natgillin/translations-raw huggingface dataset:
Fortsæt med at dreje hætteglasset frem og tilbage, indtil pulveret er helt opløst.
Continue to swirl the vial until the powder is completely dissolved.
Endvidere er det blevet påvist, at perifere neuropatier kan vare ved udover 6 måneder efter seponering af paclitaxel.
Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Der er ikke fundet nogen farmakologisk aktiv metabolit.
No pharmacologically active metabolite has been found.
Modellen pegede på, at en stigning på 0,2 m2 i legemsoverflade ville medføre en stigning i eliminationshastighed på 9 %.
The model indicated that a 0.2 m2 increase in BSA would lead to a 9% increase in the elimination rate.
Opløsningen bør administreres ved intravenøs infusion over ca. 1 time (120-140 dråber/min).
The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min).
Der er ikke gennemført studier til vurdering af interaktioner mellem Apealea og andre lægemidler.
No studies have been performed to evaluate drug-drug interactions between Apealea and other medicinal products.
Noninferioritetsmargin (1,185)
non-inferiority margin (1.185)
Palmar-plantar erytrodysæstesi-syndromc
Palmar-plantar erythrodysesthesia syndromec
• symptomer på allergisk reaktion under infusionen, herunder:
• symptoms of allergic reaction during the infusion, such as:
b Kan vare ved udover 6 måneder efter seponering af paclitaxel.c c Som rapporteret i overvågningen af paclitaxel efter markedsføring.
b Can persist beyond 6 months of paclitaxel discontinuation.c c As reported in the post-marketing surveillance of paclitaxel.
Noninferioritetsmargin (1,2)
non-inferiority margin (1.2)
Angina pectoris, takykardi
Angina pectoris, tachycardia
Paclitaxel fordeles ligeligt mellem plasma og blod, jf. publicerede in vitro-data.
Paclitaxel is distributed equally between plasma and blood as described in published in vitro data.
Det er desuden påvist, at eliminationshastigheden for paclitaxel stiger med øget kropsstørrelse.
Further it has been shown that the rate of paclitaxel elimination increased with increasing body size.
En tilsvarende effekt kan forventes for Apealea (paclitaxel (micellær)).
A similar effect can be anticipated for Apealea (paclitaxel micellar).
Patienterne bør observeres tæt under behandlingen, navnlig patienter, der tidligere har haft overfølsomhedsreaktioner over for en taxan-formulering.
Patients should be observed closely during treatment, particularly those patients who previously suffered hypersensitivity reactions with any taxane formulation.
Gravide og ammende medarbejdere må ikke håndtere Apealea.
Pregnant and breast-feeding staff should not handle Apealea.
Alopeci er en meget almindelig bivirkning og ses tidligt i behandlingen.
Alopecia is a very common adverse reaction and occurs early in treatment.
Produktet/det rekonstituerede produkt kan kun tåle håndtering i kort tid, hvis det ikke beskyttes mod lys.
The (reconstituted) product can only withstand short-term handling in absence of light protection.
Hvis opløsningen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe.
If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
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.
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.
Der foreligger kun begrænsede data om anvendelse hos patienter i alderen ≥ 75 år (2 % af patienterne i studiet).
Limited data are available on use in patients ≥ 75 years (2% of the patients in the study).
Kontakt omgående lægen eller sygeplejersken, hvis du oplever noget af følgende: • Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
Tell your doctor or nurse immediately if you have any of the following: • Very common (may affect more than 1 in 10 people):
For at sikre korrekt anvendelse af carboplatin bør den ordinerende læge også læse ordinationsoplysningerne for carboplatin.
For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well.
Infusionsrelaterede reaktioner
Infusion-associated reactions
Den anbefalede dosis carboplatin er AUC = 5-6 mg/ml × min.
The recommended dose of carboplatin is AUC = 5-6 mg/mL×min.
Fortæl det altid til lægen, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
Tell your doctor if you are using, have recently used or might use any other medicines.
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.
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.
Der foreligger kun begrænsede data om anvendelse af Apealea hos ikke-kaukasiske patienter.
There are limited data on the use of Apealea in non-Caucasian patients.
Paclitaxel hæmmer eller standser væksten af celler, der deler sig hurtigt, f.eks. tumorceller.
Paclitaxel affects or stops growth of rapidly dividing cells, such as tumour cells.
Patienter, der oplever svære reaktioner, bør ikke eksponeres for paclitaxel igen.
Patients experiencing severe reactions should not be re-challenged with paclitaxel.
Kvalme (38 %), opkastning (22 %) og diarré (15 %) var blandt de hyppigst indberettede bivirkninger i studiet.
Nausea (38%), vomiting (22%) and diarrhoea (15%) were among the most commonly reported adverse reactions in the study.
Der er rapporteret om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgansvigt.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
* 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.
* 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.
Paclitaxel-infusionen blev efterfulgt af carboplatin efter et interval på 30 minutter i begge behandlingsgrupper
The paclitaxel infusion was followed by carboplatin after an interval of 30 minutes in both treatment arms.
Når Apealea (paclitaxel (micellær)) administreres intravenøst, tyder den farmakokinetiske profil på, at formuleringen frigiver paclitaxel til blodet med det samme.
When Apealea (paclitaxel micellar) is administered intravenously, its pharmacokinetic profile suggests that the formulation immediately releases paclitaxel into the blood.
Post-hoc undergruppeanalyse pr. recidiv
Post-hoc subgroup analysis by relapse
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.
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.
Præmedicinering kan overvejes hos patienter, der tidligere har oplevet gastrointestinale symptomer ved behandling med cytotoksika.
Premedication may be considered in patients who have previously experienced gastrointestinal symptoms when being treated with cytotoxic medicinal products.
Der er ingen kendt antidot ved overdosering af paclitaxel.
There is no known antidote for paclitaxel overdose.
Paclitaxel er et antineoplastisk lægemiddel, og som for andre potentielt toksiske forbindelser skal der udvises forsigtighed ved håndtering af Apealea.
Paclitaxel is an antineoplastic medicinal product and as with other potentially toxic compounds, caution should be exercised in handling Apealea.
− lavt blodtryk
− low blood pressure
* Kan vare ved udover 6 måneder efter ophør af paclitaxel.
* Can persist beyond 6 months of paclitaxel discontinuation.
I løbet af det pivotale studie bedredes 46 % af de perifere neuropatier samt størstedelen (78 %) af de relaterede reaktioner.
During the course of the pivotal study, 46% of the peripheral neuropathies as well as the majority (78%) of the associated reactions resolved.
Der er rapporteret om binding af paclitaxel til både albumin og α1-syreglykoprotein, men andre bindingsproteiner som f.eks. lipoproteiner kan være væsentlige.
Binding of paclitaxel to both albumin and α1-acid glycoprotein has been reported, but other binding proteins such as lipoproteins might be important.
Opløsningen skal være klar og grøngul og må ikke indeholde synlige partikler eller bundfald.
The solution should be clear and greenish-yellow without visible particles or precipitates.
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, taxaner, ATC-kode: L01CD01
Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD01 Mechanism of action
Du skal holde op med at amme, mens du er i behandling, da paclitaxel udskilles i modermælk og kan skade barnet.
Stop breast-feeding while being treated, as paclitaxel passes into breast milk and may harm the child.
• smertefuld, svær hævelse af de dybe hudlag, navnlig i ansigtet
• painful severe swelling of deep skin layers, mainly in the face
Paclitaxels karcinogene aktivitet er ikke undersøgt.
The carcinogenic activity of paclitaxel has not been studied.
Tal med lægen eller sygeplejersken om hårtab og om, hvad man kan gøre for at undgå det.
Ask your doctor or nurse about hair loss and what can be done to avoid it.
Tag det antal hætteglas, der skal bruges, ud af køleskabet.
Take the desired number of vials from the refrigerator.
Gastrointestinale symptomer
Gastrointestinal symptoms
• lav kropstemperatur
• low body temperature
Andelen af patienter, der fik præmedicinering inden infusion af paclitaxel eller carboplatin eller samlet set (sikkerhedspopulation)
Proportions of patients who received premedication prior to infusion of paclitaxel or carboplatin or overall (safety population)
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.
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.
Apealea fås som et sterilt pulver, der skal rekonstitueres før anvendelse.
Apealea is supplied as a sterile powder for reconstitution before use.
Paclitaxel er et antimikrotubulus-stof, der fremmer samling af mikrotubuli fra tubulin-dimerer og stabiliserer mikrotubuli ved at forhindre depolymerisering.
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Ikke almindelig: Øget alaninaminotransferase a Se "Beskrivelse af udvalgte bivirkninger".
Uncommon: Alanine aminotransferase increased a See Description of selected adverse reactions.
Apealea-dosis i efterfølgende serier (mg/m2)b
Apealea dose for subsequent courses (mg/m2)b
Beskyt mod lys, og lad hætteglasset stå og hvile i 3-5 minutter.
Protect from light and allow the vial to stand for three to five minutes.
Under og efter infusion af Apealea forlader paclitaxel hurtigt plasmakompartmentet med en fordelingshalveringstid på ca. 0,6 timer.
During and after infusion of Apealea, paclitaxel rapidly leaves the plasma compartment with a distribution half-life of about 0.6 hours.
Apealea er til intravenøs anvendelse.
Apealea is for intravenous use.
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.
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.
Hvis patienterne oplever kvalme, opkastning eller diarré efter administration af Apealea, kan de behandles med antiemetika og/eller midler mod diarré.
If patients experience nausea, vomiting and diarrhoea following the administration of Apealea, they may be treated with antiemetics and/or antidiarrhoeal agents.
Paclitaxel i doser, der ligger under den terapeutiske dosis hos mennesker, blev forbundet med lav fertilitet og føtal toksicitet hos rotter.
Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
Sprøjt den påkrævede mængde rekonstitueret Apealea ned i en tom, steril pose af ethylenvinylacetat (EVA).
Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag.
Den store forskel i clearance mellem enkeltindivider menes at skyldes en forskel i hepatisk enzymaktivitet.
The high interindividual variability in clearance is believed to be a consequence of variability in hepatic enzyme activity.
Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af markedsføringstilladelsen.
For any information about this medicine, please contact the Marketing Authorisation Holder.
Der foreligger meget begrænsede data om, hvorvidt eliminationen af paclitaxel er forskellig hos forskellige etniciteter.
There is very little information available on whether the elimination of paclitaxel differs between races.
• giftig indvirkning på nervesystemet
• toxicity to the nervous system
Der blev udført en noninferioritetsanalyse for PFS hos pr. protokol-populationen (PP-populationen) med en præspecificeret noninferioritetsmargin.
A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin.
Det mediane antal serier med paclitaxel-/carboplatinbehandling for patienter, som fik G-CSF, var 6 i begge grupper.
The median number of cycles with paclitaxel/carboplatin treatment for patients receiving GCSF was 6 in both groups.
Næsten alle patienterne oplevede anæmi, nedsat trombocyttal og nedsat antal hvide blodlegemer (alle grader) i behandlingsperioden (hhv. 98 %, 93 % og 98 %).
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).
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.
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.
Moderate tilfælde kan kræve præmedicinering med kortikosteroider, antihistaminer og/eller H2-antagonister i forbindelse med de efterfølgende behandlingsserier.
Moderate cases may require premedication with corticosteroids, antihistamines and/or H2 antagonists for the following treatment cycles.
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.
Most of the patients enrolled in the study had ECOG performance status of 0 or 1 (≥ 96%), in similar proportions between the treatment arms.
Sig det til lægen inden behandling, hvis du er gravid, hvis du har mistanke om, at du er gravid, eller hvis du ammer.
Tell your doctor before treatment if you are pregnant, think you may be pregnant or are breast-feeding.
Det mediane antal serier med administration af G-CSF var 3 (1;6) i begge grupper, og gennemsnitsværdien var 3.1 i begge grupper.
The median number of cycles with administration of GCSF was 3 (1;6) and the mean value 3.1, each in both groups.
Apealea anbefales ikke under graviditet, da paclitaxel kan medføre alvorlige misdannelser.
Apealea is not recommended during pregnancy, as paclitaxel may cause serious birth defects.
• forstyrrelser i blodkar, f.eks.:
• blood vessel disorders, such as:
Apealea indeholder en blanding af to retinoinsyre-derivater som hjælpestoffer.
Apealea contains a mixture of two retinoic acid derivatives as excipients.
Når paclitaxel gives før cisplatin, er sikkerhedsprofilen ved solvensbaseret paclitaxel konsistent med sikkerhedsprofilen ved enkeltstofanvendelse.
When paclitaxel is given before cisplatin, the safety profile of solvent-based paclitaxel is consistent with that reported for single-agent use.
• appetitløshed
• lack of appetite
• følelsesløshed, stikkende/prikkende fornemmelse, berøringsfølsomhed eller muskelsvaghed Du kan få brug for yderligere medicin, hvis du udvikler et eller flere af disse symptomer.
• numbness, tingling, pricking sensation, sensitivity to touch or muscle weakness You may need additional medicines if you develop any of these symptoms.
Lokale reaktioner på infusionsstedet er en meget almindelig bivirkning under infusion af Apealea.
Local reactions at the infusion site are very common during Apealea infusions.
Kraftigt hårtab (≥ 50 %) forventes hos størstedelen af de patienter, der oplever alopeci.
Pronounced hair loss of ≥ 50% is expected for the majority of patients who experience alopecia.
Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
• hævelse i ankler, fødder, ansigt eller fingre
• swelling of ankles, feet, face or fingers
Den gennemsnitlige eliminationshastighed for paclitaxel var 20 % højere hos mænd end hos kvinder.
On average, the paclitaxel elimination rate was 20% higher in males compared to in females.
Til intravenøs anvendelse.
Intravenous use.
In vitro-studier med humane mikrosomer har vist, at disse derivater har hæmmende aktivitet på CYP2B6, CYP2C8, CYP2C9 og i mindre omfang CYP2D6.
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.
Lettere symptomer som flushing eller hudreaktioner kræver ikke afbrydelse af behandlingen.
Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Der blev rapporteret om andre relaterede reaktioner hos 10 % af patienterne, og disse var hovedsageligt (98 %) lette til moderate (CTCAE-grad ≤ 2).
Other associated reactions were reported in 10% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Der bør udvises omhu for at undgå utilsigtet indgift i det omgivende væv under intravenøs administration.
Care should be taken to avoid accidental administration into the surrounding tissue during intravenous administration.
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.
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.
Apealeas sikkerhed og virkning hos børn og unge i alderen 0-17 år er endnu ikke klarlagt.
Apealea in children and adolescents aged 0−17 years has not been established.
Der foreligger kun begrænsede data om anvendelse hos patienter i alderen ≥ 75 år.
Limited data are available on use in patients ≥ 75 years.
Indstil behandlingen indtil bedring til < grad 2
Withhold treatment until recovery to < grade 2
• kognitive forstyrrelser (tænkebesvær eller forstyrret tankeproces, hukommelsesbesvær)
• cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering)
• stort væsketab (dehydrering)
• excessive water loss (dehydration)
Den reducerede dosis kan øges til dosen for patienter med normal leverfunktion, hvis patienten tåler behandlingen i mindst to serier (se pkt.
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).
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.
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.
Studier med brystcancerpatienter, der blev behandlet med paclitaxel-holdige regimer, peger imidlertid på en mulig øget risiko for neuropati hos ikke-kaukasiske patienter (se pkt.
However, studies in breast cancer patients treated with paclitaxel-containing regimens indicate a possible increased risk of neuropathy in non-Caucasian patients (see section 4.2).
Når solvensbaseret paclitaxel blev givet efter cisplatin, udviste patienterne sværere myelosuppression og et fald i paclitaxel-clearance på ca. 20 %.
When solvent-based paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Det er påvist in vitro, at paclitaxel er et substrat for influx-transportproteinerne OATP1B3 og OATP1A2.
Paclitaxel has been shown in vitro to be a substrate for the influx transporter proteins OATP1B3 and OATP1A2.
Paclitaxel havde ingen mutagen aktivitet i Ames-testen eller i Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT)genmutationsanalysen.
Paclitaxel was devoid of mutagenic activity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Grøngult til gult pulver.
Greenish-yellow to yellow powder.
Den samlede plasmakoncentration af paclitaxel var næsten den samme for de to formuleringer efter infusion.
Total plasma levels of paclitaxel were similar after infusion of the two formulations.
Alternativt, kan hætteglasset anbringes på et rysteapparat og roteres i op til 20 minutter, mens det beskyttes mod lys (orbitalt rystemønster: 200-250 rpm).
Alternatively, the vial may be placed on a shaker and rotated for up to 20 minutes, while being protected from light (orbital shake pattern; 200-250 rpm).
Der er påvist kompatibilitet med administrationssæt af DEHP-fri PVC (dvs. polyvinylchlorid uden blødgøringsmidlet di-(2-ethylhexyl)-phthalat).
Compatibility with administration sets made of DEHP-free PVC (i.e. polyvinyl chloride without the plasticizer di-(2-ethylhexyl) phthalate) has been demonstrated.
Andre bivirkninger omfatter (angivet med hyppighed):
Other side effects and their frequencies include:
Eventuel dosisafhængighed, hvad angår hyppighed og sværhedsgrad af neurotoksicitet, er ikke undersøgt for Apealea, men der er set dosisafhængighed for andre paclitaxel-formuleringer i andre indikationer.
The dose-dependency of frequency and severity of neurotoxicity was not studied for Apealea, but has been observed for other paclitaxel formulations in other indications.
• feber, smerter, kulderystelser, svaghed eller andre tegn på infektion
• fever, pain, chills, weakness or other signs of infection
• carbamazepin, phenytoin: lægemidler til behandling af epilepsi og visse smertetilstande
• carbamazepine, phenytoin: medicines to treat epilepsy and certain pain conditions
Der blev udført yderligere undergruppeanalyser for at undersøge virkningen pr. recidiv (første og andet) i PP- og ITT-populationen.
Additional subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the PP and the ITT population.