0.188 and 0.220 L/day for female and male patients, respectively.
Danish: Clearance er i gennemsnit 0,188 og 0,220 l/døgn for henholdsvis kvindelige og mandlige patienter.
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of Avastin with the IFL regimen was established and considered acceptable.
Danish: Som forud planlagt blev inklusionen i arm 3 standset, så snart sikkerheden af Avastin med IFL-regimet var dokumenteret og blev anset for acceptabel.
English: Approximately 350 patients were randomised into each of the 4 trial arms in the Part II of the trial.
Danish: Omkring 350 patienter blev randomiseret i hver af de 4 behandlingsarme i del 2 af studiet.
English: There are no clinical trial data on the use of Avastin in pregnant women.
Danish: Der er ingen data fra kliniske studier om anvendelse af Avastin til gravide kvinder.
English: Infusion solutions should be used immediately after dilution.
Danish: Infusionsopløsningen skal anvendes umiddelbart efter fortyndingen.
English: Patients should have had a life expectancy of ≥ 12 weeks and no prior radiotherapy to the pelvis or abdomen.
Danish: Patienterne skulle have forventet levetid ≥ 12 uger og måtte ikke tidligere have fået strålebehandling af bækken eller abdomen.
English: ● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Danish: • hvis du får svært forhøjet blodtryk, der kræver behandling med blodtryksmedicin,
English: See Section 4.
Danish: Se punkt 4.
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Danish: • negativ påvirkning af kvinders evne til at få børn (for yderligere anbefalinger se nedenfor efter bivirkningslisten)
English: (Yes=randomized to undergo cytoreduction or randomized to not undergo cytoreduction; No= not a candidate or did not consent to cytoreduction).
Danish: (Ja = randomiseret til tumorreduktion eller randomiseret til ingen tumorreduktion; No = ikke en kandidat eller kandidaten indvilligede ikke i tumorreduktion.)
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + Avastin) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Danish: Blandt de 110 patienter randomiseret til arm 3 (5-FU/FA + Avastin) inden lukning af denne arm, var den mediane samlede overlevelse 18,3 måneder og den mediane progressionsfri overlevelse var 8,8 måneder.
English: Each pack of Avastin contains one vial.
Danish: Hver pakning med Avastin indeholder et hætteglas.
English: Symptoms usually resolve or improve within days after treatment discontinuation, although some patients have experienced some neurologic sequelae.
Danish: Symptomerne forsvinder normalt eller bedres i løbet af et par dage efter behandlingsafbrydelse, selvom nogle patienter har oplevet neurologiske sequalae.
English: Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Danish: Desuden havde 65 % af patienterne fået adjuverende kemoterapi, herunder 19 % forudgående taxaner og 49 % forudgående antracykliner.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Avastin treatment.
Danish: Hvis du har forhøjet blodtryk, som ikke er velbehandlet med blodtrykssænkende medicin, skal du kontakte din læge, fordi det er vigtigt at sikre, at dit blodtryk er under kontrol, før du starter i behandling med Avastin.
English: The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA 125 levels, or symptomatic deterioration per protocol.
Danish: Det primære endepunkt var PFS, baseret på investigators vurdering af sygdomsprogression baseret på radiologiske scanninger eller CA-125-niveauer, eller symptomatisk forværring per protokol.
English: • CT Arm (chemotherapy alone):
Danish: • Kemoterapi-arm (kemoterapi alene):
English: Please talk to your doctor since blood clots can lead to heart attack and stroke.
Danish: Tal med din læge, eftersom blodpropper kan forårsage hjerteanfald og slagtilfælde.
English: You should discuss this with your doctor.
Danish: Du bør tale med din læge herom.
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Danish: Hvis du skal opereres, hvis du har fået foretaget en større operation indenfor de sidste 28 dage, eller hvis du har et sår efter en operation, som ikke er helet, må du ikke få Avastin.
English: • Bleeding in the eye.
Danish: • blødning i øjet.
English: • infection, and in particular infection in the blood or bladder,
Danish: • infektion, specielt infektion i blodet eller blæren,
English: In trial E2100, patients were treated until disease progression.
Danish: I studie E2100 blev patienterne behandlet indtil sygdomsprogression.
English: Avastin infusions should not be administered or mixed with glucose solutions.
Danish: Infusionsvæsker med Avastin bør ikke administreres eller blandes med glucoseopløsninger.
English: Limited information is available on the continued use of Avastin in patients with other fistulae.
Danish: Der er kun begrænset information om fortsat brug af Avastin hos patienter med andre fistler.
English: Patients with recent pulmonary haemorrhage/ haemoptysis (> 2.5 ml of red blood) should not be treated with Avastin.
Danish: Patienter med nylig pulmonal blødning/hæmoptyse (> 2,5 ml rødt blod) bør ikke behandles med Avastin.
English: ● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Danish: • Risikoen for at udvikle blodpropper i arterierne (en type blodkar) kan øges, hvis du er over 65 år, hvis du har sukkersyge, eller hvis du tidligere har haft blodpropper i arterierne.
English: Day 1, prior to FOLFOX-4, every 2 weeks
Danish: Dag 1 før FOLFOX-4, hver 2. uge
English: Table 14
Danish: Tabel 14
English: Therefore, caution should be exercised before initiating therapy in these patients.
Danish: Der skal derfor iagttages forsigtighed, før behandlingen påbegyndes hos disse patienter.
English: Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Danish: Patienterne blev stratificeret i forhold til land og Motzer-score, og behandlingsarmene blev vist at være velafbalancerede i forhold til prognostiske faktorer.
English: Data are unadjusted for the differential time on treatment.
Danish: Data er ikke justeret for forskelle i tidspunktet i behandlingsforløbet.
English: You should seek help as soon as possible if you suffer from any of the below mentioned side effects.
Danish: Du skal søge hjælp så hurtigt som muligt, hvis du får en af nedenfor nævnte bivirkninger.
English: Before initiating Avastin, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Avastin bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Non-small cell lung cancer (NSCLC)
Danish: Ikke-småcellet lungekræft (NSCLC)
English: After correcting for body weight, male patients had a larger Vc (+ 20%) than female patients.
Danish: Efter korrektion for legemsvægt havde mandlige patienter et større Vc (+20 %) end kvindelige patienter.
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment.
Danish: • En sjælden neurologisk bivirkning kaldet posteriort reversibelt encefalopati- syndrom (PRES) har været knyttet til Avastinbehandling.
English: Fistulae have also been reported in post-marketing experience.
Danish: Fistler er også rapporteret post-marketing.
English: Final overall survival analysis performed when 46.9% of the patients had died.
Danish: 6 Den endelige analyse for samlet overlevelse blev udført, da 46,9 % af patienterne var døde.
English: Detailed information about these post-marketing reactions are provided in Table 3.
Danish: Detaljeret information om disse postmarketing-bivirkninger er givet i tabel 3.
English: ● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
Danish: • svært forhøjet blodtryk, som ikke kan kontrolleres med blodtrykssænkende medicin, eller hvis blodtrykket pludseligt stiger alvorligt,
English: It is recommended that the treatment with Avastin in addition to erlotinib is continued until disease progression.
Danish: Det anbefales, at behandling med Avastin i tillæg til erlotinib fortsættes indtil sygdomsprogression.
English: Median overall survival*
Danish: Median samlet overlevelse*
English: Most patients were FIGO Stage IIIC or Stage IV.
Danish: De fleste patienter var i FIGO-stadie IIIC eller IV.
English: CI, confidence interval; HR, Hazard ratio from unstratified Cox regression analysis; NR, not reached.
Danish: HR, Hazardratio fra ikke-stratificeret Cox regression analyse; NR, ikke opnået.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in Table 6 for trial NO16966.
Danish: I kemoterapiarmene anvendtes et FOLFOX-4 regime med samme dosering og frekvens som vist i tabel 6 for studie NO16966.
English: Placebo or Avastin
Danish: Placebo eller Avastin
English: IgGs are known to cross the placenta, and Avastin is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
Danish: Det vides, at IgG passerer placentabarrieren, og Avastin forventes at hæmme angiogenesen hos fostret og er dermed under mistanke for at kunne forårsage alvorlige medfødte misdannelser ved indgivelse under graviditet.
English: Major or massive pulmonary haemorrhage/haemoptysis can occur suddenly and up to two thirds of the serious pulmonary haemorrhages resulted in a fatal outcome.
Danish: Alvorlig eller massiv pulmonal blødning/hæmoptyse kan opstå pludseligt, og op mod to tredjedele af de alvorlige pulmonale blødninger havde dødelig udgang.
English: Patients were nephrectomised for primary renal cell carcinoma.
Danish: Patienterne blev nefrektomeret grundet primær renalcellekarcinom.
English: Number of patients Progression-free survival
Danish: Antal patienter Progressionfri overlevelse
English: b stratified by the duration of treatment free-interval prior to enrolling onto this study per the registration form, and secondary surgical debulking status Yes/No.
Danish: b Stratificeret efter varighed af behandlingsfri periode før inklusion i studiet per registreringsform og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
English: It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease.
Danish: Det er vigtigt, at din læge ved, om du tidligere har fået antracykliner (for eksempel doxorubicin, en speciel slags kemoterapi, som bruges mod nogle kræfttyper), om du har fået strålebehandling af brystet, eller om du har en hjertesygdom.
English: The initial dose should be delivered over 90 minutes as an intravenous infusion.
Danish: Initialdosis skal gives over 90 minutter som intravenøs infusion.
English: It should not be administered as an intravenous push or bolus.
Danish: Bør ikke administreres som intravenøs støddosis eller som bolus.
English: In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Danish: I de fleste af de kliniske studier med Avastin blev patienter med præ-eksisterende CHF af NYHA (New York Heart Association) klasse II-IV ekskluderet, og derfor findes der ingen data for risikoen for CHF i denne population.
English: • Study E2100 (paclitaxel)
Danish: • Studie E2100 (paclitaxel)
English: Pack of 1 vial.
Danish: Pakninger med 1 hætteglas.
English: There was no exclusion criterion for prior anti-angiogenic therapy.
Danish: Der var ingen eksklusionskriterier for tidligere behandling med angiogenesehæmmere.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Avastin:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Avastin:
English: f Observed in pediatric population only
Danish: Kun observeret i den pædiatriske population.
English: Of the 722 patients in the trial, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Danish: Af de 722 patienter i studiet havde hovedparten HER2-negativ sygdom (90 %), mens der var et lille antal patienter med ukendt (8 %) eller bekræftet HER2-positiv status (2 %), som tidligere var blevet behandlet med eller som blev betragtet som uegnede til trastuzumabbehandling.
English: ● Avastin can increase the risk of developing a weak heart.
Danish: • Avastin kan øge risikoen for at udvikle et svagt hjerte.