FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of therapy as a result of undesirable effects was mainly due to nausea (1% placebo; 5% cinacalcet) and vomiting (< 1% placebo; 4% cinacalcet).
Maltese: Twaqqif għal kollox tat-terapija minħabba l-effetti mhux mixtieqa kien il-biċċa l-kbira minħabba t-tqalligħ (1% plaċebo; 5% cinacalcet) u r-rimettar (< 1% placebo; 4% cinacalcet).
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 (e.ż. fluvoxamine, ciprofloxacin) fuq il-livelli ta' cinacalcet fil-plażma ma ġiex studjat.
English: Opacode Black, printing ink: (Shellac glaze (shellac), iron oxide black (E172) 6.2 Incompatibilities
Maltese: Opacode iswed, linka għall-istampar: (Shellac glaze (shellac), iron oxide iswed (E172)
English: Elderly: There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Maltese: M'hemmx differenzi klinikament rilevanti fil-farmakokinetika ta' cinacalcet minħabba l-età.
English: Effect of other medications on cinacalcet
Maltese: Effetti ta' mediċini oħra fuq cinacalcet
English: Seizures
Maltese: Aċċessjonijiet
English: While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.
Maltese: Filwaqt li l-bażi tad-differenża rrappurtata fir-rata ta' aċċessjonijiet mhix ċara, l-limitu li taħtu ma sseħx aċċessjoni huwa mnaqqas minħabba tnaqqis sinifikanti tal-livelli tal-kalċju fis-serum.
English: In vitro data indicate that cinacalcet is in part metabolised by CYP1A2.
Maltese: Tagħrif in vitro jindika li cinacalcet huwa parzjalment metabolizzat minn CYP1A2.
English: Children and adolescents: The pharmacokinetics of cinacalcet have not been studied in patients < 18 years of age.
Maltese: Il-farmakokinetika ta' cinacalcet ma ġietx studjata f'pazjenti ta' età ta' < 18-il sena.
English: The dosage of Parareg 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-dożaġġ ta' Parareg għandu jiġi ttitrat kull ġimgħatejn 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 jitnaqqas il-konċetrazzjoni ta' kalċju fis-serum sa jew inqas mil-limitu ta' fuq tan-normal.
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, ilmira 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 ilplaċebo.
English: The major circulating metabolites are inactive.
Maltese: Il-metaboliti prinċipali fiċ-ċirkulazzjoni huma inattivi.
English: Each blister pack contains either 14, 28 or 84 tablets in a carton.
Maltese: Kull pakkett ta' folji fih 14, 28 jew 84 pillola f'kartuna.
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 kkurati b'cinacalcet meta mqabbla mal-pazjenti kkurati bil-plaċebo li kienu qed jirċievu kura stàndard, u r-riżultati kienu konsistenti tul it-tlett studji.
English: The clinical significance of these reductions in serum testosterone is unknown.
Maltese: Is-sinifikat kliniku ta' dan it-tnaqqis fit-testosterone fis-serum mhux magħruf.
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 30 mg, 60 mg jew 90 mg ta' cinacalcet (bħala hydrochloride).
English: NAME OF THE MEDICINAL PRODUCT Parareg 90 mg film-coated tablets Cinacalcet
Maltese: Parareg 90 mg pillola Cinacalcet
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: Il-profil farmakokinetiku ta' cinacalcet f'pazjenti b'insuffiċjenza renali ħafifa, moderata u severa, u dawk fuq emodijalisi jew dijalisi tal-peritonew huwa komparabbli ma' dak f'voluntiera b'saħħithom.
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 ipokalċimja (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: They are oval-shaped and have “30”, “60” or “90” printed on one side and “Amgen” on the other side.
Maltese: Għandhom għamla ovali u “30”, “60” jew “90” stampat fuq naħa u “Amgen” fuq in-naħa l-oħra.
English: The volume of distribution is high (approximately 1000 litres), indicating extensive distribution.
Maltese: Il-volum ta' distribuzzjoni huwa għoli (madwar 1000 litru), b'hekk jindika distribuzzjoni estensiva.
English: Clinical trial data showed hypotension occurred in 7% of cinacalcet-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet or placebo.
Maltese: Tagħrif minn studji kliniċi wrew li kien hemm pressjoni baxxa f' 7% ta' pazjenti li ngħataw cinacalcet, fi12% ta' pazjenti li ngħataw plaċebo, u insuffiċjenza tal-qalb seħħet f'i 2% ta' pazjenti li ngħataw cinacalcet jew plaċebo.
English: Common side effects (seen in more than 1 in 100 people taking Parareg):
Maltese: Effetti sekondarji komuni (osservati f'aktar minn 1 minn kull 100 persuna li jieħdu Parareg):
English: Cinacalcet
Maltese: FARMAĊEWTIKU
English: Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g., flecainide, propafenone, metoprolol given in heart failure, desimipramine, nortriptyline, clomipramine) (see section 4.4).
Maltese: Jista' jkun hemm bżonn ta' aġġustament fid-doża ta' mediċini ttitrati individwalment, li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6 (e.ż., flecainide, propafenone, metoprolol mogħti f'każijiet ta' insuffiċjenza tal-qalb, desipramine, nortriptyline, clomipramine) meta dawn jingħataw flimkien ma' Parareg (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Parareg 30 mg film-coated tablets Cinacalcet
Maltese: Parareg 30 mg pillola Cinacalcet
English: NAME OF THE MEDICINAL PRODUCT Parareg 60 mg film-coated tablets Cinacalcet
Maltese: Parareg 60 mg pillola Cinacalcet
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: 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 tal-linja bażika ta' iPTH tul it-tlett 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 ta' l-istudju, u > 90 % kienu qed jirċievu binders tal-fosfat.
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Maltese: Cinacalcet intwera li jaqsam il-barriera plaċentari fil-fniek.
English: PTH levels should be assessed at least 12 hours after dosing with Parareg.
Maltese: Il-livelli ta' PTH għandhom jitkejjlu ta' l-inqas 12-il siegħa wara li ngħatat Parareg.
English: Concomitant therapy with phosphate binders and/or vitamin D sterols should be adjusted as appropriate.
Maltese: Terapija fl-istess ħin b'binders tal-fosfat u/jew sterols ta' Vitamina D għandhom jiġu aġġustati kif xieraq.
English: Hepatic Insufficiency: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Maltese: Indeboliment epatiku ħafif ma affettwax il-farmakokinetika ta' cinacalcet b'mod notevoli.
English: The printing ink contains: shellac glaze, iron oxide black (E172).
Maltese: Il-linka għall-istampar fiha: shellac glaze, iron oxide iswed (E172).
English: • numbness or tingling sensation (paraesthesia)
Maltese: • sensazzjoni ta' tnemnim jew tingiż (parasteżija)
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of drugs that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Maltese: Dan it-tagħrif jissuġġerixxi li cinacalcet ma jaffettwax il-farmakokinetika ta' dawk il-klassijiet ta' mediċini li huma mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż cyclosporine u tacrolimus.
English: 90 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “90” on the other.
Maltese: 90 mg: Pilloli miksija b'rita, ħodor ċari, ovali mmarkati b' “AMGEN” fuq naħa u “90” fuq in-naħa loħra.
English: Cinacalcet did not show any genotoxic or carcinogenic potential.
Maltese: Cinacalcet ma wera l-ebda potenzjal ġenotossiku jew karċinoġeniku.
English: 30 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “30” on the other.
Maltese: 30 mg: Pilloli miksija b'rita, ħodor ċari, ovali mmarkati b' “AMGEN” fuq naħa u “30” fuq in-naħa loħra.
English: Uncommon side effects (seen in more than 1 in 1000 people taking Parareg):
Maltese: Effetti sekondarji mhux komuni (osservati f'aktar minn 1 minn kull 1000 persuna li jieħdu Parareg):
English: Safety and efficacy have not been established in patients below the age of 18 years.
Maltese: Is-sigurtà u l-effikaċja ma ġewx stabbiliti f'pazjenti taħt l-età ta' 18-il sena.
English: 60 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “60” on the other.
Maltese: 60 mg: Pilloli miksija b'rita, ħodor ċari, ovali mmarkati b' “AMGEN” fuq naħa u “60” fuq in-naħa loħra.
English: The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Parareg and 19% placebo treated patients, and 27% Parareg and 15% placebo treated patients, respectively.
Maltese: L-aktar effetti mhux mixtieqa irrappurtati b'mod komuni kienu tqalligħ u rimettar, li dehru f'31% tal-pazjenti kkurati b'Parareg u f'19% tal-pazjent kkurati bil-plaċebo, u f'27% tal- pazjenti kkurati b'Parareg u fi 15% tal-pazjenti kkurati bil-plaċebo, rispettivament.
English: Parareg treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Maltese: Kura b'Parareg għandha tinbeda f'pazjenti b'kalċju fis-serum (ikkoreġut għall-albumina) taħt il-limitu l-aktar baxx tal-firxa normali.
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 C ta' cinacalcet jiżdiedu, bejn wieħed u ieħor b'mod linejari fuq il-firxa ta' dożi ta' 30 sa 180 mg darba kuljum.
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 għotja ta' doża radjutikketjata ta' 75 mg lill-voluntiera b'saħħithom, cinacalcet kien metabolizzat malajr u estensivament permezz ta' ossidazzjoni segwit minn konjugazzjoni.
English: Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Maltese: Parareg jaħdem billi jikkontrolla l-livelli ta' l-ormon tal-paratirojde (PHT), tal-kalċju u tal-fosforu filġisem tiegħek.
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-biodisponibilità assoluta ta' cinacalcet f'pazjenti sajma kienet stmata li hi madwar 20-25%.
English: Parareg is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Maltese: Parareg huwa disponibbli f'folji b'pilloli miksija b'rita ta' 30 mg, 60 mg jew 90 mg.
English: In the event of hypocalcaemia, calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium.
Maltese: F'każ ta' ipokalċimja, binders tal-fosfat li fihom il-kalċju, sterols ta' Vitamina D u/jew aġġustament tal-konċetrazzjonijiet tal-kalċju fil-fluwidu tad-dijalisi jistgħu jintużaw biex jgħollu l-livelli tal-kalċju fis-serum.
English: Protein binding of cinacalcet is not affected by impaired hepatic function.
Maltese: Ir-rabta ta' cinacalet mal-proteini mhix affettwata minn funzjoni epatika indebolita.
English: After titration to the maximum dose of Parareg, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Parareg therapy should be considered (see section 5.1).
Maltese: Wara titrazzjoni sad-doża massima ta' Parareg, il-kalċju fis-serum għandu jiġi sorveljat perjodikament; jekk ma jinżamx tnaqqis klinikment rilevanti tal-kalċju fis-serum, għandu jiġi kkunsidrat twaqqif għal kollox tat-terapija b'Parareg (ara sezzjoni 5.1).
English: Data presented from controlled studies include 656 patients who received Parareg and 470 patients who received placebo for up to 6 months.
Maltese: Tagħrif ippreżentat minn studji kkontrollati jinkludi 656 pazjent li rċevew Parareg u 470 pazjent li rċevew plaċebo sa 6 xhur.
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-livlli ta' iPTH, u dan l-effett kien konsistenti tul il-firxa tal-livelli ta' linja bażi ta' iPTH.
English: Co-administration of 200 mg bid ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
Maltese: L-għotja konkomitanti ta' 200 mg bid ketoconazole, inibitur qawwi ta' CYP3A4, wasslet għal żieda ta' madwar darbtejn fil-livelli ta' cinacalcet.
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 12il darba ikbar, rispettivament, mill-EC50 tar-riċettur li jħoss il-kalċju miġbura taħt l-istess kundizzjonijiet sperimentali.
English: EU/1/04/293/011 - carton of 84 tablets
Maltese: EU/1/04/292/011 - Kaxxa bi 84 pillola
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 ta' l-aħħar stadju.
English: Approximately 80% of the dose was recovered in the urine and 15% in the faeces.
Maltese: Madwar 80 % taddoża kienet irkuprata fl-awrina u 15 % fl-ippurgar.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of cinacalcet (as hydrochloride)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 30 mg ta' cinacalcet (bħala hydrochloride)
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Parareg 30 mg film-coated tablets Parareg 60 mg film-coated tablets Parareg 90 mg film-coated tablets Cinacalcet Read all of this leaflet carefully before you start taking this medicine.
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Parareg 30 mg pilloli miksija b'rita Parareg 60 mg pilloli miksija b'rita Parareg 90 mg pilloli miksija b'rita Cinacalcet Aqra dan il-fuljett kollu qabel tibda tieħu din il-mediċina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg of cinacalcet (as hydrochloride)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 60 mg ta' cinacalcet (bħala hydrochloride)
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 sa l-aħħar talintervall ta' dożaġġ ta' darba kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 90 mg of cinacalcet (as hydrochloride)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 90 mg ta' cinacalcet (bħala hydrochloride)
English: Medicinal product subject to medical prescription
Maltese: TAL-PRODOTT MEDIĊINALI
English: EU/1/04/293/003 - carton of 84 tablets
Maltese: EU/1/04/293/003 - Kaxxa bi 84 pillola
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, 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: Parareg is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Maltese: Parareg huwa disponibbli fi fliexken b'pilloli miksija b'rita ta' 30 mg, 60 mg jew 90 mg, ġo kartuna.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride).
Maltese: Kull pillola fiha 30 mg cinacalcet (bħala hydrochloride).
English: • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171),
Maltese: • Opadry aħdar (li fih lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blu (E132), iron oxide isfar (E172))
English: Skin and subcutaneous tissue disorders Common: rash
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni: raxx
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' awtoinduzzjoni wara dożaġġ multiplu f'pazjenti jindika li cinacalcet mhux induttur ta' CYP3A4, CYP1A2 jew CYP2C9 fil-bnedmin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg cinacalcet (as hydrochloride).
Maltese: Kull pillola fiha 90 mg cinacalcet (bħala hydrochloride).
English: Plasma levels of cinacalcet may be lower in smokers due to induction of CYP1A2-mediated metabolism.
Maltese: Il-livelli ta' cinacalcet fil-plażma jistgħu jkunu inqas f'min ipejjep minħabba l-induzzjoni ta' metaboliżmu medjat minn CYP1A2.
English: Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
Maltese: Katarretti u opaċitajiet fil-lenti kienu osservati fl-istudji ta' tossikoloġija u karċenoġeniċità fil-firien b'doża ripetuta, iżda ma kienux osservati fil-klieb jew xadini jew fi studji kliniċi fejn il-formazzjoni tal-katarretti kienet issorveljata.
English: Either the intact PTH (iPTH) or biointact PTH (biPTH) may be used to measure PTH levels; treatment with Parareg does not alter the relationship between iPTH and biPTH.
Maltese: Il-PTH intatt (iPTH) jew PTH bio-intatt (biPTH) jistgħu jintużaw biex jitkejlu l-livelli ta' PTH; kura b'Parareg ma tibdilx ir-relazzjoni bejn iPTH u biPTH.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60 mg cinacalcet (as hydrochloride).
Maltese: Kull pillola fiha 60 mg cinacalcet (bħala hydrochloride).
English: HOW TO STORE PARAREG
Maltese: Oqgħod attent ħafna b'Parareg
English: The recommended starting dose of Parareg for adults is 30 mg twice per day.
Maltese: Id-doża tal-bidu rakkomandata ta' Parareg għall-adulti hija ta' 30 mg darbtejn kuljum.
English: Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT receiving dialysis.
Maltese: Studji investigattivi fuq pazjenti b' CKD u HPT sekondarja li mhux qed jirċievu dijalisi indikaw li cinacalcet naqqas il-livelli ta' PTH b'ammont simili għal dak f'pazjenti b'ESRD u HPT sekondarja li qed jirċievu d-dijalisi.
English: • DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
Maltese: • TIEĦUX Parareg jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal cinacalcet jew sustanzi oħra ta' Parareg.
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' tagħrif miġbur minn studji kliniċi ta' 6 xhur u 12-il xahar, l-istimi Kaplan-Meier ta' ksur tal-għadam u l-paratirojdektomija kienu inqas fil-ġrupp ta' cinacalcet meta mqabbla malgrupp ta' kontroll.
English: Parareg may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Maltese: Parareg jista' jintuża bħala parti minn kors terapewtiku li jinkludi binders ta' fosfati u/jew sterols ta' Vitamina D, kif xieraq (ara sezzjoni 5.1).
English: Parathyroid carcinoma and Primary Hyperparathyroidism
Maltese: Karċinoma tal-paratirojde u Iperparatirojdiżmu Primarju
English: The pharmacokinetics of cinacalcet does not change over time.
Maltese: Il-farmakokinetika ta' cinacalcet ma tinbidilix maż-żmien.
English: Effect of cinacalcet on other medications
Maltese: Effetti ta' cinacalcet fuq mediċini oħra
English: Smoking: Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2- mediated 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: Renal excretion of metabolites was the prevalent route of elimination of radioactivity.
Maltese: Tneħħija renali tal-metaboliti kienet ir-rotta primarja għall-eliminazzjoni tar-radjuattività.
English: Parareg 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: Parareg għandu jintuża b'attenzjoni f'pazjenti b'indeboliment epatiku minn moderat għal sever u l-kura għandha tiġi sorveljata mill-qrib waqt ittitrazzjoni tad-doża u waqt kura kontinwa (ara sezzjonijiet 4.4 u 5.2).
English: If serum calcium levels decrease below the normal range, appropriate steps should be taken (see section 4.4).
Maltese: Jekk il-livelli ta' kalċju fis-serum jonqsu taħt il-livelli normali, għandhom jittieħdu passi xierqa (ara sezzjoni 4.4).
English: EU/1/04/293/007 - carton of 84 tablets
Maltese: EU/1/04/292/007 - Kaxxa bi 84 pillola
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/012
Maltese: FIS-SUQ EU/1/04/293/012
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/005 - carton of 14 tablets
Maltese: FIS-SUQ EU/1/04/293/001 - Kaxxa b'14 -il pillola EU/1/04/293/002 - Kaxxa bi 28 pillola