FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/15/1083/001 EU/1/15/1083/002 EU/1/15/1083/003 EU/1/15/1083/004 EU/1/15/1083/005 EU/1/15/1083/006 EU/1/15/1083/007 EU/1/15/1083/008 EU/1/15/1083/009 EU/1/15/1083/010 EU/1/15/1083/011
Maltese: EU/1/15/1083/006 EU/1/15/1083/007 EU/1/15/1083/008 EU/1/15/1083/009 EU/1/15/1083/010
English: Prostanoid initiation or oxygen therapy b c n (%)
Maltese: Prostanoid i.v./s.c. jew ta' terapija bl ossiġnu b ċ n (%)
English: Inhibitors of CYP2C8
Maltese: Inibituri ta' CYP2C8
English: Disease progression b n (%)
Maltese: Progressjoni talmarda b n (%)
English: Page 8
Maltese: Paġna 8
English: Selexipag is an inhibitor of platelet aggregation in vitro.
Maltese: Selexipag huwa inibitur tal-aggregazzjoni tal-plejtlits in vitro.
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Maltese: Paġna 35
English: Page 20
Maltese: Paġna 20
English: Selexipag is hydrolysed to its active metabolite by carboxylesterases (see section 5.2).
Maltese: Selexipag huwa idrolizzat għall-metabolit attiv tiegħu permezz ta' carboxylesterases (ara sezzjoni 5.2).
English: • The move to the maintenance dose (titration phase);
Maltese: • It-tranżizzjoni għal doża ta' manteniment (fażi ta' titrazzjoni);
English: 7.5% of patients on selexipag discontinued treatment due to these adverse reactions.
Maltese: 7.5% tal-pazjenti fuq selexipag waqqfu t-trattament minħabba dawn ir-reazzjonijiet avversi.
English: How should you take Uptravi?
Maltese: Meta għandek tnaqqas id-doża?
English: Page 38
Maltese: Paġna 38
English: Death due to PAH as a component of the endpoint was observed in 16 (2.8%) patients on selexipag and 14 (2.4%) on placebo.
Maltese: Mewt ikkawżat minn PAH bħala komponent tal-punt finali kien osservat f'16 (2.8%)-il pazjent fuq selexipag u 14 (2.4%) fuq plaċebo.
English: The percentages of patients with an event at Month 36 were 28.9% and 41.3% in the selexipag and placebo groups, respectively, with an absolute risk reduction of 12.4%.
Maltese: Il-persentaġġ ta' pazjenti b'avveniment f'Xahar 36 kien ta' 28.9% u 41.3% fil-gruppi ta' selexipag u plaċebo, rispettivament, bi tnaqqis assolut fir-riskju ta' 12.4%.
English: • Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil; see section 4.5).
Maltese: • Użu fl-istess waqt ta' inibituri qawwija ta' CYP2C8 (eż., gemfibrozil; ara sezzjoni 4.5).
English: Selexipag and the active metabolite are high-affinity IP receptor agonists with a high selectivity for the IP receptor versus other prostanoid receptors (EP1-EP4, DP, FP, and TP).
Maltese: Selexipag u l-metabolit attiv huma agonisti tar-riċettur ta' IP b'affinità għolja b'selettività għolja għar-riċettur IP kontra riċetturi prostanojdi oħra (EP1-EP4, DP, FP, u TP).
English: Page 5
Maltese: Paġna 5
English: Page 39
Maltese: Paġna 39
English: Page 25
Maltese: Paġna 25
English: Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively.
Maltese: Varjabilità bejn individwu u ieħor fl-esponiment kienet ta' 24% u 19% għal selexipag u l-metabolit attiv, rispettivament.
English: System organ class
Maltese: Klassi tas-sistemi u tal-organi
English: The absolute bioavailability of selexipag in humans is approximately 49%.
Maltese: Il-bijodisponibilità assoluta ta' selexipag fil-bnedmin hi madwar 49%.
English: Patients titrating selexipag to an individually tolerated dose (200 micrograms twice daily increments up to 800 micrograms twice daily; N = 33) achieved a statistically significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI]: −44.7%, −12.2%; p = 0.0045) and an increase in cardiac index (mean treatment effect) of 0.48 L/min/m2 (95% CI: 0.13, 0.83) compared to placebo (N = 10).
Maltese: kisbu tnaqqis medju statistikament sinifikanti fir-reżistenza vaskulari pulmonari ta' 30.3% (intervall ta' kunfidenza [CI - confidence interval] ta' 95%: −44.7%, −12.2%; p = 0.0045) u żieda fl-indiċi kardijaku (effett medju tat-trattament) ta' 0.48 L/min/m2 (CI ta' 95%: 0.13, 0.83) meta mqabbel mal-plaċebo (N = 10).
English: Page 40
Maltese: Paġna 40
English: Pulmonary veno-occlusive disease
Maltese: Marda veno-okklussiva tal-pulmun
English: Page 18
Maltese: Paġna 18
English: Page 30
Maltese: Paġna 30
English: 60 or 140 film-coated tablets Titration pack
Maltese: 60 jew 140 pillola miksija b'rita Pakkett ta' titrazzjoni
English: Page 28
Maltese: Paġna 28
English: Page 9
Maltese: Paġna 9
English: Selexipag did not influence the pharmacodynamic effect of warfarin on the international normalised ratio.
Maltese: Selexipag ma influwenzax l-effett farmakodinamiku ta' warfarin fuq il-proporzjon normalizzat internazzjonali.
English: Hospitalisation for PAH was observed in 86 (15.0%) patients on selexipag and 123 (21.1%) patients on placebo.
Maltese: Dħul l-isptar minħabba PAH kien osservat f'86 (15.0%) pazjent fuq selexipag u 123 (21.1%) pazjent fuq plaċebo.
English: The observed effect of selexipag versus placebo on the primary endpoint was consistent across individualised maintenance dose as shown by the hazard ratio for the three pre-defined categories (0.60 for 200-400 micrograms twice daily, 0.53 for 600-1,000 micrograms twice daily, and 0.64 for 1,200-1,600 micrograms twice daily), which was consistent with the overall treatment effect (0.60).
Maltese: L-effett osservat ta' selexipag kontra l-plaċebo fuq il-punt finali primarju kien konsistenti matul id doża ta' manteniment individwalizzata kif muri mill-proporzjon ta' periklu għat-tliet kategoriji definiti minn qabel (0.60 għal 200-400 mikrogramma darbtejn kuljum, 0.53 għal 600-1,000 mikrogramma darbtejn kuljum, u 0.64 għall 1,200-1,600 mikrogramma darbtejn kuljum), li kien konsistenti maleffett globali tat-trattament (0.60).
English: Sinus tachycardia
Maltese: Takikardija tas-sinus
English: Page 26
Maltese: Paġna 26
English: Electrocardiogram investigations showed sinus tachycardia in 11.3% of patients in the selexipag group compared to 8.8% in the placebo group (see section 5.1).
Maltese: elettrokardjogramm urew takikardija tas-sinus fi 11.3% tal-pazjenti fil-grupp ta' selexipag meta mqabbel ma' 8.8% fil-grupp tal-plaċebo (ara sezzjoni 5.1).
English: Page 10
Maltese: Paġna 10
English: Page 33
Maltese: Paġna 33
English: Page 29
Maltese: Paġna 29
English: The total number of deaths of all causes up to study closure was 100 (17.4%) for the selexipag group and 105 (18.0%) for the placebo group (HR 0.97, 99% CI: 0.68, 1.39).
Maltese: In-numru totali ta' mwiet ta' kull kawża sal-għeluq tal-istudju kien 100 (17.4%) għall-grupp ta' selexipag u 105 (18.0%) għall-grupp tal-plaċebo (HR 0.97, CI ta' 99%: 0.68, 1.39).
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Maltese: Paġna 27
English: Pain-associated events have frequently been treated with analgesics (such as paracetamol).
Maltese: Avvenimenti assoċjati ma' uġigħ b'mod frekwenti kienu ttrattati b'analġeżiċi (bħal paracetamol).
English: In clinical practice, gastro-intestinal events have been observed to respond to anti-diarrhoeal, anti-emetic, and anti-nauseant medicinal products and/or medicinal products for functional gastro-intestinal disorders.
Maltese: Fil-prattika klinika, avvenimenti gastrointestinali kienu osservati li jirrispondu għal prodotti mediċinali kontra d-dijarea, kontra r-rimettar u kontra d-dardir u/jew prodotti mediċinali għal disturbi gastrointestinali funzjonali.
English: In a study in healthy subjects, selexipag (400 micrograms twice daily) did not alter the exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 20 mg warfarin.
Maltese: Fi studju f'individwi f'saħħithom, selexipag (400 mikrogramma darbtejn kuljum) ma biddilx l-esponiment għal S-warfarin (sottostrat ta' CYP2C9) jew għal R-warfarin (sottostrat ta' CYP3A4)
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Maltese: Paġna 15
English: Since a strong inhibitor of CYP3A4 did not affect the pharmacokinetics of the active metabolite, indicating that the CYP3A4 pathway is not important in the elimination of the active metabolite, no effect of inducers of CYP3A4 on the pharmacokinetics of the active metabolite is expected.
Maltese: Peress li inibitur qawwi ta' CYP3A4 ma affettwax il-farmakokinetika tal-metabolit attiv, li jindika li l-passaġġ ta' CYP3A4 mhux importanti fl-eliminazzjoni tal-metabolit attiv, mhux mistenni effett ta' indutturi ta' CYP3A4 fuq il-farmakokinetika tal-metabolit attiv.
English: Page 17
Maltese: Paġna 17
English: Page 34
Maltese: Paġna 34
English: Midazolam At steady state after up-titration to 1,600 μg selexipag twice a day, no clinically relevant change in exposure to midazolam, a sensitive intestinal and hepatic CYP3A4 substrate, or its metabolite, 1-hydroxymidazolam, was observed.
Maltese: Fi stat fiss wara titrazzjoni 'l fuq sa 1,600 μg ta' selexipag darbtejn kuljum, ma ġiet osservata l-ebda bidla klinikament rilevanti fl-esponiment għal midazolam, sottostrat sensittiv ta' CYP3A4 intestinali u epatiku, jew il-metabolit tiegħu, 1-hydroxymidazolam.
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Maltese: Paġna 12
English: • Cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
Maltese: • Avvenimenti ċerebrovaskulari (eż., attakk iskemiku temporanju, puplesija) fl-aħħar 3 xhur.
English: Page 7
Maltese: Paġna 7
English: Page 24
Maltese: Paġna 24
English: The effect of selexipag on progression of PAH was demonstrated in a multi-centre, long-term (maximum duration of exposure approximately 4.2 years), double-blind, placebo-controlled, parallel-group, event-driven Phase 3 study in 1,156 patients with symptomatic (WHO FC I-IV) PAH.
Maltese: L-effett ta' selexipag fuq il-progressjoni ta' PAH intwera fi studju ta' Fażi 3 b'aktar minn ċentru wieħed, fit-tul (tul massimu ta' esponiment ta' madwar 4.2 snin), double-blind, ikkontrollat bil-plaċebo, bi grupp parallel u mmexxi minn avvenimenti f'1,156 pazjent b'PAH sintomatika (WHO FC I-IV).
English: Page 23
Maltese: Paġna 23
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Maltese: Paġna 37
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Maltese: Paġna 31
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Maltese: Paġna 32
English: Uptravi 200 microgram film-coated tablets are supplied in blister packs of 10 or 60 tablets and 60 or 140 tablets (titration packs).
Maltese: Uptravi 200 mikrogramma pilloli miksija b'rita huma fornuti f'pakketti b'folji ta' 10 jew 60 pillola u 60 jew 140 pillola (pakketti ta' titrazzjoni).
English: UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite.
Maltese: UGT2B7 huma involuti fil-glukuronidazzjoni tal-metabolit attiv.
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Maltese: Paġna 16
English: The exposure to selexipag and its active metabolite is increased in subjects with moderate hepatic impairment (Child-Pugh class B; see section 5.2).
Maltese: L-esponiment għal selexipag u l metabolit attiv tiegħu jiżdied f'individwi b'indeboliment moderat tal-fwied (Child-Pugh klassi B; ara sezzjoni 5.2).
English: Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated (see section 4.3).
Maltese: L-għoti ta' Uptravi flimkien ma' inibituri qawwija ta' CYP2C8 (eż., gemfibrozil) huwa kontraindikat (ara sezzjoni 4.3).
English: Page 2
Maltese: Paġna 2
English: Selexipag prevents cardiac and pulmonary remodelling in a rat model of PAH and causes proportional decreases in pulmonary and peripheral pressures, indicating that peripheral vasodilation reflects pulmonary pharmacodynamic efficacy.
Maltese: Selexipag jipprevjeni mudellar mill-ġdid kardijaku u pulmonari fil-far bħala mudell ta' PAH u jikkawża tnaqqis proporzjonali fil-pressjoni pulmonari u periferali, li jindika li l-vażodilatazzjoni periferali tirrifletti l-effikaċja farmakodinamika pulmonari.
English: * See section Description of selected adverse reactions.
Maltese: * Ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: Page 6
Maltese: Paġna 6
English: Page 11
Maltese: Paġna 11
English: Page 36
Maltese: Paġna 36
English: The effect of strong inhibitors of UGT1A3 and UGT2B7 (valproic acid, probenecid, and fluconazole) on the exposure to selexipag and its active metabolite has not been studied.
Maltese: L-effett ta' inibituri qawwija ta' UGT1A3 u UGT2B7 (valproic acid, probenecid, u fluconazole) fuq l esponiment għal selexipag u għal metabolit attiv tiegħu ma ġiex studjat.
English: The glucuronidation of the active metabolite is catalysed by UGT1A3 and UGT2B7.
Maltese: Il-glukuronidazzjoni tal-metabolit attiv hija katalizzata minn UGT1A3 u UGT2B7.
English: Hypotension (see section 4.4)
Maltese: Pressjoni baxxa (ara sezzjoni 4.4)
English: Page 4
Maltese: Paġna 4
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Maltese: Paġna 22
English: Selexipag is a selective IP receptor agonist distinct from prostacyclin and its analogues.
Maltese: Selexipag huwa agonist selettiv tar-riċettur IP distint minn prostacyclin u l-analogi tiegħu.
English: The risk of an event for this endpoint was reduced by 30% in patients receiving selexipag compared to placebo (HR 0.70, 99% CI: 0.50, 0.98; one-sided log-rank p = 0.0031).
Maltese: Ir-riskju ta' avveniment għal dan il-punt finali naqas bi 30% f'pazjenti li rċevew selexipag meta mqabbla mal-plaċebo (HR 0.70, CI ta' 99%: 0.50, 0.98; p log-rank ta' naħa waħda = 0.0031).
English: Specific drug-drug interaction studies with hormonal contraceptives have not been conducted.
Maltese: Ma twettqux studji speċifiċi ta' interazzjoni bejn mediċina u oħra ma' kontraċettivi ormonali.
English: A potential pharmacokinetic interaction with strong inhibitors of UGT1A3 and UGT2B7 cannot be excluded.
Maltese: Ma tistax tiġi eskluża interazzjoni farmakokinetika potenzjali ma' inibituri qawwija ta' UGT1A3 u UGT2B7.
English: • The identification and maintenance of a list of all Uptravi prescribers;
Maltese: • L-identifikazzjoni u l-manteniment ta' lista tat-tobba kollha li jippreskrivu Uptravi;
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Maltese: Paġna 19
English: Page 13
Maltese: Paġna 13
English: Individualised dose titration
Maltese: Titrazzjoni tad-doża individwalizzata
English: Patients were randomised to either placebo (N = 582) or selexipag (N = 574) twice daily.
Maltese: Il-pazjenti kienu randomised biex jirċievu plaċebo (N = 582) jew selexipag (N = 574) darbtejn kuljum.
English: Selexipag reduced the risk of hospitalisation for PAH as a first outcome event compared to placebo (HR 0.67, 99% CI: 0.46, 0.98; one-sided log-rank p = 0.04).
Maltese: Selexipag naqqas ir-riskju ta' dħul l-isptar minħabba PAH bħala l-ewwel avveniment li rriżulta meta mqabbel malplaċebo (HR 0.67, CI ta' 99%: 0.46, 0.98; p log-rank ta' naħa waħda = 0.04).
English: They are usually transient or manageable with symptomatic treatment (see section 4.8).
Maltese: Normalment dawn ikunu temporanji jew maniġġabbli bi trattament sintomatiku (ara sezzjoni 4.8).
English: Page 14
Maltese: Paġna 14
English: • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Maltese: • Difetti konġenitali jew akkwistati tal-valvs b'disturbi fil-funzjoni mijokardijaka klinikament rilevanti mhux relatati ma' pressjoni pulmonari għolja.
English: The safety of selexipag has been evaluated in a long-term, Phase 3 placebo-controlled study enrolling 1,156 patients with symptomatic PAH.
Maltese: Is-sigurtà ta' selexipag ġiet evalwata fi studju fit-tul, ta' Fażi 3, ikkontrollat bil-plaċebo li fih kienu rreġistrati 1,156 pazjent b'PAH sintomatika.
English: Since selexipag did not affect the exposure to the CYP3A4 substrates midazolam and R-warfarin or to the CYP2C9 substrate S-warfarin, reduced efficacy of hormonal contraceptives is not expected.
Maltese: Peress li selexipag ma affettwax l-esponiment għas-sottostrati ta' CYP3A4 midazolam u R-warfarin jew għas sottostrat ta' CYP2C9 S-warfarin, mhux mistennija effikaċja mnaqqsa ta' kontraċettivi ormonali.
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Maltese: Paġna 21
English: Selexipag was not teratogenic in rats and rabbits (exposure margins above therapeutic exposure of 13-fold for selexipag and 43-fold for the active metabolite, based on total exposure).
Maltese: Selexipag ma kienx teratoġeniku fil-firien u l-fniek (marġini ta' esponiment 'il fuq mill-esponiment terapewtiku ta' 13-il darba għal selexipag u 43 darba għall-metabolit attiv, ibbażat fuq esponiment totali).
English: Treatment with selexipag 200-1,600 micrograms twice daily resulted in a 40% reduction (hazard ratio [HR] 0.60; 99% CI: 0.46, 0.78; one-sided log-rank p value < 0.0001) of the occurrence of morbidity or mortality events up to 7 days after last dose compared to placebo (Figure 1).
Maltese: (proporzjon ta' periklu [HR - hazard ratio] ta' 0.60; CI ta' 99%: 0.46, 0.78; valur p log-rank fuq naħa waħda < 0.0001) fl-okkorrenza ta' avvenimenti ta' morbidità jew mortalità sa 7 ijiem wara l-aħħar doża meta mqabbel mal-plaċebo (Figura 1).
English: iron oxide red (E172), iron oxide black (E172), carnauba wax.
Maltese: iron oxide iswed (E172), carnauba wax.
English: Quality of life was assessed in a subset of patients in the GRIPHON study using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire.
Maltese: Il-kwalità tal-ħajja kienet evalwata f'sottogrupp ta' pazjenti fl-istudju GRIPHON bl-użu talkwestjonarju ta' Analiżi tar-Riżultat ta' Pressjoni Pulmonari Għolja ta' Cambridge (CAMPHORCambridge Pulmonary Hypertension Outcome Review).
English: Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein bound.
Maltese: Dijalisi mhux probabbli li tkun effettiva peress li selexipag u l-metabolit attiv tiegħu huma marbuta ħafna mal-proteini.
English: Page 3
Maltese: Paġna 3
English: A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.6% of selexipag-treated patients and 5.0% of placebo-treated patients.
Maltese: Tnaqqis mil-linja bażi fil-konċentrazzjoni tal-emoglobina għal inqas minn 10 g/dL kien irrappurtat fi 8.6% tal-pazjenti ttrattati b'selexipag u f'5.0% tal-pazjenti ttrattati bil-plaċebo.
English: 23% of patients on selexipag achieved maintenance doses in the range of 200-400 micrograms, 31% achieved doses in the range of 600-1,000 micrograms, and 43% achieved doses in the range of 1,200-1,600 micrograms.
Maltese: 70.7 ġimgħat għall-grupp ta' selexipag. 23% tal-pazjenti fuq selexipag kisbu dożi ta' manteniment fil firxa ta' 200-400 mikrogramma, 31% kisbu dożi fil-firxa ta' 600-1,000 mikrogramma, u 43% kisbu dożi fil-firxa ta' 1,200-1,600 mikrogramma.
English: Hyperthyroidism Thyroid-stimulating Hormone decreased (see section 4.4)
Maltese: Tnaqqis fl-ormon li jistimula t-tirojde (ara sezzjoni 4.4)
English: This dose will be your maintenance dose.
Maltese: Din tissejjaħ doża ta' manteniment.
English: Individualised maintenance dose
Maltese: Doża ta' manteniment individwalizzata
English: Selexipag and its active metabolite are substrates of OATP1B1 and OATP1B3.
Maltese: OATP1B1 u OATP1B3.
English: • Lay language version of the healthcare professional A4 laminated titration guide;
Maltese: • Linja gwida dwar it-titrazzjoni fuq karta A4 laminata għall-professjonisti fil-kura tas-saħħa;
English: Selexipag is hydrolysed by carboxylesterases to yield its active metabolite, which is approximately 37-fold more potent than selexipag.
Maltese: Selexipag huwa idrolizzat minn carboxylesterases biex jipproduċi l-metabolit attiv tiegħu, li hu madwar 37 darba aktar potenti minn selexipag.
English: (a) % of patients with an event at 36 months = 100 × (1 - Kaplan-Meier estimate); hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value (b) % of patients with an event as part of the primary endpoint up to EOT + 7 days; hazard ratio estimated using Aalen Johansen method; 2-sided p-value using Gray's test (c) Includes ‘Need for lung transplantation or atrial septostomy' (1 patient on selexipag and 2 on placebo) (d) % of patients with an event up to EOT + 7 days or up to study closure; hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value
Maltese: (a) % ta' pazjenti b'avveniment wara 36 xahar = 100 × (1 - stima Kaplan-Meier); proporzjon ta' periklu stmat bl-użu tal-mudell ta' periklu proporzjonali ta' Cox; valur p log-rank mhux stratifikat ta' naħa waħda
English: Contents of the package and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In Phase 1 and 2 studies a slight decrease in plasma levels of von Willebrand factor (vWF) was observed with selexipag; the vWF values remained above the lower limit of the normal range.
Maltese: Fi studji ta' Fażi 1 u 2 kien osservat tnaqqis żgħir fil-livelli tal-fattur von Willebrand (vWF - von Willebrand factor) fil-plażma b'selexipag; il-valuri ta' vWF baqgħu ogħla mil-limitu l-baxx tal-firxa normali.
English: Uptravi should not be administered in patients with severe liver impairment (Child-Pugh class C; see section 4.4).
Maltese: Uptravi m'għandux jingħata lill-pazjenti b'indeboliment sever tal-fwied (Child-Pugh klassi Ċ; ara sezzjoni 4.4).
English: Selectivity against EP1, EP3, FP, and TP is important because these are well-described contractile receptors in the gastro-intestinal tract and blood vessels.
Maltese: Is-selettività kontra EP1, EP3, FP, u TP hija importanti minħabba li dawn huma riċetturi li jinġibdu u jiċkienu deskritti sew fl-apparat gastrointestinali u fil-kanali tad-demm.
English: Hospitalisation due to PAH b n (%)
Maltese: Avveniment ta' morbiditàmortalità a Dħul l-isptar minħabba PAH b n (%)
English: The active metabolite is a weak substrate of the breast cancer resistance protein (BCRP).
Maltese: Il-metabolit attiv huwa sottostrat dgħajjef tal-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: Diarrhoea* Vomiting * Nausea*
Maltese: Dijarea* Rimettar* Dardir*
English: Concomitant administration of Uptravi with clopidogrel (loading dose of 300 mg or maintenance dose of 75 mg once a day), a moderate inhibitor of CYP2C8, had no relevant effect on the exposure to selexipag but increased the exposure to the active metabolite approximately 2.2 and 2.7-fold following loading dose and maintenance dose, respectively.
Maltese: manteniment ta' 75 mg darba kuljum), inibitur moderat ta' CYP2C8, ma kellu l-ebda effett rilevanti fuq l-esponiment għal selexipag iżda żied l-esponiment għall-metabolit attiv madwar 2.2 u 2.7 drabi aktar wara d-doża qawwija tal-bidu u d-doża tal-manteniment, rispettivament.
English: Headache*
Maltese: - Uġigħ
English: There are no clinical data available.
Maltese: Fertilità M'hemmx dejta klinika disponibbli.
English: In the presence of 600 mg rifampicin, once a day, an inducer of CYP2C8 (and UGT enzymes), the exposure to selexipag did not change, whereas exposure to the active metabolite was reduced by half.
Maltese: Fil-preżenza ta' 600 mg rifampicin, darba kuljum, induttur ta' CYP2C8 (u enzimi UGT), l-esponiment għal selexipag ma nbidilx, filwaqt li l-esponiment għall-metabolit attiv tiegħu naqas bin-nofs.
English: Pharmacist's telephone:
Maltese: Telefon tal-ispiżjar:
English: Uptravi 200 microgram Uptravi 400 microgram Uptravi 600 microgram Uptravi 800 microgram Uptravi 1,000 microgram Uptravi 1,200 microgram Uptravi 1,400 microgram Uptravi 1,600 microgram
Maltese: Uptravi 200 mikrogramma Uptravi 400 mikrogramma Uptravi 600 mikrogramma Uptravi 800 mikrogramma Uptravi 1,000 mikrogramma Uptravi 1,200 mikrogramma Uptravi 1,400 mikrogramma Uptravi 1,600 mikrogramma
English: Anaemia Haemoglobin decreased
Maltese: Anemija Tnaqqis fl-emoglobina
English: Cartons of 10 or 60 film-coated tablets, and 60 or 140 film-coated tablets (titration packs).
Maltese: Kaxxi tal-kartun ta' 10 jew 60 pillola miksija b'rita, u 60 jew 140 pillola miksija b'rita (pakketti ta' titrazzjoni).
English: TITRATION GUIDE - TITRATION PACK Page 1
Maltese: GWIDA GĦAT-TITRAZZJONI - PAKKETT GĦAT-TITRAZZJONI
English: For a full description of Uptravi tablets, including colours and marking, please see section 6 of this leaflet.
Maltese: Għal deskrizzjoni sħiħa tal-pilloli Uptravi, inkluż kuluri u marki, jekk jogħġbok ara s-sezzjoni 6 ta'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TITRATION PACK
Maltese: KARTUNA TA' BARRA - PAKKETT TA' TITRAZZJONI
English: The pharmacokinetics of selexipag and its active metabolite are not affected by warfarin.
Maltese: Il-farmakokinetika ta' selexipag u tal-metabolit attiv tiegħu mhix affettwata minn warfarin.