natgillin/translations-raw huggingface dataset:
Du kan få op til 6 cyklusser (24 ugers behandling).
You might receive up to 6 cycles (24 weeks).
Sjælden Testikelsygdom*, prostatitis, sygdom i mammae hos kvinder, epididymal ømhed, epididymitis, bækkensmerter, sårdannelse på vulva
Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
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.
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.
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.
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.
Pneumoni*
• Pneumonia
• Ansigtsrødmen eller bittesmå sprængte blodkar
• Facial blushing or tiny broken capillaries
HÆTTEGLAS VELCADE 1 mg
VIAL VELCADE 1 mg
Progressionsfri overlevelse, måneder 8,0 (95 % CI)
Progression Free Survival, months (95% CI)
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).
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).
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
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
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.
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.
Kaplan-Meier-estimat
Kaplan-Meier estimate.
9 celler/l på en dag med VELCADE-dosering (undtagen dag 1 i hver cyklus)
or ANC < 750 cells/μL on a VELCADE dosing day (other than Day 1 of each cycle)
VELCADE gives intravenøst på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
synstab eller -forstyrrelser og kortåndethed
visual loss or disturbances and shortness of breath
VELCADE-behandling skal indstilles i op til 2 uger, indtil patienten har ANC ≥ 0,75 x 10
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.
VELCADE må ikke indgives via andre administrationsveje.
VELCADE should not be given by other routes.
• Rødmen af huden
• Redness of the skin
Sådan skal du bruge VELCADE
How to use VELCADE
- 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.
- 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.
Alvorlige "ikke almindelige" bivirkninger, der er indberettet under behandling med VELCADE, omfatter hjerteinsufficiens, tumorlysesyndrom, pulmonal hypertension, posteriort reversibelt encefalopatisyndrom samt akutte, diffuse, infiltrative lungesygdomme.
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.
• at kravene til rekonstitution af VELCADE 3,5 mg er forskellige ved i.v.
• different reconstitution requirements for VELCADE 3.5 mg IV or SC use
Der foreligger ingen studier af anvendelse af VELCADE til ældre patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation.
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.
• Infektion eller inflammation (betændelseslignende tilstand) i mave eller tarme
• Infection or inflammation of the stomach and intentines
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.
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.
• tidligere er besvimet, har været svimmel eller ør i hovedet
• fainting, dizziness or light-headedness in the past
Patienter med ≥ grad 2 perifer neuropati ved baseline eller trombocyttal < 50 x 10
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
VELCADE pulver til injektionsvæske, opløsning, er en hvid til gullig masse eller et hvidt til gulligt pulver.
What VELCADE looks like and contents of the pack VELCADE powder for solution for injection is a white to off-white cake or powder.
#, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus
#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer Acne*, Blister*, Pigmentation disorder*
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.
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.
> 1,5-3 x ULN
> 1.5 x 3 x ULN
Tabel 16: Effektresultater fra studie LYM-3002 Effektendepunkt
Table 16: Efficacy results from study LYM-3002
Akut intervention med positive inotropiske eller pressormidler påvirkede faldet i hjertekontraktilitet og hypotension hos hunde.
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Hver pakning VELCADE 3,5 mg pulver til injektionsvæske, opløsning, indeholder et 10 ml hætteglas med kongeblåt låg i en gennemsigtig blisterpakning.
Each carton of VELCADE 3.5 mg powder for solution for injection contains a glass 10 ml vial with a royal blue cap, in a transparent blister pack.
Når VELCADE gives i kombination med andre lægemidler, henvises der til produktresuméerne for disse lægemidler vedrørende anvisninger i administration.
When VELCADE is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Almindelig Påvirket sindstilstand og stemningssving*, angsttilstande*, søvnforstyrrelser*
Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
• Infektioner inklusive lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
VELCADE kombineret med rituximab, cyclophosphamid, doxorubicin og prednison er indiceret til behandling af voksne patienter med tidligere ubehandlet mantle-celle-lymfom, som ikke er egnede til hæmatopoietisk stamcelletransplantation.
VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
• Luftvejsinfektioner, bronkitis, hoste med slim, influenza-lignende sygdom
• Respiratory infections, bronchitis, coughing with phlegm, flu like illness
CR+nCR+PR % (95 % CI) *RR (Post-transplantation) CR+nCR
CR+nCR+PR % (95% CI) *RR (Post-transplant) CR+nCR
VELCADE subkutan gruppe
VELCADE subcutaneous arm
Hyperbilirubinæmi*, abnorme proteinanalyser*, vægtstigning, abnorm blodprøve*, forhøjet C-reaktivt protein Sjælden Abnorme blodgasser*, elektrokardiografiske abnormaliteter (inkl.
Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
De bivirkninger, du kan opleve, hvis du får VELCADE til behandling af myelomatose, er angivet nedenfor:
If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:
Bortezomibs farmakokinetik påvirkes ikke hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance [CrCl] > 20 ml/min/1,73 m2).
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Bivirkning
Incidence
VELCADEs sikkerhedsprofil vurderet hos 240 MCL-patienter behandlet med VELCADE i en dosis på 1,3 mg/m2 i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP) kontra 242 patienter behandlet med rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP] var relativt overensstemmende med den, som blev observeret hos patienter med myelomatose, med de væsentligste forskelle beskrevet nedenfor.
Mantle Cell Lymphoma (MCL) The safety profile of VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Patienter, som er egnede til stamcelletransplantation Der blev gennemført to randomiserede open-label, multicenter fase III-studier (IFM-2005-01, MMY3010) til påvisning af VELCADEs sikkerhed og effekt i dobbel- og tripel-kombination med andre kemoterapeutika som induktionsterapi forud for stamcelletransplantation ved tidligere ubehandlet myelomatose.
Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of VELCADE in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Indikerer termer, der omfatter mere end én MedDRA ”foretrukken term” Indberetninger efter markedsføring, uanset indikation
Post-marketing adverse reaction regardless of indication
Samlet overlevelse* Hændelser (dødsfald) n (%) Median
Overall survival* Events (deaths) n (%) Median (95% CI)
• Der skal vælges et nyt injektionssted hver gang.
• Injection sites should be rotated for successive injections.
• Stivhed i led og muskler, følelse af tunghed, smerter i skridtet
• Joint or muscle stiffness, sense of heaviness, pain in your groin
Almindelig Hypotension*, ortostatisk hypotension, hypertension* Ikke almindelig
Hypotension*, Orthostatic hypotension, Hypertension*
• Halsbrand, oppustethed, ræben, luft i tarmene, mavesmerter, blødning fra mave eller tarm
• Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få VELCADE intravenøst sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Når VELCADE gives i kombination med andre kemoterapeutika, skal passende dosisreduktioner af disse lægemidler desuden overvejes i tilfælde af toksicitet, i henhold til anbefalingerne i de respektive produktresuméer.
In addition, when VELCADE is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Hårsygdom*
Malaise*
• Smerter i kønsorganerne, problemer med rejsning af penis
• Genital pain, problem having an erection
• Øm mund eller læber, tør mund, sår i munden eller halssmerter
• A sore mouth or lip, dry mouth, mouth ulcers or throat pain
• Ændringer i leverfunktion
• Alteration of liver function
Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyklus 2 - 4
Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
• vejledning i dosering med eksempler: Sådan beregnes patientens legemsoverflade og det nødvendige volumen rekonstitueret VELCADE (både til i.v.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted VELCADE (both IV and SC use) required for different body surface areas.
105 (81 %) og 78 (61 %) patienter i henholdsvis VcTDx og TDx-gruppen fik en enkelt autolog stamcelletransplantation.
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively.
Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/m² på dag 4 af VELCADE-behandlingscyklussen som en 1-times intravenøs infusion, der administreres efter VELCADE-injektionen.
Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the VELCADE treatment cycle as a 1 hour intravenous infusion administered after the VELCADE injection.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få VELCADE samtidig med to andre lægemidler; melphalan og prednison.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE together with two other medicines; melphalan and prednisone.
VELCADE 3,5 mg pulver til injektionsvæske, opløsning er tilgængelig til intravenøs eller subkutan administration.
VELCADE 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Muskuloskeletale smerter*
Very Common Musculoskeletal pain* Common
8 dag pause da g dag dag dag pause
Day 4 Day 8 Day rest period
spjætten
Seizures
Kun til intravenøs anvendelse.
Intravenous use only.
Behandlingen med VELCADE skal initieres under tilsyn af en læge med erfaring inden for behandling af cancerpatienter.
VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
VELCADE 1 mg pulver til injektionsvæske, opløsning, er kun beregnet til intravenøs anvendelse, mens VELCADE 3,5 mg pulver til injektionsvæske, opløsning, er til intravenøs eller subkutan anvendelse.
VELCADE 1 mg powder for solution for injection is for intravenous use only, while VELCADE 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
• Hudkræft
• Cancer of the skin
Effektresultaterne fremgår af tabel 15:
Efficacy results are presented in Table 15:
Prednison administreres oralt 100 mg/m2 på dag 1, 2, 3, 4 og 5 i hver VELCADE-behandlingscyklus.
Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each VELCADE treatment cycle.
Cerebrovaskulært attak
Uncommon Cerebrovascular accident
I cyklus 1-4 indgives VELCADE to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
In Cycles 1-4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Subkutan anvendelse: Tilsæt 1,4 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 2,5 mg/ml.
Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
subaraknoidalblødning)*, hjerneødem, transitorisk cerebral iskæmi (TCI), koma, forstyrrelser i det autonome nervesystem, autonom neuropati, kraniel parese*, paralyse*, parese*, præsynkope, hjernestammesyndrom, cerebrovaskulær sygdom, nerverodsskade, psykomotorisk hyperaktivitet, kompression af rygmarven, uspecificeret kognitiv forstyrrelse, motorisk dysfunktion, uspecificeret sygdom i nervesystemet, radikulitis, savlen, hypotoni
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Almindelig Dyspnø*, epistaxis, øvre/nedre luftvejsinfektion*, hoste* Ikke almindelig
Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
CI = konfidensinterval; CR = komplet respons; nCR = næsten komplet respons; ITT = intent to treat; RR = responsrate; Vc = VELCADE; VcDx = VELCADE, dexamethason; VDDx = vincristin, doxorubicin, dexamethason; VGPR = virkeligt godt partielt respons; PR = partielt respons, OR = odds ratio;
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcDx=VELCADE, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Sjælden Respirationssvigt, akut respiratory distress syndrome, apnø, pneumothorax, atelektase, pulmonal hypertension, hæmoptysis, hyperventilation, ortopnø, pneumonitis, respiratorisk baseosis, takypnø, lungefibrose, bronkiesygdom*, hypokapni*, interstitiel lungesygdom, lungeinfiltration, sammensnøring af halsen, tør i halsen, øget sekret i de øvre luftveje, halsirritation, øvre luftvejhoste-syndrom
Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome
Trombocytopeni*, neutropeni*, anæmi*
Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
• Irriterede eller betændte øjne, meget våde øjne, smerter i øjnene, tørre øjne, øjeninfektioner,
• Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision,
Almindelig Dehydrering, hypokaliæmi*, hyponatriæmi*, unormal blodglucose*, hypokalcæmi*, enzymforstyrrelser*
Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få VELCADE intravenøst samtidig med to andre lægemidler; melphalan og prednison.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE intravenously together with two other medicines; melphalan and prednisone.
VELCADE gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Instrumentel ADL: Dækker madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv.
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; ***Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
stafylokok), hordeolum, influenza, cellulitis, udstyrsrelateret infektion, hudinfektion*, øreinfektion*, stafylokokinfektion, tandinfektion*
#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
dag paus pause
Day rest period
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få VELCADE intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Myelomatose
Multiple Myeloma
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få VELCADE intravenøst samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få VELCADE intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
VELCADE kombineret med melphalan og prednison er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, som er uegnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation.
VELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Intravenøs anvendelse: Tilsæt 3,5 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 1 mg/ml.
Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.