FrancophonIA/ELRC3.0 huggingface dataset:
English: You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Danish: Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med VELCADE for at kontrollere niveauet af dine blodlegemer.
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Danish: Den gennemsnitlige distributionsvolumen (Vd) for bortezomib var 1.659-3.294 l efter indgift af enkeltdoser eller gentagne intravenøse doser på 1,0 mg/m2 eller 1,3 mg/m2 til patienter med myelomatose.
English: Platelets were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Danish: Trombocyttallet var lavest på dag 11 i hver cyklus af VELCADE-behandlingen og var typisk vendt tilbage til baselineniveau ved den næste cyklus.
English: During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Danish: Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika.
English: • Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
Danish: • Følsomhed, følelsesløshed, prikken eller en brændende følelse i huden eller smerter i hænder eller fødder pga. nerveskade
English: • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Danish: • Skyl det intravenøse kateter igennem med steril 9 mg/ml (0,9 %) natriumchloridinjektionsvæske.
English: • Sudden fall of blood pressure upon standing which may lead to fainting
Danish: • Pludseligt fald i blodtrykket, når du rejser dig op, hvilket kan medføre, at du besvimer
English: In study LYM-3002 in which VELCADE 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:
Danish: For studiet LYM-3002, hvor VELCADE blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), præsenteres forekomsten af perifer neuropati i kombinationregimerne i tabellen nedenfor:
English: • Redness and pain at injection site
Danish: • Rødme og smerter på injektionsstedet
English: In trials in which VELCADE was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Danish: Fra studier, hvor VELCADE blev administreret som induktionsbehandling i kombination med dexamethason (studie IFM-2005-01) og dexamethason-thalidomid (studie MMY-3010), præsenteres forekomsten af perifer neuropati ved kombinationsbehandlingerne i nedenstående tabel:
English: You will receive 4 cycles (12 weeks).
Danish: Du vil få 4 cyklusser (12 ugers behandling).
English: Once the symptoms of the toxicity have resolved, VELCADE treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
Danish: Når toksicitetssymptomerne er forsvundet, kan behandlingen med VELCADE genoptages i en dosis, der er reduceret med 25 % (1,3 mg/m2 reduceret til 1,0 mg/m2; 1,0 mg/m2 reduceret til 0,7 mg/m2).
English: Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap containing 1 mg bortezomib.
Danish: 5 ml hætteglas i type 1 glas med en grå bromobutyl-prop og en aluminiumsforsegling med grønt låg, der indeholder 1 mg bortezomib.
English: • Redness or pain at the injection site
Danish: • Rødmen eller smerte på injektionsstedet
English: In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Danish: I studiet IFM-2005-01 blev VELCADE i kombination med dexamethason [VcDx, n = 240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n = 242].
English: • Hair loss and abnormal hair texture
Danish: • Hårtab og unormal hårstruktur
English: Week Vc (1.3 mg/m
Danish: Uge Vc (1,3 mg/m
English: • Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Danish: • Muskelkramper, muskelspasmer, muskelsvaghed, smerter i dine lemmer
English: • Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
Danish: • Hjertesvigt, hjerteanfald, brystsmerter, ubehag i brystet, øget eller nedsat hjerterytme
English: • Injection site or injection device related disorders
Danish: • Forstyrrelser forbundet med injektionsstedet eller -udstyret
English: Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Danish: Patienter, som oplever bortezomibrelaterede neuropatiske smerter og/eller perifer neuropati, skal behandles som angivet i tabel 1 (se pkt.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and VcDx groups respectively; the majority of patients underwent one single transplant procedure.
Danish: 198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og VcDx-gruppen fik autolog stamcelletransplantation.
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Danish: Thalidomid administreres oralt med 50 mg dagligt dag 1-14, og hvis det tåles, øges dosis til 100 mg dagligt dag 15-28, hvorefter dosis kan øges yderligere til 200 mg dagligt fra cyklus 2 (se tabel 4).
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Danish: Derfor frarådes det at anvende dette regime med samtidig administration af højdosis cytarabin (2 g/m2 dagligt)
English: VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.
Danish: VELCADE vil blive givet af sundhedspersonale, som har erfaring med behandling med cytostatika.
English: OUTER CARTON, VELCADE 3.5 mg
Danish: YDRE KARTON, VELCADE 3,5 mg
English: 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.
Danish: I generelle toksicitetsstudier med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen, hvilket resulterede i opkastning og/eller diaré, hæmatopoietisk og lymfatisk væv, hvilket resulterede i perifere blodcytopenier, lymfoidt vævsatrofi og hæmatopoietisk knoglemarvshypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Danish: Ved anvendelse af thalidomid skal man være særligt opmærksom på behovet for graviditetsprøver og prævention (se pkt.
English: • Inflammation of the lining around your heart or fluid around your heart
Danish: • Betændelse i hjertesækken eller væske omkring hjertet
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Danish: CR = komplet respons; CRu = komplet respons ubekræftet; PR = partielt respons; CI = konfidensinterval, HR = hazard ratio; OR = oddsratio; ITT = Intent to Treat
English: • Swelling of body, to include eyes and other parts of the body
Danish: • Hævelser på kroppen, inklusive øjnene og andre steder på kroppen
English: VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Danish: VELCADE kan forbindes med træthed (meget almindeligt), svimmelhed (almindeligt), besvimelse (ikke almindeligt) og ortostatisk/postural hypotension eller sløret syn (almindeligt).
English: However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Danish: Dog er der påvist kemisk og fysisk stabilitet for det rekonstituerede produkt i 8 timer ved 25 °C i det originale hætteglas og/eller sprøjte.
English: • that VELCADE 1 mg is only for IV use
Danish: • at VELCADE 1 mg kun er til i.v.
English: • Hypersensitivity
Danish: • Overfølsomhed
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the VcR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Danish: Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i VcRCAP-armen og 1,2 % i R-CHOP-armen (se pkt.
English: Uncommon Colitis (inc clostridium difficile)*
Danish: clostridium difficile)*
English: The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.
Danish: Den normale startdosis VELCADE er 1,3 mg/m2 legemsoverflade to gange om ugen.
English: Bortezomib is a cytotoxic agent.
Danish: Bortezomib er et cytotoksisk middel.
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose or schedule of VELCADE (see section 4.2).
Danish: Patienter, der oplever ny eller forværret perifer neuropati, bør få foretaget en neurologisk evaluering og kan have brug for ændring af dosis eller behandlingsplan af VELCADE (se pkt.
English: • Vaginal tears
Danish: • Vaginale rifter
English: #, Hypersensitivity*
Danish: Angioødem #, overfølsomhed*
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE 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).
Danish: Dosisjusteringer i behandlingsforløbet og ved genoptagelse af behandling ved monoterapi VELCADE skal seponeres ved forekomst af ikke-hæmatologisk grad 3-toksicitet eller hæmatologisk grad 4-toksicitet med undtagelse af neuropati som beskrevet nedenfor (se pkt.
English: What VELCADE contains - The active substance is bortezomib.
Danish: VELCADE indeholder: - Aktivt stof: bortezomib.
English: The overall incidence of hepatitis B infections was similar in patients treated with VcR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Danish: Den samlede forekomst af hepatitis B-infektion var sammenlignelig hos patienter i VcRCAP-armen og patienter i R-CHOP-armen (henholdsvis 0,8 % vs 1,2 %).
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Danish: Kontroller at den korrekte dosis anvendes til intravenøs administration (1 mg/ml).
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy
Danish: Bemærk: OR > 1 tyder på en fordel for Vc-indeholdende induktionsterapi
English: - in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
Danish: - sammen med lægemidlerne dexamethason eller dexamethason sammen med thalidomid til patienter, hvis sygdom ikke tidligere er blevet behandlet, og før de får højdosis-kemoterapi med transplantation af blodstamceller (induktionsbehandling).
English: • Increased heartbeat, high blood pressure, sweating,
Danish: • Hurtigere hjerteslag, højt blodtryk, svedtendens
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Danish: En statistisk signifikant forskel i CR+nCR blev observeret til fordel for gruppen med VELCADE i kombination med dexamethason.
English: Day 8, 9, 10, 11
Danish: Dag 8, 9, 10, 11
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the VELCADE treatment group (VcR-CAP) as compared to the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Danish: Hos patienter med MCL (studie LYM-3002) var der en højere forekomst (56,7 % versus 5,8 %) af grad ≥ 3 trombocytopeni i VELCADE-armen (VcR-CAP) sammenlignet med non-VELCADE-armen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP]).
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma For VELCADE dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Danish: Dosisjustering af kombinationsbehandling for patienter med progressiv myelomatose Dosisjustering af VELCADE ved kombinationsbehandling skal følge retningslinjerne, der er beskrevet under monoterapi ovenfor.
English: Table 15: Efficacy results from study LYM-3002
Danish: Tabel 15: Effektresultater fra studie LYM-3002
English: At least 6 months after prior therapy, VELCADE was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Danish: Mindst 6 måneder efter den tidligere behandling initieredes VELCADE med den senest tålte dosis på 1,3 mg/m2 (n = 93) eller ≤ 1,0 mg/m2 (n = 37); VELCADE blev administreret på dag 1, 4, 8 og 11 hver 3. uge i maksimalt 8 cyklusser enten som monoterapi eller i kombination med dexamethason i henhold til gældende standardbehandling.
English: You should not breast-feed while using VELCADE.
Danish: Du må ikke amme, mens du behandles med VELCADE.
English: 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of VELCADE by either the subcutaneous or intravenous route for 8 cycles.
Danish: Dette studie omfattede 222 patienter med recidiverende eller refraktær myelomatose, som blev randomiseret i forholdet 2:1 til at få 1,3 mg/m2 VELCADE enten som subkutan eller intravenøs administration i 8 cyklusser.
English: Combination therapy with dexamethasone
Danish: Kombinationsbehandling med dexamethason
English: Marketing Authorisation Holder JANSSEN-CILAG INTERNATIONAL NV
Danish: Indehaver af markedsføringstilladelsen JANSSEN-CILAG INTERNATIONAL NV
English: Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.
Danish: Hver pakning VELCADE 1 mg pulver til injektionsvæske, opløsning, indeholder et hætteglas med grønt låg i en gennemsigtig blisterpakning.
English: CYTOTOXIC.
Danish: CYTOSTATIKUM.
English: • Hiccups, speech disorders
Danish: • Hikke, taleforstyrrelser
English: In study MMY-3010 induction treatment withVELCADE combined with thalidomide and dexamethasone [VcTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Danish: I studie MMY-3010 blev induktionsbehandling med VELCADE i kombination med thalidomid og dexamethason [VcTDx, n = 130] sammenlignet med thalidomid-dexamethason [TDx, n = 127].
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the VcR-CAP arm and 61% of patients in the R-CHOP arm.
Danish: I studie LYM-3002 fik 78 % af patienterne i VcR-CAP-armen og 61 % af patienterne i R-CHOP-armen support med kolonistimulerende faktor.
English: Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
Danish: 10 ml hætteglas i type 1 glas med en grå bromobutyl-prop og en aluminiumsforsegling med kongeblåt låg, der indeholder 3,5 mg bortezomib.
English: In studies in patients with relapsed multiple myeloma treated with VELCADE and in patients with previously untreated MCL treated with VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Danish: I studier med patienter med recidiverende myelomatose, som blev behandlet med VELCADE, og med patienter med tidligere ubehandlet MCL, som blev behandlet med VELCADE i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP), var en af de hyppigste hæmatologiske bivirkninger forbigående trombocytopeni.
English: • Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
Danish: • Leddegigt, herunder betændelsestilstand i leddene i fingre, tæer og kæben
English: • Blood clots in your lungs
Danish: • Blodpropper i lungerne
English: Subcutaneous or Intravenous use only.
Danish: Kun til subkutan eller intravenøs anvendelse.
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Danish: Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypotyroidisme
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Danish: Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-studie (MMY-3002 VISTA) med 682 patienter blev gennemført for at bestemme, om VELCADE (1,3 mg/m2 som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid til progression (TTP) ved sammenligning med melphalan (9 mg/m2) og prednison (60 mg/m2) til patienter med tidligere ubehandlet myelomatose.
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
Danish: Responsrate efter 8 cyklusser n (%) ORR (CR+PR) p-værdi
English: • If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Danish: • I tilfælde af lokale reaktioner på injektionsstedet efter en subkutan injektion af VELCADE anbefales det enten at administrere en mindre koncentreret VELCADE opløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller skifte til intravenøs administration.
English: Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with VELCADE.
Danish: Der er hos patienter behandlet med VELCADE rapporteret meget sjældne tilfælde af John Cunningham-virus (JC-virus), der førte til PML og død.
English: • diarrhoea, constipation, nausea or vomiting
Danish: • diaré, forstoppelse, kvalme eller kaster op
English: • numbness, tingling, or pain in the hands or feet (neuropathy) in the past
Danish: • tidligere har haft problemer med følelsesløshed, følelse af prikken eller smerte i hænder eller fødder (neuropati)
English: Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Danish: Både VcR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i VcR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen.
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Danish: Vaginalblødning, genitale smerter*, erektil dysfunktion
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy.
Danish: Bemærk: OR > 1 tyder på en fordel for Vc-indeholdende induktionsterapi.
English: • Itching of the skin, lumps on the skin or dry skin
Danish: • Hudkløe, buler i huden eller tør hud
English: VDDx=vincristine, doxorubicin, dexamethasone; VcDx=VELCADE, dexamethasone; TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Danish: VDDx = vincristin, doxorubicin, dexamethason; VcDx = VELCADE, dexamethason; TDx = thalidomid, dexamethason; VcTDx = VELCADE, thalidomid, dexamethason; PN = perifer neuropati Bemærk: Perifer neuropati inkluderede de foretrukne termer: perifer neuropati, perifer motorisk neuropati, perifer sensorisk neuropati og polyneuropati.
English: • Herpes virus infections
Danish: • Herpes-virusinfektioner
English: • Swelling of body, to include around eyes and other parts of the body
Danish: • Hævelser på kroppen, inklusive omkring øjnene og andre steder på kroppen
English: • Movement disorders, paralysis, twitching
Danish: • Bevægelsesforstyrrelser, lammelse, spjætten
English: • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Danish: • Trombocyttal skal være ≥ 75x 10 9 celler/l hos patienter med infiltreret knoglemarv eller sekvestration af milten.
English: Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone
Danish: Tabel 3: Dosisjusteringer under efterfølgende cyklusser med VELCADE i kombination med melphalan og prednison
English: VELCADE is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.
Danish: VELCADE bruges til behandling af myelomatose (kræft i knoglemarven) hos patienter over 18 år: - alene eller sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason til patienter, hvis sygdom forværres (er progressiv) efter mindst én forudgående behandling, og som ikke har haft gavn af eller mulighed for at få en transplantation af blodstamceller (knoglemarvstransplantation).
English: VcR-CAP=VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Danish: VcR-CAP = VELCADE, rituximab, cyclophosphamid, doxorubicin og prednison; R-CHOP = rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; PN = perifer neuropati Perifer neuropati inkluderede de foretrukne termer: perifer sensorisk neuropati, perifer neuropati, perifer motorisk neuropati og perifer sensomotorisk neuropati