FrancophonIA/ELRC3.0 huggingface dataset:
English: One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in 2 ml solution (1.6 mg per ml).
Maltese: Kull kunjett fih 3.2 mg ibritumomab tiuxetan f'2 ml ta' soluzzjoni (1.6 mg kull ml).
English: (lymphocytopenia) - allergic (hypersensitivity) reactions - severe loss of appetite (anorexia) - feeling anxious (anxiety); trouble sleeping (insomnia) - dizziness; headache, - bleeding due to decreased blood platelet counts*, - cough; runny nose - vomiting, stomach (abdominal) pain; diarrhoea; indigestion; throat irritation; constipation - rash; itching (pruritus) - joint pain (arthralgia) aching muscles (myalgia); back pain; neck pain
Maltese: (limfoċitopenija) - reazzjonijiet allerġiċi (sensittività eċċessiva) - tnaqqis sever fl-aptit (anoressija) - tħossok ansjuż (ansjetà); problemi biex torqod (insomnja) - sturdament; uġigħ ta' ras, - fsada kkawżata minn għadd imnaqqas ta' plejtlits tad-demm*, - sogħla; imnieħer iqattar - rimettar, uġigħ fl-istonku (addominali); dijarea; indiġestjoni; irritazzjoni fil-griżmejn;
English: Since Zevalin is used after pretreatment with rituximab (for details see section 4.2), see also the prescribing information of rituximab.
Maltese: Peress li Zevalin jintuża wara kura minn qabel b'rituximab (għad-dettalji ara sezzjoni 4.2), ara wkoll linformazzjon dwar il-preskrizzjoni ta' rituximab.
English: ANNEX III
Maltese: Tabella 3
English: Place each half into separate scintillation vials to which 5 ml LSC cocktail must be added (e.g. Ultima Gold, catalog No. 6013329, Packard Instruments, USA or equivalent).
Maltese: Qiegħed kull nofs ġewwa kunjetti separati tax-xintillazzjoni fejn irid jiġi miżjud 5 ml tas-soluzzjoni ta' LSC (eż. Ultima Gold, Numru tal-katologu 6013329, Packard Instruments, USA jew ekwivalenti).
English: 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.
Maltese: HR 0.304) u 29.9 vs 54.6 xhur (p=0.015;
English: Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Maltese: IgG1 kappa monoklonali mill-ġrieden, speċifiku għall-antiġen CD20 taċ-ċellula B.
English: Febrile neutropenia, Pancytopenia*, Lymphocytopenia
Maltese: Panċitopenija*, Limfoċitopenija
English: The line must be flushed with at least 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection after the infusion of Zevalin.
Maltese: - Fażi mobbli: soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) li ma fihiex batterjostatiċi.
English: 15 MBq/kg of [
Maltese: : 11 MBq/kg.
English: Hypersensitivity reactions following Zevalin administration are commonly observed.
Maltese: Reazzjonijiet ta' sensittività eċċessiva wara għoti ta' Zevalin huma osservati b'mod komuni.
English: IBRITUMOMAB TIUXETAN SOLUTION VIAL
Maltese: • Fsada waqt tromboċitopenija
English: - patients with 100,000-150,000 platelets/mm 3: 11 MBq/kg
Maltese: pazjenti b'100,000 - 150,000 plejtlit/mm
English: Y]-Zevalin
Maltese: ZEVALIN
English: After completing induction therapy, patients were randomized to receive either Zevalin (250 mg/m 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).
Maltese: Zevalin 15 MBq/kg piż tal-ġisem f'jum 0; doża massima ta' 1200MBq; [n=208]) jew l-ebda kura oħra (kontrol; n=206).
English: From the final analysis at around 7.5 years of a study investigating the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy (Study 4, Section 5.1) of the 204 patients receiving Y-90 Zevalin following first line chemotherapy, 26 (12.7%) patients in the Zevalin arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm.
Maltese: Mill-analiżi finali wara madwar 7.5 snin ta' studju li investiga l-effikaċja u s-sigurtà talkonsolidazzjoni ta' Zevalin f'pazjenti b'limfoma follikulari fl-istat avvanzat li kienu qed jirrispondu għal kimoterapija primarja (Studju 4, Sezzjoni 5.1) tal-204 pazjent li kienu qed jirċievu Y-90 Zevalin wara kimoterapija primarja, 26 (12.7%) pazjent fil-parti tal-istudju dwar Zevalin żviluppaw it-tieni tumur malinn primarju meta mqabbla ma' 14-il pazjent (6.8%) fil-parti tal-istudju dwar il-kontroll.
English: Add approximately 0.8 ml sodium chloride 9 mg/ml (0.9%) solution to developing chamber assuring the liquid will not touch the 1.4 cm origin mark on the ITCL strip.
Maltese: 1) Żid madwar 0.8 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride ġo reċipjent fejn se jsir liżvilupp, u aċċerta li l-likwidu ma jmissx mal-marka ta' l-oriġini ta' 1.4 cm fuq l-istrippa tal-ITLC.
English: How Zevalin is given Zevalin is given by intravenous infusion (drip into a vein) usually lasting about 10 minutes.
Maltese: Zevalin jingħata permezz ta' infużjoni fil-vini (dripp ġewwa vina) li ġeneralment iddum madwar 10 minuti.
English: - Hypersensitivity to rituximab or to other murine-derived proteins.
Maltese: - Sensittività eċċessiva għal rituximab jew għal xi proteini oħra derivati mill-ġrieden
English: Pharmacotherapeutic group: Various therapeutic radiopharmaceuticals, ATC code: V10XX02
Maltese: Radjufarmaċewtiċi terapewtiċi varji, Kodiċi ATC:
English: Treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL):
Maltese: Kura ta' limfoma mhux ta' Hodgkin (NHL) taċ-ċellula B follikulari CD20+ li rkadiet jew refrattarja għall-kura b'rituximab:
English: Using a 1 ml insulin syringe with a 25- to 26-G needle, place a hanging drop (7-10 µl) of [
Maltese: 2) Bl-użu ta' siringa ta' l-insulina ta' 1 ml b'labra ta' 25 sa 26 G, poġġi qatra li taqa' waħeda (7-10 µl) ta' Zevalin radjutikkettjat b'[
English: HCl concentration
Maltese: Konċentrazzjoni ta' HCl
English: 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.
Maltese: Fi provi kliniċi bl-indikazzjoni ta' NHL li rkadiet jew refrattarja, tromboċitopenija ta' grad 3 jew 4 kienet irrapportata b'ħinijiet medjana sa' l-irkupru ta' 13 u 21 ġurnata u newtropenija ta' grad 3 jew 4 b'ħinijiet medjana sa' l-irkupru ta' 8 u 14-il ġurnata.
English: The most frequently observed adverse drug reactions in patients receiving Zevalin after pretreatment with rituximab are thrombocytopenia, leukocytopenia, neutropenia, anaemia, infections, pyrexia, nausea, asthenia, rigors, petechiae, and fatigue.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina ossevati b'mod komuni f'pazjenti li kienu qed jirċievu Zevalin wara kura minn qabel b'rituximab huma tromboċitopenija, lewkoċitopenija, newtropenija, anemija, infezzjonijiet, deni, tqalligħ, astenja, tertir, petekkja, u għeja.
English: 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.
Maltese: Bl-użu ta' siringa ta' 10 ml li għandha labra ħoxna (18-20 G), tella' l-baffer tat-taħlita li jirriżulta f'volum totali kkombinat ta' 10 ml.
English: leukocytopenia, neutropenia, anaemia )* - feeling sick (nausea) - weakness, fever, chills (rigor) - infection* - tiredness** - red pinpoint spots under the skin (petechia)**
Maltese: (tromboċitopenija, lewkoċitopenija, newtropenija, anemija)* - tħossok ma tiflaħx (tqalligħ) - debbulizza, deni, sirdat (tertir) - infezzjoni* - għeja** - tbajja ħomor irqaq taħt il-ġilda (petekja)**
English: Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Maltese: Yttrium-90 jiddegrada billi jarmi partiċelli beta ta' enerġija qawwija, li għandhom half-life fiżika ta' 64.1 siegħa (2.67 ġranet).
English: Zevalin is a kit for the preparation of the active substance ibritumomab tiuxetan [
Maltese: Zevalin huwa sett għall-preparazzjoni tas-sustanza attiva ibritumomab tiuxetan [
English: Zevalin contains sodium
Maltese: Zevalin fih is-sodium
English: 3; or neutrophil count <1,500
Maltese: 3; jew għadd ta' newtrofili <1500 ċelluli/mm
English: Refractory or relapsed NHL:
Maltese: NHL refrattarja jew li rkadiet:
English: Y] ibritumomab tiuxetan in a total volume of 10 ml.
Maltese: f'volum totali ta' 10 ml.
English: Meningioma
Maltese: Meninġjoma
English: Bacterial endotoxins
Maltese: Endotossini tal-batterji
English: Y]-radiolabelled Zevalin, the median serum effective half-life of ibritumomab tiuxetan [
Maltese: Y], il-half-life effettiva medjana fis-serum ta'
English: Y]-radiolabelled Zevalin.
Maltese: Mediċini oħra u Zevalin
English: Y] 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/mm
Maltese: Y], kienu definiti aktar fit-tielet studju fejn ħadu sehem total ta' 30 pazjent li kellhom tromboċitopenija ħafifa (għadd tal-plejtlits ta' 100,000 sa 149,000 ċelluli/mm
English: However, after Yttrium-90 is added, adequate shielding of the final preparation must be maintained.
Maltese: Madankollu, wara li Yttrium-90 jiżdied, protezzjoni adegwata tal-preparazzjoni finali trid tinżamm.
English: Study 1 was a single-arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Maltese: Studju 1 kien studju bi grupp wieħed fuq 54 pazjent, b'limfoma follikulari li rkadiet, refrattarja għallkura b'rituximab.
English: Seven patients (3.4%, 7/204) were diagnosed with MDS/AML after receiving Zevalin, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years.
Maltese: Seba' pazjenti (3.4%, 7/204) ġew iddijanjostikati b'MDS/AML wara li rċivew Zevalin, meta mqabbla ma' pazjent wieħed (0.5%, 1/205) fil-parti tal-istudju dwar il-kontroll, b'follow-up medjan ta' 7.3 snin.
English: Marketing Authorisation Holder Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Maltese: Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200 1097 JB Amsterdam L-Olanda
English: Tumour pain, Myelodysplastic syndrome/Acute myeloid leukaemia*, **
Maltese: Sindrome mijelodisplastika/ Lewkimja majelojda akuta *,
English: The maximum dose must not exceed 1200 MBq.
Maltese: Id-doża massima m'għandhiex taqbes 1200 mBq.
English: In]-radiolabelled Zevalin was always given immediately following an infusion with rituximab at 250 mg/m² to deplete peripheral CD20+ cells and to optimise biodistribution.
Maltese: IN] ingħatat eżatt wara l-infużjoni ta' rituximab 250 mg/m sabiex inaqqas ħafna lgħadd ta'ċelluli periferali li għandhom l-antiġen CD20+ u biex itejjeb il-bijodistribuzzjoni.
English: Y occurs in a radius of 5 mm around the isotope.
Maltese: Y isseħħ f'raġġ ta' 5 mm madwar l-isotopu.
English: Radionuclidic purity strontium-90 content
Maltese: Purità radjunuklidika tal-kontenut ta' strontium-90  0.74
English: Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Maltese: Y], huwa indikat għall-kura ta' pazjenti adulti b'limfoma mhux ta' Hodgkin (NHL) taċ-ċellula B follikulari CD20+ li rkadiet jew refrattarja wara kura b'rituximab.
English: Spot one strip at a time and run three ITLC strips.
Maltese: Immarka strippa waħda kull darba u rrepeti tliet strippi ta' ITLC.
English: • Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Secondary malignancies
Maltese: • Neoplażmi beninni, malinni u dawk mhux speċifikati (inkluż ċesti u polipi) - Kanċer malinn sekondarju
English: Side effects for which frequency is not known: - reaction of the skin and mucous membranes (including Stevens-Johnson Syndrome)* - leakage of the infusion to the surrounding tissue (extravasation), causing skin inflammation (infusion site dermatitis) and shedding (infusion site desquamation) or injection site ulcers - tissue damage around tumours of the lymph system and complications due to swelling of such tumours
Maltese: Effetti sekondarji li għandhom frekwenza mhux magħrufa: - reazzjoni tal-ġilda u tal-membrani mukużi (inkluż is-Sindrome Stevens-Johnson)* - nixxija ta' l-infużjoni fit-tessut tal-madwar (ekstravasazzjoni), li tikkawża infjammazzjoni filġilda (dermatite fis-sit ta' l-infużjoni) u tqaxxir (deskwamazzjoni fis-sit ta' l-infużjoni) jew ulċeri fis-sit ta' l-infużjoni - ħsara lit-tessut madwar it-tumuri tas-sistema tal-limfa u komplikazzjonijiet ikkawżati minn nefħa ta' tumuri bħal dawn
English: Nausea
Maltese: Petekja
English: The overall safety profile of Zevalin after pretreatment with rituximab is based on data from 349 patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma studied in five clinical trials, on data from a study with 204 patients receiving Zevalin as consolidation therapy after first-line remission induction, and from post-marketing surveillance.
Maltese: Il-profil tas-sigurtà globali ta' Zevalin wara kura minn qabel b'rituximab huwa bbażat fuq tagħrif minn 349 pazjent b'limfoma mhux ta' Hodgkin ta' grad baxx, follikulari jew taċ-ċellula B ittrasformata li rkadiet jew refrattarja studjati f'ħamses provi kliniċi, fuq tagħrif minn studju b'204 pazjent li rċevewZevalin bħala terapija konsolidata wara induzzjoni ta' remissjoni primarja, u minn sorveljanza ta' wara t-tqegħid fis-suq.
English: • Contraception
Maltese: • Kontraċezzjoni
English: For instructions on extemporary preparation of the medicinal product before administration,see section 12.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni extemporanja tal-prodott mediċinali qabel l-għoti, ara sezzjoni 12.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Maltese: Esponiment għal radjazzjoni hi marbuta ma' induzzjoni ta' kanċer u potenzjal għall-iżviluppi ta' difetti ereditarji.
English: The maximum dose must not exceed 1200 MBq (‘megabecquerel', a unit to measure radioactivity).
Maltese: MBq (‘megabecquerel', unità biex tkejjel ir-radjuattività).
English: For storage conditions of the radiolabelled product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali radjutikkettjat, ara sezzjoni 6.3. 6.5
English: * fatal outcome has been observed ** has been observed in a study with 204 patients receiving Zevalin as consolidation after first-line remission induction
Maltese: * kien osservat riżultat fatali ** kien osservat fi studju b'204 pazjenti li rċevew Zevalin bħala terapija ta' konsolidazzjoni wara l-induzzjoni ta' remissjoni primarja
English: • Human anti-murine antibodies
Maltese: *antikorp monoklonali
English: Following Zevalin as consolidation after first line remission induction the median times to recovery was 20 days and 35 days for grade 3 or 4 thrombocytopenia and 20 days and 28 days for grade 3 or 4 neutropenia.
Maltese: Wara l-għoti ta' Zevalin bħala konsolidazzjoni wara induzzjoni ta' remissjoni primarja il-ħinijiet medjana sa' lirkupru kienu 20 ġurnata u 34 ġurnata għal tromboċitopenija ta' grad 3 jew 4 u 20 ġurnata u 28 ġurnata għal newtropenija ta' grad 3 jew 4.
English: The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
Maltese: Issekwenza ta' twaħħil hija ristretta ħafna, mingħajr cross-reactivity ma' lewkoċiti oħra jew ma' tipi oħra ta' tessuti umani.
English: In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
Maltese: IN] li jarmi raġġi gamma, bil-ġbir ta' kampjuni tad-demm u bl-użu talprogramm tal-kompjuter MIRDOSE3.
English: Y]-Zevalin activity per body weight (11 MBq/kg) was used.
Maltese: Y] aktar baxxa għall-piż tal-ġisem (11.1 MBq/kg).
English: 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.
Maltese: Fi prova klinika fejn Zevalin ingħata bħala konsolidazzjoni wara kimoterapija preferita minn qabel, kienet osservata frekwenza ogħla ta' newtropenija u ta' tromboċitopenija severa u mtawwla f'pazjenti li rċevew Zevalin fi żmien 4 xhur wara kimoterapija kombinata ta' fludarabine flimkien ma' mitoxantrone u/jew cyclophosphamide meta mqabbel ma' dawk il-pazjenti li rċevew xi kimoterpaija oħra.
English: Median TTP (Months) [Range
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Y]-radiolabelled Zevalin after pretreatment with rituximab could cause toxic effects on the male and female gonads (see sections 4.4 and 4.6).
Maltese: Y] wara kura minn qabel b'rituximab jista' jikkawża effetti tossiċi lill-organi riproduttivi ta' l-irġiel u n-nisa (ara sezzjonijiet 4.4 u 4.6).
English: Day 1: intravenous infusion of 250 mg/m rituximab.
Maltese: Y] fl-ordni li ġej: Ġurnata 1: infużjoni fil-vini ta' 250 mg/m rituximab.
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. adrenaline, antihistamines and corticosteroids, must be available for immediate use in the event of an allergic reaction during administration of rituximab or Zevalin.
Maltese: Prodotti mediċinali għall-kura ta' reazzjonijiet ta' sensittività eċċessiva, eż. adrenaline, antistamini, u kortikosterojdi, għandhom ikunu disponibbli għall-użu immedjat f'każ ta' reazzjoni allerġika waqt lgħoti ta' rituximab jew ta' Zevalin.
English: Y]radiolabelled Zevalin onto the ITLC strip at its origin.
Maltese: Y] fuq l-istrippa ta' l-ITLC.
English: Kit for radiopharmaceutical preparations for infusion.
Maltese: Sett għall-preparazzjonijiet radjufarmaċewtiċi għall-infużjoni.
English: The PRAC considered that the information on myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) in section 4.8 of the SmPC should be further clarified.
Maltese: Il-PRAC ikkunsidra li l-informazzjoni dwar is-sindrome mijelodisplastika (MDS)/ lewkimja majelojda akuta (AML) f'sezzjoni 4.8 tal-SmPC għandha tiġi ċċarata aktar.
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads (see sections ‘4.4 and 5.2).
Maltese: Y] tista' tikkawża effetti tossiċi fuq l-organi riproduttivi tan-nisa u ta' l-irġiel (ara sezzjonijiet ‘4.4 u 5.2).
English: • Infections and infestations - Data from 349 patients with relapsed or refractory low-grade, follicular lymphoma, or transformed non-Hodgkin's lymphoma studied in five trials:
Maltese: • Infezzjonijiet u infestazzjonijiet - Tagħrif minn 349 pazjent b'limfoma follikulari ta' grad baxx, li rkadiet jew refrattarja, jew limfoma mhux ta' Hodgkin ittrasformata, studjati f'ħames provi:
English: Chloride identification
Maltese: Identifikazzjoni ta' chloride
English: Ibritumomab tiuxetan vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Maltese: Kunjett fejn issir ir-reazzjoni: kunjett tal-ħġieġ tip I b'tapp tal-gomma (bromobutyl miksi bit-teflon).
English: The isotope yttrium-90 is a pure β-emitter and has a mean path length of about 5 mm.
Maltese: L-isotopu yttrium-90 jarmi radjazzjoni β pura li twassal distanza medja ta' madwar 5 mm.
English: 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/mm
Maltese: Studju 3 kien studju bi grupp wieħed li sar fuq 30 pazjent b'NHL ta' grad baxx, follikulari,jew taċċellula B ittrasformata li rkadiet jew refrattarja, li kellhom tromboċitopenija ħafifa (għadd ta' plejtlits 100,000 sa 149,000 ċelluli/mm
English: *recombinant murine IgG1 monoclonal antibody produced by DNA technology in a Chinese hamster ovary (CHO) cell line and conjugated to the chelating agent MX-DTPA.
Maltese: IgG1 mill-ġrieden magħmul permezz ta' teknoloġija tad-DNA f'linja ta' ċelluli meħudin mill-ovarju tal-ħamster ċiniż (CHO) u mwaħħal mas-sustanza kelanti MXDTPA.
English: Arthralgia, Myalgia, Back pain, Neck pain
Maltese: Artralġja, Majalġja, Uġigħ ta' dahar, Uġigħ fl-għonq
English: It may be necessary to perform a dilution (1:100) before application of the [
Maltese: Jista' jkun hemm bżonn li l-prodott jiġi dilwit (1:100) qabel ma jiġi applikat Zevalin radjutikkettjat b'[
English: • Infection
Maltese: • Infezzjoni
English: In most patients, administration of Zevalin (after pretreatment with rituximab) results in severe and prolonged cytopenia which is generally reversible (see section 4.8).
Maltese: Fil-maġġoranza talpazjenti, l-għoti ta' Zevalin (wara kura minn qabel b'rituximab) twassal għal ċitopenija severa u fit-tul li ġeneralment hija riversibbli (ara sezzjoni 4.8).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ibritumomab tiuxetan, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal ibritumomab tiuxetan, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Y]-radiolabelled Zevalin solution contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Maltese: Dan il-prodott mediċinali jista' jkun fih sa 28 mg sodium f'kull doża, skont il-konċentrazzjoni ta' radjuattività.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Ibritumomab tiuxetan solution Intravenous infusion, after preparation.
Maltese: Zevalin 1.6 mg/ml, sett għall-preparazzjonijiet radjufarmaċewtiċi għall-infużjoni Ibritumomab tiuxetan [90Y]
English: Remove ITLC strip and cut in half at the 3.5 cm cut line.
Maltese: 4) Neħħi l-istrippa ta' l-ITLC u aqsamha minn nofs, mil-linja ta' qtugħ ta' 3.5 cm.
English: Below limit of quantitation*
Maltese: Inqas mill-limitu ta' kwantifikazzjoni*
English: In]-radiolabelled ibritumomab tiuxetan predicted acceptable radiation to normal human tissue with limited levels of skeleton and bone marrow radiation.
Maltese: In] bassret radjazzjoni aċċettabli għat-tessuti umani b'livelli ta' radjazzjoni fl-għadam u fil-mudullun limitati.
English: Severe (Grade 3/4) hypersensitivity reactions including anaphylaxis occur in less than 1% of patients (see also section ‘Special warnings and precautions for use').
Maltese: Reazzjonijiet ta' sensittività eċċesiva severi (Grad 3/4 ) inkluż anafilassi jseħħu f'inqas minn 1% tal-pazjenti (ara wkoll ‘Twissijiet speċjali u prekawzjonijiet għall-użu).
English: Stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Maltese: Stabbiltà kienet dimostrata għal 8 sigħat f'temperatura ta' 2C - 8C u jekk ikun protett mid-dawl.
English: Severe mucocutaneous reactions, including Stevens-Johnson Syndrome, some with fatal outcome, have been reported in association with Zevalin after pretreatment with rituximab.
Maltese: Reazzjonijiet mukokutanji severi , inkluż is-sindrome Stevens-Johnson, uħud b'riżultat fatali, kienu irrapportati b'assoċjazzjoni ma' Zevalin wara kura minn qabel b'rituximab.
English: Urinary Bladder Wall3
Maltese: Ġisem kollu3
English: Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Maltese: Y], għandu jiġi riċevut, immaniġġjat u mogħti minn persuni kkwalifikati biss u għandu jiġi ppreparat skont il-ħtiġijiet ta' sigurtà mir-radjazzjoni u ta' kwalità farmaċewtika (għal aktar dettalji ara wkoll sezzjonijiet 4.4, 6.6 u 12).
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Maltese: Stabbiltà kimika u fiżika waqt l-użu kienet dimostrata għal 8 sigħat f'temperatura ta' 2C - 8C u jekk ikun protett mid-dawl.
English: - Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għal ibritumomab tiuxetan, għal yttrium chloride, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Empty
Maltese: Tqala
English: Empty reaction vial (10 ml)
Maltese: Kunjett vojt fejn issir ir-reazzjoni (10 ml)