FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Hver pakning VELCADE 3,5 mg pulver til injektionsvæske, opløsning, indeholder et 10 ml hætteglas med kongeblåt låg i en gennemsigtig blisterpakning.
English: When VELCADE is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Danish: Når VELCADE gives i kombination med andre lægemidler, henvises der til produktresuméerne for disse lægemidler vedrørende anvisninger i administration.
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
Danish: Almindelig Påvirket sindstilstand og stemningssving*, angsttilstande*, søvnforstyrrelser*
English: • Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Danish: • Infektioner inklusive lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom
English: 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.
Danish: 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.
English: • Respiratory infections, bronchitis, coughing with phlegm, flu like illness
Danish: • Luftvejsinfektioner, bronkitis, hoste med slim, influenza-lignende sygdom
English: CR+nCR+PR % (95% CI) *RR (Post-transplant) CR+nCR
Danish: CR+nCR+PR % (95 % CI) *RR (Post-transplantation) CR+nCR
English: VELCADE subcutaneous arm
Danish: VELCADE subkutan gruppe
English: Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Danish: Hyperbilirubinæmi*, abnorme proteinanalyser*, vægtstigning, abnorm blodprøve*, forhøjet C-reaktivt protein Sjælden Abnorme blodgasser*, elektrokardiografiske abnormaliteter (inkl.
English: If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:
Danish: De bivirkninger, du kan opleve, hvis du får VELCADE til behandling af myelomatose, er angivet nedenfor:
English: 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.
Danish: Bortezomibs farmakokinetik påvirkes ikke hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance [CrCl] > 20 ml/min/1,73 m2).
English: Incidence
Danish: Bivirkning
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Post-marketing adverse reaction regardless of indication
Danish: Indikerer termer, der omfatter mere end én MedDRA ”foretrukken term” Indberetninger efter markedsføring, uanset indikation
English: Overall survival* Events (deaths) n (%) Median (95% CI)
Danish: Samlet overlevelse* Hændelser (dødsfald) n (%) Median
English: • Injection sites should be rotated for successive injections.
Danish: • Der skal vælges et nyt injektionssted hver gang.
English: • Joint or muscle stiffness, sense of heaviness, pain in your groin
Danish: • Stivhed i led og muskler, følelse af tunghed, smerter i skridtet
English: Hypotension*, Orthostatic hypotension, Hypertension*
Danish: Almindelig Hypotension*, ortostatisk hypotension, hypertension* Ikke almindelig
English: • Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Danish: • Halsbrand, oppustethed, ræben, luft i tarmene, mavesmerter, blødning fra mave eller tarm
English: 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.
Danish: Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få VELCADE intravenøst sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
English: 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.
Danish: 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.
English: Malaise*
Danish: Hårsygdom*
English: • Genital pain, problem having an erection
Danish: • Smerter i kønsorganerne, problemer med rejsning af penis
English: • A sore mouth or lip, dry mouth, mouth ulcers or throat pain
Danish: • Øm mund eller læber, tør mund, sår i munden eller halssmerter
English: • Alteration of liver function
Danish: • Ændringer i leverfunktion
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Danish: Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyklus 2 - 4
English: • 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.
Danish: • vejledning i dosering med eksempler: Sådan beregnes patientens legemsoverflade og det nødvendige volumen rekonstitueret VELCADE (både til i.v.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively.
Danish: 105 (81 %) og 78 (61 %) patienter i henholdsvis VcTDx og TDx-gruppen fik en enkelt autolog stamcelletransplantation.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: VELCADE 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning er tilgængelig til intravenøs eller subkutan administration.
English: Very Common Musculoskeletal pain* Common
Danish: Muskuloskeletale smerter*
English: Day 4 Day 8 Day rest period
Danish: 8 dag pause da g dag dag dag pause
English: Seizures
Danish: spjætten
English: Intravenous use only.
Danish: Kun til intravenøs anvendelse.
English: 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.
Danish: Behandlingen med VELCADE skal initieres under tilsyn af en læge med erfaring inden for behandling af cancerpatienter.
English: 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.
Danish: 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.
English: • Cancer of the skin
Danish: • Hudkræft
English: Efficacy results are presented in Table 15:
Danish: Effektresultaterne fremgår af tabel 15:
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each VELCADE treatment cycle.
Danish: Prednison administreres oralt 100 mg/m2 på dag 1, 2, 3, 4 og 5 i hver VELCADE-behandlingscyklus.
English: Uncommon Cerebrovascular accident
Danish: Cerebrovaskulært attak
English: In Cycles 1-4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Danish: I cyklus 1-4 indgives VELCADE to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Danish: Subkutan anvendelse: Tilsæt 1,4 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 2,5 mg/ml.
English: 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
Danish: 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
English: Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Danish: Almindelig Dyspnø*, epistaxis, øvre/nedre luftvejsinfektion*, hoste* Ikke almindelig
English: 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.
Danish: 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;
English: 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
Danish: 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
English: Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Danish: Trombocytopeni*, neutropeni*, anæmi*
English: • 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,
Danish: • Irriterede eller betændte øjne, meget våde øjne, smerter i øjnene, tørre øjne, øjeninfektioner,
English: Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Danish: Almindelig Dehydrering, hypokaliæmi*, hyponatriæmi*, unormal blodglucose*, hypokalcæmi*, enzymforstyrrelser*
English: 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.
Danish: 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.
English: VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: VELCADE gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
English: ** 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.
Danish: Instrumentel ADL: Dækker madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv.
English: #, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Danish: stafylokok), hordeolum, influenza, cellulitis, udstyrsrelateret infektion, hudinfektion*, øreinfektion*, stafylokokinfektion, tandinfektion*
English: Day rest period
Danish: dag paus pause
English: 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.
Danish: 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.
English: Multiple Myeloma
Danish: Myelomatose
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Danish: Intravenøs anvendelse: Tilsæt 3,5 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 1 mg/ml.
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of VELCADE in patients with previously treated light-chain (AL) Amyloidosis.
Danish: Der blev udført et åbent, ikke-randomiseret fase I/II-studie for at bestemme VELCADES sikkerhed og virkning hos patienter, der tidligere var blevet behandlet for AL-amyloidose.
English: • Tiredness, feeling weak
Danish: • Træthed, svaghed
English: • Lump in the eyelid (chalazion), red and swollen eyelids
Danish: • Haglkorn (en knude i øjenlåget), røde og hævede øjenlåg
English: Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Danish: Sjælden Hudreaktion, Jessners benigne lymfocyt-infiltration, palmoplantar erytrodysæstesi (hånd-fod-syndrom), subkutan blødning, livedo reticularis, fortykkelse af huden, papler, lysfølsomhedsreaktion, seboré, koldsved, uspecificeret hudsygdom, erytrose, hudsår, neglesygdom
English: Note: VELCADE is a cytotoxic agent.
Danish: NB: VELCADE er en cellegift.
English: The most commonly reported adverse reactions during treatment with VELCADE are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia,
Danish: De almindeligste bivirkninger, der er indberettet under behandling med VELCADE, er kvalme, diarré, obstipation, opkastning, træthed, pyreksi,
English: Discontinue VELCADE
Danish: Indstil VELCADE-behandlingen
English: • Chest pains or shortness of breath with exercise
Danish: • Brystsmerter eller stakåndehed ved fysisk udfoldelse
English: Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Danish: Intravenøs anvendelse: Tilsæt 1 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 1 mg/ml.
English: • Sore mouth or lip, throat pain
Danish: • Øm mund eller ømme læber, halssmerter
English: VELCADE in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Danish: VELCADE kombineret med dexamethason eller med dexamethason og thalidomid er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation.
English: When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Danish: Når VELCADE gives sammen med pegyleret liposomal doxorubicin, får du VELCADE intravenøst som en 21-dages behandlingscyklus, og pegyleret liposomal doxorubicin gives i en dosis på 30 mg/m på dag 4 i den 21-dages behandlingscyklus med VELCADE som en intravenøs infusion efter VELCADE-injektionen.
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
Danish: 9 celler/l og absolut neutrofiltal (ANC) skal være
English: Common Vision abnormal*
Danish: Almindelig Synsforstyrrelser*
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.
Danish: Prednison gives oralt 100 mg/m 2 på dag 1, 2, 3, 4 og 5 i VELCADE-behandlingscyklussen.
English: 1 mg/m 2 to 0.7 mg/m
Danish: 1 mg/m2 eller fra 1 mg/m2 til 0,7 mg/m2).
English: Marketing Authorisation Holder JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg 30
Danish: Indehaver af markedsføringstilladelsen JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg 30
English: When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Danish: Når VELCADE gives sammen med pegyleret liposomal doxorubicin, får du VELCADE intravenøst eller subkutant i en 21-dages behandlingscyklus, og pegyleret liposomal doxorubicin gives i en dosis på 30 mg/m på dag 4 i den 21-dages behandlingscyklus med VELCADE som en intravenøs infusion efter VELCADE-injektionen.
English: Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Danish: Sjælden Hypermagnesiæmi*, acidose, forstyrrelser i elektrolytbalancen*, væskeophobning, hypokloræmi*, hypovolæmi, hyperkloræmi*, hyperfosfatæmi*, stofskiftesygdom, B-vitaminmangel, B12vitaminmangel, artritis urica, øget appetit, alkoholintolerans
English: Very Common Decreased appetite
Danish: Nedsat appetit
English: Table 2: Recommended posology for VELCADE in combination with melphalan and prednisone
Danish: Tabel 2: Anbefalet dosering for VELCADE i kombination med melphalan og prednison VELCADE to gange om ugen (cyklus 1-4)
English: CR+nCR+VGPR+PR % (95% CI) RR (Post-transplant) CR+nCR
Danish: CR+nCR+VGPR+PR % (95 % CI) RR (Post-transplantation) CR+nCR
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and VELCADE for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Danish: Patienterne fik højdosis cytarabin (2 g/m2 dagligt) ved kontinuerlig infusion over en periode på 24 timer med daunorubicin og VELCADE for recidiverende akut myeloid leukæmi (AML).
English: #, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Danish: #, blefaritis øjeninflammation*, diplopi, øjentørhed*, øjenirritation*, øjensmerter, øget tåreflåd, øjenflåd
English: VELCADE dose should be reduced by 1 dose level (from 1.3 mg/m 2 to 1 mg/m 2, or from
Danish: VELCADE-dosis skal reduceres med 1 dosisniveau (fra 1,3 mg/m 2 til 1 mg/m 2 eller fra 1 mg/m 2 til 0,7 mg/m
English: In Cycles 5-9, VELCADE is administered once weekly on days 1, 8, 22 and 29.
Danish: I cyklus 5-9 indgives VELCADE en gang om ugen på dag 1, 8, 22 og 29.
English: Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Danish: dissemineret og oftalmisk), herpes-virusinfektion*, bakterieinfektion*, øvre/nedre luftvejsinfektion*, svampeinfektion*, herpes simplex*
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Danish: #, uspecificeret blodsygdom, hæmoragisk diatese, lymfocytinfiltration,