FrancophonIA/ELRC3.0 huggingface dataset:
English: • Safety advice relevant to all patients o Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials o Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience o Use in patients with hepatic and/or renal impairment o Disposal of unwanted medicine o Local country specific arrangements for a prescription for Revlimid to be dispensed o Description of risk of hypothyroidism o Explanation of unknown risk of neuropathy with long term use
Maltese: • Pariri rilevanti dwar is-sigurtà lill-pazjenti kollha o Deskrizzjoni u mmaniġġjar ta' newtropenja u tromboċitopenja li tinkludi rati ta' inċidenzi minn studji kliniċi o Deskrizzjoni u mmaniġġjar ta' riskju tromboembolitiku li tinkludi rati ta' inċidenzi minn studji kliniċi u esperjenza ta' wara t-tqegħid fis-suq o Użu f'pazjenti b'indeboliment tal-fwied u/jew renali o Rimi ta' mediċina mhux meħtieġa o Arranġamenti speċifiċi għall-pajjiż lokali għal riċetta biex jingħata Revlimid o Deskrizzjoni tar-riskju ta' ipotirojdiżmu o Spjegazzjoni ta' riskju mhux magħruf ta' newropatija b'użu għal żmien fit-tul
English: • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception o Pregnancy test regime Advice on suitable tests Before commencing treatment During treatment based on method of contraception After finishing treatment o Need to stop Revlimid immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy
Maltese: • Pariri dwar is-sigurtà għal nisa ta' li jista' jkollhom it-tfal o Il-ħtieġa li tiġi evitata l-espożizzjoni tal-fetu o Deskrizzjoni tal-PPP o Il-ħtieġa għal kontraċezzjoni adegwata (anki jekk il-mara jkollha l-amenorrea) u definizzjoni ta' kontraċezzjoni adegwata o Kors tat-test tat-tqala Pariri dwar testijiet adattati Qabel tibda l-kura Matul il-kura bbażat fuq il-metodu ta' kontraċezzjoni Wara li tintemm il-kura o Il-ħtieġa li twaqqaf Revlimid immedjatament malli jkun hemm suspett ta' tqala o Il-ħtieġa li tgħid lit-tabib li jkun qed jipprovdi l-kura immedjatament malli jkun hemm suspett ta' tqala
English: • Documentation of childbearing status potential
Maltese: • Dokumentazzjoni ta' l-istat tal-potenzjal li jista' jkollhom it-tfal
English: The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
Maltese: L-Istati Membri għandhom jiżguraw li D-Detentur ta' L-Awtorizzazzjoni għat-tqegħid fis-suq jimplimenta Programm tal-Prevenzjoni tat-Tqala (PPP, Pregnancy Prevention Programm) ġewwa t-territorju tagħhom.
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans.
Maltese: • Li lenalidomide hu teratoġeniku fl-annimali u hu mistenni li jkun teratoġeniku fil-bnedmin
English: The Educational Healthcare Professional's Kit
Maltese: Il-Kitt Edukattiv tal-Professjonist fil-Qasam tas-Saħħa
English: The Educational Health Care Professional's Kit shall contain the following elements:
Maltese: Il-Kitt Edukattiv tal-Professjonisti fil-Qasam tas-Saħħa ser ikun fih l-elementi li ġejjin:
English: • Brief background on lenalidomide and its licensed indication
Maltese: • Verifika li ngħata parir adattat
English: • The need to use condoms if sexual partner is pregnant or a WCBP (even if man has had vasectomy) o During Revlimid treatment o For one week following final dose
Maltese: • Il-ħtieġa li jużaw il-kondoms jekk is-sieħba sesswali hi tqila jew WCBP (anki jekk ir-raġel kellu vasektomija) o Matul il-kura b'Revlimid o Għal ġimgħa wara d-doża finali.
English: Direct Healthcare Professional Communication
Maltese: Komunikazzjoni Diretta tal-Professjonisti fil-Qasam tas-Saħħa
English: March 2021
Maltese: Marzu 2021
English: MARKETING AUTHORISATION NUMBER EU/1/16/1121/001
Maltese: EU/1/16/1121/001
English: OTHER MolMed SpA
Maltese: MolMed SpA
English: Acute GvHD (33% of patients)
Maltese: GvHD akuta (33% talpazjenti)
English: Via Olgettina 58 20132 Milano Italy e-mail: info@molmed.com
Maltese: Via Olgettina 58 20132 Milano L-Italja e-mail: info@molmed.com
English: Intestinal haemorrhage
Maltese: Emorraġija intestinali
English: 20132 Milano Italy
Maltese: 20132 Milano L-Italja
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Via Olgettina 58 20132 Milano Italy
Maltese: Via Olgettina 58 20132 Milano L-Italja
English: Severity of acute GvHD was grade 1 in one case (3%), grade 2 in seven (23%), grade 3 in one (3%) and grade 4 in one (3%).
Maltese: Is-severità ta' GvHD akuta kienet ta' grad 1 f'każ wieħed (3%), grad 2 f'seba' każijiet (23%), grad 3 f'każ wieħed (3%) u grad 4 f'każ wieħed (3%).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: The dose corresponds to 1 ± 0.2 x 107 cells/kg.
Maltese: Id-doża tikkorrispondi għal 1 ± 0.2 x 107 ċellula/kg.
English: GvHD requiring systemic immunosupressive therapy.
Maltese: GvHD li teħtieġ terapija immunosoppressiva sistemika.
English: Human serum albumine, dimethyl sulphoxide, sodium chloride.
Maltese: Albumina tas-serum tal-bniedem, dimethyl sulphoxide, sodium chloride.
English: Zalmoxis 5-20 x 106 cells/mL cell dispersion for infusion contains 13.3 mmol (305.63 mg) of sodium per dose.
Maltese: Zalmoxis 5-20 x 106 ċellula/mL dispersjoni ta' ċelluli għall-infużjoni fiha 13.3 mmol (305.63 mg) ta' sodium f'kull doża.
English: Dispersion for infusion Bag volume:___________mL Dose: 1x107 cells /kg Concentration: _____x10x cells/mL Total cell number: _____x10X
Maltese: Dispersjoni għall-infużjoni Volum tal-borża:___________mL Doża: 1x107 ċellula/kg Konċentrazzjoni: ____ x10x ċellula/mL Għadd ta' ċelluli totali: ____ x10X
English: Zalmoxis adverse reactions recorded in TK007 study
Maltese: Reazzjonijiet avversi ta' Zalmoxis rreġistrati fi studju TK007
English: Zalmoxis contains sodium
Maltese: Zalmoxis fih sodium
English: Results from a matched-pair analyses that included 36 Zalmoxis patients (22 from TK007 trial and 14 from the ongoing phase III TK008 trial) and 127 control patients, showed that the Zalmoxis treated patients that had survived the first 3 weeks post-transplant without relapse benefited in terms of 1 year overall survival (OS) (40% vs 51% (p=0.03)) and 1-year NRM (42% vs 23% (p=0.04)).
Maltese: III li għadha għaddeja) u 127 pazjent ta' kontroll, urew li pazjenti ttrattati b'Zalmoxis li baqgħu ħajjin matul l-ewwel 3 ġimgħat wara t-trapjant mingħajr ma rkadew ibbenefikaw f'termini ta' sopravivenza globali (OS - overall survival) (40% kontra 51% (p=0.03)) ta' sena u NRM (42% kontra 23% (p=0.04)) ta' sena.
English: The clinical study report should be submitted by March 2021.
Maltese: Ir-rapport tal-istudju kliniku għandu jiġi sottomess sa Marzu 2021.
English: Human serum albumin Dimethyl sulfoxide
Maltese: Sodium chloride Albumina tas-serum tal-bniedem Dimethyl sulfoxide
English: The clinical study report should be submitted by Q4 2022.
Maltese: Ir-rapport tal-istudju kliniku għandu jiġi sottomess sa Q4 2022.
English: PHARMACEUTICAL FORM Dispersion for infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Dispersjoni għall-infużjoni.
English: Immune system disorders
Maltese: Disturbi fis-Sistema Immuni
English: Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per dose.
Maltese: Kull borża fiha madwar 13.3 mmol (305.63 mg) ta' sodium f'kull doża.
English: Frequency and Adverse reactions Very common
Maltese: Frekwenza u Reazzjonijiet avversi
English: It must not be administered if the following conditions occur: a) infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) at the time of infusion; b) GvHD requiring systemic immunosupressive therapy; c) ongoing systemic immunosupressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical HSCT.
Maltese: M'għandux jingħata jekk iseħħu l-kondizzjonijiet li ġejjin: a) infezzjonijiet li jeħtieġu għoti ta' ganciclovir (GCV) jew valganciclovir (VCV) fil-ħin talinfużjoni; b) GvHD li teħtieġ terapija immunosoppressiva sistemika; ċ) terapija immunosoppressiva sistemika li tibqa' tittieħed jew għoti ta' fattur li jistimula l-kolonji ta' granuloċiti (G-CSF - granulocyte colony stimulating factor) wara trapjant ta' HSCT aploidentiku.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Maltese: Sustanzi antineoplastiċi oħra, Kodiċi ATC: mhux assenjat
English: • You have not received the Certificate of Analysis.
Maltese: (CoA - Certificate of Analysis) relatat.
English: It is unlikely that you will be given too much.
Maltese: Huwa improbabbli li tingħata aktar milli suppost.
English: Zalmoxis is given intravenously (into a vein) as a drip infusion over approximately 20-60 minutes at a time interval of 21-49 days from transplantation.
Maltese: Zalmoxis jingħata fil-vini (ġewwa vina) bħala infużjoni permezz ta' dripp fuq madwar 20-60 minuta f'intervall ta' ħin ta' 21-49 ġurnata wara t-trapjant.
English: Only one patient (3%) developed an extensive chronic GvHD that occurred 159 days and 129 days from HSCT and last infusion, respectively, and fully resolved after 107 days.
Maltese: GvHD kronika estensiva li seħħet 159 jum u 129 jum wara HSCT u l-aħħar infużjoni, rispettivament, u għaddiet kompletament wara 107 ijiem.
English: Undesirable effects recorded in the clinical study TK007 are listed in Table 1 by system organ class and by frequency of occurrence.
Maltese: Effetti mhux mixtieqa rreġistrati fl-istudju kliniku TK007 huma elenkati fit-Tabella 1 skont il-klassi tas-sistemi u tal-organi u l-frekwenza tal-okkorrenza.
English: Zalmoxis should be infused intravenously over a period of 20-60 minutes.
Maltese: Zalmoxis għandu jiġi infuż fil-vini fuq perjodu ta' 20-60 minuta.
English: Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies (see section 5.1).
Maltese: Zalmoxis huwa indikat bħala trattament aġġuntiv fi trapjant ta' ċelluli staminali ematopoetiċi u aploidentiċi (HSCT - haploidentical haematopoietic stem cell transplantation) ta' pazjenti adulti b'tumuri malinni ematoloġiċi ta' riskju għoli (ara sezzjoni 5.1).
English: Other medicines and Zalmoxis
Maltese: Mediċini oħra u Zalmoxis
English: • While holding the top of the envelope bag out of the water, put it in a 37±1°C water bath being careful not to allow water to penetrate the seal.
Maltese: • Filwaqt li żżomm il-parti ta' fuq tal-borża mgeżwra barra mill-ilma, poġġiha f'banju ta' ilma b'temperatura ta' 37±1 °C waqt li toqgħod attent li ma jħallix ilma jidħol mis-siġill.
English: In vitro evaluation of oncological potential indicate that the risk of malignant transformation is low.
Maltese: Evalwazzjoni in vitro tal-potenzjal onkoloġiku tindika li r-riskju ta' trasformazzjoni malinna huwa baxx.
English: Zalmoxis should be administered after a 24-hour discontinuation period of ganciclovir or valganciclovir and immunosuppressive therapy.
Maltese: Zalmoxis għandu jingħata wara perjodu ta' 24 siegħa ta' waqfien ta' ganciclovir jew valganciclovir u tat-terapija immunosoppressiva.
English: Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Maltese: Zalmoxis 5-20 x 106 ċellula/mL dispersjoni għall-infużjoni
English: Zalmoxis is supplied as one individual treatment dose in a 50-500 mL ethylene-vinyl-acetate cryo bags.
Maltese: Zalmoxis huwa fornut bħala doża waħda ta' trattament individwali f'boroż cryo ta' 50-500 mL magħmula minn ethylene-vinyl-acetate
English: - You suffer from infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) (antiviral) at the time of infusion.
Maltese: - Tbati minn infezzjonijiet li jeħtieġu l-għoti ta' ganciclovir (GCV) jew valganciclovir (VCV) (antivirali) meta tkun ser tingħata l-infużjoni.
English: One individual treatment dose in 50-500 mL ethylene-vinyl-acetate cryo bag, inside a plastic bag and then a metal box.
Maltese: Doża waħda ta' trattament individwali f'boroż cryo ta' 50-500 mL magħmula minn ethylene-vinylacetate, ġewwa borża tal-plastik u mbagħad impoġġija ġewwa kaxxa tal-metal.
English: Remarks on the importance of reporting ADRs and encourage patients to be enrolled into study TK011 (linked with the EBMT registry)
Maltese: Rimarki dwar l-importanza ta' rappurtar ta' ADRs u inkoraġġiment tal-pazjenti biex jiġu rreġistrati fl-istudju TK011 (marbuta mar-Reġistru EBMT)
English: This may be because of manufacturing issues.
Maltese: Dan jista' jkun minħabba problemi fil-manifattura.
English: Triphosphate GCV competitively, inhibits incorporation of deoxyguanosine triphosphate (dGTP) into elongating DNA, thus killing the proliferating cells.
Maltese: TK. Triphosphate GCV b'mod kompetittiv, jinibixxi l-inkorporazzjoni ta' deoxyguanosine triphosphate (dGTP) f'DNA li qed titwal, u b'hekk joqtol iċ-ċelluli li qed jipproliferaw.
English: In the TK007 clinical study only one 66-year-old female was treated with one infusion of Zalmoxis.
Maltese: Fl-istudju kliniku TK007 mara ta' 66 sena waħda biss kienet ittrattata b'infużjoni waħda ta' Zalmoxis.
English: For the patients who achieved immune reconstitution, a nonrelapse mortality (NRM) of 17% was reported, with 35% of these patients being disease free at 5 years and 34% alive at 10 years.
Maltese: Għall-pazjenti li kisbu rikostituzzjoni immuni, kienet irrappurtata mortalità mhux ikkawżata minn rikaduta (NRM - non-relapse mortality) ta' 17%, b'35% ta' dawn il-pazjenti jkunu ħielsa mill-marda wara 5 snin u 34% ħajjin wara 10 snin.
English: Donor code:
Maltese: Kowd tad-donatur:
English: Patients characterized by condition a) could be administered Zalmoxis 24 hours following the antiviral therapy discontinuation; patients characterized by conditions b) and c) could be administered Zalmoxis after an adequate wash out period.
Maltese: Pazjenti li għandhom kondizzjoni a) jistgħu jingħataw Zalmoxis 24 siegħa wara li titwaqqaf it-terapija antivirali; pazjenti li għandhom kondizzjonijiet b) u ċ) jistgħu jingħataw Zalmoxis wara perjodu adegwata ta' wash out.
English: Relevant information about the safety concern of Concomitant immunosuppressive therapy
Maltese: Informazzjoni rilevanti dwar tħassib ta' sigurtà ta' terapija immunosoppressiva fl-Istess Waqt
English: If GvHD occurs, GCV/VCV will be administered.
Maltese: Jekk isseħħ GvHD, ser jingħata GCV/VCV.
English: The recommended infusion time is around 20-60 minutes
Maltese: 20-60 minuta
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT Lott:
English: • Zalmoxis is shipped directly to the medical facility where the infusion will be administered.
Maltese: • Zalmoxis jintbagħat direttament fil-faċilità medika fejn ser tingħata l-infużjoni.
English: High-risk haematological malignancies treated with Zalmoxis included acute myeloid leukaemia (AML), secondary AML, acute lymphoblastic leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma.
Maltese: Tumuri malinni ematoloġiċi ta' riskju għoli ttrattati b'Zalmoxis jinkludu lewkimja majelojde akuta (AML - acute myeloid leukaemia), AML sekondarja, lewkimja limfoblastika akuta, sindrome majelodisplastika u limfoma mhux ta' Hodgkin.
English: Seven patients needed to add an immunosuppressive treatment consisting of steroids, mycophenolate and/or cyclosporine.
Maltese: Seba' pazjenti kellhom bżonn iżżidu trattament immunosoppressiv li jikkonsisti minn sterojdi, mycophenolate u/jew cyclosporine.
English: Of 30 patients receiving Zalmoxis, 23 patients (77%) obtained immune reconstitution, with a median time of 31 days after the first infusion.
Maltese: Minn 30 pazjent li rċevew Zalmoxis, 23 pazjent (77%) kisbu rikostituzzjoni immuni, bi żmien medjan ta' 31 jum wara l-ewwel infużjoni.
English: A longer interval might apply in case of renal failure.
Maltese: Intervall itwal jista' jiġi applikat f'każ ta' falliment renali.
English: In absence of IR, an additional Zalmoxis dose has to be administered with an interval of 30 days up to a maximum number of four doses.
Maltese: Fl-assenza ta' IR, għandha tingħata doża addizzjonali ta' Zalmoxis b'intervall ta' 30 ġurnata sa numru massimu ta' erba' dożi.
English: • Zalmoxis is prepared from human blood of a specific donor and it consists of genetically modified cells.
Maltese: • Zalmoxis huwa ppreparat minn demm uman ta' donatur speċifiku u jikkonsisti minn ċelluli modifikati ġenetikament.
English: EXPIRY DATE Expiry date:
Maltese: DATA TA' SKADENZA Data ta' skadenza:
English: • Put the bag into two plastic envelopes (double envelopment) to avoid direct contact with water.
Maltese: • Poġġi l-borża f'żewġ involukri tal-plastik (tgeżwir doppju) biex jiġi evitat kuntatt dirett mal-ilma.
English: Women of childbearing potential / Contraception in males and females The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Maltese: Ir-riskju ta' trasmissjoni vertikali tal-virus bi tfarfir tal-virus teoretikament huwa negliġibbli madankollu mhux eskluż.
English: o Onset of GVHD requiring systemic immunosuppressive therapy o Ongoing systemic immunosuppressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical hematopoietic stem-cell transplantation
Maltese: Il-pazjenti m'għandhomx jingħataw Zalmoxis f'każ ta': o Bidu ta' GVHD li teħtieġ terapija immunosoppressiva sistemika o Terapija immunosoppressiva sistemika jew għoti ta' fattur li jistimula l-kolonji ta' granuloċiti (G-CSF - granulocyte colony stimulating factor) li tibqa tingħata wara trapjant ta' ċelluli staminali ematopoetiċi aploidentiċi
English: CONTENTS OF THE PACK AND OTHER INFORMATION What Zalmoxis contains
Maltese: KONTENUT TAL-PAKKETT U INFORMAZZJONI OĦRA X'fih Zalmoxis
English: Globally, acute episodes of GvHD occurred in 10 patients (33%) with a median time to onset of 90 days after HSCT and 42 days after last infusion of Zalmoxis cells.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Globalment, episodji akuti ta GvHD seħħew f'10 pazjenti (33%) bi żmien medjan sa bidu ta' 90 jum wara HSCT u 42 jum wara l-aħħar infużjoni ta' ċelluli ta' Zalmoxis.
English: Administration
Maltese: RESPONSABBLI
English: Zalmoxis was evaluated in a phase I/II clinical study (TK007) in adult patients with haematological malignancies at high risk of relapse who have received a stem-cell transplantation from a human leukocyte antigen (HLA) mismatched (haploidentical) donor.
Maltese: I/II (TK007) f'pazjenti adulti b'tumuri malinni ematoloġiċi li għandhom riskju għoli ta' rkadar li rċevew trapjant ta' ċelluli staminali minn donatur b'antiġen tal-lewkoċiti umani (HLA - human leukocyte antigen) mhux imqabbel (aploidentiku).
English: Primary aims of the TK007 study were to evaluate incidence and time to immune reconstitution, defined by the number of circulating CD3+ ≥ 100/μL for two consecutive observations, and incidence of GvHD and response to GCV.
Maltese: TK007 kienu li jiġu evalwati l-inċidenza u l-ħin sa rikostituzzjoni immuni, definiti min-numru ta' CD3+ ≥ 100/μL fiċ-ċirkolazzjoni għal żewġ osservazzjonijiet konsekuttivi, u l-inċidenza ta' GvHD u r rispons għal GCV.
English: Immunosuppressive therapy also affects immunocompetent cells as such infused with Zalmoxis.
Maltese: Terapija immunosuppressiva taffettwa wkoll ċelluli immunokompetenti bħal dawk infużi b'Zalmoxis.
English: EXP: Shelf life after thawing: 2 hours at room temperature (15 °C - 30 °C)
Maltese: Żmien kemm idum tajjeb wara li jinħall: sagħtejn f'temperatura ambjentali (15 °C - 30 °C)
English: Immune-reconstituted patients reached a CD3+ cell count ≥ 100/μL at a median of 77 days after
Maltese: Pazjenti b'rikostituzzjoni immuni laħqu għadd ta' ċelluli CD3+ ta' ≥ 100/μL f'medjan ta' 77 jum wara
English: If at any time during or after treatment with Zalmoxis an acute GvHD of grade equal to or greater than 2 or a chronic GvHD develop, the patient has to be treated with ganciclovir at a dose of 10 mg/kg/day divided into 2 administrations intravenously, or valganciclovir 900 mg two times per day orally for 14 days.
Maltese: GvHD akuta ta' grad daqs jew akbar minn 2 jew GvHD kronika, il-pazjent għandu jiġi ttrattat b'ganciclovir b'doża ta' 10 mg/kg/jum maqsuma f'2 amministrazzjonijiet fil-vini, jew valganciclovir 900 mg darbtejn kuljum mill-ħalq għal 14-il ġurnata.
English: The other ingredients are sodium chloride, human serum albumin and dimethyl sulfoxide (see section
Maltese: Is-sustanzi l-oħra huma sodium chloride, albumina tas-serum tal-bniedem u dimethyl sulfoxide (ara sezzjoni 2).
English: Patients could be treated with Zalmoxis 24 hours after the antiviral or immunosuppressive therapy discontinuation.
Maltese: Il-pazjenti jistgħu jiġu ttrattati b'Zalmoxis 24 siegħa wara t-twaqqif ta' terapija antivirali jew immunosoppressiva.
English: There are no data on the effect of Zalmoxis treatment on fertility.
Maltese: M'hemmx dejta dwar l-effett ta' trattament b'Zalmoxis fuq il-fertilità.
English: Patient code:
Maltese: Kategorija farmakoterapewtika:
English: One bag contains donor T cells genetically modified to express HSV-TK and ΔLNGFR at the concentration of 5-20 x 106 cells/mL.
Maltese: Borża waħda fiha ċelluli T tad-donatur modifikati ġenetikament biex jesprimu HSV-TK u ΔLNGFR f'konċentrazzjoni ta' 5-20 x 106 ċellula/mL.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number: ____x10X
Maltese: Konċentrazzjoni: ____ x10x ċellula/mL Għadd ta' ċelluli totali: ____ x10X
English: Package leaflet: Information for the patient Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Maltese: Informazzjoni għall-pazjent Zalmoxis 5-20 x 106 ċellula/mL dispersjoni għall-infużjoni
English: • At the end of infusion, wash the bag 2 or 3 times with a physiological solution using a sterile technique, in order to completely administer Zalmoxis.
Maltese: • Fl-aħħar tal-infużjoni, aħsel il-borża 2 jew 3 darbiet b'soluzzjoni fiżjoloġika permezz ta' teknika sterili, sabiex Zalmoxis jingħata kompletament.
English: The most common adverse reaction reported by patients treated with Zalmoxis in clinical trial TK007 was acute GvHD.
Maltese: L-aktar reazzjoni avversa komuni rappurtata minn pazjenti ttrattati b'Zalmoxis fil-prova klinika TK007 kienet marda akuta ta' GvHD.
English: Zalmoxis shall not be administered to patients with concurrent systemic immunosuppressive therapy as the efficacy of Zalmoxis treatment in early immune reconstitution may be reduced.
Maltese: Zalmoxis m'għandux jingħata lill-pazjenti b'terapija immunosoppressiva sistemika fl-istess waqt peress li tista' titnaqqas l-effikaċja tat-trattament ta' Zalmoxis fir-rikostituzzjoni immuni bikrija.
English: In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL, Zalmoxis treatment has to be stopped.
Maltese: F'każ li tintlaħaq IR, iddokumentata minn żewġ għadd ta' ċelluli CD3+ konsekuttivi ta' ≥ 100/ml, it-trattament b'Zalmoxis għandu jitwaqqaf.
English: Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.
Maltese: Qabel it-tqeghid fis-suq ta' Zalmoxis f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH - Marketing Authorisation Holder) għandu jaqbel dwar il-kontenut u d-disinn tal-materjal edukattivi għall-Professjonisti tal-Kura tas-Saħħa (HCPs - Health Care Professionals), mal-Awtorità Kompetenti Nazzjonali.
English: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Maltese: Ċelluli T alloġeniċi modifikati ġenetikament b'vettur retrovirali b'kowd għal forma mqassra tarriċettur tal-fattur tat-tkabbir tan-nervituri uman ta' affinità baxxa (ΔLNGFR - human low affinity nerve growth factor receptor) u thymidine kinase tal-virus herpes simplex I (HSV-TK Mut2 - herpes simplex I virus thymidine kinase).