natgillin/translations-raw huggingface dataset:
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 
• 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
Almindelig Muskelspasmer*, muskuloskeletale smerter*, ekstremitetssmerter 
Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Ikke almindelig Angioødem #, hypersensitivitet* 
#, Hypersensitivity*
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. 
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.
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 
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
tinnitus)* Ikke almindelig Vertigo*, nedsat hørelse (indtil og inkl. 
Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Dexamethason administreres oralt ved en dosis på 20 mg på dag 1, 2, 4, 5, 8, 9, 11 og 12 i bortezomibbehandlingscyklussen. 
Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomib treatment cycle.
Ikke almindelig Colitis (inkl. 
Uncommon Colitis (inc clostridium difficile)*
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. 
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.
Disse patienter skal behandles med reducerede doser af bortezomib og monitoreres nøje for toksicitet (se pkt. 
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).
Dx 40 mg Dag 1, 2, 3, 4 Dag 8, 9, 10, 
Day 1, 2, 3, 4 Day 8, 9, 10, 11
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. 
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.
venstre og højre ventrikel)*, myokardie-iskæmi, ventrikeldysfunktion* Ikke almindelig Kardiovaskulær sygdom (inkl. 
Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
I cyklus 5-9 indgives bortezomib en gang om ugen på dag 1, 8, 22 og 29. 
In cycles 5-9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
#, bronkospasme, KOL*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning 
#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Dexamethason administreres oralt i en dosis på 40 mg på dag 1, 2, 3, 4, 8, 9, 10 og 11 i bortezomib behandlingscyklussen. 
Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib treatment cycle.
Initial dosisjustering 
Modification of starting dose
* Indikerer termer, der omfatter mere end én MedDRA ”foretrukken term” # Indberetninger efter markedsføring, uanset indikation. 
* Grouping of more than one MedDRA preferred term.
Grad af nedsat leverfunktion* 
Grade of hepatic impairment*
venstre og højre ventrikel)*, arytmi*, takykardi*, palpitationer, angina pectoris, perikarditis (inkl. 
Adverse reaction left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
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. 
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.
To gange om ugen bortezomib (cyklus 1-4) Uge B (1,3 mg/m 
Table 2: Recommended posology for bortezomib in combination with melphalan and prednisone Twice weekly bortezomib (cycles 1-4) Week B (1.3 mg/m
Du må ikke amme, imens du behandles med bortezomib. 
You must not breast-feed while using bortezomib.
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). 
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.
Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning bortezomib 
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection bortezomib
Perifer sensorisk neuropati, dysæstesi*, neuralgi* 
Nervous system disorders Very common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati Ikke almindelig Forstyrrelser i det autonome nervesystem 
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Denne 4ugers periode kaldes en behandlingscyklus. 
This 4-week period is considered a treatment cycle.
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. 
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.
Tabellen omfatter også bivirkninger fremkommet efter markedsføring, som ikke er set i kliniske studier. 
Table 7 has been generated using Version 14.1 of the MedDRA. Post-marketing adverse reactions not seen in clinical trials are also included.
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. 
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.
• I cyklus 5 til 9 gives bortezomib en gang om ugen på dag 1, 8, 22 og 29. 
• In cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
• Blodpropper i lungerne • Gulfarvning af øjne og hud (gulsot) 
• Yellow discoloration of the eyes and skin (jaundice)
• I cyklus 1 til 4 gives bortezomib to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32. 
• In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and
Der gives ni behandlingscyklusser af denne kombinationsbehandling. 
Nine treatment cycles of this combination therapy are administered.
Almindelig Nedsat nyrefunktion* Ikke almindelig Akut nyresvigt, kronisk nyresvigt*, urinvejsinfektion*, urinvejssymptomer*, hæmaturi*, urinretention, miktionsforstyrrelser*, proteinuri, azotæmi, oliguri*, pollakisuri 
Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Reducér bortezomib til 1,0 mg/m eller skift behandlingsplanen for bortezomib til 1,3 mg/m én gang om ugen. 
Change bortezomib treatment schedule to 1.3 mg/m once per week.
Subaraknoidal-blødmimg)*, hjerneødem, transtorisk cerebral iskæmi (TCI), koma, forstyrrelser i det autonome nervesystem, autonom neuropati, kraniel parese*, paralyse*, parese*, præsynkope, hjernestammesyndrom, cerebrovaskulær sygdom, 
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
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 
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).
Neuropati*, perifer sensorisk neuropati, dysæstesi*, neuralgi* 
Nervous system disorders Very common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Hvert 10 ml hætteglas med bortezomib skal forsigtigt rekonstitueres med 3,5 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. 
Each 10 ml vial of bortezomib must be carefully reconstituted with 3.5 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.
Responsrate n: responseevaluérbare patienter Samlet komplet respons (CR+CRu) 
Response rate n: response-evaluable patients
• Stakåndethed eller hoste 
• shortness of breath or cough
Prednison administreres oralt i en dosis på 100 mg/m på dag 1, 2, 3, 4 og 5 i hver bortezomib behandlingscyklus. 
Prednisone is given orally at 100 mg/m on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Når bortezomib gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler kontrolleres for yderligere kontraindikationer. 
When bortezomib is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
demens)*, encefalopati*, posterior reversibelt encefalopati syndrom neurotoksicitet, epileptiske anfald*, postherpetisk neuralgi, taleforstyrrelser*, restless legs syndrom, migræne, skiatika, opmærksomhedsforstyrrelser, abnorme reflekser*, parosmi 
Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Akut pankreatitis, peritonitis*, tungeødem*, ascites, øsofagitis, læbebetændelse, fækal inkontinens, analsfinkteratoni, fækalom*, gastrointestinal ulcus og perforation*, gingival hypertrofi, megacolon, rektalt udflåd, blisterdannelse i hals og svælg*, læbesmerter, parodontitis, analfissur, forandringer i peristaltikken, proktalgi, anormal fæces 
Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
1.1 Præparation af 3,5 mg hætteglas: Tilsæt forsigtigt 3,5 ml steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske til hætteglasset, der indeholder bortezomib pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset. 
1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Psykiske forstyrrelser Almindelig Humørlidelser og humørforstyrrelser*, angsttilstande*, søvnlidelser og -forstyrrelser* 
Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
1.1 Præparation af 3,5 mg hætteglas: Tilsæt forsigtigt 1,4 ml steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske til hætteglasset, der indeholder bortezomib pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset. 
1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib powder by using a syringe of the appropriate size without removing the vial stopper.
Efter rekonstituering indeholder 1 ml opløsning til subkutan injektion 2,5 mg bortezomib. 
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Effektresultaterne fremgår af tabel 16. 
Efficacy results are presented in table 16:
Almindelig Leukopeni*, lymfopeni* Ikke almindelig Pancytopeni*, febril neutropeni, koagulopati*, 
Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Trombocytopeni*, febril neutropeni, neutropeni*, leukopeni*, anæmi*, lymfopeni* Ikke almindelig Pancytopeni* 
Very common Thrombocytopenia*, Febrile neutropenia, Neutropenia*, Leukopenia*, Anaemia*, Lymphopenia*
Almindelig Dehydrering, hypokalæmi*, hyponatræmi*, abnorm blodglucose*, hypocalcæmi*, enzymforstyrrelser * Ikke almindelig Tumourlysesyndrom, manglende trivsel*, hypomagnesæmi*, hypofosfatæmi*, hyperkalæmi*, hypercalcæmi*, hypernatræmi*, abnorm urinsyre*, diabetes mellitus*, væskeretention 
Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Almindelig Dyspnø*, hoste*, hikke Ikke almindelig Akut respiratory distress syndrome, lungeemboli, pneumonitis, pulmonal hypertension, lungeødem (inkl. 
Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Efter rekonstituering indeholder 1 ml opløsning til intravenøs injektion 1 mg bortezomib. 
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Det er uvist, om bortezomibs farmakokinetik bliver påvirket hos patienter med svært nedsat nyrefunktion (CrCl < 20 ml/min/1,73 m2), som ikke er i dialyse. 
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m Since dialysis may reduce bortezomib concentrations, bortezomib should be administered after the dialysis procedure (see section 5.2).
Kvalme og opkasning symptomer*, Diarré*, forstoppelse 
Gastrointestinal disorders Very common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
hiatus)*, nedsat sårheling*, inflammation, flebitis på injektionsstedet*, ømhed, ulcus, irritabilitet, ikke-kardielle brystsmerter, smerter på kateterstedet, fornemmelse af fremmedlegeme 
Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia (inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
I det samme lægemiddelinteraktionsstudie blev effekten af den svagere CYP3A4-induktor dexamethason på bortezomibs farmakokinetik (som intravenøs injektion) vurderet. 
In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients.
Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 
Marketing Authorisation Holder Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Efterfølgende kan bortezomib re-initieres ved en dosis, som er reduceret 1 dosisniveau (fra 1,3 mg/m til 1 
Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
efter diagnosticering (n=27), var CR-raten 67 % (95 % CI: 46, 84); den 4-mdr. 
In B-ALL patients with relapse within 18 months of diagnosis (n=27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Hypermagnesæmi*, acidose, forstyrrelser i elektrolytbalancen *, væskeophobning, hypochloræmi*, hypovolæmi, hyperchloræmi*, hyperfosfatæmi*, stofskiftesygdom, B-vitaminmangel, B12-vitaminmangel, gigt, øget appetit, alkoholintolerance 
Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Aplasi, misdannelse i mave-tarm-kanalen, iktyose 
Aplasia, Gastrointestinal malformation, Ichthyosis
B (1,3 mg/m2) Dag 1, 4 
B (1.3 mg/m
Nervesystemet 
due to nerve damage
Den mediane varighed af komplet respons var 42,1 måneder i BR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen. 
BR-CAP group compared with 18 months in the R-CHOP group.
og s.c. anvendelse) til forskellige arealer af legemsoverfladen (krydshenvisning til regnestok). 
• volume of reconstituted bortezomib (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
• Kvalme og/eller opkastning, nedsat appetit 
• Feeling sick (nausea) or vomiting, loss of appetite
Almindelig Hypotension*, ortostatisk hypotension, hypertension* Ikke almindelig Cerebrovaskulært attak 
Hypotension*, Orthostatic hypotension, Hypertension*
9/l eller 
9/l or ANC
leversygdom), hepatitis*, kolestase 
Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis
Bortezomib Fresenius Kabi 3,5 mg pulver til injektionsvæske, opløsning er tilgængelig til intravenøs eller subkutan administration. 
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
• Trombocyttal skal være ≥ 100.000 celler/µl og absolut neutrofiltal (ANC) skal være ≥ 1.500 celler/µl 
• Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be
tyndtarmsobstruktion, ileus)*, abdominalt ubehag, mundsår*, enteritis*, gastritis*, gingival blødning, gastroøsofageal reflukssygdom*, colitis (inkl. 
Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis
dissemineret & oftalmisk), herpes-virusinfektion*, bakterieinfektion*, øvre/nedre luftvejsinfektion*, svampeinfektion*, herpes simplex* Ikke almindelig Hepatitis B, infektion*, bronkopneumoni Blod og lymfesystem Meget almindelig 
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
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). 
Patients in the BDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m 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).
(95% CI) p-værdi c a 
(95% CI) p-value c a Kaplan-Meier estimate b
Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}. 
This leaflet was last revised in MM/YYYY
• Lammelse, krampeanfald, fald, bevægelsesforstyrrelser, unormale, forandrede eller nedsatte sanser (føle-, høre-, smags- eller lugtesans), opmærksomhedsforstyrrelser, skælven, spjætten 
• Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Bortezomib subkutan gruppe 
Discontinue bortezomib
Pulver til injektionsvæske, opløsning. 
PHARMACEUTICAL FORM Powder for solution for injection.
perifert), kuldegysninger, smerter*, utilpashed* 
Oedema (inc peripheral), Chills, Pain*, Malaise*
• Hukommelsestab, nedsat tankevirksomhed, gangbesvær eller synstab. 
• memory loss, trouble thinking, difficulty with walking or loss of vision.
NB: Bortezomib er en cellegift. 
Note: Bortezomib is a cytotoxic agent.
kardiogent chok), torsades de pointes, ustabil angina, hjerteklapsygdomme*, koronarinsufficiens, sinusarrest 
Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Når bortezomib gives i kombination med andre cytostatika, skal passende dosisreduktion af disse præparater overvejes i tilfælde af toksicitet. 
In addition, when bortezomib is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Rabdomyolyse, kæbeledssyndrom, fistel, ledeffusion, kæbesmerter, knoglesygdom, infektioner og inflammationer i knogler, led og bindevæv*, synovialcyste 
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
fradiagnosticering (n=33) var CR-raten 79 % (95 % CI: 61, 91) og den 4-mdr. 
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).
Almindelig Synsforstyrrelser* 
Very common Hair disorder* Common
• Problemer med nyrerne 
• kidney problems