FrancophonIA/ELRC3.0 huggingface dataset:
English: [Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
Maltese: [Isem ivvintat] jaħdem billi joqtol il-batterja li tikkawża infezzjonijiet. jekk dawn huma kkawżati minn batterja li hija suxxettibli għas-sustanza attiva moxifloxacin.
English: Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Maltese: Mediċini li jinibixxu l-peristalsi huma kontra-indikati f'pazjenti li jiżviluppaw dijarea serja.
English: - If you suffer from myasthenia gravis taking [Invented name] may worsen the symptoms of your disease.
Maltese: - Jekk issofri minn myasthenia gravis it-teħid ta' [Isem ivvintat] jista' jaggrava s-sintomi tal-marda tiegħek.
English: 4.8 Undesirable effects:
Maltese: .8 Effetti mhux mixtieqa
English: 4.2 Posology and method of administration Duration of administration Acute bacterial sinusitis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: ANNESS III EMENDI LIS-SOMMARJU TAL-KARATTERISTIĊI
English: Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Maltese: Moxifloxacin għandu jintuża għall-kura ta' ABS u AECB iddijanjosati b'mod adegwat biss meta l-użu ta' sustanzi anti-batteriċi li huma rrakkomandati b'mod komuni għall-kura tal-bidu ta' dawn l-infezzjonijiet huwa kkunsidrat bħala mhux xieraq jew meta dawn fallew li jfejjqu linfezzjoni.
English: EMA/622457/2010 EMEA/H/C/000133
Maltese: EMEA/H/C/000133
English: The full EPAR for Sifrol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Sifrol jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as ‘immediaterelease' white tablets (round: 0.088, 0.7 and 1.1 mg; oval: 0.18 and 0.35 mg) and as ‘prolongedrelease' white tablets (round: 0.26 and 0.52 mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15 mg).
Maltese: Huwa disponibbli bħala pilloli bojod ‘b'rilaxx immedjat' (tondi: 0.088, 0.7 u 1.1 mg; ovali: 0.18 u 0.35 mg) bħala pilloli bojod ‘b'rilaxx imtawwal' (tondi: 0.26 u 0.52 mg; ovali: 1.05, 1.57, 2.1, 2.62 u 3.15 mg).
English: The active substance in Sifrol, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Maltese: Is-sustanza attiva f'Sifrol, il-pramipexole, hija agonista tad-dopamina (sustanza li timita l-azzjoni taddopamina).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sifrol to Boehringer Ingelheim International GmbH on 14 October 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sifrol lil Boehringer Ingelheim International GmbH fl-14 ta' Ottubru 1997.
English: This document is a summary of the European Public Assessment Report (EPAR) for Sifrol.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal Sifrol.
English: Sifrol is a medicine that contains the active substance pramipexole.
Maltese: Sifrol huwa mediċina li fiha s-sustanza attiva pramipexole.
English: • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: • sindromu minn moderat sa gravi tar-riġlejn irrekwieti (restless legs syndrome), li huwa disturb li bih il-pazjent ikollu impuls bla rażan biex iċaqlaq riġlejh ħalli jwaqqaf sensazzjonijiet skomdi jew strambi jew li jweġġgħu fil-ġisem, normalment matul il-lejl.
English: Four studies compared Sifrol with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Maltese: Erba studji qabblu Sifrol ma' plaċebo (trattament finta): studju minnhom twettaq fuq 360 pazjent bil-marda avvanzata li diġà kienu qegħdin jieħdu levodopa li kien qed isir inqas effikaċi, u tliet studji twettqu f'total ta' 886 pazjent bil-marda fl-istadju inizjali li ma kinux qegħdin jieħdu levodopa.
English: Why has Sifrol been approved?
Maltese: Għaliex ġie approvat Sifrol?
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: • Il-marda ta' Parkinson, disturb progressiv tal-moħħ li jikkawża rogħda, dewmien fil-movimenti u ebusija tal-muskoli.
English: The maximum daily dose is three 1.1-mg immediate-release tablets or one 3.15-mg prolonged-release tablet.
Maltese: Id-doża massima kuljum hija ta' tliet pilloli b'rilaxx immedjat ta' 1.1 mg, jew pillola b'rilaxx imtawwal ta' 3.15 mg darba kuljum.
English: The second included 150 patients who took Sifrol for six months, and compared the effects of remaining on Sifrol with switching to placebo.
Maltese: It-tieni wieħed inkluda 150 pazjent li ħadu Sifrol tul sitt xhur, u qabbel l-effetti ta' meta pazjent jibqa' jieħu Sifrol jew jaqleb għal plaċebo.
English: For Parkinson's disease, the starting dose is either one 0.088-mg immediate-release tablet three times a day or one 0.26-mg prolonged-release tablet once a day.
Maltese: Għall-marda ta' Parkinson, id-doża inizjali hija ta' pillola waħda b'rilaxx immedjat ta' 0.088 mg tliet darbiet kuljum jew pillola b'rilaxx imtawwal waħda ta' 0.26 mg darba kuljum.
English: In restless legs syndrome, Sifrol immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Sifrol was greatest after four weeks before getting smaller.
Maltese: Fis-sindromu tar-riġlejn irrekwieti, il-pilloli Sifrol b'rilaxx immedjat kienu iktar effikaċi mill-plaċebo fittnaqqis tas-sintomi fuq 12-il ġimgħa, iżda d-differenza bejn il-plaċebo u Sifrol kienet l-iktar evidenti wara erba' ġimgħat qabel ma din reġgħet naqset.
English: The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg.
Maltese: Id-doża inizjali rakkomandata hija ta' 0.088 mg, iżda jekk ikun meħtieġ din tista' tiżided kull erba' sa sebat ijiem sabiex is-sintomi jibqgħu jonqsu, sa massimu ta' 0.54 mg.
English: What is Sifrol?
Maltese: X'inhu Sifrol?
English: The fifth study compared Sifrol with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.
Maltese: Il-ħames studji qabbel Sifrol ma' levodopa fi 300 pazjent bil-marda fl-istadu inizjali, u kkalkula l-għadd ta' pazjenti li kellhom sintomi filmovimenti.
English: In patients with Parkinson's disease, the following side effects are also seen in more than 1 patient in 10: dizziness, dyskinesia (difficulty controlling movement) and somnolence (sleepiness).
Maltese: Fil-pazjenti li jbatu mill-marda ta' Parkinson l-effetti sekondarji li ġejjin dehru f'aktar minn pazjent 1 minn 10: sturdament, diskinesija (diffikultà fil-kontroll tal-movimenti) u ħedla.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.
Maltese: Huwa maħsub li s-sindromu huwa kkawżat minn problemi fil-mod kif id-dopamina taħdem fil-moħħ li jista' jitjieb permezz tal-pramipexole.
English: What is the risk associated with Sifrol?
Maltese: X'inhu r-riskju assoċjat ma' Sifrol?
English: Sifrol must be given less often in patients who have problems with their kidneys.
Maltese: Sifrol għandu jingħata anqas ta' spiss lil pazjenti li għandhom problemi fil-kliewi.
English: In Parkinson's disease, Sifrol immediate-release tablets have been studied in five main studies.
Maltese: Fil-marda ta' Parkinson, il-pilloli Sifrol b'rilaxx immedjat ġew studjati f'ħames studji ewlenin.
English: How has Sifrol been studied?
Maltese: Kif ġie studjat Sifrol?
English: The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in treating Parkinson's disease.
Maltese: L-istudji addizzjonali wrew li l-pilloli b'rilaxx imtawwal kienu effikaċi daqs il-pilloli b'rilaxx immedjat fittrattament tal-marda ta' Parkinson.
English: The way pramipexole works in restless legs syndrome is not fully understood.
Maltese: Għadu mhuwiex kompletament mifhum il-mod kif taħdem il-pramipexole fis-sindromu tar-riġlejn irrekwieti.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Maltese: Il-pramipexole jistimola l-moħħ bħalma tagħmel id-dopamina, biex b'hekk il-pazjenti jkunu jistgħu jikkontrollaw il-movimenti tagħhom u jkollhom inqas sinjali u sintomi tal-marda ta' Parkinson, bħar-rogħda, l-ebusija u d-dewmien filmovimenti.
English: Other information about Sifrol:
Maltese: Aktar tagħrif dwar Sifrol:
English: Sifrol can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Maltese: Sifrol jista' jintuża jew waħdu jew flimkien ma' levodopa (mediċina oħra għallmarda ta' Parkinson), f'kull stadju tal-marda inkluż fl-aħħar stadji meta levodopa jibda jkun anqas effikaċi.
English: The first compared Sifrol with placebo over 12 weeks in 344 patients and measured the improvement in symptoms.
Maltese: L-ewwel qabbel Sifrol ma' plaċebo fuq żmien ta' 12-il ġimgħa fi 344 pazjent u kejjel it-titjib tassintomi.
English: Sifrol was also more effective that levodopa at improving movement symptoms in early disease.
Maltese: Sifrol kien iktar effikaċi wkoll minn levodopa fit-titjib tassintomi tal-moviment fil-marda fl-istadju inizjali.
English: Sifrol is used to treat the symptoms of the following diseases:
Maltese: Sifrol jintuża fit-trattament tas-sintoma tal-mard li ġej:
English: 84 capsules (3 packs of 28)
Maltese: 84 kapsula (3 pakketti ta' 28)
English: • What multiple sclerosis is;
Maltese: • X'inhi sklerożi multipla;
English: Immunosuppressive effects
Maltese: Effetti immunosuppressivi
English: Annualised relapse rate (primary endpoint)
Maltese: Ir-rata ta' rikaduta annwalizzata (endpoint primarju)
English: Respiratory system
Maltese: Is-sistema respiratorja
English: • Signs and symptoms of infection;
Maltese: • Sinjali u sintomi ta' infezzjoni;
English: Date of first authorisation: 17 March 2011 Date of latest renewal: 23 November 2015
Maltese: Data tal-aħħar tiġdid: 23 ta' Novembru 2015
English: * p<0.05, ** p<0.001, compared to interferon beta-1a.
Maltese: * p<0.05, ** p<0.001, imqabbel ma' interferon beta-1a.
English: Malignant melanoma****
Maltese: Melanoma malinna****
English: Posterior reversible encephalopathy syndrome (PRES)*
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli (PRES)*
English: • GILENYA is teratogenic.
Maltese: • GILENYA hu teratoġeniku.
English: 7 x 1 hard capsule
Maltese: 7 x 1 kapsula iebsa
English: Fingolimod blood clearance is 6.32.3 l/h, and the average apparent terminal half-life (t1/2) is 6-9 days.
Maltese: It-tneħħija ta' fingolimod mid-demm hi ta' 6.32.3 l/h, u l-medja tal-half-life terminali apparenti (t1/2) hi ta' 6-9 ijiem.
English: - Immunodeficiency syndrome.
Maltese: - Sindromu tal-immunodefiċjenza.
English: Herpes viral infections Bronchitis
Maltese: Infezzjonijiet bil-virus tal-herpes Bronkite
English: • Cardiac monitoring guidance;
Maltese: • Jipprovdu monitoraġġ kardijaku;
English: Butyl alcohol
Maltese: Alkoħol butil
English: 98 capsules
Maltese: 98 kapsula
English: The immune system effects of Gilenya may increase the risk of infections, including opportunistic infections (see section 4.8).
Maltese: L-effetti tas-sistema immuni ta' Gilenya jistgħu jżidu r-riskju ta' infezzjonijiet, inkluż infezzjonijiet opportunistiċi (ara sezzjoni 4.8).
English: Fingolimod is metabolised mainly by CYP4F2.
Maltese: Fingolimod jiġi mmetabolizzat primarjament b'CYP4F2.
English: Isopropyl alcohol
Maltese: Alkoħol isopropil
English: - Severe active infections, active chronic infections (hepatitis, tuberculosis).
Maltese: o B'infezzjonijiet attivi gravi, infezzjonijiet kroniċi attivi (epatite, tuberkulożi).
English: Hepatic enzyme increased (increased ALT, Gamma glutamyltransferase, Aspartate transaminase)
Maltese: Żieda fl-enżimi tal-fwied (żieda f'ALT, Gamma glutamyltransferase, Aspartate transaminase)
English: MRI analyses used evaluable dataset.
Maltese: L-analiżi talMRI użat sett ta' dejta evalwattiva.
English: - Patients with a baseline QTc interval ≥ 500 msec (see section 4.4).
Maltese: - Pazjenti b'intervall tal-QTc fil-linja bażi ta' ≥500 msek (ara sezzjoni 4.4).
English: Fingolimod is a sphingosine 1-phosphate receptor modulator.
Maltese: Fingolimod huwa modulatur tar-riċettur tal-isfingosina 1-fosfat.
English: Capsule fill Mannitol
Maltese: Il-mili tal-kapsula Mannitol
English: Table 4 Study D2311 (PARADIGMS): main results
Maltese: Tabella 4 Studju D2311 (PARADIGMS): riżultati ewlenin
English: Adverse reactions reported with Gilenya 0.5 mg in Studies D2301 (FREEDOMS) and D2309 (FREEDOMS II) are shown below.
Maltese: Ir-reazzjonijiet mhux mixtieqa rrappurtati b'0.5 mg Gilenya waqt Studji D2301 (FREEDOMS) u D2309 (FREEDOMS II) qed jidhru hawn taħt.
English: • While on treatment, women must not become pregnant.
Maltese: • Waqt it-trattament, in-nisa ma jistgħux joħorġu tqal.
English: Fingolimod is extensively distributed to body tissues with a volume of distribution of about 1,200260 litres.
Maltese: Fingolimod jinfirex b'mod estensiv fit-tessuti tal-ġisem b'volum ta' distribuzzjoni ta' madwar 1,200260 litru.
English: • Other medicines: o protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or telithromycin.
Maltese: • Mediċini oħra: o impedituri ta' protease, anti-infettivi bħal ma huma ketoconazole, antifungali azole, clarithromycin jew telithromycin.
English: Clinical experience and pharmacokinetic information in patients aged above 65 years are limited.
Maltese: L-esperjenza klinika u l-informazzjoni farmakokinetika f'pazjenti ta' aktar minn 65 sena huma limitati.
English: Fingolimod absorption is slow (tmax of 12-16 hours) and extensive (≥85%).
Maltese: L-assorbiment ta' fingolimod isir bilmod (tmax ta' 12-16 -il siegħa) u b'mod estensiv (≥85%).
English: Nausea***
Maltese: Dardir***
English: - Severe liver impairment (Child-Pugh class C).
Maltese: - Indeboliment qawwi tal-fwied (Klassi C ta' Child-Pugh).
English: Propylene glycol (E1520) Purified water
Maltese: Glikol tal-propilen(E1520)
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA27
Maltese: Immunosuppressanti, immunosuppressanti selettivi, Kodiċi ATC:
English: In subjects with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, and C), no change in fingolimod Cmax was observed, but fingolimod AUC was increased respectively by 12%, 44%, and 103%.
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif, moderat, jew gravi (klassi A, B u C ta' Child-Pugh), ma deher l-ebda tibdil fis-Cmax ta' fingolimod, imma l-AUC ta' fingolimod żdied bi 12%, 44%, u 103% rispettivament.
English: Potent inhibitors of transporter proteins are not expected to influence fingolimod disposition.
Maltese: Inibituri potenti ta' proteini trasportaturi mhumiex mistennija jinfluwenzaw id-dispożizzjoni ta' fingolimod.
English: The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%).
Maltese: Il-maġġoranza tal-pazjenti kienu fi stadju 2 Tanner jew ogħla (94.4%) u kienu >40 kg (95.
English: Summary of Product Characteristics (SmPC);
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (SmPC);
English: Fingolimod 0.25 mg or 0.5 mg
Maltese: Fingolimod 0.25 mg jew 0.5 mg
English: Bradycardia Atrioventricular block
Maltese: Bradikardija Imblokk atrijuventikulari
English: In clinical studies 8.0% and 1.8% of adult patients treated with Gilenya 0.5 mg experienced an asymptomatic elevation in serum levels of ALT of ≥3x ULN (upper limit of normal) and ≥5x ULN, respectively.
Maltese: Fi studji kliniċi 8.0% u 1.8% tal-pazjenti adulti kkurati b'0.5 mg Gilenya kellhom żieda asintomatika fil-livelli ta' ALT fis-serum ta' ≥3x ULN (l-ogħla limitu tan-normal) u ta' ≥5x ULN, rispettivament.
English: Multipack: 84 (3 packs of 28) hard capsules.
Maltese: Pakkett b'ħafna: 84 (3 pakketti ta' 28) kapsula iebsa.
English: Lymphoma*** Squamous cell carcinoma****
Maltese: Limfoma*** Karċinoma taċ-ċellula skwamoża****
English: C] fingolimod, the major fingolimod-related components in blood, as judged from their contribution to the AUC up to 34 days post dose of total radiolabelled components, are fingolimod itself (23%), fingolimod phosphate (10%), and inactive metabolites (M3 carboxylic acid metabolite (8%), M29 ceramide metabolite (9%) and M30 ceramide metabolite (7%)).
Maltese: C] fingolimod, il-komponenti ewlenin relatati ma' fingolimod fiddemm, kif jidher mis-sehem tagħhom fl-AUC sa 34 jum wara d-doża tal-komponenti radjummarkati kollha, huma l-fingolimod innifsu (23%), il-fingolimod fosfat (10%), il-metaboliti inattivi (M3 metabolit tal-aċidu karbossiliku (8%), M29 metabolit taċ-ċeramidi (9%) u M30 metabolit taċ-ċeramid
English: Haemophagocytic syndrome
Maltese: Sindrome emofagoċitika
English: Approximately 15-20% of T lymphocytes have an effector memory phenotype, cells that are important for peripheral immune surveillance.
Maltese: Madwar 15-20% tal-limfoċiti T għandhom memorja b'fenotip effetturi, ċelloli li huma importanti fil-ħarsien tas-sistema immuni periferali.
English: Absolute lymphocyte count <0.2x10
Maltese: Għadd assolut tal-limfoċiti <0.2x10
English: • Corticosteroids, due to a possible added effect on the immune system.
Maltese: • Kortikosterojdi, minħabba l-possibbiltà ta' effett miżjud fuq is-sistema immuni.
English: In the absence of clinical symptoms, liver transaminases should be monitored at months 1, 3, 6, 9 and 12 on therapy and periodically thereafter.
Maltese: Fin-nuqqas ta' sintomi kliniċi, it-transaminases talfwied għandhom jiġu mmonitorjati fix-xhur 1, 3, 6, 9 u 12 ta' waqt it-terapija u perjodikament minn hemm 'il quddiem.
English: Printing ink: shellac (E904), ethanol anhydrous, isopropyl alcohol, butyl alcohol, propylene glycol (E1520), purified water, ammonia solution, concentrated (E527), potassium hydroxide, black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), dimethicone.
Maltese: Il-linka għall-istampar: xellak (E904), ethanol anhydrous, alkoħol isopropil, alkoħol butil, glikol tal-propilen(E1520), ilma ppurifikat, ammonia solution, ikkonċentrata (E527), idrossidu tal-potassju, ossidu tal-ħadid iswed (E172), ossidu tal-ħadid isfar (E172), dijossidu tat-titanju (E171), dimetikonu.
English: In adult clinical trials it occurred in 4.7% of patients on fingolimod 0.5 mg, in 2.8% of patients on intramuscular interferon beta-1a, and in 1.6% of patients on placebo.
Maltese: Waqt provi kliniċi fost l-adulti ġara li f'4.7% tal-pazjenti mogħtija 0.5 mg fingolimod, fi 2.8% tal-pazjenti fuq intramuskulari interferon beta-1a, u f'1.6% tal-pazjenti fuq plaċebo.
English: Frequencies were defined 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: Il-frekwenzi kienu ddefiniti skont il-konvenzjoni li ġejja: 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 (ma tistax tittieħed stima mid-dejta disponibbli).
English: Capsule fill: mannitol, magnesium stearate.
Maltese: Il-mili tal-kapsula: mannitol, sterat tal-manjeżju.
English: Neutrophil count decreased * Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS.
Maltese: Tnaqqis fl-għadd tan-nutrofils * Mhux irrappurtati fl-Istudji FREEDOMS, FREEDOMS II u TRANSFORMS.
English: • Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as beta interferon, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate or alemtuzumab.
Maltese: • Mediċini li jrażżnu jew jimmodulaw is-sistema immuni, inkluż mediċini oħrajn użati biex jikkuraw l-SM, bħalma huma interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate jew alemtuzumab.
English: Alemtuzumab has profound and prolonged immunosuppressive effects.
Maltese: Alemtuzumab għandu effetti immunosuppressivi profondi u li jdumu.
English: Hydroxypropylcellulose Hydroxypropylbetadex Magnesium stearate
Maltese: Idroksipropilċellulosa Idroksipropilbetadeks Sterat tal-manjeżju
English: 28 hard capsules 98 hard capsules
Maltese: 28 kapsula iebsa 98 kapsula iebsa
English: o carbamazepine, rifampicine, phenobarbital, phenytoin, efavirenz or St. John's Wort (potential risk of reduced efficacy of Gilenya).
Maltese: o carbamazepine, rifampicine, phenobarbital, phenytoin, efavirenz jew St.
English: The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate.
Maltese: Il-metabolit attivi farmakoloġikament huwa responsabbli għall-effikaċja hu fingolimod fosfat.
English: Overall, 180 (84%) of patients completed the core phase on study drug (n=99 [92.5%] on fingolimod, 81 [75%] on interferon beta-1a).
Maltese: Kollox ma' kollox, 180 (84%) tal-pazjenti temmew il-fażi ewlenija tal-istudju dwar il-mediċina (n=99 [92.5%] fuq fingolimod, 81 [75%] fuq interferon beta-1a).
English: Progressive multifocal leukoencephalopathy (PML)** Cryptococcal infections** Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common:
Maltese: Lewkoenċefaloptija multifokali progressiva (PML)** Infezzjonijiet kriptokokkali** Neoplażmi beninni, malinni u dawk mhux speċifikati (inkluż ċesti u polipi) Komuni:
English: Therefore, fingolimod is not expected to alter the pharmacokinetics of medicinal products that are CYP3A4 substrates.
Maltese: Għaldaqstant, fingolimod mhuwiex mistenni li jbiddel ilfarmakokinetiċi tal-prodotti mediċinali li huma sottostrati ta' CYP3A4.
English: T-wave inversion***
Maltese: Inverżjoni tal-mewġa T***
English: Lymphomas
Maltese: Limfomi
English: Table 3 Study D2302 (TRANSFORMS): main results
Maltese: Tabella 3 Studju D2302 (TRANSFORMS): riżultati ewlenin
English: Co-administration with potent CYP450 inducers
Maltese: L-għoti flimkien ma' indutturi potenti ta' CYP450
English: *** Adverse drug reactions from spontaneous reports and literature **** The frequency category and risk assessment were based on an estimated exposure of more than 24,000 patients to fingolimod 0.5 mg in all clinical trials.
Maltese: **** Il-kategorija tal-frekwenza u l-evalwazzjoni tar-riskju ssejsu fuq espożizzjoni stmata ta' aktar minn 24,000 pazjent mogħtija 0.5 mg fingolimod waqt il-provi kollha kliniċi.
English: Animal studies have shown reproductive toxicity including foetal loss and organ defects, notably persistent truncus arteriosus and ventricular septal defect (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità tas-sistema riproduttiva inkluż telfien tal-fetu u difetti fl-organi tal-fetu, truncus arteriosus persistenti notevoli u difett settali ventrikulari (ara sezzjoni 5.3).
English: PVC/PVDC/aluminium blister packs containing 28 hard capsules.
Maltese: PVC/PVDC/pakketti b'folji tal-aluminju bi 28 kapsula iebsa.
English: Gilenya can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Maltese: Ġeneralmenti Gilenya jista' jinbeda minnufih wara li jitwaqqaf interferon jew glatiramer acetate.
English: Influenza Sinusitis
Maltese: Influwenza Sinożite