FrancophonIA/ELRC3.0 huggingface dataset:
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcTDx=VELCADE, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint
Danish: CI = konfidensinterval; CR = komplet respons; nCR = næsten komplet respons; ITT = intent to treat; RR = responsrate; Vc = VELCADE; VcTDx = VELCADE, thalidomid, dexamethason; TDx = thalidomid, dexamethason; PR = partielt respons; OR = odds-ratio;
English: • Abnormal vision, blurred vision
Danish: • Unormalt syn, sløret syn
English: Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med VELCADE Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)
Danish: Sjælden Dissemineret intravaskulær koagulation, trombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af trombocytfunktionen, trombotisk mikroangiopati (herunder trombocytopenisk purpura)
English: VELCADE 3.5 mg powder for solution for injection bortezomib
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning bortezomib
English: • Fungal infections
Danish: • Svampeinfektioner
English: Powder for solution for injection 1 vial
Danish: pulver til injektionsvæske, opløsning 1 hætteglas
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Danish: Kvalme og opkastning*, diarré*, stomatitis*, obstipation
English: • In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Danish: - I cyklus 1 til 4 gives VELCADE to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
English: Grade ≥ 3 non-haematological toxicities
Danish: Ikke-hæmatologiske, toksiske hændelser af grad
English: • Bleeding from your bowels or stomach
Danish: • Blødning fra tarm eller mave
English: Very Common Hair disorder* Common Pruritus*, Dermatitis*, Rash*
Danish: Almindelig Kløe*, dermatitis*, udslæt*
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
Danish: * Baseret på klassifikation til inddeling af nedsat leverfunktion (let, moderat, svær) udarbejdet af en arbejdsgruppe vedrørende organdysfunktion under NCI.
English: • Insufficient circulation
Danish: • Nedsat cirkulation
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline
Danish: 9/l • Ikke-hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Danish: øjenlåg), erhvervet dacryoadenitis, fotofobi, fotopsi, optisk neuropati
English: • Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
Danish: • Blod i afføringen eller blødning fra slimhinder, f.eks. i munden eller skeden
English: • Shingles (localized including around the eyes or spread across the body)
Danish: • helvedesild (lokaliseret, også omkring øjnene eller spredt over kroppen)
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and
Danish: Den gennemsnitlige totale clearance var 102 og 112 l/t.
English: When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Danish: Når VELCADE gives alene, vil du få 4 doser VELCADE intravenøst på dag 1, dag 4, dag 8 og dag 11 efterfulgt af en pause på 10 dage uden behandling.
English: When VELCADE is given alone, you will receive 4 doses of VELCADE intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Danish: Når VELCADE gives alene, vil du få 4 doser VELCADE intravenøst eller subkutant på dag 1, dag 4, dag 8 og dag 11 efterfulgt af en pause på 10 dage uden behandling.
English: • Fistula
Danish: • Fistler
English: Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Danish: Almindelig Muskelspasmer*, muskuloskeletale smerter*,
English: • Hearing loss, deafness
Danish: • Høretab, døvhed
English: Adverse reaction
Danish: Leverreaktioner
English: • shortness of breath or cough
Danish: • stakåndethed eller hoste
English: Uncommon Cardiovascular disorder (inc cardiogenic shock) Vascular disorders Common Hypertension*, Hypotension*, Orthostatic hypotension Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Almindelig Hypertension*, hypotension*, ortostatisk hypotension Luftveje, thorax og mediastinum
English: VELCADE 1 mg powder for solution for injection bortezomib
Danish: VELCADE 1 mg pulver til injektionsvæske, opløsning bortezomib
English: VELCADE 1 mg powder for solution for injection is available for intravenous administration only.
Danish: VELCADE 1 mg pulver til injektionsvæske, opløsning er kun tilgængelig til intravenøs administration.
English: • Reduced functioning of your kidneys
Danish: • Nedsat funktion af skjoldbruskkirtlen
English: Oedema (inc peripheral), Chills, Pain*, Malaise* 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: 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: VELCADE 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY.
Danish: VELCADE 1 mg pulver til injektionsvæske, opløsning ER KUN BEREGNET TIL INTRAVENØS ANVENDELSE.
English: peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Danish: trombocytopeni, anæmi, neutropeni, perifer neuropati (inklusive sensorisk neuropati), hovedpine, paræstesier, nedsat appetit, dyspnø, udslæt, herpes zoster og myalgi.
English: You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury
Danish: Du kan opleve et fald i antallet af: - blodplader, hvilket kan gøre dig mere tilbøjelig til at få blå mærker eller til at bløde uden påviselig skade (f.eks. blødning fra tarmene, maven, munden og gummerne, blødning i hjernen eller blødning fra leveren).
English: Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 1 mg bortezomib (som mannitol boronsyreester).
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Danish: • Lammelse, krampeanfald, fald, bevægelsesforstyrrelser, unormale eller forandringer i eller nedsatte sanser (føle-, høre-, smags- eller lugtesans), opmærksomhedsforstyrrelser, skælven,
English: VELCADE 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning ER BEREGNET TIL SUBKUTAN ELLER INTRAVENØS ANVENDELSE.
English: • seizures
Danish: • Svimmelhed
English: • Brittle or weak nails
Danish: • Skrøbelige eller svage negle
English: Each 5 ml vial of VELCADE must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a 1 ml syringe, without removing the vial stopper.
Danish: Hvert 5 ml hætteglas med VELCADE rekonstitueres forsigtigt med 1 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning ved hjælp af en 1 ml sprøjte og uden at fjerne proppen fra hætteglasset.
English: When VELCADE is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Danish: Når VELCADE gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler kontrolleres for yderligere kontraindikationer.
English: 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
Danish: hiatus)*, nedsat sårheling*, inflammation, flebitis på injektionsstedet*, ømhed, ulcus, irritabilitet, ikke-kardielle brystsmerter, smerter på kateterstedet, fornemmelse af fremmedlegeme
English: • If platelet counts < 25,000 cells/μL.
Danish: • Hvis trombocyttallet er < 25 x 10 9 celler/l eller ANC er < 0,75 x 10
English: e (95% CI)=1.688 (1.148; 2.481) p-value g=0.007
Danish: OR e(95 % CI) = 1,688 (1,148;
English: 1.1 Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper.
Danish: 1.1 Præparation af 1 mg hætteglas: tilsæt forsigtigt 1,0 ml steril 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske til hætteglasset, der indeholder VELCADE- pulver ved hjælp af en 1 ml sprøjte og uden at fjerne proppen fra hætteglasset.
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 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 mantle-celle-lymfom (MCL) Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP) VELCADE 1 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11, efterfulgt af en 10-dages hvileperiode dag 12-21.
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: Akut nyresvigt, kronisk nyresvigt*, urinvejsinfektion*, urinvejssymptomer*, hæmaturi*, urinretention, miktionsforstyrrelser*, proteinuri, azotæmi, oliguri*, pollakisuri Sjælden Blæreirritation
English: • In cycles 5 to 9, VELCADE is administered once weekly on days 1, 8, 22 and 29.
Danish: - I cyklus 5 til 9 gives VELCADE en gang om ugen på dag 1, 8, 22 og 29.
English: • to report any adverse event, or medication error experienced with the administration of
Danish: • at eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af VELCADE
English: VELCADE 3.5 mg powder for solution for injection
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning.
English: You should tell your doctor if you have any of the following:
Danish: Kontakt lægen, før du bruger VELCADE, hvis du lider af noget af det følgende:
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 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 mantle-celle-lymfom (MCL) Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP) VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11, efterfulgt af en 10-dages hvileperiode dag 12-21.
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Danish: septisk shock)*, bronkopneumoni, herpes virusinfektion*, herpetisk meningoencefalitis
English: Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Danish: Tumorlysesyndrom, manglende trivsel*, hypomagnesiæmi*, hypofosfatæmi*, hyperkaliæmi*, hyperkalcæmi*, hypernatriæmi*, unormal urinsyre*, diabetes mellitus*, væskeretention
English: Vertigo*
Danish: blindhed)*
English: Then, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Danish: VELCADE-behandlingen genoptages ved en dosis, som er reduceret med ét dosisniveau (fra 1,3 mg/m2 til 1 mg/m eller fra 1 mg/m til 0,7 mg/m
English: Common Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*
Danish: fra slimhinde)*, abdominal distension, dyspepsi, orofaryngeale smerter*, gastritis*, mundsår*, abdominalt ubehag, dysfagi, gastrointestinal inflammation*, abdominalsmerter (inkl.
English: Each 10 ml vial of VELCADE 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.
Danish: Hvert 10 ml hætteglas med VELCADE rekonstitueres forsigtigt med 3,5 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: 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 ischaemic
Danish: tyndtarmsobstruktion, ileus)*, abdominalt ubehag, mundsår*, enteritis*, gastritis*, gingival blødning, gastroøsofageal reflukssygdom*, colitis (inkl.
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Danish: Disse patienter skal behandles med reducerede doser af VELCADE og overvåges nøje for bivirkninger (se pkt.
English: • Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing,
Danish: • Alvorlig allergisk reaktion (anafylaktisk shock).
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Danish: 1.1 Præparation af 3,5 mg hætteglas: tilsæt forsigtigt 3,5 ml steril 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske til hætteglasset, der indeholder VELCADE- pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: Rash*, Pruritus*, Erythema, Dry skin
Danish: Almindelig Udslæt*, kløe*, erytem, tør hud Ikke almindelig
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE treatment cycle.
Danish: Dexamethason administreres oralt med 40 mg på dag 1, 2, 3, 4, 8, 9, 10 og 11 i VELCADEbehandlingscyklussen.
English: A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Danish: 1.1 Præparation af 3,5 mg hætteglas: tilsæt forsigtigt 1,4 ml steril 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske til hætteglasset, der indeholder VELCADE- pulver ved hjælp af en sprøjte af passende størrelse og uden at fjerne proppen fra hætteglasset.
English: VELCADE 1 mg powder for solution for injection
Danish: VELCADE 1 mg pulver til injektionsvæske, opløsning.
English: sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood
Danish: • Infektioner eller betændelse i munden, sår i mund, spiserør, mave og tarm, somme tider forbundet med smerter eller blødning, nedsat tarmbevægelse (herunder blokering), ubehag i maveregionen eller spiserøret, synkebesvær, opkastning af blod
English: #, Deep vein thrombosis*,
Danish: #, akne*, blister*,
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Danish: kardiogent shock), torsades de pointes, ustabil angina, hjerteklapsygdomme*, koronarinsufficiens, sinusarrest
English: • Feeling sick (nausea) or vomiting, loss of appetite
Danish: • Kvalme og opkastning, nedsat appetit
English: Posology for previously untreated multiple myeloma patients not eligible for haematopoietic stem cell transplantation
Danish: Dosering til patienter med tidligere ubehandlet myelomatose, som ikke er egnede til hæmatopoietisk stamcelletransplantation.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the VELCADE treatment cycle.
Danish: Dexamethason administreres oralt ved en dosis på 20 mg på dag 1, 2, 4, 5, 8, 9, 11 og 12 i VELCADE-behandlingscyklussen.
English: Each 10 ml vial of VELCADE 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 VELCADE rekonstitueres forsigtigt med 1,4 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske ved hjælp af en sprøjte af passsende størrelse og uden at fjerne proppen fra hætteglasset.
English: Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS Cardiac disorders Uncommon Cardiac tamponade
Danish: Sjælden Blødning i øret, vestibulær neuronitis, uspecificeret øresygdom
English: #, Different degrees of visual impairment (up to blindness)*
Danish: #, forskellige grader af synsnedsættelse
English: Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
Danish: Almindelig Leukopeni*, lymfopeni* Ikke almindelig
English: • kidney problems
Danish: • problemer med nyrerne
English: • Mouth pain
Danish: • Smerter i munden
English: Tumour lysis syndrome
Danish: • Hævede lymfekirtler
English: After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Danish: Efter rekonstitution indeholder 1 ml injektionsvæske 1 mg bortezomib.
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Danish: Den færdigblandede injektionsvæske er stabil i 8 timer ved 25 °C ved opbevaring i det originale hætteglas og/eller en sprøjte.
English: • memory loss, trouble thinking, difficulty with walking or loss of vision.
Danish: • hukommelsestab, nedsat tankevirksomhed, gangbesvær eller synstab.
English: e (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Danish: OR e(95 % CI) = 1,428 (0,749;
English: Common Sleep disorders and disturbances*
Danish: Psykiske forstyrrelser Almindelig Søvnforstyrrelser* Nervesystemet
English: • Pain in limbs
Danish: • Smerter i endetarmen
English: • Fluid retention
Danish: • Væskeophobning
English: Mild
Danish: Leversvigt
English: Nine treatment cycles of this combination therapy are administered.
Danish: Der gives ni behandlingscyklusser med denne kombinationsbehandling.
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Danish: overfladisk eller besværet vejrtrækning eller stop i vejrtrækningen, hvæsende vejrtrækning
English: Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*,
Danish: Almindelig Hypokaliæmi*, unormal blodglucose*, hyponatriæmi*, diabetes mellitus*, væskeretention
English: Age
Danish: Lot
English: Median a (95% CI)
Danish: Median c (95 % CI) (måneder)
English: N=240 (ITT population) N=242 (ITT population)
Danish: N = 242 (ITT-population)
English: > 1.0 x 1.5 x ULN Any
Danish: > 1,0-1,5 x ULN
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 3,5 mg bortezomib (som mannitolboronsyreester).
English: • Joint effusion
Danish: • Ledeffusion
English: Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m2 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 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Danish: Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis af VELCADE på 0,7 mg/m2 pr. injektion i den første behandlingscyklus;
English: * Primary endpoint
Danish: Primært endepunkt
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Danish: Tremor, perifer sensomotorisk neuropati, dyskinesi*, forstyrrelser i cerebellar koordination og balanceforstyrrelser*, hukommelsestab (ekskl.
English: 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
Danish: #, gastrointestinal inflammation*, dysfagi, colon irritabile, uspecificeret sygdom i mave-tarm-kanalen, belagt tunge, forstyrrelser af mave-tarmkanalens funktion*, sygdom i spytkirtlerne* Sjælden 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 Lever og galdeveje Almindelig Abnorme leverenzymer* Ikke almindelig
English: Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Danish: synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati
English: #, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc 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: • Hepatitis
Danish: • Hovedpine
English: 9/l or ANC
Danish: 9 celler/l, kan