FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean age of patients across the 2 studies was 58.2 (range 21 to 93) years.
Maltese: L-età medja tal-pazjenti tul iż-żewġ studji kienet ta' 58.2 (firxa 21 sa 93) sena.
English: 5 Symptomatic reductions in serum cCa < 8.3 mg/dL (2.08 mmol/L).
Maltese: Tnaqqis sintomatiku f'cCa fis-serum < 8.3 mg/dL (2.08 mmol/L).
English: Frequency category Adverse reactions
Maltese: Kategorija ta' frekwenza
English: Cases of seizures have been reported in patients treated with Parsabiv (see section 4.8).
Maltese: Każijiet ta' aċċessjonijiet ġew irrapportati f'pazjenti ttrattati b'Parsabiv (ara sezzjoni 4.8).
English: Mean (SE) baseline PTH concentrations across the 2 studies were 846.9 (21.8) pg/mL, and 835.9 (21.0) pg/mL for the Parsabiv and placebo groups, respectively with approximately 21% of subjects enrolling across both studies having baseline PTH > 1,000 pg/mL.
Maltese: Il-konċentrazzjonijiet medji (SE) ta' PTH fil-linja bażi tul iż-żewġ studji kienu 846.9 (21.8) pg/mL, u 835.9 (21.0) pg/mL għall-gruppi ta' Parsabiv u plaċebo, rispettivament b'madwar 21% tal-individwi li rreġistraw tul iż-żewġ studji b'PTH fil-linja bażi ta' > 1,000 pg/mL.
English: Patients with ≤ 300 pg/mL in PTH during the EAP, n (%)
Maltese: Pazjenti b'≤ 300 pg/mL f'PTH matul l-EAP, n
English: • Disturbances in the heart's electrical activity seen as QT prolongation on electrocardiogram
Maltese: • Disturbi fl-attività elettrika tal-qalb osservati bħala titwil tal-QT fuq l-elettrokardjogramm
English: Not known: frequency cannot be estimated from the available data • Allergic reactions (including anaphylactic reactions)
Maltese: Mhux magħruf: ma tistax tittieħed stima tal-frekwenza mid-data disponibbli • Reazzjonijiet allerġiċi (inklużi reazzjonijiet anafilattiċi)
English: 1 vial (0.5 mL) 6 vials (0.5 mL) 12 vials (0.5 mL) 42 vials (0.5 mL)
Maltese: Kunjett wieħed (0.5 mL) 6 kunjetti (0.5 mL) 12-il kunjett (0.5 mL) 42 kunjett (0.5 mL)
English: Parsabiv was non-inferior to cinacalcet for the primary endpoint, and was superior to cinacalcet for the secondary endpoints of proportion of patients achieving > 30% reduction from baseline in mean PTH during the EAP (68.2% Parsabiv versus 57.7% cinacalcet; p = 0.004); and proportion of patients achieving > 50% reduction from baseline in mean PTH during the EAP (52.4% Parsabiv versus 40.2% cinacalcet; p = 0.001).
Maltese: Parsabiv ma kienx inferjuri għal cinacalcet għall-punt finali primarju, u kien superjuri għal cinacalcet għall-punti finali sekondarji ta' proporzjon ta' pazjenti li kisbu tnaqqis ta' > 30% mil-linja bażi f'PTH medja matul l-EAP (68.2% Parsabiv kontra 57.7% cinacalcet; p = 0.004); u l-proporzjon ta' pazjenti li kisbu tnaqqis ta' > 50% mil-linja bażi f'PTH medja matul l-EAP (52.4% Parsabiv kontra 40.2% cinacalcet; p = 0.001).
English: Closely monitor serum calcium (see section 4.5).
Maltese: Issorvelja l-kalċju fis-serum mill-qrib (ara sezzjoni 4.5).
English: In the population pharmacokinetics model, volume of distribution at steady-state was approximately 796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding.
Maltese: Fil-mudell tal-farmakokinetika tal-popolazzjoni, il-volum ta' distribuzzjoni fi stat fiss kien madwar 796 L. Etelcalcetide huwa marbut b'mod predominanti mal-albumina tal-plażma permezz ta' irbit kovalenti riversibbli.
English: In vitro, etelcalcetide did not inhibit or induce CYP450 enzymes and was itself not a substrate for metabolism by CYP450 enzymes.
Maltese: In vitro, etelcalcetide ma rażżanx u ma induċiex l-enzimi ta' CYP450 u huwa stess ma kienx sottostrat għall-metaboliżmu permezz ta' enzimi ta' CYP450.
English: Patients with lower screening PTH levels typically required lower doses (median average weekly doses of 15.0 mg, 21.4 mg, 27.1 mg, respectively, for patients with screening PTH levels < 600 pg/mL, 600 to ≤ 1,000 pg/mL, and > 1,000 pg/mL).
Maltese: 0 mg, 21.4 mg, 27.1 mg, rispettivament, għall-pazjenti b'livelli ta' PTH waqt l-eżaminazzjoni ta' < 600 pg/mL, 600 sa ≤ 1,000 pg/mL, u > 1,000 pg/mL).
English: Etelcalcetide is biotransformed in blood by reversible disulphide exchange with endogenous thiols to predominantly form conjugate with serum albumin.
Maltese: Etelcalcetide jiġi bijotrasformat fid-demm permezz ta' skambju riversibbli ta' disulphide ma' thiols endoġeni biex b'mod predominanti jifforma konjugat mal-albumina tas-serum.
English: 1 vial (1 mL) 6 vials (1 mL) 12 vials (1 mL) 42 vials (1 mL)
Maltese: Kunjett wieħed (1 mL) 6 kunjetti (1 mL) 12-il kunjett (1 mL) 42 kunjett (1 mL)
English: Patients with > 30% reduction in PTH during the EAP, n (%)
Maltese: Pazjenti bi tnaqqis ta' > 30% f'PTH matul lEAP, n (%)
English: Mean (SE) baseline PTH concentrations were 1,092.12 (33.8) and 1,138.71 (38.2) pg/mL for the Parsabiv and cinacalcet groups respectively.
Maltese: 12 (33.8) u 1,138.71 (38.2) pg/mL għall-gruppi ta' Parsabiv u cinacalcet rispettivament.
English: For further information regarding potential manifestations of hypocalcaemia and serum calcium monitoring please see sections 4.4 and 4.2 respectively.
Maltese: Għal aktar informazzjoni dwar manifestazzjonijiet potenzjali ta' ipokalċimija u monitoraġġ ta' kalċju fis-serum jekk jogħġbok ara sezzjonijiet 4.4 u 4.2 rispettivament.
English: The pharmacokinetics of etelcalcetide is linear and does not change over time following single (5 to 60 mg) and multiple intravenous doses (2.5 to 20 mg) in CKD patients with secondary HPT receiving haemodialysis.
Maltese: Il-farmakokinetika ta' etelcalcetide hija lineari u ma tinbidilx maż-żmien wara dożi singoli (5 sa 60 mg) u multipli fil-vini (2.5 sa 20 mg) f'pazjenti b'CKD b'HPT sekondarju li jirċievu l-emodijalisi.
English: “Switch study”
Maltese: “Studju Swiċċ”
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH) 6
English: Two 6-month, double-blind, placebo-controlled clinical studies were conducted in SHPT patients with CKD receiving haemodialysis 3 times per week (n = 1,023).
Maltese: Twettqu żewġ studji kliniċi ta' 6 xhur, double-blind, ikkontrollati bil-plaċebo f'pazjenti b'SHPT b'CKD li kienu qed jirċievu emodijalisi 3 darbiet fil-ġimgħa (n = 1,023).
English: Placebo (N = 254)
Maltese: Plaċebo (N = 254)
English: Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia (see section 4.8).
Maltese: Tnaqqis fil-kalċju fis-serum jista' jtawwal l-intervall QT, u potenzjalment jwassal għal arritmija ventrikulari (ara sezzjoni 4.8).
English: Available data in rats have shown that etelcalcetide is excreted in milk (see section 5.3).
Maltese: Dejta disponibbli filfirien uriet li etelcalcetide hu eliminat fil-ħalib (ara sezzjoni 5.3).
English: Intravenous administration 3 times per week at the end of a haemodialysis session resulted in an effective half-life of 3 to 5 days.
Maltese: Għoti fil-vini 3 darbiet fil-ġimgħa fl-aħħar tas-sessjoni tal-emodijalisi wassal għal half-life effettiva ta' 3 sa 5 ijiem.
English: • heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
Maltese: • problemi tal-qalb, bħal insuffiċjenza tal-qalb jew arritmija (ritmu tal-qalb mhux normali);
English: Parsabiv was associated with reductions in bone metabolism markers (bone specific alkaline phosphatase and type I collagen c-telopeptide) and fibroblast growth factor 23 (exploratory endpoints) at the end of the study (week 27), compared with placebo.
Maltese: Parsabiv kien assoċjat ma' tnaqqis fil-markaturi tal-metaboliżmu tal-għadam (alkaline phosphatase u collagen c-telopeptide tip I speċifiċi għall-għadam) u fil-fattur tat-tkabbir 23 tal-fibroblasti (punti finali esploratorji) fit-tmiem tal-istudju (ġimgħa 27), meta mqabbel mal-plaċebo.
English: The primary endpoint in each study was the proportion of patients with > 30% reduction from baseline in PTH during the EAP (EAP, defined as weeks 20 to 27 inclusive).
Maltese: Il-punt finali primarju f'kull studju kien il-proporzjon ta' pazjenti bi tnaqqis ta' > 30% mil-linja bażi f'PTH matul l-EAP (EAP, definit bħala ġimgħat 20 sa 27 inklużivament).
English: 1 vial (2 mL) 6 vials (2 mL) 12 vials (2 mL) 42 vials (2 mL)
Maltese: Kunjett wieħed (2 mL) 6 kunjetti (2 mL) 12-il kunjett (2 mL) 42 kunjett (2 mL)
English: The secondary endpoints were the proportion of patients with a mean PTH ≤ 300 pg/mL during the EAP, and percent change from baseline during the EAP for PTH, serum cCa, phosphate and calcium phosphate product (Ca x P).
Maltese: Il-punti finali sekondarji kienu l-proporzjon ta' pazjenti b'PTH medja ta' ≤ 300 pg/mL matul l-EAP, u l-bidla perċentwali milllinja bażi matul l-EAP għal PTH, cCA fis-serum, fosfat u l-prodott tal-calcium phosphate (Ca x P).
English: The patient incidence of maximum post-baseline pre-dialysis QTcF > 500 msec in the Parsabiv and placebo groups was 4.8% and 1.9%, respectively.
Maltese: L-inċidenza fil-pazjenti ta' QTcF massimu wara l-linja bażi qabel iddijalisi ta' > 500 msek fil-gruppi ta' Parsabiv u tal-plaċebo kienet ta' 4.8% u 1.9%, rispettivament.
English: Switch from cinacalcet to Parsabiv
Maltese: Bidla minn cinacalcet għal Parsabiv
English: In the combined placebo-controlled studies, a higher percentage of patients in the Parsabiv group compared with the placebo group had a maximum increase from baseline of > 60 msec in the QTcF interval (1.2% Parsabiv; 0% placebo).
Maltese: Fl-istudji kkombinati kkontrollati bil-plaċebo, persentaġġ ogħla ta' pazjenti fil-grupp ta' Parsabiv mqabbel mal-grupp tal-plaċebo kellhom żieda massima mil-linja bażi ta' > 60 msec fl-intervall QTcF (1.2% Parsabiv; 0% plaċebo).
English: Noncovalent binding of etelcalcetide to plasma proteins is low with a fraction unbound ratio of 0.53.
Maltese: Irbit mhux kovalenti ta' etelcalcetide mal-proteini tal-plażma huwa baxx bi proporzjon ta' frazzjoni mhux marbuta ta' 0.53.
English: In the combined placebo-controlled studies, a higher proportion of patients in the Parsabiv group compared with patients in the placebo group developed at least one serum cCa value < 7.0 mg/dL (1.75 mmol/L) (7.6% Parsabiv; 3.1% placebo), < 7.5 mg/dL (1.88 mmol/L) (27.1% Parsabiv; 5.5% placebo), and < 8.3 mg/dL (2.08 mmol/L) (78.6% Parsabiv; 19.4% placebo).
Maltese: 3.1% plaċebo), < 7.5 mg/dL (1.88 mmol/L) (27.1% Parsabiv; 5.5% plaċebo), u < 8.3 mg/dL (2.08 mmol/L) (78.6% Parsabiv; 19.4% plaċebo).
English: Adynamic bone
Maltese: Għadam Adinamiku
English: Serum calcium levels should be closely monitored in patients with congenital long QT syndrome, previous history of QT prolongation, family history of long QT syndrome or sudden cardiac death and other conditions that predispose to QT prolongation and ventricular arrhythmia while being treated with Parsabiv.
Maltese: Il-livelli tal-kalċju fis-serum għandhom jiġu mmonitorjati mill-qrib f'pazjenti b'sindrome konġenitali ta' QT twil, storja preċedenti ta' titwil tal-QT, storja fil-familja ta' syndrome ta' QT twil jew mewt kardijaku għal għarrieda u kondizzjonijiet oħra li jippredisponu għal titwil tal-QT u arritmija ventrikolari waqt li jkunu qed jiġu ttrattati b'Parsabiv.
English: The median average weekly dose of Parsabiv during the EAP was 15.0 mg (5.0 mg per administration) and of cinacalcet was 360.0 mg (51.4 mg per administration).
Maltese: 0 mg (5.0 mg għal kull għoti) u ta' cinacalcet kien 360.0 mg (51.4 mg għal kull għoti).
English: • Muscle pain
Maltese: • Spażmi fil-muskoli
English: Parsabiv may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1).
Maltese: Parsabiv jista' jintuża bħala parti minn kors terapewtiku inkluż phosphate binders u/jew sterols talvitamina D, kif xieraq (ara sezzjoni 5.1).
English: Demographics and other baseline characteristics were similar to the placebo-controlled studies.
Maltese: Id-demografika u karatteristiċi oħra fil-linja bażi kienu simili għall-istudji kkontrollati bil-plaċebo.
English: • Numbness or tingling sensation
Maltese: • Sensazzjoni ta' tnemnim jew tingiż
English: Following 3 times a week intravenous dosing at the end of each 3 to 4 hour haemodialysis session in CKD patients, etelcalcetide plasma levels reached near steady-state 4 weeks after dosing with an observed accumulation ratio of 2- to 3-fold.
Maltese: Wara dożaġġ fil-vini 3 darbiet fil-ġimgħa fl-aħħar ta' kull sessjoni ta' emodijalisi ta' 3 sa 4 sigħat f'pazjenti b'CKD, il-livelli fil-plażma ta' etelcalcetide laħqu kważi stat fiss 4 ġimgħat wara d-dożaġġ bi proporzjon ta' akkumulazzjoni osservat ta' 2 sa 3 darbiet.
English: Blood calcium decreased1, 4
Maltese: Tnaqqis fil-kalċju fid-demm1, 4
English: The starting dose of cinacalcet was 30 mg daily, titrated every 4 weeks in 30 mg increments or 60 mg for the last uptitration to a maximum dose of 180 mg daily following the cinacalcet prescribing information.
Maltese: Id-doża tal-bidu ta' cinacalcet kienet 30 mg kuljum, ittitrata kull 4 ġimgħat b'żidiet ta' 30 mg jew 60 mg għall-aħħar żieda sa doża massima ta' 180 mg kuljum skont l-informazzjoni dwar preskrizzjoni ta' cinacalcet.
English: 4 Asymptomatic reductions in calcium below 7.5 mg/dL (1.88 mmol/L) or clinically significant asymptomatic reductions in serum cCa between 7.5 and < 8.3 mg/dL (1.88 and < 2.08 mmol/L) (that required medical management).
Maltese: Tnaqqis mingħajr sintomi fil-kalċju taħt 7.5 mg/dL (1.88 mmol/L) jew tnaqqis mingħajr sintomi klinikament sinifikanti f'cCa fis-serum bejn 7.5 u < 8.3 mg/dL (1.88 u < 2.08 mmol/L) (li jeħtieġ immaniġġjar kliniku).
English: Effects of Parsabiv on PTH, corrected serum calcium, phosphate and Ca x P in 6 month placebo-controlled studies
Maltese: Effetti ta' Parsabiv fuq PTH, kalċju ikkoreġut fis-serum, fosfat u Ca x P fi studji kkontrollati bil-plaċebo ta' 6 xhur
English: Following a single radiolabelled dose of etelcalcetide in CKD patients with secondary HPT receiving haemodialysis, approximately 60% of dosed [14C]-etelcalcetide was recovered in dialysate and approximately 7% recovered in urine and faeces combined over 175 days of collection period.
Maltese: Wara doża radjutikkettata waħda ta' etelcalcetide f'pazjenti b'CKD b'HPT sekondarju li jirċievu l-emodijalisi, madwar 60% ta' [14C]-etelcalcetide iddożat kien irkuprat fis-soluzzjoni tad-dijalisi u madwar 7% kien irkuprat fl-awrina u fl-ippurgar flimkien fuq 175 jum ta' perjodu ta' ġbir.
English: No body weight, gender, age, or race-related pharmacokinetic differences have been observed in adult patients studied.
Maltese: Ma kienu osservati l-ebda differenzi farmakokinetiċi relatati mal-piż tal-ġisem, sess, età, jew razza filpazjenti adulti studjati.
English: Open-label extension study
Maltese: Studju open-label ta' estensjoni
English: Other medicines and Parsabiv
Maltese: Mediċini oħra u Parsabiv
English: Placebo-controlled studies
Maltese: Studji kkontrollati bil-plaċebo
English: Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection etelcalcetide
Maltese: Parsabiv 2.5 mg soluzzjoni għall-injezzjoni Parsabiv 5 mg soluzzjoni għall-injezzjoni Parsabiv 10 mg soluzzjoni għall-injezzjoni Etelcalcetide
English: Following a single intravenous bolus administration of 5 mg etelcalcetide, PTH levels decreased rapidly within 30 minutes post-dose and were maximally decreased for 1 hour, before returning to baseline.
Maltese: Wara l-għoti ta' bolus wieħed fil-vini ta' 5 mg etelcalcetide, il-livelli ta' PTH jonqsu malajr fi żmien 30 minuta wara d-doża u kienu imnaqqsa b'mod massimu għal siegħa, qabel ma reġgħu lura għal-linja bażi.
English: Metabolism and nutrition disorders Very common
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: EU/1/16/1142/009 EU/1/16/1142/010 EU/1/16/1142/011 EU/1/16/1142/012
Maltese: EU/1/16/1142/009 EU/1/16/1142/010
English: Corrected serum calcium Mean percent change during the EAP, % (SE)
Maltese: Fosfat Bidla perċentwali medja matul l-EAP, % (SE)
English: The safety and efficacy of etelcalcetide in children and adolescents less than 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' etelcalcetide fit-tfal u l-adolexxenti ta' età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Etelcalcetide was mutagenic in some strains of bacteria (Ames), however was not genotoxic in in vitro and in vivo mammalian genotoxicity assays and therefore is considered non-genotoxic in humans.
Maltese: Etelcalcetide kien mutaġeniku f'ċertu razez ta' batterja (Ames), madankollu ma kellux effett tossiku fuq il-ġeni f'analiżi in vitro u in vivo dwar l-effett tossiku fuq il-ġeni fil-mammiferi u għalhekk huwa meqjus bħala li m'għandux effett tossiku fuq il-ġeni fil-bnedmin.
English: The primary endpoint was non-inferiority for the proportion of patients who achieved > 30% reduction from baseline in mean PTH during the EAP (weeks 20 to 27).
Maltese: Il-punt finali primarju kien nuqqas ta' inferjorità għall-proporzjon ta' pazjenti li kisbu tnaqqis ta' > 30% mil-linja bażi f'PTH medja matul l-EAP (ġimgħat 20 sa 27).
English: Uncommon: may affect up to 1 in 100 people • Seizures (fits or convulsions); for additional information see section 2
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100 • Aċċessjonijiet (attakki tal-qamar jew konvulżjonijiet); għal aktar informazzjoni ara s-sezzjoni 2.
English: Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg.
Maltese: Parsabiv għandu jkun ittitrat biex id-dożi jiġu individwalizzati bejn 2.5 mg u 15 mg.
English: In addition, Parsabiv decreased pre-dialysis PTH to ≤ 300 pg/mL in more than 50% of patients and decreased mean PTH, cCa, cCa x P, and phosphate from baseline.
Maltese: Barra minn hekk, Parsabiv naqas PTH ta' qabel d-dijalisi għal ≤ 300 pg/mL f'aktar minn 50% tal-pazjenti u naqqas PTH, cCa, cCa x P, u fosfat medji mil-linja bażi.
English: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL.
Maltese: Jista' jiżviluppa għadam adinamiku jekk il-livelli ta' PTH jkunu ssoppressati b'mod kroniku taħt 100 pg/mL.
English: The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL (2.08 mmol/L).
Maltese: Il-limitu l-baxx tal-firxa normali għall-kalċju ikkoreġut fis-serum kien ta' 8.3 mg/dL (2.08 mmol/L).
English: In vitro, etelcalcetide was not a substrate of efflux and uptake transporter proteins; and etelcalcetide was not an inhibitor of common transporter proteins.
Maltese: In vitro, etelcalcetide ma kienx sottostrat ta' proteini tat-trasport tal-effluss u tat-teħid mill-ġdid; u etelcalcetide ma kienx inibitur ta' proteini komuni tat-trasport.
English: Single doses up to 60 mg and multiple doses up to 22.5 mg 3 times a week at the end of dialysis in patients receiving haemodialysis were safely administered in clinical trials.
Maltese: Dożi waħdanin sa 60 mg u dożi multipli sa 22.5 mg 3 darbiet fil-ġimgħa fl-aħħar tad-dijalisi f'pazjenti li kienu qed jirċievu lemodijalisi ingħataw mingħajr periklu fi provi kliniċi.
English: Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL).
Maltese: Kull kunjett fih 2.5 mg ta' etelcalcetide f'0.5 mL ta' soluzzjoni (5 mg/mL).
English: Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures.
Maltese: Manifestazzjonijiet potenzjali ta' ipokalċimija jinkludu parasteżiji, uġigħ fil-muskoli, spażmi filmuskoli u aċċessjonijiet.
English: • Stop Parsabiv until corrected serum calcium levels are ≥ 8.3 mg/dL (2.08mmol/L) and symptoms of hypocalcaemia (if present) have resolved.
Maltese: • Waqqaf Parsabiv sakemm il-livelli ta' kalċju ikkoreġut fisserum jkunu ≥ 8.3 mg/dL (2.08 mmol/L) u s-sintomi ta' ipokalċimija (jekk preżenti) jgħaddu.
English: Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).
Maltese: Kull kunjett fih 10 mg ta' etelcalcetide f'2 mL ta' soluzzjoni (5 mg/mL).
English: • If clinically indicated: start or increase calcium supplements, calciumcontaining phosphate binders, and/or vitamin D sterols.
Maltese: • Jekk indikat klinikament: - ibda jew żid supplimenti tal-kalċju, phosphate binders li fihom il-kalċju, u/jew sterols tal-vitamina D. - żid il-konċentrazzjoni tal-kalċju fis-soluzzjoni taddijalisi.
English: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution.
Maltese: Kull kunjett fih 10 mg ta' etelcalcetide (bħala hydrochloride) f'2 mL ta' soluzzjoni.
English: Patients were maintained on dialysate calcium concentration ≥ 2.25 meq/L.
Maltese: Il-pazjenti nżammu fuq konċentrazzjoni ta' soluzzjoni ta' kalċju għad-dijalisi ta' ≥ 2.25 meq/L.
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide
Maltese: Parsabiv 2.5 mg soluzzjoni għall-injezzjoni etelcalcetide
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide
Maltese: Parsabiv 10 mg soluzzjoni għall-injezzjoni etelcalcetide
English: Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL).
Maltese: Kull kunjett fih 5 mg ta' etelcalcetide f'1 mL ta' soluzzjoni (5 mg/mL).
English: Parsabiv should not be initiated if corrected serum calcium is less than the lower limit of the normal range (see sections 4.2 and 4.4).
Maltese: Parsabiv m'għandux jingħata jekk il-kalċju ikkoreġut fis-serum ikun inqas mill-limitu l-baxx tal-firxa normali (ara sezzjonijiet 4.2 u 4.4).
English: • Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton.
Maltese: • Parsabiv huwa stabbli għal massimu ta' 7 ijiem kumulattivi jekk jinħażen fil-kartuna oriġinali.
English: The median average weekly dose of Parsabiv during the efficacy assessment period (EAP) was 20.4 mg (6.8 mg per administration).
Maltese: Il-medjan tad-doża medja ta' kull ġimgħa ta' Parsabiv matul ilperjodu ta' valutazzjoni tal-effikaċja (EAP - efficacy assessment period) kien 20.4 mg (6.8 mg għal kull għoti).
English: There were no effects on embryo-foetal development in rats and rabbits when exposed to up to 1.8 to 4.3 times clinical exposure levels during organogenesis.
Maltese: Ma kienx hemm effetti fuq l-iżvilupp fl-embrijuni u l-feti fil-firien u fil-fniek meta esposti sa 1.8 sa 4.3 darbiet il-livelli ta' esponiment kliniku matul l-organoġenesi.
English: All effects were reversible upon cessation of treatment.
Maltese: L-effetti kollha kienu riversibbli wara waqfien tat-trattament.
English: Adverse reactions from controlled clinical studies and post-marketing experience
Maltese: Reazzjonijiet avversi minn studji kliniċi kkontrollati u esperjenza ta' wara t-tqegħid fis-suq
English: Etelcalcetide is rapidly cleared in subjects with normal renal function, whilst in CKD patients requiring haemodialysis, etelcalcetide was predominantly eliminated by haemodialysis.
Maltese: Etelcalcetide jitneħħa malajr f'individwi b'funzjoni renali normali, filwaqt li f'pazjenti b'CKD li jeħtieġu l-emodijalisi, etelcalcetide fil-biċċa l-kbira kien eliminat permezz ta' emodijalisi.
English: A 6-month, double-blind, active-controlled study compared the efficacy and safety of Parsabiv with cinacalcet in 683 SHPT patients with CKD on haemodialysis.
Maltese: Studju ta' 6 xhur, double-blind u kkontrollat b'sustanza attiva qabbel l-effikaċja u s-sigurtà ta' Parsabiv ma' cinacalcet f'683 pazjent b'SHPT b'CKD fuq l-emodijalisi.
English: For patients in whom the dose is stopped, Parsabiv should be reinitiated at a lower dose once PTH returns to > 150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥ 8.3 mg/dL (2.08 mmol/L).
Maltese: Għal pazjenti li twaqfitilhom id-doża, Parsabiv għandu jinbeda mill-ġdid b'doża aktar baxxa ladarba PTH jerġa lura għal > 150 pg/mL (15.9 pmol/L) u kalċju ikkoreġut (cCa - corrected calcium) fis-serum qabel id-dijalisi ikun ≥ 8.3 mg/dL (2.08 mmol/L).