FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 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.
Danish: Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 28-dages VELCADE-behandlingscyklus, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du tolererer 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.
English: Patients in the VcR-CAP treatment arm received VELCADE (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21),
Danish: Patienterne i VcR-CAP-armen fik VELCADE (1,3 mg/m2 på dag 1, 4, 8, 11, hvileperiode dag 12-21), rituximab
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
Danish: En statistisk signifikant forskel i CR+nCR blev observeret til fordel for gruppen, der fik VELCADE i kombination med dexamethason og thalidomid.
English: • Injuries
Danish: • Skader
English: • Inject the solution subcutaneously, under a 45-90°angle.
Danish: • Injicer opløsningen subkutant i en vinkel på 45-90°.
English: • Decreased sex drive
Danish: • Nedsat sexlyst
English: • Different types of rash
Danish: • Forskellige typer udslæt
English: ≥ 2 prior lines
Danish: ≥ 2 tidligere behandlinger
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Danish: Klinisk virkning ved tidligere ubehandlet mantle-celle-lymfom (MCL) Studie LYM-3002 var et åbent, randomiseret fase III-studie, som sammenlignede effekt og sikkerhed af kombinationen af VELCADE, rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP; n = 243) i forhold til rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R-CHOP; n = 244) hos voksne patienter med tidligere ubehandlet MCL (stadie II, III eller IV).
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP).
Danish: HBV-infektion med dødelig udgang forekom hos 0,8 % (n = 2) af patienterne i non-VELCADE-armen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4 % (n = 1) af patienterne i armen med VELCADE plus rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP).
English: Discontinue VELCADE if PML is diagnosed.
Danish: Hvis PML diagnosticeres, skal VELCADE seponeres.
English: When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Danish: Hvis du får VELCADE sammen med thalidomid, skal du benytte effektiv prævention som angivet for thalidomid (se indlægssedlen for thalidomid).
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Danish: Responsrate efter 4 cyklusser n (%) ORR (CR+PR) p-værdi
English: Do not use VELCADE - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Danish: Brug ikke VELCADE: - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i VELCADE
English: • Wasting, or loss of body mass
Danish: • Hensygnen eller tab af kropsmasse
English: If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Danish: De bivirkninger, du kan opleve, hvis du får VELCADE sammen med andre lægemidler til behandling af mantle-celle-lymfom, er angivet nedenfor:
English: Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Danish: Nogle af disse sygdomme omfatter vejrtrækningsbesvær, kortåndethed, kortåndethed uden fysiske udfoldelser,
English: You might receive up to 8 cycles (24 weeks).
Danish: Du kan få op til 8 cyklusser (24 ugers behandling).
English: EBMT criteria All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
Danish: Opdatering af overlevelsesdata baseret på en median opfølgning på 60,1 måneder mdr.= måneder
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of VELCADE (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.
Danish: Klinisk virkning ved recidiverende eller refraktær myelomatose Sikkerheden og effekten ved VELCADE (som intravenøs injektion) blev vurderet i to studier med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-studie (APEX) versus dexamethason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-studie 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.
English: Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Danish: Neuropati*, perifer sensorisk neuropati, dysæstesi*, neuralgi*
English: Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Danish: dissemineret & oftalmisk), pneumoni*, herpes simplex*, svampeinfektion*
English: Time to next therapy Events n (%) Median (95% CI)
Danish: Tid til næste behandling Hændelser n (%) Median (95 % CI)
English: • General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Danish: • Generel følelse af at være syg, smerter, svimmelhed, ør i hovedet, en følelse af afkræftelse eller bevidsthedstab
English: 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
Danish: Effekten af nedsat leverfunktion på bortezomibs farmakokinetik i doseringsintervallet 0,5-1,3 mg/m blev vurderet i et fase I-studie i den første behandlingscyklus hos 61 patienter med primært solide tumorer og nedsat leverfunktion i varierende grad.
English: N=130 (ITT population)
Danish: N = 130 (ITTpopulation)
English: Patients in the VcDx group received four 21 day cycles, each consisting of VELCADE (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Danish: Patienter i VcDx-gruppen fik fire 21-dages cyklusser, hver bestående af VELCADE (1,3 mg/m2 administreret intravenøst to gange om ugen dag 1, 4, 8 og 11) og oralt dexamethason (40 mg/dag, dag 1 til 4 og dag 9 til 12 i cyklus 1 og 2 og dag 1 til 4 i cyklus 3 og 4).
English: IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day VELCADE treatment cycle.
Danish: på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 af VELCADE-behandlingscyklussens 21 dage.
English: • Coma
Danish: • Koma
English: Time to progression Events n (%) Median a (95% CI)
Danish: Tid til progressionHændelser n (%) Median a (95 % CI)
English: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Danish: Det primære effektendepunkt for studiet var post-induktions- og post-transplantationsresponsrater(CR+nCR).
English: • Haemoglobin ≥ 8 g/dL
Danish: • Hæmoglobin ≥ 8 g/dl (4,96 mmol/l)
English: • Inflammation of the spinal nerve
Danish: • Betændelse i rygmarvsnerven
English: • Bulging eyes
Danish: • Udstående øjne
English: RR (Post-induction) *CR+nCR
Danish: RR (Post-induktion) *CR+nCR
English: If local injection site reactions occur following VELCADE subcutaneous injection, either a less concentrated VELCADE solution (VELCADE 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Danish: Hvis der opstår lokale reaktioner på injektionsstedet efter en subkutan injektion af VELCADE, bør VELCADE enten gives subkutant i en lavere koncentration (VELCADE 3,5 mg rekonstitueres til 1 mg/ml i stedet for 2,5 mg/ml), eller der bør skiftes til intravenøs injektion.
English: N=127 (ITT population)
Danish: N = 127 (ITTpopulation)
English: Peripheral neuropathy in combination regimens Multiple Myeloma
Danish: Perifer neuropati ved kombinationsbehandlinger
English: Table 6: Recommended starting dose modification for VELCADE in patients with hepatic impairment
Danish: Tabel 6: Anbefalet justering af initialdosis for VELCADE hos patienter med nedsat leverfunktion Grad af leverfunktionsnedsættelse*
English: 9/l
Danish: 9/l eller
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Danish: Sjælden Leversvigt, hepatomegali, Budd-Chiaris syndrom, cytomegalovirus-hepatitis, leverblødning, kolelitiasis
English: *RR (Post-induction) CR+nCR
Danish: *RR (Post-induktion) CR+nCR
English: ≤ 30 ml/min (3% in each arm).
Danish: Tilsvarende andele af patienterne havde kreatininclearance ≤ 30 ml/min (3 % i hver gruppe).
English: When VELCADE 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 VELCADE.
Danish: Når VELCADE gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler kontrolleres før initiering af behandling med VELCADE.
English: Combination therapy with melphalan and prednisone VELCADE 1 mg powder for solution for injection is administered via intravenous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Danish: Kombinationsbehandling med melphalan og prednison VELCADE 1 mg pulver til injektionsvæske, opløsning indgives som intravenøs injektion kombineret med oral melphalan og oral prednison som vist i tabel 2.
English: 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.
Danish: Et lægemiddelinteraktionsstudie til vurdering af effekten af ketoconazol, en kraftig CYP3A4-hæmmer, på bortezomibs farmakokinetik (som intravenøs injektion) viste en gennemsnitlig stigning i bortezomibs AUC på 35 % (CI90 % (1,032 til 1,772)) baseret på data fra 12 patienter.
English: Bortezomib is a proteasome inhibitor.
Danish: Bortezomib er en proteasom-hæmmer.
English: • Problems with blood clotting
Danish: • Problemer med blodets størknen
English: VELCADE combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of VELCADE plus pegylated liposomal doxorubicin versus VELCADE monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Danish: VELCADE-kombinationsbehandling med pegyleret liposomal doxorubicin (studie DOXIL-MMY-3001) Der blev udført et randomiseret, parallelgruppe, åbent, fase III-multicenterstudie med 646 patienter for at sammenligne sikkerheden og effekten af VELCADE plus pegyleret liposomal doxorubicin versus VELCADE som monoterapi hos patienter med myelomatose, som tidligere har fået mindst 1 behandling, og som ikke progredierede under antracyklin-baseret behandling.
English: 11 in a 21 day treatment cycle.
Danish: 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Danish: Sindslidelser*, hallucinationer*, psykose*, konfusion*, rastløshed
English: Table 4: Posology for VELCADE combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Danish: Tabel 4: Dosering for VELCADE-kombinationsbehandling til patienter med tidligere ubehandlet myelomatose, som er egnede til hæmatopoietisk stamcelletransplantation
English: VELCADE is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Danish: VELCADE benyttes til behandling af mantle-celle-lymfom (en type kræft, som påvirker lymfeknuderne) i kombination med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison, hos patienter på 18 år og derover, hvis sygdom ikke tidligere er blevet behandlet, og som ikke er egnede til at gennemgå en transplantation af blodstamceller.
English: • General ill feeling
Danish: • Generel følelse af at være syg
English: Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Danish: Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi
English: Main efficacy results are presented in Table 12.
Danish: De væsentligste effektresultater er vist i Tabel 12.
English: • Swelling of the liver, bleeding from the liver
Danish: • Hævelse af leveren, blødning fra leveren
English: #, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Danish: #, neurotoksicitet, epileptiske anfald*, postherpetisk neuralgi, taleforstyrrelser*, restless legssyndrom, migræne, skiatika, opmærksomhedsforstyrrelser, abnorme reflekser*, parosmi
English: Nervous system disorders
Danish: Forstyrrelser i det autonome nervesystem
English: Patients in the VcTDx group received six 4-week cycles, each consisting of VELCADE (1.3 mg/m administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Danish: Patienter i VcTDx-gruppen fik seks 4-ugers cyklusser hver med VELCADE (1,3 mg/m2 administreret to gange om ugen dag 1, 4, 8 og 11 efterfulgt af en 17-dages pause fra dag 12 til dag 28), dexamethason (40 mg administreret oralt dag 1 til 4 og dag 8 til 11) og thalidomid (50 mg dagligt administreret oralt dag 1-14, forhøjet til 100 mg dag 15-28 og derefter til 200 mg dagligt).
English: You might receive up to 6 cycles (24 weeks).
Danish: Du kan få op til 6 cyklusser (24 ugers behandling).
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Danish: Sjælden Testikelsygdom*, prostatitis, sygdom i mammae hos kvinder, epididymal ømhed, epididymitis, bækkensmerter, sårdannelse på vulva
English: VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Danish: VELCADE som monoterapi eller i kombination med pegyleret liposomal doxorubicin eller dexamethason er indiceret til behandling af voksne patienter med progressiv myelomatose, som tidligere har fået mindst én behandling, og som allerede har gennemgået eller er uegnede til hæmatopoietisk stamcelletransplantation.
English: The 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.
Danish: Den rekonstituerede opløsning indgives 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.
English: • Pneumonia
Danish: Pneumoni*
English: • Facial blushing or tiny broken capillaries
Danish: • Ansigtsrødmen eller bittesmå sprængte blodkar
English: VIAL VELCADE 1 mg
Danish: HÆTTEGLAS VELCADE 1 mg
English: Progression Free Survival, months (95% CI)
Danish: Progressionsfri overlevelse, måneder 8,0 (95 % CI)
English: In B-ALL patients with relapse 18-36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Danish: Hos B-ALL-patienter med recidiv inden for 18-36 måneder efter diagnosticering (n = 33) var CR-raten 79 % (95 % CI: 61-91), og den hændelsesfri overlevelsesrate efter 4 måneder var 73 % (95 % CI: 54, 85).
English: chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse
Danish: Tegnene på en sådan reaktion kan være vejrtrækningsbesvær, smerter i/trykken for brystet og/eller svimmelhed/følelse af at være ved at besvime, voldsom kløe i huden eller hævede områder på huden, hævelser i ansigt, læber, tunge og/eller svælg, hvilket kan give synkebesvær, kollaps
English: VELCADE 3.5 mg 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.
Danish: VELCADE 3,5 mg rekonstitueret opløsning indgives 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.
English: Kaplan-Meier estimate.
Danish: Kaplan-Meier-estimat
English: or ANC < 750 cells/μL on a VELCADE dosing day (other than Day 1 of each cycle)
Danish: 9 celler/l på en dag med VELCADE-dosering (undtagen dag 1 i hver cyklus)
English: VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: VELCADE gives intravenøst på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
English: visual loss or disturbances and shortness of breath
Danish: synstab eller -forstyrrelser og kortåndethed
English: VELCADE therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Danish: VELCADE-behandling skal indstilles i op til 2 uger, indtil patienten har ANC ≥ 0,75 x 10
English: VELCADE should not be given by other routes.
Danish: VELCADE må ikke indgives via andre administrationsveje.
English: • Redness of the skin
Danish: • Rødmen af huden
English: How to use VELCADE
Danish: Sådan skal du bruge VELCADE
English: - in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
Danish: - sammen med lægemidlerne melphalan og prednison til behandling af patienter, der ikke tidligere er blevet behandlet for sygdommen, og som ikke er egnede til højdosiskemoterapi med transplantation af blodstamceller.
English: Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Danish: Alvorlige "ikke almindelige" bivirkninger, der er indberettet under behandling med VELCADE, omfatter hjerteinsufficiens, tumorlysesyndrom, pulmonal hypertension, posteriort reversibelt encefalopatisyndrom samt akutte, diffuse, infiltrative lungesygdomme.
English: • different reconstitution requirements for VELCADE 3.5 mg IV or SC use
Danish: • at kravene til rekonstitution af VELCADE 3,5 mg er forskellige ved i.v.
English: There are no studies on the use of VELCADE in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Danish: Der foreligger ingen studier af anvendelse af VELCADE til ældre patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation.
English: • Infection or inflammation of the stomach and intentines
Danish: • Infektion eller inflammation (betændelseslignende tilstand) i mave eller tarme
English: The most commonly reported adverse reactions during treatment with VELCADE are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Danish: De almindeligste bivirkninger, der er indberettet under behandling med VELCADE, er kvalme, diarré, obstipation, opkastning, træthed, pyreksi, trombocytopeni, anæmi, neutropeni, perifer neuropati (inklusive sensorisk neuropati), hovedpine, paræstesier, nedsat appetit, dyspnø, udslæt, herpes zoster og myalgi.
English: • fainting, dizziness or light-headedness in the past
Danish: • tidligere er besvimet, har været svimmel eller ør i hovedet
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Danish: Patienter med ≥ grad 2 perifer neuropati ved baseline eller trombocyttal < 50 x 10
English: What VELCADE looks like and contents of the pack VELCADE powder for solution for injection is a white to off-white cake or powder.
Danish: VELCADE pulver til injektionsvæske, opløsning, er en hvid til gullig masse eller et hvidt til gulligt pulver.
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer Acne*, Blister*, Pigmentation disorder*
Danish: #, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus
English: Combination therapy with melphalan and prednisone VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Danish: Kombinationsbehandling med melphalan og prednison VELCADE 3,5 mg pulver til injektionsvæske, opløsning indgives som intravenøs eller subkutan injektion kombineret med oral melphalan og oral prednison som vist i tabel 2.
English: > 1.5 x 3 x ULN
Danish: > 1,5-3 x ULN
English: Table 16: Efficacy results from study LYM-3002
Danish: Tabel 16: Effektresultater fra studie LYM-3002 Effektendepunkt
English: In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Danish: Akut intervention med positive inotropiske eller pressormidler påvirkede faldet i hjertekontraktilitet og hypotension hos hunde.