FrancophonIA/ELRC3.0 huggingface dataset:
English: First dose level reduction: Possible dose reduction: Second dose level reduction:
Danish: Første dosisreduktion: Mulig dosisreduktion: Anden dosisreduktion:
English: Any grade 3 toxicity except nausea, vomiting and diarrhoea
Danish: Enhver toksicitet af grad 4 Seponér behandlingen Enhver toksicitet af grad 3, bortset fra kvalme, opkastning og diarré
English: Patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ 10 × ULN) may be treated with the same doses as patients with normal hepatic function.
Danish: Patienter med let nedsat leverfunktion (total bilirubin > 1 - ≤ 1,5 × den øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) ≤ 10 × ULN) kan behandles med samme doser som patienter med normal leverfunktion.
English: Talk to your doctor or nurse before you are given Apealea if you have:
Danish: Kontakt lægen eller sygeplejersken, før du får Apealea:
English: Hazard Ratio (95% CI)
Danish: Hazard ratio (95 %-KI)
English: − reddening and swelling at the site of infusion
Danish: − rødme og hævelse på infusionsstedet
English: Patients should not be treated with subsequent cycles until neutrophils recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Danish: Patienterne bør ikke behandles med de efterfølgende serier, før neutrofiltallet er bedret til ≥ 1,5 × 109/l og trombocyttallet til ≥ 100 × 109/l.
English: After reconstitution of the powder, the solution for infusion is a clear, greenish-yellow solution.
Danish: Efter rekonstitution af pulveret er infusionsvæsken en klar, grøngul opløsning.
English: • deafness, inner ear disorder, ringing in the ears
Danish: • døvhed, forstyrrelse i det indre øre, ringen for ørerne
English: Patients were treated every three weeks for six cycles, either with Apealea 250 mg/m2 given as a 1-hour intravenous infusion (N = 391) or with solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion (N = 391).
Danish: Patienterne blev behandlet hver 3. uge i seks behandlingsserier, der enten bestod af Apealea 250 mg/m2 givet som en 1-times intravenøs infusion (N = 391) eller af solvensbaseret paclitaxel 175 mg/m2 givet som en 3-timers infusion (N = 391).
English: For safety data comparing the results of combination treatment with Apealea (paclitaxel micellar)/carboplatin and solvent-based paclitaxel/carboplatin, see section 4.8.
Danish: For sikkerhedsdata, hvor resultaterne af kombinationsbehandling med Apealea (paclitaxel (micellær))/carboplatin) sammenlignes med resultaterne af kombinationsbehandling med solvensbaseret paclitaxel/carboplatin, se pkt.
English: • a heart rhythm disorder causing irregular rapid activity in the upper heart chambers
Danish: • forstyrret hjerterytme (uregelmæssig, hurtig aktivitet i hjertets forkamre)
English: The reconstituted solution for infusion is a clear, greenish-yellow solution.
Danish: Den rekonstituerede infusionsvæske er en klar, grøngul opløsning.
English: Possible dose reductions: First dose level reduction: Second dose level reduction:
Danish: Mulige dosisreduktioner: Første dosisreduktion: Anden dosisreduktion:
English: Clear type I glass vial with a silicon coated butyl rubber stopper, an aluminium overseal and a plastic flip-off cap containing powder equivalent to 60 mg of paclitaxel.
Danish: Klart type I-hætteglas af glas med silikonebelagt butylgummiprop, aluminiumsforsegling og afrivelig plasthætte indeholdende pulver svarende til 60 mg paclitaxel.
English: Apealea may cause adverse reactions such as fatigue (very common) and dizziness (common) that may affect the ability to drive or use machinery.
Danish: Apealea kan have bivirkninger som træthed (meget almindelig bivirkning) og svimmelhed (almindelig bivirkning), som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Apealea is indicated to be used in combination with carboplatin (see section 4.1).
Danish: Apealea er indiceret til brug i kombination med carboplatin (se pkt.
English: Gastrointestinal adverse reactions are very common.
Danish: Gastrointestinale symptomer er meget almindelige bivirkninger.
English: Hepatic impairment has no effect on mean paclitaxel Cmax.
Danish: Nedsat leverfunktion har ingen indvirkning på gennemsnitlig Cmax for paclitaxel.
English: How Apealea is given
Danish: Sådan får du Apealea
English: • reactions at the infusion site such as pain, inflammation, discolouration, redness, swelling,
Danish: • reaktioner på infusionsstedet, såsom smerter, inflammation, misfarvning, rødme, hævelse,
English: There is no relevant use of paclitaxel in the paediatric population for the indications of epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Danish: Anvendelse af paclitaxel er ikke relevant hos den pædiatriske population til indikationerne epitelial ovariecancer, primær peritonealcancer og tubacancer.
English: The corresponding median number of cycles (min;max) for the two groups were 6 (1;12) and 6 (1;9), respectively.
Danish: for de to grupper var hhv. 6 (1;12) og 6 (1;9).
English: • severe nausea, vomiting or diarrhoea
Danish: • svær kvalme, opkastning eller diarré
English: • pain for instance in arms, legs, breast or at site of tumour
Danish: • smerter i f.eks. armene, benene, brystet eller omkring tumoren
English: The pH of lactated or acetated Ringer's solution must be in the range of 5.0 to 7.5, and acceptable ion concentrations of calcium and magnesium are listed below (Table 5).
Danish: pH-værdien i Ringers laktat- eller acetatopløsning skal ligge inden for et interval på 5,0-7,5, og de acceptable ion-koncentrationer af kalcium og magnesium er angivet nedenfor (tabel 5).
English: Very common: Astheniaa, fatiguea, infusion site reactiona,d Common:
Danish: Meget almindelig: Astenia, trætheda, reaktioner på infusionsstedeta,d Almindelig:
English: Other medicines and Apealea
Danish: Brug af anden medicin sammen med Apealea
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 × ULN) have an elimination rate in the normal range.
Danish: Et farmakokinetisk populationsstudie med albumin-bundet paclitaxel viste, at patienter med let nedsat leverfunktion (total bilirubin > 1-≤ 1,5 × ULN) havde en eliminationshastighed, der lå inden for normalområdet.
English: Ensure that the solution is clear and place a light-protective bag over the EVA infusion bag.
Danish: Kontroller, at opløsningen er klar og anbring den i en pose, der beskytter mod lys, over EVA-infusionsposen.
English: Hypoaesthesia, dizziness, paraesthesia, peripheral motor neuropathy, dysgeusia, headache
Danish: Hypoæstesi, svimmelhed, paræstesi, perifer motorisk neuropati, dysgeusi, hovedpine
English: Pack size: 1 vial.
Danish: Pakningsstørrelse: 1 hætteglas.
English: The pH of lactated or acetated Ringer's solution must be in the range of 5.0 to 7.5 and acceptable ion concentrations of calcium and magnesium are listed below (Table 1).
Danish: pH-værdien i Ringers laktat- eller acetatopløsning skal ligge inden for et interval på 5,0-7,5, og de acceptable ion-koncentrationer af kalcium og magnesium er angivet nedenfor (tabel 1).
English: Nervous system disorders grade ≥ 2 peripheral sensory neuropathy or grade ≥ 2 motor neuropathy
Danish: Nervesystemet Perifer sensorisk neuropati af grad ≥ 2
English: • taste disturbance
Danish: • smagsforstyrrelser
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis opløsningen kommer i kontakt med slimhinderne, skal slimhinderne skylles grundigt med vand.
English: Musculoskeletal and connective tissue disorders Arthralgia occurred in 19% of patients and myalgia in 10%.
Danish: Knogler, led, muskler og bindevæv Artralgi sås hos 19 % af patienterne og myalgi hos 10 %.
English: • severe lack of oxygen, arising from abnormal breathing
Danish: • svær iltmangel på grund af unormal vejrtrækning
English: • abnormal sensation such as tingling, burning, pricking or numbness of the skin or in the mouth
Danish: • føleforstyrrelser, såsom stikkende fornemmelse, brændende fornemmelse, prikkende fornemmelse eller følelsesløshed i huden eller munden
English: Haematological toxicityb neutrophil count < 1.5 × 109/L or platelet count < 100 × 109/L or febrile neutropenia
Danish: Neutrofiltal < 1,5 × 109/l eller trombocyttal < 100 × 109/l eller febril neutropeni
English: Overall Paclitaxel Carboplatin Overall Paclitaxel Carboplatin
Danish: Paclitaxel Carboplatin Samlet set
English: • coma, feeling very sleepy, drowsy and/or being deeply unresponsive
Danish: • koma, voldsom søvnighed, døsighed og/eller manglende responsivitet
English: For patients with total bilirubin > 5 × ULN or AST > 10 × ULN, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Danish: For patienter med total bilirubin > 5 × ULN eller ASAT > 10 × ULN foreligger der ikke tilstrækkelige data til at kunne fastsætte en anbefalet dosis (se pkt.
English: • indigestion, disorder of bowel function, very hard stools, bloody stool
Danish: • fordøjelsesbesvær, forstyrret tarmfunktion, meget hård afføring, blodig afføring
English: Administration precautions
Danish: Forsigtighedsregler i forbindelse med administration
English: Progression free survival (independent review) Death or progression, n (%)
Danish: Død eller progression, n (%)
English: Cardiotoxicity
Danish: Kardiotoksicitet
English: For patients with moderate to severe impairment (total bilirubin > 1.5 to ≤ 5 × ULN and AST ≤ 10 × ULN), a 20% reduction in dose is recommended.
Danish: For patienter med moderat til svært nedsat leverfunktion (total bilirubin > 1,5 - ≤ 5 × ULN og ASAT ≤ 10 × ULN) anbefales en dosisreduktion på 20 %.
English: Patients who experience neutropenia (neutrophil count < 1.5 × 109/L), febrile neutropenia or thrombocytopenia (platelet count < 100 × 109/L) during treatment should have the next treatment cycle delayed until neutrophil counts recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Danish: Dosisjustering og udskydelse af infusioner under behandlingen Patienter, der oplever neutropeni (neutrofiltal < 1,5 × 109/l), febril neutropeni eller trombocytopeni (trombocyttal < 100 × 109/l) under behandlingen, bør have den næste behandlingsserie udskudt, indtil neutrofiltallet bedres til ≥ 1,5 × 109/l og trombocyttallet til ≥ 100 × 109/l.
English: • lack of white and red blood cells, and blood platelets
Danish: • nedsat antal hvide og røde blodlegemer og blodplader
English: Kaplan-Meier curve of PFS (PP population)
Danish: Figur 1: Kaplan-Meier-kurve for PFS (PP-population)
English: Forest plot for PFS by relapse (PP population)
Danish: Forest-plot for PFS pr. recidiv (PP-population)
English: • skin discolouration, pigmentation disorder
Danish: • misfarvning af huden, pigmentforstyrrelser
English: Dose reduction:
Danish: Dosisreduktion:
English: Compared to patients with normal hepatic function, hepatically impaired patients with total bilirubin > 1.5 × ULN have an increase in mean paclitaxel AUC of approximately 20%.
Danish: Sammenholdt med patienter med normal leverfunktion havde patienter med nedsat leverfunktion (total bilirubin > 1,5 × ULN) en stigning i gennemsnitlig AUC for paclitaxel på ca. 20 %.
English: No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Danish: Hos patienter i alderen 65 år og derover anbefales ikke andre dosisreduktioner end de ovenfor skitserede.
English: Uncommon: Vision blurred, eye irritation, ocular discomfort, lacrimation increased
Danish: Ikke almindelig: Sløret syn, øjenirritation, ubehag i øjnene, øget tåreflåd
English: PFS as the primary endpoint was evaluated by blinded assessment of computerised tomography images using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0.
Danish: Response Evaluation Criteria in Solid Tumours (RECIST) 1.0.
English: What Apealea is and what it is used for What you need to know before you are given Apealea How Apealea is given
Danish: Virkning og anvendelse Det skal du vide, før du får Apealea Sådan får du Apealea
English: • depression, sleeplessness, anxiety
Danish: • depression, søvnløshed, angst
English: Using a sterile syringe, inject 60 mL of solution for reconstitution per vial.
Danish: Med en steril sprøjte sprøjtes 60 ml rekonstitutionsopløsning ned i hvert hætteglas.
English: • gemfibrozil: a medicine to lower blood fats
Danish: • gemfibrozil: et lægemiddel til sænkning af fedtindholdet i blodet
English: • nosebleed, allergic inflammation inside the nose, runny nose
Danish: • næseblod, allergisk betændelse i næsen, løbende næse
English: − muscle weakness, cramps or spasms
Danish: − muskelsvaghed, kramper eller spasmer
English: • brain damage, abnormal fluid accumulation within the brain
Danish: • hjerneskade, unormal væskeophobning i hjernen
English: Uncommon: Disseminated intravascular coagulationa, pancytopenia, haematotoxicity, coagulopathy
Danish: Ikke almindelig: Dissemineret intravaskulær koagulationa, pancytopeni, hæmatotoksicitet, koagulopati
English: • blurred vision, eye discomfort or irritation, watery eyes
Danish: • sløret syn, ubehag eller irritation i øjnene, rindende øjne
English: Antiemetics and antinauseants
Danish: Antiemetika og kvalmestillende midler
English: Back pain, bone pain, musculoskeletal pain, muscular weakness, pain in extremity
Danish: Rygsmerter, knoglesmerter, muskuloskeletale smerter, muskelsvaghed, smerter i ekstremiteterne
English: favours Apealea favours solvent-based paclitaxel
Danish: Andet favoriserer Apealea favoriserer solvensbaseret paclitaxel
English: The hazard ratios for OS in patients with first and second relapse were 0.98 (95% CI: 0.79;1.21) and 1.18 (95% CI: 0.79;1.75), respectively.
Danish: Hazard ratios for OS hos patienter med første og andet recidiv var hhv. 0,98 (95 % KI: 0,79-1,21) og 1,18 (95 % KI: 0,79-1,75).
English: Apealea is used to treat the following cancers in adults, in combination with another medicine called carboplatin:
Danish: Apealea anvendes i kombination med et andet lægemiddel (carboplatin) til behandling af følgende kræftsygdomme hos voksne:
English: Forest plot for OS by relapse (PP population)
Danish: Forest-plot for OS pr. recidiv (PP-population)
English: Febrile neutropeniaa, leukopeniaa, thrombocytopeniaa, granulocytopenia, anaemiaa
Danish: Febril neutropenia, leukopenia, trombocytopenia, granulocytopeni, anæmia
English: Women of childbearing potential/Contraception
Danish: Fertile kvinder/prævention
English: Due to negative pressure in the vial, pressure must be equilibrated by a needle or a spike before and during injection of the solution for reconstitution.
Danish: Da der er undertryk i hætteglasset, skal trykket udlignes med en kanyle eller lignende, inden og imens rekonstitutionsvæsken sprøjtes ned i hætteglasset.
English: In contrast, patients with moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 × ULN) and severe hepatic impairment (total bilirubin > 3 to ≤ 5 × ULN) had a 22% or a 26% reduction in paclitaxel elimination rate, respectively.
Danish: Til gengæld udviste patienter med moderat nedsat leverfunktion (total bilirubin > 1,5-≤ 3 × ULN) og svært nedsat leverfunktion (total bilirubin > 3-≤ 5 × ULN) en eliminationshastighed for paclitaxel, der var reduceret med hhv. 22 % og 26 %.
English: Dyspnoea, nasal congestion
Danish: Dyspnø, tilstoppet næse
English: Uncommon: Status epilepticus, coma, cerebrovascular accident, peripheral sensorimotor neuropathy, lethargy, hypotonia, neurotoxicity, polyneuropathy, polyneuropathy in malignant disease, burning sensation, somnolence, cognitive disorder, facial palsy, encephalopathy, hydrocephalus
Danish: Ikke almindelig: Status epilepticus, koma, cerebrovaskulær hændelse, perifer sensomotorisk neuropati, letargi, hypotoni, neurotoksicitet, polyneuropati, polyneuropati ved malign sygdom, brændende fornemmelse, somnolens, kognitiv forstyrrelse, facialisparese, encefalopati, hydrocephalus
English: After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar).
Danish: Efter rekonstitution indeholder hver ml opløsning 1 mg paclitaxel (micellær).
English: Hypotension, flushing, phlebitis, vein pain, hyperaemia
Danish: Hypotension, flushing, flebitis, venesmerter, hyperæmi
English: In the intention-to-treat (ITT) population (n = 789), the hazard ratios for PFS and OS were 0.85 (95% CI: 0.72;1.00) and 1.02 (95% CI: 0.85;1.22), respectively.
Danish: I intent-totreat-populationen (ITT-populationen) (n = 789) var hazard ratioerne for PFS og OS hhv. 0,85 (95 %KI: 0,72-1,00) og 1,02 (95 %-KI: 0,85-1,22).
English: • cardiac arrest, heart failure
Danish: • hjertestop, hjertesvigt
English: Heart failure has been observed in some patients receiving Apealea.
Danish: Der er set hjertesvigt hos nogle Apealea-behandlede patienter.
English: • blood circulation failure
Danish: • nedsat blodcirkulation
English: • diarrhoea, nausea, vomiting
Danish: • diarré, kvalme, opkastning
English: Uncommon: Azotaemia
Danish: Ikke almindelig: Azotæmi
English: After preparation, each millilitre of solution contains 1 mg of paclitaxel (micellar).
Danish: Efter klargøring indeholder hver milliliter opløsning 1 mg paclitaxel (micellær).
English: To reach room temperature, let the vials stand protected from light for approximately 15 to 20 minutes not above 25 °C.
Danish: Lad hætteglassene stå beskyttet mod lys i ca. 15-20 minutter ved højst 25 °C, til de når stuetemperatur.
English: • have a count of white blood cells called neutrophils below 1.5 × 109/L before start of the therapy
Danish: • hvis dit neutrofil-tal (antallet af en bestemt type hvide blodlegemer) ligger under 1,5 × 109/l inden behandlingsstart
English: • Periodic safety update reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: d Includes the following preferred terms: infusion site pain, infusion site phlebitis, infusion site reaction, infusion site discolouration, infusion site erythema, infusion site extravasation, infusion site inflammation, infusion site oedema, infusion site paraesthesia, infusion site irritation, and infusion site rash.
Danish: d Omfatter følgende foretrukne termer: Smerter på infusionsstedet, flebitis på infusionsstedet, reaktion på infusionsstedet, misfarvning på infusionsstedet, erytem på infusionsstedet, ekstravasation på infusionsstedet, inflammation på infusionsstedet, ødem på infusionsstedet, paræstesi på infusionsstedet, irritation på infusionsstedet og udslæt på infusionsstedet.
English: Uncommon: Metastatic pain
Danish: Ikke almindelig: Metastasesmerter
English: Apealea 60 mg powder for solution for infusion paclitaxel
Danish: Apealea 60 mg pulver til infusionsvæske, opløsning paclitaxel
English: The infusion site reactions observed include pain, phlebitis, discolouration, redness, oedema and rash.
Danish: De observerede reaktioner på infusionsstedet omfatter smerte, flebitis, misfarvning, rødme, ødem og udslæt.
English: Uncommon: Vaginal haemorrhage, pelvic pain, breast pain
Danish: Ikke almindelig: Vaginalblødning, bækkensmerter, brystsmerter
English: In the ITT population, the hazard ratios for PFS in the subgroups of patients with first relapse and second relapse were 0.80 (95% CI: 0.66;0.97) and 1.04 (95% CI: 0.74;1.47), respectively.
Danish: Hos ITT-populationen var hazard ratios for PFS i undergrupperne med patienter med første recidiv og andet receidiv hhv. 0,80 (95 % KI: 0,66-0,97) og 1,04 (95 % KI: 0,74-1,47).
English: a Includes the following preferred terms: infusion site phlebitis, infusion site pain, injection site reaction, injection site inflammation, infusion site erythema, injection site extravasation, infusion site reaction, injection site oedema.
Danish: a Omfatter følgende foretrukne termer: flebitis på infusionsstedet, smerter på infusionsstedet, reaktion på injektionsstedet, inflammation ved injektionsstedet, erytem på infusionsstedet, ekstravasation ved injektionsstedet, reaktion på infusionsstedet, ødem ved injektionsstedet.
English: − sodium hydroxide (for pH adjustment) See section 2 “Apealea contains sodium”.
Danish: − natriumhydroxid (til justering af pH) Se punkt.
English: • mouth and throat pain or discomfort, throat disorder, bleeding gums
Danish: • smerter eller ubehag i munden og svælget, forstyrrelser i svælget, blødende tandkød
English: Each carton contains 1 glass vial with powder equivalent to 60 mg of paclitaxel.
Danish: Hver æske indeholder 1 hætteglas med pulver svarende til 60 mg paclitaxel.
English: The terminal half-life of paclitaxel after Apealea infusion varied about 5-fold between the subjects, 5-23 hours.
Danish: Paclitaxels terminale halveringstid efter infusion af Apealea var 5-23 timer (dvs. største værdi ca. 5 gange så høj som mindste værdi).
English: • joint or muscle pain or discomfort
Danish: • smerter eller ubehag i led eller muskler
English: − bleeding
Danish: − blødning
English: Possible side effects
Danish: Alle andre bivirkninger
English: • lung inflammation, influenza, tonsil inflammation
Danish: • lungebetændelse, influenza, betændelse i mandlerne
English: • clopidogrel: a medicine that reduces the chances of getting blood clots
Danish: • clopidogrel: et lægemiddel til forebyggelse af blodpropper
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET PÅ HÆTTEGLAS
English: − puffing of the face
Danish: − opsvulmet ansigt
English: Excipients: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt, N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt, sodium hydroxide.
Danish: Hjælpestoffer: N-(all-trans-retinoyl)-L-cysteinsyre-methylester-natriumsalt, N-(13-cis-retinoyl)-L-cysteinsyre-methylester-natriumsalt, natriumhydroxid.
English: Infections and infestations Uncommon: Sepsis, abscess, pneumonia, influenza, respiratory tract infection viral, herpes simplex, infusion site cellulitis, tonsillitis, urinary tract infection, skin infection, cystitis
Danish: Ikke almindelig: Sepsis, absces, lungebetændelse, influenza, viral luftvejsinfektion, herpes simplex, cellulitis på infusionsstedet, tonsillitis, urinvejsinfektion, hudinfektion, cystitis
English: Likewise, total plasma clearance varied about 5-fold from 8 to 41 L/hour.
Danish: Tilsvarende lå total plasma-clearance på 8-41 l/t (dvs. største værdi igen ca. 5 gange så høj som mindste værdi).
English: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt Sodium hydroxide (for pH adjustment)
Danish: N-(all-trans-retinoyl)-L-cysteinsyre-methylester-natriumsalt N-(13-cis-retinoyl)-L-cysteinsyre-methylester-natriumsalt Natriumhydroxid (til justering af pH)
English: Almost all patients treated with Apealea had neutropenia of some grade, 79% of the patients had grade 3 or 4.
Danish: Næsten alle de patienter, der blev behandlet med Apealea, oplevede neutropeni af en eller anden grad.
English: Uncommon: Depression, insomnia, anxiety Nervous system disorders Very common: Peripheral sensory neuropathya,b, neuropathy peripherala,b
Danish: Meget almindelig: Perifer sensorisk neuropatia,b, perifer neuropatia,b Almindelig:
English: In comparison to the patients receiving solvent-based paclitaxel, there were more patients in the group receiving paclitaxel micellar who experienced haematological toxicities with grade 3 and 4.
Danish: Der var flere patienter i den gruppe, der fik paclitaxel (micellær), som oplevede hæmatologiske toksiciteter af grad 3 og 4, end i den gruppe, der fik solvensbaseret paclitaxel.
English: Apealea 60 mg powder for solution for infusion.
Danish: Apealea 60 mg pulver til infusionsvæske, opløsning.
English: • dry skin, nail disorder
Danish: • tør hud, negleproblemer
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Hvis du er usikker på, om noget af ovenstående gælder for dig, skal du tale med lægen eller sygeplejersken.
English: • urinary tract infection, inflammation of the bladder
Danish: • urinvejsinfektion, blærebetændelse