FrancophonIA/ELRC3.0 huggingface dataset:
English: not previously reported in clinical trials
Danish: ikke tidligere rapporteret i kliniske undersøgelser
English: < 1/10,000 including isolated reports
Danish: < 1/10.000 inklusive enkeltstående rapporter
English: Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).
Danish: Afhængigt af dosis og indikation kan dette tage fra 30 minutter til over en time (dvs. 90 minutter).
English: Paediatric population The experience in children is limited.
Danish: Pædiatrisk population Erfaring med børn er begrænset.
English: Among the seven cases reviewed, the causality was stated as probable in 4 cases and possible in 1 case.
Danish: I de syv gennemgåede tilfælde, blev kausaliteten angivet som sandsynlig i 4 tilfælde og mulig i 1 tilfælde.
English: Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
Danish: Behandling af patienter i to til tre måneder anbefales for at opnå et terapeutisk respons.
English: However, this reaction can be severe and debilitating in some patients and may require discontinuation of treatment.
Danish: Denne reaktion kan imidlertid være alvorlig og svækkende hos nogle patienter og kan påkræve afbrydelse af behandlingen.
English: However, the response was not life-threatening and the dogs recovered quickly upon discontinuation of treatment.
Danish: Responset var imidlertid ikke livstruende, og hundene kom sig hurtigtefter behandlingens ophør.
English: Myelosuppression was mostly mild or moderate and manageable.
Danish: Myelosuppression var for det meste let eller moderat og let at styre.
English: In patients experiencing this event, it is generally seen after two or three cycles of treatment.
Danish: Hos patienter, der oplever denne reaktion, ses det generelt efter to eller tre behandlingscykler.
English: Very common  1/10 Common
Danish: Meget almindelig  1/10 Almindelig
English: Reduce next dose by 25%.
Danish: Reducér næste dosis med 25 %.
English: The final analysis for overall survival (OS) performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Danish: Den endelige analyse af total overlevelse (OS), der blev udført efter en median opfølgning på 8,6 år, viste ingen signifikant forskel i OS mellem de to behandlingsarme.
English: Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Danish: Caelyx bør derfor ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary.
Danish: Dosering af begge lægemidler på dag 4 kan udskydes i op til 48 timer, hvis det er medicinsk nødvendigt.
English: No clinically significant increases in serum creatinine were reported.
Danish: Ingen klinisk signifikant stigning i serum-kreatinin blev rapporteret.
English: When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Danish: Når Caelyx anvendes alene, forekommer nogle af disse effekter i mindre grad, og nogle er overhovedet ikke forekommet.
English: The overall incidence of PPE reported was 44.0%-46.1%.
Danish: Den totale forekomst af rapporteret PPE var 44,0 %46,1 %.
English: Fever ≥ 38
Danish: Feber ≥ 38
English: The average duration of the most common severe (grade 3/4) events for both groups was 30 days or less.
Danish: Gennemsnitsvarigheden af de mest alvorlige tilfælde (grad 3/4) for begge grupper var 30 dage eller mindre.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser før anvendelse brugerens ansvar og skal ikke være længere end 24 timer ved 2°C - 8°C.
English: PPE infrequently resulted in permanent treatment discontinuation (3.7%-7.0%).
Danish: PPE resulterede sjældent i permanent afbrydelse af behandlingen (3,7 % - 7,0 %).
English: Section 4 of the package leaflet should be updated accordingly with the term “patches of skin thickening”.
Danish: Afsnit 4 i indlægssedlen bør opdateres i overensstemmelse med udtrykket "områder med fortykkelse af huden".
English: Caelyx is a unique formulation.
Danish: Caelyx er en unik formulering.
English: It is because of the potential changes in your blood cells that you will have regular blood tests.
Danish: Det er pga. de mulige ændringer i dine blodtal, at du skal have taget regelmæssige blodprøver.
English: Patients who suffer from these effects must avoid driving and operating machinery.
Danish: Patienter, der oplever sådanne virkninger, skal undlade at føre motorkøretøj og betjene maskiner.
English: Other side effects Between infusions, the following may occur:
Danish: Andre bivirkninger Mellem infusioner kan følgende forekomme:
English: Continue treatment as needed to maintain a therapeutic response.
Danish: Fortsæt behandling efter behov for at opretholde et terapeutisk respons.
English: Patients and doctors must be aware of this higher incidence and take action as appropriate.
Danish: Patienter og læger skal være klar over denne højere forekomst og handle herefter.
English: If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.
Danish: Hvis du er i tvivl om, hvilke behandlinger du har fået, eller hvilke sygdomme du har haft, bør du tale med din læge.
English: The dose is repeated every 2 to 3 weeks for 2-3 months, then as often as necessary to maintain an improvement in your condition.
Danish: Dosis gentages hver 2. til 3. uge i 23 måneder og herefter så hyppigt, som det er nødvendigt for at opretholde en bedring i din tilstand.
English: The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Danish: Graduering af toksiciteten i disse tabeller er baseret på National Cancer Institute Common Toxicity Criteria (NCI-CTC).
English: The hypotensive response was reduced in magnitude by pretreatment with antihistamines.
Danish: Det hypotensive respons blev reduceret i størrelse ved forbehandling med antihistaminer.
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet og amning Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin.
English: ○C and ANC < 1,000/mm
Danish: ○C og ANC < 1.000/mm
English: The risk of low blood counts and infections was similarly low in breast cancer studies.
Danish: Risikoen for lave blodtal og infektioner var ligeså lav i brystcancer undersøgelser.
English: If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50%.
Danish: Hvis bilirubin er > 3,0 mg/dl, reduceres den første dosis med 50 %.
English: The dosage can be increased to full dose for subsequent cycles if tolerated.
Danish: Dosis kan forøges til normaldosis i efterfølgende cykluser, hvis det tolereres.
English: Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: Sundhedseksperter anbefaler, at HIV-smittede kvinder ikke ammer deres spædbørn under nogen omstændigheder for at undgå overførsel af HIV.
English: The treatment HR for PFS when adjusted for prognostic variables was consistent with PFS for the ITT population.
Danish: Behandlings-HR for PFS, når denne justeres for prognostiske variabler, var i overensstemmelse med PFS for ITT populationen.
English: Grade 3 or 4 non-haematologic medicine related toxicity
Danish: Grad 3 eller 4 nonhæmatologisk medicinrelateret toksicitet
English: Caelyx is not recommended in patients below 18 years of age.
Danish: Caelyx anbefales ikke til patienter under 18 år.
English: Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out.
Danish: Undgå kortere intervaller end 10 dage, idet lægemiddelakkumulering og øget toksicitet ikke kan udelukkes.
English: In all patients, infusion-associated reactions occurred primarily during the first infusion.
Danish: Hos alle patienter forekom infusionsrelaterede reaktioner primært under den første infusion.
English: No grade 4 stomatitis was reported.
Danish: Ingen grad 4 stomatitis blev rapporteret.
English: Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution.
Danish: Bedring forekommer normalt efter en - to uger, og i nogle tilfælde kan det tage op til 4 uger eller længere før komplet resolution.
English: The frequency of lichenoid keratosis was determined as “rare” based on clinical trials.
Danish: Hyppigheden af lichenoid keratose blev fastlagt som "sjælden" baseret på kliniske forsøg.
English: Grade 3 PPE was reported in 5% of patients.
Danish: Grad 3 PPE blev rapporteret hos 5 % af patienterne.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Danish: En protokol-defineret interimanalyse (baseret på 249 TTP tilfælde) udløste tidlig studieterminering for effekt.
English: If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Danish: Hvis droppet svier eller gør ondt, mens du får en dosis Caelyx, skal du straks fortælle lægen herom.
English: It is generally believed that inhibition of DNA, RNA and protein synthesis is responsible for the majority of the cytotoxic effects.
Danish: Det er en almen opfattelse, at hæmning af DNA, RNA og proteinsyntesen er ansvarlig for hovedparten af den cytotoksiske effekt.
English: Caution must be observed in patients who have received other anthracyclines.
Danish: Forsigtighed skal iagttages hos patienter, der har modtaget andre antracykliner.
English: It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Danish: Det anvendes til at dræbe kræftcellerne, formindske størrelsen af tumoren, forsinke væksten af tumoren og forlænge din overlevelse.
English: Only 13 of these 88 patients (15%) had at least one clinically significant change in their LVEF, defined as an LVEF value less than 45% or a decrease of at least 20 points from baseline.
Danish: Kun 13 af disse 88 patienter (15 %) havde mindst én klinisk signifikant forandring i deres LVEF, defineret som en LVEF-værdi mindre end 45 % eller et fald på mindst 20 points fra baseline.
English: Decrease dose by 25%; return to 4 week interval
Danish: Reducer dosis med 25 %; vend tilbage til 4 ugers interval
English: Pegylated placebo liposomes are neither mutagenic nor genotoxic.
Danish: Pegylerede placebo liposomer er hverken mutagene eller genotoksiske.
English: Toxicity grade at current assessment
Danish: Grad af toksicitet ved nuværende bedømmelse
English: This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Danish: Denne proces er kendt som pegylering og beskytter liposomer fra detektion af det mononukleære fagocytsystem (MPS), hvilket øger cirkulationstiden i blodet.
English: No grade 4 PPE was reported.
Danish: Ingen Grad 4 PPE blev rapporteret.
English: Some of these abnormalities may have been related to the underlying HIV infection and not Caelyx.
Danish: Nogle af disse abnormaliteter kan have været forbundet med den tilgrundliggende HIV-infektion og ikke med Caelyx.
English: Stinging or swelling of the skin at the site of injection may also occur.
Danish: Svien eller opsvulmen på injektionsstedet kan også forekomme.
English: Grade 4 (diffuse or local process causing infectious complications, or a bedridden state or hospitalisation)
Danish: Grad 4 (diffus eller lokal proces, som forårsager infektiøse komplikationer eller en sengeliggende tilstand eller hospitalsindlæggelse)
English: In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely.
Danish: I alvorlige tilfælde kan disse reaktioner indvirke på visse daglige aktiviteter, og de kan vare i 4 uger eller længere før komplet helbredelse.
English: Caelyx should not be used in children and adolescents, because it is not known how the medicine will affect them.
Danish: Børn og unge Caelyx må ikke anvendes til børn og unge, da det ikke vides, hvordan medicinen vil påvirke dem.
English: Permanent treatment discontinuation was infrequently reported at 2%.
Danish: Vedvarende behandlingsophør blev sjældent rapporteret med 2 %.
English: These effects were mostly mild, with severe (grade 3) cases reported in 17%-19.5%.
Danish: De fleste af disse bivirkninger var lette, med alvorlige tilfælde (grad 3) rapporteret i 17 %19,5 %.
English: The reported incidence of life-threatening (grade 4) cases was < 1%.
Danish: Incidencen af rapporterede livstruende tilfælde (grad 4) var < 1 %.
English: Driving and using machines Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.
Danish: Kør ikke bil og betjen ikke værktøj eller maskiner, hvis du føler dig træt eller søvnig af behandling med Caelyx.
English: Other symptoms of Kaposi's sarcoma, such as swelling around the tumour, may also improve or disappear.
Danish: Andre symptomer på Kaposis sarkom, såsom hævelse omkring tumor, kan også forbedres eller forsvinde.
English: ** Grade 3/4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column).
Danish: ** Grad 3/4 bivirkning er baseret på bivirkningstermerne af alle sværhedsgrader med et overordnet tilfælde ≥ 5 % (se bivirkningerne listet i første kolonne).
English: It did not interfere with patients completing therapy and no dosage adjustments are generally required, unless stomatitis is affecting a patient's ability to eat.
Danish: Det influerede ikke på fuldførelsen af patienters behandling, og normalt er dosisændringer ikke nødvendige, med mindre stomatiten påvirker patientens evne til at spise.
English: Although local necrosis following extravasation has been reported very rarely, Caelyx is considered to be an irritant.
Danish: Selvom lokal nekrose efter ekstravasation kun meget sjældent har været rapporteret, betragtes Caelyx stadig som et irritant.
English: The incidence of anaemia was similar in both treatment groups (7% vs. 5%).
Danish: Forekomsten af anæmi var tilsvarende i begge behandlingsgrupper (7 % vs. 5 %).
English: In the study in dogs, the occurrence and severity of these lesions was reduced by lowering the dose or prolonging the intervals between doses.
Danish: Ved undersøgelsen hos hunde kunne forekomsten og sværhedsgraden af disse læsioner nedsættes ved at nedsætte dosis eller forlænge doseringsintervallerne mellem doserne.
English: Mutagenicity and carcinogenicity
Danish: Mutagenicitet og karcinogenicitet
English: This can be infused over 60 or 90 minutes as detailed in 4.2.
Danish: Dette kan infunderes over 60 eller 90 minutter som beskrevet i pkt.
English: Population based analysis demonstrates that age across the range tested (21-75 years) does not significantly alter the pharmacokinetics of Caelyx.
Danish: Populations-baseret analyse viser, at alder over det undersøgte område (21 - 75 år) ikke signifikant ændrer farmakokinetikken af Caelyx.
English: Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Danish: Caelyx må ikke anvendes til behandling af AIDS-KS, der kan behandles effektivt med lokal terapi eller systemisk alfa-interferon.
English: However, medications to treat these symptoms (e.g., antihistamines, corticosteroids, adrenaline, and anticonvulsants), as well as emergency equipment should be available for immediate use.
Danish: Medicin til at behandle disse symptomer (såsom antihistaminer, kortikosteroider, adrenalin og krampestillende midler) samt nødudstyr bør imidlertid være til rådighed for akut brug.
English: Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Danish: Hjerteinsufficiens på grund af kardiomyopati kan forekomme pludseligt uden forudgående ændringer i EKG og kan også forekomme flere uger efter behandlingsophør.
English: Do not use with in-line filters.
Danish: Må ikke anvendes sammen med in-line filtre.
English: These methods must be applied routinely before the initiation of Caelyx therapy and repeated periodically during treatment.
Danish: Disse metoder skal anvendes rutinemæssigt før initiering af Caelyx-behandling og bør gentages jævnligt under behandlingen.
English: Strategies to prevent and treat hand-foot syndrome include: - soaking hands and/or feet in basins of cold water when possible (e.g., while watching television,
Danish: Strategier for at modvirke og behandle hånd-fod-syndromet: - sæt hænder og/eller fødder i blød i koldt vandbad, når det er muligt (f.eks. mens du ser fjernsyn,
English: The following information is intended for medical or healthcare professionals only (see section 3):
Danish: Nedenstående oplysninger er til læger og sundhedspersonale (se pkt.
English: In rare cases, having low white blood cells may lead to severe infection.
Danish: I sjældne tilfælde kan lavt antal hvide blodlegemer medføre alvorlig infektion.
English: Therefore, any patient treated with doxorubicin should be kept under haematological supervision.
Danish: Enhver patient, behandlet med doxorubicin, bør derfor holdes under hæmatologisk overvågning.
English: Secondary oral neoplasms
Danish: Sekundære orale neoplasmer
English: Do not use Caelyx - if you are allergic to doxorubicin hydrochloride, peanut or soya, or any of the ingredients of this medicine (listed in section 6).
Danish: Brug ikke Caelyx - hvis du er allergisk over for doxorubicinhydrochlorid, jordnødder eller soja eller et af indholdsstofferne i dette lægemiddel (angivet i afsnit 6).
English: Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
Danish: Anæmi (reduktion af røde blodlegemer) kan forårsage træthed, og fald i blodplader kan give øget risiko for blødninger.
English: The suspension is sterile, translucent and red.
Danish: Suspensionen er steril, gennemsigtig og rød.
English: Other strategies to prevent and treat PPE include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting).
Danish: Andre måder til at forebygge og behandle PPE inkluderer at holde hænder og fødder kolde ved at udsætte dem for køligt vand (iblødlægning, bade eller svømning), at undgå overdreven varme/varmt vand og at holde dem nøgne (ingen strømper, handsker eller stramtsiddende sko).
English: A similar incidence of infusion reactions (12.4%) and treatment discontinuation (1.5%) was observed in the breast cancer program.
Danish: En lignende hyppighed af infusionsreaktioner (12,4 %) og behandlingsophør (1,5 %) sås i brystcancer-programmet.
English: Grade 4 (requires parenteral or enteral support)
Danish: Grad 4 (kræver parenteral eller enteral ernæring)
English: Other less frequently (< 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Danish: Andre mindre hyppigt (< 5 %) forekommende bivirkninger omfattede overfølsomhedsreaktioner inklusive anafylaktiske reaktioner.
English: Patients should be examined at regular intervals for the presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer.
Danish: Patienterne bør undersøges regelmæssigt for forekomst af mundsår eller andre orale gener, der kan være tegn på sekundær oral cancer.
English: A similar, but less severe response was also noted in dogs treated with Caelyx and standard doxorubicin.
Danish: Et lignende, men mindre udtalt respons, forekom også hos hunde, der behandledes med Caelyx og standarddoxorubicin.
English: Infusion reactions rarely recur after the first treatment cycle.
Danish: Infusionsreaktioner kommer sjældent igen efter den første behandlingscyklus.
English: These results, though not mature, constituted the protocol defined final analysis.
Danish: Disse resultater udgjorde den protokoldefinerede endelige analyse, selvom de ikke er mature.
English: Decrease dose by 25%; return to 4 week interval or withdraw patient per physician's assessment
Danish: Reducer dosis med 25 %; vend tilbage til 4 ugers interval eller træk patienten ud af behandlingen i henhold til lægens vurdering
English: Doses of bortezomib should be at least 72 hours apart.
Danish: Bortezomibdoser bør gives med mindst 72 timers interval.
English: In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows: 5% of the total dose was infused slowly over the first 15 minutes.
Danish: I undersøgelsesprogrammet for brystcancer var ændring i infusionen tilladt for de patienter, som oplevede en infusionsreaktion som følger: 5 % af den totale dosis blev infunderet langsomt i løbet af de første 15 minutter.
English: PPE appears to be primarily related to the dose schedule and can be reduced by extending the dose interval 1-2 weeks (see section 4.2).
Danish: PPE forekommer at være primært relateret til doseringen, og kan reduceres ved at forlænge dosisintervallet 1 - 2 uger (se pkt.
English: Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Danish: Støtte af vækstfaktor eller transfusion var nødvendig hos henholdsvis 5,1 % og 5,5 % af patienterne (se pkt.
English: Pyridoxine at a dose of 50-150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials.
Danish: Pyridoxin i en dosis på 50 - 150 mg om dagen og kortikosteroider er blevet anvendt forebyggende og til behandling af PPE, men denne terapi er ikke blevet evalueret i fase III-forsøg.
English: Dyspnoea, increased cough
Danish: Dyspnø, øget hoste
English: Taking into account the PRAC Assessment Report on the PSUR(s) for doxorubicin, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for doxorubicin er CHMP nået frem til følgende videnskabelige konklusioner:
English: On the basis of the scientific conclusions for doxorubicin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing doxorubicin is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for doxorubicin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder doxorubicin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances), ATC code: L01DB01.
Danish: Farmakoterapeutisk klassifikation: Cytotoksiske stoffer (antracykliner og relaterede substanser), ATCkode: L01DB01.
English: If this change occurs, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, must be considered.
Danish: Indtræder denne ændring, skal den mest definitive test for antracyklin myokardiel skade, en endomyokardiel biopsi, overvejes.
English: The apparent half-life ranged from 24-231 hours, with a mean of 73.9 hours.
Danish: Den tilsyneladende halveringstid varierer fra 24 - 231 timer, med et gennemsnit på 73,9 timer.
English: Growth factor support was required infrequently (< 5%) and transfusion support was required in approximately 15% of patients (see section 4.2).
Danish: Vækstfaktorstøtte var sjældent nødvendigt (< 5 %), og transfusionsstøtte var nødvendigt hos omkring 15 % af patienterne (se pkt.
English: Patient status
Danish: Patientstatus