natgillin/translations-raw huggingface dataset:
Slutkoncentrationen skal være mellem 0,01-0,1 mg/ml.
The final concentration should be between 0.01 and 0.1 mg/mL.
• Lægen vil muligvis nedsætte din dosis afhængigt af hvordan du reagerer på behandlingen.
• Your doctor may lower your dose based on your response to treatment.
Infusionsslangen behøver ingen beskyttelse mod lys.
The infusion line does not need to be protected from light.
På trods af større hyppighed af tidlig død post-HSCT (på dag 100) i BESPONSAarmen, sås en sen-overlevelsesfordel ved BESPONSA.
Although there was a higher frequency of early deaths post-HSCT (at Day 100) in the BESPONSA arm, there was evidence of a late survival benefit for BESPONSA.
En pakke BESPONSA indeholder:
Each pack of BESPONSA contains:
Når der opnås tilstrækkelig restitution, skal den totale dosis nedsættes med 25 % i den efterfølgende cyklus.
Once adequate recovery is achieved, decrease the total dose by 25% for the subsequent cycle.
BESPONSA må ikke blandes eller administreres som infusion med andre lægemidler.
Do not mix BESPONSA or administer as an infusion with other medicinal products.
Sikkerheden ved vaccination med levende vira under eller efter behandling med BESPONSA er ikke blevet undersøgt.
The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
Der må ikke anvendes filtre fremstillet af nylon eller blandede celluloseestere (MCE).
Do not use filters made of nylon or mixed cellulose ester (MCE).
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Skema 7 viser resultaterne fra dette studie.
Table 7 shows the efficacy results from this study.
BESPONSA forbedrede OS i forhold til investigators valg af kemoterapi for alle stratificeringsfaktorer, herunder varighed af første remission ≥ 12 måneder, status af salvagebehandling 1 og alder < 55 år ved randomisering.
BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation <55 years.
• Beregn dosis (mg) og antallet af nødvendige hætteglas BESPONSA.
• Calculate the dose (mg) and number of vials of BESPONSA required.
Dette stemmer overens med den kendte induktion af brud på DNA af calicheamicin.
This is consistent with the known induction of DNA breaks by calicheamicin.
BESPONSA virker ved at binde sig til celler med et protein, der kaldes CD22.
BESPONSA acts by attaching to cells with a protein called CD22.
Af de 93 screenede patienter blev 72 allokeret til studiemedicin og behandlet med BESPONSA.
Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Forhøjet amylase og lipase
Increased amylase and lipase
Trombocyttal, der anvendes til dosering, skal være uafhængigt af blodtransfusion.
a Platelet count used for dosing must be independent of blood transfusion.
Hvis der er behov for yderligere dosisændring, skal antallet af doser nedsættes til 2 pr. cyklus i de efterfølgende cyklusser.
If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles.
Denne sygdom kan forekomme under behandling med BESPONSA eller efter efterfølgende stamcelletransplantation.
This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant.
Kvinder i den fertile alder skal undgå at blive gravide, mens de får BESPONSA.
Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA.
BESPONSA er beregnet til behandling af akut lymfoblastær leukæmi hos voksne patienter, der tidligere har prøvet andre behandlinger, men hvor disse behandlinger ikke har virket.
BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed.
BESPONSA skal administreres under tilsyn af en læge med erfaring inden for behandling af hæmatologisk sygdom og på et sted, hvor komplet genoplivningsudstyr umiddelbart er til rådighed.
BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Antallet af patienter var for lille til at vurdere virkningen af antistoffer mod inotuzumab ozogamicin på virkning og sikkerhed.
The number of patients was too small to assess the impact of anti-inotuzumab ozogamicin antibodies on efficacy and safety.
Hvis en nedsættelse på 25 % af den totale dosis efterfulgt af en nedsættelse til 2 doser pr. cyklus ikke tolereres, skal behandlingen seponeres permanent.
If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment.
Den hyppigste anvendte TKI (42 patienter) var dasatinib efterfulgt af imatinib (24 patienter).
Dasatinib was the most commonly received TKI (42 patients) followed by imatinib (24 patients).
Skema 6 viser resultaterne fra dette studie.
Table 6 shows the efficacy results from this study.
De to primære endepunkter var CR/CRi, som blev vurderet af en blindet uafhængig bedømmelseskomite for endepunkter, og samlet overlevelse (OS).
The co-primary endpoints were CR/CRi, assessed by a blinded independent endpoint adjudication committee (EAC), and overall survival (OS).
≥ 7 dage
≥ 7 days
Hos patienter, der fortsætter med HSCT, skal der udføres hyppig monitorering af levertallene i den første måned efter HSCT, herefter mindre hyppigt i henhold til almindelig medicinsk praksis.
For patients who proceed to HSCT, liver tests should be monitored closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice.
Dosisændringer på grund af hæmatologisk toksicitet i starten af en cyklus (dag 1)
Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1)
Ascites (4 %) Abdominal udspiling (6 %)
Ascites (4%) Abdominal distension (6%)
Det kan være nødvendigt at ændre BESPONSA-dosen på grundlag af individuel sikkerhed og tolerabilitet (se pkt.
Dose modification of BESPONSA may be required based on individual safety and tolerability (see section 4.4).
Efter administration af multiple doser sås en 5,3 gange akkumulering af inotuzumab ozogamicin mellem cyklus 1 og 4.
Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was observed between Cycles 1 and 4.
Efter at have bundet sig til de lymfoblastære leukæmiceller overfører lægemidlet et stof til cellerne, som forstyrrer cellernes DNA og til slut dræber dem.
Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells' DNA and eventually kills them.
> 28 dage
> 28 days
Forkortelse: ANC = absolut neutrofiltal.
Abbreviation: ANC=absolute neutrophil count.
Længde på cyklus
Cycle length
Omhyggelig overvejelse er derfor nødvendig inden administration af BESPONSA til patienter, der tidligere har fået HSCT.
Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT.
≥ 14 dage
≥ 14 days
Under behandlingen, især i de første par dage efter behandlingsstart, kan du risikere et alvorligt fald i antallet af hvide blodlegemer (neutropeni), som kan være ledsaget af feber (febril neutropeni).
During treatment, especially in the first few days after starting treatment, your white blood cell count may be severely lowered (neutropenia), which may be accompanied by fever (febrile neutropenia).
BESPONSA-doser inden for en cyklus (dvs. dag 8 og/eller 15) behøver ikke at blive afbrudt pga. neutropeni eller trombocytopeni, men det anbefales at afbryde behandlingen inden for en cyklus ved ikke-hæmatologisk toksicitet.
BESPONSA doses within a treatment cycle (i.e. Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-haematological toxicities.
BESPONSA skal administreres i cyklusser på 3-4 uger.
BESPONSA should be administered in 3- to 4-week cycles.
Det skal du vide, før du får BESPONSA
What you need to know before you are given BESPONSA
• For højt indhold af urinsyre i blodet
• Excess of uric acid in the blood
• Øvrige indholdsstoffer: sucrose, polysorbat 80, natriumchlorid og trometamol.
• The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.
Overvej nøje benefit/risk-forholdet inden administration af BESPONSA til patienter, hos hvem fremtidig brug af HSCT-konditionerende regimer, der indeholder 2 alkylerende midler, sandsynligvis ikke kan undgås.
The benefit/risk should be carefully considered before administering BESPONSA to patients in whom the future use of HSCT conditioning regimens containing 2 alkylating agents is likely unavoidable.
Undgå brug af HSCT-konditionerende regimer, der indeholder 2 alkylerende midler.
The use of HSCT conditioning regimens containing 2 alkylating agents should be avoided.
Patienterne skal observeres for stigninger i amylase og lipase.
Patients should be monitored for increases in amylase and lipase.
Baseline-karakteristika var ens hos de 218 først randomiserede patienter.
Baseline characteristics were similar in the initial 218 patients randomised.
BESPONSA er til intravenøs anvendelse.
BESPONSA is for intravenous use.
I fase 2 delen af studiet fik 8/35 (22,9%) af patienterne en opfølgende HSCT.
In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
Toksicitet og dosisændring(er)
Toxicity and dose modification(s)
Det bør overvejes at genoptage BESPONSA ved den korrekte, terapeutiske dosis, når al toksicitet er forsvundet.
Re-initiation of BESPONSA at the correct therapeutic dose should be considered when all toxicities have resolved.
For patienter, der opnår CR/CRi, og/eller for at bedre restitution efter toksicitet, kan cyklus forlænges til 28 dage (dvs. 7 dages mellemrum uden behandling med start på dag 21).
b For patients who achieve a CR/CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e. 7-day treatment-free interval starting on Day 21).
Gravide kvinder eller patienter, der bliver gravide, mens de får inotuzumab ozogamicin, eller behandlede mandlige patienter, der har en gravid partner, skal informeres om den potentielle risiko for fosteret.
Pregnant women, or patients becoming pregnant while receiving inotuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the fetus.
Om nødvendigt gives profylaktisk behandling mod infektion og kontroltest foretages under og efter behandlingen.
As appropriate, prophylactic anti-infectives should be administered and surveillance testing should be employed during and after treatment.
Af de 326 patienter (ITT-populationen) havde 253 patienter prøver, der kunne testes både lokalt og centralt for CD22.
Of the 326 patients (ITT population), 253 patients had samples that were evaluable for CD22 testing by both local and central laboratory.
Lægemidler, der gives inden behandling med BESPONSA
Medicines given before treatment with BESPONSA
Ingen patienter med recidiverende eller refraktær ALL, som blev behandlet med BESPONSA, i kliniske studier havde fået HSCT inden for de seneste 4 måneder.
No patients with relapsed or refractory ALL who were treated with BESPONSA in clinical trials had undergone HSCT within the previous 4 months.
Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bliver gravid under behandlingen med BESPONSA og i op til 8 måneder efter afslutning af behandlingen.
Tell your doctor, pharmacist or nurse immediately if you became pregnant during the period of treatment with BESPONSA and for up to 8 months after finishing treatment.
Symptomer kan inkludere forhøjede værdier for total bilirubin, hepatomegali (som kan være smertefuld), hurtig vægtstigning og ascites.
Signs may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites.
I alt havde 276 (85%) af patienterne Ph
A total of 276 (85%) patients had Ph- ALL.
Inden behandlingen med BESPONSA får du andre lægemidler (præmedicinering) for at mindske reaktioner forårsaget af infusionen og andre mulige bivirkninger.
Before your treatment with BESPONSA, you will be given other medicines (pre-medications) to help reduce infusion reactions and other possible side effects.
Både mænd og kvinder skal søge rådgivning vedrørende bevarelse af fertiliteten inden behandlingen.
Both men and women must seek advice for fertility preservation before treatment.
For patientrapporterede resultater var de fleste scorer for funktionsdygtighed og symptomer til fordel for BESPONSA sammenlignet med investigators valg af kemoterapi.
For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy.
Skema 1 viser de anbefalede doseringsregimer.
Table 1 shows the recommended dosing regimens.
I tilfælde af svær VOD/SOS skal patienten behandles ifølge almindelig medicinsk praksis.
If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
Dosis (mg/m
Dose (mg/m2)
Sukrose Polysorbat 80 Natriumchlorid Trometamol
Sucrose Polysorbate 80 Sodium chloride Tromethamine
• Beregn det volumen af rekonstitueret opløsning, der er nødvendig for at opnå den korrekte dosis i forhold til patientens legemsoverfladeareal.
• Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient body surface area.
4.2) viser de doseringsregimer, der blev brugt til at behandle patienterne.
Table 1 (see section 4.2) shows the dosing regimen used to treat patients.
Pancytopeni b (2 %)
Pancytopeniab (2%)
• Forhøjet indhold af bilirubin, hvilket kan medføre gulfarvning af huden, øjnene og andet væv
• Raised bilirubin level which may result in a yellowish colour in the skin, eyes, and other tissues
Bemærk, at patienter kan have haft > 1 type blødning.
Note: patients may have had > 1 type of haemorrhage.
Bivirkninger er opstillet efter systemorganklasse og hyppighed i følgende grupperinger: 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 forhåndenværende data).
The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: 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).
Mediantiden til indtræden af hyperbilirubinæmi og forhøjede transaminaser var hhv. 73 dage og 29 dage.
The median time to onset of hyperbilirubinaemia and increased transaminases was 73 days and 29 days, respectively.
Vejledning i rekonstituering, fortynding og administration
Instructions for reconstitution, dilution, and administration
Afbryd næste dosis (oprethold minimum 6 dage mellem doser).
Interrupt the next dose (maintain a minimum of 6 days between doses).
Ud af de 5 patienter, der fik VOD/SOS under behandling med inotuzumab ozogamicin, men uden intervenerende HSCT, fik 2 patienter også HSCT inden BESPONSAbehandlingen.
Of the 5 patients who experienced VOD/SOS during treatment with inotuzumab ozogamicin but without an intervening HSCT, 2 patients had also received an HSCT before BESPONSA treatment.
Hvid til råhvid, frysetørret kage eller pulver.
White to off-white, lyophilised cake or powder.
Cyklus 1 varer 3 uger, men kan forlænges til 4 uger, hvis patienten opnår CR eller CRi, og/eller for at bedre restitutionen efter toksicitet.
Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a CR or CRi, and/or to allow recovery from toxicity.
Overfølsomhed (1 %)
Hypersensitivity (1%)
• En læge eller sygeplejerske giver dig BESPONSA gennem et drop i en vene (intravenøs infusion).
• A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.
BESPONSA bruges til at behandle voksne med akut lymfoblastær leukæmi.
BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Medianen (øvre grænse af 95% CI) for ændring i QTcF ved en subterapeutisk Cmax koncentration var 3,87 msek (7,54 msek).
The median (upper bound of the 95% CI) for the change in QTcF at a supratherapeutic Cmax concentration was 3.87 msec (7.54 msec).
Hvis der forekommer en infusionsrelateret reaktion, skal infusionen standses og passende medicinsk behandling iværksættes.
If an infusion related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted.
Det gennemsnitlige (SD) simulerede totale område under koncentrations-tidskurven (AUC) pr. cyklus ved steady state var 100 mkgt/ml (32,9).
The mean (SD) simulated total area under the concentration-time curve (AUC) per cycle at steady state was 100 mcgh/mL (32.9).
Patienterne skal observeres for symptomer på TLS og behandles ifølge almindelig medicinsk praksis.
Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Afbryd behandlingen indtil restitution til grad 1 eller gradniveauet inden behandlingsstart inden hver dosis.
Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.
Patienterne skal observeres nøje under og i mindst 1 time efter endt infusion for mulig indtræden af infusionsrelaterede reaktioner, herunder symptomer såsom hypotension, hedeture og vejrtrækningsproblemer.
Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING VIAL
Du vil muligvis, især i de første par dage efter start af behandlingen, have forhøjede leverenzymer.
During treatment, especially in the first few days after starting treatment, you may have raised liver enzymes.
Mænd og kvinder bør søge rådgivning om bevarelse af frugtbarheden inden behandling.
Men and women should seek advice regarding fertility preservation before treatment.
Relevansen for mennesker, af de irreversible fund hos dyr, kendes ikke.
The relevance of the irreversible animal findings to humans is uncertain.
Pancytopeni omfatter følgende indberettede foretrukne termer: Knoglemarvssvigt, febril knoglemarvsaplasi og pancytopeni.
b Pancytopenia includes the following reported preferred terms: Bone marrow failure, Febrile bone marrow aplasia, and Pancytopenia.
I kliniske studier af BESPONSA til patienter med recidiverende eller refraktær ALL blev 7/236 (3 %) patienter testet positive for antistoffer mod inotuzumab ozogamicin.
In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies.
Vaccination med levende virus frarådes i mindst 2 uger inden behandlingen med BESPONSA påbegyndes, under behandlingen og indtil B-lymfocyt restitution efter sidste cyklus.
Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle.
Hvis disse patienter fortsætter med HSCT, skal symptomer på VOD/SOS nøje monitoreres (se pkt.
If these patients do proceed to HSCT, signs and symptoms of VOD/SOS should be monitored closely (see section 4.2).
VOD/SOS inkluderer 1 yderligere patient med veno-okklusiv leversygdom, der indtraf på dag 56 uden intervenerende HSCT.
d VOD/SOS includes 1 additional patient with Venoocclusive liver disease that occurred at Day 56 with no intervening HSCT.
Sådan gives BESPONSA
How BESPONSA is given
Afbryd infusionen og iværksæt passende medicinsk behandling.
Interrupt the infusion and institute appropriate medical management.
Ud af 326 randomiserede patienter (ITT-population) havde 215 (66%) af patienterne fået et tidligere behandlingsregime og 108 (33%) af patienterne havde fået 2 tidligere behandlingsregimer for ALL.
Among all 326 randomised patients (ITT population), 215 (66%) patients had received 1 prior treatment regimen and 108 (33%) patients had received 2 prior treatment regimens for ALL.
Hos mennesker var serumniveauerne af N-acetyl-gamma-calicheamicin dimethylhydrazid typisk under kvantificeringsgrænsen (50 pg/ml), men sporadisk målbare niveauer af ikke-konjungeret calicheamicin på op til 276 pg/ml fandtes hos nogle patienter.
In humans, serum N-acetyl-gamma-calicheamicin dimethylhydrazide levels were typically below the limit of quantitation (50 pg/mL), but sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.
Den gennemsnitlige (SD) maksimale serumkoncentration (Cmax) af inotuzumab ozogamicin var 308 ng/ml (362).
The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362).
• Kom den rekonstituerede opløsning i en infusionsbeholder med natriumchloridopløsning 9 mg/ml (0,9 %) til injektion, så det totale nominelle volumen er 50 ml.
• Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
Overvej permanent seponering af BESPONSA.
Consider permanent discontinuation of BESPONSA.
• hvis du er allergisk over for inotuzumab ozogamicin eller et af de øvrige indholdsstoffer i BESPONSA (angivet i punkt 6).
• are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
Alle patienter skulle have ≥ 5% knoglemarvsblaster og tidligere have fået 1 eller 2 induktionskemoterapiregimer for ALL.
All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Hos patienter med utilstrækkeligt knoglemarvaspirat blev der testet på en perifer blodprøve.
In patients with an inadequate bone marrow aspirate sample, a peripheral blood sample was tested.
BESPONSA øgede risikoen for VOD/SOS væsentligt i forhold til den risiko, der gælder for almindelige kemoterapiregimer hos denne patientgruppe.
BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population.
Der blev indberettet VOD/SOS op til 56 dage efter sidste dosis med inotuzumab ozogamicin uden intervenerende HSCT.
VOD/SOS was reported up to 56 days after the last dose of inotuzumab ozogamicin without an intervening HSCT.
Baseret på ikkekliniske sikkerhedsfund kan inotuzumab ozogamicin forårsage embryoføtal skade, når det administreres til gravide kvinder.
Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman.
Skema 4 viser retningslinjerne for dosisændring afhængigt af varigheden af doseringsafbrydelser, der skyldes toksicitet.
Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Inotuzumab ozogamicin (som har en densitet på 1,02 g/ml ved 20 °C/68 °F) er lysfølsomt og skal beskyttes mod ultraviolet lys under rekonstituering, fortynding og administration.
Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration.