FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you are taking any of the following medicines: - Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of Parkinson's disease or depression, or used for any other condition).
Maltese: - Inibituri ta' monoamine oxidase (MAO) bħal selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (eż għall-kura tal-marda ta' Parkinson jew dipressjoni, jew użati għal kwalunkwe kundizzjoni oħra).
English: The terminal elimination half-life of total radioactivity was approximately 80 hours.
Maltese: Il-half-life ta' eliminazzjoni terminali tar-radjuattività totali kienet madwar 80 siegħa.
English: (24 weeks)
Maltese: (24 ġimgħa)
English: Use in patients with albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy (see sections 4.4 and 5.3).
Maltese: L-użu f'pazjenti b'albiniżmu, b'deġenerazzjoni tar-retina, uveite, retinopatija li tintiret jew retinopatija dijabetika progressiva severa (ara sezzjonijiet 4.4 u 5.3).
English: Arterial spasm, arteriosclerosis, hypertensive crisis
Maltese: Spażmu arterjali, arterjosklerożi, kriżi ipertensiva
English: Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection
Maltese: Bronkopulmonite, furunklu, nażofarinġite, pijoderma, rinite, infezzjoni tas-snien, infezzjoni virali
English: Each tablet contains 50 mg or 100 mg of safinamide (as methansulfonate).
Maltese: Kull pillola fiha 50 mg jew 100 mg ta' safinamide (bħala methansulfonate).
English: Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma
Maltese: Vista mċajpra, skotoma, diplopja, fotofobja, disturb retinali, konġuntivite, glawkoma
English: Xadago 100 mg tablets safinamide
Maltese: Xadago 100 mg pilloli safinamide
English: Long-term studies in animals have shown convulsions (1.6 to 12.8 times human clinical exposure, based on plasma AUC).
Maltese: Studji kliniċi fit-tul f'annimali wrew konvulsjonijiet (1.6 sa 12.8 darbiet f'esponiment kliniku tal-bnedmin, abbażi tal-AUC fil-plażma).
English: In drug-drug-interaction studies in human, a weak interaction was observed with rosuvastatin (AUC increase between 1.25 and 2.00 fold) but no significant interaction was found with diclofenac.
Maltese: Fi studji ta' interazzjoni bejn mediċina u oħra fil-bnedmin, ġiet osservata interazzjoni dgħajfa b'rosuvastatin (żieda fl-AUC ta' bejn 1.25 u 2.00 darbiet) iżda ma nstabet l-ebda interazzjoni sinifikanti b'diclofenac.
English: Date of first authorisation: 24 February 2015 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' Frar 2015
English: (d) (a) Daily targeted dose, (b) Mean (SD), (c) analysis population (mITT); MMRM model for change from Baseline to Endpoint includes treatment, region, and visit as fixed effects, and baseline value as a covariate; (d) target dose of 100 mg/day; (e) analysis population (mITT); data are presented as the number (percentage) of patients in each group meeting the responder definition (f) chi-square test of the odds ratio of the treatment groups compared to placebo using a logistic regression model, with fixed effects for treatment and country.
Maltese: (a) Doża fil-mira ta' kuljum, (b) Medja (SD), (c) popolazzjoni tal-analiżi (mITT); mudell MMRM għal bidla mil-Linja Bażi sal-Punt ta' Tmiem jinkludi l-kura, ir-reġjun, u ż-żjara bħala effetti fissi, u l-valur tal-linja bażi bħala ko-varjant; (d) doża fil-mira ta' 100 mg/kuljum; (e) popolazzjoni talanaliżi (mITT); dejta hija ppreżentata bħala n-numru (perċentwal) ta' pazjenti f'kull grupp li jissodisfa d-definizzjoni ta' dawk li jwieġbu (f) test chi-square tal-proporzjon ta' probabilità talgruppi tal-kura mqabblin mal-plaċebo bl-użu ta' mudell ta' rigressjoni loġistika b'effetti fissi għallkura u l-pajjiż.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita
English: The results obtained from carcinogenicity studies in mice and rats showed no evidence of tumorigenic potential related to safinamide at systemic exposures up to 2.3 to 4.0 times respectively, the anticipated systemic exposure in patients given the maximal therapeutic dose.
Maltese: Ir-riżultati miksuba minn studji tal-karċinoġeniċità fil-ġrieden u l-firien ma wrew ebda evidenza ta' potenzjal tumoriġeniku relatat ma' safinamide f'esponimenti sistemiċi bejn 2.3 sa 4.0 darbiet rispettivament l-esponiment sistemiku antiċipat f'pazjenti li ngħataw id-doża terapewtika massima.
English: PD Duration (years) (b)
Maltese: Durata tal-PD (snin) (b)
English: In vivo and in vitro pharmacodynamic drug interactions
Maltese: Interazzjonijiet farmakokinetiċi tal-mediċina in vivo u in vitro
English: Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis
Maltese: Alopeċija, nuffata, dermatite ta' kuntatt, dermatożi, eċċimożi, keratożi liċenojde, għaraq billejl, uġigħ fil-ġilda, disturb tal-pigmentazzjoni, psorijażi, dermatite seborrejka
English: Experience of use of safinamide in patients over 75 years of age is limited.
Maltese: L-esperjenza bl-użu ta' safinamide f'pazjenti li għandhom aktar minn 75 sena hija limitata.
English: xadago 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE xadago 100 mg
English: The pharmacokinetics of safinamide are linear after single and repeated doses.
Maltese: Il-farmakokinetika ta' safinamide hija lineari wara dożi waħedhom u ripetuti.
English: The pharmacodynamic effects of safinamide have not been assessed in children and adolescents.
Maltese: L-effetti farmakodinamiċi ta' XADAGO ma ġewx ivvalutati fi tfal u adolexxenti.
English: It is recommended to monitor patients when safinamide is taken with medicinal products that are BCRP substrates (e.g., rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide) and to refer to their SmPCs to determine if a dose adjustment is needed.
Maltese: Huwa rakkomandat li l-pazjenti jiġu mmonitorjati meta safinamide jittieħed ma' prodotti mediċinali li huma substrati tal-BCRP (eż., rosuvastatin pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac jew glyburide) u li tirreferi għall-SmPCs tagħhom biex tiddetermina jekk hemmx bżonn aġġustament fiddoża.
English: Peptic ulcer, retching, upper gastrointestinal haemorrhage
Maltese: Ulċera peptika, tqalligħ, emorraġija gastrointestinali fil-parti ta' fuq
English: At least 7 days must elapse between discontinuation of safinamide and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).
Maltese: Għandhom jgħaddu tal-inqas sebat ijiem bejn it-twaqqif ta' safinamide u l-bidu ta' kura b'inibituri MAO jew b'pethidine (ara sezzjoni 4.3 u 4.5).
English: Safinamide did not present genotoxic potential in in vivo and in several in vitro systems using bacteria or mammalian cells.
Maltese: Safinamide ma weriex potenzjal ġenotossiku in vivo u f'diversi sistemi in vitro permezz ta' batterji jew ċelloli tal-mammiferi.
English: Therefore, other amidases are likely to be involved in the conversion to NW-1153.
Maltese: Għalhekk, aktarx li jkunu involuti amidażijiet oħrajn fil-konverżjoni f'NW-1153.
English: The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' safinamide fi tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Psychiatric disorders
Maltese: Disfunzjoni erettili
English: Randomized Age (years) (b)
Maltese: Età (snin) (b)
English: Xadago is a medicine that contains the active substance safinamide.
Maltese: Xadago huwa mediċina li fiha s-sustanza attiva safinamide.
English: (2 years)
Maltese: (sentejn)
English: Absolute bioavailability is high (95%), showing that safinamide is almost completely absorbed after oral administration and first pass metabolism is negligible.
Maltese: Il-bijodisponibbiltà assoluta hija għolja (95%), turi li safinamide huwa kważi kompletament assorbit wara għoti orali u l-metaboliżmu tal-ewwel pass huwa negliġibbli.
English: Via Lillo del Duca 10 20091 Bresso (MI) - Italy
Maltese: 20091 Bresso (MI) - L-Italja
English: Very common
Maltese: Safinam ide
English: The principal pathway involves hydrolytic oxidation of the amide moiety leading to the primary metabolite ‘safinamide acid' (NW-1153).
Maltese: Il-mogħdija ewlenija tinvolvi ossidazzjoni idrolitika tal-moiety amide li twassal għall-metabolit primarju “acid safinamide” (NW-1153).
English: In human liver microsomes (HLM), the N-dealkylation step appears to be catalysed by CYP3A4, as safinamide clearance in HLM was inhibited by ketoconazole by 90%.
Maltese: Fil-mikrosomi tal-fwied tal-bniedem (HLM - Human Liver Microsomes), il-pass ta' Ndealkylation jidher li jiġi kkatalizzat minn CYP3A4, peress li t-tneħħija ta' safinamide fl-HLM kienet inibita minn ketoconazole b'90%.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: Safinamide undergoes almost complete metabolic transformation (<10% of the administered dose was found unchanged in urine).
Maltese: Safinamide jgħaddi minn trasformazzjoni metabolika kważi kompluta (<10% tad-doża mogħtija nstabet tale quale fl-awrina ).
English: Xadago is supplied in packs containing 14, 28, 30, 90 or 100 film coated tablets.
Maltese: Xadago jiġi f'pakketti li fihom 14, 28, 30, 90 jew 100 pillola miksijin b'rita.
English: Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Maltese: Huwa magħruf li jseħħu reazzjonijiet avversi serji bl-użu fl-istess ħin ta' SSRIs, SNRIs, antidipressanti triċikliċi/tetraċikliċi u inibituri tal-MAO, bħal kriżi ipertensiva (pressjoni tad-demm għolja, ħass ħażin), sindrome malinn newrolettiku (konfużjoni, għaraq, riġidità tal-muskoli, ipertermja, żieda fis-CPK), sindrome tas-seratonin (konfużjoni, ipertensjoni, ebusija tal-muskoli, alluċinazzjonijiet) u pressjoni baxxa.
English: Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.
Maltese: Kull pillola miksija b'rita fiha safinamide methansulfonate ekwivalenti għal 50 mg safinamide.
English: Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors.
Maltese: Ġew irrapportati reazzjonijiet avversi serji bl-użu konkomitanti ta' pethidine u l-inibituri MAO.
English: Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst
Maltese: Spondilite ankijolizzanti, uġigħ fil-ġenb, ġogi minfuħin, uġigħ muskolu-skelettriku, mijalġija, uġigħ fl-għonq, osteoartrite, ċist sinovjali
English: SE Standard Error, SD Standard deviation, LSM Least Square Mean, LS Diff.
Maltese: SE Żball Standard, SD Devjazzjoni standard, LSM
English: Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.
Maltese: Kull pillola miksija b'rita fiha safinamide methansulfonate ekwivalenti għal 100 mg safinamide.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Hyperhidrosis, pruritus generalised, photosensitivity reaction, erythema
Maltese: Iperidrożi, ħakk ġeneralizzat, reazzjoni ta' fotosensittività, eritema
English: This potential increase is most likely of no clinical relevance as NW-1153, the first product in the metabolic pathway, is further transformed to secondary and tertiary metabolites.
Maltese: Din iż-żieda potenzjali aktarx li ma hija ta' ebda relevanza klinika peress li NW-1153, l-ewwel prodott fil-passaġġ metaboliku, tkompli tiġi ttrasformata f'metaboliti sekondarji u terzjarji.
English: Uncommon (may affect up to 1 in 100 people): urine infection, skin cancer, low iron in your blood, low white cell count, red blood cell abnormality, decreased appetite, high fat in blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusional state, mood swings , increased interest in sex, abnormal thinking and perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction, head discomfort, difficulty in speaking, fainting, memory impairment, blurring of vision, blind spot, double vision, aversion to light, disorders of the light sensitive layer at the back of your eye, redness of the eyes, increased pressure in the eye, sensation of room spinning, feeling of heart beating, fast heartbeat, irregular heartbeat, slowed heartbeat , high blood pressure, low blood pressure, veins that have become large and twisted, cough, difficult breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, burning stomach, wind, feeling full, drooling, mouth ulcer, sweating, itching, sensitive to light, redness of the skin, back pain, joint pain, cramps, stiffness, pain in legs or arms, muscle weakness, sensation of heaviness, increased urination at night, pain upon urination, difficulty in having sex in males, fatigue, feeling weak, unsteady walking, swelling of your feet, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat in your blood, increased sugar in your blood, abnormal ECG, liver function test abnormal, abnormal urine tests, blood pressure decreased, blood pressure increased, abnormal eye test, fracture of your foot.
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): infezzjoni tal-awrina, kanċer tal-ġilda, nuqqas ta' ħadid fid-demm tiegħek, għadd baxx ta' ċelloli bojod, anormalità taċ-ċelloli ħomor taddemm, tnaqqis fl-aptit, ħafna xaħam fid-demm tiegħek, żieda fl-aptit, livell għoli ta' zokkor fid-demm, tara affarijiet li mhumiex hemm, dwejjaq, ħolm anormali, biża' u tħassib, stat ta' konfużjoni, burdati, interess ikbar fis-sess, ħsieb u perċezzjoni anormali, bla mistrieħ, disturb tal-irqad, tnemnim, tegħleb, ma tibqax tħoss, kontrazzjoni anormali sostnuta tal-muskoli, skumdità tar-ras, diffikultà biex titkellem, ħass ħażin, indeboliment tal-memorja, tiċċajpar il-vista, punt għama, vista doppja, averżjoni għaddawl, disturbi tas-saff sensittiv għad-dawl fuq wara ta' għajnejn, ħmura tal-għajnejn, żieda filpressjoni fl-għajn, tħoss rasek iddur, tħoss qalbek tħabbat, taħbit tal-qalb mgħaġġel, taħbit tal-qalb irregolari, taħbit tal-qalb iktar kalm, pressjoni għolja tad-demm, pressjoni baxxa tad-demm, vini mwessa' u li ntlewew, tqaħqiħ, diffikultà fit-teħid tan-nifs, flissjoni, stitikezza, qrusa fl-istonku,
English: Nocturia, dysuria
Maltese: Notturja, disurja
English: Paraesthesia, balance disorder, hypoaesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder
Maltese: Paresteżja, disturb fil-bilanċ, ipoesteżija, distonija, skumdità tar-ras, disatrtija, sinkope, disturb konjittiv
English: Dedicated drug-drug interaction studies performed with ketoconazole, L-dopa and CYP1A2 and CYP3A4 substrates (caffeine and midazolam), did not detect any clinically significant effects on the pharmacokinetics of safinamide, or L-dopa, caffeine and midazolam.
Maltese: Studji ddedikati bejn mediċina u oħra mwettqa b'ketoconazole, L-dopa u s-sottostrati CYP1A2 u CYP3A4
English: CARTON -film-coated tablets
Maltese: Karċinoma taċ-ċelloli talbażi
English: Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot
Maltese: Għeja, astenija, disturbi fil-mixi, edema periferali, uġigħ, fewġa
English: Change LSM (SE)
Maltese: Bidla LSM
English: ON time without troublesome dyskinesia (hrs) (c) Baseline (b)
Maltese: Ħin ON mingħajr diskinesija problematika (sigħat) (c) Linja Bażi (b)
English: The expected pattern of events or symptoms following intentional or accidental overdose with Safinamide would be those related to its pharmacodynamic profile: MAO-B inhibition with activity-dependent inhibition of Na channels.
Maltese: Il-mudell mistenni ta' avvenimenti jew sintomi wara doża eċċessiva intenzjonali jew aċċidentali b'safinamide jkunu dawk mistennija mill-profil farmakodinamiku tiegħu: l-inibizzjoni ta' MAO-B b'inibizzjoni dipendenti fuq l-attività tal-kanal tas-Na+.
English: Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Maltese: Fittex attenzjoni medika f'każ ta' kriżi ipertensiva (pressjoni tad-demm għolja ħafna, kollass), sindrome malinn newrolettiku (konfużjoni, għaraq, riġidità tal-muskoli, ipertermja, żieda fil-livell ta' enzimi tal-kreatinina tal-kinażi fid-demm tiegħek), sindrome ta' serotonin (konfużjoni, ipertensjoni, ebusija tal-muskoli, alluċinazzjonijiet), u ipotensjoni.
English: Ask your doctor for advice before taking any of the following medicines together with Xadago: - Cold or cough remedies containing dextromethorphan, ephedrine or pseudoephedrine - Medicines called selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluoxetine or fluvoxamine) - Medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine - Medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin - Fluoroquinolone antibiotic such as ciprofloxacin - Medicines that affect the immune system such as methotrexate - Medicines to treat metastatic carcinoma such as topotecan - Medicine to treat pain and inflammation such as diclofenac - Medicines to treat type 2 diabetes such as glyburide, metformin - Medicines to treat virus infection such as aciclovir, ganciclovir
Maltese: Kellem lit-tabib għal parir qabel tieħu kwalunkwe waħda mill-mediċini li ġejjin flimkien ma' Xadago: - Rimedji għal riħ jew tqaħqiħ li fihom destrometorfan, efedrina jew psewdoefedrina - Mediċini msejħin inibituri selettivi ta' teħid mill-ġdid ta' serotonin (SSRIs) ġeneralment użati biex jikkuraw disturbi tal-ansejtà, u xi disturbi tal-personalità (jiġifieri fluoxetine jew fluvoxamine) - Mediċini msejħin inibituri ta' teħid mill-ġdid ta' serotonin-norepinephrine (SNRIs), użati fil-kura ta' dipressjoni ewlenija u disturbi oħra fil-burdata, bħal venlafaxine.
English: CGI-C: patients who were much/very much improved p-value (f)
Maltese: CGI-C: pazjenti li tjiebu sew/tajjeb ħafna valur-p (e)
English: Safinamide must not be administered along with other MAO inhibitors (including moclobemide) as there may be a risk of non-selective MAO inhibition that may lead to a hypertensive crisis (see section 4.3).
Maltese: Safinamide ma għandux jingħata flimkien ma' inibituri MAO oħra (inkluż moclobemide) peress li jaf ikun hemm riskju ta' inibizzjoni MAO mhux selettiva li tista' twassal għal kriżi ta' pressjoni għolja (ara sezzjoni 4.3).
English: The amidase FAAH was able to catalyse the formation of NW-1153 at low rates only.
Maltese: L-amidażi FAAH irnexxielha tikkatalizza l-formazzjoni tal-NW-1153 b'rati baxxi biss.
English: 95% CI
Maltese: (SE) Diff LS vs Plaċebo 95% CI
English: The recommended starting dose of Xadago is one 50 mg tablet that may be increased to one 100 mg tablet, taken once daily preferably in the morning by mouth with water.
Maltese: Id-doża tal-bidu rrakkomandata ta' Xadago hija pillola waħda ta' 50 mg, li tista' tiżdied għal pillola waħda ta' 100 mg meħuda darba kuljum preferibbilment filgħodu oralment mal-ilma.
English: Cachexia, hyperkalaemia
Maltese: Kakessija, iperkalemja
English: xadago 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE xadago 50 mg
English: The relevant plasma concentrations of safinamide are substantially lower, therefore a clinically relevant interaction with co-administered substrates of these transporters is unlikely.
Maltese: Il-konċentrazzjonijiet relevanti fil-plażma ta' safinamide huma sostanzjalment inqas u, għalhekk, interazzjoni klinikament relevanti b'substrati koamministrati ta' dawn it-trasportaturi mhijiex probabbli.
English: Metabolite structure elucidation revealed three metabolic pathways of safinamide.
Maltese: Id-dettalji tal-istruttura tal-metabolit żvelat tliet mogħdijiet metaboliċi ta' safinamide.
English: Xadago is indicated for the treatment of adult patients with idiopathic Parkinson's disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Maltese: Xadago huwa indikat għall-kura ta' pazjenti adulti bil-marda idjopatika ta' Parkinson (PD) bħala terapija ta' żieda għal doża stabbli ta' levodopa (L-dopa) waħedha jew flimkien ma' prodotti mediċinali oħra kontra l-PD f'pazjenti li jvarjaw minn stadju medju sa avvanzat.
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets
Maltese: Xadago 50 mg pilloli miksijin b'rita Xadago 100 mg pilloli miksijin b'rita
English: In embryo-foetal developmental studies in rats and rabbits malformations were induced at safinamide exposures 2 and 3-fold above human clinical exposure, respectively.
Maltese: Fi studji tal-iżvilupp embrijo-fetali fil-firien u l-fniek, kienu indotti malformazzjonijiet fl-esponimenti għal safinamide darbtejn sa 3 darbiet 'il fuq mill-esponiment kliniku tal-bniedem, rispettivament.
English: Pooled analyses of adverse event data from placebo controlled studies in Parkinson's disease patients indicate that the concomitant administration of safinamide together with a broad category of commonly used medicinal products in this patient population (antihypertensive, beta-blockers cholesterol lowering, non-steroidal anti-inflammatory medicinal products, proton pump inhibitors, antidepressants, etc.) was not associated with an increased risk for adverse events.
Maltese: Analiżijiet raggruppati tad-dejta tal-avveniment avvers minn studji kkontrollati bil-plaċebo f'pazjenti bil-marda ta' Parkinson jindikaw li l-għoti konkomitanti ta' safinamide flimkien ma' kategorija wiesgħa ta' prodotti mediċinali użati b'mod komuni f'din il-popolazzjoni (prodotti mediċinali kontra l-pressjoni, prodotti mediċinali li jnaqqsu l-kolesterol, beta mblokkaturi, prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni, inibituri tal-pompa tal-proton, antidipressanti, eċċ.) ma kinitx assoċjata ma' żieda fir-riskju għal avvenimenti avversi.
English: Rare abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation
Maltese: Insomnja Alluċinazzjoni, dipressjoni, ħolm anormali, ansjetà, stat ta' konfużjoni, affett psewdobulbari, żieda fil-libido, disturb psikotiku, nuqqas ta' mistrieħ, disturb tal-irqad
English: The tabulation below includes all adverse reactions in clinical trials where adverse reactions were considered related.
Maltese: It-tabulazzjoni ta' hawn taħt tinkludi r-reazzjonijiet avversi kollha fil-provi kliniċi li fihom rreazzjonijiet avversi tqiesu relatati.