natgillin/translations-raw huggingface dataset:
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.
• 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.
Du må ikke køre bil, motorcykel eller cykle eller arbejde med værktøj eller maskiner, hvis du oplever disse bivirkninger.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you must still be cautious.
• Tidligere er besvimet, har været svimmel eller ør i hovedet
• fainting, dizziness or light-headedness in the past
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.
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.
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
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
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.
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.
• Betændelse i hjertesækken eller væsken omkring hjertet
• Inflammation of the lining around your heart or fluid around your heart
• Helvedesild (lokaliseret, herunder omkring øjnene eller spredt over kroppen)
• Shingles (localized including around the eyes or spread across the body)
• Infektioner inklusive lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections,
• Infektion eller inflammation (betændelseslignende tilstand) i mave og/eller tarme
• Infection or inflammation of the stomach and intestine
Akut intervention med positive inotropiske- eller pressormidler påvirkede faldet i hjertekontraktilitet og hypotension hos hunde.
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Tabel 9: Forekomst af perifer neuropati under induktionsbehandling ved toksicitet og seponering på grund af perifer neuropati
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01
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
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.
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*
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*
Sådan skal du bruge Bortezomib Fresenius Kabi
How to use Bortezomib Fresenius Kabi
, cyclophosphamid 750 mg/m og doxorubicin 50 mg/m 2.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m and doxorubicin at 50 mg/m
De bivirkninger, du kan opleve, hvis du får bortezomib sammen med andre lægemidler til behandling af mantle-celle-lymfom, er angivet nedenfor:
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:
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Tabel 6: Anbefalede initiale dosisjusteringer for bortezomib til patienter med nedsat leverfunktion.
Table 6: Recommended starting dose modification for bortezomib in patients with hepatic impairment
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
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.
#, uspecificeret blodsygdom, hæmoragisk diatese, lymfocytinfiltration
#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
CR-raten hos førstetilbagefald, T-celle ALL patienter (n=22) var 68 % (95 % CI: 45, 86) og den 4-mdr.
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).
• At eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af bortezomib
• to report any adverse event, or medication error experienced with the administration of bortezomib 3.5 mg.
I cyklus 1-4 indgives bortezomib to gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32.
In cycles 1-4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
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.
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.
Det skal du vide, før du begynder at bruge Bortezomib Fresenius Kabi
What you need to know before you use Bortezomib Fresenius Kabi
#, øjeninflammation*, diplopi, øjentørhed*, øjenirritation*, øjensmerter, øget tåreflåd, øjenflåd
#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge
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.
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.
Behandlingen med bortezomib skal påbegyndes under tilsyn af en kvalificeret læge med erfaring inden for behandling af cancerpatienter.
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.
Batch
BATCH NUMBER
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.
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.
*RR (Post-induktion) *CR+nCR
*RR (Post-induction) CR+nCR
#, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus
#, Stevens-Johnson syndrome Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
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.
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.
Muskoskeletale smerter*
Very common Musculoskeletal pain* Common
De bivirkninger, du kan opleve, hvis du får bortezomib til behandling af myelomatose, er angivet nedenfor:
If you are given bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
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