FrancophonIA/ELRC3.0 huggingface dataset:
English: Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow.
Danish: Mange patienter, der behandles med Caelyx, har baseline-myelosuppression som følge af faktorer såsom deres præeksisterende HIV-sygdom eller adskillige samtidige eller forudgående medicinske behandlinger eller tumorer involverende knoglemarven.
English: Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
Danish: Doxorubicinhydrochlorid er mistænkt for at forårsage alvorlige fosterskader, hvis det anvendes under graviditet.
English: The dose should be repeated as long as patients respond satisfactorily and tolerate treatment.
Danish: Dosis bør gentages så længe patienten responderer tilfredsstillende og tåler behandlingen.
English: Skin and subcutaneous tissue disorders rare lichenoid keratosis very rare erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis
Danish: Hud og subkutane væv sjældne lichenoid keratose meget sjældne erytem multiform, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
English: Caelyx is indicated: - As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.
Danish: Caelyx er indiceret: - Som monoterapi til patienter med metastaserende brystcancer, hvor der er en øget kardiel risiko.
English: If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Danish: Hvis der ikke ses infusionsreaktion, kan efterfølgende Caelyx infusioner indgives over en 60 minutters periode.
English: At cumulative doses greater than 450 mg/m2 there were no cardiac events with Caelyx.
Danish: Ved kumulative doser på over 450 mg/m2 var der ingen kardielle hændelser med Caelyx.
English: An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses > 450 mg/m2 or at lower doses for patients with cardiac risk factors.
Danish: En øget forekomst af hjerteinsufficiens er forbundet med doxorubicin-behandling ved kumulative livstidsdoser > 450 mg/m2 eller ved lavere doser hos patienter med kardielle risikofaktorer.
English: Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.
Danish: Caelyx anvendes også i kombination med et andet lægemiddel, bortezomib, til behandling af myelomatose, en kræfttype, der kan forekomme i blodet hos patienter, der har fået mindst 1 tidligere behandling.
English: During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted.
Danish: I kliniske undersøgelser hos patienter med massive tumorer (inklusive bryst- og ovariecancer), som samtidig har fået cyclophosphamid eller taxaner, sås ingen yderligere toksiciteter.
English: Redose unless patient has experienced a previous grade 3 or 4 skin toxicity, in which case wait an additional week
Danish: Gendoser medmindre patienten har haft en forudgående grad 3 eller 4 hudtoksicitet, i hvilket tilfælde der ventes en yderligere uge
English: As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required.
Danish: Da doxorubicin metaboliseres i leveren og udskilles i galden, bør dosisjustering ikke være nødvendig.
English: Breast cancer/Ovarian cancer/Multiple myeloma
Danish: Brystcancer/ovariecancer/myelomatose
English: See the SPC for bortezomib.
Danish: Se produktresumeet for bortezomib.
English: Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2-3.0 mg/dl, the first dose is reduced by 25%.
Danish: Caelyx farmakokinetik bestemt i et lille antal patienter med forhøjede total-bilirubin værdier afviger ikke fra patienter med normal total-bilirubin; indtil flere erfaringer er opnået, bør Caelyx-dosis i patienter med nedsat leverfunktion imidlertid reduceres baseret på erfaringen fra de kliniske ovarieundersøgelsesprogrammer for bryst- og ovariecancer som følger: hvis bilirubin er mellem 1,23,0 mg/dl ved initiering af behandlingen, reduceres den første dosis med 25 %.
English: As with other DNA-damaging antineoplastic agents, secondary acute myeloid leukemias and myelodysplasias have been reported in patients having received combined treatment with doxorubicin.
Danish: Som for andre DNA-beskadigende antineoplastiske stoffer har sekundære akutte myeloide leukæmier og myelodysplasier været rapporteret hos patienter, der har fået kombinationsbehandling med doxorubicin.
English: Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Danish: Forhøjet aspartataminotransferase, nedsat ejektionsfraktion, forhøjet blodkreatinin, forhøjet alaninaminotransferase
English: The pharmacokinetics of Caelyx over the dose range of 10 mg/m2 to 60 mg/m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Danish: Farmakokinetikken af Caelyx over dosisintervallet 10 mg/m2 til 60 mg/m2 blev bedst beskrevet ved en to-kompartment non-lineær model med nulte ordens input og Michaelis-Menten elimination.
English: Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Danish: Caelyx kan anvendes som førstevalgs systemisk kemoterapi eller som andenhånds kemoterapi hos AIDS-KS patienter, hvis sygdom har progredieret med, eller hos patienter, der ikke tåler forudgående systemisk kombinationskemoterapi omfattende mindst to af følgende lægemidler: Et vinka-alkaloid, bleomycin og standard doxorubicin (eller andet antracyklin).
English: The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/anthraquinones or e.g., 5-fluorouracil.
Danish: I vurderingen af den samlede dosis doxorubicinhydrochlorid skal også indgå enhver forudgående (eller samtidig) behandling med kardiotoksiske præparater såsom andre antracykliner/antraquinoner eller f.eks. 5fluorouracil.
English: Secondary haematological malignancies
Danish: Sekundære hæmatologiske maligniteter
English: Very rarely, convulsions have been observed in relation to infusion reactions.
Danish: I meget sjældne tilfælde har kramper været set i forbindelse med infusionsrelaterede reaktioner.
English: If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.
Danish: Hvis et prøveresultat tyder på mulig kardiel skade i forbindelse med Caelyx-behandling, skal fordelen ved fortsat terapi nøje vurderes over for risikoen for kardiel skade.
English: The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Danish: Den kumulative dosis, hvor kardiotoksicitet kunne give grund til betænkning hos disse AIDS-KS patienter (> 400 mg/m2) ville kræve mere end 20 serier Caelyx-behandling over en 40 - 60 ugers periode.
English: Renal toxicity has been observed with even lower single doses of doxorubicin HCl in rats and rabbits.
Danish: Nyretoksicitet er blevet set med selv lavere enkeltdoser af doxorubicinhydrochlorid hos rotter og kaniner.
English: Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area).
Danish: Beregn den dosis af Caelyx, der skal indgives (baseret på den anbefalede dosis og patientens overfladeareal).
English: Decreased testicular weights and hypospermia were present in rats after repeat doses 0.25mg/kg/day and diffuse degeneration of the seminiferous tubules and a marked decrease in spermatogenesis were observed in dogs after repeat doses of 1 mg/kg/day (see section 4.6).
Danish: Nedsat testikelvægt og hypospermi var tilstede i rotter efter gentagne doser  0,25 mg/kg/dag og diffus degeneration af de semniferøse tubuli og et markant fald i spermatogenesen blev observeret i hunde efter gentagne doser på 1 mg/kg/dag (se pkt.
English: No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies.
Danish: Der er ikke udført egentlige lægemiddelinteraktionsundersøgelser med Caelyx, dog er der udført fase II kombinationsundersøgelser med konventionelle kemoterapeutiske stoffer hos patienter med ondartede gynækologiske sygdomme.
English: Hypochromic anaemia
Danish: Hypokromisk anæmi
English: Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride.
Danish: Udvis forsigtighed ved samtidig anvendelse af lægemidler med kendt interaktion over for standard doxorubicinhydrochlorid.
English: In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2-1,680 mg/m2.
Danish: Derudover blev der foretaget endomyokardiebiopsier hos 8 patienter med massive tumorer med kumulative antracyklin-doser på 509 mg/m2- 1.680 mg/m2.
English: A study has shown that Caelyx at a single intravenous dose of over twice the clinical dose produces renal toxicity in monkeys.
Danish: En undersøgelse har vist, at Caelyx i en enkelt intravenøs dosis på mere end to gange den kliniske dosis bevirker nyretoksicitet hos aber.
English: In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
Danish: I den centrale undersøgelse hos patienter med ovariecancer behandlet med en dosis på 50 mg/m2, var myelosuppression generelt let til moderat, reversibel og var ikke forbundet med episoder af neutropenisk infektion eller sepsis.
English: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Danish: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100)
English: This allows the Caelyx liposomes to circulate for prolonged periods in the blood stream.
Danish: Dette giver Caelyx liposomerne mulighed for at cirkulere i blodet gennem længere perioder.
English: Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Danish: Indgives ikke, hvis 2 eller flere doser i en cyklus ikke er givet, reducér dosis med 25 % i de efterfølgende cykluser.
English: Increases in AST were less frequently (< 1%) reported.
Danish: Stigning i ASAT blev rapporteret mindre hyppigt (< 1 %).
English: At equivalent doses, the plasma concentration and AUC values of Caelyx which represent mostly pegylated liposomal doxorubicin hydrochloride (containing 90% to 95% of the measured doxorubicin) are significantly higher than those achieved with standard doxorubicin hydrochloride preparations.
Danish: Ved ækvivalente doser er plasmakoncentrationen og AUC-værdierne for Caelyx, der primært repræsenterer pegyleret liposomal doxorubicinhydrochlorid (indeholdende 90 % til 95 % af det målte doxorubicin), betydeligt højere end de tilsvarende værdier for standard doxorubicinhydrochloridpræparationer.
English: Dermal toxicity
Danish: Dermal toksicitet
English: Paresthesia, somnolence
Danish: Paræstesi, somnolens
English: Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections (OI's) in the AIDS population.
Danish: Bivirkninger i åndedrætssystemet forekom almindeligvis i kliniske undersøgelser med Caelyx og kan være relaterede til opportunistiske infektioner (OI'er) i AIDS-populationen.
English: In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.
Danish: Ved undersøgelser udført efter gentagen indgift af Caelyx i rotter og hunde forekom alvorlig inflammation og ulcerationer ved klinisk relevante doser.
English: In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
Danish: I en gruppe på 410 patienter med ovariecancer forekom der klinisk signifikante laboratorieabnormiteter i kliniske undersøgelser med Caelyx inklusive stigning i total-bilirubin (sædvanligvis hos patienter med levermetastaser) (5 %) og serum-kreatinin (5 %).
English: Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/mm
Danish: Afbryd midlertidigt Caelyx-behandling hos patienter med ANC tal < 1000/mm
English: Caelyx contains soya oil and sodium
Danish: Caelyx indeholder sojaolie og natrium
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Caelyx, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Fever, pain
Danish: Feber, smerte
English: Studies in rabbits have shown that the cardiotoxicity of Caelyx is reduced compared with conventional doxorubicin hydrochloride preparations.
Danish: Undersøgelser i kaniner har vist, at kardiotoksiciteten af Caelyx er reduceret i forhold til konventionelle doxorubicinhydrochlorid præparationer.
English: Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Danish: Infusionsreaktioner kommer sjældent igen efter første behandlingscyklus med Caelyx (se pkt.
English: Metabolism and nutrition disorders common anorexia
Danish: Metabolisme og ernæring almindelig anoreksi
English: What you need to know before you use Caelyx
Danish: Det skal du vide, før du begynder at bruge Caelyx
English: Adverse drug reactions identified during the post-marketing experience with Caelyx are described in Table 9.
Danish: Bivirkninger, som er blevet påvist efter markedsføringen af Caelyx, beskrives i tabel 9.
English: Clinically significant laboratory abnormalities frequently ( 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Danish: Klinisk signifikante laboratorieabnormiteter forekom hyppigt ( 5 %) omfattende forøgelse af alkalisk fosfatase, ASAT og bilirubin, der mentes at være forbundet med den tilgrundliggende sygdom og ikke med Caelyx.
English: Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx therapy.
Danish: Forbigående EKG-ændringer såsom T-takudfladning, ST-depression og godartede arytmier anses ikke for at være tvingende årsag til seponering af Caelyx.
English: Anxiety, depression, insomnia
Danish: Angst, depression, søvnløshed
English: Local toxicity
Danish: Lokal toksicitet
English: Caelyx contains soya oil.
Danish: Caelyx indeholder sojaolie.
English: The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.
Danish: Doxorubicinhydrochlorid i Caelyx er indkapslet i fine dråber, der kaldes pegylerede liposomer, der hjælper med at bringe medicinen fra blodbanen til cancervævet i højere grad end til sundt, normalt væv.
English: 3 and/or the platelet count is < 50,000/mm
Danish: 3 og/eller thrombocyttal < 50.000/mm
English: Treatment of acute overdose of the severely myelosuppressed patient consists of hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Danish: Behandling af akut overdosering af den udtalt knoglemarvssupprimerede patient omfatter hospitalsindlæggelse, antibiotika, trombocyt- og granulocyttransfusioner samt symptomatisk behandling af mucositis.
English: Stomatitis has been reported in patients receiving continuous infusions of conventional doxorubicin hydrochloride and was frequently reported in patients receiving Caelyx.
Danish: Stomatitis har været rapporteret hos patienter i behandling med kontinuerlige infusioner af konventionel doxorubicinhydrochlorid og var hyppigt rapporteret hos patienter i Caelyx-behandling.
English: Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue.
Danish: Almindelige bivirkninger, der førte til behandlingsafbrydelse af bortezomib og Caelyx, inkluderede PPE, neuralgi, perifer neuropati, perifer sensorisk neuropati, trombocytopeni, fald i ejektionsfraktion og træthed.
English: Mucositis (23% vs. 13%; grade 3/4 4% vs. 2%), and stomatitis (22% vs. 15%; grade 3/4 5% vs. 2%) were reported more commonly with Caelyx than with doxorubicin.
Danish: Mucositis (23 % mod 13 %; grad 3/4 4 % mod 2 %), og stomatitis (22 % mod 15 %; grad 3/4 5 % mod 2 %) blev rapporteret oftere med Caelyx end med doxorubicin.
English: These grading scores are consistent with no or mild cardiac toxicity.
Danish: Disse scoringer er ensbetydende med ingen eller let kardiotoksicitet.
English: Summary of the safety profile The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m every
Danish: Resumé af sikkerhedsprofilen Den hyppigst rapporterede bivirkning i bryst/ovariecancer kliniske undersøgelser (50 mg/m2 hver
English: In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride.
Danish: Hos patienter med AIDS er forværring af cyclophosphamid-induceret hæmoragisk cystitis og forstærkning af 6-merkaptopurins levertoksiske virkning rapporteret for standard doxorubicinhydrochlorid.
English: The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82-1.22).
Danish: Det protokoldefinerede mål, at påvise at Caelyx ikke var ringere end doxorubicin, blev nået, hazard ratio (HR) for progressionsfri overlevelse (PFS) var 1,00 (95 % CI for HR=0,82 - 1,22).
English: The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
Danish: De ovenfor beskrevne tests og metoder til monitorering af hjertefunktionen under antracyklinbehandling skal anvendes i følgende rækkefølge: EKG-monitorering, måling af venstre ventrikels ejektionsfraktion og endomyokardiel biopsi.
English: Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Danish: 38 % af patienterne afbrød behandlingen med det ene eller begge stoffer som følge af bivirkninger.
English: See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.
Danish: Se tabel 5 for en komplet liste over uønskede reaktioner rapporteret i Caelyx-behandlede patienter.
English: Week 5
Danish: Uge 5
English: Do not dose until recovered to grade < 2 and reduce dose by 25% for all subsequent doses.
Danish: Indgives ikke førend genvindelse af grad < 2 og reducér dosis med 25 % for alle efterfølgende doser.
English: Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Danish: Caelyx indeholder et lægemiddel, der kan påvirke kroppens celler på en sådan måde, at fortrinsvis kræftceller bliver dræbt.
English: Sepsis related to leukopaenia was rarely (< 1%) observed.
Danish: Sepsis relateret til leukopeni blev observeret sjældent (< 1 %).
English: Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx.
Danish: Aseptisk teknik skal overholdes nøje, da der ikke er konserverende eller bakteriostatiske stoffer i Caelyx.
English: Uncommon  1/1,000 and < 1/100 Rare
Danish: Ikke almindelig  1/1.000 til < 1/100 Sjældne
English: In contrast to the experience in patients with breast cancer or ovarian cancer, myelosuppression appears to be the dose-limiting adverse event in patients with AIDS-KS (see section 4.8).
Danish: I modsætning til erfaringen med bryst- eller ovariecancerpatienter synes myelosuppression at være den dosisbegrænsende bivirkning hos patienter med AIDS-KS (se pkt.
English: The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach.
Danish: Farmakokinetikken af Caelyx blev vurderet i 120 patienter fra 10 forskellige kliniske undersøgelser ved brug af fremgangsmåden for populations-farmakokinetik.
English: Myelosuppression associated with anaemia, thrombocytopaenia, leukopaenia, and rarely febrile neutropaenia, has been reported in Caelyx-treated patients.
Danish: Myelosuppression associeret med anæmi, trombocytopeni, leukopeni og sjældent febril neutropeni, har været rapporteret hos patienter behandlet med Caelyx.
English: Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported haematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Danish: Neutropeni, trombocytopeni og anæmi var de hyppigste rapporterede hæmatologiske tilfælde, der blev rapporteret ved både kombinationsbehandling med Caelyx og bortezomib og bortezomib monoterapi.
English: Grade 1 (mild erythema, swelling, or desquamation not interfering with daily activities)
Danish: Grad 1 (let erytem, hævelse eller deskvamation, som ikke forstyrrer daglige aktiviteter)
English: Infection, oral moniliasis, herpes zoster, urinary tract infection
Danish: Infektion, oral moniliasis, herpes zoster, urinvejsinfektion
English: AIDS-related KS program Clinical studies on AIDS-KS patients treated at 20 mg/m2 with Caelyx show that myelosuppression was the most frequent undesirable effect considered related to Caelyx occurring very commonly (in approximately one-half of the patients).
Danish: AIDS-relateret KS-program Kliniske undersøgelser af AIDS-KS-patienter behandlet med 20 mg/m2 Caelyx viser, at myelosuppression var den hyppigste bivirkning, der anses for at være forbundet med Caelyxbehandling, forekommende meget almindeligt (hos omkring halvdelen af patienterne).
English: If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Danish: Hvis patienten oplever tidlige symptomer eller tegn på infusionsreaktion, seponer da øjeblikkeligt infusionen, giv passende præmedicinering (antihistamin og/eller korttidsvirkende kortikosteroid) og start igen med en langsommere hastighed.
English: Although no studies have been conducted with Caelyx, doxorubicin hydrochloride, the pharmacologically active ingredient of Caelyx, is mutagenic and carcinogenic.
Danish: Selvom ingen undersøgelser er udført med Caelyx, er doxorubicinhydrochlorid, det farmakologisk aktive stof i Caelyx, mutagent og karcinogent.