natgillin/translations-raw huggingface dataset:
I generelle toksicitetsforsøg med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen (som gav opkastning og/eller diaré), hæmatopoietiske og lymfatiske væv (som gav perifere blodcytopenier), lymfoid vævsatrofi og hæmatopoietisk knoglemarvs-hypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Ved de efterfølgende doser var de gennemsnitlige maksimale plasmakoncentrationer, der blev observeret, inden for intervallet 67-106 ng/ml for dosis på 1,0 mg/m2 og 89-120 ng/ml for dosis på 1,3 mg/m2.
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to
Erythema multiforme, urticaria, akut febril neutrofil dermatose, toksisk huderuption, toksisk epidermal nekrolyse
Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
De væsentligste effektresultater ses i tabel 12.
Main efficacy results are presented in Table 12.
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Hospira for at kontrollere niveauet af dine blodlegemer.
You will have to take regular blood tests before and during your treatment with Bortezomib Hospira, to check your blood cell counts regularly.
Bortezomib gives intravenøst eller subkutant på dag 1, 4, 8 og 11, efterfulgt af en pause uden behandling.
Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Dosisjusteringer under behandling og reinitiering af behandlingen som monoterapi Behandling med Bortezomib Hospira skal afbrydes ved forekomst af enhver ikke-hæmatologisk toksicitet grad 3 eller enhver hæmatologisk toksicitet grad 4, bortset fra neuropati som beskrevet nedenfor (se også pkt.
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 28dages behandlingscyklus med bortezomib, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du kan tåle thalidomiddosen, øges den til 100 mg på dag 15-28 og kan derefter øges igen til 200 mg dagligt fra og med den anden cyklus.
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Kløe*, dermatitis*, udslæt*
Pruritus*, Dermatitis*, Rash*
Fra forsøget LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), ses forekomsten af perifer neuropati i kombinationsbehandlingerne i tabellen nedenfor:
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Hvis Bortezomib Hospira gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler gennemgås, inden behandling med Bortezomib Hospira initieres.
When Bortezomib Hospira is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib Hospira.
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få bortezomib intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
If you have not been treated before for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få bortezomib intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Hyperbilirubinæmi*, unormale proteinanalyser*, vægttab, vægtstigning
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Det skal du vide, før du begynder at bruge Bortezomib Hospira
What you need to know before you use Bortezomib Hospira
Bortezomib Hospira rekonstitueret opløsning administreres som en intravenøs bolusinjektion af 3-5 sekunders varighed gennem et perifert eller centralt intravenøst kateter efterfulgt af skylning med natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
Bortezomib Hospira reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Bemærk: Bortezomib Hospira er et cytotoksisk middel.
Note: Bortezomib Hospira is a cytotoxic agent.
Når Bortezomib Hospira gives i kombination med andre cytostatika, bør passende dosisreduktion af disse præparater desuden overvejes i tilfælde af toksicitet og i overensstemmelse med anbefalingerne i de respektive produktresuméer.
In addition, when Bortezomib Hospira is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Hos patienter med MCL (forsøg LYM-3002) var der en højere forekomst (56,7% vs. 5,8%) af thrombocytopeni grad ≥ 3 i bortezomib-gruppen (BR-CAP) sammenlignet med non-bortezomibgruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP]).
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
• Rødmen eller smerter på injektionsstedet
• Redness or pain at the injection site
5.3 vedrørende prækliniske kardiovaskulære forsøg af sikkerhedsfarmakologien.
For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Hætteglas på 10 ml (type I-glas) med gummiprop og aluminiumsforsegling, der indeholder 2,5 mg, 3 mg eller 3,5 mg bortezomib.
Type I glass 10 ml vial with a rubber stopper and an aluminium seal containing 2.5 mg, 3 mg or 3.5 mg bortezomib.
Hos patienter med MCL (forsøg LYM-3002) var forekomsten af herpes zoster-infektion 6,7% i BRCAP-gruppen og 1,2% i R-CHOP-gruppen (se pkt.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
I forsøg MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127].
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Kun til s.c. eller i.v.
SC or IV use only.
Bortezomib Hospira er kun beregnet til engangsbrug.
Bortezomib Hospira is for single use only.
Du skal straks kontakte lægen, hvis du på trods af dette alligevel bliver gravid.
If, despite these measures, pregnancy occurs, tell your doctor immediately.
En hazard ratio på mindre end 1 indikerer en fordel for VMP Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2 -mikroglobulin, albumin og region d.
A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors
Perifer neuropati omfatter de foretrukne termer: perifer sensorisk neuropati, perifer neuropati, perifer motorisk neuropati og perifer sensomotorisk neuropati
Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Fertilitet Der er ikke udført fertilitetsforsøg med Bortezomib Hospira (se pkt.
Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3).
• Afmagring eller tab af kropsmasse
• Wasting, or loss of body mass
OR for responsrater baseret på Mantel-Haenszel-estimat af den fælles odds ratio for stratificerede tabeller;
OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
Der er i kliniske forsøg indberettet hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale antidiabetika.
During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Til bekræftelse af PRESdiagnosen anvendes billeddiagnostik af hjernen, fortrinsvis magnetisk resonans (MR).
Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Reaktivering og infektion af hepatitis B-virus (HBV) Mantle-celle-lymfom
Hepatitis B Virus (HBV) reactivation and infection
1.3 Den rekonstituerede opløsning indeholder ingen konserveringsmidler og skal anvendes umiddelbart efter klargøring.
1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
HBV-infektion med fatale udfald forekom hos 0,8% (n=2) af patienterne i non-bortezomib-gruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4% (n=1) af patienterne i gruppen på bortezomib plus rituximab, cyclophosphamid, doxorubicin og prednison (BRCAP).
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
> 1,0 x -1,5 x ULN Vilkårligt
> 1.0 x -1.5 x ULN Any
Patienterne fik administreret intravenøse doser bortezomib på 0,7-1,3 mg/m 2 2 gange ugentligt.
Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of bortezomib twice weekly.
Hver pakning med 2,5 mg, 3 mg eller 3,5 mg Bortezomib Hospira indeholder et 10 ml hætteglas med gummiprop og aluminiumsforsegling.
Each carton of 2.5 mg, 3 mg or 3.5 mg Bortezomib Hospira contains a glass 10 ml vial with a rubber stopper and an aluminium seal.
Bortezomib er en proteasomhæmmer.
Bortezomib is a proteasome inhibitor.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få bortezomib intravenøst eller subkutant samtidig med to andre lægemidler melphalan og prednison.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with two other medicines; melphalan and prednisone.
• Lidelser forbundet med injektionsstedet eller injektionsudstyret
• Injection site or injection device related disorders
Afbryd behandling med Bortezomib Hospira, indtil toksicitetssymptomerne er svundet til grad 2 eller bedre.
Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
PN ≥ grad 2
≥ Grade 2 PN
De mest almindelige bivirkninger, der er indberettet under behandling med bortezomib, er kvalme, diarré, obstipation, opkastning, træthed, pyreksi, thrombocytopeni, anæmi, neutropeni, perifer neuropati (herunder sensorisk neuropati), hovedpine, paræstesi, nedsat appetit, dyspnø, udslæt, herpes zoster og myalgi.
The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Patienterne i BDx-gruppen fik 4 cyklusser af 21-dages varihed, hver bestående af bortezomib (1,3 mg/m administreret intravenøst
Patients in the BDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days
Dosisjustering ved kombinationsbehandling for patienter med progressiv myelomatose Dosisjustering af Bortezomib Hospira ved kombinationsbehandling skal følge de retningslinjer, der er beskrevet under monoterapi ovenfor.
Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib Hospira dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
VDDx=vincristin, doxorubicin, dexamethason; BDx=bortezomib, dexamethason; TDx=thalidomid, dexamethason;
VDDx=vincristine, doxorubicin, dexamethasone; BDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone;
nCR n (%) CR+PR
f n (%) nCR n (%) CR+PR
Der administreres fire behandlingscyklusser med denne kombination.
Four treatment cycles of this combination are administered.
* Gruppering af mere end én ”foretrukken term” iht.
NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
#, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus
#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
• Injicér opløsningen subkutant i en vinkel på 45-90°.
• Inject the solution subcutaneously, under a 45-90°angle.
• Generel følelse af at være syg, smerter, svimmelhed, ørhed, en følelse af afkræftelse eller bevidsthedstab
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Klinisk virkning ved recidiverende eller refraktær myelomatose Sikkerheden og effekten ved bortezomib (som intravenøs injektion) blev undersøgt i 2 forsøg med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-forsøg (APEX), vs. dexamethason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-forsøg med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression.
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
• I tilfælde af lokale reaktioner på injektionsstedet efter subkutan injektion af Bortezomib Hospira anbefales det enten at administrere en mindre koncentreret Bortezomib Hospira-opløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller at skifte til intravenøs administration.
• If local injection site reactions occur following Bortezomib Hospira injection subcutaneously, either a less concentrated Bortezomib Hospira solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Tabel 4: Dosering for kombinationsbehandling med Bortezomib Hospira til patienter med tidligere ubehandlet myelomatose, som er egnede til hæmatopoietisk stamcelletransplantation B+Dx
Table 4: Posology for Bortezomib Hospira combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation B+Dx
Hver pakning med 1 mg Bortezomib Hospira indeholder et 5 ml silikonebehandlet hætteglas med gummiprop og aluminiumsforsegling.
Each carton of 1 mg Bortezomib Hospira contains a glass 5 ml siliconised vial with a rubber stopper and an aluminium seal.
PN ≥ grad 3
≥ Grade 3 PN
• Information om, at eventuelle bivirkninger eller medicineringsfejl i forbindelse med administration af Bortezomib Hospira 1 mg, 2,5 mg, 3 mg og 3,5 mg bør indberettes.
• to report any adverse event, or medication error experienced with the administration of Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
I forsøget LYM-3002 fik 78% af patienterne i BR-CAP-gruppen og 61% af patienterne i RCHOP-gruppen understøttende behandling med kolonistimulerende faktor.
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
B = bortezomib; BDx = bortezomib, dexamethason; VDDx = vincristin, doxorubicin, dexamethason; VGPR = meget godt partielt respons; PR = partielt respons; OR = odds ratio.
B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Intent to Treat (ITT) -population p-værdi fra den stratificerede log-rank-test; analyse ud fra behandling udelukker stratifikation ifølge tidligere behandling; p < 0,0001
Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
DET ER YDERST VIGTIGT, AT DER ANVENDES ASEPTISK TEKNIK UNDER HÅNDTERINGEN AF BORTEZOMIB HOSPIRA, DA DET IKKE INDEHOLDER KONSERVERINGSMIDDEL.
Aseptic technique must be strictly observed throughout the handling of Bortezomib Hospira, since it contains no preservative.
QT-forlængelse)*, unormal INR (international normalised ratio)*, nedsat gastrisk pH, øget thrombocytaggregation, forhøjet troponin I, identifikation og serologisk test af virus*, unormal urinprøve*
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Sjælden Perifer emboli, lymfødem, bleghed, erythromelalgi, vasodilatation, misfarvning af vener, veneinsufficiens
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
(CR+nCR, CR+nCR+VGPR+PR), progressionsfri overlevelse og samlet overlevelse.
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
• Infektion eller inflammation (betændelseslignende tilstand) i mave eller tarme
• Infection or inflammation of the stomach and intestines
Der foreligger ingen forsøg af anvendelse af bortezomib til ældre patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation.
There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Nogle af disse sygdomme indebærer vejrtrækningsbesvær, stakåndethed, stakåndethed uden fysiske udfoldelser, overfladisk eller besværet vejrtrækning eller stop i vejrtrækningen, hvæsende vejrtrækning
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
I et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af ketoconazol, en potent CYP3A4hæmmer, på bortezomibs farmakokinetik (som intravenøs injektion) ses en gennemsnitlig stigning i bortezomibs AUC på 35% (CI90% [1,032 til 1,772]), baseret på data fra 12 patienter.
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Silikonebehandlet hætteglas på 5 ml (type I-glas) med gummiprop og aluminiumsforsegling, der indeholder 1 mg bortezomib.
Type I glass 5 ml siliconised vial with a rubber stopper and an aluminium seal containing 1 mg bortezomib.
Der administreres 4 behandlingscyklusser af denne kombinationsbehandling.
Four treatment cycles of this combination therapy are administered.
Det afhænger af, hvordan du reagerer på behandlingen, om du får bestemte bivirkninger, og hvilke sygdomme, du lider af (f.eks. leverproblemer).
Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati Ikke almindelig Ubalance i det autonome nervesystem
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
• Lavt blodtryk, pludseligt fald i blodtrykket, når du rejser dig.
• Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting
Hvis bortezomib gives alene, vil du få 4 doser bortezomib intravenøst eller subkutant på dag 1, 4, 8 og 11 efterfulgt af en pause på 10 dage uden behandling.
When bortezomib is given alone, you will receive 4 doses of bortezomib intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Effekten af nedsat leverfunktion på bortezomibs farmakokinetik i doseringsintervallet 0,5-1,3 mg/m blev undersøgt i et fase I-forsøg i den første behandlingscyklus hos 61 patienter med primært solide tumorer og nedsat leverfunktion i varierende grad.
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m
9/l, og absolut neutrofiltal skal være ≥ 1,0 x 10
• Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be ≥ 1.0 x 10 9/l
• helvedesild (lokaliseret, for eksempel omkring øjnene eller spredt over hele kroppen)
• Shingles (localized including around the eyes or spread across the body)
Meget almindelig Perifer sensorisk neuropati, dysæstesi*, neuralgi* Almindelig
Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common