FrancophonIA/ELRC3.0 huggingface dataset:
English: Methyl parahydroxybenzoate (E 218), and propyl parahydroxybenzoate (E 216), may cause allergic reactions (possibly delayed).
Maltese: Methyl parahydroxybenzoate (E218), u propyl parahydroxybenzoate (E216), jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment ittardjati).
English: Erythema
Maltese: Rīga
English: Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Maltese: Zyclara huwa indikat għall-kura topika ta' keratosi aktinika (AK) viżibbli jew palpabbli, klinikament tipika, mhux iperkeratotika u mhux ipertrofika, tal-wiċċ kollu jew tal-qorriegħa li qed tiqriegħ f'adulti immunokompetenti meta għażliet oħra ta' kura topika huma kontra-indikati jew inqas xierqa.
English: The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
Maltese: L-aktar avveniment avvers klinikament serju rrappurtat wara dożi orali multipli ta' ≥ 200 mg kien pressjoni baxxa li għaddiet wara għoti ta' fluwidu orali jew fil-vini.
English: The data described below reflect exposure to Zyclara or vehicle in 319 subjects enrolled in two double-blind studies.
Maltese: Id-dejta deskritta taħt tirrifletti esponiment għal Zyclara jew għall-krema mingħajr mediċina f'319 individwu irreġistrati f'żewġ studji double-blind.
English: Via Felice Casati, 20 20124 Milano Tel: +39 039 73901
Maltese: Via Felice Casati, 20 20124
English: • if you have previously used this medicine or other similar preparations in a different concentration.
Maltese: • jekk qabel użajt din il-mediċina jew preparazzjonijiet oħra simili f'konċentrazzjoni differenti.
English: It is unknown whether imiquimod/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk imiquimod/metaboliti jiġux eliminati fil-ћalib tas-sider tal-bniedem.
English: Stearyl alcohol and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Maltese: Stearyl alcohol u cetyl alcohol jistgħu jikkawżaw reazzjonijiet lokali fil-ġilda (eż. dermatite talkuntatt).
English: INSTRUCTIONS ON USE
Maltese: Ipopigmentazzjoni u iperpigmentazzjoni
English: There are no data available of the use of imiquimod in children and adolescents.
Maltese: M'hemmx dejta disponibbli dwar l-użu ta' imiquimod fi tfal u adolexxenti.
English: Imiquimod cream therapy is not recommended until the skin has healed after any previous medicinal products or surgical treatment.
Maltese: Terapija bil-krema imiquimod mhix irrakkomandata qabel ma l-ġilda tkun fieqet wara kwalunkwe kura bi prodotti mediċinali jew kirurġija.
English: Persistent topical overdosing of imiquimod cream could result in severe local skin reactions and may increase the risk for systemic reactions.
Maltese: Dożaġġ topiku eċċessiv u persistenti ta' krema imiquimod jista' jwassal għal reazzjonijiet lokali severi fil-ġilda u jista' jżid ir-riskju ta' reazzjonijiet sistemiċi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zyclara in all subsets of the paediatric population in actinic keratosis (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din ilmediċina.
English: Application site dermatitis Application site bleeding Application site papules Application site paraesthesia Application site hyperaesthesia Application site inflammation Application site scar Application site skin breakdown Application site vesicles Application site warmth Asthenia
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Use in immunocompromised patients and/or in patients with autoimmune conditions The safety and efficacy of Zyclara in immunocompromised patients (e.g. organ transplant patients) and/or patients with autoimmune conditions have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zyclara f'pazjenti immunokompromessi (eż. pazjenti li kellhom trapjant ta'
English: The mean peak serum imiquimod concentration at the end of the pharmacokinetic study was 0.323 ng/mL.
Maltese: Il-konċentrazzjoni massima medja fis-serum ta' imiquimod fit-tmiem tal-istudju dwar ilfarmakokinetika kienet ta' 0.323 ng/mL.
English: In a follow-up study where initially cleared patients with imiquimod 3.75% were followed for at least 14 months without any further AK-treatment, 40.5% of the patients showed sustained complete clearance of the whole treatment area (either full face or scalp) There are no data for imiquimod 3.75% on long-term clearance beyond that.
Maltese: Fi studju ta' segwitu fejn pazjenti li inizjalment għaddielhom b'imiquimod 3.75% kienu segwiti għal mill-inqas 14-il xahar mingħajr aktar kura għal AK, 40.5% tal-pazjenti wrew fejqan komplut sostenut tal-erja kollha li kienet ikkurata (wiċċ kollu jew qorriegħa).
English: How to store Zyclara
Maltese: X'fih Zyclara
English: The safety and efficacy of imiquimod in actinic keratosis in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' imiquimod f'keratosi aktinika fit-tfal u adolexxenti b'età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: 821 02 Bratislava Tel: +421 2 32 199 100
Maltese: Tel: +421 2 32 199 100
English: In these studies, the treated AK field was located on the balding scalp or face with a contiguous area of about 40 cm² and presenting with a median number of 7 clinically typical AK lesions at baseline.
Maltese: 40 ċm² u ppreżentata b'numru medjan ta' 7 leżjonijiet AK klinikament tipiċi fil-linja bażi.
English: Nasal congestion Pharyngo laryngeal pain
Maltese: Anoreksja Żjieda ta' glucose fid-demm
English: Missed dose
Maltese: Skomdu Infjammazzjoni
English: Conjunctival irritation Eyelid oedema
Maltese: Uġigħ fl-estremitajiet
English: These studies showed that imiquimod was better than topical diclofenac in preventing the histological progression of AK lesions to in-situ or invasive squamous cell carcinoma (SCC).
Maltese: Dawn l-istudji wrew li imiquimod kien aħjar minn diclofenac topiku fil-prevenzjoni tal-progressjoni istoloġika ta' leżjonijiet AK għal karċinoma taċ-ċelluli skwamużi (SCC - squamous cell carcinoma) in-situ jew invażiva.
English: Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [14C] imiquimod in urine and faeces.
Maltese: Esponiment sistemiku (penetrazzjoni minn ġol-ġilda) kien ikkalkulat mill-irkupru ta' carbon-14 minn
English: Lymphadenopathy
Maltese: Letarġija
English: Very rare (<1/10,000) and not known (cannot be estimated from the available data)
Maltese: Rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli)
English: Nausea Diarrhoea Vomiting
Maltese: Infezzjoni Infafet bil-materja
English: In clinical trials most patients (159/160) using Zyclara for the treatment of AK experience local skin reactions (most frequently erythema, scab, and exfoliation/application site dryness) at the application site.
Maltese: Fi provi kliniċi l-biċċa l-kbira tal-pazjenti (159/160) li jużaw Zyclara għall-kura ta' AK ikollhom esperjenza ta' reazzjonijiet lokali fil-ġilda fis-sit ta' applikazzjoni (l-aktar frekwenti eritema, qoxra, u tqaxxir/nixfa fis-sit tal-applikazzjoni).
English: Management of overdose should consist of treatment of clinical symptoms.
Maltese: Immaniġġjar ta' doża eċċessiva għandu jikkonsisti minn trattament ta' sintomi kliniċi.
English: Rare (may affect up to 1 in 1,000 people) - Flaring up of autoimmune conditions (a disease that results from an abnormal immune response is an autoimmune disease) - Skin reactions remote from the application site
Maltese: - Kondizzjonijiet awtoimmuni jaggravaw (marda li tirriżulta minn rispons immuni mhux normali hija marda awtoimmuni) - Reazzjonijiet fil-ġilda mhux fis-sit tal-applikazzjoni
English: Local skin reactions in the treatment area are in part anticipated and common due to its mode of action (see section 4.4).
Maltese: Reazzjonijiet lokali tal-ġilda fl-erja kkurata huma parzjalment mistennija u komuni minħabba l-mod ta' azzjoni tiegħu (ara sezzjoni 4.4).
English: Serious skin reactions (frequency not known) with skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores.
Maltese: Reazzjonijiet serji tal-ġilda (frekwenza mhux magħrufa) b'feriti fil-ġilda jew ponot fuq il-ġilda li jibdew bħala żoni żgħar ħomor u javanzaw għal dehra ta' nfafet żgħar, possibilment b'sintomi bħal ħakk, deni, tħossok marid b'mod ġenerali, ġogi juġgħu, problemi fil-vista, ħruq, uġigħ jew ħakk flgħajnejn u feriti fil-ħalq.
English: and rash - Swollen glands - Headache - Dizziness - Loss of appetite - Nausea - Diarrhoea - Vomiting - Flu-like symptoms - Fever - Pain - Muscle and joint pain - Chest pain - Insomnia - Tiredness - Viral infection (herpes simplex) - Increase in blood glucose
Maltese: żjieda fis-sensittività għall-mess, ċikatriċi, sensazzjoni ta' sħana, indeboliment tal-ġilda, infafet jew ponot bil-materja - Debbulizza
English: Discomfort
Maltese: Sirdat
English: The incidence corresponds well with the spectrum of spontaneous tumours, as is known in mice in correspondence with their age.
Maltese: L-inċidenza tikkorrispondi sew mal-firxa ta' tumuri spontanji, kif huwa magħruf fil-ġrieden f'korrispondenza mal età tagħhom.
English: OTHER
Maltese: Eritema
English: Systemic reactions
Maltese: Reazzjonijiet sistemiċi
English: Whilst using Zyclara and until healed, the treatment area is likely to appear noticeably different from normal skin.
Maltese: Waqt li tkun qed tuża Zyclara u sakemm tfieq, iż-żona kkurata x'aktarx li tidher b'mod evidenti differenti minn ġilda normali.
English: During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Maltese: Waqt it-terapija u sal-fejqan, il-ġilda affettwata x'aktarx li tidher b'mod notevoli differenti minn ġilda normali.
English: However, only 11% (17/160) of patients in clinical trials with Zyclara required rest periods (treatment interruption) due to local adverse reactions.
Maltese: Madankollu, fil-provi kliniċi b'Zyclara 11% (17/160) tal pazjenti biss kellhom bżonn perijodi mingħajr mediċina (interruzzjoni tal-kura) minħabba reazzjonijiet avversi lokali.
English: 30 months
Maltese: 30 xahar
English: Lethargy
Maltese: Doża maqbuża
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Maltese: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne Franza
English: EU/1/12/768/001 EU/1/12/768/002 EU/1/12/768/003 EU/1/12/768/004 EU/1/12/768/005
Maltese: EU/1/12/768/001 EU/1/12/768/002 EU/1/12/768/003 EU/1/12/768/004
English: The elimination half-life ranges from 9 to 15 hours.
Maltese: Il-half-life tal-eliminazzjoni hija bejn 9 u 15-il siegħa.
English: Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
Maltese: Il-kisja tal-pillola: hypromellose, macrogol 6000, titanium dioxide (E171).
English: See sections 4.3, 4.4 and 5.2
Maltese: Ara sezzjonijiet 4.3, 4.4 u 5
English: The active substance is riluzole.
Maltese: - Is-sustanza attiva hija riluzole.
English: EU/1/12/768/001 - 56 film-coated tablets EU/1/12/768/002 - 28 film-coated tablets EU/1/12/768/003 - 98 film-coated tablets EU/1/12/768/004 - 112 film-coated tablets EU/1/12/768/005 - 168 film-coated tablets
Maltese: EU/1/12/768/001 - 56 pillola miksija b'rita EU/1/12/768/002 - 28 pillola miksija b'rita EU/1/12/768/003 - 98 pillola miksija b'rita EU/1/12/768/004 - 112-il pillola miksija b'rita EU/1/12/768/005 - 168 pillola miksija b'rita
English: Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring within 60 to 90 minutes (Cmax=173 ± 72 (sd) ng/ml).
Maltese: Riluzole huwa assorbit malajr wara t-teħid orali b'konċentrazzjonijiet massimi fil-plażma li jintlaħqu f'60 sa 90 minuta (Cmax = 173 ± 72 (sd) ng/ml).
English: The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Maltese: Iż-żmien medjan ta' sopravivenza kien ta' 17.7 xhur kontra 14.9 xhur għal riluzole u l-plaċebo, rispettivament.
English: Each package contains 28, 56, 98, 112 or 168 tablets.
Maltese: Kull pakkett fih 28, 56, 98, 112 jew 168 pillola.
English: About 90% of the dose is absorbed and the absolute bioavailability is 60 ± 18%.
Maltese: Madwar 90% tad-doża kienet assorbita u lbiodisponibilta` assoluta kienet ta' 60 ± 18%.
English: The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Maltese: Il-passaġġ metaboliku prinċipali ta' riluzole huwa l-ossidazzjoni inizjali permezz ta' ċitokromju P450 1A2 li tipproduċi N-hydroxy-riluzole (RPR112512), il-prodott metaboliku prinċipali attiv ta' riluzole.
English: The volume of distribution of riluzole is about 245 ± 69 L (3.4 L/kg).
Maltese: Il-volum ta' distribuzzjoni ta' riluzole kien ta' madwar 245 ± 69 L (3.4
English: Study data indicate that Asian patients may be more susceptible to liver function test abnormalities3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Maltese: Id-dejta tal-istudju tindika li l-pazjenti Asjatiċi jistgħu ikunu aktar suxxettibbli għar-riżultati mhux normali fit-testijiet dwar il-funzjoni tal-fwied -3.2% (194/5995) f'pazjenti Asjatiċi u 1.8% (100/5641) ta'pazjenti Kawkasi.
English: Date of first authorisation: 07 May 2012 Date of latest renewal: {DD month YYYY}
Maltese: Data tal-ewwel awtorizzazzjoni: 7 ta' Mejju 2012 Data tal-aħħar tiġdid: 09 ta' Jannar 2017
English: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Maltese: Il-qalba tal-pillola: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Maltese: Kategorija farmakoterapewtika: mediċini oħra għas-sistema nervuża, Kodiċi ATC:
English: Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Maltese: Riluzole huwa madwar 97% marbut mal-proteini u jintrabat l-aktar ma' l-albumina tas-serum mal-lipoproteini.
English: The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
Maltese: Il-parametri farmakokinetiċi ta' riluzole wara t-teħid ta' dożi multipli (4.5 jiem ta' kura b'50 mg riluzole bid) ma kienux effetwati f'nies akbar fl-età (> 70 sena).
English: The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Maltese: xaħam (tnaqqis f'Cmax ta' 44%, tnaqqis fl-AUC ta' 17%).
English: The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Maltese: Il-komportament farmakokinetiku ta' riluzole kien evalwat f'irġiel voluntiera u b'saħħithom wara li ttieħdet doża waħda orali ta' 25 sa 300 mg, kif ukoll dożi multipli orali minn 25 mg sa 100 mg bid.
English: There is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Maltese: M'hemmx differenza sinifikanti fil-parametri farmakokinetiċi bejn pazjenti b'insuffiċjenza kronika renali ta' grad moderat, jew sever, (il-clearance tal-krejatinina bejn 10 u 50 ml fil-minuta-1) meta mqabbla ma' voluntiera b'saħħithom, wara doża waħda orali ta' 50 mg ta' riluzole.
English: 56 film-coated tablets 28 film-coated tablets 98 film-coated tablets 112 film-coated tablets 168 film-coated tablets
Maltese: 56 pillola miksija b'rita 28 pillola miksija b'rita 98 pillola miksija b'rita 112-il pillola miksija b'rita 168 pillola miksija b'rita
English: Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent.
Maltese: Il livelli fil-plażma żdiedu linearment skond id-doża, u l-komportament farmakokinetiku kien indipendenti mid-doża wżata.
English: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Maltese: Riluzole għandu jintuża b'kawtela f'pazjenti li għandhom passat mediku ta' funzjoni abnormali talfwied, jew f'dawk il-pazjenti li għandhom livelli kemmxejn għoljin ta' l-enżimi transaminases fis serum (ALT/SGPT u AST/SGOT, sa 3 darbiet aktar mill-ogħla livell fil-firxa normali (ULN)); tal bilirubina u/jew tal-livelli ta' gamma-glutamyl transferase (GGT).
English: This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Maltese: Dan il-prodott huwa mibdul malajr f'O- u N-glucuronides.
English: Severe neutropenia (see section 4.4)
Maltese: Newtropenja severa (ara sezzjoni 4.4)
English: The effect of riluzole 50 mg/day was not statistically significant compared to placebo and the effect of 200 mg/day was essentially comparable to that of 100 mg/day.
Maltese: L-effett ta' riluzole 50 mg/jum ma kienx statistikament sinifikanti meta mqabbel mal-plaċebo, u l-effett ta' 200 mg/jum kien essenzjalment komparabbli ma' dak ta' 100 mg/jum.
English: Undesirable effects ranked under headings of frequency are listed below, using the following 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: <1/100), rari (minn ≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Other medicines and Riluzole Zentiva
Maltese: Mediċini oħra u Riluzole Zentiva
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Maltese: FOLJA TAL-PVC/ALUMINJU
English: A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Maltese: (Cmax 0.85 [90% CI 0.68-1.08] u AUC inf. 0.88 [90% CI 0.69-1.13] u espożizzjoni simili tal-prodott metaboliku.
English: The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Maltese: Is-sustanza attiva ta' Riluzole Zentiva hija riluzole li taħdem fuq is-sistema nervuża.
English: The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours).
Maltese: Id-doża rrakkomandata fl-adulti u f'nies akbar fl-età hija ta' 100 mg kuljum (50 mg kull 12-il siegħa).
English: Tests on the major active metabolite of riluzole gave positive results in two in vitro tests.
Maltese: Studji fuq il-prodott metaboliku principali u attiv ta' riluzole ta riżultati pożittivi f'żewġ testijiet in vitro.
English: Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Maltese: Riluzole Zentiva huwa disponibbli f'pakkett ta' 28, 56, 98, 112 jew 168 pillola biex jittieħdu mill ħalq.
English: Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: anaemia allergic reactions inflammation of the pancreas (pancreatitis).
Maltese: Effetti sekondarji mhux komuni (jistgħu jolqtu sa persuna 1 minn kull 100) ta' Riluzole Zentiva huma: - anemija
English: Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Maltese: Riluzole Zentiva huwa kontraindikat fit-tqala (ara sezzjonijiet 4.3 u 5.3).
English: Abnormal liver function tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: How to store Riluzole Zentiva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In case of overdose, treatment is symptomatic and supportive.
Maltese: F'każ ta' doża eċċessiva, l-kura hija sintomatika u supportiva.
English: No malformations were seen in animal reproductive studies.
Maltese: Ma ġewx osservati malformazzjonijiet fi studji riproduttivi fl-annimali.
English: Interstitial lung disease (see section 4.4)
Maltese: Mard tal-pulmun interstizjali (ara sezzjoni 4.4)
English: Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Maltese: Riluzole mhux mibdul huwa s-sustanza prinċipali fil-plażma u huwa estensivament metaboliżżat minn ċitokromju P450 u permezz tal-glukoronidazzjoni sussegwenti.
English: Core
Maltese: IMPORTANTI
English: PC: SN: NN:
Maltese: Tel.:
English: These increases could be associated with jaundice.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Maltese: Studji kliniċi wrew li Riluzole Zentiva itawwal il-ħajja ta' pazjenti bl-ALS (ara sezzjoni 5.1).
English: Standard tests for genotoxicity performed with riluzole were negative.
Maltese: Testijiet standard għall-ġenotossiċita b'riluzole kienu negattivi.
English: Riluzole Zentiva 50 mg film-coated tablets
Maltese: Riluzole Zentiva 50 mg pilloli miksija b'rita
English: Breast-feeding
Maltese: Fil-fażi
English: Anaphylactoid reaction, angioedema
Maltese: Reazzjoni anafilattojdi, angjoedima
English: Tel: + 48 22 375 92 00
Maltese: Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00
English: The metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged riluzole.
Maltese: Il-prodotti metaboliċi identifikati fl-awrina huma tliet phenolic derivatives,
English: The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
Maltese: L-AUC ta' riluzole wara doża waħda orali ta' 50 mg tiżdied b'madwar 1.7 drabi f'pazjenti li għandhom insuffiċjenza kronika ħafifa tal-fwied, u b'madwar 3 darbiet f'pazjenti li għandhom insuffiċjenza kronika moderata tal-fwied.
English: With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days.
Maltese: Fil-każ ta' dożi multipli (kura ta' 10 ijiem b'doża ta' 50 mg riluzole bid), riluzole mhux mibdul akkumula fil-plażma b'bejn wieħed u ieħor id-doppju u intlaħaq stat stabbli u miżmum f'inqas minn 5 ijiem.
English: Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Maltese: Riluzole Zentiva ma ntweriex li kien effettiv fi stadji avanzati ta' ALS.
English: In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Maltese: Studji in vitro, fejn intużaw preparati mill-fwied tal-bniedem, urew li ċitokromju P450 1A2 huwa l-iżoenżima prinċipali involuta filmetaboliżmu ta' riluzole.
English: This leaflet was last approved in {MM/YYYY}.
Maltese: Ċ KONDIZZJONIJIET U REKWIŻITI OĦRA TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ.