natgillin/translations-raw huggingface dataset:
• I tilfælde af lokale reaktioner på injektionsstedet efter subkutan injektion af Bortezomib Hospira anbefales det enten at administrere en mindre koncentreret Bortezomib Hospira-opløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller at skifte til intravenøs administration. 
• If local injection site reactions occur following Bortezomib Hospira injection subcutaneously, either a less concentrated Bortezomib Hospira solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Tabel 4: Dosering for kombinationsbehandling med Bortezomib Hospira til patienter med tidligere ubehandlet myelomatose, som er egnede til hæmatopoietisk stamcelletransplantation B+Dx 
Table 4: Posology for Bortezomib Hospira combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation B+Dx
Hver pakning med 1 mg Bortezomib Hospira indeholder et 5 ml silikonebehandlet hætteglas med gummiprop og aluminiumsforsegling. 
Each carton of 1 mg Bortezomib Hospira contains a glass 5 ml siliconised vial with a rubber stopper and an aluminium seal.
PN ≥ grad 3 
≥ Grade 3 PN
• Information om, at eventuelle bivirkninger eller medicineringsfejl i forbindelse med administration af Bortezomib Hospira 1 mg, 2,5 mg, 3 mg og 3,5 mg bør indberettes. 
• to report any adverse event, or medication error experienced with the administration of Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
I forsøget LYM-3002 fik 78% af patienterne i BR-CAP-gruppen og 61% af patienterne i RCHOP-gruppen understøttende behandling med kolonistimulerende faktor. 
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
B = bortezomib; BDx = bortezomib, dexamethason; VDDx = vincristin, doxorubicin, dexamethason; VGPR = meget godt partielt respons; PR = partielt respons; OR = odds ratio. 
B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Intent to Treat (ITT) -population p-værdi fra den stratificerede log-rank-test; analyse ud fra behandling udelukker stratifikation ifølge tidligere behandling; p < 0,0001 
Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
DET ER YDERST VIGTIGT, AT DER ANVENDES ASEPTISK TEKNIK UNDER HÅNDTERINGEN AF BORTEZOMIB HOSPIRA, DA DET IKKE INDEHOLDER KONSERVERINGSMIDDEL. 
Aseptic technique must be strictly observed throughout the handling of Bortezomib Hospira, since it contains no preservative.
QT-forlængelse)*, unormal INR (international normalised ratio)*, nedsat gastrisk pH, øget thrombocytaggregation, forhøjet troponin I, identifikation og serologisk test af virus*, unormal urinprøve* 
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Sjælden Perifer emboli, lymfødem, bleghed, erythromelalgi, vasodilatation, misfarvning af vener, veneinsufficiens 
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
(CR+nCR, CR+nCR+VGPR+PR), progressionsfri overlevelse og samlet overlevelse. 
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
• Infektion eller inflammation (betændelseslignende tilstand) i mave eller tarme 
• Infection or inflammation of the stomach and intestines
Der foreligger ingen forsøg af anvendelse af bortezomib til ældre patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation. 
There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Nogle af disse sygdomme indebærer vejrtrækningsbesvær, stakåndethed, stakåndethed uden fysiske udfoldelser, overfladisk eller besværet vejrtrækning eller stop i vejrtrækningen, hvæsende vejrtrækning 
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
I et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af ketoconazol, en potent CYP3A4hæmmer, på bortezomibs farmakokinetik (som intravenøs injektion) ses en gennemsnitlig stigning i bortezomibs AUC på 35% (CI90% [1,032 til 1,772]), baseret på data fra 12 patienter. 
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Silikonebehandlet hætteglas på 5 ml (type I-glas) med gummiprop og aluminiumsforsegling, der indeholder 1 mg bortezomib. 
Type I glass 5 ml siliconised vial with a rubber stopper and an aluminium seal containing 1 mg bortezomib.
Der administreres 4 behandlingscyklusser af denne kombinationsbehandling. 
Four treatment cycles of this combination therapy are administered.
Det afhænger af, hvordan du reagerer på behandlingen, om du får bestemte bivirkninger, og hvilke sygdomme, du lider af (f.eks. leverproblemer). 
Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
synkope), encefalopati*, perifer sensomotorisk neuropati, svimmelhed*, dysgeusi*, autonom neuropati Ikke almindelig Ubalance i det autonome nervesystem 
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
• Lavt blodtryk, pludseligt fald i blodtrykket, når du rejser dig. 
• Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting
Hvis bortezomib gives alene, vil du få 4 doser bortezomib intravenøst eller subkutant på dag 1, 4, 8 og 11 efterfulgt af en pause på 10 dage uden behandling. 
When bortezomib is given alone, you will receive 4 doses of bortezomib intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Effekten af nedsat leverfunktion på bortezomibs farmakokinetik i doseringsintervallet 0,5-1,3 mg/m blev undersøgt i et fase I-forsøg i den første behandlingscyklus hos 61 patienter med primært solide tumorer og nedsat leverfunktion i varierende grad. 
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m
9/l, og absolut neutrofiltal skal være ≥ 1,0 x 10 
• Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be ≥ 1.0 x 10 9/l
• helvedesild (lokaliseret, for eksempel omkring øjnene eller spredt over hele kroppen) 
• Shingles (localized including around the eyes or spread across the body)
Meget almindelig Perifer sensorisk neuropati, dysæstesi*, neuralgi* Almindelig 
Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common
Ikke almindelig Akut respiratorisk distress syndrom, lungeemboli, pneumonitis, pulmonal hypertension, lungeødem (inkl. 
Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
105 (81%) og 78 (61%) patienter i henholdsvis BTDx- og TDx-gruppen fik en enkelt autolog stamcelletransplantation. 
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Patienterne i BR-CAP-gruppen fik bortezomib (1,3 mg/m på dag 1, 4, 8, 11, pause dag 12-21), rituximab 375 mg/m 2 i.v. 
Patients in the BR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab
Brug ikke Bortezomib Hospira - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i Bortezomib 
Do not use Bortezomib Hospira - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Dyspnø*, hoste*, hikke 
Dyspnoea*, Cough*, Hiccups
Muskelspasmer*, muskuloskeletale smerter*, ekstremitetssmerter 
Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Afbryd behandling med Bortezomib Hospira, indtil toksicitetssymptomerne er svundet til grad 1 eller niveauet ved baseline. 
Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
• Information om, at kravene til rekonstitution af Bortezomib Hospira 1 mg, 2,5 mg, 3 mg og 3,5 
• different reconstitution requirements for Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg IV or
#, bronkospasme, kronisk obstruktiv lungesygdom*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning 
#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Hvis der opstår lokale reaktioner på injektionsstedet efter en subkutan injektion af Bortezomib Hospira, bør det enten gives i en lavere koncentration (Bortezomib Hospira rekonstitueres til 1 mg/ml i stedet for 2,5 mg/ml), eller der bør skiftes til intravenøs injektion. 
If local injection site reactions occur following Bortezomib Hospira subcutaneous injection, either a less concentrated Bortezomib Hospira solution (Bortezomib Hospira to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Patienter, som er egnede til stamcelletransplantation Der blev gennemført 2 randomiserede, åbne fase III-multicenter-forsøg (IFM-2005-01, MMY-3010) til påvisning af bortezomibs sikkerhed og effekt i dobbelte og tredobbelte kombinationer med andre cytostatika 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.
Hos B-ALL-patienter med recidiv inden for 18-36 måneder efter diagnosticering (n=33) var CR-raten 79% (95% CI: 61-91), og den hændelsesfrie overlevelsesrate efter 4 måneder var 73% (95% CI: 54, 85). 
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).
Hvis bortezomib gives sammen med pegyleret liposomal doxorubicin, får du bortezomib intravenøst eller subkutant i en 21-dages behandlingscyklus, og pegyleret liposomal doxorubicin gives i en dosis på 30 mg/m2 på dag 4 i den 21-dages behandlingscyklus med bortezomib som en intravenøs infusion efter injektionen af bortezomib. 
When bortezomib is given together with pegylated liposomal doxorubicin, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the bortezomib 21-day treatment cycle as an intravenous infusion after the bortezomib injection.
Der gives 9 behandlingscyklusser med denne kombination. 
Nine treatment cycles of this combination therapy are administered.
• Stivhed i led eller muskler, følelse af tunghed, smerter i lysken 
• Joint or muscle stiffness, sense of heaviness, pain in your groin
De bivirkninger, du kan få, 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:
(24,7; 31,1) 19,2 mdr. 
27.0 mo (24.7, 31.1) 19.2 mo (17.0, 21.0)
CR-raten hos patienter med første recidiv af T-celle-ALL (n=22) var 68% (95% CI: 45-86), og den hændelsesfrie overlevelsesrate efter 4 måneder var 67% (95% CI: 42, 83). 
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).
Alvorlige, ikke almindelige bivirkninger, der er indberettet under behandling med bortezomib, omfatter hjerteinsufficiens, tumorlysesyndrom, pulmonal hypertension, posteriort reversibelt encefalopatisyndrom samt akutte, diffuse, infiltrative lungesygdomme. 
Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
B = bortezomib; BTDx = bortezomib, thalidomid, dexamethason; TDx = thalidomid, dexamethason; PR = partielt respons; 
B=bortezomib; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
Reaktivering og infektion af hepatitis B-virus (HBV) Hvis rituximab anvendes i kombination med Bortezomib Hospira, skal patienter med risiko for HBVinfektion altid screenes for HBV, inden behandlingen startes. 
When rituximab is used in combination with Bortezomib Hospira, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Der er hos patienter behandlet med bortezomib indberettet meget sjældne tilfælde af John Cunningham-virus (JC-virus), der førte til PML og dødsfald. 
Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Bortezomib Hospira pulver til injektionsvæske, opløsning, er en hvid til offwhite masse eller et hvidt til offwhite pulver. 
What Bortezomib Hospira looks like and contents of the pack Bortezomib Hospira powder for solution for injection is a white to off-white cake or powder.
Bortezomib-pulveret skal opløses, før det gives. 
Bortezomib powder has to be dissolved before administration.
Hos B-ALL-patienter med recidiv inden for 18 måneder efter diagnosticering (n=27) var CR-raten 67% (95% CI: 46-84), og den hændelsesfrie overlevelsesrate efter 4 måneder var 44% (95% CI: 26, 62). 
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).
FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Sjælden Respirationssvigt, akut respiratorisk distress syndrom, apnø, pneumothorax, atelektase, pulmonal hypertension, hæmoptysis, hyperventilation, ortopnø, pneumonitis, respirationsalkalose, takypnø, lungefibrose, bronkiesygdom*, hypokapni*, interstitiel lungesygdom, lungeinfiltration, sammensnøring af halsen, tørhed i halsen, øget sekret i de øvre luftveje, halsirritation, hostesyndrom i øvre luftveje 
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, Upperairway cough syndrome
Afbryd behandlingen med Bortezomib Hospira, indtil toksicitetssymptomerne er forsvundet. 
Withhold Bortezomib Hospira treatment until symptoms of toxicity have resolved.
• Vejledning i dosering med eksempler: Beregning af patientens legemsoverfladeareal og det nødvendige volumen rekonstitueret Bortezomib Hospira (både til i.v. 
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Hospira (both IV and SC use) required for different body surface areas.
RR (efter induktion) *CR+nCR 
RR (Post-induction) *CR+nCR
Fritaget for krav om brailleskrift. 
Justification for not including Braille accepted.
1,0 mg/m 2; 1,0 mg/m reduceret til 0,7 mg/m 2). 
1 mg/m 2, or from 1 mg/m 2 to 0.7 mg/m 2).
Bortezomib bruges til behandling af mantle-celle-lymfom (en type kræft, som påvirker lymfeknuderne) i kombination med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison, til patienter på 18 år og derover, hvis sygdom ikke tidligere er blevet behandlet, og som ikke er egnede til at gennemgå en transplantation af blodstamceller. 
Bortezomib is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Bortezomib Hospira indeholder: 
What Bortezomib Hospira contains
I det samme lægemiddelinteraktionsforsøg med undersøgelse af virkningen af dexamethason, en svagere CYP3A4-induktor, på bortezomibs farmakokinetik (som intravenøs injektion) er der ingen signifikant virkning på bortezomibs farmakokinetik, baseret på data fra 7 patienter. 
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.
• Forandringer i afføringsmønsteret eller unormalt afføringsmønster 
• Changes in or abnormal bowel function
Bortezomib Hospira 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 Hospira 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.
• Seponér Bortezomib Hospira, hvis toksiciteten ikke svinder efter afbrydelse af behandlingen som defineret ovenfor. 
• If, after Bortezomib Hospira has been held, the toxicity does not resolve, as defined above, then Bortezomib Hospira must be discontinued.
p-værdi d 
p-value c
dissemineret og oftalmisk), pneumoni*, herpes simplex*, svampeinfektion* 
Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
• Infektioner, herunder lungebetændelse, luftvejsinfektioner, bronkitis, svampeinfektioner, hoste med slim, influenzalignende sygdom 
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Henviser til responsrate efter den anden transplantation hos patienter, der blev transplanteret 2 gange 
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ]
I cyklus 5-9 indgives Bortezomib Hospira én gang om ugen på dag 1, 8, 22 og 29. 
In Cycles 5-9, Bortezomib Hospira is administered once weekly on days 1, 8, 22 and 29.
Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter) 
Very common side effects (may affect more than 1 in 10 people)
-- Dag 
Day
Der er dog påvist kemisk og fysisk stabilitet for det rekonstituerede produkt i 8 timer ved 5°C og 25°C, når det opbevares i det originale hætteglas og/eller i en sprøjte. 
However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
• Halsbrand, oppustethed, ræben, luft i tarmene, mavesmerter, blødning fra tarme eller mave 
• Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Dosering til patienter med tidligere ubehandlet mantle-celle-lymfom (MCL) Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP) Bortezomib Hospira administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal 2 gange om ugen i 2 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 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, followed by a 10-day rest period on days 12-21.
I cyklus 1-4 indgives Bortezomib Hospira 2 gange om ugen på dag 1, 4, 8, 11, 22, 25, 29 og 32. 
In Cycles 1-4, Bortezomib Hospira is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Der er dog påvist kemisk og fysisk stabilitet i 8 timer ved 5°C og 25°C, når produktet opbevares i det originale hætteglas og/eller en sprøjte. 
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
• Knoglebrud 
• Fracture
Thalidomid administreres oralt i en dosis på 50 mg dagligt på dag 1-14 og forhøjes, hvis denne dosis tolereres, til 100 mg på dag 15-28. 
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Bortezomib Hospira fås til intravenøs eller subkutan administration. 
Bortezomib Hospira is available for intravenous or subcutaneous administration.
subaraknoidal-blødning)*, hjerneødem, transitorisk cerebral iskæmi (TCI), koma, ubalance i det autonome nervesystem, autonom neuropati, kraniel parese*, paralyse*, parese*, præsynkope, hjernestammesyndrom, cerebrovaskulær sygdom, nerverodsskade, psykomotorisk hyperaktivitet, kompression af rygmarven, uspecificeret kognitiv forstyrrelse, motorisk dysfunktion, uspecificeret sygdom i nervesystemet, radikulitis, savlen, hypotoni 
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
Meget almindelig Kvalme og opkastning*, diarré*, stomatitis*, obstipation Almindelig 
Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
• Muskelkramper, muskelspasmer, muskelsvaghed, smerter i arme og ben 
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
Et lægemiddelinteraktionsforsøg med undersøgelse af virkningen af melphalan-prednison på bortezomibs farmakokinetik (som intravenøs injektion) viser en gennemsnitlig stigning i bortezomibs AUC 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.
Der er indberettet tilfælde af ileus (med frekvensen ”ikke almindelig”se pkt. 
Cases of ileus have been uncommonly reported (see section 4.8).