FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean (SD) iPTH concentrations at baseline were 757.1 (440.1) pg/mL for the cinacalcet group and 795.8 (537.9) pg/mL for the placebo group.
Maltese: Il-konċentrazzjonijiet medji (SD) ta' iPTH fillinja bażi kienu 757.1 (440.1) pg/mL għall-grupp ta' cinacalcet u 795.
English: INFORMATION IN BRAILLE mimpara 90
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 90
English: After single and multiple once daily oral doses of cinacalcet, plasma cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar to those observed in adult patients.
Maltese: Wara dożi orali singoli u multipli ta' cinacalcet darba kuljum, il-konċentrazzjonijiet ta' cinacalcet fil-plażma (valuri ta' Cmax u AUC wara normalizzazzjoni bid-doża u l-piż) kienu simili għal dawk osservati f'pazjenti adulti.
English: Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n = 1,136).
Maltese: Twettqu tliet studji kliniċi ta' 6-xhur, double-blind u kkontrollati bil-plaċebo f'pazjenti b'ESRD b'HPT sekondarju mhux ikkontrollat, li kienu qed jirċievu d-dijalisi (n = 1,136).
English: In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/mL (≤ 26.5 pmol/L)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
Maltese: F'kull wieħed mill-istudji, il-punt finali primarju (proporżjon ta' pazjenti b'iPTH ≤ 250 pg/mL (≤ 26.5 pmol/L)) intlaħaq minn 41%, 46%, u 35% tal-pazjenti li rċevew cinacalcet, meta mqabbla ma' 4%, 7%, u 6% tal-pazjenti li rċevew il-plaċebo.
English: 5, 10, 15, 30, 60, and 90
Maltese: 5, 10, 15, 30, 60, u 90
English: 2.5, 5, 7.5, 10, 15, and 30
Maltese: 2.5, 5, 7.5, 10, 15, u 30
English: 25 subjects received at least one dose of cinacalcet and the mean maximum daily dose of cinacalcet was 0.55 mg/kg/day.
Maltese: cinacalcet u d-doża massima medja ta' kuljum ta' cinacalcet kienet ta' 0.55 mg/kg/jum.
English: Among all paediatric subjects exposed to cinacalcet in clinical studies a total of 19 subjects (24.1%; 64.5 per 100 subject years) had at least one adverse event of hypocalcaemia.
Maltese: Fost l-individwi pedjatriċi kollha esposti għal cinacalcet fi studji kliniċi, total ta' 19-il individwu (24.1%; 64.5 għal kull 100 sena ta' individwu) kellhom mill-inqas avveniment avvers wieħed ta' ipokalċimija.
English: In a 28 week placebo-controlled study, 67 adult patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dL (2.82 mmol/L) but ≤ 12.5 mg/dL (3.12 mmol/L), but who were unable to undergo parathyroidectomy were included.
Maltese: Fi studju kkontrollat bi plaċebo ta' 28 ġimgħa, 67 pazjent adult b'HPT primarju li ssodisfaw il-kriterji għall-paratirojdektomija abbażi ta' kalċju totali kkoreġut fis-serum > 11.3 mg/dL (2.82 mmol/L) iżda ≤ 12.5 mg/dL (3.12 mmol/L), iżda li ma setgħux jagħmlu paratirojdektomija kienu inklużi.
English: They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.
Maltese: Għandhom għamla ovali u “30”, “60” jew “90” immarkat fuq naħa u “AMG” fuq in-naħa l-oħra.
English: Administration of Mimpara with food results in an approximate 50-80% increase in cinacalcet bioavailability.
Maltese: Għoti ta' Mimpara mal-ikel iwassal għal żieda ta' madwar 50-80% fil-bijodisponibilità ta' cinacalcet.
English: Closely monitor serum calcium levels (see section 4.2) and patient compliance during treatment with cinacalcet.
Maltese: Segwi mill-qrib il-livelli tal-kalċju fis-serum (ara sezzjoni 4.2) u l-konformità tal-pazjent waqt ittrattament b'cinacalcet.
English: INFORMATION IN BRAILLE mimpara 60
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 60
English: • parathyroid carcinoma.
Maltese: • karċinoma tal-paratirojde.
English: Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Maltese: L-għoti flimkien ma' pantoprazole (80 mg od) ) ma affettwax il-farmakokinetika ta' cinacalcet.
English: Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet (see section 4.8).
Maltese: Każijiet ta' titwilta' QT u arritmija ventrikulari kienu rrappurtati f'pazjenti ttrattati b'cinacalcet (ara sezzjoni 4.8).
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolised by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Maltese: Din id-data tissuġġerixxi li cinacalcet ma jaffettwax il-farmakokinetika ta' dawk il-klassijiet ta' mediċini li huma metabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosoppressanti, inkluż cyclosporine u tacrolimus.
English: Dose adjustment of Mimpara may be required if a patient receiving Mimpara initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme.
Maltese: Jista' jkun hemm bżonn ta' aġġustament fid-doża ta' Mimpara jekk pazjent li qed jieħu Mimpara jibda jew iwaqqaf terapija b'inibitur qawwi (eż. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) jew induttur qawwi (eż. rifampicin) ta' din l-enzima.
English: Iron oxide yellow (E172) Indigo carmine (E132)
Maltese: Iron oxide isfar (E172) Indigo carmine (E132) Titanium dioxide (E171)
English: INFORMATION IN BRAILLE mimpara 30
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 30
English: Cases of seizures have been reported in patients treated with Mimpara (see section 4.8).
Maltese: Każijiet ta' aċċessjonijiet kienu rrappurtati f'pazjenti trattati b'Mimpara (ara sezzjoni 4.8).
English: 5, 10, 15, 30, and 60
Maltese: 5, 10, 15, 30, u 60
English: Dose adjustments of concomitant medicinal products may be required when Mimpara is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine).
Maltese: Jista' jkun hemm bżonn ta' aġġustamenti fid-doża ta' prodotti mediċinali ttitrati individwalment, li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6 (eż., flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) meta dawn jingħataw flimkien ma' Mimpara.
English: In patients with parathyroid carcinoma, mean serum calcium declined from 14.1 mg/dL to 12.4 mg/dL (3.5 mmol/L to 3.1 mmol/L), while in patients with primary HPT, serum calcium levels declined from 12.7 mg/dL to 10.4 mg/dL (3.2 mmol/L to 2.6 mmol/L).
Maltese: F'pazjenti b'karċinoma tal-paratirojde, il-medja tal-kalċju fis-serum naqset minn 14.1 mg/dL għal 12.4 mg/dL (3.5 mmol/L għal 3.1 mmol/L), filwaqt li f'pazjenti b'HPT primarju, il-livelli ta' kalċju fis-serum naqsu minn 12.7 mg/dL għal 10.
English: The dose of Mimpara should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Maltese: Id-doża ta' Mimpara għandha tiġi ttitrata kull ġimagħtejn sa 4 ġimgħat permeżż ta' dożi sekwenzjali ta' 30 mg darbtejn kuljum, 60 mg darbtejn kuljum, 90 mg darbtejn kuljum, u 90 mg tlieta jew erba' darbiet kuljum, kif neċessarju biex titnaqqas il-konċetrazzjoni ta' kalċju fis-serum sa jew inqas mil-limitu ta' fuq tan-normal.
English: The study consisted of a 24-week dose titration period followed by a 6-week efficacy assessment phase (EAP), and a 30-week openlabel extension.
Maltese: L-istudju kien jikkonsisti minn perjodu ta' titrazzjoni tad-doża ta' 24 ġimgħa segwit minn fażi ta' valutazzjoni taleffikaċja ta' 6 ġimgħat (EAP - efficacy assessment phase), u estensjoni open-label ta' 30 ġimgħa.
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium
Maltese: < 8.4 mg/dL (2.1 mmol/L) u > 7.5 mg/dL (1.9 mmol/L) jew sintomi persistenti ta' ipokalċimija minkejja tentattivi biex jiżdied ilkalċju fid-demm
English: Dispose of the capsule shells.
Maltese: Armi l-qoxra tal-kapsuli.
English: In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12-fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
Maltese: Fi studji in vitro, valuri ta' IC50 għat-trasportatur ta' serotonin u tal-kanali KATP instabu li kienu 7 u 12 -il darba ikbar rispettivament mill-EC50 tar-riċettur li jħoss il-kalċju, miġbura taħt l-istess kondizzjonijiet sperimentali.
English: Seizures† Dizziness Paraesthesia Headache
Maltese: Sturdament Parasteżija Uġigħ ta' ras
English: The study did not meet its primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 17 to 20).
Maltese: L-istudju ma ssodisfax il-punt finali primarju tiegħu (tnaqqis ta' ≥ 30% mil-linja bażi fl-iPTH medju fil-plażma matul l-EAP; ġimgħat 17 sa 20).
English: ≤ 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia and Vitamin D cannot be increased
Maltese: ≤ 7.5 mg/dL (1.9 mmol/L) jew sintomi persistenti ta' ipokalċimija u l-Vitamina D ma tistgħax tiżdied
English: Mimpara 30 mg film-coated tablets
Maltese: Mimpara 30 mg pillola Cinacalcet
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.9 (0.5) mg/dL for the cinacalcet group and 9.9 (0.6) mg/dL for the placebo group.
Maltese: Il-konċentrazzjonijiet medji ta' kalċju totali kkoreġut fis-serum (SD) fil-linja bażi kienu 9.9 (0.5) mg/dL għall-grupp ta' cinacalcet u 9.9 (0.6) mg/dL għall-grupp tal-plaċebo.
English: Other medicines and Mimpara
Maltese: Mediċini oħra u Mimpara
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Maltese: Kull pillola fiha 30 mg, 60 mg jew 90 mg cinacalcet (bħala hydrochloride).
English: * Administer calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols, as clinically indicated.
Maltese: Twaqqaf it-trattament b'Mimpara.* Agħti supplimenti tal-kalċju, phosphate binders li fihom il-kalċju u/jew sterols tal-vitamina D, kif indikat klinikament.
English: Study 2 was an open-label study in which 55 patients aged 6 to < 18 years (mean 13 years) were randomised to receive either cinacalcet in addition to standard of care (SOC, n = 27) or SOC alone (n = 28).
Maltese: Studju 2 kien studju open-label li fih 55 pazjent ta' età minn 6 sa < 18-il sena (medja ta'13-il sena) kienu randomised biex jirċievu cinacalcet flimkien ma' kura standard (SOC - standard of care, n = 27) jew SOC waħdu (n = 28) .
English: The capsules have a white body and coloured caps “1 mg” (dark green cap), “2.5 mg” (yellow cap) or “5 mg” (blue cap) marked on one side and “AMG” on the other side.
Maltese: Il-kapsuli għandhom korp abjad u għotjien ikkuluriti b'“1 mg” (għatu aħdar skur), “2.5 mg” (għatu isfar) jew “5 mg” (għatu blu) immarkat fuq naħa waħda u “AMG” fuq in-naħa l-oħra.
English: Withhold administration of Mimpara until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved.
Maltese: Waqqaf l-għoti ta' Mimpara sakemm il-livelli talkalċju fis-serum jilħqu 8.0 mg/dL (2.0 mmol/L) u/jew is-sintomi ta' ipokalċimija jgħaddu.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Investigational studies have shown that adult CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dL [2.1 mmol/L]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Maltese: Studji investigattivi wrew li pazjenti adulti b'CKD li mhux qed jirċievu d-dijalisi li ngħataw cinacalcet għandhom riskju ogħla ta' ipokalċimija (livelli ta' kalċju fis-serum < 8.4 mg/dL [2.1 mmol/L]) meta mqabbla ma' pazjenti b'CKD li qed jirċievu d-dijalisi u li ngħataw cinacalcet.
English: A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 4.4).
Maltese: Riżultat fatali kien irrappurtat f'pazjent pedjatriku fi prova klinika b'ipokalċimija severa (ara sezzjoni 4.4).
English: Not known: frequency cannot be estimated from available data
Maltese: Mhux magħruf: il-frekwenza ma tistax tiġi stmata mid-data disponibbli
English: Ensure serum calcium levels are within the normal range before Mimpara is initiated (see sections 4.4 and 4.8).
Maltese: Kun ċert li l-livelli tal-kalċju fis‑serum ikunu fil-firxa normali qabel ma jinbeda Mimpara (ara sezzjonijiet 4.4 u 4.8).
English: The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Maltese: Id-doża tista' tiżdied sa doża massima ta' 2.5 mg/kg/jum, biex ma taqbiżx doża totali ta' kuljum ta' 180 mg.
English: Study 3 was a 26-week, open-label, single-arm safety study in patients aged 8 months to < 6 years (mean age 3 years).
Maltese: Studju 3 kien studju dwar is-sigurtà ta' 26 ġimgħa, open-label, bi grupp wieħed f'pazjenti minn 8 xhur sa < 6 snin (età medja ta' 3 snin).
English: Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).
Maltese: Trattament ta' iperparatirojdiżmu sekondarju (HPT - hyperparathyroidism) fi tfal ta' età minn 3 snin 'il fuq b'marda tal-kliewi tal-aħħar stadju (ESRD - end-stage renal disease) fuq terapija ta' manteniment b'dijalisi li l-HPT sekondarju tagħhom ma jkunx ikkontrollat b'mod adegwat b'terapija ta' kura standard (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Maltese: Omeostasi tal-kalċju, sustanzi anti-paratirojde.
English: Each capsule contains 1 mg, 2.5 mg or 5 mg of cinacalcet (as hydrochloride) granules.
Maltese: Kull kapsula fiha 1 mg, 2.5 mg jew 5 mg grani ta' cinacalcet (bħala hydrochloride).
English: Do not swallow the capsules whole.
Maltese: Il-qoxra tal-kapsula mhix għall-inġestjoni.
English: • muscle spasms
Maltese: • spazmi fil-muskoli
English: Paediatric population: The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis aged 3 to 17 years of age.
Maltese: Il-farmakokinetika ta' cinacalcet ġiet studjata f'pazjenti pedjatriċi b'ESRD li jirċievu d-dijalisi ta' età minn 3 snin sa 17-il sena.
English: Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening Cinacalcet
Maltese: Mimpara 1 mg grani f'kapsuli biex jinfetħu Mimpara 2.5 mg grani f'kapsuli biex jinfetħu Mimpara 5 mg grani f'kapsuli biex jinfetħu Cinacalcet
English: • low blood pressure (hypotension)
Maltese: • pressjoni baxxa (ipotensjoni)
English: • If iPTH is < 150 pg/mL (15.9 pmol/L) and ≥ 100 pg/mL (10.6 pmol/L), decrease the dose of Mimpara to the next lower dose.
Maltese: 9 pmol/L) u ≥ 100 pg/mL (10.6 pmol/L), naqqas id-doża ta' Mimpara għad-doża aktar baxxa li jmiss.
English: In CKD patients receiving dialysis who were administered Mimpara, 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'CKD li kienu qed jirċievu d-dijalisi, li ngħataw Mimpara, bejn wieħed u ieħor 30% talpazjenti kellhom tal-inqas valur wieħed ta' kalċju fis-serum inqas minn 7.5 mg/dL (1.9 mmol/L).
English: Mimpara should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Maltese: Mimpara għandu jintuża b'attenzjoni f'pazjenti b'indeboliment tal-fwied moderat sa sever u t-trattament għandu jiġi mmonitorjat mill-viċin waqt titrazzjoni tad-doża u waqt trattament kontinwu (ara sezzjonijiet 4.4 u 5.2).
English: EU/1/04/292/011 - carton of 84 tablets
Maltese: EU/1/04/292/011 - kaxxa b'84 pillola
English: None had corrected serum calcium < 8.4 mg/dL (2.1 mmol/L) for ages 2-5 years.
Maltese: L-ebda pazjent ma kellu kalċju kkoreġut fis-serum ta' < 8.4 mg/dL (2.1 mmol/L) għalletajiet ta' 2-5 snin.
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 2.5 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kapsula fiha 2.5 mg ta' cinacalcet (bħala hydrochloride).
English: Indigo carmine (E132)
Maltese: Indigo carmine (E132) Titanium dioxide (E171)
English: This study was terminated early due to a fatality with severe hypocalcaemia in the cinacalcet group (see section 4.8).
Maltese: Każijiet ta' titwil ta' QT u arritmija ventrikulari kienu rrappurtati f'pazjenti ttrattati b'cinacalcet (ara sezzjoni 4.8).
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' data 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: Parathyroid carcinoma and primary hyperparathyroidism in adults
Maltese: Karċinoma tal-paratirojde u iperparatirojdiżmu primarju fl-adulti
English: Light green, oval (approximately 12.2 mm long and 7.6 mm wide), film-coated tablet marked “AMG” on one side and “60” on the other.
Maltese: Pillola miksija b'rita, ta' lewn aħdar ċar, ovali (b'tul ta' madwar 12.2 mm u wisa' ta' 7.6 mm), immarkata b'“AMG” fuq naħa waħda u “60” fuq in-naħa l-oħra.
English: The mean age at baseline was 13 (range 6 to 18) years.
Maltese: età medja fil-linja bażi kienet ta' 13-il sena (firxa 6 sa 18-il sena).
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 ttrattati 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: Mimpara is available in bottles of 1 mg, 2.5 mg or 5 mg capsules, inside a carton.
Maltese: Mimpara huwa disponibbli fi fliexken ta' kapsuli ta' 1 mg, 2.5 mg jew 5 mg, ġewwa kartuna.
English: Either the intact PTH (iPTH) or bio-intact PTH (biPTH) may be used to measure PTH levels; treatment with Mimpara does not alter the relationship between iPTH and biPTH.
Maltese: Il-PTH intatt (iPTH - intact PTH) jew il-PTH bijo-intatt (biPTH - bio-intact PTH) jistgħu jintużaw biex jitkejlu l-livelli ta' PTH; trattament b'Mimpara ma jibdilx ir-relazzjoni bejn iPTH u biPTH.
English: Mimpara 90 mg film-coated tablets
Maltese: Mimpara 90 mg, pillola Cinacalcet
English: Mimpara 1 mg granules in capsules for opening Gelatin
Maltese: Mimpara 1 mg grani f'kapsuli biex jinfetħu Gelatin
English: Renal Insufficiency: 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: Insuffiċjenza tal-Kliewi: 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: Mimpara 2.5 mg granules in capsules for opening Gelatin
Maltese: Mimpara 2.5 mg grani f'kapsuli biex jinfetħu Gelatin
English: EU/1/04/292/007 - carton of 84 tablets
Maltese: EU/1/04/292/007 - kaxxa b'84 pillola
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.8 (0.6) mg/dL for the cinacalcet + SOC group and 9.8 (0.6) mg/dL for the SOC group.
Maltese: Il-konċentrazzjonijiet medji (SD) ta' kalċju totali kkoreġut fis-serum fil-linja bażi kienu 9.8 (0.6) mg/dL għall-grupp ta' cinacalcet + SOC u 9.8 (0.6) mg/dL għall-grupp ta' SOC. 25 individwu rċivew mill-inqas doża waħda ta'
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 1 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kapsula fiha 1 mg ta' cinacalcet (bħala hydrochloride).
English: Mimpara is also available as granules for paediatric use.
Maltese: Mimpara huwa disponibbli wkoll bħala grani għall-użu pedjatriku.
English: EU/1/04/292/003 - carton of 84 tablets
Maltese: EU/1/04/292/003 - kaxxa b'84 pillola
English: Capsule consists of a blue colour cap, marked “AMG” and white opaque body, marked “5 mg”.
Maltese: Il-kapsula tikkonsisti f'għatu ta' lewn blu, immarkat b'“AMG” u korp abjad opak, immarkat b'“5 mg”.
English: Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet-treated patients compared with placebo-treated patients receiving standard of care, and the results were consistent across the 3 studies.
Maltese: Tnaqqis sinifikanti f'iPTH, fil-prodott ta' kalċju-fosforu fis-serum (Ca x P), fil-kalċju, u fil-fosforu kien osservat fil-pazjenti ttrattati b'cinacalcet meta mqabbla mal-pazjenti ttrattati bil-plaċebo li kienu qed jirċievu kura stàndard, u r-riżultati kienu konsistenti tul it-tliet studji.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg, 2.5 mg or 5 mg cinacalcet (as hydrochloride).
Maltese: Kull kapsula fiha 1 mg, 2.5 mg jew 5 mg cinacalcet (bħala hydrochloride).
English: The usual starting dose of Mimpara for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.
Maltese: Ġeneralment id-doża tal-bidu ta' Mimpara għal tfal ta' età minn 3 snin sa inqas minn 18-il sena ma tkunx aktar minn 0.20 mg/kg ta' piż tal-ġisem kuljum.
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-pjanċi tat-tkabbir talgħadam it-twil, u bidliet limfojdi istoloġiċi (ristretti għall-kavità toraċika u attribwiti għall-emesi kronika).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 30 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 30 mg ta' cinacalcet (bħala hydrochloride).
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 multipli 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: NAME OF THE MEDICINAL PRODUCT Mimpara 2.5 mg granules in capsules for opening cinacalcet
Maltese: TAL-PRODOTT MEDIĊINALI Mimpara 2.5 mg grani f'kapsuli biex jinfetħu cinacalcet
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 60 mg of cinacalcet (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 60 mg ta' cinacalcet (bħala hydrochloride).
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/008
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/008