natgillin/translations-raw huggingface dataset:
Symptomer på cytokinfrigivelsessyndrom kan omfatte høj feber, kulderystelser, myalgi, artralgi, kvalme, opkastning, diarré, diaforese, udslæt, anoreksi, træthed, hovedpine, hypotension, encefalopati, dyspnø, takypnø og hypoksi.
Symptoms of cytokine release syndrome may include high fever, rigors, myalgia, arthralgia, nausea, vomiting, diarrhoea, diaphoresis, rash, anorexia, fatigue, headache, hypotension, encephalopathy, dyspnoea, tachypnoea, and hypoxia.
% hændelsesfri sandsynlighed efter 6 måneder Median (måneder) (95 % CI)
% event free probability at 6 months Median (months) (95% CI)
Hvis du har leukæmi, kan det betyde feber, svaghed, blødende tandkød, blå mærker.
If you have leukaemia this might include fever, feeling weak, bleeding gums, bruising.
Effektresultater fra dette studie er vist i tabel 4.
See Table 4 for efficacy results from this study.
Kymriah er udelukkende til autolog anvendelse.
Kymriah is for autologous use only.
LÆGEMIDLETS NAVN Kymriah 1,2 x 106 - 6 x 108 celler infusionsvæske, dispersion
NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion
Tidligere transplantation havde ingen indvirkning på ekspansionen/persistensen af Kymriah hos hverken pædiatriske og unge voksne B-celle ALL-patienter eller DLBCL-patienter.
Prior transplantation did not impact the expansion/persistence of Kymriah in paediatric and young adult B-Cell ALL patients or DLBCL patients.
Andre symptomer på cytokinfrigivelsessyndrom er åndedrætsbesvær, kvalme, opkasning, diarré, muskelsmerter, ledsmerter, lavt blodtryk eller svimmelhed/ørhed.
Other symptoms of cytokine release syndrome are difficulty breathing, nausea, vomiting, diarrhoea, muscle pain, joint pain, low blood pressure, or dizziness/light-headedness.
De mest almindelige ikke-hæmatologiske bivirkninger var cytokinfrigivelsessyndrom (58 %), infektioner (54 %), pyreksi (35 %), diarré (32 %), kvalme (29 %), hypotension (26 %) og træthed
The most common non-haematological adverse reactions were cytokine release syndrome (58%), infections (54%), pyrexia (35%), diarrhoea (32%), nausea (29%), hypotension (26%) and fatigue
Den mest almindelige ikke-hæmatologiske bivirkning af grad 3 og 4 var cytokinfrigivelsessyndrom (47 %).
The most common Grade 3 and 4 non-haematological adverse reaction was cytokine release syndrome (47%).
Kymriah indeholder genetisk modificerede humane blodceller.
Kymriah contains genetically-modified human blood cells.
Inkluderede patienter Infunderede patienter
Infused patients
Vaccination med levende virus-vacciner anbefales ikke i mindst 6 uger før starten af lymfodepleterende kemoterapi, under behandling med Kymriah, og indtil immunsystemet er normaliseret efter behandling med Kymriah (se pkt.
Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah (see section 4.5).
Natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion bør anvendes til at prime slangerne før infusion og til at skylle dem efter infusion.
Sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion and to rinse it after infusion.
I relation til cytokinfrigivelsessyndrom er der i nogle tilfælde blevet rapporteret dissemineret intravaskulær koagulation (DIC), med lave fibrinogenniveauer, kapillær lækage-syndrom (CLS) og hæmafagocytisk lymfohistiocytose/makrofagaktiveringssyndrom (HLH/MAS).
In some cases, disseminated intravascular coagulation (DIC), with low fibrinogen levels, capillary leak syndrome (CLS), and haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of cytokine release syndrome.
Indhold af dextran 40 og dimethylsulfoxid (DMSO)
Content of dextran 40 and dimethyl sulfoxide (DMSO)
Derfor skal læger og øvrigt sundhedspersonale tage passende forsigtighedshensyn (bære handsker og briller) under håndtering af leukaferesemateriale eller Kymriah for at undgå potentiel overførsel af smittefarlige sygdomme.
Accordingly, healthcare professionals should employ appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or Kymriah to avoid potential transmission of infectious diseases.
Dissemineret vaskulær koagulation Koagulopati
Disseminated intravascular coagulation
De mest almindelige ikke-hæmatologiske bivirkninger var cytokinfrigivelsessyndrom (77 %), infektioner (65 %), hypogammaglobulinæmi (47 %), pyreksi (40 %) og nedsat appetit (39 %).
The most common non-haematological adverse reactions were cytokine release syndrome (77%), infections (65%), hypogammaglobulinaemia (47%), pyrexia (40%) and decreased appetite (39%).
Hypotension Hypertension
Vascular disorders Hypotension Hypertension
Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Det pivotale studie (B2202) er et enkeltarm fase II-multicenterstudie hos pædiatriske og unge voksne patienter med r/r B-celle akut lymfoblastær leukæmi.
The pivotal study (B2202) is a multicentre, single-arm phase II study in paediatric and young adult patients with r/r B-cell acute lymphoblastic leukaemia.
Tabel 1 Algoritme til håndtering af cytokinfrigivelsessyndrom
Table 1 Cytokine release syndrome management algorithm
Sådan bliver Kymriah givet
How Kymriah is given
Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så tal med lægen, før du får behandling med Kymriah.
If any of the above apply to you (or you are not sure), talk to your doctor before being given Kymriah.
Tisagenlecleucel fordeles også til cerebrospinalvæsken hos pædiatriske og unge voksne B-celle ALLpatienter (studie B2101J) og persisterer i den i op til 1 år.
Tisagenlecleucel also traffics and persists in cerebrospinal fluid in paediatric and young adult B-cell ALL patients (Study B2101J) for up to 1 year.
Taleforstyrrelse omfatter taleforstyrrelser, dysartri og afasi.
Speech disorders includes speech disorders, dysarthria and aphasia.
• Slagtilfælde, som kan forårsage fx svaghed, tab af balance, talebesvær, synsforstyrrelser,
• Stroke causing, for example, weakness, loss of balance, difficulty with speech, visual disturbance, difficulty swallowing
• Øvrige indholdsstoffer: glucose, natriumchlorid, human albuminopløsning, dextran 40 til parenteral anvendelse, dimethylsulfoxid, natriumgluconat, natriumacetat, kaliumchlorid, magnesiumchlorid, natrium-N-acetyltryptophan, natriumcaprylat, aluminium, vand til injektionsvæsker.
• The other ingredients are glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, and water for injections.
Indeholder også: glucose, natriumchlorid, human albuminopløsning, dextran 40 til parenteral anvendelse, dimethylsulfoxid, natriumgluconat, natriumacetat, kaliumchlorid, magnesiumchlorid, natrium-N-acetyltryptophan, natriumcaprylat, aluminium, vand til injektionsvæsker.
Also contains: glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, water for injections.
Natriumchlorid Human albuminopløsning Dextran 40 til injektion Dimethylsulfoxid Natriumgluconat Natriumacetat Kaliumchlorid Magnesiumchlorid Natrium-N-acetyltryptophan Natriumcaprylat Aluminium
Sodium chloride Human albumin solution Dextran 40 for injection Dimethylsulfoxide Sodium gluconate Sodium acetate
Sundhedspersonale, der skal håndtere Kymriah, bør derfor tage passende forholdsregler (bære handsker og briller) for at undgå potentiel transmission of smitsomme sygdomme.
Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Sekundært nøgleendepunkt
Key secondary endpoint
Kymriah indeholder natrium, dimethylsulfoxid (DMSO) og dextran 40.
Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40.
1-3 infusionsposer indeholdende totalt 1,2 x 106 til 6 x 108 CAR-positive levende T-celler.
1-3 infusion bags containing a total of 1.2 x 106 to 6 x 108 CAR-positive viable T cells.
Din læge, der skal håndtere Kymriah, vil derfor tage passende forholdsregler (bruge handsker og sikkerhedsbriller) for at undgå potentiel overførsel af smitsomme sygdomme.
Your doctor handling Kymriah will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
synkebesvær
Asthenia
Hjertesvigtk) Arytmil) Hjertestop
Cardiac failurek) Arrhythmial) Cardiac arrest
Samlet overlevelse (OS)3 % overlevelsessandsynlighed efter 6 måneder 56,2 % overlevelsessandsynlighed efter 12 måneder 40,2 Median (måneder) (95 % CI)
Overall survival (OS)3 % survival probability at 6 months % survival probability at 12 months Median (months) (95% CI)
En tredje dosis tocilizumab eller andre metoder til behandling af cytokinfrigivelsessyndrom skal overvejes, hvis der ikke er respons på anden dosis tocilizumab.
If no response to second dose of tocilizumab, consider a third dose of tocilizumab or pursue alternative measures for treatment of cytokine release syndrome.
Samtidig administration af stoffer, der vides at hæmme T-celle funktionen, er ikke blevet undersøgt i studier.
The co-administration of agents known to inhibit T-cell function has not been formally studied.
Kymriah skal transporteres inden for behandlingscenteret i lukkede, brudsikre, lækagesikre transportbeholdere.
Kymriah should be transported within the facility in closed, break-proof, leak-proof containers.
Hos voksne DLBCL-patienter blev der rapporteret cytopenier af grad 3 og 4, der ikke var forsvundet ved dag 28, på baggrund af laboratoriefund, og de omfattede trombocytopeni (41 %), lymfopeni (28 %), neutropeni (24 %), leukopeni (21 %) og anæmi (14 %).
In adult DLBCL, patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included thrombocytopenia (41%), lymphopenia (28%), neutropenia (24%), leukopenia (21%) and anaemia (14%).
Hos pædiatriske og unge voksne B-celle ALL-patienter blev der rapporteret cytopenier af grad 3 og 4, der ikke var forsvundet ved dag 28, på baggrund af laboratoriefund, og de omfattede leukopeni (55 %), neutropeni (53 %), lymfopeni (43 %), trombocytopeni (41 %) og anæmi (12 %).
In paediatric and young adult B-cell ALL patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included leukopenia (55%), neutropenia (53%), lymphopenia (43%), thrombocytopenia (41%) and anaemia (12%).
Forberedelse af infusionsposen
Preparation for infusion
3 dage startende med den første dosis af cytarabin).
intravenous daily for 3 days starting with the first dose of fludarabine).
Den mest almindelige ikke-hæmatologiske bivirkninger af grad 3 og 4 var infektioner (32 %) og cytokinfrigivelsessyndrom
The most common Grade 3 and 4 non-haematological adverse reactions were infections (32%) and cytokine release syndrome (22%).
For særlige forholdsregler for bortskaffelse, se pkt.
For special precautions for disposal see section 6.6.
Autologe humane T-celler genetisk modificerede ex vivo ved brug af en lentiviral vektor, som koder for en anti-CD19 kimær antigenreceptor (CAR).
Autologous human T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Infunderede N=75 n (%)
Infused N=75 n (%)
Akut nyreskade omfatter akut nyreskade, anuri, azotæmi, forøget kreatinin i blodet, nyresvigt, renal tubulær dysfunktion og renal tubulær nekrose.
Acute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.
Cellekinetik hos pædiatriske og unge voksne patienter med B-celle ALL
Cellular kinetics in paediatric and young adult B-cell ALL patients
Perifær neuropatig) Taleforstyrrelseh) Krampeanfaldi)
Peripheral neuropathyg) Speech disordersh) Seizurei)
Uddannelsesmateriale til patienter
Patient educational programme
Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er, med den alvorligste bivirkning anført først.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Indeholder 1,2 x 106 til 6 x 108 CAR+ levende T-celler.
Contains 1.2 x 106 to 6 x 108 CAR+ viable T cells.
Deliriumc) Angst
Deliriumc) Anxiety Sleep disorderd)
Hoste omfatter hoste, produktiv hoste og øvre luftvej-hoste-syndrom.
Cough includes cough, productive cough and upper-airway cough syndrome.
Inkluderede N=92 n (%)
Enrolled N=92 n (%)
Før patienterne behandles, skal markedsføringsindehaveren sikre, at stedet har øjeblikkelig adgang til 4 doser af tocilizumab til hver patient til behandling af cytokinfrigivelsessyndrom(CRS).
The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
LABEL TIL INFUSIONSPOSE
INFUSION BAG LABEL
Kymriah 1,2 x 106 - 6 x 108 celler, infusionsvæske, dispersion tisagenlecleucel (CAR+ levende T-celler)
NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Der bør anvendes steril natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion til at prime slangerne før infusion og til at skylle dem efter infusion.
Sterile sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion as well as rinse it afterwards.
Inkluderede N=165 n (%)
Enrolled N=165 n (%)
Kymriah indeholder:
Update reports:
Det skal du vide, før du får behandling med Kymriah
What you need to know before you are given Kymriah
Hvis patienten oplevede en forudgående hæmoragisk cystitis af grad 4 med cyclophosphamid eller udviste en kemorefraktær tilstand i forbindelse med et cyclophosphamid-indeholdende regime administreret kort tid før lymfodepleterende kemoterapi, bør følgende anvendes: - Cytarabin (500 mg/m2 intravenøst daglig i 2 dage) og etoposid (150 mg/m2 intravenøst daglig i
If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used: - Cytarabine (500 mg/m2 intravenous daily for 2 days) and etoposide (150 mg/m2 intravenous daily for 3 days starting with the first dose of cytarabine).
Hver infusionspose af Kymriah indeholder tisagenlecleucel celledispersion i en batch-afhængig koncentration af autologe T-celler, som er genetisk modificerede til at udtrykke en anti-CD19 kimær antigenreceptor (CAR-positive levedygtige Tceller).
Each infusion bag of Kmyriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells).
I tabel 7 nedenfor er der givet en opsummering af cellekinetiske parametre for tisagenlecleucel hos pædiatriske og unge voksne patienter med B-celle ALL.
A summary of cellular kinetic parameters of tisagenlecleucel in paediatric and young adult B-cell ALL patients is provided in Table 7 below.
Kymriah er en cellulær immunterapi, der indeholder tisagenlecleucel, autologe T-celler genetisk modificerede ex vivo ved brug af en lentiviral vektor, som koder for en anti-CD19 kimær antigenreceptor (CAR).
Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
I tabel 8 nedenfor er der givet en opsummering af cellekinetiske parametre for tisagenlecleucel hos DLBCL-patienter.
A summary of cellular kinetic parameters of tisagenlecleucel in DLBCL patients is provided in Table 8 below.
Hos DLBCL-patienter viste scatter-plot af qPCR cellekinetiske parametre versus vægt ingen tilsyneladende sammenhæng mellem cellekinetiske parametre og vægt på tværs af vægtintervallerne (38,4 til 186,7 kg).
In DLBCL patients, across the weight ranges (38.4 to 186.7 kg), the scatter plots of qPCR cellular kinetic parameters versus weight revealed no apparent relationship between cellular kinetic parameters with weight.
Infusionsvæske, dispersion.
Dispersion for infusion.
• Kvalme, opkastning
• Nausea, vomiting
CR (komplet remission) var defineret som <5 % blaster i knoglemarven, cirkulerende blaster i blodet skulle være <1 %, ingen påvisning af ekstramedullær sygdom og fuldstændig normalisering af antallet af perifere blodceller (trombocyttal>100.000/μl og absolut neutrofiltal [ANC] >1.000/μl) uden blodtransfusion.
Nominal one-sided exact p-value based on H0: ORR ≤20% vs. Ha: ORR >20% CR (complete remission) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and full recovery of peripheral blood counts (platelets >100,000/μL and absolute neutrophil counts [ANC] >1,000/μL) without blood transfusion.
Væske overbelastning Hypermagnesiæmi Hyponatriæmi Hyperfosfatæmi Tumorlysesyndrom
Fluid overload Hypermagnesaemia Hyponatraemia Hyperphosphataemia Tumour lysis syndrome
De mest almindelige hæmatologiske laboratorieanomalier af grad 3 og 4 var fald i antal hvide blodceller (99 %), fald i neutrofiltal (95 %), fald i lymfocyttal (95 %), fald i trombocyttal (77 %) og fald i hæmoglobinniveau (53 %).
The most common Grade 3 and 4 haematological laboratory abnormalities were white blood cells decreased (99%), neutrophils decreased (95%), lymphocytes decreased (95%), platelets decreased (77%) and haemoglobin decreased (53%).
Natrium- og kaliumindhold
Sodium and potassium content
• Ændringer i blodprøveresultater, der viser hvordan lever og nyrer fungerer (højt niveau af:
• Changes in blood test results that report on how the liver and kidneys are working (high levels of: liver enzymes, bilirubin, creatinine)
Primært endepunkt
Primary endpoint
De mest almindelige (>25 %) hæmatologiske laboratorieanomalier af grad 3 og 4 var fald i lymfocyttal (95 %), fald i neutrofiltal (81 %), fald i antal hvide blodceller (77 %), fald i hæmoglobinniveau (59 %) og fald i trombocyttal (55 %).
The most common (>25%) Grade 3 and 4 haematological laboratory abnormalities were lymphocyte count decreased (95%), neutrophil count decreased (81%), white blood cell count decreased (77%), haemoglobin decreased (59%) and platelet count decreased (55%).
• Appetitløshed, vægttab
• Loss of appetite, weight loss
Det anbefalede lymfodepleterende kemoterapi-regime er: - Fludarabin (25 mg/m2 intravenøst daglig i 3 dage) og cyclophosphamid (250 mg/m2 intravenøst daglig i 3 dage startende med den første dosis af fludarabin).
The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (25 mg/m2 intravenous daily for 3 days) and cyclophosphamide (250 mg/m2
Hver ethylenvinylacetat (EVA) infusionspose med Kymriah indeholder tisagenlecleucel celledispersion i en batch-afhængig koncentration af autologe T-celler, der er genetisk modificerede til at udtrykke en anti-CD19 kimær antigenreceptor (CAR-positive levende T-celler) (se pkt.
Each ethylene vinyl acetate (EVA) infusion bag of Kymriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2).
Det anbefalede lymfodepleterende kemoterapi-regime er: - Fludarabin (30 mg/m2 intravenøst daglig i 4 dage) og cyclophosphamid (500 mg/m2 intravenøst daglig i 2 dage startende med den første dosis af fludarabin).
The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2
Inden infusion skal der være mindst fire doser tocilizumab og nødudstyr tilgængelige til brug i tilfælde af cytokinfrigivelsessyndrom.
A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome and emergency equipment must be available prior to infusion.
1-3 poser indeholdende i alt 1,2 x 106 - 6 x 108 CAR+ levende T-celler.
1-3 bags contain a total of 1.2 x 106 - 6 x 108 CAR+ viable T cells.
Efter optøning bør produktet opbevares ved stuetemperatur (20 °C-25 °C) og infunderes inden for 30 minutter for at bevare maksimal levedygtighed, herunder medregnet afbrydelser under infusion.
After thawing, the product should be kept at room temperature (20°C-25°C) and infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Hovedpinee) Encefalopatif) Svimmelhed
Headachee) Encephalopathyf) Dizziness
• Nervesmerter
• Nerve pain
Når Kymriah er blevet optøet og har opnået stuetemperatur (20 °C-25 °C), bør det infunderes inden for 30 minutter for at opretholde den maksimale levedygtighed af produktet, herunder også inkluderet eventuelle afbrydelser under infusionen.
Once Kymriah has been thawed and is at room temperature (20°C-25°C), it should be infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Kymriah er en celledispersion til infusion.
What Kymriah looks like and contents of the pack Kymriah is a cell dispersion for infusion.
Aktiv leukæmi eller lymfom i centralnervesystemet (CNS) Der er begrænset erfaring med brug af Kymriah i patienter med aktiv leukæmi eller lymfom i CNS.
There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma.
Responderende patienter (CR/CRi) N=80
Responding patients (CR/CRi)
Køn - n (%)
Sex - n (%)
• Muskel og ledsmerter, muskelkramper, rygsmerte
• Muscle and joint aches, muscle spasms, back pain
• Voksne patienter med recidiverende eller refraktært diffust storcellet B-celle lymfom (DLBCL)
• Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
• Hurtig hjerterytme
• Fast heart beat
• Oppustethed (udspilet mave), væskeansamling i maven
• Bloating (abdominal distension), accumulation of fluid in the abdomen
Cytopenier af længere varighed
Prolonged cytopenias
Patienter med medicinsk signifikant hjertedysfunktion skal behandles i forhold til standarder for kritisk behandling, og forholdsregler såsom ekkokardiografi bør overvejes Tumornekrosefaktor (TNF)-antagonister anbefales ikke til håndtering af Kymriah-relateret cytokinfrigivelsessyndrom.
Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
For klinisk håndtering af cytokinfrigivelsessyndrom, se pkt.
For clinical management of cytokine release syndrome, see section 4.4 and Table 1.
Febril neutropeni blev hyppigt observeret hos patienter efter infusion af Kymriah (se pkt.
Febrile neutropenia was frequently observed in patients after Kymriah infusion (see section 4.8) and may be concurrent with cytokine release syndrome.
Blødning i munden Stomatitis
Mouth haemorrhage Stomatitis
Sådan bliver du behandlet med Kymriah
How you are given Kymriah
• Pædiatriske og unge voksne patienter op til 25 år med B-celle akut lymfoblastær leukæmi
• Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
• Hjertesvigt, hjertestop
• Heart failure, stopped heart beat
Takykardij)
Cardiac disorders Tachycardiaj)
Ødem omfatter perifært ødem, generaliseret ødem, lokaliseret ødem og ansigtsødem.
Oedema includes oedema peripheral, generalised oedema, localised oedema and face oedema.