FrancophonIA/ELRC3.0 huggingface dataset:
English: Purified water Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated
Maltese: Qalba tal-pillola Ilma ppurifikat Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated
English: The least squares mean reduction from baseline to week 12 as compared to placebo was 0.16, 0.21, 0.19 and 0.37 mmol/L at 6, 9, 12 and 15 g/day respectively.
Maltese: It-tnaqqis tal-least squares mean mil-linja bażi sa ġimgħa 12 meta mqabbel mal-plaċebo kien ta' 0.16, 0.21, 0.19 u 0.37 mmol/L f'doża ta' 6, 9, 12 u 15 g/kuljum rispettivament.
English: 45 film-coated tablets 99 film-coated tablets 198 film-coated tablets 270 film-coated tablets 297 film-coated tablets
Maltese: 45 pillola miksija b'rita 99 pillola miksija b'rita 198 pillola miksija b'rita 270 pillola miksija b'rita 297 pillola miksija b'rita
English: Pharmacotherapeutic group: not yet assigned.
Maltese: Kategorija farmakoterapewtika: mhux assenjat.
English: This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus).
Maltese: pressjoni tad-demm għolja (bħal enalapril maleate), mediċini kontra l-aċċessjonijiet (bħal valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide u levetiracetam), levothyroxine (jintuża għall-kura ta' defiċjenza tal-ormoni tat-tirojde), mediċini kontraċettivi orali (oestrogen, progestogen jew pilloli kombinati), mediċini li jrażżnu lissistema immunitarja (bħal cyclosporine, mycophenolate mofetil, tacrolimus).
English: Vitamin K deficiency, calciphylaxis, electrolyte imbalance, fluid overload
Maltese: Defiċjenza ta' vitamina K, kalċifilassi, żbilanċ fl-elttroliti, ammont żejjed ta'
English: However, other effects of BindRen may affect pregnant and breast-feeding women or influence fertility, see sections 4.4 and 4.5.
Maltese: Madankollu, effetti oħrajn ta' BindRen jistgħu jaffettwaw lil nisa tqal u li jkunu qed ireddgħu jew jinfluwenzaw il-fertilità, ara sezzjonijiet 4.4 u 4.5.
English: No in vivo data are available on the possible interaction of BindRen on the absorption of the immunosuppressant medicinal products mycophenolate mofetil, ciclosporin or tacrolimus.
Maltese: L-ebda dejta in vivo mhija disponibbli dwar l-interazzjoni possibbli ta' BindRen fuq l-assorbiment tal prodotti mediċinali immunosoppressanti mycophenolate mofetil, ciclosporin jew tacrolimus.
English: Other medicines and BindRen
Maltese: Mediċini oħra u BindRen
English: Serum cholesterol
Maltese: Kolesterol fis-serum
English: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
Maltese: nefħa addominali, dardir, gastrite, dispepsija, dijarea, gass, skonfort addominali
English: Experience from clinical studies in patients above the age of 75 years is very limited.
Maltese: Esperjenza minn studji kliniċi f'pazjenti li għandhom iżjed minn 75 sena hi limitata ħafna.
English: • Seizure disorders
Maltese: • Ostruzzjoni biljari
English: Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily).
Maltese: Id-doża rakkomandata tal-bidu hi ta' 6-9 g kuljum (2-3 g tliet darbiet kuljum).
English: In subjects with baseline HbA1c ≥7.0%, colestilan showed a reduction of between 0.36 to 1.38% at week 12 in the fixed-dose study, and by 0.94 and 0.91% at week 12 in the two flexible-dose studies.
Maltese: F'individwi b'HbA1c ≥7.0% fil-linja bażi, colestilan wera tnaqqis ta' bejn 0.36 sa 1.38% f'ġimgħa 12 fl-istudju ta' doża fissa, u b'0.94 u 0.91% f'ġimgħa 12 fiż-żewġ studji ta' doża flessibbli.
English: BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.
Maltese: BindRen ma fihx calcium u t-tabib tiegħek jista' jagħtik riċetta għal pilloli addizzjonali tal-calcium.
English: They are supplied in blisters or bottles in cartons of 45, 99, 198, 270 or 297 tablets.
Maltese: Jiġu f'folji jew fliexken f'kartun ta' 45, 99, 198, 270 jew 297 pillola.
English: Caution should be exercised when treating patients with conditions which predispose to gastrointestinal haemorrhage, such as recent history of gastrointestinal haemorrhage, gastrointestinal ulcers, gastritis, diverticulosis, colitis and haemorrhoids.
Maltese: Għandu jkun hemm kawtela meta jiġu kkurati pazjenti b'kundizzjonijiet li jippredisponuhom għal emorraġija, bħal storja medika riċenti ta' emorraġija gastrointestinali, ulċeri gastrointestinali, gastrite,
English: Serum parathyroid hormone (PTH)
Maltese: Ormon paratirojde (PTH) fis-serum
English: Serum phosphorus Fixed-dose study:
Maltese: Fosfru fis-serum Studju ta' doża fissa:
English: 13.1 g. The rate of responders (either a reduction in serum phosphorus ≤ 1.78 mmol/L and/or a reduction from baseline ≥ 0.3 mmol/L) was 50.4 % and 43.8% in the two studies, respectively (placebo 30.8% and
Maltese: Irrata ta' dawk li wieġbu (jew bħala tnaqqis fil-fosfru fis-serum ≤1.78 mmol/L u/jew bħala tnaqqis mil linja bażi ≥0.3 mmol/L) kienet ta' bejn 50.4% u 43.8% fiż-żewġ studji, rispettivament (plaċebo 30.8%
English: The maximum daily dose of BindRen tested in clinical trials was 15 g per day (5 g three times daily).
Maltese: Id-doża massima ta' kuljum ta' BindRen ittestjata fil-provi kliniċi kienet ta' 15 g kuljum (5 g tliet darbiet kuljum).
English: BindRen did not induce any clinically relevant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Maltese: BindRen ma kkaġuna l-ebda tnaqqis klinikament rilevanti f'assorbiment ta' vitamini A, D, E jew K
English: Single dose interaction studies demonstrated that the bioavailability of ciprofloxacin, warfarin and enalapril were not affected when co-administered with BindRen (6-9 g/day).
Maltese: Studji dwar interazzjonijiet ta' doża waħda urew li l-bijodisponibilità ta' ciprofloxacin, warfarin u enalapril ma ġewx affettwati meta ngħataw flimkien ma' BindRen (6-9 g/kuljum).
English: • Severe hepatic impairment (see also section 4.2)
Maltese: • Indeboliment sever tal-fwied (ara wkoll sezzjoni 4.2)
English: Urticaria, rash, pruritus, dry skin
Maltese: Urtikarja, raxx, ħakk, ġilda xotta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-005
Maltese: EU/1/12/804/001-005
English: The active substance is colestilan.
Maltese: Is-sustanza attiva hi colestilan.
English: Colestilan also showed significant reductions from baseline by 35.3 and 30.1% at week 12 in two flexible-dose studies, and by 25.8% after one year in long-term studies.
Maltese: Colestilan wera wkoll tnaqqis sinifikanti mil-linja bażi b'35.3 u 30.1% f'ġimgħa 12 f'żewġ studji ta' doża flessibbli, u b'25.
English: Colestilan may also bind uric acid in the gastrointestinal tract.
Maltese: Colestilan jista' wkoll iwaħħal uric acid fil-passaġġ gastrointestinali.
English: • Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery
Maltese: diverticulum intestinali, kolite tas-sigmojd, ulċeri gastrointestinali, jew operazzjoni
English: Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with BindRen, supplementation of vitamins may be required, see section 4.4.
Maltese: Pazjenti li joħorġu tqal u fejn evalwazzjoni dwar il-benefiċċju/riskju tikkonferma kura kontinwa b'BindRen, tista' tkun meħtieġa supplementazzjoni ta' vitamini, ara sezzjoni 4.4.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mitsubishi Tanabe Pharma Europe Ltd.
Maltese: FIS-SUQ Mitsubishi Tanabe Pharma Europe Ltd.
English: The potential risk of overdosing could include adverse reactions or a worsening of adverse reactions mentioned in section 4.8.
Maltese: Ir-riskju potenzjali ta' dożaġġ eċċessiv jista' jinkludi reazzjonijiet avversi jew l-aggravament ta' reazzjonijiet avversi msemmija f'sezzjoni 4.8.
English: INFORMATION IN BRAILLE BindRen 2 g granules
Maltese: INFORMAZZJONI BIL-BRAILLE BindRen 2 g grani
English: Interaction studies have been conducted in healthy volunteers.
Maltese: Studji ta' interazzjoni twettqu f'voluntiera f'saħħithom.
English: INFORMATION IN BRAILLE BindRen 3 g granules
Maltese: INFORMAZZJONI BIL-BRAILLE BindRen 3 g grani
English: In the first study, the mean serum phosphorus level was 2.33 mmol/L at baseline and 1.96 mmol/L (mean reduction by 0.36 mmol/L) at week 12 on a colestilan mean daily dose of 11.5 g. Similarly in the second study, the mean serum phosphorus level was 2.44 mmol/L at baseline and 1.94 mmol/L at week 12 (mean reduction by 0.50 mmol/L) on a colestilan mean daily dose of
Maltese: Fl-ewwel studju, il-medja tallivell ta' fosfru fis-serum kienet ta' 2.33 mmol/L fil-linja bażi u 1.96 mmol/L (tnaqqis medju ta' 0.36 mmol/L) f'ġimgħa 12 fuq doża medja ta' kuljum ta' colestilan ta' 11.5 g.
English: White, cylindrical, film-coated granules, each approximately 3.5 mm in length and 3 mm in diameter.
Maltese: Grani miksija b'rita, bojod, ċilindriċi, kull waħda b'tul ta' madwar 3.5 mm u b'dijametru ta' 3 mm.
English: Cardiac disorders Rare:
Maltese: Disturbi fil-qalb Rari:
English: Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
Maltese: Spażmu fil-muskoli, uġigħ muskuloskeletali, artralġja, uġigħ fid-dahar,
English: Calcium-phosphorus ion product was reduced by at least 0.48 mmol2/L2 at week 12 compared to placebo at doses ≥9 g/day in fixed-dose study and by 1.05 and 0.86 mmol2/L2 at week 12 in two flexible-dose studies.
Maltese: Prodott tal-joni ta' calcium phosphorus fis-serum Il-prodott tal-joni ta' calcium phosphorus tnaqqas b'mill-inqas 0.48 mmol2/L2 f'ġimgħa 12 meta mqabbel mal-plaċebo f'dożi ta' ≥9 g/kuljum fi studju ta' doża fissa, u b'1.05 u 0.86 mmol2/L2
English: High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.
Maltese: Fliexken ta' densità għolja tal-polyethylene (HDPE), b'għatu tal-polypropylene u siġill tal-induzzjoni.
English: In a double-blind, 12-week fixed-dose study with five colestilan groups (3, 6, 9, 12 and 15 g/day) and placebo, colestilan at 6 g/day and above demonstrated a dose-dependent reduction in serum phosphorus level.
Maltese: (3, 6, 9, 12 u 15 g/kuljum) u plaċebo, colestilan f'doża ta' 6 g/kuljum u aktar, wera tnaqqis li kien jiddependi mid-doża fil-livell ta' fosfru fis-serum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/014-016
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/804/014-016
English: BindRen is not absorbed and is not systemically available.
Maltese: BindRen ma jiġix assorbit u mhuwiex disponibbli b'mod sistematiku.
English: Coronary artery disease
Maltese: Mard tal-arterja koronarja
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules colestilan
Maltese: TAL-PRODOTT MEDIĊINALI BindRen 2 g grani colestilan
English: How to take BindRen
Maltese: X'fih BindRen
English: Colestilan was also associated in dose-dependent reduction in serum uric acid, with a mean reduction of 43 micromol/L after one year of treatment.
Maltese: Colestilan ġie assoċjat ukoll ma' tnaqqis li jiddependi fuq id-doża fil-uric acid fis-serum, bi tnaqqis medju ta' 43 micromol/L wara sena ta' kura.
English: Patients previously on other phosphate binders who are switched to BindRen should start taking 6-9 g per day (2-3 g three times daily).
Maltese: Pazjenti li fil-passat kienu fuq phosphate binders oħrajn li jinqalbu għal BindRen għandhom jibdew jieħdu 6-9 g kuljum (2-3 g tliet darbiet kuljum).
English: However, BindRen did not induce any clinically relevant change in chloride and bicarbonate on treatment for up to one year.
Maltese: Madankollu, BindRen ma induċa l-ebda bidla klinikament rilevanti fi chloride u bicarbonate f'kura li damet sa sena.
English: BindRen tablets are white oval shaped film-coated tablets printed with “BINDREN” in blue ink on one side.
Maltese: Il-pilloli BindRen huma bojod, b'forma ovali, miksija b'rita, stampati bi “BINDREN” b'linka blu fuq naħa waħda.
English: Interactions have not been studied at doses >9 g daily, and greater interaction effects at higher doses of BindRen cannot be excluded.
Maltese: L-interazzjonijiet ma ġewx studjati f'dożi ta' >9 g kuljum, u effetti akbar tal-interazzjonijiet f'dożi ogħla ta' BindRen ma jistgħux jiġu esklużi.
English: Serum phosphorus
Maltese: Kalċju fis-serum
English: Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): pressjoni tad-demm baxxa, dgħufija, għatx, uġigħ ta' ras, sturdament, rogħda, ħalq xott, diffikultajiet biex tibla', tibdil fis sens tat-togħma, qrusa fl-istonku, l-ippurgar isir iebes, infjammazzjoni jew uġigħ fl-istonku jew flimsaren, tibdil fil-mod kif tipporga, ma tkunx tista' torqod, ħakk, ġilda xotta, raxx, ħorriqija, tikek ħomor bil-ħakk, akkumulazzjoni ta' demm (ematoma), pereżempju taħt il-ġilda, uġigħ fil-ġogi, uġigħ fid-dahar, uġigħ fir-riġlejn/dirgħajn. uġigħ jew spażmi fil-muskoli, żieda fil-livelli tal-ormon paratirojde (proteina), ċerti xaħmijiet fid-demm u enzimi tal-fwied u livell baxx ta' folate (vitamina).
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules
Maltese: IL-PRODOTT MEDIĊINALI BindRen 2 g grani
English: If an acceptable serum phosphorus concentration is not achieved, the dose may be increased by 3 g per day (1 g three times daily) in 2-3 weekly intervals.
Maltese: Jekk ma tinkisibx konċentrazzjoni aċċettabli ta' fosfru fis-serum, id-doża tista' tiżdied bi 3 g kuljum (1 g tliet darbiet kuljum) fi 2-3 intervalli ta' ġimgħa.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/011-013
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/804/011-013
English: Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
Maltese: Emorraġija gastrointestinali, esofagite, feċaloma, disfaġija, tibdil fil-mod kif wieħed jipporga, ħalq xott
English: Hyperparathyroidism
Maltese: Disturbi psikjatriċi
English: *A single case with a fatal outcome
Maltese: *Kien hemm każ wieħed b'riżultat fatali
English: ATC code: not yet assigned.
Maltese: Kodiċi ATC: mhux assenjat BindRen fih colestilan.
English: The safety and efficacy of BindRen in children and adolescents aged under 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' BindRen fit-tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Dose titration
Maltese: Titrazzjoni tad-doża
English: However, decreased blood concentrations have been reported for medicinal products with a similar mechanism of action to BindRen.
Maltese: Madankollu, tnaqqis fil-konċentrazzjonijiet fid-demm ġew irrapportati għal prodotti mediċinali b'mekkaniżmu ta' azzjoni simili għal BindRen.
English: Granule core
Maltese: FEJN MA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/006-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/804/006-010
English: Film-coating
Maltese: - aċċessjonijiet
English: Severe hepatic impairment
Maltese: Infezzjonijiet u infestazzjonijiet
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/804/001-010
English: After one year, the mean serum phosphorus level was 1.89 mmol/L with a significant reduction from baseline of 0.39 mmol/L and responder rate (phosphorus level <1.78 mmol/L) was 44%.
Maltese: Wara sena, il-medja tal-livell ta' fosfru fis-serum kienet ta' 1.89 mmol/L bi tnaqqis sinifikanti mil-linja bażi ta' 0.39 mmol/L u r-rata responder (livell ta' fosfru ta' <1.78 mmol/L) kienet ta' 44%.
English: Folate deficiency, hypertriglyceridaemia, polydipsia
Maltese: Defiċjenza ta' folate, ipertrigliċeridemija,
English: Pregnancy
Maltese: Ipotirojdiżmu
English: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence,
Maltese: Stitikezza, uġigħ addominali, rimettar, nefħa addominali, dardir, gastrite,
English: • Recent history of peritonitis in peritoneal dialysis patients
Maltese: • Disturbi ta' aċċessjonijiet • Storja medika riċenti ta' peritonite f'pazjenti b'dijaliżi peritoneali
English: BATCH NUMBER
Maltese: NUMRU(I)
English: Two similar 12-week, open-label, flexible-dose studies followed by a 4-week double-blind withdrawal period (comparison to placebo) were performed.
Maltese: Studji dwar doża flessibbli: Twettqu żewġ studji simili open label dwar doża flessibbli, li damu 12-il ġimgħa, segwiti minn perjodu ta' rtirar double-blind ta' 4 ġimgħat (paragun mal-plaċebo).
English: • Serum albumin <30 g/L
Maltese: • Livell ta' albumina fis-serum ta' <30 g/L Għalhekk, l-użu ta' BindRen mhuwiex rakkomandat f'pazjenti b'dawn id-disturbi.
English: Nervous system disorders Uncommon:
Maltese: Disturbi fis-sistema nervuża
English: BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Maltese: Indeboliment tal-kliewi BindRen hu indikat għall-użu f'pazjenti b'Mard Kroniku tal-Kliewi (CKD) ta' Stadju 5 li jkunu qed jirċievu emodijaliżi jew dijaliżi peritoneali.
English: The following side effects have also been seen in patients taking BindRen:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Mhux komuni:
English: White, oval shaped, film-coated tablet approximately 20.2 mm in length and 10.7 mm wide printed with “BINDREN” (in blue ink) on one side.
Maltese: Pillola miksija b'rita, bajda, b'forma ovali, b'tul ta' madwar 20.2 mm u wisa' ta' 10.7 mm stampata bi
English: Close monitoring of patients with hypothyroidism is recommended when levothyroxine is co-administered with BindRen (see section 4.5).
Maltese: Ipotirojdiżmu Monitoraġġ mill-qrib ta' pazjenti b'ipotirojdiżmu hu rakkomandat meta levothyroxine jingħata flimkien ma' BindRen (ara sezzjoni 4.5).
English: Hepatic enzymes increased
Maltese: Disturbi fis-sistema endokrinarja
English: NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules colestilan
Maltese: BindRen 3 g grani colestilan
English: Asthenia
Maltese: polidipsija
English: The recommended starting dose is 6-9 g per day taken as 2 g or 3 g three times per day with meals.
Maltese: Id-doża rakkomandata tal-bidu hija 6-9 g kuljum li tittieħed bħala 2 g jew 3 g tliet darbiet kuljum mal ikel.
English: Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you: - you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).
Maltese: - ikollok stitikezza, għax it-tabib tiegħek jista' jkun irid jimmonitorja l-funzjoni tal-imsaren tiegħek biex josserva effetti sekondarji potenzjali (ara sezzjoni 4).
English: • Bowel obstruction.
Maltese: - problemi biex tibla'
English: Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): ostruzzjoni fl-imsaren, livell baxx ta' vitamina K, ostruzzjoni tal-vini/arterji tad-demm li jipprovdu provvista tad-demm lillmuskolu tal-qalb u nefħa fl-għekiesi jew fl-estremitajiet.
English: Bottles
Maltese: fluwidu
English: Serum calcium-phosphorus ion product
Maltese: Dwar livelli għoljin ta' phosphorus fid-demm (iperfosfatemija)
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Maltese: frekwenza, ir-reazzjonijiet avversi huma kklassifikati f'ordni ta' severità dejjem tonqos.
English: - swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity
Maltese: - problemi severi fl-istonku jew biex tipporga, bħal stitikezza, ulċeri fl-istonku jew fl-imsaren jew murliti, għax dawn il-problemi jistgħu jwasslu għal żieda fir-riskju ta', pereżempju, ħruġ ta'
English: BindRen 1 g film-coated tablets colestilan
Maltese: BindRen 1 g pilloli miksija b'rita colestilan
English: BindRen binds phosphate and bile acid, with the release of chloride which is available for systemic absorption.
Maltese: BindRen iwaħħal phosphate u aċidu tal-bila, bil-ħruġ ta' chloride li hu disponibbli għal assorbiment sistemiku.
English: Patients received doses of up to 15 g per day, in three divided doses of 5 g.
Maltese: Ilpazjenti rċievew dożi sa 15 g kuljum, fi tliet dożi maqsumin ta' 5 g.
English: BindRen granules are white cylindrical granules.
Maltese: Il-grani BindRen huma grani bojod ċilindriċi.
English: Haematoma, hypotension
Maltese: Ematoma, pressjoni baxxa
English: Patients with seizure disorders were excluded from clinical trials with BindRen.
Maltese: Pazjenti b'disturbi ta' aċċessjoni ġew esklużi mill-provi kliniċi b'BindRen.
English: Talk to your doctor or pharmacist before taking BindRen if you are suffering from any of the following problems, since this medicine may not be right for you: - swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity
Maltese: Meta tagħti kwalunkwe prodott mediċinali fejn tnaqqis fil-bijodisponibilità jista' jkollu effett klinikament rilevanti fuq is-sigurtà jew l effikaċja, il-prodott mediċinali għandu jingħata mill-inqas siegħa qabel, jew 3 sigħat wara li jittieħed BindRen.
English: Approximately 30% of patients experienced at least one adverse reaction.
Maltese: Madwar 30% tal-pazjenti kellhom mill-inqas reazzjoni avversa waħda.
English: The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population.
Maltese: II u III li kienu jinvolvu 1,410 pazjenti b'CKD ta' Stadju 5 fuq id-dijaliżi kkurati b'BindRen għal mhux aktar minn sena, kienu jikkostitwixxu l-popolazzjoni tas-sigurtà.
English: Breast-feeding
Maltese: Il-Ġermanja
English: These were considered to result from a deficiency of vitamin K following a reduction in the absorption of fat-soluble vitamins (see section 4.4).
Maltese: Dawn kienu kkunsidrati li rriżultaw minn nuqqas ta' vitamina K wara tnaqqis fl-assorbiment ta' vitamini li jinħallu fix-xaħam (ara sezzjoni 4.4).