natgillin/translations-raw huggingface dataset:
Efter behandling med bexaroten udviste nogle patienter en tidligere ubemærket linseopacitet eller en forandring i allerede tilstedeværende linseopacitet, uafhængigt af behandlingens varighed eller doseringsniveau.
Lens opacities: following bexarotene treatment, some patients were observed to have previously undetected lens opacities or a change in pre-existing lens opacities unrelated to treatment duration or dose level of exposure.
En negativ virkning i form af linseopacitetsdannelse ved langtids bexaroten- behandling er dog ikke udelukket for menneskers vedkommende.
However, an adverse effect of long-term bexarotene treatment on lens opacity formation in humans has not been excluded.
Enhver bexaroten- behandlet patient, som får synsproblemer, bør få foretaget en behørig oftalmologisk undersøgelse.
Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination.
Grundet bexarotens forhold til A- vitamin bør patienter rådes til at begrænse A - vitamintilskud til ≤15. 000 IE/ dag, for at undgå mulige, additive, toksiske virkninger.
Vitamin A supplementation: because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to ≤ 15,000 IU/ day to avoid potential additive toxic effects.
Der bør udvises forsigtighed, når bexaroten anvendes hos patienter, som indtager insulin, insulinsekretionsfremmende stoffer (f. eks. sulfonylurinstoffer) eller insulinfølsomhedsfremmende midler (f. eks. thiazolidinedioner).
Patients with diabetes mellitus: caution should be exercised when administering bexarotene in patients using insulin, agents enhancing insulin secretion (e. g. sulfonylureas), or insulin-sensitisers (e. g. thiazolidinediones).
Anvendelsen af visse retinoider er sat i forbindelse med lysfølsomhed.
Photosensitivity: the use of some retinoids has been associated with photosensitivity.
Patienter bør rådes til at mindske udsættelsen for sollys og til at undgå solarier og højfjeldssole under terapiforløb med bexaroten, idet in vitro- data antyder, at bexaroten muligvis har en lysfølsomhedsfremmende virkning.
Patients should be advised to minimise exposure to sunlight and avoid sun lamps during therapy with bexarotene, as in vitro data indicate that bexarotene may potentially have a photosensitising effect.
Bexaroten kan muligvis inducere metaboliseringsenzymer og derved teoretisk mindske østro- progestative præventionsmidlers virkning.
Oral contraceptives: bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives.
Hvis behandling med bexaroten er beregnet til en kvinde i den fødedygtige alder, er en pålidelig, ikke- hormonal form for prævention således også påkrævet, da bexaroten tilhører en terapeutisk gruppe, hvor risikoen for misdannelser hos mennesker er stor.
Thus, if treatment with bexarotene is intended in a woman of childbearing potential, a reliable, non-hormonal form of contraception is also required, because bexarotene belongs to a therapeutic class for which the human malformative risk is high.
Andre stoffers virkninger på bexaroten:
Effects of other substances on bexarotene: no formal studies to evaluate interactions with bexarotene have been conducted.
Der er ikke foretaget formelle undersøgelser med henblik på at evaluere bexarotens lægemiddelinteraktion.
On the basis of the oxidative metabolism of bexarotene by cytochrome
På baggrund af bexarotens oxidative metabolisme gennem cytokrom P450 3A4 (CYP3A4), kan samtidig indgivelse af andre CYP3A4- substrater så som ketoconazol, itraconazol, proteasehæmmere, clarithromycin og erythromycin teoretisk føre til en forhøjet plasmakoncentration af bexaroten.
4 P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates such as ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin may theoretically lead to an increase in plasma bexarotene concentrations.
Der tilrådes forsigtighed i tilfælde af kombination med CYP3A4- substrater, der har en snæver terapeutisk margen, dvs. immunosuppressive midler (cyclosporin, tacrolimus, sirolimus) samt CYP3A4- metaboliserede cytotoksika, dvs. cyclophosphamid, etoposid, finasterid, ifosfamid, tamoxifen og vincaalkaloider.
Caution is advised in case of combination with CYP3A4 substrates having a narrow therapeutic margin i. e. immunosuppressive agents (cyclosporine, tacrolimus, sirolimus) as well as CYP3A4- metabolised cytotoxics, i. e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca- alcaloids.
En analyse af bexarotens plasmakoncentration hos CTCL- patienter antydede, at samtidig indtagelse af gemfibrozil medførte en væsentlig forhøjelse af bexarotens plasmakoncentration.
A population analysis of plasma bexarotene concentrations in patients with CTCL indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.
Det tyder på, at bexaroten kan inducere CYP3A4.
Effects of bexarotene on other substances: there are indications that bexarotene may induce CYP3A4.
Gentagen indtagelse af bexaroten kan derfor medføre en selvinduktion af dets eget metabolisme, og kan specielt på dosisniveauer på mere end 300 mg/ m2/ dag øge metaboliseringshastigheden og reducere plasmakoncentrationerne af andre stoffer, der metaboliseres ved hjælp af cytokrom P450 3A4, så som tamoxifen.
Therefore, repeated administration of bexarotene may result in an auto-induction of its own metabolism and, particularly at dose levels greater than 300 mg/ m2/ day, may increase the rate of metabolism and reduce plasma concentrations of other substances metabolised by cytochrome P450 3A4, such as tamoxifen.
4. 6).
For example bexarotene may reduce the efficacy of oral contraceptives (see sections 4.4 and 4.6).
Interaktioner ved laboratorieprøver:
Laboratory test interactions:
CA125 assay- værdier hos patienter med ovariecancer kan accentueres gennem bexaroten- terapi.
CA125 assay values in patients with ovarian cancer may be accentuated with bexarotene therapy.
I alle kliniske undersøgelser pålagdes patienterne at indtage Targretin- kapsler med, eller umiddelbart efter, et måltid.
Food interactions: in all clinical trials, patients were instructed to take Targretin capsules with or immediately following a meal.
I en klinisk undersøgelse var bexarotens plasmakoncentrations - AUC - og - Cmax- værdier væsentligt højere efter indtagelsen af et fedtholdigt måltid i sammenligning med indtagelsen af en glukoseopløsning.
In one clinical study, plasma bexarotene AUC and Cmax values were substantially higher following the administration of a fat-containing meal versus those following the administration of a glucose solution.
Da de sikkerheds - og virkningsmæssige oplysninger fra kliniske forsøg er baseret på samtidig indtagelse med fødevarer, anbefales det, at Targretin- kapsler indtages med fødevarer.
Because safety and efficacy data from clinical trials are based upon administration with food, it is recommended that Targretin capsules be administered with food.
Der foreligger ikke tilstrækkelige data om brugen af bexaroten hos gravide kvinder.
Pregnancy: there are no adequate data from the use of bexarotene in pregnant women.
4. 3).
Bexarotene is contraindicated in pregnancy (see section 4.3).
Fødedygtige kvinder skal anvende passende, præventive forholdsregler, mens bexaroten anvendes.
Women of childbearing potential must use adequate birth-control measures when bexarotene is used.
En negativ, følsom, graviditetsprøve (f. eks. serum- beta- humant choriongonadotropin, beta- HCG) bør foretages inden for en uge inden påbegyndelsen af bexaroten- terapi.
A negative, sensitive, pregnancy test (e. g. serum beta-human chorionic gonadotropin, beta-HCG) should be obtained within one week prior to bexarotene therapy.
Når prævention er påkrævet, anbefales det at anvende to
Male patients with sexual partners who are pregnant, possibly pregnant, or may
4. 5).
5 potentially become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.
Det vides ikke, om bexaroten udskilles i modermælk.
Lactation: it is not known whether bexarotene is excreted in human milk.
Bexarotens sikkerhed er undersøgt ved kliniske undersøgelser af 193 CTCL- patienter, som indtog bexaroten i op til 118 uger, og af 420 ikke- CTCL- cancerpatienter i andre undersøgelser.
The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in other studies.
Ved behandling med den anbefalede indledende dosering på 300 mg/ m²/ dag var de hyppigst rapporterede bivirkninger for 109 CTCL- patienters vedkommende: hyperlipidæmi ((hovedsageligt forhøjede triglycerider) 74%), hypothyroidisme (29%), hyperkolesterolæmi (28%), hovedpine (27%), leukopeni (20%), pruritus (20%), asteni (19%), udslæt (16%), eksfoliativ dermatitis (15%) og smerter (12%).
In 109 patients with CTCL treated at the recommended initial dose of 300 mg/ m2/ day, the most commonly reported adverse reactions to Targretin were hyperlipaemia ((primarily elevated triglycerides) 74%), hypothyroidism (29%), hypercholesterolaemia (28%), headache (27%), leucopenia (20%), pruritus (20%), asthenia (19%), rash (16%), exfoliative dermatitis (15%), and pain (12%).
De følgende lægemiddelrelaterede bivirkninger rapporteredes under kliniske undersøgelser af CTCL - patienter (N=109), som behandledes med den anbefalede indledende dosis på 300 mg/ m²/ dag.
The following Targretin-related adverse reactions were reported during clinical studies in patients with CTCL (N=109) treated at the recommended initial dose of 300 mg/ m2/ day.
Bivirkningernes forekomst er klassificeret som meget almindelig (> 1/ 10), almindelig (> 1/ 100, < 1/ 10), ikke almindelig (> 1/ 1. 000, < 1/ 100), sjælden (> 1/ 10. 000, < 1/ 1. 000) og meget sjælden (< 1/ 10. 000).
The frequencies of adverse reactions are classified as very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000), and very rare (< 1/ 10,000).
Blod - og lymfesystem Meget almindelig:
Blood and lymphatic system disorders Very common:
Leukopeni Lymfom- lignende reaktion, lymfadenopati, hypokrom anæmi1, 2, 3 Bloddyskrasi, purpura, koagulationsforstyrrelse, øget koagulationstid2, 3, anæmi1, trombocytopeni3, trombocytæmi, eosinofili1, leukocytose2, lymfocytose
Leucopenia Lymphoma Like Reaction, Lymphadenopathy, Hypochromic Anaemia1,2,3, Blood Dyscrasia, Purpura, Coagulation Disorder, Coagulation Time Increased2,3, Anaemia1, Thrombocytopenia3, Thrombocythemia, Eosinophilia1, Leukocytosis2, Lymphocytosis
Hypothyroidisme Thyroideasygdom Hyperthyroidisme
Hypothyroidism Thyroid Disorder Hyperthyroidism
Hyperlipidæmi, hyperkolesterolæmi Vægtøgning, forhøjet SGOT, forhøjet SGPT, forhøjet laktatdehydrogenase, forhøjet kreatinin, hypoproteinæmi
Hyperlipaemia, Hypercholesterolaemia Weight Gain, SGOT Increased, SGPT Increased, Lactic Dehydrogenase Increased, Creatinine Increased, Hypoproteinaemia,
Arthritis urica, bilirubinæmi1, 3, forhøjet BUN1, reduceret HDL- kolesterol
Gout, Bilirubinemia1,3, BUN Increased1, High Density Lipoprotein Decreased
Svimmelhed, hypæstesi, søvnløshed Ataksi, neuropati, vertigo, hyperæstesi, depression1, 2, 3, agitation
Dizziness, Hypesthesia, Insomnia Ataxia, Neuropathy, Vertigo, Hyperaesthesia, Depression1,2,3, Agitation
6 Øjne Almindelig:
Eye disorders
Tørre øjne, øjenlidelse Specificeret katarakt1, 2, 3, amblyopi3, defekt synsfelt, cornealæsion, abnormt syn1, 2, 3, blefaritis, konjunktivitis3
Dry Eyes, Eye Disorder Cataract Specified1,2,3, Amblyopia3, Visual Field Defect, Corneal Lesion, Abnormal Vision1,2,3, Blepharitis, Conjunctivitis3
Almindelig:
6 Ear and labyrinth disorders Common:
Døvhed Ørelidelse
Deafness Ear disorder
Hjerte Ikke almindelig:
Cardiac disorders
Takykardi
Uncommon:
Vaskulære sygdomme
Tachycardia
Perifert ødem Blødning, hypertension, ødem3, vasodilatation1, 2, 3, åreknuder
Peripheral Oedema Haemorrhage, Hypertension, Oedema3, Vasodilatation1,2,3, Varicose Vein
Almindelig:
Gastrointestinal disorders Common:
Opkastning, diarré1, 3, kvalme3, anoreksi1, abnorme leverfunktionsprøver, cheilitis2, mundtørhed2, 3, obstipation, flatulens
Vomiting, Diarrhoea1,3, Nausea3, Anorexia1, Liver Function Tests Abnormal, Cheilitis2, Dry Mouth2,3, Constipation, Flatulence,
Pankreatitis1, 3, leversvigt, mave- tarm- lidelse1
Skin and subcutaneous
Hud og subkutane væv Meget almindelig:
Very common:
Eksfoliativ dermatitis, pruritus, udslæt Hudsår, alopeci1, hudhypertrofi, hudknude, akne, perspiration, tør hud2, 3, hudlidelse
Exfoliative Dermatitis, Pruritus, Rash Skin Ulcer, Alopecia1, Skin Hypertrophy, Skin Nodule, Acne, Sweating, Dry Skin2,3, Skin Disorder
Serøs drænage1, herpes simplex, pustuløst udslæt, hudmisfarvning3, hårlidelse1, neglelidelse1, 3
Serous Drainage1, Herpes Simplex, Pustular Rash, Skin Discoloration3 Hair Disorder1, Nail Disorder1,3
Knogler, led, muskler og bindevæv Almindelig:
Musculoskeletal and Common:
Knoglesmerter, artralgi, myalgi Myasteni1
connective tissue disorders Bone Pain, Arthralgia, Myalgia Myasthaenia1
Albuminuri1, 3, abnorm nyrefunktion
Albuminuria1,3, Kidney Function Abnormal
Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
General Disorders and administration site conditions Very common:
Neoplasma, feber1, 2, 3, cellulitis, parasitær infektion, slimhindelidelse3, rygsmerter1, 2, 3, unormal laboratorieprøve.
Pain, Headache, Asthaenia Allergic Reaction, Infection, Chills1, Abdominal Pain, Hormone Level Altered1 Neoplasm, Fever1,2,3, Cellulitis, Infection Parasitic, Mucous Membrane Disorder3, Back Pain1,2,3, Lab Test Abnormal
1:
1: adverse reactions noted with increased frequency when bexarotene was administered at a dose > 300mg/ m2/ day.
Bivirkninger konstateret med øget hyppighed, når bexaroten blev indgivet i en dosis på > 300 mg/ m2/ dag 2:
2: adverse reactions noted with increased frequency when bexarotene was administered at a dose of 300 mg/ m2/ day in non-CTCL cancer patients.
Bivirkninger konstateret med øget hyppighed, når bexaroten blev indgivet i en dosis på > 300 mg/ m2/ dag til non- CTCL- cancerpatienter (sammenlignet med indgivelse til CTCL- patienter i en dosis på 300 mg/ m2/ dag).
3: adverse reactions noted with increased frequency when bexarotene was administered at a dose of > 300 mg/ m2/ day (compared to administration to CTCL patients at 300 mg/ m2/ day) in non-CTCL cancer patients.
Yderligere observationer af bivirkninger ved brug ud over den anbefalede dosis og indikation (d. v. s. anvendt til CTCL- patienter med en initialdosis på > 300 mg/ m2/ dag eller ikke- CTCL - cancerindikationer):
Additional adverse reactions observed when used outside of the recommended dose and indication (i. e. used in CTCL at an initial dose > 300mg/ m2/ day or in non-CTCL cancer indications):
Ekkymose, petekkier, abnorme hvide blodlegemer, reduceret tromboplastin, abnorme erytrocytter, dehydrering, forøget gonadotropt luteiniserende hormon, vægttab, forøget alkalisk fosfatase, forøget kreatininfosfokinase, forøget lipase, hyperkalcæmi, migræne, perifer neuritis, paræstesi, hypertoni, konfusion, angst, emotionel labilitet, somnolens, nedsat
Newly observed adverse reactions: ecchymosis, petechia, abnormal white blood cells, thromboplastin decreased, abnormal erythrocytes, dehydration, increased gonadotrophic luteinizing hormone, weight loss, increased alkaline phosphatase, increased creatinine phosphokinase, lipase increased, hypercalcaemia, migraine, peripheral neuritis, paraesthesia, hypertonia, confusion, anxiety, emotional lability, somnolence, decreased libido, nervousness, night blindness, nystagmus, lacrimation disorder, tinnitus, taste perversion, chest pain, arrhythmia, peripheral vascular disorder, generalized oedema, haemoptysis, dyspnoea, increased cough, sinusitis, pharyngitis, dysphagia, mouth ulceration, oral
7 libido, nervøsitet, natteblindhed, nystagmus, lakrimeringsforstyrrelser, tinnitus, smagsforvrængning, thoraxsmerter, arytmi, perifer vaskulær lidelse, universelt ødem, hæmoptyse, dyspnø, øget hosten, sinuitis, pharyngitis, dysfagi, sårdannelse i munden, oral moniliasis, stomatitis, dyspepsi, tørst, abnorm afføring, opstød, vesikobulløst udslæt, makulopapulært udslæt, kramper i benene, hæmaturi, influenzasyndrom, bækkensmerter og kropslugt.
7 moniliasis, stomatitis, dyspepsia, thirst, abnormal stools, eructation, vesicobullous rash, maculopapular rash, leg cramps, haematuria, flu syndrome, pelvic pain, and body odour.
Knoglemarvsdepression, nedsat protrombin, nedsat gonadotropt luteiniserende hormon, forøget amylase, hyponatriæmi, hypokaliæmi, hyperurikæmi, hypokolesterolæmi, hypolipæmi, hypomagnesæmi, unormal gang, stupor, circumoral paræstesi, abnorm tankegang, øjensmerter, hypovolæmi, subduralt hæmatom, kronisk hjerteinsufficiens, palpitation, epistaxis, vaskulær anomali, vaskulær lidelse, bleghed, pneumoni, respiratorisk lidelse, lungelidelse, pleural lidelse, cholecystitis, leverskade, gulsot, kolestatisk gulsot, melæna, opkastning, laryngisme, tenesmus, rhinitis, øget appetit, gingivitis, herpes zoster, psoriasis, furunculose, kontaktdermatitis, seborrhoea, likenoid dermatitis, artritis, ledlidelse, urinretention, problemer med vandladning, polyuri, nykturia, impotens, urinabnormitet, brystforstørrelse, carcinom, lysoverfølsomhedsreaktion, ansigtsødem, utilpashed, virusinfektion, forstørret abdomen.
Single observations of the following were also reported: bone marrow depression, decreased prothrombin, decreased gonadotrophic luteinizing hormone, increased amylase, hyponatraemia, hypokalaemia, hyperuricaemia, hypocholesterolaemia, hypolipaemia, hypomagnesaemia, abnormal gait, stupor, circumoral paraesthesia, abnormal thinking, eye pain, hypovolaemia, subdural haematoma, congestive heart failure, palpitation, epistaxis, vascular anomaly, vascular disorder, pallor, pneumonia, respiratory disorder, lung disorder, pleural disorder, cholecystitis, liver damage, jaundice, cholestatic jaundice, melaena, vomiting, laryngismus, tenesmus, rhinitis, increased appetite, gingivitis, herpes zoster, psoriasis, furunculosis, contact dermatitis, seborrhoea, lichenoid dermatitis, arthritis, joint disorder, urinary retention, impaired urination, polyuria, nocturia, impotence, urine abnormality, breast enlargement, carcinoma, photosensitivity reaction, face oedema, malaise, viral infection, enlarged abdomen.
Det bemærkedes, at flertallet af bivirkningerne forekom hyppigere ved doser på mere end 300 mg/ m²/ dag.
The majority of adverse reactions were noted at a higher incidence at doses greater than 300 mg/ m2/ day.
Denne forekomst var den eneste hos en CTCL- patient.
Of these, liver failure, subsequently determined to be not related to bexarotene, was the only one to occur in a CTCL patient.
Hypothyroidisme indtræder almindeligvis 4- 8 uger efter terapiens påbegyndelse.
Hypothyroidism generally occurs 4-8 weeks after commencement of therapy.
Den svinder, når lægemidlet ikke længere indtages.
It may be asymptomatic and responds to treatment with thyroxine and resolves upon withdrawal of treatment.
Bexaroten har en anderledes bivirkningsprofil end andre orale, ikke- retinoide X- receptor (RXR) - selektive retinoidlægemidler.
Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR) - selective retinoids.
Disse er ofte angivet i forbindelse med retinsyrereceptor (RAR) - bindende stoffer.
Owing to its primarily RXR-binding activity, bexarotene is less likely to cause mucocutaneous, nail, and hair toxicities; arthralgia; and myalgia; which are frequently reported with retinoic acid receptor (RAR) -binding agents.
Der er i kliniske undersøgelser indtaget bexaroten i doser på op til 1000 mg/ m2/ dag uden akut, toksisk virkning.
Doses up to 1000 mg/ m2/ day of bexarotene have been administered in clinical studies with no acute toxic effects.
Enkelte doser på 1500 mg/ kg (9000 mg/ m2) og 720 mg/ kg (14. 400 mg/ m2) tolereredes uden væsentlig toksicitet hos henholdsvis rotter og hunde.
Single doses of 1500 mg/ kg (9000 mg/ m2) and 720 mg/ kg (14,400 mg/ m2) were tolerated without significant toxicity in rats and dogs, respectively.
Farmakoterapeutisk klassifikation: andre antineoplastiske stoffer ATC- kode:
Pharmacotherapeutic Group: other antineoplastic agents, ATC code:
Bexaroten er en syntetisk forbindelse, som udøver sin biologiske virkning gennem selektiv binding og aktivering af de tre RXR’ er: α, βog γ.
Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: α, β, and γ.
Efter aktivering fungerer disse receptorer som transkriptionsfaktorer, som regulerer processer såsom celledifferentiering og - proliferation, apoptose og insulinsensibilisering.
Once activated, these receptors function as transcription factors that regulate processes such as cellular differentiation and proliferation, apoptosis, and insulin sensitisation.
RXR’ ernes mulighed for at danne heterodimer i forbindelse med adskillige receptorer, som er af betydning for cellefunktion og fysiologi, antyder at bexarotens biologiske aktiviteter er mere mangeartede end de forbindelser, som aktiverer RAR’ erne.
The ability of the RXRs to form heterodimers with various receptor partners that are important in cellular function and in physiology indicates that the biological activities of bexarotene are more diverse than those of compounds that activate the RARs.
In vitro hæmmer bexaroten væksten af svulst- cellelinier af hæmatopoietisk og hudkræft- relateret oprindelse.
In vitro, bexarotene inhibits the growth of tumour cell lines of haematopoietic and squamous cell origin.
8 Bexarotens nøjagtige virkningsmekanisme i behandlingen af kutant T- celle- lymfom (CTCL) er dog ukendt.
However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Bexaroten- kapsler evalueredes ved kliniske forsøg omfattende 193 CTCL- patienter, hvoraf 93 havde sygdommen på et fremskredet stadium og var resistente over for tidligere, systemisk behandling.
8 Bexarotene capsules were evaluated in clinical trials of 193 patients with CTCL of whom 93 had advanced stage disease refractory to prior systemic therapy.
Blandt de 61 patienter behandlede med en indledende dosis på 300 mg/ m2/ dag var den overordnede respons rate ifølge lægens globale vurdering 51% (31/ 61) med en klinisk fuldstændig respons rate på 3%.
Among the 61 patients treated at an initial dose of 300 mg/ m2/ day, the overall response rate, according to a global assessment by the physician, was 51% (31/ 61) with a clinical complete response rate of 3%.
Respons blev også fastslået ved sammenlægning af fem kliniske tegn (overfladeareal, erythema, plakforhøjelse, skorpedannelse, og hypo - / hyperpigmentering), der også tog hensyn til alle ekstrakutane CTCL- manifestationer.
Responses were also determined by a composite score of five clinical signs (surface area, erythema, plaque elevation, scaling and hypo/ hyperpigmentation) which also considered all extracutaneous CTCL manifestations.
I følge den sammenlagte vurdering var den overordnede respons rate 31% (19/ 61) med en fuldstændig klinisk respons rate på 7% (4/ 61).
The overall response rate according to this composite assessment was 31% (19/ 61) with a clinical complete response rate of 7% (4/ 61).
Farmakokinetikken var lineær ved doser på op til 650 mg/ m2.
Absorption/ dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/ m2.
Efter gentagen, enkeltstående, daglig indtagelse ved doseringsniveauer på ≥ 230 mg/ m2 var Cmax og AUC for nogle patienters vedkommende lavere end de respektive enkeltdosisværdier.
Following repeat once daily dose administration at dose levels ≥ 230 mg/ m2, Cmax and AUC in some patients were less than respective single dose values.
Ved det anbefalede, indledende, daglige doseringsniveau (300 mg/ m2) var de farmakokinetiske parametre for bexaroten ens for både enkeltstående og gentagen daglig dosering.
At the recommended initial daily-dose level (300 mg/ m2), single-dose and repeated daily-dose bexarotene pharmacokinetic parameters were similar.