FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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.
English: When solvent-based paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Danish: Når solvensbaseret paclitaxel blev givet efter cisplatin, udviste patienterne sværere myelosuppression og et fald i paclitaxel-clearance på ca. 20 %.
English: Paclitaxel has been shown in vitro to be a substrate for the influx transporter proteins OATP1B3 and OATP1A2.
Danish: Det er påvist in vitro, at paclitaxel er et substrat for influx-transportproteinerne OATP1B3 og OATP1A2.
English: Paclitaxel was devoid of mutagenic activity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Danish: Paclitaxel havde ingen mutagen aktivitet i Ames-testen eller i Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT)genmutationsanalysen.
English: Greenish-yellow to yellow powder.
Danish: Grøngult til gult pulver.
English: Total plasma levels of paclitaxel were similar after infusion of the two formulations.
Danish: Den samlede plasmakoncentration af paclitaxel var næsten den samme for de to formuleringer efter infusion.
English: 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).
Danish: Alternativt, kan hætteglasset anbringes på et rysteapparat og roteres i op til 20 minutter, mens det beskyttes mod lys (orbitalt rystemønster: 200-250 rpm).
English: Compatibility with administration sets made of DEHP-free PVC (i.e. polyvinyl chloride without the plasticizer di-(2-ethylhexyl) phthalate) has been demonstrated.
Danish: Der er påvist kompatibilitet med administrationssæt af DEHP-fri PVC (dvs. polyvinylchlorid uden blødgøringsmidlet di-(2-ethylhexyl)-phthalat).
English: Other side effects and their frequencies include:
Danish: Andre bivirkninger omfatter (angivet med hyppighed):
English: 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.
Danish: 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.
English: • fever, pain, chills, weakness or other signs of infection
Danish: • feber, smerter, kulderystelser, svaghed eller andre tegn på infektion
English: • carbamazepine, phenytoin: medicines to treat epilepsy and certain pain conditions
Danish: • carbamazepin, phenytoin: lægemidler til behandling af epilepsi og visse smertetilstande
English: Additional subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the PP and the ITT population.
Danish: Der blev udført yderligere undergruppeanalyser for at undersøge virkningen pr. recidiv (første og andet) i PP- og ITT-populationen.
English: The tissue distribution is extensive, with a volume of distribution on the terminal elimination phase of about 155 L/m2 corresponding to about 280 L for an average patient with a body surface area of 1.8 m2.
Danish: Der ses omfattende vævsfordeling med et fordelingsvolumen i den terminale eliminationsfase på ca. 155 l/m2, svarende til ca. 280 l for en gennemsnitlig patient med en legemsoverflade på 1,8 m2.
English: This was in agreement with the mean fu after albumin-bound paclitaxel infusion which varied between 5.5% and 4.5% over time.
Danish: Dette stemte overens med den gennemsnitlige ubundne fraktion efter infusion af albumin-bundet paclitaxel, der varierede mellem 5,5 % og 4,5 % over tid.
English: Very common: Arthralgiaa, myalgiaa Common:
Danish: Meget almindelig: Artralgia, myalgia Almindelig:
English: • skin infections, including infections at the infusion site
Danish: • hudinfektioner, herunder infektioner på infusionsstedet
English: • cancer of the fallopian tubes (the connection between the ovaries and the womb) It is used when other therapies have not worked.
Danish: • kræft i æggelederne (forbindelsen mellem æggestokkene og livmoderen) Denne behandling anvendes, når andre behandlinger ikke har virket.
English: • blue tinged lips or skin
Danish: • blåfarvede læber eller blålig hud
English: It is important to flush the infusion set and catheter/cannula before and after the administration using the solution for reconstitution in order to avoid accidental administration into the surrounding tissue and to ensure administration of the complete dose.
Danish: Det er vigtigt at skylle infusionssættet og kateteret/kanylen før og efter administration ved brug af rekonstitutionsvæsken for at undgå utilsigtet indgift i det omgivende væv og for at sikre, at hele dosen indgives.
English: From a microbiological point of view, unless the method of opening and reconstituting precludes the risks of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes med det samme, medmindre metoden til åbning og rekonstitution udelukker risiko for kontaminering med mikroorganismer.
English: The powder should be greenish-yellow to yellow.
Danish: Pulveret skal være grøngult til gult.
English: • herpes simplex (a viral infection), viral airways infections
Danish: • herpes simplex (en virusinfektion), virusinfektion i luftvejene
English: Apealea is supplied as a greenish-yellow to yellow powder in a glass vial with a rubber stopper and aluminium seal.
Danish: Apealea fås som et grøngult til gult pulver i et hætteglas af glas med gummiprop og aluminiumsforsegling.
English: Apealea should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Danish: Apealea bør kun administreres under tilsyn af en erfaren onkolog på afdelinger med speciale i administration af cytotoksika.
English: • are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for paclitaxel eller et af de øvrige indholdsstoffer i Apealea (angivet i punkt 6)
English: For Apealea, dose reductions of initially 50 mg/m2 and additionally 25 mg/m2 should be considered for subsequent courses (see Table 1).
Danish: For Apealea bør dosisreduktioner med først 50 mg/m2 og dernæst yderligere 25 mg/m2 overvejes ved de efterfølgende serier (se tabel 1).
English: Repeat dose toxicity studies have shown non-reversible, toxic effects on male reproductive organs.
Danish: Toksicitetsstudier med gentagne doser har vist irreversibel toksisk effekt på hannens kønsorganer.
English: Most hypersensitivity reactions related to Apealea were mild to moderate (see section 4.4).
Danish: De fleste overfølsomhedsreaktioner relateret til Apealea var lette til moderate (se pkt.
English: • severe reactions at the site of infusion
Danish: • svære reaktioner på infusionsstedet
English: When reconstituted, this medicinal product contains up to approximately 1.6 g sodium per dose (0.9 g/m2 BSA; 3.6 mg per mL), equivalent to 80% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Efter rekonstitution indeholder dette lægemiddel op til ca. 1,6 g natrium pr. dosis (0,9 g/m2 legemsoverflade, 3,6 mg pr. ml), svarende til 80 % af den af WHO anbefalede daglige indtagelse af 2 g natrium for en voksen.
English: Overall, there were higher rates of serious adverse events with paclitaxel micellar (41%) than with solvent-based paclitaxel (27%).
Danish: Samlet set var der højere forekomst af alvorlige bivirkninger ved brug af paclitaxel (micellær) (41 %) end ved brug af solvensbaseret paclitaxel (27 %).
English: Treatment delay and dose level reductions for adverse drug reactions Observationa
Danish: Udskydelse af behandling og dosisreduktion ved bivirkninger Observationa
English: Clinically relevant pharmacokinetic interaction has been observed between paclitaxel and cisplatin.
Danish: Der er observeret klinisk relevant farmakokinetisk interaktion mellem paclitaxel og cisplatin.
English: Patients who experience severe pain or other reactions to the infusion of Apealea are recommended to be considered for a central venous catheter.
Danish: Hos patienter, der oplever svære smerter og andre reaktioner under infusion af Apealea, anbefales det at overveje anvendelse af et centralt venekateter.
English: In studies with Apealea, 45% of patients reported alopecia during therapy.
Danish: I studierne af Apealea rapporterede 45 % af patienterne om alopeci under behandlingen.
English: Based on literature data, no clinically relevant pharmacokinetic interaction between paclitaxel and carboplatin is expected.
Danish: Ud fra litteraturdata forventes ingen klinisk relevant farmakokinetisk interaktion mellem paclitaxel og carboplatin.
English: Standard dose:
Danish: Standarddosis:
English: In vitro and in vivo studies have demonstrated that paclitaxel is a substrate for the efflux protein P-glycoprotein.
Danish: In vitro- og in vivo-studier har vist, at paclitaxel er et substrat for efflux-proteinet P-glykoprotein.
English: Patients treated with paclitaxel and cisplatin may have an increased risk of renal failure as compared to cisplatin alone in gynaecological cancers.
Danish: Patienter, der behandles med paclitaxel og cisplatin, kan have øget risiko for nyresvigt, sammenholdt med cisplatin alene ved gynækologiske kræftsygdomme.
English: • epithelial ovarian cancer - a cancer of the ovary, the organ that produces a woman's egg cells
Danish: • epitelial æggestokkræft - en kræftsygdom i æggestokkene, dvs. de organer, der producerer kvindens ægceller
English: Median time to death or disease progression [months] (95% CI)
Danish: Median tid til død eller sygdomsprogression [måneder] (95 %-KI)
English: For CTCAE grade ≥ 2 sensory or motor neuropathy withhold treatment until resolution to < grade 2, followed by a dose reduction for all subsequent courses (see section 4.2).
Danish: Ved sensorisk eller motorisk neuropati af CTCAE-grad ≥ 2 indstilles behandlingen indtil bedring til < grad 2, hvorefter dosis reduceres i alle efterfølgende serier (se pkt.
English: Neutropenia occurred in 79% and 66%, leukopenia in 53% and 34%, thrombocytopenia in 18% and 10%, and anaemia in 24% and 14% of the patients in the treatment arms receiving either paclitaxel micellar or solvent-based paclitaxel, respectively.
Danish: Neutropeni sås hos hhv. 79 % og 66 %, leukopeni hos hhv. 53 % og 34 %, trombocytopeni hos hhv. 18 % og 10 % og anæmi hos hhv. 24 % og 14 % af patienterne i de behandlingsgrupper, der fik enten paclitaxel (micellær) eller solvensbaseret paclitaxel.
English: Reconstitution of the medicinal product
Danish: Rekonstitution af lægemidlet
English: • pus in body tissue
Danish: • pus i kropsvævet
English: Second 71 40
Danish: Første 240 139
English: After reconstitution, the solution contains 1 mg/mL of paclitaxel formulated as micellar nanoparticles.
Danish: Efter rekonstitution indeholder opløsningen 1 mg/ml paclitaxel formuleret som micellære nanopartikler.
English: Acceptable ion concentrations for calcium and magnesium in lactated and acetated Ringer's solutions suitable for reconstitution
Danish: Acceptable ion-koncentrationer af kalcium og magnesium i Ringers laktat- eller acetatopløsninger til rekonstitution
English: Based on the combined data from monotherapy studies, very common adverse reactions and those of special interest were the following: neutropenia (45%), fatigue (37%), leukopenia (33%), alopecia (30%), nausea (27%), infusion site reactiona (23%), peripheral sensory neuropathy (20%), diarrhoea (17%), asthenia (15%), pyrexia (12%), constipation (12%), arthralgia (12%), paraesthesia (11%), pain (11%), vomiting (9%), myalgia (9%), peripheral motor neuropathy (5%), neuropathy (5%), neuropathy peripheral (5%), thrombocytopenia (4%), febrile neutropenia (2%), sepsis (2%), tachycardia (2%), phlebitis (2%), thrombosis (2%).
Danish: Ifølge kombinerede data fra studier med enkeltstofbehandling sås følgende meget almindelige bivirkninger og bivirkninger af særlig interesse: neutropeni (45 %), træthed (37 %), leukopeni (33 %), alopeci (30 %), kvalme (27 %), reaktion på infusionsstedeta (23 %), perifer sensorisk neuropati (20 %), diarré (17 %), asteni (15 %), pyreksi (12 %), forstoppelse (12 %), artralgi (12 %), paræstesi (11 %), smerter (11 %), opkastning (9 %), myalgi (9 %), perifer motorisk neuropati (5 %), neuropati (5 %), perifer neuropati (5 %), trombocytopeni (4 %), febril neutropeni (2 %), sepsis (2 %), takykardi (2 %), flebitis (2 %), trombose (2 %).
English: • increased sweating, cold sweat
Danish: • øget svedtendens, koldsved
English: Apealea is not recommended for patients with severely reduced liver or kidney function.
Danish: Apealea anbefales ikke til patienter med svært nedsat lever- eller nyrefunktion.
English: The true incidence, severity and time to onset of hypersensitivity reactions due to Apealea could not be established during clinical development due to the combination treatment with carboplatin.
Danish: Den faktiske incidens, sværhedsgrad og tid til debut af overfølsomhedsreaktioner, der skyldes Apealea, kunne som følge af kombinationsbehandlingen med carboplatin ikke fastsættes under den kliniske udvikling.
English: Possible dose reductions:
Danish: Mulige dosisreduktioner:
English: Neuropathy
Danish: Neuropati
English: Because of potential serious adverse reactions in children being breastfed, Apealea is contraindicated during lactation.
Danish: På grund af potentielt alvorlige bivirkninger hos børn, som ammes, er Apealea kontraindiceret i ammeperioden.
English: The formation of these metabolites is catalysed by CYP2C8 and CYP3A4.
Danish: Dannelsen af disse metabolitter katalyseres af CYP2C8 og CYP3A4.
English: Patients who can become pregnant should use effective contraception during treatment with Apealea and for six months afterwards.
Danish: Patienter, der kan blive gravide, skal bruge sikker prævention under behandling med Apealea og i 6 måneder efter behandlingen.
English: The plasma levels of unbound paclitaxel, i.e. the concentration that represents pharmacologically active paclitaxel in the body, were demonstrated to be bioequivalent (Cmax and AUC) after administration of albumin-bound paclitaxel and Apealea.
Danish: Det blev påvist, at plasmaniveauet af ubundet paclitaxel, dvs. den koncentration, der repræsenterer farmakologisk aktivt paclitaxel i kroppen, var bioækvivalent (Cmax og AUC) efter administration af albumin-bundet paclitaxel og Apealea.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Neutropenia as a serious adverse reaction occurred in 29% of the patients and febrile neutropenia occurred in 3% of the patients.
Danish: Neutropeni som alvorlig bivirkning sås hos 29 % af patienterne, og febril neutropeni sås hos 3 % af patienterne.
English: • blood poisoning
Danish: • blodforgiftning
English: Severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angioedema or generalised urticaria require immediate discontinuation of paclitaxel and initiation of symptomatic treatment.
Danish: Svære reaktioner, såsom behandlingskrævende hypotension, bronkodilatator-krævende dyspnø, angioødem eller generaliseret urticaria, nødvendiggør øjeblikkelig seponering af paclitaxel og iværksættelse af symptombehandling.
English: Thereby, non-inferiority was shown in the ITT population for PFS, but not for OS. At the time of analysis of the OS data, death had occurred in 56% of the patients in the group treated with paclitaxel micellar compared to 60% in the group treated with solvent-based paclitaxel (ITT population).
Danish: Der blev således også vist noninferioritet hos ITTpopulationen for PFS, men ikke for OS. På analysetidspunktet for OS-dataene var der indtruffet dødsfald hos 56 % af de patienter, der blev behandlet med paclitaxel (micellær), sammenholdt med 60 % i den gruppe, der blev behandlet med solvensbaseret paclitaxel (ITT-populationen).
English: Type of premedication
Danish: Type præmedicinering
English: • previously had nausea, vomiting and diarrhoea during cancer treatment
Danish: • hvis du tidligere har haft kvalme, opkastning og diarré i forbindelse med kræftbehandling.
English: Paclitaxel (solvent-based)
Danish: Paclitaxel (solvensbaseret)
English: Since renal elimination is a minor pathway for paclitaxel, increased plasma levels are not expected in this patient group.
Danish: Da paclitaxel kun udskilles gennem nyrerne i begrænset omfang, forventes øgede plasmaniveauer ikke i denne patientgruppe.
English: In addition, a study with a crossover design compared total and unbound paclitaxel concentrations in plasma after a 1-hour infusion of Apealea 260 mg/m2 with those after a 1-hour infusion of albumin-bound paclitaxel at the same dose.
Danish: Desuden sammenlignede et studie med overkrydsningsdesign plasmakoncentrationen af totalt og ubundet paclitaxel efter en 1-times infusion af Apealea 260 mg/m2 med plasmakoncentrationen efter en 1-times infusion af albumin-bundet paclitaxel i samme dosis.
English: Table 2 lists adverse reactions associated with the administration of Apealea in combination with carboplatin observed in a clinical study (N = 391) and adverse reactions from post-marketing experience.
Danish: Tabel 2 viser de bivirkninger, der er forbundet med indgift af Apealea i kombination med carboplatin i et klinisk studie (N = 391) og bivirkninger fra erfaring efter markedsføring.
English: In vitro studies using different cell systems have shown paclitaxel to be clastogenic inducing chromosomal aberrations, micronuclei and DNA damage.
Danish: In vitro-studier har under anvendelse af forskellige cellesystemer vist, at paclitaxel er klastogent og medfører kromosomafvigelser og mikronukleus- og dna-skader.
English: The mean unbound fraction of paclitaxel (fu) varied between 5.2% and 4.3% over time after Apealea infusion.
Danish: Den gennemsnitlige ubundne fraktion af paclitaxel varierede mellem 5,2 % og 4,3 % over tid efter infusion af Apealea.
English: After reconstitution, this medicine contains approximately up to 1.6 g sodium (component of cooking salt) per dose.
Danish: Efter rekonstitution indeholder dette lægemiddel op til ca.1,6 g natrium (hovedkomponent af madlavnings-/bordsalt) pr. dosis.
English: Peripheral sensory neuropathy represented the most common reaction and was reported in 16% of patients.
Danish: Perifer sensorisk neuropati var den bivirkning, der forekom hyppigst (blev rapporteret hos 16 % af patienterne).
English: If particles, precipitates, discolouration (orange) or opalescence are observed, the solution should be discarded.
Danish: Hvis der ses partikler, bundfald, misfarvning (orange farve) eller uigennemsigtighed, skal opløsningen kasseres.
English: Infusion site reactions, such as pain, phlebitis, and erythema, were seen in 12% of patients (see section 4.4).
Danish: Reaktioner på infusionsstedet, f.eks. smerter, flebitis og erytem, sås hos 12 % af patienterne (se pkt.
English: Contents of the pack and other information What Apealea contains
Danish: Pakningsstørrelser og yderligere oplysninger Apealea indeholder
English: Neutropenia is a dose-dependent and dose-limiting adverse reaction.
Danish: Neutropeni er en dosisafhængig og dosisbegrænsende bivirkning.
English: Patients received premedication prior to infusion of solvent-based paclitaxel, paclitaxel micellar and carboplatin as summarised in Table 3 below.
Danish: Patienterne fik præmedicinering forud for infusionen af solvensbaseret paclitaxel, paclitaxel (micellær) og carboplatin, som det fremgår af tabel 3 nedenfor.
English: If any sign of extravasal injection occurs, take immediate action: terminate the infusion, aspirate fluid from the catheter/cannula before the needle is withdrawn, infuse the affected area with sterile saline or lactated or acetated Ringer's solution and closely monitor the area.
Danish: Hvis der ses tegn på ekstravasal injektion, skal der gribes ind med det samme: Stands infusionen, aspirér væske fra kateteret/kanylen, inden kanylen trækkes ud, infundér en steril saltvandsopløsning eller en Ringers laktat- eller acetatopløsning ind i det berørte område, og overvåg dette tæt.
English: • abnormally high levels of nitrogen-containing compounds in the blood
Danish: • unormalt højt niveau af kvælstof-holdige forbindelser i blodet
English: Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Danish: Paclitaxel formodes at medføre alvorlige misdannelser, hvis det anvendes under graviditet.
English: Withhold treatment until recovery
Danish: Indstil behandlingen indtil bedring
English: • cisplatin: a medicine to treat cancer
Danish: • cisplatin: et lægemiddel mod kræft
English: Pharmacokinetic data for patients with total bilirubin > 5 × ULN are not available.
Danish: Der foreligger ingen farmakokinetiske data for patienter med total bilirubin > 5 × ULN.
English: − fever
Danish: − feber
English: Dose reductions or/and delays should be considered as a result of any clinically significant adverse reaction as presented in Table 1.
Danish: Dosisreduktion og/eller udskydelse bør overvejes ved en eller flere klinisk signifikante bivirkninger, jf. tabel 1.
English: Chromosomal aberrations have also been detected in in vivo studies in mice and monkeys.
Danish: Der er også set kromosomafvigelser hos mus og aber i in vivo-studier.
English: The frequency of paclitaxel-related hypersensitivity reactions was similar in both groups (5% of the patients receiving paclitaxel micellar and 7% of the patients receiving solvent-based paclitaxel), whereas a higher frequency of carboplatin-related hypersensitivity reactions was observed in the group receiving paclitaxel micellar (12% vs 7%).
Danish: Hyppigheden af paclitaxel-relaterede overfølsomhedsreaktioner var næsten den samme i de to grupper (5 % af patienterne fik paclitaxel (micellær), og 7 % af patienterne fik solvensbaseret paclitaxel), mens hyppigheden af carboplatin-relaterede overfølsomhedsreaktioner var størst i den gruppe, der fik paclitaxel (micellær) (12 % vs. 7 %).
English: Apealea should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Danish: Apealea må kun klargøres og administreres af uddannet personale med erfaring i håndtering af cytotoksiske stoffer.
English: Each vial contains 3.77 mg (0.164 mmol) sodium.
Danish: Hvert hætteglas indeholder 3,77 mg (0,164 mmol) natrium.
English: In the clinical study, the proportion of patients receiving six treatment cycles was 81% in the group treated with paclitaxel micellar and 87% in the group receiving solvent-based paclitaxel.
Danish: I det kliniske studie var andelen af patienter, der fik seks behandlingsserier, 81 % i den gruppe, der fik paclitaxel (micellær), og 87 % i den gruppe, der fik solvensbaseret paclitaxel.
English: However, a population pharmacokinetics study of 168 patients (86 males and 82 females) treated with solvent-based paclitaxel has been reported.
Danish: Der er imidlertid gennemført et farmakokinetisk populationsstudie med solvensbaseret paclitaxel hos 168 patienter (86 mænd og 82 kvinder).
English: The pharmacokinetics of paclitaxel were studied in 22 patients with solid tumours after 1-hour infusions of Apealea (dose levels of 90 to 275 mg/m2).
Danish: Paclitaxels farmakokinetik blev undersøgt hos 22 patienter med solide tumorer efter 1-times infusioner af Apealea (doser på 90-275 mg/m2).