FrancophonIA/ELRC3.0 huggingface dataset:
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: #, akne*, blister*, fejlpigmentering* Sjælden Hudreaktion, Jessners benigne lymfocyt-infiltration, palmoplantar erythrodysæstesi (hånd-fod-syndrom), subkutan blødning, livedo reticularis, fortykkelse af huden, papler, lysfølsomhedsreaktion, seboré, koldsved, uspecificeret hudsygdom, erythrose, hudsår, neglesygdom
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Danish: Der blev udført et randomiseret, åbent, fase III-multicenterforsøg i parallelgrupper med 646 patienter for at sammenligne sikkerheden og effekten af bortezomib plus pegyleret liposomal doxorubicin vs. bortezomib som monoterapi hos patienter med myelomatose, som tidligere havde fået mindst 1 behandling, og som ikke progredierede under antracyklin-baseret behandling.
English: 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 balance*, hukommelsestab (ekskl.
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 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/m2 dagligt) som kontinuerlig infusion over en periode på 24 timer med daunorubicin og bortezomib til behandling af recidiverende akut myeloid leukæmi (AML).
English: When toxicity resolves re-initiate Bortezomib Hospira treatment and reduce dose to 0.7 mg/m2 once per week.
Danish: Reinitiér Bortezomib Hospira og reducér dosis til 0,7 mg/m2 én gang om ugen, når toksiciteten er forsvundet.
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: Tumorlysesyndrom, manglende trivsel*, hypomagnesiæmi*, hypofosfatæmi*, hyperkaliæmi*, hypercalcæmi*, hypernatriæmi*, anormal urinsyre*, diabetes mellitus*, væskeretention Sjælden Hypermagnesiæmi*, acidose, forstyrrelser i elektrolytbalancen*, væskeophobning, hypochloræmi*, hypovolæmi, hyperchloræmi*, hyperfosfatæmi*, stofskiftesygdom, B-vitaminmangel, B12-vitaminmangel, artritis urica, øget appetit, alkoholintolerans
English: Bortezomib Hospira 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 Hospira 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: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Danish: Efter rekonstitution indeholder 1 ml injektionsvæske til intravenøs injektion 1 mg bortezomib.
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Danish: venstre og højre ventrikel)*, myokardie-iskæmi, ventrikeldysfunktion*
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Danish: besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Danish: Cushings syndrom*, hyperthyreoidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypothyreoidisme Metabolisme og ernæring Meget almindelig
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP;
Danish: Klinisk virkning ved tidligere ubehandlet mantle-celle-lymfom (MCL) Forsøg LYM-3002 var et randomiseret, åbent fase III-forsøg med sammenligning af effekten og sikkerheden ved kombination af bortezomib, rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP; n=243) og effekten og sikkerheden ved rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R-CHOP; n=244) hos voksne patienter med tidligere ubehandlet MCL (stadie II, III eller IV).
English: What Bortezomib Hospira is and what it is used for What you need to know before you use Bortezomib Hospira How to use Bortezomib Hospira Possible side effects
Danish: Det skal du vide, før du begynder at bruge Bortezomib Hospira Sådan skal du bruge Bortezomib Hospira Bivirkninger
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Danish: Prednison 100 mg/m gives oralt på dag 1, 2, 3, 4 og 5 i behandlingscyklussen med bortezomib.
English: • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion) and red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
Danish: • Irriterede eller betændte øjne, meget våde øjne, smerter i øjnene, tørre øjne, øjeninfektioner,
English: • Alteration of liver function
Danish: • Ændret leverfunktion
English: Day 1 Day 2 Day 3 Day rest period rest period
Danish: Dag 1 Dag 2 Dag 3 Dag
English: Seizures
Danish: • Udslæt
English: Time to next therapy Events n (%) Median a (95% CI)
Danish: Tid indtil næste behandling Hændelser n (%) Medianværdi a
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Hospira as outlined in Table 1.
Danish: Afbryd og/eller modificér behandling med Bortezomib Hospira som beskrevet i tabel 1 i tilfælde af bortezomib-relaterede neuropatiske smerter og/eller perifer neuropati.
English: • A sore mouth or lip, dry mouth, mouth ulcers or throat pain
Danish: • Ømhed i munden eller på læberne, mundtørhed, sår i munden eller halssmerter
English: • If toxicity resolves i.e. patient has an ANC ≥ 750cells/μL and a platelet count ≥ 25,000 cells/μL, Bortezomib Hospira 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 0.7 mg/m
Danish: • Bortezomib Hospira kan reinitieres i en dosis, der er reduceret med 1 dosisniveau (fra 1,3 mg/m til 1 mg/m eller fra 1 mg/m2 til 0,7 mg/m2), hvis toksiciteten svinder - dvs. patienten har et ANC på ≥ 750 celler/μl og et thrombocyttal på ≥ 25.000 celler/μl.
English: Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*,
Danish: Almindelig Dehydrering, hypokaliæmi*, hyponatriæmi*, unormal blodglucose*, hypocalcæmi*, enzymanomali*
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* Sjælden Meningitis (inkl.
English: • Hepatitis
Danish: • Leverbetændelse (hepatitis)
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with Bortezomib Hospira at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Danish: Disse patienter skal behandles med reducerede doser Bortezomib Hospira og overvåges nøje for bivirkninger (se pkt.
English: • Feeling sick (nausea) or vomiting, loss of appetite
Danish: • Kvalme eller opkastning, nedsat appetit
English: Common 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* Sjælden Død (inkl.
English: • that Bortezomib Hospira is to be given only by IV or SC injections; no other route of administration is allowed
Danish: eller s.c. injektion og om, at andre administrationsveje ikke er tilladte
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 opheling*, inflammation, flebitis på injektionsstedet*, ømhed, ulcus, irritabilitet, ikke-kardielle brystsmerter, smerter på katetersted, fornemmelse af fremmedlegeme
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each Bortezomib Hospira treatment cycle.
Danish: Prednison administreres oralt med 100 mg/m2 på dag 1, 2, 3, 4 og 5 i hver behandlingscyklus med
English: Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Danish: synkope), svimmelhed*, dysgeusi*, letargi, hovedpine*
English: • Bleeding from your bowels or stomach
Danish: • Blødning fra tarme eller mave
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Danish: (n=37); bortezomib blev administreret på dag 1, 4, 8 og 11 hver 3. uge i maksimalt 8 cyklusser, enten som monoterapi eller i kombination med dexamethason i henhold til gældende standardbehandling.
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: Sjælden Akut pankreatitis, peritonitis*, tungeødem*, ascites, øsofagitis, cheilitis, fækal inkontinens, analsfinkteratoni, fækalom*, gastrointestinal ulcus og perforation*, gingival hypertrofi, megacolon, rektalt udflåd, blisterdannelse i hals og svælg*, læbesmerter, periodonitis, analfissur, forandringer i peristaltikken, proktalgi, unormal fæces
English: Discontinue Bortezomib Hospira
Danish: Seponér Bortezomib Hospira
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild,
Danish: * Baseret på en klassifikation til inddeling af nedsat leverfunktion (let, moderat, svær), udarbejdet af en arbejdsgruppe vedrørende organdysfunktion under NCI.
English: T 100 mg a
Danish: T 100 mg
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Danish: Bortezomib Hospira 2,5 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 2,5 mg bortezomib (som mannitolborsyreester).
English: Dosage adjustments for transplant eligible patients For Bortezomib Hospira dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Danish: Dosisjustering af Bortezomib Hospira skal følge de retningslinjer, der er beskrevet under monoterapi.
English: Common Renal impairment* Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Danish: Akut nyreinsufficiens, kronisk nyreinsufficiens*, urinvejsinfektion*, urinvejssymptomer*, hæmaturi*, urinretention, miktionsforstyrrelser*, proteinuri, azotæmi, oliguri*, pollakisuri
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Danish: Bortezomib Hospira 3,5 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 3,5 mg bortezomib (som mannitolborsyreester).
English: Bortezomib Hospira dose should be reduced by 1 dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m 2 to
Danish: Reducér dosis af Bortezomib Hospira med 1 dosisniveau (fra 1,3 mg/m2 til 1 mg/m2 eller fra 1 mg/m2 til 0,7 mg/m
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including Thrombocytopenic purpura)
Danish: Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi Sjælden Dissemineret intravaskulær koagulation, thrombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af thrombocytfunktionen, thrombotisk mikroangiopati (herunder thrombocytopenisk purpura)
English: How Bortezomib Hospira is given
Danish: Sådan gives Bortezomib Hospira
English: How to use Bortezomib Hospira
Danish: Sådan skal du bruge Bortezomib Hospira
English: Combination therapy with dexamethasone and thalidomide Bortezomib Hospira 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 in a 28-day treatment cycle.
Danish: Kombinationsbehandling med dexamethason og thalidomid Bortezomib Hospira administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal 2 gange om ugen i 2 uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
English: 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* Uncommon Colitis (inc clostridium difficile)*
Danish: fra slimhinde)*, abdominal distension, dyspepsi, orofaryngeale smerter*, gastritis*, mundsår*, abdominalt ubehag, dysfagi, gastrointestinal inflammation*, abdominalsmerter (inkl.
English: Pigmentation disorder*
Danish: Synsforstyrrelser*
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Danish: • Lammelse, krampeanfald, fald, bevægelsesforstyrrelser, unormale sanser eller ændrede eller nedsatte sanser (følesans, høresans, smagssans eller lugtesans), opmærksomhedsforstyrrelser,
English: Lymphadenopathy, Haemolytic anaemia
Danish: akut), pulmonal alveolær blødning
English: 56.4 mo (52.8, 60.9)
Danish: (52,8; 60,9) 43,1 mdr.
English: Bortezomib Hospira 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Danish: Bortezomib Hospira 1 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 1 mg bortezomib (som mannitolborsyreester).
English: Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 1 mg bortezomib (som mannitolborsyreester).
English: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Danish: Den rekonstituerede opløsning skal kasseres, hvis der ses misfarvning eller partikler.
English: Adverse reaction Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest Vascular disorders Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Danish: kardiogent shock), torsades de pointes, ustabil angina, hjerteklapsygdomme*, koronarinsufficiens, sinusarrest
English: Bortezomib Hospira 3 mg powder for solution for injection Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Danish: Bortezomib Hospira 3 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 3 mg bortezomib (som mannitolborsyreester).
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-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: Bortezomibs sikkerhedsprofil vurderet hos 240 MCL-patienter behandlet med bortezomib i en dosis på 1,3 mg/m2 i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP) vs.
English: Combination therapy with pegylated liposomal doxorubicin Bortezomib Hospira 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 in a 21-day treatment cycle.
Danish: Kombinationsbehandling med pegyleret liposomal doxorubicin Bortezomib Hospira administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal 2 gange om ugen i 2 uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
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: perikardieeffusion)*, kardiomyopati*, ventrikeldysfunktion*, bradykardi Sjælden Atrieflagren, myokardieinfarkt*, atrioventrikulært blok*, kardiovaskulær sygdom (inkl.
English: Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 2,5 mg bortezomib (som mannitolborsyreester).
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 3,5 mg bortezomib (som mannitolborsyreester).
English: Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Danish: perifert), kuldegysninger, reaktion på injektionsstedet*, utilpashed*
English: Incidence of PN (%)
Danish: Forekomst af PN (%) PN uanset grad
English: Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Danish: Hvert hætteglas indeholder 3 mg bortezomib (som mannitolborsyreester).
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Danish: Clostridium difficile)*, iskæmisk kolitis gastrointestinal inflammation*, dysfagi, colon irritabile, uspecificeret sygdom i mave-tarm-kanalen, tungebelægning, forstyrrelser i den gastrointestinale motilitet*, sygdom i spytkirtlerne*
English: Bortezomib Hospira 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 in a 21-day treatment cycle.
Danish: Bortezomib Hospira administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m legemsoverfladeareal 2 gange om ugen i 2 uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Powder for solution for injection.
Danish: Pulver til injektionsvæske, opløsning
English: • Sore mouth or lip, throat pain
Danish: • Ømhed i munden eller på læberne, halssmerter
English: 375 mg/m 2 IV on day 1; cyclophosphamide 750 mg/m 2 IV on day 1; doxorubicin 50 mg/m 2 IV on day 1;
Danish: på dag 1, cyclophosphamid 750 mg/m 2 i.v.
English: Common Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness,
Danish: Almindelig Muskelspasmer*, ekstremitetssmerter, muskelsvaghed Ikke almindelig
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Danish: Infektion*, bakterieinfektion*, virusinfektioner*, sepsis (inkl.
English: Bortezomib Hospira 1 mg powder for solution for injection bortezomib
Danish: Bortezomib Hospira 1 mg pulver til injektionsvæske, opløsning bortezomib
English: Bortezomib Hospira 1 mg powder for solution for injection
Danish: Bortezomib Hospira 1 mg pulver til injektionsvæske, opløsning
English: Bortezomib Hospira 3 mg powder for solution for injection
Danish: Bortezomib Hospira 3 mg pulver til injektionsvæske, opløsning
English: • SmPC
Danish: • Mavepine
English: Bortezomib Hospira 3 mg powder for solution for injection bortezomib
Danish: Bortezomib Hospira 3 mg pulver til injektionsvæske, opløsning bortezomib
English: Once the symptoms of the toxicity have resolved, Bortezomib Hospira treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2, 1.0 mg/m2 reduced to 0.7 mg/m2).
Danish: Når toksicitetssymptomerne er forsvundet, kan behandling med Bortezomib Hospira reinitieres i en dosis, der er reduceret med 25% (1,3 mg/m reduceret til
English: Uncommon Angioedema
Danish: Sjælden Blæreirritation
English: collapse
Danish: Pause
English: Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Danish: Bortezomib Hospira 3,5 mg pulver til injektionsvæske, opløsning bortezomib
English: Common Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion
Danish: Øjenblødning*, øjenlågsinfektion*, chalazion
English: • Cerebrovascular disorders
Danish: • Hævede lymfekirtler
English: CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
Danish: Tid indtil respons CR+PR (dage)
English: Bortezomib Hospira 2.5 mg powder for solution for injection bortezomib
Danish: Bortezomib Hospira 2,5 mg pulver til injektionsvæske, opløsning bortezomib
English: Ear discomfort*
Danish: Clostridium difficile)*
English: Bortezomib Hospira 3.5 mg powder for solution for injection
Danish: Bortezomib Hospira 3,5 mg pulver til injektionsvæske, opløsning
English: Intravenous use: Add 2.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Danish: Intravenøs anvendelse: Tilsæt 2,5 ml 0,9% natriumchlorid, så der opnås en endelig koncentration på 1 mg/ml.
English: • Breast disorders
Danish: • Brystsygdom
English: Subcutaneous use: Add 0.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Danish: Subkutan anvendelse: Tilsæt 0,4 ml 0,9% natriumchlorid, så der opnås en endelig koncentration på 2,5 mg/ml.
English: Bortezomib Hospira 2.5 mg powder for solution for injection
Danish: Bortezomib Hospira 2,5 mg pulver til injektionsvæske, opløsning