FrancophonIA/ELRC3.0 huggingface dataset:
English: This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.
Maltese: Dawn jirreferu għal żewġ indikazzjonijiet (trattament tal-kanċer tal-prostata lokalment avvanzat mingħajr metastażi, fejn kastrazzjoni kirurġika jew tip ieħor ta' intervent mediku ma jkunx indikat jew ikun inaċċettabli, u bħala monoterapija f'fażi bikrija tat-trattament jew bħala aġġunt ma' trattament bir-radjuterapija jew prostatektomija radikali f'pazjenti b'kanċer fil-prostata (T3-T4, kull Stadju N, M0) u dan ġie kkunsidrat bħala fattur serju ta'tħassib pubbliku.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' l-arbitraġġ bdiet fis-26 ta' April 2007 permezz ta' l-adozzjoni ta' lista ta' domandi.
English: The final opinion was converted into a Decision by the European Commission on 22 November 2007.
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fit-22 ta' Novembru 2007.
English: During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Settembru ta' l-2007, il-CHMP, fid-dawl tat-tagħrif sottomess kollu u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji kien favorevoli għal Bicaluplex u ismijiet assoċjati, li l-objezzjonijiet imqajma mill-Ġermanja ma għandhomx jimpedixxu lgħoti ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, it-tikketta u lfuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.
Maltese: IrRepubblika Ċeka rreferiet ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fit-30 ta' Marzu ta' l-2007.
English: Significant differences have been identified with regard to the benefit/risk ratio of the product.
Maltese: Ġew identifikati differenzi sinnifikattivi fir-rigward tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2007.
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq ta spjegazzjonijiet bil-miktub fl-20 ta' Lulju 2007.
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Maltese: 90 (3 x 30) pillola
English: 03410 Saint Victor France
Maltese: 03410 Saint Victor Franza
English: Packs of 10, 20, 30, 50, 90, 100 capsules.
Maltese: Pakketti ta' 10, 20, 30, 50, 90, 100 kapsula.
English: Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg capsules only)
Maltese: Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg kapsuli biss)
English: Total score
Maltese: Skor totali
English: Difference (95% CI) vs placebo
Maltese: Differenza (95% CI)
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Dan l-effett ma jibqax wara t-twaqqif ta' Silodosin Recordati.
English: The absolute bioavailability is approximately 32%.
Maltese: Il-bijodisponibilità assoluta hija ta' madwar 32%.
English: 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
Maltese: 10 kapsuli ibsin 20 kapsula iebsa 30 kapsula iebsa 50 kapsula iebsa 90 kapsula iebsa 100 kapsula iebsa
English: Silodosin has a volume of distribution of 0.81 L/kg and is 96.6% bound to plasma proteins.
Maltese: Silodosin għandu volum ta' distribuzzjoni ta' 0.81 l/kg u 96.6% jeħel mal-proteini tal-plażma.
English: Irritative symptoms
Maltese: Sintomi irritattivi
English: Silodosin Recordati is available in packs containing 10, 20, 30, 50, 90, 100 capsules.
Maltese: Silodosin Recordati jiġi f'pakketti ta' 10, 20, 30, 50, 90, 100 kapsula.
English: De uts chland Recordati Pharma GmbH Tel: + 49 731 70470
Maltese: Recordati Pharma GmbH Tel: + 49 731 70470
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Maltese: b'silodosin 4 jew 8 mg darba kuljum, ġie osservat titjib akbar fil-punteġġ ta' indiċi tas-sintomi tal-Assoċjazzjoni Uroloġika Amerikana (AUA) b'silodosin 8 mg (-6.8 ± 5.8, n = 90; p 0.0018) u silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) meta mqabbel mal-plaċebo (-4.0 ± 5.5, n = 83).
English: Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04.
Maltese: Uroloġiċi, antagonisti tal-adrenoriċetturi alpha, Kodiċi ATC:
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Is-sustanzi mhux attivi l-oħra huma pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, ġelatina, titanium dioxide (E171), yellow iron oxide (E172).
English: Obstructive symptoms
Maltese: Sintomi ostruttivi
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż
English: Orthostatic effects
Maltese: Effetti ortostatiċi
English: Carcinoma of the prostate
Maltese: Karċinoma tal-prostata
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Maltese: FOLJI TAL-PVC/PVDC/ALUMINJU
English: Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7.
Maltese: Silodosin huwa mmetabolizzat b'mod estensiv, l-aktar permezz ta' CYP3A4, alcohol dehydrogenase u UGT2B7.
English: Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) protein bound.
Maltese: Id-dijalisi mhijiex probabbli li tkun ta' benefiċċju sinifikanti billi silodosin jeħel ħafna (96.6%) mal-proteini tal-plażma.
English: In the subjects over 65 years, the mean decreases at the various time points were between 5 and 15 mmHg (systolic) and 0 and 10 mmHg (diastolic).
Maltese: Fil-persuni ta' iżjed minn 65 sena, it-tnaqqis medju f'ħinijiet varji kien bejn 5 u 15 mmHg (sistolika) u 0 u 10 mmHg (dijastolika).
English: Minimal pharmacodynamic interactions have been observed between silodosin and maximum doses of sildenafil or tadalafil.
Maltese: Ġew osservati interazzjonijiet farmakodinamiċi minimi bejn silodosin u dożi massimi ta' sildenafil jew tadalafil.
English: Silodosin is also a substrate for P-glycoprotein.
Maltese: Silodosin huwa wkoll substrat għall-glikoproteina P.
English: EU/1/18/1343/001 EU/1/18/1343/002 EU/1/18/1343/003 EU/1/18/1343/004 EU/1/18/1343/005 EU/1/18/1343/006
Maltese: EU/1/18/1343/001 EU/1/18/1343/002 EU/1/18/1343/003 EU/1/18/1343/004
English: PDE-5 inhibitors
Maltese: Inibituri ta' PDE-5
English: The other ingredients are pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, gelatin, titanium dioxide (E171).
Maltese: Is-sustanzi mhux attivi l-oħra huma pregelatinised maize starch, mannitol (E421), magnesium stearate, sodium laurilsulfate, ġelatina, titanium dioxide (E171).
English: Tel: + 48 22 206 84 50
Maltese: Recordati Polska sp. z o.o. Tel: + 48 22 206 84 50
English: Silodosin Tamsulosin Placebo
Maltese: Silodosin Tamsulosin
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Maltese: (CLCR ≥ 50 sa ≤ 80 mL/min).
English: Silodosin Placebo
Maltese: vs plaċebo
English: Intraoperative Floppy Iris Syndrome (IFIS)
Maltese: Sindromu tal-Iris Mitluqa Waqt Operazzjoni (IFIS)
English: EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010 EU/1/18/1343/011 EU/1/18/1343/012
Maltese: EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010
English: Silodosin Recordati belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Maltese: Silodosin Recordati jappartieni għal grupp ta' mediċini msejħa imblokkaturi tal-adrenoriċettur alpha1A.
English: PHARMACEUTICAL PARTICULARS
Maltese: Recordati Pharmaceuticals
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: 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); very rare (< 1/10,000), not known (cannot be estimated from available data).
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi rrappurtati fl-istudji kliniċi kollha u li għalihom teżisti relazzjoni kawżali raġonevoli huma elenkati skond is-sistema tal-klassifika tal-organi tal-ġisem fid-database MedDRA u l-frekwenza: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf
English: It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin (162:1) is extremely high.
Maltese: In vitro ġie muri li l-proporzjon ta' rbit α1A:α1B ta' silodosin (162:1) huwa għoli ħafna.
English: The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.
Maltese: Il-kapsuli jiġu f'folji tal-PVC/PVDC/fojl tal-aluminju, ippakkjati f'kartun.
English: The responder rate (i.e. improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) and tamsulosin group (65%), as compared to placebo (53%).
Maltese: Ir-rata ta' rispons (jiġifieri titjib fl-iskor totali tal-IPSS għallinqas ta' 25%) kienet ferm ogħla fil-grupp li ħadu silodosin (68%) u tamsulosin (65%), meta mqabbel mal-plaċebo (53%).
English: Protein binding of silodosin glucuronide is 91%.
Maltese: 91% ta' silodosin glucuronide jeħel mal-proteini tad-demm.
English: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Maltese: Kura tas-sinjali u s-sintomi ta' iperplasija beninna tal-prostata (benign prostatic hyperplasia, BPH)
English: In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Maltese: F'irġiel b'saħħithom fil-medda ta' etajiet fil-mira (n = 16, età medja 55 ± 8 snin) wara l-għoti mill-ħalq ta' 8 mg darba kuljum immedjatament wara l-kolazzjon għal 7t ijiem, kienu miksuba l-parametri farmakokinetiċi li ġejjin: Cmax 87 ± 51 ng/mL (SD), tmax 2.5 sigħat (medda 1.0-3.0), AUC
English: The exposure to the main metabolite in plasma, silodosin glucuronide (KMD-3213G), at steady-state is about 3-fold that of the parent substance.
Maltese: L-esponiment għall-metabolit prinċipali fil-plażma, silodosin glucuronide (KMD-3213G), fl-istat fiss huwa madwar 3 darbiet dak tas-sustanza oriġinali.
English: Silodosin Recordati 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Maltese: Silodosin Recordati 8 mg kapsuli ibsin Kapsula iebsa bajda, opaka tal-ġelatina, daqs 0 (madwar 21.7 x 7.6 mm).
English: The use of silodosin in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.2 and 5.2).
Maltese: Mhux irrakkomandat l-użu ta' silodosin f'pazjenti b'indeboliment sever tal-kliewi (CLCR < 30 mL/min) (ara sezzjonijiet 4.2 u 5.2).
English: EU/1/18/1343/001 EU/1/18/1343/002 EU/1/18/1343/003 EU/1/18/1343/004 EU/1/18/1343/005 EU/1/18/1343/006 EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010 EU/1/18/1343/011 EU/1/18/1343/012
Maltese: EU/1/18/1343/006 EU/1/18/1343/007 EU/1/18/1343/008 EU/1/18/1343/009 EU/1/18/1343/010
English: Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Maltese: Bijotrasformazzjoni Silodosin jiġi mmetabolizzat b'mod estensiv permezz ta' glukoronidazzjoni (UGT2B7), alkoħol u aldehyde dehydrogenase u mogħdijiet ossidattivi, b'mod prinċipali CYP3A4.
English: This medicine contains less than 1 mmoL sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Maltese: Silodosin Recordati 8 mg huma kapsuli ibsin tal-ġelatina, bojod, opaki, daqs 0 (madwar 21.7 x 7.6 mm).
English: The terminal half-life of parent drug and its glucuronide is approximately 11 hours and 18 hours, respectively.
Maltese: Il-half-life terminali tal-mediċina oriġinali u l-glucoronide tagħha hija madwar 11-il siegħa u 18-il siegħa, rispettivament.
English: In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
Maltese: Indeboliment tal-kliewi Fi studju ta' doża waħda, l-esponiment għal silodosin (mhux imwaħħal) f'pazjenti b'indeboliment ħafif (n = 8) u moderat tal-kliewi (n = 8) rriżulta, bħala medja, f'żieda fil-Cmax (1.6 darbiet) u fl-AUC (1.7 darbiet) meta mqabbel ma' persuni b'funzjoni tal-kliewi normali (n = 8).
English: The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2).
Maltese: Mhux irrakkomandat l-użu f'pazjenti b'indeboliment sever tal-kliewi (CLCR < 30 mL/min) (ara sezzjonijiet 4.4 u 5.2).
English: An in vitro study with Caco-2 cells showed that silodosin is a substrate for P-glycoprotein.
Maltese: Studju in vitro b'ċelloli Caco-2 wera li silodosin huwa substrat għall-glikoproteina P.
English: IFIS has been reported during cataract surgery (see section 4.4).
Maltese: IFIS ġie rrappurtat waqt operazzjoni tal-katarretti (ara sezzjoni 4.4).
English: The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with silodosin and 1.0% with placebo.
Maltese: L-inċidenza ta' pressjoni ortostatika baxxa fl-istudji kliniċi kkontrollati bil-plaċebo kienet 1.2%
English: Europe
Maltese: Österreich
English: Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Maltese: Wara l-għoti mill-ħalq ta' silodosin 14C-tikkettat, l-irkupru tar-radjuattività wara 7 ijiem kien madwar 33.5% fl-awrina u 54.9% fl-ippurgar.
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 f'kull 1,000 persuni)
English: Warnings and precautions
Maltese: Konġestjon i talimnifsejn
English: • Abnormal results of liver function tests
Maltese: • Riżultati mhux normali għal testijiet tal-funzjoni ta' fwied
English: In vitro data indicate that silodosin does not have the potential to inhibit or induce cytochrome P450 enzyme systems.
Maltese: Informazzjoni in vitro tindika li silodosin m'għandux il-potenzjal li jinibixxi jew jinduċi s-sistemi tal-enzimi taċ-ċitokromu P450.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati.
Maltese: • mediċini antifungali (bħal ketoconazole jew itraconazole), mediċini użati għal infezzjoni tal-HIV/AIDS (bħal ritonavir) jew mediċini użati wara t-trapjanti biex jevitaw ir-rifjut tal-organi (bħal cyclosporin) billi dawn il-mediċini jistgħu jżidu l-konċentrazzjoni fid-demm ta'
English: Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Maltese: III wera li l-livelli totali ta' silodosin wara 4 ġimgħat ta' kura ma nbidlux f'pazjenti b'indeboliment ħafif (n = 70), meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali (n = 155), filwaqt li l-livelli bħala medja rduppjaw f'pazjenti b'indeboliment moderat (n = 7).
English: Silodosin Recordati may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Maltese: Silodosin Recordati jista' jikkawża kumplikazzjonijiet waqt operazzjoni tal-katarretti (operazzjoni fl-għajnejn minħabba lenti mtappna, ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra.
Maltese: Silodosin huwa selettiv ħafna għall-adrenoriċetturi-α1A li jinsabu primarjament fil-prostata umana, fil-bażi tal-bużżieqa tal-awrina, fl-għonq tal-bużżieqa tal-awrina, fil-kapsula tal-prostata u fl-uretra tal-prostata.
English: Silodosin Recordati 4 mg and 8 mg hard capsules Capsule content
Maltese: Silodosin Recordati 4 mg u 8 mg kapsuli ibsin Kontenut tal-kapsula
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Maltese: 18.9 punti, 77.1% kellhom rispons għal silodosin (kif evalwat minn bidla mil-linja bażi fl-iskor totali tal-IPSS ta' mill-inqas 25%).
English: Each capsule contains 8 mg of silodosin.
Maltese: Kull kapsula iebsa fiha 8 mg silodosin.
English: Skin rash1, Pruritus1
Maltese: Pressjoni baxxa1
English: Allergictype reactions including facial swelling, swollen tongue and pharyngeal oedema1
Maltese: Reazzjonijie t ta' tip allerġiku inklużi nefħa filwiċċ, nefħa fl-ilsien, edema fil farinġi1
English: The pharmacokinetics of silodosin is linear throughout this dose range.
Maltese: Il-farmakokinetika ta' silodosin hija lineari tul din il-firxa tad-doża.
English: Silodosin has a substantially lower affinity for the α1B-adrenoreceptors that are primarily located in the cardiovascular system.
Maltese: Silodosin għandu affinità ferm aktar baxxa għall-adrenoriċetturi-α1B li jinsabu primarjament fis-sistema kardjovaskulari.
English: Silodosin and its glucuronide reach steady-state after 3 days and 5 days of treatment, respectively.
Maltese: Silodosin u l-glucoronide tiegħu jilħqu stat fiss wara 3t ijiem u 5t ijiem ta' kura, rispettivament.
English: Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Maltese: (bħal ketoconazole, itraconazole, ritonavir jew cyclosporine) mhux irrakkomandat.
English: There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Maltese: M'hemm l-ebda użu rilevanti ta' Silodosin Recordati fil-popolazzjoni pedjatrika għall-indikazzjoni ta' iperplasija beninna tal-prostata (benign prostatic hyperplasia, BPH).
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodosin Recordati may be reduced.
Maltese: • mediċini kontra l-epilessija jew rifampicin (mediċina għall-kura tat-tuberkulożi), billi jista'
English: Approximately half of the patients reported an improvement in the most bothersome symptoms complained at baseline by the patients (i.e. nocturia, frequency, decreased stream, urgency, terminal dribbling and incomplete emptying), as assessed by the ICS-male questionnaire.
Maltese: Madwar nofs il-pazjenti rrappurtaw titjib fl-iktar sintomi ta' dwejjaq irrappurtati fil-linja bażi mill-pazjenti (jiġifieri nokturja, frekwenza, tnaqqis fit-tnixxija, urġenza, taqtir terminali u żvojtar mhux komplet), kif evalwat mill-kwestjonarju ICS għall-irġiel.
English: Intraoperative Floppy Iris Syndrome
Maltese: Sindromu tal-Iris Mitluqa Waqt
English: Silodosin Recordati 8 mg hard capsules Silodosin Recordati 4 mg hard capsules silodosin
Maltese: Silodosin Recordati 8 mg kapsuli ibsin Silodosin Recordati 4 mg kapsuli ibsin silodosin
English: In a placebo-controlled study in 24 subjects 45-78 years of age receiving silodosin, the co-administration of sildenafil 100 mg or tadalafil 20 mg induced no clinically meaningful mean decreases in systolic or diastolic blood pressure, as assessed by orthostatic tests (standing versus supine).
Maltese: Fi studju kkontrollat bil-plaċebo fuq 24 pazjent ta' 45-78 sena li kienu qegħdin jieħdu silodosin, l-għoti fl-istess ħin ta' sildenafil 100 mg jew tadalafil 20 mg ma kkaġunax tnaqqis medju klinikament sinifikanti fil-pressjoni sistolika jew dijastolika tad-demm, kif imkejjel b'testijiet ortostatiċi (bilwieqfa mqabbel ma' mimdud).
English: In an interaction study, a 3.7-fold increase in maximum silodosin plasma concentrations and a 3.1-fold increase in silodosin exposure (i.e. AUC) were observed with concurrent administration of a potent CYP3A4 inhibitor (ketoconazole 400 mg).
Maltese: Fi studju tal-interazzjoni, ġiet osservata żieda ta' 3.7 darbiet fil-konċentrazzjonijiet massimi ta' silodosin fil-plażma u żieda ta' 3.1 darbiet fl-esponiment għal silodosin (jiġifieri AUC) bl-għoti simultanju ta' inibitur b'saħħtu ta' CYP3A4
English: Syncope Loss of consciousness1
Maltese: Urtikarja1 Eruzzjoni minħabba lmediċina1
English: INFORMATION IN BRAILLE silodosin recordati 4 mg
Maltese: silodosin recordati 4 mg
English: In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during treatment with silodosin (see section 4.8), due to the pharmacodynamic properties of silodosin.
Maltese: Fi studji kliniċi, ġie osservat is-seħħ ta' eġakulazzjoni b'inqas jew l-ebda semen waqt kura b'silodosin (ara sezzjoni 4.8), dovut għall-karatteristiċi farmakodinamiċi ta' silodosin.
English: Each capsule contains 4 mg of silodosin.
Maltese: Kull kapsula iebsa fiha 4 mg silodosin.
English: Dizziness
Maltese: Ġelatina
English: Baseline value (± SD)
Maltese: TWISSIJA(IET) SPEĊJALI
English: In total, 1,581 patients have received silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year.
Maltese: B'kollox, 1,581 pazjent irċevew silodosin f'doża ta' 8 mg darba kuljum, fosthom 961 pazjent esposti għal mill-anqas 6 xhur u 384 pazjent esposti għal sena.
English: Other medicines and Silodosin Recordati
Maltese: Mediċini oħra u Silodosin Recordati
English: Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Maltese: Billi teżisti biss esperjenza limitata f'pazjenti b'indeboliment moderat tal-kliewi (n = 35), hija rrakkomandata doża inizjali aktar baxxa ta' 4 mg.
English: If you have taken more than one capsule, inform your doctor as soon as possible.
Maltese: Jekk ħadt iżjed minn kapsula waħda, informa lit-tabib tiegħek mill-aktar fis possibbli.
English: Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Maltese: Silodosin Recordati jintuża f'irġiel adulti sabiex jittratta sintomi urinarji assoċjati ma' tkabbir beninn tal-prostata (iperplasija tal-prostata), bħal: