FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium acetate vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Maltese: Kunjett ta' sodium acetate: kunjett tal-ħġieġ tip I b'tapp tal-gomma (bromobutyl miksi bit-teflon) li fih soluzzjoni ta' 2 ml.
English: You will be given a total of 3 infusions in the course of two visits to a medical facility, 7 to 9 days apart.
Maltese: Se tingħata total ta' 3 infużjonijiet imqassma bejn żewġ visti fil-fakulta medika, 7 sa 9t ijiem bogħod minn xulxin.
English: Before radiolabelling, bring refrigerated Zevalin cold kit to room temperature 25°C.
Maltese: Qabel ir-radjutikkettjar, oħroġ is-sett kiesaħ ta' Zevalin mill-friġġ u stenna sakemm jilħaq temperatura tal-kamra, 25ºC.
English: Y) radiolabelled ibritumomab tiuxetan.
Maltese: Kunjett wieħed ta' ibritumimab tiuxetan.
English: Zevalin is not recommended for use in children below age 18 since safety and efficacy have not been established.
Maltese: Zevalin mhux irrakkomandat għall-użu fi tfal taħt l-età ta' 18-il sena peress li s-sigurtà u l-effikaċja ma ġewx stabbiliti.
English: *murine IgG1 monoclonal antibody produced by recombinant 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 tat-tfassil tad-DNA f'linja ta' ċelluli tal-ovarju tal-ħamster ċiniż (CHO) u mwaħħal mas-sustanza kelanti MX-DTPA.
English: Sepsis*, Pneumonia*, Urinary tract infection, Oral candidiasis
Maltese: Infezzjoni* Sepsi*, Pnewmonja*, Infezzjoni flapparat ta' lawrina,
English: This medicine contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Maltese: Din il-mediċina fiha sa 28 mg ta' sodium f'kull doża, skont il-konċentrazzjoni ta' radjuattività.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (MedDRA).
Maltese: Ir-reazzjonijiet avversi mniżżla isfel huma kklassifikati skont il-frekwenza u s-Sistema tal-Klassifika tal-Organi (MedDRA).
English: Limited data in elderly patients (aged ≥ 65 years) are available.
Maltese: Hemm disponibbli tagħrif limitat f'pazjenti anzjani (età ≥ 65 sena).
English: Vascular disorders Petechiae**
Maltese: Pressjoni baxxa**
English: • extravasation (leakage of the infusion to the surrounding tissue): pain, burning sensation, stinging or another reaction at the infusion site during administration.
Maltese: • ekstravasazzjoni (nixxija ta' l-infużjoni fit-tessut tal-madwar): uġigħ, sensazzjoni ta' ħruq, tingiż jew reazzjoni oħra fis-sit ta' l-infużjoni waqt l-għoti.
English: Uncommon Rare
Maltese: Effetti sekondarji rari:
English: (radiolabelling).
Maltese: (xhur)
English: Flu-like symptoms, Malaise,
Maltese: Sintomi jixbħu lill-influwenza, Telqa,
English: A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/m weekly times 4 doses.
Maltese: Total ta' 73 pazjent ingħataw il-kors terapewtiku ta' Zevalin, u 70 pazjent irċevew rituximab li ngħata bħala infużjoni fil-vini ta' 375 mg/mm2 darba fil-gimgħa għal 4
English: • Risk Management Plan (RMP) 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 agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fil-Pjan ta' Farmakoviġilanza, kif maqbul f'verżjoni 1.1 tal-Pjan tal-Ġestjoni tar-Riskju (RMP) ippreżentat filModulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Median progression free survival (PFS) was calculated at a median follow-up of 2.9 years.
Maltese: Iż-żmien medjan ta' sopravivenza mingħajr progressjoni (PFS) ġiet ikkalkulata b'follow-up medja ta' 2.9 snin.
English: Adrenals Brain
Maltese: Adrenali
English: The prepared solution must be given as a slow intravenous infusion over 10 minutes.
Maltese: Is-soluzzjoni ppreparata għandha tingħata bħala infużjoni bil-mod fil-vini fuq medda ta' 10 minuti.
English: Formulation buffer vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 10 ml solution.
Maltese: Kunjett tal-baffer għat-taħlita: kunjett tal-ħġieġ tip I b'tapp tal-gomma (bromobutyl miksi bit-teflon) li fih soluzzjoni ta' 10 ml.
English: If the average radiochemical purity is less than 95%, the preparation must not be administered.
Maltese: Jekk il-purità medja radjukimika hija inqas minn 95%, il-preparazzjoni m'għandhiex tingħata.
English: Stomach Thymus
Maltese: Peress li
English: One vial contains 3.2 mg ibritumomab tiuxetan* to be diluted in 2 ml solution (1.6 mg per ml).
Maltese: Kunjett wieħed fih 3.2 mg ibritumomab tiuxetan* li għandu jiġi dilwit f'2 ml ta' soluzzjoni (1.6 mg kull ml).
English: Zevalin is used to treat patients suffering from specific subgroups of B-cell non-Hodgkin's lymphoma (CD20+ indolent or transformed B-cell NHL) if an earlier rituximab, another monoclonal antibody, treatment has not worked, or has stopped working (refractory or relapsed disease).
Maltese: Zevalin jintuża biex jikkura pazjenti li qed isofru minn sottogruppi speċifiċi ta' limfoma mhux ta' Hodgkin taċ-ċellula B (CD20+ indolenti jew NHL taċ-ċellula B ittrasformata) jekk kura minn qabel b'rituximab, antikorp monoklonali ieħor, ma ħadmitx, jew waqfet taħdem (marda li ma rrispondietx jew irkadiet).
English: • Blood and lymphatic system disorders
Maltese: • Disturbi tad-demm u tas-sistema limfatika
English: Directions for radio-labelling of Zevalin with yttrium-90:
Maltese: Kriterji maġġuri għall-inklużjoni kienu:
English: Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes.
Maltese: Ibritumomab tiuxetan jaqbad ma' l-antiġen CD20, li jinsab fuq ilwiċċ tal-limfoċiti B malinni kif ukoll fuq dawk normali.
English: Formulation buffer vial: Clear yellow to amber coloured solution.
Maltese: Soluzzjoni ċara safra sa ambra.
English: - One formulation buffer glass vial, with 10 ml clear, yellow to amber coloured solution.
Maltese: - Kunjett tal-ħġieġ ta' baffer għat-taħlita, b'10 ml ta' soluzzjoni safra sa ambra.
English: These adverse drug reactions are based upon 349 patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma studied in 5 clinical trials.
Maltese: Dawn irreazzjonijiet avversi tal-mediċina huma bbażati fuq 349 pazjent b'limfoma mhux ta' Hodgkin ta' grad baxx, follikulari jew taċ-ċellula B ittrasformata, li rkadiet jew refrattarja, studjati f'5 provi kliniċi.
English: If you are given Zevalin less than 4 months after chemotherapy containing the active substance fludarabine, you may have a higher risk of having a reduced number of blood cells.
Maltese: Jekk tingħata Zevalin inqas minn 4 xhur wara kimoterapija li fiha s-sustanza attiva fludarabine, jista' jkollok riskju ogħla li jkollok numru mnaqqas ta' ċelluli tad-demm.
English: • Severe mucocutaneous reactions
Maltese: • Reazzjonijiet mukokutanji severi
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion
Maltese: Zevalin 1.6 mg/ml, sett għall-preparazzjonijiet radjufarmaċewtiċi għall-infużjoni
English: The description of the ADR in the same section of the SmPC should be amended accordingly to clarify which statements relate to each of the two indications (consolidation therapy in follicular lymphoma vs relapsed or refractory Non-Hodgkin's lymphoma (NHL)).
Maltese: Id-deskrizzjoni tal-ADR fl-istess sezzjoni tal-SmPC għandha tiġi emendata kif xieraq sabiex jiġi ċċarat liema dikjarazzjonijiet jirrelataw għal kull waħda miż-żewġ indikazzjonijiet (terapija ta' konsolidazzjoni f'limfoma follikulari kontra limfoma mhux ta' Hodgkin (NHL)) li rkadiet jew refrattarja.
English: Infections were very commonly observed.
Maltese: Infezzjonijiet kienu osservati b'mod komuni ħafna.
English: Y]- or
Maltese: Y].
English: Table 1: Adverse drug reactions reported in clinical trials or during post-marketing surveillance in patients treated with Zevalin after pretreatment with rituximab
Maltese: Tabella 1: Reazzjonijiet avversi tal-mediċina rrapportati fi provi kliniċi jew waqt sorveljanza ta' wara t-tqegħid fis-suq f'pazjenti kkurati b'Zevalin wara kura minn qabel b'rituximab
English: Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Maltese: Y] ippreparat għandha tiġi analizzata skond il-proċedura mniżżla taħt.
English: Positive
Maltese: EFFETTI
English: • infections of the lung (pneumonia): breathing difficulties
Maltese: • infezzjoniet tal-pulmun (pnewmonja): diffikultajiet biex tieħu nifs
English: net CPM bottom half x 100 net CPM top half + net CPM bottom half
Maltese: Is-CHMP jaqbel mal-konklużjonijiet xjentifiċi magħmula mill-PRAC.
English: Irradiation by the emitted beta particles from
Maltese: Irridazzjoni mill-partiċelli beta mormija minn
English: You must not be given Zevalin: - if you are allergic (hypersensitive) to any of the following: ibritumomab tiuxetan, yttrium chloride or to any of the other ingredients of Zevalin (listed in section 6 ‘What Zevalin contains') rituximab or other murine-derived proteins - if you are pregnant or breast-feeding (see also section “pregnancy and breast feeding”).
Maltese: M'għandekx tingħata Zevalin: - jekk inti allerġiku (għandek sensittività eċċessiva) għal xi wieħed minn dawn: ibritumomab tiuxetan, yttrium chloride jew sustanzi oħra ta' Zevalin (elenkati f'sezzjoni 6 ‘X'fih Zevalin') rituximab jew proteini oħra li ġejjin mill-ġrieden - jekk inti tqila jew qed tredda' (ara wkoll sezzjoni “tqala u treddigħ”).
English: • Severe mucocutaneous reactions (see also ‘Special warnings and precautions for use')
Maltese: • Reazzjonijiet mukokutanji severi (ara wkoll ‘Twissijiet speċjali u prekawzjonijiet għall-użu')
English: Study 4 investigated the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy.
Maltese: 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.
English: Radiochemical purity of the yttrium-90 chloride solution
Maltese: Purità radjukimika tas-soluzzjoni ta' chloride ta' yttrium-90
English: Sodium acetate vial: Sodium acetate Water for injections
Maltese: Sodium acetate Ilma għall-injezzjonijiet
English: Assay procedure:
Maltese: Użu ripetut:
English: • Severe and prolonged cytopenias (see also ‘Special warnings and precautions for use')
Maltese: • Ċitopeniji severi u mtawwla (ara wkoll ‘Twissijiet speċjali u prekawzjonijiet għall-użu')
English: Severe hypersensitivity reactions including anaphylaxis occur in < 1 % of patients (see also section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jinkludu anafilassi jseħħu f'< 1% tal-pazjenti (ara wkoll sezzjoni 4.8).
English: Deaths due to second primary malignancy included 8 (3.9%) patients in the Zevalin arm compared to 3 (1.5%) patients in the control arm.
Maltese: Imwiet minħabba t- tieni tumuri malinni primarji kienu jinkludu 8 (3.9%) pazjenti fil-parti tal-istudju dwar Zevalin meta mqabbla ma' 3 (1.5%) pazjenti fil-parti tal-istudju dwar il-kontroll.
English: Y]-radiolabelled Zevalin also leads to depletion of normal CD20+ B-cells.
Maltese: Y] iwassal ukoll għal tnaqqis taċ-ċelluli B normali li għandhom lantiġen CD20.
English: - On day 1 you will be given one rituximab infusion - On day 7, 8, or 9 you will be given one rituximab infusion, followed by one Zevalin infusion shortly afterwards (within 4 hours).
Maltese: - Fl-ewwel ġurnata se tingħata infużjoni waħda ta' rituximab - Fi ġranet 7, 8, jew 9 se tingħata infużjoni waħda ta' rituximab, segwita ftit wara (fi żmien 4 sigħat) minn infużjoni waħda ta' Zevalin.
English: Grade 3 and grade 4 infections were reported commonly.
Maltese: Infezzjonijiet ta' Grad 3 u grad 4 kienu rrapportati b'mod komuni.
English: Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting (see also section ‘Special warnings and precautions for use').
Maltese: Tossiċità fid-demm kienet osservata b'mod komuni ħafna fil-provi kliniċi, u hija limitata mid-doża (ara wkoll sezzjoni ‘Twissijiet speċjali u prekawzjonijiet għall-użu').
English: • allergic (hypersensitivity) reactions/infusion reactions: symptoms for allergic reactions/ infusion reactions may be skin reactions, breathing difficulties, swelling, itching, flushing, chills, dizziness (as potential sign for low blood pressure).
Maltese: • reazzjonijiet allerġiċi (sensittività eċċessiva)/reazzjonijiet għall-infużjoni: sintomi ta' reazzjonijiet allerġiċi/ reazzjonijiet għall-infużjoni jistgħu jkunu reazzjonijiet fil-ġilda, diffikultajiet biex tieħu nifs, nefħa, ħakk, fwawar, sirdat, sturdament (bħala sinjal potenzjali ta' pressjoni baxxa).
English: Rash, Pruritus
Maltese: Sturdament, Uġigħ ta' ras
English: Consolidation therapy after remission induction in previously untreated patients with follicular lymphoma patients with ≥ 150,000 platelets/mm³: 15 MBq/kg up to a maximum of 1200 MBq for patients with less than 150,000 platelets per mm³ see section ‘4.4' Repeated use: Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.
Maltese: Terapija ta' konsolidazzjoni wara l-induzzjoni ta' remissjoni f'pazjenti b'limfoma follikulari li ma kienux ikkurati minn qabel pazjenti b'≥ 150,000 plejtlit/mm
English: - pain; flu-like symptoms; generally feeling unwell (malaise), swelling caused by build-up of fluid in the arms and legs and other tissues (peripheral oedema); increased sweating - high blood pressure (hypertension)** - low blood pressure (hypotension)** - absence of menstruation (amenorrhea)**
Maltese: stitikezza - raxx; ħakk (prurite) - uġigħ fil-ġogi (artralġja) muskoli juġgħu (majalġja); uġigħ fid-dahar; uġigħ fl-għonq - uġigħ; sintomi li jixbħu lill-influwenza; tħossok ma tiflaħx b'mod ġenerali (telqa), nefħa kkawżata minn akkumulazzjoni ta' fluwidu fid-dirgħajn u r-riġlejn u f'tessuti oħra (edima periferali); żjieda fl-għaraq - pressjoni għolja (ipertensjoni)**
English: The adverse drug reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known“.
Maltese: Ir-reazzjonijiet avversi tal-mediċina identifikati biss waqt is-sorveljanza ta' wara t-tqegħid fissuq, u li għalihom ma setgħetx tiġi stmata frekwenza, huma mniżżla taħt “mhux magħruf”.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Sodium acetate solution
Maltese: Sett ta' Zevalin 1.6 mg/ml għall-preparazzjonijiet radjufarmaċewtiċi Soluzzjoni ta' sodium acetate
English: You may need to read it again.
Maltese: Ansjetà, Nuqqas ta' rqad
English: Range
Maltese: DOŻIMETRIJA
English: There are no known interactions with other medicinal products.
Maltese: Mhux magħruf li din il-mediċina ma taqbilx ma xi prodotti mediċinali oħra.
English: The frequencies of the adverse drug reactions which were considered to be at least possibly related to Zevalin after pretreatment with rituximab are represented in the table below.
Maltese: Il-frekwenza tar-reazzjonijiet avversi tal-mediċina li kienu kkunsidrati li huma ta' l-inqas possibilment relatati ma' Zevalin wara kura minn qabel b'rituximab huma rappreżentati fit-tabella isfel.
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads.
Maltese: Y] tista' tikkawża effetti tossiċi fuq l-organi riproduttivi tal-mara u tar-raġel.
English: to deliver radiation more specifically to the lymphoma B-cells.
Maltese: - Reċipjent fejn se tiġi żviluppata l-kromatografija.
English: Zevalin attaches to a protein (CD20) on the surface of certain white blood cells (B-cells) and kills them by irradiation.
Maltese: Zevalin jeħel ma' proteina (CD20) li tinstab fuq il-wiċċ ta' ċertu ċelluli bojod tad-demm (ċelluli B) u toqtolhom permezz ta' irradjazzjoni.
English: Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling
Maltese: Hemm riskju potenzjali li radjazzjoni jonizzanti minn Zevalin tista' tagħmel ħsara lill-ovarji u littestikoli.
English: On the basis of the scientific conclusions for ibritumomab tiuxetan the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ibritumomab tiuxetan is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għal ibritumomab tiuxetan is-CHMP huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodott(i) mediċinali li fih/fihom ibritumomab tiuxetan ma' nbidilx suġġett għall-bidliet proposti għall-informazzjoni tal-prodott.
English: The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Maltese: Il-kors terapewtiku ta' Zevalin ingħata f'żewġ fażijiet (ara 4.2).
English: Y forms a stable complex with ibritumomab tiuxetan, the biodistribution of the radiolabel follows the biodistribution of the antibody.
Maltese: Materjali kontaminati għandhom jintremew bħala skart radjuattiv permezz tal-metodu awtorizzat.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Formulation buffer solution
Maltese: Sett ta' Zevalin 1.6 mg/ml għall-preparazzjonijiet radjufarmaċewtiċi Soluzzjoni ta' baffer għat-taħlita
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2)
English: - neutrophil counts < 1,500/mm - prior bone marrow transplant or stem cell support
Maltese: - għadd ta' newtrofili < 1,500/mm
English: The kit allows the coupling of antibody ibritumomab tiuxetan with the radioactive isotope yttrium
Maltese: Dan il-fuljett huwa disponibbli fil-lingwi kollha tal-UE fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini.
English: Using a 2-3 ml sterile syringe, transfer 1.3 ml ibritumomab tiuxetan solution to the reaction vial.
Maltese: Bl-użu ta' siringa sterili ta' 2-3 ml ittrasferixxi 1.3 ml ta' soluzzjoni ta' ibritumomab tiuxetan ġolkunjett fejn se ssir ir-reazzjoni.
English: Bone Surfaces Ovaries
Maltese: Ż-ŻGĦAR EWLENIN
English: The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 2).
Maltese: Il-mira principali ta' l-effikaċja ta' l-istudju kienet li tkun determinata l-ORR bl-użu talIWRC (ara tabella 2).
English: Myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) has been reported in eleven out of 211 patients with relapsed or refractory NHL assigned to treatment with Zevalin in four studies.
Maltese: F'erba' studji, ħdax minn 211-il pazjent b'NHL refrattarja jew li rkadiet, li ġew assenjati għall-kura b'Zevalin, kienu rrappurtati s-Sindrome mijelodisplastika (MDS)/ lewkimja majelojda akuta (AML).
English: The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Maltese: Is-sigurtà u l-effikaċja tal-kors terapewtiku ta' Zevalin kienu stmati f'żewġ provi b'aktar minn ċentru wieħed fejn ħadu sehem total ta'197 persuna.
English: SODIUM ACETATE VIAL
Maltese: KUNJETT TA' SODIUM ACETATE
English: Organ region of interest Sacrum region of interest Whole body region of interest
Maltese: Parti mill-organu ta' interess Parti mis-sakrum ta' interess Parti mill-ġisem sħiħ ta' interess
English: D-82377 Penzberg Germany
Maltese: D-82377 Penzberg
English: Date of latest renewal: 15 May 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2007 Data tal-aħħar tiġdid: 15 ta' Mejju 2012
English: EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 EU/1/07/400/024
Maltese: EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018
English: In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were aged 75 years and over.
Maltese: Fi istudji kliniċi 24% tal-pazjenti kkurati b'MIRCERA kellhom età ta' 65 sa 74 sena, waqt li 20%
English: Adverse reactions observed only during post-marketing are marked (*).
Maltese: Reazzjonijiet avversi osservati biss wara t-tqegħid fis-suq huma mmarkati (*).
English: Adverse reactions in Table 2 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi f'Tabella 2 huma elenkati skont is-sistema tal-klassifika tal-organi MedDRA u l-kategorija ta' frekwenza.
English: Step5.
Maltese: Pass 5.
English: Rash, maculopapular
Maltese: Raxx makulopapulari
English: Analysis of the individual components of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), stroke 1.92 (1.38, 2.68), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Maltese: Analiżi tal-komponenti ndividwali tad-diversi punti finali uriet l-HR (CI ta' 95%) li ġejjin: mewt 1.05 (0.92, 1.21), puplesija 1.92 (1.38, 2.68), insuffiċjenza konġestiva tal-qalb (CHF) 0.89 (0.74, 1.08), infart mijokardijaku (MI) 0.96 (0.75, 1.23), dħul l-isptar minħabba iskemija mijokardijaka 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
English: A post-authorisation safety study showed similar incidence rate of stroke between MIRCERA (6.3%) and reference ESAs groups (epoetin alfa, darbepoetin alfa and epoetin beta) (7%).
Maltese: Studju dwar is-sigurtà wara l-awtorizzazzjoni wera inċidenza simili ta' puplesija bejn il-gruppi ta' MIRCERA (6.3%) u ta' ESAs ta' referenza (epoetin alfa, darbepoetin alfa u epoetin beta) (7%).
English: Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F).
Maltese: Dejjem aħżen is-siringa fi friġġ f'temperatura ta' 2 - 8°C (35.6 - 46.
English: Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.
Maltese: Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 u ilma għall-injezzjonijiet.
English: Thrombosis*
Maltese: Trombożi*
English: Stevens-Johnson syndrome / toxic epidermal necrolysis*
Maltese: Mhux magħrufa Sindrome ta' Stevens-Johnson / nekrolisi tossika tal-epidermide*
English: Frequency categories are defined using the following convention: very common (³1/10); common (³1/100 to <1/10); uncommon (³1/1,000 to <1/100); rare (³1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (³1/10); komuni (³1/100 sa <1/10); mhux komuni (³1/1,000 sa <1/100); rari
English: Its use is limited to adult patients (aged 18 years or older).
Maltese: L-użu tiegħu huwa limitat għal pazjenti adulti (età minn 18-il sena 'l fuq).
English: MIRCERA is a medicine produced by gene-technology.
Maltese: MIRCERA hija mediċina prodotta permezz ta' teknoloġija tal-geni.
English: Risk Management plan (RMP)
Maltese: Pjan tal-Ġestjoni tar-Riskju (RMP)
English: (b) Tabulated list of adverse reactions
Maltese: (b) Lista f'tabella tar-reazzjonijiet avversi
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA03
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet oħra kontra l-anemija, Kodiċi ATC:
English: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).
Maltese: Kura ta' anemija sintomatika assoċjata ma' mard kroniku tal-kliewi (CKD) f'pazjenti adulti (ara sezzjoni 5.1).
English: After preparation of the syringe as described in steps 1 to 5:
Maltese: Wara l-preparazzjoni tas-siringa kif deskritt f'passi 1 sa 5: