FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: A total of 49 patients were enrolled in the study.
Maltese: Fl-istudju ħadu sehem total ta' 49 pazjent.
English: Figure I
Maltese: Figura I
English: Figure V
Maltese: Figura V
English: Figure F
Maltese: Figura F
English: • sodium chloride
Maltese: • klorur tas-sodju
English: Hypocalcaemia, a common clinical manifestation of hypoparathyroidism, was reported in clinical trials with Natpar.
Maltese: Ipokalċimija, manifestazzjoni klinika komuni ta' ipoparatirojdiżmu, kienet irrapportata fi provi kliniċi b'Natpar.
English: Figure T
Maltese: Figura T
English: Figure R
Maltese: Figura R
English: • Call Shire at +44 (0)800 055 6614.
Maltese: • Ċempel lil Shire fuq +44 (0)800 055 6614.
English: In the placebo-controlled study, 9.5% (8/84) Natpar-treated patients and 15% (6/40) placebo-treated patients experienced an injection site reaction, all of which were mild or moderate in severity.
Maltese: Fl-istudju kkontrollat bi plaċebo, 9.5% (8/84) tal-pazjenti li ngħataw kura b'Natpar u 15% (6/40) talpazjenti li ngħataw kura bi plaċebo esperjenzaw reazzjoni fis-sit tal-injezzjoni, li kollha kienu ħfief jew moderati fis-severità.
English: In addition, 87% (73/84) of patients treated with Natpar showed a ≥50% reduction in oral active vitamin D versus 45% (18/40) in the placebo group.
Maltese: Barra minn hekk, 87% (73/84) tal-pazjenti li ngħataw kura b'Natpar wrew tnaqqis ta' ≥50% fil-vitamina D attiva orali meta mqabbla ma' 45% (18/40) fil-grupp tal-plaċebo.
English: Figure W
Maltese: Figura W
English: • feeling nervous or anxious
Maltese: • tħossok nervuż jew anzjuż
English: Paediatric population Pharmacokinetic data in paediatric patients are not available.
Maltese: Ma hemm l-ebda data farmakokinetika disponibbli fuq pazjenti pedjatriċi.
English: vomiting*
Maltese: rimettar*
English: 1 • Check the expiration date (EXP) on the pen (See Figure A).
Maltese: 1 • Iċċekkja d-data ta' skadenza (JIS) fuq ilpinna (Ara Figura A).
English: Figure D
Maltese: Figura D
English: *Signs and symptoms potentially associated with hypercalcaemia that were observed in the clinical trials.
Maltese: *Sinjali u sintomi potenzjalment assoċjati ma' iperkalċimija li kienu osservati fil-provi kliniċi.
English: A pharmacokinetic study in non-hypoparathyroidism subjects was conducted in 6 men and 6 women with moderate hepatic impairment (Child-Pugh Classification of 7-9 [Grade B]) as compared with a matched group of 12 subjects with normal hepatic function.
Maltese: Twettaq studju farmakokinetiku f'individwi mingħajr ipoparatirojdiżmu fuq 6 irġiel u 6 nisa b'indeboliment epatiku moderat (Klassifikazzjoni ta' Child-Pugh ta' 7-9 [Grad B]) meta mqabbla ma' grupp imqabbel ta' 12-il individwu b'funzjoni epatika normali.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA03
Maltese: Omeostasi tal-kalċju, ormoni tal-paratirojde u analogi, Kodiċi ATC:
English: In patients using Natpar concomitantly with cardiac glycosides (such as digoxin or digitoxin), monitor serum calcium and cardiac glycoside levels and patients for signs and symptoms of digitalis toxicity (see section 4.5).
Maltese: F'pazjenti li jkunu qed jużaw Natpar flimkien ma' glikosidi kardijaċi (bħal digoxin jew digitoxin), immonitorja l-livelli talkalċju u tal-glikosidi kardijaċi fis-serum u l-pazjenti għal sinjali u sintomi ta' tossiċità diġitalis (ara sezzjoni 4.5).
English: Natpar 50 micrograms
Maltese: Natpar 50 mikrogramma
English: Figure G
Maltese: Figura G
English: Pharmacokinetics following a single 100 micrograms subcutaneous dose of Natpar was evaluated in 16 non-impaired subjects (creatinine clearance (CLcr) >80 mL/min) and 16 subjects with renal impairment.
Maltese: Il-farmakokinetika wara doża unika ta' 100 mikrogramma ta' Natpar taħt il-ġilda ġiet ivvalutata f'16-il individwu mingħajr indeboliment (eliminazzjoni tal-kreatinina (CLcr) >80 mL/min) u f'16-il individwu b'indeboliment renali.
English: Natpar is a protein that is not metabolised by and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g., cytochrome P450 isoenzymes).
Maltese: Natpar huwa proteina li ma tiġix metabolizzata minn u ma tinibixxix l-enzimi mikrosomali epatiċi li jimmetabolizzaw il-mediċina (eż. isoenzimi taċ-ċitokromju P450).
English: *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Maltese: *L-ormon tal-paratirojde (rDNA), prodott f'E. coli permezz ta' teknoloġija tad-DNA rikombinanti, huwa identiku għas-sekwenza tal-amminoaċidu 84 tal-ormon endoġenu tal-paratirojde tal-bniedem.
English: Natpar 25 micrograms
Maltese: Natpar 25 mikrogramma
English: Figure S
Maltese: Figura S
English: Figure N
Maltese: Figura N
English: Figure P
Maltese: Figura P
English: Other medicines and Natpar
Maltese: Mediċini oħra u Natpar
English: No drug-drug interaction study has been conducted with cardiac glycosides and Natpar (see section 4.4).
Maltese: Ma twettaq l-ebda studju ta' interazzjoni bejn il-mediċini bi glikosidi kardijaċi u Natpar (ara sezzjoni 4.4).
English: The mean maximum concentration (Cmax) of PTH following 100 micrograms parathyroid hormone (rDNA) in subjects with mild-to-moderate renal impairment (CLcr 30 to 80 mL/min) was approximately 23% higher than that observed in subjects with normal renal function.
Maltese: Il-konċentrazzjoni massima medja (Cmax) ta' PTH wara 100 mikrogramma ta' ormon tal-paratirojde (rDNA) f'individwi b'indeboliment renali ħafif sa moderat (CLcr 30 sa 80 mL/min) kienet ta' madwar 23% ogħla minn dik osservata f'individwi b'funzjoni renali normali.
English: Then consider resuming Natpar, calcium and active vitamin D at lower doses (see sections 4.2 and 4.8).
Maltese: Imbagħad ikkunsidra li tkompli Natpar, il-kalċju u l-vitamina D attiva f'dożi aktar baxxi (ara sezzjonijiet 4.2 u 4.8).
English: A greater increase in the levels of 1,25-(OH)2D in serum were observed with the 50 micrograms dose than with the 100 micrograms dose, likely due to direct inhibition of the renal 25-hydroxyvitamin D-1-hydroxylase enzyme by serum calcium.
Maltese: Kienet osservata żieda akbar fil-livelli ta' 1,25-(OH)2D fis-serum bid-doża ta' 50 mikrogramma milli bid-doża ta' 100 mikrogramma, x'aktarx minħabba l-inibizzjoni diretta tal-enzima 25-hydroxyvitamin D-1-hydroxylase fil-kliewi mill-kalċju fis-serum.
English: No studies were conducted in patients on renal dialysis.
Maltese: Ma twettaq l-ebda studju f'pazjenti fuq dijalisi renali.
English: Figure Z
Maltese: Figura Z
English: At the end of treatment, 46/84 (54.8%) patients treated with Natpar achieved the primary endpoint versus 1/40 (2.5%) with placebo (p<0.001).
Maltese: Fl-aħħar tal-kura, 46/84 (54.8%) tal-pazjenti li ngħataw kura b'Natpar laħqu l-punt ta' tmiem primarju meta mqabbla ma' 1/40 (2.5%) bi plaċebo (p<0.
English: Figure E
Maltese: Figura E
English: Renal and urinary disorders hypercalciuria pollakiuria
Maltese: Disturbi fil-kliewi u fis-sistema urinarja iperkalċijurja*, pollakurja
English: At Week 24, for patients who completed the study, 34/79 (43%) Natpar patients were independent of active vitamin D treatment and were receiving no more than 500 mg of calcium citrate, compared with 2/33 (6.1%) placebo patients (p<0.001).
Maltese: Fil-Ġimgħa 24, għall-pazjenti li temmew l-istudju, 34/79 (43%) tal-pazjenti fuq Natpar kienu indipendenti mill-kura bil-vitamina D attiva u ma kinux qegħdin jirċievu aktar minn 500 mg ta' ċitrat tal-kalċju, meta mqabbla ma' 2/33 (6.1%) tal-pazjenti fuq plaċebo (p<0.
English: Signs and symptoms potentially associated with hypocalcaemia that were observed in the clinical trials.
Maltese: Sinjali u sintomi potenzjalment assoċjati ma' ipokalċimija li kienu osservati fil-provi kliniċi.
English: There is limited information on the safety of Natpar in pregnant women.
Maltese: L-informazzjoni dwar is-sigurtà ta' Natpar f'nisa tqal hija limitata.
English: These medicines include calcium or vitamin D.
Maltese: Dawn il-mediċini jinkludu kalċju jew Vitamina D.
English: Sixty-nine percent (58/84) of subjects randomised to Natpar showed a reduction in oral calcium of ≥50% compared to 7.5% (3/40) of subjects randomised to placebo.
Maltese: Disgħa u sittin fil-mija (58/84) tal-individwi randomizzati għal Natpar wrew tnaqqis ta' ≥50% filkalċju orali meta mqabbla ma' 7.5% (3/40) tal-individwi randomizzati għal plaċebo.
English: The mean percent change from baseline in oral calcium was -51.8% (SD 44.6) in subjects receiving Natpar compared to 6.5% (SD 38.5) in the placebo group (p<0.001).
Maltese: Il-bidla perċentwali medja fil-linja bażi fil-kalċju orali kienet ta' -51.8% (SD 44.6) f'individwi li kienu qed jirċievu Natpar meta mqabbla ma' 6.5% (SD 38.5) fil-grupp tal-plaċebo (p<0.
English: Across all clinical studies in patients with hypoparathyroidism following treatment with Natpar for up to 4 years, the immunogenicity incidence rate was 17/87 (19.5%) and did not appear to increase over time.
Maltese: Fl-istudji kliniċi kollha f'pazjenti b'ipoparatirojdiżmu wara kura b' Natpar għal massimu ta' 4 snin, irrata ta' inċidenza ta' immunoġeniċità kienet ta' 17/87 (19.5 %) u ma dehritx tiżdied maż-żmien.
English: Treatment with Natpar produces a decrease in urinary calcium excretion by 13 and 23% (50 and 100 microgram dose, respectively) to a nadir in the 3 to 6 hour time point, which returns to pre-dosing levels by 16 to 24 hours.
Maltese: Il-kura b'Natpar tipproduċi tnaqqis fl-eliminazzjoni tal-kalċju fl-awrina ta'13 u 23% (doża ta' 50 u 100 mikrogramma, rispettivament) għal nadir fil-punt ta' żmien ta' 3 sa 6 sigħat, li terġa' lura għallivelli ta' qabel id-dożaġġ wara 16 sa 24 siegħa.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Natpar 25 mcg/dose powder for solution for injection Natpar 50 mcg/dose powder for solution for injection Natpar 75 mcg/dose powder for solution for injection Natpar 100 mcg/dose powder for solution for injection Parathyroid hormone (rDNA) Subcutaneous use
Maltese: Natpar 25 mcg/doża trab għal soluzzjoni għall-injezzjoni Natpar 50 mcg/doża trab għal soluzzjoni għall-injezzjoni Natpar 75 mcg/doża trab għal soluzzjoni għall-injezzjoni Natpar 100 mcg/doża trab għal soluzzjoni għall-injezzjoni Ormon tal-paratirojde (rDNA) Użu għal taħt il-ġilda
English: The apparent transient nature of antibodies to PTH is likely due to the low titre.
Maltese: In-natura temporanja evidenti tal-antikorpi għall-PTH hija x'aktarx dovuta għat-titrazzjoni baxxa.
English: If severe hypercalcaemia (>3.0 mmol/L or above upper limit of normal with symptoms) develops, hydration and temporarily stopping Natpar, calcium and active vitamin D should be considered until serum calcium returns to the normal range.
Maltese: Jekk tiżviluppa iperkalċimija severa (>3.0 mmol/L jew ogħla mil-limitu ta' fuq tan-normal b'sintomi), għandha titqies idratazzjoni u t-twaqqif temporanju ta' Natpar, tal-kalċju u tal-vitamina D attiva sakemm il-kalċju fis-serum jerġa' lura għall-medda normali.
English: Endogenous parathyroid hormone (PTH) is secreted by the parathyroid glands as a polypeptide of 84 amino acids.
Maltese: L-ormon tal-paratirojde (PTH) endoġenu jiġi sekretat mill-glandoli tal-paratirojde bħala polipeptid talamminoaċidi 84.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I
English: In a multi-centre clinical trial, albumin-corrected serum calcium (ACSC) values 6-10 hours post-dose were on average 0.25 mmol/L higher than the pre-dose values, with a maximum increase observed of 0.7 mmol/L.
Maltese: Fi prova klinika multiċentrika, il-valuri ta' kalċju fis-serum ikkoreġuti bl-albumina (ACSC) 6-10 sigħat wara d-doża kienu bħala medja 0.25 mmol/L ogħla millvaluri ta' qabel id-doża, b'żieda massima osservata ta' 0.7 mmol/L.
English: A responder was defined using a composite primary efficacy endpoint of at least a 50% reduction from the baseline active vitamin D dose AND at least a 50% reduction from the baseline oral calcium AND an albumin-corrected total serum calcium concentration maintained or normalised compared with the baseline value (≥1.875 mmol/L) and did not exceed the upper limit of the laboratory normal range.
Maltese: Pazjent li rrisponda għall-kura kien definit permezz ta' punt ta' tmiem kompost tal-effikaċja primarja ta' tnaqqis ta' mill-inqas 50 % mid-doża ta' vitamina D attiva meta mqabbla mal-linja bażi U tnaqqis ta' mill-inqas 50 % mill-kalċju orali meta mqabbla mal-linja bażi U konċentrazzjoni totali ta' kalċju fis-serum korretta bl-albumina miżmuma jew normalizzata meta mqabbel mal-valur fil-linja bażi (≥ 1.875 mmol/L) u ma li qabiżx il-limitu ta' fuq tal-medda normali skont ir-riżultati tal-laboratorju.
English: In the kidney, PTH (1-84) increases renal tubular reabsorption of calcium and promotes phosphate excretion.
Maltese: Fil-kliewi, PTH (1-84) iżid ir-riassorbiment tubulari tal-kalċju mill-kliewi u jippromwovi l-eliminazzjoni tal-fosfat.
English: Effect on mineral metabolism
Maltese: Effett fuq il-metaboliżmu tal-minerali
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a(4) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Figure Y
Maltese: Figura Y
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: At randomisation, active forms of vitamin D were reduced by 50% and patients were allocated to Natpar 50 micrograms daily or placebo.
Maltese: Fir-randomizzazzjoni, il-forom attivi ta' vitamina D tnaqqsu b'50 % u l-pazjenti kienu allokati għal Natpar 50 mikrogramma kuljum jew għal plaċebo.
English: If you have questions at any time, see the “Frequently Asked Questions” in Section E, contact your doctor or nurse, call Shire at +44 (0)800 055 6614, or email at medinfoEMEA@shire.com for help.
Maltese: Jekk ikollok mistoqsijiet fi kwalunkwe ħin, ara l-“Mistoqsijiet Frekwenti” fis-Sezzjoni E, ikkuntattja lit-tabib jew lill-infermier tiegħek, ċempel lil Shire fuq +44 (0)800 055 6614, jew ibgħat email fuq medinfoEMEA@shire.com għall-għajnuna.
English: Musculoskeletal and connective tissue disorders arthralgia*, muscle spasms muscle twitching musculoskeletal pain myalgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja*, spażmi filmuskoli ġbid involontarju filmuskoli
English: Hypersensitivity reactions can include anaphylaxis, dyspnoea, angioedema, urticaria, rash, etc.
Maltese: Reazzjonijiet ta' sensittività eċċessiva jistgħu jinkludu anafilassi, qtugħ ta' nifs, anġjoedima, urtikarja, raxx, eċċ.
English: Distribution Following intravenous administration, Natpar has a volume of distribution of 5.35 L at steady state.
Maltese: Distribuzzjoni Wara l-għoti ġol-vina, Natpar għandu volum ta' distribuzzjoni ta' 5.35 L fi stat fiss.
English: The maximum mean increases of serum calcium, which occurred at 12 hours, were approximately 0.125 mmol/L and 0.175 mmol/L with the 50 micrograms and 100 micrograms dose, respectively.
Maltese: Iż-żidiet massimi mejdi tal-kalċju fis-serum, li seħħew wara 12-il siegħa, kienu ta' madwar 0.125 mmol/L u 0.175 mmol/L bid-doża ta' 50 mikrogramma u ta' 100 mikrogramma, rispettivament.
English: There are no data in patients with severe renal impairment.
Maltese: M'hemm ebda data fuq pazjenti b'indeboliment renali sever.
English: Serum 1,25-(OH)2D increases following a single dose of Natpar to maximum levels at about 12 hours with a return to near baseline levels by 24 hours.
Maltese: 1,25-(OH)2D fis-serum jiżdied wara doża unika ta' Natpar għal livelli massimi wara 12-il siegħa b'ritorn li jkun iqarreb il-livelli fil-linja bażi wara 24 siegħa.
English: Exposure to PTH as measured by AUC0-last and baseline-corrected AUC0-last was approximately 3.9% and 2.5%, respectively, higher than that observed for subjects with normal renal function.
Maltese: L-esponiment għal PTH kif imkejjel bl-AUC0-aħħar u l-AUC0-aħħar ikkoreġut fil-linja bażi kien ta' madwar 3.9% u 2.5%, rispettivament, ogħla minn dak osservat għal individwi b'funzjoni renali normali.
English: Figure K
Maltese: Figura K
English: Hypercalcaemia was reported in clinical trials with Natpar.
Maltese: Iperkalċimija kienet irrapportata fi provi kliniċi b'Natpar.
English: In this trial, patients with chronic hypoparathyroidism receiving calcium and active forms of vitamin D (vitamin D metabolite or analogues) were randomised to Natpar (n=84) or placebo (n=40).
Maltese: F'din il-prova, il-pazjenti b'ipoparatirojdiżmu kroniku li kienu qed jirċievu kalċju u forom attivi ta' vitamina D (metabolit jew analogi tal-vitamina D) kienu randomizzati għal Natpar (n=84) jew għal plaċebo (n=40).
English: This protects the medicine from light (See Figure Y).
Maltese: Dan jipproteġi l-mediċina mid-dawl (Ara Figura Y).
English: Natpar contains sodium
Maltese: Jekk tinsa tuża Natpar
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol (23 mg) ta' sodju f'kull doża.
English: In the powder:
Maltese: Fit-trab:
English: No osteosarcomas have been observed in clinical trials.
Maltese: L-ebda osteosarkoma ma ġiet osservata fil-provi kliniċi.
English: Concomitant use with cardiac glycosides
Maltese: L-użu konkomitanti ma' glikosidi kardijaċi
English: Pre-dose serum calcium
Maltese: Kalċju fis-serum qabel id-doża
English: The aim of treatment with Natpar is to achieve a pre-dose serum calcium concentration of 2.0-2.25 mmol/L and an 8-12 hour post-dose serum calcium concentration <2.55 mmol/L.
Maltese: L-għan tal-kura b'Natpar huwa li tintlaħaq konċentrazzjoni ta' kalċju fis-serum ta' 2.0-2.25 mmol/L qabel id-doża u konċentrazzjoni ta' kalċju fis-serum ta' <2.55 mmol/L 8-12-il siegħa wara d-doża.
English: 11 • Check if the yellow dose counter lines up with the number “14” (See Figure L).
Maltese: 11 • Iċċekkja jekk l-indikatur isfar tad-doża huwiex bi dritt in-numru “14” (Ara Figura L).
English: Always store your pen in the refrigerator between 2°C to 8°C.
Maltese: Dejjem aħżen il-pinna tiegħek fil-friġġ f'temperatura bejn 2°C sa 8°C.
English: If serum concentration of 25-OH vitamin D is low then appropriate supplementation may restore serum calcium response to Natpar (see section 4.2).
Maltese: Jekk il-konċentrazzjoni tal-vitamina D 25-OH fis-serum tkun baxxa, supplimentazzjoni xierqa tista' treġġa' lura r-rispons tal-kalċju fis-serum għal Natpar (ara sezzjoni 4.2).
English: Important: Carefully read Step 10 through Step 14 before injecting.
Maltese: Aqra Pass 10 sa Pass 14 bir-reqqa qabel ma tinjetta.
English: No, you should only use 31G x 8mm, 31G x 5mm or 32G x 4mm pen needles.
Maltese: Le, għandek tuża biss labar tal-pinna 31G x 8mm, 31G x 5mm jew 32G x 4mm.
English: • citric acid monohydrate
Maltese: • aċidu ċitriku monoidrat
English: Natpar 100 micrograms/dose Blue pen label.
Maltese: Natpar 100 mikrogramma/doża Tikketta tal-pinna kaħla.
English: • sodium hydroxide (for pH adjustment)
Maltese: • idrossidu tas-sodju (għall-aġġustament tal-pH)
English: Investigations anti-PTH antibody positive, blood 25-hydroxycholecalcif erol decreased vitamin D decreased
Maltese: Investigazzjonijiet antikorpi kontra l-PTH pożittivi, tnaqqis fil25-hydroxycholecalcif erol fid-demm tnaqqis fil-vitamina D
English: 31 December 2035.
Maltese: sal-31 ta' Diċembru 2035
English: • stomach pain*
Maltese: • uġigħ fl-istonku*
English: 1 • If you just completed “New Pen Setup & Mixing” (Section B), go to Step 8 below.
Maltese: 1 • Jekk għadek kemm lestejt “Preparazzjoni u Taħlit ta' Pinna Ġdida” (Sezzjoni B), mur għall-Pass 8 hawn taħt.
English: Parathyroid hormone (rDNA) was evaluated in an open-label PK/PD study in which 7 patients with hypoparathyroidism received single subcutaneous doses of 50 and 100 micrograms with a 7-day washout interval between doses.
Maltese: L-ormon tal-paratirojde (rDNA) ġie vvalutat fi studju b'tikketta miftuħa talfarmakokinetika/farmakodinamika li fih 7 pazjenti b'ipoparatirojdiżmu irċevew dożi uniċi ta' 50 u 100 mikrogramma taħt il-ġilda b'intervall ta' 7 ijiem mingħajr kura bejn id-dożi (washout interval).
English: • Confirm serum magnesium is within the reference range.
Maltese: • Ikkonferma li l-manjeżju fis-serum huwa fil-limiti ta' referenza.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: PC SN NN
Maltese: Kif taħżen Natpar
English: Following injection with Natpar, serum phosphate levels decrease proportionally to PTH(1-84) levels over the first 4 hours and persist over 24 hours post-injection.
Maltese: Wara injezzjoni b'Natpar, il-livelli ta' fosfat fis-serum jonqsu b'mod proporzjonali għal-livelli PTH(1-84) matul l-ewwel 4 sigħat u jippersistu għal 24 siegħa wara l-injezzjoni.
English: It is normal to see small air bubbles in the medicine.
Maltese: Huwa normali li tara bżieżaq tal-arja żgħar fil-mediċina.
English: The reconstituted pre-filled pen should be discarded after the 14-day period.
Maltese: • Ipprepara pinna ġdida kull 14-il jum.
English: Parathyroid hormone receptors belong to the family of G-coupled protein receptors.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Important - Read this information before getting started:
Maltese: Importanti - Aqra din l-informazzjoni qabel ma tibda:
English: Animal data do not indicate any impairment of fertility.
Maltese: Id-data dwar l-annimali ma tindikax xi indeboliment tal-fertilità.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 mL/min).
Maltese: Ma hemm bżonn ta' ebda aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif sa moderat (tneħħija tal-kreatinina ta' 30 sa 80 mL/min).
English: Hypocalcaemia may be minimised by following the recommended dosing, the monitoring information, and asking patients about any symptoms of hypocalcaemia (see sections 4.2 and 4.8).
Maltese: L-ipokalċimija tista' tiġi mnaqqsa billi jiġi segwit iddożaġġ rakkomandat, tiġi segwita l-informazzjoni dwar il-monitoraġġ, u billi l-pazjenti jiġu mistoqsija dwar kwalunkwe sintomu ta' ipokalċimija (ara sezzjonijiet 4.2 u 4.8).
English: 2/L
Maltese: TAS-SUSTANZA/I)
English: Each pre-filled pen contains 1050 micrograms parathyroid hormone (rDNA).
Maltese: Kull pinna mimlija għal-lest fiha 1050 mikrogramma tal-ormon tal-paratirojde (rDNA).
English: • Discard all pens on the “Discard On” date, 14 days after mixing (see Medicine Tracker).
Maltese: Nhar”, 14-il jum wara li tkun ġiet imħallta (ara t-Traċċatur tal-Mediċina).
English: Natpar is a hormone replacement for adults with under-active parathyroid glands, a condition known as ‘hypoparathyroidism'.
Maltese: Natpar huwa sostitut tal-ormoni għal adulti bi glandoli tal-paratirojde b'attività baxxa, kundizzjoni magħrufa bħala ‘ipoparatirojdiżmu'.
English: • Call your doctor or nurse.
Maltese: • Ċempel lit-tabib jew lill-infermier tiegħek.