FrancophonIA/ELRC3.0 huggingface dataset:
English: The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.
Maltese: Id-deċiżjoni li ramucirumab jitkompla wara intervent kirurġiku għandha tkun ibbażata fuq opinjoni klinika ta' fejqan xieraq tal-ferita.
English: Table 7: ADRs reported in patients treated with ramucirumab in combination with chemotherapy in phase 3 clinical trials (RAINBOW, REVEL and RAISE)
Maltese: Tabella 6: L-ADRs irrapportati f'pazjenti ttrattati b' ramucirumab bħala monoterapija f'provi kliniċi ta' fażi
English: In case of pre-filled intravenous infusion container usage Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the pre-filled 250 ml intravenous container.
Maltese: F'każ li jkun qed jintuża kontenitur mimli għal-lest b'infużjoni għal ġol-vini Abbażi tal-volum ikkalkulat ta' ramucirumab, neħħi l-volum li jaqbel miegħu ta' soluzzjoni għall injezzjoni ta' sodium chloride 9 mg/ml (0.9%) mill-kontenitur ta' 250 ml mimli għal-lest b'użu għal ġol-vini.
English: After dilution When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives.
Maltese: Meta jiġu ppreparati skont l-istruzzjonijiet, soluzzjonijiet ta' infużjoni ta' Cyramza ma jkunx fihom preservattivi kontra l-mikrobi.
English: Cyramza+Paclitaxel Placebo+Paclitaxel
Maltese: Cyramza bħala sustanza waħedha
English: Following the dose regimen of 8 mg/kg every 2 weeks, the geometric means of ramucirumab Cmin prior to administration of the fourth and seventh dose of ramucirumab given as a single agent in advanced gastric cancer patients' serum were 49.5 μg/ml (range of 6.3-228 μg/ml) and 74.4 μg/ml (range of 13.8-234 μg/ml), respectively.
Maltese: .2 Tagħrif farmakokinetiku Wara l-programm ta' kura b'doża ta' 8 mg/kg kull ġimagħtejn, il-medji ġeometriċi tas-Cmin ta' ramucirumab fis-serum qabel ma tingħata r-raba' u s-seba' doża ta' ramucirumab mogħti bħala sustanza waħidha f'pazjenti b'kanċer gastriku avvanzat kienu 49.5 μg/ml (medda ta' 6.3-228 μg/ml) u
English: See prescribing information for paclitaxel, for components of FOLFIRI and for docetaxel, as applicable, for premedication requirements and additional information.
Maltese: Ara l-informazzjoni dwar kif paclitaxel, il-komponenti ta' FOLFIRI u docetaxel għandhom jiġu ordnati b'riċetta, skont kif ikun rilevanti, għall-ħtiġijiet ta' premedikazzjoni u informazzjoni addizzjonali.
English: REACH-2 was a global, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC that randomised (2:1) 292 patients with HCC who had a serum AFP ≥ 400 ng/ml at study entry.
Maltese: REACH-2 kien studju double-blind, globali u magħmul b'mod arbitrarju ta' Cyramza flimkien ma' BSC kontra plaċebo flimkien ma' BSC fejn mad-dħul fl-istudju ntagħażlu b'mod arbitrarju (2:1)
English: Overall survival, months Median (95% CI)
Maltese: Sopravivenza totali, xhur Medjan (95% CI)
English: A separate infusion line with a protein sparing 0.22 micron filter must be used for the infusion and the line must be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection at the end of the infusion.
Maltese: Għall-infużjoni għandu jintuża pajp separat tal-infużjoni b'filtru ta' 0.22 mikron li jħalli l-proteini jgħaddu u l-pajp għandu jitlaħlaħ b'soluzzjoni għall injezzjoni ta' sodium chloride 9 mg/ml (0.9%) fi tmiem l-infużjoni.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: min ikun qed jużah u s-soltu ma jkunux aktar minn 24 siegħa f'temperatura ta' 2°C - 8°C, ħlief jekk id-dilwizzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vvalidati.
English: Antibodies are principally cleared by catabolism.
Maltese: L-antikorpi jiġu mneħħija b'mod prinċipali permezz ta' kataboliżmu.
English: If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed.
Maltese: Jekk il-proteina fl-awrina tkun ≥2+ fuq l-istikka li tiċċekkja l awrina, l-awrina għandha tinġabar għal 24 siegħa.
English: Table 5: Dose modification of FOLFIRI components due to specific ADRs
Maltese: Modifikazzjoni fid-doża tal-komponenti ta' FOLFIRI minħabba ADRs speċifiċi ADR
English: Administer via infusion pump.
Maltese: Agħti permezz ta' pompa tal-infużjoni.
English: 1 vial
Maltese: Figura 1: Kurvi
English: Cyramza 10 mg/ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Cyramza 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Patients may be at increased risk for the development of fistula when treated with Cyramza.
Maltese: Il-pazjenti jistgħu jkunu f'riskju akbar għall-iżvilupp ta' fistla meta jkunu kkurati bi Cyramza.
English: There is no relevant use of ramucirumab in the paediatric population for the indications of advanced gastric cancer or gastro-oesophageal adenocarcinoma, adenocarcinoma of the colon and rectum, lung carcinoma, and hepatocellular carcinoma.
Maltese: kanċer avvanzat tal-istonku jew adenokarċinoma gastroesofaġali, adenokarċinoma tal-kolon u tarrektum, karċinoma tal-pulmun u karċinoma epatoċellulari.
English: The metabolism of ramucirumab has not been studied.
Maltese: Il-metaboliżmu ta' ramucirumab ma ġiex studjat.
English: There are no data regarding ramucirumab administration in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Ma hemm l-ebda dejta dwar l-għoti ta' ramucirumab f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).
Maltese: Il-monoterapija bi Cyramza hija indikata għall-kura ta' pazjenti adulti b'kanċer avvanzat tal-istonku jew b'adenokarċinoma fl-għaqda gastro-esofaġali bi progressjoni tal-marda wara li tkun ingħatat kimoterapija li jkun fiha platinum jew fluoropyrimidine, f'dawk fejn il-kura flimkien ma' paclitaxel ma tkunx xierqa (ara sezzjoni 5.1).
English: The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.
Maltese: Pazjenti b'ipertensjoni mhux ikkontrollata ġew esklużi mill-provi: il-kura b'ramucirumab m'għandhiex tinbeda f'pazjenti bħal dawn sakemm l-ipertensjoni li diġà jkun hemm qabel ma tiġix ikkontrollata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 ml vial
Maltese: TIKKETTA TAL-KUNJETT - kunjett ta' 50 ml
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: +371 67364000
Maltese: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
English: The ORR in the
Maltese: IL-PROVVISTA U L
English: 84 tablets
Maltese: 84 pillola
English: 10 to < 12.5
Maltese: 10 sa < 12.5
English: LIST OF EXCIPIENTS Lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Lactose monohydrate.
English: 4.8 Undesirable effects a) Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa a) Sommarju tal-profil tas-sigurta
English: Common*
Maltese: Komuni*
English: d) Paediatric population
Maltese: d) Populazzjoni pedjatrika
English: - The active substance is cinacalcet.
Maltese: - Is-sustanza attiva hi cinacalcet.
English: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
Maltese: Pre-gelatinised starch (qamħirrun) Microcrystalline cellulose Povidone
English: Date of latest renewal: 23 September 2009
Maltese: Data tal-aħħar tiġdid: 23 ta' Settembru 2009
English: Available sequential dose levels (mg)
Maltese: Livelli ta' dożi sekwenzjali disponibbli (mg)
English: See section 6.1
Maltese: Ara s-sezzjoni 6.1
English: Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate,
Maltese: Opadry II aħdar: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate,
English: • Opadry clear (containing hypromellose, macrogol)
Maltese: • Opadry ċar (li fih hypromellose, macrogol)
English: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine);
Maltese: • mediċini wżati għat-trattament tad-depressjoni (amitriptyline, desipramine, nortriptyline u clomipramine);
English: 10, 15, 30, 60, 90, and 120 15, 30, 60, 90, 120, and 180
Maltese: 10, 15, 30, 60, 90, u 120 15, 30, 60, 90, 120, u 180
English: †see section 4.4 *see section c c) Description of selected adverse reactions
Maltese: †ara sezzjoni 4.4 *ara sezzjoni c c) Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: • a medicine used to treat depression (fluvoxamine).
Maltese: • mediċina wżata għat-trattament tad-depressjoni (fluvoxamine).
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): Cinacalcet is a strong inhibitor of CYP2D6.
Maltese: Prodotti mediċinali metabolizzati mill-enzima P450 2D6 (CYP2D6): Cinacalcet huwa inibitur qawwi ta' CYP2D6.
English: ≥ 50 to < 75
Maltese: ≥ 50 sa < 75
English: ≥ 36 to < 50
Maltese: ≥ 36 sa < 50
English: FD&C Blue (E132), iron oxide yellow (E172))
Maltese: FD&C Blu (E132), iron oxide isfar (E172))
English: EU/1/04/292/001 - 30 mg carton with 14 tablets EU/1/04/292/002 - 30 mg carton with 28 tablets EU/1/04/292/003 - 30 mg carton with 84 tablets EU/1/04/292/004 - 30 mg bottle with 30 tablets EU/1/04/292/005 - 60 mg carton with 14 tablets EU/1/04/292/006 - 60 mg carton with 28 tablets EU/1/04/292/007 - 60 mg carton with 84 tablets EU/1/04/292/008 - 60 mg bottle with 30 tablets EU/1/04/292/009 - 90 mg carton with 14 tablets EU/1/04/292/010 - 90 mg carton with 28 tablets EU/1/04/292/011 - 90 mg carton with 84 tablets EU/1/04/292/012 - 90 mg bottle with 30 tablets
Maltese: EU/1/04/292/006 - kartuna ta' 60 mg bi 28 pillola EU/1/04/292/007 - kartuna ta' 60 mg b'84 pillola EU/1/04/292/008 - flixkun ta' 60 mg bi 30 pillola EU/1/04/292/009 - kartuna ta' 90 mg b'14-il pillola EU/1/04/292/010 - kartuna ta' 90 mg bi 28 pillola
English: • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
Maltese: • Opadry aħdar (li fih lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blu (E132), iron oxide isfar (E172))
English: • Titanium dioxide (E171) (1 mg, 2.5 mg and 5 mg capsules)
Maltese: • Titanium dioxide (E171) (kapsuli ta' 1 mg, 2.5 mg u 5 mg)
English: Capsule Printing ink: iron oxide black, shellac, propylene glycol
Maltese: Kapsula Linka għall-istampar: iron oxide iswed, shellac, propylene glycol
English: Each 60 mg tablet contains 5.47 mg of lactose.
Maltese: Kull pillola ta' 60 mg fiha 5.47 mg ta' lactose.
English: b) Tabulated list of adverse reactions
Maltese: b) Lista ta' reazzjonijiet avversi f'tabella
English: ≥ 12.5 to < 25
Maltese: ≥ 12.5 sa < 25
English: Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo-controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Reazzjonijiet avversi, ikkunsidrati bħala tal-inqas possibbilment attribwiti għal trattament b'cinacalcet fi studji kkontrollati bil-placebo u studji bi grupp wieħed ibbażati fuq valutazzjoni tal-aqwa evidenza ta' kawżalità huma mniżżla hawn taħt skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna
English: • Indigo carmine (E132) (1 mg and 5 mg capsules)
Maltese: • Indigo carmine (E132) (kapsuli ta' 1 mg u 5 mg)
English: Insufficient data are available.
Maltese: Data disponibbli hija insufficjenti.
English: Mimpara contains lactose
Maltese: Mimpara fih lactose
English: Each 90 mg tablet contains 8.21 mg of lactose.
Maltese: Kull pillola ta' 90 mg fiha 8.21 mg ta' lactose.
English: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of all-cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving dialysis.
Maltese: EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) kien studju kliniku randomised, double-blind biex jevalwa cinacalcet kontra plaċebo għat-tnaqqis tar-riskju ta' mortalità mill-kawżi kollha u avvenimenti kardjovaskulari f'3,883 pazjent b'HPT sekondarja u CKD li kienu qed jirċievu dijalisi.
English: • Printing ink: iron oxide black, shellac, propylene glycol
Maltese: • Linka għall-istampar: iron oxide iswed, shellac, propylene glycol
English: ≥ 25 to < 36
Maltese: ≥ 25 sa < 36
English: After adjusting for baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 95% CI: 0.79, 0.97.
Maltese: Wara aġġustament għall-karatteristiċi tal-linja bażi f'analiżi sekondarja, l-HR għallpunt finali kompost primarju kien 0.88; CI ta' 95%: 0.79, 0.97.
English: Starting dose (mg)
Maltese: Doża tal-bidu (mg)
English: In vitro data indicate that cinacalcet is in part metabolised by CYP1A2.
Maltese: Data in vitro tindika li cinacalcet huwa parzjalment metabolizzat minn CYP1A2.
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 data in vitro, cinacalcet huwa inibitur qawwi ta' CYP2D6, iżda f'konċentrazzjonijiet milħuqa klinikament, la huwa inibitur ta' enzimi ta' CYP oħra, inkluż CYP1A2, CYP2C8, CYP2C9, CYP2C19, u CYP3A4, u lanqas induttur ta' CYP1A2, CYP2C19 u CYP3A4.
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia
Maltese: < 8.4 mg/dL (2.1 mmol/L) u > 7.5 mg/dL (1.9 mmol/L), jew fil-preżenza ta' sintomi kliniċi ta' ipokalċimija
English: INFORMATION IN BRAILLE mimpara 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 2.5 mg
English: Mimpara is used in adults:
Maltese: Mimpara jintuża fl-adulti:
English: The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Maltese: L-istudju ma ssodisfax l-għan primarju tiegħu li juri tnaqqis fir-riskju ta' mortalità mill-kawżi kollha jew avvenimenti kardjovaskulari inkluż infart mijokardijaku, dħul l-isptar minħabba anġina instabbli, insuffiċjenza tal-qalb jew avveniment vaskulari periferali (HR 0.93; CI ta' 95%: 0.85, 1.02; p = 0.112).
English: Each 30 mg tablet contains 2.74 mg of lactose.
Maltese: Kull pillola ta' 30 mg fiha 2.74 mg ta' lactose.
English: 1, 2.5, 5, 7.5, 10 and 15
Maltese: 1, 2.5, 5, 7.5, 10 u 15
English: Mimpara is used in children aged 3 years to less than 18 years of age:
Maltese: Mimpara jintuża fi tfal ta' età minn 3 snin sa inqas minn 18-il sena:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 October 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Ottubru 2004
English: INFORMATION IN BRAILLE mimpara 1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 1 mg
English: The mean (SD) iPTH concentrations at baseline were 946 (635) pg/mL for the cinacalcet + SOC group and 1228 (732) pg/mL for the SOC group.
Maltese: Il-konċentrazzjonijiet medji (SD) ta' iPTH fil-linja bażi kienu 946 (635) pg/mL għallgrupp ta' cinacalcet + SOC u 1228 (732) pg/mL għall-grupp ta' SOC.
English: Iron oxide yellow (E172) Titanium dioxide (E171)
Maltese: Iron oxide isfar (E172) Titanium dioxide (E171)
English: Mimpara 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: Mimpara għandu jiġi ttitrat kull ġimagħtejn sa 4 ġimgħat sa doża massima ta' 180 mg darba kuljum biex tintlaħaq il-mira tal-ormon tal-paratirojde (PTH - parathyroid hormone) f'pazjenti bid-dijalisi ta' bejn 150-300 pg/mL (15.9-31.8 pmol/L) fl-analiżi ta' PTH intatt (iPTH - intact PTH).
English: Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
Maltese: L-għoti ta' 90 mg cinacalcet darba kuljum flimkien ma' 50 mg desipramine, antidepressant triċikliku metabolizzat primarjament minn CYP2D6, żied b'mod sinifikanti l-esponiment għal desipramine bi 3.6 darbiet (CI ta' 90% 3.0, 4.4) f'metabolizzaturi estensivi ta' CYP2D6.
English: The starting dose of cinacalcet was 0.20 mg/kg.
Maltese: Id-doża tal-bidu ta' cinacalcet kienet ta' 0.20 mg/kg.
English: • 4 to 6 capsules a day use at least 2 tablespoons (30 mL)
Maltese: • 4 sa 6 kapsuli kuljum uża tal-inqas 2mgħaref (30mL)
English: Study 1 was a double-blind, placebo-controlled study in which 43 patients aged 6 to < 18 years were randomised to receive either cinacalcet (n = 22) or placebo (n = 21).
Maltese: Studju 1 kien studju double-blind, ikkontrollat bil-plaċebo li fih 43 pazjent ta' età minn 6 snin sa < 18-il sena kienu randomised biex jirċievu cinacalcet (n = 22) jew plaċebo (n = 21).
English: • Iron oxide yellow (E172) (1 mg and 2.5 mg capsules)
Maltese: • Iron oxide isfar (E172) (kapsuli ta' 1 mg u 2.5 mg)
English: • a medicine used to relieve cough (dextromethorphan);
Maltese: • mediċina wżata biex ittaffi s-sogħla (dextromethorphan);
English: 60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
Maltese: Pilloli ta' 60 mg huma madwar 12.2 mm twal u 7.6 mm wiesgħa.
English: In a clinical study of adult 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 adulti b'ESRD fuq id-dijalisi, il-livelli ta' testosterone ħieles naqsu b'medjan ta' 31.3% fil-pazjenti ttrattati b'Mimpara u b'16.3% fil-pazjenti ttrattati bil-plaċebo wara 6 xhur ta' trattament.
English: 90 mg tablets are approximately 13.9 mm long and 8.7 mm wide.
Maltese: Pilloli ta' 90 mg huma madwar 13.9 mm twal u 8.7 mm wiesgħa.
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja ta' Aclar/PVC/PVAc/Aluminju li fiha 14-il pillola.
English: Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.
Maltese: F'metabolizzaturi estensivi ta' CYP2D6 dożi multipli ta' 50 mg cinacalcet żiedu l-AUC ta' 30 mg dextromethorphan (metabolizzat primarjament minn CYP2D6) bi 11-il darba.
English: Reduction of ≥ 30% from baseline in mean plasma iPTH during the EAP was achieved by 22% of patients in the cinacalcet + SOC group and 32% of patients in the SOC group.
Maltese: Tnaqqis ta' ≥ 30% mil-linja bażi fl-iPTH medju fil-plażma matul lEAP intlaħaq minn 22% tal-pazjenti fil-grupp ta' cinacalcet + SOC u 32% tal-pazjenti fil-grupp ta' SOC.
English: Eighteen (18) of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Maltese: Tmintax (18) minn 29 pazjent (62%) b'karċinoma tal-paratirojde u 15 minn 17-il individwu (88%) b'HPT primarju laħqu tnaqqis tal-kalċju fis-serum ta'  1 mg/dL ( 0.25 mmol/L).
English: Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Maltese: Trattament ta' iperparatirojdiżmu sekondarju (HPT - hyperparathyroidism) f'pazjenti adulti b'marda tal-kliewi tal-aħħar stadju (ESRD - end-stage renal disease) fuq terapija ta' manteniment b'dijalisi.
English: • a medicine used to treat HIV infection and AIDS (ritonavir);
Maltese: • mediċina wżata għat-trattament ta' infezzjoni tal-HIV u AIDS (ritanovir);
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/013 - 1 mg capsules for opening EU/1/04/292/014 - 2.5 mg capsules for opening EU/1/04/292/015 - 5 mg capsules for opening
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/292/013 - kapsuli ta' 1 mg biex jinfetħu EU/1/04/292/014 - kapsuli ta' 2.5 mg biex jinfetħu EU/1/04/292/015 - kapsuli ta' 5 mg biex jinfetħu
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);
Maltese: • mediċini wżati għat-trattament ta' infezzjonijiet tal-ġilda u infezzjonijiet ikkawżati minn fungu (ketoconazole, itraconazole u voriconazole);
English: Each bottle contains 30 capsules.
Maltese: Kull flixkun fih 30 kapsula.
English: 30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.
Maltese: Pilloli ta' 30 mg huma madwar 9.7 mm twal u 6.0 mm wiesgħa.
English: What Mimpara contains - The active substance is cinacalcet.
Maltese: X'fih Mimpara - Is-sustanza attiva hi cinacalcet.
English: • If iPTH < 100 pg/mL (10.6 pmol/L), stop Mimpara treatment, restart Mimpara at the next lower dose once the iPTH is > 150 pg/mL (15.9 pmol/L).
Maltese: • Jekk l-iPTH huwa < 100 pg/mL (10.6 pmol/L), waqqaf it-trattament b'Mimpara, erġa ibda Mimpara mill-ġdid bid-doża aktar baxxa li jmiss hekk kif l-iPTH ikun > 150 pg/mL (15.9 pmol/L).
English: PHARMACEUTICAL FORM AND CONTENTS Granules in capsules for opening 30 capsules
Maltese: FARMAĊEWTIKA U KONTENUT Grani f'kapsuli biex jinfetħu 30 kapsula
English: INFORMATION IN BRAILLE mimpara 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE mimpara 5 mg
English: Sevelamer: Co-administration of sevelamer (2,400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Maltese: L-għoti flimkien ma' sevelamer (2,400 mg tid) ) ma affettwax il-farmakokinetika ta' cinacalcet.
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'persuni li jpejpu meta mqabbla ma' dawk li ma jpejpux.
English: The percentage of patients who achieved the primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 25 to 30) was 55% in the cinacalcet group and 19.0% in the placebo group (p = 0.02).
Maltese: Il-persentaġġ ta' pazjenti li kisbu l-punt finali primarju (tnaqqis ta' ≥ 30% fl-iPTH medju fil-plażma mil-linja bażi matul l-EAP; ġimgħat 25 sa 30) kien ta' 55% fil-grupp ta' cinacalcet u 19.0% fil-grupp tal-plaċebo (p = 0.02).
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dL (≥ 0.25 mmol/L).
Maltese: Il-punt finali primarju tal-istudju kien tnaqqis tal-kalċju fis-serum ta'  1 mg/dL ( 0.25 mmol/L).
English: Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets
Maltese: Mimpara 30 mg pilloli miksija b'rita Mimpara 60 mg pilloli miksija b'rita Mimpara 90 mg pilloli miksija b'rita
English: Mimpara is also available as tablets.
Maltese: Mimpara huwa disponibbli wkoll bħala pilloli.
English: iPTH concentrations from baseline were reduced by ≥ 30% in 71% (12 out of 17) of patients in the study.
Maltese: Il-konċentrazzjonijiet ta' iPTH mill-linja bażi ġew imnaqqsa b'≥ 30% f'71% (12 minn 17) tal-pazjenti fl-istudju.
English: Each blister pack contains either 14, 28 or 84 tablets in a carton.
Maltese: Kull pakkett bilfolji fih 14, 28 jew 84 pillola f'kartuna.
English: - The capsule shell contains:
Maltese: - Il-qoxra tal-kapsula fiha: