FrancophonIA/ELRC3.0 huggingface dataset:
English: Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norway
Danish: Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norge
English: After incorporation into DNA, gemcitabine appears to induce the programmed cell death process known as apoptosis.
Danish: Efter optagelse i DNA synes gemcitabin at inducere den programmerede proces for celledød kendt som apoptose.
English: Particular attention was given to the therapeutic indications of Gemzar.
Danish: Der blev lagt særlig vægt på Gemzars terapeutiske indikationer.
English: These medicines kill dividing cells, including cancer cells.
Danish: Denne slags medicin dræber celler, der er i gang med at dele sig, herunder kræftceller.
English: • you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).
Danish: • du får svært ved at trække vejret eller føler dig meget svag og er meget bleg (det kan være tegn på nyresvigt).
English: No specific interaction studies have been performed (see section 5.2)
Danish: Der er ikke udført interaktionsundersøgelser (se pkt.
English: Evaluation of experimental animal studies has shown reproductive toxicity e.g. birth defects and other effects on the development of the embryo or foetus, the course of gestation or peri- and postnatal development.
Danish: Evalueringen af eksperimentielle dyrestudier har vist reproduktiv toksicitet, som fødselsdefekter og andre effekter på udviklingen af embryo og foster, svangerskabsforløbet eller peri- og postnatal udvikling.
English: Gemzar was included in the list of products for SPC harmonisation, in accordance with Article 30(2) of Directive 2001/83/EC, as amended because of the divergences existing amongst the nationally authorised SPCs due to the divergent national decisions taken by Member States.
Danish: Gemzar indgik på listen over produkter, hvis produktresuméer skal harmoniseres i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer, på grund af divergenser mellem de nationalt godkendte produktresuméer, som skyldes medlemsstaternes indbyrdes afvigende nationale beslutninger.
English: Eli Lilly Ges.m.b.H Kölblgasse 8-10 1030 Wien Austria
Danish: Eli Lilly Ges.m.b.H Kölblgasse 8-10 1030 Wien Østrig
English: • Cycle delay of more than 1 week due to toxicity
Danish: 6/l • Udsættelse af cyklus på mere end 1 uge grundet toksicitet
English: Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity.
Danish: Forlængelse af infusionstiden og øget i doseringsfrekvens has vist sig at øge toksiciteten.
English: • you have, or have previously had liver disease, heart disease or vascular disease.
Danish: • du har, eller har haft en leversygdom, hjertesygdom eller kredsløbssygdom.
English: The CHMP therefore adopted the remaining five indications for Gemzar, as worded in the revised SPC.
Danish: CHMP har derfor vedtaget de resterende fem indikationer for Gemzar som formuleret i det reviderede produktresumé.
English: Reconstituted solution:
Danish: Rekonstitueret opløsning:
English: PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Cyprus
Danish: PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Cypern
English: However, the combination of gemcitabine and cisplatin had a better toxicity profile than MVAC.
Danish: Kombinationen af gemcitabin og cisplatin havde dog en bedre toksicitetsprofil end MVAC.
English: Liver problems: found through abnormal blood test results Blood in urine
Danish: Leverproblemer: opdages ved unormale blodprøveresultater Blod i urinen
English: Percentage of standard dose of Gemzar (%)
Danish: Procent af standarddosis for Gemzar (%)
English: Postmarketing experience (spontaneous reports) frequency not known (can't be estimated from the available data)
Danish: Postmarketing erfaring (spontane indberetninger) ikke kendt frekvens (kan ikke estimeres ud fra forhåndenværende data)
English: The patient should be monitored carefully after the administration.
Danish: Patienten skal monitoreres omhyggeligt efter indgivelsen.
English: Lilly, S.A., Avenida de la Industria, 30 28108 Alcobendas Madrid Spain
Danish: Lilly, S.A., Avenida de la Industria, 30 28108 Alcobendas Madrid Spanien
English: • Dyspnoea -usually mild and passes rapidly without treatment
Danish: Dyspnø - sædvanligvis mild og ophører hurtigt uden behandling
English: Therefore the CHMP considers that the proposed broad indication “bladder cancer” is not justified, as the data provided was not sufficient to support the indication in superficial bladder cancer.
Danish: CHMP anser derfor ikke den foreslåede brede indikation “blærecancer” for at være berettiget, da de fremlagte data ikke er tilstrækkelige til at understøtte indikationen for overfladisk blærecancer.
English: Gemzar belongs to a group of medicines called “cytotoxics”.
Danish: Gemzar tilhører en gruppe af medicin, der kaldes cytostatika.
English: Your doctor will discuss with you the potential risk of taking Gemzar during pregnancy.
Danish: Din læge vil rådgive dig med hensyn til den mulige risiko, der er ved at få Gemzar under graviditet.
English: Paediatric population (< 18 years)
Danish: Børn (< 18 år)
English: It is not known whether gemcitabine is excreted in human milk and adverse effects on the suckling child cannot be excluded.
Danish: Det er uvist om gemcitabin udskilles i modermælken, og bivirkninger hos det diende barn kan ikke udelukkes.
English: The following table of undesirable effects and frequencies is based on data from clinical trials.
Danish: Følgende tabel med bivirkninger og tilhørende frekvenser er baseret på data fra kliniske undersøgelser.
English: Dose modifications of gemcitabine within a cycle should be performed according to the following tables:
Danish: I løbet af en cyklus Dosisændringer af gemcitabin i løbet af en cyklus bør foretages i henhold til følgende tabeller:
English: The dose should be given on Days 1, 8 and 15 of each 28-day cycle in combination with cisplatin.
Danish: Dosis bør gives på dag 1, 8 og 15 i hver 28 dages cyklus i kombination med cisplatin.
English: Mild to moderate renal insufficiency (GFR from 30 ml/min to 80 ml/min) has no consistent, significant effect on gemcitabine pharmacokinetics.
Danish: Mild til moderat nyreinsufficiens (GFR fra 30 ml/min til 80 ml/min) har ingen konsistent, signifikant effekt på gemcitabins farmakokinetik.
English: Second, dFdCTP competes with dCTP for incorporation into DNA (self-potentiation).
Danish: For det andet konkurrerer dFdCTP med dCTP om optagelsen i DNA (selvforstærkende).
English: For Section 4.8, the CHMP requested the clarification of the presentation of the post-marketing spontaneous report and also proposed a list of revised terms to be used in all the tables of adverse event in combination use in this section.
Danish: 4.8, ønskede CHMP at få præciseret fremstillingen af den spontane rapportering efter markedsføringen og foreslog ligeledes en række reviderede termer til brug i alle fortegnelser over uønskede hændelser ved kombineret brug under dette punkt.
English: In vitro, the cytotoxic effect of gemcitabine is dependent on both concentration and time.
Danish: In vitro er den cytotoksiske effekt af gemcitabin både koncentrations- og tidsafhængig.
English: Gemzar is tolerated well during infusion and may be administered ambulant.
Danish: Gemcitabin er veltolereret under infusion og kan indgives ambulant.
English: dFdCTP kinetics
Danish: dFdCTP-kinetik
English: You must contact your doctor immediately if you notice any of the following: Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Danish: Du skal omgående kontakte din læge, hvis du mærker nogen af følgende bivirkninger: Feber eller infektion (almindelig): Hvis din temperatur er 38ºC eller højere, hvis du sveder eller viser andre tegn på infektion (fordi du muligvis har færre hvide blodlegemer end normalt, hvilket er meget almindeligt).
English: Urinary excretion: All.
Danish: Urinudskillelse: Fuldstændig.
English: Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
Danish: Gemcitabin må kun ordineres af en læge, som er uddannet i brug af anticancer kemoterapi.
English: Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.
Danish: Gul feber vaccine og andre levende, svækkede vacciner anbefales ikke, på grund af risikoen for systemisk sygdom, som kan være fatal, specielt hos patienter med immunosuppression.
English: Intravenous use and intravesical use
Danish: Intravenøs brug and intravesikal use
English: Reconstituted solution: The product should be used immediately.
Danish: Opløst og færdigfortyndet opløsning: Produktet skal bruges med det samme.
English: Monitoring for toxicity and dose modification due to toxicity
Danish: Monitorering for toksicitet og dosisjustering som følge af toksicitet
English: You may want to seek counselling on sperm storage before starting your therapy.
Danish: Det kan muligvis være en god ide at søge rådgivning om opbevaring af sæd, inden du starter behandlingen.
English: For the recommended dosing schedule, gemcitabine elimination should be virtually complete within 5 to 11 hours of the start of the infusion.
Danish: For det anbefalede dosisregime skulle udskillelse af gemcitabin i realiteten være afsluttet i løbet af 5 til 11 timer fra start af infusionen.
English: If no safety box is available, the equipment should be supplemented with a mask and protective glasses.
Danish: Hvis et ”sikkerhedsskab” (særligt indrettet rum) ikke er til rådighed, skal udstyret suppleres med anvendelse af maske og beskyttelsesbriller.
English: This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Danish: Denne dosis kan blive justeret, eller behandlingen kan blive udskudt afhængigt af dine blodprøver og din generelle tilstand.
English: During the week following administration, 92 to 98% of the dose of gemcitabine administered is recovered, 99% in the urine, mainly in the form of dFdU and 1% of the dose is excreted in faeces.
Danish: I løbet af ugen efter infusionen udskilles 92 til 98% af gemcitabin, heraf udskilles 99% i urinen, hovedsageligt i form af dFdU og 1% af dosis udskilles i fæces.
English: Peripheral blood counts may continue to deteriorate after gemcitabine administration has been stopped.
Danish: Perifere blodværdier kan fortsat forværres efter ophør med gemcitabinbehandling.
English: The CHMP requested clarifications on treatment continuation and more details specific to the individual indications, in particular breast cancer and ovarian cancer.
Danish: CHMP anmodede om en præcisering af den fortsatte behandling og om en nærmere beskrivelse af de enkelte indikationer, navnlig brystcancer og ovariecancer.
English: If, however, gemcitabine is given every third or fourth day, it can be administered in nonlethal doses with substantial antitumoural activity against a broad spectrum of mouse tumours.
Danish: Gives gemcitabin derimod hver 3. eller 4. dag, kan det gives i ikke-letale doser, med betydelig antitumoraktivitet mod et bredt spektrum af musetumorer.
English: For the recommended gemcitabine dose of 1000 mg/m2 given as a 30-minute infusion, lower clearance values for women and men should not necessitate a decrease in the gemcitabine dose.
Danish: For den anbefalede gemcitabin dosis på 1000 mg/ m givet som en 30 minutters infusion, bør de lavere clearance værdier for både mænd og kvinder ikke nødvendiggøre, at gemcitabin dosis nedsættes.
English: Vascular disorders Clinical signs of peripheral vasculitis and gangrene
Danish: Vaskulære sygdomme Kliniske tegn på perifer vaskulitis og gangræn
English: Irregular heart rate (arrhythmia) (frequency not known).
Danish: Uregelmæssig puls (arytmi) (hyppighed ikke kendt).
English: Renal failure may not be reversible with discontinuation of therapy and dialysis may be required.
Danish: Nyresvigt er muligvis ikke reversibel ved seponering af behandlingen og dialysebehandling kan blive nødvendig.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Danish: Kemisk og fysisk stabilitet er påvist under brug i 24 timer ved 30ºC.
English: This should be repeated once weekly for 3 weeks, followed by a 1-week rest period.
Danish: Dette gentages en gang ugentligt i 3 uger efterfulgt af 1 uges pause.
English: The primary metabolite, 2'-deoxy-2', 2'-difluorouridine (dFdU), is not active and is found in plasma and urine.
Danish: Den primære metabolit 2'-deoxy-2',2'-difluoruridine (dFdU) er inaktiv og findes i plasma og urin.
English: The indication in pancreatic cancer is based on data from the pivotal Phase 3 study JHAY and the supporting study JHAZ.
Danish: Indikationen for pancreascancer bygger på data fra den pivotale fase III-undersøgelse, JHAY, og den understøttende undersøgelse, JHAZ.
English: Inhibition of this enzyme by dFdCDP reduces the concentration of deoxynucleosides in general and, in particular, dCTP.
Danish: Hæmning af dette enzym med dFdCDP giver en reduktion i koncentrationen af deoxynukleosider generelt og specielt dCTP.
English: Cough, rhinitis, malaise, perspiration and sleeping difficulties have also been reported.
Danish: Hoste, rhinit, utilpashed, svedtendens og søvnbesvær er også rapporteret.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Therefore the CHMP agreed with the proposal but asked the MAH to justify the proposed wording regarding 5-FU refractory patients.
Danish: CHMP var derfor enig i forslaget, men bad indehaveren af markedsføringstilladelsen om at begrunde den foreslåede tekst vedrørende patienter, der er refraktære over for 5-FU.
English: At gemcitabine plasma concentrations above 5 µg/ml, dFdCTP levels do not increase, suggesting that the formation is saturable in these cells.
Danish: Ved gemcitabinplasmakoncentrationer over 5 µg/ml øges koncentrationen af dFdCTP ikke, hvilket indikerer, at mætning opnås i disse celler.
English: The following pharmacokinetic parameters were obtained for doses ranging from 500 to 2,592 mg/m2 that were infused from 0.4 to 1.2 hours.
Danish: Følgende pharmakokinetiske parametre var nået for doser mellem 500 til 2.592 mg/m2, som blev indgivet fra 0,4 til 1,2 timer.
English: Eli Lilly farmacevtska družba, d.o.o.
Danish: Slovenien Eli Lilly farmacevtska družba, d.o.o.
English: Cisplatin has been used at doses between 75-100 mg/m2 once every 3 weeks.
Danish: Cisplatin har været anvendt i doser mellem 75-100 mg/m en gang hver 3. uge.
English: However, gemcitabine has been reported to cause mild to moderate somnolence, especially in combination with alcohol consumption.
Danish: Det er dog rapporteret, at gemcitabin kan forårsage mild til moderat somnolens, særligt i kombination med alkoholindtag.
English: Injury, poisoning and procedural complications Radiation recall
Danish: Traumer, forgiftninger og behandlingskomplikationer Radiation recall
English: Women should be advised not to become pregnant during treatment with gemcitabine and to warn their attending physician immediately, should this occur after all.
Danish: Kvinder skal rådes til ikke at blive gravide under behandling med gemcitabin og til straks at underrette deres behandlende læge, hvis graviditet alligevel skulle indtræde.
English: The CHMP considered the data submitted in support of the bladder cancer indication and noted that all the submitted studies were conducted in patients with locally advanced or metastatic bladder cancer.
Danish: CHMP har behandlet de fremlagte data til støtte for blærecancerindikationen og bemærket, at alle de fremlagte undersøgelser er udført på patienter med lokalt fremskreden eller metastaserende blærecancer.
English: The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution.
Danish: Normale sikkerhedsforanstaltninger for arbejde med cytostatika skal følges ved forberedelse og destruktion af infusionsopløsningen.
English: The volume of distribution of the central compartment was 12.4 l/m2 for women and 17.5 l/m2 for men (inter-individual variability was 91.9%).
Danish: Distribution Fordelingsvolumen i det centrale fordelingsrum var 12,4 l/ m for kvinder og 17,5 l/ m for mænd (interindividuel variabilitet var 91,9%).
English: and or and or
Danish: og eller og eller
English: Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
Danish: Allergiske reaktioner: Hvis du udvikler udslæt (meget almindelig)/kløe (almindelig) eller feber (meget almindelig).
English: Antitumoral activity in preclinical models
Danish: Antitumoraktivitet i prækliniske modeller
English: DNA polymerase epsilon lacks the ability to eliminate gemcitabine and to repair the growing DNA strands.
Danish: DNA polymerase er ikke i stand til at fjerne gemcitabin og reparere de voksende DNA-strenge.
English: If you are concerned about any side effects, talk to your doctor.
Danish: Hvis du er bekymret over nogle af bivirkningerne, så tal med din læge om det.
English: The CHMP therefore considered that the greatest benefit from gemcitabine is achieved when it is administered in the first and second line setting in combination with taxanes and adopted the following wording:
Danish: CHMP mente derfor, at den største fordel ved gemcitabin opnås ved indgivelse i forbindelse med første- og andetvalgsbehandling i kombination med taxaner, og vedtog følgende ordlyd:
English: Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
Danish: Din læge kan beslutte at ændre dosis eller udsætte behandlingen, afhængig af din generelle tilstand, og om dine blodprøveværdier er for lave.
English: Because no studies have been made in patients with renal or hepatic impaired, the CHMP did not consider there to be a need for an absolute contraindication, nor did it consider radiotherapy to be an absolute contra-indication.
Danish: Da der ikke er gennemført undersøgelser med patienter med nedsat nyre- eller leverfunktion, mente CHMP ikke, at der var behov for en absolut kontraindikation, ligesom man heller ikke anså strålebehandling for at være en absolut kontraindikation.
English: Type I flint glass vials, stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal, combined with a polypropylene cap.
Danish: Hætteglas af type I flint glas, med en grå bromobutylgummiprop og forseglet med en aluminiumforsegling kombineret med en polypropylenhætte.
English: This should be repeated once weekly for up to 7 weeks followed by a week of rest.
Danish: Dette gentages en gang ugentlig i 7 uger efterfulgt af en uges pause.
English: Pre-clinical and clinical studies have shown that gemcitabine has radiosensitising activity.
Danish: Prækliniske og kliniske forsøg har vist, at gemcitabin forøger følsomheden over for stråling.
English: In repeat-dose studies of up to 6 months in duration in mice and dogs, the principal finding was schedule and dose-dependent haematopoietic suppression which was reversible.
Danish: I undersøgelser af op til 6 måneders varighed med gentagne doser på mus og hunde var hovedfundet regime og dosisafhængig hæmatopoietisk påvirkning, som var reversibel.
English: LILLY France SAS 13, rue Pagès 92158 Suresnes Cedex France
Danish: LILLY France SAS 13, rue Pagès 92158 Suresnes Cedex Frankrig
English: Trough concentration following once weekly dosing: 0.07-1.12 µg/ml, with no apparent accumulation.
Danish: mg/m Steady-state koncentration efter dosering én gang ugentlig: 0,07-1,12 µg/ml uden synlig akkumulation.
English: Dose modifications due to haematological toxicity in subsequent cycles, for all indications The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following haematological toxicities:
Danish: Dosisændringer som skyldes hæmatologisk toksicitet i efterfølgende cykler, gældende for alle indikationer Gemcitabindosis bør reduceres til 75% af den oprindelige startdosis i en cyklus i tilfælde af følgende hæmatologiske toksiciteter:
English: Gemcitabine is rapidly metabolised by cytidine deaminase in the liver, kidney, blood and other tissues.
Danish: Gemcitabin metaboliseres hurtigt af cytidin-deaminase i lever, nyre, blod og andet væv.
English: The usual dose of Gemzar is 1000-1250 mg for every square metre of your body's surface area.
Danish: Den sædvanlige dosis af Gemzar er 1000-1250 mg pr. kvadratmeter af din krops overflade.
English: If such effects develop, consideration should be made to discontinuing gemcitabine therapy.
Danish: Hvis disse virkninger udvikles, bør det overvejes at seponere behandlingen med gemcitabin.
English: Renal clearance was 2 to 7 l/hr/m2.
Danish: Renal clearance: 2 til 7 l/t/ m
English: The frequency and severity of the adverse reactions are affected by the dose, infusion rate and intervals between doses (see section 4.4).
Danish: Frekvensen og alvorligheden af bivirkninger påvirkes af dosis, infusionshastighed og intervaller mellem doseringerne (se pkt.
English: The following indications are currently approved for Gemzar and were assessed by the CHMP: 1) Bladder cancer, 2) Advanced Non- small cell lung cancer, 3) Advanced pancreatic cancer, 4) Breast cancer and 5) Ovarian cancer.
Danish: Følgende indikationer er i øjeblikket godkendt for Gemzar og vurderet af Udvalget for Humanmedicinske Lægemidler (CHMP): 1) blærecancer, 2) fremskreden ikke-småcellet lungecancer (NSCLC), 3) fremskreden pancreascancer, 4) brystcancer og 5) ovariecancer.
English: This improvement in PFS and response rate is only associated with some additional, readily manageable toxicity, resulting in a favourable risk benefit profile.
Danish: Forbedringen i progressionsfri overlevelse (PFS) og responsraten er kun forbundet med en vis yderligere, let kontrollerbar toksicitet, hvilket giver et gunstigt risk/benefit-forhold.
English: Each pack contains 1 vial
Danish: Hver pakning indeholder 1 hætteglas
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til ved behandling af patienter på en kontrolleret natrium- eller saltdiæt.
English: • Influenza-like symptoms - the most common symptoms are fever, headache, chills, myalgia, asthenia and anorexia.
Danish: Influenzalignende symptomer - de hyppigst forekommende symptomer er feber, hovedpine, kulderystelser, myalgi, asteni og anoreksi.
English: The MAH supported its position by providing guidelines from major oncology societies and review of the literature and proposed a new wording for the single agent in NSCLC indication.
Danish: Indehaveren af markedsføringstilladelsen underbyggede sit standpunkt ved at fremlægge retningslinjer fra væsentlige onkologiske selskaber og litteraturgennemgange og foreslog en omformulering af teksten om enkeltstoffet i NSCLC-indikationen.
English: Calculate the dose and the number of Gemzar vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Gemzar.
English: 1000 mg gemcitabine
Danish: 1000 mg gemcitabin
English: Concurrent (given together or ≤ 7 days apart) - Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of gemcitabine, frequency of gemcitabine administration, dose of radiation, radiotherapy planning technique, the target tissue, and target volume.
Danish: Samtidig behandling (administreret samtidigt eller ≤ 7 dages mellemrum) -Toksicitet forbundet med denne multimodale behandling afhænger af mange forskellige faktorer, blandt andet dosis af gemcitabin, hyppighed af gemcitabinadministration, stråledosis, planlægningsteknikken for strålebehandlingen, det tumorvæv, som er mål for behandlingen, og tumorstørrelsen.