FrancophonIA/ELRC3.0 huggingface dataset:
English: Promising data in advanced bladder cancer and the need for other treatments for superficial bladder cancer led to the study of gemcitabine by intravesical administration in superficial bladder cancer but although the CHMP acknowledged that gemcitabine has shown activity in non-muscle invasive bladder cancer in intermediate and high risk patients, no actual data from Phase III trials has been submitted.
Danish: Lovende data vedrørende fremskreden blærecancer og behovet for andre behandlinger af overfladisk blærecancer førte til undersøgelsen med intravesikal administration af gemcitabin ved overfladisk blærecancer, men selvom CHMP anerkender, at gemcitabin har udvist aktivitet ved ikke-muskelinvasiv blærecancer hos middel- og højrisikopatienter, er der ikke fremlagt faktiske data fra fase III-undersøgelser.
English: Prior chemotherapy should have included an anthracycline unless clinically contraindicated.”
Danish: Tidligere kemoterapi burde have omfattet en anthracyclin, medmindre dette var klinisk kontraindiceret.”
English: Serious liver damage, including liver failure
Danish: Alvorlig leverskade, herunder leversvigt
English: Hungary Eli Lilly Nederland BV PO Box 379
Danish: Eli Lilly Nederland BV PO Box 379
English: Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Danish: Træthed, svimmelhed, hurtigt taber vejret, eller hvis du er bleg (fordi du muligvis har mindre hæmoglobin end normalt, hvilket er meget almindeligt).
English: Hampshire RG24 9NL United Kingdom
Danish: Hampshire RG24 9NL
English: Pharmacotherapeutic group: pyrimidine analogues ATC code: L01BC05
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber Farmakoterapeutisk klassifikation: pyrimidin analoger, ATC-kode: L 01 BC 05
English: Administration of gemcitabine in patients with concurrent liver metastases or a pre-existing medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.
Danish: Administration af gemcitabin til patienter, som samtidig har levermetastaser eller tidligere har haft hepatitis, alkoholisme eller levercirrose, kan føre til forværring af den tilgrundliggende leverinsufficiens.
English: For all indications, the patient must be monitored before each dose for platelet and granulocyte counts.
Danish: For alle indikationer gælder, at patienten skal monitoreres for blodplade- og granulocyttal før hver dosis.
English: After 377 deaths, the overall survival was 18.6 months versus 15.8 months (log rank p=0.0489, HR 0.82) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel and the overall response rate was 41.4% and 26.2% respectively (p= 0.0002).
Danish: Efter 377 dødsfald var den totale overlevelsestid 18,6 måneder hos patienter behandlet med gemcitabin/paclitaxel i forhold til 15,8 måneder (log rank p=0,0489, HR 0,82) hos patienter behandlet med gemcitabin/paclitaxel sammenlignet med patienter behandlet med paclitaxel, og den totale responsrate var henholdsvis 41,4% og 26,2% (p= 0,0002).
English: The MAH focused the discussion on the pivotal randomized Phase 3 Study JHQJ, and the main supportive single-arm Phase 2 Study JHRW.
Danish: Indehaveren af markedsføringstilladelsen fokuserede på den pivotale randomiserede fase IIIundersøgelse, JHQJ, og den vigtigste understøttende enkeltgruppe-fase II-undersøgelse, JHRW.
English: Gemcitabine (difluorodeoxy-cytidine (dFdC)) is a cytotoxic anti-cancer agent, which exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells through the G1/S phase boundary.
Danish: Gemcitabin (difluorodeoxycytidin (dFdC)) er et cytotoksisk anticancermiddel, som udviser cellefasespecificitet, idet det primært dræber celler under DNA-syntesen (S-fasen), og som under visse betingelser blokerer progressionen af celler gennem G1/S-fase-grænsen.
English: The CHMP required the MAH to reflect the target population (patients with advanced/metastatic bladder cancer) and the combination treatment with cisplatin in the harmonized indication.
Danish: CHMP pålagde indehaveren af markedsføringstilladelsen at afspejle målpopulationen (patienter med fremskreden/metastaserende blærecancer) og kombinationsbehandlingen med cisplatin i den harmoniserede indikation.
English: Gemzar (gemcitabine) is a pyrimidine antagonist (an antimetabolite) that is metabolised intracellularly to active diphosphate and triphosphate nucleosides which inhibit DNA synthesis.
Danish: Gemzar (gemcitabin) er en pyrimidinantagonist (antimetabolit), der metaboliseres intracellulært til aktive difosfat- og trifosfatnukleosider, som hæmmer DNA-syntesen.
English: Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
Danish: Gemcitabin monoterapi kan overvejes til behandling af ældre patienter eller til patienter med performance status 2.
English: Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke,
Danish: Storbrittanien Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke,
English: The CHMP assessed the SPC wording proposed by the MAH and the submitted rationales for the proposal.
Danish: CHMP har vurderet det forslag til formulering af produktresuméet, som er fremsat af indehaveren af markedsføringstilladelsen, og de fremlagte rationaler for forslaget.
English: The MAH also considered that the limited data available does not permit any dose modifications to be suggested in the SPC for patients with renal or hepatic impairment and that the precautions already adequately reflect the information available.
Danish: Indehaveren af markedsføringstilladelsen mente desuden, at de begrænsede tilgængelige data ikke tillader, at der foreslås dosisændringer i produktresuméet for patienter med nedsat nyre- eller leverfunktion, og at forsigtighedsreglerne allerede afspejler de tilgængelige oplysninger i tilstrækkelig grad. CHMP reviderede teksten under pkt.
English: For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination therapy, please refer to the corresponding Summary of Product Characteristics.
Danish: For justering af dosis af cisplatin, carboplatin og paclitaxel i kombinationsbehandling, henvises til de pågældende produktresuméer.
English: Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.”
Danish: Monoterapi med gemcitabin kan overvejes til ældre patienter eller patienter med en performance status på 2”.
English: Triphasic plasma concentration versus time curve, mean half-life of terminal phase - 65 hours (range 33-84 hr).
Danish: I en trifasisk plasmakoncentrations-tidskurve er den gennemsnitlige terminale halveringstid 65 timer (3384 timer).
English: Tissue distribution: Extensive.
Danish: Vævsfordeling: Udtalt.
English: Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy.
Danish: Pulmonære virkninger, som kan være alvorlige (såsom pulmonalt ødem, interstitiel pneumoni og Adult Respiratory Distress Syndrome (ARDS), er set i forbindelse med gemcitabinbehandling.
English: As no studies were available to support the use of gemcitabine as single agent neither in first or second line, the CHMP requested the MAH to further discuss the indication of Gemzar in ovarian cancer.
Danish: Da der ikke foreligger undersøgelser, der understøtter anvendelsen af gemcitabin som enkeltstof ved første- eller andetvalgsbehandling, anmodede CHMP indehaveren af markedsføringstilladelsen om at gøre yderligere rede for indikationen for Gemzar til ovariecancer.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler skal kontrolleres visuelt for partikler og misfarvning før indgivelse.
English: The indication in non-small cell lung cancer is based on data from Phase II and Phase III trials and indicated that gemcitabine has been shown to be active in the treatment of non-small cell lung cancer (NSCLC) and that in addition to gemcitabine single-agent activity, a preponderance of data supports the activity and safety of its combination with cisplatin in the treatment of NSCLC, irrespective of the different doses and schedules.
Danish: Indikationen for ikke-småcellet lungecancer bygger på data fra fase II- og fase III-undersøgelser og indikerer, at gemcitabin har vist sig at være aktiv ved behandling af ikke-småcellet lungecancer (NSCLC), og at en overvægt af data ud over gemcitabins aktivitet som enkeltstof understøtter dets aktivitet og sikkerhed i kombination med cisplatin ved behandling af NSCLC, uanset de forskellige doser og behandlingsplaner.
English: The MAH agreed that platinum-based combination therapies are the standard of care but defended the use of gemcitabine monotherapy in the treatment of elderly patients and patients with a Performance Status of 2, as these groups are at higher risk for chemotherapy-related morbidities or in cases where platinum-based combinations cannot be tolerated.
Danish: Indehaveren af markedsføringstilladelsen var enig i, at platinbaserede kombinationsterapier er standardbehandling, men forsvarede anvendelsen af monoterapi med gemcitabin til behandling af ældre patienter og patienter med en performance status på 2, da disse grupper har højere risiko for kemoterapirelateret morbiditet, eller i tilfælde, hvor platinbaserede kombinationer ikke tåles.
English: The MAH provided an updated posology taking into account the CHMP comments.
Danish: Indehaveren af markedsføringstilladelsen sørgede for at ajourføre doseringen, således at den tager højde for CHMP's bemærkninger.
English: For Section 4.4, the MAH addressed impaired renal and hepatic function, paediatric recommendations and concomitant administration of gemcitabine and radiotherapy.
Danish: 4.4 behandlede indehaveren af markedsføringstilladelsen nedsat nyre- og leverfunktion, pædiatriske anbefalinger og samtidig administration af gemcitabin og strålebehandling.
English: The MAH concluded that the studies demonstrated that gemcitabine plus carboplatin is superior to carboplatin in terms of time to disease progression (TtDP) and response rate in patients with platinumsensitive recurrent ovarian cancer.
Danish: Indehaveren af markedsføringstilladelsen konkluderede, at undersøgelserne viste, at gemcitabin plus carboplatin er mere effektivt end carboplatin med hensyn til tid til sygdomsprogression (TtDP) og responsraten hos patienter med platinsensitiv recidiverende ovariecancer.
English: For the indication in bladder cancer, the MAH provided data from two Phase 2 studies and from a pivotal Phase 3, showing that gemcitabine chemotherapy is active, tolerable, displays manageable toxicity and superiority to MVAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy in the treatment of patients with advanced or metastatic transitional cell carcinoma of the urothelium.
Danish: Med henblik på indikationen for blærecancer har indehaveren af markedsføringstilladelsen fremlagt data fra to fase II-undersøgelser og fra en pivotal fase III-undersøgelse, der viser, at kemoterapi med gemcitabin er aktiv, tålelig, udviser kontrollerbar toksicitet og superioritet i forhold til kemoterapi med MVAC (methotrexat, vinblastin, adriamycin og cisplatin) ved behandling af patienter med fremskreden eller metastaserende transitionalcellekarcinom i urothelium.
English: For instructions on reconstitution, see section 6.6
Danish: Instruktioner vedrørende rekonstitution, se pkt.
English: After this addition there is essentially a complete inhibition in further DNA synthesis (masked chain termination).
Danish: Denne nukleotidforøgelse betyder i princippet en fuldstændig hæmning af den fortsatte DNA-syntese (maskeret kædeterminering).
English: • not known: frequency can't be estimated from the available data
Danish: • Bivirkninger, hvor hyppigheden ikke er kendt: Hyppigheden kan ikke bestemmes ud fra forhåndenværende data.
English: Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Danish: Du vil regelmæssigt få taget blodprøver til vurdering af, hvor godt dine nyrer og din lever fungerer.
English: Gemzar may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Danish: Afhængig af typen af kræft kan Gemzar enten bruges alene eller sammen med anden medicin mod kræft
English: In fertility studies, gemcitabine caused reversible hypospermatogenesis in male mice.
Danish: I fertilitetsstudier, har gemcitabin forårsaget reversibel hypospermatogenese i hanmus.
English: In addition, the use of gemcitabine for the treatment of recurrent ovarian cancer has been widely recognized and the MAH therefore believes that carboplatin plus gemcitabine represents a valuable option for treating patients with recurrent ovarian cancer.
Danish: Desuden er anvendelsen af gemcitabin til behandling af recidiverende ovariecancer almindeligt anerkendt, og indehaveren af markedsføringstilladelsen mener derfor, at carboplatin plus gemcitabin udgør en værdifuld valgmulighed til behandling af patienter med recidiverende ovariecancer.
English: The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
Danish: - Øvrige indholdsstoffer: mannitol (E421), natriumacetat, saltsyre og natriumhydroxid.
English: Cisplatin is given at a recommended dose of 70 mg/m2 on Day 1 following gemcitabine or day 2 of each 28-day cycle.
Danish: Cisplatin indgives i en anbefalet dosis på 70 mg/m på dag 1 efter gemcitabininfusionen eller dag 2 i hver 28 dages cyklus.
English: Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply) Heart failure
Danish: Stråleskade - ar-dannelse i lungernes luftsække forbundet med strålebehandling Iskæmisk colitis (betændelse i tyktarrmens væg, forårsaget af nedsat blodtilførsel) Hertesvigt
English: First, dFdCDP inhibits ribonucleotide reductase, which is uniquely responsible for catalysing the reactions that produce deoxynucleoside triphosphates (dCTP) for DNA synthesis.
Danish: For det første hæmmer dFdCDP ribonukleotid-reduktase, som er den eneste katalysator for produktionen af deoxynukleosid-trifosfater til DNA-syntesen.
English: Gastrointestinal disorders Ischaemic colitis
Danish: Mave-tarmkanalen Iskæmisk colitis
English: Gemcitabine can suppress bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia.
Danish: Gemcitabin kan undertrykke knoglemarvsfunktionen, som viser sig ved leukopeni, trombocytopeni og anæmi.
English: This yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Danish: Dette giver en gemcitabinkoncentration på 38 mg/ml, hvor der er taget højde for forskydningsvolumen af det lyofiliserede pulver.
English: Radiation injury has been reported on targeted tissues (e.g. oesophagitis, colitis, and pneumonitis) in association with both concurrent and non-concurrent use of gemcitabine.
Danish: Der er rapporteret om stråleskade på det tumorvæv, som er mål for behandlingen (f.eks. øsofagitis, colitis og pneumoni) både i forbindelse med samtidig og ikke-samtidig brug af gemcitabin.
English: As with other cytotoxic treatments, the risk of cumulative bone-marrow suppression must be considered when gemcitabine treatment is given together with other chemotherapy
Danish: Risikoen for kumulativ knoglemarvssuppression skal overvejes som med andre cytotoksiske behandlinger, når gemcitabin gives sammen med anden kemoterapi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg gemcitabine
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mg gemcitabin
English: Important information about some of the ingredients of Gemzar Gemzar contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Gemzar Gemzar indeholder 3,5 mg (< 1 mmol) natrium i hvert 200 mg hætteglas og 17,5 mg natrium i hvert 1000 mg hætteglas.
English: A randomised phase III study of 405 patients with advanced or metastatic urothelial transitional cell carcinoma showed no difference between the two treatment arms, gemcitabine/cisplatin versus methotrexate/vinblastine/adriamycin/cisplatin (MVAC), in terms of median survival (12.8 and 14.8 months respectively, p=0.547), time to disease progression (7.4 and 7.6 months respectively, p=0.842) and response rate (49.4% and 45.7% respectively, p=0.512).
Danish: En randomiseret fase III undersøgelse med 405 patienter med fremskreden eller metastatisk urothelialt transitiocellulært karcinom, sås ingen forskel mellem de to behandlingsarme, gemcitabin/cisplatin versus methotrexat/vinblastin/adriamycin/cisplatin (MVAC), hvad angår median overlevelse (henholdsvis 12,8 måneder og 14,8 måneder, p=0,547), tid til progression i sygdommen (henholdsvis 7,4 måneder og 7,6 måneder, p=0,842) og responsrate (henholdsvis 49,4% og 45,7%, p=0,512).
English: A statistically significant prolongation of the time to progression of disease, from 5.8 to 8.6 months (log-rank p= 0.0038) was observed in the patients treated with GCb compared to patients treated with Cb.
Danish: En statistisk signifikant forlængelse af tiden til progression af sygdommen, fra 5,8 til 8,6 måneder (log rank p=0,0038) blev observeret hos patienter behandlet med GCb i forhold til patienter behandlet med Cb.
English: Concomitant radiotherapy (given together or ≤7 days apart): Toxicity has been reported (see section 4.5 for details and recommendations for use).
Danish: Samtidig røntgenbehandling (givet samtidig eller ≤ 7 dage derfra): Toksicitet er rapporteret (se pkt.
English: Adult respiratory distress syndrome (see section 4.4)
Danish: Adult Respiratory Distress Syndrome (ARDS) (se pkt.
English: The CHMP reviewed the MAH responses and agreed that as a single agent, gemcitabine has a specific role in patients with a borderline performance status and elderly patients and that gemcitabine is an option between other treatments, although no specific agent has been identified to be better than others.
Danish: CHMP gennemgik svarene fra indehaveren af markedsføringstilladelsen og var enig i, at gemcitabin som enkeltstof spiller en specifik rolle hos patienter, hvis performance status er et grænsetilfælde, og hos ældre patienter, og at gemcitabin er en af flere behandlingsmuligheder, uagtet at det ikke påvist, at et bestemt stof er bedre end de øvrige stoffer.
English: Instructions for reconstitution (and further dilution, if performed) The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
Danish: Instruktioner for rekonstitution (og yderligere fortynding, hvis det foretages) Det eneste godkendte opløsningsmiddel til rekonstitution af gemcitabin steril pulver er natriumklorid 9 mg/ml (0,9%) injektionsvæske, opløsning (uden konservering).
English: Oedema is usually reversible after stopping treatment
Danish: Ødemer er sædvanligvis reversible efter behandlingsophør
English: Studies done subsequently have suggested that it is feasible to administer gemcitabine at lower doses with concurrent radiotherapy with predictable toxicity, such as a phase II study in non-small cell lung cancer, where thoracic radiation doses of 66 Gy were applied concomitantly with an administration with gemcitabine (600 mg/m2, four times) and cisplatin (80 mg/m2 twice) during 6 weeks.
Danish: Senere undersøgelser indikerer, at det er muligt at administrere gemcitabin i lavere doser med samtidig strålebehandling med en forudsigelig toksicitet, som i et fase II studie af ikke-småcellet lungecancer, hvor der blev anvendt torakalbestråling i doser på 66Gy samtidig med gemcitabin (600 mg/m
English: This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Danish: Denne opløsning giver en gemcitabinkoncentration på 38 mg/ml, hvor der er taget højde for forskydningsvolumen af det lyofiliserede pulver.
English: Peak plasma concentrations (3-15 minutes after end of 30-minute infusion, 1000 mg/m2): 28-52 µg/ml.
Danish: dFdU-kinetik Maksimale plasmakoncentrationer (3-15 minutter efter afslutningen af 30 minutters infusion 1000 2): 28-52 µg/ml.
English: Non small Cell lung cancer
Danish: Ikke-småcellet lungecancer
English: In animal tumour models, antitumoural activity of gemcitabine is schedule-dependent.
Danish: I dyremodeller er gemcitabins antitumoraktivitet afhængig af administrationsfrekvensen.
English: Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
Danish: Anvend aseptisk teknik under rekonstitutionen og enhver yderligere fortynding af gemcitabin til indgivelse via intravenøs infusion.
English: Hepatobiliary disorders Serious hepatotoxicity, including liver failure and death
Danish: Lever og galdeveje Alvorlig hepatotoksicitet, herunder leverinsufficiens og død
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: • breast cancer, together with paclitaxel.
Danish: - Brystkræft, hvor det bruges sammen med paclitaxel.
English: Pain, redness, swelling or sores in the mouth Itching
Danish: Smerter, rødmen, hævelse eller sår i munden Kløe
English: Unopened vial: Store below 30°C
Danish: Uåbnet hætteglas: Opbevares under 30°C
English: Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke, Hampshire, RG 216XA5
Danish: Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke, Hampshire, RG 216XA5 Storbritannien
English: Dose-limiting adverse reactions are reductions in thrombocyte, leucocyte and granulocyte counts (see section 4.2).
Danish: De dosisbegrænsende bivirkninger, der er set, er reduktion af blodplader, leukocytter og granulocytter (se pkt.
English: The MAH defended the use of gemcitabine for the ovarian cancer indication based on a number of guidelines, considering that based on the demonstrated significant benefits of gemcitabine in combination with carboplatin, the acceptable toxicity profile and the tolerability of the treatment, this combination presents a favourable risk/benefit relationship in the treatment of recurrent ovarian cancer patients.
Danish: Indehaveren af markedsføringstilladelsen forsvarede anvendelsen af gemcitabin til ovariecancerindikationen på grundlag af en række retningslinjer, idet det anførtes, at en kombination af gemcitabin og carboplatin i lyset af de væsentlige fordele påvist herved, den acceptable toksicitetsprofil og behandlingens tolerabilitet udviser et gunstigt risk/benefit-forhold ved behandling af recidiverende ovariecancerpatienter.
English: Breast-feeding must be discontinued during gemcitabine therapy.
Danish: Amning skal ophøre under gemcitabinbehandling.
English: Skin scaling, ulceration or blister formation Injection site reactions
Danish: Afskalning af huden, sår- eller blæredannelse Reaktioner ved infusionsstedet
English: Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function.
Danish: Du vil få taget blodprøver før den første infusion, for at vurdere om du har tilstrækkelig nyre- og leverfunktion.
English: Dose modification due to haematological toxicity
Danish: Dosisjustering som følge af hæmatologisk toksicitet
English: There is no known antidote for overdose of gemcitabine.
Danish: 4.9 Overdosering Der findes ingen kendt antidot mod gemcitabin ved overdosering.
English: Low haemoglobin level (anaemia) Low white blood cells
Danish: Meget almindelige bivirkninger Lavt hæmoglobinniveau (anæmi) Lavt antal hvide blodlegemer