natgillin/translations-raw huggingface dataset:
[90Y] radioaktivt mærket Zevalin bør ikke indgives til patienter, som har sandsynlighed for at udvikle livstruende tegn på hæmatologisk toksicitet.
[90Y]-radiolabelled Zevalin should not be administered to patients who are likely to develop life- threatening haematological toxicity signs.
Patienter, der får Zevalin som konsolidering, skal være kommet sig helt oven på induktionskemoterapien, og have et neutrofiltal på > 1. 500/ mm³ og et blodpladetal på > 150. 000/ mm³, før der gives Zevalin.
Patients receiving Zevalin as consolidation should have recovered from induction chemotherapy and have achieved a neutrophil count > 1,500/ mm³ and a platelet count > 150,000/ mm³ before Zevalin administration.
Zevalin bør ikke indgives til de nedenfor nævnte patienter, da sikkerheden og effekten ikke er blevet fastslået:
Zevalin should not be administered in the patients mentioned below as safety and efficacy has not been established:
- patienter hos hvem mere end 25% af knoglemarven er infiltreret af lymfomceller,
- patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells,
- patienter, som tidligere er behandlet med ekstern strålebehandling, der involverede mere end 25%
- patients who have received prior external beam radiation involving more than 25% of active
af den aktive knoglemarv,
bone marrow,
- patienter med blodpladetal < 100. 000/ mm3, der får Zevalin som monoterapi, og patienter med et
- patients receiving Zevalin as monotherapy with platelet counts < 100,000/ mm3 and patients
blodpladetal på < 150. 000/ mm3, som får Zevalin som konsolidering efter remissionsinduktion,
receiving Zevalin as consolidation after remission induction with platelet counts < 150,000/ mm3
- patienter med et neutrofiltal på < 1. 500/ mm3
- patients with neutrophil counts < 1,500/ mm3,
- patienter som tidligere har fået foretaget knoglemarvstransplantation eller stamcellesupport.
- patients who have received prior bone marrow transplant or stem cell support,
- børn og unge under 18 år.
- children and adolescents under 18 years of age.
Patienten må ikke blive behandlet med vækstfaktorer, fx G- CSF, i 2 uger før behandlingen med Zevalin og i 2 uger efter afslutningen af behandlingen, da hurtigt delende myeloide celler er potentielt sensive over for stråling..
Patients should not receive growth factor treatment such as G-CSF for 2 weeks prior to Zevalin treatment as well as for 2 weeks following completion of the regimen because of the potential sensitivity of rapidly dividing myeloid cells to radiation.
Særlig forsigtighed er indiceret med hensyn til knoglemarvssvind.
Special caution is required with respect to bone marrow depletion.
Patienter, som blev behandlet med murin- deriverede proteiner inden Zevalin behandlingen, bør testes for humane anti- mus antistoffer (HAMA).
Patients who had received murine-derived proteins before Zevalin treatment, should be tested for human anti-mouse antibodies (HAMA).
Hos patienter, der har udviklet HAMA, kan der forekomme allergiske reaktioner eller overfølsomhedsreaktioner, når de behandles med Zevalin eller andre murin - deriverede proteiner.
Patients who have developed HAMA may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Under eller efter infusion med rituximab kan der opstå alvorlige infusionsreaktioner, som kan omfatte smerte i brystet, kardiogent shock, myokardieinfarkt, pulmonært ødem, ventrikulær fibrillation, apnø, bronkospasme, dyspnø, hypoksi, angioneurotisk ødem, rødmen, hypotension, ARDS og lungeinfiltration.
Severe infusion reactions may occur during or following rituximab infusion, which may be associated with chest pain, cardiogenic shock, myocardial infarction, pulmonary edema, ventricular fibrillation, apnea, bronchospasm, dyspnea, hypoxia, angioneurotic edema, flushing, hypotension, ARDS, and lung infiltration.
Infusionsrelaterede reaktioner på grund af Zevalin er mindre almindelige og mindre svære.
Infusion– related reactions due to Zevalin are less common and less severe.
4 Anafylaktiske reaktioner og andre overfølsomhedsreaktioner er blevet rapporteret hos mindre end 1% af patienterne efter intravenøs indgivelse af proteiner.
4 Anaphylactic and other hypersensitivity reactions have been reported in fewer than 1% of patients following the intravenous administration of proteins to patients.
Medicin til behandling af overfølsomhedsreaktioner, f. eks. adrenalin, antihistaminer og kortikosteroider, bør være umiddelbart tilgængelig i tilfælde af allergiske reaktioner under indgivelse af rituximab og radioaktivt mærket Zevalin.
Medicinal products for the treatment of hypersensitivity reactions, e. g. adrenaline, antihistamines and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of rituximab and radiolabelled Zevalin.
Efter anvendelse af Zevalin bør patienter generelt testes for HAMA, inden yderligere behandling med mus- deriverede proteiner.
After use of Zevalin, patients should generally be tested for HAMA before any further treatment with mouse derived proteins.
I forbindelse med Zevalin- behandling, som omfatter rituximab og radioaktivt mærket Zevalin, er der i sjældne tilfælde indberettet alvorlige mukokutane reaktioner, herunder Steven- Johnsons syndrom med fatalt udfald.
Severe mucocutaneous reactions, including Stevens-Johnson Syndrome with fatal outcome, have rarely been reported in association with the Zevalin therapeutic regimen, which includes rituximab and radiolabelled Zevalin.
Starten af reaktionerne varierede fra dage til måneder.
The onset of the reactions varied from days to months.
Patienter, der oplever en mukokutan reaktion, bør ikke få yderligere komponenter af Zevalin- behandlingen.
Patients experiencing a mucocutaneous reaction should not receive any further component of the Zevalin regimen.
På grund af stoffets beskaffenhed bør kvinder i den fødedygtige alder samt mænd anvende effektive præventionsmidler under behandlingen med Zevalin og i 12 måneder efter behandlingen.
Due to the nature of the compound, females of child-bearing potential, as well as males, should use effective contraceptive measures during treatment with Zevalin and for 12 months afterwards.
Der er ikke foretaget studier af sikkerheden ved immunisering med vacciner, især levende virusvacciner, efter behandling med Zevalin.
The safety of immunisation with any vaccine, particularly live viral vaccines, following therapy with Zevalin has not been studied.
Der er heller ikke foretaget undersøgelser af evnen til at generere primær eller anamnestisk humoral respons over for vacciner.
The ability to generate a primary or anamnestic humoral response to any vaccine has also not been studied.
Der foreligger ikke data om patienter med CNS- lymfomer, da disse patienter ikke indgik i de kliniske studier.
No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
For at undgå strålerelaterede vævsskader kræves nøje overvågning for at opdage eventuel extravasering under Zevalin- administrationen.
Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Hvis der opstår tegn eller symptomer på extravasering, skal infusionen stoppes øjeblikkeligt, og genoptages i en ny vene.
If any signs or symptoms of extravasation have occurred,, the infusion should be immediately terminated and restarted in another vein.
Da IgG vides at passere placenta og på grund af den samtidige brug af stråling, må Zevalin ikke anvendes under graviditet.
Since IgG is known to pass the placenta and because of the concomitant use of radiation, Zevalin must not be used during pregnancy.
Kvinder i den fødedygtige alder samt mænd bør anvende effektive præventionsmidler under behandlingen med Zevalin og i 12 måneder efter behandlingen.
Females of childbearing potential as well as males should use effective contraceptive methods during treatment with Zevalin and for 12 months afterwards.
Når det er nødvendigt at indgive Zevalin til kvinder i den fødedygtige alder, bør der altid forhøres om en evt. graviditet.
When it is necessary to administer Zevalin to women of childbearing potential, information should always be sought about pregnancy.
Ved udebleven menstruation skal kvinden betragtes som gravid, indtil andet er påvist, og alternative behandlinger, der ikke involverer ioniserende stråling, bør derefter overvejes.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise and alternative therapies which do not involve ionising radiation should be then considered.
Det vides ikke, om ibritumomab tiuxetan udskilles i modermælk.
It is not known whether ibritumomab tiuxetan is excreted in human milk.
Da humant IgG udskilles i modermælk, og da muligheden for absorption og immunosuppression hos barnet er ukendt, skal kvinder ophøre med amning.
Because human IgG is excreted in human milk and because the potential for absorption and immunosuppression in the infant is unknown, women must discontinue breast-feeding.
Strålingsdosen fra den terapeutiske udsættelse kan resultere i sekundære maligniteter og i udvikling af arvelige defekter.
The radiation dose resulting from therapeutic exposure may result in secondary malignancies and in development of hereditary defects.
Det er nødvendigt at sikre, at risiciene fra strålingen er mindre end risiciene fra selve sygdommen.
It is necessary to ensure that the risks of the radiation are less than from the disease itself.
Majoriteten af behandlede patienter kan forventes at opleve bivirkninger.
The majority of patients may be expected to experience adverse reactions.
Hyppigheden af bivirkninger rapporteret nedenfor (meget almindelig ≥1/ 10, almindelig ≥1/ 100 til < 1/ 10, usædvanlig ≥ 1/ 1. 000 til < 1/ 100, sjælden: ≥ 1/ 10. 000 til < 1/ 1. 000; meget sjælden: < 1/ 10. 000) er baseret på data fra kliniske forsøg.
The frequencies of the adverse reactions reported below (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) are based on clinical trial data.
Bivirkninger, som optrådte efter markedsføringen, beskrives separat.
Adverse drug reactions deriving from post-marketing experience are described separately.
Bivirkningerne blev vurderet til i det mindste at have en mulig relation til den terapeutiske Zevalin- behandling, som omfatter rituximab og radioaktivt mærket Zevalin.
The adverse drug reactions are at least possibly related to the Zevalin therapeutic regimen which includes rituximab and radiolabelled Zevalin.
Anafylaktiske reaktioner og overfølsomhed Anafylaktiske reaktioner og andre overfølsomhedsreaktioner er blevet rapporteret hos mindre end 1% af patienterne efter intravenøs indgivelse af proteiner til patienter.
Anaphylactic reactions and hypersensitivity Anaphylactic and other hypersensitivity reactions have been reported in fewer than 1% of patients following the intravenous administration of proteins to patients.
Medicin til behandling af overfølsomhedsreaktioner, f. eks. adrenalin, antihistaminer og kortikosteroider, bør være umiddelbart tilgængelig i tilfælde af allergiske reaktioner under indgivelse af Zevalin.
Medicinal products for the treatment of hypersensitivity reactions, e. g. adrenaline, antihistamines and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of Zevalin.
Hæmatologiske bivirkninger Hæmatologisk toksicitet er observeret meget hyppigt i kliniske forsøg og er dosisbegrænsende.
Haematological adverse reactions Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting.
Gennemsnitstiden til opnået blodplade - og granulocytnadir var cirka 60 dage efter behandlingsstart.
Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
I de kliniske studier med indikationen recidiverende eller refraktær NHL blev trombocytopeni grad 3 eller 4 indberettet med en gennemsnitstid til regenerering på 13 og 21 dage og neutropeni grad 3 eller 4 med en gennemsnitstid til regenerering på 8 og 14 dage.
In clinical trials with the indication of relapsed and refractory NHL, Grade 3 or 4 thrombocytopenia was reported with median times to recovery of 13 and 21 days and grade 3 or 4 neutropenia with median times to recovery of 8 and 14 days.
20 og 35 dage for trombocytopeni grad 3 eller 4, og 20 og 28 dage for neutropeni grad 3 eller 4.
Following Zevalin as consolidation after first line remission induction, the median times to recovery were 20 days and 35 days for Grade 3 or 4 thrombocytopenia and 20 days and 28 days for Grade 3 or 4 neutropenia.
Infektioner I løbet af de første 13 uger efter behandling med Zevalin udviklede patienter meget hyppigt infektioner.
Infections During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
Grad 3 og grad 4 infektioner rapporteredes hyppigt.
Grade 3 and grade 4 infections were reported commonly.
Under opfølgningen opstod der hyppigt infektioner.
During follow-up, infections occurred commonly.
Af disse var grad 3 hyppig og grad 4 mindre hyppig.
Of these, grade 3 was common, grade 4 uncommon.
Sekundære maligniteter Myelodysplasi / akut myeloid leukæmi (AML) er blevet rapporteret hos 5 ud af 211 patienter, som modtog Zevalin- behandling.
Secondary malignancies Myelodysplasia/ acute myeloid leukaemia (AML) has been reported in five out of 211 patients assigned to treatment with Zevalin.
Da alle disse patienter blev forbehandlet med alkylerende stoffer, giver de tilgængelige resultater utilstrækkelige data med hensyn til, hvorvidt Zevalin bidrager til en forøget risiko for myelodysplasi eller utilstrækkelige data vedrørende risikoens omfang.
Since all of these patients were pre-treated with alkylating agents, available results provide insufficient data on whether Zevalin contributes to an increased risk of myelodysplasia, or on the extent of risk.
Bivirkninger opstillet efter systemorganklasse Tabellen nedenfor viser bivirkninger sorteret efter systemorganklasse:
Incidence of adverse reactions by System Organ Class The table below reports adverse reactions by System Organ Class:
Totalt forekom infektioner af forskellige årsager meget hyppigt, men de er opført i tabellen under den specifikt rapporterede term.
In total, infections of any cause occurred very commonly but are listed in the table under the specifically reported term.
Opstillet efter systemorganklasse
System Organ Class (MedDRA)
(≥1/ 10. 000 til < 1/ 1. 000)
(≥ 1/ 10,000 to < 1/ 1,000)
Infektion *, Sepsis *, Pneumoni *, Urinvejsinfektion Oral moniliasis,
Infection *, Sepsis *, Pneumonia *,
6 Opstillet efter systemorganklasse
6
Meget almindelig
System Organ Class (MedDRA)
Tumorsmerter, Myelodysplastisk syndrom / akut myeloid leukæmi *,
Tumour pain, Myelodysplastic syndrome / Acute myeloid leukaemia *
Thrombocytopeni, Leukocytopeni, Neutropeni, Anæmi *
Thrombocytopenia, Leukocytopenia, Neutropenia, Anemia *
Febril neutropeni, Pancytopeni *, Lymfocytopeni
Febrile neutropenia, Pancytopenia *, Lymphocytopenia
Immunsystemet
Immune system disorders Metabolism and nutrition disorders
Overfølsomheds - reaktion
Hypersensitivity reaction Anorexia
Metabolisme og ernæring
Anxiety, Insomnia Dizziness, Headache
Anorexi
Tachycardia
Psykiske forstyrrel - ser
Vascular disorders
Ængstelse, Søvnløshed
Hemorrhage while thrombocytopenic *
Nervesystemet
Cough, rhinitis
Svimmelhed, Hovedpine,
Gastrointestinal disorders
Hjertet
Nausea
Takykardi
Skin and subcutaneous tissue disorders
Vaskulære sygdomme
Rash, Pruritus,
Blødning under thrombocytopeni
Musculoskeletal, connective tissue and bone disorders
Intrakraniel blødning under trombocytopeni *
Arthralgia, Myalgia, Back pain, Neck pain
Luft - veje, thorax og mediastinum
7 System Organ Class (MedDRA)
Hoste, Rhinitis
Very common
Mave - tarmkanalen
Common
Opkastning Abdominalsmerter, Diarré, Dyspepsi, Halsirritation, Forstoppelse
Rare
Hud og subkutane væv
(≥ 1/ 10)
Udslæt Pruritus
(≥ 1/ 100 to < 1/ 10)
Knogler, led, muskler og bindevæv
(≥ 1/ 1,000 to < 1/ 100)
Arthralgi, Myalgi, Rygsmerter Nakkesmerter
(≥ 1/ 10,000 to < 1/ 1,000)
Almene symptomer og reaktioner på administrations - stedet
General disorders Asthenia, and administration Pyrexia, site conditions Rigors
Asteni, Pyrexi, Rigors
Pain, Flu like symptoms, Malaise, Peripheral edema, Sweating increased
Smerter Influenza- lignende symptomer, Ubehag, Perifert ødem, Øget svedafsondring
* fatal outcome has been observed either in
* Dødelig udgang er blevet observeret enten i kliniske afprøvninger eller post- marketing erfaringer
clinical trials or in post-marketing experience
Den mest passende MedDRA betegnelse er anvendt til at beskrive en bestemt reaktion og dens synonymer og tilhørende tilstande.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Betegnelserne for bivirkningerne er baseret på MedDRA version 9. 1.
ADR term representation is based on MedDRA version 9.1.
7 Inden for hver gruppe af hyppigheder angives bivirkningerne i rækkfølge af aftagende alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Sygdomsprogression er den naturlige udvikling af den underliggende sygdom.
Disease progression is the natural evolution of the underlying disease.
I studiet med de 204 patienter, som fik Zevalin- konsolideringsbehandling efter remissionsinduktion med 1. linjebehandling, forekom der infektioner hyppigere end angivet i tabellen ovenfor (meget almindeligt).
In the study with 204 patients receiving Zevalin as consolidation following first-line remission induction, infections were observed more frequently than as described in the above table (very common).
I samme studie blev der desuden set følgende bivirkninger:
In addition, the following adverse drug reactions were observed in this study:
• MedDRA Almene symptomer og reaktioner på administrationsstedet: træthed (meget almindelig)
• MedDRA SOC General disorders and administration site conditions: fatigue (very common)
• MedDRA Vaskulære sygdomme: petekkier (meget almindelig), hypertension (almindelig), hypotension (almindelig)
• MedDRA SOC Vascular disorders: petechia (very common), hypertension (common), hypotension (common)
• MedDRA Det reproduktive system og mammae: amenorrhoea (almindelig)
• MedDRA SOC Reproductive system and breast disorders: amenorrhoea (common) Post-marketing experience:
MedDRA Hud og subkutane væv
MedDRA SOC Skin and subcutaneous tissue disorders
Der er i sjældne tilfælde indberettet mukokutane reaktioner, herunder Stevens- Johnson syndrom med fatalt udfald efter markedsføringen.
Mucocutaneous reaction, including Stevens Johnson Syndrome with fatal outcome, has been rarely reported in post-marketing experience.
MedDRA Almene symptomer og reaktioner på administrationsstedet Enkeltstående tilfælde af extravasering med efterfølgende reaktioner på administreringsstedet som f. eks.. dermatitis, deskvamation, og sår på injektionsstedet er indberettet.
Isolated reports of extravasation with subsequent infusion site reaction, like dermatitis, desquamation, and site ulcer have been received.
Enkeltstående tilfælde er indberettet, der viser, at Zevalin- relateret stråling kan skade vævet omkring lymfomet og forårsage komplikationer pga forstørrelse af lymfomet.
Isolated reports have been received showing that Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling.
Da terapeutisk behandling med Zevalin omfatter anvendelsen af rituximab, bør man også læse produktresumeet for rituximab.
Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.
Der er i kliniske studier forekommet overdoseringer på helt op til 19, 2 MBq/ kg af [90Y] radioaktivt mærket Zevalin.
Overdose as high as 19.2 MBq/ kg of [90Y]-radiolabelled Zevalin occurred in clinical trials.
Der blev observeret forventet hæmatologisk toksicitet i grad 3 eller grad 4.
Expected haematological toxicity was observed, comprising Grade 3 or 4.
Patienterne kom sig efter disse tegn på toksicitet, og overdoserne fik ikke alvorlige eller fatale følger.
Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Der er ingen kendt specifik antidot mod overdosering med [90Y] radioaktivt mærket Zevalin.
8 There is no known specific antidote for [90Y]-radiolabelled Zevalin overdosage.
Hvis tilgængelig, bør der administreres autolog stamcellestøtte til behandling af hæmatologisk toksicitet.
If available, autologous stem cell support should be administered to manage haematological toxicity.
I tilfælde af utilsigtet indgivelse af det rene radiofarmaceutiske mærkningsprodukt yttrium- 90, se produktinformationen for yttrium- 90.
For accidental administration of the pure radiopharmaceutical precursor product yttrium-90, refer to the product information of yttrium-90.
ATC- kode:
Various therapeutic radiopharmaceuticals ATC code:
8 Ibritumomab tiuxetan er et rekombinant murint IgG1 kappa- monoklonalt antistof specifikt for B- celle antigenet CD20.
Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Ibritumomab tiuxetan er specifik for antigenet CD20, som befinder sig på overfladen af maligne og normale B- lymfocytter.
Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes.
Under B- celle modning viser CD20 sig først i mellemstadiet af B- lymfoblast (præ- B- celle) og forsvinder under slutstadiet af B- cellernes modning til plasmaceller.
During B-cell maturation, CD20 is first expressed in the midstage of B-lymphoblast (pre-B-cell), and is lost during the final stage of B-cell maturation to plasma cells.
Det konjugerede antistof har en tilsyneladende affinitetskonstant til CD20 antigenet på cirka 17 nM.
The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
[90Y] radioaktivt mærket Zevalin bindes specifikt til B- celler, inklusive maligne celler, der udtrykker CD20.
[90Y]-radiolabelled Zevalin binds specifically to B-cells, including CD20-expressing malignant cells.
Isotopen yttrium- 90 er en ren β- emitter og har en gennemsnitlig vejlængde på cirka 5 mm.
The isotope yttrium-90 is a pure β -emitter and has a mean path length of about 5 mm.
Rituximab forbehandling er nødvendig for at fjerne cirkulerende B- celler, således at Zevalin kan videregive den radioaktive stråling mere specifikt til lymfomerne.
Rituximab pre-treatment is necessary to clear circulating B-cells, enabling Zevalin to deliver radiation more specifically to the lymphomas.
Behandling med [90Y] radioaktivt mærket Zevalin fører desuden til depletering af normale CD20+ B - celler.
Treatment with [90Y]-radiolabelled Zevalin also leads to depletion of normal CD20+ B-cells.
Farmakodynamiske analyser påviste, at dette var en midlertidig virkning; restitution af normale B- celler begyndte inden for 6 måneder, og gennemsnitsantallet af B- celler var inden for normalområdet inden for 9 måneder efter behandlingen.
Pharmacodynamic analysis demonstrated that this was a temporary effect; recovery of normal B-cells began within 6 months and median counts of B-cells were within normal range within 9 months after treatment.
Sikkerheden og effektiviteten af terapeutisk Zevalin- regimen er blevet evalueret i to multicenterstudier, hvori der i alt deltog 197 patienter.
The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Det terapeutiske Zevalin- regimen blev indgivet i to trin (se afsnit 4. 2).
The Zevalin therapeutic regimen was administered in two steps (see 4.2).