FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Lynparza are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Lynparza hija ssorveljata kontinwament.
English: • A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).
Maltese: • Studju ta' 295 pazjent b'kanċer rikadut tal-ovarji, tat-tubu fallopjan jew tal-peritonjum sab li dawk li ngħataw Lynparza għexu medja ta' 19.1 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 5.5 xhur għal pazjenti li ngħataw plaċebo (kura finta).
English: • continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
Maltese: • tkomplija ta' kura ta' kanċers ta' grad għoli (li jikbru malajr) tal-ovarji, tat-tubi fallopjani (li jgħaqqdu l-ovarji mal-ġuf) u l-peritonjum (ir-rita tal-membrana tal-addome) f':
English: Lynparza is a cancer medicine used on its own for:
Maltese: Lynparza huwa mediċina kontra l-kanċer li tintuża waħedha għal:
English: • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
Maltese: • kura tal-kanċer tas-sider li jkun negattiv għall-HER2 u li jkun infirex lil hinn mis-sit oriġinali f'pazjenti b'mutazzjonijiet fil-ġeni BRCA1 jew BRCA2 li kienu kkurati b'ċerti mediċini kontra l-kanċer tas-sider (sakemm dawn il-mediċini ma kinux adegwati).
English: The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Maltese: Is-sustanza attiva f'Lynparza, l-olaparib, timblokka l-azzjoni ta' enzimi li jissejħu polipolimerażi talbniedem (ribożju ADP) (PARP), li jgħinu jsewwu DNA danneġġata f'ċelloli (kemm f'ċelloli normali kif ukoll f'ċelloli tal-kanċer) waqt id-diviżjoni taċ-ċelloli.
English: How is Lynparza used?
Maltese: Lynparza?
English: The side effects with Lynparza were mostly mild or moderate and were generally manageable.
Maltese: L-effetti sekondarji b'Lynparza kienu l-aktar ħfief jew moderati u kienu ġeneralment maniġġabbli.
English: For the full list of side effects and restrictions with Lynparza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Lynparza, ara l-fuljett ta' tagħrif.
English: How does Lynparza work?
Maltese: Kif jintuża Lynparza?
English: In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the next cycle of platinum chemotherapy.
Maltese: Il-kumpanija li tqiegħed Lynparza fis-suq se twettaq studji biex tikkonferma aktar il-benefiċċju, inkluż il-benefiċċju fit-tul tal-mediċina f'pazjenti b'kanċer tal-ovarji.
English: Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.
Maltese: Il-pazjenti kkurati b'Lynparza għexu medja ta' 7.0 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbla ma' 4.2 xhur f'pazjenti kkurati b'mediċina oħra kontra l-kanċer tal-għażla tat-tabib.
English: The full EPAR for Vimpat 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: Vimpat lacosamide
Maltese: Vimpat lakosamid
English: The active substance in Vimpat, lacosamide, is an epilepsy medicine.
Maltese: Is-sustanza attiva f'Vimpat, il-lakosamid, hija mediċina kontra l-epilessija.
English: Other information about Vimpat
Maltese: Informazzjoni oħra dwar Vimpat
English: This is a summary of the European public assessment report (EPAR) for Vimpat.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vimpat.
English: Why is Vimpat approved?
Maltese: Għaliex ġie approvat Vimpat?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Vimpat valida fl-Unjoni Ewropea kollha fid-29 ta' Awwissu 2008.
English: Vimpat can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip) into a vein.
Maltese: Vimpat jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala pilloli (50 mg; 100 mg; 150 mg; 200 mg), bħala mistura (10 mg/ml) u bħala soluzzjoni għall-infużjoni (dripp) fil-vina.
English: It contains the active substance lacosamide.
Maltese: Fih is-sustanza attiva lakosamid.
English: A fourth study involving 888 recently diagnosed patients showed that Vimpat, used on its own by mouth at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another medicine for epilepsy.
Maltese: Ir-raba' studju li involva 888 pazjent dijanjostikati riċentament wera li Vimpat, użat waħdu u meħud mill-ħalq f'doża ta' 200 mg sa 600 mg kuljum, kien tal-inqas effettiv daqs carbamazepine, mediċina oħra kontra l-epilessija.
English: Around 78% of Vimpat-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.
Maltese: Madwar 78% tal-pazjenti kkurati b'Vimpat u 83% ta' dawk ikkurati b'carbamazepine ma kellhomx attakk għal 12-il xahar.
English: The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Maltese: Id-doża ta' 600-mg kienet effettiva daqs iddoża ta' 400-mg, iżda kellha aktar effetti sekondarji.
English: This was found to be 90% in those taking Vimpat and 91% in those taking carbamazepine.
Maltese: Dan instab f'90% f'dawk li kienu qed jieħdu Vimpat u f'91% f'dawk li kienu qed jieħdu carbamezapine.
English: Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines.
Maltese: Vimpat kien aktar effettiv minn plaċebo (kura finta) fit-tnaqqis tal-attakki fi tliet studji ewlenin li fihom ħadu sehem total ta' 1,308 pazjenti minn 16-il sena 'l fuq li kienu qed jieħdu wkoll mediċini oħra kontra l-epilessija.
English: This compared with 23% of the patients taking placebo.
Maltese: Dan tqabbel ma' 23% tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Vimpat (li dehru f'aktar minn pazjent 1 minn 10) huma sturdament, uġigħ ta' ras, diplopija (viżta doppja) u nawżja (tħossok ma tiflaħx).
English: Taking the results of the three main studies together, 34% of the patients taking Vimpat 200 mg a day and 40% of the patients taking Vimpat 400 mg a day with their existing treatment had a reduction in their seizures by at least half.
Maltese: Meta ttieħdu r-riżultati tat-tliet studji ewlenin flimkien, 34% tal-pazjenti li ħadu Vimpat 200 mg kuljum u 40% tal-pazjenti li ħadu Vimpat 400 mg kuljum mal-kura eżistenti tagħhom kellhom tnaqqis tal-inqas bin-nofs fl-attakki tagħhom.
English: The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Maltese: Il-mod eżatt ta' kif taħdem il-lakosamid għadu mhuwiex ċar, iżda jidher li din tnaqqas l-attività tal-kanali tas-sodju (pori fil-wiċċ taċ-ċelloli tan-nervituri) li jippermettu t-trażmissjoni ta' impulsi elettriċi bejn iċ-ċelloli tan-nervituri.
English: Vimpat is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 4 years and older.
Maltese: Vimpat huwa mediċina kontra l-epilessija li tintuża biex tikkura attakki li jevolvu b'mod parzjali (attakki epilettiċi li jibdew minn parti speċifika tal-moħħ) f'pazjenti li jbatu mill-epilessija u li għandhom minn 4 sena 'l fuq.
English: Patients were given Vimpat by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo in addition to their existing treatment of up to three other epilepsy medicines.
Maltese: Il-pażjenti ngħataw Vimpat meħud mill-ħalq f'doża ta' 200 mg, 400 mg jew 600 mg kuljum, jew plaċebo mal-kura eżistenti tagħhom ta' mhux aktar minn tliet mediċini oħra kontra lepilessija.
English: The usual starting dose in adults and older children (weighing at least 50 kg) is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Maltese: Id-doża standard tal-bidu f'adulti u tfal akbar (li jiżnu mill-inqas 50 kg) hija 50 mg darbtejn kuljum li tista' tiżdied kull ġimgħa għal doża massima ta' 300 mg darbtejn kuljum jekk jintuża waħdu, jew 200 mg darbtejn kuljum jekk jingħata ma' mediċini oħra kontra l-epilessija.
English: Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Maltese: Żewġ studji addizzjonali ħarsu lejn it-tul xieraq tal-infużjoni għal soluzzjoni ta' Vimpat u qabblu ssigurtà tagħha ma' dik tal-infużjonijiet tal-plaċebo fuq total ta' 199 pazjent.
English: Vimpat must not be used in people who have second or third degree AV block (a type of heart rhythm disorder).
Maltese: Vimpat ma għandux jintuża f'persuni li għandhom imblokk AV tat-tielet grad (tip ta' disturb fir-rittmu tal-qalb).
English: For the full list of all side effects and restrictions with Vimpat, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Vimpat, ara l-fuljett ta' tagħrif.
English: Vimpat is given on its own or combined with other medicines for epilepsy.
Maltese: Vimpat jingħata waħdu jew flimkien ma' mediċini oħra kontra l-epilessija.
English: How is Vimpat used?
Maltese: Kif jaħdem Vimpat?
English: The company also provided data to support dosing of Vimpat in children from 4 years of age and supportive results from studies of the safety of Vimpat in this population.
Maltese: Il-kumpanija pprovdiet ukoll data biex tappoġġa d-dożaġġ ta' Vimpat fi tfal minn 4 snin 'il fuq u riżultati ta' appoġġ minn studji dwar is-sigurtà ta' Vimpat f'din il-popolazzjoni
English: This action may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Maltese: Din l-azzjoni tisia' tipprevjeni l-attività elettrika anormali milli tinfirex mal-moħħ kollu, b'hekk titnaqqas il-possibbiltà ta' attakk epilettiku.
English: It is not intended to provide practical advice on how to use Vimpat.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Vimpat.
English: Taking the known side effects into account, the Agency considered Vimpat's benefits to be greater than its risks and recommended that it be given marketing authorisation.
Maltese: Meta jitqiesu leffetti sekondarji magħrufa, l-Aġenzija kkunsidrat li l-benefiċċji ta' Vimpat huma akbar mir-riskji tiegħu u rrakkomandat li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: - depression (St. John's Wort).
Maltese: - depressjoni (St. John's Wort).
English: - The active substance is riociguat.
Maltese: - Is-sustanza attiva hi riociguat.
English: ATC code: C02KX05
Maltese: C02KX05
English: 15 to 56
Maltese: 15 sa 56
English: Date of latest renewal: 18 January 2019
Maltese: Data tal-aħħar tiġdid: 18 ta' Jannar 2019
English: -11 to 31
Maltese: -11 sa 31
English: Highly active antiretroviral therapy (HAART)
Maltese: Terapija antiretrovirali attiva ħafna (HAART - highly active antiretroviral therapy)
English: Adempas contains lactose
Maltese: Adempas fih lactose
English: Gastritis,
Maltese: Gastrite,
English: Adempas contains the active substance riociguat.
Maltese: Adempas fih is-sustanza attiva riociguat.
English: 35 to 81
Maltese: 35 sa 81
English: 29 to 79
Maltese: 29 sa 79
English: 14 to 62
Maltese: 14 sa 62
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 March 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Marzu 2014
English: 95% CI, [p-value]
Maltese: CI ta' 95%, [valur p]
English: Alternative treatments should be considered.
Maltese: Għandhom jiġu kkunsidrati trattamenti alternattivi.
English: 29 to 83
Maltese: 29 sa 83
English: respective laboratory parameters)
Maltese: Anemija (li tinkludi parametri rispettivi tallaboratorju)
English: cellulose microcrystalline crospovidone (type B) hypromellose 5 cP magnesium stearate lactose monohydrate sodium laurilsulfate
Maltese: cellulose microcrystalline crospovidone (tip B) hypromellose 5 cP magnesium stearate lactose monohydrate sodium laurilsulfate
English: -10 to 63
Maltese: -10 sa 63
English: -10 to 61
Maltese: -10 sa 61
English: Crushed tablets:
Maltese: Pilloli mfarrka:
English: - epilepsy (e.g. phenytoin, carbamazepine, phenobarbitone).
Maltese: (eż. phenytoin, carbamazepine, phenobarbitone jew St.
English: -843.0 to -45.0 [<0.0001]
Maltese: -843.0 sa -45.0
English: -303.3 to -189.5 [<0.0001]
Maltese: -303.3 sa -189.5
English: Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 42, 84, 90 jew 294 pillola miksija b'rita.
English: The absolute bioavailability of riociguat is high (94%).
Maltese: Il-bijodisponibilità assoluta ta' riociguat hi għolja (94%).
English: Adempas contains sodium
Maltese: Adempas fih sodium
English: INFORMATION IN BRAILLE Adempas 0.5 mg, 1 mg, 1.5 mg, 2 mg or 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Adempas 0.5 mg, 1 mg, 1.5 mg, 2 mg jew 2.5 mg
English: Crushed tablets
Maltese: Pilloli mfarrka
English: In cigarette smokers riociguat exposure is reduced by 50-60% (see section 5.2).
Maltese: F'persuni li jpejpu, l-esponiment għal riociguat jitnaqqas b'50-60% (ara sezzjoni 5.2).
English: Moderate passage across the placental barrier was observed.
Maltese: Kien osservat passaġġ moderat mill-barriera tal-plaċenta.
English: Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator.
Maltese: Riociguat hu tip ta' mediċina li tissejjaħ stimulatur ta' guanylate cyclase (sGC - guanylate cyclase stimulator).
English: Table 3: Effects of riociguat in CHEST-1 on PVR, NT-proBNP and WHO functional class at last visit PVR
Maltese: Tabella 3: Effetti ta' riociguat f'CHEST-1 fuq PVR, NT-proBNP u klassi funzjonali tad-WHO flaħħar vista
English: 25 to 67 [<0.0001]
Maltese: 25 sa 67 [<0.
English: Pulmonary haemorrhage*
Maltese: Emorraġija fil-pulmun*
English: Inhibitors for the UDP-Glykosyltransferases (UGT) 1A1 and 1A9 may potentially increase the exposure of the riociguat metabolite M1, which is pharmacologically active (pharmacological activity: 1/10th to 1/3rd of riociguat).
Maltese: Inibituri ta' UDP-Glykosyltransferases (UGT) 1A1 u 1A9 għandhom potenzjal li jżidu l-esponiment għall-metabolit ta' riociguat M1, li huwa farmakoloġikament attiv (attività farmakoloġika: 1/10 sa 1/3 dik ta' riociguat).
English: Film-coat: hydroxypropylcellulose, hypromellose 3 cP, propylene glycol (E 1520) and titanium dioxide (E 171).
Maltese: Kisja b'rita: hydroxypropylcellulose, hypromellose 3 cP, propylene glycol (E 1520) u titanium dioxide (E 171).
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-trabi li jkunu qed jerdgħu mhux eskluż.
English: PVR= pulmonary vascular resistance
Maltese: PVR= reżistenza vaskulari fil-pulmun
English: Baseline (ng/L) [SD]
Maltese: Linja bażi (ng/L) [SD]
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 98%, 96% and 93% respectively, and for patients of WHO functional class III at baseline was 96%, 91% and 84% respectively.
Maltese: Sopravivenza f'pazjenti bi klassi funzjonali WHO II fil-linja bażi wara sena, sentejn u 3 snin kienet ta' 98%, 96% u 93% rispettivament, u għall-pazjenti bi klassi funzjonali WHO III fil-linja bażi kienet ta' 96%, 91% u 84% rispettivament.
English: Baseline (m) [SD]
Maltese: Linja bażi (m) [SD]
English: Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
Maltese: Adempas huwa indikat għall-kura ta' pazjenti adulti bi klassi funzjonali (FC - Functional Class) WHO II sa III b'
English: An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
Maltese: Studju open-label ta' estensjoni (CHEST-2) kien jinkludi 237 pazjent li kienu temmew CHEST-1.
English: 20 to 52 [<0.0001]
Maltese: 20 sa 52 [<0.
English: Concomitant use with CYP3A4 inducers
Maltese: Użu flimkien ma' indutturi ta' CYP3A4
English: IIP) (see section 5.1)
Maltese: (ara sezzjoni 5.1).
English: Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Maltese: Pazjenti b'ALT ta' > 3 x ULN u bilirubina ta' > 2 x ULN ma ġewx studjati (ara sezzjoni 4.4).
English: Terminal half-life increased from 7.3 to 9.2 hours and total body clearance decreased from 6.1 to 2.4 L/h.
Maltese: Il-half-life terminali żdiedet minn 7.3 għal 9.2 sigħat u t-tneħħija totali mill-ġisem naqset minn 6.1 għal 2.4
English: Tablet core: cellulose microcrystalline, crospovidone (type B), hypromellose 5 cP, lactose monohydrate, magnesium stearate and sodium laurilsulfate (see end of section 2 for further information on lactose).
Maltese: Qalba tal-pillola: cellulose microcrystalline, crospovidone (tip B), hypromellose 5 cP, lactose monohydrate, magnesium stearate u sodium laurilsulfate (ara t-tmiem ta' sezzjoni 2 għal informazzjoni addizzjonali dwar lactose).
English: Frequencies are defined as: very common (≥1/10), 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) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni ħafna (≥1/10), 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: A randomised, double-blind, multi-national, placebo controlled, phase III study (PATENT-1) was conducted in 443 adult patients with PAH (riociguat individual dose titration up to 2.5 mg three times daily: n=254, placebo: n=126, riociguat “capped” dose titration (CT) up to 1.5 mg (exploratory dose arm, no statistical testing performed; n=63)).
Maltese: III, randomised, double-blind, multinazzjonali, ikkontrollat bi plaċebo, (PATENT-1), twettaq fuq 443 pazjent adult b'PAH (titrazzjoni tad-doża individwali ta' riociguat sa 2.5 mg tliet darbiet kuljum: n=254, plaċebo: n=126, titrazzjoni tad-doża ta' riociguat “capped” (CT - capped titration) sa 1.5 mg (parti tal-istudju dwar doża esploratorja, ma twettaq l-ebda ttestjar statistiku; n=63)).
English: Co-administration of the antacid aluminium hydroxide / magnesium hydroxide reduced riociguat mean AUC by 34% and mean Cmax by 56% (see section 4.2).
Maltese: Għoti flimkien tal-antaċidu aluminium hydroxide / magnesium hydroxide naqqas l-AUC medja ta' riociguat b'34% u Cmax medja b'56% (ara sezzjoni 4.2).
English: In nonsmoking individuals with mild (creatinine clearance 80-50 mL/min), moderate (creatinine clearance <50-30 mL/min) or severe (creatinine clearance <30 mL/min) renal impairment, riociguat plasma concentrations (AUC) were increased by 53%, 139% or 54%, respectively.
Maltese: F'individwi li ma jpejpux b'indeboliment ħafif (tneħħija tal-krejatinina 80-50 mL/min), moderat (tneħħija tal-krejatinina <50-30 mL/min) jew sever (tneħħija tal-krejatinina <30 mL/min) tal-kliewi, il-konċentrazzjonijiet ta' riociguat fil-plażma (AUC) żdiedu bi 53%, 139% jew 54%, rispettivament.
English: Table 6: Effects of riociguat in PATENT-1 on events of clinical worsening Clinical Worsening Events
Maltese: L-effetti ta' riociguat f'PATENT-1 fuq avvenimenti ta' aggravar kliniku
English: Adverse Events leading to discontinuation occurred at a similar frequency in both treatment groups (riociguat individual dose titration (IDT) 1.0-2.5 mg, 2.9%; placebo, 2.3%).
Maltese: Avvenimenti avversi li wasslu għal twaqqif tal-mediċina seħħew bi frekwenza simili fiż-żewġ gruppi ta' kura (titrazzjoni individwali tad-doża (IDT - individual dose titration) ta' riociguat) 1.0-2.5 mg, 2.9%; plaċebo, 2.3%).
English: (in 2 mg and 2.5 mg tablets only)
Maltese: (f'pilloli ta' 2 mg u 2.5 mg biss)
English: In vitro, abacavir, rilpivirine, efavirenz, ritonavir, cobicistat and elvitegravir inhibited CYP1A1 and the metabolism of riociguat in the order listed with abacavir as the strongest inhibitor.
Maltese: In vitro, abacavir, rilpivirine, efavirenz, ritonavir, cobicistat u elvitegravir inibixxew CYP1A1 u lmetaboliżmu ta' riociguat fl-ordni elenkata b'abacavir bħala l-aktar inibitur b'saħħtu.
English: Adverse Events leading to discontinuation occurred less frequently in both riociguat treatment groups than in the placebo group (riociguat IDT 1.0-2.5 mg, 3.1%; riociguat CT 1.6%; placebo, 7.1%).
Maltese: Avvenimenti avversi li wasslu għat-twaqqif tal-mediċina seħħew bi frekwenza iktar baxxa fiż-żewġ gruppi ta' kura ta' riociguat milli fil-grupp tal-plaċebo (riociguat IDT 1.0-2.5 mg, 3.1%; riociguat CT 1.6%; plaċebo, 7.1%).
English: Lack of pharmacokinetic interactions between riociguat and the CYP2C9 substrate warfarin was demonstrated in vivo.
Maltese: In vivo intwera nuqqas ta' interazzjonijiet farmakokinetiċi bejn riociguat u s-substrat ta' CYP2C9 warfarin.
English: The impact of HAART (including different combinations of abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, and tenofovir) on riociguat exposure was investigated in a dedicated study in HIV patients.
Maltese: L-impatt ta' HAART (inklużi kombinazzjonijiet differenti ta' abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, lamivudine, rilpivirine, ritonavir, u tenofovir) fuq l-esponiment għal riociguat ġie investigat fi studju dedikat f'pazjenti bl-HIV.
English: -281.4 to -170.1[<0.0001]
Maltese: -281.4 sa -170.
English: Riociguat also directly stimulates sGC independently of NO.
Maltese: Riociguat jistimula direttament ukoll lil sGC indipendentement minn NO.
English: PK data show that higher riociguat exposure was observed in patients with moderate hepatic impairment (Child Pugh B) (see section 5.2).
Maltese: Data PK turi li esponiment ogħla għal riociguat kien osservat f'pazjenti b'indeboliment moderat tal-fwied (Child Pugh B) (ara sezzjoni 5.2).
English: Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Maltese: Riociguat totali (is-sustanza oriġinali u l-metaboliti) jitneħħa kemm mill-kliewi (33-45%) kif ukoll mir-rotot biljari/tal-ippurgar (48-59%).
English: • coughing up blood (haemoptysis) (common side effect, may affect up to 1 in 10 people),
Maltese: • tisgħol id-demm (emoptisi) (effett sekondarju komuni, jista' jaffettwa sa persuna waħda minn kull 10 persuni),
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 97%, 94% and 90% respectively, and for patients of WHO functional class III at baseline was 97%, 93% and 88% respectively.
Maltese: Sopravivenza f'pazjenti bi klassi funzjonali WHO II fil-linja bażi wara sena, sentejn u 3 snin kienet ta' 97%, 94% u 90% rispettivament, u għall-pazjenti bi klassi funzjonali WHO III fil-linja bażi kienet ta' 97%, 93% u 88% rispettivament