FrancophonIA/ELRC3.0 huggingface dataset:
English: SPKRPE-EUPASS: Non-interventional PASS: In order to further characterise the safety including long-term safety of Luxturna, the applicant should conduct and submit a study based on data from a disease registry in patients vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations.
Maltese: PASS mhux ta' intervent: Sabiex tiġi kkaratterizzata aktar is-sigurtà inkluża s-sigurtà fit-tul ta' Luxturna, l-applikant għandu jwettaq u jissottometti studju bbażat fuq data minn reġistru tal-mard f'telf tal-vista tal-pazjenti minħabba distrofija tar-retina li tintiret kkawżata minn mutazzjonijiet RPE65 bijalleliċi kkonfermati.
English: 3 days prior to Luxturna administration
Maltese: Kif jingħata Luxturna
English: Post-operative
Maltese: Wara l-operazzjoni
English: Based on non-clinical studies and clinical data from trials of AAV2 vectors, and considering the subretinal route of administration of Luxturna, inadvertent germ-line transmission with AAV vectors is highly unlikely.
Maltese: Abbażi tal-istudji mhux kliniċi u data mhux klinika minn provi ta' vetturi AAV2, u filwaqt li titqies irrotta ta' amministrazzjoni taħt ir-retina ta' Luxturna, trażmissjoni fil-linja ġerminali involontarja b'vetturi AAV hija improbabbli ħafna.
English: The monocular MLMT change score significantly improved in the treatment group and was similar to the binocular MLMT results (see Table 4).
Maltese: Il-punteġġ tal-bidla MLMT monokulari tjieb b'mod sinifikanti fil-grupp ta' kura u kien simili għarriżultati tal-MLMT binokulari (ara t-Tabella 4).
English: • All materials that may have come in contact with voretigene neparvovec (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines.
Maltese: • Il-materjali kollha li ġew f'kuntatt ma' voretigene neparvovec (eż. kunjett, siringa, labra, garża tal-qoton, ingwanti, maskli jew medikaturi) għandhom jintremew skont il-linji gwida lokali għall-bijosikurezza.
English: VIAL LABEL (SOLVENT)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT (SOLVENT)
English: Unused medicinal product must be disposed of in compliance with the local biosafety guidelines.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni M'hemm l-ebda interazzjoni klinikament sinifikanti.
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a commercially available subretinal injection cannula introduced via pars plana.
Maltese: • Wara li titlesta l-vitrektomija, Luxturna jingħata permezz ta' injezzjoni taħt ir-retina bl-użu ta' kannula ta' injezzjoni taħt ir-retina disponibbli kummerċjalment li tiġi introdotta fil-pars plana.
English: 1411 DD Naarden The Netherlands
Maltese: 1411 DD Naarden L-Olanda
English: ATC code: V03AE02.
Maltese: V03AE02.
English: Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, the Netherlands
Maltese: Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, L-Olanda
English: Genzyme Ltd.
Maltese: Genzyme Ireland Ltd.
English: Changing treatment:
Maltese: Trattameti addizzjonali:
English: MedDRA System Organ Class
Maltese: Sistema talKlassifika talOrgani
English: - The active substance is sevelamer hydrochloride.
Maltese: - Is-sustanza attiva hi sevelamer hydrochloride.
English: Intestinal obstruction and ileus/subileus
Maltese: Imblukkar tal-intestini u l-ileus/subileus
English: SANOFI BULGARIA EOOD
Maltese: BULGARIA EOOD
English: Genzyme Limited 37 Hollands Road Suffolk
Maltese: Genzyme Ltd. 37 Hollands Road Suffolk
English: Serum chloride
Maltese: Chloride fis-serum
English: • Hypophosphataemia
Maltese: • Ipofosfatemija
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Maltese: Genzyme Ltd 37 Hollands Road Haverhill, Suffolk CB9 8PU Ir-Renju Unit
English: Inflammatory Gastrointestinal Disorders
Maltese: Disturbi Infjammatorji Gastrointestinali
English: - The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172) and propylene glycol.
Maltese: - Is-sustanzi l-oħra huma silica colloidal anhydrous u stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide iswed (E172) u propylene glycol.
English: Tasermity 800 mg
Maltese: 800mg
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation
Maltese: Sadd intestinali, ileju/sottileju, perforazzjoni talimsaren
English: 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: rapportaġġ hi kklassifikata bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf ( ma tistax tiġi stmata mit-tagħrif disponibbli).
English: • Hypersensitivity to sevelamer or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal sevelamer jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Hypocalcaemia/hypercalcaemia
Maltese: Ipokalċemja/Iperkalċemja
English: In clinical trials mean total and LDL cholesterol declined by 15-31%.
Maltese: Fi studji kliniċi l-livell medju tal-kolesterol tat-tip LDL u totali naqas bi 15-31%.
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
Maltese: Fil-letteratura ġew irrapportati każijiet ta' disturbi infjammatorji serji f'partijiet differenti talpassaġġ gastrointestinali (inkluż komplikazzjonijiet serji bħal fsada, perforazzjoni, ulċerazzjoni, nekrozi, kolite,...) assoċjati mal-preżenza ta' kristalli ta' sevelamer.
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis,
Maltese: • disturbi tal-motilità gastrointestinali, li jinkludu gastroparesi mhux trattata jew severa,
English: Pack size: 1 bottle of 180 tablets
Maltese: Daqs tal-pakkett: flixkun 1 ta' 180 pillola
English: • patients with a history of major gastrointestinal surgery
Maltese: • pazjenti bi storja medika ta' interventi gastrointestinali kirurġiċi.
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection).
Maltese: Livelli mnaqqsa ta' ciclosporin, mycophenolate mofetil u tacrolimus ġew irrapportati f'pazjenti bi trapjant meta ngħata sevelamer hydrochloride magħhom mingħajr konsegwenzi kliniċi (i.e. trapjant riġettat).
English: Old Kilmeaden Road
Maltese: IDA Industrial Park Old Kilmeaden Road Waterford
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).
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity.
Maltese: • L-effetti ta' mediċini bħal ciclosporin, mycophenolate mofetil u tacrolimus (mediċini użati minn pazjenti li għamlu trapjant) jista' jitnaqqas b'Tasermity.
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Maltese: L-aktar reazzjonijiet avversi li seħħew (≥ 5% ta' pazjenti) kienu lkoll disturbi gastrointestinali fis sistema tal-klassifika tal-organi.
English: 1 tablet, 3 times per day 2 tablets, 3 times per day
Maltese: 2 pilloli, 3 darbiet kuljum
English: One gram of sevelamer hydrochloride contains approximately 180 mg (5.1 mEq) chloride.
Maltese: Gramma waħda ta' sevelamer hydrochloride fih bejn wieħed u ieħor 180 mg (5.1 mEq) ta' chloride.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Maltese: TIKKETTA Bil-Kaxxa Blu - FLIXKUN 1 TA' 180 PILLOLA TA' 800 mg MINGĦAJR ILKARTUNA TA' BARRA
English: Sevelamer hydrochloride does not contain calcium.
Maltese: Sevelamer hydrochloride ma fihx kalċju.
English: Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with sevelamer at 8-20 times the maximum human dose of 200 mg/kg.
Maltese: sevelamer li kienet bejn 8 u 20 darba aktar mid-doża massima umana ta' 200 mg/kg.
English: The dose range may vary between 1 and 5 tablets of 800 mg per meal.
Maltese: Il-firxa tad-doża tista' tvarja bejn 1 u 5 pilloli ta' 800 mg ma' kull ikla.
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali stitikezza
English: Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Maltese: Skont it-teħid ta' dieta u n-natura tal-aħħar fażi ta' insuffiċjenza renali, pazjenti fuq dijalisi jistgħu jiżviluppaw livelli baxxi ta' vitamina A, D, E u K.
English: Triglycerides, HDL cholesterol and albumin did not change.
Maltese: It-trigliċeridi, il-kolesterol HDL u l-albumina baqgħu l-istess.
English: Starting dose of Sevelamer hydrochloride 800 mg tablets
Maltese: Doża inizjali ta' Sevelamer hydrochloride pilloli ta' 800 mg
English: The marketing authorisation holder shall submit the first periodic safety update report for this product with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini
English: In interaction studies in healthy volunteers, sevelamer hydrochloride had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Maltese: Fi studji ta' interazzjoni fuq voluntiera b'saħħithom, sevelamer hydrochloride ma kellux effett fuq il bijodisponibilità ta' digoxin, warfarin, enalapril jew metoprolol.
English: In 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 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) li seħħew matul l-istudji kliniċi jew li ġew irrapportati b'mod spontanju wara li lprodott tqiegħed fis-suq huma elenkati skont il-frekwenza fit-tabella t'hawn isfel.
English: Each tablet contains 800 mg sevelamer hydrochloride.
Maltese: Kull pillola fiha 800 mg sevelamer hydrochloride.
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 Tasermity.
Maltese: • Jekk qed/a tieħu mediċini bħal omeprazole, pantoprazole, jew lansoprazole għattrattament ta' ħruq ta' stonku, mard ta' refluss gastroesofagali (GERD) jew ulċeri gastriċi għandek tikkonsulta mat-tabib tiegħek meta tkun qed/a tieħu Tasermity.
English: Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Maltese: Sevelamer wera li hu kapaċi jorbot aċidi tal-bile in vitro u in vivo f'mudelli esperimentali ta'
English: • Bowel obstruction.
Maltese: • disturbi meta jibilgħu
English: Tasermity contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Maltese: Tasermity fih sevelamer, polimer li jgħaqqad poly(allylamine hydrochloride) tal-fosfat mhux assorbit li ma fihx metall u kalċju.
English: Special note for patients on peritoneal dialysis:
Maltese: Nota speċjali għal pazjenti b'dijalisi peritoneali
English: Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.8 g three times per day (2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5 mg/dl) or less.
Maltese: Il-livelli ta' fosfat fis-serum għandhom ikunu monitorjati sewwa u d-doża ta' sevelamer hydrochloride ittittrata b'żidiet ta' 0.8 g tliet darbiet kuljum (2.4 g/jum) bl-għan li l-livell tal-fosfat fis-serum jitnaqqas għal 1.76 mmol/L (5.5 mg/dl) jew inqas.
English: Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): dijarea, indiġistjoni, uġigħ addominali, stitikezza, gass.
English: In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected.
Maltese: Skont studju fil-firien, l-għoti ta‘ sevelamer fi 15-30 x id-doża umana rriżulta f'żjieda fil-livell tal copper fis-serum.
English: Anti-arrhythmics and anti-seizure medicinal products 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 antiarritmiċi u ta' kontra l-konvulżjonijiet Pazjenti li ħadu prodotti mediċinali antiarritmiċi għall-kontroll ta' arritmiji u prodotti mediċinali ta' kontra l-konvulżjonijiet għall-kontroll tad-disturb fil-konvulżjonijiet kienu esklużi mill-provi kliniċi.
English: However, in vitro and in vivo studies have indicated that sevelamer does not have genotoxic potential.
Maltese: Imma, studji in vitro u dawk in vivo indikaw li sevelamer ma għandux riskju genotossiku potenzjali.
English: The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer hydrochloride.
Maltese: kuljum li ntużat fil-fażi kronika ta' studju kliniku ta' sena kien ta' 7 grammi ta' sevelamer hydrochloride.
English: Sevelamer hydrochloride has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of seventeen 800 mg tablets, per day for eight days with no undesirable effects.
Maltese: Sevelamer hydrochloride ingħata lill-voluntieri normali b'saħħithom f'dożi sa 14-il gramma, lekwivalent għall-sbatax-il pillola ta' 800 mg kuljum għal tmint ijiem mingħajr l-ebda effetti mhux mixtieqa.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride 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' sevelamer hydrochloride fi studju ta' doża waħda.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Tasermity contains sevelamer as the active ingredient.
Maltese: Tasermity fih sevelamer bħala s-sustanza attiva.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride.
Maltese: F'każijiet rari ħafna, l-imblukkar tal-intestini u l-ileus/subileus kienu osservati f'pazjenti waqt li kienu qed jiġu kkurati b‘sevelamar hydrochloride.
English: Not known (frequency cannot be estimated from the available data): cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in the intestine wall have been reported.
Maltese: Mhux magħruf ( il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): ġew irrapportati każijiet ta' ħakk, raxx, uġigħ addominali, moviment bil-mod tal-imsaren, imblokk flimsaren, infjammazzjoni anormali ta' boroż żgħar (imsejħa divertikuli) fil-musrana l-kbira u perforazzjoni fil-ħajt intestinali.
English: CB9 8PU
Maltese: Haverhill, CB9 8PB IR-RENJU UNIT
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 clinical trials, sevelamer hydrochloride has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Maltese: Fi provi kliniċi sevelamer hydrochloride wera li jista' jkun effettiv billi jnaqqas il-fosforu fis-serum f'pazjenti li qed jirċievu emodijalisi jew dijalisi peritoneali.
English: • if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
Maltese: • jekk għandek dijarea li ddum fit-tul jew uġigħ fl-addome (sintomi ta' marda attiva infjammatorja tal-imsaren)
English: Date of first authorisation: 26 February 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Frar, 2015
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin 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 talkonċentrazzjonijiet ta' mycophenolate mofetil, ciclosporin u tacrolimus fid-demm għandu jiġi kkonsidrat waqt l-użu konġunt u wara li jitwaqqaf.
English: retention of gastric contents and abnormal or irregular bowel motion
Maltese: divertikolite, żamma tal-kontenut gastriku u ippurgar annormali jew irregolari
English: Tasermity 800 mg film-coated tablets
Maltese: Tasermity 800 mg pilloli miksijin b'rita
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with sevelamer hydrochloride, a number of peritonitis cases were reported.
Maltese: Il-peritonite hija kumplikazzjoni magħrufa f' pazjenti li qed jirċievu dijalisi peritoneali (PD) u fi studju kliniku b'sevelamer hydrochloride, għadd ta' każijiet ta' peritonite ġew rapportati.
English: The recommended starting dose of Tasermity for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.
Maltese: Tasermity għall-adulti u dawk anzjani (>65 sena) hi ta' pillola waħda jew żewġ pilloli ma' kull ikla 3 darbiet kuljum.
English: During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine.
Maltese: Matul l-esperjenza ta' wara t-tqegħid fis-suq, każijiet rari ħafna ta' żieda fil-livelli tal-ormon li jistimula t-tirojde (TSH) ġew irrapportati f'pazjenti li ngħataw sevelamer hydrochloride u levothyroxine flimkien.
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 il-pazjenti.
English: This effect is observed after 2 weeks is maintained with long-term treatment.
Maltese: 2 ġimgħat u jibqa' ikun sostnut bi trattament fit-tul.
English: Tasermity 800 mg film-coated tablets sevelamer hydrochloride
Maltese: Tasermity 800 mg pilloli miksija b'rita sevelamer hydrochloride
English: Also the medicinal product is not absorbed in the gastrointestinal tract.
Maltese: Barra minn dan, il-prodott mediċinali mhux assorbit fis-sistema gastrointestinali.
English: In animal studies there was no evidence that sevelamer induced embryo-foetal toxicity.
Maltese: Fi studju fuq annimali ma kien hemm xejn x'juri li sevelamer ikkaġuna tossiċità fl-embriju-fetu.
English: How to take Tasermity
Maltese: X'fih Tasermity
English: Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side.
Maltese: Il-pilloli offwajt, ovali għandhom “SH800” stampat fuq naħa waħda.
English: Sevelamer hydrochloride is not absorbed and may affect the bioavailability of other medicinal products.
Maltese: Sevelamer hydrochloride mhux assorbit u jista' jaffettwa l-bijodisponibilità ta' prodotti mediċinali oħra.
English: In patients with secondary hyperparathyroidism sevelamer hydrochloride 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, sevelamer hydrochloride 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: In the clinical studies in haemodialysis patients, sevelamer hydrochloride 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 hydrochloride waħdu ma kellux effett konsistenti u klinikalment sinifikanti fuq l-ormon paratirojde intatt fis-serum (iPTH).
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and levothyroxine is recommended (see section 4.5).
Maltese: Ipotajrojdiżmu Hu rakkomandat li jkun hemm monitoraġġ mill-qrib ta' pazjenti b'ipotajrojdiżmu li jingħata sevelamer hydrochloride u levothyroxine flimkien (ara sezzjoni 4.5).
English: How to store Tasermity
Maltese: Tiħux Tasermity:
English: Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported.
Maltese: Rapporti mhux komuni ta' diffikultà biex persuna tibla' l-pillola ta' sevelamer hydrochloride ġew irrappurtati.
English: In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity or teratogenicity at the doses tested (up to 1 g/kg/day in rabbits and up to 4.5 g/kg/day in rats).
Maltese: M'hemm xejn x'juri fl-istudji dwar ir-riproduzzjoni, li sevelamer iżid l-embrijoletalità, il-fetutossiċità jew it-teratoġeniċità fid-dożi ittestjati (sa 1 g/kg/kuljum fil-fniek u sa 4.5 g/kg/kuljum fil-firien).
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Maltese: Tista' tiżviluppa peritonite (infezzjoni tal fluwidu addominali tiegħek) li hi assoċjata mad-dijalisi peritoneli tiegħek.
English: The recommended starting dose of sevelamer hydrochloride is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Maltese: Id-doża rakkomandata tal-bidu ta' sevelamar hydrochloride hi ta' 2.4 g jew 4.8 g kuljum skont ilħtiġijiet kliniċi u l-livell ta' fosforu fis-serum.
English: Sevelamer hydrochloride 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: Sevelamer hydrochloride 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.