FrancophonIA/ELRC3.0 huggingface dataset:
English: Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.
Maltese: Mozobil jintuża flimkien mal-ormon il-fattur stimolanti tal-kolonja ta' granuloċiti (G-CSF) u huwa biss għal pazjenti li fihom huwa diffiċli li jinġabru ċelloli staminali.
English: As for all medicines, data on the use of Mozobil is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Mozobil hija ssorveljata kontinwament.
English: Side effects reported with Mozobil are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Mozobil huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: This protein normally helps to keep stem cells within the bone marrow.
Maltese: Din il-proteina normalment tgħin biex iżżomm iċ-ċelloli staminali fil-mudullun.
English: In both studies the patients were also receiving G-CSF.
Maltese: Fiż-żewġ studji l-pazjenti kienu qed jirċievu wkoll G-CSF.
English: How does Mozobil work?
Maltese: Kif jaħdem Mozobil?
English: What measures are being taken to ensure the safe and effective use of Mozobil?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mozobil?
English: Mozobil is given 6 to 11 hours before the patient's blood is taken and the stem cells are extracted.
Maltese: Mozobil jingħata bejn 6 u 11-il siegħa qabel ma jittieħed id-demm tal-pazjent u jiġu estratti ċ-ċelloli staminali.
English: For the full list of side effects and restrictions with Mozobil, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet b'Mozobil, ara l-fuljett ta' tagħrif.
English: 20 November 2013
Maltese: 20 ta' Novembru 2013
English: What is Didanosine?
Maltese: X'inhu Didanosine?
English: It is available as gastroresistant tablets.
Maltese: Huwa disponibbli bħala pilloli gastro-reżistenti.
English: Aurobindo Pharma (Malta) Limited submitted Didanosine to the UK medicines regulatory agency for a decentralised procedure.
Maltese: Aurobindo Pharma (Malta) Limited ippreżentat Didanosine lill-aġenzija regolatorja tal-mediċini tarRenju Unit għal proċedura deċentralizzata.
English: Didanosine is an antiviral medicine used in combination with other medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Didanosine huwa mediċina antivirali li tintuża f'kombinazzjoni ma' mediċini oħra fil-kura ta' pazjenti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu talimmunodefiċjenza akkwiżita (AIDS).
English: Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Didanosine u ismijiet assoċjati (didanosine, kapsuli gastro-reżistenti, 200, 250 u 400 mg)
English: authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance France, Germany, Italy, Netherlands, Portugal, Romania and Spain).
Maltese: għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ Franza, il-Ġermanja, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, ir-Rumanija u Spanja).
English: Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs).
Maltese: Didanosine jagħmel parti minn klassi ta' mediċini msejħa analogi nukleosidi jew inibituri tattranskrittażi inversa (NRTIs).
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Maltese: Jimblokka l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV-1 li tippermettilu jipproduċi aktar virusijiet fiċ-ċelloli li jkun infetta.
English: Didanosine is a hybrid medicine which means that it is similar to a ‘reference medicine' already authorised in the EU called Videx EC.
Maltese: Didanosine huwa mediċina ibrida li jfisser li huwa simili għal 'mediċina ta' referenza' diġà awtorizzata fl-UE msejħa Videx EC.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Didanosine outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: France, Germany, Italy, the Netherlands, Portugal, Romania and Spain.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Didanosine jegħlbu r-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fir-Renju Unit u fl-Istati Membri tal-UE li ġejjin: Franza, il-Ġermanja, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, ir-Rumanija u Spanja.
English: On 19 September 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Didanosine.
Maltese: Fid-19 ta' Settembru 2013, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Didanosine.
English: The European Commission issued a decision on 20 November 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fi 20 ta' Novembru 2013.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine has been shown when taken on an empty stomach, and under fed conditions when considering the overall exposure to the active substance (a measure known as AUC).
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li meta wieħed iqis l-espożizzjoni totali għas-sustanza attiva (kejl magħruf bħala AUC) il-bijoekwivalenza mal-mediċina ta' referenza kienet intweriet meta jittieħed fuq stonku vojt, u taħt kundizzjonijiet mitmugħa.
English: Although the Committee noted that the maximum concentrations of active substance in the blood when taken with food were somewhat higher after Didanosine than after the reference medicine, it considered that the difference was not clinically relevant since the medicine should be taken on an empty stomach, which produces much higher concentrations, and these small variations in the concentration of the active substance in the blood would therefore not increase the risks.
Maltese: Għalkemm il-Kumitat innota li l-konċentrazzjonijiet massimi tassustanza attiva fid-demm meta jittieħed mal-ikel kienu kemxejn ogħla wara Didanosine milli wara lmediċina ta' referenza, huwa kkunsidra li d-differenza ma kinitx klinikament rilevanti peress li lmediċina għandha tittieħed fuq stonku vojt, li tipproduċi konċentrazzjonijiet ħafna ogħla, u għalhekk dawn il-varjazzjonijiet żgħar fil-konċentrazzjoni tas-sustanza attiva fid-demm ma kinux se jżidu rriskji.
English: Why was Didanosine reviewed?
Maltese: Għalxiex ġie rivedut Didanosine?
English: By blocking this enzyme, didanosine, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Billi jimblokka din l-enzima, didanosine, meta jittieħed f'kombinazzjoni ma' mediċini antivirali oħra, inaqqas l-ammont tal-HIV fid-demm u jżommu f'livell baxx.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 4 March 2013.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u fl-4 ta' Marzu 2013 l-aġenzija regolatorja talmediċini tar-Renju Unit irriferiet il-kwistjoni lis-CHMP għal arbitraġġ.
English: Didanosine does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Didanosine ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immuni u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini huma bijoekwivalenti jekk jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: The grounds for the referral were objections raised by France and the Netherlands that the bioequivalence study carried out under fed conditions did not show that Didanosine was bioequivalent to its reference medicine, Videx EC.
Maltese: Ir-raġunijiet għar-riferiment kienu oġġezzjonijiet imqajma minn Franza u l-Pajjiżi l-Baxxi li l-istudju ta' bijoekwivalenza li kien sar taħt kondizzjonijiet mitmugħa ma kienx wera li Didanosine kien bijoekwivalenti għall-mediċina ta' referenza tiegħu, Videx EC.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jivvaluta mediċina bil-għan li tingħata awtorizzazzjoni
English: Although the presence of food in the stomach lowers the amount of active substance that can be absorbed and these medicines should therefore be taken on an empty stomach, as Didanosine is a gastro-resistant preparation bioequivalence in fed conditions must be shown to grant the marketing authorisation.
Maltese: Għalkemm il-preżenza tal-ikel fl-istonku tnaqqas l-ammont tas-sustanza attiva li tista' tiġi assorbita u huwa għalhekk li dawn il-mediċini għandhom jittieħdu fuq stonku vojt, peress li Didanosine huwa preparazzjoni gastro-reżistenti, ilbijoekwivalenza għandha tintwera f'kundizzjonijiet mitmugħa sabiex tkun tista' tingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: System Organ Class (MedDRA)
Maltese: Sistema talKlassifika talOrgani (MedDRA)
English: 1.67 to 3.34 GBq/ml
Maltese: 1.67 sa 3.34 GBq/ml
English: Amenorrhea**
Maltese: Amenorreja**
English: 1097 JB Amsterdam The Netherlands
Maltese: 1097 JB Amsterdam
English: Y]-Zevalin mGy/MBq Median
Maltese: Y]-Zevalin mGy/MBq Medjan
English: Adequate shielding is mandatory.
Maltese: Protezzjoni adegwata hi obbligatorja.
English: (monotherapy) and <150,000/mm
Maltese: (monoterapija) u <150,000/mm
English: Manufacturer CIS bio international RN 306- Saclay B.P.
Maltese: CIS bio international RN 306- Saclay B.P. 32
English: Zevalin is indicated in adults.
Maltese: Zevalin hu indikat fl-adulti.
English: 91192 Gif-sur-Yvette Cedex France
Maltese: 91192 Gif-sur-Yvette Cedex Franza
English: Process residuals (e.g. ammonia, nitrate)
Maltese: Residwi tal-proċess (eż. ammonia, nitrate)
English: IWRC: International Workshop response criteria CRu: Unconfirmed complete response
Maltese: International Workshop Response Criteria CRu: Rispons komplet mhux ikkonfermat
English: Metal impurities Total metals*
Maltese: Impuritajiet metalliċi Total ta' metalli*
English: Sterility
Maltese: Sterilità
English: Average % RCP =
Maltese: 6) Persentaġġ (%) medju ta' RCP =
English: (consolidation treatment)
Maltese: (kura ta' konsolidazzjoni)
English: Name and address of the manufacturer of the biological active substance Biogen IDEC, Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Biogen IDEC, Inc.
English: • The active substance is ibritumomab tiuxetan.
Maltese: • Is-sustanza attiva hi ibritumomab tiuxetan.
English: Mucocutaneous reaction (including Stevens Johnson
Maltese: Reazzjoni mukokutanja (Inkluż is-sindrome Stevens Johnson)*
English: Consolidation therapy:
Maltese: Terapija ta' konsolidazzjoni:
English: Table 3.
Maltese: Tabella 2.
English: Induction therapies included CVP n=106, CHOP (-like) n=188, fludarabine combinations n=22, chlorambucil n=39 and rituximab-chemotherapy combinations n=59.
Maltese: 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.
English: Frequency groupings are defined according to the following convention: (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to 1/100, rare:  1/10,000 to <1/1,000; very rare: <1/10,000).
Maltese: (komuni ħafna ≥ 1/10, komuni ≥ 1/100 sa ≤ 1/10, mhux komuni ≥ 1/1,000 sa 1/100, rari:  1/10,000
English: • Haematological toxicity
Maltese: • Tossiċità ematoloġika
English: Y]-radiolabelled Zevalin at activities of 15 MBq/kg and 11 MBq/kg was calculated according to Medical Internal Radiation Dosimetry (MIRD) (Table 3).
Maltese: Y] f'attività ta' 15MBq/kg u 11MBq/kg, kienet ikkalkulata skond il-Medical Internal Radiation Dosimetry (MIRD) (Tabella 3).
English: Expected haematological toxicity was observed, including grade 3 or 4.
Maltese: Kienet osservata tossiċità ematoloġika mistennija, inkluż grad 3 jew 4.
English: • NHL with CNS involvement
Maltese: • NHL b'involviment tas-CNS
English: In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
Maltese: B'kollox, 87% tal-pazjenti kienu f'CR(u); 76% f'CR u 11% f'Cru.
English: 3.2 mg/2 ml
Maltese: INDIVIDWALI 3.2 mg/2 ml
English: • Mucocutaneous reactions, including Stevens-Johnson Syndrome
Maltese: • Fsada intrakranjali waqt tromboċitopenija • Reazzjonijiet mukokutanji, inkluż is-Sindrome Stevens-Johnson
English: Cough, Rhinitis
Maltese: Sogħla, Rinite
English: • Extravasation
Maltese: • Ekstravasazzjoni
English: Characteristics of yttrium-90
Maltese: Karatteristiċi ta' yttrium-90
English: Gallbladder Wall Muscle
Maltese: Kisja tal-marrara Muskoli
English: Total Alpha impurities
Maltese: Total ta' l-impuritajiet Alpha
English: Date of latest renewal: 16 January 2009
Maltese: Data tal-aħħar tiġdid: 16 ta' Jannar, 2009
English: Total extractable activity to deliver at time of use  1.48 GBq corresponding to 0.44 ml to 0.89 ml of yttrium-90 solution
Maltese: Total ta' attività li tista' tingħata fil-ħin ta' l-użu 1.49 GBq li jikkorrispondi għal 0.44 ml sa 0.89ml ta' soluzzjoni ta' yttrium-90
English: • Pancytopenia
Maltese: • Panċitopenija
English: Individual metals*
Maltese: Metalli ndividwali*
English: • Immune system disorders
Maltese: • Disturbi fis-sistema immuni
English: The side effects marked with two asterisks (**) were observed additionally under consolidation therapy.
Maltese: L-effetti sekondarji mmarkati b'żewġ asterisks (**) kienu osservati b'mod addizzjonali waqt terapija ta' konsolidazzjoni.
English: Zevalin therapeutic regimen N = 54
Maltese: Kors terapewtiku ta' Zevalin N=54
English: Total Gamma impurities
Maltese: Total ta' impuritajiet Gamma
English: Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Maltese: Prins Bernhardplein 200
English: Y], a monoclonal antibody labelled with the radioactive substance yttrium-90 (
Maltese: Y], antikorpi monokolonali ittikkettjat bis-sustanza radjuattiva yttrium-90 (
English: Objective, durable clinical responses were observed [67% ORR (95% CI: 48-85%), 11.8 months median DR (range: 4-17 months)] and resulted in a greater incidence of haematologic toxicity (see 4.8) than in Studies 1 and 2.
Maltese: Kien osservat rispons kliniku oġġettivi u li baqgħa fit-tul, [67% ORR (95% CI: 48-85%), DR medjan ta' 11.8 xhur (firxa: 4-17-il xahar) u rriżulta f'inċidenza ogħla ta' tossiċità ematoloġika (ara 4.8) minn Studji 1 u 2.
English: One ibritumomab tiuxetan vial.
Maltese: Kunjett ta' ibritumomab tiuxetan:
English: Disodium phosphate dodecahydrate Human albumin solution Hydrochloric acid, diluted (for pH adjustment) Pentetic acid
Maltese: Disodium phosphate dodecahydrate Soluzzjoni ta' albumina umana Hydrochloric acid, dilwit (għall-aġġustament tal-pH) Pentetic acid
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion Ibritumomab tiuxetan [
Maltese: Zevalin 1.6 mg/ml sett għall-preparazzjonijiet radjufarmaċewtiċi għall-infużjoni Ibritumomab tiuxetan [
English: Human albumin solution Sodium chloride
Maltese: Soluzzjoni ta' albumina umana Sodium chloride
English: • The other ingredients are: - ibritumomab tiuxetan vial: sodium chloride, water for injections - sodium acetate vial: sodium acetate, water for injections - formulation buffer vial: human albumin solution, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid (diluted) for pH adjustment, water for injections
Maltese: • Is-sustanzi l-oħra huma: - kunjett ta' ibritumomab tiuxetan: sodium chloride, ilma għall-injezzjonijiet - kunjett ta' sodium acetate: sodium acetate, ilma għall-injezzjonijiet - kunjett ta' baffer għat-taħlita: soluzzjoni ta' l-albumina umana, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid (dilwit) għall-aġġustament tal-pH, ilma għallinjezzjonijiet
English: Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Maltese: Perijodu ta' radjutikkettar ta' aktar minn 6 minuti jew iqsar minn 4 minuti jirriżulta f'inkorporazzjoni inadekwata ta' radjuattività.
English: Zevalin therapeutic regimen N = 73
Maltese: Kors terapewtiku ta' Zevalin N=73
English: Yttrium identification
Maltese: Identifikazzjoni ta' Yttrium
English: • Sepsis
Maltese: • Sepsi
English: Total other Beta impurities (non-strontium-90)
Maltese: Total ta' l-impuritajiet Beta oħra (mhux dawk ta' Strontium-90)
English: The final formulation after radiolabelling contains 2.08 mg [
Maltese: Il-formulazzjoni finali wara r-radjutikkettar fiha 2.08 mg [
English: Radiochemical purity of the radiolabelled preparation applies as long as more than 95% of yttrium-90 is incorporated into the monoclonal antibody.
Maltese: Il-purità radjukimika tat-taħlita radjutikkettjata tapplika biss jekk aktar minn 95% ta' yttrium-90 jiġi inkorporat fl-antikorp monoklonali.
English: Thrombocytopenia, Leukocytopenia, Neutropenia, Anaemia*
Maltese: Tromboċitopenija Lewkoċitopenija, Newtropenija, Anemija*
English: Vomiting, Abdominal pain, Diarrhoea, Dyspepsia, Throat irritation, Constipation
Maltese: Rimettar, Uġigħ addominali, Dijarea, Dispepsja, Irritazzjoni filgriżmejn, Stitikezza
English: Total organic carbon (e.g. organic chelators)
Maltese: Total ta' faħam organiku (eż. Kelanti organiċi)
English: The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
Maltese: L-antikorp konjugat għandu kostanti evidenti ta' affinità għall-antiġen CD20 ta' madwar 17 nM.
English: - Developing chamber for chromatography - Mobile phase: sodium chloride 9 mg/ml (0.9%) solution, bacteriostatic-free - ITLC strips (e.g. ITLC TEC-Control Chromatography Strips, Biodex, Shirley, New York, USA, Art. Nr. 150-772 or equivalent, dimensions: approximately 0.5-1 cm x 6 cm) - Scintillation vials - Liquid scintillation cocktail (e.g. Ultima Gold, catalog No. 6013329, Packard Instruments, USA or equivalent)
Maltese: - Strippi għall-ITLC (eż. ITLC TEC-Control Chromatography Strips, Biodex, Shirley, New York, USA, Oġġett Numru 150-772 jew ekwivalenti, qisien: madwar 0.5-1 ċm x 6 ċm) - Kunjetti ta' xintillazzjoni - Taħlita likwida ta' xintillazzjoni (eż. Ultima Gold, Numru tal-katologu 6013329, Packard Instruments, USA jew ekwivalenti).
English: EU/1/03/264/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/264/001
English: Hydrochloric acid, diluted Water for injections
Maltese: Hydrochloric acid, dilwit Ilma għall-injezzjonijiet
English: The use of Zevalin is associated with an increased risk of secondary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), (see also section 4.8).
Maltese: L-użu ta' Zevalin hu assoċjat ma riskju miżjud ta' tumuri malinni sekondarji, li jinkludu lewkimja majelojde akuta (AML) u sindrome majelodisplastiku (MDS), (ara wkoll sezzjoni 4.8).
English: The product of radioactive decay is stable zirconium-90.
Maltese: Il-prodott tad-deġenerazzjoni radjuattiva huwa zirconium-90 stabbli.
English: Zevalin is used with another medicine containing the active substance rituximab.
Maltese: Zevalin jintuża flimkien ma' mediċina oħra li fiha s-sustanza attiva rituximab.
English: Date of first authorisation: 16 January 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Jannar 2004
English: The path length of beta emission (90) by yttrium-90 in tissue is 5 mm.
Maltese: B(90) minn yttrium-90 fit-tessuti tal-ġisem hija ta' 5 mm.
English: Major inclusion criteria were: CD20+ grade 1 or 2 follicular lymphoma; stage III or IV at diagnosis; normal peripheral blood cell counts; < 25% bone marrow involvement; age ≥ 18 yrs; and complete response (CR/Cru) or partial response (PR) after first-line chemotherapy determined by physical examination, CT scans and bone marrow biopsy.
Maltese: limfoma follikulari ta' grad 1 jew 2, CD20+; stadju III jew IV waqt id-dijanjosi; għadd ta' ċelluli taddemm 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.
English: PFS increased from 13.5 months (control) to 37 months (Zevalin; p<0.0001; HR 0.465).
Maltese: PFS żdieded minn 13.5 xhur (kontrol) għal 37 xahar (Zevalin; p<0.
English: Signs and symptoms of infusion reactions may include dizziness, cough, nausea, vomiting, rash, pruritus, tachycardia, asthenia, pyrexia and rigors (see section 4.8).
Maltese: Sinjali u sintomi ta' reazzjonijiet għall-infużjoni jistgħu jinkludu sturdament, sogħla, tqalligħ, rimettar, raxx, ħakk, takikardija, astenja, deni u tertir (ara sezzjoni 4.8).
English: • Secondary malignancies
Maltese: • Tumuri malinni sekondarji
English: Preparation of Zevalin
Maltese: Preparazzjoni ta' Zevalin
English: The ORR was significantly higher (80% vs. 56%, p = 0.002) for patients treated with the Zevalin therapeutic regimen.
Maltese: L-ORR kien ogħla b'mod sinifikanti (80% vs. 56%, p=0.002) għall-pazjenti kkurati bil-kors terapewtiku ta' Zevalin.
English:  95% of free ionic yttrium-90
Maltese: 95% ta' yttrium-90 joniku ħieles
English: No incompatibilities have been observed between Zevalin and infusion sets.
Maltese: Ma kienu osservati l-ebda inkompatibilitajiet bejn Zevalin u settijiet ta' l-infużjoni.
English: - Data from 204 patients receiving Zevalin as consolidation therapy after first line remission induction:
Maltese: - Tagħrif minn 204 pazjent li rċevew Zevalin bħala terapija ta' konsolidazzjoni wara induzzjoni ta' remissjoni primarja:
English: What is in this leaflet:
Maltese: Proċedura ta' analiżi:
English: Y]-radiolabelled ibritumomab tiuxetan binds specifically to CD20-expressing B-cells, including malignant cells.
Maltese: Y] jaqbad speċifikament maċ-ċelluli B li għandhom fuqhom CD20, inkluż ċelluli malinni.
English: • Myelodysplastic syndrome / Acute myeloid leukaemia
Maltese: • Sindrome mijelodisplastika / lewkimja majelojda akuta
English: Calculate the average Radiochemical Purity (RCP) as follows:
Maltese: Ikkalkula l-medja ta' Purità Radjukimika (RCP) hekk:
English: Uncommon side effects: (may effect up to 1 in 100 people) - rapid heart beat (tachycardia),
Maltese: Effetti sekondarji mhux komuni: (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - rata ta' taħbit tal-qalb mgħaġġla (takikardija),
English: 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.
Maltese: Il-kelant, tiuxetan jifforma kumpless stabbli mar-radju-isotopi yttrium-90 u indium-111 u hija mistennija degradazzjoni żgħira biss ikkawżata minn radjolisi.
English: • infection: fever, chills
Maltese: • infezzjoni: deni, sirdat
English: Reporting suspected adverse reactions afterauthorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.