FrancophonIA/ELRC3.0 huggingface dataset:
English: Veltassa is a medicine that contains the active substance patiromer.
Maltese: Veltassa hi mediċina li fiha s-sustanza attiva patiromer.
English: EU/1/17/1179/001 EU/1/17/1179/002 EU/1/17/1179/003 EU/1/17/1179/004 EU/1/17/1179/005 EU/1/17/1179/006 EU/1/17/1179/007 EU/1/17/1179/008 EU/1/17/1179/009
Maltese: EU/1/17/1179/006 EU/1/17/1179/007 EU/1/17/1179/008 EU/1/17/1179/009
English: Higher K+ Stratum:
Maltese: K+ Stratum Iktar Għoli:
English: Mean (95% Cl) Serum Potassium (mEq/L)
Maltese: Medja (95% CI) Potassium fis-Serum (mEq/L)
English: Concomitant administration of patiromer did however not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin.
Maltese: Madankollu, l-għoti fl-istess ħin ta' patiromer ma affettwax il-bijodisponibilità kif imkejla miż-żona taħt il-kurva (AUC, area under the curve) ta' amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil u warfarin.
English: Pack sizes: boxes of 30, 60 or 90 sachets.
Maltese: Daqsijiet tal-pakkett: kaxxi ta' 30, 60 jew 90 qartas.
English: INFORMATION IN BRAILLE VELTASSA 16.8 G
Maltese: INFORMAZZJONI BIL-BRAILLE VELTASSA 16.8 G
English: • quinidine: a medicine to treat irregular heart rhythm.
Maltese: • quinidine: mediċina għall-kura ta' ritmu irregolari tal-qalb.
English: INFORMATION IN BRAILLE VELTASSA 8.4 G
Maltese: INFORMAZZJONI BIL-BRAILLE VELTASSA 8.4 G
English: Serum potassium levels
Maltese: Livelli ta' potassium fis-serum
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Lulju, 2017
English: Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or less.
Maltese: Tnaqqis medju tal-magnesium fis-serum kien ta' 0.17 mg/dL (0.070 mmol/L) jew inqas.
English: Take within 1 hour after preparation of suspension.
Maltese: Uża fi żmien siegħa wara l-preparazzjoni tas-suspensjoni.
English: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), 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 komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients treated with patiromer.
Maltese: Fl-istudji kliniċi, valuri tal-magnesium fis-serum ta' <1.4 mg/dL (0.58 mmol/L) seħħew f'9% talpazjenti kkurati b'patiromer.
English: In Part A, 243 patients were treated with patiromer for 4 weeks.
Maltese: F'Parti A, 243 pazjent ġew ikkurati b'patiromer għal 4 ġimgħat.
English: There were also fewer patients in the patiromer group with serum potassium values >5.5 mEq/L (7.3% vs. 24.5%; p=0.027) and more patients on spironolactone 50 mg/day (90.9% versus 73.5%, p=0.022).
Maltese: Kien hemm ukoll inqas pazjenti fil-grupp ta' patiromer b'valuri ta' l-potassium fis-serum ta' >5.5 mEq/L (7.3% kontra 24.5%; p = 0.027) u aktar pazjenti fuq spironolactone 50 mg/jum (90.9% kontra 73.5%, p = 0.022).
English: Frequencies are defined as:
Maltese: Numru ta' Individwi:
English: Veltassa contains sorbitol.
Maltese: Veltassa fih is-sorbitol.
English: Baseline Serum K+ > 5.5 to < 6.0 mEq/L
Maltese: Serum K+ > 5.5 sa 6.0 mEq/L fil-Linja Bażi
English: The majority of the adverse reactions (ARs) reported from trials were gastrointestinal disorders, with the most frequently reported ARs being constipation (6.2%), diarrhoea (3%), abdominal pain (2.9%), flatulence (1.8%) and hypomagnesaemia (5.3%).
Maltese: Il-maġġoranza tar-reazzjonijiet avversi (ARs, adverse drug reactions) irrappurtati mill-provi, kienu disturbi gastrointestinali, bl-ARs li ġew irrappurtati l-aktar ta' spiss li kienu stitikezza (6.2%), dijarea (3%), uġigħ addominali (2.9%), gass (1.8%), u ipomanjesemija (5.3%).
English: • maximum dose: 25.2 g patiromer (the content of one 25.2 g sachet) once daily
Maltese: • doża massima: 25.2 g ta' patiromer (il-kontenut ta' qartas wieħed ta' 25.
English: Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension patiromer (as patiromer sorbitex calcium)
Maltese: Veltassa 8.4 g trab għal suspensjoni orali Veltassa 16.8 g trab għal suspensjoni orali Veltassa 25.2 g trab għal suspensjoni orali patiromer (bħala patiromer sorbitex calcium)
English: Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5).
Maltese: L-għoti ta' Veltassa għandu jkun separat bi 3 sigħat minn prodotti mediċinali orali oħrajn (ara sezzjoni 4.5).
English: The active substance is patiromer (as patiromer sorbitex calcium).
Maltese: Is-sustanza attiva hi patiromer (bħala patiromer sorbitex calcium).
English: Severe hyperkalaemia
Maltese: Iperkalemija severa
English: Veltassa is available in packs containing 30, 60 or 90 sachets.
Maltese: Veltassa hu disponibbli f'pakketti li jkun fihom 30, 60 jew 90 qartas.
English: Patients with end-stage renal disease (ESRD)
Maltese: Pazjenti b'mard tal-kliewi fl-aħħar stadju (ESRD, end-stage renal disease)
English: Low Magnesium
Maltese: Magnesium Baxx
English: Patiromer was not genotoxic in the reverse mutation test (Ames assay), chromosome aberration or rat micronucleus assays.
Maltese: Patiromer ma kienx ġenotossiku fit-test tal-mutazzjoni bil-maqlub (reverse mutation test) (assaġġ ta' Ames), fl-assaġġi tal-aberrazzjoni tal-kromożomi jew tal-mikronukleu tal-firien.
English: As patiromer is not absorbed or metabolised by the body, there are limited effects on the function of other medicinal products.
Maltese: Minħabba li patiromer ma jiġix assorbit jew metabolizzat mill-ġisem, hemm effetti limitati fuq il-funzjoni ta' prodotti mediċinali oħrajn.
English: • Add about 40 mL (3 tablespoons) of additional water and stir thoroughly.
Maltese: • Żid madwar 40 ml (3 mgħaref) addizzjonali ta' ilma u ħawwad tajjeb.
English: The mean age of patients was 64 years (54% aged 65 and over, 17% aged 75 and over), 58% of patients were men, and 98% were Caucasian.
Maltese: L-età medja tal-pazjenti kienet ta' 64 sena (54% li kellhom 65 sena u aktar, 17% li kellhom 75 sena u aktar), 58% tal-pazjenti kienu rġiel u 98% kienu Kawkasi.
English: For the Part A secondary outcome, 76% (95% CI: 70%, 81%) of patients had a serum potassium in the target range of 3.8 mEq/L to <5.1 mEq/L at Part A Week 4.
Maltese: Għar-riżultat sekondarju ta' Parti A, 76% (95% CI: 70%, 81%) tal-pazjenti, kellhom potassium fis-serum fil-medda tal-mira ta' 3.8 mEq/L sa < 5.1 mEq/L f'Parti A Ġimgħa 4.
English: Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² and patients receiving dialysis treatment.
Maltese: Patiromer ġie studjat biss f'numru limitat ta' pazjenti b'rata stmata ta' filtrazzjoni glomerulari (eGFR, estimated glomerular filtration rate) ta' <15 mL/min/1.73 m² u f'pazjenti li jirċievu kura permezz taddijalisi.
English: The mean daily doses of patiromer were 13 g and 21 g in patients with serum potassium of 5.1 to <5.5 mEq/L and 5.5 to <6.5 mEq/L, respectively.
Maltese: Il-medja tad-dożi ta' kuljum ta' patiromer kienu ta' 13 g u 21 g f'pazjenti b'potassium fis-serum ta' 5.1 sa < 5.5 mEq/L u 5.5 sa < 6.5 mEq/L, rispettivament.
English: 5.5 to <6.5 mEq/L (n=147) Serum Potassium (mEq/L)
Maltese: 5.5 sa < 6.5 mEq/L (n=147)
English: The mean age of patients was 66 years (59.9% aged 65 and over, 19.7% aged 75 and over), 63% of patients were men, and all were Caucasian.
Maltese: L-età medja talpazjenti kienet ta' 66 sena (59.9% li kellhom 65 sena u aktar, 19.7% li kellhom 75 sena u aktar), 63% tal-pazjenti kienu rġiel u kollha kienu Kawkasi.
English: 21 [0.07] mEq/L) as compared to the placebo group (LS mean [SEM]: +0.23 [0.07] mEq/L).
Maltese: +0.23 [0.07] mEq/L).
English: • severe stomach or bowel problems
Maltese: • problemi biex tibla'
English: There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Maltese: Hemm esperjenza limitata f'pazjenti b'konċentrazzjonijiet ta' potassium fis-serum ta' 6.5 mmol/L.
English: Part B than patiromer patients (15% [95% CI: 6%, 24%]), p<0.001.
Maltese: 56%]), p < 0.001.
English: Other medicines and Veltassa
Maltese: Mediċini oħra u Veltassa
English: NAME OF THE MEDICINAL PRODUCT Veltassa 25.2 g powder for oral suspension patiromer
Maltese: Veltassa 25.2 g trab għal suspensjoni orali patiromer
English: The other ingredient is xanthan gum.
Maltese: Is-sustanza mhux attiva l-oħra hi xanthan gum.
English: Information about calcium
Maltese: Informazzjoni dwar il-calcium
English: PHARMACEUTICAL FORM AND CONTENTS powder for oral suspension
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT trab għal suspensjoni orali
English: Patients may store Veltassa below 25°C for up to 6 months.
Maltese: Jista' jinħażen f'temperatura taħt 25°C għal sa 6 xhur.
English: • low blood magnesium seen in tests
Maltese: • livell baxx ta' magnesium li ġie osservat fit-testijiet
English: More placebo patients (91% [95% CI: 83%, 99%]) developed a serum potassium ≥5.1 mEq/L at any time during Part B than patiromer patients (43% [95% CI: 30%, 56%]), p<0.001.
Maltese: Aktar pazjenti fuq il-plaċebo (91% [95% CI: 83%, 99%]) żviluppaw potassium fis-serum ta' ≥ 5.1 mEq/L fi kwalunkwe ħin matul Parti B milli minn pazjenti fuq patiromer (43% [95% CI: 30%,
English: Veltassa contains sorbitol as part of the counterion complex.
Maltese: Veltassa fih sorbitol bħala parti mill-kumpless counterion.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension Veltassa 16.8 g powder for oral suspension Veltassa 25.2 g powder for oral suspension
Maltese: Veltassa 8.4 g trab għal suspensjoni orali Veltassa 16.8 g trab għal suspensjoni orali Veltassa 25.2 g trab għal suspensjoni orali
English: The potential of patiromer to enable concomitant RAAS inhibitor treatment was also assessed in part B. Fifty two percent (52%) of subjects receiving placebo discontinued RAAS inhibitor treatment because of recurrent hyperkalaemia compared with 5% of subjects treated with patiromer.
Maltese: Il-potenzjal ta' patiromer li jippermetti kura b'inibitur ta' RAAS fl-istess ħin ġie evalwat ukoll f'Parti B: Tnejn u ħamsin fil-mija (52%) tal-individwi li kienu qed jirċievu plaċebo ma komplewx ilkura b'inibitur ta' RAAS minħabba iperkalemija rikorrenti, meta mqabbla ma' 5% tal-individwi kkurati b' patiromer.
English: Hypomagnesaemia was mild to moderate, with no patient developing a serum magnesium level <1 mg/dL (0.4 mmol/L).
Maltese: L-ipomanjesemija kienet ħafifa sa moderata, u l-ebda pazjent ma żviluppa livell ta' magnesium fis-serum ta' < 1.0 mg/dL (0.4 mmol/L).
English: • Prepare about 40 mL (3 tablespoons) of water in a glass.
Maltese: • Ipprepara madwar 40 ml (3 mgħaref) ta' ilma f'tazza.
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex France
Maltese: 100-101 Terrasse Boieldieu Tour Franklin La
English: Approximately 97% of patients had hypertension, 57% had type 2 diabetes, and 42% had heart failure.
Maltese: Madwar 97% tal-pazjenti kellhom pressjoni għolja, 57% kellhom dijabete ta' tip 2, u 42% kellhom insuffiċjenza tal-qalb.
English: 8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Maltese: 2 g ta' patiromer, bħala trab fi qratas magħmulin minn ħames saffi: polyethylene, aluminju, polyethylene, polyester u karta.
English: Mean baseline serum potassium values were 4.71 mEq/L for patiromer and 4.68 mEq/L for placebo.
Maltese: Il-valuri medji tal-potassium fis-serum fil-linja bażi kienu ta' 4.71 mEq/L għal patiromer u 4.68 mEq/L għall-plaċebo.
English: • Veltassa 16.8 g powder for oral suspension: each sachet contains 16.8 g of patiromer.
Maltese: • Veltassa 16.8 g ta' trab għal suspensjoni orali: kull qartas ta' 16.8 g fih 16.8 g ta' patiromer.
English: In patients with a baseline serum potassium of >5.0 to 5.5 mEq/L who received an initial dose of 8.4 g patiromer per day, the mean daily dose was 14 g; in those with a baseline serum potassium of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g patiromer per day, the mean daily dose was 20 g during the entire study.
Maltese: F'pazjenti b'potassium fis-serum fil-linja bażi ta' > 5.0 sa 5.5 mEq/L li rċivew doża inizjali ta' 8.4 g ta' patiromer kuljum, id-doża medja ta' kuljum kienet ta' 14 g; f'dawk b'potassium fis-serum fil-linja bażi ta' > 5.5 sa < 6.0 mEq/L, li rċivew doża inizjali ta' 16.8 g ta' patiromer kuljum, id-doża medja ta' kuljum kienet ta' 20 g matul l-istudju kollu.
English: Baseline, mean (SD) Week 4 Change from Baseline, Mean ± SE (95% CI) p value
Maltese: Bidla mil-Linja Bażi f'Ġimgħa 4, Medja ± SE (95% CI) valur p
English: Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion.
Maltese: Patiromer hu cation exchange polymer li ma jiġix assorbit, li fih kumpless ta' calcium-sorbitol bħala counterion.
English: Overall, in the phase 2 and 3 clinical studies, 99.4% of patients were receiving RAAS inhibitor therapy at baseline, 81.2% had CKD with eGFR <60 mL/min/1.73 m2, 72.8% had diabetes mellitus and 48.7% had heart failure.
Maltese: 2% kellhom CKD b'eGFR ta' <60 mL/min/1.73 m², 72.8% kellhom dijabete mellitus, u 48.7% kellhom insuffiċjenza tal-qalb.
English: Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies.
Maltese: Pazjenti bi storja medika ta' ostruzzjoni fl-imsaren jew operazzjoni gastrointestinali maġġuri, disturbi gastrointestinali severi, jew disturbi fil-bligħ, ma ġewx inklużi fl-istudji kliniċi.
English: Table 1: Patiromer treatment phase (Part A): Primary endpoint Baseline Potassium
Maltese: Tabella 1: Fażi ta' kura b'patiromer (Parti A):
English: Mean serum potassium levels and change in serum potassium from Part A Baseline to Part A Week 4 is shown in Table 1.
Maltese: Il-medja tal-livelli tal-potassium fis-serum u l-bidla tal-potassium fis-serum minn Parti A fil-Linja Bażi sa Parti A Ġimgħa 4, qed tintwera f'Tabella 1.
English: The ability of patiromer to enable concomitant spironolactone treatment was investigated in a randomised, double-blind, placebo-controlled study in heart failure patients who were clinically indicated to receive AA.
Maltese: L-abilità ta' patiromer li spironolactone jippermetti kura fl-istess, ġiet investigata fi studju li fih ilparteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, li sar fuq pazjenti b'insuffiċjenza tal-qalb, li kienu klinikament indikati biex jirċievu AA.
English: Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders.
Maltese: Iskemija gastrointestinali, nekrożi u/jew perforazzjoni intestinali ġew irrappurtati b'binders oħrajn tal-potassium.
English: • Veltassa 25.2 g powder for oral suspension: each sachet contains 25.2 g of patiromer.
Maltese: • Veltassa 25.2 g ta' trab għal suspensjoni orali: kull qartas ta' 25.
English: Decreases in serum potassium with patiromer treatment were maintained over 1 year of chronic treatment as shown in Figure 1, with a low incidence of hypokalaemia (2.3%) and the majority of subjects reaching (97.7%) and maintaining target serum potassium levels (overall during maintenance period, serum potassium was within the target range for approximately 80% of the time).
Maltese: Tnaqqis tal-potassium fis-serum bil-kura b' patiromer nżamm fuq perjodu ta' sena ta' kura kronika kif muri f'Figura 1, b'inċidenza baxxa ta' ipokalemija (2.3%), u l-maġġoranza tal-individwi li laħqu (97.7%) u żammew il-livelli fil-mira tal-potassium fisserum (b'mod ġenerali matul il-perjodu ta' manteniment, il-potassium fis-serum kien fil-medda filmira għal madwar 80% taż-żmien).
English: The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer.
Maltese: 4 kcal) għal kull 8.4 g ta' patiromer.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 16.8 g powder for oral suspension patiromer
Maltese: Veltassa 16.8 g trab għal suspensjoni orali patiromer
English: • Add the required number of Veltassa sachets and stir.
Maltese: • Żid in-numru meħtieġ ta' qratas ta' Veltassa u ħawwad.
English: • starting dose: 8.4 g patiromer (the content of one 8.4 g sachet) once daily
Maltese: • doża tal-bidu: 8.4 g ta' patiromer (il-kontenut ta' qartas wieħed ta' 8.4 g) darba kuljum
English: Hypomagnesaemia
Maltese: Uġigħ addominali
English: Veltassa is indicated for the treatment of hyperkalaemia in adults.
Maltese: Veltassa huwa indikat għall-kura ta' iperkalemija fl-adulti.
English: NAME OF THE MEDICINAL PRODUCT Veltassa 8.4 g powder for oral suspension patiromer
Maltese: Veltassa 8.4 g trab għal suspensjoni orali patiromer
English: In patients randomised to patiromer, the mean daily dose was 21 g at the start of Part B and during Part B.
Maltese: F'pazjenti magħżula b'mod każwali għal patiromer, id-doża medja ta' kuljum kienet ta' 21 g fil-bidu ta' Parti B u matul Parti B.
English: Daily urinary calcium excretion increased from baseline by 53 mg/day.
Maltese: It-tneħħija tal-calcium fl-awrina kuljum żdiedet mil-linja bażi bi 53 mg/jum.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia.
Maltese: Mediċini għall-kura ta' ipokalemija u iperfosfatemija.
English: Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.
Maltese: Il-magnesium fis-serum għandu jiġi mmonitorjat għal mill-inqas xahar wara l-bidu tal-kura, u supplimentazzjoni ta' magnesium għandha tiġi kkunsidrata f'pazjenti li jiżviluppaw livelli baxxi ta' magnesium fis-serum.
English: Number of Subjects: Lower K+ Stratum:
Maltese: K+ Stratum Iktar Baxx:
English: • wind
Maltese: • gass
English: Patients with a baseline serum potassium of 5.1 mEq/L to <5.5 mEq/L (mmol/L) received a starting dose of 8.4 g patiromer per day (as a divided dose) and patients with a baseline serum potassium of 5.5 mEq/L to <6.5 mEq/L received a starting dose of 16.8 g patiromer per day (as a divided dose).
Maltese: Pazjenti b'potassium fis-serum fillinja bażi ta' 5.1 mEq/L sa < 5.5 mEq/L (mmol/L), irċivew doża tal-bidu ta' 8.4 g ta' patiromer kuljum (bħala doża maqsuma), u pazjenti b'potassium fis-serum fil-linja bażi ta' 5.5 mEq/L sa < 6.5 mEq/L, irċivew doża tal-bidu ta' 16.8 g ta' patiromer kuljum (bħala doża maqsuma), Id-doża ġiet ittitrata, skont il-ħtieġa, ibbażata fuq il-livell tal-potassium fis-serum, evalwata b'bidu f'Jum 3, u mbagħad filviżti ta' kull ġimgħa sat-tmiem tal-perjodu ta' kura ta' 4 ġimgħat, bil-għan li l-potassium fis-serum jinżamm fil-medda fil-mira (3.8 mEq/L sa < 5.1 mEq/L).
English: Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to the following steps:
Maltese: Veltassa għandu jitħallat mal-ilma u jitħawwad sa ma tifforma suspensjoni ta' konsistenza uniformi, skont il-passi li ġejjin:
English: • metformin: a medicine to treat diabetes
Maltese: • metformin: mediċina għall-kura tad-dijabete
English: (CKD) on stable doses of at least one RAAS inhibitor (i.e. angiotensin converting enzyme inhibitor [ACEI], angiotensin II receptor blocker [ARB] or aldosterone antagonist [AA]).
Maltese: Is-sigurtà u l-effikaċja ta' patiromer intwerew fi studju maqsum f'żewġ partijiet, single-blind, dwar ittwaqqif tal-mediċina, li fih il-parteċipanti ntgħażlu b'mod każwali, li evalwa din il-kura f'pazjenti iperkalemiċi b'mard kroniku tal-kliewi (CKD) li kienu fuq dożi stabbli ta' mill-inqas inibitur wieħed ta' RAAS (i.e., inibitur ta' enzima li tibdel angiotensin, [ACEI, angiotensin-converting enzyme inhibitor], imblokkatur tar-riċettur ta' angiotensin II [ARB, angiotensin II receptor blocker], jew antagonist ta' aldosterone [AA, aldosterone antagonist]).
English: Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the patiromer dose is titrated.
Maltese: Il-potassium fis-serum għandu jiġi mmonitorjat meta indikat klinikament, inkluż wara li jsiru l-bidliet lil prodotti mediċinali li jaffettwaw il-konċentrazzjoni tal-potassium fis-serum (eż. inibituri ta' RAAS jew dijuretiċi), u wara li d-doża ta' patiromer tiġi ttitrata.
English: Animal studies showed no effects on reproductive function or fertility (see section 5.3).
Maltese: Studji fl-annimali ma wrew l-ebda effett fuq il-funzjoni riproduttiva jew fuq il-fertilità (ara sezzjoni 5.3).
English: Xanthan gum
Maltese: ANNESS II
English: Following discontinuation of patiromer, potassium levels remained stable for 24 hours after the last dose, then rose again during a 4-day observation period.
Maltese: Wara t-twaqqif ta' patiromer, il-livelli tal-potassium baqgħu stabbli għal 24 siegħa wara l-aħħar doża, u mbagħad żdiedu mill-ġdid matul perjodu ta' osservazzjoni ta' 4 ijiem.
English: • Veltassa 8.4 g powder for oral suspension: each sachet contains 8.4 g of patiromer
Maltese: • Veltassa 8.4 g ta' trab għal suspensjoni orali: kull qartas ta' 8.4 g fih 8.4 g ta' patiromer.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
Maltese: Kull qartas fih 16.8 g ta' patiromer (bħala patiromer sorbitex calcium)
English: EU/1/17/1179/008 60 sachets
Maltese: EU/1/17/1179/008 60 qartas
English: Patiromer is excreted approximately 24 to 48 hours after intake, based on average gastrointestinal transit time.
Maltese: Patiromer jitneħħa madwar 24 sa 48 siegħa wara li jittieħed, skont il-medja tal-ħin ta' transitu gastrointestinali.
English: Once you have received Veltassa, it can be stored below 25°C for up to 6 months.
Maltese: Il-pazjenti jistgħu jaħżnu Veltassa taħt 25°C għal sa 6 xhur.
English: EU/1/17/1179/006 90 sachets
Maltese: EU/1/17/1179/006 90 qartas
English: In an open label study to assess the time to onset of action, a statistically significant reduction in serum potassium in hyperkalaemic patients was observed at 7 hours after the first dose.
Maltese: Fi studju open-label biex jiġi evalwat il-ħin għall-bidu tal-azzjoni, ġie osservat tnaqqis statistikament sinifikanti tal-potassium fis-serum f'pazjenti iperkalemiċi, 7 sigħat wara l-ewwel doża.
English: Do not use this medicine after the expiry date which is stated on the carton or sachet after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara “JIS”.
English: Figure 1: Mean (95% CI) serum potassium over time Baseline Serum K+ > 5.0 to 5.5 mEq/L
Maltese: Figura 1: Medja (95% CI) potassium fis-serum matul iż-żmien
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Maltese: Kull qartas fih 8.4 g ta' patiromer (bħala patiromer sorbitex calcium)
English: Of the 105 patients who were randomised and received study treatment (patiromer 56; placebo 49), mean age was 68.3 years, 60.6% were men, 97.1% were Caucasian, and mean eGFR was 81.3 mL/min.
Maltese: Mill-105 pazjent li ntgħażlu b'mod każwali u li rċivew il-kura tal-istudju kienu li fih il-parteċipanti ntgħażlu b'mod każwali u studju rċeviet trattament (patiromer 56; plaċebo 49), il-medja tal-età kienet ta' 68.3 sena, 60.6% kienu irġiel, 97.1% kienu Kawkasi, u eGFR medju kien ta' 81.3 mL/min.
English: The effect of treatment with patiromer for up to 52 weeks was evaluated in an open label study of 304 hyperkalaemic patients with CKD and type 2 diabetes mellitus on stable doses of a RAAS inhibitor.
Maltese: L-effett tal-kura b'patiromer għal sa 52 ġimgħa, ġie evalwat fi studju open-label li sar fuq 304 pazjenti iperkalemiċi b'CKD u dijabete mellitus ta' tip 2 fuq dożi stabbli ta' inibitur ta' RAAS.