FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati b'HIV li għandhom defiċjenza immunitarja serja fiż-żmien li tinbeda t-terapija antiretrovirali kkombinata (CART), jista' jkun hemm reazzjoni infjammatorja għal infezzjonijiet asintomatiċi jew opportunistiċi residwali.
English: Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Maltese: Saquinavir/ritonavir u Nevirapine
English: Nevirapine Teva 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Maltese: Tfal kbar, speċjalment adoloxxenti, li għandhom anqas minn 16-il sena, u jiżnu 50 kg jew li l-erja superfiċjali ta' ġisimhom hija aktar minn 1.25 m2 , skont l-iskeda tad-dożaġġ mogħtija deskritta hawn fuq jistgħu jingħataw pilloli ta' Nevirapine Teva ta' 200 mg kif spjegat hawn fuq.
English: You must take Nevirapine Teva together with other antiretroviral medicines.
Maltese: Inti għandek tieħu Nevirapine Teva flimkien ma' mediċini antiretrovirali oħra.
English: Post-Exposure-Prophylaxis: Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of nevirapine in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Maltese: Twissijiet oħra Profilassi ta' wara l-espożizzjoni: epatotossiċità serja, li tinkludi insuffiċjenza tal-fwied li tkun teħtieġ trapjant, ġiet irrapportata f'individwi mhux infettati b'HIV li qed jingħataw dożi multipli ta' nevirapine bħala profilassi ta' wara l-espożizzjoni (PEP), f'użu mhux approvat.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Maltese: Irriżultat kliniku ta' dan it-tnaqqis osservat tal-inqas livelli tal konċentrazzjonijiet ta' boceprevir ma ġiex evalwat direttament.
English: EE Cmin ND
Maltese: Ġeneru Sesswali u persuni aktar anzjani
English: Recommendations concerning co-administration
Maltese: IMPEDITURI TA' INTEGRASE
English: Nevirapine Teva administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Maltese: Meta Nevirapine Teva jingħata f'dożi ogħla minn dawk irrakkomandati jista' jwassal għal żieda fil-frekwenza u l-gravità tar-reazzjonijiet fil-ġilda, bħas-sindromu Stevens-Johnson u nekroliżi epidermali tossika.
English: Weight and metabolic parameters:
Maltese: Metaboliti ta' nevirapine:
English: Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Maltese: Punti ta' riferiment prinċipali tal-istudju (perċentwali ta' pazjenti b'falliment fit-kura) u punti ta' riferiment sekondarji tal-istudju kif ukoll t-terapija fl-isfond kienu simili għall-istudju oriġinali 2NN.
English: Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Maltese: Ġew irrapportati wkoll każijiet fatali ta' SJS, TEN u reazzjoni minħabba l-mediċina b'esinofilja u sintomi sistemiċi reazzjonijiet ipersensittivi.
English: It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.
Maltese: Ġeneralment m'għandekx tredda' jekk int infettata b'HIV għax hu possibbli li t-tarbija tiegħek tista' tiġi infettata b'HIV permezz tal ħalib tas-sider.
English: Methadone Individual Patient Dosing
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: The most frequently reported adverse reactions related to nevirapine therapy, across all clinical studies, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
Maltese: L-aktar reazzjonijiet avversi rapportati ta' spiss waqt l-istudji kliniċi kollha li saru b'nevirapine, kienu: raxx, reazzjonijiet allerġiċi, epatite, testijiet anormali tal-funzjonament tal-fwied, dardir, remettar,
English: General disorders and administration site conditions Common pyrexia, fatigue
Maltese: It-dejta limitata disponibbli minn studju ta' fażi
English: Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN.
Maltese: Pazjenti li għandhom indeboliment serju tal-fwied (Child-Pugh C), jew 'l ASAT jew ALAT > 5
English: Reverse transcriptase is an enzyme that HIV needs in order to multiply.
Maltese: Reverse transcriptase hi enzima li l-HIV jeħtieġ biex jimmultiplika.
English: - if you have taken Nevirapine Teva before and had to stop the treatment because you suffered from: - severe skin rash - skin rash with other symptoms for example: - fever - blistering - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath
Maltese: - jekk kont tieħu Nevirapine Teva u kellek twaqqaf it-trattament minħabba li kien ikollok: - raxx tal-ġilda sever - raxx tal-ġilda u sintomi oħra bħal pereżempju
English: They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue nevirapine and immediately seek medical evaluation, which should include liver function tests.
Maltese: Għandhom ikunu wkoll infurmati li jekk jiżviluppaw sintomi ta' epatite, dan għandu jwassalhom biex iwaqqfu nevirapine minnufih u ifittxu għal evalwazzjoni medika, li għandha tinkludi testijiet dwar il-funzjonament tal fwied.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: L-assorbiment ta' nevirapine mhuwiex affettwat bl-ikel, antaċidi jew prodotti mediċinali li huma fformulati b'sustanza ta' bafer alkalina.
English: The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
Maltese: immunodefiċjenza miksub, jew żieda fil-livelli tal-RNA tal-HIV-1 għal 200 kopja jew aktar f'kull millilitru.
English: Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Maltese: l-espożizzjoni għal metabolit 14-OH
English: Biotransformation and elimination: In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites.
Maltese: Studji fil-bniedem in vitro kif ukoll fil-laboratorju fuq mikrożomi tal-fwied tal-bniedem urew li nevirapine jiġi mibdul f'diversi metaboliti idrossilati,
English: Lactose: Nevirapine Teva tablets contain 336 mg of lactose per maximum recommended daily dose.
Maltese: Il-pilloli Nevirapine Teva fihom 336 mg ta' lattosju għal kull doża massima rrakkomandata ta' kuljum.
English: Combination therapy with nevirapine is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Maltese: Terapija kkombinata li fiha nevirapine mhix kura fejjieda fuq pazjenti infettati b'HIV-1;
English: Titration and maintenance
Maltese: Titrazzjoni u manteniment
English: Diarrhoea occurred in 11.6% of patients in clinical trials.
Maltese: Id­dijarea seħħet fi 11.6% tal-pazjenti fil-provi kliniċi.
English: Table 1 Adverse reactions detected in clinical trials System Organ Class
Maltese: Tabella 1 Reazzjonijiet avversi osservati fil-provi kliniċi Sistema tal-Klassifika tal-Organi
English: In vitro studies with the following active substances did not show any relevant interaction: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone and quinidine.
Maltese: Studji in vitro bis-sustanzi attivi li ġejjin ma wrew l­ebda interazzjoni rilevanti: acetylsalicylic acid, cephalexin, cinacalcet, ciprofloxacin, clopidogrel, enalapril, hydrochlorothiazide, metformin, metoprolol, nifedipine, pioglitazone u quinidine.
English: INFORMATION IN BRAILLE velphoro
Maltese: INFORMAZZJONI BIL-BRAILLE velphoro
English: EU/1/14/943/002 90 chewable tablets
Maltese: EU/1/14/943/002 90 pillola li tomgħodhom
English: Do not take Velphoro:
Maltese: Tiħux Velphoro:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 August 2014
Maltese: DATA TAL­EWWEL AWTORIZZAZZJONI/TIĠDID TAL­AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Awissu 2014
English: 92042 Paris la Défense Cedex France
Maltese: 92042 Paris la Défense Cedex Franza
English: Neohesperidin-dihydrochalcone Magnesium stearate
Maltese: Neohesperidin-dihydrochalcone
English: Elderly population (≥65 years of age)
Maltese: Popolazzjoni ġerjatrika (≥65 sena)
English: The active moiety of Velphoro, pn-FeOOH, is not metabolised.
Maltese: Il­parti attiva ta' Velphoro, pn­FeOOH, ma tiġix metabolizzata.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Maltese: Ir-rata ta' rappurtar hija kklassifikata bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100).
English: The response rates, defined as the proportion of subjects achieving serum phosphorus levels within the KDOQI (Kidney Disease Outcomes Quality Initiative) recommended range were 45.3% and 59.1% at week 12 and 51.9% and 55.2% at week 52, for Velphoro and sevelamer carbonate, respectively.
Maltese: Ir­rati ta' rispons, definiti bħala l­proporzjon ta' individwi li kisbu livelli ta' phosphorus fis-serum filmedda rakkomandata ta' KDOQI (Kidney Disease Outcomes Quality Initiative) kienu 45.3% u 59.1% f'ġimgħa 12 u 51.9% u 55.2% f'ġimgħa 52, għal Velphoro u sevelamer carbonate, rispettivament.
English: In healthy subjects, the median uptake of radiolabelled iron in the blood was estimated to be 0.43% (range 0.16 - 1.25%) on Day 21, in pre-dialysis patients 0.06% (range 0.008 - 0.44%) and in haemodialysis patients 0.02% (range 0 - 0.04%).
Maltese: F'individwi b'saħħithom, il­medjan tal-assorbiment ta' ħadid radjutikkettat fid-demm kien stmat li hu ta' 0.43% (medda 0.16-1.25%) f'Jum 21, f'pazjenti qabel id­dijalisi 0.06% (medda 0.008-0.44%) u f'pazjenti fuq l­emodijalisi 0.02% (medda 0-0.04%).
English: Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 and over, while 8.7% were aged 75 and over.
Maltese: Min-numru totali ta' individwi fl­istudji kliniċi ta' Velphoro, 29.7% kellhom 65 sena jew aktar, filwaqt li 8.7% kellhom 75 sena jew aktar.
English: Each tablet also contains 750 mg sucrose and 700 mg starches.
Maltese: Kull pillola fiha wkoll 750 mg sucrose u 700 mg starches.
English: - The other ingredients are woodberry flavour, neohesperidin-dihydrochalcone, magnesium stearate, colloidal anhydrous silica.
Maltese: - Is­sustanzi mhux attivi l­oħra huma togħma ta' woodberry, neohesperidin-dihydrochalcone, magnesium stearate, colloidal anhydrous silica.
English: Tablets have a 20 mm diameter and a thickness of 6.5 mm.
Maltese: Il­pilloli għandhom dijametru ta' 20 mm u ħxuna ta' 6.5 mm.
English: Hypercalcaemia Hypocalcaemia
Maltese: Iperkalċemija Ipokalċemija
English: Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches.
Maltese: Velphoro fih taħlita ta' polynuclear iron(III)-oxyhydroxide (pn­FeOOH), sucrose u starches.
English: The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch) per tablet.
Maltese: Is-sustanza attiva sucroferric oxyhydroxide fiha 750 mg ta' sucrose u 700 mg ta' starches (starch talpatata u starch tal-qamħirrun ġelatinizzat minn qabel) f'kull pillola.
English: Velphoro is almost not absorbed from the gastrointestinal tract.
Maltese: Velphoro kważi ma jiġix assorbit mill-apparat gastrointestinali.
English: The iron uptake from radiolabelled Velphoro drug substance, 2,000 mg iron in 1 day was investigated in 16 CKD patients (8 pre-dialysis and 8 haemodialysis patients) and 8 healthy volunteers with low iron stores (serum ferritin <100 mcg/L).
Maltese: L­assorbiment ta' ħadid mis-sustanza mediċinali Velphoro radjutikkettat, 2,000 mg ta' ħadid f'jum wieħed, ġie investigat f'16­il pazjent b'CKD (8 pazjenti qabel id­dijalisi u 8 b'emodijalisi) u f'8 voluntiera b'saħħithom b'ħażna baxxa ta' ħadid (serum ferritin ta' <100 mcg/L).
English: The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet been established.
Maltese: Is­sigurtà u l­effikaċja ta' Velphoro fi tfal u adolexxenti li għandhom inqas minn 18­il sena għadhom ma ġewx determinati s'issa.
English: In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2 - 4-week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg iron/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
Maltese: Fi Studju­05A, 1,055 pazjent fuq l­emodijalisi (N=968) jew dijalisi peritoneali (N=87) b'phosphorus fis-serum ta' ≥1.94 mmol/L wara perjodu ta' 2 - 4 ġimgħat ta' phosphate binder washout, intgħażlu b'mod każwali u ġew ikkurati jew b'Velphoro, b'doża tal-bidu ta' 1,000 mg ta' ħadid/jum (N=707), jew kontroll attiv (sevelamer carbonate, N=348) għal 24 ġimgħa.
English: They have been conducted in healthy human male and female subjects with losartan, furosemide, digoxin, warfarin, and omeprazole.
Maltese: Dawn twettqu fuq individwi umani rġiel u nisa b'saħħithom b'losartan, furosemide, digoxin, warfarin, u omeprazole.
English: In vitro data suggest that the sucrose and starch components of the drug substance can be digested to glucose and fructose, and maltose and glucose, respectively.
Maltese: Dejta in vitro tissuġġerixxi li l­komponenti tas-sucrose u starch tas-sustanza mediċinali jistgħu jiġu ddiġeriti għal glucose u fructose, u għal maltose u glucose, rispettivament.
English: - Peel back the paper foil at the corner.
Maltese: - Qaxxar il­paper foil fil-kantuniera.
English: Following completion of Study-05A, 658 patients (597 on hemodialysis and 61 on peritoneal dialysis) were treated in the 28-week extension study (Study-05B) with either Velphoro (N=391) or sevelamer carbonate (N=267) according to their original randomization.
Maltese: Wara li tlesta Studju­05A, 658 pazjent (597 fuq l­emodijalisi u 61 fuq dijalisi peritoneali) ġew ikkurati fl­istudju ta' estensjoni ta' 28 ġimgħa (Studju­05B) jew b'Velphoro (N=391) jew b'sevelamer carbonate (N=267) skont kif kienu ntgħażlu b'mod każwali oriġinarjament.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vifor Fresenius Medical Care Renal Pharma France
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Vifor Fresenius Medical Care Renal Pharma Franza
English: Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Maltese: Il­livelli ta' Vitamina D u ta' Vitamina 1,25­dihydroxy baqgħu mhux mibdula.
English: Colloidal anhydrous silica 6.2 Incompatibilities
Maltese: Colloidal anhydrous silica
English: Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Maltese: Daqsijiet tal-pakkett ta' 30 × 1 jew pakkett multiplu ta' 90 (3 pakketti ta' 30 × 1)pillola li tomgħodhom.
English: Other reproduction toxicity studies showed no adverse effects.
Maltese: Studji oħra dwar it­tossiċità fir-riproduzzjoni ma wrew l­ebda effetti avversi.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) chewable tablets.
Maltese: U KONTENUT Pakkett multiplu: 90 (3 pakketti ta' 30) pillola li tomgħodhom.
English: The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
Maltese: Id­doża massima rakkomandata hi ta' 3,000 mg ta' ħadid (6 pilloli) kuljum.
English: Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Maltese: Velphoro huwa indikat għall-kontroll tal-livelli ta' phosphorus fis-serum f'pazjenti adulti b'mard kroniku tal-kliewi (CKD) li jkunu fuq l­emodijalisi (HD) jew dijalisi peritoneali (PD).
English: Serum phosphorus levels and calcium-phosphorus product levels were reduced as a consequence of the reduced dietary phosphate absorption.
Maltese: Il­livelli ta' phosphorous fis-serum u l­livelli tal-prodott ta' calcium-phosphorus tnaqqsu bħala konsegwenza tat-tnaqqis fl­assorbiment talphosphate dijetiku.
English: Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved dosing regimen.
Maltese: Velphoro ngħata lil aktar minn 248 anzjan (li kellhom ≥65 sena) skont il­kors ta' dożaġġ approvat.
English: 90 chewable tablets
Maltese: 90 pillola li tomgħodhom
English: The serum phosphorus reduction was maintained over 55 weeks.
Maltese: It­tnaqqis ta' phosphorous fis-serum inżamm matul il­55 ġimgħa.
English: See leaflet for furher information.
Maltese: Aqra l­fuljett ta' tagħrif għal aktar informazzjoni.
English: Velphoro contains potato starch and pregelatinised maize starch.
Maltese: Velphoro fih starch tal-patata u starch tal-qamħirrun ġelatinizzat minn qabel.
English: Due to the insolubility and degradation characteristics of Velphoro, no classical pharmacokinetic studies can be carried out, e.g., determination of the distribution volume, area under the curve, mean residence time, etc.
Maltese: Minħabba l­karattersitiċi ta' insolubilità u ta' degradazzjoni ta' Velphoro, ma jistgħu jsiru l­ebda studji farmakokinetiċi klassiċi, eż., id­determinazzjoni tal-volum ta' distribuzzjoni, l­erja taħt il­kurva, il­ħin medju ta' residenza, eċċ.
English: Uncommon (may affect up to 1 in 100 people): bloating (abdominal distension), inflammation of the stomach, abdominal discomfort, difficulty swallowing, acid coming back up from the stomach (gastrooesophageal reflux disease), tongue discolouration, low or high calcium levels in the blood seen in tests, tiredness, itch, rash, headache, shortness of breath.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): nefħa fiż-żaqq, infjammazzjoni talistonku, skumdità fiż-żaqq, diffikultà biex tibla, aċidu li jitla' mill-istonku (mard tar-rifluss gastroesofagali), tibdil fil-kulur tal-ilsien, livelli għoljin jew baxxi ta' calcium fid-demm osservati fittestijiet, għeja, ħakk, raxx, uġigħ ta' ras, qtugħ ta' nifs.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: DIKJARAZZJONI TAS­SUSTANZA(I) ATTIVA(I)
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il­benefiċċju u r­riskju tal-prodott mediċinali.
English: Velphoro does not affect guaiac based (Haemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests.
Maltese: Velphoro ma jaffettwax it­testijiet li juru hemmx demm moħbi fl­ippurgar, ibbażati fuq guaiac (Haemoccult) jew l­immunoloġija (iColo Rectal u Hexagon Obti).
English: Treatment of patient sub-populations from week 24 to week 27 with maintenance dose of Velphoro (1,000 to 3,000 mg iron/day) or low dose (250 mg iron/day) of Velphoro demonstrated superiority of the maintenance dose.
Maltese: Kura ta' sottopopolazzjonjiet ta' pazjenti minn ġimgħa 24 sa ġimgħa 27 b'doża ta' manteniment ta' Velphoro (1,000 sa 3,000 mg ta' ħadid/kuljum) jew doża baxxa (250 mg ta' ħadid/jum) ta' Velphoro, uriet is­superjorità tad-doża ta' manteniment.
English: No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
Maltese: Ma ġew osservati l-ebda tendenzi dipendenti fuq id-doża fil-profil tarreazzjonijiet avversi ta' Velphoro.
English: Abdominal distension Gastritis Abdominal discomfort Dysphagia Gastro-oesophageal reflux disease (GORD) Tongue discolouration
Maltese: Nefħa addominali Gastrite Skonfort addominali Disfaġija Mard tar-rifluss gastroesofagali (GORD) Tibdil fil-kulur tal-ilsien
English: The chewable tablets are brown, circular, and embossed with PA500 on one side.
Maltese: Il­pilloli li tomgħodhom huma kannella, tondi, u mnaqqxa b'PA500 fuq naħa waħda.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il­mediċina tinsab fuq is­sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L).
Maltese: Il­livelli ta' phosphorous fis-serum kienu ta' 2.5mmol/L fil-linja bażi u ta' 1.8 mmol/L f'ġimgħa 12 għal Velphoro (tnaqqis b' 0.7 mmol/L). Livelli korrispondenti għal sevelamer carbonate fil-linja bażi kienu ta' 2.4 mmol/L u ta' 1.7 mmol/L f'ġimgħa 12 (tnaqqis ta' 0.7 mmol/L), rispettivament.
English: - Push the tablet through the aluminium foil.
Maltese: - Imbotta l­pillola minn ġol-foil tal-aluminju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Maltese: Kull pillola li tomgħodha fiha 500 mg ta' ħadid bħala sucroferric oxyhydroxide magħruf ukoll bħala taħlita ta' polynuclear iron(III)-oxyhydroxide, sucrose, u starches.
English: PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 × 1 pillola li jintmagħdu
English: The mean daily dose of Velphoro over 55 weeks of treatment was 1,650 mg iron and the mean daily dose of sevelamer carbonate was 6,960 mg.
Maltese: Id­doża medja ta' kuljum ta' Velphoro matul il­55 ġimgħa ta' kura kienet ta' 1,650 mg ta' ħadid u d­doża medja ta' kuljum ta' sevelamer carbonate kienet ta' 6,960mg.
English: Other medicines and Velphoro
Maltese: Mediċini oħra u Velphoro
English: Adult patients with hyperphosphataemia (serum phosphorus levels ≥1.94 mmol/L) were treated with Velphoro at a starting dose of 1,000 mg iron/day followed by an 8-week dose titration period.
Maltese: Pazjenti adulti b'iperfosfatemija (livelli ta' phosphorus fis-serum ta' ≥1.94 mmol/L) ġew ikkurati b'Velphoro b'doża tal-bidu ta' 1,000 mg ta' ħadid/jum segwita minn perjodu ta' titrazzjoni tad-doża ta' 8 ġimgħat.
English: The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Velphoro treatment of up to 55 weeks.
Maltese: Il-profil kurrent tas­sigurtà ta' Velphoro hu bbażat fuq total ta' 778 pazjent fuq l­emodijalisi u 57 pazjent fuq dijalisi peritoneali li rċivew Velphoro b'kura ta' sa 55 ġimgħa.
English: - The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Maltese: - Is-sustanza attiva hija ħadid bħala sucroferric oxyhydroxide magħruf ukoll bħala taħlita ta' polynuclear iron(III)-oxyhydroxide, sucrose, u starches.
English: Velphoro contains starches.
Maltese: Velphoro fih l-istarches.
English: Velphoro is available in packs containing 30 or 90 chewable tablets.
Maltese: Velphoro hu disponibbli f'pakketti li jkun fihom 30 jew 90 pillola li tomgħodhom.
English: See section 2 for further information on sucrose and starches.
Maltese: Informazzjoni dwar is-sucrose u starches (karboidrati)
English: Drug-drug interaction studies have only been performed in healthy volunteers.
Maltese: Studji dwar interazzjonijiet bejn mediċina u oħra twettqu biss fuq voluntiera b'saħħithom.
English: Velphoro can cause black stools.
Maltese: Velphoro jista' jikkawża ppurgar iswed.
English: Woodberry flavour
Maltese: Togħma ta' woodberry