FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib 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: Bortezomib 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: • If local injection site reactions occur following bortezomib injection subcutaneously, either a less concentrated bortezomib solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Danish: I tilfælde af lokale reaktioner på injektionsstedet efter en subkutan injektion af bortezomib anbefales det enten at administrere en mindre koncentreret bortezomib opløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller skifte til intravenøs administration.
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you must still be cautious.
Danish: Du må ikke køre bil, motorcykel eller cykle eller arbejde med værktøj eller maskiner, hvis du oplever disse bivirkninger.
English: • fainting, dizziness or light-headedness in the past
Danish: • Tidligere er besvimet, har været svimmel eller ør i hovedet
English: Bortezomib 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: Bortezomib 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: 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: Respirationssvigt, akut respiratory distress syndrome, apnø, pneumothorax, atelektase, pulmonal hypertension, hæmoptysis, hyperventilation, ortopnø, pneumonitis, respiratorisk alkalose, takypnø, lungefibrose, bronkiesygdom*, hypokapni*, interstitiel lungesygdom, lungeinfiltration, sammensnøring af halsen, tør i halsen, øget sekret i de øvre luftveje, halsirritation, øvre luftvej-hoste-syndrom
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib 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), for at bestemme sikkerheden og effekten af bortezomib i dobbel- og tripel-kombination med andre kemoterapeutika som induktionsterapi forud for stamcelletransplantation hos patienter med tidligere ubehandlet myelomatose.
English: • Inflammation of the lining around your heart or fluid around your heart
Danish: • Betændelse i hjertesækken eller væsken omkring hjertet
English: • Shingles (localized including around the eyes or spread across the body)
Danish: • Helvedesild (lokaliseret, herunder omkring øjnene eller spredt over kroppen)
English: • Infections, including pneumonia, respiratory infections, bronchitis, fungal infections,
Danish: • Infektioner inklusive lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom
English: • Infection or inflammation of the stomach and intestine
Danish: • Infektion eller inflammation (betændelseslignende tilstand) i mave og/eller tarme
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.
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01
Danish: Tabel 9: Forekomst af perifer neuropati under induktionsbehandling ved toksicitet og seponering på grund af perifer neuropati
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m and 1.3 mg/m 2, respectively.
Danish: For efterfølgende doser lå den gennemsnitlige totale clearance på 15-32 l/t og 18-32 l/t for doser på henholdsvis 1,0 mg/m og 1,3 mg/m
English: Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
Danish: Ikke almindelig Almen fysisk helbredsforringelse*, ansigtsødem*, reaktion på injektionsstedet*, slimhindegener*, smerter i brystet, gangforstyrrelser, kuldefornemmelse, ekstravasation*, kateterrelaterede komplikationer*, forandringer i væskebehov*, trykken for brystet, fornemmelse af ændret legemstemperatur*, smerter på injektionsstedet*
English: How to use Bortezomib Fresenius Kabi
Danish: Sådan skal du bruge Bortezomib Fresenius Kabi
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m and doxorubicin at 50 mg/m
Danish: , cyclophosphamid 750 mg/m og doxorubicin 50 mg/m 2.
English: If you are given bortezomib 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 bortezomib sammen med andre lægemidler til behandling af mantle-celle-lymfom, er angivet nedenfor:
English: -- -- -- -- rest period
Danish: -- Pause -
English: Table 6: Recommended starting dose modification for bortezomib in patients with hepatic impairment
Danish: Tabel 6: Anbefalede initiale dosisjusteringer for bortezomib til patienter med nedsat leverfunktion.
English: The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m and doxorubicin at 50 mg/m Prednisone is administered orally at 100 mg/m on days 1, 2, 3, 4 and 5 of each bortezomib treatment cycle.
Danish: Følgende lægemidler administreres som intravenøs infusion på dag 1 i hver 3-ugers behandlingscyklus med bortezomib: rituximab 375 mg/m2, cyclophosphamid 750 mg/m og doxorubicin 50 mg/m
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Danish: #, uspecificeret blodsygdom, hæmoragisk diatese, lymfocytinfiltration
English: The CR rate in first-relapsed T-cell ALL patients (n=22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Danish: CR-raten hos førstetilbagefald, T-celle ALL patienter (n=22) var 68 % (95 % CI: 45, 86) og den 4-mdr.
English: • to report any adverse event, or medication error experienced with the administration of bortezomib 3.5 mg.
Danish: • At eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af bortezomib
English: In cycles 1-4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Danish: I cyklus 1-4 indgives bortezomib to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
English: Bortezomib 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: Bortezomib 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: What you need to know before you use Bortezomib Fresenius Kabi
Danish: Det skal du vide, før du begynder at bruge Bortezomib Fresenius Kabi
English: #, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
Danish: #, øjeninflammation*, diplopi, øjentørhed*, øjenirritation*, øjensmerter, øget tåreflåd, øjenflåd
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Danish: I et lægemiddelinteraktionsstudie til vurdering af effekten af rifampicin, som er en potent CYP3A4induktor, på bortezomibs farmakokinetik (som intravenøs injektion) sås en gennemsnitlig reduktion af AUC for bortezomib på 45 % baseret på data fra 6 patienter.
English: Bortezomib treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however bortezomib may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Danish: Behandlingen med bortezomib skal påbegyndes under tilsyn af en kvalificeret læge med erfaring inden for behandling af cancerpatienter.
English: BATCH NUMBER
Danish: Batch
English: In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Danish: Et lægemiddelinteraktionsstudie til vurdering af effekten af omeprazol, en potent CYP2C19-inhibitor, på bortezomibs farmakokinetik (som intravenøs injektion) viste ingen signifikant effekt på bortezomibs farmakokinetik baseret på data fra 17 patienter.
English: *RR (Post-induction) CR+nCR
Danish: *RR (Post-induktion) *CR+nCR
English: #, Stevens-Johnson syndrome Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Danish: #, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus
English: A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients.
Danish: Et lægemiddelinteraktionsstudie til vurdering af effekten af melphalan-prednison på bortezomibs farmakokinetik (som intravenøs injektion) viste en gennemsnitlig stigning i AUC for bortezomib på 17 % baseret på data fra 21 patienter.
English: Very common Musculoskeletal pain* Common
Danish: Muskoskeletale smerter*
English: If you are given bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
Danish: De bivirkninger, du kan opleve, hvis du får bortezomib til behandling af myelomatose, er angivet nedenfor:
English: • Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, 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: Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Danish: Almindelig Muskelspasmer*, muskuloskeletale smerter*, ekstremitetssmerter
English: #, Hypersensitivity*
Danish: Ikke almindelig Angioødem #, hypersensitivitet*
English: When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the bortezomib, 21-day treatment cycle.
Danish: Når bortezomib gives sammen med dexamethason, får du bortezomib intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus.
English: Skin reaction, Jessner's lymphocytic infiltration, Palmar-plantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Danish: 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: Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Danish: tinnitus)* Ikke almindelig Vertigo*, nedsat hørelse (indtil og inkl.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomib treatment cycle.
Danish: Dexamethason administreres oralt ved en dosis på 20 mg på dag 1, 2, 4, 5, 8, 9, 11 og 12 i bortezomibbehandlingscyklussen.
English: Uncommon Colitis (inc clostridium difficile)*
Danish: Ikke almindelig Colitis (inkl.
English: When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 21-day treatment cycle.
Danish: Når bortezomib gives sammen med dexamethason, får du bortezomib intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver bortezomib 21-dages behandlingscyklus.
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Danish: Disse patienter skal behandles med reducerede doser af bortezomib og monitoreres nøje for toksicitet (se pkt.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Danish: Dx 40 mg Dag 1, 2, 3, 4 Dag 8, 9, 10,
English: Bortezomib 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: Bortezomib 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: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Danish: venstre og højre ventrikel)*, myokardie-iskæmi, ventrikeldysfunktion* Ikke almindelig Kardiovaskulær sygdom (inkl.
English: In cycles 5-9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
Danish: I cyklus 5-9 indgives bortezomib en gang om ugen på dag 1, 8, 22 og 29.
English: #, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Danish: #, bronkospasme, KOL*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib treatment cycle.
Danish: Dexamethason administreres oralt i en dosis på 40 mg på dag 1, 2, 3, 4, 8, 9, 10 og 11 i bortezomib behandlingscyklussen.
English: Modification of starting dose
Danish: Initial dosisjustering
English: * Grouping of more than one MedDRA preferred term.
Danish: * Indikerer termer, der omfatter mere end én MedDRA ”foretrukken term” # Indberetninger efter markedsføring, uanset indikation.
English: Grade of hepatic impairment*
Danish: Grad af nedsat leverfunktion*
English: Adverse reaction left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Danish: venstre og højre ventrikel)*, arytmi*, takykardi*, palpitationer, angina pectoris, perikarditis (inkl.
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BR-CAP) Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11, followed by a 10-day rest period on days 12-21.
Danish: Dosering til patienter med tidligere ubehandlet mantlecellelymfom (MCL) Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP) Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11, efterfulgt af en 10-dages pause på dag 12-21.
English: Table 2: Recommended posology for bortezomib in combination with melphalan and prednisone Twice weekly bortezomib (cycles 1-4) Week B (1.3 mg/m
Danish: To gange om ugen bortezomib (cyklus 1-4) Uge B (1,3 mg/m
English: You must not breast-feed while using bortezomib.
Danish: Du må ikke amme, imens du behandles med bortezomib.
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m per day) by continuous infusion over 24 hours with daunorubicin and bortezomib 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/m daglig) ved kontinuerlig infusion over en periode på 24 timer med daunorubicin og bortezomib for recidiverende akut myeloid leukæmi (AML).
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection bortezomib
Danish: Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning bortezomib
English: Nervous system disorders Very common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Danish: Perifer sensorisk neuropati, dysæstesi*, neuralgi*
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Danish: synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati Ikke almindelig Forstyrrelser i det autonome nervesystem
English: This 4-week period is considered a treatment cycle.
Danish: Denne 4ugers periode kaldes en behandlingscyklus.
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Danish: Hvert 10 ml hætteglas med bortezomib skal forsigtigt rekonstitueres med 1,4 ml natriumchlorid 9 mg/ml (0,9 %) til injektionsvæske, opløsning ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: Table 7 has been generated using Version 14.1 of the MedDRA. Post-marketing adverse reactions not seen in clinical trials are also included.
Danish: Tabellen omfatter også bivirkninger fremkommet efter markedsføring, som ikke er set i kliniske studier.
English: Bortezomib 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: Bortezomib 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: • In cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
Danish: • I cyklus 5 til 9 gives bortezomib en gang om ugen på dag 1, 8, 22 og 29.
English: • Yellow discoloration of the eyes and skin (jaundice)
Danish: • Blodpropper i lungerne • Gulfarvning af øjne og hud (gulsot)
English: • In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and
Danish: • I cyklus 1 til 4 gives bortezomib to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
English: Nine treatment cycles of this combination therapy are administered.
Danish: Der gives ni behandlingscyklusser af denne kombinationsbehandling.
English: Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Danish: Almindelig Nedsat nyrefunktion* Ikke almindelig Akut nyresvigt, kronisk nyresvigt*, urinvejsinfektion*, urinvejssymptomer*, hæmaturi*, urinretention, miktionsforstyrrelser*, proteinuri, azotæmi, oliguri*, pollakisuri
English: Change bortezomib treatment schedule to 1.3 mg/m once per week.
Danish: Reducér bortezomib til 1,0 mg/m eller skift behandlingsplanen for bortezomib til 1,3 mg/m én gang om ugen.
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: Subaraknoidal-blødmimg)*, hjerneødem, transtorisk cerebral iskæmi (TCI), koma, forstyrrelser i det autonome nervesystem, autonom neuropati, kraniel parese*, paralyse*, parese*, præsynkope, hjernestammesyndrom, cerebrovaskulær sygdom,
English: Patients with moderate or severe hepatic impairment should be started on bortezomib at a reduced dose of 0.7 mg/m per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m may be considered based on patient tolerability (see table 6 and sections 4.4 and 5.2).
Danish: Patienter med moderat eller svært nedsat leverfunktion skal starte med en reduceret dosis af bortezomib på 0,7 mg/m2 pr. injektion i den første behandlingscyklus; efterfølgende dosisøgning til 1,0 mg/m eller yderligere dosisreduktion til
English: Nervous system disorders Very common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Danish: Neuropati*, perifer sensorisk neuropati, dysæstesi*, neuralgi*