FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino Pharma 75 mg film-coated tablets Clopidogrel NAME OF THE MARKETING AUTHORISATION HOLDER Acino Pharma GmbH EXPIRY DATE
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Acino Pharma GmbH
English: Haematuria
Danish: Hæmatom
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gældende sammendrag af produktkarakteristik, mærkning og indlægsseddel er de endelige versioner, som man er nået frem til under koordinationsgruppens arbejdsproces.
English: Summary of product characteristics, labelling and package leaflet
Danish: Sammendrag af produktkarakteristik, mærkning og indlægsseddel
English: If you have pain, redness, swelling or sores in your mouth (very common).
Danish: Hvis De har smerter, rødmen, hævelse eller sår i munden (meget almindelig).
English: Ελλάδα ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Danish: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: The overall response rate was 14.1 %.
Danish: Den samlede responsrate var 14,1 %.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobielt synspunkt skal produktet anvendes med det samme.
English: You might have any of these symptoms and/or conditions.
Danish: De vil muligvis kunne opleve nogle af disse symptomer og/eller tilstande.
English: Date of latest renewal: 20 September 2009
Danish: Dato for seneste fornyelse: 20. september 2009
English: This is further supported with data from a clinical study.
Danish: Dette understøttes yderligere af data fra et klinisk studie.
English: Instructions for use, handling and disposal.
Danish: Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse.
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10%; Almindelig - > 5% og < 10%.
English: Reconstituted and Infusion Solutions: The product should be used immediately.
Danish: Rekonstituerede opløsninger og infusionsopløsninger: Produktet skal anvendes med det samme.
English: Progression-Free Survival
Danish: Progressionsfri overlevelse
English: Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy.
Danish: Deres læge vil sammen med Dem drøfte den potentielle risiko ved at tage ALIMTA under graviditet.
English: Between patient variability in clearance is moderate at 19.3 %.
Danish: Der er en moderat variation i clearance blandt patienterne på 19,3 %.
English: Unopened vial 3 years.
Danish: Ubrudt hætteglas 3 år.
English: In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins.
Danish: In vitro-forsøg tyder på, at omtrent 81 % bindes til plasmaproteiner.
English: Diarrhoea without colostomy
Danish: Diarré uden kolostomi
English: Superiority p-value
Danish: Superioritet p-værdi
English: The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Danish: Opløsningen bliver derefter klar og kan variere i farve fra farveløs til gul eller grøngul, uden at det har negativ indflydelse på produktets kvalitet.
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Danish: Følsomhedsanalyser af hovedvirkningens endepunkter blev også bedømt ud fra den protokolkvalificerede (PQ) population.
English: Additional medicines:
Danish: Andre lægemidler:
English: Based on the planned date of your infusion of ALIMTA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for Deres infusion af ALIMTA og/eller status for Deres nyrefunktion skal Deres læge fortælle Dem, hvilke typer medicin De må tage, og hvornår De må tage dem.
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Danish: PFS data blev delvist bekræftet af en uafhængig undersøgelse (400/1715 patienter blev randomiseret og udvalgt til undersøgelsen).
English: Particular attention should be paid to these patients and caution exercised with use of other radiosensitising agents.
Danish: Man skal være særlig opmærksom ved disse patienter, og der bør udvises forsigtighed ved brug af andre radiosensibiliserende stoffer.
English: Side effects with ALIMTA may include:
Danish: Bivirkninger med ALIMTA kan være:
English: Frequency estimate: 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) and not known (cannot be estimated from available data).
Danish: Hyppighed: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
Danish: Pemetrexeds samlede systemiske eksponering (AUC) og maksimale plasmakoncentration er proportionalt stigende med dosis.
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Danish: Pemetrexed har et steady state-fordelingsvolumen på 9 l/m2.
English: Do not use ALIMTA - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of of this medicine (listed in section 6).
Danish: Brug ikke ALIMTA: hvis De er overfølsom (allergisk) over for pemetrexed eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt 6.3.
English: 75 % of previous dose (both ALIMTA and cisplatin)
Danish: 75 % af tidligere dosis (både ALIMTA og cisplatin)
English: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and hyperpigmentation.
Danish: Som resultat heraf er der tilstrækkelig evidens, som antyder et årsagsforhold mellem anvendelsen af pemetrexed og hyperpigmentering.
English: The results of these analyses of efficacy are summarised in the table below:
Danish: Resultaterne af disse effektanalyser er vist i nedenstående tabel:
English: The total bilirubin should be ≤ 1.5 times upper limit of normal.
Danish: Total-bilirubin skal være ≤ 1,5 gange den normale øvre grænseværdi.
English: Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea.
Danish: Alle tilfælde af diarré, der kræver indlæggelse (uanset grad) eller diarré af grad 3 eller 4.
English: Non-inferiority p-value (HR) Progression free survival (months) Median
Danish: P-værdi for non-inferioritet (HR) Progressionsfri overlevelse (måneder) Median
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS.
Danish: Den uafhængige evaluering af patienternes skanninger bekræftede investigatorernes vurdering af PFS.
English: ALIMTA is a medicine used in the treatment of cancer.
Danish: ALIMTA er et lægemiddel, der anvendes til behandling af kræft.
English: The 1 year and 2 year survival rates for patients on ALIMTA were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Danish: Den 1-årige og 2årige overlevelsesrate for patienterne i behandling med ALIMTA var henholdsvis 58 % og 32 % sammenlignet med 45 % og 21 % for patienterne i placebo-behandling.
English: Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Danish: Ikke kendt: hyppigheden kan ikke vurderes udfra forhåndenværende data Hævelse i de nedre lemmer med smerte og rødme Øget urinproduktion
English: ** In the ALIMTA/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Danish: ** I ALIMTA/cisplatin-armen, randomiseret og behandlet (n = 225) og fuldt tilskud (n = 167)
English: Intravenous use
Danish: Intravenøs brug
English: Safety was assessed for patients who were randomised to receive pemetrexed (N=800).
Danish: Sikkerheden blev vurderet for de patienter, som blev randomiseret til pemetrexed (N=800).
English: In Vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter.
Danish: In vitro-studier indikerer, at pemetrexed udskilles ved aktiv sekretion via OAT3 (organisk anion-transporter).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Dere dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: 1998) definition of ≥CTC Grade 2 bleeding
Danish: definition på ≥CTC grad 2 blødning.
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Danish: Respons (n: kvalificeret til respons) Responsrate (%) (95 %-CI) Stabil sygdom (%)
English: It is not known whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i human mælk, og en påvirkning af ammede børn kan ikke udelukkes.
English: Pharmacotherapeutic group: Folic acid analogues, ATC code: L01BA04
Danish: Farmakoterapeutisk klassifikation: Folsyreanaloger, ATC-kode L01BA04
English: Very common (may affect more than 1 in 10 people) Low white blood cells
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter) Lavt antal hvide blodlegemer
English: During a periodic regulatory review of the use of pemetrexed a number of cases describing pigmentation disorders has been described with a common frequency.
Danish: Ved en periodisk regulatorisk gennemgang af anvendelsen af pemetrexed blev der beskrevet en række tilfælde af pigmenteringsforstyrrelser med hyppigheden almindelig.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pemetrexed, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for pemetrexed er CHMP nået frem til følgende videnskabelige konklusioner:
English: Caution should be made when these drugs are combined with pemetrexed.
Danish: Der skal udvises forsigtighed, når disse stoffer bruges i kombination med pemetrexed.
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data fra anvendelse af pemetrexed til gravide kvinder, men ligesom andre anti-metabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: You will always receive ALIMTA by infusion into one of your veins.
Danish: De vil altid få ALIMTA ved infusion i en af Deres blodårer.
English: First line doublet therapy containing ALIMTA was not included.
Danish: 1. linje-dubletbehandling inkluderende ALIMTA blev ikke inkluderet.
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Danish: * Se National Cancer Institute CTC version 2 for hver grad af toksicitet, undtagen udtrykket "nedsat kreatinin-clearance", ** som stammer fra udtrykket "andre renale/genitourinære faktorer".
English: On the basis of the scientific conclusions for pemetrexed the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pemetrexed is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for pemetrexed er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder pemetrexed, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The pH of the reconstituted solution is between 6.6 and 7.8.
Danish: Den rekonstituerede opløsning har en pH-værdi på 6,6-7,8.
English: Prior chemotherapy did not include ALIMTA.
Danish: Forudgående kemoterapi inkluderede ikke ALIMTA.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of ALIMTA has finished.
Danish: Cisplatin indgives også ved infusion i en af Deres blodårer, cirka 30 minutter efter at infusionen med ALIMTA er afsluttet.
English: Efficacy and safety were measured from the time of randomisation after completion of first line (induction) therapy.
Danish: Virkning og sikkerhed blev målt fra randomiseringstidspunktet efter fuldførelse af 1. linje-behandlingen (induktionsbehandlingen).
English: Creatinine clearance should be ≥ 45 ml/min.
Danish: Kreatinin-clearance skal være ≥ 45 ml/min.
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for ALIMTA used as a single agent or in combination with cisplatin.
Danish: Efter rekonvalescens skal patienter efterbehandles ud fra retningslinjerne i tabel 1, 2 og 3, der gælder for brug af ALIMTA som enkeltstof eller i kombination med cisplatin.
English: SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSFORHOLD
English: Thus, drainage of third space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Danish: Derfor bør drænage af ekstracellulære væskeansamlinger inden behandling med pemetrexed overvejes, men er muligvis ikke nødvendig.
English: The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Danish: Effekten af ekstracellulærvæske, såsom pleuraeffusion eller ascites, på pemetrexed er ikke fuldt defineret.
English: Time to treatment failure (TTTF - months) Median
Danish: Tid til behandlingssvigt (TTTF - måneder) Median
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Danish: Den høje intra-individuelle variation i koagulationsstatus under sygdomsforløb og risikoen for interaktion mellem orale antikoagulantia og kemoterapi mod cancer kræver hyppigere monitorering af INR (International Normalised Ratio), hvis der træffes beslutning om at behandle patienten med orale antikoagulantia.
English: Efficacy of ALIMTA vs docetaxel in NSCLC - ITT population ALIMTA
Danish: Effekt af ALIMTA versus docetaxel mod NSCLC - ITT-population ALIMTA
English: Infection (sepsis) may be severe and could lead to death.
Danish: En infektion (sepsis − blodforgiftning) kan være alvorlig og kan medføre døden.
English: a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Danish: a Statistisk signifikans for non-inferiøritet med hele konfidensintervallet for HR pænt under 1,17645 for noninferiøritet-margin (p <0,001).
English: ALIMTA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: ALIMTA må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.
Danish: Hvis produktet ikke anvendes med det samme, er det brugerens ansvar at vurdere holdbarheden og opbevaringsforholdene, inden produktet anvendes, og holdbarheden vil højst være 24 timer ved 2 °C-8 °C.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Danish: Mange af de patienter, der oplevede disse bivirkninger, havde underliggende risikofaktorer for udvikling af nyrepåvirkninger inklusive dehydrering, tidligere hypertension eller diabetes.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun beregnet til engangsbrug.
English: Large cell (N=153)
Danish: Store celler (N=153)
English: The primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who received study drug (randomised and treated).
Danish: Den primære analyse af dette studie blev udført på en population bestående af alle de patienter, som var randomiseret til en behandlingsarm, og som modtog studiemedicinen (randomiseret og behandlet).
English: Rarely, skin reactions may be severe and could lead to death.
Danish: Hudreaktioner kan i sjældne tilfælde være alvorlige og kan medføre døden.
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Danish: Dette kortikosteroidpræparat skal svare til 4 mg dexamethason indgivet oralt 2 gange dagligt (se pkt 4.4).
English: Adjusted hazard ratio (HR) (95% CI)
Danish: Justeret Hazard ratio (HR) (95% CI)
English: Fisher's exact p-value*
Danish: Fishers eksakte p-niveau*
English: Calculate the dose and the number of ALIMTA vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med ALIMTA.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the ALIMTA arm versus 21.7% on the placebo arm.
Danish: På tidspunktet for den endelige analyse af den totale overlevelse var 28,7 % af patienterne i ALIMTA-armen i live eller kunne ikke følges op versus 21,7 % i placebo-armen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ALIMTA in all subsets of the paediatric population in the granted indications (see Section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ALIMTA i alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt 4.2 for oplysninger om pædiatrisk anvendelse).
English: Gently swirl each vial until the powder is completely dissolved.
Danish: Vend forsigtigt hvert hætteglas op og ned, indtil pulveret er helt opløst.
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Danish: Effektalyser med brug af PQ-populationen er konsistente med analyser for ITT-populationen og understøtter noninferiøriteten af AC mod GC.
English: Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Danish: Pemetrexed udskilles primært med urinen, og 70-90 % af den indgivne dosis kan genfindes uforandret i urinen inden for de første 24 timer efter indgift.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Danish: Resultaterne af in vitro-forsøg med humane levermikrosomer tyder på, at pemetrexed ikke burde forårsage en klinisk signifikant inhibition af den metaboliske clearance af lægemidler, der metaboliseres af CYP3A, CYP2D6, CYP2C9 og CYP1A2.
English: *P-values <0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Danish: *P-værdier <0.05 sammenligning af pemetrexed/cisplatin med gemcitabin/cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2.0; NCI 1998) for hver toksicitetsgrad.
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10-minute period.
Danish: Pemetrexeds farmakokinetiske egenskaber efter enkeltstofadministration er blevet vurderet hos 426 cancerpatienter med forskellige typer massive tumorer i doser på 0,2-838 mg/m2 infunderet over 10 minutter.
English: Creatinine clearance decreased**
Danish: Nedsat kreatininclearance**
English: Each pack of ALIMTA consists of one ALIMTA vial.
Danish: Hver pakke ALIMTA indeholder ét ALIMTA hætteglas.
English: Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Danish: Immun-medieret hæmolytisk anæmi (antistof-medieret ødelæggelse af de røde blodlegemer) Leverbetændelse (hepatitis)
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: De skal omgående kontakte Deres læge, hvis De mærker nogen af følgende bivirkninger: Feber eller infektion (almindelig): Hvis Deres temperatur er 38 ºC eller højere, hvis De sveder eller viser andre tegn på infektion (fordi De muligvis har færre hvide blodlegemer end normalt, hvilket er meget almindeligt).
English: Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Danish: Allergisk reaktion: Hvis De udvikler udslæt (meget almindelig)/en brændende eller prikkende fornemmelse (almindelig) eller feber (almindelig).
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Danish: Forbehandling med dexamethason (eller tilsvarende) kan reducere incidensen og sværhedsgraden af hudreaktioner (se pkt.
English: Of the 939 patients treated with ALIMTA plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Danish: Ud af de 939 patienter, som blev behandlet med ALIMTA og cisplatin i induktionfasen, blev 539 patienter randomiseret til vedligeholdelsesbehandling med pemetrexed eller placebo.
English: 2 rue du Colonel Lilly 67640 Fegersheim France
Danish: 2 rue du Colonel Lilly 67640 Fegersheim Frankrig
English: Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration.
Danish: Pemetrexed udskilles primært uforandret gennem nyrerne ved tubulær sekretion og i mindre grad ved glomerulær filtration.
English: You must take at least 5 doses during the seven days before the first dose of ALIMTA.
Danish: De skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis ALIMTA.
English: During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Danish: I forbindelse med overvågning efter markedsføring er der rapporteret følgende bivirkninger hos patienter behandlet med pemetrexed:
English: If you are concerned about any side effects, talk to your doctor.
Danish: Hvis De er bekymret over eventuelle bivirkninger, bør De tale med Deres læge.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: BILAG IV VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN
English: Event**
Danish: Bivirkning**
English: EXP Read the leaflet for the shelf life of the reconstituted product.
Danish: EXP Læs indlægssedlen angående opbevaringstid af det rekonstituerede lægemiddel.
English: The active substance is pemetrexed.
Danish: - Aktivt stof: Pemetrexed.
English: ALIMTA contains sodium
Danish: ALIMTA indeholder natrium
English: Talk to your doctor or hospital pharmacist before receiving ALIMTA.
Danish: Kontakt lægen eller sundhedspersonalet, før De får ALIMTA.