FrancophonIA/ELRC3.0 huggingface dataset:
English: Activity in cell culture and/or biochemical studies
Maltese: Attività fil-kultura taċ-ċelloli u/jew l-istudji bijokimiċi
English: Clinical monitoring and dose adjustment may be required for levothyroxine
Maltese: Monitoraġġ kliniku u aġġustament fid-doża jista' jkun meħtieġ għal levothyroxine
English: ANTITPLATELET AGENTS Ticagrelor
Maltese: ANTIFUNGALI Ketoconazole
English: Similar effect is expected as observed with Viekirax + dasabuvir.
Maltese: Effett simili hu mistenni kif osservat b'Viekirax + dasabuvir.
English: Sirolimus 0.5 mg single dose5
Maltese: 0.5 mg doża waħda5
English: Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Maltese: kellhom ċirrożi kkumpensata; 86% ma kinux irċivew trattamenti għall-HCV; 14% ma rnexxielhomx jieħdu trattament minn qabel b' pegIFN / RBV; 68% kellhom infezzjoni b'HCV ġenotip 1a.
English: In all eight trials, the Viekirax dose was 25 mg/150 mg/100 mg once daily and the dasabuvir dose was 250 mg twice daily.
Maltese: Fi tmien provi kollha, id-doża ta' Viekirax kienet 25 mg/150 mg/100 mg darba kuljum u d-doża ta' dasabuvir kienet 250 mg darbtejn kuljum.
English: Age, median (range) years Male gender, n (%) Prior HCV Treatment: naïve, n (%) Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Maltese: Eta, snin medja (firxa) Sess maskil, n (%) Qabel it-trattament ta' HCV:
English: open-label, single-arm, global multicentre
Maltese: tikketta miftuħa, fergħa waħda, multiċentriku globali
English: If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).The increase in rosuvastatin when combined with Viekirax without dasabuvir is less pronounced.
Maltese: Jekk it-trattament b'rosuvastatin huwa meħtieġ waqt il-perjodu ta' trattament, id-doża massima ta' kuljum ta' rosuvastatin għanda tkun ta' 5 mg (ara sezzjoni 4.5, Tabella 2).
English: GT1-infected subjects with or without cirrhosis with severe renal impairment or end-stage renal disease (ESRD)
Maltese: Individwi infettati bil-GT1 bi jew mingħajr ċirrożi b'indeboliment sever tal-kliewi jew mard renali flaħħar stadju (ESRD)
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders, and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Maltese: Il-pazjenti kkurati (N=179) kellhom età medja ta' 57 sena (medda: 26 sa 70); 35.2% kienu pazjenti li ma rrispondew xejn preċedentement għal pegIFN/RB; 28.5% kienu pazjenti li preċedentement irrispondew b'mod parzjali għal pegIFN/RBV, u 36.3% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV;
English: In the 7 genotype 1b infected subjects, treatment-emergent variants were observed in NS3 in 4 subjects, in NS5A in 2 subjects, and in both NS3 and NS5A in 1 subject.
Maltese: 7 individwi infettati bil-ġenotip 1b, kienu osservati varjanti emerġenti mill-kura f'NS3 f'4 individwi,
English: SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
Maltese: Provi kliniċi f'adulti naïve għall-kura SAPPHIRE-I - naïve għall-kura, ġenotip 1, mingħajr ċirrożi
English: Ombitasvir and paritaprevir block two proteins essential for the virus to multiply.
Maltese: Ombitasvir u paritaprevir jibblokkaw żewġ proteini essenzjali għall-virus biex jimmultiplikaw.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Viekirax jista' jingħata bi jew mingħajr dasabuvir.
English: Coadministration with ethinyloestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Maltese: L-għoti flimkien ma' oetinylestradiol jistgħu jżidu r-riskju ta' elevazzjonijiet ta' ALT (ara sezzjonijiet 4.3 u 4.4).
English: GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Maltese: GT1a Fergħa A: Viekirax u dasabuvir + RBV Fergħa B: Viekirax u dasabuvir
English: nordiazepam
Maltese: ↑ pimozide
English: The doses of paritaprevir were 100 mg and 200 mg and ombitasvir 25 mg.
Maltese: Id-dożi ta' paritaprevir kienu ta'100 mg u 200 mg u dak ta'ombitasvir kien ta'25 mg.
English: Concomitant use with efavirenz is contraindicated (see section 4.3).
Maltese: Użu konkomitanti huwa kontraindikat (ara sezzjoni 4.3).
English: The MAH shall complete, within the stated timeframe, the below measures:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI
Maltese: Viekirax u dasabuvir ma' RBV għal 12-il ġimgħa n/N % 95% CI
English: 10 subjects (29.4%) had at least one post baseline haemoglobin value of less than 10 g/dL.
Maltese: 10 individwi (29.4%) kellhom mill-inqas linja ta' bażi waħda ta'
English: EXP
Maltese: Zolpidem
English: Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Maltese: 97.5% intervall ta' kunfidenza jintuża għall-punti ta' tmiem tal-effikaċja primarja (rata SVR12 globali); jintużaw 95% intervalli ta' kunfidenza għal punti ta' tmiem addizzjonali tal-effikaċja (rati
English: These medicines can affect the way Viekirax works and Viekirax can affect the way these other medicines work.
Maltese: mediċina minn ħxejjex għal ansjetà u dipressjoni ħafifa.
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy.
Maltese: Elevazzjonijit fl-ALT kienu tipikament asintomatiċi, ġeneralment seħħew matul l ewwel 4 ġimgħat ta' trattament (ħin medju 20 ġurnata, medda 8-57 ijiem) u ħafna ġew solvuti b' terapijakontinwa.
English: Ritonavir dose in Viekirax will provide atazanavir pharmacokinetic enhancement).
Maltese: Doża ta' ritonavir f'Viekirax se jipprovdi żieda farmakokinetika f'atazanavir.
English: Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Maltese: Rati ta' rikaduta bil-valuri tal-linja bażi tal-laboratorju wara 12 u 24
English: These medicinal products may show clinically relevant increases in exposures of paritaprevir (e.g., ritonavir with atazanavir, erythromycin, diltiazem or verapamil).
Maltese: Dawn il-prodotti mediċinali jistgħu juru żidiet klinikament rilevanti fil-espożizzjonijiet ta' paritaprevir (eż ritonavir ma' atazanavir, erythromycin,
English: Low dose ritonavir, which is part of the fixed dose combination Viekirax, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Maltese: Doża baxxa ta' ritonavir, li hija parti mill-kombinazzjoni ta' doża fissa ta' Viekirax, tista' tagħżel għal reżistenza tal- PI f'pazjenti ko-infettati bl-HIV mingħajr terapija antiretrovirali kontinwa.
English: Concomitant use is contraindicated (see section
Maltese: Użu konkomitanti huwa kontraindikat (ara sezzjoni
English: Serious and/or life threatening events have been observed with co-administration of Viekirax and dasabuvir with systemic tacrolimus, and a similar risk can be expected with sirolimus and everolimus.
Maltese: tacrolimus sistemiku, u riskju simili jista'jkun mistenni ma' sirolimus u everolimus.
English: Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg.
Maltese: Bl-istess mod, paritaprevir /ritonavir ma kienx karċinoġeniku f'studju tal-ġrieden transġeniċi ta' sentejn sal-ogħla dożaġġ ittestjat (300 mg/30 mg/kg/kuljum), li rriżulta f'espożizzjonijiet ta' AUC ta' paritaprevir madwar 8 darbiet ogħla minn dawk fil-bnedmin f'150 mg.
English: Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Maltese: *AFP= fetoprotein alfa fis-serum F' individwi bi tliet valuri tal-laboratorju kollha favorevoli bl-linja ta' bażi (AFP <20 ng / mL, plejtlets ≥
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Maltese: Subtrati ta' CYP2D6 (e.ż. desipramine,
English: Fexofenadine
Maltese: Pożoloġija
English: These metabolites are not expected to have antiviral activity or off-target pharmacologic activity.
Maltese: Dawn il-metaboliti mhumiex mistennija li jkollhom attività antivirali jew attività farmakoloġika mhux fil mira.
English: Increase in dasabuvir exposure is possibly due to CYP2C8 inhibition and increase in paritaprevir possibly due to OATP1B1 inhibition by gemfibrozil.
Maltese: Żieda flespożizzjoni ta' dasabuvir minħabba l inibizzjoni ta' CYP2C8 minn gemfibrozil.
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) with genotype 1 HCV infection received the recommended regimen (see section 4.2).
Maltese: Fi provi kliniċi tal-Fażi 3, 1075 individwu (inkluż 181 b'ċirrożi kkumpensata) b'infezzjoni ta' HCV tal ġenotip 1 irċevew ir-reġim irrakkomandat (ara sezzjoni 4.2).Tabella 16 turi r-rati SVR għal dawn l individwi.
English: Drug interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni ta' mediċina twettqu biss f'adulti.
English: Co-administration of Viekirax and dasabuvir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Maltese: L-użu konkomitanti ta' Viekirax u fluticasone partikolarment fit-tul, għandu jinbeda biss jekk il-benefiċċju potenzjali tat trattament hu akbar mir riskju ta' effetti sistemiċi tal-kortikosterojdi (ara sezzjoni 4.4)
English: Clinical monitoring and dose adjustment maybe needed for s-mephenytoin.
Maltese: Monitoraġġ kliniku u aġġustament fid-doża jista' jkun meħtieġ għall-s mephenytoin.
English: Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1'.
Maltese: 0mm, oblongi, roża, immarkati b''AV1'.
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Maltese: Il-pazjenti kkurati (N=631) kellhom età medja ta' 52 sena (medda: 18 sa 70), 54.5% kienu rġiel; 5.4% kienu Suwed;; 15.
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with or without dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment.
Maltese: ml/min), moderat (CrCl: 30 sa 59 ml/min), u sever (CrCl: 15 sa 29 ml/min), tal-fwied.
English: Viekirax without dasabuvir may increase the plasma concentrations of dabigatran etexilate.
Maltese: Dawn il-metaboliti mhumiex mistennija li jkollhom attività antivirali.
English: Astemizole Terfenadine Mechanism: CYP3A4 inhibition by ritonavir.
Maltese: Inibizzjoni ta' OATP1B minn paritaprevir u CYP3A4 inibizzjoni minn ritonavir.
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Maltese: Fis-67 individwu infettat bil-ġenotip 1a, kienu osservati varjanti NS3 f'50 individwu, kienu osservati varjanti NS5A f'46 individwu, kienu osservati varjanti NS5B
English: Dronedarone
Maltese: Deidrazzjoni
English: Clinical trial in patients receiving opioid substitution therapy
Maltese: Provi kliniċi f'individwi li qegħdin jirċievu terapija ta' sostituzzjoni ta' opjojdi
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Viekirax and dasabuvir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Maltese: Kienu osservati elevazzjonijiet temporanji fis-serum bilirubin (prinċipalment indiretti) f'individwi li jingħataw Viekirax u dasabuvir ma' ribavirin, relatati mal-inibizzjoni tat-trasportaturi ta' bilirubin
English: Viekirax + dasabuvir atazanavir ombitasvir paritaprevir
Maltese: Viekirax + dasabuvir paritaprevir
English: Subjects with HCV GT4 received Viekirax with ribavirin for 12 or 24 Weeks.
Maltese: Suġġetti b'HCV GT4 irċevew Viekirax b'ribavirin għal 12 jew 24 Ġimgħa.
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders, and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Maltese: Il-pazjenti kkurati (N=394) kellhom età medja ta' 54 sena (medda: 19 sa 71); 49.0% kienu pazjenti li ma rrispondew xejn preċedentement għal pegIFN/RB; 21.8% kienu pazjenti li preċedentement irrispondew b'mod parzjali għal pegIFN/RBV, u 29.2% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV;
English: Nifedipine Mechanism: CYP3A4 inhibition
Maltese: Prodotti mediċinali li jinibixxu CYP3A4
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Maltese: Id-dijabetiċi jistgħu jesperjenzaw kontroll imtejjeb tal-glukożju, li potenzjalment jirriżulta f'ipoglaċemija sintomatika, wara li tingħata l-bidu l-kura b'antivirali HCV li jaġixxi direttament.
English: Potential for Viekirax to affect the pharmacokinetics of other medicinal products In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Maltese: Potenzjal ta' Viekirax li jaffetwa il-farmakokinetiċi ta' prodotti tal- mediċini oħra Studji in vivo li jinvolvu l-interazzjoni tal-mediċina evalwaw l-effett nett tat-trattament f' kombinazzjoni.
English: Use of colchicine is contraindicated with Viekirax with or without dasabuvir in patients with renal or hepatic impairment (see sections 4.3 and 4.4).
Maltese: Għal rakkomandazzjonijiet ta' dożaġġ ma' prodotti mediċinali antivirali għal HIV, irreferi għas-sezzjonijiet 4.4 u 4.5.
English: This is due to liver function changes during treatment with Viekirax ± dasabuvir.
Maltese: It-taqsima li ġejja tiddeskrivi t-trasportaturi speċifiċi u l-enżimi metabolizzanti li huma affettwati mill dasabuvir.
English: See Table 2 for guidance regarding potential interactions with other medicinal products and dosing recommendations.
Maltese: Ara Tabella 2 għall-gwida dwar interazzjonijiet potenzjali ma' prodotti mediċinali u rakkomandazzjonijiet ta 'dożaġġ.
English: Viekirax tablets are usually taken with other anti-viral medicines such as “dasabuvir” and “ribavirin”.
Maltese: Pilloli ta' Viekirax huma normalment meħudin ma' mediċini anti-virali oħra bħal "dasabuvir" u
English: Viekirax tablets are packed into foil blisters containing 2 tablets.
Maltese: Il-pilloli ta' Viekirax huma ppakkjat f'folji tal-fojl li fihom 2 pilloli.
English: The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg tablets once daily with food.
Maltese: Id-doża orali rrakkomandata ta' Viekirax hi ta' żewġ 12.5mg/75mg/50mg pilloli darba kuljum mal-ikel.
English: Tabulated list of adverse reactions
Maltese: Sommarju f'tabella tar-reazzjonijiet avversi
English: Viekirax is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see sections 4.2 and 5.1).
Maltese: Viekirax mhux rrakkomandat għal amministrazzjoni bħala monoterapija u għandu jiġi użat biex jingħata flimkien ma' prodotti mediċinali oħra għall-kura ta' infezzjoni tal-epatite Ċ (ara sezzjoni 4.2 u 5.1).
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Maltese: L-ebda individwu b'infezzjoni tal-ġenotip 1b HXV ma esperjenza nuqqas viroloġiku fil-kura u 2 individwi b'infezzjoni tal-ġenotip 1b HCV esperjenzaw rikaduta.
English: HIV co-infected patients without suppressive antiretroviral therapy should not be treated with Viekirax.
Maltese: Pazjenti koinfettati bl-HIV mingħajr terapija antiretrovirali soppressiva m'għandhomx jiġu kkurati Viekirax.
English: Mechanism: CYP3A4 inhibition by ritonavir.
Maltese: inibizzjoni ta' CYP3A4 minn ritonavir.
English: The adverse reactions are listed below by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt mill-klassi tas-sistema tal-organi u l-frekwenza.
English: The pharmacokinetics of Viekirax in paediatric patients has not been established (see section 4.2).
Maltese: Il-farmokokinetika ta' Viekirax f'pazjenti pedjatriċi ma ġiex stabbilita (ara sezzjoni 4.2).
English: The full EPAR for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Strimvelis
Maltese: Informazzjoni oħra dwar Strimvelis
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Strimvelis jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Strimvelis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Strimvelis.
English: Serious side effects with Strimvelis may include effects linked to autoimmunity (when the immune system attacks the body's own cells) such as haemolytic anaemia (low red blood cell counts due to their too rapid breakdown), aplastic anaemia (low blood cell counts due to damaged bone marrow), hepatitis (liver inflammation), thrombocytopenia (low blood platelet count) and Guillain-Barré syndrome (damage to nerves that can result in pain, numbness, muscle weakness and difficulty walking).
Maltese: L-effetti sekondarji serji bi Strimvelis jistgħu jinkludu effetti marbuta mal-awtoimmunità (meta ssistema immuni tattakka ċ-ċelluli tal-ġisem stess) bħal anemija emolitika (għadd baxx ta' ċelluli ħomor tad-demm minħabba t-tkissir malajr ħafna tagħhom), anemija aplastika (għadd baxx ta' ċelluli taddemm minħabba ħsara fil-mudullun), epatite (infjammazzjoni tal-fwied), tromboċitopenija (għadd baxx ta' plejtlits tad-demm) u sidrome ta' Guillain-Barré (ħsara lin-nervaturi li tista' twassal għal uġigħ, tnemnim, dgħufija fil-muskoli u diffikultà biex timxi).
English: Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID).
Maltese: Strimvelis huwa mediċina użata għal kura ta' immunodefiċjenza kkombinata severa minħabba defiċjenza ta' adenosine deaminase (ADA-SCID).
English: Why is Strimvelis approved?
Maltese: Għaliex ġie approvat Strimvelis?
English: Strimvelis is given as an infusion (drip) into a vein over about 20 minutes.
Maltese: Strimvelis jingħata bħala infużjoni (dripp) ġol-vina fuq perjodu ta' madwar 20 minuta.
English: Because the number of patients with ADA-SCID is low, the disease is considered ‘rare', and Strimvelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Maltese: Minħabba li n-numru ta' pazjenti b'ADA-SCID huwa wieħed baxx, il-marda hija meqjusa bħala ‘rari', u Strimvelis ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fis-26 ta' Awwissu 2005.
English: Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Maltese: Frazzjoni awtologa taċ-ċellula arrikita CD34 + li fiha ċelluli CD34+ transdotti b'vettur retrovirali li jikkodifika għas-sekwenza ADA cDNA tal-bniedem
English: Strimvelis is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Strimvelis huwa tip ta' mediċina ta' terapija avvanzata msejħa ‘prodott ta' terapija tal-ġeni'.
English: The benefits of Strimvelis have been shown in one main study involving 12 patients from 6 months to around 6 years old with ADA-SCID.
Maltese: Il-benefiċċji ta' Strimvelis ġew murija fi studju ewlieni wieħed li involva 12-il pazjent minn 6 xhur għal madwar 6 snin b'ADA-SCID.
English: ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine deaminase (ADA).
Maltese: ADA-SCID hija kundizzjoni rari li tintiret fejn hemm bidla (mutazzjoni) fil-ġene meħtieġ sabiex tiġi prodotta enzima li tissejjaħ adenosine deaminase (ADA).
English: The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years.
Maltese: Ir-rata ta' infezzjonijiet severa naqset wara l-kura u baqgħet tonqos wara segwitu aktar fit-tul lil hinn minn 3 snin.
English: What are the risks associated with Strimvelis?
Maltese: X'inhuma r-riskji assoċjati ma' Strimvelis?
English: How is Strimvelis used?
Maltese: Kif jaħdem Strimvelis?
English: A risk management plan has been developed to ensure that Strimvelis is used as safely as possible.
Maltese: Hemm ukoll il-potenzjal ta' riskju ta' mard awtoimmuni.
English: Once given back to the patient into a vein, Strimvelis is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal lymphocytes that can produce ADA.
Maltese: Ladarba jingħata lura lill-pazjent ġol-vina, Strimvelis huwa ttrasportat fiċ-ċirkolazzjoni tad-demm għal mudullun fejn iċ-ċelluli CD34+ jibdew jikbru u jagħmlu limfoċiti normali li jistgħu jipproduċu ADA.
English: Some of the cells (called CD34+ cells) have been genetically modified to contain a working gene for ADA.
Maltese: Xi wħud miċ-ċelluli (li jissejħu ċelluli CD34+) ġew modifikati ġenetikament sabiex ikollhom ġene li jaħdem għal ADA.
English: Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied.
Maltese: Rigward is-sigurtà, Strimvelis kien tollerat pjuttost tajjeb għalkemm id-data hija limitata minħabba n-numru żgħir ta' pazjenti studjati.
English: Because Strimvelis is produced using a retrovirus, there could be a potential risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Maltese: Minħabba li Strimvelis huwa prodott bl-użu ta' retrovirus, jista' jkun hemm il-potenzjal ta' riskju ta' kanċer ikkawżat minn tibdiliet mhux intenzjonati fil-materjal ġenetiku, għalkemm ma ġewx irrapportati każijiet bħal dawn s'issa.
English: For the full list of restrictions and side effects reported with Strimvelis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Strimvelis, ara l-fuljett ta' tagħrif.