FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Maltese: Ibbażat fuq paragun ta' bejn l-istudji, il-bijodisponibilità assoluta ta' cinacalcet f'pazjenti sajma kienet stmata li hi madwar 20-25%.
English: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Maltese: Kura ta' iperparatirojdiżmu sekondarju (HPT) f'pazjenti b'marda renali tal-aħħar stadju (ESRD) fuq terapija ta' manutenzjoni b'dijalisi.
English: In Chronic Kidney Disease (CKD) patients receiving dialysis who were administered cinacalcet, approximately 30% of patients had at least one serum calcium value less than 7.5 mg/dl (1.9 mmol/l).
Maltese: F' pazjenti b' mard tal-kliewi kronika CKD li qed jirċievu d-dijalisi, li ngħataw cinacalcet bejn wieħed u ieħor 30% tal-pazjenti kellhom minn ta' l-inqas valur wieħed ta' kalċju fid-demm inqas minn 7.5 mg/dl (1.9 mmol/l)
English: Common: may affect up to 1 in 10 people
Maltese: Komuni: jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni
English: In toxicity studies in juvenile dogs, tremors secondary to decreased serum calcium, emesis, decreased body weight and body weight gain, decreased red cell mass, slight decreases in bone densitometry parameters, reversible widening of the growth plates of long bones, and histological lymphoid changes (restricted to the thoracic cavity and attributed to chronic emesis) were observed.
Maltese: Fi studji dwar l-effett tossiku fi klieb frieħ, kienu osservati rogħda sekondarja għal tnaqqis tal-kalċju fis-serum, emesi, tnaqqis fil-piż tal-ġisem u żieda fil-piż tal-ġisem, tnaqqis fil-massa ta' ċelluli ħomor, tnaqqis ħafif fil-parametri ta' densitometrija tal-għadam, twessigħ riversibbli tal-growth plates talgħadam it-twil, u bidliet limfojdi istoloġiċi (ristretti għall-kavità toraċika u attribwiti għall-emesi kronika).
English: The effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
Maltese: L-effett ta' inibituri ta' CYP1A2 (eż. fluvoxamine, ciprofloxacin) fuq il-livelli ta' cinacalcet fil-plażma ma ġiex studjat.
English: Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ml (77.8 and 72.4 pmol/l) for the cinacalcet and placebo groups, respectively.
Maltese: Konċetrazzjonijiet medji fil-linja bażi ta' iPTH tul it-tliet studji kienu 733 u 683 pg/ml (77.8 u 72.4 pmol/l) għall-gruppi ta' cinacalcet u plaċebo, rispettivament. 66% tal-pazjenti kienu qed jirċievu sterols ta' vitamina D fil-bidu tal-istudju, u > 90% kienu qed jirċievu binders tal-fosfat.
English: The threshold for seizures is lowered by significant reductions in serum calcium levels.
Maltese: Il-limitu għall-aċċessjonijiet huwa mnaqqas permezz ta' tnaqqis sinifikanti fil-livelli ta' kalċju fis-serum.
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole)
Maltese: (ketoconazole, itraconazole u voriconazole);
English: • abdominal pain, abdominal pain - upper
Maltese: • uġigħ abdominali, uġigħ abdominali - naħa ta' fuq
English: 10.0 mm x 6.4 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI30 on the other side.
Maltese: 0 mm x 6.4 mm, ta' lewn aħdar, ovali u bikonvessa, b'tarf imżerżaq, imnaqqxa b'M fuq naħa waħda tal-pillola u CI30 fuq in-naħa l-oħra.
English: HDPE bottle with polypropylene (PP) screw cap closure with induction sealing liner containing 100 tablets.
Maltese: Flixkun tal-HDPE b'għatu li jagħlaq bil-kamini tal-polypropylene (PP) b'induction sealing liner li jkun fih 100 pillola.
English: Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
Maltese: Madwar 60% tal-pazjenti kkurati b'cinacalcet laħqu tnaqqis ta' ≥ 30% fil-livelli ta' iPTH, u dan l-effett kien konsistenti tul il-firxa tal-livelli ta' iPTH fil-linja bażi.
English: There are no clinical data relating to the effect of cinacalcet on fertility.
Maltese: M'hemm l-ebda dejta klinika dwar l-effett ta' cinacalcet fuq il-fertilità.
English: In post-hoc analyses of pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and parathyroidectomy were lower in the cinacalcet group compared with the control group.
Maltese: F'analiżi post-hoc ta' dejta miġbura minn studji kliniċi ta' 6 xhur u 12-il xahar, l-istimi Kaplan-Meier ta' ksur tal-għadam u paratirojdektomija kienu inqas fil-ġrupp ta' cinacalcet meta mqabbla mal-grupp ta' kontroll.
English: The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers.
Maltese: Il-profil farmakokinetiku ta' cinacalcet f'pazjenti b'insuffiċjenza tal-kliewi ħafifa, moderata u severa, u dawk fuq emodijalisi jew dijalisi tal-peritonew huwa komparabbli ma' dak f'voluntiera b'saħħithom.
English: The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
Maltese: L-AUC u Cmax ta' cinacalcet jiżdiedu, bejn wieħed u ieħor b'mod lineari fuq il-firxa ta' dożi ta' 30 sa 180 mg darba kuljum.
English: Administration of cinacalcet with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Maltese: Għoti ta' cinacalcet mal-ikel wassal għal żjieda ta' madwar 50 - 80% fil-bijodisponibilità ta' cinacalcet.
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in cinacalcet-treated patients.
Maltese: Estensjoni open-label ta' dan l-istudju ma wrietx aktar tnaqqis fil-konċentrazzjoni ta' testosterone ħieles u fil-konċentrazzjoni ta' testosterone totali fuq perijodu ta' 3 snin f'pazjenti kkurati b' cinacalcet.
English: Very Common Common
Maltese: Komuni ħafna
English: This analysis showed no significant impact of age, sex, race, body surface area, and body weight on cinacalcet pharmacokinetics.
Maltese: Din l-analiżi ma wriet l-ebda impatt sinifikanti tal-età, sess, razza, erja tas-superfiċje talġisem u piż tal-ġisem fuq il-farmakokinetika ta' cinacalcet.
English: Medicinal products known to reduce serum calcium Concurrent administration of other medicinal products known to reduce serum calcium and cinacalcet may result in an increased risk of hypocalcaemia (see section 4.4).
Maltese: Prodotti mediċinali magħrufa li jnaqqsu l-kalċju fis-serum L-għoti ta' prodotti mediċinali oħra magħrufa li jnaqqsu l-kalċju fis-serum flimkien ma' cinacalcet jista' jwassal għal żieda fir-riskju ta' ipokalċimija (ara sezzjoni 4.4).
English: 12.5 mm x 8.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI60 on the other side.
Maltese: Pillola miksija b'rita b'daqs ta' 12.5 mm x 8.0 mm, ta' lewn aħdar, ovali u bikonvessa, b'tarf imżerżaq, imnaqqxa b'M fuq naħa waħda tal-pillola u CI60 fuq in-naħa l-oħra.
English: A significantly higher percentage of cinacalcet treated patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dl (2.57 mmol/l) and ≥ 1 mg/dl (0.25 mmol/l) decrease from baseline in mean corrected total serum calcium concentration, when compared with the placebo treated patients (75.8% versus 0% and 84.8% versus 5.9% respectively).
Maltese: 3 mg/dl (2.57 mmol/l) u tnaqqis ta' ≥ 1 mg/dl (0.25 mmol/l) mil-linja bażi medja kkoreġuta ta' konċentrazzjoni totali ta' calcium fis-serum, meta mqabbla mal-pazjenti kkurati bil-plaċebo (75.
English: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Maltese: Indeboliment ħafif tal-fwied ma affettwax il-farmakokinetika ta' cinacalcet b'mod notevoli.
English: Parathyroid carcinoma and Primary Hyperparathyroidism In one study, 46 adult patients (29 with parathyroid carcinoma and 17 with primary HPT and severe hypercalcaemia (who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT).
Maltese: Karċinoma tal-paratirojde u Iperparatirojdiżmu Primarju Fi studju wieħed, 46 pazjent adult (29 b'karċinoma tal-paratirojde u 17 b'HPT primarja u b'iperkalċimija severa (li kienu fallew jew li kellhom kontra-indikazzjonijiet għall-paratirojdektomija) irċevew cinacalcet sa 3 snin (medja ta' 328 ġurnata għall-pazjenti b'karċinoma tal-paratirojde u medja ta' 347 ġurnata għall-pazjenti b'HPT primarja). Cinacalcet ingħata f'firxa ta' dożi minn 30 mg darbtejn kuljum sa 90 mg erba' darbiet kuljum.
English: Approximately 80% of the dose was recovered in the urine and 15% in the faeces.
Maltese: Madwar 80% tad-doża kienet irkuprata fl-awrina u 15% fl-ippurgar.
English: Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment.
Maltese: Phosphate binders li fihom il-kalċju, sterols talvitamina D u/jew aġġustament talkonċentrazzjonijiet tal-kalċju fil-fluwidu taddijalisi jistgħu jintużaw biex jgħollu l­kalċju fisserum skont il-ġudizzju kliniku.
English: Myalgia Muscle spasms Back pain
Maltese: Uġigħ fil muskoli Spażmi muskolarji Uġigħ fid-dahar
English: Cinacalcet Mylan 90 mg film-coated tablets cinacalcet
Maltese: Cinacalcet Mylan 90 mg pilloli miksija b'rita cinacalcet
English: After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and a terminal half-life of 30 to 40 hours.
Maltese: Wara l-assorbiment, il-konċentrazzjonijiet ta' cinacalcet jonqsu b'mod bifażiku b'half-life tal-bidu ta' madwar 6 sigħat u half-life terminali ta' 30 sa 40 siegħa.
English: Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Maltese: Iperparatirojdiżmu sekondarju, karċinoma tal-paratirojde, u iperparatirojdiżmu primarja Ibbażata fuq dejta disponibbli minn pazjent li qed jirċievu cinacalcet f'studji kkontrollati b' placebo u studji b'id waħda l-aktar reazzjonijiet avversi rrappurtati b'mod komuni kienu tqalligħ u rimettar.
English: Protein binding of cinacalcet is not affected by impaired hepatic function.
Maltese: Ir-rabta ta' cinacalet mal-proteini mhix affettwata minn funzjoni tal-fwied indebolita.
English: Cinacalcet Mylan 60 mg film-coated tablets Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' cinacalcet (bħala hydrochloride).
English: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2mediated metabolism.
Maltese: It-tneħħija ta' cinacalcet hija ogħla f'min ipejjep milli f'min ma jpejjipx, probabbilment minħabba induzzjoni ta' metaboliżmu medjat minn CYP1A2.
English: Cinacalcet Mylan 60 mg film-coated tablets cinacalcet
Maltese: Cinacalcet Mylan 60 mg pilloli miksija b'rita cinacalcet
English: Cinacalcet Mylan reduces calcium levels.
Maltese: Cinacalcet Mylan inaqqas il-livelli tal-kalċju.
English: Pantoprazole: Co-administration of pantoprazole (80 mg, once daily) did not alter the pharmacokinetics of cinacalcet.
Maltese: L-għoti flimkien ta' pantoprazole (80 mg darba kuljum) ma affettwax il-farmakokinetika ta' cinacalcet.
English: 14.3 mm x 9.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI90 on the other side.
Maltese: Pillola miksija b'rita b'daqs ta' 14.3 mm x 9.0 mm, ta' lewn aħdar, ovali u bikonvessa, b'tarf imżerżaq, imnaqqxa b'M fuq naħa waħda tal-pillola u CI90 fuq in-naħa l-oħra.
English: Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Maltese: Dożi mutlipli orali ta' cinacalcet ma affettwawx il-farmakokinetika jew il-farmakodinamika (kif imkejla mill-ħin prothrombin u l-fattur VII li jgħaqqad id-demm) ta' warfarin.
English: Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Maltese: Madwar 97% ta' cinacalcet huwa marbut mal-proteini tal-plażma u ftit li xejn jiġi distribwit fiċ-ċelluli l-ħomor tad-demm.
English: Cinacalcet Mylan 30 mg film-coated tablets Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 30 mg ta' cinacalcet (bħala hydrochloride).
English: • loss (anorexia) or decrease of appetite
Maltese: • telf (anoreksja ) jew tnaqqis ta' l-aptit
English: Children under the age of 18 must not take Cinacalcet Mylan.
Maltese: Tfal u adoloxxenti Tfal taħt l-età ta' 18-il sena m'għandhomx jieħdu Cinacalcet Mylan.
English: Cinacalcet Mylan 30 mg film-coated tablets cinacalcet
Maltese: Cinacalcet Mylan 30 mg pilloli miksija b'rita cinacalcet
English: The lack of effect of cinacalcet on the pharmacokinetics of R-and S-warfarin and the absence of autoinduction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Maltese: In-nuqqas ta' effett ta' cinacalcet fuq il-farmakokinetika ta' R- u S-warfarin u n-nuqqas ta' awto-induzzjoni wara dożaġġ multiplu f'pazjenti jindika li cinacalcet mhux induttur ta' CYP3A4, CYP1A2 jew CYP2C9 fil-bnedmin.
English: Cinacalcet Mylan 90 mg film-coated tablets Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 90 mg ta' cinacalcet (bħala hydrochloride).
English: Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Maltese: Karatteristiċi demografiċi u tal-linja bażi kienu rappreżentattivi tal-popolazzjoni ta' pazjenti fuq dijalisi b'HPT sekondarja.
English: • Hives (urticaria).
Maltese: • Ħorriqija (urtikarja)
English: Film-coat:
Maltese: Pantoprazole:
English: Hypocalcaemia Hyperkalaemia Reduced testosterone levels†
Maltese: Ipokalċimija Iperkalimija Tnaqqis fil livelli ta' testosterone
English: Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in subjects with moderate impairment and approximately 4-fold higher in subjects with severe impairment.
Maltese: Meta mqabbla ma' individwi b'funzjoni normali tal-fwied, l-AUC medja ta' cinacalcet kienet madwar darbtejn ogħla f'individwi b'indeboliment moderat u madwar 4-darbiet ogħla f'individwi b'indeboliment sever.
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are:
Maltese: Inċidenza ta' reazzjonijiet avversi u esperjenza ta' wara t-tqegħid fis-suq huma:
English: Parathyroid carcinoma and primary hyperparathyroidism:
Maltese: Karċinoma tal-paratirojde u iperparatirojdiżmu primarju
English: Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once-daily dosing interval.
Maltese: Minn hemm 'l quddiem, kif il-livelli ta' cinacalcet jibdew jonqsu, il-livelli ta' PTH jiżdiedu sa 12-il siegħa wara d-doża, u wara s-soppressjoni ta' PTH tibqa' bejn wieħed u ieħor kostanti sal-aħħar tal-intervall ta' dożaġġ ta' darba kuljum.
English: • medicines used to treat changes in heart rate (flecainide and propafenone)
Maltese: • mediċini wżati għall-kura ta' tibdil fir-rata tal-qalb (flecainide u propafenone);
English: Recommendations
Maltese: Astenja
English: Concurrent administration may result in severe hypocalcaemia.
Maltese: Għoti fl-istess waqt jista' jwassal għal ipokalċimija severa.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01
Maltese: Pazjenti li jkunu qed jirċievu cinacalcet m'għandhomx jingħataw etelcalcetide (ara sezzjoni 4.4).
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Maltese: Cinacalcet intwera li jaqsam il-barriera tal-plaċenta fil-fniek.
English: PTH levels should be assessed at least 12 hours after dosing with cinacalcet.
Maltese: Il-livelli ta' PTH għandhom jitkejjlu tal-inqas 12-il siegħa wara li jingħata cinacalcet.
English: After titration to the maximum dose of cinacalcet, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of cinacalcet therapy should be considered (see section 5.1).
Maltese: Wara titrazzjoni sad-doża massima ta' cinacalcet, il-kalċju fis-serum għandu jiġi ssorveljat perjodikament; jekk ma jinżamx tnaqqis klinikment rilevanti tal-kalċju fis-serum, għandu jiġi kkunsidrat twaqqif għal kollox tat-terapija b'cinacalcet (ara sezzjoni 5.1).
English: Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 persuni • tqalligħ u rimettar, dawn l-effetti sekondarji normalment huma ħfief u ma jdumux ħafna.
English: How to take Cinacalcet Mylan
Maltese: X'fih Cinacalcet Mylan
English: Testosterone levels are often below the normal range in patients with end-stage renal disease.
Maltese: Livelli ta' testosterone ta' spiss ikunu taħt il-firxa normali f'pazjenti b'mard renali tal-aħħar stadju.
English: In the event that corrected serum calcium levels fall below 8.4 mg/dl (2.1 mmol/l) and/or symptoms of hypocalcaemia occur the following management is recommended:
Maltese: F'każ li l-livelli ta' kalċju kkoreġut fis-serum jonqsu taħt 8.4 mg/dL (2.1 mmol/L) u/jew iseħħu sintomi ta' ipokalċimija huwa rakkomandat l-immaniġġjar li jmiss:
English: Either the intact PTH (iPTH) or biointact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the relationship between iPTH and biPTH.
Maltese: Il-PTH intatt (iPTH) jew il-PTH bijo-intatt (biPTH) jistgħu jintużaw biex jitkejlu l-livelli ta' PTH; kura b'cinacalcet ma tibdilx ir-relazzjoni bejn iPTH u biPTH.
English: Cinacalcet Mylan 30 mg film-coated tablets.
Maltese: IL-PRODOTT MEDIĊINALI Cinacalcet Mylan 30 mg pilloli miksija b'rita.
English: • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Maltese: • HPT primarja fejn paratirojdektomija għandha tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta' kura rilevanti), iżda fejn paratirojdektomija mhux klinikament xierqa jew hija kontraindikata.
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Maltese: Ma kienx hemm effetti fuq il-fertilità fl-irġiel jew n-nisa f'espożizzjonijiet sa 4 darbiet id-doża umana ta' 180 mg/kuljum (marġini ta' siġurtà fil-popolazzjoni żgħira ta' pazjenti mogħtija id-doża klinika massima ta' 360 mg kuljum tkun madwar nofs dawk mogħtija hawn fuq).
English: EU/1/15/1054/005 EU/1/15/1054/006 EU/1/15/1054/007 EU/1/15/1054/012
Maltese: EU/1/15/1054/011 EU/1/15/1054/012
English: You should not take Cinacalcet Mylan together with etelcalcetide.
Maltese: M'għandekx tirċievi Cinacalcet Mylan flimkien ma' etelcalcetide.
English: The normal calcium range may differ depending on the methods used by your local laboratory.
Maltese: Il-firxa normali tal-kalċju tista' tvarja skont il-metodi wżati mil-laboratorju lokali tiegħek.
English: Riarify (beclomethasone / formoterol / glycopyrronium bromide)
Maltese: Riarify (beklometażona / formoterol / glikopirronju bromur)
English: Further information on Riarify can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/riarify-previously-chf-5993-chiesifarmaceutici-spa.
Maltese: Aktar informazzjoni fuq Riarify tinstab fis-sit elettroniku tal-Aġenzija: https://www.ema.europa.eu/en/medicines/human/EPAR/riarify-previously-chf-5993-chiesifarmaceutici-spa.
English: Other information about Riarify
Maltese: Informazzjoni oħra dwar Riarify
English: Riarify received a marketing authorisation valid throughout the EU on 23 April 2018.
Maltese: Riarify ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' April 2018.
English: What are the risks associated with Riarify?
Maltese: X'inhuma r-riskji assoċjati ma' Riarify?
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system.
Maltese: Din taħdem b'mod simili għall-ormoni kortikosterojdi li jseħħu b'mod naturali, fejn tnaqqas l-attività tas-sistema immunitarja.
English: Formoterol is a long-acting beta-2 agonist.
Maltese: Il-formoterol hija agonista ta' beta-2 li taħdem fit-tul.
English: Glycopyrronium bromide is a long-acting muscarinic receptor antagonist.
Maltese: Il-glikopirronju bromur hija antagonista ta' riċettur muskariniku.
English: Side effects with Riarify include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
Maltese: L-effetti sekondarji b'Riarify jinkludu kandidjażi orali (infezzjoni fungali tal-ħalq ikkawżata minn ħmira msejħa Candida), spażmi tal-muskoli u ħalq xott.
English: Riarify contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Maltese: Riarify fih is-sustanzi attivi beklometażona, formoterol u l-glikopirronju bromur.
English: By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Riarify (beclometasone plus formoterol).
Maltese: B'paragun, l-FEV1 żdied b'1 u b'145 ml qabel u wara d-doża rispettivament f'pazjenti kkurati b'mediċina li fiha biss tnejn mis-sustanzi attivi li jinsabu f'Riarify (il-beklometażona flimkien ma' formoterol).
English: The company that makes Trimbow has agreed that its scientific data can be used for Riarify (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Trimbow qablet li d-data xjentifika tagħha tista' tintuża għal Riarify (“kunsens infurmat”).
English: In the first study lasting a year, after 26 weeks of treatment Riarify improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose.
Maltese: Riarify tejjeb l-FEV1 (il-volum massimu ta' arja li persuna tista' toħroġ man-nifs f'sekonda) tal-pazjenti b'82 ml qabel doża u b'261 ml wara doża.
English: In the third study lasting a year, patients treated with Riarify had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Maltese: Fit-tielet studju li dam sena, il-pazjenti kkurati b'Riarify kellhom 15 % taħrix inqas fis-sena minn pazjenti kkurati b'kombinazzjoni ta' indakaterol (agonista ta' beta-2 li taħdem fit-tul) u glikopirronju bromur.
English: Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
Maltese: Agonisti ta' beta-2 u antagonisti ta' riċettur muskariniku jgħinu biex il-passaġġi tal-arja jitwessgħu; il-kortikosterojdi jnaqqsu l-infjammazzjoni fil-passaġġi tal-arja u fil-pulmuni.