FrancophonIA/ELRC3.0 huggingface dataset:
English: In the treatment of invasive aspergillosis, the proportion of patients responding to treatment was higher with Vfend than with amphotericin B (53% versus 31%).
Maltese: Fil-kura ta' asperġillożi invażiva, il-proporzjon ta' pazjenti li rrispondew għall-kura kien ogħla b'Vfend milli bl-amfoteriċina B (53% meta mqabbel ma' 31%).
English: • ritonavir (used to treat HIV infection) at doses of 400 mg or more twice a day;
Maltese: • ir-ritonavir (użata għall-kura tal-HIV) f'dożi ta' 400 mg u aktar darbtejn kuljum;
English: What is Vfend?
Maltese: X'inhu Vfend?
English: • serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
Maltese: • infezzjonijiet invażivi serji mill-Candida meta l-fungu jkun reżistenti għall-flukonażol (mediċina antifungali oħra);
English: The list of fungi against which Vfend is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' fungi li Vfend huwa attiv kontrihom tinstab fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: • high dose efavirenz (used to treat HIV infection).
Maltese: • l-efavirenz b'doża għolja (użata għall-kura tal-HIV).
English: In most of these (15 out of 24), the response was complete.
Maltese: F'ħafna minn dawn (15 minn 24), ir-rispons kien wieħed komplet.
English: Vfend has also been studied in the treatment of serious refractory Candida infections in 55 patients, in scedosporiosis in 38 patients, and in fusariosis in 21 patients.
Maltese: Vfend ġie studjat ukoll f'infezzjonijiet rifrattorji serji bil-Candida fuq 55 pazjent, bl-iskedosporjożi fi 38 pazjent, u bil-fużarjożi f'21 pazjent. “Rifrattorji” tfisser li l-infezzjonijiet ma kinux qed jirrispondu għallkura.
English: In the treatment of scedosporiosis and fusariosis, 28 out of 59 patients had a complete or partial response to treatment.
Maltese: Fil-kura tal-iskedosporjożi u tal-fużarjożi, 28 minn 59 pazjent kellhom rispons sħiħ jew parzjali għallkura.
English: For candidaemia, the percentage of responders to Vfend treatment at the end of therapy was the same as for the comparator (72%).
Maltese: Għal kandidaemija, il-perċentwal ta' dawk li rrispondew għall-kura b'Vfend fi tmiem it-terapija kien listess bħal dak tal-komparatur (72%).
English: It works by disrupting the formation of ergosterol, which is an important component of fungal cell membranes.
Maltese: Din taħdem billi timpedixxi l-formazzjoni tal-ergosterol, li hija parti importanti tal-membrani taċ-ċelloli fungali.
English: • serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Maltese: • infezzjonijiet fungali serji kkawżati mis-Scedosporium jew mill-Fusarium (żewġ tipi differenti ta'
English: • carbamazepine (used to treat seizures [fits]);
Maltese: • il-karbamażepina (użata għall-kura ta' attakki ta' puplesija);
English: In adults, both the loading and the maintenance doses can be given by infusion or by mouth using either the tablets or the suspension, but in children it is recommended to start treatment with the infusion and to consider switching to the suspension if an improvement is seen.
Maltese: Fl-adulti, kemm id-doża ta' tagħbija u kemm dik ta' manteniment jistgħu jingħataw b'infużjoni jew mill-ħalq permezz ta' pilloli jew ta' sospensjoni, iżda huwa rrakkomandat li t-tfal jibdew il-kura blinfużjoni u li mbagħad, jekk jidher titjib, jitqies il-qlib għas-sospensjoni.
English: How does Vfend work?
Maltese: fungu).
English: • phenobarbital (used for severe insomnia and seizures);
Maltese: • il-fenobarbital (użata għal nuqqas ta' rqad sever u attakki ta' puplesija);
English: • candidaemia (another type of fungal infection due to Candida) in patients with a normal white blood cell count;
Maltese: • kandidaemija (tip ieħor ta' infezzjoni fungali kkaġunata mill-Kandida) f'pazjenti li għandhom għadd normali ta' ċelluli bojod fid-demm;
English: • quinidine (used for irregular heart beat);
Maltese: • il-kinidina (użata għal taħbit tal-qalb irregolari);
English: Treatment was considered to be successful if a patient was able to continue treatment for 100 days after the transplantation and had not developed a fungal infection by day 180.
Maltese: Ilkura ġiet meqjusa li rnexxiet kemm-il darba pazjent seta' jkompli l-kura għal 100 ġurnata wara ttrapjant mingħajr ma jiżviluppa infezzjoni fungali sal-ġurnata 180.
English: Vfend is also used to prevent invasive fungal infections in patients who have had undergone haematopoietic (blood) stem-cell transplant (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Maltese: Vfend jintuża wkoll biex jipprevjeni infezzjonijiet fungali invażivi f'pazjenti li jkun sarilhom trapjant ta' ċelloli staminali (tad-demm) ematopojetiċi (trapjant ta' tip ta' ċelloli staminali li jistgħu jiżviluppaw f'ċelloli tad-demm) u li jkunu f'riskju għoli ta' infezzjoni.
English: A risk management plan has been developed to ensure that Vfend is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vfend jintuża bl-aktar mod sigur possibbli.
English: Vfend is used for the treatment of adults and children over the age of two years who have the following fungal infections:
Maltese: Vfend jintuża fil-kura ta' adulti u tfal ta' aktar minn sentejn li għandhom l-infezzjonijiet fungali li ġejjin:
English: When used to prevent infections in patients who have had blood stem-cell transplantation, Vfend is given on the day of the transplantation and for up to 100 days after.
Maltese: Meta jingħata biex jipprevjenti infezzjonijiet f'pazjenti li jkun sarilhom trapjant ta' ċelloli staminali taddemm, Vfend jingħata fil-ġurnata tat-trapjant u jibqa' jingħata sa 100 ġurnata wara.
English: Treatment duration should be as short as possible.
Maltese: Il-kura għandha ddum l-inqas possibbli.
English: • sirolimus (used in transplant patients);
Maltese: • is-sirolimus (użata fuq pazjenti li jkunu sarulhom trapjanti);
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vfend.
Maltese: Id-doża ta' Vfend li għandha tingħata tiddependi mill-piż tal-pazjent u skont liema formulazzjoni tal-mediċina tintuża.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: - Sadd fl-imsaren (sinjali jinkludu: nefħa kbira fl-istonku; uġigħ addominali, nefħa jew bugħawwiġijiet;
English: Digoxin, warfarin, enalapril or metoprolol
Maltese: Digoxin, warfarin, enalapril u metoprolol
English: Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford
Maltese: IDA Industrial Park Old Kilmeaden Road Waterford
English: 1105 BP Amsterdam The Netherlands
Maltese: Paasheuvelweg 25 1105 BP Amsterdam L-Olanda
English: 1 See inflammatory gastrointestinal disorders warning in section 4.4
Maltese: 1Ara twissija ta' disturbi infjammatorji gastrointestinali f'sezzjoni 4.4
English: Genzyme Europe B.V. Paasheuvelweg 25
Maltese: Genzyme Europe B.V.
English: Children and adolescents (>6 years of age and a BSA of >0.75m2):
Maltese: Tfal/adolexxenti (>6 snin ta' età u BSA ta' >0.75m2)
English: - The other ingredients are microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, iron oxide iswed (E172), isopropyl alcohol, propylene glycol u hypromellose (E464).
English: Frequency is not known.
Maltese: Frekwenza mhux magħrufa.
English: Special note for patients on peritoneal dialysis:
Maltese: Nota speċjali għal pazjenti fuq dijalisi peritoneali:
English: Crystal deposit intestine1
Maltese: kristalli fl-intestin*1
English: Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate.
Maltese: Sevelamer carbonate Winthrop fiha s-sustanza attiva sevelamer carbonate.
English: • Hypophosphataemia.
Maltese: • Ipofosfatemja
English: Method of administration:
Maltese: Trattamenti addizzjonali:
English: • severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion
Maltese: • disturbi ta' motilità gastrointestinali severi li jinkludu gastroparesi mhux ittrattata, iż-żamma tal kontenut gastriku u caqlieq irregolari tal-imsaren
English: EU/1/14/952/002 60 sachets EU/1/14/952/003 90 sachets
Maltese: EU/1/14/952/002 60 qartas EU/1/14/952/003 90 qartas
English: EU/1/14/952/001 180 film-coated tablets EU/1/14/952/004 30 film-coated tablets
Maltese: EU/1/14/952/001 180 pilloli miksija b'rita EU/1/14/952/004 30 pilloli miksija b'rita
English: The most serious adverse reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency).
Maltese: L-aktar reazzjonijiet avversi serji huma sensittività eċċessiva (frekwenza rari ħafna), ostruzzjoni intestinali (frekwenza mhux magħrufa), ileju/sottileju (frekwenza mhux magħrufa), perforazzjoni intestinali (frekwenza mhux magħrufa), disturbi infjammatorji serji assoċjati mal-presenza ta' kristalli ta' sevelamer (frekwenza mhux magħrufa).
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop.
Maltese: • L-effetti ta' mediċini bħal ciclosporin, mycophenolate mofetil u tacrolimus (mediċini użati biex irażżnu s-sistema immuni) jistgħu jkunu mnaqqsa b'Sevelamer carbonate Winthrop .
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħrufa ( il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli):
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: Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day).
Maltese: 9 g/kg/jum) u firien (0.3, 1, jew 3 g/kg/jum).
English: • major gastrointestinal tract surgery
Maltese: • intervent kirurġiku tal-passaġġ gastrointestinali maġġuri
English: Intestinal ulceration1, Gastrointestinal necrosis1, Colitis1, Intestinal mass1
Maltese: Nekrożi gastrointestinali*1, Kolite*1,
English: Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.
Maltese: Sevelamer carbonate Winthrop huwa indikat għall-kontroll ta' iperfosfatemija f'pazjenti pedjatriċi (>6 snin ta' età u erja tas-superfiċje tal-ġisem (Body Surface Area- BSA) ta' >0.75 m2) b'mard kroniku tal-kliewi.
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions.
Maltese: Sevelamer hydrochloride, li fih l-istess porzjon attiv bħal sevelamer carbonate, ingħata lil voluntieri normali b'saħħithom f'dożi sa 14-il gramma kuljum għal 8 ijiem mingħajr reazzjonijiet avversi.
English: Sevelamer carbonate Winthrop 2.4 g powder for oral suspension sevelamer carbonate
Maltese: Sevelamer carbonate Winthrop 2.4 g trab għal suspensjoni orali sevelamer carbonate
English: Sevelamer carbonate Winthrop 0.8 g powder for oral suspension sevelamer carbonate
Maltese: Sevelamer carbonate Winthrop 0.8 g trab għal suspensjoni orali sevelamer carbonate
English: Dialysis
Maltese: Dijalisi
English: • vomiting,
Maltese: • remettar,
English: • Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Sevelamer carbonate Winthrop.
Maltese: pantoprazole, jew lansoprazole,magħrufa bħala “inibituri tal-proton pump ”, jistgħu jnaqsu leffikaċja ta' Sevelamer carbonate Winthrop.
English: EU/1/14/952/001 180 film-coated tablets
Maltese: EU/1/14/952/001 180 pillola miksijin b'rita
English: Packs of 1 bottle of 30 tablets or bottles of 180 tablets without outer carton.
Maltese: Pakketti ta' flixkun 1 ta' 30 pillola jew fliexken ta' 180 pillola mingħajr il-kartuna ta' barra.
English: • Sevelamer carbonate Winthrop should not be taken at the same time as ciprofloxacin (an antibiotic).
Maltese: • Sevelamer carbonate Winthrop m'għandiex tittieħed fl-istess ħin bħal ciprofloxacin (antibijotiku).
English: • upper abdominal pain,
Maltese: Uġigħ addominali,
English: The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown.
Maltese: Il-possibbiltà ta' riskju ta' Sevelamer carbonate Winthrop waqt it-tqala umana mhijiex magħrufa.
English: Constipation can be an early symptom of serious gastrointestinal adverse reactions.
Maltese: L-istitikezza tista' tkun sintomu bikri ta' reazzjonijiet avversi serji gastrointestinali.
English: Intestinal obstruction, Ileus/subileus, Intestinal perforation1
Maltese: Sadd intestinali, Ileju/sottileju, Perforazzjoni talimsaren1,
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: Is-sintomi osservati f'każ ta' doża eċċessiva huma simili għar-reazzjonijiet avversi mniżżla f'sezzjoni 4.8, inkluż l-iżjed stitikezza u disturbi gastrointestinali magħrufa oħra.
English: Sevelamer carbonate Winthrop 800 mg film-coated tablets sevelamer carbonate
Maltese: Sevelamer carbonate Winthrop 800 mg pilloli miksija b'rita sevelamer carbonate
English: Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft rejection).
Maltese: Ciclosporin, mycophenolate mofetil u tacrolimus f'pazjenti li fuqhom sar trapjant Livelli mnaqqsa ta' ciclosporin, mycophenolate mofetil u tacrolimus ġew rapportati f'pazjenti li fuqhom sar trapjant meta ngħataw sevelamer hydrochloride ma dawn mingħajr konsegwenzi kliniċi (eż. riġetazzjoni tal-graft).
English: • Bowel obstruction.
Maltese: • disturbi biex tibla'
English: The white to off-white tablets are imprinted with “SC800” on one side.
Maltese: Pilloli bojod għal ofwajt li fuqhom hemm stampat “SC800” fuq naħa waħda.
English: Sevelamer carbonate Winthrop 800 mg film-coated tablets
Maltese: Sevelamer carbonate Winthrop 800 mg pilloli miksija b'rita
English: EU/1/14/952/004 30 film-coated tablets
Maltese: EU/1/14/952/004 30 pilloli miksija b'rita
English: Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothyroxine is recommended (see section 4.5).
Maltese: Monitoraġġ mill-qrib ta' pazjenti b'iptajrojdiżmuli jingħataw fl-istess ħin sevelamer carbonate u levothyroxine hu rakkomandat (ara sezzjoni 4.5).
English: How to store Sevelamer carbonate Winthrop
Maltese: Tiħux Sevelamer carbonate Winthrop:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 TABLETS
Maltese: KARTUNA TA' BARRA - FLIXKUN TA' 30 PILLOLA
English: Diarrhoea, Dyspepsia, Flatulence, Abdominal pain
Maltese: Dijarea, Dispepsja, Gass,
English: Date of first authorisation: 15 January 2015 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Jannar, 2015
English: Other medicines and Sevelamer carbonate Winthrop
Maltese: Mediċini oħra u Sevelamer carbonate Winthrop
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Sevelamer carbonate Winthrop.
Maltese: • Jekk qed tieħu mediċini għal problemi marbuta mat-taħbit tal-qalb jew għal epilessija, għandek tikkonsulta t-tabib tiegħek meta tieħu Sevelamer carbonate Winthrop .
English: How to take Sevelamer carbonate Winthrop 4.
Maltese: Kif għandek tieħu Sevelamer carbonate Winthrop 4.
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: Is-sigurtà u l-effikaċja ta' sevelamer carbonate ma ġewx determinati s'issa f'pazjenti adulti b'mard talkliewi kroniku li mhumiex fuq dijalisi b'livell ta; fosforu fis-serum < 1.78 mmol/l.
English: Preparation using a dosing spoon:
Maltese: Preparazzjoni bl-użu ta' kuċċarina tad-dożaġġ:
English: • slow intestine motility (movement).
Maltese: • raxx, • motilità (moviment) bilmod tal-imsaren,
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop.
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 Sevelamer carbonate Winthrop .
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 din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus > 1.78 mmol/L.
Maltese: Sevelamer carbonate Winthrop hi indikata wkoll għal kontroll ta' iperfosfatemja f'pazjenti adulti b'mard talkliewi kroniku(CKD- chronic kidney disease), mhux fuq dijalisi, b'livell ta' fosforu fis-serum ta' > 1.78 mmol/l.
English: • nausea.
Maltese: żmien.
English: Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a regular basis.
Maltese: It-tabib tiegħek ser jiċċekkja għal interazzjonijiet bejn Sevelamer carbonate Winthrop u mediċini oħra fuq bażi regolari.
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class: nausea (very common), vomiting (very common), upper abdominal pain (very common), constipation (very common), diarrhea (common), dyspepsia (common), and flatulence (common).
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti li seħħew (≥ 5% ta' pazjenti) kienu lkoll fil-klassi tas-sistema talorgani abbinata mad-disturbi gastrointestinali: nawsea (komuni ħafna), rimettar (komuni ħafna), uġigħ finnaħa ta' fuq tal-addome (komuni ħafna), stitikezza (komuni ħafna), dijarea (komuni), dispepsja (komuni) u gass fl-istonku (komuni).
English: 180 film-coated tablets
Maltese: Kull flixkun fih 30 pillola jew 180 pillola
English: Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Maltese: Bijodisponibilità Sevelamer carbonate mhijiex sustanza li tiġi assorbita u tista' taffettwa l-bijodisponibilità ta' prodotti mediċinali oħra.
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,
English: Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinicaltrial 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: Do not chew.
Maltese: F'każ ta'
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford
Maltese: Genzyme Ireland Ltd.
English: Gastrointestinal hemorrhage1, Intestinal ulceration1, Gastrointestinal necrosis1, Colitis1, Intestinal mass1
Maltese: Emorraġija gastrointestinali*1,
English: Sevelamer carbonate Winthrop 0.8 g powder for oral suspension
Maltese: Sevelamer carbonate Winthrop 0.8 g trab għal suspensjoni orali.
English: Sevelamer carbonate Winthrop 2.4 g powder for oral suspension
Maltese: Sevelamer carbonate Winthrop 2.4 g trab għal suspensjoni orali.
English: Patients who are constipated should be monitored carefully while being treated with sevelamer carbonate.
Maltese: Pazjenti li huma stitiċi għandhom ikunu monitorati b'attenzjoni waqt li jkunu qed jiġu ttrattati b'sevelamer carbonate .
English: EU/1/14/952/005 90 sachets EU/1/14/952/006 90 sachets (with dosing spoon)
Maltese: EU/1/14/952/006 90 qartas (b'kuċċarina għad-dożaġġ)
English: For children, the powder is preferred, as tablets are not appropriate for this population.
Maltese: Għat-tfal, t-trab huwa preferut, peress li l-pilloli mhumiex adatti għal din il-popolazzjoni.
English: IRELAND
Maltese: L-IRLANDA
English: 90 sachets per carton
Maltese: 90 qartas f'kull kartuna
English: • stomach ache ,
Maltese: • uġigħ fl-istonku,
English: Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer f. Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Maltese: Sevelamer carbonate Winthrop fiha sevelamer, polimer tal-fosfat li ma jiġix assorbit u li jingħaqad b'mod inkroċjat, ħieles minn metalli u kalċju.
English: Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Maltese: Sevelamer carbonate Winthrop hi indikata wkoll għal kontroll ta' iperfosfatemja f'pazjenti adulti b'mard tal kliewi kroniku (CKD) mhux fuq dijalisi b'livell ta' fosforu fis-serum ta' ≥ 1.78 mmol/l.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Intestinal obstruction and ileus/subileus
Maltese: Prodotti mediċinali kontra l-arritmija u kontra l-konvulżjonijiet
English: Drink within 30 minutes of being prepared.
Maltese: Issuspensjoni għandha tittieħed fi żmien 30 minuta minn wara li tiġi ppreparata.
English: For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet.
Maltese: Għal doża ta' 2.4 g trab għal suspenjoni orali għandu jitħallat f'60 ml ilma għal kull qartas.
English: Sevelamer carbonate Winthrop 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: Sevelamer carbonate Winthrop għandha tintuża 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.