FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of Adempas in patients with CTEPH and PAH appeared to be similar, therefore adverse reactions identified from placebo controlled 12 and 16 weeks clinical studies are presented as pooled frequency in the table listed below (see table 1).
Maltese: Il-profil tas-sigurtà ta' Adempas f'pazjenti b'CTEPH u PAH deher li kien simili, u għalhekk reazzjonijiet avversi identifikati minn studji kliniċi kkontrollati bi plaċebo li damu 12 u 16-il ġimgħa huma ppreżentati bħala frekwenza miġbura fit-tabella elenkata hawn taħt (ara tabella 1).
English: MSD Polska Sp.z o.o.
Maltese: MSD Α.Φ.Β.Ε.Ε
English: FC II patient population
Maltese: Pazjenti b'FC II
English: Patients with moderate hepatic impairment (Child Pugh B) showed a higher exposure to this medicinal product (see section 5.2).
Maltese: Pazjenti b'indeboliment moderat talfwied (Child Pugh B) urew esponiment ogħla għal dan il-prodott mediċinali (ara sezzjoni 5.2).
English: Pulmonary arterial hypertension (PAH)
Maltese: Pressjoni għolja fl-arterji tal-pulmun (PAH - Pulmonary arterial hypertension)
English: Placebo (n=82)
Maltese: Plaċebo (n=82)
English: In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg three times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive haemodynamic effects.
Maltese: Fi studju esploratorju dwar l-interazzjonijiet f'7 pazjenti b'PAH fuq kura stabbli b'sildenafil (20 mg tliet darbiet kuljum) dożi waħedhom ta' riociguat (0.5 mg u 1 mg sekwenzjalment) urew effetti emodinamiċi addittivi.
English: Stable
Maltese: Stabbli
English: In a clinical study the highest dose of Adempas (2.5 mg tablets three times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake.
Maltese: Fi studju kliniku, l-ogħla doża ta' Adempas (pilloli ta' 2.5 mg tliet darbiet kuljum) saħħet l-effett ta' nitroglycerin taħt l-ilsien (0.4 mg) meħud 4 u 8 sigħat wara t-teħid, li jnaqqas il-pressjoni.
English: When initiating Adempas in patients on stable doses of strong multi pathway CYP and P-gp/BCRP inhibitors, such as azole antimycotics (e.g. ketoconazole, posaconazole, itraconazole) or HIV protease inhibitors (e.g. ritonavir), consider a starting dose of 0.5 mg, three times a day to mitigate the risk of hypotension.
Maltese: Meta jinbeda Adempas f'pazjenti fuq dożi stabbli ta' inibituri qawwija ta' passaġġi multipli ta' CYP u P-gp/BCRP, bħall-antimikotiċi azole (eż. ketoconazole, posaconazole, itraconazole) jew inibituri talprotease tal-HIV (eż. ritonavir), ikkunsidra doża tal-bidu ta' 0.5 mg, tliet darbiet kuljum biex jitnaqqas ir-riskju ta' pressjoni baxxa.
English: Placebo (n=73)
Maltese: Plaċebo (n=73)
English: Table 5: Effects of riociguat in PATENT-1 on PVR and NT-proBNP at last visit PVR
Maltese: Effetti ta' riociguat f'PATENT-1 fuq PVR, NT-proBNP fl-aħħar vista
English: Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.
Maltese: Madwar 9-44% tad-doża mogħtija instabet bħala riociguat mhux mibdul flippurgar.
English: These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Maltese: Dawn ir-riżultati kienu konformi ma' titjib fil-parametri emodinamiċi addizzjonali (ara tabella 5).
English: Concomitant use with other CYP and P-gp/BCRP inhibitors
Maltese: P-gp/BCRP).
English: Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
Maltese: Dħul l-isptar minħabba PH Tnaqqis f'6MWD minħabba PH Aggravar persistenti tal-Klassi Funzjonali minħabba PH Bidu ta' kura ġdida minħabba PH
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early due to an increased risk of mortality and serious adverse events in patients treated with riociguat and a lack of efficacy.
Maltese: Studju randomizzat, double blind, ikkontrollat bi plaċebo tal-fażi II (RISE-IIP) sabiex jevalwa leffikaċja u s-sigurtà ta' riociguat f'pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (PH-IIP) twaqqaf kmieni minħabba żieda fir-riskju ta' mortalità u ta' avvenimenti avversi serji f'pazjenti ttrattati b'riociguat u nuqqas ta' effikaċja.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Maltese: Ma twettqux studji biex jinvestigaw il-farmakokinetika ta' riociguat f'pazjenti pedjatriċi.
English: Strong CYP1A1 inhibitors should be used with caution (see section 4.4).
Maltese: Inibituri qawwija ta' CYP1A1 għandhom jintużaw b'attenzjoni (ara sezzjoni 4.4).
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Maltese: Vasodilataturi pulmonari jistgħu jaggravaw b'mod sinifikanti l-istat kardjovaskulari ta' pazjenti b'mard venookklużiv tal-pulmun (PVOD - pulmonary veno-occlusive disease).
English: To mitigate the risk of hypotension when Adempas is initiated in patients on stable doses of strong multi pathway CYP (especially CYP1A1 and CYP3A4) and P-gp/BCRP inhibitors, e.g. ketoconazole, posaconazole or itraconazole consider a reduced starting dose.
Maltese: Biex jittaffa r-riskju ta' pressjoni baxxa meta Adempas jinbeda f'pazjenti fuq dożi stabbli inibituri qawwija ta' passaġġi multipli ta' CYP (speċjalment CYP1A1 u CYP3A4) u P-gp/BCRP, eż. ketoconazole, posaconazole jew itraconazole ikkunsidra doża tal-bidu mnaqqsa.
English: Serious haemoptysis occurred in 1% (5/490) patients taking riociguat compared to 0/214 patients taking placebo, including one event with fatal outcome.
Maltese: Emoptisi serja seħħet f'1% (5/490) tal-pazjenti li kienu qed jieħdu riociguat meta mqabbla ma' 0/214-il pazjent li kienu qed jieħdu plaċebo, inkluż avveniment wieħed b'riżultat fatali.
English: Placebo (n=68)
Maltese: Plaċebo (n=68)
English: Patients with any clinical worsening Death
Maltese: Pazjenti bi kwalunkwe aggravar kliniku
English: Placebo (n=87)
Maltese: Plaċebo (n=87)
English: CYP1A1 catalyses the formation of riociguat's main metabolite in liver and lungs and is known to be inducible by polycyclic aromatic hydrocarbons, which, for example, are present in cigarette smoke.
Maltese: CYP1A1 jikkatalizza l-formazzjoni tal-metabolit ewlieni ta' riociguat fil-fwied u fil-pulmun u hu magħruf li huwa indott minn hydrocarbons aromatiċi poliċikliċi, li, pereżempju, jinsabu fid-duħħan tas-sigaretti.
English: Placebo (n=88)
Maltese: Plaċebo (n=88)
English: Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported.
Maltese: Kienu rrappurtati dożi eċċessivi aċċidentali b'dożi totali ta' kuljum ta' 9 sa 25 mg ta' riociguat bejn jumejn sa 32 jum.
English: - if you have severe liver problems (severe hepatic impairment, Child Pugh C).
Maltese: - jekk għandek problemi severi tal-fwied (indeboliment sever tal-fwied, Child Pugh Ċ).
English: Changes from baseline suggested beneficial effects in selected patients, e.g. improvement in 6MWD (+31m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels (-347 pg/mL) and WHO FC I/II/III/IV,% (2/52/46/0), cardiac index (+0.3 L/min/m2).
Maltese: Bidliet mil-linja bażi jissuġġerixxu effetti ta' benefiċċju f'pazjenti magħżula, eż. titjib f'6MWD (+31m), fil-livelli tal-N-terminal prohormone tal-peptide natriuretiku talmoħħ (NT-proBNP - N-terminal prohormone of brain natriuretic peptide)
English: Elderly patients (65 years or older) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 40% higher in elderly, mainly due to reduced (apparent) total and renal clearance.
Maltese: Pazjenti anzjani (65 sena jew aktar) urew konċentrazzjonijiet ogħla fil-plażma minn pazjenti iżgħar, b'valuri medji tal-AUC li kienu madwar 40% ogħla fl-anzjani, l-aktar minħabba tnaqqis (apparenti) fit-tneħħija totali u mill-kliewi.
English: Concomitant administration of HAART combinations led to an increase in riociguat mean AUC of up to about 160% and to an approximate 20% increase in mean Cmax.
Maltese: L-għoti flistess waqt ta' kombinazzjonijiet ta' HAART wassal għal żieda fl-AUC medja ta' riociguat sa madwar 160% u għal żieda ta' madwar 20% f'Cmax medja.
English: Table 4: Effects of riociguat on 6MWD in PATENT-1 at last visit Entire patient population Riociguat IDT (n=254)
Maltese: Tabella 4: L-effetti ta' riociguat fuq 6MWD f'PATENT-1 fl-aħħar vista
English: Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets riociguat
Maltese: Adempas 2 mg pilloli miksija b'rita Adempas 2.5 mg pilloli miksija b'rita riociguat
English: Gastro-oesophageal reflux disease,
Maltese: Marda ta' rifluss gastroesofagali, Disfaġja,
English: Baseline (dyn·s·cm-5) [SD]
Maltese: Linja bażi (dyn·s·cm-5)
English: - stomach disease or heartburn (antacids such as aluminium hydroxide/magnesium hydroxide).
Maltese: - kanċer (bħal erlotinib, gefitinib). - mard fl-istonku jew ħruq ta' stonku (antaċidi bħal aluminium hydroxide/magnesium hydroxide).
English: Riociguat exhibits a reduced solubility at neutral pH vs. acidic medium.
Maltese: Riociguat juri solubilità mnaqqsa f'pH newtrali vs sustanza aċiduża.
English: Therefore co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form, including recreational drugs called ‘poppers', is contraindicated (see section 4.3).
Maltese: Għalhekk, lgħoti ta' Adempas flimkien ma' nitrates jew donaturi ta' nitric oxide (bħal amyl nitrite) fi kwalunkwe forma, inkluż drogi għar-rikreazzjoni msejħa ‘poppers', hu kontraindikat (ara sezzjoni 4.3).
English: Deteriorated p-value
Maltese: Għall-agħar valur p
English: In some PAH patients, an adequate response on the 6-minute walk distance (6MWD) may be reached at a dose of 1.5 mg three times a day (see section 5.1).
Maltese: F'xi pazjenti b'PAH, rispons adegwat fuq id-distanza tal-mixja ta' 6 minuti (6MWD - 6-minute walk distance) jista' jintlaħaq b'doża ta' 1.5 mg tliet darbiet kuljum (ara sezzjoni 5.1).
English: There is no clinical experience with riociguat in patients with elevated liver aminotransferases (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (> 2 x ULN) prior to initiation of treatment; riociguat is not recommended in these patients.
Maltese: M'hemm l-ebda esperjenza klinika b'riociguat f'pazjenti b'livelli għolja ta' aminotransferases filfwied (> 3 x il-Limitu ta' Fuq tan-Normal (ULN - Upper Limit of Normal)) jew b'livell għoli ta' bilirubina diretta (> 2 x ULN) qabel il-bidu tal-kura; riociguat mhuwiex rakkomandat f'dawn ilpazjenti.
English: What you need to know before you take Adempas 3.
Maltese: X'għandek tkun taf qabel ma tieħu Adempas 3.
English: Based on in vitro data riociguat and its main metabolite are substrates of the transporter proteins P-gp (P-glycoprotein) and BCRP (breast cancer resistance protein).
Maltese: Ibbażat fuq data in vitro, riociguat u l-metabolit ewlieni tiegħu huma substrati tal-proteini tattrasportatur P-gp (glikoproteina P) u BCRP (proteina tar-reżistenza tal-kanċer tas-sider).
English: If you are stopping tadalafil, you must wait at least 48 hours before you take Adempas.
Maltese: Jekk qed twaqqaf tadalafil, għandek tistenna mill-inqas 48 siegħa qabel ma tieħu Adempas.
English: • certain types of pulmonary arterial hypertension (PAH).
Maltese: • ċerti tipi ta' pressjoni għolja fl-arterji tal-pulmun (PAH - pulmonary arterial hypertension).
English: Mean change from baseline (ng/L) [SD]
Maltese: Bidla medja mil-linja bażi (ng/L) [SD]
English: Adempas 0.5 mg film-coated tablets
Maltese: Adempas 0.5 mg pilloli miksija b'rita
English: It sensitises sGC to endogenous NO by stabilising the NO-sGC binding.
Maltese: Jissensibilizza sGC għal NO endoġenu billi jistabbilizza ttwaħħil ta' NO-sGC.
English: Adempas 2 mg film-coated tablets EU/1/13/907/010
Maltese: Adempas 2 mg pilloli miksija b'rita EU/1/13/907/010
English: N-demethylation, catalysed by CYP1A1, CYP3A4, CYP3A5 and CYP2J2 is the major biotransformation pathway of riociguat leading to its major circulating active metabolite M-1 (pharmacological activity: 1/10th to 1/3rd of riociguat) which is further metabolised to the pharmacologically inactive N-glucuronide.
Maltese: N-demethylation, ikkatalizzat minn CYP1A1, CYP3A4, CYP3A5 u CYP2J2, hu l-passaġġ maġġuri ta' bijotrasformazzjoni ta' riociguat li jwassal għal metabolit attiv maġġuri tiegħu fiċ-ċirkolazzjoni M-1
English: Approximately 4-19% of the administered dose was excreted as unchanged riociguat via the kidneys.
Maltese: Madwar 4-19% tad-doża mogħtija tneħħiet bħala riociguat mhux mibdul mill-kliewi.
English: Adempas 2.5 mg film-coated tablets EU/1/13/907/013
Maltese: Adempas 2.5 mg pilloli miksija b'rita EU/1/13/907/013
English: Adempas 2 mg film-coated tablets
Maltese: Adempas 2 mg pilloli miksija b'rita
English: Adempas 2.5 mg - pack of 294 film-coated tablets - EU/1/13/907/020
Maltese: Adempas 2.5 mg - pakkett ta' 294 pillola miksija b'rita - EU/1/13/907/020
English: Table 2: Effects of riociguat on 6MWD in CHEST-1 at last visit Entire patient population
Maltese: Tabella 2: L-effetti ta' riociguat fuq 6MWD f'CHEST-1 fl-aħħar vista
English: - fungal infections (such as ketoconazole, posaconazole, itraconazole) or HIV infection (such as abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine or ritonavir) because alternative treatment options may be considered.
Maltese: - disfunzjoni erettili (bħal sildenafil, tadalafil, vardenafil), għax m'għandekx tieħu dawn ilmediċini flimkien ma' Adempas. - infezzjonijiet ikkawżati mill-fungu (bħal ketoconazole, posaconazole, itraconazole) jew infezzjoni bl-HIV (bħal abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine jew ritonavir) għax jistgħu jiġu kkunsidrati għażliet ta' trattament alternattiv.
English: Adempas 0.5 mg film-coated tablets EU/1/13/907/001
Maltese: Adempas 0.5 mg pilloli miksija b'rita EU/1/13/907/001
English: Adempas 2.5 mg film-coated tablets
Maltese: Adempas 2.5 mg pilloli miksija b'rita
English: A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg three times daily) and riociguat (1.0 mg to 2.5 mg three times daily) compared to sildenafil alone was performed.
Maltese: Twettaq studju ta' kombinazzjoni ta' 12-il ġimgħa fi 18-il pazjent b'PAH, fuq kura stabbli ta' sildenafil (20 mg tliet darbiet kuljum) u riociguat (1.0 mg sa 2.5 mg tliet darbiet kuljum) meta mqabbel ma' sildenafil waħdu.
English: In rabbits, starting at systemic exposure of about 3-fold of human exposure (2.5 mg three times daily) abortion and foetal toxicity were seen.
Maltese: Fil-fniek, b'bidu ta' esponiment sistemiku ta' madwar 3 darbiet l-esponiment fil-bniedem (2.5 mg tliet darbiet kuljum) kienu osservati abort u tossiċità fuq il-fetu.
English: Adempas 1 mg - pack of 90 film-coated tablets - EU/1/13/907/006
Maltese: Adempas 1 mg - pakkett ta' 90 pillola miksija b'rita - EU/1/13/907/006
English: Adempas 1 mg film-coated tablets EU/1/13/907/004
Maltese: Adempas 1 mg pilloli miksija b'rita EU/1/13/907/004
English: These findings were in accordance with improvements in additional haemodynamic parameters.
Maltese: Dawn ir-riżultati kienu konformi ma' titjib fil-parametri emodinamiċi addizzjonali.
English: Serious haemorrhagic events also included 2 patients with vaginal haemorrhage, 2 with catheter site haemorrhage, and 1 each with subdural haematoma, haematemesis, and intra-abdominal haemorrhage.
Maltese: Avvenimenti emorraġiċi serji kienu jinkludu wkoll 2 pazjenti b'emorraġija vaġinali, 2 pazjenti b'emorraġija fis-sit tal-kateter, u pazjent wieħed b'ematoma subdurali, ieħor b'rimettar ta' demm, u ieħor b'emorraġija intra-addominali.
English: Adempas 1.5 mg film-coated tablets EU/1/13/907/007
Maltese: Adempas 1.5 mg pilloli miksija b'rita EU/1/13/907/007
English: Data in patients with severe renal impairment (creatinine clearance <30 mL/min) are limited and there are no data for patients on dialysis.
Maltese: Data f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-krejatinina ta' <30 mL/min) hi limitata u m'hemmx data għal pazjenti fuq id-dijalisi.
English: Adempas 2 mg - pack of 90 film-coated tablets - EU/1/13/907/012
Maltese: Adempas 2 mg - pakkett ta' 90 pillola miksija b'rita - EU/1/13/907/012
English: Plasma protein binding in humans is high at approximately 95%, with serum albumin and alpha 1-acidic glycoprotein being the main binding components.
Maltese: It-twaħħil mal-proteini fil-plażma fil-bnedmin hu għoli, ta' madwar 95%, bl-albumina fis-serum u alpha 1-acidic glycoprotein li huma l-komponenti ewlenin tat-twaħħil.
English: Riociguat and its main metabolite are strong inhibitors of CYP1A1 in vitro.
Maltese: In vitro, Riociguat u l-metabolit prinċipali tiegħu huma inibituri qawwija ta' CYP1A1.
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Maltese: L-effetti osservati fi studji dwar l-effett tossiku minn dożi ripetuti kienu primarjament minħabba lattività farmakodinamika esaġerat ta' riociguat (effetti emodinamiċi u rilassament tal-muskoli l-lixxi).
English: Adempas 1 mg film-coated tablets
Maltese: Adempas 1 mg pilloli miksija b'rita
English: Each 2.5 mg film-coated tablet contains 35.8 mg lactose (as monohydrate).
Maltese: Adempas 2.5 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 2.5 mg fiha 35.8 mg ta' lactose (bħala monohydrate).
English: Adempas 2 mg - pack of 84 film-coated tablets - EU/1/13/907/011
Maltese: Adempas 2 mg - pakkett ta' 84 pillola miksija b'rita - EU/1/13/907/011
English: • 2.5 mg tablet: red-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2.5 and an “R” on the other side.
Maltese: • Pillola ta' 2.5 mg: pilloli oranġjo fl-aħmar, tondi, bikonvessi ta' 6 mm, immarkati bis-salib ta' Bayer fuq naħa waħda u 2.5 u “R” fuq in-naħa l-oħra.
English: To mitigate the risk of hypotension, consider dose reduction and monitoring for signs and symptoms of hypotension (see sections 4.2 and 4.5).
Maltese: Biex jitnaqqas ir-riskju ta' pressjoni baxxa, ikkunsidra tnaqqis fid-doża u monitoraġġ għal sinjali u sintomi ta' pressjoni baxxa (ara sezzjonijiet 4.2 u 4.5).
English: Adempas 1 mg - pack of 294 film-coated tablets - EU/1/13/907/017
Maltese: Adempas 1 mg - pakkett ta' 294 pillola miksija b'rita - EU/1/13/907/017
English: • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
Maltese: • CTEPH persistenti jew rikorrenti wara kura kirurġika, biex ittejjeb il-kapaċità tal-eżerċizzju (ara sezzjoni 5.1).
English: The mean change in 6MWD from baseline to week 12 (last observation until week 12) in CHEST-2 (28 weeks on-study for CHEST-1 + CHEST-2) was 57 m in the former 1.0-2.5 mg riociguat group and 43 m in the former placebo group.
Maltese: Il-bidla medja f'6MWD mil-linja bażi sa ġimgħa 12 (l-aħħar osservazzjoni sa ġimgħa 12) f'CHEST-2 (28 ġimgħa waqt l-istudju għal CHEST-1 + CHEST-2) kienet ta' 57 m fil-grupp ta' qabel ta' 1.0-2.5 mg ta' riociguat u ta' 43 m fil-grupp ta' qabel tal-plaċebo.
English: The primary endpoint of the study was the placebo adjusted change from baseline in 6-minute walk distance (6MWD) at the last visit (week 16).
Maltese: Il-punt finali primarju tal-istudju kienet il-bidla aġġustata għall-plaċebo mil-linja bażi fid-distanza tal-mixja ta' 6 minuti (6MWD - 6-minute walk distance) fl-aħħar vista (ġimgħa 16).
English: The safety profile observed in HIV patients taking a single dose of 0.5 mg riociguat together with different combinations of HIV drugs used in HAART was generally comparable to other patient populations.
Maltese: Il-profil tas-sigurtà osservat f'pazjenti bl-HIV li kienu qed jieħdu doża waħda ta' 0.5 mg riociguat flimkien ma' kombinazzjonijiet differenti ta' mediċini għall-HIV użati f'HAART ġeneralment kien komparabbli ma' dak ta' popolazzjonijiet oħra ta' pazjenti.
English: • 1.5 mg tablet: yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1.5 and an “R” on the other side.
Maltese: • Pillola ta' 1.5 mg: pilloli sofor fl-oranġjo, tondi, bikonvessi ta' 6 mm, immarkati bis-salib ta' Bayer fuq naħa waħda u 1.5 u “R” fuq in-naħa l-oħra.
English: Riociguat pharmacokinetics are linear from 0.5 to 2.5 mg. Inter-individual variability (CV) of riociguat exposure (AUC) across all doses is approximately 60%.
Maltese: Il-varjabilità bejn l-individwi (CV) talesponiment għal riociguat (AUC) fid-dożi kollha hi madwar 60%.
English: Adempas 0.5 mg - pack of 90 film-coated tablets - EU/1/13/907/003
Maltese: Adempas 0.5 mg - pakkett ta' 90 pillola miksija b'rita - EU/1/13/907/003
English: Adempas 1.5 mg - pack of 90 film-coated tablets - EU/1/13/907/009
Maltese: Adempas 1.5 mg - pakkett ta' 90 pillola miksija b'rita - EU/1/13/907/009
English: Nervous system disorders Dizziness, Headache
Maltese: Disturbi fis-sistema nervuża
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Bayer AG 51368 Leverkusen
English: Adempas 2.5 mg - pack of 42 film-coated tablets - EU/1/13/907/013
Maltese: Adempas 2.5 mg - pakkett ta' 42 pillola miksija b'rita - EU/1/13/907/013
English: Adempas 1.5 mg - pack of 42 film-coated tablets - EU/1/13/907/007
Maltese: Adempas 1.5 mg - pakkett ta' 42 pillola miksija b'rita - EU/1/13/907/007
English: Adempas 1 mg - pack of 84 film-coated tablets - EU/1/13/907/005
Maltese: Adempas 1 mg - pakkett ta' 84 pillola miksija b'rita - EU/1/13/907/005
English: Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to study drug.
Maltese: Sitt pazjenti (10%) esperjenzaw mill-inqas avveniment wieħed ta' aggravar kliniku, inkluż 2 imwiet mhux relatati mal-mediċina tal-istudju.
English: Adempas 0.5 mg - pack of 42 film-coated tablets - EU/1/13/907/001
Maltese: Adempas 0.5 mg - pakkett ta' 42 pillola miksija b'rita - EU/1/13/907/001
English: Adempas 2.5 mg - pack of 84 film-coated tablets - EU/1/13/907/014
Maltese: Adempas 2.5 mg - pakkett ta' 84 pillola miksija b'rita - EU/1/13/907/014
English: Adempas 2.5 mg - pack of 90 film-coated tablets - EU/1/13/907/015
Maltese: Adempas 2.5 mg - pakkett ta' 90 pillola miksija b'rita - EU/1/13/907/015
English: • 2 mg tablet: pale orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2 and an “R” on the other side.
Maltese: • Pillola ta' 2 mg: pilloli oranġjo ċari, tondi, bikonvessi ta' 6 mm, immarkati bis-salib ta' Bayer fuq naħa waħda u 2 u “R” fuq in-naħa l-oħra.
English: To mitigate the risk of hypotension when Adempas is initiated in patients on stable doses of strong multi pathway CYP (especially CYP1A1 and CYP3A4) and P-gp/BCRP inhibitors, e.g. as contained in HAART, consider a reduced starting dose.
Maltese: Biex jitnaqqas ir-riskju ta' pressjoni baxxa meta Adempas jinbeda f'pazjenti fuq dożi stabbli ta' inibituri qawwija ta' passaġġi multipli ta' CYP (speċjalment CYP1A1 u CYP3A4) u P-gp/BCRP, eż. kif preżenti f'HAART, ikkunsidra doża tal-bidu mnaqqsa.
English: Adempas 1.5 mg - pack of 84 film-coated tablets - EU/1/13/907/008
Maltese: Adempas 1.5 mg - pakkett ta' 84 pillola miksija b'rita - EU/1/13/907/008
English: The most commonly reported adverse reactions, occurring in ≥10% of patients under Adempas treatment (up to 2.5 mg three times daily), were headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni, li seħħew f'≥10% tal-pazjenti li kienu qed jieħdu kura b'Adempas (sa 2.5 mg tliet darbiet kuljum), kienu wġigħ ta' ras, sturdament, dispepsja, edima periferali, dardir, dijarea u rimettar.