FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; Ara-C=cytarabine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; EAC=Endpoint Adjudication Committee; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HIDAC=high dose cytarabine; HSCT=haematopoietic stem cell transplant; ITT=intent-to-treat; MRD=minimal residual disease; MXN=mitoxantrone; N/n=number of patients; OS=overall survival; PFS=progression-free survival.
Danish: Forkortelser: ALL = akut lymfoblastær leukæmi, ANC = absolut neutrofiltal, Ara-C = cytarabin, CI = konfidensinterval, CR = komplet remission, CRi = komplet remission med delvis hæmatologisk restitution, DoR = varighed af remission, EAC = Endpoint Adjudication Committee, FLAG = fludarabin + cytarabin + granulocytkolonistimulerende faktor, HIDAC = højdosis cytarabin, HSCT = hæmatopoietisk stamcelletransplantation,
English: For periodic monitoring of ECG and electrolyte levels, see section 4.4.
Danish: 4.4 vedrørende regelmæssig måling af EKG og elektrolytter.
English: If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Danish: Hvis ANC falder, skal næste cyklus afbrydes, indtil ANC 9/l.
English: By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Danish: Centrale og lokale laboratorietest viste ≥70% CD22-positive leukæmiske blaster ved baseline hos henholdsvis 231/253 (91,3%) og 130/253 (51,4%) af patienterne.
English: [4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
Danish: Risikorate [95 % CI] = 0,751 [0,588-0,959] 2-sidet p-værdi = 0,0210
English: United States (USA)
Danish: USA
English: For storage conditions after reconstitution and dilution, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding, se pkt.
English: Men must use effective contraception during treatment and for at least 5 months after the last dose of treatment.
Danish: Mænd skal bruge sikker prævention under behandlingen og i mindst 5 måneder efter sidste dosis.
English: • have previously had severe venoocclusive disease (a condition in which the blood vessels in the liver become damaged and blocked by blood clots) which was confirmed or have ongoing venoocclusive disease.
Danish: • hvis du tidligere har haft en sygdom, hvor blodkarrene i leveren var beskadiget og tilstoppet af blodpropper (veno-okklusiv sygdom), eller du har det nu.
English: Based on population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with mild renal impairment (CLcr 60-89 mL/min; n=237), moderate renal impairment (CLcr 30-59 mL/min; n=122), or severe renal impairment (CLcr 15-29 mL/min; n=4) was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=402) (see section 4.2).
Danish: Baseret på populationsfarmakokinetiske analyser af 765 patienter var clearance af inotuzumab ozogamicin hos patienter med let nedsat nyrefunktion (CLcr 60-89 ml/min, n = 237), moderat nedsat nyrefunktion (CLcr 30-59 ml/min, n = 122) eller svært nedsat nyrefunktion (CLcr 15-29 ml/min, n = 4) den samme som hos patienter med normal nyrefunktion (CLcr ≥ 90 ml/min, n = 402) (se pkt.
English: Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended.
Danish: Det anbefales at bruge infusionsslanger fremstillet af PVC (med eller uden DEHP), polyolefin (polypropylen og/eller polyethylen) eller polybutadien.
English: Maximum time from reconstitution through the end of administration ≤ 8 hoursa Reconstituted solution
Danish: Maksimal tid fra rekonstitution til fuldendt administration ≤ 8 timer Rekonstitueret opløsning
English: Each vial contains 1 mg inotuzumab ozogamicin.
Danish: Hvert hætteglas indeholder 1 mg inotuzumab ozogamicin.
English: If the diluted solution is stored in a refrigerator (2 °C-8 °C), bring it to room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Danish: Hvis den fortyndede opløsning opbevares i køleskab (2-8 °C), skal den stå ved stuetemperatur (20-25 °C) i ca. 1 time inden administration.
English: Dose modifications for non-haematological toxicities at any time during treatment Non-haematological toxicity Dose modification(s)
Danish: Dosisændringer på grund af ikke-hæmatologisk toksicitet på ethvert tidspunkt i løbet af behandling
English: Grade 3 thrombocytopenia and neutropenia were reported in 23 (14%) and 33 (20%) patients, respectively.
Danish: Der blev indberettet grad 3 trombocytopeni og neutropeni hos hhv. 23 (14 %) og 33 (20 %) patienter.
English: If the reconstituted solution cannot be used immediately, it may be stored for up to 4 hours in a refrigerator (2 °C-8 °C).
Danish: Hvis den rekonstituerede opløsning ikke kan bruges med det samme, kan den opbevares i op til 4 timer i køleskab (2-8 °C).
English: Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CRc or CRid:
Danish: 21 dage Doseringsregime for efterfølgende cyklusser afhængig af respons på behandlingen Patienter, der har opnået CR c eller CRi
English: Day 8a
Danish: Dag 8
English: [2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
Danish: Risikorate [95% CI] = 0,471 [0,366-0,606] 2-sidet p-værdi < 0,0001
English: MRD negativityc for patients achieving CR/CRi; rated (%) [95% CI]
Danish: MRD-negativitet c for patienter, der opnåede CR/CRi, frekvens d (%) [95 %
English: For periodic monitoring of increased amylase and lipase, see section 4.4.
Danish: 4.4. vedrørende regelmæssig monitorering af forhøjet amylase og lipase.
English: In the Phase 1 portion of the study, 37 patients received BESPONSA at a total dose of 1.2 mg/m2 (n=3), 1.6 mg/m2 (n=12), or 1.8 mg/m2 (n=22).
Danish: I studiets fase 1 fik 37 patienter BESPONSA ved en total dosis på 1,2 mg/m 2 (n = 3) 1,6 mg/m
English: BESPONSA is a powder for concentrate for solution for infusion.
Danish: BESPONSA er et pulver til koncentrat til infusionsvæske, opløsning.
English: Interrupt dosing until recovery of total bilirubin to ≤ 1.5 × ULN and AST/ALT to ≤ 2.5 × ULN prior to each dose unless due to Gilbert's syndrome or haemolysis.
Danish: Afbryd behandlingen indtil restitution af total bilirubin til ≤ 1,5 × ULN og ASAT/ALAT til ≤ 2,5 × ULN inden hver dosis, medmindre det skyldes Gilberts syndrom eller hæmolyse.
English: Bleeding/haemorrhage
Danish: Blødning/hæmoragi
English: • venoocclusive liver disease (see section 2); signs and symptoms include rapid weight gain, pain in the upper right side of your abdomen, increase in the size of the liver, accumulation of fluid causing abdominal swelling, and increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
Danish: • Veno-okklusiv leversygdom (se afsnit 2), symptomerne kan være hurtig vægtstigning, smerter i den øverste højre side af maven, forstørret lever, væskeophobning som giver hævelse af maven, og blodprøver som viser forhøjet bilirubin og/eller leverenzymer (kan give gulfarvning af hud og øjne).
English: The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤
Danish: Den maksimale tid fra rekonstituering til fuldendt administration skal være ≤ 8 timer, og der skal være
English: In a randomised clinical study in patients with relapsed or refractory ALL (Study 1), maximum increases in QTcF interval of ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patients in the inotuzumab ozogamicin arm, respectively, versus18/124 (15%) and 3/124 (2%) in the Investigator's choice of chemotherapy arm, respectively.
Danish: I et randomiseret klinisk studie af patienter med recidiverende eller refraktær ALL (Studie 1) blev der målt maksimale stigninger i QTcF interval på ≥ 30 msek og ≥ 60 msek fra baseline hos henholdsvis 30/162 (19 %) og 4/162 (3 %) patienter i inotuzumab ozogamicin-armen henholdsvis 18/124 (15 %) og 3/124 (2 %) i behandlingsarmen med investigators valg af kemoterapi.
English: Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA.
Danish: Lægen vil regelmæssigt tage blodprøver for at måle leverenzymer under behandlingen med BESPONSA.
English: In patients receiving inotuzumab ozogamicin, complications associated with neutropenia and thrombocytopenia (including infections and bleeding/haemorrhagic events, respectively) were reported in some patients (see section 4.8).
Danish: Hos nogle patienter, der fik inotuzumab ozogamicin, er der indberettet neutropeni- og trombocytopenirelaterede komplikationer (herunder hhv. infektioner og blødning/hæmoragi) (se pkt.
English: Platelet count was ≥ 50 × 109/La
Danish: Trombocyttallet ≥ 50 × 10 9/l a
English: In patients with relapsed or refractory ALL treated with inotuzumab ozogamicin at the recommended starting dose of 1.8 mg/m2/cycle (see section 4.2), steady-state exposure was achieved by Cycle 4.
Danish: Hos patienter med recidiverende eller refraktær ALL behandlet med inotuzumab ozogamicin ved den anbefalede startdosis på 1,8 mg/m2/cyklus (se pkt.
English: • Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Danish: • Den fortyndede opløsning infunderes over 1 time ved en hastighed på 50 ml/time ved stuetemperatur (20-25 °C).
English: The NOAEL was not identified for the effects on male reproductive organs, which were observed at approximately 0.3 times the human clinical exposure based on AUC.
Danish: NOAEL blev ikke identificeret for påvirkning af reproduktionsorganerne hos handyr, som blev observeret ved ca. 0,3 gange den kliniske eksponering hos mennesker baseret på AUC (se pk t. 4.6).
English: Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring.
Danish: Du vil muligvis få medicin og ekstra væske, inden du bliver behandlet med BESPONSA, for at forhindre, at der opstår tumorlysesyndrom.
English: ECG QT prolonged (1%) Increased amylase (5%)
Danish: Forlænget QT-interval ved EKG (1 %)
English: d Rate was defined as number of patients who achieved MRD negativity divided by the total number of patients who achieved CR/CRi per EAC. e PFS was defined as the time from date of randomisation to earliest date of the following events: death,
Danish: Raten blev defineret som antal patienter, der opnåede MRD-negativitet divideret med det samlede antal patienter, der opnåede CR/CRi ifølge EAC.
English: In the pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were reported in 54/ (33%) patients.
Danish: I pivotalstudiet (N = 164) blev der indberettet blødning/hæmoragiske hændelser, de fleste af mild sværhedsgrad, hos 54 (33 %) patienter.
English: • If the diluted solution is stored in a refrigerator (2 °C-8 °C), it must be allowed to equilibrate at room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Danish: • Hvis den fortyndede opløsning opbevares i køleskab (2-8 °C), skal den stå ved stuetemperatur (20-25 °C) i ca. 1 time inden administration.
English: In patients receiving inotuzumab ozogamicin, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening, have been reported (see section 4.8).
Danish: Der er indberettet neutropeni, trombocytopeni, anæmi, leukopeni, febril neutropeni, lymfopeni og pancytopeni, heraf livstruende tilfælde, hos patienter, der fik inotuzumab ozogamicin (se pkt.
English: - Use immediately or store in a refrigerator (2 °C-8 °C) for up to 4 hours.
Danish: - Bruges straks eller opbevares i køleskab (2-8 °C) i op til 4 timer.
English: • Excessive accumulation of fluid in the abdomen
Danish: • Omfattende væskeansamling i underlivet
English: BESPONSA 1 mg powder for concentrate for solution for infusion
Danish: BESPONSA 1 mg pulver til koncentrat til infusionsvæske, opløsning
English: ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
Danish: 9/l, og/eller trombocyttallet < 50 × 10
English: The active ingredient in BESPONSA is inotuzumab ozogamicin.
Danish: Det virksomme stof i BESPONSA er inotuzumab ozogamicin.
English: An infusion container made of polyvinyl chloride (PVC) (di(2-ethylhexyl)phthalate [DEHP]- or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or ethylene vinyl acetate (EVA) is recommended.
Danish: Det anbefales at bruge en infusionsbeholder af polyvinylchlorid (PVC) (med eller uden di(2-ethylhexyl) phthalat (DEHP)), polyolefin (polypropylen og/eller polyethylen) eller ethylenvinylacetat (EVA).
English: Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
Danish: +) recidiverende eller refraktær CD22-positiv B-celle prækursor ALL skal have behandlingssvigt efter mindst 1 tyrosinkinasehæmmer (TKI).
English: ANC was ≥ 1 × 109/L
Danish: ANC var < 1 × 10
English: Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection during treatment and after HSCT (see section 5.1), bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment.
Danish: Foretag komplet blodtælling inden hver dosis BESPONA, og undersøg om der er symptomer på infektion under behandlingen og efter HSCT (se pkt.
English: For clinical management of infections, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af infektioner.
English: - Store in a refrigerator (2 °C-8 °C).
Danish: - Opbevares i køleskab (2-8 °C).
English: Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see Table 3 and section 4.4).
Danish: Seponer behandlingen permanent, hvis total bilirubin ikke restituerer til ≤ 1,5 × ULN, eller ASAT/ALAT ikke restitierer til ≤ 2,5 × ULN (se Skema 3 og pkt.
English: Talk to your doctor, pharmacist or nurse before using BESPONSA if you:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du:
English: [2.6 to 4.7]
Danish: 4.4 og 4.8).
English: Other medicines and BESPONSA
Danish: Brug af anden medicin sammen med BESPONSA
English: c Haemorrhage also includes other types of haemorrhage (17%).
Danish: Blødning omfatter også andre typer af blødning (17 %).
English: After reconstitution each vial contains 0.25 mg/mL of inotuzumab ozogamicin.
Danish: Efter rekonstituering indeholder hvert hætteglas 0,25 mg/ml inotuzumab ozogamicin.
English: What BESPONSA is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: • QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
Danish: • Ændre hjertets elektriske aktivitet (forlænge QT-intervallet) (se afsnit 2), der kan give alvorlig uregelmæssig hjerterytme.
English: Or
Danish: CI]
English: For patients with a high tumour burden, pre-medication to reduce uric acid levels and hydration is recommended prior to dosing (see section 4.4).
Danish: Inden behandling af patienter med høj tumorbyrde anbefales præmedicinering for at reducere urinsyreniveauet i blodet og hydrering (se pkt.
English: • have signs and symptoms of tumour lysis syndrome, which may be associated with symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps), during or shortly after the BESPONSA infusion.
Danish: • har haft symptomer på tumorlysesyndrom, der kan være forbundet med symptomer i maven og tarmene (fx kvalme, opkastning, diarré), hjertet (fx ændringer i hjerterytmen), nyrerne (fx mindre mængde urin, blod i urinen), nerverne og musklerne (fx muskelspasmer, muskelsvækkelse, muskelkramper) under eller kort efter infusionen af BESPONSA.
English: For clinical management of TLS, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af TLS.
English: If ANC and/or platelet count decreases, interrupt the next cycle of treatment until at least one of the following occurs: - ANC and platelet count recover to at least baseline levels for the prior cycle, or - ANC recovers to ≥ 1 × 109/L and platelet count recovers to ≥ 50 × 109/La, or - Stable or improved disease (based on most recent bone marrow assessment) and the ANC and platelet count decrease is considered to be due to the underlying disease (not considered to be BESPONSA-related toxicity).
Danish: Hvis ANC og/eller trombocyttallet falder, skal næste cyklus afbrydes, indtil mindst et af følgende sker: - ANC og trombocyttallet restitueres til mindst baselineniveau for det foregående forløb, eller - ANC ≥ 1 × 10
English: Tumour lysis syndrome is associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Danish: Tumorlysesyndrom er forbundet med forskellige symptomer i maven og tarmene (fx kvalme, opkastning, diarré), hjertet (fx ændringer i hjerterytmen), nyrerne (fx mindre mængde urin, blod i urinen), nerverne og musklerne (fx muskelspasmer, muskelsvækkelse, muskelkramper).
English: (see below).
Danish: Se i pkt.
English: Inotuzumab ozogamicin is considered to have the potential to impair reproductive function and fertility in men and women based on non-clinical findings (see section 4.6).
Danish: Baseret på ikke-kliniske fund anses inotuzumab ozogamicin for at have potentiale til at påvirke reproduktion og fertilitet hos mænd og kvinder (se pkt.
English: Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy.
Danish: social rolle (64,7 versus 53,4: forbedringsgrad lille), fysisk funktionsdygtighed (75,0 versus 68,1: forbedringsgrad lille), social funktionsdygtighed (68,1 versus 59,8: forbedringsgrad medium) og appetittab (17,6 versus 26,3: forbedringsgrad lille) sammenlignet med investigators valg af kemoterapi.
English: If the reconstituted solution cannot be used immediately, it may be stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Danish: Hvis den rekonstituerede opløsning ikke kan bruges med det samme, kan den opbevares i køleskab (2-8 °C) i op til 4 timer.
English: Infection (48%)a (includes Sepsis and Bacteraemia [17%], Fungal infection [9%], Lower respiratory tract infection [12%)], Upper respiratory tract infection [12%], Bacterial infection [1%], Viral infection [7%], Gastrointestinal infection [4%], Skin infection [4%])
Danish: (herunder sepsis og bakteriæmi (17 %), svampeinfektion (9 %), nedre luftvejsinfektion (12 %), øvre luftvejsinfektion (12 %), bakteriel infektion (1 %), virusinfektion (7 %), gastrointestinal infektion (4 %), hudinfektion (4 %))
English: Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA.
Danish: Lægen vil regelmæssigt tage blodprøver for at måle dine blodtal under behandlingen med BESPONSA, se også afsnit 4.
English: Pre-medication to reduce uric acid levels and hydration is recommended prior to dosing for patients with a high tumour burden (see section 4.2).
Danish: For at reducere urinsyreniveauet anbefales det, at præmedicinere og hydrere patienter med høj tumorbyrde inden behandlingen påbegyndes (se pkt.
English: Withdraw this amount from the vial(s) using a syringe.
Danish: Træk denne mængde op af hætteglasset/-glassene vha. en sprøjte.
English: Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see section 4.4).
Danish: Seponer behandlingen permanent, hvis total bilirubin restituere til ≤ 1,5 × ULN, eller ASAT/ALAT ikke restituere til ≤ 2,5 × ULN (se pkt.
English: After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Danish: Efter rekonstituering indeholder 1 ml opløsning 0,25 mg inotuzumab ozogamicin.
English: For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids,
Danish: Hos patienter med cirkulerende lymfoblaster anbefales cytoreduktion med en kombination af hydroxyurea, steroid, og/eller vincristin til et perifert blasttal ≤ 10.000/mm
English: • If the medicine works well, but you are not going to receive a stem cell transplant (see section
Danish: • Hvis behandlingen fungerer godt, men du ikke skal have en stamcelletransplantation, får du op til højst 6 behandlingsforløb.
English: Haemorrhagec (33%) (includes Central nervous system haemorrhage [1%], Upper gastrointestinal haemorrhage [6%], Lower gastrointestinal haemorrhage [4%], Epistaxis
Danish: Blødning c (33 %) (herunder blødning i centralnervesystemet (1 %), øvre gastrointestinal blødning (6 %), nedre gastrointestinal blødning (4 %), næseblod (15 %)
English: No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført studier af inotuzumab ozogamicin hos patienter med nedsat leverfunktion.
English: For clinical management of bleeding/haemorrhagic events, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af blødning/hæmoragiske hændelser.
English: • tumour lysis syndrome (see section 2); this may be associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Danish: • Tumorlysesyndrom (se afsnit 2), dette kan give forskellige symptomer i mave-tarmkanalen (fx kvalme, opkastning og diarre), hjertet (fx ændringer i hjerterytmen), nyrerne (fx nedsat mængde urin, blod i urinen), nerver og muskler (muskelspasmer, -svaghed og -kramper)
English: Management of some adverse drug reactions may require dosing interruptions and/or dose reductions, or permanent discontinuation of BESPONSA (see sections 4.4 and 4.8).
Danish: Behandling af visse bivirkninger kan nødvendiggøre dosisafbrydelse og/eller -nedsættelse eller permanent seponering af BESPONSA (se pkt.
English: • have signs or symptoms of a low number of blood cells known as neutrophils (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or a low number of blood components known as platelets; these signs and symptoms include developing an infection or fever or bruising easily or getting frequent nose bleeds.
Danish: • har symptomer på et lavt antal blodlegemer, der kaldes for neutrofile (nogen gange ledsaget af feber), røde blodlegemer, hvide blodlegemer, lymfocytter eller et lavt antal blodplader.
English: For clinical management of infusion related reactions, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af infusionsrelaterede hændelser.
English: Use reconstituted solution immediately or after being stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Danish: Den rekonstituerede opløsning skal bruges straks eller efter opbevaring i køleskab (2-8 °C) i op til 4 timer.
English: No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with renal impairment.
Danish: Der er ikke udført studier af inotuzumab ozogamicin hos patienter med nedsat nyrefunktion.