qanastek/EMEA-V3 huggingface dataset:
Table 1 summarizes efficacy data from this study.
It- tabella 1, turi fil- qosor, l - informazzjoni fuq l- effikaċja tal- mediċina li nġabret minn dan l- istudju.
9 Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen to treatment with rituximab.
Studju 2 kien studju randomised, ikkontrollat u multi- ċentrali li qabbel il- kors terapewtiku ta ’ Zevalin mal- kura b’ rituximab.
The trial was conducted in 143 patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL), or transformed B-cell NHL.
Il- provi saru fuq 143 pazjent li kellhom limfoma ta ’ grad baxx jew limfoma follikulari non- Hodgkin (NHL) jew NHL li kellha trasformazzjoni ta ’ ċelluli B minħabba li rkadew jew għax ma bdewx jirreaġixxu għall- kura li kienu ngħataw.
A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/ m2 weekly times 4 doses.
Total ta ’ 73 pazjent ingħataw il- kors terapewtiku ta ’ Zevalin, waqt li 70 pazjent ingħataw rituximab bħala infużjoni ġol- vina ta 375 mg/ mm2 darba fil- gimgħa għal 4 ġimgħat.
The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 1).
Il- mira principali ta ’ dan l- istudju biex tiġi evalwata l - effikaċja tal- prodott, kien li titkejjel l- ORR bl- użu tal- IWRC (ara tabella 1).
The ORR was significantly higher (80% vs.
L- ORR kien ogħla b’ mod sinifikanti (80% vs. 56%, p=0. 002) għal dawk il- pazjenti li ħadu kors terapewtiku ta ’ Zevalin.
56%, p = 0.002) for patients treated with the Zevalin therapeutic regimen.
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).
The secondary endpoints, duration of response and time to progression, were not significantly different between the two treatment arms.
F’ dan il- każ, l- studju wera li ma tantx kien hemm differenza bejn iż- żewġ kuri.
Summary of Efficacy Data1
Tabella 1 Sommarju tat- Tagħrif dwar l- Effikaċja tal- Mediċina1
Study 1 Zevalin Zevalin
Studju 1
therapeutic regimen
Kors terapewtiku Kors terapewtiku b ’ Zevalin b ’ Zevalin
therapeutic regimen
rituximab
N = 73
N=54 N=73
Overall Response Rate (%)
Persentaġġ ta ’ pazjenti li rrispondew għall- kura (%)
74
74 80
Complete Response Rate (%)
Persentaġġ ta ’ pazjenti li rrispondew kompletament għall- kura (%)
15
15 30
[1.1-25.9+]
Rata ta ’ CRu 2 (%) DR 3, 4 Medjana (xhur) [firxa fil- livell5] TTP3, 6 Medju (xhur) [firxa fil- livell 5]
[0.8-31.5+]
0 4 6. 4 13. 8 [0. 5- 24. 9+] [1. 0- 30. 1+] 6. 8 11. 2 [1. 1- 25. 9+] [0. 8- 31. 5+]
[0.7-26.1]
4 11. 8 [1. 2- 24. 5] 10. 1 [0. 7- 26. 1]
6 Time to Disease Progression: interval from the first infusion to disease progression.
Mhux konfermat li l- pazjent irrisponda kompletament għall- kura 3 Stmat fil- firxa ta ’ livell osservat 4 Kemm dam jirrispondi l- pazjent għall- mediċina: intervall bejn meta l- pazjent beda jirrispondi sakemm reġa ’ rkada, 5 “ + ” jindika li l- proċess għadu għaddej 6 Zmien sakemm il- pazjent jerġa ’ jirkadi: intervall minn meta ngħata l- infużjoni sakemm il- pazjent reġa ’ rkada.
Study 3 was a single arm study of 30 patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/ mm3).
Studju 3 kien studju partikolari li sar fuq 30 pazjent li rkadew jew li għandhom limfoma ħafifa follikulari jew ta ’ trasformazzjoni ta ’ celloli B non- Hodgkin (NHL), li ma rrispondewx għall- kura, u li kellhom tromboċitopenija ħafifa (plejtlits 100, 000 sa 149, 000 ċelluli/ mm3).
Excluded from the study were patients with ≥ 25% lymphoma marrow involvement and/ or impaired bone marrow reserve.
Dawk il- pazjenti li kellhom iktar minn 25% tal- mudullun mimli bil- limfoma u/ jew dawk li kellhom problema fir- riżerva tal- mudullun kienu esklużi mill- istudju.
Patients were considered to have impaired bone marrow reserve if they had any of the following: prior myeloablative therapy with stem cell support; prior external beam radiation to > 25% of active marrow; a platelet count < 100,000 cells/ mm3; or neutrophil count < 1,500 cells/ mm3.
Pazjenti kienu kkunsidrati li kellhom problema fir- riserva tal - mudullun jekk kellhom xi waħda minn dawn li ġejjin: kienu diġà ħadu kura majeloablativa b’ ċelluli staminali, ħadu radjazzjoni esterna fuq iktar minn 25% tal- mudullun, livell ta ’ plejtlits < 10, 000/ mm3; l- għadd ta ’ newtrofili < 1500 ċelluli/ mm3.
In this study, a modification of the Zevalin therapeutic regimen with a lower [90Y]-Zevalin activity per body weight (11 MBq/ kg) was used.
F’ dan l- istudju saret modifika fil- kors terapewtiku ta ’ 90 Zevalin, fejn ingħata Zevalin radjutikkettjat b ’ [Y] b’ attività aktar baxxa (11. 1 MBq/ kg) għall- piz
48-85%), 11.8 months median DR (range:
Kienu osservati reazzjonijiet kliniċi oġġettivi u li baqgħu fit- tul, [67% ORR (95% CI:
4-17 months)] and resulted in a greater incidence of haematologic toxicity (see 4.8) than in Studies 1 and 2.
48 - 85%), medjan ta ’ 11. 8 xhur DR (firxa tal- livell 4- 17- il xahar) u rriżulta f’ inċidenza ogħla ta ’ effett tossiku fid- demm (ara 4. 8) minn Studji 1 and 2.
Major inclusion criteria were:
Studju 4 investiga l- effikaċja u s- sigurtà ta ’ konsolidazzjoni b’ Zevalin f’ pazjenti b’ limfoma follikulari ta ’ stadju avvanzat li rrispondew għall- kimoterapija preferita.
10 blood cell counts; < 25% bone marrow involvement; age ≥ 18 yrs; and complete response (CR/ Cru) or partial respone (PR) after first-line chemotherapy determined by physical examination, CT scans and bone marrow biopsy.
Kriterji maġġuri għall- inklużjoni kienu: limfoma follikulari ta ’ grad 1 jew 2 pożittiva għal CD20; stadju III jew IV fid- dijanjosi; għadd ta ’ ċelluli tad- demm periferali normali; implikazzjoni tal- mudullun tal- għadam ta ’ < 25%; età ≥18 yrs; u rispons komplet (CR/ Cru) jew parzjali (PR) determinat permezz ta ’ eżaminazzjoni fiżika, skans CT u bijopsija tal- mudullun tal- għadam wara kimoterapija preferita.
After completing induction therapy, patients were randomized to receive either Zevalin (250 mg/ m2 rituximab on day -7 and on day 0 followed on day 0 by Zevalin 15 MBq/ kg body weight; maximal dose 1200 MBq; [n=208]) or no further treatment (control; n=206).
Wara t- tmiem ta ’ terapija ta ’ induzzjoni, il- pazjenti kienu randomised biex jirċievu Zevalin (250 mg/ m2 rituximab f’ jum - 7 u f’ jum 0 segwit minn Zevalin 15 MBq/ kg piż tal- ġisem f’ jum 0; doża massima ta ’ 1200MBq; [n=208]) jew l- ebda kura oħra (kontrol; n=206).
Induction therapies included CVP n=106, CHOP (-like) n=188, fludarabine combinations n=22, chlorambucil n=39 and rituximab-chemotherapy combinations n=59.
Terapiji ta ’ induzzjoni inkludew CVP n=106, CHOP (l- istess) n=188, taħlitiet ta ’ fludarabine n=22, chlorambucil n=39 u taħlitiet ta ’ kimoterapija b’ rituximab n=59.
With a median follow-up of 2.9 years, the median progression free survival (PFS) increased from 13.5 months (control) to 37 months (Zevalin; p < 0.0001; HR 0.465).
B’ vista ta ’ wara medjana ta ’ 2. 9 snin, is- sopravivenza mingħajr progressjoni (PFS) medjana żdieded minn 13. 5 xhur (kontrol) għal 37 xahar (Zevalin; p < 0. 0001; HR 0. 465).
For patient subgroups in PR or CR after induction, median PFS was 6.3 vs 29.7 months (p < 0.0001; HR 0.304) and 29.9 vs 54.6 months (p=0.015; HR 0.613), respectively.
Għal sottogruppi ta ’ pazjenti f’ PR jew CR wara l- induzzjoni, PFS medjan kien 6. 3 vs 29. 7 xhur (p < 0. 0001; HR 0. 304) u 29. 9 vs 54. 6 xhur (p=0. 015; HR 0. 613), rispettivament.
After Zevalin consolidation, 77% of patients in PR after induction therapy converted to CR.
Wara konsolidazzjoni b’ Zevalin, 77% tal- pazjenti f’ PR wara terapija ta ’ induzzjoni qalbu għal CR.
Patients whose response status changed after Zevalin from PR to CR showed a significantly longer median progression free survival time (986 days) compared to those patients who remained in PR (median progression free survival time of 460 days, p=0.0004).
Pazjenti li wara Zevalin l- istat ta ’ rispons tagħhom inbidel minn PR għal CR urew żmien medjan ta ’ sopravivenza mingħajr progressjoni sinifikament itwal (986 jum) meta mqabbel ma ’ dawk il- pazjent li baqgħu f’ PR (żmien medjan ta ’ sopravivenza mingħajr progressjoni ta ’ 460 jum, p=0. 0004).
In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
B’ kollox, 87% tal- pazjenti kienu f’ CR( u); 76% f’ CR u 11% f’ CRu.
In patients given IV infusions of 250 mg/ m2 rituximab followed by intravenous injections of 15 MBq/ kg of [90Y]-radiolabelled Zevalin, the median serum effective half-life of [90Y]-radiolabelled Zevalin was 28 h.
F’ pazjenti li ngħataw infużjoni ta ’ rituximab 250 mg/ m2 u li wara ngħataw titqiba ġol- vina b’ 14. 8 90 MBq/ kg ta ’ Zevalin radjutikkettjat b ’ [Y], il- half- life effettiva medjana fis- serum ta ’ Zevalin radjutikkettjat b ’ [90Y] kienet ta ’ 28 siegħa.
As yttrium-90 forms a stable complex with ibritumomab tiuxetan, the biodistribution of the radiolabel follows the biodistribution of the antibody.
Peress li yttrium- 90 jifforma kumpless stabbli ma ’ ibritumomab tiuxetan, il- biodistribuzzjoni tar - radju- tikketta hija l- istess bħal dik ta ’ l- antikorpu.
Irradiation by the emitted beta particles from yttrium-90 occurs in a radius of 5 mm around the isotope.
Irridazzjoni mill- partiċelli beta mormija mill - yttrium- 90 għandhom raġġ ta ’ 5 mm madwar l- iżotopju.
5.3 Preclinical safety data
5. 3 Studju qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity.
Informazzjoni mhux klinika ma wriet l- ebda periklu speċjali għall- bnedmin ibbażat fuq studji dwar it - tossiċità tad- doża li tingħata darba jew b’ mod ripetut.
The human radiation dose estimates derived from biodistribution studies in mice with [90Y]- or [111In]- radiolabelled ibritumomab tiuxetan predicted acceptable radiation to normal human tissue with limited levels of skeleton and bone marrow radiation.
Id- doża ta ’ radjazzjoni li tingħata lill- bniedem stmata minn studji fuq il- biodistribuzzjoni fil- ġrieden ta ’ [90Y] u [111In] imwaħħlin ma ’ ibritumomab tiuxetan bassret radjazzjoni aċċettabli għat- tessuti umani u l- livelli ta ’ radjazzjoni fl- għadam u fil- mudullun limitati.
The linker chelate tiuxetan forms a stable complex with the radioisotopes yttrium-90 and indium-111 and only negligible degradation due to radiolysis is expected.
Il- kelant, tijuxeten, jaqbad mar - radju- iżotopju yttrium- 90 u indium- 111 bil- formazzjoni ta ’ prodott stabbli li ftit jiddegrada ruħu bir - radjoliżi.
The single and repeated dose toxicity studies of the non-radioactive compound in cynomolgus monkeys did not indicate any other risk than the expected B-cell depletion arising from the use of ibritumomab tiuxetan alone or in combination with rituximab.
L- istudji ta ’ l- effett tossiku tal- prodott mhux radjuattiv, fuq doża waħda u dożi ripetuti, li saru fuq xadini cynomolgus, ma ndikawx li hemm riskji oħra għajr il- fatt mistenni li n- numru ta’ ċelluli B fid - demm jonqsu ħafna meta jingħata ibritumomab tiuxetan waħdu jew ma ’ rituximab.
Studies on reproductive and developmental toxicity have not been performed (see sections 4.4 and 4.6).
Ma sarux studji fuq l- effett tossiku fuq is- sistema riproduttiva u fuq l- iżvilupp (ara sezzjonijiet 4. 4 u 4. 6).
Studies on the mutagenic and carcinogenic potential of Zevalin have not been performed.
Studji fuq il- potenzjal mutaġeniku, u karċinoġeniku ta ’ Zevalin ma sarux.
Due to the exposure to ionising radiation derived from the radiolabel, a risk of mutagenic and carcinogenic effects has to be taken into account.
Minnħabba l- fatt li jkun hemm espożizzjoni għall- radjazzjoni joniżżanti li ġejja mill- prodott radjutikkettjat, wieħed irid iżomm f’ moħħu r- riskju mutaġeniku u karċinoġeniku potenzjali.
Ibritumomab tiuxetan vial:
Il- vjala ta ’ Ibritumomab tiuxetan:
Sodium acetate Water for injections
Il- vjala ta ’ sodium acetate Sodium acetate Ilma għall- injezzjonijiet
Formulation buffer vial:
Il- vjala tat- soluzzjoni tal- baffer:
Human albumin solution Sodium chloride Disodium phosphate dodecahydrate Sodium hydroxide Potassium dihydrogen phosphate Potassium chloride Pentetic acid Hydrochloric acid, diluted Water for injections
Soluzzjoni ta ’ albumina umana Sodium Chloride Disodium phosphate dodecahydrate Sodium hydroxide Potassium dihydrogen phosphate Potassium chloride Pentetic acid Hydrochloric acid, dilwit Ilma għal- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 12.
No incompatibilities have been observed between Zevalin and infusion sets.
Ma kienu osservati l- ebda inkompatibilitajiet bejn Zevalin u settijiet ta ’ l- infużjoni.
After radiolabelling, an immediate use is recommended.
Wara r- radju- tikkettar, ikun aħjar li l- prodott jintuża minnufih.
Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Irriżulta li l- prodott hu stabbli kemm kimikament kif ukoll fiżikament għal 8 sigħat f’ temperatura ta ’ bejn 20C - 80C, jekk ikun imħares mid - dawl.
Store in the original package in order to protect from light.
Żomm fil- pakkett oriġinali biex tipproteġih mid- dawl.
For storage conditions of the radiolabeled product see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali radjutikkettjat, ara sezzjoni 6. 3.
Storage should be in accordance with local requirements for radioactive materials.
Il- ħażna ta ’ dan il- prodott għandha tkun konformi mal- ħtiġijiet lokali għall- materjal radjuattiv.
2 ml of solution of ibritumomab tiuxetan in a vial (type I glass) with a rubber stopper (teflon-lined bromobutyl)
2 ml soluzzjoni ta ’ ibritumomab tiuxetan fi vjala (ta ’ ħġieġ ta’ Tip 1) magħluq b’ tapp tal- gomma (bromobutyl miksi bit- Teflon).
2 ml of solution of sodium acetate solution in a vial (type I glass) with a rubber stopper (teflon-lined bromobutyl)
2 ml soluzzjoni ta ’ sodium acetate fi vjala (ta’ ħġieġ ta’ Tip 1) magħluq b’ tapp tal- gomma (bromobutyl miksi bit- Teflon).
10 ml of formulation buffer in a vial (type I glass) with a rubber stopper (teflon-lined bromobutyl)
12 10 ml ta ’ formulazzjoni ta ’ baffer fi vjala (ta’ ħġieġ ta’ Tip 1) magħluq b’ tapp tal- gomma (bromobutyl miksi bit- Teflon).
10 ml empty reaction vial (type I glass) with a rubber stopper (teflon-lined bromobutyl)
Vjala ta ’ 10 ml vojta (ta’ ħġieġ ta’ Tip 1) magħluq b’ tapp tal- gomma (bromobutyl miksi bit- Teflon).
Pack size of 1 kit
Il- kontenut tal- kaxxa – pakkett wieħed
12 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali għar- rimiPrekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Preparation
Preparazzjoni
Proper aseptic technique and precautions for handling of radioactive materials should be employed.
Hu importanti li tintuża teknika asettika u jittieħdu l- prekawzjonijiet meta jiġu mmaniġġjati materjali radjuattivi.
Waterproof gloves should be utilised in the preparation and during the determination of radiochemical purity of [90Y]-radiolabelled Zevalin.
Dawn għandhom jintużaw ukoll meta jsiru l- provi li jistabilixxu l- purità radjukimika ta ’ Zevalin radjutikkettjat b ’ [90Y].
For instructions for preparation, see section 12.
Għal struzzjonijiet dwar il- preparazzjoni, ara sezzjoni 12.
Radiation protection
Protezzjoni mir- radjazzjoni
Radiation protection precaution in accordance with local regulations must be taken, since administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc..
Għalhekk hu importanti li jittieħdu l- prekawzjonijiet meħtieġa dwar protezzjoni minn radjazzjoni imposti mill- liġijiet lokali, minħabba li t- teħid ta ’ radjufarmaċewtiċi jinvolvi riskji għall- persuni oħrajn minħabba radjazzjoni esterna jew kontaminazzjoni minn tixrid ta ’ awrina, rimettar, eċċ..
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema b’ mod konformi mal- liġijiet lokali.
Contaminated materials must be disposed of as radioactive waste by the authorised route.
Materjal kontaminat għandu jintrema bħala skart radjuattiv b’ sistema awtorizzata.
Bayer Schering Pharma AG 13342 Berlin Germany
Bayer Schering Pharma AG 13342 Berlin Ġermanja
January 2004
16 ta ’ Jannar 2004
Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Yttrium- 90 jiddegrada billi jarmi partiċelli beta ta ’ enerġija qawwija, li għandhom half- life fiżika ta ’ 64. 1 siegħa (2. 67 ġranet).
The product of radioactive decay is stable zirconium-90.
Meta Yttrium- 90 jispiċċa radjuattivament, jsir zirconium- 90 stabbli.
The path length of beta emission (χ 90) by yttrium-90 in tissue is 5 mm.
Id - distanza ta ’ emissjoni ta ’ partiċelli B( χ90) minn yttrium- 90 fit- tessuti tal- ġisem hi ta ’ 5 mm.
Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [111In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
Analiżi ta ’ l- istima tad- doża ta ’ radjazzjoni assorbita saret permezz ta ’ mmaġini kwantitattivi bl- użu ta ’ Zevalin radjutikkettjat b ’ [111IN] li jarmi raġġi gamma, bil- ġbir ta ’ kampjuni tad- demm u bl- użu tal - programm tal- kompjuter MIRDOSE3.
The imaging dose of [111In]-radiolabelled Zevalin was always given immediately following an infusion with rituximab at 250 mg/ m² to deplete peripheral CD20+ cells and to optimise bio-distribution.
Id- doża li tintuża biex toħloq immaġini ta ’ Zevalin radjutikkettjat b ’ [111IN] ingħatat eżatt wara l- infużjoni ta ’ rituximab 250 mg/ m2 sabiex inaqqas ħafna l - għadd ta’ ċelluli periferiċi li għandhom l- antiġen CD20+ u biex itejjeb il- bijodistribuzzjoni.
Following administration of [111In]-radiolabelled Zevalin, whole body scans were performed at up to eight time-points, acquiring both anterior and posterior images.
Wara li ngħata Zevalin radjutikkettjat b ’ [111IN], ittieħdu scans tal- ġisem sħiħ fi tmien ħinijiet differenti, b’ hekk inġabru immaġini kemm ta ’ quddiem kif ukoll ta ’ wara tal- ġisem.
Blood samples, used to calculate residence times for red marrow, were drawn up to eight time-points.
Kampjuni ta ’ demm li ttieħdu fi tmien ħinijiet differenti, ġew analizzati biex jindikaw kemm il- mediċina radjuattiva ddum fil- mudullun l- aħmar.
13 Based upon dosimetry studies with [111In]-radiolabelled Zevalin, the estimated radiation dosimetry for individual organs following administration of [90Y]-radiolabelled Zevalin at activities of 15 MBq/ kg and 11 MBq/ kg was calculated according to Medical Internal Radiation Dosimetry (MIRD) (Table 2).
Imsejsa fuq l- istudji tad- dożimetrija b’ Zevalin radjutikkettjat b ’ [111IN], l- istima tad- dożimetrija tar - 90 radjazzjoni f’ organi differenti tal- ġisemwara l- għotja ta ’ Zevalin radjutikkettjat b ’ [Y] f’ attività ta ’ 15MBq/ kg u 11MBq/ kg, ġew ikkalkulati skond il- Medical Internal Radiation Dosimetry (MIRD) (Tabella 2).
The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.
Id- dożi stimati tar- radjazzjoni assorbiti minn organi normali tal- ġisem kienu ħafna anqas mill- ogħla livell ta ’ radjazzjoni li hu meqjus bħala mhux perikoluż.
Individual patient dosimetry results were not predictive for [90Y]-radiolabelled Zevalin toxicity.
Studji tad- doża tar- radjazzjoni fil - 90 ġisem ta ’ kull pazjent ma bassrux l- effett tossiku ta ’ Zevalin radjutikkettjat b ’ [Y].
Table 2.
14 Tabella 2
Estimated Radiation Absorbed Doses From [90Y]-Zevalin
Stima tad- Dożi ta ’ Radjazzjoni Assorbita wara li ngħata 90 Zevalin radjutikkettjat b ’ [Y]
[90Y]-Zevalin mGy/ MBq
Zevalin [90Y] radjutikkettat Organu mGy/ MBq
Organ
Medjan
Median
Firxa
Range
2. 0 - 6. 7
Spleen1 Liver1
Kisja tal- Qalb1
9.4 4.8
Pulmun
1.8 - 20.0 2.9 - 8.1
1. 2 – 3. 4
Lower Large Intestinal Wall
Testikoli1
1
0. 8 – 2. 1 0. 6 – 1. 8 0. 7 – 1. 3
4.7
0. 9
3.1 – 8.2
0. 5 – 1. 2
Upper Large Intestinal Wall Heart Wall1 Lungs1 Testes1 Small Intestine1 2
Ovarji
3.6 2.9 2.0 1.5 1.4
0. 4
2.0 – 6.7 1.5 - 3.2 1.2 - 3.4 1.0 – 4.3 0.8 – 2.1
0. 3 – 0. 5
Red Marrow
Utru3 Adrenali3 3
3
0. 4 0. 3
0.6 - 1.8
0. 3 – 0. 5 0. 2 – 0. 5
Urinary Bladder Wall 2
Moħħ 3
0.9
0. 3
0.7 - 1.3
0. 2 – 0. 5
Bone Surfaces Ovaries3 Uterus3 Adrenals3 Brain3 3
0. 3
0.9 0.4 0.4 0.3 0.3
0. 2 – 0. 5
Breasts 3
Kisja tal- marrara3 Muskoli3 Frixa3 3
0.3
0. 3 0. 3 0. 3
0.2 - 0.5
0. 2 – 0. 5 0. 2 – 0. 5 0. 2 – 0. 5
Gallbladder Wall Muscle3 Pancreas3 Skin3 Stomach3 3
Ġilda 3
0.3 0.3 0.3 0.3 0.3
0. 3
0.2 - 0.5 0.2 - 0.5 0.2 - 0.5 0.2 - 0.5 0.2 - 0.5
0. 2 – 0. 5
Thymus 3
0. 3
0.2 - 0.5
0. 2 – 0. 5
Thyroid 1
Thymus3 Tirojde3 1
0.3
0. 1
0.2 - 0.5
0. 0 – 0. 3
Kidneys Total Body3
Ġisem kollu
0.1 0.5
0. 5
0.0 - 0.3 0.4- 0.7
0. 4 – 0. 7
Organ region of interest 2 Sacrum region of interest 3 Whole body region of interest
Parti mis- sakrum ta ’ interess 3 Parti mill- ġisem sħiħ ta ’ interess
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart għandu jintrema b’ mod konformi mal- ħtiġijiet lokali.
Read complete directions thoroughly before starting the preparation procedure.
Aqra l- istruzzjonijiet kollha bl- attenzjoni qabel ma ribda l- proċedura tal- preparazzjoni.
Proper aseptic technique and precautions for handling radioactive materials should be employed.
Għandha tintuża teknika asettika u jittieħdu l- prekawzjonijiet meta jiġu mmaniġġjati materjali radjuattivi.
Waterproof gloves should be utilised in the preparation and during the determination of radiochemical purity of [90Y]-radiolabelled Zevalin.
Għandhom jintużaw ingwanti li ma jgħaddix l- ilma minnhom meta titħallat il- mediċina u meta jsiru l - 90 provi li jistabilixxu l- purità radjukimika ta ’ Zevalin radjutikkettjat b ’ [Y].
Characteristics of yttrium-90
Karatteristiċi ta ’ yttrium- 90
• The following minimum yttrium-90 characteristics are recommended:
• Dawn huma l- karatteristiċi minimi ta ’ yttrium- 90 rakkomandati
Radioactivity concentration at time of use
Konċentrazzjoni radjuattiva fil- ħin ta ’ l- użu
1.67 to 3.34 GBq/ ml
1. 67 sa 3. 34 GBq/ ml
Total extractable activity to deliver at time of use
Total ta ’ attività li tista ’ tingħata fil- ħin ta ’ l- użu
≥ 1.48 GBq corresponding to 0.44 ml to 0.89 ml of yttrium-90 solution
≥1. 49 GBq li jikkorrispondi ma ’ 0. 44 ml sa 0. 89ml ta ’ soluzzjoni ta ’ yttrium- 90
HCl concentration
Konċentrazzjoni ta ’ HCl
0.035-0.045 M
0. 035- 0. 045 M
Chloride identification
Identifikazzjoni tal- chloride
Positive
Pożittiva
Yttrium identification
Identifikazzjoni ta ’ Yttrium
Radiochemical purity of the yttrium-90 chloride solution
Purità radjukimika tas- soluzzjoni ta ’ chloride ta ’ yttrium- 90
≥ 95% of free ionic yttrium-90
≥95% tal- jonju ħieles ta ’ yttrium- 90
≤ 150 EU/ ml
≤150 EU/ ml Endotossini tal- batteri
No growth
Ma jikber xejn
Radionuclidic purity strontium-90 content
Purità tal- kontenut radjonuklidiku fi strontium- 90
≤ 0.74 MBq strontium-90 / 37 GBq yttrium-90
≤ 0. 74 MBq strontium- 90 / 37 GBq yttrium- 90
≤ 50 ppm
Impuritajiet metalliċi ≤ 50 ppm Total ta ’ metalli *
≤ 10 ppm each
≤ 10 ppm minn kull wieħed Kull metall individwali * * Il- metalli li huma inklużi għandhom ikunu ibbażati fuq il- proċess speċifiku ta ’ manifattura.
Control of these metals can be achieved either through process validation or release test.
Kontroll ta ’ dawn il- metalli jista ’ jsir jew matul il- proċess ta ’ validazzjoni jew mit- testijiet li jsiru qabel ma l - prodott ikun jista ’ jitqassam fis- suq.
• Additional testing that might be required for suitability assessment:
• Testijiet oħra li jistgħu jkunu meħtieġa għall- aċċertamenti qabel ma l- prodott jiġi meqjus tajjeb biex jintuża.
Process-specific impurities:
Kelanti organiċi) Residwi tal- proċess (eż.
Total organic carbon (e. g. organic chelators) Process residuals (e. g. ammonia, nitrate) Total Alpha impurities Total other Beta impurities (non-strontium-90) Total Gamma impurities
Ammonia, nitrate) Total ta ’ l- impuritajiet Alpha Total ta ’ l- impuritajiet Beta (mhux dawk ta ’ Strontium- 90)
Below limit of quantitation* Below limit of quantitation* Below limit of quantitation* Below limit of quantitation* Below limit of quantitation*
Inqas mill- limitu ta ’ kwantifikazzjoni * Inqas mill- limitu ta ’ kwantifikazzjoni * Inqas mill- limitu ta ’ kwantifikazzjoni * Inqas mill- limitu ta ’ kwantifikazzjoni *
16 * Needs to be included as release test or controlled through process validation if above limit of quantitation
Inqas mill- limitu ta ’ kwantifikazzjoni *
Directions for radio-labelling of Zevalin with yttrium-90:
16 * dawn iridu jiġu inklużi bħala provi li jsiru qabel ma l- prodott ikun jista ’ jitqassam fis- suq jew jiġu kkontrollati meta l- proċess jiġi validat jekk il- limitu jkun ogħla minn dak ta ’ kwantifikazzjoni.
Sterile, pyrogen-free yttrium-90 chloride of the above specified quality must be used for the preparation of [90Y]-radiolabelled Zevalin.
Struzzjonijiet kif tagħmel ir- radju- tikkettar ta ’ Zevalin b’ yttrium- 90 90 Għall- preparazzjoni ta ’ Zevalin radjutikkettjat b ’ [Y] għandu jintuża chloride ta ’ yttrium- 90 tal - kwalità speċifikata li jkun sterilizzat u mingħajr piroġeni.
Before radiolabelling, bring refrigerated Zevalin cold kit to room temperature 25°C.
Qabel ir- radjutikkettjar, oħroġ il- pakkett kiesaħ ta ’ Zevalin mill- friġġ u stenna sakemm jieħu t - temperatura tal- kamra, 25ºC.
Clean the rubber stopper of all cold kit vials and the yttrium-90 chloride vial with a suitable alcohol swab and allow to air dry.
Naddaf bl- alkoħol it- tapp tal- gomma ta ’ kull vjala li tkun ħriġt mill- friġġ u l- vjala ta ’ yttrium- 90 b’ biċċa mxarba bl- alkoħol u ħallihom jinxfu.
Place cold kit reaction vial in a suitable dispensing shield (plastic enclosed in lead).
Poġġi il- pakkett kiesaħ ta ’ Zevalin wara lqugħ ta ’ protezzjoni addatt, biex wieħed jista ’ jiftħu (plastik magħluq biċ- ċomb)
Step 1:
1 Stadju:
Transfer sodium acetate solution to the reaction vial
Itrasferixxi s- soluzzjoni ta ’ sodium acetate ġol- vjala fejn ser issir ir- reazzjoni
Using a 1-ml sterile syringe, transfer sodium acetate solution to reaction vial.
Permezz ta ’ siringa sterili ta ’ 1 ml itrasferixxi is- soluzzjoni tas- sodium acetate ġol- vjala fejn ser issir ir- reazzjoni.
The volume of sodium acetate solution added is equivalent to 1.2 times the volume of yttrium-90 chloride to be transferred in step 2.
Il- volum ta ’ soluzzjoni ta ’ sodium acetate hija daqs 1. 2 l- volum ta ’ chloride ta ’ yttrium- 90 li ser jiġi trasferit fit- 2 stadju.
Step 2:
2 Stadju:
Transfer yttrium-90 chloride to the reaction vial
Itrasferixxi il- chloride ta ’ yttrium- 90 ġol- vjala fejn ser issir ir- reazzjoni
Aseptically transfer 1500 MBq of yttrium-90 chloride with a 1 ml sterile syringe to the reaction vial containing the sodium acetate solution transferred in step 1.
Ittrasferixxi b’ mod asettiku 1500 MBq ta ’ chloride ta ’ yttrium- 90 b’ siringa sterili ta’ 1 ml ġol- vjala fejn ser issir ir- reazzjoni li jkun fiha s- soluzzjoni ta ’ sodium acetate li tkun ġiet ttrasferita fl- ewwel stadju.
Mix completely by coating the entire inner surface of the reaction vial.
Ħawwad billi tiksi kompletament l- wiċċ ta ’ ġewwa tal- vjala fejn ser issir ir- reazzjoni.
Mix by inversion, rolling the container, avoid foaming or agitating the solution.
Ħawwad billi tqalleb il- vjala rasa ’ l isfel u ’ l fuq, u billi tirrombla l- vjala, evita li tagħmel r- ragħwa u li tħawwad bil - qawwi.
Step 3:
3 Stadju:
Transfer ibritumomab tiuxetan solution to the reaction vial
Itrasferixxi is- soluzzjoni ta ’ ibritumomab tiuxetan ġol- vjala fejn ser issir ir- reazzjoni
Using a 2-3 ml sterile syringe, transfer 1.3 ml ibritumomab tiuxetan solution to the reaction vial.
Uża siringa sterili ta’ 2- 3 ml biex titrasferixxi 1. 3 ml tas- soluzzjoni ta ’ ibritumomab tiuxetan ġol- vjala fejn ser issir ir- reazzjoni.
Mix completely by coating the entire inner surface of the reaction vial.
Ħawwad billi tiksi kompletament l- wiċċ ta ’ ġewwa tal- vjala fejn ser issir ir - reazzjoni.
Mix by inversion, rolling the container, avoid foaming or agitating the solution.
Ħawwad billi tqalleb il- vjala rasa ’ l isfel u ’ l fuq, u billi tirrombla l- vjala, evita li tagħmel r - ragħwa u li tħawwad bil- qawwi.
Incubate the yttrium-90 chloride/ acetate/ ibritumomab tiuxetan solution at room temperature for five minutes.
Inkuba s- soluzzjoni tal- chloride ta ’ yttrium- 90/ aċetat/ ibritumomab tiuxetan f’ temperatura tal- kamra għal ħames minuti.
Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Il- perijodu ta ’ inkubazzjoni biex isir ir- radjutikkettar ma jridx ikun ta ’ aktar minn 6 minuti jew iqsar minn 4 minuti għax jirriżulta f’ inkorporazzjoni inadekwata ta ’ radjuattività.
Step 4:
4 Stadju:
Add the formulation buffer to the reaction vial
Żid is- soluzzjoni tal- baffer ġol- vjala fejn issir ir- reazzjoni
Using a 10-ml syringe with a large bore needle (18-20 G), draw formulation buffer that will result in a combined total volume of 10 ml.
Uża siringa ta ’ 10 ml li għandha labra ħoxna (18- 20G), tella ’ l- baffer li jirriżulta f’ volum totali kkombinat ta ’ 10 ml.
After the five-minute incubation period, add the formulation buffer to the reaction vial terminating incubation.
Wara l- perijodu ta ’ inkubazzjoni ta ’ ħames minuti, żid il- baffer ġol- vjala fejn ser issir ir- reazzjoni u hekk twaqqaf l- inkubazzjoni.
Immediately prior to this addition withdraw an equal volume of air from the reaction vial in order to normalise pressure.
Eżatti qabel ma żżid dan, iġbed volum indaqs ta ’ arja minn ġol- vjala fejn ser issir ir- reazzjoni biex tinnormalizza l- pressjoni.
Gently add the formulation buffer down the side of the reaction vial.
Żid il- baffer mal- ġenb tal- fjal fejn qed issir ir - reazzjoni.
Do not foam, shake, or agitate the mixture.
Tagħmilx rawgħa, tħawwadx, u ċċaqlaqx is- soluzzjoni.
Step 5:
90 5 Stadju:
Assay the [90Y]-radiolabelled Zevalin solution for its specific radioactivity
Ittestja s- soluzzjoni ta ’ Zevalin radjutikkettjat b ’ [Y] għar- radjuattività speċifika tiegħu
Radiochemical purity of the radiolabelled preparation applies as long as more than 95% of yttrium-90 is incorporated into the monoclonal antibody.
Il- purità radjukimika tal- prodott radjutikkettjat tapplika biss jekk aktar minn 95% ta ’ yttrium- 90 jiġi inkorporat fl- antikorp monoklonali.
17 Before administration to the patient, the percent radioincorporation of the prepared [90Y]-radiolabelled Zevalin must be checked according to the procedure outlined below.
17 Qabel tingħata l- mediċina lill- pazjent, il- persentaġġ ta ’ radju- inkorporazzjoni ta ’ Zevalin radjutikkettjat b ’ [90Y] għandha tiġi analizzata skond il- proċedura stabbilita hawn isfel.
Patient dose not to exceed 1200 MBq.
Id- doża għal kull pazjent m’ għandiex taqbes 1200 MBq.
Instructions for determining the percent radioincorporation.
Struzzjonijiet biex jiġi stabbilit il- persentaġġ ta ’ radju- inkorporazzjoni.
The radioincorporation assay for radiochemical purity, is performed by Instant Thin Layer Chromatography (ITLC) and should be carried out according to the following procedure.
L- analiżi tar- radju- inkorporazzjoni għall- purità radjukimika issir permezz ta ’ Kromatografija Instantanja ta ’ Saff Irqieq (Instant Thin Layer Chromatography (ITLC)) u jrid isir skond il- proċedura hawn taħt imsemmija.
Required materials not supplied in the Zevalin kit:
Materjali meħtieġa li ma jinstabux fil- pakkett ta ’ Zevalin
- Developing chamber for chromatography
- Reċipjent fejn ser tiġi żviluppata l- kromatografija.
- Mobile phase: sodium chloride 9 mg/ ml (0.9%) solution, bacteriostatic-free
- Fażi mobbli: soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) li ma fijiex batterjostatiċi.
- ITLC strips (e. g.
- Strippi għall- ITLC (p. e.
ITLC silica gel (SG) plates Art.
ITLC silica gel (SG) plates Art.
61885, Gelman Sciences, Ann Arbor,
No. 61885, Gelman Sciences, Ann Arbor,
Michigan, USA or equivalent; dimensions:
Michigan, USA jew ekwivalenti; dimensjonijiet:
0.5 cm x 6 cm, origin:
0. 5 cm X 6 cm, oriġini:
1.4 cm, cut line:
1. 4 cm, mill- linja tal- qtugħ:
3.5 cm, solvent front:
3. 5 cm, il- linja tas- solvent:
5.4 cm)
5. 4 cm)
- Scintillation vials
- Vjali ta ’ xintillizazzjoni
- Liquid scintillation cocktail (e. g.
- Soluzzjoni ta ’ xintillizazzjoni (LSC) (eż.
6013329, Packard Instruments, USA or
Ultima Gold, Numru tal- katologu 6013329, Packard
equivalent)
Instruments, USA jew ekwivalenti).
Assay procedure:
Il- proċedura ta ’ l- analiżi
1.) Add approximately 0.8 ml 0.9% sodium chloride solution to developing chamber assuring the liquid will not touch the 1.4 cm origin mark on the ITCL strip.
1) Żid bejn wieħed u ieħor 0. 8 ml ta ’ 0. 9% tas- soluzzjoni ta ’ sodium chloride ġo reċipjent fejn ser issir l- iżvilupp, u aċċerta li l- likwidu ma jmissx mal- marka ta ’ l- oriġini ta ’ 1. 4cm fuq l- istrippa tal- ITLC.
2.) Using a 1 ml insulin syringe with a 25- to 26-G needle, place a hanging drop (7-10 µl) of [90Y]- radiolabelled Zevalin onto the ITLC strip at its origin.
2) Uża siringa ta ’ l- insulina ta ’ 1 ml b’ labra 25 sa 26 G u poġġi qatra li taqa ’ waħeda (7- 10 µl) ta ’ 90 Zevalin radjutikkettjat b ’ [Y] fuq il- marka ta ’ l- oriġini ta ’ l- istrippa ta ’ l- ITLC.
Spot one strip at a time and run three ITLC strips.
Immarka strippa waħda kull darba u rrepeti għal tlett strippi ITLC.
It may be necessary to perform a dilution (1:100) before application of the [90Y]-radiolabelled Zevalin to the ITLC strips.
Jista ’ jkun hemm bżonn li l- prodott jiġi dilwit 90 (1: 100) qabel ma jiġi applikat Zevalin radjutikkettjat b ’ [Y] fuq l- istrippa ta ’ l- ITLC.
3.) Place ITLC strip in the developing chamber and allow the solvent front to migrate past the 5.4 cm mark.
3) Qiegħed l- istrippa ta ’ l- ITLC fir- reċipjent ta ’ l- iżvilupp u ħalli s- solvent jitla ’ sal- marka ta ’ 5. 4 cm.
4.) Remove ITLC strip and cut in half at the 3.5 cm cut line.
4) Neħħi l- istrippa ta ’ l- ITLC u aqsamha minn nofs, mit- 3. 5cm linja ta ’ qtugħ.
Place each half into separate scintillation vials to which 5 ml LSC cocktail should be added (e. g.
Qiegħed kull parti ta ’ l - istrippa separatament ġo vjali tax- xintillazzjoni fejn irid jiġi miżjud 5 ml tas- soluzzjoni ta ’ LSC (e. ż.
6013329, Packard Instruments, USA or equivalent).
Ultima Gold, Numru tal- katologu 6013329, Packard Instruments, USA jew ekwivalenti).
Count each vial in a beta counter or in an appropriate counter for one minute (CPM), record net counts, corrected for background.
Qiegħed kull vjala ġo kontatur xieraq tal- partiċelli beta, jew ġo kontatur xieraq għal minuta (CPM) irrekordja l - partiċelli beta netti meħlusa f’ minuta, wara li tkun naqqast l- ammont ta ’ radjazzjoni fl- isfond.
5.) Calculate the average Radiochemical Purity (RCP) as follows:
5) Ikkalkula l- medja ta ’ purità radjukimika (RCP) hekk:
6.) Average% RCP =
6) Persentaġġ (%) medju ta ’ RCP =
net CPM bottom half x 100
nett CPM minn nofs l- isfel × 100
net CPM top half + net CPM bottom half
Nett CPM minn- nofs ’ l fuq + nett CPM minn nofs ’ l isfel
7.) If the average radiochemical purity is less than 95%, the preparation should not be administered.
7.) Jekk il- medja tal- purità radjokimika hija inqas minn 95%, is- soluzzjoni m’ għandiex tingħata.
18 ANNEX II
18 ANNESS II
Bayer Schering Pharma AG Müllerstrasse 178 13342 Berlin GERMANY
Bayer Schering Pharma AG Müllerstrasse 178 13342 Berlin Ġermanja
Risk Management Plan
Pjan ta ’ Mmaniġġjar ta ’ Riskji
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u l- attivitajiet ta ’ Farmakoviġilanza oħra kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 1. 1 tal- Pjan ta ’ Mmaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2. tal- applikazzjoni tal- Awtorizazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar Sistemi ta ’ Immaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess waqt mar - Rapport Perjodiku Aġġornat ta ’ Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Barra minn hekk, għandu jiġi sottomess RMP aġġornat ● Meta tinkiseb informazzjoni ġdida li jista ’ jkollha impatt fuq Speċifikazzjonijiet ta ’ Sigurtà attwali, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskji. ● Fi żmien 60 ġurnata minn meta tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskji). ● Mat- talba ta ’ l- EMEA
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Zevalin 1.6 mg/ ml Kit for radiopharmaceutical preparation for infusion Ibritumomab tiuxetan
Zevalin 1. 6mg/ ml Pakkett għall- preparazzjoni radjufarmaċewtika għall- infużjoni Ibritumomab tiuxetan
One ml contains ibritumomab* tiuxetan.
1 ml fih Ibritumomab * tiuxetan
1.6 mg per ml
1. 6 mg kull ml
One vial contains 3.2 mg of ibritumomab tiuxetan
Vjala jkun fiha 3. 2 mg ta ’ Ibritumomab tiuxetan
Kit for radiopharmaceutical preparation for infusion (in vials):
Pakkett għall- preparazzjoni radjufarmaċewtika għall- infużjoni (fi vjali)
3.2 mg ibritumomab tiuxetan in sodium chloride solution
3. 2 mg ta ’ ibritumimab tiuxetan ġo soluzzjoni ta ’ sodium chloride
2 ml of sodium acetate solution
2 ml ta ’ soluzzjoni ta ’ sodium acetate
10 ml of formulation buffer: human albumin solution, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid diluted, water for injections
10 ml ta ’ baffer magħmul b’ soluzzjoni ta ’: soluzzjoni ta ’ l- albumina umana, Sodium Chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pantetic acid, hydrochloric acid dilwit, ilma għall- injezzjoni.
Empty reaction vial (10 ml)
Vjala vojta fejn issir ir- reazzjoni (10 ml)
Must be combined with yttrium-90 prior to intravenous administration.
Irid jiġi kkombinat ma ’ yttrium- 90 qabel ma jingħata ġol- vina.
Refer to Summary of Product Characteristics of yttrium-90 for instructions on preparation and use.
Għall- istruzzjonijiet fuq il- preparazzjoni u l- użu ta yttrium- 90, irreferi għall- karaterristiċi tal- Prodott ta ’ yttrium- 90.
Must be administered by authorised personnel only
Għandu jingħata minn persuni awtorizzati biss
After radiolabelling, an immediate use is recommended.
Wara li l- mediċina tiġi radjutikkettjata, hu rakkomandat li l- mediċina tintuża mill- iktar fis possibbli.
Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Ġie dimostrat li l- prodott hu stabbli kemm kimikament kif ukoll fiżikament għal 8 sigħat f’ temperatura ta ’ bejn 2ºC - 8ºC, u jekk ikun protett mid- dawl.
Store at 2°C – 8°C (in a refrigerator) Do not freeze Store in the original container in order to protect from light
Aħżen f’ temperatura ta ’ bejn 2°C – 8°C (fil- friġġ) Tagħmlux fil- friża Aħżen fil- kontenitur oriġinali biex tipproteġih mid- dawl
Bayer Schering Pharma AG, 13342 Berlin, Germany
Bayer Schering Pharma AG, 13342 Berlin, Il- Ġermanja
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL)
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN (VJALA)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U JEKK HEMM BŻONN MNEJN JINGĦATA
Ibritumomab tiuxetan solution
Soluzzjoni ta ’ Ibritumomab tiuxetan
Lot {number}
< Lott > {numru}
3.2 mg/ 2 ml
3. 2 mg/ 2 ml
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL)
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN (VJALA)
Sodium acetate solution
Soluzzjoni ta ’ sodium acetate
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDUALI.
26 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL)
26 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN (VJALA)
Formulation buffer solution
Taħlita tal- baffer
EXP {MM/ YYYY}
< JIS [XX/ SSSS] >
Lot {number}
< Lott > [numru]
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL)
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN (VJALA)
Reaction vial
Vjala fejn issir ir- reazzjoni
EXP {MM/ YYYY}
< JIS {XX/ SSSS} >
empty
vojta
Zevalin 1.6 mg/ ml Kit for radiopharmaceutical preparation for infusion Ibritumomab tiuxetan
Zevalin 1. 6mg/ ml, Pakkett għall- preparazzjoni radjufarmaċewtika għall- infużjoni Ibritumomab tiuxetan
Read all of this leaflet carefully before this medicine is given to you.
Aqra dan il- fuljett kollu qabel ma tingħatalek din il- mediċina
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew l- ispiżjar tiegħek.
What Zevalin is and what it is used for 2.
X’ INHU ZEVALIN U GĦALXIEX JINTUŻA 2.
Before you are given Zevalin 3.
QABEL MA JINGĦATALEK ZEVALIN 3.
How to use Zevalin 4.
KIF GĦANDEK TUŻA ZEVALIN 4.
Possible side effects 5.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU 5.
How to store Zevalin 6.
KIF TAĦŻEN ZEVALIN 6.
What Zevalin is and what it is used for
X’ INHU ZEVALIN U GĦAL XIEX JINTUŻA
Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Zevalin issibu bħala pakkett għall- preparazzjoni ta ’ ibritumomab tiuxetan radjo- tikkettat b’ yttrium- 90.
Zevalin is one of a family of medicines (called selective monoclonal antibodies) which target certain body cells.
Zevalin hu membru tal- familja ta ’ mediċini (li jissejħu antikorpi monokolonali selettivi) u li jaqbdu ma ’ ċertu ċelluli tal- ġisem.
It comes as a solution, in a four-vial kit.
Jiġi f’ forma ta ’ soluzzjoni ġo pakkett li jkun fih 4 fjali.
It is used with a radioactive substance called yttrium, which gives Zevalin a tiny radioactive charge to use when it reaches its target.
Jiġi wżat mas - sustanza radjuattiva, yttrium, li jagħti lil Zevalin ftit enerġija radjuattiva li tintuża meta Zevalin jilħaq il- mira tiegħu.
Zevalin is used to treat non-Hodgkin’ s lymphoma.
Zevalin hu wżat biex jikkura limfoma non- Hodgkin.
This is a malignant disease of certain white blood cells called lymphocytes.
Din hija tip ta ’ marda malinna ta ’ ċertu tip ta ’ ċelluli bojod li jissejħu limfoċiti.
Zevalin is used following (successful) remission induction or if an earlier treatment has not worked, or has stopped working.
Zevalin jintuża wara l- induzzjoni ta ’ remissjoni (b’ suċċess) jew meta kuri oħra ma ħadmux jew waqfu jaħdmu.
The white blood cells called lymphocytes normally take part in the body’ s fight against disease.
Iċ- ċelluli bojod li jissejħu limfoċiti jieħdu sehem fil- ġlieda tal- ġisem kontra l- mard.
In people with non-Hodgkin’ s lymphoma, the body produces too many abnormal lymphocytes, which do not work properly and which can displace healthy cells in the bone marrow (where most new blood cells are formed) and in the blood.
F’ dawk il- persuni li jkunu qed ibatu mill- limfoma non- Hodgkin, il- ġisem jipproduċi ammonti kbar tal- limfoċiti mhux normali, li ma jaħdmux sew u li jieħdu post dawk iċ- ċelluli tajbin li jkun hemm fil- mudullun (il- post fejn jiffurmaw ħafna miċ- ċelluli tad- demm), u fid- demm.
This can lead to infections, anaemia, bruising, excessive bleeding or even organ failure.
Dan iwassal għall- infezzjonijiet, anemija, tbenġil, fsad eċċessiv kif ukoll organi tal- ġisem li jistgħu jieqfu jaħdmu.
The illness may also cause the lymph nodes and other organs such as liver and spleen to increase in size.
Il- marda tista ’ taffettwa in - nodi limfatiċi, u organi oħra bħal fwied u l- milsa jistgħu jikbru fid- daqs.
Zevalin is a targeted treatment which fixes to the abnormal white cells.
Zevalin hija kura mmirata li teħel maċ- ċelluli l- bojod mhux normali.
After being combined with the radioactive substance yttrium, Zevalin takes tiny doses of radiation to the sites of the abnormal cell growth and kills the abnormal cells.
Wara li jkun kombinat mas - sustanza radjuattiva yttrium, Zevalin jieħu dożi żgħar ta ’ radjazzjoni fiz- zoni fejn ikun hemm ċelluli mhux normali u b’ hekk joqtol dawn iċ- ċelluli.
Before you are given Zevalin itself, you are given another medicine – called rituximab.
Qabel ma tingħata Zevalin innifsu, inti ser tingħata mediċina oħra – imsejħa rituximab.
Therefore please also refer to the package leaflet of rituximab for further information regarding treatment and possible effects of rituximab.
Għalhekk, jekk jogħġbok irreferi wkoll għall- fuljett fil- pakkett ta ’ rituximab għal aktar tagħrif dwar il- kura u l- effetti possibbli ta ’ rituximab.
Before you are given Zevalin
QABEL MA JINGĦATALEK ZEVALIN
Do not use Zevalin:
TUŻAX ZEVALIN
If you are allergic (hypersensitive) to ibritumomab tiuxetan, to yttrium chloride, to rituximab, to other mouse-derived proteins, or to any of the other ingredients of Zevalin, see ingredients listed in section 6..
jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal ibritumomab tiuxetan, għal yttrium chloride, għal rituximab jew proteini oħrajn li jinkisbu mill- ġrieden, jew għal xi sustanza oħra ta ’ Zevalin elenkati f’ sezzjoni 6.
If you are pregnant or could be pregnant.
Jekk inti tqila jew tista ’ tkun tqila.
You must not have Zevalin if you are pregnant; see the detailed advice in section ‘ Pregnancy precautions’.
Tiħux Zevalin jekk inti tqila; ara l- parir dettaljat, fis - sezzjoni ‘ Prekawzjonijiet fit- tqala ’.
You must not have Zevalin if you are breast-feeding; see the detailed advice in section ‘ Breast-feeding’.
Jekk qed tredda ’ Tiħux Zevalin jekk qed tredda ’: ara l- parir dettaljat fis- sezzjoni ‘ Tirdigħ ’.
Tell your doctor.
Għid lit- tabib tiegħek.
► Tell your doctor, if you think that any of this may apply to you.
► Għid lit- tabib tiegħek, jekk taħseb li din tgħodd għalik.
Take special care with Zevalin:
OQGĦOD ATTENT ĦAFNA JEKK SER TUŻA ZEVALIN:
If you notice any tiredness, frequent infections, more bleeding than usual after injury or fever, tell your doctor.
Jekk tinnota kwalunkwe għeja, infezzjonijiet frekwenti, iktar ħruġ ta ’ demm min- normal wara xi korriment jew deni, għid lit- tabib tiegħek.
Most patients treated with Zevalin experience a severely reduced number of blood cells, which needs some time to normalise again after treatment.
Il- biċċa l- kbira tal- pazjenti kkurati b’ Zevalin ikollhom numru mnaqqas ħafna ta ’ ċelluli tad- demm, li jeħtieġ xi żmien biex jerġa ’ lura għan- normal wara l - kura.
If you receive Zevalin 4 months or less after another chemotherapy which included the medicine fludarabine, you may have a higher risk to develop a reduced number of blood cells.
Jekk inti tirċievi Zevalin 4 xhur jew inqas wara kemjoterapija oħra li tkun tinkludi l- mediċina fludarabine, inti jista ’ jkollok riskju ikbar li tiżviluppa numru mnaqqas ħafna ta ’ ċelluli tad- demm.
If you are especially prone to develop such symptoms, which may even be life-threatening, then you should not receive Zevalin.
Jekk inti partikolarment suxxettibli li tiżviluppa sintomi bħal dawn, li jistgħu jkunu wkoll ta ’ periklu għal ħajja, int m’ għandekx tirċievi Zevalin.