FrancophonIA/ELRC3.0 huggingface dataset:
English: • if the cartridge has not been stored correctly (see section 5 ‘How to store Fiasp').
Maltese: • jekk il-kunjett ma ġiex maħżun tajjeb (ara sezzjoni 5 ‘Kif taħżen Fiasp').
English: • Check the name and strength on the label of your pen, to make sure that it contains Fiasp 100 units/mL.
Maltese: • Iċċekkja l-isem u l-qawwa fuq it-tikketta tal-pinna tiegħek, biex taċċerta ruħek li jkun fiha Fiasp 100 unità/mL.
English: Insulin appeared in the circulation approximately 4 minutes after administration (Figure 1).
Maltese: L-insulina dehret fiċċirkolazzjoni madwar 4 minuti wara l-għoti (Figura 1).
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation (see sections 4.4 and 5.1).
Maltese: Dawn jistgħu jinkludu għaraq kiesaħ, ġilda pallida u kiesħa, telqa, nervi jew tregħid, ansjetà, għeja jew debbulizza mhux tas-soltu, konfużjoni, diffikultà biex tikkonċentra, tħeddil, ħafna ġuħ li ma jkunx normali, tibdil fil-vista, uġigħ ta' ras, dardir u palpitazzjoni (ara sezzjoni 4.4 u 5.1).
English: Instructions on how to use Fiasp FlexTouch
Maltese: Istruzzjonijiet dwar kif tuża Fiasp FlexTouch
English: Elderly
Maltese: NovoRapid
English: Based on results from clinical trials with insulin aspart in general, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Maltese: Skont riżultati minn studji kliniċi b'insulina aspart in ġenerali, m'hemmx indikazzjoni li hemm xi differenza fil-frekwenza, fit-tip u fis-severità tar-reazzjonijiet avversi osservati f'pazjenti anzjani u f'pazjenti b'indeboliment renali jew epatiku minn dawk li dehru fil-popolazzjoni ġenerali.
English: Patients using CSII should be instructed in the use of the pump and use the correct reservoir and tubing for pump (see section 6.6).
Maltese: Pazjenti li jużaw CSII għandhom jingħataw istruzzjonijiet dwar l-użu tal-pompa u li jużaw ir-reċipjent u t-tubi l-korretti għall-pompa (ara sezzjoni 6.6).
English: Whites and Hispanics vs. non-Hispanics) on the total insulin exposure of Fiasp was based on results from a population pharmacokinetic analysis in patients with type 1 diabetes.
Maltese: L-effett tar-razza u l-etniċità (Suwed kontra Bojod u Ispaniċi kontra persuni mhux Ispaniċi) fuq lespożizzjoni totali tal-insulina ta' Fiasp kienet ibbażata fuq ir-riżultati minn analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'dijabete ta' tip 1.
English: This is usually only short-lasting.
Maltese: Dan normalment ma jdumx għal tul ta' żmien.
English: Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.
Maltese: Din il-mediċina hija suġġetta għal monitoraġġ addizzjonali.
English: The onset of action was 5 minutes earlier and time to maximum glucose infusion rate was 11 minutes earlier with Fiasp than with NovoRapid.
Maltese: Il-bidu tal-azzjoni kien 5 minuti aktar kmieni, u l-ħin sar-rata massima tal-infużjoni tal-glukosju kien ta' 11-il minuta aktar kmieni b'Fiasp milli b'NovoRapid.
English: EXP During use: Use within 4 weeks (including time in a pump reservoir)
Maltese: Uża fi żmien 4 ġimgħat (inkluż il-ħin fir-reċipjent tal-pompa)
English: Do not use this medicine after the expiry date which is stated on the label and carton, after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara ‘JIS'.
English: Disposal
Maltese: Lipodistrofija
English: Insulins, including insulin aspart, the active ingredient in Fiasp, exert their specific action through binding to insulin receptors.
Maltese: L-insulini, inkluż insulina aspart, is-sustanza attiva fi Fiasp, jeżerċitaw l-azzjoni speċifika tagħhom billi jintrabtu marriċetturi tal-insulina.
English: 6.3 Shelf life
Maltese: Siġill protettiv
English: Children: Fiasp should be injected right before (0-2 minutes) the start of the meal, with the possibility to inject up to 20 minutes after starting the meal in situations, when there is uncertainty about how the child will eat.
Maltese: Tfal: Fiasp għandu jiġi injettat eżatt qabel (0-2 minuti) il-bidu tal-ikla, bil-possibbiltà li jiġi injettat sa 20 minuta wara li tinbeda l-ikla f'sitwazzjonijiet fejn m'hemmx ċertezza dwar meta t-tifel/tifla se jiekol.
English: In this trial the efficacy and safety of Fiasp administered at mealtime (0-2 minutes before meal) or postmeal (20 minutes after meal start) and NovoRapid administered at mealtime, both used in combination with insulin degludec, were compared.
Maltese: F'din il-prova, ġew mqabbla, l-effikaċja u s-sigurtà ta' Fiasp mogħti fil-ħin tal-ikel (0-2 minuti qabel l-ikel) jew wara l-ikel (20 minuta wara li tkun bdiet likla) u NovoRapid mogħti fil-ħin tal-ikel, it-tnejn li huma użati flimkien ma' insulin degludec.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: • cool pale skin
Maltese: GĦAMLA KWALITATTIVA
English: • oral contraceptives (birth control pills)
Maltese: • kontraċettivi li jittieħdu mill-ħalq (pilloli li jikkontrollaw biex ma tinqabadx tqala)
English: When your pen contains less than 80 units, the dose counter stops at the number of units left.
Maltese: Meta l-pinna tiegħek ikun fiha inqas minn 80 unità, ilkontatur tad-doża jieqaf fuq in-numru ta' unitajiet li jkun fadal.
English: No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
Maltese: B'mod globali, ma ġew osservati l-ebda differenzi fis-sigurtà u l-effikaċja bejn pazjenti anzjani u pazjenti li kienu iżgħar.
English: Figure 2 Mean insulin profiles in patients with type 1 diabetes in a CSII setting (0-5 hours) corrected for basal insulin infusion
Maltese: 2 Medja tal-profili tal-insulina f'pazjenti b'dijabete ta' tip 1 fi sfond ta' CSII (0-5 sigħat) ikkoreġuta għal infużjoni ta' insulina bażilari
English: Fiasp 100 units/mL solution for injection in cartridge insulin aspart
Maltese: Fiasp 100 unità/mL soluzzjoni għall-injezzjoni fi skartoċċ insulina aspart
English: Each vial contains 10 mL solution.
Maltese: Kull kunjett fih 10 mL ta' soluzzjoni.
English: The effect of gender on the pharmacokinetics of Fiasp was examined in an across-trial analysis of the pharmacokinetic studies.
Maltese: L-effett tas-sess fuq il-farmakokinetika ta' Fiasp ġie eżaminat f'analiżi tal-provi kollha tal-istudji farmakokinetiċi.
English: Fiasp may be used in an infusion pump (CSII) for a maximum of 6 days, as described in section 4.2 and in the package leaflet.
Maltese: Fiasp jista' jintuża f'pompa tal-infużjoni (CSII) għal massimu ta' 6 ijiem, kif deskritt f'sezzjoni 4.2 u fil-fuljett ta' tagħrif.
English: The cartridge (Penfill) is designed to be used with Novo Nordisk reusable insulin pens and NovoFine Plus, NovoFine or NovoTwist injection needles for subcutaneous injection only.
Maltese: L-iskartoċċ (Penfill) hu maħsub biex jintuża ma' pinen tal-insulina NovoNordisk li jerġgħu jintużaw u labar tal-injezzjoni NovoFine Plus, NovoFine jew NovoTwist għall-injezzjoni biss minn taħt il-ġilda.
English: Hypersensitivity Anaphylactic reactions
Maltese: Reazzjonijiet allerġiċi tal-ġilda
English: After first opening or if carried as a spare: You can carry your vial with you and keep it at room temperature (not above 30°C) or in a refrigerator (2°C-8°C) for up to 4 weeks (including time in a pump reservoir).
Maltese: Tista' ġġorr il-kunjett miegħek u żżommu f'temperatura tal-kamra (mhux aktar minn 30°C) jew fi friġġ (2°C - 8°C) sa perjodu ta' 4 ġimgħat (inkluż il-ħin fir-reċipjent tal-pompa).
English: Fiasp is a mealtime insulin.
Maltese: Ħares minn ġot-tieqa tal-insulina.
English: The pre-filled pen (FlexTouch) is designed to be used with NovoFine Plus, NovoFine or NovoTwist injection needles.
Maltese: Il-pinna mimlija għal-lest (FlexTouch) hi maħsuba biex tintuża ma' labar tal-injezzjoni NovoFine Plus, NovoFine jew NovoTwist.
English: Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Maltese: L-alkoħol jista' jżid jew inaqqas l-effett ipogliċemiku tal-insulina.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction after exposure to insulin aspart.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u effett tossiku fuq is-sistema riproduttiva wara l-espożizzjoni għal insulina aspart, ma juri l-ebda periklu speċjali għall-bnedmin.
English: • Take a new needle and tear off the paper tab.
Maltese: • Tinjettax ġo vina jew ġo muskolu.
English: Dose for type 1 and type 2 diabetes
Maltese: Doża għad-dijabete ta' tip 1 u ta' tip 2
English: In elderly patients with type 1 diabetes Fiasp showed, an earlier onset of exposure and a higher early insulin exposure whilst maintaining a similar total exposure and maximum concentration compared to NovoRapid.
Maltese: F'pazjenti anzjani b'dijabete ta' tip 1, Fiasp wera bidu aktar kmieni ta' espożizzjoni u espożizzjoni bikrija ogħla tal-insulina filwaqt li żamm espożizzjoni totali simili u konċentrazzjoni massima simili meta mqabbel ma' NovoRapid.
English: Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes aged 2 to less than 18 years.
Maltese: Is-sigurtà u l-effikaċja ġew investigati f'prova terapewtika konfermatorja fit-tfal bid-dijabete mellitus ta' tip 1 ta' età minn sentejn sa inqas minn 18-il sena.
English: 30 tablets
Maltese: 30 pillola
English: ATC code: H05BX01.
Maltese: H05BX01.
English: Via San Martino 12 I-20122 Milan Italy
Maltese: Via San Martino 12 I-20122 Milan Italja
English: General
Maltese: Generali
English: 14 tablets 28 tablets 84 tablets
Maltese: 14-il pillola 28 pillola 84 pillola
English: Italy
Maltese: Italja
English: Testosterone Levels
Maltese: Livelli ta' Testosterone
English: The active substance is cinacalcet.
Maltese: Is-sustanza attiva hi cinacalcet.
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Maltese: It-tnaqqis medju ta' Ca x P, kalċju, u fosforu fis-serum kienu 14%, 7% u 8%, rispettivament.
English: Interactions
Maltese: Interazzjonijiet
English: • Opadry clear (containing hypromellose, macrogol)
Maltese: • Opadry ċar (fih hypromellose, macrogol)
English: Opadry clear:
Maltese: Opadry ċar:
English: Adults and elderly (> 65 years)
Maltese: Adulti u anzjani (> 65 sena)
English: Carnauba Wax Opadry II green:
Maltese: Carnauba Wax Opadry II aħdar:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 22 October 2004
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 22 ta' Ottubru 2004
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Maltese: Folja ta' Aclar/PVC/PVAc/Aluminju li fiha 14-il pillola.
English: Metabolism and nutrition disorders Common: anorexia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni: anoressija
English: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline, clomipramine and
Maltese: • mediċini wżati għall-kura tad-depressjoni (amitriptyline, desipramine, nortriptyline,
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: Pharmacovigilance system
Maltese: Sistema ta' Farmakoviġilanza
English: • allergic reaction (hypersensitivity)
Maltese: • reazzjoni allerġika (sensittività eċċessiva)
English: Information regarding the pharmacokinetic/pharmacodynamic (PK/PD) profile of cinacalcet is given in section 5.1
Maltese: Informazzjoni dwar il-profil farmakokinetiku/farmakodinamiku (PK/PD) ta' cinacalcet tingħata f'sezzjoni 5.1
English: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172)
Maltese: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blu (E132), iron oxide isfar (E172)
English: Adverse reactions, defined as adverse events considered at least possibly attributable to cinacalcet treatment based on best-evidence assessment of causality and reported in excess of placebo in doubleblind clinical studies are listed below using the following convention: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare
Maltese: Reazzjonijiet avversi, definiti bħala episodi avversi ikkunsidrati bħala ta' l-inqas possibilment attribwiti mal--kura b'cinacalcet ibbażat fuq valutazzjoni ta' l-aqwa evidenza ta' kawżalità u rrappurtati aktar milli bil-plaċebo fl-istudji kliniċi double-blind huma mniżżla hawn taħt skond ilkonvenzjoni li ġejja: komuni ħafna (>1/10); komuni (>1/100, <1/10); mhux komuni (>1/1,000, <1/100); rari (>1/10,000, <1/1,000); rari ħafna (<1/10,000).
English: Serum Calcium
Maltese: Calcium carbonate:
English: Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Maltese: Daqsijiet tal-pakketti ta' folja waħda (14-il pillola), żewġ folji (28 pillola), 6 folji (84 pillola) f'kull kartuna.
English: • indigestion (dyspepsia)
Maltese: • indiġestjoni (dispepsja)
English: • muscle pain (myalgia)
Maltese: • uġigħ fil-muskoli (majalġja)
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 li ma tantx huma solubili.
English: Cinacalcet is metabolised in part by the enzyme CYP3A4.
Maltese: Cinacalcet huwa metabolizzat parzjalment mill-enżima CYP3A4.
English: Steady state drug levels are achieved within 7 days with minimal accumulation.
Maltese: Livelli tal-mediċina fi stat stabbli jintlaħqu f'7 ijiem b'akkumulazzjoni minima.
English: • antibiotic used to treat bacterial infections (ciprofloxacin).
Maltese: • anti-bijotiċi wżati għall-kura ta' infezzjonijiet ikkawżati mill-batterji (ciprofloxacin).
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole, voriconazole);
Maltese: • mediċini wżati għall-kura ta' infezzjonijiet tal-ġilda u tal-fungu (ketoconazole, itraconazole,
English: Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n=1136).
Maltese: Twettqu tlett studji kliniċi ta' 6-xhur, double-blind u kkontrollati bil-plaċebo f'pazjenti b'ESRD b'HPT sekondarja mhux kontrollata, li kienu qed jirċievu d-dijalisi (n=1136).
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 tagħrif in vitro, cinacalcet huwa inibitur qawwi ta' CYP2D6, iżda f'konċentrazzjonijiet milħuqa klinikament, la huwa inibitur ta' enżimi ta' CYP oħra, inkluż CYP1A2, CYP2C8, CYP2C9, CYP2C19, u CYP3A4, u lanqas induttur ta' CYP1A2, CYP2C19 u CYP3A4.
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 enżimi, primarjament CYP3A4 u CYP1A2 (il-kontribuzzjoni ta' CYP1A2 għadha ma ġietx ikkaratterizzata klinikament).
English: Eighteen 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 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: In CKD patients receiving dialysis who were administered Parareg, 4% of serum calcium values were less than 7.5 mg/dl (1.875 mmol/l).
Maltese: F'pazjenti b'CKD li jkunu qed jirċievu d-dijalisi li ngħataw Parareg, 4% tal-valuri tal-kalċju fis-serum, kienu inqas minn 7.5 mg/dl (1.875 mmol/l).
English: Dose adjustment of Parareg may be necessary (see section 4.5).
Maltese: Jista' jkun hemm bżonn ta' aġġustament fid-doża ta' Parareg (ara sezzjoni 4.5).
English: Hepatic Insufficiency
Maltese: Indeboliment epatiku
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-għotja ta' cinacalcet (90 mg) flimkien ma' midazolam (2 mg) mogħti b'mod orali, substrat ta' CYP3A4 u CYP3A5, ma biddlitx il-farmakokinetika ta' midazolam.
English: • loss of appetite (anorexia)
Maltese: • telf ta' l-aptit (anoressija)
English: Immune system disorders Uncommon: hypersensitivity reactions
Maltese: -sistema immuni Mhux komuni: rezzjonijiet ta' sensitività eċċessiva
English: In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-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'Parareg u b'16.3% fil-pazjenti kkurati bil-plaċebo wara 6 xhur ta' kura.
English: Parareg is used:
Maltese: Parareg jintuża:
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 metabolizers.
Maltese: L-għotja ta' 90 mg cinacalcet darba kuljum flimkien ma' 50 mg desipramine, antidepressanti triċikliċi metabolizzat primarjament minn CYP2D6, żiedet b'mod sinifikanti lespożizzjoni ta' desipramine bi 3.6 darbiet (90 % CI 3.0, 4.4) f'metabolizzaturi estensivi ta' CYP2D6.
English: Pharmacotherapeutic group: anti-parathyroid agents.
Maltese: Kategorija farmakoterapewtika: sustanzi anti-paratirojde, Kodiċi ATC:
English: Sevelamer: Co-administration of sevelamer (2400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Maltese: L-għotja konkomitanti ta' sevelamer (2400 mg tid) ) ma affettwatx il-farmakokinetika ta' cinacalcet.
English: Musculoskeletal, connective tissue and bone disorders Common: myalgia
Maltese: Disturbi muskolu-skeletrali, tal-connective tissue u tal-għadam Komuni: mijalġja
English: Administration of Parareg with food results in an approximate 50 - 80% increase in cinacalcet bioavailability.
Maltese: Għotja ta' Parareg ma' l-ikel wasslet għal żieda ta' madwar 50 - 80% filbiodisponibilità ta' cinacalcet.
English: Each bottle holds 30 tablets.
Maltese: Kull flixkun fih 30 pillola.
English: EXP.:
Maltese: Tipjip:
English: Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Maltese: It-tipjip jinduċi CYP1A2; it-tneħħija ta' cinacalcet instabet li kienet 36-38% ogħla f'min ipejjep meta mqabbla ma' dawk li ma jpejpux.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version of 9 November 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazjoni għat-Tqegħid fuq is-Suq (MAH) jikkommetti ruħu li jwettaq l-istudji u l-attivitajiet miżjuda ta' farmakoviġilanza kif dettaljat fil-Pjan ta' Famakoviġilanza, kif miftiehem fil-verżjoni tad-9 ta' Novembru 2007 tal-Pjan ta' Mmaniġġjar ta' Riskju (RMP) ippreżentata f'Modulu 1.8.2. ta' l-Applikazzjoni għal l-Awtorizzazjoni għat-Tqegħid fis-Suq u kull tiġdid sussegwenti ta' lRMP kif miftiehem mis-CHMP.
English: In these studies, seizures were observed in 1.4% of Parareg treated patients and 0.4% of placebo-treated patients.
Maltese: F'dawn l-istudji, aċċessjonijiet kienu osservati f'1.4% tal-pazjenti kkurati b'Parareg u f'0.4% fil-pazjenti kkurati bil-plaċebo.
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 ta' l-istudju kienet tnaqqis tal-kalċju fis-serum ta' ≥ 1 mg/dL (≥ 0.25 mmol/l).
English: Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Maltese: L-għotja konkomitanti ta' pantoprazole (80 mg od) ) ma affettwatx il-farmakokinetika ta' cinacalcet.
English: • parathyroid carcinoma.
Maltese: • karċinoma fil-paratirojde.
English: Nervous system disorders Common: dizziness, paraesthesia Uncommon: seizures
Maltese: Disturbi fis-sistema nervuża Komuni: sturdament, parasteżija Mhux komuni: aċċessjonijiet
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA) http://www.emea.europa.eu/
English: Calcium carbonate: Co-administration of calcium carbonate (single 1500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Maltese: L-għotja konkomitanti ta' calcium carbonate (doża waħda ta' 1500 mg) ma affettwatx il-farmakokinetika ta' cinacalcet.
English: Dose adjustment of Parareg may be required if a patient receiving Parareg initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Maltese: Jista' jkun hemm bżonn ta' aġġustament fid-doża ta' Parareg jekk pazjent li qed jieħu Parareg jibda jew iwaqqaf terapija b'inibitur qawwi (e.ż. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) jew induttur qawwi (eg rifampicin) ta' din l-enżima (ara sezzjoni 4.4).
English: Parareg 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: Parareg għandu jiġi ttitrat kull ġimgħatejn sa 4 ġimgħat sa doża massima ta' 180 mg darba kuljum biex tintlaħaq il-mira talormon tal-paratirojde (PTH) f'pazjenti bid-dijalisi li hija bejn 150-300 pg/ml (15.
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 fisserum naqsu minn 12.7 mg/dl għal 10.
English: High Density Polyethylene (HDPE) bottle with a desiccant canister and polyester coil, and a childresistant polypropylene cap with an induction seal, packed into a carton.
Maltese: Flixkun ta' High Density Polyethylene (HDPE) b'ċilindru ta' dessicant u kolja tal-polyester, u tapp tal-polypropylene li ma jinfetaħx faċilment mit-tfal b'siġill ta' induzzjoni, ippakkjat ġo kartuna.
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, kalċju u ta' fosforu indipendentament mill-livelli ta' linja bażika ta' iPTH jew livelli ta' Ca x P, modalità ta' dijalisi (PD kontra