natgillin/translations-raw huggingface dataset:
Median Cmax, AUC og Tmax for MMAE efter en enkelt dosis på 1,8 mg/kg var henholdsvis 3,73 ng/ml, 17,3 ng*dag/ml og 1,92 dage hos patienter < 12 år og henholdsvis 6,33 ng/ml, 42,3 ng*dag/ml og 1,82 dage hos patienter ≥ 12 år.
Median Cmax, AUC, and Tmax of MMAE after a single 1.8 mg/kg dose were 3.73 ng/mL, 17.3 ng*day/mL, and 1.92 days, respectively, in patients < 12 years of age and 6.33 ng/mL, 42.3 ng*day/mL, and 1.82 days, respectively, in patients ≥ 12 years of age.
Et studie evaluerede farmakokinetikken for brentuximab vedotin og MMAE efter administration af ADCETRIS 1,2 mg/kg til patienter med let (n = 4), moderat (n = 3) og svært (n = 3) nedsat nyrefunktion.
A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (n = 4), moderate (n = 3) and severe (n = 3) renal impairment.
Et studie evaluerede farmakokinetikken for brentuximab vedotin og MMAE efter administration af ADCETRIS 1,2 mg/kg til patienter med let (Child-Pugh A; n=1), moderat (Child-Pugh B; n=5) eller svært (Child-Pugh C; n=1) nedsat leverfunktion.
A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (Child-Pugh A; n = 1), moderate (Child-Pugh B; n = 5) and severe (Child-Pugh C; n = 1) hepatic impairment.
32 år (18-76)
32 years (18-76)
35 år (18-82)
35 years (18-82)
Behandlingen med ADCETRIS skal stilles i bero ved enhver mistanke om akut pancreatitis.
ADCETRIS should be held for any suspected case of acute pancreatitis.
Objektiv responsrate (CR + PR) Komplet remission (CR)
Objective response (CR + PR) Complete remission (CR)
I det kliniske forsøg med ADCETRIS som kombinationsbehandling medførte neutropeni doseringsudsættelse hos 24 % af patienterne.
In the clinical trial of ADCETRIS as combination therapy, neutropenia led to dose delays in 24% of patients.
Infusionsreaktioner
Infusion reactions
Ti (10) patienter (17 %) modtog 16 behandlingsserier ADCETRIS; og det mediane antal modtagne behandlingsserier var 7 (interval fra 1 til 16).
Ten (10) patients (17%) received 16 cycles of ADCETRIS; the median number of cycles received was 7 (range, 1 to 16).
Median Cmax og AUC for ADC efter en enkelt dosis på 1,8 mg/kg var henholdsvis 29,8 µg/ml og 67,9 µg*dag/ml hos patienter < 12 år og henholdsvis 34,4 µg/ml og 77,8 µg*dag/ml hos patienter ≥ 12 år.
Median Cmax and AUC of ADC after a single 1.8 mg/kg dose were 29.8 µg/ mL and 67.9 µg*day/ mL, respectively, in patients < 12 years of age and 34.4 µg/mL and 77.8 µg*day/mL, respectively, in patients ≥ 12 years of age.
Patientkarakteristika
Patient characteristics
Patienterne blev behandlet med 1,8 mg/kg ADCETRIS intravenøst over 30 minutter hver 3. uge i op til 16 behandlingsserier eller lægens valg i op til 48 uger.
Patients were treated with 1.8 mg/kg of ADCETRIS intravenously over 30 minutes every 3 weeks for up to 16 cycles or physician's choice for up to 48 weeks.
Den passende mængde rekonstitueret Adcetris skal trækkes op af hætteglasset/ne og tilsættes til infusionsposen indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske for at opnå en endelig koncentration på 0,4-1,2 mg/ml Adcetris.
The appropriate amount of reconstituted Adcetris must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection in order to achieve a final concentration of 0.4-1.2 mg/mL Adcetris.
Bivirkningerne kan optræde hyppigere hos ældre patienter (≥ 65 år).
If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
ADCETRIS kan medføre både sensorisk og motorisk perifer neuropati.
ADCETRIS may cause peripheral neuropathy, both sensory and motor.
Der blev rapporteret IRR, som for eksempel hovedpine, udslæt, rygsmerter, opkastning, kulderystelser, kvalme, dyspnø, pruritus og hoste, hos 13 % af patienterne.
IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus and cough were reported in 13% of patients.
n (%) III IV Ikke relevant Mangler Ekstranodal involvering på tidspunktet for diagnosticering, n (%) IPFP
Extranodal involvement at time of diagnosis, n (%) IPFP
Klargøring af infusionsopløsningen
Preparation of infusion solution
IRF for patienter med stadie IV-sygdom, herunder alder, område, ekstranodale steder ved baseline, antal IPFP-risikofaktorer, B-symptomer ved baseline, ECOG-status ved baseline og køn.
Post-hoc subgroup analyses of modified PFS per IRF for patients with Stage IV disease were performed including age, region, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, baseline ECOG status and gender.
Seponer dosis, indtil toksiciteten vender tilbage til ≤ Grad 1 eller baseline, genoptag derefter behandlingen med en reduceret dosis på 1,2 mg/kg op til højst 120 mg hver 3. uge
Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg up to a maximum of 120 mg every 3 weeks
Tabel 14: Virkningsresultater hos CTCL-patienter behandlet med 1,8 mg/kg ADCETRIS hver 3. uge (ITT-population)
Table 14: Efficacy results in CTCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks (ITT population)
Median Cmax, AUC og Tmax of MMAE efter en enkelt 1,8 mg/kg dosis ADC i et fase 1-studie var henholdsvis cirka 4,97 ng/ml, 37,03 ng/ml x dag og 2,09 dag.
Median Cmax, AUC and Tmax of MMAE after a single 1.8 mg/kg of the ADC in a phase 1 study was approximately 4.97 ng/ mL, 37.03 ng/ mL x day and 2.09 days respectively.
Tabel 7: Resultater for effekt hos HL-patienter med øget risiko for recidiv eller progression efter ASCT behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
Table 7: Efficacy results in HL patients at increased risk of relapse or progression following ASCT treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Når ADCETRIS administreres i kombination med AVD, anbefales primær profylakse med G-CSF til alle patienter uanset alder, startende med den første dosis.
In combination therapy with AVD, advanced age was a risk factor for febrile neutropenia.When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients regardless of age beginning with the first dose.
4.8), fastlagde den maksimale tolererede dosis (MTD) for pædiatriske patienter og/eller den anbefalede fase 2-dosis (RP2D) samt vurderede ADCETRIS' farmakokinetik (se pkt.
Phase 1 of the study assessed the safety profile (see section 4.8), determined the paediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D),
Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
General disorders and administration site conditions Very common:
Forelæggelse af resultaterne af det igangværende ikke-intervenerende sikkerhedsstudie efter godkendelse (PASS) udført med patientpopulationer med Hodgkins lymfom (HL) og systemisk anaplastisk storcellet lymfom (sALCL) (Studie MA25010).
Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Virkningen og sikkerheden for ADCETRIS som enkeltstofbehandling blev evalueret i et open-label, enkelt-armet multicenter-studie på 58 patienter med recidiverende eller refraktær sALCL.
The efficacy and safety of ADCETRIS as a single agent was evaluated in an open-label, single-arm, multicenter study in 58 patients with relapsed or refractory sALCL.
Feber samtidigt med lavt antal hvide blodlegemer kan være et tegn på alvorlig infektion - oplever svimmelhed, mindre vandladning, konfusion, opkastning, kvalme, hævelse, kortåndethed eller forstyrrelser af hjerterytmen (dette kan være en livstruende komplikation, der kaldes tumorlysesyndrom) - oplever influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der breder sig og danner blærer herunder omfattende afskalning af huden, hvilket kan være livstruende (dette kan være en alvorlig hudreaktion kaldet Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse)
A fever with a low white blood cell count may be a sign of serious infection experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome) experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin that may be life-threatening (this may be a serious skin reaction known as Stevens-Johnson syndrome and toxic epidermal necrolysis) have new or worsening stomach pain, nausea, vomiting, constipation as these may be symptoms of a serious and potentially fatal stomach or intestinal complication (gastrointestinal complications)
For patienter, som oplevede perifer neuropati, var den mediane tid til debut af perifer neuropati 12 uger.
For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 12 weeks.
I kliniske forsøg medførte neutropeni doseringsudsættelse hos 14 % af patienterne.
In clinical trials, neutropenia led to dose delays in 14% of patients.
- har problemer med en forandring af hudens følsomhed, specielt i hænder eller fødder, så som følelsesløshed, snurren, en brændende fornemmelse, smerter, ubehag eller svækkelse (neuropati) - har hovedpine, føler dig træt, oplever svimmelhed, ser bleg ud (anæmi) eller har usædvanlige blødninger eller blåfarvning under huden, bløder længere end normalt efter en blodprøve eller bløder fra tandkødet (trombocytopeni) - får kuldegysninger eller kulderystelser eller føler dig varm; du bør tage din temperatur, da du kan have feber.
For more detailed information, see “Infusion reactions” in section 4. have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy) have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia) develop chills or shivering, or feel warm; you should take your temperature as you may have a fever.
Syv patienter med recidiverende sALCL fik en startdosis på 1,8 mg/kg, og én patient fik en startdosis på 1,2 mg/kg ADCETRIS administreret intravenøst over 30 minutter hver 3. uge.
Seven patients with relapsed sALCL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
I tilfælde af nye eller forværrede lungesymptomer (f.eks. hoste, dyspnø) skal en diagnostisk evaluering straks udføres og patienterne behandles på passende vis. Overvej at tilbageholde ADCETRIS-dosis under evalueringen og indtil symptomatisk forbedring.
In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately.
Kvinder i den fertile alder bør benytte to effektive præventionsmetoder under og i 6 måneder efter behandling med brentuximab vedotin.
Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.
Samlet overlevelse
Overall Survival
Virkningen og sikkerheden for ADCETRIS som enkeltstofsbehandling blev evalueret i et pivotalt open-label, enkelt-armet multicenter-studie på 102 patienter med recidiverende eller refraktær HL.
The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal open-label, single-arm, multicenter study in 102 patients with relapsed or refractory HL.
Tabel 13: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 3-CTCL-studiet (ITT-population)
Table 13: Summary of baseline patient and disease characteristics in the phase 3 CTCL Study (ITT Population)
Mangler
Missing
37 år (18-83)
37 years (18-83)
Der blev rapporteret IRR, som for eksempel hovedpine, udslæt, rygsmerter, opkastning, kulderystelser, kvalme, dyspnø, pruritus, hoste, smerter på infusionsstedet og pyreksi, hos 9 % af patienterne.
IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus, cough, infusion site pain and pyrexia were reported in 9% of patients.
33 M (52%)/31 K (48%)
33M (52%)/31F (48%)
IRF hos patienter med stadie IV-sygdom (ADCETRIS + AVD kontra ABVD)
Figure 2: Modified progression-free survival per IRF in patients with Stage IV disease (ADCETRIS + AVD vs. ABVD)
4.8, 5.1 og 5.2.
Currently available data are described in sections 4.8, 5.1 and 5.2.
Ikke kendt:
Unknown
20 patienter med recidiverende eller refraktært HL fik en startdosis på 1,8 mg/kg, og én patient fik en startdosis på 1,2 mg/kg ADCETRIS administreret intravenøst over 30 minutter hver 3. uge.
Twenty patients with relapsed or refractory HL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
2,16 hætteglas
2.16 vials
Tabel 11: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 2-studiet af recidiverende eller refraktær sALCL
Table 11: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory sALCL study
Infusionsslangen skal gennemskylles efter administrationen med natriumchlorid 9 mg/ml (0,9%) injektionsopløsning, 5% dextrose til injektion eller Ringerlaktat til injektion.
The infusion line should be flushed following administration with sodium chloride 9 mg/ mL (0.9%) solution for injection, 5% dextrose for injection, or Lactated Ringer's for injection.
2,88 hætteglas
2.88 vials
1,44 hætteglas
1.44 vials
Hvis patienten vejer mere end 100 kg, skal dosiskalkulationen beregnes ud fra 100 kg (se pkt.
If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see section 6.6).
IRF Median (måneder)
Progression Free Survival (PFS) per IRF Median (months)
Tabel 10: Virkningsresultater hos patienter med recidiverende eller refraktært Hodgkins lymfom behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
Table 10: Efficacy results in relapsed or refractory Hodgkin lymphoma patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Sygdomsstadie a ved indledende diagnosticering af HL,
Disease stage at initial diagnosis of HL Stage I
Seponer dosis, indtil toksiciteten vender tilbage til ≤ Grad 1 eller baseline, og genoptag derefter behandlingen med en reduceret dosis på 1,2 mg/kg hver 3. uge
Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg every 3 weeks
Efter rekonstitution indeholder hvert hætteglas 5 mg/ml brentuximab vedotin.
After reconstitution each vial contains 5 mg/ml of brentuximab vedotin
PRODUKTRESUMÉ
Manufacturer
IRF hos ITT-populationen (ADCETRIS + AVD kontra ABVD)
Figure 1: Modified progression-free survival per IRF in the ITT population (ADCETRIS + AVD vs. ABVD)
Patienterne blev behandlet med ADCETRIS 1,8 mg/kg intravenøst over 30 minutter hver 3. uge i op til 16 behandlingsserier.
Patients were treated with ADCETRIS 1.8 mg/kg intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Grade 3 (<1,000-500/mm <1,0-0,5 x 10
Grade 3 (< 1,000-500/mm < 1.0-0.5 x 10 9/L) or
- får eller tidligere har fået medicin, der kan påvirke dit immunsystem, så som kemoterapi eller immunsuppressive midler - har eller tror du har en infektion.
have new or worsening shortness of breath or cough as these may be symptoms of a serious and potentially fatal lung complication (pulmonary toxicity) are taking, or have previously taken, medicines which may affect your immune system, such as chemotherapy or immunosuppressive agents have, or think you have, an infection.
Tabel 6: Oversigt over patient- og sygdomskarakteristika ved baseline i HL post ASCT fase 3-studiet
Table 6: Summary of baseline patient and disease characteristics in the phase 3 HL post-ASCT Study
Sikkerheden og effekten af ADCETRIS blev evalueret hos 329 patienter med HL med risiko for recidiv eller progression efter ASCT i et randomiseret, dobbeltblindt, placebokontrolleret multicenterforsøg med 2 arme.
The efficacy and safety of ADCETRIS were evaluated in a randomised, double-blind, placebo-controlled, 2-arm multicenter trial in 329 patients with HL at risk of relapse or progression following ASCT.
Progressionsfri overlevelse (PFS) iht.
Progression Free Survival per IRF
Tabel 12: Virkningsresultater hos patienter med recidiverende eller refraktær sALCL behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
Table 12: Efficacy results in relapsed or refractory sALCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal hvide blodlegemer - nedsat antal blodplader - nedsat antal hvide blodlegemer med deraf følgende feber - infektion i de øvre luftveje - vægttab - infektion - kvalme - mavesmerter - usædvanligt hårtab eller udtynding - muskelsmerter - ledsmerter eller smertende, hævede led - svimmelhed - forhøjede leverenzymniveauer - nedsat appetit - søvnløshed - knoglesmerter - ømhed eller betændelse i munden
Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells decreased level of blood platelets decreased level of white blood cells with a fever upper respiratory tract infection decrease in weight infection nausea abdominal pain unusual hair loss or thinning muscle pain joint pain or painful, swollen joints dizziness increased liver enzyme levels decreased appetite not being able to sleep bone pain sore or inflammation in the mouth
37 M (58%)/27 K (42%)
37M (58%)/27F (42%)
Patienterne blev behandlet med 1,8 mg/kg ADCETRIS eller en tilsvarende placebodosis givet intravenøst i løbet af 30 minutter hver 3. uge i op til 16 behandlingsserier.
Patients were treated with 1.8 mg/kg of ADCETRIS or matching placebo intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
If you get any side effects, talk to your doctor.
Antal risikofaktorer = 1 Antal risikofaktorer ≥ 2 Antal risikofaktorer ≥ 3
Number of Risk Factors ≥ 3
Tabel 9: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 2-studiet af recidiverende eller refraktær HL
Table 9: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory HL study
- nye eller tilbagevendende cytomegalovirusinfektioner (CMV) - infektion i blodet (blodforgiftning) og/eller septisk shock (en livstruende form for blodforgiftning) - Stevens-Johnsons syndrom og toksisk epidermal nekrolyse - en sjælden, alvorlig sygdom, hvor du kan opleve influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der spreder sig og danner blærer, herunder omfattende afskalning af huden - nedsat antal hvide blodlegemer med deraf følgende feber - skader på nerver og nerveskeder (demyeliniserende polyneuropati)
- Stevens-Johnson syndrome and toxic epidermal necrolysis - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - decreased level of white blood cells with a fever - damage to the nerves and nerve coverings (demyelinating polyneuropathy)
Den anbefalede startdosis ved genbehandling af patienter, som tidligere har responderet på behandling med ADCETRIS, er 1,8 mg/kg administreret som en intravenøs infusion over 30 minutter hver 3. uge.
The recommended starting dose for the retreatment of patients who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
ADCETRIS som en del af det kliniske studie SG035-0004 oplevede en klinisk forbedring målt ved længere progressionsfri overlevelse (PFS) sammenlignet med deres seneste tidligere behandling.
An exploratory intra-patient analysis showed that approximately 69% of the sALCL patients treated with ADCETRIS as part of the SG035-0004 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Tabel 4: Oversigt over patient- og sygdomskarakteristika ved baseline i ikke tidligere behandlet HL - fase 3-studiet
Table 4: Summary of baseline patient and disease characteristics in the phase 3 previously untreated HL study
Patienter med nedsat nyrefunktion skal nøje monitoreres for bivirkninger.
Patients with hepatic impairment should be closely monitored for adverse events.
1,92 hætteglas
1.92 vials
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal hvide blodlegemer - infektion i de øvre luftveje - vægttab - infektion - kvalme - mavesmerter - kløe - muskelsmerter - ledsmerter eller smertende, hævede led
Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells upper respiratory tract infection decrease in weight infection nausea abdominal pain itching muscle pain joint pain or painful, swollen joints
Den anbefalede dosis er 1,8 mg/kg administreret som en intravenøs infusion over 30 minutter hver 3. uge.
The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Patienter med nedsat leverfunktion skal nøje monitoreres for bivirkninger (se pkt.
Patients with renal impairment should be closely monitored for adverse events (see section 5.2).
Patienter med nedsat leverfunktion skal nøje monitoreres for bivirkninger.
Patients with renal impairment should be closely monitored for adverse events.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - lungebetændelse - ømme, cremegule hævede områder i munden (trøske) - nedsat antal blodplader - svimmelhed - blærer, der kan danne skorpe eller sår - forhøjet blodsukkerniveau - forhøjede leverenzymniveauer - usædvanligt hårtab eller udtynding
Common side effects (may affect up to1 in 10 people) pneumonia sore, creamy-yellow, raised patches in the mouth (thrush) decreased level of blood platelets dizziness blisters which may crust or scab increased level of blood sugar increased liver enzyme levels unusual hair loss or thinning
Hvert hætteglas indeholder 50 mg brentuximab vedotin.
Each vial contains 50 mg of brentuximab vedotin.
Se Tabel 11 nedenfor for en oversigt over patient- og sygdomskarakteristika ved baseline.
See Table 11 below for a summary of baseline patient and disease characteristics.
Hjælpestoffer: Citronsyremonohydrat, natriumcitratdihydrat, α,α-trehalosedihydrat, polysorbat 80.
Excipients: Citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, polysorbate 80 See package leaflet for further information
(95 % CI [0,36; 0,70])
(95% CI [0.36, 0.70])b
Se Tabel 9 nedenfor for en oversigt over patient- og sygdomskarakteristika ved baseline.
See Table 9 below for a summary of baseline patient and disease characteristics.
Knoglesmerter, artralgi, rygsmerter, myalgi
Bone pain, arthralgia, back pain, myalgia
Totalt volumen der skal fortyndes b = total dosis divideret med den rekonstituerede hætteglaskoncentration [5 mg/ml]
total dose divided by reconstituted vial concentration [5 mg/mL])
Hvis en perifer sensorisk eller motorisk neuropati opstår eller forværres under behandlingen, se da
If peripheral sensory or motor neuropathy emerges or worsens during treatment see Table 2 below for appropriate dosing recommendations (see section 4.4).
IR
NA
Tabel 4 indeholder en oversigt over patient- og sygdomskarakteristika ved baseline.
Table 4 provides a summary of the baseline patient and disease characteristics.