FrancophonIA/ELRC3.0 huggingface dataset:
English: Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Danish: Pazenir-monoterapi er indiceret til behandling af metastaserende brystkræft hos voksne patienter ved progression efter førstelinjebehandling, hvor standardbehandling med antracyklinholdigt regime ikke er indiceret (se pkt.
English: Other medicines and Pazenir
Danish: Brug af anden medicin sammen med Pazenir
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of human serum albumin-paclitaxel nanoparticles after > 6 courses of treatment was not evaluated and remains unknown.
Danish: Det naturlige forløb af perifer neuropati, forårsaget af kumulativ toksicitet af nanopartikler bestående af humant serumalbumin-paclitaxel efter mere end 6 behandlinger, indtil neuropatien vendte tilbage til baseline, blev ikke evalueret og forbliver ukendt.
English: • medicine used for heartburn or stomach ulcers (e.g. cimetidine)
Danish: • medicin, der anvendes mod halsbrand eller mavesår (f.eks. cimetidin)
English: Adverse reactions were assessed in 421 patients treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas in a phase III randomized, controlled, open-label trial.
Danish: Der blev vurderet bivirkninger hos 421 patienter, behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin, og hos 402 patienter behandlet med gemcitabin-monoterapi, der fik systemisk førstelinjebehandling mod metastatisk adenokarcinom i pancreas i et randomiseret, kontrolleret, åbent fase III-studie.
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Danish: Metabolismen af paclitaxel katalyseres delvist af CYP-isoenzymerne CYP2C8 og CYP3A4 (se pkt.
English: There were no clinically relevant pharmacokinetic interactions between human serum albumin-paclitaxel nanoparticlesand carboplatin.
Danish: Der var ingen klinisk relevante farmakokinetiske interaktioner mellem nanopartikler bestående af humant serumalbumin-paclitaxel og carboplatin.
English: This includes medicines obtained without a prescription, including herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer
Danish: Tabel 5: Dosisreduktioner ved ikke-hæmatologiske toksiciteter hos patienter med ikke-småcellet lungecancer
English: Package leaflet: Information for the user Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Danish: Indlægsseddel: Information til brugeren Pazenir 5 mg/ml pulver til infusionsvæske, dispersion paclitaxel
English: Pazenir should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Danish: Pazenir bør gives under overvågning af en kvalificeret onkolog på afdelinger, der er specialiseret i administration af cytotoksiske midler.
English: Very common: Neutropenia1, thrombocytopenia1, anaemia1, leukopenia1 Common: Febrile neutropenia, lymphopenia Uncommon: Pancytopenia
Danish: Meget almindelig: Neutropeni1, trombocytopeni1, anæmi1, leukopeni1 Almindelig: Febril neutropeni, lymfopeni Ikke almindelig: Pancytopeni
English: • Pain in back, bone pain
Danish: • Smerter i ryggen, knoglesmerter
English: CI = confidence interval; HRA/T = hazard ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solventbased paclitaxel/carboplatin; pA/pT = response rate ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solvent-based paclitaxel/carboplatin.
Danish: CI = konfidensinterval, HRA/T = Hazard ratio af nanopartikler bestående af humant serumalbumin-paclitaxel/carboplatin til solvensbaseret paclitaxel/carboplatin, pA/pT = responsrate for nanopartikler bestående af humant serumalbumin-paclitaxel/carboplatin i forhold til solvensbaseret paclitaxel/carboplatin.
English: • Gas, stomach cramps, painful or sore gums, rectal bleeding
Danish: • Luft i maven, mavekramper, smertefulde eller ømme gummer, rektal blødning
English: The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 human serum albumin-paclitaxel nanoparticlesonce every three weeks in the pivotal phase III clinical study.
Danish: Følgende bivirkninger er de hyppigste og klinisk mest relevante bivirkninger relateret til 229 patienter med metastatisk brystkræft, som blev behandlet med 260 mg/m2 nanopartikler bestående af humant serumalbumin-paclitaxel én gang hver 3. uge i det pivotale kliniske fase III-studie.
English: The European Medicines Agency has waived the obligation to submit the results of studies with human serum albumin-paclitaxel nanoparticles in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med nanopartikler bestående af humant serumalbumin-paclitaxel i alle undergrupper af den pædiatriske population ved behandling af metastaserende brystkræft, adenokarcinom i pancreas og ikke-småcellet lungecancer (se pkt.
English: Dose of carboplatin (AUC mg•min/mL)1
Danish: Carboplatin-dosis (AUC mg•min/ml)1
English: First
Danish: Første
English: Central nervous system metastases
Danish: Metastaser i centralnervesystemet
English: Very common: Insomnia, depression Common: Anxiety
Danish: Meget almindelig: Søvnløshed, depression Almindelig: Angst
English: Non-small cell lung cancer (human serum albumin-paclitaxel nanoparticles administered in combination with carboplatin)
Danish: Ikke-småcellet lungecancer (nanopartikler bestående af humant serumalbumin-paclitaxel administreret i kombination med carboplatin)
English: There are insufficient data available to recommend dose modifications of Pazenir in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 ml/min) (see section 5.2).
Danish: Data er utilstrækkelige til at anbefale justering af Pazenir-dosis til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (estimeret kreatininclearance < 30 ml/min) (se pkt.
English: The protein binding of paclitaxel following human serum albumin-paclitaxel nanoparticles was evaluated by ultrafiltration in a within-patient comparison study.
Danish: Paclitaxels proteinbinding efter administration af nanopartikler bestående af humant serumalbumin-paclitaxel blev vurderet ved ultrafiltrering i et intraindividuelt sammenligningsstudie.
English: Pancreatic adenocarcinoma
Danish: Adenokarcinom i pancreas
English: • Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis
Danish: • Svage eller manglende reflekser, ufrivillige bevægelser, smerter langs en nerve, besvimelse,
English: Stability of the reconstituted dispersion in the vial
Danish: Stabilitet af den rekonstituerede dispersion i hætteglasset
English: Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G(95% Cl)a
Danish: Antal dødsfald (%) Median samlet overlevelse, måneder (95% CI) HRA+G/G(95% Cl)a P-værdib
English: Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Danish: Antal dødsfald, n (%) Median OS (95% CI) (måneder) HRA/T (95,1% CI)
English: The reconstituted dispersion in the intravenous drip may be stored for up to 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Danish: Den rekonstituerede dispersion i det intravenøse drop kan opbevares i op til 24 timer ved en temperatur på 2 °-8 °C, beskyttet mod lys, efterfulgt af 4 timer ved en temperatur på 15 °-25 °C.
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood
Danish: • Nedsat fosfor i blodet, væskeansamling, lavt albumin i blodet, øget tørst, nedsat kalcium i blodet, nedsat blodsukker, nedsat natrium i blodet
English: • Pain in the breast
Danish: • Smerte i brystet
English: A pharmacokinetic study was conducted with human serum albumin-paclitaxel nanoparticles and carboplatin in non-small cell lung cancer patients.
Danish: Der blev udført et farmakokinetisk studie med nanopartikler bestående af humant serumalbumin-paclitaxel og carboplatin hos patienter med ikke-småcellet lungecancer.
English: After reconstitution, each ml of dispersion contains 5 mg of paclitaxel.
Danish: Efter rekonstituering indeholder hver ml dispersion 5 mg paclitaxel.
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Danish: For patienter med metastatisk brystkræft og for patienter med ikke-småcellet lungecancer med moderat til svært nedsat leverfunktion (total bilirubin > 1,5 til ≤ 5 x øvre normalværdi og ASAT ≤ 10 x øvre normalværdi) anbefales 20% dosisreduktion.
English: Bone marrow suppression (primarily neutropenia) occurs frequently with human serum albuminpaclitaxel nanoparticles.
Danish: Knoglemarvssuppression (primært neutropeni) forekommer hyppigt ved behandling med nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Gemcitabine
Danish: Gemcitabin
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
Danish: • medicin, der anvendes mod hiv og aids (f.eks. ritonavir, sequinavir, indinavir, nelfinavir,
English: Breast cancer (human serum albumin-paclitaxel nanoparticles administered as monotherapy)
Danish: Brystkræft (nanopartikler bestående af humant serumalbumin-paclitaxel administreret som monoterapi)
English: Patients 75 years and older
Danish: Hos meget ældre patienter (≥ 75 år),
English: Pazenir should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Danish: Pazenir bør kun anvendes under supervision af en erfaren onkolog på afdelinger specialiseret i anvendelse af cytotoksiske lægemidler.
English: How to use Pazenir
Danish: Sådan skal du bruge Pazenir
English: Solvent-based paclitaxel (200 mg/m2 every 3 weeks) + carboplatin (N=531)
Danish: Solvensbaseret paclitaxel (200 mg/m2 hver 3. uge) + carboplatin (N = 531)
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Danish: Hjælpestoffer: Humant albumin (indeholdende natrium, natriumcaprylat og D/L-N-acetyl-tryptophan).
English: Alopecia was observed in >80% of the patients treated with human serum albumin-paclitaxel nanoparticles.
Danish: Alopeci blev observeret hos mere end 80% af patienterne, som blev behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Danish: Sepsis blev rapporteret med en hyppighed på 5% hos patienter med eller uden neutropeni, som fik nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin i løbet af et studie hos patienter med adenokarcinom i pancreas.
English: Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population) Human serum albumin-paclitaxel nanoparticles (125 mg/m2)/gemcitabine (N=431)
Danish: Tabel 11: Virkningsresultater fra randomiseret studie hos patienter med adenokarcinom i pancreas (intent-to-treat-population) Nanopartikler bestående af humant serumalbumin-paclitaxel (125 mg/m2)/gemcitabin (N=431)
English: Uncommon: Drug hypersensitivity, hypersensitivity
Danish: Ikke almindelig: Lægemiddeloverfølsomhed, overfølsomhed
English: On Days 8 or 15 of the 21-day cycle reduce the dose of Pazenir; reduce the dose of carboplatin in the subsequent cycle.
Danish: På Dag 8 eller 15 i 21-dages cyklussen reduceres dosis af Pazenir.
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression.
Danish: Patienter med nedsat leverfunktion har muligvis en øget risiko for toksicitet, især i form af myelosuppression.
English: In the very elderly (≥75 years) who received Pazenir and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Danish: som fik Pazenir og gemcitabin, var der en højere forekomst af alvorlige bivirkninger og bivirkninger, der førte til seponering af behandlingen, herunder hæmatologiske toksiciteter, perifer neuropati, nedsat appetit og dehydrering.
English: Table 6 lists adverse reactions associated with the administration of human serum albumin-paclitaxel nanoparticles to patients from studies in which human serum albumin-paclitaxel nanoparticles has been administered as monotherapy at any dose in any indication (N = 789).
Danish: Tabel 6 angiver bivirkninger forbundet med administration af nanopartikler bestående af humant serumalbumin-paclitaxel til patienter fra studier, hvor nanopartikler bestående af humant serumalbumin-paclitaxel er blevet administreret som monoterapi i forskellige doseringer til forskellige indikationer (N = 789).
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Danish: Almindelig: Takykardi, arytmi, supraventrikulær takykardi Sjælden: Bradykardi, hjertestop, nedsat venstre ventrikelfunktion, kongestiv hjerteinsufficiens, atrioventrikulært blok2
English: p-value
Danish: P-værdia
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Danish: Ud af de 514 patienter med ikke-småcellet lungecancer i det randomiserede studie, som fik nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med carboplatin, var 31% 65 år eller ældre, og 3,5% var 75 år eller ældre.
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Danish: Ikke almindelig: Oral candidiasis, nasofaryngit, cellulit, herpes simplex, virusinfektion, pneumoni, kateterrelateret infektion, svampeinfektion, herpes zoster, infektion på infusionsstedet, sepsis2, neutropenisk sepsis2
English: • Reduction in the number of platelets in the blood
Danish: • Nedsat antal blodplader i blodet
English: Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine or with gemcitabine.
Danish: Tabel 8 angiver hyppigheder og sværhedsgrader af hæmatologiske, laboratoriedetekterede anomalier hos patienter i behandling med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin eller med gemcitabin.
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal præparatet anvendes med det samme, medmindre metoden for åbning, rekonstitution, fortynding udelukker risiciene for mikrobiel kontamination.
English: • Reduction in all blood cell counts
Danish: • Nedsat antal af alle blodlegemer
English: Discontinue Treatment
Danish: Seponer behandlingen
English: • Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased phosphorus in the blood
Danish: • Øget vægt, øget mælkesyredehydrogenase i blodet, nedsat nyrefunktion, øget blodsukker, øget fosfor i blodet
English: Pneumonitis has been reported at a rate of 4% with the use of human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine.
Danish: Pneumonitis er blevet rapporteret med en hyppighed på 4% under anvendelse af nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin.
English: What Pazenir is and what it is used for What you need to know before you are given Pazenir How to use Pazenir
Danish: Virkning og anvendelse Det skal du vide, før du begynder at få Pazenir Sådan skal du bruge Pazenir Bivirkninger
English: Pazenir is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Danish: Pazenir anbefales ikke hos patienter, der har total bilirubin > 5 x øvre normalværdi eller ASAT > 10 x øvre normalværdi.
English: human serum albuminpaclitaxel nanoparticles were administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Danish: Nanopartikler bestående af humant serumalbumin-paclitaxel blev administreret til patienter (N = 431) som intravenøs infusion i løbet af 30-40 minutter ved en dosis på 125 mg/m2, efterfulgt af gemcitabin som intravenøs infusion i løbet af 30-40 minutter ved en dosis på 1.000 mg/m2, givet på Dag 1, 8 og 15 i hver 28-dages cyklus.
English: ANC <1500/mm3)
Danish: (nadir-ANC < 1.500/mm3)
English: 50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Danish: Hætteglas 50 ml (type 1-glas) med prop (butylgummi) og hætte (aluminium) indeholdende 100 mg paclitaxel formuleret som albuminbundne nanopartikler.
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of human serum albumin-paclitaxel nanoparticles.
Danish: Kranienervepareser, parese af stemmebåndene og sjældne tilfælde af kraftige overfølsomhedsreaktioner er blevet rapporteret under postmarketing-overvågning af nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Arthralgia occurred in 32% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 6% of cases.
Danish: Artralgi forekom hos 32% af patienterne, der fik nanopartikler bestående af humant serumalbuminpaclitaxel, og var svær i 6% af tilfældene.
English: Table 12: Overall response rate in randomized non-small cell lung cancer trial (intentto-treat population)
Danish: Tabel 12: Samlet responsrate i et randomiseret studie af ikke-småcellet lungecancer (intent-totreat-population)
English: Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver ml koncentrat indeholder 0,183 mmol natrium, hvilket svarer til 4,2 mg natrium.
English: For patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Danish: Hos patienter i behandling med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin var mediantiden til første forekomst af grad 3 perifer neuropati 140 dage.
English: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Danish: Dag 15 ≥ 500 men < 1.000 ELLER ≥ 50.000 men < 75.000
English: If you are a woman of childbearing age, you should use effective contraception during and up to 1 month after receiving treatment with Pazenir.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under og i op til en måned efter at have fået behandling med Pazenir.
English: For febrile neutropenia, withhold Pazenir and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Danish: Ved febril neutropeni skal Pazenir og gemcitabin afbrydes, indtil feberen går væk, og ANC ≥ 1.500 celler/mm3, hvorefter behandlingen genoptages med reducerede dosisniveauer (se pkt.
English: • Nausea, diarrhoea, constipation, sore mouth, loss of appetite
Danish: • Kvalme, diarré, forstoppelse, ømhed i munden, appetitløshed
English: If Pazenir contacts mucous membranes, the membranes should be flushed thoroughly with water.
Danish: Hvis Pazenir kommer i kontakt med slimhinder, skal der skylles grundigt med vand.
English: In addition, Pazenir is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x
Danish: Desuden anbefales Pazenir ikke hos patienter med metastatisk adenokarcinom i pancreas, der har moderat til svært nedsat leverfunktion (totalbilirubin > 1,5 x øvre normalværdi og ASAT ≤ 10 x øvre normalværdi (se pkt.
English: Myalgia occurred in 24% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 7% of cases.
Danish: Myalgi forekom hos 24% af patienterne, som fik nanopartikler bestående af humant serumalbumin-paclitaxel, og var svær i 7% af tilfældene.
English: Breast-feeding must be discontinued for the duration of therapy.
Danish: Amning skal ophøre under hele behandlingen.
English: Common: Insomnia, depression, anxiety Uncommon: Restlessness
Danish: Almindelig: Søvnløshed, depression, angst Ikke almindelig: Rastløshed
English: No toxicities occurred notably more frequently among patients at least 65 years of age who received human serum albumin-paclitaxel nanoparticles.
Danish: Der var ingen bivirkninger, der forekom med markant højere frekvens hos patienter på 65 år eller derover, der fik nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Danish: Pazenir 5 mg/ml pulver til infusionsvæske, dispersion paclitaxel
English: • Painful urination, frequent urination, blood in the urine, inability to hold your urine
Danish: • Smertefuld vandladning, hyppig vandladning, blod i urinen, blæresvækkelse
English: For Grade 3 sensory neuropathy, withhold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses.
Danish: Ved grad 3 sensorisk neuropati holdes pause i behandlingen, indtil neuropatien er faldet til grad 1 eller 2, hvorefter dosis reduceres i alle efterfølgende behandlinger.
English: • if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3
Danish: • hvis du har et nedsat antal hvide blodlegemer (neutrofiltal ved baseline < 1.500 celler/mm3 - din læge kan fortælle dig om dette).
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with human serum albumin-paclitaxel nanoparticles.
Danish: Der har været sjældne rapporter om nedsat synsskarphed på grund af cystoidt makulaødem under behandling med nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Patients should not be retreated with subsequent cycles of Pazenir until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section 4.2).
Danish: Patienter bør ikke genoptage behandlingen med efterfølgende serier af Pazenir, før neutrofiltallet atter er > 1.500 celler/mm3 og trombocyttallet atter er > 100.000 celler/mm3 (se pkt.
English: • Chest or throat pain
Danish: • Bryst- eller halssmerter