FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir dasabuvi r + ombitas vir/parit aprevir/r itonavir dolutegravir
Maltese: Mekkaniżmu: żieda f'dasabuvir possibilment minħabba l inibizzjoni ta' CYP2C8 mnn trimethoprim dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir
Maltese: GT1b dasabuvir u ombitasvir/paritaprevir/ritonavir
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Maltese: Każijiet ta' attivazzjoni mill-ġdid tal-virus tal-epatite B (HBV, hepatitis B virus), xi wħud minnhom fatali, ġew irrappurtati matul jew wara trattament b'sustanzi antivirali li jaħdmu b'mod dirett.
English: Your doctor may also give you an antiviral medicine called ribavirin.
Maltese: Din il-mediċina tista' tkun disponibbli mingħajr riċetta
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: tkun minħabba l inibizzjoni ta' OATPs minn atazanavir.
English: Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of dasabuvir and ombitasvir/paritaprevir/ritonavir and concomitant medicinal products.
Maltese: Kwadrati (90% Intervall ta' Fiduċja) fuq ilkonċentrazzjonijiet ta' dasabuvir u ombitasvir/paritaprevir/ritonavir u prodotti mediċinali li jittieħdu magħhom.
English: Pruritus
Maltese: Perjodu
English: For the use of HIV protease inhibitors other than atazanavir and darunavir refer to the Summary of Product Characteristics of ombitasvir/ paritaprevir /ritonavir.
Maltese: Jekk inibitur ta' HIV protease huwa miżjud (atazanavir, darunavir), l-espożizzjoni ta' rilpivirine tista' tiżdid anke aktar u għalhekk mhux rrakkomandat.
English: Clinical monitoring and dose adjustment may be required for levothyroxine.
Maltese: Monitoraġġ kliniku u aġġustament fid-doża jista' jkun meħtieġ għal levothyroxine.
English: paritaprevir the same time as dasabuvir +ombitasvir/paritaprevi r/ritonavir.
Maltese: dasabuvir + ombitasvir/paritaprevi r/ritonavir.
English: ombitas vir/parit aprevir/ ritonavi r carbamaze pine 10, 11epoxide section 4.3).
Maltese: sirolimus ma' dasabuvir + ombitasvir/paritaprevi r/ritonavir mhux irrakkomandat sakemm il-benefiċċji jegħlbu r-riskji (ara sezzjoni 4.4).
English: Apalutamide
Maltese: Alprazolam
English: The SVR12 rates in HCV/HIV-1 co-infected subjects were thus consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Maltese: Ir-rati ta' SVR12 f'individwi b'ko-infezzjoni ta' HCV/HIV-1 kienu konsistenti ma' r-rati ta' SVR12 fil-provi kliniċi ta' fażi 3 ta' individwi mono-infettati b'HCV.
English: Use in diabetic patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: ↑ dabigatran etexilate dasabuvir + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Maltese: ↑ nor elgestromine dasabuvir ombitasvir paritaprevir nor-ethindrone (pillola ta' progestin biss)
English: Potential for other medicinal products to affect the pharmacokinetics of dasabuvir
Maltese: Potenzjal ta' prodotti mediċinali oħra biex jaffetwaw il-farmakokinetiċi ta' dasabuvir
English: Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Maltese: inibizzjoni ta' P-gp minn dasabuvir, paritaprevir, u ritonavir.
English: The interactions with pitavastatin and fluvastatin have not been investigated.
Maltese: L-interazzjonijiet ma' pitavastatin u fluvastatin ma ġewx investigati.
English: Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Maltese: Inibizzjoni ta' BCRP minn paritaprevir, ritonavir u dasabuvir.
English: The marketing authorisation holder (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: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talAwtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
Maltese: Fl istudju ma kienu osservati l-ebda reazzjonijiet avversi jew abnormalitajiet tal-laboratorju klinikament sinifikanti relatati mal-mediċina.
English: NA Concomitant use is contraindicated (see section 4.3).
Maltese: NA L-użu konkomitanti huwa kontraindikat (ara sezzjoni 4.3).
English: Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Maltese: Dasabuvir m'għandhomx jintużaw f'pazjenti b'indeboliment epatiku moderat għal sever (Child-Pugh B jew Ċ) (ara sezzjoni 5.2).
English: Use with caution.
Maltese: Popolazzjoni ta' pazjenti
English: 300 mg single dose itonavir ombitasvir/paritaprevir/ ritonavir.
Maltese: Dejjem jittieħdu ma' mediċini anti-virali oħra bħal ombitasvir/paritaprevir/ritonavir.
English: Other
Maltese: JIS
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2C9 substrate warfarin.
Maltese: Dasabuvir u ombitasvir/paritaprevir/ritonavir f'kombinazzjoni ma ribavirin huma rrakkomandati għal 24 ġimgħa f' pazjenti li kellhom trapjant tal-fwied.
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Maltese: 12-il ġimgħa 8 ġimgħat jistgħu jiġu kkunsidrati f'pazjenti infettati f'ġenotip 1b b'fibrożi minima sa moderata li ma kienux għadhom ġew ittrattati ** (ara sezzjoni 5.1, studju GARNET)
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicine, such medicinal products are contraindicated with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Maltese: Peress li l-inċidenza ta' elevazzjonijiet bħal dawn kien ta' 26% fost in-nisa li jieħdu ukoll mediċina li fiha ethinyloestradiol, dawn il-prodotti mediċinali huma kontraindikati ma' dasabuvir u ombitasvir/paritaprevir/ritonavir.
English: Liver transplant recipients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Clinical monitoring and lower doses of imatinib are recommended.
Maltese: Monitoraġġ kliniku u dożi aktar baxxi ta' imatinib huma rrakkomandati.
English: Persistence of resistance-associated substitutions
Maltese: Persistenza ta' sostituzzjonijiet assoċjati ma' reżistenza
English: The EC50 of dasabuvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 7.7 and 1.8 nM, respectively.
Maltese: replikon kien ta' 7.7 u 1.8 nM, rispettivament.
English: Table 16 shows SVR rates for these subjects.
Maltese: Tabella 16 turi r-rati SVR għal dawn l-individwi.
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser HCV genotype 1b
Maltese: ebda rispons qabel pegIFN/RBV Pazjenti li kellhom rispons parzjali qabel pegIFN/RBV Pazjenti li rkadew qabel pegIFN/RBV
English: No dose adjustment of dasabuvir is warranted in elderly patients (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda aġġustament tad-doża ta' dasabuvir f'pazjenti anzjani (ara sezzjoni 5.2).
English: Vomiting
Maltese: IMBLOKKATURI
English: The dose of ribavirin was individualized at the discretion of the investigator, with most subjects receiving 600 to 800 mg as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Maltese: Id-doża ta' ribavirin ġiet individwalizzata fid-diskrezzjoni ta' l-investigatur, b'aktar suġġetti li jirċievu 600 sa 800 mg bħala doża tal-bidu, u ħafna mill-individwi li wkoll jirċievu 600 sa 800 mg kuljum fit-tmiem tal kura.
English: Mechanism: CYP3A4 inhibition by ritonavir dasabu vir +
Maltese: Inibizzjoni ta' CYP3A4 minn ritonavir hydrocodone
English: dasabuvir ombitasvir paritaprevir CALCIUM CHANNEL BLOCKERS Amlodipine 5 mg single dose dasabu vir + ombitas vir/parit amlodipine
Maltese: Bidliet għal dasabuvir u ombitasvir, paritaprevir huma listess kif muri għal paracetamol hawn fuq
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Maltese: kienu Ażjatiċi; 0.6% kienu Suwed; 68.5% kellhom IL28B ġenotip mhux CC; 7.2% kellhom livelli ta' HCV RNA fil-linja bażi ta' mill-anqas 6,000,000 IU għal kull ml; 9% kellhom fibrożi avvanzata (F3) u 98.2% kellhom infezzjoni tal-ġenotip 1b HCV (kull individwu kellu ġenotip infezzjoni b'1a, 1d, u
English: The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows mean Cmax and AUC of dasabuvir 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
Maltese: Fi-tmien provi kollha, id-doża ta' dasabuvir kienet 250 mg darbtejn kuljum u d-doża ta'ombitasvir/ paritaprevir/ ritonavir kienet 25/150/100 mg darba kuljum.
English: TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Maltese: TOTAL + Tipi oħra ta' fallimenti ta' pegIFN/RBV jinkludu każijiet li ma rrispondewx għat-trattament, rikaduta/avvanz jew falliment ieħor ta' pegIFN li kienu inqas iddokumentati sew.
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r everolimus
Maltese: dasabuvir ombitasvir/ paritaprevi r/ritonavir everolimus
English: The full EPAR for Axumin 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: This is a summary of the European public assessment report (EPAR) for Axumin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Axumin.
English: Axumin is a ‘radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.
Maltese: Axumin huwa “radjufarmaċewtiku”: fih is-sustanza attiva fluciclovine (18F), li temetti ammont żgħir ta' radjazzjoni.
English: Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.
Maltese: Axumin huwa disponibbli bħala soluzzjoni għal injezzjoni, li tingħata f'vina madwar 3 sa 5 minuti qabel ma l-pazjent ikun se jsirlu skenn PET.
English: Why is Axumin approved?
Maltese: Għaliex ġie approvat Axumin?
English: The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Axumin (jidhru f'bejn pazjent 1 u 10 minn kull 100) huma ddisturbi fit-tegħim, bidla fis-sens tax-xamm, u wġigħ jew raxx fil-post tal-injezzjoni.
English: Other information about Axumin
Maltese: Informazzjoni oħra dwar Axumin
English: The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells.
Maltese: Is-sustanza attiva f'Axumin, fluciclovine (18F), temetti ammont żgħir ta' radjazzjoni u taħdem billi tidħol fiċ-ċelloli tal-kanċer tal-prostrata permezz ta' strutturi (LAT-1 u ASCT2) li huma preżenti f'ammonti kbar fuq is-superfiċje ta' dawn iċ-ċelloli.
English: The side effects seen with the product are mild and rare, and there are no serious safety risks.
Maltese: L-effetti sekondarji li jidhru mal-prodott huma rari u moderati, u m'hemmx riskji serji għas-sigurtà.
English: In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling).
Maltese: Fi studju ewlieni li jinvolvu rekords mediċi minn 115-il raġel, b'mod korrett 79 % tad-drabi l-iskenns PET b'Axumin urew li l-kanċer reġa' tfaċċa f'pazjent, kif ġie sussegwentement ikkonfermat mill-istudji tat-tessut tal-laboratorju.
English: Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.
Maltese: Axumin iwassal ammont żgħir ħafna ta' radjazzjoni li tista' toħloq riskju żgħir ħafna ta' kanċer u anormalitajiet ereditarji.
English: It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.
Maltese: Dan huwa speċifikament użat mal-iskenn tal-ġisem magħruf bħala tomografija b'emissjoni ta' pożitroni (PET, positron-emission tomography) f'irġiel li t-test tad-demm tagħhom għal antiġen speċifiku għallprostata (PSA) jindika li l-kanċer jista' jkun preżenti.
English: What are the risks associated with Axumin?
Maltese: X'inhuma r-riskji assoċjati ma' Axumin?
English: For the full list of side effects and restrictions reported with Axumin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet irrappurtati b'Axumin, ara l-fuljett ta' tagħrif.
English: The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin.
Maltese: Il-kumpanija li tqiegħed Axumin fis-suq ser tiżgura li l-professjonisti kollha tal-kura tas-saħħa li huma mistennija jużaw dan il-prodott jingħataw il-materjal edukattiv sabiex jonqsu l-iżbalji fl-interpretazzjoni tal-immaġni tal-iscan PET.
English: PET scans with Axumin are effective in detecting prostate cancer and can help exclude the presence of the cancer.
Maltese: Skenns PET b'Axumin huma effettivi biex jidentifikaw il-kanċer tal-prostrata u jistgħu jgħinu biex tiġi eskluża l-preżenza tal-kanċer.
English: However, because some scans with Axumin were falsely positive (showing that cancer had returned when tissue sampling was negative), a positive result on its own is not enough to make a diagnosis.
Maltese: Huwa importanti jiġi nnutat li skenn negattiv ma kienx garanzija li l-kanċer ma reġax tfaċċa.
English: How does Axumin work?
Maltese: Kif jaħdem Axumin?
English: Content (concentration)
Maltese: Kontenut (konċentrazzj oni)
English: 1 pre-filled syringe with needle safety guard
Maltese: Daqs talpakkett siringa mimlija għal-lest (ħġieġ) bi protezzjoni tas sigurtà tallabra siringa mimlija għal-lest (ħġieġ) bi protezzjoni tas sigurtà tallabra
English: Pharmaceutical form Route of administration
Maltese: Għamla farmaċewtika
English: EMA/673031/2013 rev1 EMEA/H/A-31/1267
Maltese: 18 ta' Settembru 2013 EMA/422612/2012 rev1 EMEA/H/A-31/1267
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Maltese: Eżitu ta' proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE kif emendata
English: What are antifibrinolytics?
Maltese: X'inhuma l-antifibrinolitiċi?
English: What are the conclusions of the CHMP?
Maltese: Liema dejta rreveda s-CHMP?
English: The CHMP reviewed data from the BART study, including additional data and analyses that became available since 2007.
Maltese: Is-CHMP irreveda dejta mill-istudju BART, inkluż dejta u analiżijiet addizzjonali li saru disponibbli mill2007.
English: Aminocaproic acid and tranexamic acid are the commonly used antifibrinolytics in the EU.
Maltese: L-aminocaproic acid u t-tranexamic acid huma l-antifibrinolitiċi użati b'mod komuni fl-UE.
English: On 5 November 2007, the German medicines regulatory authority (BfArM) suspended the marketing authorisations for aprotinin-containing medicines in Germany.
Maltese: Fil-5 ta' Novembru 2007, l-awtorità regolatorja Ġermaniża tal-mediċini (BfArM) issospendiet lawtorizzazzjonijiet għat-tqegħid fis-suq tal-mediċini li fihom aprotinin fil-Ġermanja.
English: On 14 February 2012, the European Medicines Agency completed a review of the antifibrinolytic medicines aprotinin, aminocaproic acid and tranexamic acid.
Maltese: Fl-14 ta' Frar 2012, l-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni tal-mediċini antifibrinolitiċi aprotinin, aminocaproic acid u tranexamic acid.
English: This decision was triggered by the early results of a study (the BART study) that showed a higher number of deaths 30 days after heart surgery among patients given aprotinin compared with patients given other antifibrinolytic treatments (aminocaproic acid and tranexamic acid).
Maltese: Din id-deċiżjoni kienet instigata mir-riżultati bikrin ta' studju (l-istudju BART) li wrew numru ogħla ta' mwiet 30 jum wara operazzjoni tal-qalb fost il-pazjenti li ngħataw aprotinin meta mqabbel mal-pazjenti li ngħataw trattamenti antifibrinolitiċi oħra (aminocaproic acid u tranexamic acid).
English: • A registry will be set up in EU monitor the pattern of use of aprotinin.
Maltese: • Se jiġi stabbilit reġistru fl-UE biex jiġi mmonitorjat l-użu ta' aprotinin.
English: Why were antifibrinolytics reviewed?
Maltese: Għaliex ġew riveduti l-antifibrinolitiċi?
English: The Committee also looked at data from other clinical studies, the published literature, spontaneous reports of side effects and data submitted by companies that market antifibrinolytics.
Maltese: Il-Kumitat ħares ukoll lejn dejta minn studji kliniċi oħra, id-dokumentazzjoni ppubblikata, rapporti spontanji tal-effetti sekondarji u d-dejta sottomessa mill-kumpaniji li jqiegħdu fis-suq lantifibrinolitiċi.
English: Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid)
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni ta' mediċini antifibrinolitiċi (aprotinin, aminocaproic acid u tranexamic acid)
English: The results from the BART study were not replicated in other studies, and when data from several studies (excluding BART) were analysed together, the results did not show that aprotinin is linked to a higher risk of death compared with other antifibrinolytics.
Maltese: Ir-riżultati mill-istudju BART ma kinux replikati fi studji oħra, u meta d-dejta minn diversi studji (eskluż BART) ġiet analizzata f'daqqa, ir-riżultati ma wrewx li aprotinin huwa marbut ma' riskju ogħla ta' mewt meta mqabbel ma' antifibrinolitiċi oħra.
English: The suspension in Germany led to an EU-wide review by the CHMP which recommended the suspension of aprotinin throughout the EU on 21 November 2007.
Maltese: Is-sospensjoni fil-Ġermanja wasslet għal reviżjoni madwar l-UE kollha mis-CHMP li rrakkomanda s-sospensjoni ta' aprotinin fl-UE kollha fil-21 ta' Novembru 2007.1
English: • Prescribers should follow the new harmonised recommendations for the use of aminocaproic acid and tranexamic acid.
Maltese: • Min jippreskrivi għandu jsegwi r-rakkomandazzjonijiet armonizzati ġodda għall-użu tal-aminocaproic acid u t-tranexamic acid.
English: The CHMP also recommended important changes to the prescribing information for aprotinin medicines, including restricting their use to isolated heart bypass surgery in adults at high risk of major blood loss and the inclusion of a warning on the risk of giving patients too little heparin (‘under heparinisation').
Maltese: Is-CHMP irrakkomanda wkoll bidliet importanti fl-informazzjoni ta' preskrizzjoni għall-mediċini li fihom aprotinin, inkluża l-limitazzjoni tal-użu tagħhom għal operazzjoni iżolata tal-bypass tal-qalb f'persuni adulti f'riskju għoli ta' telf kbir ta' demm u l-inklużjoni ta' twissija dwar ir-riskju tal-għoti ta' ftit wisq eparina (‘għoti ta' inqas eparina milli suppost') lill-pazjenti.
English: During the review, the CHMP took advice from a scientific advisory group, consisting of experts in cardiovascular and bleeding disorders.
Maltese: Matul ir-reviżjoni, is-CHMP ħa parir minn grupp konsultattiv xjentifiku, li kien magħmul minn esperti dwar id-disturbi kardjovaskulari u tal-fsad.
English: The European Commission issued a decision for aminocaproic acid on 10 October 2012.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għall-aminocaproic acid fl-10 ta' Ottubru 2012.
English: A registry will be set up in the EU to monitor the use of aprotinin, and the CHMP has approved a risk management plan for aprotinin medicines.
Maltese: Se jiġi stabbilit reġistru fl-UE biex jiġi mmonitorjat l-użu ta' aprotinin, u s-CHMP approva pjan ta' ġestjoni tar-riskju għall-mediċini li fihom aprotinin.
English: Questions and answers on the suspension of aprotinin
Maltese: 1 Mistoqsijiet u Tweġibiet dwar is-sospensjoni ta' aprotinin
English: On 12 March 2010, the German medicines agency asked the CHMP to carry out a full assessment of the benefits and risks of aprotinin, as well as those of aminocaproic acid and tranexamic acid, and to issue an opinion on their authorisation in the EU.
Maltese: Fit12 ta' Marzu 2010, l-aġenzija Ġermaniża tal-mediċini talbet lis-CHMP sabiex iwettaq valutazzjoni sħiħa tal-benefiċċji u r-riskji ta' aprotinin, kif ukoll dawk tal-aminocaproic acid u t-tranexamic acid, u biex joħroġ opinjoni dwar l-awtorizzazzjoni tagħhom fl-UE.
English: New analyses showed flaws in the way the study was carried out, which cast doubt on the previous conclusions.
Maltese: Analiżijiet ġodda wrew nuqqasijiet fil-mod kif kien twettaq listudju, li xeħtu dubju dwar il-konklużjonijiet preċedenti.
English: The European Commission issued a decision for tranexamic acid on 10 October 2012.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni għat-tranexamic acid fl-10 ta' Ottubru 2012.
English: The CHMP set out conditions for the reintroduction of aprotinin medicines onto the market and also made recommendations on the use of aminocaproic acid and tranexamic acid.
Maltese: Is-CHMP stabbilixxa kundizzjonijiet għallintroduzzjoni mill-ġdid fis-suq ta' mediċini li fihom aprotinin u għamel ukoll rakkomandazzjonijiet dwar l-użu tal-aminocaproic acid u tat-tranexamic acid.
English: The CHMP therefore concluded that the benefits of aprotinin outweigh its risk in appropriately managed patients undergoing isolated heart bypass surgery (not combined with other heart surgery), and recommended that the suspension of aprotinin medicines in the EU be lifted for this revised indication.
Maltese: Is-CHMP għalhekk ikkonkluda li l-benefiċċji ta' aprotinin jisbqu r-riskju tiegħu f'pazjenti ġestiti tajjeb li jkunu ser jagħmlu operazzjoni iżolata tal-bypass tal-qalb (mhux kombinata ma' operazzjoni oħra tal-qalb), u rrakkomanda li titneħħa s-sospensjoni tal-mediċini li fihom aprotinin fl-UE għal din l-indikazzjoni riveduta.
English: They work by reducing the activity of an enzyme called plasmin that is responsible for breaking up the fibres in blood clots.
Maltese: Huma jaħdmu billi jnaqqsu l-attività ta' enzima msejħa plasmin li hija responsabbli għat-tkissir tal-fibri flemboli.
English: Furthermore, the CHMP advised that careful consideration be given to benefits and risks of aprotinin, and the availability of alternative treatments.
Maltese: Barra minn hekk, is-CHMP irrakkomanda li jiġu kkunsidrati sewwa l-benefiċċji u r-riskji ta' aprotinin, u d-disponibbiltà ta' trattamenti alternattivi.
English: The CHMP was informed of ongoing pharmacokinetic studies which are to be finalised and assessed by national authorities.
Maltese: Is-CHMP ġie infurmat bl-istudji farmakokinetiċi li għaddejjin li għandhom jiġu finalizzati u valutati mill-awtoritajiet nazzjonali.
English: The amended information for tranexamic acid can be found here.
Maltese: L-informazzjoni emendata dwar it-tranexamic acid tista' tinstab hawnhekk.
English: The CHMP's review of aminocaproic acid and tranexamic acid, which are currently on the market in the EU, did not reveal any new safety concerns.
Maltese: Ir-reviżjoni min-naħa tas-CHMP, tal-aminocaproic acid u t-tranexamic acid, li attwalment qegħdin fissuq fl-UE, ma żvelat l-ebda tħassib ġdid dwar is-sigurtà.