natgillin/translations-raw huggingface dataset:
Forekomsten af herpes zoster blandt patienter i Vc+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse. 
The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
(95 % CI) Hazard ratio (95 % CI) p-værdi Responsrate population e n = 668 
Hazard ratio (95% CI) p-value Response rate population e n=668
• Infektioner, herunder urinvejsinfektioner, influenza, herpes virus infektioner, øreinfektion og cellulitis 
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Hepatitis B-virus (HBV)-reaktivering og -infektion 
Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Fra en uddybende effektanalyse rapporteredes en responsrate på 67,3 % (inklusive en CR-rate på 28,6 %) bestemt ud fra hæmatologisk respons (M-protein) hos 49 evaluerbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m2 en gang ugentligt og 
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Ved sammenligning med patienter med normal leverfunktion ændrede en let nedsættelse af leverfunktionen ikke bortezomibs AUC justeret i forhold til standarddosis. 
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
I fase III-studiet til sammenligning af VELCADE administreret intravenøst versus subkutant var forekomsten af hændelser med ≥ grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen, der fik intravenøse injektioner (p = 0,0124). 
In the Phase III study comparing VELCADE administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Den gennemsnitlige TTP var 6,5 måned for patienter i monoterapi med VELCADE sammenlignet med 9,3 måneder for patienter i kombinationsbehandling med VELCADE plus pegyleret liposomal doxorubicin. 
The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Thalidomid-dosis øges kun til 100 mg fra uge 3 i cyklus 1, hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles. 
Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med VELCADE: rituximab 375 mg/m 2, cyclophosphamid 750 mg/m 2 og doxorubicin 50 mg/m 
The following medicinal products are administered on day 1 of each VELCADE 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Patienterne skal monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4hæmmere. 
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Varigheden af det samlede respons var 21,4 måneder længere i VcR-CAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen). 
The duration of overall response was 21.4 months longer in the VcR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Demografiske og baseline-sygdomskarakteristika var generelt afbalanceret mellem de to behandlingsarme: Den mediane patientalder var 66 år, 74 % var mænd, 66 % var kaukasere og 32 % asiater, 69 % af patienterne havde et positivt knoglemarvsaspirat og/eller en positiv knoglemarvsbiopsi for MCL, 54 % af patienterne havde en IPI-score (International Prognostic Index) på ≥ 3, og 76 % var i sygdomsstadie IV. Behandlingens varighed (median = 17 uger) og varigheden af opfølgningen (median = 40 måneder) var sammenlignelige i de to behandlingsarme. 
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
dag 29 pause 
Day 29 rest period
Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis. 
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Der blev identificeret ethundredeogsyvogtyve matchede par patienter. 
One hundred and twenty seven matched pairs of patients were identified.
Hepatitis B-infektion*, bronkopneumoni 
Uncommon Hepatitis B, Infection*, Bronchopneumonia
CR + nCR+ PR+MR Median varighed dage (måneder) Tiden indtil respons CR + PR (dage) 
CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
Forekomsten af herpes zoster blandt patienter i VcR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt. 
The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
• Forandringer i eller unormalt afføringsmønster 
• Changes in or abnormal bowel function
En oddsratio (OR) > 1 angiver en fordel for VcR-CAP. 
An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
VELCADE kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn. 
VELCADE might cause tiredness, dizziness, fainting, or blurred vision.
Når toksiciteten er forsvundet, gives VELCADE igen, dosis reduceres til 0,7 mg/m2 en gang om ugen. 
When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/m2 once per week.
VELCADE skal rekonstitueres af sundhedspersonale (se pkt. 
VELCADE must be reconstituted by a healthcare professional (see section 6.6).
Samtidig behandling med andre lægemidler 
Concomitant medicinal products
• Blodudtrædninger, fald og skader 
• Bruises, falls and injuries
• Ringen for ørene, ubehag i ørerne 
• Ringing in the ears, ear discomfort
Instruktioner for rekonstitution VELCADE skal rekonstitueres af sundhedspersonale. 
Instructions for reconstitution VELCADE must be reconstituted by a healthcare professional.
• Trombocyttal skal være ≥ 70 x 10 
• Platelet counts should be ≥ 70 x 10
Du vil derfor få taget regelmæssige blodprøver før og under din behandling med VELCADE for at kontrollere niveauet af dine blodlegemer. 
Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Kontroller koncentrationen på hætteglasset for at sikre, at den korrekte dosis anvendes til intravenøs administration (1 mg/ml). 
Confirm concentration on vial to ensure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Hvis du får VELCADE for myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du oplever nogle af nedenstående bivirkninger: - muskelkramper, muskelsvaghed - forvirring, synstab eller -forstyrrelser, blindhed, krampeanfald, hovedpiner - åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet. 
If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Bemærkelsesværdige forskelle i MCL-patientpopulationen sammenlignet med patienter i myelomatose-studierne var en ≥ 5 % højere forekomst af hæmatologiske bivirkninger (neutropeni, trombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme. 
Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Hos patienter, der udvikler PRES, skal behandlingen med VELCADE seponeres. 
In patients developing PRES, VELCADE should be discontinued.
Gastrointestinal og intracerebral blødning er blevet rapporteret i forbindelse med VELCADEbehandling. 
Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
Patienter ≥ 75 år tolererede begge regimer dårligere, både VcR-CAP og R-CHOP (se pkt. 
In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Der er rapporteret sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, f.eks. pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i VELCADE-behandling (se pkt. 
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Median OS var 30,8 måneder (95 % CI: 25,2-36,5 måneder) for patienter i monoterapi med VELCADE og 33,0 måneder (95 % CI: 28,9-37,1 måneder) for patienter i kombinationsbehandling med VELCADE plus pegyleret liposomal doxorubicin. 
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the VELCADE monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med VELCADE: 
The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:
• Henfald af muskelfibre med følgetilstande 
• Breakdown of muscle fibers leading to other complications
Rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m 
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
VELCADE-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet. 
Withhold VELCADE treatment until symptoms of toxicity have resolved.
HR b(95 % CI) = 0,63 (0,50; 0,79) p-værdi d < 0,001 
b (95% CI)=0.63 (0.50; 0.79) p-value d < 0.001
• Godartede cyster 
• Benign cysts
VELCADE-kombinationsbehandling med dexamethason Der blev på grund af mangel på en direkte sammenligning af VELCADE og VELCADE i kombination med dexamethason hos patienter med progressiv myelomatose, gennemført en statistisk "matchet par"-analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med VELCADE i kombination med dexamethason (åbent fase II-studie MMY-2045) med resultaterne fra VELCADE-monoterapiarmene fra forskellige randomiserede fase III-studier (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation. 
VELCADE combination treatment with dexamethasone In the absence of any direct comparison between VELCADE and VELCADE in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of VELCADE in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the VELCADE monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Dosisjustering til transplantationsegnede patienter For justering af VELCADE-dosis: retningslinjerne for dosisændringer som beskrevet for monoterapi skal følges. 
Dosage adjustments for transplant eligible patients For VELCADE dosage adjustments, dose modification guidelines described for monotherapy should be followed.
• Øreproblemer, blødning fra øre 
• Problems with your ear, bleeding from your ear
YDRE KARTON, VELCADE 1 mg 
OUTER CARTON, VELCADE 1 mg
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i VcR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser. 
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the VcR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Det er yderst vigtigt, at der anvendes aseptisk teknik under håndteringen af VELCADE, da det ikke indeholder konserveringsmiddel. 
Aseptic technique must be strictly observed throughout the handling of VELCADE, since it contains no preservative.
• Betændelse i en vene, blodpropper i vener eller lunger 
• Inflammation of a vein, blood clots in your veins and lungs
ANC-værdien ≤ 0,75 x 10 
≤ 0.75 x 10
Et risikoforhold på mindre end 1 indikerer en fordel for VMP Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: 2-mikroglobulin, albumin og region p-værdi for responsrate (CR+PR) fra Cochran-Mantel-Haenszel chi-square-test justeret for stratifikationsfaktorer Responspopulation omfatter patienter, som havde målbar sygdom ved baseline CR = fuldstændigt respons; PR = partielt respons. 
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: 2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med VELCADE for at kontrollere niveauet af dine blodlegemer. 
You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
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. 
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.
Trombocyttallet var lavest på dag 11 i hver cyklus af VELCADE-behandlingen og var typisk vendt tilbage til baselineniveau ved den næste cyklus. 
Platelets were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika. 
During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
• Følsomhed, følelsesløshed, prikken eller en brændende følelse i huden eller smerter i hænder eller fødder pga. nerveskade 
• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
• Skyl det intravenøse kateter igennem med steril 9 mg/ml (0,9 %) natriumchloridinjektionsvæske. 
• Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
• Pludseligt fald i blodtrykket, når du rejser dig op, hvilket kan medføre, at du besvimer 
• Sudden fall of blood pressure upon standing which may lead to fainting
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: 
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:
• Rødme og smerter på injektionsstedet 
• Redness and pain at injection site
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: 
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:
Du vil få 4 cyklusser (12 ugers behandling). 
You will receive 4 cycles (12 weeks).
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). 
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).
5 ml hætteglas i type 1 glas med en grå bromobutyl-prop og en aluminiumsforsegling med grønt låg, der indeholder 1 mg bortezomib. 
Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap containing 1 mg bortezomib.
• Rødmen eller smerte på injektionsstedet 
• Redness or pain at the injection site
I studiet IFM-2005-01 blev VELCADE i kombination med dexamethason [VcDx, n = 240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n = 242]. 
In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
• Hårtab og unormal hårstruktur 
• Hair loss and abnormal hair texture
Uge Vc (1,3 mg/m 
Week Vc (1.3 mg/m
• Muskelkramper, muskelspasmer, muskelsvaghed, smerter i dine lemmer 
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
• Hjertesvigt, hjerteanfald, brystsmerter, ubehag i brystet, øget eller nedsat hjerterytme 
• Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
• Forstyrrelser forbundet med injektionsstedet eller -udstyret 
• Injection site or injection device related disorders
Patienter, som oplever bortezomibrelaterede neuropatiske smerter og/eller perifer neuropati, skal behandles som angivet i tabel 1 (se pkt. 
Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og VcDx-gruppen fik autolog stamcelletransplantation. 
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.
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). 
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).
Derfor frarådes det at anvende dette regime med samtidig administration af højdosis cytarabin (2 g/m2 dagligt) 
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.
VELCADE vil blive givet af sundhedspersonale, som har erfaring med behandling med cytostatika. 
VELCADE will be administered by a health care professional experienced in the use of cytotoxic medicines.
YDRE KARTON, VELCADE 3,5 mg 
OUTER CARTON, VELCADE 3.5 mg
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. 
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 anvendelse af thalidomid skal man være særligt opmærksom på behovet for graviditetsprøver og prævention (se pkt. 
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
• Betændelse i hjertesækken eller væske omkring hjertet 
• Inflammation of the lining around your heart or fluid around your heart
CR = komplet respons; CRu = komplet respons ubekræftet; PR = partielt respons; CI = konfidensinterval, HR = hazard ratio; OR = oddsratio; ITT = Intent to Treat 
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
• Hævelser på kroppen, inklusive øjnene og andre steder på kroppen 
• Swelling of body, to include eyes and other parts of the body
VELCADE kan forbindes med træthed (meget almindeligt), svimmelhed (almindeligt), besvimelse (ikke almindeligt) og ortostatisk/postural hypotension eller sløret syn (almindeligt). 
VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
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. 
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.
• at VELCADE 1 mg kun er til i.v. 
• that VELCADE 1 mg is only for IV use
• Overfølsomhed 
• Hypersensitivity
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. 
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).
clostridium difficile)* 
Uncommon Colitis (inc clostridium difficile)*
Den normale startdosis VELCADE er 1,3 mg/m2 legemsoverflade to gange om ugen. 
The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.
Bortezomib er et cytotoksisk middel. 
Bortezomib is a cytotoxic agent.
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. 
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).
• Vaginale rifter 
• Vaginal tears
Angioødem #, overfølsomhed* 
#, Hypersensitivity*
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. 
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).