FrancophonIA/ELRC3.0 huggingface dataset:
English: At doses above 200 mg, the absorption was saturated probably due to poor solubility.
Maltese: F'dożi ogħla minn 200 mg, l-assorbiment kien saturat probabbilment minħabba solubilità baxxa.
English: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine)
Maltese: • mediċini wżati għall-kura tad-depressjoni (amitriptyline, desipramine, nortriptyline u clomipramine);
English: The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).
Maltese: Il-kisja tal-pillola fiha hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), iron oxide yellow (E172).
English: The other ingredients are cellulose, microcrystalline; silica, colloidal anhydrous; povidone; crospovidone; magnesium stearate.
Maltese: Is-sustanzi l-oħra huma cellulose, microcrystalline; silica, colloidal anhydrous; povidone; crospovidone; magnesium stearate.
English: Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: 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); not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi, kkunsidrati bħala tal-inqas possibilment attribwiti mal-kura b'cinacalcet f' studji ikkontrolati b' placebo u studji single-arm ibbażati fuq valutazzjoni tal-aqwa evidenza ta' kawżalità u huma mniżżla hawn taħt skont il-konvenzjoni li ġejja: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): cinacalcet is a strong inhibitor of CYP2D6.
Maltese: Prodotti mediċinali metabolizzati mill-enżima P450 2D6 (CYP2D6): Cinacalcet huwa inibitur qawwi ta' CYP2D6.
English: • reduced testosterone levels
Maltese: • tnaqqis fil-livelli ta' testosterone
English: After adjusting for baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 95% CI: 0.79, 0.97.
Maltese: Wara l-aġġustament għall-karatteristiċi tal-linja bażi f'analiżi sekondarja, lHR għall-endpoint kompost primarju kien 0.88; 95% CI: 0.79, 0.97.
English: Reporting of side effects
Maltese: Rapurtar ta' effetti sekondarji
English: • muscle spasms
Maltese: • spazmi muskolarji
English: Cinacalcet is metabolised in part by the enzyme CYP3A4.
Maltese: Cinacalcet huwa metabolizzat parzjalment mill-enzima CYP3A4.
English: Serum calcium
Maltese: Calcium carbonate:
English: Paediatric population
Maltese: d) Populazzjoni pedjatrika
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia
Maltese: <8.4 mg/dL (2.1 mmol/L) u>7.5 mg/dL (1.9 mmol/L), jew fil-preżenza ta' sintomi kliniċi ta' ipokalċimija
English: Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
Maltese: Ibbażat fuq dejta in vitro, cinacalcet huwa inibitur qawwi ta' CYP2D6, iżda f'konċentrazzjonijiet milħuqa klinikament, la huwa inibitur ta' enzimi ta' CYP oħra, inkluż CYP1A2, CYP2C8, CYP2C9, CYP2C19, u CYP3A4, u lanqas induttur ta' CYP1A2, CYP2C19 u CYP3A4.
English: The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Maltese: L-istudju ma ssodisfax l-għan primarju tiegħu li juri tnaqqis fir-riskju ta' mortalità mill-kawżi kollha jew avvenimenti kardjovaskulari inkluż infart mijokardijaku, ammissjoni għallisptar għal anġina instabbli, insuffiċjenza tal-qalb jew avveniment vaskulari periferali (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
English: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of allcause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis.
Maltese: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) kien studju kliniku randomized, double-blind biex jevalwa cinacalcet kontra plaċebo għat-tnaqqis tar-riskju ta' mortalità mill-kawżi kollha u avvenimenti kardjovaskulari f'3883 pazjent b' HPT sekondarja u CKD li qed jirċievu dijalisi.
English: The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution.
Maltese: Il-volum ta' distribuzzjoni huwa għoli (madwar 1,000 litru), u dan jindika distribuzzjoni estensiva.
English: Anorexia Decreased appetite
Maltese: Anoreksja Tnaqqis fl-aptit
English: Closely monitor serum calcium (see section 4.5).
Maltese: Immonitorja l-kalċju fis-serum mill-viċin (ara sezzjoni 4.5).
English: In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the cinacalcet-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Maltese: Fi studju kliniku ta' pazjenti b'ESRD fuq id-dijalisi, il-livelli ta' testosterone ħieles naqsu b'medjan ta' 31.3% fil-pazjenti kkurati b'cinacalcet u b'16.3% fil-pazjenti kkurati bil-plaċebo wara 6 xhur ta' kura.
English: Pharmacokinetic/pharmacodynamic relationships
Maltese: Relazzjoni(jiet) farmakokinetiċi/farmakodinamiċi
English: • a medicine used to treat depression (fluvoxamine).
Maltese: • mediċina wżata għall-kura tad-depressjoni (fluvoxamine).
English: Midazolam: Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam.
Maltese: L-għoti ta' cinacalcet (90 mg) flimkien ma' midazolam (2 mg) mogħti b'mod orali, substrat ta' CYP3A4 u CYP3A5, ma biddilx il-farmakokinetika ta' midazolam.
English: Eighteen (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Maltese: Tmintax (18) minn 29 pazjent (62%) b'karċinoma tal-paratirojde u 15 minn 17-il individwu (88%) b'HPT primarja laħqu tnaqqis tal-kalċju fis-serum ta' ≥ 1 mg/dl (≥ 0.25 mmol/l).
English: Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
Maltese: L-għoti ta' 90 mg cinacalcet darba kuljum flimkien ma' 50 mg desipramine, antidepressant triċikliku metabolizzat primarjament minn CYP2D6, żied b'mod sinifikanti l-espożizzjoni għal desipramine bi 3.6 darbiet (90% CI 3.0, 4.4) f'metabolizzaturi estensivi ta' CYP2D6.
English: Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Maltese: Cinacalcet jiġi metabolizzat minn bosta enzimi, primarjament CYP3A4 u CYP1A2 (il-kontribuzzjoni ta' CYP1A2 għadha ma ġietx ikkaratterizzata klinikament).
English: Steady state levels of cinacalcet are achieved within 7 days with minimal accumulation.
Maltese: Livelli ta' cinacalcet fi stat fiss jintlaħqu fi żmien 7 ijiem b'akkumulazzjoni minima.
English: Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Maltese: L-għoti flimkien ma' calcium carbonate (doża waħda ta' 1,500 mg) ma affettwax il-farmakokinetika ta' cinacalcet.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Din tippermetti monitoraġġ kontinwu tal-bilanċ tal- benefiċċju / riskju tal-prodott mediċinali.
English: Suomi/Finland Mylan Finland OY
Maltese: Suomi/Finland
English: • a medicine used to relieve cough (dextromethorphan)
Maltese: • mediċina wżata biex ittaffi s-sogħla (dextromethorphan);
English: • seizures (convulsions or fits)
Maltese: • aċċessjoniiet (konvulżjonijiet jew fits)
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics.
Maltese: Saret analiżi tal-farmakokinetika tal-popolazzjoni biex jiġu evalwati l-effetti tal-karatteristiċi demografiċi.
English: Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet 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' cinacalcet jekk pazjent li jkun qed jieħu cinacalcet jibda jew iwaqqaf terapija b'inibitur qawwi (eż. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) jew induttur (eż. rifampicin) ta' din l-enzima.
English: Cinacalcet Mylan is used:
Maltese: Cinacalcet Mylan jintuża:
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 sekondarja mhux ikkontrollata, li kienu qed jirċievu d-dijalisi (n=1,136).
English: Cases of seizures have been reported in patients treated with cinacalcet (see section 4.8).
Maltese: Każijiet ta' aċċessjonijiet kienu rrappurtati f'pazjenti trattati b'cinacalcet (ara sezzjoni 4.8).
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, ilkonċentrazzjonijiet 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: • medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin)
Maltese: • mediċini wżati għall-kura ta' infezzjonijiet ikkawżati mill-batterja (telithromycin, rifampicin u ciprofloxacin);
English: Tablet core:
Maltese: Iperparatirojdiżmu sekondarju:
English: • a medicine used to treat HIV infection and AIDS (ritonavir)
Maltese: • mediċina wżata għall-kura ta' infezzjoni tal-HIV u AIDS (ritanovir);
English: Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.
Maltese: F'metabolizzaturi estensivi ta' CYP2D6 dożi multipli ta' 50 mg cinacalcet żiedu lAUC ta' 30 mg dextromethorphan (metabolizzat primarjament minn CYP2D6) bi 11-il darba.
English: Cinacalcet Mylan contains the active ingredient cinacalcet, which works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Maltese: Cinacalcet Mylan fih is-sustanza attiva cinacalcet, li taħdem billi tikkontrolla l-livelli tal-ormon paratirojde (PTH), calcium u phosphorous fil-ġisem tiegħek.
English: Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs of 28 tablets and perforated unit dose blister packs of 28 x 1, 30 x 1 and 84 x 1 tablets.
Maltese: Cinacalcet Mylan 30 mg, 60 mg, 90 mg pilloli miksija b'rita huma disponibbli f'pakketti bil-folji ta' 28 pillola u pakketti bil-folji perforati b'doża tal-unità ta' 28 x 1, 30 x 1 u 84 x 1 pillola.
English: Vascular disorders
Maltese: Disturbi vaskularji
English: Other medicines and Cinacalcet Mylan
Maltese: Mediċini oħra u Cinacalcet Mylan
English: Seizures† Dizziness Paraesthesia Headache
Maltese: Aċċessjonijiet Sturdament Parasteżija Uġigħ ta' ras
English: EU/1/15/1054/008 EU/1/15/1054/009 EU/1/15/1054/010 EU/1/15/1054/013
Maltese: EU/1/15/1054/008 EU/1/15/1054/009 EU/1/15/1054/010
English: 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: Cinacalcet Mylan 30 mg film-coated tablets Cinacalcet Mylan 60 mg film-coated tablets Cinacalcet Mylan 90 mg film-coated tablets cinacalcet
Maltese: Cinacalcet Mylan 30 mg pilloli miksija b'rita Cinacalcet Mylan 60 mg pilloli miksija b'rita Cinacalcet Mylan 90 mg pilloli miksija b'rita cinacalcet
English: Cinacalcet Mylan 30 mg, 60 mg and 90 mg film-coated tablets PVC/PVdC/Alu blisters of 28 tablets and perforated unit dose blisters of 28 x 1, 30 x 1 and 84 x 1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Cinacalcet Mylan 30 mg, 60 mg u 90 mg pilloli miksija b'rita Folji tal-PVC/PVdC/Alu ta' 28 pillola u folji perforati b'doża tal-unità ta' 28 x 1, 30 x 1 u 84 x 1 pillola.
English: Elderly There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Maltese: Anzjani M'hemmx differenzi klinikament rilevanti fil-farmakokinetika ta' cinacalcet minħabba l-età.
English: Effect of other medicines on cinacalcet
Maltese: Effetti ta' mediċini oħra fuq cinacalcet
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-mira primarja (proporżjon ta' pazjenti b'iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) intlaħqet minn 41%, 46%, u 35% tal-pazjenti li rċevew cinacalcet, meta mqabbla ma' 4%, 7%, u 6% tal-pazjenti li rċevew il-plaċebo.
English: • liver problems;
Maltese: • problemi tal-fwied;
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Maltese: Il-mira pimarja tal-istudju kienet tnaqqis tal-kalċju fis-serum ta' ≥ 1 mg/dL (≥ 0.25 mmol/l).
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, torasiċi u medjastinali
English: Tabulated list of adverse reactions
Maltese: b) Lista f' forma tabulari tar-reazzjonijiet avversi
English: Dose adjustments of concomitant medicinal products may be required when cinacalcet 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' aġġustament 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' cinacalcet.
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: 28 Film-coated tablets 28 x 1 Film-coated tablets 30 x 1 Film-coated tablets 84 x 1 Film-coated tablets
Maltese: 28 Pillola miksija b'rita 28 x 1 Pillola miksija b'rita 30 x 1 Pillola miksija b'rita 84 x 1 Pillola miksija b'rita
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 primarja, l-livelli ta' kalċju fis-serum naqsu minn 12.7 mg/dl għal 10.
English: • upper respiratory infection
Maltese: • infezzjoni respiratorja ta' fuq
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 l­Vitamina D ma tistgħax tiżdied
English: Withhold administration of cinacalcet 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' cinacalcet sakemm il-livelli tal-kalċju fis-serum jilħqu 8.0 mg/dL (2.0 mmol/L) u/jew is-sintomi ta' ipokalċimija jgħaddu.
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 kundizzjonijiet sperimentali.
English: Seizures
Maltese: Dispneja
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 primarja li ssodisfaw il-kriterji għal paratirojdettomija abbażi ta' calcium fis-serum totali kkoreġut (> 11.3 mg/dl (2.82 mmol/l) iżda ≤ 12.5 mg/dl (3.12 mmol/l ), iżda li ma setgħux jagħmlu paratirojdettomija kienu inklużi. Cinacalcet inbeda f'doża ta' 30 mg darbtejn kuljum u ġie ttitrat biex tinżamm konċentrazzjoni totali korretta ta' calcium fis-serum fil-medda normali.
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' ipokalċimja severa (ara sezzjoni 4.4).
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including ciclosporin and tacrolimus.
Maltese: Din id-dejta tissuġġerixxi li cinacalcet ma jaffettwax il-farmakokinetika ta' dawk il-klassijiet ta' mediċini li huma mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż ciclosporin u tacrolimus.
English: EU/1/15/1054/001 EU/1/15/1054/002 EU/1/15/1054/003 EU/1/15/1054/004 EU/1/15/1054/011
Maltese: EU/1/15/1054/001 EU/1/15/1054/002 EU/1/15/1054/003
English: Upper respiratory infection Dyspnoea
Maltese: Infezzjoni respiratorja ta' fuq
English: The dose of cinacalcet 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' cinacalcet 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: Secondary hyperparathyroidism:
Maltese: Dextromethorphan:
English: Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.
Maltese: Cinacalcet Mylan 30 mg pilloli miksija b'rita huma disponibbli fi fliexken tal-plastik ta' 100 pillola.
English: After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Maltese: Wara għoti ta' doża radjutikketjata ta' 75 mg lill-voluntiera f'saħħithom, cinacalcet kien metabolizzat malajr u estensivament permezz ta' ossidazzjoni segwit minn konjugazzjoni.
English: The safety and efficacy of cinacalcet in the paediatric population have not been established.
Maltese: Is-sigurtà u l-effikaċja ta ' cinacalcet filpopolazzjoni pedjatrika ma ġewx stabbiliti.
English: Investigational studies have shown that 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 b'CKD li mhux qed jirċievu d-dijalisi li ngħataw cinacalcet għandhom riskju ogħla għal 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: Cinacalcet should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH) assay.
Maltese: Cinacalcet għandu jiġi ttitrat kull ġimagħtejn sa 4 ġimgħat sa doża massima ta' 180 mg darba kuljum biex tintlaħaq il-mira tal-ormon tal-paratirojde (PTH) f'pazjenti bid-dijalisi li hija bejn 150-300 pg/ml (15.
English: Cinacalcet decreased iPTH and Ca x P, calcium and phosphorus levels regardless of baseline iPTH or Ca x P level, dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols were administered.
Maltese: Cinacalcet naqqas il-livelli ta' iPTH u ta' Ca x P, tal-kalċju u tal-fosforu indipendentament mill-livell fil-linja bażi ta' iPTH jew il-livell ta' Ca x P, modalità ta' dijalisi (PD kontra
English: Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Maltese: Cinacalcet Mylan jista' jintuża bħala parti minn kors terapewtiku li jinkludi binders ta' fosfat u/jew sterols ta' Vitamina D, kif xieraq (ara sezzjoni 5.1).
English: Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet (see section 4.8).
Maltese: Każijiet ta' titwil ta' QT u arritmija ventrikulari kienu rrappurtati f'pazjenti kkurati b'cinacalcet (ara sezzjoni 4.8).
English: Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis).
Maltese: Tnaqqis f'PTH kien assoċjat ma' tnaqqis mhux sinifikanti fil-markaturi tal-metaboliżmu tal-għadam (alkaline phosphatase speċifiku għall-għadam, N-telopeptide, tibdil tal-għadam u fibrożi tal-għadam).
English: Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are green, oval, biconvex, bevelled edge tablets marked with M on one side of the tablet and CI30, CI60 or CI90 on the other side.
Maltese: Cinacalcet Mylan 30 mg, 60 mg, 90 mg pilloli miksija b'rita huma ta' lewn aħdar, ovali u bikonvessi, b'tarf imżerżaq, immarkati b'M fuq naħa waħda tal-pillola u CI30, CI60 jew CI90 fuq in naħa l-oħra.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali huwa importanti.
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 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 kkurati b'cinacalcet meta mqabbla mal-pazjenti kkurati bil-plaċebo li kienu qed jirċievu kura stàndard, u r-riżultati kienu konsistenti tul it-tliet studji.