FrancophonIA/ELRC3.0 huggingface dataset:
English: A survival benefit was also demonstrated in patients that had not achieved a complete/partial response following azacitidine treatment.
Danish: En overlevelsesfordel blev ligeledes påvist hos patienter, som ikke havde opnået et komplet/partielt respons efter behandling med azacitidin.
English: Vidaza contains the active substance ‘azacitidine'.
Danish: Vidaza indeholder det aktive stof 'azacitidin '.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Patients should be advised to report oliguria and anuria to the health care provider immediately.
Danish: Patienterne skal rådes til straks at rapportere oliguri og anuri til sundhedspersonalet.
English: Within the Intent to Treat population (ITT), the median age was 69 years (range 38 to 88 years).
Danish: Medianalderen inden for "Intent to Treat"-populationen (ITT) var 69 år (range fra 38 til 88 år).
English: The Vidaza suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Danish: Suspensionen med Vidaza kan klargøres umiddelbart før brug, og den rekonstituerede suspension skal administreres inden for 45 minutter.
English: Before giving you Vidaza, your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle.
Danish: Inden du får Vidaza vil din læge give dig anden medicin for at forebygge kvalme og opkastning ved begyndelsen af hver behandlingscyklus.
English: The majority of adverse reactions occurred during the first 2 cycles and tended to decrease with subsequent cycles.
Danish: Størstedelen af bivirkningerne opstod i løbet af de første 2 behandlingscyklusser og havde tendens til at aftage i de efterfølgende cyklusser.
English: You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle').
Danish: Du vil få taget blodprøver, inden du påbegynder behandlingen med Vidaza og ved begyndelsen af hver behandlingsperiode (kaldet en ”cyklus”).
English: It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the medicinal product after reconstitution.
Danish: Bemærk, at der findes filtre i nogle adaptere, spikes og lukkede systemer, hvorfor sådanne systemer ikke må anvendes til administration af lægemidlet efter rekonstitution.
English: Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial.
Danish: På grund af tilbageholdelse i hætteglasset og kanylen kan det muligvis ikke lade sig gøre at trække al suspensionen ud af hætteglasset.
English: One case of overdose with azacitidine was reported during clinical trials.
Danish: Der blev rapporteret ét tilfælde af overdosering med azacitidin under de kliniske studier.
English: These are diseases which affect the bone marrow and can cause problems with normal blood cell production.
Danish: Det er sygdomme, der påvirker knoglemarven, og som kan forårsage problemer med den normale produktion af blodlegemer.
English: The requirements for submission of periodic safety update reports for this medicinal are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Pharmacotherapeutic group: Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, pyrimidin-analoger; ATC-kode: L01BC07
English: Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Danish: Tal med din læge, hvis du ønsker, at din sæd opbevares, før du får denne behandling.
English: However, exposure was within the same general range of exposures observed for subjects with normal renal function.
Danish: Eksponeringen var imidlertid inden for det samme generelle eksponeringsinterval som hos personer med normal nyrefunktion.
English: Vidaza is an anti-cancer agent which belongs to a group of medicines called ‘anti-metabolites'.
Danish: Vidaza er et stof mod kræft, der tilhører en gruppe lægemidler, der kaldes 'antimetabolitter '.
English: Vidaza should be reconstituted with water for injections.
Danish: Vidaza skal rekonstitueres med vand til injektionsvæsker.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for azacitidine, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for azacitidin er CHMP nået frem til følgende videnskabelige konklusioner:
English: Men should not father a child while receiving treatment with Vidaza.
Danish: Mænd bør ikke få børn, mens de behandles med Vidaza.
English: The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates.
Danish: Det rekonstituerede produkt er en ensartet, uklar suspension, uden agglomerater.
English: Total dose (mg) = Dose (mg/m2) x BSA (m2)
Danish: Samlet dosis (mg) = Dosis (mg/m2) x BSA(m2)
English: There is limited safety information available with azacitidine in patients ≥85 years (with 14 [5.9%] patients ≥85 years in AZA-AML-001 study).
Danish: Der er begrænsede sikkerhedsoplysninger for azacitidin hos patienter ≥85 år (med 14 [5,9 %] patienter ≥85 år i AZA-AML-001-studiet).
English: Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du har spørgsmål om Vidazas virkning, og hvorfor du har fået ordineret dette lægemiddel.
English: • Blood in your urine.
Danish: • Blod i urinen.
English: There is no known specific antidote for azacitidine overdose.
Danish: Der er ingen kendt specifik antidot mod overdosering af azacitidin.
English: • The recommended dose is 75 mg per m2 body surface area.
Danish: • Den anbefalede dosis er 75 mg pr. m2 legemsoverfladeareal.
English: After reconstitution, the suspension should not be filtered.
Danish: Efter rekonstitution må suspensionen ikke filtreres.
English: A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m2, almost 4 times the recommended starting dose.
Danish: En patient fik diarré, kvalme og opkastning efter at have fået en enkelt intravenøs dosis af ca. 290 mg/m2, hvilket er næsten 4 gange den anbefalede startdosis.
English: When IPSS cytogenetic subgroups were analysed, similar findings in terms of median overall survival were observed in all groups (good, intermediate, poor cytogenetics, including monosomy 7).
Danish: Ved analyse af cytogenetiske undergrupper i henhold til IPSS, blev der observeret lignende fund mht. den mediane, samlede overlevelse i alle grupper (god, intermediær, ringe cytogenetik, herunder monosomi 7).
English: Early embryotoxicity studies in mice revealed a 44 % frequency of intrauterine embryonal death (increased resorption) after a single intraperitoneal injection of azacitidine during organogenesis.
Danish: Tidlige embryotoksicitetsundersøgelser hos mus afslørede en frekvens på 44 % af intrauterin embryodød (øget resorption) efter en intraperitoneal enkeltinjektion af azacitidin under organogenesen.
English: However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table.
Danish: Hvis restituering imidlertid ikke er opnået inden for 14 dage, bør dosis reduceres i overensstemmelse med følgende tabel.
English: Not Known
Danish: Sjælden Ikke kendt
English: A tumorigenicity study in rats revealed an increased incidence of testicular tumours.
Danish: En tumorgenicitets-undersøgelse hos rotter afslørede en øget incidens af testikeltumorer.
English: However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined.
Danish: Hvis restituering imidlertid ikke er opnået inden for 14 dage, bør knoglemarvscellulariteten bestemmes.
English: White lyophilised powder.
Danish: Hvidt, lyofiliseret pulver.
English: These cutaneous reactions have to be distinguished from soft tissue infections, sometimes occurring at injection site.
Danish: Disse kutane reaktioner skal adskilles fra infektion i bløddele, som til tider forekommer på injektionsstedet.
English: If the bone marrow cellularity is > 50 %, no dose adjustments should be made.
Danish: Hvis knoglemarvscellulariteten er > 50 %, bør der ikke foretages dosisjusteringer.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Dose mg/m2
Danish: Dosis mg/m2
English: The effect of known cytidine deaminase polymorphisms on azacitidine metabolism has not been formally investigated.
Danish: Virkningen af kendte cytidindeaminase-polymorfismer på metabolismen af azacitidin er ikke formelt undersøgt.
English: On the basis of the scientific conclusions for azacitidine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing azacitidine is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for azacitidin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder azacitidin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel
English: Azacitidine is cleared rapidly from plasma with a mean elimination half-life (t½) after subcutaneous administration of 41 ± 8 minutes.
Danish: Azacitidin udskilles hurtigt fra plasma med en gennemsnitlig elimineringshalveringstid (t½) efter subkutan administration på 41 ± 8 minutter.
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
English: Azacitidine undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase.
Danish: Azacitidin undergår spontan hydrolyse og deaminering medieret af cytidindeaminase.
English: If bone marrow cellularity is ≤ 50 %, treatment should be delayed and the dose reduced according to the following table:
Danish: Hvis knoglemarvscellulariteten er ≤ 50 %, bør behandlingen udsættes, og dosis reduceres i overensstemmelse med følgende tabel:
English: For doses requiring more than 1 vial, the dose should be equally divided e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe.
Danish: Ved doser, der kræver mere end 1 hætteglas, bør dosen opdeles ligeligt (f.eks. dosis 150 mg = 6 ml, 2 sprøjter med 3 ml i hver sprøjte).
English: In case of an anaphylactic-like reaction, treatment with azacitidine should be immediately discontinued and appropriate symptomatic treatment initiated.
Danish: I tilfælde af en anafylaktisk-lignende reaktion bør behandlingen med azacitidin øjeblikkeligt seponeres, og en passende symptomatisk behandling indledes.
English: For later use
Danish: Til senere anvendelse
English: Also, some other medicines may affect the way Vidaza works.
Danish: Anden medicin kan også påvirke den måde, hvorpå Vidaza virker.
English: Vidaza therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated.
Danish: Behandling med Vidaza bør seponeres hos patienter, der udvikler nekrotiserende fasciitis, og der skal omgående påbegyndes passende behandling.
English: It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Danish: Det menes at virke ved at ændre den måde, cellerne tænder og slukker for generne på, samt ved at påvirke produktionen af nyt RNA og DNA.
English: Azacitidine becomes incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)).
Danish: Azacitidin indbygges i cellernes genetiske materiale (ribonukleinsyre (RNA) og deoxyribonukleinsyre (DNA).
English: For unopened vials of this medicine - there are no special storage conditions.
Danish: For uåbnede hætteglas med dette lægemiddel - der er ingen særlige forholdsregler vedrørende opbevaringen.
English: Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA.
Danish: Inkorporering af azacitidin i DNA resulterer i inaktivering af DNA-metyltransferaser, hvilket fører til hypometylering af DNA.
English: • Chest pain or shortness of breath which may be accompanied with a fever.
Danish: • Brystsmerter eller kortåndethed, som kan være ledsaget af feber.
English: A survival benefit was also demonstrated in patients that had not achieved a complete response for Vidaza compared to CCR.
Danish: Der blev også vist overlevelsesfordel hos patienter, der ikke havde opnået et fuldstændigt respons, for Vidaza, sammenlignet med CCR.
English: The one-year survival rates were 46.5% in patients receiving Vidaza versus 34.3% in patients receiving CCR.
Danish: Overlevelsesrate efter et år var 46,5 % hos patienter i behandling med Vidaza versus 34,3 % hos patienter, der fik CCR.
English: Elderly population
Danish: Ældre population
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 mg
English: Patients should be monitored for signs and symptoms of bleeding, particularly those with pre-existing or treatmentrelated thrombocytopenia.
Danish: Patienter bør monitoreres for objektive tegn og for symptomer på blødning - især patienter, som har forudgående eller behandlingsrelateret trombocytopeni.
English: % Dose in the next cycle, if recovery* is not achieved within 14 days
Danish: % dosis i den næste cyklus, hvis restituering* ikke opnås inden for 14 dage
English: Pericarditis is the most reported PT (n=35 cases) followed by endocarditis (n=10) and myocarditis (n=9).
Danish: Perikarditis er den hyppigst rapporterede foretrukne term (PT) (n=35 tilfælde) efterfulgt af endokarditis (n=10) og myokarditis (n=9).
English: Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
Danish: Patienter med svært kongestivt hjertesvigt, klinisk ustabil hjertesygdom eller lungesygdom i anamnesen blev ekskluderet fra de pivotale registreringsstudier (AZA PH GL 2003 CL 001 og AZAAML-001), og azacitidins sikkerhed og virkning hos disse patienter er derfor ikke klarlagt.
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International
Danish: • intermediær-2 og højrisiko myelodysplastiske syndromer (MDS) i henhold til International
English: DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancersuppressing functions to cancer cells.
Danish: DNA-hypometylering af afvigende metylerede gener, der er involveret i regulering af normal cellecyklus, differentiering og celledød, kan resultere i reekspression af genet og genopretning af cancersupprimerende funktioner til cancerceller.
English: No formal clinical drug interaction studies with azacitidine have been conducted.
Danish: Der er ikke udført formelle kliniske interaktionsstudier med azacitidin.
English: Storage of the reconstituted product
Danish: Opbevaring af det rekonstituerede præparat
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: • if you have ever had a heart condition or heart attack or any history of lung disease.
Danish: • Hvis du tidligere har lidt af en hjertesygdom eller haft et hjerteanfald, eller hvis du tidligere har haft en lungesygdom
English: In rats, azacitidine caused no adverse reactions when given preimplantation, but it was clearly embryotoxic when given during organogenesis.
Danish: Azacitidin forårsagede ingen uønskede virkninger hos rotter, når det blev givet før implantation, men det var klart embryotoksisk, når det blev givet under organogenesen.
English: • A viral infection causing cold sores (herpes).
Danish: • En virusbetændelse, der forårsager forkølelsessår (herpes).
English: No accumulation occurs after subcutaneous administration of 75 mg/m2 azacitidine once daily for 7 days.
Danish: Der forekommer ingen akkumulering efter subkutan indgivelse af 75 mg/m2 azacitidin én gang dagligt i 7 dage.
English: The Cox PH model adjusted for pre-specified baseline prognostic factors defined a HR for Vidaza versus CCR of 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
Danish: Cox-PH-modellen justeret for præspecificerede prognostiske faktorer ved baseline definerede en HR for Vidaza versus CCR på 0,80 (95% CI= 0,66; 0,99; p = 0,0355).
English: • Skin infection (cellulitis).
Danish: • Hudinfektion (cellulitis).
English: muscle spasms, myalgia
Danish: muskelspasmer, myalgi
English: As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Danish: Som en del af inklusionskriterierne var det påkrævet, at patienterne skulle have en performancestatus på 0-2 i henhold til Eastern Cooperative Oncology Group (ECOG).
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: 1 vial - 100 mg METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: 1 hætteglas - 100 mg ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles (see section 4.8).
Danish: Behandling med azacitidin er associeret med anæmi, neutropeni og trombocytopeni, især under de første 2 behandlingscyklusser (se pkt.
English: Bleeding may occur with patients receiving azacitidine.
Danish: Der kan forekomme blødninger hos patienter, der får azacitidin.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Painful skin ulceration (pyoderma gangrenosum).
Danish: • Smertefulde hudsår (pyoderma gangrenosum).
English: The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration (single 75 mg/m2 doses) was approximately 89% based on area under the curve (AUC).
Danish: Den absolutte biotilgængelighed af azacitidin efter subkutan administration i forhold til intravenøs administration (enkeltdoser på 75 mg/m2) var ca. 89 % baseret på arealet under kurven (AUC).
English: Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively,
Danish: Efter intravenøs og subkutan administration af 14C-azacitidin, blev hhv. 85 og 50 % af den administrerede radioaktivitet genfundet i urin, mens < 1 %
English: The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Danish: Resultaterne vist nedenfor udgør intent-to-treat-populationen undersøgt i AZA-AML-001 (se pkt.
English: • Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion, restlessness or fatigue.
Danish: • Hævede ben og fødder, rygsmerter, nedsat vandladning, øget tørst, hurtig puls, svimmelhed og kvalme, opkastning eller nedsat appetit og følelse af forvirring, rastløshed eller træthed.
English: Each pack contains one vial of Vidaza.
Danish: Hver pakning indeholder et hætteglas med Vidaza.
English: Do not filter the suspension after reconstitution since this could remove the active substance.
Danish: Suspensionen må ikke filtreres efter rekonstitution, da filtrering kan fjerne det aktive stof.
English: Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding inside your head.
Danish: F.eks. blod i afføringen pga. blødning i maven eller tarmen eller f.eks. blødning inde i hovedet.
English: • Reduced red blood count (anaemia).
Danish: • Nedsat antal røde blodlegemer (anæmi).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Developmental abnormalities in the brain have been detected in mice given azacitidine on or before closure of the hard palate.
Danish: Der blev påvist udviklingsanomalier i hjernen hos mus, der fik azacitidin ved eller før lukningen af den hårde gane.
English: In the event of overdose, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary.
Danish: I tilfælde af overdosering bør patienten monitoreres med passende analyser af de relevante hæmatologiske parametre og modtage understøttende behandling, såfremt det er nødvendigt.
English: Patients received this pre-selected regimen if not randomised to Vidaza.
Danish: Patienterne fik dette prædefinerede regime, hvis de ikke blev randomiseret til Vidaza.
English: • Feeling generally unwell.
Danish: • Generel følelse af utilpashed.
English: The median age of the subjects was 75.0 years (range: 64 to 91 years), 75.2% were Caucasian and 59.0% were male.
Danish: Medianalderen var 75,0 år (interval 64 til 91 år), 75,2 % var kaukasiere, og 59,0 % var mænd.
English: There are no human data on the effect of azacitidine on fertility.
Danish: Der er ingen data fra mennesker om azacitidins indvirkning på fertiliteten.
English: These complications are caused by the product of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.
Danish: Disse komplikationer skyldes produkt fra døende cancerceller og kan omfatte følgende: ændringer i blodkemi såsom høj kalium, fosfor, urinsyre og lav calcium førende til ændringer i nyrefunktion, hjerterytme, krampeanfald og nogle gange død.
English: • chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,
Danish: • kronisk myelomonocytleukæmi (CMML) med 10-29 % blaster i marv uden myeloproliferativ sygdom,
English: Treatment of male rats resulted in decreased weight of the testes and epididymides, decreased sperm counts, decreased pregnancy rates, an increase in abnormal embryos and increased loss of embryos in mated females (see section 4.4).
Danish: Behandling af hanrotter resulterede i reduceret vægt af testes og epididymides, reduceret sædcelletal, reducerede graviditetsrater, en stigning i anormale embryoer og øget tab af embryoer hos parrede hunrotter (se pkt.