FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it blocks enzymes known as tyrosine kinases, which can be found in some receptors in mast cells including
Maltese: Dan ifisser li timblokka lenzimi magħrufin bħala tirożina kinażi, li jinsabu f'ċerti riċetturi fiċ-ċelluli mastoċiti inklużi dawk involuti
English: The CHMP was concerned about the reliability of the study results because a routine GCP (good clinical practice) inspection at the study sites revealed serious failings in the way the study had been conducted.
Maltese: Is-CHMP kien imħasseb dwar l-affidabbiltà tar-riżultati tal-istudju minħabba li spezzjoni ta' rutina GCP (GCP, good clinical practice - prattika klinika tajba) fil-postijiet tal-istudju żvelat nuqqasijiet serji filmod kif kien twettaq l-istudju.
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Isem inventat Qawwa Għamla farmaċewtika
English: EU/1/98/069/020 Plavi
Maltese: Mnejn jingħata Il-pakkett
English: A/equine-2/South Africa/4/03 strain 50 AU/ml A/equine-2/Newmarket/2/93 strain
Maltese: A/equine-2/ Newmarket/2/93
English: Horse Intramuscular use Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Maltese: Fjala (ħġieġ tip I) magħluqa b'tapp talgomma halogenobutyl u kappa tal-aluminjum
English: 1 dose 10 pre-filled syringes
Maltese: 10 fjali talħġieġ
English: --1 Equine influenza virus strains:
Maltese: --1 Strejn tal-virus tal-influenza taż-żwiemel A/equine-2/ South Africa/4/03
English: 1 dose 1 pre-filled syringe
Maltese: Isem ivvintat Qawwa Għamla farmaċewtika
English: Further information on Flucelvax Tetra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
Maltese: Aktar informazzjoni dwar Flucelvax Tetra tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
English: The recommended dose is one single injection into a muscle (0.5 ml), preferably in the upper arm.
Maltese: Id-doża rrakkomandata hija injezzjoni waħda f'muskolu (0.5 ml), preferibbilment fil-parti ta' fuq tad-driegħ.
English: Other information about Flucelvax Tetra
Maltese: Informazzjoni oħra dwar Flucelvax Tetra
English: Flucelvax Tetra contains proteins from four different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains), chosen based on the official recommendation for the annual flu season.
Maltese: Flucelvax Tetra fih proteini minn erba' razez differenti ta' virusis tal-influwenza A u B inattivati (tip AH1N1, tip A-H3N2, u żewġ razez ta' tip B), magħżulin abbażi tar-rakkomandazzjoni uffiċjali għall-istaġun tal-influwenza annwali.
English: Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza AH3N2 virus, and one influenza B virus.
Maltese: Storikament, il-vaċċini tal-influwenza staġjonali fihom tliet razez tal-influwenza: virus wieħed tal-influwenza A-H1N1, virus wieħed tal-influwenza A-H3N2, u virus wieħed tal-influwenza B. Flucelvax Tetra jinkludi razza tal-virus B addizzjonali.
English: Flucelvax Tetra is as effective as the comparator vaccines at stimulating immune responses against the 4 strains included in the vaccine in people from 9 years of age.
Maltese: Flucelvax Tetra huwa effettiv daqs il-vaċċini komparaturi biex jistimula reazzjonijiet immunitarji kontra l4 razez inklużi fil-vaċċin f'persuni minn 9 snin ‘il fuq.
English: Flucelvax Tetra is a vaccine.
Maltese: Flucelvax Tetra huwa vaċċin.
English: The studies assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies.
Maltese: L-istudji vvalutaw il-kapaċità tal-vaċċini li jistimulaw rispons immunitarju kontra l-influwenza, billi jkejlu lproduzzjoni ta' antikorpi protettivi.
English: They involved over 5,000 people from 4 years of age.
Maltese: Huma involvew aktar minn 5,000 persuna minn 4 snin ‘il fuq.
English: The inclusion of two influenza B strains in Flucelvax Tetra can provide a broader protection against influenza B. In terms of safety, side effects with Flucelvax Tetra are similar to those observed with vaccines containing three influenza strains and are mostly mild to moderate in severity.
Maltese: F'termini ta' sikurezza, l-effetti sekondarji bi Flucelvax Tetra huma simili għal dawk osservati b'vaċċini li fihom tliet razez tal-influwenza u huma l-aktar ħfief sa moderati fis-severità.
English: What are the risks associated with Flucelvax Tetra?
Maltese: X'inhuma r-riskji assoċjati ma' Flucelvax Tetra?
English: Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.
Maltese: Flimkien il-vaċċini komparaturi fihom l-erba' razez ta' influwenza fi Flucelvax Tetra.
English: Results showed that Flucelvax Tetra lead to similar levels of protective antibodies as the comparator vaccines in people from 9 years of age.
Maltese: Irriżultati juru li Flucelvax Tetra jwassal għal livelli simili ta' antikorpi protettivi bħall-vaċċini komparaturi f'persuni minn 9 snin ‘il fuq.
English: As for all medicines, data on the use of Flucelvax Tetra are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Flucelvax Tetra hija ssorveljata kontinwament.
English: Flucelvax Tetra includes an additional B virus strain.
Maltese: Flucelvax Tetra (vaċċin kontra l-influwenza [antiġen tassuperfiċje inattivat ikkultivat fiċ-ċelluli])
English: Flucelvax Tetra is a vaccine used to protect adults and children from 9 years of age against influenza (flu).
Maltese: Flucelvax Tetra huwa vaċċin li jintuża biex jipproteġi l-adulti u t-tfal minn 9 snin ‘il fuq kontra linfluwenza.
English: The viruses used to produce Flucelvax Tetra are grown in mammalian cells.
Maltese: Il-viruses li ntużaw biex jipproduċu Flucelvax Tetra jitkabbru f'ċelloli mammiferi.
English: The most common side effects with Flucelvax Tetra (which may affect more than 1 in 10 people) are pain at the injection site, reddening of the skin and hardening at the injection site, headache, tiredness and muscle pain.
Maltese: L-effetti sekondarji l-aktar komuni bi Flucelvax Tetra (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma wġigħ fis-sit tal-injezzjoni, ħmura tal-ġilda u twebbis fis-sit tal-injezzjoni, uġigħ ta' ras, għeja u uġigħ fil-muskoli.
English: How is Flucelvax Tetra used?
Maltese: Kif jintuża Flucelvax Tetra?
English: For the full list of side effects and restrictions with Flucelvax Tetra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha bi Flucelvax Tetra, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Flucelvax Tetra?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Flucelvax Tetra?
English: Why is Flucelvax Tetra authorised in the EU?
Maltese: Għaliex Flucelvax Tetra ġie awtorizzat fl-UE?
English: An overview of Flucelvax Tetra and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Flucelvax Tetra u għalfejn huwa awtorizzat fl-UE
English: Flucelvax Tetra was compared with two comparator vaccines in 2 main studies.
Maltese: Flucelvax Tetra tqabbel ma' żewġ vaċċini komparaturi f'żewġ studji ewlenin.
English: EMA/477404/2014 EMEA/H/C/000393
Maltese: EMEA/H/C/000393
English: The full EPAR for Liprolog 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: Liprolog insulin lispro
Maltese: Liprolog insulina lispro
English: • Liprolog Basal: insulin lispro protamine suspension;
Maltese: • Liprolog Basal: sospensjoni insulina lispro protamina;
English: Other information about Liprolog
Maltese: Informazzjoni oħra dwar Liprolog
English: • Liprolog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Maltese: • Liprolog: soluzzjoni ta' insulina lispro, disponibbli b'qawwa standard jew ogħla (100 jew 200 unità/ml);
English: Liprolog contains the active substance insulin lispro.
Maltese: Liprolog fih is-sustanza attiva insulina lispro.
English: The active substance in Liprolog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Maltese: Is-sustanza attiva f'Liprolog, l-insulina lispro, tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi magħmul minn batterji li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu l-insulina lispro.
English: This is a summary of the European public assessment report (EPAR) for Liprolog.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Liprolog.
English: Liprolog Mix, Liprolog Basal and Liprolog 200 units/ml should never be given into a vein.
Maltese: Liprolog Mix, Liprolog Basal u Liprolog 200 unità/ml ma għandhom qatt jingħataw fil-vina.
English: Insulin lispro is very slightly different from human insulin.
Maltese: L-insulina lispro hija ftit biss differenti mill-insulina umana.
English: What is Liprolog?
Maltese: X'inhu Liprolog?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Liprolog on 1 August 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Liprolog valida fl-Unjoni Ewropea kollha fl-1 ta' Awwissu 2001.
English: Liprolog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Maltese: Liprolog 100 unità/ml jista' jingħata wkoll permezz ta' infużjoni kontinwa bl-użu ta' pompa tal-insulina jew fil-vina.
English: What is the risk associated with Liprolog?
Maltese: X'inhu r-riskju assoċjat ma' Liprolog?
English: The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer-acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix):
Maltese: Il-varjetà Liprolog fiha soluzzjonijiet ta' insulina li taġixxi b'mod mgħaġġel (Liprolog), sospensjonijiet ta' insulina li taġixxi aktar fit-tul (Liprolog Basal) u kumbinazzjonijiet tat-tnejn fi porzjonijiet varji (Liprolog Mix):
English: Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Maltese: Liprolog, Liprolog Basal u Liprolog Mix jistgħu jingħataw b'injezzjoni taħt il-ġilda tal-parti ta' fuq taddriegħ, koxxa, warrani jew fil-parti addominali (iż-żaqq).
English: Studies also looked at the use of Liprolog in 542 patients aged between two and 19 years, and the use of Liprolog in combination with sulphonylureas.
Maltese: L-istudji eżaminaw ukoll l-użu ta' Liprolog f'542 pazjent li għandhom bejn sentejn u 19-il sena, u l-użu ta' Liprolog flimkien ma' sulfonilureji.
English: Why has Liprolog been approved?
Maltese: Għaliex ġie approvat Liprolog?
English: Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Maltese: L-insulina lispro hija disponibbli bħala Liprolog f'forma solubbli, li taġixxi pjuttost immedjatament wara l-injezzjoni, u bħala Liprolog Basal f'forma ta' ‘sospensjoni protamina', li hija assorbita aktar bil-mod sabiex taħdem aktar fit-tul. Liprolog Mix hija taħlita ta' dawn iż-żewġ formulazzjonijiet.
English: Liprolog is a replacement insulin which is very similar to the insulin made by the body.
Maltese: Liprolog huwa insulina ta' sostituzzjoni simili ħafna tal-insulina li jipproduċi l-ġisem.
English: Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Maltese: Liprolog u Humulin R kellhom effett simili fuq il-kontroll tad-dijabete, kif imkejla mill-HbA1c u l-livelli ta' glukożju fi stat ta' sawm.
English: The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Maltese: L-effikaċja ta' Liprolog tqabblet ma' dik ta' Humulin R (rikombinant tad-DNA solubbli tal-insulina umana), meta ġew miżjuda ma' insulini li jaġixxu fit-tul u mogħtija darba jew darbtejn kuljum.
English: Liprolog is supplied in vials, cartridges and prefilled pens (Liprolog KwikPen).
Maltese: Liprolog jiġi fornut f'kunjetti, stoċċijiet u pinen mimlija minn qabel (Liprolog KwikPen).
English: Liprolog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Maltese: Liprolog ġie studjat oriġinarjament fi tmien provi kliniċi li kienu jinkludu 2951 pazjent li għandhom jew id-dijabete tat-tip1 (fejn il-ġisem ma jistax jipproduċi insulina) jew id-dijabete tat-tip 2 (meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effikaċi).
English: The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Liprolog huma akbar mir-riskji tiegħu għall-kura ta' pazjenti bid-dijabete mellitu li jeħtieġu l-insulina għażżamma ta' omeostażi tal-glukożju normali, u għall-istabbilizzazzjoni inizjali tad-dijabete mellitu.
English: The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Maltese: Id-differenza tfisser li l-insulina lispro hija assorbita aktar malajr mill-ġisem minn insulina regolari umana u tista' għalhekk taġixxi aktar malajr.
English: How has Liprolog been studied?
Maltese: Kif ġie studjat Liprolog?
English: Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Maltese: Liprolog jista' jintuża flimkien ma' insulina li taġixxa aktar fit-tul jew flimkien ma' sulfonilureji ((grupp ta' mediċini antidijabetiċi li jittieħdu oralment).
English: Liprolog is a range of solutions and suspensions for injection.
Maltese: Liprolog huwa varjetà ta' soluzzjonijiet u sospensjonijiet għall-injezzjoni.
English: What benefit has Liprolog shown during the studies?
Maltese: Liema benefiċċju wera Liprolog waqt l-istudji?
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours).
Maltese: L-istudji kejlu l-livell ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm qed jiġi kkontrollat tajjeb il-glukożju fiddemm, u l-livelli ta' glukożju fid-demm 'fi stat ta' sawm' (imkejla wara li l-pazjent ma jkunx kiel għal tal-inqas tmien sigħat).
English: Further information on Venclyxto can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Venclyxto.
Maltese: ema.europa.eu/medicines/human/EPAR/Venclyxto.
English: Venclyxto (venetoclax)
Maltese: Venclyxto (venetoklaks)
English: This was converted into a full marketing authorisation on 20 November 2018.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fl-20 ta' Novembru 2018.
English: In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto.
Maltese: Fi studju ewlieni ta' 107 pazjenti kkurati minn qabel b'CLL u bi tħassir ta' 17p, 75 % irrispondew kompletament jew b'mod parzjali għal Venclyxto.
English: The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2.
Maltese: Is-sustanza attiva f'Venclyxto, il-venetoklaks, teħel ma' proteina msejħa Bcl-2.
English: Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
Maltese: Venclyxto huwa mediċina kontra l-kanċer li tintuża fil-kura tal-adulti b'kanċer tad-demm magħruf bħala lewkimja limfoċitika kronika (CLL).
English: Other information about Venclyxto
Maltese: Informazzjoni oħra dwar Venclyxto
English: Venclyxto contains that active substance venetoclax.
Maltese: Venclyxto fih dik is-sustanza attiva venetoklaks.
English: In another study of 127 patients with or without 17p deletion or TP53 mutation, the response rate was 70%.
Maltese: Fi studju ieħor ta' 127 pazjent bi jew mingħajr tħassir ta' 17p jew mutazzjoni ta'TP53, ir-rata ta' rispons kienet 70 %.
English: The most common side effects with Venclyxto used on its own (seen in more than 1 in 5 people) are low levels of neutrophils (a type of white blood cell), diarrhoea, nausea, anaemia (low red blood cell counts), nose and throat infection and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Venclyxto użat waħdu (li dehru f'aktar minn persuna 1 minn kull 5) huma livelli baxxi ta' newtrofili (tip ta' ċelloli bojod tad-demm), dijarea, nawżja, anemija (għadd baxx ta' ċelloli ħomor tad-demm), infezzjoni fl-imnieħer u fil-gerżuma u għeja.
English: • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment).
Maltese: • f'pazjenti b'tibdil ġenetiku partikolari (tħassir ta' 17p jew mutazzjoni ta' TP53) li jagħmluhom mhux adattati għall-kimoimmunoterapija (tip ta' kura tal-kanċer).
English: Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016.
Maltese: Venclyxto rċieva awtorizzazzjoni kondizzjonali ta' tqegħid fis-suq valida fl-UE kollha fil5 ta' Diċembru 2016.
English: Patients should have taken Venclyxto at the daily dose of 400 mg for 7 days before starting therapy with rituximab.
Maltese: Il-pazjenti kellhom jieħdu Venclyxto bid-doża ta' kuljum ta' 400mg għal 7 ijiem qabel ma jibdew it-terapija b'ritussimab.
English: The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg.
Maltese: Iddoża tal-bidu hija 20 mg kuljum u d-doża tiżdied gradwalment fuq 5 ġimgħat għal 400mg.
English: When Venclyxto is used in combination with rituximab, the recommended dose of Venclyxto is 400 mg once a day.
Maltese: Meta Venclyxto jintuża f'kombinazzjoni ma' ritussimab, id-doża rakkomandata ta' Venclyxto hija 400mg darba kuljum.
English: What are the risks associated with Venclyxto?
Maltese: X'inhuma r-riskji assoċjati ma' Venclyxto?
English: Venclyxto is available as tablets (10, 50 and 100 mg) to be taken by mouth once a day with a meal.
Maltese: Venclyxto jiġi bħala pilloli (10, 50 u 100mg) li għandhom jittieħdu mill-ħalq darba kuljum mal-ikel.
English: Studies showed patients with particular genetic mutations (17p deletion or TP53 mutations) that make them unsuitable for chemo-immunotherapy responding well to Venclyxto used on its own.
Maltese: Studji wrew li pazjenti b'mutazzjonijiet ġenetiċi partikolari (tħassir ta' 17p jew mutazzjonijiet TP53) li jagħmluhom mhux adattati għal kimoimmunoterapija jirrispondu tajjeb għal Venclyxto użat waħdu.
English: Regarding safety, the medicine's side effects are considered acceptable.
Maltese: Fir-rigward ta' sigurtà, l-effetti sekondarji tal-mediċina huma kkunsidrati aċċettabbli.
English: Another study in 389 patients with CLL who received at least one previous treatment showed that patients treated with Venclyxto plus rituximab lived longer without their disease getting worse (progression-free survival) than patients treated with rituximab and bendamustine (another cancer medicine).
Maltese: Studju ieħor fi 389 pazjent b'CLL li rċevew mill-inqas kura waħda preċedenti wera li l-pazjenti kkurati b'Venclyxto flimkien ma' ritussimab għexu aktar fit-tul mingħajr ma l-marda tagħhom marret għallagħar (sopravivenza mingħajr progressjoni) minn pazjenti kkurati b'ritussimab u bendamustin (mediċina oħra kontra l-kanċer).
English: The most common serious side effects (seen in more than 2 in 100 people) in patients receiving Venclyxto in combination with rituximab or on its own are pneumonia (lung infection), fever associated with reduced neutrophils and tumour lysis syndrome (a complication caused by breakdown of cancer cells).
Maltese: L-effetti sekondarji serji l-aktar komuni (li dehru f'aktar minn 2 persuni minn kull mija) f'pazjenti li kienu qed jirċievu Venclyxto f'kombinazzjoni ma' ritussimab jew waħdu huma pulmonite (infezzjoni filpulmun), deni assoċjat ma' newtrofili mnaqqsa u s-sindromu tat-tumur ta' lisi (komplikazzjoni minħabba t-tkissir taċ-ċelloli tal-kanċer).
English: The most common side effects when Venclyxto is used with rituximab are low level of neutrophils, diarrhoea and nose and throat infection.
Maltese: L-effetti sekondarji l-aktar komuni meta Venclyxto jintuża ma' ritussimab huma livelli baxxi ta' newtrofili, dijarea u infezzjoni flimnieħer u fil-gerżuma.
English: As for all medicines, data on the use of Venclyxto are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Venclyxto hija ssorveljata kontinwament.
English: Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
Maltese: Venclyxto jista' jintuża flimkien ma' ritussimab (mediċina oħra kontra l-kanċer) f'pazjenti li rċevew talinqas kura preċedenti waħda.
English: Venclyxto must not be used with medicines known as ‘strong CYP3A inhibitors' during the early stages of treatment and must also not be used with St. John's wort (a herbal preparation used to treat anxiety and depression).
Maltese: Venclyxto m'għandux jintuża ma' mediċini magħrufa bħala “inibituri CYP3A b'saħħithom' matul l-istadji bikrin tal-kura u lanqas m'għandu jintuża ma' St.John's wort (preparazzjoni erbali li tintuża biex tikkura l-ansjetà u d-dipressjoni).
English: In these patients, Venclyxto is used when medicines known as B-cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
Maltese: Il-kura b'Venclyxto għandha tinbeda u tiġi ssorveljata minn tabib esperjenzat fil-mediċini kontra lkanċer u l-mediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: How is Venclyxto used?
Maltese: Venclyxto?
English: For the full list of side effects with Venclyxto, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Venclyxto, ara l-fuljett ta' tagħrif.
English: Why is Venclyxto authorised in the EU?
Maltese: Għaliex Venclyxto huwa awtorizzat fl-UE?
English: Venclyxto should be taken for 24 months from day 1 of the first cycle of rituximab.
Maltese: Venclyxto għandu jittieħed għal 24 xahar mill-ewwel jum talewwel ċiklu ta' ritussimab.
English: Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.
Maltese: Għalkemm hemm riskju tas-sindromu tat-tumur ta' lisi, kumplikazzjoni li tinqala' meta ċ-ċelloli tal-kanċer ikunu qed jinqerdu malajr wisq, dan ir-riskju jista' jitrażżan permezz ta' miżuri preventivi, bħaż-żieda fid-doża gradwalment jew it-tnaqqis tad-doża, jekk ikun meħtieġ.
English: EMA/464718/2015 EMEA/V/C/003829
Maltese: EMEA/V/C/003829
English: The full EPAR for Vectormune ND can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: No signs of MDV or NDV outbreaks were detected from samples taken from both groups at days 35, 66, 102 and completion at day 118.
Maltese: Ma kienx hemm sinjali ta' tifqigħat MDV jew NDV minn kampjuni li ttieħdu miż-żewġ gruppi fil-35, 66, 102 jum u meta tlesta fil-118-il jum.