FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.
Danish: Den anbefalede dosis ved ikke-småcellet lungekræft er 100 mg/m2 legemsoverflade, givet i løbet af 30 minutter.
English: Very common: Dyspnoea, epistaxis, cough Common: Pneumonitis2, nasal congestion Uncommon: Dry throat, nasal dryness
Danish: Meget almindelig: Dyspnø, epistaxis, hoste Almindelig: Pneumonitis2, nasal tilstopning Ikke almindelig: Tør hals, nasal tørhed
English: Common: Interstitial pneumonitis3, dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Danish: Almindelig: Interstitiel pneumonitis3, dyspnø, epistaxis, faryngolaryngeale smerter, hoste, rinit, rinorré
English: Very common: Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia
Danish: Meget almindelig: Perifer neuropati, neuropati, hypæstesi, paræstesi
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Pazenir administration on Days 1, 8 and 15 of each 28-day cycle.
Danish: Den anbefalede samtidige dosis af gemcitabin er 1.000 mg/m2 administreret intravenøst i løbet af 30 minutter, umiddelbart efter administrationen af Pazenir er gennemført på Dag 1, 8 og 15 i hver 28-dages cyklus.
English: Pazenir contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Danish: Paclitaxel er bundet til det humane protein albumin i form af bittesmå partikler, der kaldes nanopartikler.
English: Uncommon1: Hypersensitivity Rare: Severe hypersensitivity
Danish: Ikke almindelig1: Overfølsomhed Sjælden: Svær overfølsomhed
English: For each subsequent weekly dose of Pazenir, patients must have an ANC ≥500 cells/mm3 and platelets >50,000 cells/mm3 or the dose is to be withheld until counts recover.
Danish: Ved hver efterfølgende ugentlige dosis af Pazenir skal patienterne have ANC ≥ 500 celler/mm3 og trombocytter > 50.000 celler/mm3,
English: Pazenir 5 mg/ml powder for dispersion for infusion.
Danish: Pazenir 5 mg/ml pulver til infusionsvæske, dispersion.
English: Common: Hypotension, hypertension
Danish: Vaskulære sygdomme Almindelig: Hypotension, hypertension
English: ANC count (cells/mm3)
Danish: ANC-tal (celler/mm3)
English: Efficacy variable human serum albuminpaclitaxel nanoparticles (260 mg/m2)
Danish: Nanopartikler bestående af humant serumalbumin-paclitaxel (260 mg/m2)
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be filled into an infusion bag immediately.
Danish: Fra et mikrobiologisk synspunkt skal præparatet fyldes i en infusionspose med det samme, medmindre metoden for åbning, rekonstitution, fortynding udelukker risiciene for mikrobiel kontamination.
English: Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Pazenir.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i en måned efter behandlingen med Pazenir.
English: No patients treated with human serum albumin-paclitaxel nanoparticles and carboplatin experienced Grade 4 peripheral neuropathy.
Danish: Ingen patienter i behandling med nanopartikler bestående af humant serumalbumin-paclitaxel og carboplatin oplevede grad 4 perifer neuropati.
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Danish: Almindelig: Perifer sensorisk neuropati, hovedpine, smagsforstyrrelser, svimmelhed, perifer motorisk neuropati, ataksi, sensorisk forstyrrelse, døsighed
English: Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Danish: Almindelig: Infektion, urinvejsinfektion, follikulit, infektion i øvre luftveje, candidiasis, sinuit
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Danish: ≥ 500 men < 1.000 ELLER ≥ 50.000 men < 75.000
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine
Danish: Tabel 8: Hæmatologiske laboratoriedetekterede anomalier i studiet af adenokarcinom i pancreas Nanopartikler bestående af humant serumalbumin-paclitaxel (125 mg/m2)/gemcitabin
English: Patients who have baseline neutrophil counts <1500 cells/mm
Danish: Patienter med baseline-neutrofiltal under 1.500 celler/mm3.
English: • Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing - this means that they die.
Danish: Det virker ved at forhindre, at kræftcellerne deler sig - dette betyder, at de dør.
English: Lung cancer
Danish: Lungekræft
English: Day 15: If Day 8 doses were withheld:
Danish: Dag 15: Hvis Dag 8 doser blev afbrudt:
English: Gemcitabine dose (mg/m2)
Danish: Gemcitabin dosis (mg/m2)
English: The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Pazenir may result in the formation of proteinaceous strands.
Danish: infusionsposer) til at rekonstituere og administrere Pazenir kan føre til dannelse af proteinholdige tråde.
English: Very common: Neutropenia, anaemia, thrombocytopenia Common: Pancytopenia
Danish: Meget almindelig: Neutropeni, anæmi, trombocytopeni Almindelig: Pancytopeni
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Danish: Almindelig: Akut nyresvigt Ikke almindelig: Hæmolytisk uræmisk syndrom
English: Treatment effects on OS favoured the human serum albumin-paclitaxel nanoparticles/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Danish: Behandlingens virkning på OS favoriserede nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin-armen i flertallet af de præspecificerede undergrupper (herunder køn, KPS, geografisk region, primær lokalitet af pancreascancer, stadie ved diagnosticering, tilstedeværelse af levermetastaser, tilstedeværelse af peritoneal karcinomatose, tidligere Whippleprocedure, tilstedeværelse af galdevejsstent ved baseline, tilstedeværelse af lungemetastaser og antallet af metastasesteder).For patienter ≥ 75 år i nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin- og gemcitabin-armene var hazard ratio (HR) for overlevelse 1,08 (95% CI 0,653; 1,797).
English: Of the 229 patients in the randomized study who received human serum albumin-paclitaxel nanoparticles monotherapy for breast cancer, 13% were at least 65 years of age and < 2% were 75 years and older.
Danish: I et randomiseret studie, hvor 229 patienter fik monoterapi med nanopartikler bestående af humant serumalbumin-paclitaxel for brystkræft, var 13% mindst 65 år, og < 2% var 75 år og ældre.
English: However, chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, and protected from bright light.
Danish: Kemisk og fysisk stabilitet under brug er dog blevet påvist i 24 timer ved 2 °C-8 °C i den originale karton og beskyttet mod stærkt lys.
English: Withhold dose until improves to
Danish: eller dosis skal afbrydes, indtil tallene forbedres.
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Danish: Ud af de 421 patienter med adenokarcinom i pancreas i det randomiserede studie, hvor nanopartikler bestående af humant serumalbumin-paclitaxel blev givet i kombination med gemcitabin, var 41% 65 år og ældre, og 10% var 75 år og ældre.
English: Preparation and administration precautions
Danish: Forholdsregler ved klargøring og administration
English: For combination use of Pazenir and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Pazenir and carboplatin (see section 4.2).
Danish: Hvis der udvikles perifer neuropati af grad 3 eller højere ved kombinationsbehandling med Pazenir og carboplatin, bør behandlingen afbrydes indtil bedring til grad 0 eller 1, og dosis reduceres ved alle efterfølgende behandlingsforløb med Pazenir og carboplatin (se pkt.
English: Pazenir is available in glass vials containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Pazenir fås i hætteglas, der indeholder 100 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Common: Vertigo Uncommon: Ear pain, tinnitus
Danish: Almindelig: Svimmelhed Ikke almindelig: Øresmerter, tinnitus
English: For treatment of advanced pancreatic cancer, Pazenir is given on days 1, 8 and 15 of each 28day treatment cycle with gemcitabine being given immediately after the Pazenir.
Danish: Til behandling af fremskreden kræft i bugspytkirtlen gives Pazenir på dag 1, 8 og 15 i hver 28-dages behandlingscyklus.
English: When Pazenir is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Pazenir is recommended (see section 4.2).
Danish: Når Pazenir anvendes som monoterapi, og hvis der udvikles grad 3 sensorisk neuropati, anbefales det at stoppe behandlingen indtil stigning til grad 1 eller 2, hvorefter dosis reduceres i alle efterfølgende Pazenir-behandlingsserier (se pkt.
English: The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period.
Danish: Den anbefalede dosis for fremskreden kræft i bugspytkirtlen er 125 mg/m2 legemsoverflade, givet i løbet af 30 minutter.
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis
Danish: Meget almindelig: Kvalme, diarré, opkastning, forstoppelse, stomatit
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Danish: Tabel 3: Dosismodifikationer ved andre bivirkninger hos patienter med adenokarcinom i pancreas
English: Very common: Fatigue, asthenia, pyrexia
Danish: Meget almindelig: Træthed, asteni, pyreksi
English: Reconstituted Pazenir dispersion is administered intravenously using an infusion set incorporating a 15 µm filter.
Danish: Administrer den rekonstituerede Pazenir-dispersion intravenøst via et infusionssæt med et indsat 15 µm filter.
English: Common: Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis
Danish: Almindelig: Øget tåreflåd, sløret syn, tørre øjne, keratoconjunctivitis sicca, tab af øjenvipper og -bryn
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Pazenir over a minimum of 1 minute.
Danish: Ved brug af en steril sprøjte injiceres 20 ml natriumchloridinfusionsvæske, opløsning, 9 mg/ml (0,9%) langsomt (i løbet af mindst et minut) ind i et hætteglas med 100 mg Pazenir.
English: Very common: Peripheral neuropathy2 Common: Dysgeusia, headache, dizziness
Danish: Meget almindelig: Perifer neuropati2 Almindelig: Dysgeusi, hovedpine, svimmelhed
English: Uncommon: Metastatic pain, tumour necrosis
Danish: Ikke almindelig: Metastatiske smerter, tumornekrose
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine.
Danish: Tabel 7 angiver bivirkninger vurderet hos patienter med adenokarcinom i pancreas i behandling med nanopartikler beståend af humant serumalbumin-paclitaxel i kombination med gemcitabin.
English: Table 7: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine (N=421)
Danish: Tabel 7: Bivirkninger rapporteret med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin (N = 421)
English: When reconstituted, Pazenir concentrate contains 4.2 mg of sodium per ml.
Danish: Efter rekonstitution indeholder hver ml Pazenir-koncentrat 4,2 mg natrium pr. ml.
English: Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Danish: Ikke almindelig: Polyneuropati, arefleksi, dyskinesi, hyporefleksi, neuralgi, hyposensibilitet, synkope, postural svimmelhed, neuropatiske smerter, tremor
English: Common: Lacrimation increased Uncommon: Cystoid macular oedema
Danish: Almindelig: Øget tåreflåd Ikke almindelig: Cystoidt makulaødem
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gammaglutamyltransferase, increased blood alkaline phosphatase
Danish: Almindelig: Nedsat vægt, forhøjet alaninaminotransferase (ALAT), forhøjet aspartataminotransferase (ASAT), nedsat hæmatokrit, nedsat antal røde blodlegemer, øget legemstemperatur, forhøjet gammaglutamyltransferase, forhøjet serum-alkalisk fosfatase
English: Human serum albumin-paclitaxel nanoparticles (100 mg/m2/week)+ carboplatin (N=521)
Danish: Nanopartikler bestående af humant serumalbuminpaclitaxel (100 mg/m2/uge) + carboplatin (N = 521)
English: Teva Nederland B.V. (additional entity) Swensweg 5
Danish: (ekstra enhed) Swensweg 5
English: Table 9: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with carboplatin (N = 514)
Danish: Tabel 9: Bivirkninger rapporteret med nanopartikler bestående af humant serumalbuminpaclitaxel i kombination med carboplatin (N = 514)
English: Febrile neutropenia occurred in four patients on human serum albuminpaclitaxel nanoparticles.
Danish: Febril neutropeni forekom hos fire patienter, som fik nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Pazenir dose (mg/m2)
Danish: Pazenir dosis (mg/m2)
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Pazenir over a minimum of 1 minute.
Danish: Ved brug af en steril sprøjte injiceres 20 ml natriumchloridinfusionsvæske, opløsning, 9 mg/ml (0,9%) langsomt (i løbet af mindst et minut) ind i et hætteglas med Pazenir.
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Danish: Meget almindelig: Neutropeni, anæmi, leukopeni, trombocytopeni, lymfopeni, knoglemarvssuppression
English: Human serum albumin-paclitaxel nanoparticles induced infertility in male rats (see section 5.3).
Danish: Nanopartikler bestående af humant serumalbumin-paclitaxel, forårsagede infertilitet hos hanrotter (se pkt.
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Danish: Meget almindelig: Vægtreduktion, forhøjet alaninaminotransferase Almindelig: Forhøjet aspartataminotransferase, forhøjet bilirubin i blodet, forhøjet kreatinin i blodet
English: Survival (months)
Danish: 75. percentil for samlet overlevelse (måneder)
English: For storage conditions after reconstitution, see package leaflet.
Danish: Opbevaringsforhold efter rekonstitution, se indlægssedlen.
English: Table 9 lists adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles in combination with carboplatin.
Danish: Tabel 9 angiver bivirkninger forbundet med administration af nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med carboplatin.
English: Table 4: Dose reductions for haematologic toxicities in patients with non-small cell lung cancer Haematologic Toxicity
Danish: Tabel 4: Dosisreduktioner ved hæmatologisk toksicitet hos patienter med ikke-småcellet lungecancer
English: No patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine had Grade 4 peripheral neuropathy.
Danish: Ingen patienter i behandling med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin havde grad 4 perifer neuropati.
English: 2 As reported in the post-marketing surveillance of human serum albumin-paclitaxel nanoparticles 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving human serum albumin-paclitaxel nanoparticlesmonotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Danish: 3 Hyppigheden af pneumonitis er beregnet på grundlag af poolede data hos 1.310 patienter i kliniske studier, der fik monoterapi med nanopartikler bestående af humant serumalbumin-paclitaxel for brystkræft og for andre indikationer, på grundlag af MedDRA, SMQ interstitiel lungesygdom.
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Danish: Almindelig: Rødmen, hedeture, hypertension, lymfødem Ikke almindelig: Hypotension, perifer kuldefornemmelse, ortostatisk hypotension
English: There was a significant difference in overall response rate in the human serum albumin-paclitaxel nanoparticles/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Danish: Der var en signifikant forskel i den samlede responsrate til fordel for nanopartikler bestående af humant serumalbumin-paclitaxel/carboplatin-armen sammenlignet med kontrolarmen hos patienter med ikke-småcellet lungecancer med pladecellehistologi (N = 450, 41% versus 24%, p < 0,001), denne forskel førte imidlertid ikke til en forskel i PFS eller OS. Der var ingen forskel i samlet responsrate mellem de 2 behandlingsarme for patienter med ikke-pladecellehistologi (N = 602, 26% versus 25%, p = 0,808).
English: • Itching, dry skin, nail disorder
Danish: • Kløe, tør hud, neglelidelser
English: However chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Danish: Kemisk og fysisk stabilitet under brug er dog blevet påvist i 24 timer ved en temperatur på 2 °-8 °C, beskyttet mod lys, efterfulgt af 4 timer ved en temperatur på 15 °-25 °C.
English: Very common: Peripheral neuropathy1, dysgeusia, headache, dizziness Uncommon: VIIth nerve paralysis
Danish: Meget almindelig: Perifer neuropati1, dysgeusi, hovedpine, svimmelhed Ikke almindelig: Parese af 7. nerve
English: Keep the container in the outer carton until use in order to protect from light.
Danish: Opbevar beholderen i den ydre karton indtil brug for at beskytte mod lys.
English: Patients received a median treatment duration of 3.9 months in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Danish: 32% af patienterne i nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin-armen, sammenlignet med 15% af patienterne i gemcitabin-armen fik behandling i 6 måneder eller mere.
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin enhances transport of paclitaxel across endothelial cells.
Danish: Under intravenøs administration dissocierer nanopartiklerne hurtigt til opløselige, albuminbundne paclitaxel-komplekser med en størrelse på ca. 10 nm. Albumin vides at formidle caveolae-endoteltranscytose af plasmabestanddele, og in vitro-studier har vist, at tilstedeværelsen af albumin øger transporten af paclitaxel gennem endotelceller.
English: Very common: Fatigue, oedema peripheral, pyrexia, asthenia, chills Common: Infusion site reaction
Danish: Meget almindelig: Træthed, perifer ødem, pyreksi, asteni, kulderystelser Almindelig: Reaktion på infusionsstedet
English: There was a statistically significant improvement in PFS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Danish: Der var en statistisk signifikant forbedring i PFS (med 1,8 måneders forbedring i median PFS) hos patienter, der blev behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin versus gemcitabin alene.
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis den kommer i kontakt med slimhinder, skal der skylles grundigt med vand.
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Danish: Ikke almindelig: Produktiv hoste, dyspnø ved anstrengelse, tillukning af bihuler, nedsat respirationslyd, pleural effusion, allergisk rinit, hæshed, nasal tilstopning, nasal tørhed, astmastisk respiration, lungeemboli, pulmonal tromboembolisme
English: The very common side effects may affect more than 1 in 10 people:
Danish: Følgende meget almindelige bivirkninger kan forekomme hos flere end 1 ud af 10 personer:
English: Return to the Day 1 dose levels and follow with WBC Growth Factors ORTreat with same doses as Day 8
Danish: Vend tilbage til Dag 1 dosisniveau og følg op med vækstfaktorer for WBC ELLER Behandl med den samme dosis som Dag 8
English: Stability of the reconstituted dispersion in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Danish: Stabilitet af den rekonstituerede dispersion i infusionsposen Kemisk og fysisk stabilitet under brug er blevet påvist i 24 timer ved en temperatur på 2 °-8 °C, beskyttet mod lys, efterfulgt af 4 timer ved en temperatur på 15 °-25 °C.
English: Uncommon: Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face
Danish: Ikke almindelig: Ømhed af neglelejet, urticaria, hudsmerter, fotosensibilitet, pigmenteringsforstyrrelser, kløende udslæt, hudlidelse, hyperhidrose, negletab, erytematøst udslæt, generaliseret udslæt, dermatit, nattesved, makulopapuløst udslæt, vitiligo, hypotrikose, ubehag ved neglene, generaliseret pruritus, makuløst udslæt, papulært udslæt, hudlæsion, opsvulmet ansigt
English: The solution should be directed onto the inside wall of the vial.
Danish: Infusionsvæsken bør sprøjtes mod indersiden af hætteglasset.
English: Survival, months (95% CI)
Danish: Median progressionsfri overlevelse, måneder (95% CI)
English: Unopened vials: Keep the container in the outer carton until use in order to protect from light.
Danish: Uåbnede hætteglas: Opbevar beholderen i den ydre karton indtil brug for at beskytte mod lys.
English: • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight, skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face
Danish: • Fingerneglssmerte, fingerneglsubehag, tab af fingernegle, udslæt, hudsmerte, rød hud fra sollys,