FrancophonIA/ELRC3.0 huggingface dataset:
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Danish: Stabilisering resulterer i hæmning af den normale dynamiske reorganisering af mikrotubulus-netværket, der er afgørende for den vitale interfase og de mitotiske cellefunktioner.
English: Patients who had pre-existing neuropathy of grade ≥ 2 or serious medical risk factors involving any of the major organ systems were not allowed to enter the study.
Danish: Patienter, der havde eksisterende neuropati af grad ≥ 2 eller alvorlige medicinske risikofaktorer for et eller flere af de større organsystemer, måtte ikke deltage i studiet.
English: Delayed reactions related to paclitaxel occurring during or after infusion of carboplatin cannot be excluded.
Danish: Forsinkede reaktioner relateret til paclitaxel under eller efter infusion af carboplatin kan ikke udelukkes.
English: However, paclitaxel is potentially carcinogenic based on its mechanism of action and demonstrated genotoxic activity.
Danish: Paclitaxel er dog potentielt carcinogent baseret på dets virkningsmekanisme og dets påviste genotoksiske aktivitet.
English: Paclitaxel is excreted in human milk.
Danish: Paclitaxel udskilles i human mælk.
English: Oasmia Pharmaceutical AB Uppsala, Sweden
Danish: Oasmia Pharmaceutical AB Uppsala, Sverige
English: Continue to swirl the vial until the powder is completely dissolved.
Danish: Fortsæt med at dreje hætteglasset frem og tilbage, indtil pulveret er helt opløst.
English: Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Danish: Endvidere er det blevet påvist, at perifere neuropatier kan vare ved udover 6 måneder efter seponering af paclitaxel.
English: No pharmacologically active metabolite has been found.
Danish: Der er ikke fundet nogen farmakologisk aktiv metabolit.
English: The model indicated that a 0.2 m2 increase in BSA would lead to a 9% increase in the elimination rate.
Danish: Modellen pegede på, at en stigning på 0,2 m2 i legemsoverflade ville medføre en stigning i eliminationshastighed på 9 %.
English: The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min).
Danish: Opløsningen bør administreres ved intravenøs infusion over ca. 1 time (120-140 dråber/min).
English: No studies have been performed to evaluate drug-drug interactions between Apealea and other medicinal products.
Danish: Der er ikke gennemført studier til vurdering af interaktioner mellem Apealea og andre lægemidler.
English: non-inferiority margin (1.185)
Danish: Noninferioritetsmargin (1,185)
English: Palmar-plantar erythrodysesthesia syndromec
Danish: Palmar-plantar erytrodysæstesi-syndromc
English: • symptoms of allergic reaction during the infusion, such as:
Danish: • symptomer på allergisk reaktion under infusionen, herunder:
English: b Can persist beyond 6 months of paclitaxel discontinuation.c c As reported in the post-marketing surveillance of paclitaxel.
Danish: b Kan vare ved udover 6 måneder efter seponering af paclitaxel.c c Som rapporteret i overvågningen af paclitaxel efter markedsføring.
English: non-inferiority margin (1.2)
Danish: Noninferioritetsmargin (1,2)
English: Angina pectoris, tachycardia
Danish: Angina pectoris, takykardi
English: Paclitaxel is distributed equally between plasma and blood as described in published in vitro data.
Danish: Paclitaxel fordeles ligeligt mellem plasma og blod, jf. publicerede in vitro-data.
English: Further it has been shown that the rate of paclitaxel elimination increased with increasing body size.
Danish: Det er desuden påvist, at eliminationshastigheden for paclitaxel stiger med øget kropsstørrelse.
English: A similar effect can be anticipated for Apealea (paclitaxel micellar).
Danish: En tilsvarende effekt kan forventes for Apealea (paclitaxel (micellær)).
English: Patients should be observed closely during treatment, particularly those patients who previously suffered hypersensitivity reactions with any taxane formulation.
Danish: Patienterne bør observeres tæt under behandlingen, navnlig patienter, der tidligere har haft overfølsomhedsreaktioner over for en taxan-formulering.
English: Pregnant and breast-feeding staff should not handle Apealea.
Danish: Gravide og ammende medarbejdere må ikke håndtere Apealea.
English: Alopecia is a very common adverse reaction and occurs early in treatment.
Danish: Alopeci er en meget almindelig bivirkning og ses tidligt i behandlingen.
English: The (reconstituted) product can only withstand short-term handling in absence of light protection.
Danish: Produktet/det rekonstituerede produkt kan kun tåle håndtering i kort tid, hvis det ikke beskyttes mod lys.
English: If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis opløsningen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe.
English: Thus, the results in the subgroup of patients with first relapse are consistent with the results in the overall population and in addition, there was an indication of PFS benefit for Apealea.
Danish: Derfor er resultaterne fra undergrupperne af patienterne med første recidiv i overensstemmelse med resultaterne for den samlede population, og desuden var den en indikation for PFS-fordel for Apealea.
English: Limited data are available on use in patients ≥ 75 years (2% of the patients in the study).
Danish: Der foreligger kun begrænsede data om anvendelse hos patienter i alderen ≥ 75 år (2 % af patienterne i studiet).
English: Tell your doctor or nurse immediately if you have any of the following: • Very common (may affect more than 1 in 10 people):
Danish: Kontakt omgående lægen eller sygeplejersken, hvis du oplever noget af følgende: • Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well.
Danish: For at sikre korrekt anvendelse af carboplatin bør den ordinerende læge også læse ordinationsoplysningerne for carboplatin.
English: Infusion-associated reactions
Danish: Infusionsrelaterede reaktioner
English: The recommended dose of carboplatin is AUC = 5-6 mg/mL×min.
Danish: Den anbefalede dosis carboplatin er AUC = 5-6 mg/ml × min.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: With regard to age, the population model indicated an approximate 5% decline in paclitaxel elimination rate for each 10-year increase in age compared to the median age of 56 years of the study.
Danish: Med hensyn til alder viste populationsmodellen et fald på ca. 5 % i eliminationshastighed for paclitaxel for hvert tiår, alderen steg, sammenholdt med den mediane alder i studiet på 56 år.
English: There are limited data on the use of Apealea in non-Caucasian patients.
Danish: Der foreligger kun begrænsede data om anvendelse af Apealea hos ikke-kaukasiske patienter.
English: Paclitaxel affects or stops growth of rapidly dividing cells, such as tumour cells.
Danish: Paclitaxel hæmmer eller standser væksten af celler, der deler sig hurtigt, f.eks. tumorceller.
English: Patients experiencing severe reactions should not be re-challenged with paclitaxel.
Danish: Patienter, der oplever svære reaktioner, bør ikke eksponeres for paclitaxel igen.
English: Nausea (38%), vomiting (22%) and diarrhoea (15%) were among the most commonly reported adverse reactions in the study.
Danish: Kvalme (38 %), opkastning (22 %) og diarré (15 %) var blandt de hyppigst indberettede bivirkninger i studiet.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Danish: Der er rapporteret om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgansvigt.
English: * Solutions containing both Ca2+ and Mg2+ should have a total (combined) concentration of Ca2+ and Mg2+ within the range of 1.0 to 3.5 mmol/L.
Danish: * Opløsninger med både Ca2+ og Mg2+ skal have en samlet (kombineret) koncentration af Ca2+ og Mg2+, der ligger inden for et interval på 1,0-3,5 mmol/l.
English: The paclitaxel infusion was followed by carboplatin after an interval of 30 minutes in both treatment arms.
Danish: Paclitaxel-infusionen blev efterfulgt af carboplatin efter et interval på 30 minutter i begge behandlingsgrupper
English: When Apealea (paclitaxel micellar) is administered intravenously, its pharmacokinetic profile suggests that the formulation immediately releases paclitaxel into the blood.
Danish: Når Apealea (paclitaxel (micellær)) administreres intravenøst, tyder den farmakokinetiske profil på, at formuleringen frigiver paclitaxel til blodet med det samme.
English: Post-hoc subgroup analysis by relapse
Danish: Post-hoc undergruppeanalyse pr. recidiv
English: As a result of the combined treatment, it is not possible to determine whether this observation is due to Apealea or to other factors, and delayed reactions related to paclitaxel cannot be excluded.
Danish: Da der er tale om en kombinationsbehandling, kan det ikke fastslås, om dette fund kan tilskrives Apealea eller andre faktorer, og forsinkede reaktioner relateret til paclitaxel kan ikke udelukkes.
English: Premedication may be considered in patients who have previously experienced gastrointestinal symptoms when being treated with cytotoxic medicinal products.
Danish: Præmedicinering kan overvejes hos patienter, der tidligere har oplevet gastrointestinale symptomer ved behandling med cytotoksika.
English: There is no known antidote for paclitaxel overdose.
Danish: Der er ingen kendt antidot ved overdosering af paclitaxel.
English: Paclitaxel is an antineoplastic medicinal product and as with other potentially toxic compounds, caution should be exercised in handling Apealea.
Danish: Paclitaxel er et antineoplastisk lægemiddel, og som for andre potentielt toksiske forbindelser skal der udvises forsigtighed ved håndtering af Apealea.
English: − low blood pressure
Danish: − lavt blodtryk
English: * Can persist beyond 6 months of paclitaxel discontinuation.
Danish: * Kan vare ved udover 6 måneder efter ophør af paclitaxel.
English: During the course of the pivotal study, 46% of the peripheral neuropathies as well as the majority (78%) of the associated reactions resolved.
Danish: I løbet af det pivotale studie bedredes 46 % af de perifere neuropatier samt størstedelen (78 %) af de relaterede reaktioner.
English: Binding of paclitaxel to both albumin and α1-acid glycoprotein has been reported, but other binding proteins such as lipoproteins might be important.
Danish: Der er rapporteret om binding af paclitaxel til både albumin og α1-syreglykoprotein, men andre bindingsproteiner som f.eks. lipoproteiner kan være væsentlige.
English: The solution should be clear and greenish-yellow without visible particles or precipitates.
Danish: Opløsningen skal være klar og grøngul og må ikke indeholde synlige partikler eller bundfald.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD01 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, taxaner, ATC-kode: L01CD01
English: Stop breast-feeding while being treated, as paclitaxel passes into breast milk and may harm the child.
Danish: Du skal holde op med at amme, mens du er i behandling, da paclitaxel udskilles i modermælk og kan skade barnet.
English: • painful severe swelling of deep skin layers, mainly in the face
Danish: • smertefuld, svær hævelse af de dybe hudlag, navnlig i ansigtet
English: The carcinogenic activity of paclitaxel has not been studied.
Danish: Paclitaxels karcinogene aktivitet er ikke undersøgt.
English: Ask your doctor or nurse about hair loss and what can be done to avoid it.
Danish: Tal med lægen eller sygeplejersken om hårtab og om, hvad man kan gøre for at undgå det.
English: Take the desired number of vials from the refrigerator.
Danish: Tag det antal hætteglas, der skal bruges, ud af køleskabet.
English: Gastrointestinal symptoms
Danish: Gastrointestinale symptomer
English: • low body temperature
Danish: • lav kropstemperatur
English: Proportions of patients who received premedication prior to infusion of paclitaxel or carboplatin or overall (safety population)
Danish: Andelen af patienter, der fik præmedicinering inden infusion af paclitaxel eller carboplatin eller samlet set (sikkerhedspopulation)
English: In the pivotal study, about a third of the patients received granulocyte colony stimulating factor (GCSF) to treat neutropenia and clinicians should consider whether individual cases could benefit from GCSF.
Danish: I det pivotale studie fik ca. en tredjedel af patienterne granulocyt-kolonistimulerende faktor (G-CSF) til behandling af neutropeni, og klinikerne bør overveje, om patienterne i de enkelte tilfælde kan have gavn af G-CSF.
English: Apealea is supplied as a sterile powder for reconstitution before use.
Danish: Apealea fås som et sterilt pulver, der skal rekonstitueres før anvendelse.
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Danish: Paclitaxel er et antimikrotubulus-stof, der fremmer samling af mikrotubuli fra tubulin-dimerer og stabiliserer mikrotubuli ved at forhindre depolymerisering.
English: Uncommon: Alanine aminotransferase increased a See Description of selected adverse reactions.
Danish: Ikke almindelig: Øget alaninaminotransferase a Se "Beskrivelse af udvalgte bivirkninger".
English: Apealea dose for subsequent courses (mg/m2)b
Danish: Apealea-dosis i efterfølgende serier (mg/m2)b
English: Protect from light and allow the vial to stand for three to five minutes.
Danish: Beskyt mod lys, og lad hætteglasset stå og hvile i 3-5 minutter.
English: During and after infusion of Apealea, paclitaxel rapidly leaves the plasma compartment with a distribution half-life of about 0.6 hours.
Danish: Under og efter infusion af Apealea forlader paclitaxel hurtigt plasmakompartmentet med en fordelingshalveringstid på ca. 0,6 timer.
English: Apealea is for intravenous use.
Danish: Apealea er til intravenøs anvendelse.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C in lactated and acetated Ringer's solution and for 4 hours at 2 °C to 8 °C in sodium chloride 9 mg/mL (0.9%) solution when protected from light.
Danish: Kemisk og fysisk stabilitet fra anbrud til anvendelse er påvist i 24 timer ved temperaturer på 2-8 ºC i Ringers laktat- og acetatopløsning, og i 4 timer ved 2 °C til 8 °C i natriumchloridopløsning 9 mg/ml (0,9 %), og under beskyttelse mod lys.
English: If patients experience nausea, vomiting and diarrhoea following the administration of Apealea, they may be treated with antiemetics and/or antidiarrhoeal agents.
Danish: Hvis patienterne oplever kvalme, opkastning eller diarré efter administration af Apealea, kan de behandles med antiemetika og/eller midler mod diarré.
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
Danish: Paclitaxel i doser, der ligger under den terapeutiske dosis hos mennesker, blev forbundet med lav fertilitet og føtal toksicitet hos rotter.
English: Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag.
Danish: Sprøjt den påkrævede mængde rekonstitueret Apealea ned i en tom, steril pose af ethylenvinylacetat (EVA).
English: The high interindividual variability in clearance is believed to be a consequence of variability in hepatic enzyme activity.
Danish: Den store forskel i clearance mellem enkeltindivider menes at skyldes en forskel i hepatisk enzymaktivitet.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af markedsføringstilladelsen.
English: There is very little information available on whether the elimination of paclitaxel differs between races.
Danish: Der foreligger meget begrænsede data om, hvorvidt eliminationen af paclitaxel er forskellig hos forskellige etniciteter.
English: • toxicity to the nervous system
Danish: • giftig indvirkning på nervesystemet
English: A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin.
Danish: Der blev udført en noninferioritetsanalyse for PFS hos pr. protokol-populationen (PP-populationen) med en præspecificeret noninferioritetsmargin.
English: The median number of cycles with paclitaxel/carboplatin treatment for patients receiving GCSF was 6 in both groups.
Danish: Det mediane antal serier med paclitaxel-/carboplatinbehandling for patienter, som fik G-CSF, var 6 i begge grupper.
English: Almost all patients experienced anaemia, decreased platelet count and decreased white blood cell count of any grade during the treatment period (98%, 93% and 98%, respectively).
Danish: Næsten alle patienterne oplevede anæmi, nedsat trombocyttal og nedsat antal hvide blodlegemer (alle grader) i behandlingsperioden (hhv. 98 %, 93 % og 98 %).
English: Of the 391 patients with ovarian cancer in the randomised study who received Apealea in combination with carboplatin, 13% were between 65 and 74 years old.
Danish: Ud af de 391 patienter med ovariecancer, der fik Apealea i kombination med carboplatin i det randomiserede studie, var 13 % i alderen 65-74 år.
English: Moderate cases may require premedication with corticosteroids, antihistamines and/or H2 antagonists for the following treatment cycles.
Danish: Moderate tilfælde kan kræve præmedicinering med kortikosteroider, antihistaminer og/eller H2-antagonister i forbindelse med de efterfølgende behandlingsserier.
English: Most of the patients enrolled in the study had ECOG performance status of 0 or 1 (≥ 96%), in similar proportions between the treatment arms.
Danish: De fleste af de patienter, der var inkluderet i studiet, havde en ECOG-performancescore på 0 eller 1 (≥ 96 %), og andelen var lige stor mellem behandlingsgrupperne.
English: Tell your doctor before treatment if you are pregnant, think you may be pregnant or are breast-feeding.
Danish: Sig det til lægen inden behandling, hvis du er gravid, hvis du har mistanke om, at du er gravid, eller hvis du ammer.
English: The median number of cycles with administration of GCSF was 3 (1;6) and the mean value 3.1, each in both groups.
Danish: Det mediane antal serier med administration af G-CSF var 3 (1;6) i begge grupper, og gennemsnitsværdien var 3.1 i begge grupper.
English: Apealea is not recommended during pregnancy, as paclitaxel may cause serious birth defects.
Danish: Apealea anbefales ikke under graviditet, da paclitaxel kan medføre alvorlige misdannelser.
English: • blood vessel disorders, such as:
Danish: • forstyrrelser i blodkar, f.eks.:
English: Apealea contains a mixture of two retinoic acid derivatives as excipients.
Danish: Apealea indeholder en blanding af to retinoinsyre-derivater som hjælpestoffer.
English: When paclitaxel is given before cisplatin, the safety profile of solvent-based paclitaxel is consistent with that reported for single-agent use.
Danish: Når paclitaxel gives før cisplatin, er sikkerhedsprofilen ved solvensbaseret paclitaxel konsistent med sikkerhedsprofilen ved enkeltstofanvendelse.
English: • lack of appetite
Danish: • appetitløshed
English: • numbness, tingling, pricking sensation, sensitivity to touch or muscle weakness You may need additional medicines if you develop any of these symptoms.
Danish: • følelsesløshed, stikkende/prikkende fornemmelse, berøringsfølsomhed eller muskelsvaghed Du kan få brug for yderligere medicin, hvis du udvikler et eller flere af disse symptomer.
English: Local reactions at the infusion site are very common during Apealea infusions.
Danish: Lokale reaktioner på infusionsstedet er en meget almindelig bivirkning under infusion af Apealea.
English: Pronounced hair loss of ≥ 50% is expected for the majority of patients who experience alopecia.
Danish: Kraftigt hårtab (≥ 50 %) forventes hos størstedelen af de patienter, der oplever alopeci.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: • swelling of ankles, feet, face or fingers
Danish: • hævelse i ankler, fødder, ansigt eller fingre
English: On average, the paclitaxel elimination rate was 20% higher in males compared to in females.
Danish: Den gennemsnitlige eliminationshastighed for paclitaxel var 20 % højere hos mænd end hos kvinder.
English: Intravenous use.
Danish: Til intravenøs anvendelse.
English: In vitro studies using human microsomes have shown these derivatives to have inhibitory activity on CYP2B6, CYP2C8, CYP2C9, and to a lesser extent on CYP2D6.
Danish: In vitro-studier med humane mikrosomer har vist, at disse derivater har hæmmende aktivitet på CYP2B6, CYP2C8, CYP2C9 og i mindre omfang CYP2D6.
English: Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Danish: Lettere symptomer som flushing eller hudreaktioner kræver ikke afbrydelse af behandlingen.
English: Other associated reactions were reported in 10% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Danish: Der blev rapporteret om andre relaterede reaktioner hos 10 % af patienterne, og disse var hovedsageligt (98 %) lette til moderate (CTCAE-grad ≤ 2).
English: Care should be taken to avoid accidental administration into the surrounding tissue during intravenous administration.
Danish: Der bør udvises omhu for at undgå utilsigtet indgift i det omgivende væv under intravenøs administration.
English: In the absence of in vivo studies addressing inhibition of CYP2B6 and CYP2C9, the concomitant use of Apealea and substances metabolised primarily by these CYP enzymes should be exercised with caution.
Danish: Da der ikke er gennemført in vivo-studier til vurdering af hæmningen af CYP2B6 og CYP2C9, bør samtidig anvendelse af Apealea og stoffer, der primært metaboliseres af disse CYP-enzymer, ske med forsigtighed.
English: Apealea in children and adolescents aged 0−17 years has not been established.
Danish: Apealeas sikkerhed og virkning hos børn og unge i alderen 0-17 år er endnu ikke klarlagt.
English: Limited data are available on use in patients ≥ 75 years.
Danish: Der foreligger kun begrænsede data om anvendelse hos patienter i alderen ≥ 75 år.
English: Withhold treatment until recovery to < grade 2
Danish: Indstil behandlingen indtil bedring til < grad 2
English: • cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering)
Danish: • kognitive forstyrrelser (tænkebesvær eller forstyrret tankeproces, hukommelsesbesvær)
English: • excessive water loss (dehydration)
Danish: • stort væsketab (dehydrering)
English: The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles (see sections 4.4 and 5.2).
Danish: Den reducerede dosis kan øges til dosen for patienter med normal leverfunktion, hvis patienten tåler behandlingen i mindst to serier (se pkt.
English: There are no reports of active substances able to displace protein-bound paclitaxel, nor is paclitaxel a likely candidate as a displacer of other active substances given its low molar concentrations in plasma.
Danish: Der er ingen rapporter om aktive stoffer, der kan fortrænge proteinbundet paclitaxel, ligesom paclitaxel sandsynligvis ikke kan fortrænge andre aktive stoffer, jf. dets lave molære koncentration i plasma.