natgillin/translations-raw huggingface dataset:
Generelle bivirkninger og reaktioner på injektionsstedet:
General disorders and administration site disorders:
Asteni/ træthed blev rapporteret af 40% af patienterne.
Asthenia/ Fatigue was reported in 40% of the patients.
Tabel 1 angiver bivirkninger forbundet med administration af Abraxane til patienter fra undersøgelser, hvor Abraxane er blevet administreret som et enkeltstof i forskellige doseringer til forskellige indikationer (N = 789).
Table 1 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as a single agent at any dose in any indication (N = 789).
Hyppigheden af bivirkninger angivet i tabel 1 er angivet i henhold til følgende konvention:
5 The frequency of undesirable effects listed in table 1 is defined using the following convention:
Meget almindelig (≥1/ 10); almindelig (≥ 1/ 100, < 1/ 10); usædvanlig (≥1/ 1, 000, < 1/ 100); sjælden (≥1/ 10, 000, < 1/ 1, 000); meget sjælden (< 1/ 10, 000).
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).
De alvorligste bivirkninger skal anføres først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bivirkninger rapporteret med Abraxane i forskellige doser i kliniske forsøg.
Adverse reactions reported with Abraxane at any dose in clinical trials.
Nedsat vægt, forhøjet alanin aminotransferase (ALAT), forhøjet aspartat aminotransferase (ASAT), nedsat hæmatokrit, nedsat antal røde blodlegemer, øget legemstemperatur, forhøjet Undersøgelser: gamma- glutamyltransferase, forhøjet serum alkalisk fosfatase
Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased Investigations: gamma-glutamyltransferase, increased blood alkaline phosphatase
Usædvanlige:
Uncommon:
Blod - og lymfesystem:
Increased blood pressure, increased weight, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium Cardiac disorders:
Takykardi Meget almindelige:
Tachycardia Very Common:
Neutropeni, anæmi, leukopeni, thrombocytopeni, lymfopeni Almindelige:
lymphopenia Common:
Febril neutropeni Meget almindelige:
Febrile neutropenia Very Common:
Perifer neuropati, neuropati, hypaesthesi, paraesthesi.
Peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia.
Perifer sensorisk neuropati, hovedpine, smagsforstyrrelser, svimmelhed, perifer motorisk neuropati, ataxi, sensorisk forstyrrelse, somnolens.
Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence.
Polyneuropati, areflexi, dyskinesi, hyporeflexi, neuralgi, hyposensibilitet, synkope, postural svimmelhed, neuropatiske smerter, tremor Almindelig:
Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor Common:
Øjne:
Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis Eye disorders:
Øjenirritation, øjensmerter, synsforstyrrelser, sløret syn, konjunktivit, kløe i øjet Almindelige:
Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus Ear and labyrinth disorders:
Svimmelhed Øre og labyrint:
Common:
Usædvanlig:
Vertigo Uncommon:
Øresmerter, tinnitus Almindelige:
Ear pain, tinnitus Common:
Dyspnøe, epistaxis, faryngolaryngeale smerter, hoste, rhinit, rhinorrhoea
Dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Luftveje, thorax og mediastinum:
Respiratory, thoracic and mediastinal disorder:
Produktiv hoste, dyspnøe ved anstrengelse, tillukning af bihuler, nedsat respirationslyd, pleural effusion, allergisk rhinit, hæshed, nasal tilstopning, nasal tørhed, astmastisk respiration
Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing
Interstitiel pneumonit
Interstitial pneumonitis Very Common:
6 Tabel 1:
Common:
Bivirkninger rapporteret med Abraxane i forskellige doser i kliniske forsøg.
Abdominal pain, abdominal distension, upper abdominal pain, Gastrointestinal dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia disorders:
Kvalme, diarré, opkastning, forstoppelse, stomatit
Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage Renal and urinary disorders:
Almindelige:
Uncommon:
Mavesmerter, oppustethed, øvre mavesmerter, dyspepsi, Mave- tarmkanalen:
Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
gastro- øsofageal reflux, oral hypaesthesi
Adverse reactions reported with Abraxane at any dose in clinical trials.
Usædvanlige:
Very Common:
Hårtab, udslæt
Alopecia, rash
Negleforandringer, pruritus, tør hud, erythem, misfarvning af negle, hyperpigmentering af hud, onycholyse
Nail disorder, pruritus, dry skin, erythema, nail discolouration, skin hyperpigmentation, onycholysis Skin and subcutaneous tissue disorders:
Ømhed af neglelejet, urticaria, hudsmerter, fotosensibilitet, pigmenteringsforstyrrelser, kløende udslæt, hudlidelse, hyperhidrose, negletab, erythematøst udslæt, generaliseret udslæt, dermatit, nattesved, maculo- papulært udslæt, vitiligo, hypotrichose, ubehag ved neglene, generaliseret pruritus, maculært udslæt, papulært udslæt, hudlæsion, opsvulmet ansigt Meget almindelige:
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 Very Common:
Arthralgi, myalgi.
Arthralgia, myalgia.
Ekstremitetssmerter, knoglesmerter, rygsmerter,
Musculoskeletal and connective tissue disorders:
Knogler, led, muskler og bindevæv:
Metabolism and nutrition disorders:
muskelkramper, smerter i lemmerne Usædvanlige:
Pain in extremity, bone pain, back pain, muscle cramps, limb pain Uncommon:
Anoreksi
Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness Very common:
Almindelige:
Anorexia Common:
Dehydrering, nedsat appetit, hypokalæmi Usædvanlige:
Dehydration, decreased appetite, hypokalaemia Uncommon:
Hypofosfatæmi, væskeretention, hypoalbuminæmi, polydipsi, hyperglycæmi, hypocalcæmi, hypoglycæmi, hyponatræmi Almindelige:
Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia Common:
Infektion, urinvejsinfektion, folliculit, infektion i øvre luftveje, candidiasis, sinusitis
Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
sygdomme:
infestations:
Traumer, forgiftninger og procedurerelaterede komplikationer:
Injury, poisoning and procedural complications:
Oral candidiasis, nasopharyngit, cellulit, herpes simplex, virusinfektion, pneumoni, kateter- relateret infektion, svampeinfektion, herpes zoster, infektion på infusionsstedet Usædvanlige:
Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection Uncommon:
Kontusion Sjældne:
Contusion Rare:
Recall fænomen ved strålingbehandling
Radiation recall phenomenon
uspecificerede tumorer (inkl. cyster og polypper):
malignant and unspecified (including cysts and polyps):
Metastatiske smerter, tumornekrose Almindelige: ” Flushing ”, hedeture, hypertension, lymfeødem
Flushing, hot flushes, hypertension, lymphoedema Uncommon:
Vaskulære sygdomme:
Thrombosis Very Common:
Thrombose
General disorders and administration site conditions:
7 Tabel 1:
Common:
Bivirkninger rapporteret med Abraxane i forskellige doser i kliniske forsøg.
Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Træthed, asteni, pyrexi.
Immune system disorders:
Generelle bivirkninger og reaktioner på infusionsstedet:
Hypersensitivity
Perifert ødem, slimhindeinflammation, smerter, stivhed, ødem, svaghed, nedsat performance status, brystsmerter, influenza- lignende sygdom, generel utilpashed, letargi, hyperpyrexi
Hepatobiliary disorders Reproductive system and breast disorders:
Ubehag i brystet, gangforstyrrelser, hævelser, reaktion på injektionsstedet
Breast pain
Immunsystemet:
7 Table 1:
Psykiske forstyrrelser:
Adverse reactions reported with Abraxane at any dose in clinical trials.
Brystsmerter Almindelige:
Common:
Søvnløshed, depression, angst
Insomnia, depression, anxiety Psychiatric disorders:
Rastløshed 1 Hyppigheden af overfølsomhedsreaktioner er udregnet ud fra ét helt sikkert tilfælde i en population på 789 patienter
Restlessness 1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients
Post- marketing erfaringer
Post-marketing experience
Kranienervepareser, parese af stemmebåndene og sjældne rapporter om kraftige overfølsomhedsreaktioner er blevet rapporteret under postmarketing overvågning af Abraxane.
Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Hos nogle patienter, der tidligere havde været eksponeret for capecitabin, har der været rapporter om palmo- plantar erythrodysaesthesi som en del af den løbende overvågning af Abraxane.
In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
Da disse hændelser er blevet rapporteret frivilligt under klinisk praksis, kan der ikke foretages faktiske estimater af hyppighederne, og et kausalt forhold til hændelserne er ikke blevet fastslået.
Because these events have been reported voluntarily during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.
I tilfælde af en overdosis skal patienten overvåges nøje.
In the event of an overdose, the patient should be closely monitored.
Behandlingen bør rettes mod den udtalte formodede toksicitetsområde, som er knoglemarvssuppression, mucosit og perifer neuropati.
Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Farmakoterapeutisk gruppe:
Pharmacotherapeutic group:
Taxaner, ATC- kode:
Taxanes, ATC Code:
Paclitaxel er et antimikrotubulus stof, der fremmer samlingen af mikrotubulus fra tubulindimerer og stabiliserer mikrotubulus ved at forhindre depolymerisering.
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Denne stabilitet resulterer i hæmningen af den normale dynamiske reorganisering af netværket a mikrotubuli, der er afgørende for nødvendige cellefunktioner i interfase og mitose.
This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Derudover inducerer paclitaxel dannelse af abnorme rækker eller “ bundter ” af mikrotubuli igennem hele cellecyklus og multiple ” stråler ” af mikrotubuli ved centrosomet under mitosen.
In addition, paclitaxel induces abnormal arrays or “ bundles ” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Abraxane indeholder nanopartikler bestående af humant serum- albumin og paclitaxel.
Abraxane contains human serum albumin-paclitaxel nanoparticles.
Albumin vides at formidle endothelial transcytose af plasmabestanddele og in vitro undersøgelser har vist, at tilstedeværelsen af albumin øger transporten af paclitaxel gennem endotheliale celler.
Albumin is known to mediate endothelial transcytosis of plasma constituents and in vitro studies demonstrated that the presence of albumin enhances transport of paclitaxel across endothelial cells.
Der er fremsat hypotese om, at denne øgede transendotheliale transport formidles af gp- 60 albumin receptoren, og at der er akkumulering af paclitaxel i tumorområdet på grund af det albumin- bindende protein SPARC (secerneret surt cysteinrigt protein).
It is hypothesised that this enhanced transendothelial transport is mediated by the gp-60 albumin receptor, and that there is accumulation of paclitaxel in the area of tumour due to the albumin-binding protein SPARC (secreted protein acidic rich in cysteine).
8 Brystkarcinom:
Breast carcinoma:
Data fra 106 patienter, der indgik i to enkelt- armede, ublindede undersøgelser og fra 454 patienter, der blev behandlet i en randomiseret fase III sammenlignende undersøgelse understøtter brugen af Abraxane ved metastatisk brystkræft.
Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Enkelt- armede, ublindede undersøgelser
Single-arm open-label studies
I én undersøgelse blev Abraxane indgivet som en 30- minutters infusion i en dosis på 175 mg/ m2 til 43 patienter med metastaserende brystkræft.
In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/ m2 to 43 patients with metastatic breast cancer.
Den anden undersøgelse anvendte en dosis på 300 mg/ m2 som en 30 minutters infusion hos 63 patienter med metastaserende brystkræft.
The second trial utilised a dose of 300 mg/ m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Patienterne blev behandlet uden præmedicinering med steroider eller planlagt G- CSF støtte.
Patients were treated without steroid pre- treatment or planned G-CSF support.
Behandlingerne blev givet med 3 ugers intervaller.
Cycles were administered at 3 week intervals.
Responsraterne hos alle patienter var henholdsvis 39, 5% (95% CI:
The response rates in all patients were 39.5% (95% CI:
24, 9% - 54, 2%) og 47, 6% (95% Cl:
24.9% - 54.2%) and 47.6%
Den mediane tid til sygdomsprogression var 5, 3 måneder (175 mg/ m2; 95% CI:
The median time to disease progression was 5.3 months (175 mg/ m2; 95% CI:
4, 6 – 6, 2 måneder) og 6, 1 måneder (300 mg/ m2; 95% CI:
4.6 – 6.2 months) and 6.1 months (300 mg/ m2; 95% CI:
4, 2 – 9, 8 måneder).
4.2 – 9.8 months).
Randomiseret, sammenlignende undersøgelse:
Randomised comparative study:
Denne multi- center undersøgelse blev gennemført hos patienter med metastatisk brystkræft, der blev behandlet hver 3. uge med paclitaxel som enkeltstof, enten som opløsningsmiddel- baseret paclitaxel 175 mg/ m2 givet som en 3- timers infusion med præmedicinering for at forhindre overfølsomhedsreaktioner (N = 225), eller som Abraxane 260 mg/ m2 givet som en 30 minutters infusion uden præmedicinering (N = 229).
This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/ m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/ m2 given as a 30 minute infusion without premedication (N = 229).
Fireogtreds procent af patienterne havde nedsat performance status (ECOG 1 eller 2) ved indgang i undersøgelsen; 79% havde viscerale metastaser; og 76% havde > 3 metastaselokalisationer.
Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Fjorten procent af patienterne havde ikke tidligere fået kemoterapi; 27% havde alene fået kemoterapi som adjuverende behandling, 40% alene som behandling for metastaserende sygdom og 19% havde fået både adjuverende behandling og behandling for metastaserende sygdom.
Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Nioghalvtreds procent fik forsøgsmedicinen som anden eller højere linie behandling.
Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Syvoghalvfjerds procent af patienterne havde tidligere været eksponeret for anthracykliner.
Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Den samlede responsrate, tid til sygdomsprogression, progressionsfri overlevelse og samlet overlevelse for patienter der fik > 1. linie behandling er vist nedenfor.
Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Resultater for samlet responsrate, mediantid til sygdomsprogression og progressionsfri og samlet overlevelse, baseret på investigators vurderinger.
Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator
Opløsningsmiddel- baseret paclitaxel (175 mg/ m2)
Solvent-based paclitaxel (175 mg/ m2)
Responsrate [95% CI] (%) > 1. linie behandling
Response rate [95% CI] (%)
* Mediantid til sygdomsprogression [95% CI] (uger) > 1. linie behandling
*Median time to disease progression [95% CI] (weeks)
20, 9 [15, 7, 25, 9] (n = 131)
> 1st-line therapy
16, 1 [15, 0, 19, 3] (n = 135)
20.9 [15.7, 25.9] (n = 131)
Abraxane (260 mg/ m2)
16.1 [15.0, 19.3] (n = 135)
p- værdi
0.011b
overlevelse [95% CI] (uger)
*Median Progression Free Survival [95% CI] (weeks)
> 1. linie behandling
> 1st-line therapy
* Samlet overlevelse [95% CI] (uger)
*Survival [95% CI] (weeks)
* Disse data er baseret på den kliniske undersøgelsesrapport:
* This data is based on Clinical Study Report:
CA012- 0 Appendiks dateret Endelig udgave (23. marts 2005) a Chi2 test b Log- rank test
CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
229 patienter, der blev behandlet med Abraxane i det randomiserede, kontrollerede kliniske forsøg blev evalueret med hensyn til sikkerhed.
9 229 patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
Neurotoksicitet forårsaget af paclitaxel blev evalueret indtil der var opnået en forbedring svarende til én grad hos patienter der oplevede grad 3 perifer neuropati på et hvilket som helst givet tidspunkt under behandlingen.
Neurotoxictiy to paclitaxel was evaluated through improvement by one grade for patients experiencing grade 3 peripheral neuropathy at any time during therapy.
Det spontante forløb for den perifere neuropati, der var forårsaget af den kumulative toksicitet af Abraxane efter mere end 6 behandlinger, indtil neuropatien var tilbage ved udgangsniveauet blev ikke evalueret og forbliver ukendt.
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Farmakokinetikken ved total paclitaxel efter 30 - og 180- minutters infusioner af Abraxane ved doseringsniveauer på 80 til 375 mg/ m2 blev bestemt i kliniske undersøgelser.
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/ m2 were determined in clinical studies.
Lægemiddeleksponeringen (AUC) øgedes lineært fra 2653 til 16736 ng. t/ ml efter dosering fra 80 til 300 mg/ m2.
The drug exposure (AUC) increased linearly from 2653 to 16736 ng. hr/ ml following dosing from 80 to 300 mg/ m2.
Efter intravenøs indgift af Abraxane til patienter med metastatisk brystkræft med den anbefalede kliniske dosis på 260 mg/ m2, gik paclitaxel plasmakoncentrationer nedad på en multifasisk måde.
Following intravenous administration of Abraxane to patients with metastatic breast cancer at the recommended clinical dose of 260 mg/ m2, paclitaxel plasma concentrations declined in a multiphasic manner.
Middel Cmax af paclitaxel, der forekom ved afslutningen af tilførslen, var 18, 7 µg/ ml.
The mean Cmax of paclitaxel, which occurred at the end of the infusion, was 18.7 µg/ ml.
Middel total clearance var 15 l/ t/ m2.
The mean total clearance was 15 l/ hr/ m2.
Den terminale halveringstid var omkring 27 timer.
The terminal half-life was about 27 hours.
Middel fordelingsvolumen var 632 l/ m2; det store fordelingsvolumen indikerer omfattende ekstravaskulær fordeling og/ eller vævsbinding af paclitaxel.
The mean volume of distribution was 632 l/ m2; the large volume of distribution indicates extensive extravascular distribution and/ or tissue binding of paclitaxel.
I en undersøgelse hos patienter med fremskredne, solide svulster, blev de farmakokinetiske karakteristika ved paclitaxel efter Abraxane givet intravenøst som 260 mg/ m2 over 30 minutter sammenlignet med dem efter 175 mg/ m2 af den opløsningsmiddel- baserede paclitaxel indsprøjtning givet over tre timer.
In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following Abraxane administered intravenously at 260 mg/ m2 over 30 minutes were compared with those following 175 mg/ m2 of the solvent-based paclitaxel injection administered over 3 hours.
Clearance af paclitaxel med Abraxane var større (43%) end den efter en opløsningsmiddel- baseret paclitaxel indsprøjtning og fordelingsvolumen var også højere (53%).
The clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Forskelle i Cmax og Cmax korrigeret for dosering reflekterede forskelle i total dosering og tilførselshastighed.
Differences in Cmax and Cmax corrected for dose reflected differences in total dose and rate of infusion.
Proteinbindingen for paclitaxel efter Abraxane indgift er estimeret til omkring 90%.
The protein binding of paclitaxel following Abraxane administration is estimated at about 90%.
Baseret på den offentliggjorte litteratur indikerer in vitro undersøgelser af binding til humane serumproteiner, som anvender paclitaxel ved koncentrationer, der strækker sig fra 0, 03 til 1, 2 µM, at omkring 87%
Based on the published literature, in vitro studies of binding to human serum proteins, using paclitaxel at concentrations ranging from 0.03 to 1.2 µM, indicate that about 87% of paclitaxel is bound; the presence of ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Baseret på den offentliggjorte litteratur viser in vitro undersøgelser med humane levermikrosomer og vævssnit, at paclitaxel primært bliver metaboliseret til 6α- hydroxypaclitaxel og til to mindre metabolitter, 3 ’ - p- hydroxypaclitaxel og 6α- 3 ’ - p- dihydroxypaclitaxel.
Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α -hydroxypaclitaxel; and to two minor metabolites, 3’ -p-hydroxypaclitaxel and 6α -3’ -p-dihydroxypaclitaxel.
Dannelsen af disse hydroxylerede metabolitter katalyseres af CYP2C8, - 3A4, og af henholdsvis både - 2C8 og - 3A4.
The formation of these hydroxylated metabolites is catalysed by CYP2C8, -3A4, and both -2C8 and -3A4 respectively.
Virkningen af renal eller hepatisk fejlfunktion på dispositionen af paclitaxel er ikke blevet formelt undersøgt.
The effect of renal or hepatic dysfunction on the disposition of paclitaxel has not been formally investigated.