FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
Danish: Frekvenser er defineret som: meget almindelig ( 1/10), almindelig( 1/100 til <1/10), ikke almindelig ( 1/1.000 til 1/100), sjælden ( 1/10.000 til 1/1.000), meget sjælden (<1/10.000).
English: Renal
Danish: Renalt
English: The optimum regimen for safe administration of gemcitabine with therapeutic doses of radiation has not yet been determined in all tumour types.
Danish: Der er endnu ikke fastlagt et optimalt doseringsregime til sikker administration af gemcitabin sammen med terapeutiske strålingsdoser for alle slags tumorer.
English: Further dilution by a healthcare provider may be done.
Danish: Opløsningen kan fortyndes yderligere af sundhedsfagligt personale.
English: WHAT GEMZAR IS AND WHAT IT IS USED FOR
Danish: GEMZAR'S VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: Fatigue and febrile neutropaenia occur more frequently when gemcitabine is used in combination with paclitaxel.
Danish: Træthed og febril neutropeni opstår hyppigere, når gemcitabin anvendes i kombination med paclitaxel.
English: Non-concurrent (given >7 days apart)- Analysis of the data does not indicate any enhanced toxicity when gemcitabine is administered more than 7 days before or after radiation, other than radiation recall.
Danish: Ikke samtidig behandling (> 7 dages mellemrum) - Der foreligger ikke data, som indikerer betydelig øget toksicitet, når gemcitabin indgives mere end 7 dage før eller efter strålebehandling, bortset fra en genkaldelse af strålebivirkningerne.
English: Gemcitabine plus cisplatin arm (N=200)
Danish: Gemcitabin plus cisplatin arm (N=200)
English: Severe skin reactions, including desquamation and bullous skin eruptions, Lyell's Syndrome, StevenJohnson Syndrome
Danish: Alvorlige hudreaktioner, inklusiv deskvamation og bulløst udslæt, Lyell's syndrom, Stevens -Johnsons syndrom
English: The CHMP was of the opinion that gemcitabine has shown activity as single agent in MBC but the lack of Phase III trials in this setting makes it difficult to give a specific recommendation about the precise place of gemcitabine in the treatment of advance breast cancer.
Danish: CHMP var af den opfattelse, at gemcitabin har vist aktivitet som enkeltstof ved MBC, men manglen på fase III-undersøgelser i forbindelse med denne behandling gør det vanskeligt at komme med en specifik anbefaling om den præcise placering af gemcitabin ved behandling af fremskreden brystcancer.
English: The frequency of grade 3 and 4 haematological toxicities, particularly neutropaenia, increases when gemcitabine is used in combination with paclitaxel.
Danish: Frekvensen af grad 3 og 4 hæmatologiske toksiciteter, specielt neutropeni, stiger når gemcitabin anvendes i kombination med paclitaxel.
English: The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP.
Danish: Den cytotoksiske effekt af gemcitabin skyldes en hæmning af DNA-syntesen ved hjælp af to virkningsmekanismer af dFdCDP og dFdCTP.
English: • Bronchospasm -usually mild and transient but may require parenteral treatment
Danish: 4.4), bronkospasme - sædvanligvis mild og kortvarig, men kan kræve parenteral behandling
English: After gemcitabine is incorporated into DNA, one additional nucleotide is added to the growing DNA strands.
Danish: Efter gemcitabin er optaget i DNA øges de voksende DNA-strenge med et ekstra nukleotid.
English: Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/ml.
Danish: Ud fra overvejelser omkring opløselighed, er den øvre grænse for gemcitabin-koncentration efter rekonstitution 40 mg/ml.
English: Differences in response rate of 47.2% in the GCb arm versus 30.9% in the Cb arm (p=0.0016) and median survival 18 months (GCb) versus 17.3 (Cb) (p=0.73) favoured the GCb arm.
Danish: Forskelle i responsrate, 47,2% i GCb armen versus 30,9% i Cb armen (p=0,0016), og i median overlevelsestid, 18 måneder (GCb) versus 17,3 måneder (Cb) (p=0,73) favoriserede GCb armen.
English: Systemic clearance ranged from 29.2 l/hr/m2 to 92.2 /hr/m2 depending on gender and age (inter-individual variability was 52.2%).
Danish: Elimination Systemisk clearance: Fra 29,2 l/t/m til 92,2 l/t/m afhængig af køn og alder (interindividuel variabilitet var 52,2%).
English: Dose modification due to non haematological toxicity Periodic physical examination and checks of renal and hepatic function should be made to detect non haematological toxicity.
Danish: Dosisjustering som følge af ikke-hæmatologisk toksicitet Periodiske helbredsundersøgelser og kontrol af nyre- og leverfunktion skal udføres for at kunne påvise ikke-hæmatologisk toksicitet.
English: In general, the CHMP considered the proposed wording to be adequate, but implemented a number of revisions, including sections on impaired bone-marrow function, combination with carboplatin and cisplatin, live attenuated vaccines and Pharmacovigilance reports on cardiovascular events and viral hepatitis reactivation.
Danish: CHMP anså generelt den foreslåede tekst for at være tilstrækkelig, men foretog en række ændringer, bl.a. i afsnittene om nedsat knoglemarvsfunktion, kombination med carboplatin og cisplatin, levende svækkede vacciner samt lægemiddelovervågningsindberetninger vedrørende kardiovaskulære hændelser og reaktivering af viral hepatitis.
English: • Febrile neutropaenia
Danish: Febril neutropeni
English: What Gemzar is and what it is used for Before you are given Gemzar How Gemzar is given Possible side effects How to store Gemzar Further information
Danish: Gemzar's virkning og hvad du skal bruge det til Det skal du vide, før du begynder at bruge Gemzar Sådan skal du bruge Gemzar Bivirkninger
English: For storage conditions of the reconstituted medicinal product see section 6.3
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Studier i dyr har vist reproduktionstoksicitet (se pkt.
English: Fever accompanied by low white blood cell count (febrile neutropaenia) Anorexia (poor appetite)
Danish: Feber ledsaget af lavt antal hvide blodlegemer (febril neutropeni) Appetitløshed
English: Patients should be cautioned against driving or operating machinery until it is established that they do not become somnolent.
Danish: Patienter skal frarådes at køre bil eller betjene maskiner, indtil det er afklaret, om de bliver somnolente som følge af behandlingen.
English: Do not drive a car or use machinery until you are sure that Gemzar treatment has not made you feel sleepy.
Danish: Du bør ikke køre bil eller betjene maskiner, før du er sikker på, at du ikke bliver søvnig som følge af behandlingen.
English: Intracellular metabolism of gemcitabine produces the gemcitabine mono, di and triphosphates (dFdCMP, dFdCDP and dFdCTP) of which dFdCDP and dFdCTP are considered active.
Danish: Den intracellulære metabolisme af gemcitabin danner gemcitabin mono-, di- og trifosfater (dFdCMP, dFdCDP og dFdCTP), hvoraf dFdCDP og dFdCTP anses for aktive.
English: Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human tumour cells.
Danish: Gemcitabin udviser betydelig cytotoksicitet overfor en række forskellige murine og humane tumorceller i cellekultur.
English: The MAH agreed to delete the indication in superficial bladder cancer and the CHMP accordingly proposed the following revised wording:
Danish: Indehaveren af markedsføringstilladelsen indvilligede i at slette indikationen for overfladisk blærecancer, og CHMP foreslog derfor følgende reviderede ordlyd:
English: Gemcitabine solutions are for single use only.
Danish: Gemcitabinopløsninger er kun beregnet til engangsbrug.
English: Thus, the reduced intracellular concentration of dCTP potentiates the incorporation of dFdCTP into DNA.
Danish: Således forstærker reduktionen i den intracellulære koncentration af dCTP optagelsen af dFdCTP i DNA.
English: In the event of suspected overdose, the patient should be monitored with appropriate blood counts and receive supportive therapy, as necessary.
Danish: Ved mistanke om overdosering bør patienten monitoreres med relevante laboratorieprøver og behandles efter behov.
English: For intravenous use after reconstitution
Danish: Til intravenøs brug efter rekonstitution.
English: Each pack of Gemzar contains 1 vial.
Danish: Hver pakke Gemzar indeholder 1 hætteglas.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton
English: Peak plasma concentrations (obtained within 5 minutes of the end of the infusion) were 3.2 to 45.5 µg/ml.
Danish: Maksimale plasmakoncentrationer (nået inden for 5 minutter efter afslutning på infusionen) var 3,2 til 45,5 µg/ml.
English: Yellow fever vaccine and other live attenuated vaccines are not recommended in patients treated with gemcitabine (see section 4.5).
Danish: Gul feber vaccine og andre levende, svækkede vacciner anbefales ikke til patienter i behandling med gemcitabin(se pkt.
English: Suspension or modification of therapy should be considered when drug-induced bone marrow depression is detected (see section 4.2).
Danish: Afbrydelse eller ændring af behandlingen skal overvejes lægemiddelinduceret knoglemarvsdepression bliver påvist (se pkt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstid og -forhold før anvendelse på brugerens ansvar og vil normalt ikke være længere end 24 timer ved stuetemperatur, medmindre rekonstitution/opløsning har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
Danish: Blødninger fra gummer, næse eller mund eller andre blødninger, som ikke vil stoppe, rødlig eller lyserød urin, uventede blå mærker (fordi du muligvis har færre blodplader end normalt, hvilket er meget almindeligt).
English: Intracellular concentrations increase in proportion to gemcitabine doses of 35-350 mg/ m2/30-minutes, which give steady state concentrations of 0.4-5 µg/ml.
Danish: Intracellulære koncentrationer øges proportionalt med gemcitabin-doser på 35-350 mg/m2/30 minutter, hvilket giver steady-state koncentrationer på 0,4-5 µg/ml.
English: Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemzar.
Danish: Før hver infusion vil du få taget blodprøver for at vurdere, om du har tilstrækkeligt antal af forskellige celler i blodet til at kunne få Gemzar.
English: Eli Lilly Denmark, Nybrovej 110, 2800 Lyngby
Danish: Eli Lilly Danmark, Nybrovej 110, 2800 Lyngby
English: See leaflet for further information.
Danish: Se indlægsseddel for yderligere information
English: In general, for severe (Grade 3 or 4) nonhaematological toxicity, except nausea/vomiting, therapy with gemcitabine should be withheld or decreased depending on the judgement of the treating physician.
Danish: Ved svær (grad 3 eller 4) ikke-hæmatologisk toksicitet, kvalme/opkastning undtaget, skal gemcitabinbehandling normalt holdes tilbage eller reduceres afhængig af den behandlende læges vurdering.
English: Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity.
Danish: Enkeltdoser op til 5700 mg/m er blevet givet ved intravenøs infusion over 30 minutter, hver 2. uge, med klinisk acceptabel toksicitet.
English: Omit dose* *Treatment omitted will not be re-instated within a cycle.
Danish: Udeladt behandling vil ikke blive genoptaget i løbet af en cyklus.
English: Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used.
Danish: Håndtering af infusionsopløsningen bør foregå i et ”sikkerhedsskab” (særligt indrettet rum) og beskyttende kittel og handsker bør anvendes.
English: Due to the risk of cardiac and/or vascular disorders with gemcitabine, particular caution must be exercised with patients presenting a history of cardiovascular events.
Danish: På grund af risikoen for hjerte og/eller vaskulære lidelser ved brug af gemcitabin, skal der tages særlige forholdsregler ved behandling af patienter med kardiovaskulære tilfælde i anmnesen.
English: Reconstituted solution is a clear colourless to light straw-coloured solution.
Danish: En rekonstitueret opløsning er en klar farveløs til lys strågul opløsning.
English: 3990 GD Houten
Danish: 3990 GD Houten Holland
English: Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
Danish: Opløsninger af rekonstitueret gemcitabin må ikke opbevares i køleskab, da der kan forekomme udkrystallisering.
English: Platelet count (x 106/l)
Danish: Blodbladetal (x 106/l)
English: Plasma concentrations of the parent compound following a dose of 1,000 mg/m2/30-minutes are greater than 5 µg/ml for approximately 30-minutes after the end of the infusion, and greater than 0.4 µg/ml for an additional hour.
Danish: Plasmakoncentrationer af modersubstansen efter en dosis på 1.000 mg/ m2 / 30 minutter er større end 5 µg/ml i ca. 30 minutter efter afslutning af infusionen og større end 0,4 µg/ml i endnu en time.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution(and further dilution, if applicable) has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart efter tilberedning, er opbevaringstid og -forhold forud for anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved stuetemperatur, medmindre rekonstitution (og yderligere fortynding, hvis nødvendigt) er foretaget under kontrollerede og validerede aseptiske forhold.
English: Runny nose
Danish: Løbende næse
English: Regarding ovarian cancer, the MAH proposed a wording for combination use in this indication, although activity is shown by gemcitabine as a single agent, and provided a clinical expert report and supplementary information to support the indication.
Danish: Hvad angår ovariecancer, foreslog indehaveren af markedsføringstilladelsen en formulering om kombinationsanvendelse ved denne indikation, uagtet at der er påvist aktivitet af gemcitabin som enkeltstof, og fremlagde en klinisk ekspertrapport og supplerende oplysninger, der understøttede indikationen.
English: Gangrene of fingers or toes
Danish: Koldbrand i fingre og tæer
English: Its action is phase-specific such that gemcitabine primarily kills cells that are undergoing DNA synthesis (S-phase) and, under certain circumstances, blocks the progression of cells at the junction of the G1/S phase boundary.
Danish: Virkningen er fasespecifik, idet gemcitabin primært dræber celler, der undergår DNA-syntese (Sfase) og under visse forhold blokerer cellecyklus på grænsen mellem G1 og S-fasen.
English: No effect on the fertility of females has been detected.
Danish: Der er ikke påvist nogen effekt på fertiliteten hos hunmus.
English: Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Sloughing of skin and severe skin blistering
Danish: Anafylaktisk reaktion (alvorlig overfølsomhed/allergisk reaktion) Afskalning af hud og voldsomme blærer på huden.
English: Laboratory Anaemia Neutropaenia Thrombocytopaenia Leucopaenia Non-laboratory Haemorrhage Febrile neutropaenia Infection without neutropaenia Sensory neuropathy was also more frequent in the combination arm than with single agent carboplatin
Danish: Laboratorieværdier Anæmi Neutropeni Thrombocytopeni Leukopeni Ikkelaboratorieværdier Blødning Febril neutropeni Infektion uden neutropeni Sensorisk neuropati var også mere hyppigt forekommende ved kombinationsbehandlingen end ved behandling med carboplatin alene.
English: Bone-marrow suppression is usually mild to moderate and mostly affects the granulocyte count (see section 4.2)
Danish: Myelosuppression er sædvanligvis mild til moderat og påvirker hovedsaglig granulocyttallet (se pkt.
English: No specific studies were performed in severely renally or hepatically impaired patients but based on published literature, the MAH considered that there was no indication that these patients differ significantly from the mild to moderate renally impaired group, in terms of Cmax or clearance.
Danish: Der er ikke gennemført specifikke undersøgelser med patienter med svært nedsat nyre- eller leverfunktion, men indehaveren af markedsføringstilladelsen mente ud fra tidligere offentliggjort litteratur, at der ikke er noget, der tyder på, at disse patienter er væsentligt forskellige fra gruppen med let til moderat nedsat nyrefunktion med hensyn til Cmax eller clearance.
English: Shake to dissolve.
Danish: Ryst for at opløse.
English: You will always receive Gemzar by infusion into one of your veins.
Danish: Du vil altid få Gemzar ved indsprøjtning i en blodåre.
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Gemzar.
Danish: - Det produktresumé, den etikettering og den indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelsen, er blevet vurderet på grundlag af den forelagte dokumentation og den faglige drøftelse i udvalget anbefaler CHMP en ændring af markedsføringstilladelserne.
English: Arrythmias, predominantly supraventricular in nature Heart failure
Danish: Arytmier, hovedsaglig af supraventrikulær karakter Hjerteinsufficiens
English: After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Danish: Efter rekonstitution indeholder opløsningen 38 mg/ml gemcitabin.
English: In a randomised phase III study, 356 patients with advanced epithelial ovarian carcinoma who had relapsed at least 6 months after completing platinum based therapy were randomised to therapy with gemcitabine and carboplatin (GCb), or carboplatin (Cb).
Danish: I en randomiseret fase III undersøgelse blev 356 patienter med fremskreden epitelial ovariekarcinom med tilbagefald mindst 6 måneder efter at have afsluttet platinbaseret behandling randomiseret til behandling med gemcitabin og carboplatin (GCb), eller carboplatin (Cb).
English: Laboratory Anaemia Thrombocytopaenia Non-laboratory Nausea and vomiting Diarrhoea Infection Stomatitis
Danish: Laboratorieværdier Anæmi Trombocytopeni Ikkelaboratorieværdier Kvalme og opkastning Diarré Infektion Stomatitis
English: The MAH also defended the use of gemcitabine by intravesical administration, based on the proven activity in advanced bladder cancer, on the pharmacokinetic attributes of gemcitabine and on its high total body clearance.
Danish: Indehaveren af markedsføringstilladelsen har også forsvaret brugen af gemcitabin ved intravesikal administration på grundlag af den påviste aktivitet ved fremskreden blærecancer, gemcitabins farmakokinetiske egenskaber og dets høje totale kropsclearance.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse, er bivirkningerne listet efter faldende grad af alvorlighed.
English: Men are advised not to father a child during and up to 6 months following treatment with Gemzar.
Danish: Det tilrådes ikke, at mænd gør en kvinde gravid under behandlingsforløbet eller op til 6 måneder efter behandling med Gemzar.
English: 3991 RA Houten The Netherlands
Danish: 3991 RA Houten Holland
English: The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively.
Danish: Det totale volumen efter rekonstitution er henholdsvis 5,26 ml (200 mg hætteglas) eller 26,3 ml (1000 mg hætteglas).
English: Gemcitabine should be discontinued at the first signs of any evidence of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopaenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH.
Danish: Behandlingen med gemcitabin bør seponeres ved de første tegn på mikroangiopatisk hæmolytisk anæmi såsom hurtigt faldende hæmoglobinniveau med samtidig trombocytopeni, stigning i serumbilirubin, serumkreatinin, serumcarbamid eller LDH.
English: The MAH therefore considered the positive benefit-risk ratio to be established for the use of gemcitabine/cisplatin in the treatment of NSCLC.
Danish: Indehaveren af markedsføringstilladelsen fandt derfor, at der var påvist et positivt benefit/risk-forhold for anvendelsen af gemcitabin/cisplatin til behandling af NSCLC.
English: You should not be given Gemzar: - if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemzar.
Danish: Brug ikke Gemzar - hvis du er overfølsom (allergisk) over for det aktive stof eller et af de øvrige indholdsstoffer.
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Denmark
Danish: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby Danmark
English: Gemcitabine and paclitaxel combination therapy Combination therapy did not alter the pharmacokinetics of either gemcitabine or paclitaxel.
Danish: Kombinationsbehandling med gemcitabin og paclitaxel Kombinationsbehandling ændrer ikke farmakokinetikken af hverken gemcitabin eller paclitaxel.
English: • Leucopaenia (Neutropaenia Grade 3 = 19.3 %; Grade 4 = 6 %).
Danish: Leukopeni (Neutropeni: hyppigheden for hhv. Grade 3 og Grade 4 er 19.3% og 6%)
English: In summary the MAH has deleted the indication for intravesical use and for 5-FUrefractory pancreatic cancer while the indication in ovarian cancer has been justified.
Danish: Sammenfattende har indehaveren af markedsføringstilladelsen slettet indikationen for intravesikal anvendelse og for pancreascancer, der er refraktær over for 5-FU, mens indikationen for ovariecancer er begrundet.
English: Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Danish: Forudgående kemoterapi bør have inkluderet et antracyklin, medmindre dette har været klinisk kontraindiceret.
English: For Section 4.3, the MAH proposal retained only two of the existing 8 contraindications (relating to hypersensitivity and breast feeding) and removed 6 (hepatic or renal impairment, cisplatin for patients with severe renal failure, pregnancy and lactation, combination with yellow fever, usage in children and concomitant administration of gemcitabine and radiotherapy).
Danish: 4.3 fastholdt indehaveren af markedsføringstilladelsen kun to af de eksisterende otte kontraindikationer (vedrørende overfølsomhed og amning) i sit forslag, mens seks blev slettet (nedsat nyre- eller leverfunktion, cisplatin til patienter med svær nyresvigt, graviditet og amning, kombination med gul feber, anvendelse til børn og samtidig administration af gemcitabin og strålebehandling).