qanastek/EMEA-V3 huggingface dataset:
In both studies, the main measure of effectiveness was the number of patients whose disease responded partially or completely to treatment.
Fiż- żewġ studji, il- kejl ewlieni tal- effikaċja kien l- għadd ta ’ pazjenti li l- marda tagħhom irrispondiet parzjalment jew totalment għat- trattament.
What benefit has Zevalin shown during the studies?
Liema benefiċċji wera Zevalin fl- istudji mwettqa?
When Zevalin was used as consolidation therapy, patients survived for longer without their disease getting worse than when they received no further treatment.
Meta Zevalin intuża bħala terapija ta ’ konsolidament, il- pazjenti damu jgħixu għal iktar żmien mingħajr ma taggravalhom il- marda milli meta ġew ittrattati bl- ebda trattament ulterjuri.
Patients receiving radiolabelled Zevalin survived for an average of 37 months until their disease got worse, compared with 14 months in those who did not receive any further treatment.
Il- pazjenti ttrattati b’ Zevalin radjommarkat għexu għal perjodu medju ta ’ 37 xahar sakemm il- marda tagħhom marret għall- agħar, meta mqabbla mal- 14- il xahar ta ’ dawk li ma ngħataw l- ebda trattament ulterjuri.
In patients who were not responding to other treatments or whose disease had come back after previous treatment, Zevalin was more effective than rituximab:
Madankollu, kien hemm ammont żgħir wisq ta ’ pazjenti li ġew ittrattati b’ rituximab bħala parti mit - trattament ta ’ induzzjoni tagħhom biex jiġi ddeterminat jekk ikunx hemm benefiċċju jekk jużaw Zevalin bħala trattament ta ’ konsolidament f’ dawn il- pazjenti.
80% of the patients receiving radiolabelled Zevalin responded, compared with 56% of the patients receiving rituximab.
Fil- pazjenti li ma kinux qegħdin jirrispondu għat- trattamenti l- oħrajn jew li rkadew wara trattament preċedenti, Zevalin irriżulta aktar effikaċi minn rituximab: irrisponda perċentwal ta ’ 80% tal- pazjenti ttrattati b’ Zevalin radjommarkat, meta mqabbel ma ’ 56% tal- pazjenti ttrattati b’ rituximab.
However, the time taken for the disease to get worse after treatment was the same in both groups (about 10 months).
Madankollu, iż- żmien li marda ħadet biex taggrava wara t- trattament kien identiku fiż- żewġ gruppi (wara 10 xhur).
In the additional study, radiolabelled Zevalin brought about a response in about half of the patients.
Fl- istudju addizzjonali, Zevalin radjommarkat irreġistra rispons f’ madwar nofs il- pazjenti.
What is the risk associated with Zevalin?
X’ inhu r- riskju assoċjat ma ’ Zevalin?
Radiolabelled Zevalin is radioactive and its use may carry a risk of cancer and hereditary defects.
Zevalin radjommarkat jipproduċi radjoattività u jista ’ jwassal għal riskju ta ’ kanċer jew difetti ereditarji.
The doctor who prescribes it must ensure that the risks linked to the exposure to the radioactivity are lower than the risks from the disease itself.
It- tabib li jippreskrivi l- mediċina għandu jassigura li r- riskji marbuta mal- esponiment għar - radjoattività jkunu inqas minn dawk tal- marda stess.
The most common side effects with Zevalin (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), leucocytopenia and neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), asthenia (weakness), pyrexia (fever), rigors (stiffness) and nausea (feeling sick).
L- effetti sekondarji l- aktar komuni b’ Zevalin (li dehru f’ aktar minn pazjent 1 minn 10) huma anemija (għadd baxx ta ’ ċelluli tad- demm ħomor), lewkoċitopenija u newtropenija (għadd baxx ta ’ ċelluli tad- demm bojod), tromboċitopenija (għadd baxx ta ’ platelets), astenija (debbulizza), piressija (deni), riġidità (ebusija) u nawżea (dardir).
For the full list of all side effects reported with Zevalin, see the Package Leaflet.
Għal - lista sħiħa tal- effetti sekondarji rrappurtati b’ Zevalin, ara l- Fuljett ta ’ Tagħrif.
Zevalin should not be used in people who may be hypersensitive (allergic) to ibritumomab, yttrium chloride, mouse proteins or any of the other ingredients.
Zevalin ma għandux jingħata lil pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għal ibritumomab, għall- ittrju klorur, għall- proteini tal- ġurdien jew għal kwalunkwe ingredjent ieħor.
Zevalin must not be used in patients who are pregnant or breast feeding.
Zevalin ma għandux jintuża waqt it- tqala jew it- treddigħ.
Why has Zevalin been approved?
Għaliex ġie approvat Zevalin?
The Committee recommended that Zevalin be given marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Zevalin huma akbar mir- riskji tiegħu bħala terapija ta ’ konsolidament wara induzzjoni ta ’ remissjoni f’ pazjenti mhux ittrattati qabel li jbatu minn linfoma follikulari u fit- trattament ta ’ pazjenti adulti li jbatu minn linfoma mhux ta ’ Hodgkin follikulari b’ ċelluli B CD20 pożittiv, b’ attakki reċidivi jew refrattarji għat- trattament b’ rituximab.
Zevalin was originally authorised under ‘ Exceptional Circumstances ’ because it had not been possible to obtain complete information about Zevalin.
Il- Kumitat irrakkomanda li Zevalin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Zevalin:
2/ 3 Oriġinarjament, Zevalin ġie awtorizzat f ’’ Ċirkostanzi Eċċezzjonali ’ minħabba li ma kienx possibbli li jinkiseb tagħrif komplut dwaru.
The European Commission granted a marketing authorisation valid throughout the European Union for Zevalin to Bayer Schering Pharma AG on 16 January 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Zevalin lil Bayer Schering Pharma AG fis- 16 ta ’ Jannar 2004.
The marketing authorisation was renewed on 16 January 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Jannar 2009.
The full EPAR for Zevalin is available here.
L- EPAR sħiħ dwar Zevalin jista ’ jiġi kkonsultat hawn.
Kit for radiopharmaceutica l preparation for infusion
Kitt għall - preparazzjoni radjufarmaċewtika għall- infużjoni
1 kit containing:
1 kitt fih:
1 vial of ibritumomab tiuxetan, 1 vial of sodium acetate solution, 1 vial of formulation buffer and 1 empty reaction vial
1 kunjett ta ’ ibritumomab tiuxetan, 1 kunjett ta ’ soluzzjoni ta ’ sodium acetate, 1 kunjett ta ’ baffer tal- formulazzjoni u 1 kunjett vojt għar- reazzjoni
Zevalin 1.6 mg/ ml, Kit for radiopharmaceutical preparation for infusion
Zevalin 1. 6 mg/ ml, Kitt għall- preparazzjoni ta ’ prodott radjufarmaċewtiku għall- infużjoni.
1.6 mg per ml
1. 6 mg għal kull ml
One vial contains 3.2 mg of ibritumomab tiuxetan
Vjala waħda fiha 3. 2 mg ta ’ Ibritumomab tiuxetan
*produced by a genetically engineered Chinese Hamster Ovary (CHO) cell line conjugated to the chelating agent MX-DTPA
* magħmul ġenetikament minn linja ta ’ ċelluli meħudin mill- bajd ta ’ l- utru tal- ħamster ċiniż (CHO) u mwaħħal mal- molekula kelanti MX- DTPA
Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Zevalin issibu bħala pakkett li fih issib kollox għall- preparazzjoni ta ’ Ibritumomab tiuxetan radjutikkettjat b’ yttrium- 90.
The final formulation after radiolabeling contains 2.08 mg ibritumomab tiuxetan in a total volume of 10 ml.
It- soluzzjoni finali wara li tiġi radjutikkettjata, jkun fiha 2. 08 mg ta ’ Ibritumomab tiuxetan f’ volum totali ta ’ 10 ml.
For a full list of excipients, see section 6.1.
Għal lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
Kit for radiopharmaceutical preparation for infusion
Kitt għall- preparazzjoni radjufarmaċewtika għall- infużjoni
Clear, colourless solution.
Soluzzjoni mingħajr kulur u ċara
The [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Zevalin radjutikkettjat b ’ [90Y] huwa ndikat bħala terapija ta ’ konsolidazzjoni wara l - induzzjoni ta ’ remissjoni f’ pazjenti b’ limfoma follikulari li ma kienux ikkurati qabel.
The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Il - benefiċċju ta ’ Zevalin wara rituximab flimkien ma ’ kimoterapija ma ġiex stabbilit.
The [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
90 Zevalin radjutikkettjat b ’ [Y], hu indikat għall- kura ta ’ pazjenti adulti li jkunu reġgħu żviluppaw il - limfoma non- Hodgkin taċ- ċelluli B follikulari CD20+ (NHL) b’ mod refrattorju jew wara li jkunu ġew ikkurati b’ rituksimab.
[90Y]-radiolabelled Zevalin should only be handled and administered by qualified personnel with appropriate authorisation for the use and manipulation of radionuclides within a designated clinical setting.
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata 90 Zevalin radjutikkettjat b ’ [Y], għandu jiġi mmaniġġat u mogħti biss lill- pazjent minn persuni li għandhom il- kwalifiki meħtieġa b’ awtorizzazzjoni xierqa għall- użu u l- manipulazzjoni ta’ radjunuklidi f’ ambjenti kliniċi mfassla apposta.
Its preparation, use, transfer, storage and disposal are subject to the regulations and/ or appropriate authorisation.
Il- preparazzjoni, l- użu, it- trasferiment u r- rimi ta ’ din il- mediċina għandhom isiru b’ mod li jkun konformi mar- regolamenti u/ jew b’ awtorizzazzjoni xierqa.
Infusions should be administered under the close supervision of an experienced physician with full resuscitation facilities immediately available (for radiopharmaceutical precautions see also sections 4.4, 6.6 and 12).
L - infużjonijiet għandhom jiġu mogħtija lill- pazjent taħt is- sorveljanza ta ’ tabib b’ esperjenza meħtieġa u f’ post mgħammar b’ faċilitajiet li jkunu meħtieġa għall- irxuxtar, disponibbli fil- pront (ara wkoll sezzjonijiet 4. 4, 6. 6 u 12 għal prekawzjonijiet għall- użu ta ’ radjufarmaċewtiċi).
Zevalin should be used following pre-treatment with rituximab.
Zevalin għandu jintuża wara kura b’ rituximab.
Refer to the product information of rituximab for detailed guidance on its use.
Irreferi għat- tagħrif tal- prodott ta ’ rituximab, biex tkun taf aktar informazzjoni kif għandek tuża dan il - prodott.
The prepared infusion solution must be given as a slow intravenous administration over 10 minutes.
2 L- infużjoni li tkun ġiet ippreparata għandha tingħata bħala infużjoni ġol- vina bil- mod fuq ħin ta ’ l fuq minn 10 minuti.
Do not use as an intravenous bolus.
Din is- soluzzjoni qatt ma għandha tingħata f’ daqqa ġol- vina bħala bolus.
2 The [90Y]-radiolabelled Zevalin solution must be prepared according to section 12.
90 Is- soluzzjoni ta ’ Zevalin radjutikkettjat b ’ [Y] għandha tiġi ppreparata b’ mod li jkun konformi ma ’ kif hemm stabbilit f’ sezzjoni 12.
For instructions on disposal, see section 6.6.
Għal struzzjonijiet dwar ir- rimi, ara sezzjoni 6. 6.
Before administration to the patient, the percent radioincorporation of the prepared [90Y]-radiolabelled Zevalin must be checked according to the procedure outlined in section 12.
Qabel ma din il- mediċina tingħata lill- pazjent, il- perċentwali ta ’ radjuattività li ġiet inkorporata fis - 90 soluzzjoni ta ’ Zevalin radjutikkettjat b ’ [Y], trid tiġi ċċekkjata billi jsiru ċertu testijiet skond il - proċedura stabbilita f’ sezzjoni 12.
If the average radiochemical purity is less than 95%, the preparation should not be administered.
Jekk il- purità radjukimika medja tkun ta ’ inqas minn 95%, din it- taħlta ma għandhiex tingħata lill - pazjent.
The recommended radioactivity for patients receiving Zevalin as monotherapy is:
Ir- radjuattività rakkomandata għall- pazjenti li qed jirċievu Zevalin bħala monoterapija hi:
patients with 150,000 platelets per mm3 and more:
pazjenti li għandhom 150, 000 plejtlits jew aktar għal kull mm3:
15 MBq [90Y]-radiolabelled Zevalin per kg body weight up to a maximum of 1200 MBq.
radjutikkettjat b ’ [90Y] għal kull kg tal- piż tal- ġisem tal- pazjent, sa doża massima ta ’ 1200 mBq.
patients with fewer than 150,000 but more than 100,000 platelets per mm3:
90 plejtlits għal kull mm3:
11 MBq [90Y]- radiolabelled Zevalin per kg body weight up to a maximum of 1200 MBq.
11. 1 MBq Zevalin radjutikkettjat b ’ [Y] għal kull kg tal- piż tal - ġisem tal- pazjent, sa doża massima ta ’ 1200 mBq.
The recommend radioactivity for patients receiving Zevalin as consolidation after remission induction is:
Ir- radjuattività rrakkomandata għall- pazjenti li qed jirċievu Zevalin bħala konsolidazzjoni wara l - induzzjoni ta ’ remissjoni hi:
patients with 150,000 platelets per mm³ and more:
pazjenti li għandhom 150, 000 plejtlit jew aktar għal kull mm3:
15 MBq [90Y]-radiolabelled Zevalin per kg body weight up to a maximum of 1200 MBq.
15 MBq Zevalin
patients with fewer than 150,000 platelets per mm³ should not receive Zevalin consolidation treatment.
- pazjenti li għandhom inqas minn 150, 000 plejtlit għal kull mm³ m’ għandhomx jirċievu
[90Y]-radiolabelled Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
90 Zevalin radjutikkettjat b ’ [Y], jista ’ jiġi infuż direttament ġol- vina billi titwaqqaf it- tnixxija mill - borża tad- dripp u jiġi mogħti direttament fil- pajp tad- dripp.
A 0.2 or 0.22 micron low protein binding filter must be on line between the patient and the infusion port.
Filtru li għandu toqob ta ’ bejn 0. 2 u 0. 22 mikroni u li għandu affinità baxxa għall- proteini għandu jiġi mwaħħal bejn il- pazjent u l- post min fejn 90 ħierġa l- infużjoni tal- mediċina.
Flush the line with at least 10 ml of sodium chloride 9 mg/ ml (0.9%) solution after the infusion of [90Y]-radiolabelled Zevalin.
Wara l- infużjoni ta ’ Zevalin radjutikkettjat b ’ [Y], laħlaħ il- pajp tad- dripp b’ ta ’ l- inqas 10 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) sodium chloride.
Treatment consists of two intravenous administrations of rituximab and one administration of [90Y]- radiolabelled Zevalin in the following order:
Il- kura tikkonsisti fl- għotja ta ’ żewġ infużjonijiet ġol- vina ta ’ rituximab u waħda ta ’ Zevalin radjutikkettjat b ’ [90Y].
Day 1: an intravenous infusion of rituximab.
Infużjoni ġol- vina ta ’ rituximab.
Rituximab infusion dose schedule:
Id- doża skedata ta ’ l- infużjoni b’ rituximab:
250 mg/ m2 of rituximab.
250 mg/ m2 ta ’ rituximab.
Day 7, 8, or 9: an intravenous infusion of rituximab shortly before the administration of [90Y]- radiolabelled Zevalin.
Infużjoni ġol- vina ta ’ rituximab li tingħata ftit qabel l- għotja ta ’ Żevalin [90Y] radjutikkettjat.
Rituximab infusion dose schedule:
Id- doża skedata ta ’ l- infużjoni ta ’ rituximab:
[90Y]-radiolabelled Zevalin infusion:
90
10 minute intravenous infusion of [90Y]-radiolabelled Zevalin is given up to a maximum dose of 1200 MBq.
f’ ħin ta ’ 10 minuti sa doża massima ta ’ 1200 MBq.
If the average radiochemical purity is less than 95%, the preparation should not be administered.
Jekk il- purità radjukimika tkun inqas minn 95%, din is- sustanza m’ għandiex tingħata lill- pazjent.
Repeated use Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.
Użu ripetut 90 Ma hemmx informazzjoni dwar pazjenti li reġgħu ġew ikkurati b’ Zevalin radjutikkettjat b ’ [Y].
There is no experience in children or adolescents below 18 years of age.
M’ hemmx esperjenza fit- tfal jew adoloxxenti taħt it- 18- il sena.
- Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, to rituximab, to other murine
- Sensittività eċċessiva għas- sustanzi attivi, ibritumomab tiuxetan, yttrium chloride, għal
proteins or to any of the excipients.
rituximab, u għall- proteini tal- ġrieden jew għal xi sustanzi mhux attivi fil- prodott.
- Pregnancy and lactation.
- Fit- tqala u waqt li mara tkun qed tredda ’.
Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.
Minħabba li l- kors terapewtiku b’ Zevalin jinkludi l- użu ta ’ rituximab, ara wkoll it- tagħrif tal - preskrizzjoni ta ’ rituximab.
Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides.
Ir- radjufarmaċewtiċi għandhom jiġu wżati biss minn ħaddiema kwalifikati u bl- approvazzjoni xierqa mill- gvern għall- użu u l- manipulazzjoni ta ’ radjunuklidi.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated settings.
Din il- mediċina radjufarmaċewtika għandha tiġi milqugħa, użata u mogħtija minn persuni awtorizzati biss, f’ ambjenti xierqa.
Its receipt, storage, use, transfer, and disposal are subject to the regulations and/ or appropriate licences of the local competent official organisations.
Il- qligħ, il- ħażna, l - użu, it- trasferiment u r- rimi ta ’ din il- mediċina għandhom isiru b’ mod li jikkonformi mar- regolamenti u / jew b’ liċenzji xierqa li ġew mogħtija minn organizzazzjonijiet uffiċjali kompetenti lokali.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Ir - radjufarmaċewtiċi għandhom jiġu ppreparati b’ mod li jissodisfaw kemm ir- regoli tas- sigurtà fl- użu tar- radjazzjoni kif ukoll dawk dwar il- ħtiġijiet ta ’ kwalità farmaċewtika.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Għandhom jittieħdu l - prekawzjonijiet asettiċi kollha meħtieġa biex wieħed jimxi mar- regolamenti ta ’ Prattika Tajba tal - Manifattura tal- farmaċewtiċi.
In most patients Zevalin administration results in severe and prolonged cytopenia which is generally reversible.
Fil- biċċa l- kbira tal- pazjenti, l- għoti ta ’ Zevalin jirriżulta f’ ċitopenja severa u fit- tul, li hi ġeneralment riversibbli.
In a clinical trial in which Zevalin was administered as consolidation after prior first line chemotherapy a higher frequency of severe and prolonged neutropenia and thrombocytopenia was observed in patients who had received Zevalin within 4 months after a combination chemotherapy of fludarabine with mitoxantrone and/ or cyclophosphamide compared to those patients who had received any other chemotherapy.
Fi prova klinika li fiha Zevalin ingħata bħala konsolidazzjoni wara l- kemjoterapija tal- bidu, kienet osservata frekwenza ogħla ta 'newtropenja u tromboċitopenja severa u fit- tul, f' pazjenti li kienu rċivew Zevalin sa 4 xhur was kemjoterapija kombinata ta ’ fludarabine ma ’ mitoxantrone u/ jew cyclophosphamide meta mqabbla ma ’ dawk il- pazjenti li kienu rċivew kwalunkwe kemjoterapija oħra.
Hence the risk of haematological toxicity may be increased when Zevalin is administered shortly (< 4 months) after fludarabine containing regimens.
Għalhekk, ir- riskju ta ’ tossiċità ematoloġika jista ’ jiżdied meta Zevalin jingħata f’ qasir żmien (< 4 xhur), wara korsijiet li jkun fihom fludarabine.
[90Y]-radiolabelled Zevalin should not be administered to patients who are likely to develop life- threatening haematological toxicity signs.
90 Zevalin radjutikkettjat b ’ [Y], m’ għandux jingħata lill- pazjenti li x’ aktarx jistgħu jiżviluppaw effetti tossiċi fid- demm li jistgħu jipperikolawlhom ħajjithom.
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.
Pazjenti li qed jirċievu Zevalin bħala konsolidazzjoni għandhom ikunu rkupraw minn kimoterapija ta ’ induzzjoni u jkunu laħqu għadd ta ’ newtrofili ta ’ > 1, 500/ mm³ u għadd ta ’ plejtlits ta ’ > 150, 000/ mm³ qabel l- għoti ta ’ Zevalin.
Zevalin should not be administered in the patients mentioned below as safety and efficacy has not been established:
Zevalin m’ għandux jiġi mgħoti lill- pazjenti msemmija hawn taħt għax is- sigurtà u l- effikaċjà ta ’ din il - mediċina f’ dawn il- każijiet, għadhom ma ġewx stabbiliti:
- patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells,
- pazjenti li għandhom iktar minn 25% tal- mudullun infiltrat b’ ċelluli tal- limfoma
- patients who have received prior external beam radiation involving more than 25% of active
- pazjenti li diġà ngħataw radjazzjoni minn barra ‘ l- ġisem li tinvolvi aktar minn 25% tal -
- patients receiving Zevalin as monotherapy with platelet counts < 100,000/ mm3 and patients
mudullun attiv, pazjenti li qed jirċievu Zevalin bħala monoterapija u li għandhom l- għadd tal- plejtlits
receiving Zevalin as consolidation after remission induction with platelet counts < 150,000/ mm3
< 100, 000/ mm3 u pazjenti li qed jirċievu Zevalin bħala konsolidazzjoni wara l- induzzjoni ta ’ 3 remissjoni b’ għadd tal- plejtlits ta ’ < 150, 000/ mm pazjenti b’ għadd tan- newtrofili ta ’ < 1, 500/ mm3
- patients who have received prior bone marrow transplant or stem cell support,
- pazjenti li diġà kellhom trapjant tal- mudullun, jew terapija b’ ċelluli staminali
- children and adolescents under 18 years of age.
- tfal u adoloxxenti taħt 18- il sena.
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.
Pazjenti m’ għandhomx jirċievu kura b’ fattur tat- tkabbir bħal G- CSF għal ġimagħtejn qabel kura b’ Zevalin kif ukoll għal ġimagħtejn wara li jintemm il- kors minħabba l- potenzjal ta ’ sensittività għar- radjazzjoni taċ- ċelluli mijelojdi li qed jinqasmu b’ ritmu mgħaġġel.
Special caution is required with respect to bone marrow depletion.
4 Attenzjoni speċjali għandha tittieħed minħabba li l- kwantità ta ’ mudullun tal- għadam tista ’ tonqos.
Patients who had received murine-derived proteins before Zevalin treatment, should be tested for human anti-mouse antibodies (HAMA).
Pazjenti li jkunu diġà ngħataw proteini tal- ġrieden qabel kura b’ Zevalin, għandhom jiġu ttestjati għall - preżenza ta ’ HAMA (antikorpi umani kontra l- proteini tal- grieden).
Patients who have developed HAMA may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Pazjenti li jkunu żviluppaw il - HAMA jista ’ jkollhom reazzjonijiet allerġiċi jew reazzjonijiet ta ’ sensittività eċċessiva jekk jiġu kkurati b’ Zevalin jew prodotti oħra li fihom proteini li ġejjin mill- ġrieden.
Infusion– related reactions due to Zevalin are less common and less severe.
Reazzjonijiet serji għall- infużjoni li jistgħu jkunu assoċjati ma ’ uġigħ fis- sider, xokk kardjoġeniku, infart mijokardijaku, edima pulmonari, fibrillazzjoni ventrikolari, żamm ta ’ nifs, spasmu bronkjali, qtugħ ta ’ nifs, nuqqas ta ’ ossiġnu, edima anġonewrotika, fwawar, ipotensjoni, ARDS u infiltrazzjonijiet fil- pulmun, jistgħu jiġru waqt jew wara infużjoni ta ’ rituximab. Reazzjonijiet relatati ma ’ l- infużjoni minħabba Zevalin huma inqas komuni u inqas serji.
4 Anaphylactic and other hypersensitivity reactions have been reported in fewer than 1% of patients following the intravenous administration of proteins to patients.
Reazzjonijiet anafilattiċi jew ta ’ sensittività eċċessiva ġew osservati f’ inqas minn 1% tal- pazjenti wara li ġew mgħotija l- infużjoni tal- proteini.
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.
Mediċini li jintużaw għall- kura ta ’ reazzjonijiet ta ’ sensittività eċċessiva, eżempju: adrenalina, anti- istaminiċi, u kortikosterojdi, għandhom ikunu disponibbli għall - użu mmedjat f’ każ li l- pazjent jiżviluppa reazzjoni allerġika meta jingħata rituximab ma ’ Zevalin radjutikkettjat.
After use of Zevalin, patients should generally be tested for HAMA before any further treatment with mouse derived proteins.
Wara li pazjent ikun ingħata Zevalin, għandhom isirulu t- testijiet għall- preżenza tal- HAMA qabel ma jingħataw kura oħra bi proteini li ġejjien mill- ġrieden.
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.
Rejazzjonijiet mukokutanji qawwija, inkluż is- sindromu ta ’ Stevens- Johnson b’ riżultat fatali, ġew irrappurtati rarament b’ assoċazzjoni ma ’ kors terapewtiku ta ’ Zevalin, li jinkludu rituximab u Zevalin radjutikkettjat.
The onset of the reactions varied from days to months.
Il- bidu tar- reazzjonijiet varja minn jiem sa xhur.
Patients experiencing a mucocutaneous reaction should not receive any further component of the Zevalin regimen.
Pazjenti li jkun qed ikollhom reazzjoni monokutanja m' għandhom jirċievu l- ebda komponent ieħor tal- kors ta ’ Zevalin.
Long-term animal studies on the effect on fertility and reproductive function have not been performed.
Ma sar l- ebda studju fuq perijodu ta ’ żmien twil fuq l- effetti ta ’ din il- mediċina fuq il- fertilità u l - funzjoni riproduttiva ta ’ l- annimali.
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.
Minħabba n- natura tal- prodott, nisa li għadhom ta ’ età li jista ’ jkollhom it- tfal, kif ukoll irġiel, għandhom jużaw metodi effettivi ta ’ kontraċezzjoni matul iż- żmien li jkunu qegħdin jieħdu l- kura b’ Zevalin u għal 12- il xahar wara li tkun spiċċat il- kura.
The safety of immunisation with any vaccine, particularly live viral vaccines, following therapy with Zevalin has not been studied.
Ma sar l- ebda studju dwar is- sigurtà ta ’ tilqim b’ vaċċini, l- aktar dawk b’ virus ħaj, wara kura b’ Zevalin.
The ability to generate a primary or anamnestic humoral response to any vaccine has also not been studied.
Il- ħila tal- ġisem li jipproduċi antikorpi wara li jingħata kwalunkwe vaċċin; li sseħħ jew bħala reazzjoni primarja jew inkella minħabba stimoli antiġeniċi li jikkawżaw produzzjoni ta ’ antikorpi differenti minn dawk li ħolqu r- reazzjoni; għadha ma ġietx studjata.
No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
L- ebda tagħrif ma huwa disponibbli dwar pazjenti b’ limfoma fis- CNS peress li dawn il - pazjenti ma kienux inklużi fi studji kliniċi.
Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Sorveljanza mill- qrib ta ’ ekstravasazzjoni waqt l- injezzjoni ta ’ Zevalin hija meħtieġa sabiex jiġi evitat ħsara lit- tessut assoċjata ma ’ radjazzjoni.
If any signs or symptoms of extravasation have occurred,, the infusion should be immediately terminated and restarted in another vein.
Jekk iseħħu xi sinjali u sintomi ta ’ exkstravasazzjoni, l - infużjoni għandha titwaqqaf minnufih u tinbeda mill- ġdid f’ vina oħra.
There are no known interactions with other medicinal products.
S’ issa ma jidhirx li din il- mediċina ma taqbilx ma xi mediċini oħra.
Animal reproduction studies were not conducted with ibritumomab tiuxetan.
Studji fuq l- effetti ta ’ ibritumomab tiuxetan fuq is- sistema riproduttiva ta ’ l- annimali ma sarux.
Since IgG is known to pass the placenta and because of the concomitant use of radiation, Zevalin must not be used during pregnancy.
Minħabba li hu magħruf li l- IgG jgħaddi mil- plaċenta, kif wkoll minħabba l- użu ta ’ radjazzjoni, Zevalin m’ għandux jintuża waqt it- tqala.
Pregnancy must be excluded before the start of treatment in women.
Qabel ma tibda il- kura b’ din il- mediċina wieħed għandu jaċċerta li l- mara m’ hiex tqila.
Females of childbearing potential as well as males should use effective contraceptive methods during treatment with Zevalin and for 12 months afterwards.
Nisa li jista ’ jkollhom it- tfal, kif ukoll l- irġiel, għandhom jużaw metodu effettiv ta ’ kontraċezzjoni matul iż- zmien li jkunu qegħdin jieħdu l- kura b’ Zevalin u għal 12- il xahar
When it is necessary to administer Zevalin to women of childbearing potential, information should always be sought about pregnancy.
Meta jkun ta ’ bżonn li mara ta ’ età li jista ’ jkollha t- tfal tingħata Zevalin, hu importanti li jiġi żgurat jekk hiex tqila jew le.
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.
Kull mara li ma kellhiex il- pirjid fl- aħħar xahar għandha tkun meqjusa bħala tqila kemm- il darba ma tiġix eskluża l- possibiltà ta ’ tqala u terapiji alternattivi li ma jinvolvux l- użu ta ’ radjazzjoni joniżżanti għandhom jiġu kkunsidrati.
It is not known whether ibritumomab tiuxetan is excreted in human milk.
Mhux magħruf jekk ibritumomab tiuxetan joħroġx fil- ħalib tal- bniedem.
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.
Peress li l- IgG fil- bniedem jiġi eliminat fil- ħalib u minħabba l- possibiltà li l- mediċina tista ’ tiġi assorbita u s- suppressjoni mmunitarja fit- tarbija għadha mhiex magħrufa, nisa għandhom jieqfu milli jreddgħu.
Zevalin could affect the ability to drive and to use machines, as dizziness has been reported as a common side effect.
Zevalin jista ’ jkollu effett fuq il- ħila biex issuq u tħaddem magni, minħabba li sturdament kien irrappurtat bħala effett mhux mixieq komuni.
The radiation dose resulting from therapeutic exposure may result in secondary malignancies and in development of hereditary defects.
Id- doża tar- radjazzjoni li tingħata f’ din it- terapija tista ’ tikkawża kanċer sekondarju u żviluppi ta ’ difetti ereditarji.
It is necessary to ensure that the risks of the radiation are less than from the disease itself.
Hu meħtieġ li jiġi żgurat li r- riskju tar- radjazzjoni fuq il- ħajja tal- pazjent hu inqas minn dak tal- marda minnha nfisha.
The majority of patients may be expected to experience adverse reactions.
Il- maġġoranza ta ’ pazjenti huma mistennija li jkollhom effetti mhux mixtieqa.
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.
1/ 10, 000 sa < 1/ 1, 000; rari ħafna: < 1/ 10, 000) huma msejsa fuq informazzjoni li nġabret minn provi kliniċi.
Adverse drug reactions deriving from post-marketing experience are described separately.
Effetti mhux mixtieqa li jiġu minn esperjenza ta ’ wara t- tqegħid fis- suq huma deskritti separatament.
The adverse drug reactions are at least possibly related to the Zevalin therapeutic regimen which includes rituximab and radiolabelled Zevalin.
L- effetti mhux mixtieqa huma mill- inqas possibbilment relatati ma ’ kors terapewtiku ta ’ Zevalin, li jinkludi rituximab u Zevalin radjutikkettjat.
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.
Reazzjonijiet anafilattiċi u ta ’ sensitività eċċessiva Reazzjonijiet anafilattiċi u ta’ sensitività eċċessiva ġew irrappurtati f’ inqas minn 1% tal- pazjenti wara li ġew mgħotija l- infużjoni tal- proteini.
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.
Prodotti mediċinali li jintużaw għall- kura ta ’ reazzjonijiet ta ’ sensittività eċċessiva, eżempju: adrenalina, anti- istaminiċi, u kortikosterojdi, għandhom ikunu disponibbli għall- użu immedjat f’ każ li l- pazjent jiżviluppa reazzjoni allerġika meta jingħata Zevalin.
Haematological adverse reactions Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting.
Dawn l- effetti jistabilixxu d - doża tal- mediċina li tista ’ tingħata.
Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Il- ħin medjan sabiex il- livelli tal- plejtlits u l- granuloċiti jilħqu l - aktar livell baxx, kien ta ’ bejn wieħed u ieħor ta ’ madwar 60 jum mill- bidu tal- kura.
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.
Fi provi kliniċi bl- induzzjoni ta ’ NHL li rkadiet u refrattarja, iż- żmien medjan meħtieġ biex in- numru ta ’ plejtlits jitla ’ għan- normal f’ każijiet ta ’ tromboċitopenija ta ’ Grad 3 u Grad 4 kien ta ’ bejn 13 u 21 jum u dak ta ’ newtropenja Grad 3 u Grad 4 kien ta ’ bejn 8 u 14- il jum.
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.
Wara Zevalin bħala konsolidazzjoni wara induzzjoni preferita ta ’ remissjoni, ż- żmien medjan sal- irkupru kien ta ’ 20 jum u 35 jum għal tromboċitopenja ta ’ Grad 3 jew 4 u 20 jum u 28 jum għal newtropenja ta ’ Grad 3 jew 4.
Infections During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
Infezzjonijiet Matul l- ewwel 13- il jum wara l- kura b’ Zevalin, ir- rata ta ’ pazjenti li żviluppaw infezzjonijiet kienet għolja ħafna.
Grade 3 and grade 4 infections were reported commonly.
Infezzjonijiet ta ’ Grad 3 u Grad 4 ġew osservati.
During follow-up, infections occurred commonly.
Ħafna drabi, l- pazjenti nstabu li qed ibgħatu minn infezzjonijiet, meta ġew għaż- żjara regolari ta ’ wara l- kura.
Of these, grade 3 was common, grade 4 uncommon.
F’ dawn il- każijiet ħafna drabi l- infezzjonijiet kienu l- iktar ta ’ Grad 3, filwaqt li dawk ta ’ Grad 4 kienu rari.
Secondary malignancies Myelodysplasia/ acute myeloid leukaemia (AML) has been reported in five out of 211 patients assigned to treatment with Zevalin.
Kanċer Sekondarju Majelodispleżja / lewkimja majelojdja akuta (AML) kienu rrappurtati f’ 5 mill- 211 pazjent li ġew ikkurati b’ Zevalin.
The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Ir- riskju li wieħed jiżviluppa majelodisplażja jew lewkimja wara l- kura b ’ “ alkylating agents ” hu magħruf sew.
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.
Peress li dawn il- pazjenti kollha kienu diġà ħadu kura b ’ “ alkylating agents ”, ma teżistix informazzjoni biżzejjed biex turi jekk Zevalin ikkontribwixxiex għal żieda fir- riskju ta ’ majelodisplażja, jew ta ’ l- ammont ta ’ riskju.
Incidence of adverse reactions by System Organ Class The table below reports adverse reactions by System Organ Class:
6 It- tabella hawn taħt turi l- effetti mhux mixtieqa skond is- sistema tal- klassifika ta ’ l- organi.
In total, infections of any cause occurred very commonly but are listed in the table under the specifically reported term.
Dawn huma mniżżla fit- tabella taħt it- terminu speċifikament irrapportat.
System Organ Class (MedDRA)
Sistema tal - Klassifika ta ’ l -
(≥ 1/ 10)
Organi (MedDRA) (> 1/ 10)
(≥ 1/ 10,000 to < 1/ 1,000)
(> 1/ 10, 000 sa < 1/ 1, 000)
Infection *, Sepsis *, Pneumonia *,
Infezzjoni *, Sepsi *, Pnewmonja *, Infezzjoni fis - sistema ta ’ l - awrina, Monilijażi fil- ħalq,
System Organ Class (MedDRA)
Neoplażmi beninni u malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
Very common
Uġigħ ġej mit - tumur, Sindromu mjelodisplastiku / Lewkimja mjeloġenika akuta *
(≥ 1/ 10)
Meninġjoma
(≥ 1/ 100 to < 1/ 10)
Tromboċitopenja, Disturbi tad -
(≥ 1/ 1,000 to < 1/ 100)
Newtropenja
(≥ 1/ 10,000 to < 1/ 1,000)
Lewkoċitopenja, demm u tas -
Meningioma
febbrili,
Blood and lymphatic system disorders
Newtropenja, sistema limfatika
Thrombocytopenia, Leukocytopenia, Neutropenia, Anemia *
Panċitopenja *,
Febrile neutropenia, Pancytopenia *, Lymphocytopenia
Anemija * Disturbi tas - sistema immuni Disturbi fil - metaboliżmu u fin- nutrizzjoni Disturbi psikjatriċi Disturbi fis - sistema nervuża Disturbi fil- qalb
Immune system disorders Metabolism and nutrition disorders
Limfoċitopenja Reazzjoni tas - sensittività eċċessiva Anoressija Ansjetà, Nuqqas ta ’ rqad Sturdament, Uġigħ ta ’ ras
Hypersensitivity reaction Anorexia
Takikardja
Anxiety, Insomnia Dizziness, Headache
Disturbi vaskulari
Tachycardia
Emorraġija waqt
Vascular disorders
Emorraġija
Hemorrhage while thrombocytopenic *
Disturbi respiratorji, toraċiċi u medjastinali
Intracranial hemorrhage while thrombocyto- penic *
tromboċitopenija * Sogħla, rinite
Respiratory, thoracic, and mediastinal disorders
intrakranjali waqt tromboċitopenija *
Skin and subcutaneous tissue disorders
Disturbi gastro - intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Rash, Pruritus,
Dardir
Musculoskeletal, connective tissue and bone disorders
Rimettar, Uġigħ addominali, Dijarrea, Dispepsja, Irritazzjoni fil - griżmejn, Stitikezza Raxx, Ħakk
Very common
Sistema tal - Klassifika ta ’ l -
General disorders Asthenia, and administration Pyrexia, site conditions Rigors
Disturbi muskolo - skeletrali u tal - connective tissue u tal- ghadam
Pain, Flu like symptoms, Malaise, Peripheral edema, Sweating increased
Disturbi ġenerali u Astenija, kondizzjonijiet ta ’ Deni, Sirdat mnejn jingħata
* fatal outcome has been observed either in
Uġigħ, Sintomi bħal ta ’ l - influwenza, Telqa, Edima periferali, Żjieda fl- għaraq
clinical trials or in post-marketing experience
* riżultat aħħari fatali kien osservat jew fil- provi kliniċi jew fl- esperjenza ta ’ wara t- tqegħid fis- suq
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
L- iktar terminu xieraq tal- MedDRA qed jintuża biex jiddeskrivi ċerta rejazzjoni u s- sintomi tagħha u kondizzjonijiet relatati.
ADR term representation is based on MedDRA version 9.1.
Ir- rapreżentazzjoni tat- termini ta ’ l- ADR hija bbażata fuq MedDRA verżjoni 9. 1.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma ppreżentati skond klassifikazzjoni ta 'gravità li tkun qed tonqos.
Disease progression is the natural evolution of the underlying disease.
Progress tal- marda hija l- evoluzzjoni naturali tal- marda eżistenti.
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).
Fl- istudju b’ 204 pazjent li kienu qed jirċievu Zevalin bħala konsolidazzjoni wara l- induzzjoni preferita ta ’ remissjoni, infezzjonijiet kienu osservati b’ mod aktar frekwenti minn kif deskritt fit- tabella fuq (komuni ħafna).
In addition, the following adverse drug reactions were observed in this study:
Barra dawn, ir- reazzjonijiet avversi tal- mediċina li ġejjin kienu osservati f’ dan l- istudju:
• MedDRA SOC General disorders and administration site conditions: fatigue (very common)
• SOC MedDRA Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: għeja (komuni ħafna)
• MedDRA SOC Vascular disorders: petechia (very common), hypertension (common), hypotension (common)
• SOC MedDRA Disturbi vaskulari: petekja (komuni ħafna), pressjoni għolja (komuni), pressjoni baxxa (komuni)
• MedDRA SOC Reproductive system and breast disorders: amenorrhoea (common) Post-marketing experience:
• SOC MedDRA Disturbi fis- sistema riproduttiva u fis- sider: amenorreja (komuni)
MedDRA SOC Skin and subcutaneous tissue disorders
Esperjenza ta ’ wara t- tqegħid fis- suq:
Mucocutaneous reaction, including Stevens Johnson Syndrome with fatal outcome, has been rarely reported in post-marketing experience.
SOC MedDRA Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rejazzjoni mukokutanja, inkluż is- Sindromu ta ’ Stevens- Johnson b’ riżultat fatali, ġiet irrappurtata rarament f’ esperjenza ta ’ wara t- tqegħid fis- suq
MedDRA SOC General disorders and administration site conditions
Minħabba li l- kors terapewtiku b’ Zevalin jinkludi l- użu ta ’ rituximab, ara wkoll it- tagħrif tal - preskrizzjoni ta ’ rituximab.
Isolated reports of extravasation with subsequent infusion site reaction, like dermatitis, desquamation, and site ulcer have been received.
SOC MedDRA Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Isolated reports have been received showing that Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling.
Ġew irrappurtati rapporti isolati ta ’ ekstravasazzjoni segwita minn reazzjoni fis- sit ta ’ l- infużjoni, bħal dermatite, deskwamazzjoni, u ulċera fis- sit.
Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.
Ġew irrappurtati rapporti isolati li juri li radjazzjoni assoċjata ma ’ Zevalin tista ’ tikkawża ħsara lit - tessut ta ’ madwar il- limfoma u kuplikazzjonijiet minħabba nefħa tal- limfoma.
Overdose as high as 19.2 MBq/ kg of [90Y]-radiolabelled Zevalin occurred in clinical trials.
8 4. 9 Doża eċċessiva 90 Doża eċċessiva sa 19. 2 MBq/ kg ta ’ Zevalin radjutikkettjat b ’ [Y] seħħet waqt provi kliniċi.
Expected haematological toxicity was observed, comprising Grade 3 or 4.
Kif kien mistenni, dan irriżulta f’ effett tossiku ematoloġiku ta’ Grad 3 jew Grad 4.
Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Il- pazjenti irpiljaw minn dawn is- sintomi ta ’ tossiċità, u l- kazi ta’ dożi eċċessivi ma kienux marbuta ma ’ konsegwenzi serji jew fatali.
8 There is no known specific antidote for [90Y]-radiolabelled Zevalin overdosage.
M’ hemmx antidotu speċifiku għal meta jkun hemm doża eċċessiva ta ’ Zevalin radjutikkettjat b ’ [90Y].
Treatment consists of discontinuation of Zevalin and supportive therapy, which may include growth factors.
F’ każ ta ’ doża eċċessiva, il- kura b’ Zevalin għandha titwaqqaf u għandha tingħata kura ta ’ appoġġ, li tista ’ tinkludi prodotti li jistimulaw iċ- ċelluli tad- demm biex jerġgħu jikbru.
If available, autologous stem cell support should be administered to manage haematological toxicity.
Jekk disponibbli, kura ta ’ appoġġ biċ- ċelluli staminali ta ’ l- istess pazjent għandha tintuża, biex jiġi kkurat l - effett tossiku ematoloġiku.
For accidental administration of the pure radiopharmaceutical precursor product yttrium-90, refer to the product information of yttrium-90.
Jekk aċċidentalment il- pazjent ingħata l- prodott radjuattiv yttrium- 90, irreferi għall- informazzjoni fuq il- prodott ta ’ yttrium- 90.
Various therapeutic radiopharmaceuticals ATC code:
Radjufarmaċewtiċi terapewtiċi varji Kodiċi ATC:
Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Ibritumomab tiuxetan huwa IgG1, antikorpu monoklonali kappa rikombinati tal- ġrieden, speċifiku għall- antiġen CD20 ta ’ ċelluli- B.
Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes.
Ibritumomab tiuxetan jaqbad ma ’ CD20, li tinsab fil- wiċċ tal - limfoċiti- B malinni kif ukoll normali.
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.
Matul il- maturazzjoni taċ- cellola- B, l- antiġen CD20, l- ewwel jiġi espress meta ċ- ċellola tkun waslet f’ nofs tal- maturazzjoni tagħha għal- limfoblast- B (ċellola pre - B), u mbagħad tintilef meta ċ- ċellola- B issir ċellola plażma.
It is not shed from the cell surface and does not internalise on antibody binding.
L- antiġen CD20 ma tintreħhiex mill- wiċċ taċ- ċellola u lanqas ma tidħol ġewwa ċ- ċellola hekk kif jeħel l- antikorp magħha.
The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
L- antikorp ikkonjugat għandu affinità kostanti għal CD20 ta ’ bejn wieħed u ieħor 17 nM.
The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
L- iskema ta ’ rabta hija ristretta ħafna u m’ hemmx reattività inkroċjata (cross reactivity) ma ’ lewkoċiti oħra jew ma ’ xi tessuti oħra tal - ġisem.
[90Y]-radiolabelled Zevalin binds specifically to B-cells, including CD20-expressing malignant cells.
Dawn jinkludu ċelluli malinni li jkollhom fuqhom l- antiġen CD20.
The isotope yttrium-90 is a pure β -emitter and has a mean path length of about 5 mm.
L- iżotop yttrium- 90 jarmi radjazzjoni beta pura li twassal bejn wieħed u ieħor distanza ta ’ 5 mm.
This results in the ability to kill both targeted and neighbouring cells.
Din twassal biex jinqatlu kemm iċ- ċelluli mmirati li jkunu qabdu mal- mediċina kif ukoll dawk ta ’ madwarhom.
Rituximab pre-treatment is necessary to clear circulating B-cells, enabling Zevalin to deliver radiation more specifically to the lymphomas.
B’ hekk Zevalin ikun jista ’ jwassal b’ mod aktar speċifiku r- radjazzjoni lill- limfoma.
Rituximab is administered in a reduced dose when compared with the approved monotherapy.
Rituximab jingħata f’ doża iktar baxxa meta mqabbel ma ’ monoterapija approvata.
Treatment with [90Y]-radiolabelled Zevalin also leads to depletion of normal CD20+ B-cells.
90 Kura b’ Zevalin radjutikkettjat b ’ [Y] inaqqas iċ- ċelluli- B normali li għandhom l- antiġen CD20.
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.
L- irpiljar ta ’ ċelluli B normali, beda wara 6 xhur u l- għadd medjan taċ- ċelluli B laħqu il- livelli normali wara 9 xhur mill- bidu tal- kura.
The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Is- sigurtà u l- effikaċja tal- kors terapewtiku b ’ Zevalin ġew studjati f’ żewġ provi multi- ċentrali fejn ħadu sehem total ta’ 197 persuna.
The Zevalin therapeutic regimen was administered in two steps (see 4.2).
It- terapija b ’ Zevalin ingħatat f’ żewġ fażijiet (ara 4. 2).
The efficacy and toxicity of a variation of the Zevalin therapeutic regimen employing a reduced activity of [90Y]-Zevalin was further defined in a third study enrolling a total of 30 patients who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/ mm3).
L- effikaċja u t- tossicità ta ’ varjazzjoni fil- kors terapewtiku ta ’ Zevalin, fejn intużat attività iktar baxxa ta ’ Zevalin radjutikkettjat b ’ [90Y], ġew imfissra aħjar fit- tielet studju fejn ħadu sehem 30 pazjent li kellhom tromboċitopenija ħafifa (100, 000 – 149, 000 plejtlits / mm3).
Study 1 was a single arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Studju 1, kien studju partikulari fuq 54 pazjent, li reġa ’ kellhom limfoma follikulari refrattorja wara kura b’ rituximab.
Patients were considered refractory if their last prior treatment with rituximab did not result in a complete or partial response, or if time to disease progression (TTP) was < 6 months.
Il- pazjenti ġew ikkunsidrati bħala li għandhom marda li ma ċċedix, jekk l- aħħar kura b’ rituximab ma kellhiex rispons komplet jew parzjali, jew inkella reġgħu irkadew f’ inqas minn 6 xhur (żmien li l- marda tieħu biex tirkadi - TTP).
The primary efficacy endpoint of the study was the overall response rate (ORR) using the International Workshop Response Criteria (IWRC).
Il- mira principali ta ’ dan l- istudju biex tiġi evalwata l - 9 effikaċja tal- prodott, kien li titkejjel ir- rata globali ta ’ pazjenti li rrispondew għall- mediċina (ORR) billi ntużaw International Workshop Response Criteria (IWRC).
Secondary efficacy endpoints included time to disease progression (TTP) and duration of response (DR).
It- tieni mira biex titkejjel l- effikaċja tal- prodott inkludiet iż- żmien li pazjent jieħu biex jerġa jirkadi (TTP) u kemm il- pazjent idum jirrispondi għall- mediċina (DR).
In a secondary analysis comparing objective response to the Zevalin therapeutic regimen with that observed with the most recent treatment with rituximab, the median duration of response following the Zevalin therapeutic regimen was 6 vs.
Dan wera li t- tul medjan tal- pazjenti li ħadu l- kors ta ’ Zevalin damu jirrispondu għal 6 xhur, kontra 4 xhur ta ’ rituximab.