natgillin/translations-raw huggingface dataset:
Ud fra det begrænsede bidrag (7%) fra CYP2D6 til metaboliseringen af bortezomib, forventes det ikke, at den CYP2D6- fænotype som metaboliserer dårligt, påvirker den samlede tilbøjelighed for bortezomib.
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metabolizer phenotype is not expected to affect the overall disposition of bortezomib.
En interaktionsundersøgelse baseret på data fra 12 patienter til vurdering af effekten af ketoconazol, en kraftig CYP3A- hæmmer, viste en gennemsnitlig stigning i AUC for bortezomib på 35% (CI90% (1, 032 til 1, 772)).
An interaction study based on data from 12 patients, assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, showed a bortezomib AUC mean increase of 35% (CI90% [1.032 to 1.772]).
Patienterne skal derfor monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4- hæmmere (f. eks. ketoconazol, ritonavir).
Therefore patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, ritonavir).
En interaktionsundersøgelse baseret på data fra 17 patienter til vurdering af effekten af omeprazol, en kraftig CYP2C19- hæmmer, viste ingen signifikant effekt på farmakokinetikken for bortezomib.
In an interaction study based on data from 17 patients, assessing the effect of omeprazole, a potent CYP2C19 inhibitor, there was no significant effect on the pharmacokinetics of bortezomib.
Patienterne skal monitoreres omhyggeligt, når der gives bortezomib sammen med CYP2C19- hæmmere (f. eks. fluoxetin).
Patients should be closely monitored when given bortezomib in combination with CYP2C19 inhibitors (e. g. fluoxetine).
Hvis der ikke foreligger interaktionsundersøgelser af effekten af CYP3A4- inducere på farmakokinetikken for bortezomib, skal patienterne monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4- inducere (f. eks. rifampicin).
In the absence of interaction studies investigating the effect of CYP3A4 inducers on the pharmacokinetics of bortezomib, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inducers (e. g. rifampicin).
En interaktionsundersøgelse til vurdering af effekten af melphalan- prednison på bortezomib viste en stigning på 17% i gennemsnitlig AUC for bortezomib baseret på data fra 21 patienter.
An interaction study assessing the effect of melphalan-prednisone on bortezomib showed a 17% increase in mean bortezomib AUC based on data from 21 patients.
Der er i kliniske forsøg rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes- patienter i behandling med orale hypoglykæmika.
During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Patienter i
Patients on oral antidiabetic agents receiving
7 behandling med orale antidiabetika, som behandles med VELCADE, kan have brug for nøje monitorering af deres blodsukkerniveau og justering af deres antidiabetikadosis.
7 VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Det teratogeniske potentiale ved bortezomib er ikke fuldstændigt undersøgt.
The teratogenic potential of bortezomib has not been fully investigated.
I ikke- kliniske forsøg havde bortezomib ingen indvirkning på fostrets udvikling hos rotter og kaniner ved den højest tålte dosis hos mater.
In non-clinical studies, bortezomib had no effects on embryonal/ foetal development in rats and rabbits at the highest maternally tolerated doses.
Der er ikke gennemført dyreforsøg til bestemmelse af bortezomibs effekt på fødslen og den postnatale udvikling (se pkt.
Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
VELCADE bør kun anvendes på tvingende indikation til gravide.
VELCADE should not be used during pregnancy unless clearly necessary.
Der foreligger ikke kliniske data for brug af VELCADE under graviditet.
For VELCADE no clinical data with regard to exposure during pregnancy are available.
Mandlige og kvindelige patienter i den fødedygtige alder skal anvende sikker kontraception under og i 3 måneder efter behandlingen.
Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Det vides ikke, om bortezomib udskilles i modermælken.
It is not known whether bortezomib is excreted in human milk.
Som følge af risikoen for alvorlige bivirkninger hos ammede børn, bør amning ophøre under behandling med VELCADE.
Because of the potential for serious undesirable effects in breast-fed infants, lactation should be discontinued during treatment with VELCADE.
VELCADE påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
VELCADE may have a moderate influence on the ability to drive and use machines.
VELCADE kan forbindes med træthed (meget almindeligt), svimmelhed (almindeligt), besvimelse (ikke almindeligt), ortostatisk/ postural hypotension eller sløret syn (almindeligt).
VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly, orthostatic/ postural hypotension or blurred vision commonly.
4. 8).
Therefore, patients must be cautious when operating machinery, or when driving (see section 4.8).
Følgende bivirkninger ansås af investigatorerne for mindst at have en mulig eller sandsynlig årsagsmæssig sammenhæng med VELCADE ved gennemførelsen af fem ikke- komparative fase II - forsøg og et komparativt fase III- forsøg med VELCADE versus dexamethason hos 663 patienter med recidiverende eller refraktær multipelt myelom, hvoraf 331 fik VELCADE som det eneste middel.
The following undesirable effects were considered by the investigators to have at least a possible or probable causal relationship to VELCADE during the conduct of 5 non-comparative Phase II studies and 1 comparative Phase III trial VELCADE vs. dexamethasone in 663 patients with relapsed or refractory multiple myeloma, of whom 331 received VELCADE as single agent.
Sikkerhedsdatabasen indeholder data fra patienter med multipelt myelom eller B- celle lymfocytisk leukæmi (CLL).
The safety database comprises data from patients with multiple myeloma or B-cell lymphocytic leukemia (CLL).
Patienterne blev behandlet med VELCADE som eneste middel eller kombineret med dexamethason.
Patients were treated with VELCADE as a single agent, or in combination with dexamethasone.
Frekvensen defineres som:
Frequencies are defined as:
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100 til < 1/ 10); ikke almindelig (≥ 1/ 1. 000 til < 1/ 100); sjælden (≥ 1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt (kan ikke estimeres ud fra tilgængelige data).
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Tabel 4:
8 Table 4:
Bivirkninger hos patienter med recidiverende eller refraktær multipelt myelom Undersøgelser Almindelig: vægttab, øget blodlaktatdehydrogenase.
Adverse reactions in patients with relapsed/ refractory multiple myeloma Infections and infestations Very common: herpes zoster (including disseminated).
Hjerte Ikke almindelig: hjertestop, kardiogent chok, myokardieinfarkt, angina pectoris, ustabil angina, udvikling eller forværring af kongestiv hjerteinsufficiens (se pkt.
Common: pneumonia, bronchitis, sinusitis, nasopharyngitis, herpes simplex.
4. 4), hjertesvigt ventikel- hypokinesi, lungeødemer og akutte lungeødemer, sinusstop, fuldstændig atrioventrikulær blokering, takykardi,
Uncommon: sepsis, bacteraemia, pneumonia pneumococcal, bronchopneumonia, upper and lower respiratory tract infection, catheter related infection, pleural infection, haemophilus infection, cytomegalovirus infection, influenza, infectious mononucleosis, varicella, urinary tract infection, gastroenteritis, candidal infection, fungal infection, post herpetic neuralgia, oral candidiasis, blepharitis, infection.
Sjælden: ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel.
Neoplasms benign and malignant (including cysts and polyps) Uncommon: tumour lysis syndrome (see section 4.4).
4. 4) Meget almindelig:
Blood and the lymphatic system disorders (see section 4.4) Very common:
trombocytopeni, neutropeni, anæmi.
thrombocytopenia, neutropenia, anaemia.
Almindelig: leukopeni, lymfopeni.
Common: leukopenia, lymphopenia.
Ikke almindelig: pancytopeni, febril neutropeni, hæmolytisk anæmi, trombocytopenisk purpura, lymfadenopati.
Uncommon: pancytopenia, febrile neutropenia, haemolytic anaemia, thrombocytopenic purpura, lymphadenopathy.
Almindelige: polyneuropati, forværret perifer neuropati, svimmelhed (eksklusive vertigo), smagsforstyrrelser, dysæstesi, hypoæstesi, tremor.
Immune system disorders Uncommon: hypersensitivity, immunocomplex mediated hypersensitivity, potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis (see section 4.4).
Ikke almindelig: paraplegia, intrakraniel blødning, subaraknoid blødning, konvulsioner (se pkt.
Endocrine disorders Uncommon: inappropriate antidiuretic hormone (ADH) secretion.
Øjne Almindelig: sløret syn (se pkt.
Metabolism and nutrition disorders Very common:
4. 7), øjensmerter.
appetite decreased.
Øre og labyrint Almindelig: vertigo.
Common: dehydration, hypokalaemia, hyperglycaemia.
Ikke almindelig: døvhed, tinnitus, hypoacusis, nedsat hørelse.
Uncommon: hyperkalaemia, cachexia, hypercalcaemia, hypocalcaemia, hypernatraemia, hyponatraemia, hypoglycaemia, hyperuricaemia, vitamin B12 deficiency, appetite increased, hypomagnesaemia, hypophosphataemia.
Luftveje, thorax og mediastinum Meget almindelig: dyspnø Almindelig: anstrengelsesudløst dyspnø, epistaxis, hoste, rhinorre.
Psychiatric disorders Common: confusion, depression, insomnia, anxiety.
Ikke almindelig: respirationsstop, hypoksi, pulmonal kongestion, pleuralekssudat, astma, respirationsalkalose, tarkypnø, hvæsen, hæshed, rhinitis, hyperventilation, ortopnø, smerter i thoraxvæggen, sinussmerter, sammensnøret hals, produktiv hoste.
Uncommon: agitation, delirium, hallucinations, restlessness, mood swings, mental status changes, sleep disorder, irritability, abnormal dreams.
Mave- tarm- kanalen (se pkt.
Nervous system disorders (see sections 4.4 and 4.7) Very common:
4. 4) Meget almindelig: opkastning, diaré, forstoppelse.
paraesthesia, headache.
Almindelig: mavesmerter, stomatitis dyspepsi, løs afføring, smerter i øvre abdomen, flatulens, distension af abdomen, hikke, ulceration i mundhulen, faryngolaryngeale smerter, mundtørhed.
Common: polyneuropathy, peripheral neuropathy aggravated, dizziness (excluding vertigo), dysgeusia, dysaesthesia, hypoaesthesia, tremor.
Ikke almindelig: akut pancreatitis, paralytisk ileus, antibiotikarelateret colitis, colitis, hæmatemes, blødende diaré, blødning i mave/ tarm, rektal blødning, enteritis, dysfagi, ubehag i abdomen, opstød, gastroinstestinal motilitetssygdom, orale smerter, opkastning, ændring i afføringsmønster, smerter i milten, øsofagitis, gastritis, gastroøsofageal reflukssygdom, gastrointestinale smerter, gingivalblødning, gingivalsmerter, hiatushernia, irritabel tarm, oral mukosepetekkier, hypersekretion af spyt, belagt tunge, misfarvning af tungen, fastkilen af fæces.
Uncommon: paraplegia, intracranial haemorrhage, subarachnoid haemorrhage convulsions (see section 4.4), peripheral motor neuropathy, syncope, paresis, disturbance in attention, increased activity, ageusia, somnolence, migraine, cognitive disorder, jerky movements, dizziness postural, sciatica, mononeuropathy, speech disorder, restless leg syndrome.
Nyrer og urinveje Almindelig: nyrepåvirkning, dysuri.
Eye disorders Common: vision blurred (see section 4.7), eye pain.
Ikke almindelig: akut nyresvigt, nyresvigt, oliguri, nyrekolik, hæmaturi, proteinuri, urinretention urinfrekvens, mikturationsbesvær, lændesmerter, inkontinens, mikturationstrang.
Uncommon: eye haemorrhage, vision abnormal, dry eye, conjunctivitis, eye discharge, photophobia, eye irritation, lacrimation increased, conjunctival hyperaemia, eye swelling.
Hud og subkutane væv Meget almindelig: udslæt.
9 Ear and labyrinth disorders Common: vertigo.
Almindelig: periorbitalt ødem, urticaria, pruritisk udslæt, pruritus, erytem, øget svedtendens, tør hud, eksem.
Uncommon: deafness, tinnitus, hypoacusis, hearing impaired.
9 ansigtet, dermatit, alopeci, neglesygdomme, misfarvning af huden, atopisk dermatit, abnorm hårtekstur, varmeudslæt, nattesved, tryksår, iktyose.
Rare: new onset of decreased left ventricular ejection fraction.
Knogler, led, muskler og bindevæv Meget almindelig: myalgi.
Vascular disorders Common: hypotension, orthostatic and postural hypotension (see sections 4.4 and 4.7), phlebitis, haematoma, hypertension.
Ikke almindelig: muskelspasmer, muskeltrækninger eller fornemmelse af tyngde, muskelstivhed, opsvulmen af led, opsvulmen, smerter i kæbe.
Uncommon: cerebral hemorrhage, vasculitis, cerebrovascular accident, pulmonary hypertension, petechiae, ecchymosis, purpura, vein discolouration, vein distended, wound hemorrhage, flushing, hot flushes.
Det endokrine system Ikke almindelig: uhensigtsmæssig antidiuretisk hormonudskillelse (ADH).
Respiratory, thoracic and mediastinal disorders Very common:
Metabolisme og ernæring Meget almindelig:
Common: dyspnoea exertional, epistaxis, cough, rhinorrhoea.
nedsat appetit.
Gastrointestinal disorders (see section 4.4) Very common:
Almindelig: dehydrering, hypokaliæmi, hyperglykæmi.
vomiting, diarrhoea, nausea, constipation.
Ikke almindelig: hyperkaliæmi, kakeksi, hyperkalcæmi, hypokalcæmi, hypernatræmi, hyponatræmi, hypoglykæmi, hyperurikæmi, B12- vitaminmangel, øget appetit, hypomagnesæmi, hypofosfatæmi.
Common: abdominal pain, stomatitis, dyspepsia, loose stools, abdominal pain upper, flatulence, abdominal distension, hiccups, mouth ulceration, pharyngolaryngeal pain, dry mouth.
Infektioner og parasitære sygdomme Meget almindelig: herpes zoster (inklusive dissemineret).
Hepato-biliary disorders (see section 4.4) Uncommon: hepatitis, hepatic haemorrhage, hypoproteinaemia, hyperbilirubinaemia.
Almindelig: pneumoni, bronkitis, sinusitis, nasofaryngitis, herpes simplex.
Common: periorbital skin, eczema.
Traumer, forgiftninger og behandlingskomplikationer Ikke almindelig:
rash. oedema, urticaria, rash pruritic, pruritus, erythema, sweating increased, dry
Kateter- relaterede komplikationer, smerter efter procedurer, blødning efter procedurer, forbrændinger.
Uncommon: vasculitic rash, rash erythematous, photosensitivity reaction, contusion, pruritus generalised, rash macular, rash papular, psoriasis, rash generalized, eyelid oedema, face oedema, dermatitis, alopecia, nail disorder, skin discolouration, dermatitis atopic, hair texture abnormal, heat rash, night sweats, pressure sore, ichthyosis, skin nodule.
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Ikke almindelig: tumorlysesyndrom (se pkt.
Musculoskeletal, connective tissue and bone disorders Very common:
4. 4).
myalgia.
4. 4 og 4. 7), phlebitis, hæmatom, hypertension.
Common: muscle weakness, musculoskeletal pain, pain in limb, muscle cramps, arthralgia, bone pain, back pain, peripheral swelling.
Ikke almindelig: cerebral blødning, vasculitis, cerebrovaskulær ulykke, pulmunalt hypertension, petekkier, ekkymose, purpura, misfarvning af vener, udspilede vener, sårblødning, rødmen, hedeture.
Uncommon: muscle spasms, muscle twitching or sensation of heaviness, muscle stiffness, joint swelling, joint stiffness, buttock pain, swelling, pain in jaw.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: træthed (se pkt 4. 7), pyreksi.
10 Renal and urinary disorders Common: renal impairment, dysuria.
Almindelig: asteni, svaghed, døsighed, kulderystelser, utilpashed, influenzalignende sygdom, perifere ødemer, brystsmerter, smerter, ødemer.
Uncommon: renal failure acute, renal failure, oliguria, renal colic, haematuria, proteinuria, urinary retention, urinary frequency, difficulty in micturition, loin pain, urinary incontinence, micturition urgency.
Ikke almindelig: fald, blødning i slimhinde, mukosal inflammation, neuralgi, flebitis på indgivelsesstedet, ekstravasationinflammation, ømhed, erytem på indgivelsesstedet, kuldefornemmelse, trykken for brystet, brystubehag, lyskesmerter, trangbrystethed.
Reproductive system and breast disorders Uncommon: testicular pain, erectile dysfunction.
4. 4).
General disorders and administration site conditions Very common:
Lever og galdeveje (se pkt.
fatigue (see section 4.7), pyrexia.
10 Det reproduktive system og mammae Ikke almindelig: tekstikelsmerter og erektil dysfunktion.
Common: asthenia, weakness, lethargy, rigors, malaise, influenza like illness, oedema peripheral, chest pain, pain, oedema.
Psykiske forstyrrelser Almindelig: konfusion, depression, insomnia, uro.
Investigations Common: weight decreased, blood lactate dehydrogenase increased.
Ikke almindelig: agitation, delirium, hallucinationer, rastløshed, humørsvingninger, ændringer i mental status, søvnforstyrrelser, irritation, unormale drømme.
Injury and poisoning Uncommon: catheter related complications, post procedural pain, post procedural haemorrhage, burns.
Oversigt over sikkerhedsdata hos patienter med tidligere ubehandlet myelomatose:
Summary of safety data in patients with previously untreated multiple myeloma:
Den følgende tabel 5 beskriver sikkerhedsdata fra 340 patienter med tidligere ubehandlet myelomatose, som fik VELCADE (1, 3 mg/ m2) kombineret med melphalan (9 mg/ m2) og prednison (60 mg/ m2) i et prospektivt fase III- forsøg.
The following table 5 describes safety data from 340 patients with previously untreated multiple myeloma who received VELCADE (1.3 mg/ m2) in combination with melphalan (9 mg/ m2) and prednisone (60 mg/ m2) in a prospective Phase III study.
Overordnet set lignede sikkerhedsprofilen for patienter behandlet med VELCADE som monoterapi den profil, som blev observeret hos patienter behandlet med VELCADE i kombination med melphalan og prednison.
Overall, the safety profile of patients treated with VELCADE in monotherapy was similar to that observed in patients treated with VELCADE in combination with melphalan and prednisone.
Uønskede hændelser i forbindelse med behandling med lægemidlet rapporteret hos ≥ 10% af patienterne behandlet med VELCADE i kombination med melphalan og prednison
Treatment emergent drug-related adverse reactions reported in ≥ 10% of patients treated with VELCADE in combination with melphalan and prednisone -------------- Vc+M+P ------------ ---------------- M+P ---------------
Vc+M+P -------------- (n=340)
(n=340)
---------------- M+P --------------- (n=337)
(n=337)
MedDRA- systemorganklasse
MedDRA System Organ Class
Toksicitetsgrad, n (%) I alt Toksicitet
Total Toxicity
I alt Toksicitetsgrad, n (%) I alt
Grade, n
Toksicitetsgrad, n (%)
(%) Total Toxicity Grade, n (%)
Foretrukken term Infektioner og parasitære sygdomme
Preferred Term Infections and Infestations
Herpes Zoster Blod og lymfesystem
Herpes Zoster Blood and lymphatic system disorders
Trombocytopeni Neutropeni Anæmi Leukopeni Lymfopeni Metabolisme og ernæring
Thrombocytopenia Neutropenia Anaemia Leukopenia Lymphopenia Metabolism and nutrition disorders
164 (48) 160 (47) 109 (32) 108 (32) 78 (23)
164 (48) 60 (18) 160 (47) 101 (30) 33 109 (32) 41 (12) 108 (32) 64 (19) 78 (23) 46 (14)
60 (18) 101 (30) 41 (12) 64 (19) 46 (14)
39 (12) 42 (12) 18 (5) 11 (3) 7 (2)
57 (17) 33 (10) 4 (1) 8 (2) 17 (5)
MedDRA System Organ Class
140 (42) 143 (42) 156 (46) 93 (28) 51 (15)
Total Toxicity
48 (14) 77 (23) 61 (18) 53 (16) 26 (8)
(%) Total Toxicity Grade, n (%)
39 (12) 42 (12) 18 (5) 11 (3) 7 (2)
≥ 4 n (%) 3
Anoreksi Psykiske forstyrrelser
Anorexia Psychiatric disorders
64 (19)
64 (19)
6 (2)
6 (2)
Insomni Nervesystemet
Insomnia Nervous system disorders
35 (10)
35 (1
1 (< 1)
1 (< 1) 0
21 (6)
42 (12)
Perifer neuropati Neuralgi Paræstesi Mave- tarm- kanalen
Neuralgia Paraesthesia Gastrointestinal disorders
156 (46) 117 (34) 42 (12)
117 (34) 42 (12)
42 (12) 27 (8) 6 (2)
27 (8) 6 (2)
2 (1) 2 (1) 0
1
4 (1) 1 (< 1) 4 (1)
1 (< 1)
0 0 0
2 (1)
0 0 0
1 (< 1)
Kvalme Diaré Opkastning Forstoppelse Smerter i den øverste del af maven Hud og subkutane væv
Vomiting Constipation Abdominal Pain Upper Skin and subcutaneous tissue disorders
134 (39) 119 (35) 87 (26) 77 (23) 34 (10)
87 (26) 77 (23) 34 (10)
10 (3) 19 (6) 13 (4) 2 (1) 1 (< 1)
13 (4) 2 (1) 1 (< 1)
0 2 (1) 0 0 0
0 0 0
70 (21) 20 (6) 41 (12) 14 (4) 20 (6)
41 (12) 14 (4) 20 (6)
1 (< 1) 1 (< 1) 2 (1) 0 0
2 (1) 0 0
0 0 0 0 0
0 0 0
Udslæt Almene symptomer og reaktioner på administrationsstedet
Rash General disorders and administration site conditions
Træthed Asteni Pyreksi
Fatigue Asthenia
85 (25) 54 (16) 53 (16)
85 (25) 54 (16)
19 (6) 18 (5) 4 (1)
19 (6) 18 (5)
2 (1) 0 0
(1) 0
48 (14) 23 (7) 19 (6)
48 (14) 23 (7)
4 (1) 3 (1) 1 (< 1)
1 (< 1)
0 0 1 (< 1)
1 (< 1)
11 Herpes zoster virusreaktivering
Herpes zoster virus reactivation
I fase III- forsøget med tidligere ubehandlede myelomatosepatienter, fik 27% af patienterne profylatisk behandling med antivirale stoffer i Vc+M+P- gruppen.
In the Phase III study in patients with previously untreated multiple myeloma, 27% of patients received prophylactic antivirals in the Vc+M+P arm.
I dette forsøg var herpes zoster- reaktivering mere almindelig hos patienter behandlet med Vc+M+P sammenlignet med M+P (henholdsvis 11% og 3%).
In this study, herpes zoster reactivation was more common in patients treated with Vc+M+P compared with M+P (11% vs 3% respectively).
Tre (3%) af de 91 patienter i Vc+M+P- behandlingsgruppen, der fik profylatisk behandling med antivirale stoffer, udviklede herpes zoster- reaktivering.
Three (3%) of the 91 patients in the Vc+M+P treatment group who received prophylactic antivirals developed herpes zoster reactivation.
Klinisk signifikante utilsigtede reaktioner er nævnt i tabel 6, hvis de er indberettet efter godkendelsen af VELCADE og er eller er ikke indberettet fra kliniske forsøg:
Post-marketing experience Clinically significant adverse reactions are listed in Table 6, if they have been reported during post approval use of VELCADE and may or may not have been reported in clinical trials.
Frekvensen er ukendt.
Their frequency is not known.
Bivirkninger rapporteret efter markedsføringen Infektioner og parasitære sygdomme Ikke kendt:
Adverse reactions from post-marketing reports Infections and infestations Not known:
Herpes meningoencephalitis, septisk shock
Herpes meningoencephalitis, septic shock
Encefalopati, autonom neuropati
Encephalopathy, autonomic neuropathy
Herpes ophthalmicus
Ophthalmic herpes
Hjertetamponade, perikardit, hjerte - og hjerte- lungestop, ventrikulær Ikke kendt:
Cardiac tamponade, pericarditis, cardiac and cardiopulmonary arrest,
arytmi, totalt atrioventrikulært blok, atrieflimren, takykardi, sinus - og ventrikulær takykardi.
Gastrointestinal disorders
4. 4) Pneumonitis, pneumoni, interstitiel pneumonia, Acute Respiratory Distress Syndrome (ARDS), akut diffus infiltrativ lungesygdom, Ikke kendt: pulmonal hypertension, respirationssvigt, pulmonal alveolær blødning, akut lungeødem, lungeødem, lungeemboli, perifer emboli.
disease, pulmonary hypertension, respiratory failure, pulmonary alveolar haemorrhage, acute pulmonary oedema, pulmonary oedema, pulmonary embolism, peripheral embolism
Mave- tarmkanalen Ikke kendt:
Not known:
Iskæmisk colitis
Ischemic colitis
5. 3).
(For preclinical cardiovascular safety pharmacology studies, see section 5.3.
4. 2 og 4. 4).
In the event of an overdose, the patient ’ s vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/ or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Dette lægemiddel er blevet godkendt under ” særlige omstændigheder ”.
This medicinal product has been authorised under “ Exceptional Circumstances”.
Det betyder, at det af videnskabelige årsager. ikke har været muligt at opnå fuldstændig dokumentation.
This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.