natgillin/translations-raw huggingface dataset:
Toksicitetsudviklingsforsøg på rotter og kaniner har vist fosterdødelighed ved maternelt toksiske doser, men ingen direkte fostertoksicitet ved ikke maternelt toksiske doser.
Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic dosages, but no direct embryo-foetal toxicity below maternally toxic dosages.
Der er ikke gennemført fertilitetsforsøg, men vurdering af reproduktivt væv har fundet sted i generelle toksicitetsforsøg.
Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
I forsøg med 6- måneders rotter, sås degenerative virkninger i både testikler og ovarier.
In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Peri - og postnatale udviklingsforsøg er ikke gennemført.
Peri- and postnatal development studies were not conducted.
I generelle toksicitetsforsøg med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave- tarm- kanalen, hvilket resulterede i opkastning og/ eller diaré, hæmatopoietisk og lymfatisk væv, hvilket resulterede i perifere blodcytopenier, lymfoidt vævsatrofi og hæmatopoietisk knoglemarvs - hypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/ or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Baseret på dyreforsøg synes gennemtrængningen af bortezomib gennem blod/ hjerne- barrieren at være begrænset, om overhovedet nogen og relevansen for mennesker er ukendt.
Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
2- 3 gange den anbefalede kliniske dosis på mg/ m2- basis er forbundet med pulsstigninger, fald i kontraktilitet, hypotension og dødsfald.
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/ m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Akut internvention med positive inotropiske eller pressormidler påvirkede faldet i hjertekontraktilitet og hypotension i hunde.
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Desuden sås i hundeforsøg en lille stigning i det korrigerede QT- interval.
Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Mannitol (E421) Nitrogen.
Mannitol (E 421) Nitrogen.
Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under punkt 6. 6.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Den rekonstituerede opløsning skal anvendes umiddelbart efter præparering.
19 The reconstituted solution should be used immediately after preparation.
Hvis den rekonstituerede opløsning ikke anvendes omgående, er opbevaringstider og - betingelser før anvendelsen brugerens ansvar.
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
8 timer i sprøjten.
However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25 °C stored in the original vial and/ or a syringe prior to administration, with a maximum of 8 hours in the syringe.
Opbevar hætteglasset i den ydre karton, så det er beskyttet mod lys.
Keep the vial in the outer carton in order to protect from light.
6. 3 for opbevaringsforhold for det rekonstituerede produkt.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Type 1, 5 ml hætteglas med en grå bromobutyl- prop og en aluminiumsforsegling med grønt låg.
Type 1 glass 5 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a green cap.
Pakning med 1 engangshætteglas.
Pack containing 1 single-use vial.
Generelle forholdsregler Bortezomib er et cytotoksisk middel.
General precautions Bortezomib is a cytotoxic agent.
Det er yderst vigtigt, at der anvendes aseptisk teknik til håndtering af VELCADE, da det ikke indeholder konserveringsmiddel.
Aseptic technique must be strictly observed throughout handling of VELCADE, since it contains no preservative.
Instruktioner for rekonstitution Hvert 5 ml hætteglas rekonstitueres med 1 ml natriumchlorid til injektion 9 mg/ ml (0, 9%).
Instructions for reconstitution Each vial must be reconstituted with 1 ml of sodium chloride 9 mg/ ml (0.9%) for injection.
Den rekonstituerede opløsning er klar og farveløs med en pH- værdi på 4- 7.
The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Den rekonstituerede opløsningen skal inspiceres visuelt for partikler og misfarvning før anvendelse.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Bortskaffelse Kun til engangsbrug.
Disposal For single use only.
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg 30 B- 2340 Beerse Belgien
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg 30 B-2340 Beerse Belgium
Dato for første tilladelse: 26/ 04/ 2004.
26/ 04/ 2004 Date of latest renewal:
VELCADE 3, 5 mg pulver til injektionsvæske, opløsning.
VELCADE 3.5 mg powder for solution for injection
Hvert hætteglas indeholder 3, 5 mg bortezomib (som mannitolborester).
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Dosisjusteringer i behandlingsforløbet og ved genoptagelse af behandling ved monoterapi
Currently there are limited data concerning re-treatment with VELCADE.
4. 4).
22 Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
21 Hvis toksiciteten ikke forsvinder, eller hvis den forekommer igen ved den laveste dosis, skal seponering af VELCADE overvejes, medmindre fordelene ved behandlingen tydeligt opvejer risici.
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE must be considered unless the benefit of treatment clearly outweighs the risk.
4. 4).
Patients who experience bortezomib-related neuropathic pain and/ or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Dosisændringer Ingen ændring
Posology modification of dose and regimen No action
Grad 4 (invaliderende sensorisk neuropati eller motorisk neuropati, som er livstruende eller medfører lammelse)
Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis) and/ or severe autonomic neuropathy
4. 8).
Elderly patients There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age (see section 4.8).
Det er derfor ikke nødvendigt at justere doseringen til disse patienter.
Renal impairment The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (CCl > 20 ml/ min/ 1.73 m2); therefore, dose adjustments are not necessary for these patients.
Det er uvist, om bortezomibsfarmakokinetik bliver påvirket hos patienter med svært nedsat nyrefunktion, som ikke er i dialyse (CrCL < 20 ml/ min/ 1, 73 m2).
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CCl < 20 ml/ min/ 1.73 m2).
Nedsat leverfunktion VELCADE er ikke undersøgt til patienter med nedsat leverfunktion.
Hepatic impairment VELCADE has not been studied in patients with impaired hepatic function.
Dosering ved kombinationsbehandling VELCADE (bortezomib) indgives som en intravenøs bolusinjektion kombineret med oral melphalan og oral prednison i ni 6- ugers behandlingscyklusser som vist i tabel 2.
Posology combination therapy VELCADE (bortezomib) is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 2.
I cyklus 5- 9 indgives VELCADE en gang om ugen (dag 1, 8, 22 og 29).
23 (days 1, 8, 22 and 29).
22 Tabel 2- Anbefalet dosering for VELCADE i kombination med melphalan og prednison til patienter med tidligere ubehandlet myelomatose VELCADE to gange om ugen (cyklus 1- 4)
Table 2: Recommended Posology for VELCADE in combination with melphalan and prednisone for patients with previously untreated multiple myeloma Twice weekly VELCADE (cycles 1-4)
Vc (1, 3 mg/ m2)
Vc
dag dag dag
Day Day 8 Day
hvile
Day Day Day
hvile
1.3 mg/ m2) 2
4
29
-- --
32
hvile -- -- -- --
period
hvile
M P
VELCADE en gang om ugen (cyklus 5- 9)
(9 mg/ m) (60 mg/ m2)
1
Day Day Day Day 1 2
5
--
6
rest period
Vc (1, 3 mg/ m
--
2)
--
dag
--
-- -- --
--
dag hvile dag
rest period
dag dag
rest
dag dag
(
P (60 mg/ m2)
1.3 mg/ m2)
2) 1 2
period
3
M P
Dosisændringer ved kombinationsbehandling Dosisændringer og genoptagelse af behandling, når VELCADE indgives i kombination med melphalan og prednison.
Dose adjustments for combination therapy Dose modification and re-initiation of therapy when VELCADE is administered in combination with melphalan and prednisone
Før påbegyndelse af en ny behandlingscyklus: • Trombocyttal skal være ≥70 x 109/ l, og absolut neutrofiltal skal være ≥ 1, 0 x 109/ l • Ikke- hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline
Prior to initiating a new cycle of therapy: • Platelet counts should be ≥ 70 x 109/ l and the absolute neutrophils count should be ≥ 1.0 x 109/ l • Non-haematological toxicities should have resolved to Grade 1 or baseline
Toksicitet
Table3: Posology modifications during subsequent cycles Toxicity Haematological toxicity during a cycle
Dosisændring eller udsættelse
Posology modification or delay
Indgivelsesmåde Den rekonstituerede opløsning indgives som en intravenøs bolusinjektion af 3- 5 sekunders varighed gennem et perifert eller centralt intravenøst kateter, efterfulgt af skylning med natriumchlorid 9 mg/ ml (0, 9%) injektionsvæske.
24 Method of administration The reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ ml (0.9%) solution for injection.
23 4. 3 Kontraindikationer
4.3 Contraindications
4. 8), og derfor skal patienter, som oplever forstoppelse, monitoreres omhyggeligt.
Cases of ileus have been uncommonly reported (see section 4.8), therefore patients who experience constipation should be closely monitored.
24 Krampeanfald Der er rapporteret enkelte tilfælde af krampeanfald hos patienter, som ikke tidligere har oplevet sådanne anfald eller epilepsi.
25 Seizures Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Hypotension Behandlingen med VELCADE forbindes almindeligvis med ortostatisk/ postural hypotension.
Hypotension VELCADE treatment is commonly associated with orthostatic/ postural hypotension.
I et randomiseret, komparativt fase III- forsøg med monoterapi var forekomsten af hjerteinsufficiens i VELCADE - gruppen den samme som i dexamethason- gruppen.
In a single-agent Phase III randomised, comparative study the incidence of heart failure in the VELCADE group was similar to that in the dexamethasone group.
Derfor frarådes det at anvende dette regime ved samtidig administration af højdosis cytarabin (2 g/ m2 dagligt) ved kontinuerlig infusion over en periode på 24 timer.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2g/ m2 per day) by continuous infusion over 24 hours is not recommended.
Disse patienter skal monitoreres nøje (se pkt.
Such patients should be monitored closely.
25 Nedsat leverfunktion Patienter med nedsat leverfunktion skal behandles med største forsigtighed, og der skal overvejes en dosisreduktion (se pkt.
Hepatic impairment Patients with hepatic impairment should be treated with extreme caution and a dose reduction should be considered (see sections 4.2, 4.3 and 5.2).
4. 2, 4. 3 og 5. 2).
Hepatic reactions
Leverreaktioner Der er rapporteret sjældne tilfælde af akut leversvigt hos patienter, der tager flere forskellige slags medicin samtidig og med alvorlige tilgrundliggende helbredsproblemer.
26 Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
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).
26 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.
4. 6 Graviditet og amning
27 4.6 Pregnancy and lactation
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 parturition and post-natal development were not conducted (see section 5.3).
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.
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.
Ikke almindelig: øget alaninaminotransferase, øget aspartataminotransferase, øget blodbilirubin, øget basisk fosfatase i blod, øget blodkreatinin, øget blodurinstof, øget gammaglutamyltransferase, øget blodamylase, abnorm leverfunktionstest, fald i antal røde blodlegemer, fald i hvide blodlegemer, fald i
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.
Hjerte Ikke almindelig: hjertestop, kardiogent chok, myokardieinfarkt, angina pectoris, ustabil angina, udvikling eller forværring af kongestiv hjerteinsufficiens (se pkt.
Neoplasms benign and malignant (including cysts and polyps) Uncommon: tumour lysis syndrome (see section 4.4).
4. 4) Meget almindelig:
28 Blood and lymphatic system disorders (see section 4.4) Very common:
4. 4), perifer motorisk neuropati, synkope, parese, opmærksomhedsforstyrrelser, øget aktivitetsniveau, ageusi, somnolens, migræne, kognitive forstyrrelser, rykvise bevægelser, postural svimmelhed, iskias, mononeuropati, taleforstyrrelser, uro i benene.
Metabolism and nutrition disorders Very common:
Ikke almindelig: respirationsstop, hypoksi, pulmonal kongestion, pleuralekssudat, astma, respirationsalkalose, tarkypnø, hvæsen, hæshed, rhinitis, hyperventilation, ortopnø, smerter i thoraxvæggen, sinussmerter, sammensnøret hals, produktiv hoste.
Nervous system disorders(see sections 4.4 and 4.7) Very common:
Mave- tarm- kanalen (se pkt.
peripheral neuropathy, peripheral sensory neuropathy (see section 4.4),
28 Hud og subkutane væv Meget almindelig: udslæt.
Ear and labyrinth disorders Common: vertigo.
Ikke almindelig: vaskulitisk udslæt, erytematøst udslæt, fotosensitivitetsreaktion, kontusion, generel pruritus, makulært udslæt, papulært udslæt, psoriasis, generelt udslæt, ødemer i øjenlågene, ødemer i ansigtet, dermatit, alopeci, neglesygdomme, misfarvning af huden, atopisk dermatit, abnorm hårtekstur, varmeudslæt, nattesved, tryksår, iktyose.
Cardiac disorders Uncommon: cardiac arrest, cardiogenic shock, myocardial infarction, angina pectoris, angina unstable, development or exacerbation of congestive heart failure (see section 4.4), cardiac failure, ventricular hypokinesia, pulmonary oedema and acute pulmonary oedema, sinus arrest, atrioventricular block complete, tachycardia, sinus tachycardia, supraventricular tachycardia, arrhythmia, atrial fibrillation, palpitations.
Knogler, led, muskler og bindevæv Meget almindelig: myalgi.
Rare: new onset of decreased left ventricular ejection fraction.
Almindelig: muskelsvækkelse, smerter i muskler og knogler, smerter i ekstremiteter, muskelkramper, artralgi, knoglesmerter, rygsmerter, perifer opsvulmen.
Vascular disorders Common: hypotension, orthostatic and postural hypotension (see sections 4.4 and 4.7), phlebitis, haematoma, hypertension.
Metabolisme og ernæring Meget almindelig:
29 Respiratory, thoracic and mediastinal disorders Very Common:
nedsat appetit.
dyspnoea.
Almindelig: dehydrering, hypokaliæmi, hyperglykæmi.
Common: dyspnoea exertional, epistaxis, cough, rhinorrhoea.
Ikke almindelig: hyperkaliæmi, kakeksi, hyperkalcæmi, hypokalcæmi, hypernatræmi, hyponatræmi, hypoglykæmi, hyperurikæmi, B12- vitaminmangel, øget appetit, hypomagnesæmi, hypofosfatæmi.
Gastrointestinal disorders (see section 4.4) Very common:
Infektioner og parasitære sygdomme Meget almindelig: herpes zoster (inklusive dissemineret).
vomiting, diarrhoea, nausea, constipation.
Almindelig: pneumoni, bronkitis, sinusitis, nasofaryngitis, herpes simplex.
Common: abdominal pain, stomatitis, dyspepsia, loose stools, abdominal pain upper, flatulence, abdominal distension, hiccups, mouth ulceration, pharyngolaryngeal pain, dry mouth.
Ikke almindelig: sepsis, bakteriæmi, pneumoniapneumococcus- infektion, bronkopneumoni, øvre og nedre luftvejsinfektioner, kateterrelateret infektion, pleuralinfektion, haemophilus- infektion, cytomegalovirusinfektion, infektiøs mononukleose, varicella, urinvejsinfektion, gastroenteritis, candida - infektion, svampeinfektion, post- herpetisk neuralgi, oral candidias, blepharitis, infektion.
Uncommon: acute pancreatitis, ileus paralytic, antibiotic associated colitis, colitis, haematemesis, diarrhoea haemorrhagic, gastrointestinal haemorrhage, rectal haemorrhage, enteritis, dysphagia, abdominal discomfort, eructation, gastrointestinal motility disorder, oral pain, retching, change in bowel habit, spleen pain, oesophagitis, gastritis, gastro-oesophageal reflux disease, gastrointestinal pain, gingival bleeding, gingival pain, hiatus hernia, irritable bowel syndrome, oral mucosal petechiae, salivary hypersecretion, tongue coated, tongue discolouration, faecal impaction.
Traumer, forgiftninger og behandlingskomplikationer Ikke almindelig:
Hepato-biliary disorders (see section 4.4) Uncommon: hepatitis, hepatic haemorrhage, hypoproteinaemia, hyperbilirubinaemia.
Kateter- relaterede komplikationer, smerter efter procedurer, blødning efter procedurer, forbrændinger.
Skin and subcutaneous tissue disorders Very common:
4. 4).
rash.
Vaskulære sygdomme Almindelig: hypotension, ortostatisk og postural hypotension (se pkt.
Common: periorbital oedema, urticaria, rash pruritic, pruritus, erythema, sweating increased, dry skin, eczema.
4. 4 og 4. 7), phlebitis, hæmatom, hypertension.
Musculoskeletal and, connective tissue bone disorders Very Common:
Ikke almindelig: cerebral blødning, vasculitis, cerebrovaskulær ulykke, pulmunalt hypertension, petekkier, ekkymose, purpura, misfarvning af vener, udspilede vener, sårblødning, rødmen, hedeture.
myalgia.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: træthed (se pkt 4. 7), pyreksi.
Common: muscle weakness, musculoskeletal pain, pain in limb, muscle cramps, arthralgia, bone pain, back pain, peripheral swelling.
Almindelig: asteni, svaghed, døsighed, kulderystelser, utilpashed, influenzalignende sygdom, perifere ødemer, brystsmerter, smerter, ødemer.
Uncommon: muscle spasms, muscle twitching or sensation of heaviness, muscle stiffness, joint swelling, joint stiffness, buttock pain, swelling, pain in jaw.
Ikke almindelig: fald, blødning i slimhinde, mukosal inflammation, neuralgi, flebitis på indgivelsesstedet, ekstravasationinflammation, ømhed, erytem på indgivelsesstedet, kuldefornemmelse, trykken for brystet, brystubehag, lyskesmerter, trangbrystethed.
Uncommon: renal failure acute, renal failure, oliguria, renal colic, haematuria, proteinuria, urinary retention, urinary frequency, difficulty in micturition, loin pain, urinary incontinence, micturition urgency.
Immunsystemet Ikke almindelig: hypersensitivitet, immunocomplex- medieret hypersensitivitet, potentielt immunkompleksmedierede reaktioner som f. eks.
Reproductive system and breast disorders Uncommon: testicular pain, erectile dysfunction.
4. 4).
General disorders and administration site conditions Very Common:
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.
Oversigt over sikkerhedsdata hos patienter med tidligere ubehandlet myelomatose:
30 Summary of safety data in patients with previously untreated multiple myeloma:
I alt
(n=337)
Toksicitetsgrad, n (%) I alt Toksicitet
MedDRA System Organ Class
I alt Toksicitetsgrad, n (%) I alt
Total Toxicity Grade, n
n (%)
n (%) 3
140 (42) 143 (42) 156 (46) 93 (28) 51 (15)
57 (17) 140 (42) 48 (14) (10) 143 (42) 77 (23) 4 (1) 156 (46) 61 (18) 8 (2) 93 (28) 53 (16) 17 (5) 51 (15) 26 (8)
48 (14) 77 (23) 61 (18) 53 (16) 26 (8)
39 (12) 42 (12) 18 (5) 11 (3) 7 (2)
64 (19)
64 (19) 6 (2)
1 (< 1)
35 (10) 1 (< 1)
Perifer neuropati Neuralgi Paræstesi Mave- tarm- kanalen
Peripheral Neuropathy Neuralgia Paraesthesia Gastrointestinal disorders
156 (46) 117 (34) 42 (12)
156 (46) 42 (12) 117 (34) 27 (8) 42 (12) 6 (2)
Kvalme Diaré Opkastning Forstoppelse Smerter i den øverste del af maven Hud og subkutane væv
Nausea Diarrhoea Vomiting Constipation Abdominal Pain Upper Skin and subcutaneous tissue disorders
134 (39) 119 (35) 87 (26) 77 (23) 34 (10)
134 (39) 10 (3) 119 (35) 19 (6) 87 (26) 13 (4) 77 (23) 2 (1) 34 (10) 1 (< 1)
10 (3) 19 (6) 13 (4) 2 (1) 1 (< 1)
0 70 (21) 1 (< 1) 2 (1) 20 (6) 1 (< 1) 0 41 (12) 2 (1) 0 14 (4) 0 0 20 (6) 0
0 2 (1) 0 0 0
0 0 0 0 0
70 (21) 20 (6) 41 (12) 14 (4) 20 (6)
Rash General disorders and administration site conditions
7 (2)
0 7 (2) 0
MedDRA- systemorganklasse
Fatigue Asthenia Pyrexia
4 (1) 3 (1)
2 (1) 48 (14) 4 (1) 0 23 (7) 3 (1) 0 19 (6) 1 (< 1)
1 (< 1)
0 0 1 (< 1)
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%).
Three (3%)
Tre (3%) af de 91 patienter i Vc+M+P- behandlingsgruppen, der fik profylatisk behandling med antivirale stoffer, udviklede herpes zoster- reaktivering.
31 of the 91 patients in the Vc+M+P treatment group who received prophylactic anti-virals developed herpes zoster reactivation.