FrancophonIA/ELRC3.0 huggingface dataset:
English: These belong to a group of medicines called local anaesthetics.
Maltese: Dawn jappartjenu għal grupp ta' mediċini msejħa anestetiċi lokali.
English: Also the loss of protective reflexes can permit corneal irritation and potential abrasion.
Maltese: Barra minn hekk, it-telf tar-riflessi protettivi jistgħu jwasslu għal irritazzjoni tal-kornea u grif potenzjali.
English: • Feeling light-headed or dizzy
Maltese: • ħmura fuq il-pene u madwaru
English: Deterioriation was observed when Fortacin was used with polyurethane-based female and male condoms.
Maltese: Kienet osservata deterjorazzjoni meta Fortacin ntuża ma' kondoms tal-irġiel u n-nisa magħmulin millpolyurethane.
English: Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects.
Maltese: L-iskumdità vulvovaġinali jew is-sensazzjoni ta' ħruq ikkawżaw il-waqfien tat-trattament f'0.3% tas-suġġetti.
English: Women of childbearing potential / contraception in male and females
Maltese: Nisa li jistgħu jinqabdu tqal / kontraċezzjoni fl-irġiel u n-nisa
English: The effectiveness of the medicinal product has been demonstrated to persist on repeat use over time.
Maltese: L-effikaċja tal-prodott mediċinali ntweriet li tippersisti bl-użu ripetut matul iż-żmien.
English: • Benzocaine - a local anaesthetic used to treat pain and itching
Maltese: • Benzocaine - anestetiku lokali li jintuża biex jittratta l-uġigħ u l-ħakk
English: Patients with severe hepatic impairment
Maltese: Pazjenti b'indeboliment epatiku sever
English: The following side effects have been reported with Fortacin in female partners:
Maltese: Ġew irrappurtati l-effetti sekondarji li ġejjin b'Fortacin fil-pazjenti rġiel:
English: In an in vitro study of rats Fortacin has shown a reduction in sperm motility when 22.5 mg lidocaine and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm.
Maltese: Effett fuq il-fertilità Fi studju in vitro tal-firien, Fortacin wera tnaqqis fil-motilità tal-isperma meta 22.5 mg lidocaine u
English: At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation.
Maltese: Profil ta' Eġakulazzjoni Prematura (PEP) relatat mal-kontroll ipperċepit fuq l-eġakulazzjoni, l iskumdità personali relatata mal-eġakulazzjoni, is-sodisfazzjon bl-att sesswali, u d-diffikultà interpersonali fir-rigward tal-eġakulazzjoni.
English: Fortacin provides topical anaesthesia to the glans penis.
Maltese: Fortacin jipprovdi anestesija topika għall-pene glans.
English: There are no or limited amount of data from the use of lidocaine and prilocaine in pregnant women.
Maltese: M'hemmx data jew hemm data limitata dwar l-użu ta' lidocaine u prilocaine f'nisa tqal.
English: 3 inhalers (3 x 60 doses)
Maltese: 3 inalaturi (3 x 60 doża)
English: 1 inhaler (60 doses)
Maltese: Inalatur wieħed (60 doża)
English: MA (EU) number Invented name Strength Pharmaceutical
Maltese: Numru tal-MA (EU)
English: The full EPAR for Revatio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Revatio contains the active substance sildenafil.
Maltese: Revatio fih is-sustanza attiva s-sildenafil.
English: The CHMP concluded that Revatio provides an alternative treatment option for PAH.
Maltese: Is-CHMP ikkonkluda li Revatio jipprovdi għażla ta' kura alternattiva għall-PAH.
English: Revatio is available as tablets (20 mg), a solution for injection (0.8 mg/ml) and a powder to be made up into an oral suspension (10 mg/ml).
Maltese: Revatio jiġi f'kapsuli (20 mg), soluzzjoni għall-injezzjoni (0.8 mg/ml) u trab li jinħall f'sospensjoni orali (10 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revatio on 28 October 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Revatio valida fl-Unjoni Ewropea kollha fit-28 ta' Ottubru 2005.
English: The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Maltese: Is-sustanza attiva f'Revatio, is-sildenafil, tappartjeni lil grupp ta' mediċini msejħa “inibituri talfosfodjesterażi tat-tip 5 (PDE5)”, li jfisser li timblokka l-enzima PDE5.
English: Why is Revatio approved?
Maltese: Għaliex ġie approvat Revatio?
English: This is a summary of the European public assessment report (EPAR) for Revatio.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Revatio.
English: In children aged 1 to 17 years, the recommended dose is 10 mg three times a day in children weighing less than 20 kg and 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Maltese: Fi tfal minn sena sa 17-il sena, id-doża rakkomandata hija 10 mg tliet darbiet kuljum fi tfal li jiżnu inqas minn 20 kg, jew 20 mg tliet darbiet kuljum f'dawk li jiżnu iżjed minn 20 kg.
English: In adults, Revatio is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Maltese: Fl-adulti, Revatio jintuża fuq pazjenti li jbatu minn PAH tal-klassi II (limitazzjoni parzjali fl-attività fiżika) jew talklassi III (limitazzjoni notevoli fl-attività fiżika).
English: Revatio must not be taken by patients who have ever had a problem with blood flow in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Maltese: Revatio ma għandux jittieħed minn pazjenti li xi darba kellhom problema bil-fluss tad-demm flgħajnejn imsejħa neuropatija ottika iskemika anterjuri non-arteritika (NAION).
English: Other information about Revatio
Maltese: Aktar informazzjoni dwar Revatio
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Maltese: PAH hija marda debilitanti u jkun hemm restrizzjoni (tidjiq) gravi fil-vażijiet tal-pulmuni.
English: Revatio must not be taken with nitrates (medicines used to treat angina), or with medicines that could affect the way that Revatio is broken down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to treat HIV infection).
Maltese: Revatio ma għandux jittieħed flimkien ma' nitriti (grupp ta' mediċini użat fil-kura tal-anġina), jew ma' mediċini li aktarx jaffettwaw il-mod kif Revatio jitkisser fil-ġisem, bħall-ketokonażolu jew l-itrakonażolu (mediċini antifungali) u r-ritonavir (użat fil-kura tal-infezzjoni HIV).
English: What are the risks associated with Revatio?
Maltese: X'inhuma r-riskji assoċjati ma' Revatio?
English: The main study in adults involved 277 patients with PAH, most of whom had class II or class III disease.
Maltese: Fl-istudju ewlieni fuq l-adulti ħadu sehem 277 pazjent b'PAH, li l-parti l-kbira minnhom kellhom ilmarda tal-klassi II jew III.
English: The main study in children involved 235 children aged 1 to 17 years with PAH.
Maltese: Fl-istudju ewlieni fuq it-tfal ħadu sehem 235 tifel u tifla b'PAH li kellhom bejn sena u 17-il sena.
English: In adults, Revatio is taken at a dose of 20 mg three times a day.
Maltese: Fl-adulti, Revatio jittieħed f'doża ta' 20 mg tliet darbiet kuljum.
English: The company also presented the results of studies showing that the tablets were equivalent to the oral suspension (produced similar levels of sildenafil in the blood), and that a 10 mg injection was equivalent to a 20 mg tablet.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studji li juru li l-pilloli kienu ekwivalenti għas-sospensjoni orali (kapaċi jipproduċu livelli simili tas-sildenafil fid-demm), u li injezzjoni ta' 10 mg kienet ekwivalenti għal pillola ta' 20 mg.
English: Before treatment, adults with class II disease could walk an average of 378m in 6 minutes.
Maltese: Qabel il-kura, l-adulti bil-marda tal-klassi II setgħu jimxu distanza medja ta' 378m f'6 minuti.
English: After 16 weeks, the maximum volume of oxygen the children used during exercise increased on average by 10.2% with Revatio compared with 0.5% with placebo.
Maltese: 2% b'Revatio meta mqabbel ma' 0.5% bil-plaċebo.
English: This enzyme is found in the blood vessels of the lungs.
Maltese: Din l-enzima tinstab fil-vażijiet tal-pulmuni.
English: In children, the most common side effects (which may affect up to 1 patient in 10) are throat and nose infections, headache, vomiting, fever, diarrhoea, flu and nosebleeds.
Maltese: Fit-tfal, leffetti sekondarji l-aktar komuni (li jistgħu jaffettwaw sa pazjent 1 minn 10) huma infezzjonijiet talgriżmejn u tal-imnieħer, uġigħ ta' ras, rimettar, deni, dijarrea, influwenza u fsada mill-imnieħer.
English: In adults who cannot take the tablets or oral suspension, the solution for injection is injected into a vein by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day.
Maltese: Fladulti li ma jistgħux jieħdu l-pilloli jew is-sospensjoni orali, is-soluzzjoni għal injezzjoni tiġi injettata filvina minn tabib jew ners f'doża ta' 10 mg (12.5 ml) tliet darbiet kuljum.
English: Revatio is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Maltese: Revatio huwa mediċina li tintuża fil-kura tal-adulti u tfal minn sena 'l fuq li jbatu minn ipertensjoni pulmonari arterjali (PAH, pressjoni tad-demm għolja mhux normali fl-arterji tal-pulmun).
English: How does Revatio work?
Maltese: Kif jaħdem Revatio?
English: The most common side effects with Revatio in adults (which may affect more than 1 patient in 10) are headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and pain in arm or leg. Side effects are similar with the solution for injection.
Maltese: L-effetti sekondarji l-aktar komuni fl-adulti bl-użu ta' Revatio (li jistgħu jaffettwaw aktar minn pazjent 1 minn 10) kienu wġigħ ta' ras, vampi (ħmura fil-ġilda), dispepsija (ħruq ta' stonku), dijarrea u wġigħ fid-dirgħajn jew ir-riġlejn.
English: Revatio was more effective than placebo (a dummy treatment) at improving exercise capacity in one main study in adults and another main study in children.
Maltese: Revatio kien aktar effettiv minn plaċebo (kura finta) fit-titjib tal-kapaċità għall-eżerċizzju fi studju ewlieni wieħed fuq l-adulti u studju ewlieni ieħor fuq it-tfal.
English: Adults with class III disease could walk an average of 326 m at the start of the study.
Maltese: L-adulti bil-marda tal-klassi III setgħu jimxu distanza medja ta' 326 m fil-bidu tal-istudju.
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Maltese: Meta tiġi imblukkata, sustanza msejħa "gwanina monofosfat ċikliku" (cGMP) ma tkunx tista' titkisser u tibqa' fil-vażijiet fejn tikkawża rilassament u twessigħ tal-vażijiet.
English: The company that markets Revatio will agree with each European Union Member State on how the solution for injection will be distributed.
Maltese: Il-kumpanija li tqiegħed lil Revatio fis-suq se tiftiehem ma' kull Stat Membru tal-Unjoni Ewropea dwar kif is-soluzzjoni għall-injezzjoni se tiġi distribwita.
English: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10
Maltese: Razza A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136) 10
English: --1 1 dose (0.2 ml) contains:
Maltese: --1 1 doża (0.2 ml) fiha:
English: 10 sprayers
Maltese: 10 sprejers
English: Nasal spray, suspension
Maltese: Sprej għallimnieħer, sospensjoni
English: Reassortant influenza virus* (live attenuated) of the following strain**:
Maltese: Virus tal-influwenza reassortanti* (attenwat ħaj) tar-razza li ġejja**:
English: EU/1/16/1089/001 Pandemic influenza vaccine H5N1 AstraZeneca
Maltese: EU/1/16/1089/001 Tilqima kontra linfluwenza
English: ** produced in VERO cells by reverse genetic technology.
Maltese: ** prodott f'ċelluli VERO permezz ta' teknoloġija ġenetika riversa.
English: Nasal use sprayer (glass) in trays
Maltese: Użu nażali sprejer (ħġieġ) fi trejs
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Maltese: * propagat fil-bajd fertilizzat tat-tiġieġ minn qtajja' ta' tiġieġ f'saħħithom.
English: *** fluorescent focus units
Maltese: Dan il-prodott fih organiżmu ġenetikament modifikat (OĠM). *** unitajiet ta' fokus fluworexxenti
English: Strength Pharmaceutical Form Route of Administration
Maltese: Isem (Ivvintat) Qawwa Għamla Farmaċewtika
English: Immediate Packaging
Maltese: Daqs tal-Pakkett
English: EMA Number
Maltese: Numru tal-proċedura talEMA
English: Pack size
Maltese: Il-Pakkett li Jmiss mal-Prodott
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015 EMA/683814/2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015
English: Inductos to be suspended in the EU EMA/683814/2015
Maltese: EMA/683814/2015
English: • There are alternative treatments available in the EU.
Maltese: • M'hemm ebda kura alternattiva disponibbli fl-UE.
English: EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements.
Maltese: L-EMA bdiet reviżjoni ta' Inductos wara spezzjoni mill-awtoritajiet Olandiżi u Spanjoli li sabet li s-sit ta' manifattura tal-isponża assorbibbli mhuwiex konformi mar-rekwiżiti ta' manifattura.
English: On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
Maltese: Fit-22 ta' Ottubru 2015, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat is-sospensjoni ta' Inductos, impjant li jintuża biex jgħin fl-iżvilupp ta' għadam ġdid f'pazjenti bi problemi fid-disk talispina u bi ksur fis-saqajn.
English: Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix).
Maltese: Inductos huwa disponibbli bħala kitt għal impjant li fih trab, solvent u sponża (jew matriċi) tal-kollaġen assorbibbli.
English: Suspension will remain until manufacturing issues are resolved
Maltese: Is-sospensjoni ser tibqa' effettiva sakemm jiġu solvuti l-kwistjonijiet ta' manifattura
English: The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue.
Maltese: Is-sustanza attiva hija dibotermin alfa, proteina li taġixxi fuq l-istruttura tal-għadam u tgħin bilformazzjoni ta' tessut tal-għadam ġdid.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali li torbot legalment applikabbli fl-Istati Membri tal-UE kollha fi 20/11/2015.
English: The review of Inductos was initiated on 23 July 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Inductos inbdiet fil-23 ta' Lulju 2015 fuq talba mill-Kummissjoni Ewropea, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process.
Maltese: Għalkemm m'hemm ebda indikazzjoni ta' riskju għall-pazjenti marbut mas-sejbiet tal-ispezzjoni, ilKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA kkunsidra li l-kwalità ta' Inductors ma tistax tiġi assigurata bil-proċess ta' manifattura attwali.
English: Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
Maltese: Inductos ser jibqa' sospiż sakemm jiġu solvuti l-kwistjonijiet bis-sit ta' manifattura għal wieħed mill-komponenti ta' Inductos (sponża assorbibbli).
English: • Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
Maltese: • Ġew identifikati problemi bil-mod li bih tiġi mmanifattura l-isponża assorbibbli f'Inductos.
English: • Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
Maltese: • Għalkemm m'hemm ebda indikazzjoni ta' riskju għall-pazjenti, Inductos ġie sospiż u mhux ser jibqa' disponibbli iktar fl-UE sakemm jiġu solvuti l-kwistjonijiet bis-sit ta' manifattura għall-isponża assorbibbli.
English: It was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Maltese: Din twettqet mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP), responsabbli għal mistoqsijiet dwar il-mediċini għall-użu mill-bnedmin.
English: Inductos was authorised centrally in the EU in September 2002.
Maltese: Inductos kien awtorizzat fuq livell ċentrali fl-UE f'Settembru 2002.
English: It is used during surgery in patients with damaged spinal discs or leg (tibia) fractures.
Maltese: Ġeneralment jintuża matul operazzjoni f'pazjenti b'disks tal-ispina bi ħsara jew ksur fissaqajn (qasba tas-sieq).
English: The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Maltese: L-ispetturi osservaw li l-manifattur, li jinsab fl-Istati Uniti, ma kellux miżuri adegwati fis-seħħ biex jipprevjeni lkontaminazzjoni bil-frak tal-isponoż.
English: The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.
Maltese: Ir-rakkomandazzjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li approvatha u ħarġet deċiżjoni finali li torbot legalment.
English: More about the medicine
Maltese: Iktar dwar il-mediċina
English: IMPORTANT
Maltese: IMPORTANTI
English: Each package contains 56 tablets.
Maltese: Kull pakkett fih 56 pillola.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE RILUTEK
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: Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Maltese: Inibituri ta' CYP 1A2 (eż. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline u quinolones) potenzjalment jistgħu jnaqqsu r-rata tat-tneħħija ta' riluzole, fil-waqt li indutturi ta' CYP 1A2 (e.g. id-duħħan tas-sigaretti, ikel mixwi fuq il-faħam, rifampicin u omeprazole) jistgħu jżidu r-rata tat-tneħħija ta' riluzole.
English: Impaired renal function
Maltese: Indeboliment fil-funzjoni renali
English: Core:
Maltese: NN:
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: Ir-rata u l-grad ta' assorbiment tnaqqsu meta riluzole ittieħed ma' ikliet li kellhom kontenut għoli ta' xaħam (tnaqqis f'Cmax ta' 44%, tnaqqis fl-AUC ta' 17%).
English: date of first authorisation: 10 June 1996 date of last renewal: 10 June 2006
Maltese: Data ta' l-aħħar tiġdid: 10 ta' Ġunju 2006
English: Marketing Authorisation Holder Sanofi Mature IP
Maltese: Sanofi Mature IP
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: Il-grupp Ġappuniż wera espożizzjoni anqas ta' riluzole (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: Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Maltese: Kull pillola fiha 50 mg ta' riluzole u b'“RPR 202” imnaqqax fuq naħa waħda.
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: 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 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, wieħed tat-tip ureido u riluzole mhux mibdul.
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: L-effetti mhux mixtieqa miġburin,, huma mniżżlin skond il-frekwenza tagħhom, skond din ilkonvenzjoni: komuni ħafna (1/10), komuni (minn 1/100 sa <1/10), mhux komuni (minn 1/1,000 sa <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: Impaired hepatic function
Maltese: Indeboliment fil-funzjoni epatika
English: RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
Maltese: RILUTEK huwa kontraindikat fit-tqala (ara sezzjonijiet 4.3 u 5.3).
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 fisserum (ALT/SGPT u AST/SGOT, sa 3 darbiet aktar mill-ogħla livell fil-firxa normali (ULN)); talbilirubina u/jew tal-livelli ta' gamma-glutamyl transferase (GGT).
English: The active substance in RILUTEK is riluzole which acts on the nervous system.
Maltese: Is-sustanza attiva ta' RILUTEK hija riluzole li taħdem fuq is-sistema nervuża.
English: Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8).
Maltese: Żieda fil-linja bażi ta' diversi testijiet tal-funzjoni tal-fwied (speċjalment livelli għoljin ta' bilirubina) jipprekludi l-użu ta' riluzole (ara sezzjoni 4.8).
English: RILUTEK
Maltese: Tqala
English: Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Maltese: Studji ta' fertilità fil-firien urew xi ftit ta' indeboliment fil-ħila riproduttiva u l-fertilità f'dożi ta' 15 mg/kg/jum (li hija ogħla mid-doża terapewtika), probabbli minħabba ħedla u l-letarġija.