FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1097/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1097/001
English: Very common > 1/10 Common ≥1/100 to <1/10
Maltese: Komuni ħafna > 1/10 Komuni
English: Eighty three percent were white (56% Caucasian/European heritage and 28% Arabic/North African heritage), 11% African American/African, and 6% Asian.
Maltese: Tlieta u tmenin fil-mija kienu bojod (56% Kawkasi/patrimonju Ewropew)u 28% Għarab/patrinomju tal-Afrika ta' Fuq, 11% Amerikani Afrikani/Afrikani, u 6% Asjatiċi.
English: Name and address of the manufacturer of the biological active substance MolMed SpA
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva MolMed SpA
English: A total of 18 patients with ADA-SCID were treated with Strimvelis as part of one open-label pivotal trial (AD1115611; N=12), two early open-label pilot studies (AD1117054/AD1117056; N=3), and a compassionate use program (AD1117064; N=3).
Maltese: Total ta' 18-il pazjent b'ADA-SCID kienu kkurati bi Strimvelis bħala parti minn prova pivitali waħda openlabel (AD1115611; N=12), żewġ studji pilota open-label kmieni (AD1117054/AD1117056; N=3), u programm tal-użu b'kompassjoni (AD1117064; N=3).
English: T-lymphocyte (x106/l) n median (range) % subjects with venous RBC dAXP <100 nmol/ml after Strimvelisd n
Maltese: Limfoċita-T (x106/l) n medjan (medda) % ta' individwi b' RBC dAXP minn ġol-vina <100 nmol/ml wara
English: e At baseline 9 of 11 (82%) patients had dAXP <100 nmol/ml.
Maltese: e Fil-linja bażi, 9 minn 11-il pazjent (82%) kellhom dAXP <100 nmol/ml.
English: Hepatic impairment
Maltese: Epatite awtoimmuni
English: The median percentages of genetically modified cells in peripheral blood at one year and 3 years after treatment were 28% (range 6%-92%) and 30% (range 8%-101%) of CD19+, and 73% (range 20%-100%) and 67% (range 39%-82%) of CD3+ cells, respectively.
Maltese: Il-perċentwali medjani ta' ċelluli modifikati ġenetikament fid-demm periferali f'sena u 3 snin wara l-kura kienu 28% (firxa 6%-92%) u 30% (firxa 8%-101%) ta' CD19+, u 73% (firxa 20%-100%) u 67% (firxa 39%82%) ta' ċelluli CD3+, rispettivament.
English: This medicine contains approximately 3.5 mg sodium per millilitre.
Maltese: Din il-mediċina fiha bejn wieħed u ieħor 3.5 mg ta' sodium għal kull millilitru.
English: Exp.: {DD MMM YY} {hh:mm} SPECIAL STORAGE CONDITIONS
Maltese: Jis.: {JJ XXX SS} {hh:mm}
English: No clinical data on exposed pregnancies are available.
Maltese: M'hemmx dejta klinika disponibbli dwar tqala esposta.
English: Also contains sodium chloride.
Maltese: TA' EĊĊIPJENTI Fih ukoll sodium chloride.
English: Asthma, rhinitis allergic
Maltese: Ażma, rinite allerġika
English: One year post treatment, median ADA activity (mononuclear cells adenosine deaminase) in peripheral blood lymphocytes was 181.2 (range 42.11678.2) nmol/h/mg protein, compared to a baseline median (range) of 80.6 (30.5-92.3) nmol/h/mg protein.
Maltese: Sena wara l-kura, l-attività medjana ta' ADA (ċelluli mononukleari adenosine deaminase) f'limfociti tad-demm perfierali kienet ta' 181.2 (firxa 42.11678.2) nmol/h/mg proteina, meta mqabbla ma' medjan (firxa) tal-linja bażi ta' 80.6 (30.5-92.3) nmol/h/mg proteina.
English: Hepatic enzyme increaseda, antinuclear antibody (ANA) positive
Maltese: Żieda fl-enzima talfwieda, antikorp antinukleari (ANA) filpożittiv
English: Rate of severe infections per person-year of observation (95% confidence
Maltese: Rata ta' infezzjonijiet severi għal kull sena ta' persuna ta' osservazzjoni (b'kunfidenza ta'95% )
English: This medicinal product contains 0.15 mmol sodium per ml (see section 4.4).
Maltese: Dan il-prodott mediċinali fih 0.15 mmol sodium għal kull ml (ara sezzjoni 4.4).
English: 67% (12 of 18) of Strimvelis treated patients had either autoimmune antibodies or other manifestations (e.g. autoimmune thrombocytopenia, autoimmune aplastic anaemia, autoimmune hepatitis and Guillain-Barré syndrome) (see section 4.8).
Maltese: Il-pazjenti jistgħu jiżviluppaw l-awtoimmunità. 67% (12 minn 18) ta' pazjenti kkurati bi Strimvelis kellhom antikorpi awtoimmuni jew manifestazzjonijiet oħrajn (eż. tromboċitopenija awtoimmuni, anemija aplastika awtoimmuni, epatite awtoimmuni u sindrome ta' Guillain-Barré) (ara sezzjoni 4.8).
English: If busulfan AUC exceeds 4000 nanograms/ml*h (974 µmol/L.minute), the dose should be appropriately reduced based on the AUC.
Maltese: Jekk busulfan AUC jaqbeż 4000 nanogramma/ml*h, (974 µmol/L.minute), id-doża għandha titnaqqas b'mod xieraq ibbażat fuq l-AUC.
English: • the treatment sample, 4 to 5 days before.
Maltese: • il-kampjun ta' kura, 4 sa 5 ijiem qabel.
English: Bag No.:
Maltese: Borża Nru.:
English: The median age across the program was 1.7 years (range 0.5 to 6.1) and 61% were males.
Maltese: L-età medjana fil-programm kienet 1.7 snin (firxa 0.5 sa 6.1) u 61% kienu rġiel.
English: The concentration is 1-10 million CD34+ cells/ml.
Maltese: Il-konċentrazzjoni hija 1-10 miljun ċelluli CD34+/ml.
English: The 3 month hospitalisation period immediately post gene therapy was excluded from the calculation d dAXP=dAMP+dADP+dATP.
Maltese: Ilperjodu ta' rikoveru l-isptar ta' 3 xhur immedjatament wara t-terapija tal-ġeni ġie eskluż mill-kalkolazzjoni d dAXP=dAMP+dADP+dATP.
English: Serious adverse reactions include autoimmunity (e.g. autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune hepatitis, autoimmune thrombocytopenia and Guillain-Barré syndrome).
Maltese: Reazzjonijiet avversi serji jinkludu l-awtoimmunità (eż. anemija emolitika awtoimmuni, anemija aplastika awtoimmuni, epatite awtoimmuni, tromboċitopenija awtoimmuni u sindrome ta' Guillain-Barré).
English: Treatment with Strimvelis resulted in a 100% survival rate at 3 years post therapy, a decrease in the severe infection rate, an increase in T-lymphocytes (CD3+) and all subjects having post-baseline venous red blood cell deoxyadenosine nucleotide (RBC dAXP) levels below pathological levels (>100 nmol/ml).
Maltese: Il-kura bi Strimvelis irriżultat f'rata ta' sopravivenza ta' 100% 3 snin wara t-terapija, tnaqqis fir-rata ta' infezzjoni severa, żieda fil-limfoċiti-T (CD3+) u l-individwi kollha kellhom livelli wara l-linja bażi minn ġol-vina ta' deoxyadenosine nucleotide taċ-ċelluli ħomor tad-demm (RBC dAXP) taħt il-livelli patoloġiċi (>100 nmol/ml).
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot:
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KODIĊIJIET TAL-PRODOTT Lott:
English: Adverse events related to the use of central venous catheters (CVCs) have been reported (e.g., serious CVC infections and thrombosis in the device).
Maltese: Ġew irrapportati avvenimenti avversi relatati mal-użu ta' kateters ġol-vina ċentrali (CVCs) (eż., infezzjonijiet serji tas-CVC u trombożi fit-tagħmir).
English: Contents of the pack and further information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: It is recommended that an intravenous antihistamine be administered 15-30 minutes before the infusion of Strimvelis.
Maltese: Premedikazzjoni Huwa rrakkomandat li tingħata antistamina minn ġol-vina 15-30 minuta qabel l-infużjoni ta' Strimvelis.
English: Severe infections n
Maltese: Infezzjonijiet severi n
English: Strimvelis is given…
Maltese: Strimvelis jingħata…
English: The total busulfan dose is 4 mg/kg, divided into 8 doses of 0.5 mg/kg.
Maltese: Id-doża totali ta' busulfan hi 4 mg/kg, maqsuma fi' tmien dożi ta' 0.5 mg/kg.
English: Autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune thrombocytopenia
Maltese: Anemija emolitika awtoimmuni, anemija aplastika awtoimmuni, tromboċitopenija awtoimmuni
English: The nature of Strimvelis is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Maltese: In-natura ta' Strimvelis hija b'tali mod li studji konvenzjonali fuq il-farmakokinetiċi, l-assorbiment, id-distribuzzjoni, il-metaboliżmu, u l-eliminazzjoni mhumiex applikabbli.
English: The infusion rate should not exceed 5 ml/kg/h.
Maltese: Ir-rata tal-infużjoni ma għandhiex taqbeż 5 ml/kg/h.
English: This medicinal product contains 0.15 mmol sodium per ml.
Maltese: Dan il-prodott mediċinali fih 0.15 mmol sodium għal kull ml.
English: Elderly Strimvelis is not intended for use in patients >65 years of age, and has not been studied in this age group.
Maltese: Anzjani Strimvelis mhuwiex intenzjonat għall-użu f'pazjenti >65 sena, u ma ġiex studjat fil-grupp ta' din l-età.
English: However, vector insertions into chromosomal regions previously associated with leukaemia in comparable trials of gene therapy in Wiskott Aldrich Syndrome, X-SCID and Chronic Granulomatous Disease have been documented.
Maltese: Madankollu, ġew dokumentati inserzjonijiet vektorali fir-reġjuni kromosomali assoċjati qabel mal-lewkimja fi provi komparabbli ta' terapija tal-ġeni fis-Sindrome ta' Wiskott Aldrich, X-SCID u Chronic Granulomatous Disease.
English: T cell function: In the patients treated in the pivotal study, T cell proliferation was demonstrated in response to stimulation with anti-CD3 antibodies (median 62629 cpm, range 4531 to 252173) and phytohemaglutinin (median 140642 cpm, range 11119 to 505607) at 1 year post gene therapy, and these responses were sustained through Year 3.
Maltese: Funzjoni taċ-ċellula T: Fil-pazjenti kkurati fl-istudju pivotali, il-proliferazzjoni taċ-ċellula T intweriet bħala rispons għall-istimulazzjoni b'antikorpi anti-CD3 (62629 cpm medjan, firxa 4531 sa 252173) u phytohemaglutinin (140642 cpm medjan, firxa 11119 sa 505607) sena wara t-terapija tal-ġeni, u dawn irrisponsi ġew sostnuti matul Sena 3. Is-sejbiet li TREC (ċrieki ta' tneħħija tar-riċettur taċ-ċellula T) fillimfoċiti tad-demm periferali żdiedu 'l fuq mil-linja bażi (141 medjan, firxa 56 sa 1542 kopja/100ng DNA) fis-Snin 1 u nżamm sa 3 wara l-kura u li l-individwi kollha kellhom evidenza ta' ktajjen Vbeta poliklonali f'punt taż-żmien wieħed jew aktar wara t-terapija tal-ġeni, jipprovdu aktar evidenza ta' appoġġ ta' żvilupp taċ-ċellula T funzjonali.
English: Strimvelis is a type of medicine called a gene therapy.
Maltese: Strimvelis huwa tip ta' mediċina msejħa terapija tal-ġeni.
English: The safety of Strimvelis was evaluated in 18 subjects, with a median duration of follow-up of 7 years.
Maltese: Is-sigurtà ta' Strimvelis ġiet evalwata fi 18-il individwu, b'dewmien medjan ta' segwitu ta' 7 snin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fillista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew talmediċini.
English: T-lymphocyte (CD3+) and NK (CD56+) cell counts improved following treatment with Strimvelis.
Maltese: L-għadd tal-limfoċiti-T (CD3+) u ċelluli NK (CD56+) tjieb wara l-kura bi Strimvelis.
English: The frequency categories used are:
Maltese: Il-kategoriji ta' frekwenza użati huma:
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants , ATC code: not yet assigned
Maltese: Immunostimulanti, immunostimulanti oħra, kodiċi ATC: għadu mhux assenjat
English: • reduced numbers of blood cells (autoimmune haemolytic anaemia, autoimmune aplastic anaemia)
Maltese: • numru mnaqqas ta' ċelluli ħomor (anemija emolitika awtoimmuni, anemija aplastika awtoimmuni)
English: Strimvelis is intended for autologous use only (see section 4.4).
Maltese: Strimvelis huwa intenzjonat għall-użu awtologu biss (ara sezzjoni 4.4).
English: Retroviral insertion sites (RIS) have been detected adjacent to or within CCND2 and LMO2 and there is a potential risk of leukaemic transformation following treatment with Strimvelis.
Maltese: Ġew osservati siti ta' inserzjoni retrovirali (RIS) li jinstabu ħdejn jew fi ħdan CCND2 u LMO2 u hemm ir-riskju potenzjali ta' trasformazjoni lewkemika wara l-kura bi Strimvelis.
English: Strimvelis is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Maltese: Mhux mistenni li Strimvelis jinteraġixxi mal-familja ta' enzimi taċċitokromu tal-fwied P-450 jew trasportaturi tal-mediċina.
English: 50 ml ethylene vinyl acetate (EVA) infusion bag, with a luer spike interconnector closed with a luer lock cap, packed in a re-usable outer container.
Maltese: Borża tal-infużjoni ta' 50 ml ethylene vinyl acetate (EVA), b'interkonnettur b'labra rqiqa luer magħluq b'għatu li jissakkar luer, ippakkjata f'reċipjent ta' barra li jista' jerġa' jintuża mill-ġdid.
English: Studies evaluated the use of Strimvelis with a range of 0.9 million - 18.2 million CD34+ cells/kg.
Maltese: L-istudji evalwaw l-użu ta' Strimvelis b'firxa ta' 0.9 miljun - 18.2 miljun ċellula CD34+/kg.
English: - The other ingredient is sodium chloride (see section 2, Strimvelis contains sodium).
Maltese: - L-ingredjent l-ieħor huwa sodium chloride (ara sezzjoni 2, Strimvelis fih is-sodium).
English: • blood test results positive for antineutrophil cytoplasmic antibody and smooth muscle antibody
Maltese: • riżultati tat-testijiet tad-demm pożittivi għal antikorp ċitoplażmiku antinewtrofiliku u antikorp tal muskolu lixx
English: Strimvelis is used to treat a serious condition called ADA-SCID (Adenosine Deaminase-Severe Combined Immune Deficiency).
Maltese: Strimvelis jintuża sabiex jikkura kundizzjoni serja li tissejjaħ ADA-SCID (Immunodefiċjenza Kkombinata Severa ta' Adenosine Deaminase).
English: Antineutrophil cytoplasmic antibody positive, smooth muscle antibody positive aAdverse reactions considered potentially related to busulfan conditioning
Maltese: Antikorp ċitoplażmiku antinewtrofiliku filpożittiv, antikorp talmuskolu lixx fil-pożittiv aReazzjonijiet avversi meqjusa potenzjalment relatati mal-kundizzjonament ta' busulfan
English: Anaemiaa Neutropeniaa
Maltese: Anemijaa Newtropenijaa
English: • inflamed itchy skin (atopic dermatitis, eczema)
Maltese: • ġilda infjammata li tqabbad il-ħakk (dermatite atopika, ekżema)
English: - Keep this leaflet.
Maltese: Huwa rrakkomandat segwitu kontinwu.
English: Immune reconstitution
Maltese: Rikostituzzjoni immuni
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Strimvelis infusion bag(s) and/or container (see sections 4.4 and 6.6).
Maltese: Qabel l-infużjoni, għandu jiġi kkonfermat li l-identità tal-pazjent taqbel mal-informazzjoni unika essenzjali tal-pazjent fuq il-borża/boroż u/jew kontenitur tal-infużjoni Strimvelis (ara sezzjonijiet 4.4 u 6.6).
English: Strimvelis contains sodium
Maltese: Strimvelis fih is-sodium
English: • increases in liver enzymes*
Maltese: • żidiet fl-enzimi tal-fwied*
English: Posology The recommended dose range of Strimvelis is between 2 and 20 million CD34+ cells/kg.
Maltese: Pożoloġija Il-firxa rakkomandata tad-doża ta' Strimvelis hija bejn 2 u 20 miljun ċellula CD34+/kg.
English: Name and address of the manufacturer responsible for batch release MolMed SpA
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott MolMed SpA
English: • weakness and pain in the feet and hands (Guillain-Barré syndrome)
Maltese: • dgħufija u uġigħ fis-saqajn u l-idejn (sindrome ta' Guillain-Barré)
English: The period of administration is approximately 20 minutes (see section 6.6).
Maltese: Il-perjodu tal-għoti huwa bejn wieħed u ieħor ta' 20 minuta (ara sezzjoni 6.6).
English: Four subjects had previously received an unsuccessful stem cell transplant from a haploidentical donor and 15 of 18 subjects had previously received prior enzyme replacement therapy with polyethylene-glycol-modified bovine adenosine deaminase (PEG-ADA).
Maltese: Erba' individwi kienu rċevew minn qabel trapjant ta' ċelluli staminali mingħajr suċċess minn donatur aploidentiku (haploidentical) u 15 minn 18-il individwu kienu rċevew terapija ta' sostituzzjoni tal-enzima b'adenosine deaminase bovin modifikat ta' polyethylene-glycol (PEG-ADA).
English: • inflamed liver (autoimmune hepatitis)
Maltese: • fwied infjammat (epatite awtoimmuni)
English: Cases of skin papillomas, abnormal serum protein electrophoresis and one case each of lipofibroma, pulmonary mass and decreased T-cell V beta repertoire were reported.
Maltese: Ġew irrapportati każijiet ta' papillomi tal-ġilda, elettroforeżi tal-protetina ta' serum anormali u każ kull wieħed ta' lipofibroma, massa pulmonari u repertorju imnaqqsa ta'beta V taċ-ċellula-T.
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells.
Maltese: Frazzjoni taċ-ċellula arrikkita awtologa CD34+ li fiha ċelluli CD34+ transdotti b'vettur retrovirali li jikkodifika għas-sekwenza adenosine deaminase (ADA) cDNA tal-bniedem minn ċelluli ematopoetiċi/ staminali /proġenituri tal-bniedem (CD34+).
English: The ones marked * may be related to busulfan.
Maltese: Dawk immarkati b'* jistgħu jkunu relatati ma' busulfan.
English: • raised temperature (pyrexia)
Maltese: • temperatura għolja (deni)
English: Strimvelis is an autologous cellular therapy.
Maltese: Strimvelis huwa terapija awtologa taċ-ċelluli.
English: Dermatitis atopic, eczema
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Patient ID:
Maltese: ID tal-pazjent:
English: In addition, the allergy related adverse reactions in the table were reported mostly during the 3 month to 3 year follow-up period.
Maltese: Barra minn hekk, ir-reazzjonijiet avversi relatati mal-allerġija fit-tabella kienu rrapportati laktar waqt il-perjodu ta' segwitu ta' 3 xhur sa 3 snin.
English: The long term effects and durability of response to Strimvelis on ADA-SCID are unknown (see section 5.1).
Maltese: L-effetti fit-tul u d-durabilità tar-rispons għal Strimvelis fuq ADA-SCID mhumiex magħrufa (ara sezzjoni 5.1).
English: Patients should be closely monitored for the occurrence of severe and opportunistic infections, immune reconstitution parameters and the need for replacement intravenous immunoglobulin (IVIG); in case of lack of response, it is recommended to introduce other ADA-SCID treatments under the supervision of a physician.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għall-okkorrenza ta' infezzjonijiet severi u opportunistiċi, parametri ta' rikostituzzjoni immuni u l-ħtieġa għal immunoglobulina ta' ġol-vini ta' sostituzzjoni (IVIG, intravenous immunoglobulin); fil-każ ta' nuqqas ta' rispons, huwa rrakkomandat li jiġu introdotti kuri
English: • inflamed thyroid gland (autoimmune thyroiditis)
Maltese: • glandola tat-tirojde infjammata (tirojdite awtoimmuni)
English: • decreases in the number of red or white blood cells (anaemia, neutropenia)*
Maltese: • tnaqqis fin-numru ta' ċelluli ħomor jew bojod tad-demm (anemija, newtropenija)*
English: Pre-treatment conditioning
Maltese: Pre treatment
English: About 15 to 30 minutes before treatment
Maltese: Madwar 15 sa 30 minuta qabel kura
English: Pyrexia
Maltese: Treddigħ
English: Hypersensitivity to the product or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għall-prodott jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: After infusion, CD34+ cells engraft in the bone marrow where they repopulate the haematopoetic system with a proportion of cells that express pharmacologically active levels of the ADA enzyme.
Maltese: Wara l-infużjoni, iċ-ċelluli CD34+ jitlaqqmu fil-mudullun fejn jirripopolaw is-sistema ematopojetika bi proporzjon ta' ċelluli li jesprimu livelli farmakoloġikament attivi tal-enzima tal-ADA.
English: Package leaflet: Information for the patient or carer Strimvelis 1-10 million cells/ml dispersion for infusion Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Maltese: Informazzjoni għall-pazjent jew għal min jieħu ħsiebu Strimvelis 1-10 miljun ċellula/ml tixrid għall-infużjoni Frazzjoni awtologa taċ-ċellula arrikkita CD34 + li fiha ċelluli CD34+ transdotti b'vettur retrovirali li jikkodifika għas-sekwenza ADA cDNA tal-bniedem.
English: NAME OF THE MEDICINAL PRODUCT Strimvelis 1-10 million cells/ml dispersion for infusion.
Maltese: Strimvelis 1-10 miljun ċellula/ml tixrid għall-infużjoni.
English: For more information on what happens before and during treatment, see section 3, How Strimvelis is given.
Maltese: Għal aktar informazzjoni dwar x'jiġri qabel u waqt il-kura, ara sezzjoni 3, Kif jingħata Strimvelis.
English: The MAH will review the occurrence of angioedema, anaphylactic reactions, systemic allergic events and severe cutaneous adverse reactions during the FU period, particularly in those patients who had unsuccessful response and received ERT or SCT.
Maltese: L-MAH ser jirrevedi l-okkorrenza ta' anġjodema, reazzjonijiet anafilattiċi, avvenimenti allerġiċi sistemiċi u reazzjonijiet avversi severi tal-ġilda waqt il-perjodu FU, b'mod partikolari f'dawk il-pazjenti li kellhom rispons mingħajr suċċess u rċevew ERT jew SCT.
English: PHARMACEUTICAL FORM Dispersion for infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Tixrid għall-infużjoni.
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence with a concentration of 1-10 million CD34+ cells/ml.
Maltese: ATTIVA(I) Frazzjoni taċ-ċellula arrikkita awtologa CD34+ li fiha ċelluli CD34+ transdotti b'vettur retrovirali li jikkodifika għas-sekwenza ADA cDNA tal-bniedem b'konċentrazzjoni ta' 1-10 miljun ċellula CD34+/ml.
English: interval)
Maltese: TIKKETTAR
English: When
Maltese: ISEM
English: to make the bone marrow ready for Strimvelis
Maltese: Qabel u wara l-kura bi Strimvelis
English: These autoimmune adverse reactions were reported for subjects post-gene therapy.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Strimvelis will be administered at a specialist transplant centre, and by physicians with previous experience in the treatment and management of patients with ADA-SCID and the use of autologous CD34+ ex vivo gene therapy products.
Maltese: Strimvelis ser jingħata f'ċentru ta' trapjanti speċjalizzat, u minn tobba b'esperjenza preċedenti fil-kura u limmaniġġjar ta' pazjenti b'ADA-SCID u l-użu ta' prodotti awtologi ta' terapija tal-ġeni ex vivo CD34+.
English: • underactive thyroid gland (hypothyroidism)
Maltese: • glandola tat-tirojde anqas attiva (ipotajrojdiżmu)
English: The finished product is composed of one or more ethylene vinyl acetate (EVA) bags which contain an autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
Maltese: Il-prodott lest huwa magħmul minn borża waħda jew aktar ta' ethylene vinyl acetate (EVA) li fihom frazzjoni taċ-ċellula arrikkita awtologa CD34+ li fiha ċelluli CD34+ transdotti b'vettur retrovirali li jikkodifika għas-sekwenza ADA cDNA tal-bniedem.
English: Strimvelis is not tested for transmissible infectious agents.
Maltese: Strimvelis mhuwiex ittestjat għal aġenti tal-infezzjoni trasmissibbli.
English: The majority were reported during the 3 month to 3 year follow-up period and resolved, with the exception of hypothyroidism and positive ANA tests.
Maltese: Il-maġġoranza kienu rrapportati waqt il-perjodu ta' segwitu ta' 3 xhur sa 3 snin u solvuti, bl-eċċezzjoni ta' ipotirojdiżmu u testijiet ANA pożittivi.
English: People with ADA-SCID cannot produce enough of an enzyme called adenosine deaminase (ADA) because the gene to make it is faulty.
Maltese: Persuni b'ADA-SCID ma jistgħux jipproduċu biżżejjed minn enzima li tissejjaħ adenosine deaminase (ADA) minħabba li l-ġene li tipproduċiha hija difettuża.