FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.6 Pregnancy and Lactation
Maltese: Taqsima 4.6 - Tqala u Treddigħ
English: Vascace Plus was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product.
Maltese: Vascace Plus kien inkluż fil-lista tal-prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatterisitiċi tal-Prodott (SPC), minħabba d-deċiżjonijiet nazzjoniali diverġenti li ttieħdu mill-Istati Membri dwar lawtorizzazzjoni tal-prodott.
English: Moreover, the names and order of System Organ Classes (SOCs) have been aligned for cilazapril and hydrochlorothiazide according to MedDRA.
Maltese: Barra minn hekk, l-ismijiet u l-ordni tas-Sistema tal-Klassifika tal-Ordni (SOCs) ġiet allinjata għal cilazapril u hydrochlorothiazide skont MedDRA.
English: The CHMP considered a number of areas of disharmony in the Product Information.
Maltese: Is-CHMP ikkunsidra numru ta' oqsma ta' nuqqas ta' armonija fil-Fuljett ta' Informazzjoni.
English: For ADRs listed in the SPC that were not reported in the clinical trials, the relevant frequency category had been assigned using the `rule of 3' approach recommended in the SmPC guideline.
Maltese: Għall-ADRs elenkati fl-SPC li ma kinux irrapportati għall-provi kliniċi, il-kategorija tal-frekwenza relevanti ġiet assenjata skont il-mod tar‘regola tat-3' irrakkomandat fil-linja ta' gwida tal-SmPC.
English: Based on these data the combination of cilazapril 5 mg with hydrochlorothiazide 12.5 mg, given once daily, is a rational clinical choice for patients whose blood pressure is not normalized on cilazapril monotherapy.
Maltese: Fuq il-bażi ta' din id-dejta, il-kombinazzjoni ta' cilazapril 5 mg ma' hydrochlorothiazide 12.5 mg, li tingħata darba kuljum, hija għażla klinika razzjonali għal pazjenti li l-pressjoni tad-demm tagħhom ma tiġix normalizzata b'monoterapija ta' cilazapril.
English: This was based on results of an epidemiological study which found that exposure to ACE inhibitors restricted to the first trimester of pregnancy was associated with increased risk of major congenital malformations including central nervous system and kidney malformations.
Maltese: Dan kien ibbażat fuq riżultati ta' studju epidemjoloġiku li sab li l-espożizzjoni għall-inibituri ACE ristretta għall-ewwel trimetru tat-tqala kien assoċjat ma' riskju akbar ta' malformazzjonijiet konġenitali kbar inklużi malformazzjonijiet fis-sistema nervuża ċentrali u fil-kliewi.
English: In addition to the patients of these clinical trials the efficacy of the combination was also assessed in 1.297 patients of the original cilazapril monotherapy new drug application (NDA) who were treated with cilazapril and adjunctive hydrochlorothiazide (HCTZ).
Maltese: Barra mill-pazjenti ta' dawn il-provi kliniċi, l-effikaċja tal-kombinazzjoni ġiet evalwata wkoll f'1.297 pazjent bl-applikazzjoni tal-mediċina ġdida tal-monoterapija oriġinali ta' cilazapril (NDA) li kienu kkurati b'cilazapril u bl-aġġuntiv hydrochlorothiazide.
English: Gout was listed as a contraindication in some SPCs for Vascace Plus, and was included under section 4.4 in most others and in the CDS.
Maltese: Il-gotta ġiet elenkata bħala kontra-indikazzjoni f'xi SPCs għal Vascace Plus, u ġiet inkluża f'taqsima 4.4 f'ħafna mill-oħrajn u fis-CDS Il-MAH ippropona li jinkludi twissijiet separata dwar din ilkwistjoni f'taqsima 4.4.
English: • the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Vascace Plus and associated names (see Annex I).
Maltese: • is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar, u l-fuljett ta' tagħrif proposti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ġew evalwati fuq il-bażi ta' dokumentazzjoni sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat
English: The current CDS and some SPCs included a warning concerning the use of thiazides in patients with porphyria based on a warning in Martindale's review.
Maltese: Is-CDS attwali u xi SPCs inkludew twissija li tikkonċerna l-użu ta' thiazides f'pazjenti bi porfirja fuq il-bażi ta' twissija f'reviżjoni ta' Martindale.
English: The MAH used the published meta-analyses of mono- and combination therapy as basis for this section.
Maltese: Il-MAH uża l-meta-analiżi ippubblikata tal-mono-terapija u terapija ta' kombinazzjoni bħala bażi għal din it-taqsima.
English: The MAH proposed to include a warning concerning hypotension and renal impairment resulting from combination therapy with cilazapril and hydrochlorothiazide in patients with renal artery stenosis.
Maltese: Il-MAH ippropona li jinkludi twissija dwar il-pressjoni baxxa u indeboliment renali li jirriżulta minn terapija ta' kombinazzjoni b'cilazapril u b'hydrochlorothiazide f'pazjenti bi stenożi renali arterjali.
English: Description of selected adverse reactions as follows: “Headache is a commonly reported adverse event, although the incidence of headache is greater in patients receiving placebo than in those receiving cilazapril + hydrochlorothiazide”.
Maltese: Nota ta' spjegazzjoni ġiet inkluża fis-subsezzjoni (ċ) Deskrizzjoni tar-reazzjonijiet avversi magħżulin kif ġej: “L-uġigħ ta' ras huwa avveniment avvers irrapportat b'mod komuni, għalkemm l-inċidenza tal-uġigħ ta' ras hija akbar f'pazjenti li jingħataw plaċebo milli f'dawk li jingħataw cilazapril + hydrochlorothiazide”.
English: Some SPCs included under the heading “hypotension” warnings about the use of anaesthetics.
Maltese: Xi SPCs inkludew taħt l-intestatura “pressjoni baxxa” twissijiet dwar l-użu ta' anesteżija.
English: The CHMP agreed the following: “When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril.
Maltese: Is-CHMP adotta dan li ġej: “Meta terapija dijuretika konkomittanti tkun meħtieġa f'pazjenti b'indeboliment renali sever, ikun ippreferut dijuretiku loop milli dijuretiku thiazide sabiex jintuża ma' cilazapril.
English: The MAH proposed as harmonised text the following wording: “Vascace Plus is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone or hydrochlorothiazide alone and who have been stabilized on the individual components given in the same proportions.”
Maltese: Il-MAH ippropona l-kliem li ġej bħala test armonizzat: “Vascace Plus huwa indikat għall-kura talpressjoni għolja f'pazjenti li l-pressjoni tad-demm tagħhom mhijiex ikkontrollata b'mod adegwat f'cilazapril waħdu jew b'hydrochlorothiazide waħdu li ġew stabbilizzati fuq il-komponenti individwali li ingħataw fl-istess proporzjon.
English: Reviewing recent publications on this topic information on the pharmacokinetic properties of cilazapril and hydrochlorothiazide, which was considered relevant for physicians to treat their patients with Vascace Plus and which should be included in this document was not identified.
Maltese: Ir-reviżjoni ta' pubblikazzjonijiet reċenti dwar din l-informazzjoni topika dwar ilkaratteristiċi farmakokinetiċi ta' cilazapril u hydrochlorothiazide, li tqieset relevanti għat-tobba sabiex jikkuraw lill-pazjenti tagħhom b'Vascace Plus u li għandha tiġi inkluża f'dan id-dokument, ma ġietx identifikata.
English: The CHMP did not agree with the MAH's position.
Maltese: Is-CHMP ma jaqbilx mal-pożizzjoni tal-MAH.
English: The CHMP asked the MAH to align the SPC for Vascace Plus with the approved SPC of Vascace and endorsed the harmonized wording for this subparagraph.
Maltese: Is-CHMP talab lill-MAH sabiex jallinja l-SPC għal Vascace Plus mal-SPC approvat ta' Vascace u awtorizza l-formolazzjoni tal-kliem armonizzata għal dan is-subparagrafu.
English: The magnitude of the antihypertensive effect of the combination at peak (i. e. 15 mm Hg) did not render an increased incidence of hypotensive events, which could be of concern in elderly patients.
Maltese: Iddaqs tal-effett kontra l-pressjoni għolja tat-taħlita fl-ogħla tagħha (jiġifieri 15 mm Hg) ma wassalx għal inċidenza akbar ta' avvenimenti ta' pressjoni baxxa, li jista' jkun ta' tħassib f'pazjenti anzjani.
English: In several countries there was no information in section 4.2 on this group of patients.
Maltese: F'bosta pajjiżi, ma kien hemm ebda informazzjoni fis-sezzjoni 4.2 dwar dan il-grupp ta' pzjenti.
English: Where warnings and precautions concerned cilazapril, the MAH proposed a text similar to that used in the recently harmonized Vascace.
Maltese: Fejn twissijiet u prekawzjonijiet kienu jikkonċernaw cilazapril, il-MAH ippropona test simili għal dak użat fil-Vascace armonizzat dan l-aħħar.
English: As requested, the ADR “arrhythmia”, already shown in the table of ADRs attributable to cilazapril, has been added to the table of ADRs attributable to hydrochlorothiazide.
Maltese: Kif mitlub, l-ADR “arythmia”, diġà murija fittabella ta' ADRs attribwibbli għal cilazapril, żdiedet mat-tabella ta' ADRs attribwibbli għal hydrochlorothiazide.
English: Section 4.2 Posology and Method of Administration
Maltese: Taqsima 4.2 - Pożoloġija u metodu ta' kif għandu jingħata
English: 196 (2 x 98) capsules (multipack)
Maltese: (2 x 98) kapsula (pakkett multiplu)
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Maltese: Is-CHMP li ikkunsidra l-applikazzjoni huwa tal-fehma li l-bilanċ bejn ir-riskju u l-benefiċċju huwa favur ir-rakkomandazzjoni tal-għoti tal-awtorizzazzjoni fis-suq taħt ċirkostanzi eċċezzjonali kif spjegat fir-Rapport ta' Valutazzjoni Pubblika Ewropeja.
English: • Marketing authorisation under exceptional circumstances
Maltese: • Awtorizzazjoni għat-tqegħid fis-suq taħt ċirkustanzi eċċezzjonali
English: Conclusions presented by the European Medicines Agency on:
Maltese: Konklużjonijiet ppreżentati mill-Aġenzija Ewropeja għall-Mediċini fuq:
English: ANNEX IV
Maltese: U PPREŻENTATI MILL-AĠENZIJA EWROPEJA GĦALL-MEDIĊINI
English: Date of first authorisation: 20 April 2007 Date of latest renewal: 15 March 2012
Maltese: Data ta' l-ewwel awtorizzazzjoni: 20 ta' April 2007 Data ta' l-aħħar tiġdid: 15 ta' Marzu 2012
English: Bioavailability of the active metabolite is 52%.
Maltese: Il-bijodisponibilità tal-metabolit attiv hi ta' 52%.
English: Responder rate (treatment response)#
Maltese: Rata ta' respons (respons għat-trattament)#
English: • The active substance is fesoterodine fumarate.
Maltese: • Is-sustanza attiva hi fesoterodine fumarate.
English: • Severe hepatic impairment (Child Pugh C)
Maltese: • Indeboliment epatiku serju (Child Pugh C)
English: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany
Maltese: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Il-Ġermanja
English: Adults (including elderly)
Maltese: Adulti (inkluż l-anzjani)
English: Angioedema; Urticaria
Maltese: Anġjoedema; Urtikarja
English: The coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, indigo carmine aluminium lake (E132).
Maltese: Il-kisja: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, indigo carmine aluminium lake (E132
English: Titanium dioxide (E171) Macrogol (3350)
Maltese: Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol (3350)
English: TOVIAZ contains lactose.
Maltese: TOVIAZ fih lactose.
English: Contraindicated
Maltese: Kontra-indikat
English: • Toxic megacolon.
Maltese: • Megakolon tossiku.
English: Cardiac electrophysiology
Maltese: Elektrofisjoloġija kardijaka
English: See sections 4.3, 4.4 and 4.5
Maltese: Ara sezzjonijiet 4.3, 4.4 and 4.5
English: The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
Maltese: Il-qalba tal-pillola: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
English: Microcrystalline cellulose Hypromellose Glycerol dibehenate Talc
Maltese: Lactose monohydrate Microcrystalline cellulose Hypromellose Glycerol dibehenate Talc
English: Responder rate p-value
Maltese: Rata ta' respondaturi valur-p
English: (1) Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = <30 ml/min (2) Cautious dose increase.
Maltese: Kontra-indikat (1) GFR ħafif = 50-80 ml/min; GFR moderat = 30-50 ml/min; GFR serju = <30 ml/min (2) Żieda fid-doża għandha ssir b'kawtela.
English: • Severe ulcerative colitis
Maltese: • Kolite ulċerattiva serja
English: Tachycardia; Palpitations
Maltese: Takikardja; Palpitazzjonijiet
English: • sleepiness (somnolence)
Maltese: • ħedla (somnolenza)
English: See sections 4.4, 4.5 and 5.2 (3) Moderate CYP3A4 inhibitors.
Maltese: Ara sezzjonijiet 4.4, 4.5 and 5.2 (3) Inibituri moderati ta CYP3A4.
English: Female (79%) and male (21%) patients with a mean age of 58 years (range 19-91 years) were included.
Maltese: Pazjenti nisa (79%) u rġiel (21%) b'età medja ta 58 sena (etajiet bejn 19-il-sena u 91 sena) kienu inklużi.
English: TOVIAZ 8 mg tablets
Maltese: TOVIAZ 8 mg pilloli
English: Fesoterodine is a competitive, specific muscarinic receptor antagonist.
Maltese: Fesoterodine huwa antagonist kompetittiv speċifiku tar-riċettur muskariniku.
English: • Myasthenia gravis
Maltese: • Majestenja gravis
English: The incidence rates of QTc 500 ms post baseline or QTc increase of 60 ms is 1.9%, 1.3%, 1.4% and 1.5%, for fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively.
Maltese: Ir-rati ta' inċidenza ta' QTc 500 ms wara l-linja tal-bażi ta' referenza, jew żieda fil-QTc ta' 60 ms huma 1.9%, 1.3%, 1.4% u 1.5%, għal Fesoterodine 4 mg, 8 mg, 12 mg u plaċebo rispettivament.
English: TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 30, 56, 84, 98 or 100 tablets.
Maltese: Il-pilloli TOVIAZ ta' 4 mg u 8 mg huma ppakjati f'folji ta' l-aluminju/aluminju f'kartun li fihom 7, 14, 28, 30, 56, 84, 98 jew 100 pillola.
English: Active comparator
Maltese: Komparatur Attiv
English: TOVIAZ 4 mg tablets
Maltese: TOVIAZ 4 mg pilloli
English: Number of urge incontinence episodes per 24 hours
Maltese: Għadd ta'episodji ta' impuls qawwi ta' inkontinenza kull 24 siegħa
English: N=223 N=205
Maltese: N=223 N=205 N=228
English: N=283 N=266
Maltese: N=283 N=266 N=267
English: CYP2D6 inhibitors
Maltese: Impedituri ta' CYP2D6
English: Electrocardiograms were obtained from 782 patients treated with 4 mg, 785 treated with 8 mg, 222 treated with 12 mg fesoterodine and 780 with placebo.
Maltese: Elekrokardjogrammi ttieħdu minn fuq 782 pazjent li kienu trattati b'4 mg, 785 trattati bi 8 mg, 222 trattati bi 12 mg fesoterodine u 780 bi plaċebo.
English: In vitro data demonstrate that the active metabolite of fesoterodine does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant plasma concentrations.
Maltese: Dejta minn studji li saru in vitro juru li l-metabolit attiv ta' fesoterodine ma jimpedixxiex l-azzjoni ta' CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A4 jew jistimula l-effett ta' CYP1A2, 2B6, 2C9, 2C19 jew 3A4 f'konċentrazzjonijiet fil-plażma li huma klinikament rilevanti.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffetwaw sa persuna 1 minn kull 1,000)
English: Pfizer Europe MA EEIG (as MA Holder logo)
Maltese: Pfizer Europe MA EEIG (bħala lowgo tad-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq)
English: Parameter Placebo Fesoterodine 4 mg
Maltese: Parametru Plaċebo Fesoterodine 4 mg
English: Pfizer Ελλάς A.E. Τλ: +30 210 6785800
Maltese: Τλ: +30 210 6785800
English: Placebo Fesoterodine 4 mg
Maltese: Plaċebo Fesoterodine 4 mg
English: Voided volume per micturition (ml)
Maltese: Volum żvojtjat kull mikturizzjoni (ml)
English: The adverse reactions are reported in this table with the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000).
Maltese: Ir-reazzjonijiet avversi huma rrapportati f'din it-tabella skont il-konvenzjoni għal-frekwenza li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100) jew rari (1/10,000 sa <1/1,000).
English: Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161
Maltese: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161
English: The active metabolite is further metabolised in the liver to its carboxy, carboxy-N-desisopropyl, and N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4.
Maltese: Il-metabolit attiv ikompli jkun metaboliżżat ġol-fwied u jifforma l-metaboliti carboxy, carboxy-N-desisopropyl u N-desisopropyl bl-involviment ta' CYPD6 u CYP3A4.
English: - Hepatic impairment (see sections 4.2, 4.3 and 5.2) - Renal impairment (see sections 4.2, 4.3 and 5.2) - Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and
Maltese: - Indeboliment epatiku (ara sezzjonijiet 4.2, 4.3 u 5.2) - Indeboliment renali (ara sezzjonijiet 4.2, 4.3 u 5.2) - L-għoti fl-istess waqt ta' inibituri potenti jew moderati ta' CYP3A4
English: Other medicines and TOVIAZ
Maltese: Mediċini oħra u TOVIAZ
English: A total of 33% of patients were ≥65 years of age and 11% were ≥75 years of age.
Maltese: B'kollox 33% talpazjenti kienu ≥65 sena u 11% kienu ≥75 sena.
English: TOVIAZ 4 mg tablets Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose.
Maltese: Ġo kull pillola ta' 4mg li terħi l-mediċina bil-mod hemm 0.525mg soya lecithin u 91.125mg ta' lactose.
English: The effect of fesoterodine 4 mg and 28 mg on the QT interval was thoroughly evaluated in a double-blind, randomised, placebo- and positive-controlled (moxifloxacin 400 mg) parallel group study with once-daily treatment over a period of 3 days in 261 male and female subjects aged 45 to 65 years.
Maltese: L-effett ta' fesoterodine 4 mg u 28 mg fuq l-intervall ta' QT kien valutat sew fi studju double-blind, parallel, randomised, b'kontroll pożittiv (moxifloxacin 400mg) u bil-plaċebo b'trattamentt ta' darba kuljum li dam tliet ijiem, u li sar fuq 261 raġel u mara li kellhom bejn il-45 u 65 sena.
English: - medicines containing the active substance methadone (used in the treatment of severe pain and abuse problems).
Maltese: -mediċini li fihom is-sustanza attiva methadone (użata fit-trattament ta' uġiegħ qawwi u problemi ta' abbuż)
English: Pharmacotherapeutic group: Urologicals, Urinary antispasmodics, ATC code: G04BD11.
Maltese: Uroloġiċi, Antispasmodiċi urrinarji, Kodiċi ATC:
English: TOVIAZ contains lactose and soya oil
Maltese: TOVIAZ fih lactose u żejt tas-soja
English: In patients with moderate hepatic impairment (Child Pugh B), Cmax and AUC of the active metabolite increased 1.4 and 2.1-fold, respectively, as compared to healthy subjects.
Maltese: F'pazjenti b'indeboliment epatiku moderat (Child Pugh B), is-Cmax u l-AUC tal-metabolit attiv żdied b'1.4 u 2.1-drabi rispettivament, meta mqabblin ma individwi b'saħħithom.
English: Flatulence, Gastroesophage al reflux
Maltese: Gass, Marda ta' rifluss gastroesofagali
English: TOVIAZ 8 mg tablets EU/1/07/386/006-010 EU/1/07/386/012
Maltese: TOVIAZ 8 mg pilloli EU/1/07/386/006-010
English: TOVIAZ 8 mg tablets Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose.
Maltese: Ġo kull pillola ta' 8mg li terħi l-mediċina bil-mod hemm 0.525mg soya lecithin u 58.125mg ta' lactose.
English: Supratherapeutic concentrations of the active metabolite of fesoterodine, have been shown to inhibit K+ current in cloned human ether-à-go-go-related gene (hERG) channels and prolong action potential duration (70% and 90% repolarisation) in canine isolated Purkinje fibres.
Maltese: Konċentrazzjonijiet supraterapewtiċi tal-metabolit attiv ta' fesoterodine, urew li jimpedixxu l-kurrent + f'kanali fil-ġene uman ikklownjat ether-à-go-go (hERG) u wkoll żieda fit-tul ta' l-azzjoni potenzjali (ripolariżazzjoni 70% u 90%) fil-fibri ta' Purkinje iżolati mill-klieb.
English: Plasma protein binding of the active metabolite is low with approximately 50% bound to albumin and alpha-1-acid glycoprotein.
Maltese: L-irbit tal-metabolit attiv mal-proteini tal-plażma huwa baxx, b'50% tal-metabolit marbut ma' lalbumina u mal-alpha-1-acid glycoprotein.
English: Induction of CYP3A4 may lead to subtherapeutic plasma levels.
Maltese: Stimulazzjoni ta' CYP3A4 tista' tirriżulta f'livelli sottoterapewtiċi fil-plażma.
English: 7 prolonged-release tablets 14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 56 prolonged-release tablets 84 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets
Maltese: 7 pilloli li jerħu l-mediċina bil-mod 14-il pillola li jerħu l-mediċina bil-mod 28 pillola li jerħu l-mediċina bil-mod 30 pillola li jerħu l-mediċina bil-mod 56 pillola li jerħu l-mediċina bil-mod 84 pillola li jerħu l-mediċina bil-mod 98 pillola li jerħu l-mediċina bil-mod 100 pillola li jerħu l-mediċina bil-mod
English: Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Maltese: Fesoterodine ma jimpedixxiex it-trażżin ta' l-ovulazzjoni b'kontraċettivi ormonali orali.
English: In patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 2.3-fold, respectively.
Maltese: F'pazjenti li għandhom indeboliment renali serju (GFR < 30 ml/min), is-Cmax u l-AUC huma ogħla 2.0 u 2.3 drabi, ispettivament.
English: At 45 mg/kg/day, a lower number of corpora lutea, implantation sites and viable foetuses was observed in female mice administered fesoterodine for 2 weeks prior to mating and continuing through day 7 of gestation.
Maltese: F'45 mg/kg/jum, ġie osservat numru iżgħar ta' corpora lutea, siti ta' impjantazzjoni u fetijiet vijabbli fi ġrieden nisa li ngħataw fesoterodine għal ġimagħtejn qabel it-tgħammir u dan baqa' għaddej sa jum 7 tal-ġestazzjoni.
English: Maximum plasma levels are reached after approximately 5 hours.
Maltese: Il-livelli massimi fil-plażma jintlaħqu wara bejn wieħed u ieħor 5 sigħat.
English: Hepatic metabolism and renal excretion contribute significantly to the elimination of the active metabolite.
Maltese: Il-metaboliżmu epatiku u l-eliminazzjoni renali jikkontribwixxu b'mod sinifikanti għall-eliminazzjoni tal-metabolit attiv.
English: Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, Cmax and AUC of the active metabolite of fesoterodine increased 2.0 and 2.3-fold in CYP2D6 extensive metabolisers and 2.1 and 2.5-fold in CYP2D6 poor metabolisers, respectively.
Maltese: Wara inibizjoni ta' CYP3A4 li rriżulta wara l-għoti flimkien ta' 200mg ketoconazole darbtejn kuljum, is-Cmax u l-AUC tal-metabolit attiv ta' fesoterodine żdiedu b'fatturi ta' 2.0 u 2.3 f'metaboliżżaturi estensivi ta' CYP2D6 u b'fatturi ta' 2.1 u 2.5 f'metaboliżżaturi dgħajfin ta' CYP2D6 rispettivament.
English: Should be avoided
Maltese: Għandu jiġi evitat
English: Dry mouth, the only very common adverse reactions, occurred with a frequency of 28.8% in the fesoterodine group compared to 8.5% in the placebo group.
Maltese: Il-ħalq xott, li kien l-uniku reazzjoni avversa li kien komuni ħafna, seħħ bi frekwenza ta' 28.8% filgrupp li ħa Fesoterodine meta mqabbel ma' 8.5% fil-grupp li ħa l-plaċebo.
English: • difficulty tasting (dysgeusia)
Maltese: • problemi fis-sens tat- togħma (disgewsja)