FrancophonIA/ELRC3.0 huggingface dataset:
English: In rat and rabbit reproductive toxicology studies, baricitinib was shown to reduce foetal growth/weight and produce skeletal malformations (at exposures of approximately 10 and 39 times the human exposure, respectively).
Maltese: Fi studji dwar tossiċità fir-riproduzzjoni fil-far u l-fenek, baricitinib intwera li jnaqqas it-tkabbir/piż tal-fetu u jipproduċi formazzjonijiet ħżiena fl-iskeletru (b'esponimenti ta' madwar 10 darbiet u 39 darba aktar mill-esponiment uman, rispettivament).
English: Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a haemoglobin value less than 8 g/dL.
Maltese: It-trattament m'għandux jinbeda f'pazjenti b'għadd assolut ta' limfoċiti (ALC, absolute lymphocyte count) li huwa anqas minn 0.5 x 109 ċelluli/L, għadd assolut ta' newtrofili (ANC, absolute neutrophil count) anqas minn 1 x 109 ċellula/L, jew li għandhom valur ta' emoglobina anqas minn 8 g/dL.
English: Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in significant improvements in all individual ACR components, including tender and swollen joint counts, patient and physician global assessments, HAQ-DI, pain assessment and CRP, compared to placebo or MTX monotherapy.
Maltese: Trattament b'Olumiant 4 mg, waħdu jew flimkien ma' cDMARDs, wassal għal titjib sinifikanti fil komponenti individwali kollha ta' ACR, inkluż l-għadd ta' ġogi sensittivi u minfuħa, l-istimi globali tal-pazjenti u t-tobba, l-HAQ-DI, l-istima tal-uġigħ u s-CRP, meta mqabbla mal-plaċebo jew ma' monoterapija b'MTX.
English: In controlled studies, for up to 16 weeks, decreases in neutrophil counts below 1 x 109 cells/L occurred in 0.3 % of patients treated with Olumiant compared to 0 % of patients treated with placebo.
Maltese: Fi studji kkontrollati, sa 16-il ġimgħa, tnaqqis fl-għadd tan-newtrofili għal inqas minn 1 x 109 ċelluli/L seħħ f'0.3% tal-pazjenti ttrattati b'Olumiant meta mqabbel ma' 0% tal-pazjenti ttrattati bi plaċebo.
English: The RA-BEGIN Study in MTX-naïve patients is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs (section 4.1).
Maltese: L-Istudju RA-BEGIN f'pazjenti li qatt ma ħadu MTX huwa ta' sostenn għall-popolazzjoni ta' pazjenti fil-mira li kellhom rispons mhux adegwat, jew intolleranza għal DMARDs oħra (sezzjoni 4.1).
English: Malignancy
Maltese: Olumiant
English: Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib.
Maltese: Olumiant 2 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 2 mg baricitinib.
English: Olumiant 4 mg film-coated tablets Each film-coated tablet contains 4 mg baricitinib.
Maltese: Olumiant 4 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 4 mg baricitinib.
English: MTX-naïve1
Maltese: MTX1
English: In female rats there were decreased numbers of corpora lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine survival of the embryos.
Maltese: Fil-firien nisa kien hemm tnaqqis fl-għadd tal-corpora lutea u l-postijiet ta' implantazzjoni, żieda fit-telf qabel l-impjantazzjoni, u/jew effetti avversi fuq issopravivenza tal-embriji ġewwa l-utru.
English: Blood and lymphatic system disorders
Maltese: disturbi limfoproliferattivi.
English: The effect of Olumiant on progression of structural joint damage was evaluated radiographically in studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Maltese: L-effett ta' Olumiant fuq il-progressjoni ta' ħsara strutturali fil-ġog ġie evalwat b'mod radjugrafiku flistudji RA-BEGIN, RA-BEAM u RA-BUILD u stmat bl-użu tal-Punteġġ Totali modifikat ta' Sharp
English: In controlled studies, for up to 16 weeks, increases in platelet counts above 600 x 109 cells/L occurred in 2.0 % of patients treated with Olumiant 4 mg and 1.1 % of patients treated with placebo.
Maltese: Fi studji kkontrollati, sa 16-il ġimgħa, żidiet fl-għadd tal-plejtlets ta' aktar minn 600 x 109 ċelluli/L seħħew f'2.0% tal-pazjenti ttrattati b'Olumiant 4 mg u 1.1% tal-pazjenti ttrattati bi plaċebo.
English: Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in pain compared to all comparators (placebo, MTX, adalimumab), as measured on a 0-100 visual analogue scale, at 12 weeks.
Maltese: Trattment b'Olumiant 4 mg, waħdu jew flimkien ma' cDMARDs, wassal għal titjib sinifikanti fl uġigħ meta mqabbel mal-kumparaturi l-oħra kollha (plaċebo, MTX, adalimumab), imkejjel fuq skala analoga viżwali minn 0-100, fit-12-il ġimgħa.
English: Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins - If you notice any of the following serious side effects you need to tell a doctor straight away: - chest tightness - wheezing - severe dizziness or light-headedness - swelling of the lips, tongue or throat - hives (itching or skin rash)
Maltese: Minħabba li ma kien hemm l-ebda effetti fuq l-iskopijiet finali tal-ispermatoġenesi (stmat permezz ta' istopatoloġija) jew tas-semen/tal-isperma fil-firien irġiel, ittnaqqis fit-twettiq totali ta' tgħammir x'aktarx kien riżultat ta' dawn l-effetti fin-nisa.
English: • Fever, wounds, feeling more tired than usual, or dental problems.
Maltese: • Deni, feriti, tħossok aktar għajjien/a mis soltu, jew problemi fis-snien.
English: Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Week 52 25 % 42 %*** 46 %***
Maltese: Ġimgħa 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Ġimgħa 24 21 % 42 %*** 40 %*** 8 % 30 %***†
English: No relevant differences regarding efficacy and safety were observed in subgroups defined by types of concomitant DMARDs used in combination with baricitinib.
Maltese: Ma kienu osservati l-ebda differenzi rilevanti dwar l-effikaċja u s-sigurtà f'sottogruppi ddefiniti bit-tipi ta' DMARDs użati flimkien ma' baricitinib.
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with Olumiant 4 mg compared to placebo at weeks 24 and 52.
Maltese: Il-proporzjon ta' pazjenti mingħajr l-ebda progressjoni radjugrafika (bidla ta' ≤ 0 fl-mTSS) kienet ogħla b'mod sinifikanti b'Olumiant 4 mg meta mqabbel mal-plaċebo fil-ġimgħat 24 u 52.
English: Olumiant is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Maltese: Olumiant mhuwiex irrakkomandat biex jintuża f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
English: Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis (see section 5.3).
Maltese: Studji fl-annimali jissuġġerixxu li t-trattament b'baricitinib għandu l-possibbiltà li jnaqqas il-fertilità fin-nisa waqt li jkunu fuq it-trattament, iżda ma kien hemm l-ebda effett fuq l-ispermatoġenesi fl-irġiel (ara sezzjoni 5.3).
English: You should not be given certain (live) vaccines while using Olumiant - have cancer, because your doctor will have to decide if you can still be given Olumiant - have poor liver function - have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism).
Maltese: - għandek kanċer, minħabba li t-tabib se jkollu jiddeċiedi jekk inti tistax xorta tingħata Olumiant - għandek funzjoni dgħajfa tal-fwied - preċedentement kellek tgħaqqid tad-demm fil-vini ta' saqajk (trombożi fil-vini tal-fond) jew fil pulmun (emboliżmu pulmonari).
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: Istudju (t
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1. Tqala (ara sezzjoni 4.6).
English: NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg tablets baricitinib
Maltese: Kull pillola fiha 2 mg baricitinib
English: Moreover, recurrent DVT and subsequent PE observed September 2018 in patient who continued treatment with baricitinib after the first DVT also confirm possible relationship between use of baricitinib and occurrence of VTE.
Maltese: Barra minn hekk, DVT rikorrenti u s-susussegwenti PE osservati f'Settembru 2018 f'pazjenti li baqgħu bit-trattament ta' baricitinib wara l-ewwel DVT ukoll jikkonfermaw il-possibbiltà ta' relazzjoni bejn l-użu ta' baricitinib u l-okkorenza ta' VTE.
English: Tablet cores
Maltese: Tumuri malinni
English: There was no change in the LDL/HDL ratio.
Maltese: Ma kien hemm l-ebda bidla fil proporzjon ta' LDL/HDL.
English: In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.
Maltese: Għat-tilqim bil-vaċċin tat-tetnu, inkiseb rispons immunitarju IgG sodisfaċenti f'43.1 % (95 % CI: 34.0 %, 52.8 %) tal-pazjenti.
English: • Primary endpoint: ACR20 at week 24
Maltese: ACR20 f'ġimgħa 24
English: In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F).
Maltese: Kroniku (FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue score).
English: The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106 RA patients under stable treatment with baricitinib 2 or 4 mg, receiving inactivated pneumococcal or tetanus vaccination.
Maltese: L-influwenza ta' baricitinib fuq ir-rispons umorali għat-tilqim b'vaċċini mhux ħajjin ġie evalwat f'106 pazjenti b'RA taħt trattament stabbli b'baricitinib 2 jew 4 mg, li kienu qed jirċievu tilqim b'vaċċin inattivat tal-pnewmokokku jew tat-tetnu.
English: Administration of baricitinib resulted in a dose dependent inhibition of IL-6 induced STAT3 phosphorylation in whole blood from healthy subjects with maximal inhibition observed 2 hours after dosing which returned to near baseline by 24 hours.
Maltese: rutina tal-pazjent u tiġi ssuspettata ħsara fil-fwied ikkaġunata mill-mediċina, Olumiant għandu jitwaqqaf b'mod temporanju sakemm tiġi eskluża din id-dijanjosi.
English: The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see section 4.5).
Maltese: Trasportatur 3 tal-Anjoni Organiċi (OAT3, Organic Anion Transporter 3) bil-possibbiltà ta'
English: The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis.
Maltese: Ir-risku ta' tumuri malinni inkluż limfoma tiżdied f'pazjenti b'artrite rewmatojd.
English: In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.
Maltese: Fi studji farmakoloġiċi kliniċi, l-għoti ta' baricitinib flimkien ma' ketoconazole (inibitur qawwi ta' CYP3A) ma' wassal għall-ebda effett ta' sinifikat kliniku fuq il-PK ta' baricitinib.
English: Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Maltese: Trattament b'Olumiant 4 mg wassal għal inibizzjoni sinifikanti b'mod statistiku fil-progressjoni ta'
English: EMA/724832/2014 EMEA/H/C/003821
Maltese: EMEA/H/C/003821
English: Ofev is available as capsules (100 and 150 mg).
Maltese: Ofev huwa disponibbli bħala (100 u 150 mg).
English: Ofev contains the active substance nintedanib.
Maltese: Ofev fih is-sustanza attiva nintedanib.
English: The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml).
Maltese: L-FVC medja tal-pazjenti qabel il-kura kien bejn 2600 u 2700 millilitru (ml).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Ofev.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ofev.
English: The full EPAR and risk management plan summary for Ofev 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 Ofev
Maltese: Informazzjoni oħra dwar Ofev
English: The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Maltese: Is-sustanza attiva f'Ofev, in-nintedanib, timblokka l-attività ta' xi enzimi magħrufin bħala tyrosine kinases.
English: Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF).
Maltese: Ofev huwa mediċina li tintuża għall-kura ta' adulti b'fibrożi pulmonari idjopatika (IPF).
English: Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF.
Maltese: Ofev tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew total ta' 1,066 pazjenti b'IPF.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ofev fil-15 ta' Jannar 2015.
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Ofev was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 April 2013.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn IPF huwa baxx, il-marda hija kkunsidrata ‘rari', u Ofev ġie kklassifikat bħala ”mediċina orfni” (mediċina li tintuża f'mard rari) fis-26 ta' April 2013.
English: In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo.
Maltese: Fit-tieni studju, it-tnaqqis medju kien ta' 114 ml għal Ofev meta mqabbel ma' 207 ml għallplaċebo.
English: What are the risks associated with Ofev?
Maltese: X'inhuma r-riskji assoċjati ma' Ofev?
English: Why is Ofev approved?
Maltese: Għaliex ġie approvat Ofev?
English: In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo.
Maltese: Fl-ewwel studju, it-tnaqqis medju fl-FVC f'sena kien 115 ml f'pazjenti li kienu qed jieħdu Ofev meta mqabbel ma' tnaqqis ta' 240 ml f'pazjenti li kienu qed jieħdu plaċebo.
English: The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common.
Maltese: L-effetti sekondarji l-aktar komuni b'Ofev (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea, dardir (tħossok ma tiflaħx), uġigħ addominali (uġigħ fl-istonku) u livelli elevati ta' enzimi tal-fwied fid-demm (sinjal ta' problemi tal-fwied); rimettar, nuqqas ta' aptit u telf ta' piż huma wkoll komuni.
English: These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue seen in IPF.
Maltese: Dawn l-enzimi huma preżenti f'ċerti riċetturi (bħal riċetturi VEGF, FGF u PDGF) f'ċelloli filpulmun, fejn jattivaw diversi proċessi involuti fil-ġenerazzjoni ta' tessut fibruż li jidher f'IPF.
English: By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse.
Maltese: Billi jimblokka dawn l-enzimi, nintedanib jgħin sabiex inaqqas il-formazzjoni ta' tessut fibruż fil-pulmun, b'hekk jipprevjeni milli jiggravaw is-sintomi ta' IPF.
English: How is Ofev used?
Maltese: Ofev?
English: A risk management plan has been developed to ensure that Ofev is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ofev jintuża bl-aktar mod sigur possibbli.
English: For the full list of all side effects reported with Ofev, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ofev, ara l-fuljett ta' tagħrif.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ofev's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ofev huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Maltese: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Il-Kroazja
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone)
Maltese: Urikosuriċi (benzbromarone, probenecid, sulfinpyrazone)
English: Do not store above 25°C.
Maltese: Aħżen f'temperatura inqas minn 25°C.
English: See section 4. .
Maltese: Ara sezzjoni 4.
English: 305, Opava - Komárov,
Maltese: Ostravská 29, č.p. 305, Opava - Komárov,
English: System Organ Class
Maltese: Klassifika talOrgani
English: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Il-Ġermanja
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Twaqqfu avvenimenti kardjovaskulari ġodda (punt primarju ta' tmien), bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI:-26.9, 26.7), 6% (CI:-33.5, 34.3) u 14% (CI:-31.6, 44.2), waqt l-intervalli ta' studju ta' 0-1, 1-3, 3-6, 6-9 u 9-12-il xhar, rispettivament.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren-Weiler Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3 D-89143 Blaubeuren-Weiler Il-Ġermanja
English: Teva Operations Poland Sp. z.o.o.
Maltese: Teva Operations Poland Sp. z.o.o. ul.
English: Aluminium + Dessicant - Aluminium blisters.
Maltese: Aluminju + Dessikant - Folji tal-aluminju.
English: East Sussex, BN22 9AG United Kingdom
Maltese: East Sussex, BN22 9AG Ir-Renju Unit
English: • Severe renal impairment.
Maltese: • Indeboliment renali sever.
English: Doses of 100-500 mg/day:
Maltese: Dożi ta' 100-500 mg/kuljum:
English: Titanium dioxide (E171) Quinoline yellow aluminium lake (E104) Talc
Maltese: Titanium dioxide (E171) Quinoline yellow aluminium lake (E104)
English: Pack sizes of 10, 14, 28, 30, 50, 90 and 100 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 10, 14, 28, 30, 50, 90 u 100 pillola miksijin b'rita.
English: Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol.
Maltese: Prodotti mediċinali li jinibixxu CYP2C19 jinkludu omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine u chloramphenicol.
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Maltese: • Fsada patoloġika attiva bħal ulċera peptika jew emorraġija intrakranjali.
English: The tablets have a length of 14.0 mm and a width of 6.8 mm.
Maltese: Il-pilloli huma twal 14.0 mm u wisgħin 6.8 mm.
English: The use of clopidogrel in CURE was associated with a decrease in the need for thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Maltese: L-użu ta' clopidogrel fi CURE kien assoċjat mat-tnaqqis fil-bżonn ta' kura trombolitika (TRR =43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (TRR = 18.2%; CI: 6.5%, 28.
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Maltese: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), u ACTIVE-A (n=601), kif ukoll numru ta' studji ko-orti ppubblikat.
English: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
Maltese: - tossiċità kardjopulmonarja ( għeluq prematur tad-ductus arteriosus u ipertensjoni
English: The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Maltese: Il-prova CLARITY inkludiet 3,491 pazjenti li ppreżentaw fi żmien 12-il siegħa mill-bidu ta' infart mijokardijaku b'ST elevat, fejn kien ippjanat li tingħata t-terapija trombolitika.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tagħhom hija definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Maltese: F'konċentrazzjonijiet baxxi (<100 mikrogrammi/ml), kważi 90 % ta' salicylic acid huwa marbut mal-albumina.
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: In vitro, clopidogrel u l-metabolit (inattiv) prinċipali li qed jiċċirkola jintrabtu b'mod riversibbli malproteini fil-plażma uman (98 % u 94 % rispettivament).
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASA-related GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Maltese: Disturbi gastro-intestinali tan-naħa ta' fuq tal-imsaren (esofaġite, ulċerazzjoni esofaġeali, perforazzjoni,gastrite erosiva, dwodenite erosiva, ulċera/perforazzjoni gastro-dwodenali*, disturbi gastro-intestinali tan-naħa t'isfel tal-imsaren (ulċeri tal-intestin iż-żgħir [ġeġunu u ilju] u l-kbir [kolon u rettu] kolite u perforazzjoni intestinali)*; sintomi gastriċi u tan-naħa ta' fuq tal-imsaren* bħal gastralġja (ara sezzjoni 4.4); dawn ir-reazzjonijiet gastro-intestinali relatati ma' ASA jistgħu jew jistgħu ma jkunux assoċjati ma' emorraġija u jistgħu jseħħu bi kwalunkwe doża ta' acetylsalicylic acid u kemm f'pazjenti b'sintomi ta' twissija jew mingħajr u kemm f'pazjenti li m'għandhomx passat mediku ta' avvenimenti gastro-intestinali serji*.