FrancophonIA/ELRC3.0 huggingface dataset:
English: • If symptoms do not worsen at 400 mg for at least 1 treatment cycle, the dose may be increased to 600 mg If symptoms worsen at 600 mg, temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Danish: Hvis symptomerne forværres ved 600 mg, afbrydes behandlingen midlertidigt, i maksimalt 6 uger efter dag 1 i den seneste behandlingsserie, indtil symptomerne er reduceret til grad ≤ 2.
English: Common Phlebitis
Danish: Almindelig Flebitis
English: Rare (≥1/10,000 to <1/1,000)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000)
English: Recommendations for the management of infusion-related and skin reactions are provided in tables 1 and 2.
Danish: I tabel 1 og 2 er der givet anbefalinger til håndtering af infusionsrelaterede reaktioner og hudreaktioner.
English: Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert 50 ml hætteglas indeholder ca. 76 mg natrium.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Portrazza Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis.
Danish: I et klinisk studie med avanceret ikke-planocullær NSCLC, blev venøse tromboemboliske hændelser (VTEs) rapporteret hos ca. 11 % af de patienter, som blev behandlet med necitumumab i kombination med pemetrexed og cisplatin (versus 8 % af patienterne i pemetrexed + cisplatin-armen), og disse var hovedsageligt lungeembolier og dybe venetromboser.
English: Portrazza can cause blood clots in your arteries or your veins.
Danish: - Blodpropper i arterierne eller i venerne Portrazza kan forårsage blodpropper i arterierne eller i venerne.
English: In patients with detectable EGFR protein expression, there was no trend observed for increased efficacy with increasing levels of EGFR expression.
Danish: Der blev ikke observeret en tendens til øget effekt med øgede niveauer af EGFR-proteinekspression hos patienter med påviselig EGFR-proteinekspression.
English: There was no premedication for Portrazza mandated by the study.
Danish: I studiet var der ingen obligatorisk præmedicinering før administration af Portrazza.
English: In a clinical trial in advanced non-squamous NSCLC, patients experienced an increased rate of serious thromboembolic events (including fatal events) in the necitumumab plus pemetrexed and cisplatin arm as compared to the pemetrexed and cisplatin arm (see also section 4.8).
Danish: I et klinisk studie af avanceret ikke-planocellulær NSCLC var der en øget forekomst af alvorlige tromboemboliske hændelser (herunder hændelser med dødelig udgang) hos patienterne i behandlingsarmen med necitumumab plus pemetrexed og cisplatin sammenlignet med armen med pemetrexed og cisplatin (se også pkt.
English: The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC.
Danish: Ved avanceret ikke-planocellulær NSCLC forbedrede tilføjelsen af necitumumab ikke effektendepunktet i forhold til pemetrexed og cisplatin alene.
English: NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Portrazza 800 mg koncentrat til infusionsvæske, opløsning
English: For management and dose adjustments, see section 4.2.
Danish: 4.2 for at få oplysninger om håndtering og dosisjusteringer.
English: Each mL of concentrate for solution for infusion contains 16 mg of necitumumab.
Danish: Hver ml koncentrat til infusionsvæske, opløsning indeholder 16 mg necitumumab.
English: This medicine is given as an intravenous (into a vein) infusion via a drip.
Danish: Dette lægemiddel gives som en intravenøs (i en blodåre) infusion via et drop over et tidsrum på ca. 60 minutter.
English: Vascular disorders Common Venous thromboembolic events
Danish: Almindelig Venøse tromboemboliske hændelser
English: Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab.
Danish: Hver milliliter koncentrat til infusionsvæske, opløsning indeholder 16 mg necitumumab.
English: Severe ATEs were reported in 3 % of patients.
Danish: Der blev rapporteret om alvorlige ATE'er hos ca. 3 % af patienterne.
English: Based on the results of the population pharmacokinetic analysis, there was no impact of renal function as assessed by creatinine clearance [CrCl] on the pharmacokinetics of necitumumab.
Danish: På basis af resultaterne af den populationsfarmakokinetiske analyse blev farmakokinetikken af necitumumab ikke påvirket af nyrefunktion bestemt ud fra kreatininclearance (CrCl).
English: o Description of cardiorespiratory disorders including incidence rates from clinical trials o Information that the incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
Danish: o Information om, at den øgede risiko for kardiopulmonalt stop eller pludselig død hos patienter med koronararteriesygdom, hjerteinsufficiens eller arytmi i anamnesen sammenlignet med patienter uden disse komorbiditeter, ikke kendes.
English: You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza.
Danish: Inden du får Portrazza, vil du eventuelt få medicin, der nedsætter risikoen for en infusionsrelateret reaktion eller en hudreaktion.
English: Common Hypersensitivity reactions/infusionrelated reactions
Danish: Hudreaktioner Almindelig Overfølsomheds reaktioner/infusionsrelaterede reaktioner
English: Eye disorders
Danish: Trikomegali af øjenvipper
English: Only sodium chloride 9 mg/mL (0.9 %) solution for injection should be used as a diluent.
Danish: Der må kun bruges 0,9 % (9 mg/ml) natriumchloridopløsning til injektion som fortyndingsmiddel.
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab.
Danish: Der er ikke udført formelle studier med henblik på at vurdere effekten af nedsat nyrefunktion på farmakokinetikken af necitumumab.
English: Hypersensitivity/Infusion-related reactions
Danish: Overfølsomhedsreaktioner/infusionsrelaterede reaktioner
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction.
Danish: Arterielle tromboemboliske hændelser (ATE'er) blev rapporteret hos ca. 4 % af de patienter, som blev behandlet med necitumumab i kombination med pemetrexed og cisplatin (versus 6 % af patienterne i pemetrexed + cisplatin-armen), og disse var hovedsageligt slagtilfælde og myokardieinfarkt.
English: Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab
Danish: Instruktioner i håndtering Portrazza 800 mg koncentrat til infusionsvæske, opløsning necitumumab
English: DO NOT FREEZE OR SHAKE the infusion solution.
Danish: Infusionsopløsningen MÅ IKKE NEDFRYSES ELLER OMRYSTES.
English: Other medicines and Portrazza
Danish: Dosis og indgivelsesmåde
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: Alvorlig eller livstruende overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Hypomagnesaemiac
Danish: Hypomagnesiæmic
English: Common Muscle spasms
Danish: Almindelig Muskelspasmer
English: Severe VTEs were reported in approximately 6 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Danish: Alvorlige VTE'er blev rapporteret hos ca. 6 % af de patienter, som blev behandlet med necitumumab i kombination med pemetrexed og cisplatin (versus 4 % af patienterne i pemetrexed + cisplatin-armen).
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL.
Danish: Administration ved brug af tomme beholdere til intravenøs infusion Overfør aseptisk 50 ml necitumumab-koncentrat til en tom beholder til intravenøs infusion, og tilsæt 200 ml steril 0,9 % (9 mg/ml) natriumchloridopløsning til injektion til beholderen for at bringe det samlede volumen op på 250 ml.
English: • Following improvement to Grade ≤ 2, resume at reduced dose of
Danish: Efter bedring til grad ≤ 2
English: To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL.
Danish: Administration ved brug af fyldte beholdere til intravenøs infusion Udtag aseptisk 50 ml 0,9 % (9 mg/ml) natriumchloridopløsning til injektion fra den fyldte 250 ml beholder, og overfør 50 ml necitumumab-koncentrat til beholderen, så det endelige volumen i beholderen igen bliver 250 ml.
English: - The other ingredients are sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (see section 2 “Portrazza contains sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) and water for injections.
Danish: Natriumcitratdihydrat (E 331) Citronsyre, vandfri (E 330) Natriumchlorid Glycin (E 640) Mannitol (E 421) Polysorbat 80 (E 433) Vand til injektionsvæsker
English: Mannitol (E421) Polysorbate 80 (E433) Water for injections
Danish: 2 'Portrazza indeholder natrium'), glycin (E 640), mannitol (E 421), polysorbat 80 (E 433) og vand til injektionsvæsker.
English: A doctor experienced in the use of anti-cancer medicines will supervise your Portrazza therapy.
Danish: Din behandling med Portrazza vil være under tilsyn af en læge med erfaring i brug af kræftmedicin.
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL.
Danish: Administration ved brug af tomme beholdere til intravenøs infusion Overfør aseptisk 50 ml necitumumab-koncentrat til en tom beholder til intravenøs infusion, og tilsæt 200 ml 0,9 % (9 mg/ml) natriumchloridopløsning til injektion til beholderen for at bringe det samlede volumen op på 250 ml.
English: Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8).
Danish: Ved behandling med necitumumab i kombination med gemcitabin og cisplatin blev der observeret venøse tromboemboliske hændelser (VTE'er) og arterielle tromboemboliske hændelser (ATE'er), herunder dødelige tilfælde (se også pkt.
English: Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Sodium chloride Glycine (E640)
Danish: - Øvrige indholdsstoffer: natriumcitratdihydrat (E 331), citronsyre, vandfri (E 330), natriumchlorid (se afsnit.
English: Portrazza 800 mg concentrate for solution for infusion necitumumab
Danish: Portrazza 800 mg koncentrat til infusionsvæske, opløsning necitumumab
English: Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Danish: ATE'er blev rapporteret hos ca. 3 % af de patienter, som blev behandlet med necitumumab i kombination med pemetrexed og cisplatin (versus 4 % af patienterne i pemetrexed + cisplatin-armen).
English: - Skin reactions
Danish: - Hudreaktioner
English: Common Dysphagia Common Mouth ulceration
Danish: Nyrer og urinveje Almindelig Dysuri
English: Key elements of the physician educational material: o Importance of assessing the risks before starting treatment with necitumumab o Description of thromboembolic events including incidence rates from clinical trials o Advice that patients and physicians should be aware of signs and symptoms of thromboembolism.
Danish: Hovedelementerne i undervisningsmaterialet til læger: o Vigtigheden af at vurdere risici inden påbegyndelse af necitumumabbehandling.
English: What Portrazza is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Renal impairment
Danish: Efter fortynding
English: Posology
Danish: Se afsnit
English: 11 January 2019
Danish: 11. januar 2019
English: The European Commission issued an EU-wide legally binding decision on 11 January 2019.
Danish: Europa-Kommissionen vedtog den 11. januar 2019 en afgørelse, der er retligt bindende i hele EU.
English: The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.
Danish: Gennemgangen af Paclitaxel Hetero blev indledt på anmodning af Portugal i medfør af artikel 29 i direktiv 2001/83/EF.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de giver de samme niveauer af det aktive stof i kroppen og derfor forventes at have samme effekt.
English: It blocks the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Danish: Det blokerer kræftcellernes evne til at nedbryde deres interne "skelet", en evne, der gør det muligt for dem at dele sig og formere sig.
English: On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation.
Danish: Den 18. oktober 2018 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Paclitaxel Hetero efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse.
English: However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den portugisiske lægemiddelstyrelse indbragte den 2. november 2017 sagen for EMA med henblik på voldgift.
English: Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure.
Danish: Viladecans (Barcelona) indsendte en ansøgning om godkendelse af Paclitaxel Hetero til den portugisiske lægemiddelstyrelse med henblik på en decentral procedure.
English: Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes'.
Danish: Paclitaxel hører til den gruppe af lægemidler mod kræft, der kaldes "taxaner".
English: In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles.
Danish: Navnlig havde virksomheden ikke fremlagt data for en direkte sammenligning med referencelægemidlet, hvilket er et normalt krav for lægemidler, der er formuleret i miceller.
English: This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in EU called Taxol.
Danish: Det betyder, at Paclitaxel Hetero indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder Taxol.
English: It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).
Danish: Det skulle leveres som et koncentrat til infusionsvæske, opløsning (6 mg/ml), til behandling af brystkræft, æggestokkræft, ikkesmåcellet lungekræft og Kaposis sarkom (kræft i blodkar) hos patienter med erhvervet immundefektsyndrom (aids).
English: Paclitaxel Hetero is a medicine that contains the active substance paclitaxel.
Danish: Paclitaxel Hetero er et lægemiddel, der indeholder det aktive stof paclitaxel.
English: Paclitaxel Hetero was developed as a generic medicine.
Danish: Paclitaxel Hetero er udviklet som et generisk lægemiddel.
English: The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.
Danish: Paclitaxel i Paclitaxel Hetero og i Taxol er indeholdt i bittesmå partikler, kaldet miceller, for at det bedre kan opløses i infusionsvæsken.
English: The Agency therefore concluded that the benefits of Paclitaxel Hetero do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Danish: Agenturet konkluderede, at fordelene ved Paclitaxel Hetero ikke opvejer risiciene, og anbefalede, at der ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater.
English: The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).
Danish: Agenturet konkluderede, at fordelene ved Paclitaxel Hetero ikke opvejer risiciene, og at der derfor ikke kan udstedes markedsføringstilladelse i Portugal eller andre medlemsstater (Tyskland, Holland og Storbritannien).
English: What is Paclitaxel Hetero?
Danish: Hvad er Paclitaxel Hetero?
English: Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.
Danish: Virksomheden fremlagde i stedet indirekte sammenlignende data og et studie, der sammenlignede niveauet af paclitaxel i blodet ved behandling med Paclitaxel Hetero med niveauerne ved behandling med andre generiske paclitaxel-holdige lægemidler, hvilket Holland ikke anså for tilstrækkeligt.
English: Why was Paclitaxel Hetero reviewed?
Danish: Hvorfor blev Paclitaxel Hetero undersøgt?
English: Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol and that their active substances behave in the same way in the body.
Danish: På grundlag af de aktuelt tilgængelige data konkluderede agenturet, at de ikke var tilstrækkelige til at påvise, at Paclitaxel Hetero er bioækvivalent med Taxol, og at deres aktive stoffer opfører sig på samme måde i kroppen.
English: The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol.
Danish: Indbringelsen skyldtes Hollands påstand om, at de indsendte data til støtte for ansøgningen ikke var tilstrækkelige til at påvise Paclitaxel Heteros bioækvivalens med Taxol.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States', in this instance Germany, the Netherlands and the UK).
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Portugal) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land og i andre
English: This may take between 30 to 60 minutes.
Danish: Dette kan tage mellem 30 og 60 minutter.
English: Only use clear solutions.
Danish: Brug kun klare opløsninger.
English: No delayed hypotension has been noted.
Danish: Ingen forsinket hypotension blev bemærket.
English: Close monitoring of INR is recommended.
Danish: Nøje monitorering af INR anbefales.
English: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Danish: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italien <{tlf.}> <{fax}> <{e-mail}>
English: • water for injections or,
Danish: • vand til injektion eller
English: • high blood pressure • low blood pressure
Danish: • højt blodtryk • lavt blodtryk
English: Bleeding has been reported.
Danish: Blødning er blevet indberettet.
English: Blood pressure usually normalizes within a few hours after cessation of the infusion.
Danish: Blodtrykket normaliseres som regel inden for et par timer efter ophøret af infusionen.
English: The mean volumes of distribution at steady state range from 18 to 29 liters .
Danish: De gennemsnitlige fordelingsvolumener ved steady state rækker fra 18 til 29 liter.
English: It will be given as a slow infusion into a vein.
Danish: Det vil blive givet som en langsom infusion i en vene.
English: When restarting the infusion, a slower administration rate should be used.
Danish: Ved genopstart af infusionen skal en langsommere administrationshastighed anvendes.
English: However, if this does occur your doctor will treat any symptoms that follow.
Danish: Hvis dette imidlertid skulle ske, vil din læge behandle eventuelle symptomer, som måtte forekomme.
English: The safety profile between paediatric patients and adults is expected to be similar.
Danish: Sikkerhedsprofilen for pædiatriske og voksne patienter forventes at være den samme.
English: The stock solution should be used as soon as possible.
Danish: Stamopløsningen skal bruges hurtigst muligt.
English: Administration and Dosage
Danish: Administration og dosering
English: Exact measuring must be ensured for withdrawal.
Danish: Der skal sikres nøjagtig måling ved udtrækning.
English: If spikes are used they should be equipped with particle filters or other measures should be taken (e.g. inline-filters) to ensure that only particle free solutions are administered.
Danish: Hvis der bruges spidser, skal de udstyres med partikelfiltre, eller der skal træffes andre foranstaltninger (f.eks. inline-filtre) for at sørge for, at der kun administreres partikelfri opløsninger.
English: The doctor may sometimes prescribe a different dose particularly if you are receiving, or have received, other treatments for your cancer or if you have kidney problems.
Danish: Lægen vil undertiden ordinere en anden dosis, særligt hvis du får eller har fået andre behandlinger for din kræft, eller hvis du har nyreproblemer.
English: <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Danish: <Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}> <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: *Myelosuppression with fatal outcome has been reported **Anaphylactic reactions can be fatal ***Seizure is occasionally associated with allergic reactions.
Danish: * Myelosuppression med døden til følge er blevet indberettet **Anafylaktiske reaktioner kan være dødelige ***Krampeanfald er lejlighedsvist forbundet med allergiske reaktioner.
English: All steps of preparation must be carried out under Laminar Air Flow conditions.
Danish: Alle forberedelsestrin skal udføres i laminart airflow.