natgillin/translations-raw huggingface dataset:
Alder Bortezomibs farmakokinetik er beskrevet efter intravenøs bolus-administration af 1,3 mg/m2 2 gange om ugen til 104 pædiatriske patienter (2-16 år) med akut lymfoblast leukæmi (ALL) eller akut myeloid leukæmi (AML).
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Du vil derfor regelmæssigt få taget blodprøver før og under din behandling med bortezomib for at kontrollere dine blodtal.
Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Gastrointestinal og intracerebral blødning er blevet indberettet i forbindelse med behandling med bortezomib.
Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Skift behandlingsplan for Bortezomib Hospira til 1,3 mg/m én gang om ugen
Change Bortezomib Hospira treatment schedule to 1.3 mg/m2 once per week
Bortezomib Hospira kan være forbundet med træthed (meget almindeligt), svimmelhed (almindeligt), synkope (ikke almindeligt) og ortostatisk/postural hypotension eller sløret syn (almindeligt).
Bortezomib Hospira may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Bortezomib Hospira må ikke indgives via andre administrationsveje.
Bortezomib Hospira should not be given by other routes.
En normal leverfunktion skal bekræftes, og der skal udvises forsigtighed hos patienter, der behandles med orale antidiabetika (se pkt.
Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycaemics (see section 4.5).
Der er i sjældne tilfælde indberettet potentielt immunkompleksmedierede reaktioner, for eksempel serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis.
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Doseringsændring
Posology modification
• Bevidsthedstab
• Loss of consciousness
Tabel 16: Effektresultater fra forsøg LYM-3002 Effektendepunkt
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Der er indberettet enkelte tilfælde af krampeanfald hos patienter, som ikke tidligere har haft sådanne anfald eller epilepsi.
Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
• Information om, at Bortezomib Hospira 1 mg, 2,5 mg, 3 mg og 3,5 mg kan administreres både intravenøst og subkutant
• Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg can be administered both intravenously and subcutaneously
• Forandringer i bevidsthedsniveau, forvirring, nedsat hukommelse eller hukommelsestab
• Altered levels of consciousness, confusion, memory impairment or loss
Diagrammet over regimer med induktionstransplantation skal indeholde følgende nøgleelementer:
Induction Transplant Regimens Graph shall contain the following key elements:
Nedsæt Bortezomib Hospira til 1,0 mg/m eller
Reduce Bortezomib Hospira to 1.0 mg/m or
• Øreproblemer, blødning fra ørerne
• Problems with your ear, bleeding from your ear
I alt har 74 evaluerbare patienter fået dexamethason sammen med bortezomib.
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Tabel 3: Dosisjusteringer under efterfølgende cyklusser med Bortezomib Hospira i kombination med melphalan og prednison
Table 3: Posology modifications during subsequent cycles of Bortezomib Hospira therapy in combination with melphalan and prednisone
Et fase II-forsøg med en enkelt behandlingsgruppe og undersøgelse af aktivitet, sikkerhed og farmakokinetik, udført af Children's Oncology Group, vurderede man virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoide maligniteter (akut præ-B-celle lymfoblast leukæmi [ALL], T-celle-ALL og T-celle lymfoblast lymfom [LL]).
A Phase II, single-arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Hvis du får Bortezomib Hospira sammen med thalidomid, skal du følge det svangerskabsforebyggende program for thalidomid (se indlægssedlen for thalidomid).
When bortezomib is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Tabel 10: Forekomsten af perifer neuropati i forsøg LYM-3002, inddelt efter toksicitet og behandlingsseponering på grund af perifer neuropati
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Antiviral profylakse bør overvejes til patienter, der behandles med Bortezomib Hospira.
Antiviral prophylaxis is recommended in patients being treated with Bortezomib Hospira.
I fase III-forsøget til sammenligning af bortezomib administreret intravenøst vs. subkutant var forekomsten af bivirkninger med perifer neuropati ≥ grad 2 24% i gruppen, der fik subkutane injektioner, og 41% i gruppen, der fik intravenøse injektioner (p=0,0124).
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Hvis du har fået for meget Bortezomib Hospira Da dette lægemiddel gives af en læge eller sygeplejerske, er det usandsynligt, at du vil få for meget.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Pause Dag
Day rest period
Der har været fatale tilfælde af utilsigtet intratekal administration af Bortezomib Hospira.
There have been fatal cases of inadvertent intrathecal administration of Bortezomib Hospira.
Thrombocyttransfusion skal overvejes, når det er klinisk relevant (se pkt.
Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Plakaten om rekonstitution skal indeholde følgende hovedpunkter:
The Reconstitution poster shall contain the following key elements:
Både BR-CAP og R-CHOP er mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger er i BR-CAP-gruppen 68% sammenlignet med 42% i R-CHOP-gruppen.
Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
• Diagram over regimer med induktionstransplantation.
• Induction Transplant Regimens Graph.
Patienter, der får Bortezomib Hospira i kombination med thalidomid, skal overholde det særlige svangerskabsforebyggende program for thalidomid.
Patients receiving Bortezomib Hospira in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Ikke-hæmatologiske toksiciteter grad ≥ 3
Grade ≥ 3 non-haematological toxicities
Den geometriske gennemsnitsratio AUClast var 0,99, og 90% konfidensintervaller var 80,18%-122,80%.
The AUClast- geometric mean ratio was 0.99 and 90% confidence intervals were
Hos patienter med fremskredent myelom var sværhedsgraden af thrombocytopeni forbundet med thrombocyttallet inden behandlingen: Med et thrombocyttal ved baseline på < 75.000/μl havde 90% af 21 patienter et tal på ≤ 25.000/μl under forsøget, herunder 14% på < 10.000/μl.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Patienter, som har bortezomib-relaterede neuropatiske smerter og/eller perifer neuropati, skal behandles som vist i tabel 1 (se pkt.
Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Det gennemsnitlige distributionsvolumen (Vd) for bortezomib er 1.659-3.294 l efter administration af intravenøse enkeltdoser eller gentagne doser på 1,0 mg/m2 eller 1,3 mg/m2 til patienter med myelomatose.
The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Tabel 6: Anbefalet justering af initialdosis af Bortezomib Hospira hos patienter med nedsat leverfunktion Grad af leversvækkelse*
Table 6: Recommended starting dose modification for Bortezomib Hospira in patients with hepatic impairment Grade of hepatic impairment*
En periode på 6 uger anses for at være en behandlingscyklus.
A 6-week period is considered a treatment cycle.
Læs indlægssedlerne for alle de lægemidler, du skal tage sammen med Bortezomib Hospira, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med Bortezomib Hospira.
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Hospira for information related to these medicines before starting treatment with Bortezomib Hospira.
Bortezomib-kombinationsbehandling med dexamethason I mangel af en direkte sammenligning af bortezomib og bortezomib i kombination med dexamethason hos patienter med progressiv myelomatose blev der gennemført en statistisk "matchede par"-analyse for at sammenligne resultaterne fra den ikke-randomiserede gruppe med bortezomib i kombination med dexamethason (åbent fase II-forsøg, MMY-2045) med resultaterne fra grupperne i monoterapi med bortezomib fra forskellige randomiserede fase III-forsøg (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation.
Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
• Ringen for ørerne, ubehag i ørerne
• Ringing in the ears, ear discomfort
BTDx=bortezomib, thalidomid, dexamethason; PN=perifer neuropati Bemærk: Perifer neuropati omfatter de foretrukne termer: perifer neuropati, perifer motorisk neuropati, perifer sensorisk neuropati og polyneuropati.
BTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
• ketoconazol, der bruges til behandling af svampeinfektioner
• ketoconazole, used to treat fungal infections
SGOTniveau (ASAT)
SGOT (AST) levels
Bortezomib Hospira kan forårsage træthed, svimmelhed, besvimelse eller sløret syn.
Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Median-OS var 30,8 måneder (95% CI; 25,2-36,5 måneder) patienter i monoterapi med bortezomib og 33,0 måneder (95% CI; 28,937,1 måneder) for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin.
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af forsøg med referencelægemidlet, som indeholder bortezomib, i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
• Hæfte om rekonstitution, dosering og administration
• Reconstitution, dosing and administration booklet
• Plakat om rekonstitution
• Reconstitution poster
I dette forsøg deltog 222 patienter med recidiverende/refraktær myelomatose, der blev randomiseret i forholdet 2:1 til behandling med 1,3 mg/m2 bortezomib i 8 cyklusser, enten subkutant eller intravenøst.
This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med bortezomib:
The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
og s.c. anvendelse, herunder information om behovet for at skifte injektionssteder ved s.c. anvendelse
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
• Smerter i kønsorganerne, erektionsproblemer
• Genital pain, problem having an erection
Hyperbilirubinæmi*, unormale proteinanalyser*, vægtstigning, unormal blodprøve*, forhøjet C-reaktivt protein
Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased
De væsentligste effektresultater ses i tabel 13.
Main efficacy results are presented in Table 13.
Varigheden af det samlede respons var 21,4 måneder længere i BRCAP-gruppen (medianværdi 36,5 måneder vs. 15,1 måneder i R-CHOP-gruppen).
The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
I forsøg med patienter med recidiverende myelomatose, som blev behandlet med bortezomib, og med patienter med tidligere ubehandlet MCL, som blev behandlet med bortezomib i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP), var en af de mest almindelige hæmatologiske bivirkninger forbigående thrombocytopeni.
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
I en multivariansanalyse var responsraten uafhængig af myelomtype, performance status, kromosom 13-deletionsstatus og antallet eller typen af tidligere behandlinger.
performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Den estimerede 4-årige overlevelsesrate var 53,9% i R-CHOP-gruppen og 64,4% i BR-CAP-gruppen.
There was a trend towards prolonged overall survival favouring the BR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BR-CAP group.
Sjælden Malign neoplasme, leukaemia plasmacytica, nyrecellekarcinom, masse, mycosis fungoides, benign neoplasme*
Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyklus 2 til 4
Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Neutrofiltallet var lavest på dag 11 i hver cyklus af behandling med bortezomib og var typisk vendt tilbage til baseline-niveau ved den næste cyklus.
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Patienter med tidligere behandlet let-kæde AL-amyloidose Der blev udført et åbent, ikke-randomiseret fase I/II-forsøg for at fastlægge bortezomibs sikkerhed og virkning hos patienter, der tidligere var blevet behandlet for AL-amyloidose.
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Du må ikke køre bil, eller betjene værktøj eller maskiner, hvis du får sådanne bivirkninger.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-forsøg (MMY-3002 VISTA) med 682 patienter blev gennemført for at fastlægge, om bortezomib (1,3 mg/m som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid indtil progression (TTP) sammenlignet med melphalan (9 mg/m2) og prednison (60 mg/m2) til patienter med tidligere ubehandlet myelomatose.
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Der er indberettet sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, for eksempel pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i behandling med bortezomib (se pkt.
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
MCL-patientpopulationen sammenlignet med patienter i myelomatose-forsøgene er en ≥ 5% højere forekomst af hæmatologiske bivirkninger (neutropeni, thrombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme.
Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
• Høretab, døvhed eller ringen for ørerne, ubehag i ørerne
• Hearing loss, deafness or ringing in the ears, ear discomfort
Samlet overlevelse* Hændelser (dødsfald) n (%) Median a
Overall survival* Events (deaths) n (%) Median a (95% CI)
Aktivt stof: bortezomib.
The active substance is bortezomib.
I fase III-forsøget havde patienter, der fik bortezomib subkutant sammenlignet med intravenøst indgivet, en 13% lavere samlet forekomst af bivirkninger i forbindelse med behandlingen i form af toksicitet grad 3 og en 5% lavere forekomst af seponering af behandling med bortezomib.
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Der er yderligere oplysninger i produktresuméet for rituximab.
Refer to the Summary of Product Characteristics of rituximab for more information.
Den samlede forekomst af hepatitis B-infektioner var sammenlignelig hos patienter i BR-CAPgruppen og patienter i R-CHOP-gruppen (henholdsvis 0,8% vs. 1,2%).
The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
• diaré, forstoppelse, kvalme eller opkastning
• diarrhoea, constipation, nausea or vomiting
• Leddegigt, herunder betændelse i leddene i fingre, tæer og kæbe
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
Forsøgets primære effektendepunkt var responsraterne efter induktion og efter transplantation (CR+nCR).
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Den rekonstituerede opløsning skal anvendes umiddelbart efter klargøring.
The reconstituted solution should be used immediately after preparation.
• Søvnbesvær eller søvnproblemer, svedeture, angst, humørsvingninger, nedtrykthed,
• Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 i bortezomib-behandlingscyklussens 21 dage.
and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Thrombocyttallet var lavest på dag 11 i hver cyklus af behandling med bortezomib og var typisk vendt tilbage til baseline-niveau ved den næste cyklus.
Platelets were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Tabel 9: Forekomsten af perifer neuropati ved induktionsbehandling, inddelt efter toksicitet og behandlingsseponering på grund af perifer neuropati
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/m² på dag 4 af behandlingscyklussen med Bortezomib Hospira som en 1-times intravenøs infusion, der administreres efter injektionen af Bortezomib Hospira.
Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Tabel 5: Dosisjusteringer under behandlingen af patienter med tidligere ubehandlet mantle-cellelymfom
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Toxicity
• Dødsfald
• Death
Bortezomib vil blive givet af sundhedspersonale, som har erfaring med anvendelse af cytostatika.
Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Der foreligger begrænsede oplysninger om genbehandling med bortezomib af recidiverende myelomatose.
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
• Rødmen og smerter på injektionsstedet
• Redness and pain at injection site
Fra forsøg, hvor bortezomib blev administreret som induktionsbehandling i kombination med dexamethason (forsøg IFM-2005-01) og dexamethason-thalidomid (forsøg MMY-3010), ses forekomsten af perifer neuropati ved kombinationsbehandlingerne i nedenstående tabel:
In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
I forsøget IFM-2005-01 blev bortezomib i kombination med dexamethason [BDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242].
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].