FrancophonIA/ELRC3.0 huggingface dataset:
English: Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Empagliflozin jista' jżid l-effett dijuretiku ta' thiazide u dijuretiċi loop u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets Empagliflozin
Maltese: Jardiance 10 mg pilloli Empagliflozin
English: An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), add-on to basal insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1%, placebo 35.3% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8%, empagliflozin 25 mg: 41.3%, placebo: 37.2% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1%, empagliflozin 25 mg: 57.7%, placebo: 58% over the 52-week trial).
Maltese: Żieda fil-frekwenza kienet innutata meta mogħti bħala terapija addizzjonali ma' metformin u sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, plaċebo: 8.4%), terapija addizzjonali għal insulina basali bi jew mingħajr metformin u bi jew mingħajr sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, plaċebo: 20.6 waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg u 25 mg: .36.1%, plaċebo 35.3% fuq prova ta' 78 ġimgħa), u terapija aġġuntiva għal insulina
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi Differenza millplaċebo
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Maltese: Pazjenti (%) li jiksbu HbA1c <7% b'linja bażi ta' HbA1c ≥7% f'ġimgħa
English: The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għallprodotti elenkati fl-Anness A;
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.6%, empagliflozin 25 mg: 0.4%) and placebo (0.3%).
Maltese: Il-frekwenza globali ta' żvojtjar tal-volum (li jinkludi termini mfissra minn qabel ta' pressjoni taddemm (ambulatorja) mnaqqsa, pressjoni tad-demm sistolika mnaqqsa, dieidratazzjoni, pressjoni baxxa, ipovolemja, pressjoni baxxa meta tqum minn pożizzjoni ta' serħan u sinkope) kienet simili f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 0.6%, empagliflozin 25 mg: 0.4%) u plaċebo (0.3%).
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI) Mean adjusted for baseline value Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints MMRM model on FAS (OC) included baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Maltese: Mhux evalwati għas-sinifikat statistiku; mhux parti mill-proċedura ta' ttestjar sekwenzjali għall-punti ta' tmiem sekondarji Mudell MMRM fuq FAS (OC) inkluda HbA1c tal-linja bażi, eGFR (MDRD) tal-linja bażi, reġjun ġeografiku, żjara, trattament, u trattament b'interazzjoni permezz ta' żjara.
English: 1 (97.5% CI) Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% Body Weight (kg) Baseline (mean) Change from baseline Difference from glimepiride
Maltese: (97.5% CI) Pazjenti (%) li jiksbu HbA1c <7% b'linja bażi
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Maltese: C]-empagliflozin lil voluntiera b'saħħithom, ittqassim ta' ċelluli ħomor tad-demm kien madwar 37% u t-twaħħil mal-proteini fil-plażma kien ta' 86%.
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Maltese: Il-maġġoranza tat-tossiċita kienet marbuta ma' farmakoloġija sekondarja relatata ma' telf ta' glukosju urinarju u żbilanċi fl-elettroliti li jinkludu tnaqqis fil-piż talġisem u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidratazzjoni, tnaqqis ta' glukosju fisserum u żidiet f'parametri oħra fis-serum li jirriflettu żieda fil-metaboliżmu ta' proteini u glukoneoġenesi, bidliet urinarji bħal polijurja u glukosurja, u bidliet mikroskopiċi li jinkludu mineralizzazzjoni fil-kliewi u xi tessuti rotob u vaskulari.
English: Empagliflozin as add-on to basal insulin
Maltese: Empagliflozin bħala terapija addizzjonali għal insulina bażali
English: Package leaflet: Information for the patient Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Maltese: Informazzjoni għall-pazjent Jardiance 10 mg pilloli miksija b'rita Jardiance 25 mg pilloli miksija b'rita empagliflozin
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo
Maltese: SBP (mmHg) Linja bażi (medja) Bidla mil-linja bażi Differenza millplaċebo
English: Increased urination (including the predefined terms pollakiuria, polyuria, and nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.5%, empagliflozin 25 mg: 3.3%) compared to placebo (1.4%).
Maltese: Żieda fil-mgħodija tal-awrina (li jinkludi t-termini mfissra minn qabel ta' pollakijurja, polijurja u nokturja) kienu osservati bi frekwenza ogħla f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 3.5%, empagliflozin 25 mg: 3.3%) meta mqabbel ma' plaċebo (1.4%).
English: Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Maltese: Empagliflozin bħala terapija addizzjonali għal metformin, sulphonylurea, pioglitazone Empagliflozin bħala terapija aġġuntiva għal metformin, metformin u sulphonylurea, jew pioglitazone bi jew mingħajr metformin irriżulta fi tnaqqis statistikament sinifikanti (p<0.
English: They have “S25” on one side and the Boehringer Ingelheim logo on the other side.
Maltese: Għandhom "S25" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Maltese: Empagliflozin għandu jitwaqqaf f'pazjenti li jkollhom eGFR b'mod persistenti taħt 45 mL/min/1.73 m jew CrCl b'mod persistenti taħt 45 ml/min.
English: HbA1c (%) at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour SBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour DBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) Full analysis set (FAS) LOCF, values after taking antidiabetic rescue therapy censored Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 ** p-value <0.001
Maltese: Il-medja aġġustata għal SBP tal-linja bażi, HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja Il-medja aġġustata għal DBP tal-linja bażi, HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja * valur p <0.
English: The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as monotherapy, add-on to metformin, add-on to pioglitazone with or without metformin, as add-on to linagliptin and metformin, and as adjunct to standard care therapy and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components.
Maltese: Il-frekwenza ta' ipogliċemija kienet tiddependi fuq it-terapija fl-isfond fl-istudji rispettivi u kienet simili għal empagliflozin u plaċebo bħala monoterapija, b'metformin bħala terapija aġġuntiva, pioglitazone bħala terapija aġġuntiva bi jew mingħajr metformin, bħala terapija aġġuntiva għal linagliptin u metformin, u bħala żieda mat-terapija ta' trattament standard u għall-kombinazzjoni ta' empagliflozin ma' metformin f'pazjenti li qatt ma ngħataw trattament qabel mqabbla ma' dawk ittrattati b'empagliflozin u metformin bħala komponenti individwali.
English: Serum lipids increased
Maltese: Żvojtjar talvolum
English: Major hypoglycaemia (events requiring assistance) No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, add-on to pioglitazone with or without metformin, add-on to linagliptin and metformin, as adjunct to standard care therapy and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components.
Maltese: L-ebda żieda f'ipogliċemija maġġuri ma kienet osservata b'empagliflozin meta mqabbel mal-plaċebo bħala monoterapija, bħala terapija aġġuntiva ma' metformin u sulfonylurea, bħala terapija aġġuntiva ma' pioglitazone bi jew mingħajr metformin, terapija aġġuntiva għal linagliptin u metformin, bħala żieda għal terapija ta' trattament standard u għall-kombinazzjoni ta' empagliflozin ma' metformin f'pazjenti li qatt ma ngħataw trattament qabel mqabbla ma' dawk ittrattati b'empagliflozin u metformin bħala komponenti individwali.
English: Treatment with empagliflozin once daily resulted in statistically significant improvement in HbA1c, and 24 hour mean systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (Table 11).
Maltese: Trattament b'empagliflozin darba kuljum irriżulta f'titjib statistikament sinifikanti f'HbA1c, u l-pressjoni tad-demm sistolika u dijastolika medja fuq 24 siegħa kif stabbilit b'monitoraġġ ambulatorju tal-pressjoni tad-demm (Tabella 11).
English: The tablet is 11.1 mm long and has a width of 5.6 mm.
Maltese: Il-pilloli huma 11.1 ċm twal u għandhom wisgħa ta' 5.6 mm
English: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 10 mg empagliflozin darba kuljum għal monoterapija u bħala terapija kombinata miżjuda ma' prodotti mediċinali oħra għat-trattament tad-dijabete.
English: In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily.
Maltese: F'pazjenti li jittolleraw empagliflozin li għandhom eGFR li jaqa' b'mod persistenti taħt 60 ml/min/1.73 m2 jew CrCl taħt 60 ml/min, id-doża ta' empagliflozin għandha tiġi aġġustata jew tinżamm f'ammont ta' 10 mg darba kuljum.
English: An increased frequency was noted when given as add-on to basal insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, placebo: 1.6% during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
Maltese: Żieda fil-frekwenza kienet osservata meta mogħti bħala terapija aġġuntiva mal-insulina basali bi jew mingħajr metformin u bi jew mingħajr sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, plaċebo: 0% waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, plaċebo 0% fuq prova ta' 78 ġimgħa), u terapija aġġuntiva għall-insulina
English: Full analysis set (FAS) - Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy mean adjusted for baseline value * p-value <0.0001 ** p-value <0.025
Maltese: Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet miġjuba 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: Table 2: Efficacy results of a 24 week placebo-controlled study of empagliflozin as monotherapy Placebo
Maltese: Tabella 2: Riżultati ta' effikaċja għal empagliflozin bħala monoterapija fi studju ta' 24 ġimgħa kkontrolat bi plaċebo
English: Empagliflozin exposure was similar with and without co-administration with verapamil, a P-gp inhibitor, indicating that inhibition of P-gp does not have any clinically relevant effect on empagliflozin.
Maltese: Empagliflozin ma wera l-ebda effetti avversi fuq il-fertilità jew l-iżvilupp embrijoniku bikri, f'esponimenti suffiċjentement eċċessivi mill-esponiment fil-bniedem wara dożi terapewtiċi.
English: Table 6: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add-on to metformin
Maltese: Tabella 6: Riżultati ta' effikaċja wara 104 ġimgħat fi studju kontrollat b'mod attiv li qabbel empagliflozin ma' glimepiride bħala terapija addizzjonali għal metformin Empagliflozin 25 mg
English: The efficacy and safety of empagliflozin as add-on to basal insulin with or without metformin and/or a sulphonylurea was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' empagliflozin bħala terapija addizzjonali għal insulina bażali bi jew mingħajr terapija b'metformin u/jew sulphonylurea ġew evalwati fi studju double blind ikkontrollat bi plaċebo li dam 78 ġimgħa.
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Up to 4 mg glimepiride Mean adjusted for baseline value LOCF, values after antihypertensive rescue censored * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Maltese: 0001 għal nuqqas ta' inferjorità, u valur p = 0.0153 għal superjorità ** valur p <0.
English: Jardiance 25 mg film-coated tablets
Maltese: Jardiance 25 mg pilloli miksija b'rita
English: C]-empagliflozin solution to healthy volunteers, approximately 96% of the drug-related radioactivity was eliminated in faeces (41%) or urine (54%).
Maltese: Wara l-għoti ta' doża orali ta' soluzzjoni ta' C] empagliflozin lil voluntiera b'saħħithom, madwar 96% tar-radjuattività marbuta mal-mediċina ġiet eliminata fl-ippurgar (41%) jew fl-awrina (54%).
English: Cardiovascular outcome
Maltese: TAL-PRODOTT MEDIĊINALI
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received empagliflozin in placebo-controlled studies are presented in the table below (Table 1).
Maltese: Ir-reazzjonijiet avversi kklassifikati skont is-sistema tal-organi u t-termini ppreferuti MedDRA rrappurtati f'pazjenti li rċivew empagliflozin fi studji fejn plaċebo intuża bħala kontroll huma ppreżentati fit-tabella ta' taħt (ara tabella 1).
English: Patients with renal impairment, 52 week placebo controlled data The efficacy and safety of empagliflozin as add-on to antidiabetic therapy was evaluated in patients with renal impairment in a double-blind, placebo-controlled study for 52 weeks.
Maltese: Pazjenti b'indeboliment tal-kliewi, 52 ġimgħa b'dejta kkontollata bi plaċebo L-effikaċja u s-sigurtà ta' empagliflozin bħala terapija addizzjonali għal terapija antidijabetika ġew evalwati f'pazjenti b'indeboliment tal-kliewi fi studju double blind ikkontrollat bi plaċebo li dam 52 ġimgħa.
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Empagliflozin
Maltese: Jardiance 10 mg pilloli miksija b'rita Kull pillola fiha 10 mg empagliflozin
English: Jardiance 10 mg film-coated tablets
Maltese: Jardiance 10 mg pilloli miksija b'rita
English: No such effect was seen at systemic exposure equal to the maximal clinical exposure to empagliflozin.
Maltese: L-ebda effett bħal dan ma' ġie osservat f'esponiment sistemiku ekwivalenti għall-esponiment kliniku massimu ta' empagliflozin.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Maltese: L-għoti ta' empagliflozin 25 mg wara teħid ta' ikla b'ħafna xaħam u ħafna kaloriji rriżulta f'esponiment ftit aktar baxx; l-AUC naqas b'madwar 16% u Cmax b'madwar 37% meta mqabbel mal-kondizzjoni tassawm.
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Maltese: Ilmekkaniżmu ta' azzjoni ta' empagliflozin huwa indipendenti mill-funzjoni taċ-ċelluli beta u r-rotta talinsulina u dan jikkontribwixxi għal riskju baxx ta' ipogliċemija.
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni, l-AUC kienet stmata li kienet 13.5% ogħla f'persuni millAżja b'indiċi tal-piż tal-ġisem ta' 25 kg/m2, meta mqabbla ma' individwi mhux Ażjatiċi b'indiċi tal-piż tal-ġisem ta' 25 kg/m
English: EU/1/10/643/001
Maltese: EU/1/10/643/001 Rapiscan
English: 5 ml (80 microgram/ml)
Maltese: 5 ml (80 mikrogramma/ml)
English: Rapiscan 400 microgram
Maltese: 400 mikrogramma Soluzzjoni għall-injezzjoni
English: Vial (glass)
Maltese: Mnejn jingħata Il-pakkett
English: Astellas Pharma Co. Ltd
Maltese: Astellas Pharma Co.
English: Diclofenac Sodium Spray Gel 4% cutaneous spray, solution
Maltese: Diclofenac Sodium Spray Gel 4% Sprej għallġilda, soluzzjoni
English: United Kingdom Mika Pharma GmbH
Maltese: Ir-Renju Unit
English: Further information on Volibris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/volibris.
Maltese: ema.europa.eu/medicines/human/EPAR/volibris.
English: Volibris is available as tablets (5 and 10 mg).
Maltese: Volibris jiġi bħala pilloli (5 u 10 mg).
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: “klassi II” tinvolvi limitazzjoni żgħira tal-attività fiżika u “klassi III” tinvolvi limitazzjoni notevoli tal-attività fiżika.
English: Other information about Volibris
Maltese: Informazzjoni oħra dwar Volibris
English: Volibris received a marketing authorisation valid throughout the EU on 21 April 2008.
Maltese: Volibris ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-21 ta' April 2008.
English: Various doses of Volibris (2.5, 5 and 10 mg) have been compared with placebo (a dummy treatment) in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease that was of unknown cause or caused by connective tissue disease.
Maltese: Tqabblu diversi dożi ta' Volibris (2.5, 5 u 10 mg) ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew 394 pazjent b'kollox li jbatu bil-PAH, li l-biċċa l-kbira kellhom il-marda tal-klassi II jew talklassi III li l-kawża tagħha ma kinitx magħrufa jew li kienet ikkawżata minn mard tat-tessut konnettiv.
English: The company that markets Volibris will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Maltese: Il-kumpanija li tqiegħed Volibris fis-suq se tipprovdi kard tal-pazjenti li fiha informazzjoni importanti dwar l-effetti sekondarji tal-mediċina u l-ħtieġa li tiġi evitata t-tqala waqt il-kura.
English: Over a three-year period the likelihood of the disease getting worse was 32% with the combined treatment and 44% with a single medicine.
Maltese: Fuq perjodu ta' tliet snin ilprobabbiltà li l-marda taggrava kienet 32 % bil-kura kombinata u 44 % b'mediċina waħda.
English: In addition, treatment with a combination of Volibris (10 mg) and tadalafil has been compared with either Volibris or tadalafil alone in another main study involving 605 patients with PAH.
Maltese: Barra minn dan, il-kura b'kombinazzjoni ta' Volibris (10mg) u tadalafil tqabblet jew ma' Volibris jew tadalfil waħedhom fi studju ewlieni ieħor li involva 605 pazjenti bil-PAH.
English: Why is Volibris approved?
Maltese: Għaliex ġie approvat Volibris?
English: What are the risks associated with Volibris?
Maltese: X'inhuma r-riskji assoċjati ma' Volibris?
English: The most common side effects with Volibris (seen in more than 1 patient in 10) are headache (including sinus headache and migraine), peripheral oedema (swelling, especially of the ankles and feet) and fluid retention.
Maltese: L-effetti sekondarji l-aktar komuni b'Volibris (li dehru f'aktar minn pazjent 1 f'10) huma wġigħ ta' ras (inklużi wġigħ ta' ras tas-sinus u emikranja), edema periferika (nefħa, speċjalment tal-għekiesi u ssaqajn) u żamma ta' fluwidi.
English: Results showed that 18% of patients (46 out of 253) given combination treatment died or their disease got worse compared with 31% (77 out of 247) given either Volibris or tadalafil alone.
Maltese: Ir-riżultati wrew li 18 % tal-pazjenti (46 minn 253) li ngħataw il-kura kkombinata mietu jew il-marda tagħhom marret għallagħar meta mqabbla ma' 31 % (77 minn 247) li ngħataw Volibris jew tadalfil waħedhom.
English: The increased dose of 10 mg is recommended when the medicine is used with tadalafil (another medicine for PAH).
Maltese: Iż-żieda fid-doża ta' 10 mg hija rakkomandata meta l-mediċina tintuża ma' tadalfil (mediċina oħra għall-PAH).
English: Patients with class III disease and those with PAH caused by connective tissue disease gained a greater benefit from the 10 mg dose than from the 5 mg dose.
Maltese: Pazjenti li kellhom il-marda tal-klassi III u dawk li kellhom ilPAH ikkawżata minn mard tat-tessut konnettiv akkwistaw benefiċċju akbar mid-doża ta' 10 mg milli mid-doża ta' 5 mg.
English: The risk of the disease getting worse or the patient dying within a year was 11% in patients given the combination treatment and 24% in those given a single medicine (Volibris or tadalafil).
Maltese: Ir-riskju li lmarda taggrava jew li l-pazjenti jmutu fi żmien sena kien 11 % f'pazjenti li ngħataw il-kura kombinata u 24 % f'dawk li ngħataw mediċina waħda (Volibris jew tadalafil).
English: Results showed that Volibris was more effective than placebo at improving exercise capacity (the ability to carry out physical activity).
Maltese: Ir-riżultati wrew li Volibris kien aktar effettiv mill-plaċebo fit-titjib tal-kapaċità tal-eżerċizzju (il-kapaċità li titwettaq attività fiżika).