FrancophonIA/ELRC3.0 huggingface dataset:
English: Each sachet of 2.4 g of powder is to be dispersed in 60 mL of water prior to administration (see section 6.6).
Maltese: Kull qartas ta' 2.4 g ta' trab għandu jiġi maħlul f'60 ml ilma qabel ma jingħata (ara sezzjoni 6.6) .
English: Film-coating:
Maltese: Kodiċi ATC:
English: Each sachet of 0.8 g of powder is to be dispersed in 30 mL of water prior to administration (see section 6.6).
Maltese: Kull qartas ta' 0.8 g ta' trab għandu jiġi maħlul f'30 ml ilma qabel ma jingħata (ara sezzjoni 6.6) .
English: The highest dose in this study was 4.5 g/kg/day (human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA).
Maltese: L-ogħla doża f'dan l-istudju kien ta' 4.5 g/kg/jum (doża ekwivalenti tal-bniedem darbtejn id-doża massima fil-prova klinika ta' 13 g/kuljum ibbażat fuq paragun ta' BSA relattiva).
English: Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Maltese: Prodotti mediċinali kontra l-arritmija u kontra l-konvulżjonijiet Pazjenti li qed jieħdu prodotti mediċinali antiarritmiċi għal kontroll ta' arritmiji u prodotti mediċinali ta' kontra l-konvulżjonijiet għal kontroll ta' disturbi ta' konvulżjoni kienu esklużi fil-provi kliniċi.
English: Renvela 2.4 g powder for oral suspension
Maltese: Renvela 2.4 g trab għal suspensjoni orali.
English: Each sachet contains 2.4 g sevelamer carbonate.
Maltese: Kull qartas fih 2.4 g sevelamer carbonate.
English: • adult patients on dialysis (a blood clearance technique).
Maltese: • pazjenti adulti fuq id-dijalisi (teknika biex jitnaddaf id-demm ).
English: • Renvela should not be taken at the same time as ciprofloxacin (an antibiotic).
Maltese: • Renvela m'għandiex tittieħed fl-istess ħin bħal ciprofloxacin (antibijotiku).
English: Animal studies have shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3).
Maltese: Studji fl-annimali wrew ftit tossiċità riproduttiva meta sevelamer kien amministrat lil firien f'dożi għoljin (ara sezzjoni 5.3).
English: Renvela 800 mg film-coated tablets
Maltese: Renvela 800 mg pilloli miksija b'rita
English: The most frequently occurring (≥ 5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti li seħħew (≥ 5% ta' pazjenti) kienu lkoll fil-klassi tas-sistema tal organi abbinata mad-disturbi gastrointestinali.
English: Each bottle contains 30 tablets or 180 tablets.
Maltese: Kull flixkun fih 30 pillola jew 180 pillola.
English: Sevelamer carbonate does not contain any calcium.
Maltese: Sevelamer carbonate ma fiha ebda kalċju.
English: The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with CKD was evaluated in a multicenter study with a 2-week, randomised, placebo-controlled, fixed dose period (FDP) followed by a 6-month, single-arm, open-label, dose titration period (DTP).
Maltese: Is-sigurtà u l-effettività ta' sevelamer carbonate f'pazjenti pedjatriċi iperfosfatemiċi b'CKD ġie evalwat f'studju multiċentriku fejn kien hemm perijodu ta' doża fissa (Fixed Dose Period - (FDP ) ta' ħmistax ,
English: Renvela 0.8 g powder for oral suspension
Maltese: Renvela 0.8 g trab għal suspensjoni orali.
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal.
Maltese: Il-possibilità ta' interazzjoni ma tistax tiġi eskluża u monitoraġġ mill-qrib tal-konċentrazzjonijiet tad-demm ta' ciclosporin, mycophenolate mofetil u tacrolimus għandha tiġi kkonsidrata waqt l-użu tal-kombinazzjoni u wara li titwaqqaf.
English: - The other ingredients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride,
Maltese: - Is-sustanzi l-oħra huma propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose u iron oxide isfar (E172).
English: There was an increased incidence of urinary bladder transitional cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 14.4 g).
Maltese: Kien hemm inċidenza ogħla ta' papilloma fiċ-ċelluli transizzjonali tal-bużżieqa awrinarja fil-firien irġiel tal-grupp b'doża għolja (doża ekwivalenti għal bniedem d-doppju d-doża massima fil-prova klinka ta' 14.4 g).
English: Each sachet contains 0.8 g sevelamer carbonate.
Maltese: Kull qartas fih 0.8 g sevelamer carbonate.
English: • Bowel obstruction.
Maltese: • problemi biex tibla'.
English: There was no increased incidence of tumours observed in mice (human equivalent dose 3 times the maximum clinical trial dose).
Maltese: Ma kienx hemm żieda fl-inċidenza ta' tumuri osservati fil-ġrieden (doża ekwivalenti għal bniedem 3 darbiet id-doża massima fil-prova klinika).
English: You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
Maltese: Għandek tgħarraf lit-tabib tiegħek minnufih jekk tesperjenza sinjali jew sintomi ta' brim addominali, nefħa addominali, uġigħ addominali, tenerezza addominali, jew twebbis addominali, stitikezza, deni, sirdat, tqalligħ jew rimettar.
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Maltese: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 1600
English: Appropriate symptomatic treatment should be provided.
Maltese: Għandu jiġi pprovdut trattament sintomatiku xieraq.
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothyroxine is recommended (see section 4.5).
Maltese: Ipotajrojdiżmu Monitoraġġ mill-qrib ta' pazjenti b'iptajrojdiżmuli jingħataw fl-istess ħin sevelamer carbonate u levothyroxine hu rakkomandat (ara sezzjoni 4.5).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue box - BOTTLE OF 30 TABLETS
Maltese: KARTUNA TA' BARRA bil-kaxxa l-Blu - FLIXKUN TA' 30 PILLOLA
English: In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Maltese: Fi studju ta' interazzjoni f'voluntieri b'saħħithom, sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamar carbonate, ma kellux effett fuq il-bijodisponibilità ta' digoxin, warfarina, enalapril jew metoprolol.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.>
English: Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Maltese: Sevelamer intwera li jista' jingħaqad ma' aċidi biljari in vitro u in vivo f'mudelli sperimentali fuq l-annimali.
English: Most of these adverse reactions were mild to moderate in intensity.
Maltese: Ħafna minn dawn ir-reazzjonijiet avversi kienu minn ħfief sa moderati fl-intensità.
English: Batch
Maltese: trab.
English: Renvela 800 mg film-coated tablets sevelamer carbonate
Maltese: Renvela 800 mg pilloli miksija b'rita sevelamer carbonate
English: In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP.
Maltese: F'pazjenti pedjatriċi b'iperfosfatemija sekondarja għal CKD, sevelamer carbonate naqqas b'mod sinifikanti l-livelli tal-fosforu fis-serum meta mqabbel ma' plaċebo waqt ħmistax ta' FDP.
English: - Allergic reaction (signs including rash, hives, swelling, trouble breathing).
Maltese: - Reazzjoni allerġika (sinjali jinkludu raxx, urtikarja, nefħa, diffikultà biex tieħu n-nifs).
English: Organ Class
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: The first study demonstrated that sevelamer carbonate tablets dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 79 haemodialysis patients treated over two randomised 8 week treatment periods (mean serum phosphorus time-weighted averages were 1.5 ± 0.3 mmol/l for both sevelamer carbonate and sevelamer hydrochloride).
Maltese: L-ewwel studju wera li l-pilloli ta' sevelamer carbonate dożati tleit darbiet kuljum kienu ekwivalenti għal pilloli ta' sevelamer hydrochloride ddożati tliet darbiet kuljum f'79 pazjent ta' emodijaliżi ttrattati fuq żewġ perijodi każwali ta' 8 ġimgħat (fosforu fis-serum medju, b'medji piżati bil-ħin ikunu ta' 1.5 ± 0.3 mmol/l kemm għal sevelamer carbonate u sevelamer hydrochloride).
English: Inflammatory disorders may resolve upon sevelamer discontinuation.
Maltese: Id-distrubi infjammatorji jistgħu jmorru lura għan-normal wara li jitwaqqaf sevelamer.
English: For paediatric patients with a <1.2 BSA (m2), the oral suspension should be administered, as tablet formulations were not tested in this population and therefore are not appropriate for this population.
Maltese: Għal pazjenti pedjatriċi b'BSA (m2) <1.2 għandha tingħata s-suspensjoni orali peress li l-formulazzjonijiet tal-pilloli ma ġewx ittestjati f'din il-popolazzjoni u għalhekk mhumiex adatti għal din il-popolazzjoni.
English: Pale yellow powder.
Maltese: Użu orali.
English: • you have bowel obstruction
Maltese: • disturbi biex tibla'
English: Anti-arrhythmics and anti-seizure medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: - Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported.
Maltese: - Infjammazzjoni serja tal-musrana l-kbira (sintomi jinkludu: uġigħ sever addominali, disturbi fl-istonku jew fl-imsaren jew demm fl-ippurgar [fsada gastrointestinali]) u depożitu ta' kristalli fl-intestin ġew irrapportati.
English: Deficits in skeletal ossification were observed in several locations in foetuses of female rats dosed with sevelamer at intermediate and high doses (human equivalent dose less than the maximum clinical trial dose of 14.4 g).
Maltese: Żbilanċi fl-ossifikazzjoni skeletrika kienu osservati f'diversi lokazzjonijiet fil-feti u fil-firien nisa li kienu dożati b'sevelamer f'dożi intermedji u għoljin (doża ekwivalenti għal bniedem inqas mid-doża massima filprova klinika ta' 14.4 g).
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Maltese: Għandek mnejn tiżviluppa peritonite (infezzjoni fil-fluwidu addominali tiegħek) li tkun assoċjata maddijalisi peritoneali.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when coadministered with sevelamer hydrochloride in a single dose study.
Maltese: Fi studji ta' interazzjoni fuq voluntiera b'saħħithom, sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamer carbonate , naqqas il-bijodisponibilità ta' ciprofloxacin b'madwar 50% meta ngħata flimkien ma' sevelamer hydrochloride fi studju ta' doża waħda.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer carbonate.
Maltese: F'każijiet rari ħafna, sadd intestinali u ileju/sottileju ġie osservati f'pazjenti waqt it-trattament b'sevelamer hydrochloride (kapsuli/pilloli), li fih hemm l-istess porzjon attiv bħal sevelamer carbonate.
English: Because sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, E and K.
Maltese: Minħabba li sevelamer jingħaqad ma' aċidi biljari, jista' jxekkel l-assorbiment ta' vitamini li jinħallu fix-xaħam bħal A, D, E u K.
English: These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.
Maltese: L-ammini protonati jorbtu ijoni ċċarġjati b'mod negattiv bħal fosfat djetetiku fl imsaren.
English: A total of 101 patients (6 to 18 years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study.
Maltese: Total ta' mitt pazjent u wieħed ( 6 sa 18-il sena b'marġni ta' BSA ta' 0.8 m2 sa 2.4 m2 ) ġew magħżula b'mod arbitrarju għall-istudju.
English: As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 100grams/120 ml) and consumed within 30 minutes.
Maltese: 100gramma/120 ml) u kkonsumat fi żmien 30 minuta.
English: Starting dose
Maltese: Iperparatajrojdiżmu
English: Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinical trial with sevelamer hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control group.
Maltese: Il-peritonite hija kumplikazzjoni magħrufa f'pazjenti li qed jirċievu dijalisi peritoneali u fi prova klinika b'sevelamer hydrochloride, għadd akbar ta' każijiet ta' peritonite ġew irrapportati fil-grupp ta' sevelamer milli fil-grupp ta' kontroll.
English: In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and folic acid.
Maltese: Fil-firien u l-klieb, sevelamer naqqas l-assorbiment ta' vitamini li jinħallu fix-xaħam D, E u K (fatturi tal-koagulazzjoni), u folic acid.
English: Not known: cases of itching, rash, slow intestine motility (movement)
Maltese: każijiet ta' ħakk, raxx, motilità (moviment) bil-mod tal-imsaren ġew irrappurtati.
English: Pharmacokinetic studies have not been carried out with sevelamer carbonate.
Maltese: Ma sarux studji farmakokinetiċi b'sevelamer carbonate.
English: • active inflammatory bowel disease
Maltese: • infjammazzjoni attiva tal-imsaren
English: In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Maltese: Għal pazjenti b'dijalisi peritoneali monitoraġġ addizzjonali ta' vitamini li jinħallu fix-xaħam u tal-folic acid hu rakkomandat, peress li l-livelli ta' vitamina A, D, E u K ma kienux mkejla fi studju kliniku f'dawn il-pazjenti.
English: The recommended starting dose of Renvela tablets for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Maltese: Id-doża rrakkomandata tal-bidu tal-pilloli Renvela għal adulti u anzjani hi ta' pillola waħda jew żewġ pilloli ta' 800 mg ma' kull ikla, 3 darbiet kuljum.
English: Skin and subcutaneous tissue disorders
Maltese: Sadd intestinali u ileju/sottileju
English: By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum.
Maltese: Bl-irbit ma' fosfati fil-passaġġ gastrointestinali u t-tnaqqis fl-assorbiment, sevelamer inaqqas il-konċentrazzjoni ta' fosforu fis-serum.
English: If you stop taking Renvela
Maltese: Kif gћandek tieћu Renvela
English: - Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported.
Maltese: - Ftuq tal-intestin (sinjali jinkludu: uġigħ qawwi fl-istonku, tkexkix, deni, dardir, rimettar jew addome sensittiv) ġie rrappurtat.
English: Stir the suspension and drink it within 30 minutes of being prepared.
Maltese: Issuspensjoni għandha tittieħed fi żmien 30 minuta minn wara li tiġi ppreparata.
English: This information was obtained from studies in which sevelamer hydrochloride was used.
Maltese: Din l-informazzjoni kienet miksuba minn studji fejn intuża sevelamer hydrochloride.
English: Other side effects have been reported in patients taking Renvela:
Maltese: Effetti sekondarji oħra inqas importanti ġew irrapportati f'pazjenti li qed jieħdu Renvela:
English: *Plus subsequent titrating, see section “Titration and maintenance” Children/adolescents (>6 years of age and a BSA of >0.75m2) The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based on the patient's BSA category.
Maltese: **Tfal u adolexxenti (>6 snin ta' età u BSA ta' >0.75m2)
English: In two randomised, cross over clinical trials, sevelamer carbonate in both tablet and powder formulations when administered three times per day has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
Maltese: F'żewġ provii kliniċi każwali, u inkroċjati, sevelamer carbonate fl-għamliet kemm ta' pillola u ta' trab, meta ġew mogħtija tliet darbiet kuljum intwerew li jistgħu jkunu terapewtikament ekwivalenti għal sevelamer hydrochloride u għalhekk effettivi biex jikkontrollaw il-fosforu fis-serum f'pazjenti CKD fuq emodijalisi.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Maltese: Pazjenti li huma stitiċi għandhom ikunu monitorati b'attenzjoni waqt li jkunu qed jiġu ttrattati b'Renvela .
English: It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.
Maltese: Hi tingħaqad mal-fosfat mill-ikel tal-passaġġ diġestiv u għalhekk tnaqqas il-livelli ta' fosforu fis-serum fid-demm.
English: Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.
Maltese: Sevelamer hydrochloride ma kienx mutaġeniku fl-assaġġ ta' mutazzjoni batterika ta' Ames.
English: In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on iPTH.
Maltese: Fil-provi kliniċi f'pazjenti fuq emodijalisi, sevelamer waħdu m'għandux effett konsistenti u klinikament sinifikanti fuq iPTH.
English: In CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single daily dose.
Maltese: F'pazjenti bilmard tal-kliewi kroniku, id-doża massima medja ta' kuljum li ġiet studjata kienet ta' 14.4 grammi ta' sevelamer carbonate f'doża waħda kuljum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - CARTON OF 60 or 90 SACHETS
Maltese: KARTUNA TA' BARRA - KARTUNA TA' 60 jew 90 QARTAS
English: Renvela film-coated tablets are white tablets with Renvela 800 imprinted on one side.
Maltese: Il-pilloli miksija b'rita ta' Renvela huma pilloli bojod b' Renvela 800 stampat fuq naħa waħda minnhom.
English: Very rare cases of hypothyroidism have been reported in patients co-administered with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine.
Maltese: Każijiet rari ħafna ta' ipotajrojdiżmu ġew rapportati f'pazjenti li ngħataw wkoll fl-istess ħin sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamer carbonate u levothyroxine.
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract, as confirmed by an absorption study in healthy volunteers.
Maltese: Sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamer carbonate, ma jiġix assorbit fil-passaġġ gastrointestinali, kif ikkonfermat fl-istudju ta' assorbiment f'voluntieri b'saħħithom.
English: Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving sevelamer carbonate and levothyroxine.
Maltese: Monitoraġġ mill-qrib tal-livelli tal-ormon li jistimula t-tirojde (TSH) hu għalhekk rakkomandat f'pazjenti li qed jirċievu sevelamer carbonate u levothyroxine.
English: The safety and efficacy of Renvela in children over 6 year of age and a BSA >0.75 m2 have been established.
Maltese: Tfal/adolexxenti (>6 snin ta' età u BSA ta' >0.75m2)
English: For adult patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Maltese: Għal pazjenti adulti, il-livelli ta' fosforu fis-serum għandhom jiġu monitorati u d-doża ta' sevelamer carbonate tiġi ttittrata b'żidiet ta' 0.8 g tliet darbiet kuljum (2.4 g/jum) kull 2-4 ġimgħat sakemm jintlaħaq livell aċċettabbli ta' fosforu fis-serum, b'monitoraġġ regolari wara dan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Increased levels of serum phosphorus can lead to hard deposits in your body called calcification.
Maltese: Livelli ogħla ta' fosforu fis-serum jistgħu jwasslu għal depożiti iebsin f'ġismek li jissejħu kalċifikċazzjoni.
English: Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Maltese: Renvela għandha tintuża fi ħdan kuntest ta' metodu terapewtiku multiplu, li jista' jinkludi supplimenti talkalċju, 1,25 - dihydroxy Vitamin D3 jew wieħed mill-analogi tiegħu biex jikkontrollaw l-iżvilupp tal-mard ta' l-għadam renali.
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA.
Maltese: Studji fl-annimali wrew li sevelamer ma indebbolixxiex il-fertilità f'firien irġiel u nisa f'espożizzjonijiet li huma ekwivalenti għal doża fil-bniedem ta' darbtejn id-doża massima fil-prova klinika ta' 13 g/kuljum, ibbażat fuq paragun tal-BSA relattiva.
English: Contents of the pack and other information What Renvela contains
Maltese: INFORMAZZJONI BIL-BRAILLE Renvela
English: The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Maltese: mhux fuq dijalisi, b'livell ta' fosforu fis-serum ta' > 1.78 mmol/l.
English: Regular monitoring of serum phosphorus levels is always necessary during phosphate binder administration.
Maltese: Monitoraġġ regolari tal-livelli ta' fosforu fis-serum huwa dejjem meħtieġ waqt l-għoti tal-binder tal-fosfat.
English: In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E and K status should be assessed regularly.
Maltese: F'pazjenti li ma jieħdux vitamini supplimentali, imma li qegħdin fuq sevelamer, l-istat tal-vitamini A, D, E u K fis-serum għandu jiġi analizzat regolarment.
English: The symptoms observed in case of overdose are similar to adverse reactions listed in section 4.8, including mainly constipation and other known gastrointestinal disorders.
Maltese: F'każ ta' doża eċċessiva, is-sintomi osservati kienu simili għar-reazzjonijiet avversi mniżżla f'sezzjoni 4.8, li jinkludu l-iżjed stitikezza u disturbi gastrointestinali magħrufa oħra.
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela.
Maltese: • Żbilanċ tal-ormon tat-tajrojd jista' jiġi osservat mhux b'mod komuni f'ċertu persuni li jkunu qed jieħdu levothyroxine (li jintuża biex jittratta livelli baxxi tat-tirojde) u Renvela.
English: The study met its primary endpoint, meaning Sevelamer carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and secondary efficacy endpoints.
Maltese: L-istudju laħaq l-għan primarju tiegħu, li fisser li Sevelamer carbonate naqqas il-fosforu fis-serum b'medja ta' differenza fl-LS ta'0.90 mg/dL meta mqabbel mal-plaċebo, u l-għanijiet sekondarji ta' effikaċja.