FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 2 (erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)
Danish: Grad 2 (erytem, deskvamation eller hævelse, som forstyrrer, men ikke udelukker, normale fysiske aktiviteter; små blister eller sårdannelser mindre end 2 cm i diameter)
English: Persistent severe myelosuppression, may result in superinfection or haemorrhage.
Danish: Vedvarende alvorlig myelosuppression kan medføre superinfektion eller blødning.
English: G-CSF (or GM-CSF) may be given as concomitant therapy to support the blood count when the ANC count is < 1,000/mm
Danish: G-CSF (eller GM-CSF) kan gives som samtidig behandling for at øge antallet af blodlegemer, når ANC-tallet er < 1000/mm
English: Breast cancer/Ovarian cancer Caelyx is administered intravenously at a dose of 50 mg/m once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.
Danish: Brystcancer/ovariecancer Caelyx indgives intravenøst i en dosis på 50 mg/m2 én gang hver fjerde uge, så længe sygdommen ikke progredierer, og patienten fortsætter med at tolerere behandlingen.
English: Pegylated liposomes are small enough (average diameter of approximately 100 nm) to pass intact (extravasate) through defective blood vessels supplying tumours.
Danish: Pegylerede liposomer er tilstrækkeligt små (gennemsnitsdiameter cirka 100 nm) til i intakt tilstand at kunne passere (ekstravasere) gennem beskadigede blodkar som forsyner tumorer.
English: Undesirable effects observed in patients with AIDS-related KS according to CIOMS III frequency categories
Danish: Bivirkninger observeret hos patienter med AIDS-relateret KS i henhold til CIOMS III-hyppighedskategorier
English: Caelyx is administered as an intravenous infusion.
Danish: Caelyx administreres som intravenøs infusion.
English: Standard doxorubicin hydrochloride displays extensive tissue distribution (volume of distribution: 700 to 1,100 l/m 2) and a rapid elimination clearance (24 to
Danish: Standard doxorubicinhydrochlorid udviser udbredt vævsdistribution (distributionsvolumen 700 til 1.100 liter/m 2) og en hurtig eliminationsclearance
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp.
English: Cases of secondary oral cancer were diagnosed both, during treatment with Caelyx, and up to 6 years after the last dose.
Danish: Der er diagnosticeret tilfælde af sekundær oral cancer såvel under behandling med Caelyx og i op til 6 år efter den sidste dosis.
English: - For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4counts (< 200 CD4 lymphocytes/mm
Danish: - Til behandling af AIDS-relateret Kaposis sarkom (KS) hos patienter med lave CD4-tal (< 200 CD4-lymfocytter/mm
English: Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant.
Danish: Da det aktive stof doxorubicinhydrochlorid i Caelyx kan forårsage misdannelser, er det vigtigt at fortælle din læge, hvis du tror, du er gravid.
English: Breast cancer n=404
Danish: Brystcancer n=404
English: Oral pain
Danish: Oral smerte
English: The infusion may be given through a peripheral vein.
Danish: Infusionen kan gives i en perifer vene.
English: AIDS-related KS
Danish: AIDS-relateret KS
English: Caelyx has no or negligible influence on the ability to drive and use machines.
Danish: Caelyx påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.
Danish: Behandling vil omfatte indgift af antibiotika, transfusioner med blodplader, anvendelse af faktorer som stimulerer produktionen af hvide blodlegemer og symptomatisk behandling af mundsår.
English: Fertility The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).
Danish: Fertilitet Virkningen af doxorubicinhydrochlorid på human fertilitet er ikke undersøgt (se pkt.
English: In this case, the dose interval may be extended by 1-2 weeks or the dose reduced (see section 4.2).
Danish: I så fald kan dosisintervallet forlænges med 1 - 2 uger eller dosis nedsættes (se pkt.
English: The exact mechanism of the antitumour activity of doxorubicin is not known.
Danish: Den eksakte virkningsmekanisme for doxorubicins tumorhæmmende effekt er ikke kendt.
English: Some of these effects may be related to your disease and not to Caelyx; - general feeling of tiredness, weakness, feeling of pins and needles or pain in hands and feet; - hair loss.
Danish: Nogle af disse virkninger kan skyldes din sygdom og ikke Caelyx; - generel følelse af træthed, svaghed, stikkende fornemmelse eller smerter i hænder og fødder.
English: Maximum plasma concentration* (µg/ml) Plasma clearance (l/h/m Volume of distribution (l/m AUC (µg/mlh)
Danish: Maksimal plasmakoncentration* (µg/ml) Plasmaclearance (liter/time/m Fordelingsvolumen (liter/m AUC (µg/mltime)
English: This interim analysis showed a TTP risk reduction of 45% (95% CI: 29-57%), p < 0.0001.
Danish: Denne interimanalyse viste en risikoreduktion i TTP på 45 % (95 % CI: 29-57 %), p < 0,0001.
English: The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx that exceeds a lifetime cumulative anthracycline dose of 450 mg/m
Danish: Vurderingen af venstre ventrikels funktion betragtes som obligatorisk før hver yderligere indgift af Caelyx, der overstiger en kumulativ dosis over livstid for antracyklin på 450 mg/m
English: Wait until ANC  1,500 and platelets  75,000; decrease dose by 25% or continue full dose with growth factor support.
Danish: Vent til ANC  1.500 og blodplader  75.000; reducer dosis med 25 % eller fortsæt normaldosis med støtte af vækstfaktor.
English: - In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
Danish: - I kombination med bortezomib til behandlingen af progressiv myelomatose hos patienter, der har modtaget mindst én tidligere behandling, og som allerede har gennemgået eller er uegnede til knoglemarvstransplantation.
English: The incidence of life threatening (grade 4) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
Danish: Incidensen af livstruende (grad 4) hæmatologiske reaktioner var < 1,0 % og sepsis blev rapporteret hos 1 % af patienterne.
English: 4 weeks) was palmar-plantar erythrodysesthesia (PPE).
Danish: 4. uge) var palmoplantar erytrodysæstesi (PPE).
English: In very rare cases, seizures (convulsions) have occurred.
Danish: I meget sjældne tilfælde er anfald (kramper) forekommet.
English: The bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8, and 11 every 3 weeks.
Danish: Behandlingen med bortezomib består af 1,3 mg/m2 på dag 1, 4, 8 og 11 hver 3. uge.
English:  1/100 and < 1/10
Danish:  1/100 til < 1/10
English: Weight decreased
Danish: Nedsat vægt
English: The range of Billingham cardiotoxicity scores was grades 0-1.5.
Danish: Billingham-skalaen var grad 0 - 1,5.
English: Reduction in haemoglobin and platelets were less frequently (< 5%) reported.
Danish: Reduktion af hæmoglobin og trombocytter var mindre hyppigt rapporteret (< 5 %).
English: Caelyx is also used to produce an improvement in your Kaposi's sarcoma including flattening, lightening and even shrinkage of the cancer.
Danish: Caelyx anvendes også til at give en forbedring af Kaposis sarkom blandt andet ved lindring, lettelse og endog formindskelse af canceren.
English: To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
Danish: For at modvirke bivirkninger som palmoplantar erytrodysæstesi (PPE) og stomatitis eller hæmatologisk toksicitet kan dosis reduceres eller udskydes.
English: Furthermore, based on the pooled analysis of 4,231 patients across indications, the SmPC should be updated to in order to better detail the risk of cardiotoxicity associated with Caelyx.
Danish: Baseret på den samlede analyse af 4.231 patienter på tværs af alle indikationer, bør produktresuméet desuden opdateres for bedre at redegøre for risikoen for kardiotoksicitet i forbindelse med Caelyx.
English: The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.
Danish: Dosen gentages hver fjerde uge så længe sygdommen ikke tiltager og du tåler behandlingen.
English: Based on the review of the safety data of pegylated liposomal doxorubicin hydrochloride (Caelyx), a signal of lichenoid keratosis was detected with a total of 10 cases reported.
Danish: Baseret på gennemgangen af sikkerhedsdataene for pegyleret liposomal doxorubicinhydrochlorid (Caelyx) blev der registreret et signal af lichenoid keratose med i alt 10 rapporterede tilfælde.
English: These linear MPEG groups extend from the liposome surface creating a protective coating that reduces interactions between the lipid bilayer membrane and the plasma components.
Danish: Disse lineære MPEG-grupper udgår fra overfladen af liposomerne og danner derved en beskyttende kappe, der reducerer interaktioner mellem den tolagede lipidmembran og plasmakomponenterne.
English: The tables for PPE (Table 1) and stomatitis (Table 2) provide the schedule followed for dose modification in clinical trials in the treatment of breast or ovarian cancer (modification of the recommended 4 week treatment cycle): if these toxicities occur in patients with AIDS-related KS, the recommended 2 to 3 week treatment cycle can be modified in a similar manner.
Danish: Tabellerne for PPE (tabel 1) og stomatitis (tabel 2) angiver fremgangsmåden, som blev fulgt for dosisjustering i kliniske undersøgelser af bryst- eller ovariecancerbehandling (justering af den anbefalede 4 ugers behandlingscyklus): hvis disse toksiciteter forekommer i patienter med AIDS relateret KS, kan den anbefalede 2 til 3 ugers behandlingscyklus modificeres på tilsvarende vis.
English: Population pharmacokinetic data (in the range of creatinine clearance tested of 30-156 ml/min) demonstrate that Caelyx clearance is not influenced by renal function.
Danish: Populations-farmakokinetiske data (i det undersøgte område for creatinin clearance 30 - 156 ml/min) viser, at udskillelsen af Caelyx ikke påvirkes af nyrefunktionen.
English: This is probably the result of intercalation of the anthracycline between adjacent base pairs of the DNA double helix thus preventing their unwinding for replication.
Danish: Dette skyldes formentlig indføjelse af antracyklin mellem tilstødende basepar i DNA dobbelt helix, hvorved udfoldelsen af DNA forud for replikationen hæmmes.
English: Do not dose this cycle if before day 4; if after day 4, reduce next dose by 25%.
Danish: Indgiv ikke denne cyklus, hvis det er før dag 4; hvis det er efter dag 4, reducér næste dosis med 25 %.
English: Haematological toxicity may require dose reduction or suspension or delay of therapy.
Danish: Hæmatologisk toksicitet kan nødvendiggøre dosisreduktion, seponering eller udsættelse af behandlingen.
English: Temporarily stopping the infusion usually resolves these symptoms without further therapy.
Danish: Midlertidig afbrydelse af infusionen afhjælper sædvanligvis disse symptomer uden yderligere behandling.
English: If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water.
Danish: Såfremt Caelyx kommer i berøring med hud eller slimhinder, skal man straks vaske området omhyggeligt med vand og sæbe.
English: Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx treatment.
Danish: Da mange lægemidler, inklusive antracykliner, udskilles i modermælk og på grund af muligheden for alvorlige uønskede reaktioner hos diende spædbørn skal mødre derfor ophøre med at amme før påbegyndelse af Caelyx-behandling.
English: Caelyx resulted in mild to moderate ovarian and testicular atrophy in mice after a single dose of 36 mg/kg.
Danish: Caelyx resulterede i let til moderat ovarie- og testisatrofi i mus efter en enkelt dosis på 36 mg/kg.
English: The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Danish: Den primære analyse af kardiel toksicitet viste, at risikoen for udvikling af kardielle tilfælde som en funktion af den kumulative antracyklindosis var signifikant lavere med Caelyx end med doxorubicin (HR=3,16, p < 0,001).
English: Evidence of penetration of pegylated liposomes from blood vessels and their entry and accumulation in tumours has been seen in mice with C-26 colon carcinoma tumours and in transgenic mice with KS-like lesions.
Danish: Beviser på penetrering af pegylerede liposomer fra blodkar og deres indgang og ophobning i tumorer er set i mus med C-26 kolon karcinom-tumorer og i transgene mus med KSlignende læsioner.
English: Redose unless patient has experienced a previous grade 3 or 4 stomatitis in which case wait an additional week
Danish: Gendoser medmindre patienten har haft en forudgående grad 3 eller 4 stomatitis, i hvilket tilfælde der ventes en yderligere uge
English: Similar dermal lesions, which are described as palmar-plantar erythrodysesthesia were also observed in patients after long-term intravenous infusion (see section
Danish: Lignende hudlæsioner, kendt som palmoplantar erytrodysæstesi, rapporteres også hos patienter efter langtids intravenøs infusion (se pkt.
English: If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i.e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2.
Danish: Hvis patienten tolererer den første dosis uden en stigning i serum-bilirubin eller leverenzymer, kan dosis i cyklus 2 forøges til det næste dosisniveau, det vil sige hvis første dosis er reduceret med 25 %, øg til normaldosis i cyklus 2; hvis første dosis er reduceret med 50 %, øg til 75 % af normaldosis i cyklus 2.
English: Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood.
Danish: Akut overdosering forværrer bivirkninger som sår i munden eller fald i antallet af hvide blodlegemer og blodplader i blodet.
English: Cardiac toxicity was defined as a decrease of 20 points or greater from baseline if the resting LVEF remained in the normal range or a decrease of 10 points or greater if the LVEF became abnormal (less than the lower limit for normal).
Danish: Kardiel toksicitet blev defineret som et fald på 20 points eller mere fra baseline, hvis venstre ventrikels ejektionsfraktion (LVEF) i hvile forblev inden for normalområdet, eller et fald på 10 points eller mere, hvis LVEF blev unormal (lavere end den nedre grænse af normalområdet).
English: In most patients treatment can be resumed after all symptoms have resolved, without recurrence.
Danish: Hos de fleste patienter kan behandling genoptages, efter at alle symptomer er ophørt, uden recidiv.
English: The dose is repeated as long as you respond satisfactorily and tolerate treatment.
Danish: Dosis gentages så længe du reagerer tilfredsstillende og tolererer behandlingen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Danish: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgien
English: It is not known whether Caelyx is excreted in human milk.
Danish: Det vides ikke, om Caelyx udskilles i modermælk.
English: Caelyx will be given to you by your doctor in a drip (infusion) into a vein.
Danish: Caelyx vil blive givet af din læge direkte i en vene gennem et drop (som infusion).
English: In nearly all patients, Caelyx treatment can be resumed after all symptoms have resolved without recurrence.
Danish: I næsten alle patienter kan Caelyx-behandling genoptages, efter alle symptomer er ophørt, uden recidiv.
English: Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Danish: Undgå at blive gravid, mens du eller din partner er i behandling med Caelyx samt i de første seks måneder efter ophør med Caelyx-behandling.
English: Dosage adjustments for Caelyx + bortezomib combination therapy - patients with multiple myeloma
Danish: Dosisjustering for caelyx + bortezomib kombinationsbehandling - patienter med myelomatose
English: Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Danish: Retningslinjer for Caelyx-dosisjustering sekundært til ovennævnte bivirkninger er angivet i tabellerne nedenfor.
English: Clinically significant laboratory abnormalities (grades 3 and 4) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and < 1% of patients respectively.
Danish: Klinisk signifikante afvigelser i laboratorieværdier (grad 3 og 4) i denne gruppe var lav med øget total bilirubin, ASAT og ALAT rapporteret hos henholdsvis 2,4 %, 1,6 % og < 1 % af patienterne.
English: No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.
Danish: Der findes ingen farmakokinetiske data for patienter med creatinin clearance under 30 ml/minut.
English: The most frequently observed OI's in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
Danish: De hyppigst forekommende OI'er i kliniske undersøgelser var candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumoni og mycobakterium avium kompleks.
English: Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.
Danish: Caelyx kan, som andre doxorubicinhydrochlorid-præparater, potensere toksiciteten af anden cancerbehandling.
English: Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g., < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.
Danish: Ved mistanke om kardiomyopati, det vil sige når venstre ventrikels ejektionsfraktion er faldet væsentligt i forhold til værdierne før behandlingen, og/eller venstre ventrikels ejektionsfraktion er lavere end en prognostisk relevant værdi (for eksempel < 45 %), kan endomyokardiel biopsi overvejes og fordelen ved fortsat behandling skal omhyggeligt vurderes over for risikoen for at udvikle irreversibel skade på hjertet.
English: If any signs or symptoms of extravasation occur (e.g., stinging, erythema) terminate the infusion immediately and restart in another vein.
Danish: Hvis der opstår tegn eller symptomer på ekstravasation (f.eks. svien eller erytem) afsluttes infusionen straks og genstartes i en anden vene.
English: Because of the potential for bone marrow suppression, periodic blood counts must be performed frequently during the course of Caelyx therapy, and at a minimum, prior to each dose of Caelyx.
Danish: På grund af risikoen for knoglemarvssuppression skal regelmæssige blodtællinger foretages under behandling med Caelyx, og som minimum før hver dosis af Caelyx.
English: Grades 3/4** n=318
Danish: Grad 3/4** n=318
English: 1 half-life (hours)
Danish: 1halveringstid (timer) 2halveringstid (timer)
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Danish: Dog anses reduktion af QRSbølgen som tegn på kardial toksicitet.
English: Do not dose this cycle if before day 4; if after day 4 reduce next dose by 25% in the following cycles if bortezomib is reduced for haematologic toxicity.
Danish: Indgiv ikke denne cyklus, hvis det er før dag 4; hvis det er efter dag 4, reducér næste dosis med 25 % i de efterfølgende cyklusser, hvis bortezomib er reduceret for hæmatologisk toksicitet.
English: For multiple myeloma patients treated with Caelyx in combination with bortezomib who experience PPE or stomatitis, the Caelyx dose should be modified as described in Table 1 and 2 above respectively.
Danish: For patienter med myelomatose, der bliver behandlet med Caelyx i kombination med bortezomib, og som oplever PPE eller stomatitis, bør Caelyx-dosis ændres som beskrevet i henholdsvis Tabel 1 og 2 ovenfor.
English: Multiple myeloma program
Danish: Myelomatose-program
English: Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Danish: Desuden stoppede kun 1 patient (kumulativ antracyklin dosis på 944 mg/m2) forsøgsbehandlingen på grund af kliniske symptomer på hjerteinsufficiens.
English: For further instructions on preparation and special precautions for handling see section 6.6.
Danish: For yderligere instruktioner om tilberedning og særlige forholdsregler for håndtering, se pkt.
English: Grade 3 stomatitis was reported in 2% of patients in the combination therapy group.
Danish: Grad 3 stomatitis blev rapporteret hos 2 % af patienterne i gruppen, der fik kombinationsbehandling.
English: - For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
Danish: - Til behandling af fremskreden ovariecancer hos kvinder, hvor førstevalgs platinbaseret kemoterapeutisk behandling er mislykket.
English: Take the appropriate volume of Caelyx up into a sterile syringe.
Danish: Sug den beregnede mængde Caelyx op i en steril sprøjte.
English: Grade 3 (blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
Danish: Grad 3 (blisterdannelse, sårdannelse eller hævelse, som forstyrrer gang eller normale daglige aktiviteter; kan ikke bære almindeligt tøj)
English: Exercise caution in patients with impaired cardiac function who receive Caelyx.
Danish: Udvis forsigtighed over for patienter med forringet hjertefunktion, der behandles med Caelyx.
English: Caution must be exercised in handling Caelyx solution.
Danish: Der skal udvises forsigtighed ved håndtering af Caelyx-opløsningen.
English: The haematological toxicity for ovarian cancer patients is less severe than in the AIDS-KS setting (see section for ovarian cancer patients above).
Danish: Den hæmatologiske toksicitet for ovariecancerpatienter er mindre svær end for AIDS-KS-gruppen (se afsnittet for patienter med ovariecancer ovenfor).
English: Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.
Danish: Caelyx bør kun indgives under opsyn af en kvalificeret onkolog specialiseret i indgift af cytotoksiske midler.
English: Vascular disorders common vasodilatation
Danish: Vaskulære sygdomme almindelig vasodilatation
English: Following marketing, bullous eruption has been reported rarely in this population.
Danish: Efter markedsføring har bulløst udslæt været rapporteret i sjældne tilfælde i denne patientgruppe.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Danish: Kemisk og fysisk holdbarhed under brug er påvist for 24 timer ved 2°C - 8°C.