natgillin/translations-raw huggingface dataset:
175 mg/ m2 Paxene givet som en 3 timers intravenøs infusion efterfulgt af 75 mg/ m2 cisplatin ever tredje uge eller 135 mg/ m2 Paxene som en 24 timers infusion efterfulgt af 75 mg/ m2 cisplatin hver tredje uge.
Paxene 175 mg/ m2 administered as a 3 hour intravenous infusion, followed by cisplatin 75 mg/ m2 every three weeks or Paxene 135 mg/ m2 as a 24 hour infusion, followed by cisplatin 75 mg/ m2 every three weeks.
Fremskreden ikke- småcellet lungekræft Den anbefalede dosis Paxene er 175 mg/ m2 givet som en 3 timers intravenøs infusion efterfulgt af cisplatin i en dosis på 80 mg/ m2 hver tredje uge.
The recommended dose of Paxene is 175 mg/ m2 administered as a 3 hour intravenous infusion, followed by cisplatin at a dose of 80 mg/ m2 every three weeks.
Justering af dosering under behandlingen
Dosage adjustments during treatment
Metastatisk brystkræft, ovariekræft og ikke- småcelletlungekræft:
Metastatic breast carcinoma, ovarian cancer and non-small cell lung carcinoma:
Behandling med Paxene bør ikke gentages, før antallet af neutrofile granulocytter er mindst 1. 500 celler/ mm3, og antallet af trombocytter er på mindst 100. 000 celler/ mm3.
Courses of Paxene should not be repeated until the neutrophil count is at least 1,500 cells/ mm3 and the platelet count is at least 100,000 cells/ mm3.
Patienter, der oplever alvorlig neutropeni (neutrofile granulocytter < 500 celler/ mm3 i en uge eller mere) eller alvorlig perifer neuropati under behandling med Paxene, bør få reduceret deres dosis med 20% (NSCLC og førstevalgs behandling af ovariekræft) eller 25% (MBC og MOC) ved efterfølgende behandlinger med Paxene.
Patients who experience severe neutropenia (neutrophils < 500 cells/ mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dosage reduced by 20% (NSCLC and first-line treatment of ovarian cancer) or 25% (MBC and MOC) for subsequent courses of Paxene.
Patienter, der oplever mucositis (grad 2 eller værre) under behandling med Paxene, bør have deres dosis nedsat med 25% ved efterfølgende behandlinger med Paxene.
Patients who experience mucositis (Grade 2 or worse) during Paxene therapy should have their dosage reduced by 25% for subsequent courses of Paxene.
AIDS- relateret Kaposis sarkom:
AIDS-related Kaposi’ s sarcoma:
Behandling med Paxene bør ikke gentages, før antallet af neutrofile granulocytter er mindst 1. 000 celler/ mm3, og antallet af trombocytter er på mindst 75. 000 celler/ mm3.
Courses of Paxene should not be repeated until the neutrophil count is at least 1,000 cells/ mm3 and the platelet count is at least 75,000 cells/ mm3.
Patienter, der oplever alvorlig neutropeni (neutrofile granulocytter < 500 celler/ mm3 i en uge eller mere), alvorlig perifer neuropati eller mucositis (grad 3 eller værre) under behandling med Paxene, bør få reduceret dosis med 25% til 75 mg/ m² ved efterfølgende behandlinger med Paxene.
Patients who experience severe neutropenia (neutrophils < 500 cells/ mm3 for a week or longer), severe peripheral neuropathy or mucositis (Grade 3 or worse) during Paxene therapy should have their dosage reduced by 25% to 75 mg/ m2 for subsequent courses of Paxene.
4. 4 og 5. 2).
Adequate data are not available to recommend dosage alterations in patients with mild to moderate hepatic impairment (see 4.4 and 5.2).
5. 2).
Studies in patients with impaired renal function have not been performed and there are insufficient data to permit dosage recommendations (see 5.2).
Sikkerhed og effekt er ikke påvist for børn (under 18 år).
Safety and efficacy in children (under 18 years) has not been established.
Sygdomshistorie med alvorlige overfølsomhedsreaktioner over for paclitaxel eller polyoxyethyleret ricinusolie.
History of severe hypersensitivity reaction to paclitaxel or polyethoxylated castor oil.
4 Neutrofiltælling på < 1. 500 celler/ mm3 ved behandlingsstart (< 1. 000 celler/ mm3 for AIDS- KS).
3 Baseline neutrophil count < 1,500 cells/ mm3 (< 1,000 cells/ mm3 for AIDS-KS).
Paxene indeholder polyetoxyethyleret ricinusolie, som kan provokere en allergisk reaktion.
Paxene contains polyethoxylated castor oil, which can cause an allergic reaction.
4. 2).
Patients must be routinely premedicated with a corticosteroid, an antihistamine, and an H2-receptor antagonist prior to Paxene to prevent severe hypersensitivity reactions (see 4.2).
4. 5).
Paxene should be given before cisplatin when used in combination (see 4.5).
Alvorlige reaktioner såsom hypotension, der kræver behandling, dyspnø, der kræver bronchiedilatorer, angioødemer eller generel urticaria kræver imidlertid øjeblikkelig ophør af behandlingen med paclitaxel og intensiv symptomatisk behandling.
However, severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angio- oedema or generalised urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy.
Patienter med neutrofiltælling på < 1. 500 celler/ mm3 før behandlingen (< 1. 000 celler/ mm3 for AIDS- KS) bør ikke få paclitaxel.
Patients with baseline neutrophil counts < 1,500 cells/ mm3 (< 1,000 cells/ mm3 for AIDS-KS) should not receive paclitaxel.
Patienter bør ikke genbehandles med efterfølgende cyklusser med paclitaxel, før deres neutrofiltælling kommer tilbage på ≥1. 500 celler/ mm3 (≥1. 000 celler/ mm3 for AIDS- KS patienter) og leukocyttal når et niveau på ≥100. 000 celler/ mm3 (≥75. 000 celler for AIDS- KS patienter).
Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophil counts recover to ≥ 1,500 cells/ mm3 (≥ 1,000 cells/ mm3 for AIDS-KS patients) and platelets recover to a level of ≥ 100,000 cells/ mm3 (≥ 75,000 cells/ mm3 for AIDS-KS patients).
4. 2)
Patients with severe neutropenia (< 500 cells/ mm3 for 7 days or more) during a course of paclitaxel or neutropenic sepsis should have their dose of paclitaxel reduced for subsequent courses of Paxene therapy (see 4.2).
Mucositis
Mucositis
4. 2).
However, if treatment is to be continued in the event of moderate or severe reactions, the dose of paclitaxel should be reduced for subsequent courses of Paxene (see 4.2).
Kraftig perifer neuropati forekom hos 3% af patienterne, der blev behandlet med den anbefalede dosis og regime af Paxene.
Severe peripheral neuropathy occurred in 3% of patients treated with the recommended dose and schedule of Paxene.
I behandlingen af NSCLC og førstevalgs behandling af ovariekræft resulterede indgivelsen af paclitaxel som en 3 timers infusion i kombination med cisplatin i en større incidens af kraftig neurotoksicitet end både paclitaxel som enkeltmiddel og cyklofosfamid efterfulgt af cisplatin
In the treatment of NSCLC and the first-line treatment of ovarian cancer, the administration of paclitaxel as a 3 hour infusion in combination with cisplatin resulted in a greater incidence of severe neurotoxicity than both single-agent paclitaxel and cyclophosphamide followed by cisplatin.
5 Hvis alvorlige perifer neuropati skulle opstå, bør en fortsat behandling afvejes overfor risici.
If severe peripheral neuropathy occurs the benefit of continued treatment should be weighed against the risks.
4. 2).
However, if treatment is to be continued, the dose of paclitaxel should be reduced for all subsequent courses of Paxene (see 4.2).
Ledningsforstyrrelser i hjertet og arytmi
4 Cardiac conduction abnormalities and arrhythmias
Desuden observeredes der i undersøgelser af Paxene hos patienter med MBC og MOC takykardi, palpitation og synkobe.
Additionally, in Paxene MBC and MOC studies tachycardia, palpitation and syncopes were observed.
I MBC - og MOC- undersøgelserne oplevede i alt to patienter kongestiv hjerteinsufficiens, grad 4.
In the MBC and MOC studies a total of two patients experienced Grade 4 congestive heart failure.
Et enkelt tilfælde af hjertesvigt i forbindelse med Paxene er observeret i den kliniske AIDS- KS undersøgelse.
A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.
Patienter med nedsat leverfunktion kan eventuelt have øget risiko for toksicitet, især grad 3- 4 myelosuppression.
Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression.
4. 2).
Patients should be closely monitored for the development of profound myelosuppression (see 4.2).
5. 2).
Adequate data are not available to recommend dosage alterations in patients with mild to moderate hepatic impairments (see 5.2).
Gastrointestinal
Gastrointestinal
4. 7).
As Paxene contains ethanol (392 mg/ ml), possible effects on the CNS and other effects should be considered (see 4.7).
Paclitaxel kan, især i kombination med strålebehandling af lungerne og/ eller gemcitabin, uden hensyn til deres kronologiske rækkefølge, medvirke til udvikling af interstitiel pneumonitis.
Paclitaxel, particularly in combination with radiation of the lung and/ or gemcitabine, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
6 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Når paclitaxel gives før cisplatin, er sikkerhedsprofilen for paclitaxel konsistent med den, der er rapporteret for enkeltmiddel brug.
When paclitaxel is given before cisplatin, the safety profile of paclitaxel is consistent with that reported for single-agent use.
Når paclitaxel blev givet efter cisplatin, udviste patienterne en mere udtalt myelosuppression og et cirka 20% fald i paclitaxel clearance.
When paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Paclitaxel bør administreres 24 timer efter doxorubicin, da eliminationen af doxorubicin og dens aktive metabolitter kan være nedsat når paclitaxel og doxorubicin anvendes i kombination.
5 Since elimination of doxorubicin and its active metabolites may be reduced when paclitaxel and doxorubicin are used in combination, paclitaxel should be administered 24 hours after doxorubicin.
Da paclitaxel metaboliseres af cytochrome P450 isoenzymerne CYP 3A4 og 2C8, bør anden medicin, der hæmmer (f. eks. erythromycin, fluoxetin, gemfibrozil, imidazol svampedræbende midler) eller inducerer (f. eks. rifampicin, carbamazepin, phenytoin, fenobarbital, efavirenz, nevirapin) disse enzymer, anvendes med forsigtighed, da de eventuelt kan påvirke paclitaxels farmakokinetik.
Since paclitaxel is metabolised by cytochrome P450 isoenzymes CYP 3A4 and 2C8, caution should be exercised with other drugs known to inhibit (e. g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals) or induce (e. g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) these enzymes as they may affect the pharmacokinetics of paclitaxel.
Samtidig anvendelse af ketoconazole, en kendt, kraftig CYP 3A4- hæmmer, hæmmer ikke elimineringen af paclitaxel hos patienterne; derfor kan begge lægemidler indgives sammen uden justering af doseringen.
Concurrent administration of ketoconazole, a known potent inhibitor of CYP3A4, does not inhibit the elimination of paclitaxel in patients; thus, both medicinal products may be administered together without dosage adjustment.
Der er begrænsede yderligere oplysninger om de potentielle lægemiddelinteraktioner mellem paclitaxel og andre CYP 3A4- substrater / - hæmmere.
Further data on the potential of drug interactions between paclitaxel and other CYP3A4 substrates/ inhibitors are limited.
Undersøgelser af AIDS- KS patienter, der tog Paxene og andre medikamenter samtidigt, viser, at den systemiske clearance af paclitaxel var betydeligt lavere (p < 0, 05) i tilfælde, hvor der blev givet nelfinavir og ritonavir, men ikke i kombination med indinavir.
Studies conducted in AIDS-KS patients who were taking Paxene and multiple concomitant medications suggest that the systemic clearance of paclitaxel was significantly lower (p < 0.05) in the presence of nelfinavir and ritonavir, but not with indinavir.
Paclitaxel i en intravenøs dosis på 0, 6 mg/ kg/ dag havde toksisk effekt på forplantning og fosterudvikling hos rotter.
Paclitaxel at an intravenous dose of 0.6 mg/ kg/ day produced reproductive and foetal developmental toxicity in rats.
Paxene er kontraindiceret under graviditet.
Paxene is contraindicated for use in pregnancy.
4. 4 og 6. 1).
Following an infusion of Paxene, the patients’ performance at skilled tasks (driving, operating machinery, etc.) may be impaired due to the alcohol content of Paxene (see 4.4 and 6.1).
De følgende bivirkninger drejer sig om 166 MBC og 120 MOC patienter, der blev behandlet med 175 mg/ m2 Paxene givet som en 3 timers infusion som andetsvalg kemoterapi i to kliniske undersøhgelser og blev betragtet som muligvis eller sandsynligvis relateret til Paxene.
The following adverse reactions relate to 166 MBC and 120 MOC patients treated with 175 mg/ m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
4. 8.
As the AIDS-KS population is very specific, safety data from a clinical study of 107 AIDS-KS patients are presented separately at the end of Section 4.8.
I hele behandlingsperioden opstod alvorlig neutropeni (< 500 celler/ mm3) hos 26% af patienterne, behandlet
Severe neutropenia (< 500 cells/ mm3) occurred in 26% of patients treated with Paxene during the entire treatment period.
19% af patienterne havde svær neutropeni i > 7 dage.
19% of patients had severe neutropenia for > 7 days.
Trombocytopeni blev observeret hos 6% af patienterne.
Thrombocytopenia was observed in 6% of patients.
To procent af patienterne havde et trombocyttal nadir < 50. 000 celler/ mm3.
Two percent of patients had a platelet count nadir < 50,000 cells/ mm3.
Anæmi (Hb < 11g/ dl) konstateredes hos cirka 9% af de behandlede patienter, men var alvorlig hos mindre end 1% (Hb < 8g/ dl).
Anaemia (Hb < 11 g/ dl) was observed in approximately 9% of treated patients but was severe in less than 1% (Hb < 8 g/ dl).
Neuropati forekom hos 18% af patienterne behandlet med Paxene.
Neuropathy occurred in 18% of patients treated with Paxene.
Paræstesi blev observeret hos 48% af patienterne.
Paraesthesia was observed in 48% of patients.
Alvorlig neuropati og kraftig paræstesi for hos henholdsvis 3% og 5% af patienterne.
Severe neuropathy and severe paraesthesia occurred in 3% and 5% of patients, respectively.
Præ- eksisterende neuropatier resulterende fra tidligere behandlinger er ikke en kontraindikation for behandling med paclitaxel.
Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
De andre mest almindeligt rapporterede sygdomme i nervesystemet er somnolens, som påvirkede 14% af patienterne.
6 The other most commonly reported nervous system disorder is somnolence, which affected 14% of patients.
Artralgi blev rapporteret hos 32% af alle patienter (5% alvorlig) og myalgi hos 47% (6% alvorlig).
Arthralgia was reported in 32% of all patients (5% severe) and myalgia in 47% (6% severe).
Reaktioner på injektionsstedet, herunder sekundære reaktioner på ekstravasation, var generelt milde og bestod af erythema, ømhed, misfarvning af huden eller opsvulmen ved injektionsstedet, men kan medføre cellulitis.
Injection site reactions including reactions secondary to extravasation were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site but can result in cellulitis.
Recidiv af hudreaktioner på et sted med tidligere ekstravasation efter administration af paclitaxel på et andet sted er blevet rapporteret i sjældne tilfælde.
Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel at a different site i. e. “ recall” has been reported rarely.
En specifik behandling af ekstravasation kendes p. t. ikke.
There is no known specific treatment for extravasation reactions.
Tabellen nedenfor angiver bivirkninger forbundet med administrationen af enkeltmiddel paclitaxel som en 3 timers infusion under metastatiske forhold (286 patienter behandlet i kliniske undersøgelser af Paxene, og 812 patienter behandlet i andre paclitaxel kliniske undersøgelser) og dem, der blev rapporteret i den postmarkedsføringsmæssige overvågning af paclitaxel *.
The table below lists undesirable effects associated with the administration of single agent paclitaxel as a 3 hour infusion in the metastatic setting (286 patients treated in Paxene clinical studies and 812 patients treated in other paclitaxel clinical studies), and those reported in the postmarketing surveillance of paclitaxel*.
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100; < 1/ 10), usædvanlig (≥ 1/ 1, 000; < 1/ 100), sjælden (≥ 1/ 10, 000; < 1/ 1, 000) og meget sjælden (< 1/ 10, 000), herunder enkeltstående indberetninger.
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Infektion (inklusive herpes simplex, oral candidiasis, faryngitis, rhinitis
Very common: infection (including herpes simplex, oral candidiasis, pharyngitis, rhinitis)
Almindelig: Infuenza syndrom
Common: flu syndrome
Kraftige infektioner, septisk shock
Uncommon: severe infections, septic shock
Sygdomme i blod - og lymfesystem:
Rare*: pneumonia Blood and lymphatic system disorders:
Alvorlig neutropeni,, alvorlig leukopeni, trombocytopeni, anæmi, myelosuppression
Very common: severe neutropenia, severe leucopenia, thrombocytopenia, anaemia, myelosuppression
Neutropeniske febertilfælde
Common: neutropenic fever
Usædvanlig: alvorlig anæmi
Uncommon: severe anaemia
Akut myeloid leukæmi, myelodysplastisk syndrom
Very rare*: acute myeloid leukaemia, myelodysplastic syndrome Immune system disorders:
Mindre overfølsomhedsreaktioner (hovedsagelig rødmen og udslæt)
Very common: minor hypersensitivity reactions (mainly flushing and rash)
Hypotension, angioneurotisk ødem, respiratorydistress, generel urticaria)
(delayed) hypersensitivity, significant hypersensitivity reactions requiring therapy (e. g., hypotension, angioneurotic oedema, respiratory distress, generalised urticaria)
Anafylaktiske reaktioner
Rare*: anaphylactic reactions
Anafylaktisk shock (inklusive fatal overfølsomhed)
Very rare*: anaphylactic shock (including fatal hypersensitivity) Metabolism and nutrition disorders:
Dehydrering, vægttab og - forøgelse
Very common: anorexia Uncommon: dehydration, weight loss and gain
Tilstand af forvirring
Very rare*: confusional state
Sygdomme i nervesystemet:
7 Nervous system disorders:
Neuropati (hovedsagelig perifer),, paræstesi, somnolens
Very common: neuropathy (mainly peripheral), paraesthesia, somnolence
Alvorlig neuropati (hovedsagelig perifer), svimmelhed, nervøsitet, søvnløshed, depression, abnorm tankegang, hypokinesi, abnorm gangart, hypæstesi, smagsforstyrrelser, hovedpine
Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion, headache
Motorisk neuropati (med resulterende mindre distal svaghed)
Rare*: motor neuropathy (with resultant minor distal weakness)
Akut encefalopati, autonom neuropati (resulterende i paralytisk ileus og ortostatisk hypotension), krampeanfald
Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), seizures
Usædvanlig: øjentørhed, amblyopi, defekt af synsfelt
Uncommon: dry eyes, amblyopia, visual field defect
Optiske nerve og/ eller visuelle forstyrrelser (scintillerende scotomata), især hos patienter, der har fået højere doser end anbefalet
Very rare*: optic nerve and/ or visual disturbances (scintillating scotoma), particularly in patients who have received higher doses than recommended
Almindelig:
Common: tinnitus
Sensorisk- neuralt høretab, vertigo
Very rare*: sensorineural hearing loss, vertigo
Takykardi, palpitation, bradykardi, synkope
Common: tachycardia, palpitation, bradycardia, syncope
Kongestiv hjerteinsufficiens, kardiomyopati, asymptomatisk ventrikulær takykardi, takykardi med bigemini, AV- blok og synkope, myokardieinfarkt
Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction
Atriefibrillering Vaskulære lidelser:
Very rare*: atrial fibrillation Vascular disorders:
Hypotension
Very common: hypotension
Vasodilatation (rødmen)
Common: vasodilatation (flushing)
Tromboflebitis, hypertension, trombose
Uncommon: thrombophlebitis, hypertension, thrombosis
Sygdomme i åndedrætsorganer, brysthule og mediastinum
Very rare*: shock Respiratory, thoracic and mediastinal disorders:
Pleural effusion, lungefibrose
Common: dyspnoea, epistaxis Rare: pleural effusion, lung fibrosis
Hosten, pulmonal hypertension
Very rare*: cough, pulmonary hypertension
Kvalme, opkastning, diarré, inflammation af mukosa, forstoppelse, stomatitis, mavesmerter
Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain
Mundtørhed, mundulceration, melæna, dyspepsi
Common: dry mouth, mouth ulceration, melaena, dyspepsia
Tarmobstruktion, tarmperforation, pseudomembranøs colitis, iskæmisk colitis, mesenterisk trombose, nekrotiserende enterocolitis, øsofagitis, ascites, akut pancreatitis
Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis
Sygdomme i lever og galde:
Hepatobiliary disorders:
Meget sjælden *: levernekrose, leverencefalopati
Very rare*: hepatic necrosis, hepatic encephalopathy
Kortvarige hudforandringer, tør hud, exfoliativ dermatitis, pruritus, udslæt, acne, forbigående og milde negleændringer
Very common: alopecia Common: transient skin change, dry skin, exfoliative dermatitis, pruritis, rash, acne, transient and mild nail changes
Forandringer i neglepigmentering eller misfarvning af neglelejet)
Uncommon: changes in nail pigmentation or discoloration of nail bed
Erytem
Rare*: erythema
Meget sjælden *:
Very rare*:
Steven- Johnson syndrom, epidermal nekrolyse, erythema multiforme, urticarie, onykolyse (patienter i behandling bør bære solbeskyttelse på hænderne og fødderne
Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, urticaria, onycholysis (patients on therapy should wear sun protection on hands and feet)
Sygdomme i bevægeapparatet og Meget almindelig:
Musculoskeletal and connective tissue disorders:
Knoglesmerter, lægkramper, myasteni, rygsmerter
Very common: arthralgia, myalgia Common: bone pain, leg cramps, myasthenia, back pain
Dysuri
Common: dysuria
Almene lidelser og reaktioner på Meget almindelig:
General disorders and administration site conditions:
ødemer og ansigtsødemer
Very common: asthenia, pain, oedema including peripheral and face
Milde reaktioner på injektionsstedet (erythema, ømhed, misfarvning af huden eller opsvulmen, smerter, ekstravasation kan medføre cellulitis og hudulceration), utilpashed, brystsmerter, kulderystelser, pyrexi
Common: mild injection site reactions (erythema, tenderness, skin discoloration or swelling, pain, extravasation, can result in cellulitis and skin ulceration), malaise, chest pain, chills, pyrexia
Kraftig stigning i transaminaser, kraftig stigning
Common: severe elevation in transaminases, severe elevation in alkaline phosphatase
Kraftig stigning i bilirubin
Uncommon: severe elevation in bilirubin
5. 1).
The following discussion refers to two major trials for the first-line chemotherapy of ovarian cancer (paclitaxel + cisplatin: over 1050 patients) and two Phase III trials for the treatment of advanced NSCLC (paclitaxel + cisplatin: over 360 patients) (see section 5.1).