FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no clinical data in patients with severe renal impairment (CLcr less than 30 mL/min), therefore rucaparib is not recommended for use in patients with severe renal impairment.
Maltese: M'hemmx data klinika f'pazjenti b'indeboliment sever tal-kliewi (CLcr inqas minn 30 mL/min), u għalhekk rucaparib mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment sever tal-kliewi.
English: • abnormal blood tests - increase in blood creatinine levels
Maltese: • testijiet tad-demm anormali - żieda fil-livelli tal-kreatinina fid-demm
English: You may get sunburn more easily during treatment with Rubraca.
Maltese: Inti tista' tinħaraq aktar faċilment matul it-trattament b'Rubraca.
English: In a medicinal product interaction study in cancer patients, the effects of steady-state rucaparib at 600 mg twice daily on CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp were evaluated with single oral doses of sensitive probes (caffeine, S-warfarin, omeprazole, midazolam, and digoxin, respectively).
Maltese: Meta jingħataw flimkien prodotti mediċinali li huma substrati ta' CYP1A2 b'indiċi terapewtiku dejjaq (eż., warfarin, phenytoin), aġġustamenti fid-doża jistgħu jiġu kkunsidrati, jekk ikunu indikati klinikament.
English: Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 250 mg of rucaparib.
Maltese: Kull pillola miksija b'rita fiha rucaparib camsylate li jikkorrispondi għal 250 mg ta' rucaparib.
English: Effect of other medicinal products on rucaparib
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq rucaparib
English: 60 film-coated tablets.
Maltese: 60 pillola miksija b'rita.
English: • Keep this leaflet.
Maltese: • Rubraca mhuwiex rakkomandat waqt it-tqala.
English: Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.
Maltese: Kull pillola fiha rucaparib camsylate li jikkorrispondi għal 200 mg ta' rucaparib.
English: Elevations in creatinine with rucaparib treatment may be due to inhibition of the renal transporters MATE1 and MATE2-K (see section 4.5).
Maltese: Erba' (0.4%) pazjenti rrappurtaw reazzjoni ta' CTCAE Grad 3. Iż-żidiet tal-kreatinina bit-trattament ta' rucaparib jistgħu jkunu minħabba l-inibizzjoni tat-trasportaturi renali MATE1 u MATE2-K (ara sezzjoni 4.5).
English: Following administration of a single oral dose of [14C]-rucaparib to patients with solid tumours, unchanged rucaparib accounted for 64.0% of the radioactivity in plasma.
Maltese: Wara l-għoti ta' doża orali waħda ta' [14C]-rucaparib lil pazjenti b'tumuri solidi, rucaparib mhux mibdul ammonta għal 64.0 % tar-radjuattività fil-plażma.
English: All 106 patients received rucaparib 600 mg twice daily.
Maltese: Il-106 pazjent kollha rċivew rucaparib 600 mg darbtejn kuljum.
English: Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.
Maltese: Kull pillola fiha rucaparib camsylate li jikkorrispondi għal 300 mg ta' rucaparib.
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
Maltese: Wieħed għandu juża l-kawtela u jikkunsidra monitoraġġ addizzjonali tal-Proporzjon Normalizzat Internazzjonali (INR, International Normalised Ratio) blgħoti fl-istess ħin ta' warfarin, u monitoraġġ terapewtiku tal-livell tal-mediċina ta' phenytoin, jekk jintuża fl-istess ħin ma' rucaparib.
English: 300 mg twice daily (one 300 mg tablet twice daily)
Maltese: 300 mg darbtejn kuljum (pillola waħda ta' 300 mg darbtejn kuljum)
English: How to store Rubraca
Maltese: Tiħux Rubraca jekk:
English: Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 200 mg of rucaparib.
Maltese: Kull pillola miksija b'rita fiha rucaparib camsylate li jikkorrispondi għal 200 mg ta' rucaparib.
English: Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Maltese: Jekk għandek ċerti effetti sekondarji t-tabib tiegħek jista' jirrakkomanda doża aktar baxxa, jew iwaqqaf it-trattament temporanjament.
English: There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Maltese: manteniment ta' pazjenti adulti b'kanċer tal-ovarji epiteljali (EOC), kanċer tat-tubi fallopjani (FTC), jew kanċer primarju tal-peritonew (PPC) ta' grad għoli rikadut li jkunu f'rispons sħiħ jew parzjali għal kimoterapija bbażata fuq il-platinum.
English: In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Maltese: Rubraca huwa indikat bħala trattament billi jingħata waħdu (monoterapija) għal kanċer sensittiv għallplatinum, li jirkadi jew progressiv f'pazjenti adulti b'mutazzjoni ta' BRCA (germline BRCA u/jew mutazzjonijiet somatiċi), kanċer tal-ovarji epiteljali ta' grad għoli, tat-tubi fallopjani, jew kanċer primarju tal-peritonew, li jkunu ġew ittrattati bi tnejn jew aktar korsijiet ta' kimoterapija bbażata fuq il-platinum fil-passat, u li mhumiex kapaċi jittolleraw aktar kimoterapija bbażata fuq il-platinum.
English: Package leaflet: Information for the patient Rubraca 200 mg film-coated tablets
Maltese: Informazzjoni għall-pazjent Rubraca 200 mg pilloli miksija b'rita
English: Detection of BRCA mutation
Maltese: Grupp mhux BRCA LOH
English: • medicines to treat allergic reactions - such as astemizole or terfenadine
Maltese: • mediċini biex jittrattaw reazzjonijiet allerġiċi - bħal astemizole jew terfenadine
English: Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 300 mg of rucaparib.
Maltese: Kull pillola miksija b'rita fiha rucaparib camsylate li jikkorrispondi għal 300 mg ta' rucaparib.
English: Decreased appetite, Dehydration
Maltese: Tnaqqis fl-aptit, Deidratazzjoni
English: Mechanism of action and pharmacodynamics effects
Maltese: Mekkaniżmu ta' azzjoni ueffetti farmakodinamiċi
English: The pharmacokinetic characteristics of rucaparib in patients with CLcr less than 30 mL/min or patients on dialysis are unknown (see section 4.2).
Maltese: Il-karatteristiċi farmakokinetiċi ta' rucaparib f'pazjenti b'CLcr ta' inqas minn 30 mL/min jew pazjenti fuq id-dijalisi mhumiex magħrufa (ara sezzjoni 4.2).
English: • itching
Maltese: • dijarea
English: The progression-free interval to penultimate platinum therapy was 6-12 months in 39% of patients and > 12 months in 61%.
Maltese: L-intervall mingħajr progressjoni għal terapija bil platinum ta' qabel tal-aħħar kien 6-12-il xahar f'39 % tal-pazjenti u >12-il xahar f'61 %.
English: Rubraca 300 mg film-coated tablets
Maltese: Rubraca 300 mg pilloli miksija b'rita
English: Craigavon
Maltese: Anzjani
English: No dose adjustment is considered necessary for co-administered medicinal products that are CYP2C19 substrates.
Maltese: Lebda aġġustament fid-doża mhu kkunsidrat li hu meħtieġ għal prodotti mediċinali mogħtija flimkien li huma substrati ta' CYP2C19.
English: Tablet core
Maltese: Testijiet tad-demm
English: • medicines to treat severe pain - such as alfentanil or fentanyl
Maltese: • mediċini biex jittrattaw l-uġigħ - bħal alfentanil jew fentanyl
English: Rubraca 250 mg film-coated tablet
Maltese: Rubraca 250 mg pillola miksija b'rita
English: Inhibition of MRP4 by rucaparib cannot be fully ruled out at clinical exposures.
Maltese: Jista' jkun hemm inibizzjoni ta' MRP4 minn rucaparib flespożizzjonijiet kliniċi.
English: EMA/635489/2015 EMEA/H/C/003960
Maltese: EMA/635489/2015 EMA/H/C/003960
English: The full EPAR and risk management plan summary for Cotellic 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: Cotellic is available as tablets (20 mg).
Maltese: Cotellic jiġi bħala pilloli (20 mg).
English: The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhoea, rash, nausea (feeling sick), vomiting, pyrexia (fever), photosensitivity (light sensitivity) reaction, abnormal results for certain liver function tests (increased levels of alanine aminotransferase, aspartate aminotransferase) and abnormal results for an enzyme related to muscle breakdown (creatine phosphokinase).
Maltese: L-effetti sekondarji l-aktar komuni b'Cotellic (li jistgħu jaffettwaw aktar minn 1 minn kull 5) huma dijarea, raxx, nawżja (tħossok ma tiflaħx), rimettar, deni, reazzjoni ta' fotosensittività (sensittività għad-dawl), riżultati anormali għal ċerti testijiet tal-funzjoni tal-fwied (żieda fil-livelli ta' alanine aminotransferase, aspartate aminotransferase) u riżultati anormali għall-enżima relatata mat-tkissir tal-muskoli (creatine phosphokinase).
English: It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Maltese: Jingħata f'doża rakkomandata ta' 60 mg kuljum (3 pilloli ta' 20 mg).
English: In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on the protein MEK.
Maltese: F'melanoma bil-mutazzjoni BRAF V600, tiġi prodotta forma anormali tal-proteina BRAF, li tattiva l-proteina MEK.
English: This is a summary of the European public assessment report (EPAR) for Cotellic.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cotellic.
English: Why is Cotellic approved?
Maltese: Għaliex ġie approvat Cotellic?
English: The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein involved in stimulating normal cell division.
Maltese: Is-sustanza attiva f'Cotellic, il-cobimetinib, hija inibitur ta' MEK, proteina li tistimula l-qsim normali taċċelloli.
English: Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Maltese: Il-kura b'Cotellic tingħata f'ċikli ta' 28 jum: il-pilloli jittieħdu għal 21 jum wara xulxin, segwiti minn waqfa ta' 7 ijiem.
English: Other information about Cotellic
Maltese: Informazzjoni oħra dwar Cotellic
English: What are the risks associated with Cotellic?
Maltese: X'inhuma r-riskji assoċjati ma' Cotellic?
English: Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Maltese: Cotellic huwa mediċina kontra l-kanċer li tintuża fil-kura ta' adulti b'melanoma (tip ta' kanċer tal-ġilda) li nfirex għal partijiet oħrajn tal-ġisem u ma jistax jitneħħa b'operazzjoni.
English: Cotellic has been studied in one main study involving 495 patients with melanoma that had spread or that could not be surgically removed, and whose melanoma had a BRAF V600 mutation.
Maltese: Cotellic ġie studjat fi studju ewlieni wieħed li involva 495 pazjent b'melanoma li kienet infirxet għal partijiet oħra tal-ġisem jew li ma setgħetx titneħħa b'operazzjoni, u li l-melanoma tagħhom kellha mutazzjoni BRAF V600.
English: In this study, adding Cotellic to vemurafenib was more effective than adding placebo to vemurafenib: it took on average 12.3 months before the disease got worse in patients given Cotellic, compared with 7.2 months in patients given placebo.
Maltese: F'dan l-istadju, meta Cotellic żdied ma' vemurafenib, kien iktar effikaċi minn meta plaċebo żdied ma' vemurafenib: bħala medja l-marda ħadet madwar 12.3 xhur biex taggrava f'pazjenti li ngħataw Cotellic, meta mqabbel ma' 7.2 xhur f'pazjenti li ngħataw plaċebo.
English: The Committee noted that Cotellic in combination with vemurafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation, when compared with vemurafenib alone.
Maltese: Il-Kumitat ikkunsidra li meta Cotellic intuża f'kombinazzjoni ma' vemurafenib wera benefiċċju klinikament rilevanti f'pazjenti li l-melanoma tagħhom kellha mutazzjoni BRAF V600, meta mqabbel ma' vemurafenib waħdu.
English: For the full list of all side effects and restrictions reported with Cotellic, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Cotellic, ara l-fuljett ta' tagħrif.
English: Cotellic is used in combination with another medicine called vemurafenib.
Maltese: Ilmediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Cotellic jintuża bl-aktar mod sigur possibbli.
English: Section 4:
Maltese: Sezzjoni 4:
English: Frequency ‘common': colitis
Maltese: Frekwenza ‘komuni': kolite
English: Natalizumab - Anaemia (EPITT no 18137)
Maltese: Natalizumab - Anemija (EPITT nru 18137)
English: Leflunomide - Colitis (EPITT no 18189)
Maltese: 3. Leflunomide - Kolite (EPITT nru 18189)
English: Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Maltese: Fingolimod - Lewkoenċefalopatija Multifokali Progressiva (PML) (EPITT nru 18241)
English: Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Maltese: Frekwenza ‘komuni': Kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenika.
English: Adopted at the 4-7 May 2015 PRAC
Maltese: Adottati fil-PRAC ta' bejn l-4 u s-7 ta' Mejju 2015
English: Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Maltese: Latanoprost (Xalatan) - Żieda fir-rapportar ta' disturbi flgħajnejn, b'mod partikolari irritazzjoni tal-għajnejn, wara bidla fil-formulazzjoni (EPITT nru 18068)
English: PML is an opportunistic infection caused by JohnCunningham virus (JCV) which may be fatal or result in severe disability.
Maltese: PML hija infezzjoni opportunistika kkawżata mill-virus ta' John-Cunningham (JCV) li tista' tkun fatali jew tirriżulta f'diżabbiltà severa.
English: Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Maltese: Frekwenza "mhux magħrufa": Lewkoenċefalopatija multifokali progressiva (PML) Fuljett ta' Tagħrif:
English: The symptoms of PML may be similar to an MS relapse.
Maltese: Is-sintomi ta' PML jistgħu jkunu simili għal rikaduta ta' MS.
English: Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Maltese: Wara li kkunsidra l-evidenza disponibbli mill-provi kliniċi (kolite rrapportata f'1% sa <3% fil-fergħa ta' kura), minn każijiet spontanji inkluż każijiet ta' de-challenge u re-challenge pożittivi rrapportati kif ukoll rapporti ta' appoġġ fid-dokumentazzjoni, il-PRAC qabel li l-MAH(s) ta' prodotti li fihom leflunomide għandhom jissottomettu varjazzjoni fi żmien xahrejn, biex jemendaw l-informazzjoni dwar il-prodott kif deskritt hawn taħt (test ġdid sottolinjat).
English: Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Maltese: Riskju ta' infezzjoni rari tal-moħħ imsejħa lewkoenċefalopatija multifokali progressiva (PML).
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - Progressive multifocal leukoencephalopathy) ġiet irrapportata taħt kura b'fingolimod mill-awtorizzazzjoni għat-tqegħid fis-suq (ara sezzjoni 4.8).
English: Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Maltese: Wara li ġiet ikkunsidrata l-evidenza disponibbli minn rapporti spontanji, EudraVigilance u ddokumentazzjoni, il-PRAC jikkunsidra li l-pazjenti li jirċievu Xalatan għandhom jiġu avżati dwar limportanza li jfittxu parir mediku jekk ikollhom irritazzjoni eċċessiva tal-għajnejn.
English: The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Maltese: Il-PRAC qabel li jitlob parir lil grupp konsultattiv xjentifiku (SAG - scientific advisory group) fir-rigward tal-fatturi ta' riskju u s-sorveljanza (eż. MRI, status JCV, proporzjon CD4+/CD8+) tal-pazjenti kkurati b'fingolimod, sabiex jingħataw pariri dwar il-possibbiltajiet li tittejjeb il-pronjożi tal-pazjenti dijanjostikati kmieni, u biex jiġu identifikati dawk il-pazjenti f'riskju li jiżviluppaw PML.
English: • Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
Maltese: • Irritazzjoni tal-għajnejn (sensazzjoni ta' ħruq, grif, ħakk, tingiż jew is-sensazzjoni ta' xi ħaġa barranija f'għajnejk).
English: Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Maltese: Wara li kkunsidra l-evidenza disponibbli, inkluż id-dejta sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH), u filwaqt li qies li Lewkoenċefalopatija Multifokali Progressiva (PML) hija marda kumplessa li tista' tieħu żmien twil qabel ma ssir klinikament sintomatika, il-PRAC qabel li aġġornament tal-informazzjoni dwar il-prodott huwa ġġustifikat.
English: In case of PML is suspected, treatment with fingolimod should be discontinued.
Maltese: F'każ li tkun suspettata PML, il-kura b'fingolimod għandha titwaqqaf.
English: Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Maltese: Wara li kkunsidra d-dejta sottomessa mill-MAH, kif ukoll l-evidenza mill-każijiet tal-EudraVigilance, u d-dokumentazzjoni, il-MAH ta' Tysabri għandu jissottometti varjazzjoni fi żmien 60 jum biex iżid “anemija” u “anemija emolitika” fis-sezzjoni 4.8 tal-SmPC u biex jaġġorna l-Fuljett ta' Tagħrif kif xieraq.
English: Summary of Product Characteristics (SmPC): Section 4.4 - Special warnings and precautions for use Infections
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Infezzjonijiet
English: Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Maltese: Għalhekk, id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għal fingolimod għandu jissottometti varjazzjoni fi żmien xahrejn, biex jemenda l-informazzjoni dwar il-prodott kif deskritt hawn taħt (test ġdid sottolinjat) u biex jinkludi l-PML fl-RMP bħala riskju identifikat importanti (taħt ir-riskju ta' infezzjonijiet).
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Kolite, inkluż kolite mikroskopika ġiet irrapportata f'pazjenti kkurati b'leflunomide.
English: In patients on leflunomide treatment presenting unexplained chronic diarrhoea appropriate diagnostic procedures should be performed.
Maltese: Kellem lit-tabib tiegħek jekk ikollok dijarea kronika mhux spjegata.
English: Section 2: What you need to know before you take Arava Warning and precautions
Maltese: Sezzjoni 2: X'għandek tkun taf qabel ma tieħu Arava Twissijiet u prekawzjonijiet
English: Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Maltese: Aktar informazzjoni dwar Symtuza tinstab fis-sit web talAġenzija: ema.europa.eu/en/medicines/human/EPAR/symtuza.
English: Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)
Maltese: Symtuza (darunavir / kobiċistat / emtriċitabina / tenofovir alafenamid)
English: This overview was last updated in 07-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'07-2019.
English: Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Maltese: Symtuza jiġi bħala pilloli, li kull waħda fiha 800 mg darunavir, 150 mg kobiċistat, 200 mg emtriċitabina u 10 mg tenofovir alafenamid.
English: Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Maltese: B'mod globali, 75 % tal-pazjenti li kienu qed jieħdu Symtuza (77 pazjent minn 103) kisbu dan it-tnaqqis wara 24 ġimgħa ta' kura, li kien simili għall-74 % (37 minn 50) tal-pazjenti li kisbuh bil-komparatur.
English: Other information about Symtuza
Maltese: Informazzjoni oħra dwar Symtuza
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: L-HIV-1 huwa virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Maltese: Symtuza rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-21 ta' Settembru 2017.
English: Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg).
Maltese: Symtuza huwa mediċina antivirali li tintuża għall-kura tal-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1) f'adulti u f'adoloxxenti minn 12-il sena 'l fuq (u li jiżnu mill-inqas 40 kg).
English: Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.
Maltese: Symtuza fih is-sustanzi attivi darunavir, kobiċistat, emtriċitabina u tenofovir alafenamid.
English: What are the risks associated with Symtuza?
Maltese: X'inhuma r-riskji assoċjati ma' Symtuza?
English: It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected.
Maltese: Dan jimblokka protease, enzima tal-virus li tippermettilu jipproduċi lilu nnifsu fiċ-ċelloli li jkun infetta.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml.
Maltese: L-effettività tkejlet minn tnaqqis fit-tagħbija virali (l-ammont ta' HIV-1 fiddemm) għal inqas minn 50 kopja/ml.
English: • Darunavir is a type of antiviral agent called a ‘protease inhibitor'.
Maltese: • Id-darunavir hija tip ta' aġent antivirali li jissejjaħ “inibitur ta' protease”.