FrancophonIA/ELRC3.0 huggingface dataset:
English: Celvapan contains a virus called A(H1N1)v 2009.
Maltese: Celvapan fih virus imsejjaħ A(H1N1)v 2009.
English: For the full list of all side effects reported with Celvapan, see the
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Celvapan,
English: How has Celvapan been studied?
Maltese: Kif ġie studjat Celvapan?
English: Celvapan is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Maltese: Celvapan huwa vaċċin li jipproteġi kontra l-influwenza kkawżata mill-virus A (H1N1)v 2009.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan on 4 March 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Celvapan fl-4 ta' Marzu 2009.
English: The viruses used in Celvapan are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Maltese: Il-virusis użati f'Celvapan jitkabbru f'ċelloli tal-mammiferi (‘ċelloli vero'), bil-kontra tal-bajd tat-tiġieġ.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-virus inattivat bħala “barrani” u tagħmel antikorpi kontrih.
English: Celvapan must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Maltese: Celvapan m'għandux jingħata lil nies li fil-passat kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi (baxxi ħafna) fil-vaċċin, bħalma huma l-formaldeħajd, il-benzonase jew iz-zokkor tal-kannamieli.
English: Celvapan was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Maltese: Celvapan kien oriġinarjament żviluppat bħala vaċċin pandemiku, biex jintuża matul il-pandemija talinfluwenza A (H1N1) li ġiet iddikjarata f'Ġunju 2009.
English: A risk management plan has been developed to ensure that Celvapan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Celvapan jintuża bl-aktar mod sigur possibbli.
English: It contains influenza (flu) viruses that have been inactivated.
Maltese: Fih virusis tal-influwenza li ġew diżattivati.
English: Celvapan is given by injection into the muscle of the shoulder or thigh, as two doses at least three
Maltese: Is-sistema immunitarja mbagħad tkun tista' tipproduċi antikorpi aktar malajr meta tkun esposta darb'oħra għall-virus.
English: The most common side effects with Celvapan (seen in more than 1 people vaccinated in 10) are headache and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Celvapan (li dehru f'aktar minn persuna1 minn 10 li ħadet ilvaċċin) huma wġigħ ta' ras u għeja.
English: Celvapan is given
Maltese: Paġna 2/2
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali talġisem) kif tiddefendi ruħha kontra marda.
English: Dr. Franje Tuđmana 3 Sveta Nedjelja
Maltese: Dr. Franje Tuđmana 3 Sveta
English: Kodaňská 1441/46 110 00 Prague 10
Maltese: Kodaňská 1441/46 110 00
English: s r. o. Trnavská cesta 50
Maltese: Trnavská cesta 50
English: Denmark Meda AS Solvang 8
Maltese: Id-Danimarka Meda AS Solvang 8
English: Belgium Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels
Maltese: Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels Belgium
English: Sweden Meda AB Box 906
Maltese: Meda AB Box 906
English: de Castilla, 2 Edificio Berlín 2ª planta Parque Empresarial San Fernando
Maltese: MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2ª planta Parque Empresarial San Fernando
English: Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul.
Maltese: Warszawskie Zakłady Farmaceutyczne POLFA S.A.
English: 19002 Paiania, Greece
Maltese: PaianiasMarkopoulou, 19002 Paiania, Greece
English: Aurum Pharmaceuticals Limited, Bampton Road Harold Hill
Maltese: Ir-Renju Unit Aurum Pharmaceuticals Limited, Bampton Road Harold Hill
English: Lithuania SIA Meda Pharma Vienibas gatve 109
Maltese: Il-Litwanja SIA Meda Pharma Vienibas gatve 109
English: Bulgaria
Maltese: Bulgarija
English: Epipen auto-injector 0.3mg
Maltese: Epipen auto-injecto 0.3mg
English: 01-207 Warszawa
Maltese: Karolkowa 22/24 01-207 Warszawa
English: Romford Essex RM3 8UG
Maltese: RM3 8UG
English: Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford CM22 6PU
Maltese: Ir-Renju Unit Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford
English: Meda Pharmaceuticals Limited
Maltese: Ir-Renju Unit Meda Pharmaceuticals Limited
English: 1, 61352 Bad Homburg v.d. Höhe Germany
Maltese: Benzstr. 1, 61352 Bad Homburg v.d. Höhe
English: DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof.
Maltese: SIA A.E., 1st Km Leof.
English: Salisbury SP2 0AH Great Britain
Maltese: Salisbury SP2 0AH
English: Sweden Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
Maltese: Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
English: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
Maltese: In-Norveġja Meda AS Askerveien 61
English: Hersholm 2970 Denmark
Maltese: Hersholm 2970
English: Skyway House, Parsonage Road, Takeley Bishops Stortford CM22 6PU
Maltese: Skyway House, Parsonage Road, Takeley
English: EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
Maltese: EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml l-Islanda
English: SIA Meda Pharma Vienibas gatve 109, Riga LV-1058
Maltese: SIA Meda Pharma Vienibas gatve 109, Riga
English: EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
Maltese: EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml l-Ungerija
English: Luxembourg Alk Abello A/S Boge Alle 6-8
Maltese: Lussemburgu Alk Abello A/S Boge Alle 6-8
English: Germany PharmaSwiss Ceska republika s.r.o.
Maltese: Il-Ġermanja PharmaSwiss Ceska republika s.r.o.
English: Sweden ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm
Maltese: ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm
English: 300 mcg Solution for infusion Intramuscular use
Maltese: 300 mcg Soluzzjoni għallinfużjoni
English: ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark
Maltese: ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970
English: 150 mcg Solution for infusion Intramuscular use
Maltese: 150 mcg Soluzzjoni għallinfużjoni
English: Germany MEDA Pharma GmbH & Co. KG
Maltese: Lussemburgu Meda Pharma GmbH&Co.KG
English: Slovenia
Maltese: Lithuania
English: Denmark ALK-Abello A/S Bøge Alle 6-8
Maltese: ALK-Abello A/S Bøge Alle 6-8
English: Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre
Maltese: Il-Litwanja Lincoln Medical Ltd Unit 8, Wilton Business Centre
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika (għamliet farmaċewtiċi), qawwa (qawwiet) tal-prodott (i) mediċinali, mnejn jingħata, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
Maltese: Id-Danimarka Lincoln Medical Ltd Unit 8 Wilton Business Centre
English: Alk Abello A-S Boge Alle 6-8.
Maltese: Ir-Renju Unit Alk Abello A-S Boge Alle 6-8.
English: MEDA Pharma GmbH & Co. KG
Maltese: Meda Pharma GmbH & Co.
English: Denmark Lincoln Medical Limited Unit 8 Wilton Business Centre
Maltese: Id-Danimarka Lincoln Medical Limited Unit 8 Wilton Business Centre
English: MEDA PHARMA S.P.A. Viale Brenta 18
Maltese: Viale Brenta 18
English: Meda Pharma spol.
Maltese: Meda Pharma spol. s r. o.
English: Germany ALK-ABELLO A/S Boge Alle 6-8
Maltese: Il-Ġermanja ALK-ABELLO A/S Boge Alle 6-8
English: Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
Maltese: In-Norveġja Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
English: n/N Proportion 95% CI
Maltese: n/N Proporzjon 95% CI
English: Maintenance (day)
Maltese: Manteniment (jum)
English: P-value vs. placebo
Maltese: Valur-p vs. plaċebo
English: Intestinal perforation
Maltese: Perforazzjoni intestinali
English: Date of first authorisation: 22 March 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu 2018
English: Lokelma 10 g three times daily (N=749)
Maltese: Lokelma 10 g tliet darbiet kuljum (N=749)
English: Lokelma dose (three times daily) Placebo 1.25 g 2.5 g 5 g 10 g
Maltese: Doża ta' Lokelma (tliet darbiet kuljum) Plaċebo 1.25 g 2.5 g 5 g 10 g
English: Powder for oral suspension.
Maltese: Trab għal sospensjoni orali.
English: 28 sachets
Maltese: 28 qartas
English: List of adverse reactions in clinical studies System Organ class
Maltese: Lista ta' reazzjonijiet avversi fi studji kliniċi Sistema tal-Klassifika tal-Organi
English: • atazanvir, nefilnavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir and rilpivirine (used to treat HIV infection)
Maltese: • atazanvir, nefilnavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir u rilpivirine (użati biex jikkuraw infezzjoni tal-HIV)
English: Oedema related events
Maltese: Avvenimenti relatati mal-edema
English: Pack sizes: 3, 28 or 30 sachets
Maltese: Daqsijiet tal-pakkett: 3, 28 jew 30 qartas
English: • ketokonazole, itraconazole and posaconazole (used to treat fungal infections)
Maltese: • ketokonazole, itraconazole u posaconazole (użati biex jikkuraw infezzjonijiet fungali)
English: • tyrosin kinase inhibitors such as eroltinib, dasatinib and nilotinib (used to treat cancer)
Maltese: • tyrosin kinase inhibitors such as eroltinib, dasatinib u nilotinib (użati biex jikkuraw il-kanċer)
English: Hypersensitivity to the active substance.
Maltese: Sensittività eċċessiva għas-sustanza attiva.
English: Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1).
Maltese: Lokelma huwa indikat għall-kura tal-iperkalimja f'pazjenti adulti (ara sezzjoni 4.4 u 5.1).
English: Correction Phase (CP)
Maltese: Fażi ta' Korrezzjoni (CP)
English: CP at 24 hours
Maltese: CP wara 24 siegħa
English: CP at 48 hours
Maltese: CP wara 48 siegħa
English: Serum potassium 3.5 to 5.5 mmol/L, inclusive n/N Proportion 95% CI
Maltese: Potassium fis-serum 3.5 sa 5.5 mmol/L, inklussiv n/N Proporzjon 95% CI
English: • diuretics (medicines that increase urine production)
Maltese: • dijuretiċi (mediċini li jżidu l-produzzjoni tal-awrina)
English: Normokalaemia was achieved in 494/748 (66%), 563/748 (75%) and 583/748 (78%) of subjects after 24, 48 and 72 hours of correction phase dosing with an average reduction in serum potassium of 0.81 mmol/L, 1.02 mmol/L and 1.10 mmol/L at 24 (n=748), 48 (n=104) and 72 (n=28) hours, respectively.
Maltese: Normokalaemija ntlaħqet f'494/748 (66%), 563/748 (75%) u 583/748 (78%) tal-individwi wara 24, 48 u 72 siegħa tad-dożaġġ tal-fażi ta' korrezzjoni bi tnaqqis medju fil-potassium fis-serum ta' 0.81 mmol/L, 1.02 mmol/L u 1.10 mmol/L wara 24 (n=748), 48 (n=104) u 72 (n=28) siegħa, rispettivament.
English: Serum potassium 3.5 to 5.0 mmol/L, inclusive
Maltese: Potassium fis-serum 3.5 sa 5.0 mmol/L, inklussiv
English: NS: not significant
Maltese: NS: mhux sinifikanti
English: Oedema related events, including fluid overload, fluid retention, generalised oedema, hypervolaemia, localised oedema, oedema, oedema peripheral and peripheral swelling, were reported by 5.7% of Lokelma patients.
Maltese: Avvenimenti relatati mal-edema, inklużi l-eċċess ta' fluwidu, iż-żamma ta' fluwidu, edema ġeneralizzata, l- ipervolemja, edema lokalizzata, edema, edema periferali u nefħa periferali, ġew irrappurtati b'5.7 % tal-pazjenti li jieħdu Lokelma.
English: CP at 72 hours/CP Last
Maltese: CP wara 72 siegħa/CP L-aħħar
English: How to store Lokelma
Maltese: Tiħux Lokelma
English: In 2 clinical studies with open label exposure of Lokelma up to 1 year in 874 subjects, the following events were reported as related by investigators: gastrointestinal events [constipation (2.9%), diarrhea (0.9%), abdominal pain/distension (0.5%), nausea (1.6%) and vomiting (0.5%)]; and hypersensitivity reactions [rash (0.3%) and pruritus (0.1%)].
Maltese: F'2 studji kliniċi b'esponiment b'tikketta mikxufa ta' Lokelma sa sena fi 874 individwu, ġew irrapportati l-avvenimenti li ġejjin kif mogħtija mill-investigaturi: avvenimenti gastro-intestinali [stitikezza (2.9%), dijarea (0.9%), uġigħ/distensjoni addominali (0.5%), dardir (1.6%) u rimettar (0.5%)]; u reazzjonijiet ta' sensittivita eċċessiva [raxx (0.3%) u ħakk (0.1%)].
English: Examples of medicinal products that should be administered 2 hours before or after sodium zirconium cyclosilicate to avoid possible raised gastric pH drug interaction are azole antifungals (ketoconazole, itraconazole and posaconazole), anti-HIV drugs (atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir and rilpivirine) and tyrosine kinase inhibitors (erlotinib, dasatinib and nilotinib).
Maltese: Eżempji ta' prodotti mediċinali li għandhom jingħataw sagħtejn qabel jew wara sodium zirconium cyclosilicate biex tiġi evitata interazzjoni tal-mediċina tal-pH gastriku possibbilment għolja huma antifungali azole (ketoconazole, itraconazole u posaconazole), mediċini anti-HIV (atazanavir, nelfinavir, indinavir, ritonavir, saquinavir, raltegravir, ledipasvir u rilpivirine) u inibituri tat-tyrosine kinase (erlotinib, dasatinib u nilotinib).
English: Comorbid conditions included chronic kidney disease (65%), diabetes mellitus (64%), heart failure (15%) and hypertension (83%).
Maltese: Kundizzjonijiet komorbidi inkludew mard kroniku tal-kliewi (65%), diabetes mellitus (64%), kollass tal-qalb (15%)
English: 30 sachets
Maltese: 30 qartas
English: Hypokalaemia may be observed (see section 4.8).
Maltese: Tista' tiġi osservata l-ipokalimja (ara sezzjoni 4.8).
English: Serum Potassium with 95% CI (mmol/L)
Maltese: Potassium fis-serum b'CI ta' 95% (mmol/L)
English: 3 sachets
Maltese: 3 snin
English: There was a mean decrease in serum potassium of 0.77 mmol/L, 1.10 mmol/L, 1.19 mmol/L and 0.44 mmol/L, respectively, and the proportion of subjects who remained normokalaemic was 71%, 76%, 85% and 48% in the 5 g, 10 g, 15 g once daily doses of Lokelma and placebo groups, respectively.
Maltese: Kien hemm tnaqqis medju filpotassium fis-serum ta' 0.77 mmol/L, 1.10 mmol/L, 1.19 mmol/L u 0.44 mmol/L, rispettivament u lproporzjon ta' individwi li baqgħu normokalemiċi kien ta' 71 %, 76 %, 85 % u 48 % fil-gruppi ta' dożi ta'darba kuljum ta' Lokelma 5 g, 10 g, 15 g u ta' plaċebo, rispettivament.
English: Baseline serum potassium, mmol/L 5.3 Normokalaemic at 48 hours, % 48 p-value vs. placebo
Maltese: Normokalemiċi fi 48 siegħa, % 48 valur-p vs. plaċebo
English: During maintenance phase, 75.6% of subjects maintained normokalaemia, despite use of RAAS inhibitors.
Maltese: Matul il-fażi ta' manteniment, 75.6% tal-individwi żammew normokalaemija, minkejja l-użu ta' inibituri RAAS.
English: A study in chronic kidney disease patients with hyperkalaemia This study was a double-blind placebo-controlled dose-escalating study in 90 patients (60 Lokelma patients; 30 controls) with baseline eGFR between 30-60 ml/min/1.73m2 and hyperkalaemia (baseline serum potassium 5.2 mmol/L, range 4.6-6 mmol/L).
Maltese: Dan l-istudju kien studju double-blind ikkontrollat bi plaċebo ta' doża inkrimentali f'90 pazjent (60 pazjent ta' Lokelma; 30 ta' kontrolli) b'eGFR tal-linja bażi ta' bejn 30-60 ml/min/1.73m2 u iperkalimja (linja bażi tal-potassium fis-serum 5.2 mmol/L, firxa 4.6 - 6 mmol/L).
English: The active substance is sodium zirconium cyclosilicate.
Maltese: Is-sustanza attiva hija sodium zirconium cyclosilicate.
English: The maintenance studies included patients with chronic kidney disease (58%), heart failure (10%), diabetes mellitus (62%) and RAAS inhibitor therapy (68%).
Maltese: L-istudji ta' manteniment inkludew pazjenti b'marda kronika tal-kliewi (58%), kollass tal-qalb (10%), diabetes mellitus (62%) u terapija b'inibitur RAAS (68%).
English: Correction and maintenance phases (Study 2): mean serum potassium over time with 95% CI
Maltese: Fażijiet ta' korrezzjoni u manteniment (Studju 2): potassium fis-serum medju mażżmien b'CI ta' 95%
English: Adults, including the elderly
Maltese: Adulti, inklużi l-anzjani
English: Serum potassium levels
Maltese: Il-livelli tal-potassium fis-serum
English: Use of diuretics and RAAS inhibitors was reported by 51 and 70% of subjects, respectively.
Maltese: Użu ta' dijuretiċi u inibituri ta' RAAS ġie rrapportat minn 51 u 70% talindividwi, rispettivament.
English: The risk of interaction with X-rays
Maltese: Ir-riskju ta' interazzjoni ma' raġġi X
English: Correction phase (Study 1): Percentage of normokalaemic subjects after 48 hours of Lokelma
Maltese: Fażi ta' korrezzjoni (Studju 1): Perċentwal ta' individwi normokalemiċi wara 48 siegħa ta' Lokelma
English: CPBL=Correction Phase Baseline, MPBL=Maintenance Phase Baseline Exit=Last Visit within 1 day of Last Dose, EOS=End of Study (7 days +/- 1 day after Last Dose)
Maltese: CPBL= Linja Bażi Fażi ta' Korrezzjoni, MPBL= Linja Bażi Fażi ta' Manteniment Ħruġ=L-Aħħar Żjara fi żmien 1 jum tal-Aħħar Doża, EOS=Tmiem tal-Istudju (7 ijiem +/- 1 jum wara l-Aħħar Doża)
English: Lokelma contains the active substance sodium zirconium cyclosilicate.
Maltese: Lokelma fih is-sustanza attiva sodium zirconium cyclosilicate.
English: Responses were larger in patients with more severe hyperkalaemia; serum potassium fell 0.8, 1.2 and 1.5 mmol/L in patients with baseline serum potassium < 5.5, 5.5-5.9 and ≥ 6 mmol/L, respectively.
Maltese: Ir-risponsi kienu akbar f'pazjenti b'iperkalimja aktar severa; il-potassium fis-serum niżel 0.8, 1.2 u 1.5 mmol/L f'pazjenti bil-potassium fis-serum tal-linja bażi < 5.5, 5.5-5.9 u ≥ 6 mmol/L, rispettivament.
English: Median time to normokalaemia was 2.2 hours with 66% of patients achieving normokalaemia at 24 hours and 88% at 48 hours.
Maltese: Il-ħin medju għannormokalimja kien ta' 2.2 sigħat b'66% tal-pazjenti jiksbu n-normokalimja wara 24 siegħa u 88 % wara 48 siegħa.
English: Typically, normokalaemia is achieved within 24 to 48 hours.
Maltese: Tipikament, in-normokalemija tinkiseb fi żmien 24 sa 48 siegħa.
English: A two-phase, placebo-controlled correction and maintenance use study A two-part, double-blind, randomised, placebo-controlled clinical trial of 753 patients (mean age of 66 years, range 22 to 93 years) with hyperkalaemia (5 to ≤ 6.5 mmol/L, baseline potassium average 5.3 mmol/L), and included patients with chronic kidney disease, heart failure, diabetes mellitus and those on RAAS inhibitor therapy.
Maltese: Studju ta' użu ta' żewġ fażijiet, ikkontrollat bi plaċebo ta' korrezzjoni u manteniment Prova klinika ta' żewġ partijiet, double-blind, randomizzata, ikkontrollata bi plaċebo ta' 753 pazjent (età medja ta' 66 sena, firxa 22 sa 93 sena) bl-iperkalimja (5 sa ≤ 6.5 mmol/L, medja tal-potassium fil-linja bażi 5.3 mmol/L), u li inkludiet pazjenti b'mard kroniku tal-kliewi, insuffiċjenza tal-qalb, dijabete mellitus u dawk fuq terapija ta' inibitur RAAS.
English: In a clinical drug-drug interaction study conducted in healthy subjects co-administration of sodium zirconium cyclosilicate with amlodipine, clopidogrel, atorvastatin, furosemide, glipizide, warfarin, losartan or levothyroxine did not result in clinically meaningful drugdrug interactions.
Maltese: Fi studju kliniku dwar l-interazzjoni bejn il-mediċini mwettaq f'individwi b'saħħithom, l-għoti flimkien ta' sodium zirconium cyclosilicate ma' amlodipine, clopidogrel atorvastatin, furosemide, glipizide, warfarin, losartan, jew levothyroxine ma rriżultax f'interazzjonijiet klinikament sinifikanti bejn il-mediċini.
English: 5 or 10 g of powder in sachets made of a PET/alu/LLDPE or PET/LDPE/alu/EAA/LLDPE laminate
Maltese: 5 jew 10 g ta' trab fi qratas laminati magħmula minn PET/alu/LLDPE jew PET/LDPE/alu/EAA/LLDPE
English: In addition, mean reductions in blood urea nitrogen (BUN) were observed in the 5 g (1.1 mg/dL) and 10 g (2.0 mg/dL) three times daily groups compared with small mean increases in the placebo (0.8 mg/dL) and low dose sodium zirconium cyclosilicate (0.3 mg/dL) groups.
Maltese: Barra minn hekk, it-tnaqqis medju fin-nitroġenu tal-urea fid-demm (BUN, blood urea nitrogen) kien osservat fil-gruppi ta' 5 g (1.1 mg/dL) u ta' 10 g (2.0 mg/dL) tliet darbiet kuljum meta mqabbel ma' żidiet żgħar medji fil-gruppi tal-plaċebo (0.8 mg/dL) u ta' doża baxxa ta' sodium zirconium cyclosilicate (0.3 mg/dL).
English: The proportion of subjects with average serum potassium < 5.1 mmol/L was 88%, the average serum potassium level was 4.66 mmol/L and the proportion of serum potassium measurements below 3.5 mmol/L was less than 1%; between 3.5 and 5.1 mmol/L was 77%; or between 3.5 and 5.5 mmol/L was 93%, irrespective of other factors that might influence the serum potassium.
Maltese: Il-proporzjon ta' individwi b'potassium fis-serum medju < 5.1 mmol/L kien ta' 88 %, il-livell medju ta' potassium fis-serum kien 4.66 mmol/L u l-proporzjon ta' kejl ta' potassium fis-serum taħt 3.5 mmol/L kien inqas minn 1 %; bejn 3.5 u 5.1 mmol/L kien 77%; jew bejn 3.5 u 5.5 mmol/L kien 93 %, irrispettivament minn fatturi oħra li jistgħu jinfluwenzaw il-potassium fis-serum.
English: ANNEX III
Maltese: 3 LISTA
English: Sodium zirconium cyclosilicate starts reducing serum potassium concentrations as soon as 1 hour after ingestion and normokalaemia can be achieved typically within 24 to 48 hours.
Maltese: Sodium zirconium cyclosilicate jibda jnaqqas il-konċentrazzjonijiet ta' potassium fis-serum sa siegħa wara l-inġestjoni u normalment, in-normokalemija tinkiseb fi żmien 24 sa 48 siegħa.
English: Sodium excretion was unchanged relative to placebo (10 g, increase by 25.4 mmol/24 h compared to placebo increase by 36.9 mmol/24 h (NS)).
Maltese: L-eliminazzjoni tas-sodium ma nbidlitx meta mqabbla mal-plaċebo (10 g, żieda b'25.4 mmol/24 h meta mqabbla mal-plaċebo, żieda b'36.9 mmol/24
English: Since intestinal perforation has been reported with polymers that act in the gastrointestinal tract, specific attention should be paid to signs and symptoms related to intestinal perforation.
Maltese: Peress li ġiet irrappurtata perforazzjoni intestinali b'polimers li jaġixxu fil-passaġġ gastrointestinali, għandha tingħata attenzjoni speċjali lil sinjali u sintomi relatati mal-perforazzjoni intestinali.
English: EU/1/17/1173/001 3 sachets EU/1/17/1173/005 28 sachets EU/1/17/1173/002 30 sachets EU/1/17/1173/007 3 sachets EU/1/17/1173/008 28 sachets EU/1/17/1173/009 30 sachets
Maltese: EU/1/17/1173/001 3 qratas EU/1/17/1173/005 28 qartas EU/1/17/1173/002 30 qartas EU/1/17/1173/007 3 qratas EU/1/17/1173/008 28 qartas EU/1/17/1173/009 30 qartas
English: EU/1/17/1173/001 EU/1/17/1173/002 EU/1/17/1173/003 EU/1/17/1173/004 EU/1/17/1173/005 EU/1/17/1173/006 EU/1/17/1173/007 EU/1/17/1173/008 EU/1/17/1173/009 EU/1/17/1173/010 EU/1/17/1173/011 EU/1/17/1173/012
Maltese: EU/1/17/1173/006 EU/1/17/1173/007 EU/1/17/1173/008 EU/1/17/1173/009 EU/1/17/1173/010
English: • angiotensin converting enzyme (ACE) inhibitors such as enalapril, and angiotensin receptor blockers which name ends with sartan (medicines for high blood pressure and for heart problems)
Maltese: • inibituri ta' enzimi li jikkonvertu l-anġjotensin (ACE, angiotensin converting enzyme) bħal enalapril, u imblukkaturi tar-riċettur anġjotensin li isimhom jispiċċa b'“sartan” (mediċini għal pressjoni tad-demm għolja u problemi tal-qalb)
English: The following convention was used for frequency of adverse reactions: 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), not known (cannot be estimated from the available data).
Maltese: Rari (≥ 1/10,000 sa < 1/1,000);
English: See section 4.
Maltese: Ara s-sezzjoni 4: