FrancophonIA/ELRC3.0 huggingface dataset:
English: When Vidaza is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Maltese: Meta Vidaza jiġi rikostitwit bl-użu ta' ilma għall-injezzjonijiet li jkun tpoġġa fi friġġ (2°C sa 8°C), l-istabbiltà kimika u fiżika tal-prodott mediċinali rikostitwit, waqt li jkun qed jintuża intweriet f'temperatura ta' 2°C sa 8°C għal 22 siegħa.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Celgene Europe B.V.
English: • Painless swelling in the finger tips (clubbing).
Maltese: • Nefħa bla wġigħ fit-truf tas-swaba' (clubbing).
English: Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90o angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Maltese: Vidaza rikostitwit għandu jkun injettat taħt il-ġilda (daħħal il-labra f'angolu ta' 45-90°) billi tuża labra 25-gauge fil-parti ta' fuq tad-driegħ, koxxa jew addome.
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin < 30 g/L.
Maltese: Pazjenti b'tagħbija estensiva tat-tumur minħabba mard metastatiku kienu irrappurtati li ġarrbu koma epatika progressiva u mewt matul il-kura b'azacitidine, speċjalment f'pazjenti bħal dawn li jkollhom albumina fis-serum fil-linja bażi ta' < 30 g/L.
English: You are also more likely to get infections.
Maltese: Ikun mistenni wkoll li jkollok infezzjonijiet.
English: The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates.
Maltese: Il-prodott rikostitwit hu suspensjoni omoġenja u mċajpra, mingħajr agglomerati.
English: Musculoskeletal and connective tissue disorders arthralgia, musculoskeletal pain (includes back, bone and pain in extremity)
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi artralġja, uġigħ fl-muskolu-skeletrali (jinkludi wġigħ fid-dahar, fl-għadam u fl-estremitajiet)
English: It is recommended that patients be treated for a minimum of 6 cycles.
Maltese: Hu rakkomandat li l-pazjenti jkunu kkurati għal minimu ta' 6 ċikli.
English: Absorption Following subcutaneous administration of a single 75 mg/m2 dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first sampling point).
Maltese: Wara l-għoti taħt il-ġilda ta' doża waħda ta' 75 mg/m2, azacitidine kien assorbit b'mod mgħaġġel b'konċentrazzjonijiet massimi ta' azacitidine fil-plażma ta' 750 ± 403 ng/mL li seħħew wara 0.5 siegħa wara d-dożaġġ (l-ewwel darba li ttieħed kampjun).
English: DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancersuppressing functions to cancer cells.
Maltese: Il-hypomethylation tad-DNA ta' ġeni li kienu methylated b'mod anormali, involuti fir-regolazzjoni taċ-ċiklu taċ-ċelluli normali, fid-differenzazzjoni u fil-passaġġi tal-mewt, tista' tirriżulta fl-espressjoni mill-ġdid tal-ġeni u fir-restorazzjoni tal-funzjonijiet li jrażżnu l-kanċer liċ-ċelluli tal-kanċer.
English: Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.
Maltese: Il-biċċa l-kbira tar-reazzjonijiet avversi ematoloġiċi kienu mmaniġġjati bil-monitoraġġ ta' rutina tal-għadd komplet taċ-ċelluli tad-demm u billi l-għoti ta' azacitidine jiġi ttardjat fiċ-ċiklu li jmiss, antibijotiċi profilattiċi u/jew sapport tal-fattur tat-tkabbir (eż. G-CSF) għan-newtropenija u trasfużjonijiet għall-anemija jew tromboċitopenja kif meħtieġ.
English: • A viral infection causing cold sores (herpes).
Maltese: • Infezzjoni virali li tikkawża nfafet fil-ġilda (herpes).
English: Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents.
Maltese: Anormalitajiet renali li jvarjaw minn livelli għolja ta' krejatinina fis-serum sa insuffiċjenza renali u mewt kienu rrappurtati f'pazjenti kkurati b'azacitidine mogħti ġol-vina flimkien ma' sustanzi kemoterapewtiċi oħra.
English: The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways.
Maltese: L-effetti ċitotossiċi ta' azacitidine jistgħu jirriżultaw minn mekkaniżmi multipli, li jinkludu l-inibizzjoni tad-DNA, RNA u s-sintesi tal-proteina, l-inkorporazzjoni fl-RNA u DNA, u l-attivazzjoni tal-passaġġi tal-ħsara tad-DNA.
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
Maltese: Pazjenti b'ammont estensiv ta' tumur minħabba mard metastatiku kienu rrappurtati li jġarrbu insuffiċjenza tal-fwied, koma epatika progressiva u mewt matul il-kura b'azacitidine (ara sezzjoni 4.4).
English: 4.1 Therapeutic indications
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: • Having trouble sleeping (insomnia).
Maltese: • Ikollok problemi biex torqod (insomnja).
English: Gastrointestinal disorders diarrhoea, vomiting, constipation, nausea, abdominal pain (includes upper and abdominal discomfort)
Maltese: Disturbi gastro-intestinali dijarea, rimettar, stitikezza, nawseja, uġigħ addominali (jinkludi wġigħ addominali fil-parti ta' fuq u skonfort addominali)
English: Very common Common
Maltese: Mhux Komuni
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration (single 75 mg/m2 doses) was approximately 89% based on area under the curve (AUC).
Maltese: Il-bijodisponibilità assoluta ta' azacitidine wara l-għoti taħt il-ġilda meta mqabbla mal-għoti ġol-vina (dożi waħidhom ta' 75 mg/m2) kienet ta' madwar 89% ibbażata fuq l-erja taħt il-kurva (AUC).
English: These adverse reactions were managed symptomatically with anti-emetics for nausea and vomiting; anti-diarrhoeals for diarrhoea, and laxatives and/or stool softeners for constipation.
Maltese: Dawn ir-reazzjonijiet avversi kienu mmaniġġjati b'mod sintomatiku b'mediċini kontra n-nawseja u rimettar; mediċini kontra d-dijarea, u lassattivi u/jew mediċini li jrattbu l-ippurgar għall-istitikezza.
English: Nadir counts
Maltese: TAGĦRIF
English: Renal and urinary disorders renal failure*, haematuria, elevated serum creatinine renal tubular acidosis
Maltese: Disturbi fil-kliewi u fis-sistema urinarja insuffiċjenza tal-kliewi*, ematurja, livell għoli ta' krejatinina fis-serum aċidożi tubulari tal-kliewi
English: • Dizziness.
Maltese: • Uġigħ ta' ras.
English: Renal impairment has no major effect on the pharmacokinetic exposure of azacitidine after single and multiple subcutaneous administrations.
Maltese: Il-proċeduri għall-immaniġġjar u rimi kif suppost ta' prodotti mediċinali kontra l-kanċer għandhom jiġu segwiti.
English: Area under the curve and maximum plasma concentration (Cmax) of subcutaneous admiminstration of azacitidine were approximately proportional within the 25 to 100 mg/m2 dose range.
Maltese: L-erja taħt il-kurva u l-konċentrazzjoni massima fil-plażma (Cmax) tal-għoti taħt il-ġilda ta' azacitidine kienu bejn wieħed u ieħor proporzjonali fil-medda ta' doża ta' 25 sa 100 mg/m2.
English: Biotransformation
Maltese: Bijotrasformazzjoni
English: • Raised itchy rash on the skin (urticaria).
Maltese: • Raxx bil-ħakk imqabbeż 'il fuq fuq il-ġilda (urtikarja).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for injection.
Maltese: U KONTENUT Trab għal suspensjoni għall-injezzjoni.
English: The injection is given into a vein over several minutes.
Maltese: L-injezzjoni tingħata ġol-vina fuq diversi minuti.
English: The full EPAR and risk management plan summary for Iblias 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 Iblias
Maltese: Informazzjoni oħra dwar Iblias
English: If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Maltese: Jekk jiġu esperjenzati jistgħu jinkludu: anġjodema (nefħa fit-tessuti ta' taħt il-ġilda), ħruq u tingiż fis-sit tal-injezzjoni, tertir, fwawar, raxx bil-ħakk fuq il-ġisem kollu, uġigħ ta' ras, ħorriqija, ipotensjoni (pressjoni tad-demm baxxa), ħedla, nawżja (tħossok ma tiflaħx), nuqqas ta' sabar, takikardja (taħbit tal-qalb mgħaġġel), għafis tas-sider, tnemnim, rimettar u tħarħir ta' nifs.
English: This is a summary of the European public assessment report (EPAR) for Iblias.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Iblias.
English: Why is Iblias approved?
Maltese: Għal xiex ġiet approvat Iblias?
English: It contains the active substance octocog alfa, which is the same as human factor VIII.
Maltese: Fiha s-sustanza attiva octocog alfa, li hija l-istess bħall-fattur VIII uman.
English: About 70% of the bleeding events that occurred were managed with a single injection of Iblias, and about another 15% responded to a second injection; the response was considered good or excellent in around 80% of cases.
Maltese: Madwar 70 % tal-avvenimenti ta' fsada li seħħew kienu mmaniġġjati b'injezzjoni waħda ta' Iblias, u madwar 15 % oħra rrispondew għal injezzjoni oħra; ir-rispons kien ikkunsidrat bħala tajjeb jew eċċellenti f'madwar 80 % tal-każijiet.
English: The active substance in Iblias, octocog alfa, works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'Iblias, octocog alfa, taħdem fil-ġisem bl-istess mod bħall-fattur VIII uman.
English: What are the risks associated with Iblias?
Maltese: X'inhuma r-riskji assoċjati ma' Iblias?
English: The effectiveness of Iblias in preventing and treating bleeding has been shown in a main study involving 62 patients aged 12 years or older with severe haemophilia A who were previously treated with other factor VIII products.
Maltese: L-effikaċja ta' Iblias fil-prevenzjoni u l-kura ta' fsada ntweriet fi studju ewlieni li involva 62 pazjent li għandhom 12-il sena jew iktar b'emofilja A severa li kienu kkurati qabel bi prodotti oħrajn talfattur VIII.
English: A risk management plan has been developed to ensure that Iblias is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Iblias jintuża bl-aktar mod sigur possibbli.
English: Iblias is available as a powder and solvent used to make a solution for injection.
Maltese: Iblias jiġi bħala trab u solvent li jintuża biex tiġi prodotta soluzzjoni għall-injezzjoni.
English: Data from a supportive study also confirmed the benefits of preventative treatment with Iblias in reducing the number of bleeds.
Maltese: Id-data minn studju ta' appoġġ ikkonfermat ukoll il-benefiċċji tal-kura preventiva b'Iblias biex jitnaqqas in-numru ta' fsadat.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm ukoll riskju li bil-mediċini ta' fattur VIII ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra fattur VIII, fejn il-mediċina tieqaf tkun effettiva u dan jirriżulta f'telf tal-kontroll tal-fsada.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems such as bleeding into the joints, muscles and internal organs.
Maltese: Pazjenti b'emofilja A m'għandhomx fattur VIII, proteina neċessarja għall-koagulazzjoni normali taddemm, u bħala riżultat jinfasdu faċilment u jista' jkollhom problemi ta' fsada, bħal emorraġija fil-ġogi,
English: For the full list of all side effects and restrictions with Iblias, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Iblias, ara l-fuljett ta' tagħrif.
English: Iblias is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Maltese: Iblias jintuża għall-kura u l-prevenzjoni ta' fsada f'pazjenti li jbatu mill-emofilja A (marda li tintiret u kkaġunata minħabba nuqqas ta' proteina li tgħaqqad id-demm li tissejjaħ fattur VIII).
English: Hypersensitivity (allergic) reactions are uncommon with Iblias, affecting from 1 patient in 1,000 to less than 1 patient in 100.
Maltese: Reazzjonijiet (allerġiċi) ta' sensittività eċċessiva mhumiex komuni b'Iblias, hekk kif jaffettwaw minn pazjent wieħed minn kull 1,000 sa inqas minn pazjent wieħed minn kull 100.
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tinstab fis-sommarju tal-pjan tal-ġestjoni tar-riskju.
English: The number of bleeds that occurred during Iblias treatment was calculated as 3.8 bleeds per year on average (mostly into joints).
Maltese: In-numru ta' fsadat li seħħew matul il-kura b'Iblias kien ikkalkolat bħala 3.8 fsadat fis-sena bħala medja (fil-biċċa l-kbira fil-ġogi).
English: Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins.
Maltese: Il-pazjenti jistgħu jiżviluppaw antikorpi għall-proteini tal-ħamster jew tal-ġrieden; il-mediċina ma għandhiex tintuża f'pazjenti li għandhom sensittività eċċessiva (huma allerġiċi) għal octocog alfa jew għall-proteini tal-ħamster jew tal-ġrieden.
English: How is Iblias used?
Maltese: Iblias?
English: A second study involved 51 children under 12 years of age previously treated with other factor VIII products, who also had 3.8 bleeds per year on average during treatment with Iblias (mostly related to injuries).
Maltese: Studju ieħor involva 51 tifel u tifla li għandhom anqas minn 12-il sena li ġew ikkurati qabel bi prodotti oħra tal-fattur VIII, li kellhom ukoll 3.8 fsadat fis-sena bħala medja matul il-kura b'Iblias (fil-biċċa lkbira relatati ma' ġrieħi).
English: Response to treatment was considered good or excellent in about 90% of cases.
Maltese: Ir-rispons għall-kura kien ikkunsidrat bħala tajjeb jew eċċellenti f'madwar 90 % tal-każijiet.
English: What measures are being taken to ensure the safe and effective use of Iblias?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Iblias?
English: In addition, the company that markets Iblias will complete studies to investigate the safety and efficacy of the medicine in patients who have not previously been treated with other factor VIII products, and to provide further evidence of the safety and efficacy of long-term treatment with Iblias in children.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Iblias fis-suq sejra tlesti studji biex tinvestiga s-sigurtà u leffikaċja tal-mediċini f'pazjenti li ma ġewx ikkurati qabel bi prodotti oħra tal-fattur VIII, u biex tipprovdi iktar evidenza dwar is-sigurtà u l-effikaċja ta' kura fit-tul b'Iblias fit-tfal.
English: This compared with an average of 6.9 bleeds per year before Iblias treatment.
Maltese: Dan meta mqabbel ma' medja ta' 6.9 fsadat fis-sena qabel ilkura b'Iblias.
English: How does Iblias work?
Maltese: Kif jaħdem Iblias?
English: Iblias has been shown to be effective in both preventing and treating bleeds, including managing blood loss during surgery, and can be used in all age groups.
Maltese: Iblias intwera li huwa effettiv kemm fil-prevenzjoni kif ukoll fil-kura ta' fsadat, inkluż l-immaniġġjar tat-telf ta' demm matul il-kirurġija, u jista' jintuża fil-gruppi ta' età kollha.
English: Regarding safety, the reported effects are in line with those expected for a factor VIII product.
Maltese: Rigward is-sigurtà, l-effetti rrapportati huma f'konformità ma' dawk mistennija għal prodott tal-fattur VIII.
English: Further information on Zydelig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zydelig.
Maltese: Aktar informazzjoni dwar Zydelig tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/zydelig.
English: This overview was last updated in 12-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'12-2019.
English: Other information about Zydelig
Maltese: Informazzjoni oħra dwar Zydelig
English: Zydelig is available as 100 mg and 150 mg tablets.
Maltese: Zydelig jiġi bħala pilloli ta' 100 mg u 150 mg.
English: Zydelig received a marketing authorisation valid throughout the EU on 18 September 2014.
Maltese: Zydelig ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Settembru 2014.
English: Zydelig contains the active substance idelalisib.
Maltese: Zydelig fih is-sustanza attiva idelalisib.
English: The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta.
Maltese: Is-sustanza attiva f'Zydelig, l-idelalisib, timblokka l-effetti ta' enzima msejħa PI3K-delta.
English: The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections (including lung infection caused by Pneumocystis jirovecii, and cytomegalovirus infections), neutropenia (low levels of neutrophils, a type of white blood cell), lymphocytosis (increased levels of lymphocytes, another type of white blood cell), diarrhoea, blood tests showing changes in the liver, rash, fever and increased blood fat levels.
Maltese: L-effetti sekondarji l-aktar komuni b'Zydelig (li jistgħu jaffettwaw aktar minn persuna waħda minn 10) huma infezzjonijiet (inkluż infezzjoni tal-pulmun ikkawżata minn Pneumocystis jirovecii, u infezzjonijiet taċ-ċitomegalovirus), newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), limfoċitożi (żieda fil-livelli ta' limfoċiti, tip ieħor ta' ċellola bajda tad-demm), dijarea, testijiet tad-demm li juru bidliet fil-fwied, raxx, deni u żieda fil-livelli tax-xaħam fid-demm.
English: In a main study of 220 patients with previously treated CLL, Zydelig was more effective at treating the cancer than placebo (a dummy treatment) when both were given in combination with rituximab: 75% of patients taking Zydelig had an improvement in their disease compared with 15% of patients receiving placebo.
Maltese: Fi studju ewlieni fuq 220 pazjent b'CLL ikkurata preċedentement, Zydelig kien aktar effettiv fil-kura talkanċer mill-plaċebo (kura finta) meta t-tnejn li huma ngħataw flimkien ma' rituximab: 75 % talpazjenti li ħadu Zydelig kellhom titjib fil-marda tagħhom meta mqabbla ma' 15 % tal-pazjenti li ħadu lplaċebo.
English: Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
Maltese: Zydelig huwa mediċina kontra l-kanċer li tintuża biex tikkura lewkimja limfoċitika kronika (CLLchronic lymphocytic leukaemia, kanċer ta' tip ta' ċelloli bojod tad-demm imsejħa limfoċiti B) u limfoma follikulari (kanċer ieħor li jaffettwa l-limfoċiti B).
English: How is Zydelig used?
Maltese: Kif jaħdem Zydelig?
English: What are the risks associated with Zydelig?
Maltese: X'inhuma r-riskji assoċjati ma' Zydelig?
English: Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment.
Maltese: Zydelig kien effettiv, b'54 % tal-pazjenti b'limfoma follikulari li kellhom jew rispons komplet jew rispons parzjali għall-kura.
English: Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments.
Maltese: Studju ewlieni ieħor evalwa lil Zydelig f'pazjenti b'limfomas differenti, inklużi 72 pazjent b'limfoma follikulari li fuqhom żewġ kuri preċedenti ma kinux ħadmu.
English: In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
Maltese: F'CLL, Zydelig jintuża flimkien ma' mediċina oħra (rituximab jew ofatumumab) f'pazjenti li rċevew talinqas kura waħda preċedenti u f'pazjenti li ċ-ċelloli tal-kanċer tagħhom għandhom mutazzjonijiet ġenetiċi (bidliet) imsejħa tħassir ta' 17p jew mutazzjoni TP53 u li ma jistgħux jiġu kkurati bi kwalunkwe terapija oħra.
English: As for all medicines, data on the use of Zydelig are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zydelig hija ssorveljata kontinwament.
English: Zydelig (idelalisib)
Maltese: Kif jintuża Zydelig?
English: All patients treated with Zydelig should also be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia, and this should be continued for up to 6 months after stopping treatment with Zydelig.
Maltese: Il-pazjenti kollha kkurati b'Zydelig għandhom jingħataw ukoll medikazzjoni preventiva kontra linfezzjoni tal-pulmun, pulmunite Pneumocystis jirovecii u din għandha titkompla sa 6 xhur wara li lkura b'Zydelig tkun twaqqfet.
English: For the full list of side effects and restrictions of Zydelig, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet rrappurtati b'Zydelig, ara l-fuljett ta' tagħrif.
English: Zydelig was also effective in chronic lymphocytic leukaemia patients whose cancer cells have the 17p deletion or TP53 mutation, who usually have a poor outcome.
Maltese: Zydelig kien effettiv ukoll f'pazjenti b'lewkimja limfoċitika kronika li ċ-ċelloli tal-kanċer tagħhom għandhom it-tħassir ta' 17p jew il-mutazzjoni TP53, li normalment ikollhom eżitu ħażin.
English: In a study of 261 previously treated CLL patients, it took over 16 months on average before the disease got worse in patients treated with Zydelig plus ofatumumab, compared with 8 months in those treated with ofatumumab alone.
Maltese: Fi studju fuq 261 pazjent b'CLL ikkurata preċedentement, għaddew aktar minn 16-il xahar bħala medja qabel ma lmarda marret għall-agħar f'pazjenti kkurati b'Zydelig flimkien ma' ofatumumab, meta mqabbla ma' 8 xhur f'dawk ikkurati b'ofatumumab waħdu.
English: Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Zydelig huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ ΛΤΔ Γ. ΚΡΑΝΙΔΙΩΤΗ
Maltese: ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ ΛΤΔ Γ.
English: 22578 1522 ΛΕΥΚΩΣΙΑ Κ Υ Π Ρ Ο Σ
Maltese: Τ. Θ. 22578 1522 ΛΕΥΚΩΣΙΑ Κ Υ Π Ρ Ο Σ
English: Rare*
Maltese: Rari*
English: First Floor, Park Point, 17 High Street, Longbridge
Maltese: First Floor, Park Point, 17 High Street,