FrancophonIA/ELRC3.0 huggingface dataset:
English: Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Maltese: F'Settembru 2007, il-vildagliptin weħidha kienet ġiet approvata mill-Unjoni Ewropea (UE) bl-isem ta' Galvus, filwaqt li l-metformina ilha disponibbli fl-UE sa mill-1959.
English: Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin' hormones in the body.
Maltese: Ilvildagliptin, li huwa inibitur tad-dipeptidil peptidażi 4 (DPP-4), jaħdem billi jimblokka t-tkissir talormoni ‘inkretini' fil-ġisem.
English: • in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
Maltese: • fil-pazjenti li diġà qegħdin jieħdu l-kombinazzjoni ta' vildagliptin u metformina f'pilloli separati;
English: The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Eucreas (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżja (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq) u telf tal-aptit.
English: In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.3%.
Maltese: B'kuntrast ta' dan, ilpazjenti li żiedu l-plaċebo kellhom bidliet iżgħar fil-livelli ta' HbA1c, b'żieda ta' 0.23 % punti perċentwali minn livell tal-bidu ta' 8.3%.
English: What is Eucreas?
Maltese: X'inhu Eucreas?
English: What is the risk associated with Eucreas?
Maltese: X'inhu r-riskju assoċjat ma' Eucreas?
English: How has Eucreas been studied?
Maltese: Kif ġiet studjata Eucreas?
English: Vildagliptin has been shown to be more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Maltese: Il-vildagliptin kienet aktar effikaċi mill-plaċebo (trattament finta) fit-tnaqqis tal-livelli ta' HbA1c meta din żdied mal-metformina.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Eucreas in the same indications.
Maltese: L-istudji b'Galvus bħala terapija aġġuntiva għall-metformina, ilmetformina u s-sulfonilurea, jew il-metformina u l-insulina ntużaw bħala sostenn għall-użu ta' Eucreas fl-istess indikazzjonijiet.
English: Why has Eucreas been approved?
Maltese: Għaliex ġie approvat Eucreas?
English: It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Maltese: M'għandux jintuża f'pazjenti li għandhom ketoaċidożi dijabetika (livelli għolja ta' ketones u aċidi fid-demm), prekoma dijabetika, problemi bil-fwied jew bilkliewi, kondizzjonijiet li jistgħu jaffettwaw il-kliewi, jew marda kkawżata minn provvista mnaqqsa ta' ossiġnu lit-tessuti bħal insuffiċjenza tal-qalb jew tal-pulmun jew xi attakk tal-qalb reċenti.
English: • in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea;
Maltese: • flimkien mas-sulfonilurea (tip ieħor ta' mediċina antidijabetika) flimkien mad-dieta u l-eżerċizzju,
English: Eucreas is used to treat adults with type 2 diabetes.
Maltese: Eucreas jintuża fil-kura ta' adulti li jbatu bid-dijabete tat-tip 2.
English: The studies compared Galvus with placebo and measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji qabblu Galvus mal-plaċebo u kejlu l-livelli ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni dwar kemm qed jiġi kkontrollat tajjeb il-glukożju fid-demm.
English: The CHMP also noted that the combination of vildagliptin and metformin was effective as an add-on to a sulphonylurea or insulin.
Maltese: Is-CHMP innota wkoll li l-vildagliptin u l-metformina meħudin flimkien kienu effettivi bħala terapija aġġuntiva mas-sulfonilurea jew l-insulina.
English: Elderly patients taking Eucreas should have their kidney function monitored regularly.
Maltese: Il-pazjenti anzjani li jkunu qed jieħdu Eucreas għandu jkollhom ilfunzjoni tal-kliewi ssorveljata regolarment.
English: In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
Maltese: Fi studji oħra, il-vildagliptin flimkien mal-metformina ntwera li kien aktar effikaċi mill-plaċebo meta użat mas-sulfonilurea jew l-insulina.
English: • in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
Maltese: • flimkien mal-insulina kif ukoll bid-dieta u bl-eżerċizzju, f'pazjenti li d-dijabete tagħhom ma tkunx ikkontrollata biżżejjed flimkien ma' doża stabbli ta' insulina u l-metformina.
English: What benefit has Eucreas shown during the studies?
Maltese: Liema benefiċċju wera Eucreas waqt l-istudji mwettqa?
English: Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Il-vildagliptin tnaqqas ukoll l-ammont ta' glukożju prodott mill-fwied, billi żżid il-livelli tal-insulina u tnaqqas il-livelli tal-ormon glukagon.
English: • in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone;
Maltese: • f'pazjenti li d-dijabete tagħhom ma tkunx ikkontrollata biżżejjed bid-doża massima tollerata ta'
English: Taking Eucreas with or just after food may reduce any stomach problems caused by metformin.
Maltese: Meta wieħed jieħu Eucreas mal-ikel jew eżatt wara, jistgħu jitnaqqsu problemi tal-istonku kkawżati mill-metformina.
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi żżid il-livelli ta' ormoni inkretini fid-demm, il-vildagliptin tistimula l-frixa tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: Eucreas contains two active substances, which each have a different mode of action.
Maltese: Eucreas fih żewġ sustanzi attivi, li kull waħda minnhom għandha azzjoni differenti.
English: Co. Meath,
Maltese: Meath,
English: • The active substance is tafamidis.
Maltese: • Is-sustanza attiva hi tafamidis.
English: Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Maltese: Cmax(ss) u Cmin(ss) kienu 2.7 u 1.6 μg/ml, rispettivament.
English: Penn Pharmaceutical Services Limited Units 23-24, Tafarnaubach Industrial Estate Tafarnaubach
Maltese: Units 23-24,Tafarnaubach Industrial Estate Tafarnaubach
English: The apparent steady state volume of distribution is 25.7 liters.
Maltese: Il-volum apparenti taddistribuzzjoni fi stat fiss huwa ta' 25.7 litri.
English: • The other ingredients are: gelatin (E441), glycerin (E422), sorbitol (E420), mannitol (E421), sorbitan, yellow iron oxide (E172), titanium dioxide (E171), purified water, macrogol 400 (E1521), sorbitan monooleate (E494), polysorbate 80 (E433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E1520), carmine (E120), brilliant blue FCF (E133) and ammonium hydroxide (E527).
Maltese: • Is-sustanzi l-oħra huma ġelatina (E441), ġliċerina (E422), sorbitol (E420), mannitol (E421), sorbitan, yellow iron oxide (E172), titanium dioxide (E171), ilma ppurifikat, macrogol 400 (E1521), sorbitan monooleate (E494), polysorbate 80 (E433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E1520), carmine (E120), brilliant blue fcf (E133) u ammonium hydroxide (E527).
English: Vyndaqel N=64 P-value
Maltese: Vyndaqel N=64
English: PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters.
Maltese: Folji tal-PVC/PA/Alu/PVC-Alu/PET/Karta perforati għal dożi singoli.
English: Vyndaqel versus Placebo: NIS-LL and TQOL at Month 18 (Study Fx-005) Placebo
Maltese: Vyndaqel versus Plaċebo: NIS-LL f'xahar18 (Study Fx-005)
English: Tafamidis is highly protein bound (99.9%) in plasma.
Maltese: Tafamidis jintrabat b'mod qawwi mal-proteini (99.9%) fil-plażma.
English: In vitro data also indicated that tafamidis meglumine does not significantly inhibit cytochrome P450 enzymes CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
Maltese: Dejta in vitro indikat ukoll li tafamidis meglumine ma jinibixxix sinifikament l-enżimi taċ-ċitokromu P450 CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19 u CYP2D6.
English: Vyndaqel contains the active substance tafamidis.
Maltese: Vyndaqel fih is-sustanza attiva tafamidis.
English: Sorbitol (E420) Mannitol (E421) Titanium dioxide (E171) Purified water
Maltese: Sorbitol (E420) Mannitol (E421) Titanium Dioxide (E171)
English: Date of latest renewal: 22 July 2016
Maltese: Data tal-aħħar tiġdid: 22 ta' Lulju 2016
English: 30 x 1 soft capsules.
Maltese: 30 x 1 kapsuli rotob.
English: Vyndaqel contains sorbitol (E420).
Maltese: Vyndaqel fih sorbitol (E420).
English: Vyndaqel contains sorbitol
Maltese: Vyndaqel fih sorbitol
English: Vyndaqel % change relative to Placebo
Maltese: Bidla % ta' Vyndaqel relatata mal-plaċebo
English: - non-steroidal anti-inflammatory drugs - diuretic medicines (e.g. furosemide, bumetanide) - anti-cancer medicines (e.g. methotrexate, imatinib) - statins (e.g. rosuvastatin) - anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine,
Maltese: mediċini anti-infjammatorji mhux sterojdali mediċini dijuretiċi (eż. furosemide, bumetanide) mediċini kontra l-kanċer (eż. methotrexate, imatinib) statini (eż. rosuvastain) mediċini antivirali (eż. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)
English: Capsule shell
Maltese: Kapsula ratba
English: (CYPRUS BRANCH), Τηλ: +357 22 817690
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Τηλ: +357 22 817690
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura ta' aktar minn 25°C.
English: Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (1/10), Common (1/100 to <1/10), and Uncommon (1/1,000 to <1/100).
Maltese: Komuni ħafna (1/10), Komuni (1/100 sa <1/10), u Mhux Komuni (1/1,000 sa <1/100).
English: The overall clinical data reflect exposure of 127 TTR amyloid polyneuropathy patients to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days).
Maltese: Id-dejta klinika globali tirrifletti l-esponiment ta' 127 pazjent bil-polinewropatija amyloid tat-tip TTR għal 20 mg ta' tafamidis meglumine amministrata kuljum għal medja ta' 538 ġurnata (medda ta' 15 sa 994 ġurnata).
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17
Maltese: Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: In vitro studies with tafamidis meglumine suggest that it is unlikely tafamidis meglumine will cause drug interactions at clinically relevant concentrations with substrates of UDP glucuronosyltransferase (UGT), P-gp transporters, or organic anion-transporting polypeptide transporters (OATP1B1 and 1B3).
Maltese: Studji in vitro b'tafamidis meglumine jissuġġerixxu li huwa improbabbli li tafamidis meglumine jikkawża interazzjonijiet ma' mediċini oħra f'konċentrazzjonijiet klinikament rilevanti ma' substrati ta' UDP-glucuronosyltransferase (UGT), trasportaturi ta' P-gp, jew trasportaturi ta' polypeptide li jittrasporta l-anjoni organiku (OATP1B1 u 1B3).
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Vyndaqel is available in two pack sizes of PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules.
Maltese: Vynaqel huwa disponibbli f'żewġ daqsijiet ta' pakketti b'folji tal-PVC/PA/Alu/PVC-Alu/PET/Karta perforati għal dożi singoli: pakkett ta' 30 x 1 kapsuli rotob u pakkett ta' ħafna b'90 kapsula rotob li fih 3 kaxxi, li kull waħda fiha 30 x 1 kapsuli rotob.
English: Pfizer Europe MA EEIG (as MA Holder logo)
Maltese: Pfizer Europe MA EEIG (bħala lowgo tad-Detentur ta' l-Awtorizzazjoni għat-tqegħid fis-suq)
English: Likewise, tafamidis meglumine inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 µM and IC50=2.36 µM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine).
Maltese: Bl-istess mod, tafamidis meglumine jinibixxi t-trasportaturi tal-uptake OAT1 u OAT3 (trasportaturi tal-anjoni organiċi) b'IC50=2.9 µM u IC50=2.36 µM, rispettivament, u jista' jikkawża interazzjonijiet ma' mediċini oħra f'konċentrazzjonijiet klinikament rilevanti ma' substrati ta' dawn it-trasportaturi (eż. mediċini anti-infjammatorji mhux sterojdi, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine).
English: TTR amyloid polyneuropathy is a multi-faceted, progressive, axonal degenerative neuropathy characterized by sensory, motor and autonomic impairment.
Maltese: Polinewropatija amyloid tat-tip TTR, għanda diversi aspetti, progressiva, teffetwa d-deġenerazzjoni tal-axon li hija kkaratterizzata b'indeboliment tas-sensi, tal-movimenti u tas-sistema awtonomika.
English: 30 x 1 soft capsules
Maltese: 30 x 1 kapsuli rotob
English: The capsule contains sorbitol (E420).
Maltese: Il-kapsula fiha sorbitol (E420).
English: Pharmacokinetic data indicated decreased systemic exposure (approximately 40%) and increased total clearance (0.52 l/h vs. 0.31l/h) of tafamidis in patients with moderate hepatic impairment (Child-Pugh Score of 7-9 inclusive) compared to healthy subjects due to a higher unbound fraction of tafamidis.
Maltese: Id-dejta farmakokinetika indikat tnaqqis fl-esponiment sistemiku (bejn wieħed u ieħor 40%) u żieda fit-tneħħija totali (0.52 l/siegħa vs. 0.31 l/siegħa) ta' tafamidis f'pazjenti b'indeboliment moderat talfwied (Child-Pugh Score ta' 7-9 inkluż) meta mqabbla mas-suġġetti b'saħħithom, minħabba ammont akbar ta' tafamidis mhux marbut.
English: Tafamidis meglumine is a specific stabilizer of transthyretin.
Maltese: Mekkaniżmu ta' azzjoni Tafamidis meglumine hu stabilizzatur speċifiku għal transthyretin.
English: Urinary tract infection Vaginal infection
Maltese: Infezzjoni fit-tratt urinarju Infezzjoni vaġinali
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Maltese: Data ta' l-ewwel awtorizazzjoni: 16 ta' Novembru, 2011
English: Results from once-daily dosing with tafamidis meglumine 15, 30, or 60 mg for 14 days demonstrated dose-dependent increases in Cmax and AUC between doses of 15 mg and 30 mg and less than dose proportional between 30 and 60 mg, indicating saturation of absorption process beyond 30 mg.
Maltese: Riżultati minn dożaġġ ta' darba kuljum b'tafamidis meglumine 15, 30, jew 60 mg għal 14-il ġurnata wrew żieda li tiddependi mid-doża fis-Cmax u fl-AUC bejn id-dożi ta' 15 mg u 30 mg u inqas mid-doża b'mod proporzjonali bejn 30 mg u 60 mg.
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 f'sezzjoni 6.1.
English: Soft capsule Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red.
Maltese: Kapsula safra, opaka, b'forma oblunga (bejn wieħed u ieħor 21 mm) li fuqha hemm stampat “VYN 20” bl-aħmar.
English: Macrogol 400 (E1521) Sorbitan monooleate (E494) Polysorbate 80 (E433)
Maltese: Kontenut tal-kapsula Macrogol 400 (E1521) Sorbitan monooleate (E494)
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code N07XX08 Mechanism of action
Maltese: Mediċini oħra tas-sistema nervuża, Kodiċi ATC:
English: Pack of 30 x 1 soft capsules - WITH BLUE BOX
Maltese: Pakkett ta' 30 x 1 kapsuli rotob - BIL-KAXXA BLU
English: Perforated unit dose blisters of 10 x 20 mg Vyndaqel soft capsules
Maltese: Folji perforati għal dożi singoli ta' 10 x 20mg Vyndaqel kapsuli rotob
English: Amyloid can build up around your nerves and in other places in your body, preventing them from working normally.
Maltese: Amyloid jista' jinġema madwar in-nervituri u f'postijiet oħra fil-ġisem, u twaqqafhom milli jaħdmu normali.
English: Multipack: 90 (3 packs of 30 x 1) soft capsules.
Maltese: Pakkett ta' ħafna: 90 (3 pakketti ta' 30 x 1) kapsula rotob.
English: The NOAEL for viability and growth in the F1 generation offspring following maternal treatment during pregnancy and lactation with tafamidis was 5 mg/kg (HED=0.8 mg/kg), a dose approximately 4.6-times the recommended dose.
Maltese: L-NOAEL għal vijabilità u tkabbir tal-ġenerazzjoni F1 tal-wild wara li l-omm kienet trattata waqt it-tqala u t-treddigħ b'tafamidis kien ta 5 mg/kg (HED = 0.8 mg/kg), doża li bejn wieħed u ieħor hija 4.6-il darba d-doża rakkomandata.
English: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Maltese: Vyndaqel huwa indikat għat-trattament ta' amyloidosis ta' transthyretin f'pazjenti adulti bilpolinewropatija sintomatika fi stadju 1 sabiex jittardja l-indeboliment periferali newroloġiku.
English: Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) imprinted with “VYN 20” in red.
Maltese: Vyndaqel kapsuli rotob huma ta' kulur isfar, opak, b'forma oblunga (bejn wieħed u ieħor 21 mm) li fuqha hemm stampat “VYN 20” bl-aħmar.
English: Secondary Endpoints Changes from Baseline to Month 18 LSMean (Standard Error) (Intentto-Treat Population) (Study Fx-005) Placebo N=61
Maltese: Bidliet fil-Punti tat-tmiem Sekondarji mil-linja bażi sal-LSMean tat-18-il xahar (Żbalji standard) (Popolazzjoni li se tiġi trattata) (Studju Fx-005) Plaċebo N=61
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) Pre-specified Efficacy Evaluable Analysis
Maltese: Pazjenti li jirrispondu għal NIS-LL (% Pazjenti) Differenza (Vyndaqel nieqes Plaċebo) 95% CI ta' Differenza (valur p) Bidla f'TQOL mil-linja bażi tal-LSMean
English: 5.2 Pharmacokinetic properties
Maltese: .2 Proprjetajiet farmakokinetiku
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tafamidis in milk.
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli fl-annimali wriet eliminazzjoni ta' tafamidis filħalib.
English: Each soft capsule contains no more than 44 mg of sorbitol (E420).
Maltese: Kull kapsula fiha mhux aktar minn 44 mg ta' sorbitol (E420).
English: A supra-therapeutic, single, 400 mg oral dose of tafamidis solution in healthy volunteers demonstrated no prolongation of the QTc interval.
Maltese: Doża waħda orali supraterapewtika ta' 400 mg ta' soluzzjoni ta' tafamidis f'voluntiera b'saħħithom ma wrietx titwil fl-intervall tal-QTc.
English: Vyndaqel 20 mg soft capsules tafamidis meglumine
Maltese: Vyndaqel 20 mg kapsuli rotob tafamidis meglumine
English: Decreased foetal weights in males were associated with delayed sexual maturation (preputial separation) and impaired performance in a water-maze test for learning and memory.
Maltese: Tnaqqis fil-piż tal-feti maskili kien assoċjat ma' dewmien fil-maturità sesswali (separazzjoni tal-prepuzju) u indeboliment fil-kapaċità ta' tagħlim u memorja fit-test watermaze.
English: 4 PHARMACEUTICAL FORM AND CONTENTS
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: However, in vitro tafamidis meglumine inhibits the efflux transporter BCRP (breast cancer resistant protein) with IC50=1.16 µM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib).
Maltese: Madankollu, tafamidis meglumine in vitro jinibixxi t-trasportatur tal-effluss BCRP (proteina reżistenti għall-kanċer tas-sider) b'IC50=1.16µM u jista' jikkawża interazzjonijiet ma' mediċini oħra f'konċentrazzjonijiet klinikament rilevanti ma' substrati ta' dan it-trasportatur (eż. methotrexate, rosuvastatin, imatinib).
English: Vyndaqel 20 mg soft capsules
Maltese: Vyndaqel 20 mg kapsuli rotob
English: Adverse reactions reported from the clinical programme in the tabular listing below reflect the rates at which they occurred in the Phase 3, double-blind, placebo-controlled study (Fx-005).
Maltese: Reazzjonijiet avversi rrappurtati mill-programm kliniku fillista tabulari hawn taħt jirriflettu r-rati li fihom seħħew fl-istudju ta' Fażi 3, double-blind, ikkontrollat bi plaċebo (Fx-005).
English: Annual Reassessment
Maltese: Rivalutazzjoni annwali
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Maltese: Fertilità L-ebda tnaqqis fil-fertilità ma ġie osservat fi studji li mhumiex kliniċi (ara sezzjoni 5.3).
English: Each capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis.
Maltese: Kull kapsula fiha 20 mg tafamidis meglumine ekwivalenti għal 12.2 mg ta' tafamidis.
English: The pivotal study of tafamidis meglumine was an 18-month, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of once-daily 20 mg tafamidis meglumine in 128 patients with TTR amyloid polyneuropathy with the V30M mutation and primarily stage 1 disease (do not routinely require assistance with ambulation).
Maltese: Dan l-istudju evalwa s-sigurtà u l-effikaċja ta' tafamidis meglumine 20 mg darba kuljum f'128 pazjent bil-polinewropatija tat-tip TTR amyloid b'tibdil ta' V30M u primarjament bil-marda fi stadju 1 (normalment mhux meħtieġ li l-pazjent jibqa' ġos-sodda).
English: Other outcome measures included composite scores of large nerve fiber (nerve conduction, vibration threshold and heart rate response to deep breathing - HRDB) and small nerve fiber function (heat pain and cooling threshold and HRDB) and nutritional assessments utilizing the modified body mass index (mBMI - BMI multiplied by serum albumin in g/L).
Maltese: Riżultati oħra jinkludu numru ta' punteġġi tal-fibri kbar tan-nerv (trasmissjoni ta' impulsi fin-nervituri, l-aktar limitu baxx għal-vibrazzjoni u r-rispons tar-rata tat-taħbit tal-qalb fuq nifs fil-fond - HRDB) u l-funzjoni tal-fibri żgħar tan-nerv (uġigħ relatat mas-sħana u l-aktar limitu baxx tat-tkessiħ u HRDB) u valutazzjonijiet tan-nutrizzjoni bl-użu tal-indiċi tal-massa tal-ġisem immodifikat (mBMI - BMI mmultiplikat bil-grammi ta' albumina fis-serum f'kull litru).
English: The recommended dose is one capsule (20 mg Tafamidis meglumine) of Vyndaqel once a day.
Maltese: Id-doża rakkomandata hija ta' kapsula waħda (20 mg Tafamidis meglumine) ta' Vyndaqel darba kuljum.
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) In the pre-specified ITT NIS-LL Responder analysis, patients who discontinued prior to the 18-month time point due to liver transplantation were categorized as non-responders.
Maltese: (SE) 95% CI ta' Differenza (valur p) Fl-analiżi, ITT speċifikata minn qabel, tal-pazjenti li jirrispondu għal NIS-LL, il-pazjenti li waqqfu ittrattament qabel it-18-il xahar minħabba trapjant tal-fwied kienu kategorizzati bħala pazjenti li mhux jirrispondu.