FrancophonIA/ELRC3.0 huggingface dataset:
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation1,
Maltese: Sadd intestinali, ileju/sottileju, divertikulite, perforazzjoni talimsaren1, ,
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Renagel
English: Renagel 800 mg
Maltese: 800 mg
English: Renagel contains sevelamer as the active ingredient.
Maltese: Renagel fih sevelamer bħala s-sustanza attiva.
English: Common Uncommon Very Rare
Maltese: Komuni Ħafna Komuni
English: In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Maltese: Fi studji ta' interazzjoni fuq voluntiera b'saħħithom, Renagel ma kellux effett fuq il-bijodisponibilità ta' digoxin, warfarin, enalapril jew metoprolol.
English: Date of first authorisation: 28 January 2000 Date of latest renewal: 28 January 2015
Maltese: Data tal-aħħar tiġdid: 28 ta' Jannar, 2015
English: Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10000): sensittività eċċessiva.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
Maltese: • L-effetti ta' mediċini bħal ciclosporin, mycophenolatemofetilu tacrolimus (mediċini użati minn pazjenti li għamlu trapjant) jista' jitnaqqas b'Renagel.
English: Nausea, vomiting
Maltese: Dijarea, dispepsja,
English: However, in vitro and in vivo studies have indicated that Renagel does not have genotoxic potential.
Maltese: Imma, studji in vitro u dawk in vivo indikaw li Renagel ma għandux riskju genotossiku potenzjali.
English: These amines become partially protonated in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.
Maltese: Dawn l-amini jsiru parzjalment protonati fl-intestin u jinterraġixxu mal-molekuli ta' fosfat permezz ta' l-għaqda ionika u ta' hydrogen bonding.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Renagel in a single dose study.
Maltese: Skont studji ta' interazzjon f'voluntiera b'saħħithom, sevelamar hydrochloride naqqas ilbijodisponibilità ta‘ cipofloxacin b'madwar 50% meta ingħata flimkien ma Renagel fi studju ta' doża waħda.
English: Special note for patients on peritoneal dialysis
Maltese: Nota speċjali għal pazjenti b'dijalisi peritoneali
English: OUTER CARTON with Blue Box - MULTIPACK OF 360 (2 BOTTLES OF 180) TABLETS 800 mg
Maltese: KARTUNA TA' BARRA bil-Kaxxa Blu - PAKKETT MULTIPLU TA' 360 (2 FLIEXKEN TA' 180) PILLOLA 800 mg
English: Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.4 g or 0.8 g three times per day (1.2 g/day or 2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5mg/dl) or less.
Maltese: Il-livelli ta' fosfat fis-serum għandhom ikunu monitorjati sewwa u d-doża ta' sevelamer hydrochloride ttittrata b'żidiet ta' 0.4 g jew 0.8 g tliet darbiet kuljum (1.2 g/jum jew 2.4 g/jum) bl-għan li jitnaqqas il livell tal-fosfat fis-serum għal 1.76 mmol/1 (5.5mg/dl) jew inqas.
English: 4 tablets, 3 times per day
Maltese: 4 pilloli, 3 darbiet kuljum
English: Parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted.
Maltese: Ġew magħmula studji tat-tip paralleli li involvew 244 pazjent b'emodijalisi b'kura li damet għal 54 ġimgħa u 97 pazjent b'dijalisi peritoneali b'kura li damet għal 12-il ġimgħa.
English: Pack sizes are:
Maltese: Meta taqleb it-trattament:
English: • If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Renagel.
Maltese: • Jekk qed/a tieħu mediċini bħal omeprazole, pantoprazole, jew lansoprazole għat-trattament ta' ħruq ta' stonku, mard ta' refluss gastroesofagali (GERD) jew ulċeri gastriċi għandek tikkonsulta mat-tabib tiegħek meta tkun qed/a tieħu Renagel.
English: How to take Renagel
Maltese: Tieħux Renagel:
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis retention of gastric contents and abnormal or irregular bowel motion
Maltese: • disturbi tal-motilità gastrointestinali, li jinkludu gastroparesi mhux trattata jew severa,
English: Inflammatory disorders may resolve upon sevelamer discontinuation.
Maltese: Id-distrubi infjammatorji jistgħu jmorru lura għan normal wara li jitwaqqaf sevelamer.
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Maltese: kuljum li ntużat fil-fażi kronika ta' studju kliniku ta' sena kien ta' 7 grammi ta' sevelamer.
English: Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Maltese: Monitoraġġ addizzjonali ta' vitamini u folic acid hu rrakkomandat f'pazjenti li jkunu fuq dijalisi peritoneali, peress li fl-istudju kliniku l-livelli ta' vitamina A, D, E u K ma kienux mkejla f'dawn ilpazjenti.
English: The recommended starting dose of sevelamer hydrochloride is 2.4 g, 3.6 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Maltese: Id-doża rakkomandata tal-bidu ta' sevelamer hydrochloride hi 2.4 g, 3.6 g jew 4.8 g kuljum skont il ħtiġijiet kliniċi u l-livell ta' fosforu fis-serum.
English: EU/1/99/123/008 1 bottle of 180 film-coated tablets EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton EU/1/99/123/013 multipacks containing 180 film-coated tablets (6 bottles of 30 tablets)
Maltese: EU/1/99/123/008 flixkun 1 ta' 180 pillola miksija b'rita EU/1/99/123/009 pakketti multipli li fihom 360 pillola miksija b'rita (2 fliexken ta' 180 pillola) EU/1/99/123/010 pakketti multipli li fihom 540 pillola miksija b'rita (3 fliexken ta' 180 pillola) EU/1/99/123/011 flixkun 1 ta' 100 pillola miksija b'rita
English: • patients with a history of major gastrointestinal surgery Therefore caution should be exercised when Renagel is used in patients with these disorders.
Maltese: • pazjenti bi storja medika ta' interventi gastrointestinali kirurġiċi.
English: Pharmacokinetic studies have not been carried out in renal failure patients (see section 4.4).
Maltese: Studji farmakokinetiċi ma sarux fuq pazjenti li kellhom insuffiċjenza renali (ara sezzjoni 4.4 Avviżi speċjali u prekawzjonijiet speċjali għall-użu).
English: 2 tablets, 3 times per day
Maltese: 2 pilloli, 3 darbiet kuljum
English: Renagel is not absorbed and may affect the bioavailability of other medicinal products.
Maltese: Renagel mhux assorbit u jista' jaffettwa l-bijodisponibilità ta' prodotti mediċinali oħra.
English: 1 bottle of 360 film-coated tablets multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Maltese: Id-daqsijiet tal-pakketti huma: flixkun 1 ta' 360 pillola pakketti multipli li fihom 720 pillola (2 fliexken ta' 360 pillola) pakketti multipli li fihom 1080 pillola (3 fliexken ta' 360 pillola)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 BOTTLE OF 100 TABLETS 800 mg OUTER CARTON - 1 BOTTLE OF 180 TABLETS 800 mg
Maltese: KARTUNA TA' BARRA - FLIXKUN 1 TA' 100 PILLOLA 800 mg KARTUNA TA' BARRA - FLIXKUN 1 TA' 180 PILLOLA 800 mg
English: The dose range may vary between 1 and 10 tablets per meal.
Maltese: Il-firxa tad-doża tista' tvarja bejn 1 u 10 pilloli ma' kull ikla.
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets
Maltese: EU/1/99/123/011 Flixkun 1 ta' 100 pillola miksija b'rita EU/1/99/123/008 Flixkun 1 ta' 180 pillola miksija b'rita
English: Each tablet contains 800 mg sevelamer hydrochloride.
Maltese: Kull pillola fih 800 mg sevelamer hydrochloride.
English: 1 bottle of 180 film-coated tablets multipacks containing 180 film-coated tablets (6 bottles of 30 tablets) multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Maltese: Id-daqsijiet tal-pakketti huma: flixkun 1 ta' 100 pillola flixkun 1 ta' 180 pillola pakketti multipli li fihom 180 pillola (6 fliexken ta' 30 pillola) pakketti multipli li fihom 360 pillola (2 fliexken ta' 180 pillola)
English: Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of thirty five 400 mg tablets per day for eight days with no undesirable effects.
Maltese: Renagel ingħata lill-voluntieri normali b'saħħithom f'dożi sa 14-il gramma, l-ekwivalent għall-ħamsa u tletin pillola ta' 400 mg kuljum għal tmint ijiem mingħajr l-ebda effetti mhux mixtieqa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 BOTTLE OF 360 TABLETS 400 mg
Maltese: KARTUNA TA' BARRA - FLIXKUN 1 TA' 360 PILLOLA 400 mg
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “Renagel 800” on one side.
Maltese: Il-pilloli offwajt, ovali għandhom “Renagel 800” stampat fuq naħa waħda.
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “Renagel 400” on one side.
Maltese: Il-pilloli offwajt, ovali għandhom “Renagel 400” stampat fuq naħa waħda.
English: In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Maltese: Fi provi kliniċi sevelamer wera li jista' jkune effettiv billi jnaqqas il-fosforu fis-serum f'pazjenti li qed jirċievu emodijalisi jew dijalisi peritoneali.
English: Renagel 400 mg film-coated tablets sevelamer hydrochloride
Maltese: Renagel 400 mg pilloli miksija b'rita sevelamer hydrochloride
English: B. PACKAGE LEAFLET
Maltese: TAL-PAKKETT MULTIPLU)
English: EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Maltese: EU/1/99/123/006 pakketti multiplu: 720 pillola miksija b'rita (2 fliexken ta' 360) EU/1/99/123/007 pakketti multiplu: 1080 pillola miksija b'rita (3 fliexken ta' 360)
English: Renagel 800 mg film-coated tablets sevelamer hydrochloride
Maltese: Renagel 800 mg pilloli miksija b'rita sevelamer hydrochloride
English: 3 tablets, 3 times per day
Maltese: 3 pilloli, 3 darbiet kuljum
English: • Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
Maltese: • Renagel m'għandux jittieħed fl-istess żmien ma' ciprofloxacin (antibijotiku).
English: Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients), and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Maltese: Reazzjonijiet avversi minn dawn l-istudji (299 pazjent), minn provi kliniċi mingħajr kontrolli (384 pazjent) u li ġew irrapportati b'mod spontanju mill-esperjenza wara li l-prodott tqiegħed fis-suq huma elenkati skont il-frekwenza fit-tabella t'hawn isfel.
English: Renagel 800 mg film-coated tablets
Maltese: Renagel 800 mg pilloli miksijin b'rita
English: Not known (frequency cannot be estimated from the available data): cases of itching, rash, abdominal pain, slow intestine motility (movement), inflammation of abnormal small pouches (called diverticula) in the large intestine, blockages in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation), rupture in the intestine wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen), 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: Mhux magħrufa ( il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): każijiet ta' ħakk, raxx, motilità (moviment) bilmod tal-imsaren, sadd fl-imsaren (sinjali jinkludu: nefħa severa fl-istonku; uġigħ addominali, nefħa jew krampi; stitikezza severa), tiċrit fil-ħajt tal-musrana
English: EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Maltese: EU/1/99/123/009 pakketti multipli li fihom 360 pillola miksija b'rita (2 fliexken ta' 180 pillola) EU/1/99/123/010 pakketti multipli li fihom 540 pillola miksija b'rita (3 fliexken ta' 180 pillola)
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Maltese: Il-peritonite hija kumplikazzjoni magħrufa f' pazjenti li qed jirċievu dijalisi peritoneali u fi studju kliniku b'Renagel, għadd ta' każijiet ta' peritonite ġew rapportati.
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see section 4.8).
Maltese: nekrozi, kolite u massa kolonika/tal-musrana l-għamja -caecal) assoċjati mal-preżenza ta' kristalli ta' sevelamer (ara sezzjoni 4.8).
English: Your doctor will check for interactions between Renagel and other medicines on a regular basis.
Maltese: It-tabib tiegħek ser jiċċekkja għal interazzjonijiet bejn Renagel u mediċini oħra fuq bażi regolari.
English: Multipack: 180 (6 bottles of 30) film-coated tablets
Maltese: Pakkett multiplu: 180 (6 fliexken ta' 30) pillola miksija b'rita.
English: Each tablet contains 400 mg sevelamer hydrochloride.
Maltese: Kull pillola fih 400 mg sevelamer hydrochloride.
English: Very Common
Maltese: Mhux Komuni
English: OUTER CARTON with Blue Box - MULTIPACK OF 540 (3 BOTTLES OF 180) TABLETS 800 mg
Maltese: KARTUNA TA' BARRA bil-Kaxxa Blu - PAKKETT MULTIPLU TA' 180 (6 FLIEXKEN TA' 30) PILLOLA 800 mg
English: LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Maltese: TIKKETTA - FLIXKUN TA' 100 PILLOLA TA' 800 mg TIKKETTA - FLIXKUN TA' 180 PILLOLA TA' 800 mg BIL-KARTUNA TA' BARRA
English: EU/1/99/123/005 1 bottle of 360 film-coated tablets EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Maltese: EU/1/99/123/006 pakketti multipli li fihom 720 pillola miksija b'rita (2 fliexken ta' 360 pillola) EU/1/99/123/007 pakketti multipli li fihom 1080 pillola miksija b'rita (3 fliexken ta' 360 pillola)
English: The recommended starting dose of Renagel for adults and the elderly (>65 years) is two to four tablets with each meal 3 times a day.
Maltese: Id-doża rrakkomandata tal bidu ta' Renagel għall-adulti u dawk anzjani (>65 sena) hi ta' tnejn jew erba' pilloli ma' kull ikla 3 darbiet kuljum.
English: Starting dose of Renagel 400 mg tablets
Maltese: TA' 360) PILLOLA 400 mg
English: When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.
Maltese: Meta taqleb minn binder tal-fosfat ieħor għal Renagel, it-tabib tiegħek għandu mnejn jikkonsidra li jrid jissorvelja l-livelli ta' bikarbonat fid-demm tiegħek mill-qrib peress li Renagel jista' jnaqqas illivelli ta' bikarbonat.
English: OUTER CARTON with the Blue Box - MULTIPACK OF 720 (2 BOTTLES OF 360) TABLETS 400 mg
Maltese: KARTUNA TA' BARRA bil-Kaxxa Blu - PAKKETT MULTIPLU TA' 720 (2 FLIEXKEN
English: In preclinical studies in rats and dogs, Renagel at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
Maltese: Skont studji ta' qabel l-użu kliniku fuq firien u klieb, meta Renagel ingħata f'doża ta' 10 darbiet id dożi massimi li jingħataw lill-bnedmin, dan naqqas l-assorbiment tal-vitamini liposolubbli D, E u K, u folic acid.
English: Multipack: 360 (2 bottles of 180) film-coated tablets Multipack: 540 (3 bottles of 180) film-coated tablets.
Maltese: Pakkett multiplu: 360 (2 fliexken ta' 180) pillola miksija b'rita.
English: In patients with secondary hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Maltese: Fil-każ ta' dawk il-pazjenti li kellhom iperparatirojdiżmu sekondarju, Renagel għandu jintuża fil-kuntest ta' metodu terapewtiku multiplu, li jista' jinkludi supplimenti ta' kalċju, 1,25 - dihydroxy Vitamin D3 jew wieħed mill-analogi tiegħu biex ibaxxi l-livelli tal-iPTH.
English: Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Maltese: Renagel hu indikat għall-kontroll ta' l-iperfosfatemija f'pazjenti adulti li qed jirċievu dijalisi tad-demm jew dijalisi peritoneali.
English: As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2).
Maltese: żmien ma jistgħux ikunu kompletament esklużi (ara sezzjoni 5.2).
English: Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side.
Maltese: Il-pilloli Renagel huma miksija b'rita, offwajt u ovali li fuqhom hemm stampat Renagel 800 fuq naħa minnhom.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: RAPPREŻENTAZZJONI TA' PAKKETT MULTIPLU)
English: • In certain people taking levothyroxine (a thyroid hormone) and Renagel, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body's chemical functions) may very rarely be observed.
Maltese: Renagel kien hemm żieda fil-livelli tal-ormon li jistimula t-tirojde (TSH, sustanza fid-demm tiegħek li jgħin biex jiġu kkontrollati il-funzjonijiet kimiċi tal-ġisem tiegħek).
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets with outer carton EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton
Maltese: EU/1/99/123/011 flixkun 1 ta' 100 pillola miksija b'rita EU/1/99/123/008 flixkun 1 ta' 180 pillola miksija b'rita bil-kartuna ta' barra
English: How to store Renagel
Maltese: Kif gћandek tieћu Renagel
English: Renagel 400 mg film-coated tablets
Maltese: Renagel 400 mg pilloli miksijin b'rita
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel.
Maltese: Id-doża ta' kuljum attwali medja li ntużat fil-fażi kronika ta' studju kliniku ta' sena kien ta' 7 grammi sevelamer.
English: Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Maltese: Renagel għandu jintuża fi ħdan kuntest ta' metodu terapewtiku multiplu, li jista' jinkludi supplimenti tal-kalċju, 1,25-dihydroxy Vitamin D3 jew wieħed mill-analogi tiegħu biex jikkontrollaw l-iżvilupp tal-mard ta' l-għadam renali.
English: 1 bottle of 100 film-coated tablets
Maltese: Pillola 1, 3 darbiet kuljum
English: Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq l-kartuna u l-flixkun wara “JIS”.
English: Other medicines and Renagel
Maltese: Doża inizjali tal-pilloli Renagel
English: Package leaflet: Information for the user Renagel 800 mg film-coated tablets sevelamer hydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 800 mg sevelamer hydrochloride
English: Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Maltese: Renagel jintuża biex jiġi kkontrollat il-livell tal-fosfat fid-demm f'pazjenti adulti b'insuffiċjenza talkliewi u li qegħdin fuq kura ta' emodijalisi jew dijalisi peritoneali.
English: In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
Maltese: Fi studji kliniċi f'pazjenti li kienu qed jirċievu dijalisi tad-demm, sevelamer waħdu, biss ma kellux effett konsistenti u klinikalment sinifikanti fuq l-ormon paratirojde intatt fis-serum (iPTH).
English: It contains multiple amines separated by one carbon from the polymer backbone.
Maltese: Fih amini multipli li huma separati permezz ta' carbon wieħed mill-istruttura ċentrali tal-polimer.
English: 360 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 360 pillola miksija b'rita.
English: Renagel contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Maltese: Il-pilloli Renagel fihom sevelamer, polimer li jgħaqqad poly(allylamine hydrochloride) tal-fosfat mhux assorbit li ma fihx metall u kalċju.
English: OUTER CARTON with the Blue Box - MULTIPACK OF 1080 (3 BOTTLES OF 360) TABLETS 400 mg
Maltese: KARTUNA TA' BARRA bil-Kaxxa Blu - PAKKETT MULTIPLU TA' 1080 (3 FLIEXKEN
English: Package leaflet: Information for the user Renagel 400 mg film-coated tablets sevelamer hydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 400 mg sevelamer hydrochloride
English: 360 film-coated tablets
Maltese: 360 pillola miksija b'rita
English: Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side.
Maltese: Il-pilloli Renagel huma miksija b'rita, offwajt u ovali li fuqhom hemm stampat Renagel 400 fuq naħa minnhom.
English: 1 bottle of 360 tablets multipacks containing 720 tablets (2 bottles of 360 tablets) multipacks containing 1080 tablets (3 bottles of 360 tablets)
Maltese: Pakkett multiplu: 720 (2 fliexken ta' 360) pillola miksija b'rita Pakkett multiplu: 1080 (3 fliexken ta' 360) pillola miksija b'rita
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 body surface area.
Maltese: Studji fl-annimali wrew li sevelamer ma indebbolixxiex il-fertilità f'firien irġiel u nisa f'espożizzjonijiet li huma ekwivalenti fil bniedem għal doża ta' darbtejn id-doża massima tal-prova klinika ta' 13 g/kuljum skont il-paragunbejn is-superfiċji relattivi tal-erja tal-ġisem..
English: Talk to your doctor while taking Renagel:
Maltese: Kellem lit-tabib tiegħek waqt li qed/a tieħu Renagel:
English: By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Maltese: Sevelamer jbaxxi l-konċentrazzjoni ta' fosfat fis-serum għax jorbot fosfat fl-apparat gastrointestinali.
English: • The active substance is axitinib.
Maltese: • Is-sustanza attiva hi axitinib.
English: Elderly (≥ 65 years) and race
Maltese: Anzjani (≥ 65 sena) u razza
English: Date of latest renewal: 22 May 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 3 ta' Settembru 2012 Data tal-aħħar tiġdid: 22 ta' Mejju 2017
English: 56 tablets
Maltese: 60 pillola
English: d Cutoff date: 01 November 2011.
Maltese: Data ta' qtugħ il-linja: 01 ta' Novembru 2011.