FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 5-year open-label treatment study, augmentation occurred in 11.9% of patients treated with the approved dosages for RLS (1-3 mg/24 h), and 5.1% were considered clinically significant.
Maltese: F'studju open-label ta' 5-snin, l-awmentazzjoni ġrat f'11.9% tal-pazjenti trattati biddożaġġi għal RLS (1-3 mg/24 siegħa), u 5.1% kienu kkonsidrati klinikament sinifikanti.
English: UCB Pharma Sp. z o.o.
Maltese: UCB Pharma Sp. z o.o. Tel.:
English: Impulse control disorders
Maltese: Disturbi fil-kontrol tal-impulsi
English: Interactions with other forms of hormonal contraception have not been investigated.
Maltese: Interazzjonijiet ma' forom oħra ta' kontraċezzjoni ormonali ma ġewx investigati.
English: The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001).
Maltese: Id-differenza medja aġġustata kienet ta' -6.5 punti (CI95% -8.7; -4.4, p <0.
English: Very common Common Uncommon Rare
Maltese: Mhux komuni Rari
English: • being aggressive
Maltese: • tkun aggressiv
English: atrial fibrillation e, supraventricular tachycardia e
Maltese: Palpitazzjonijiet e, fibrillazzjoni atrijalie, supraventrikular i takikardjae
English: Treatment differences for the coprimary variables were statistically significant (p=0.0002 and p<0.0001).
Maltese: Id-differenzi fit-trattament fil-fatturi ko-primarji li jvarjaw kienu statistikament sinifikanti (p=0.0002 u p<0.0001).
English: • psychotic disorders
Maltese: • disturbi psikotiċi
English: (see
Maltese: (ara
English: The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Maltese: L-effikaċja ta' rotigotine kienet mkejla f'5 studji kontrollati minn plaċebo b'iżjed minn 1,400 pazjent bis-Sindromu ta' Restless Legs idjopatiku (RLS).
English: Sulphite sensitivity
Maltese: Sensitivita` ghal sulphite
English: Erectile dysfunction
Maltese: Disfunzjoni eretilie
English: Fertility
Maltese: Fertilita`
English: • Parkinson's disease - lowered by 2 mg every other day.
Maltese: • Marda ta' Parkinson - titnaqqas b' 2 mg kull jumejn.
English: Limited pharmacokinetic data obtained in adolescent patients with RLS (13-17 years, n=24) following treatment with multiple doses of 0.5 to 3mg/24h showed that systemic exposure to rotigotine was similar to that observed in adults.
Maltese: Dejta limitata dwar il-farmakokinetika li inġabru minn pazjenti adoloxxenti b'RLS (13-17-il sena, n=24) li ghamlu trattament b'dożi multipli ta' 0.5 sa 3mg/24siegħa wrew li l-esponiment sistemiku għal rotigotine kien simili għal dak osservat fl'adulti.
English: • The maximum dose is 16 mg each day.
Maltese: • Id-doża massima hi ta' 16 mg kuljum.
English: Ltd Τηλ: +357-22 05 63 00
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ: +357-22 05 63 00
English: Leganto is available in the following pack-sizes:
Maltese: Leganto hu disponibbli fid-daqsijiet tal-pakketti li ġejjin:
English: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and
Maltese: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) u
English: All differences between the active treatments and placebo were statistically significant.
Maltese: Id-differenzi kollha bejn il-kuri attivi u l-plaċebo kienu statistikament sinifikanti.
English: Dopamine dysregulation syndromec, perception disturbances e
Maltese: Sindromu ta' disregulazzjoni ta' dopamina, disturbi filperċessjonie
English: Aggressive behaviour/ aggressionb, disorientation d
Maltese: Aġir aggressiv/ aggressjonib, diżorjentazzjoni d
English: The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.
Maltese: Il-profil farmakokinetiku juri eliminazzjoni bifażika b'half-life inizjali ta' madwar 2 sa 3 sigħat.
English: Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Maltese: Leganto huwa indikat għat-trattament tas-sintomi tas-sindromu ta' Restless Legs (RLS) idjopatiku moderat għal sever fl-adulti.
English: Therefore, it is recommended to taper treatment (see section 4.2).
Maltese: Għalhekk hu rakkomandat li t-trattament jitwaqqaf ftit ftit (ara sezzjoni 4.2).
English: In two 6-month, double-blind, placebo-controlled studies, clinically relevant augmentation was observed in 1.5% of rotigotine-treated patients versus 0.5% of placebo treated patients.
Maltese: F'żewġ studji double-blind, ikkontrollati mill-plaċebo ta' 6-xhur, awmentazzjoni klinikament rilevanti kienet osservata f' 1.5% tal-pazjenti trattati b' rotigotine versus 0.5% tal-pazjenti ttrattati bil-plaċebo.
English: Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, baseline 19.3) and 1.9 points (placebo, baseline 20.5).
Maltese: It-titjib fil-medja tar-riżult totali tal-PDSS-2 kien 5.9 (rotigotine, linja bażi 19.3) u 1.9 punt (plaċebo, linja bażi 20.5).
English: Other medicines and Leganto
Maltese: Mediċini oħra u Leganto
English: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotinetreated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients.
Maltese: L-irqad (PDSS) tjieb b' 4.1 ± 13.8 punti f'pazjenti trattati b' rotigotine, u b' 2.5 ± 13.5 punt għal pazjenti fuq ropinirole.
English: Leganto with food, drink and alcohol
Maltese: Leganto ma' ikel, xorb u alkoħol
English: Leganto contains sodium metabisulphite (E223) Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Maltese: Sodium metabisulphite (E223) rarament jista' jikkawża reazzjonijiet severi ta' ipersensittivita` (allerġija) u bronkospażmu (problemi fin-nifs ikkawżat minn djuq fil-pajpijiet tan-nifs).
English: Leganto is for transdermal use.
Maltese: Leganto jiġi applikat darba kuljum.
English: Each patch of 30 cm contains 13.5 mg of rotigotine.
Maltese: Kull impjastru ta' 30 cm2 fih 13.5 mg ta' rotigotine.
English: Dopamine is a messenger in the brain which is important for movement.
Maltese: Dopamine huwa messaġġier filmoħħ importanti għal moviment.
English: This effect was not confirmed in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test.
Maltese: Dan l-effett ma kienx ikkonfermat in vivo fil-Test Mikronukleari fil-Ġrieden u fit-test Unscheduled DNA Synthesis (UDS) fil-firien.
English: • involuntary muscle spasms (convulsion)
Maltese: • spażmi muskolari involontarji (konvulzjoni)
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ tal-benefiċċju/riskju tal-prodott mediċinali.
English: Irritability
Maltese: Irritibilita`
English: • Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Maltese: • Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, sodium metabisulphite (E223), ascorbyl palmitate (E304) u DL-α-tocopherol (E307).
English: Each patch of 5 cm contains 2.25 mg of rotigotine.
Maltese: Kull impjastru ta' 5 cm2 fih 2.25 mg ta' rotigotine.
English: Psychotic disorder, obsessivecompulsive disorder, aggressive behaviour/ aggression b,
Maltese: Mard psikożi, mard ossessiv kompulsiv, Aġir aggressiv/ aggressjoni b, delużjonid, delirjud
English: • feeling agitated, disorientated, confused or paranoid
Maltese: • tħossok aġitat, disorjentat, konfużjoni u paranoja
English: Transdermal patch.
Maltese: Użu transdermali.
English: At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 16.6%, CI95% 7.6%; 25.7%).
Maltese: Titjib ta' 20% kien osservat fi 52% tal-pazjenti li kienu qed jirċievu rotigotine, 68% tal-pazjenti li kienu qed jirċievu ropinirole u 30% tal-pazjenti li kienu qed jirċievu l-plaċebo (id-differenza ta' rotigotine kontra l-plaċebo 21.7%; CI95% 11.1%; 32.4% , id-differenza ta' ropinirole kontra l-plaċebo 38.4% CI95% 28.1%; 48.6%, id-differenza ta' ropinirole kontra rotigotine 16.6%; CI95% 7.6%; 25.
English: Each patch of 15 cm contains 6.75 mg of rotigotine.
Maltese: Kull impjastru ta' 15 cm2 fih 6.75 mg ta' rotigotine.
English: The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Maltese: Ilperċentaġġ ta' pazjenti li waqqfu kienu 25-38% iżjed mill-ewwel sena, 10% fit-tieni sena, u 11% fittielet sena.
English: Improvements were seen in UPDRS Parts I - IV scores.
Maltese: Titjib kien osservat fil-marki tal UPDRS Parti I-IV.
English: Reproductive system and breast disorder
Maltese: Disturbi fissistema riproduttiva u fissider
English: The changes from baseline in the International RLS Rating Scale (IRLS) and CGI-item 1 (severity of illness) were primary efficacy parameters.
Maltese: RLS (IRLS) u CGI-item 1 (is-severita` talmarda) kienu parametri tal-effikaċja primarji.
English: Vomiting, dyspepsia
Maltese: Rimettar, dispepsja
English: Magnetic resonance imaging or cardioversion (see section 4.4).
Maltese: Immaġni bir-riżonanza manjetika jew kardjoverżjoni (ara sezzjoni 4.4).
English: CGI-I responder rates (much improved, very much improved) were 43.0% and 67.5% for placebo and rotigotine respectively (difference 24.5% CI 95%: 14.2%; 34.8%, p<0.0001).
Maltese: 0001). Ir-rati CGI-responder (tjieb sew, tjieb ħafna) kienu ta' 43.0% u 67.5% għal plaċebo u rotigotine rispettivament (differenza 24.5% CI 95%: 14.2%; 34.8%, p<0.0001).
English: • The maximum dose is 3 mg per day.
Maltese: • Id-doża massima hi ta' 3 mg kuljum.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw sa 1 minn kull 1,000 pazjent
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 60% of the subjects receiving rotigotine, 67% of the subjects receiving pramipexole and 35% of the subjects receiving placebo (Difference rotigotine versus placebo 25%, CI95% 13%; 36%, difference pramipexole versus placebo 32%, CI95% 21%; 43%, difference pramipexole versus rotigotine 7%, CI95% -2%; 17%).
Maltese: Fl-aħħar tal-kura tal-manteniment, titjib ta' mill-inqas 30% kien osservat f'60% tal-pazjenti li kienu qed jirċievu rotigotine, f'67% tal-pazjenti li kienu qed jirċievu pramipexole u f'35% tal-pazjenti li kienu qed jirċievu l-plaċebo (Id-differenza ta' rotigotine kontra l-plaċebo 25%; CI95% 13%; 36%, differenza ta' pramipexole kontra l-plaċebo 32% CI95% 21%; 43%, differenza ta' pramipexole kontra rotigotine 7%; CI95% -2% ; 17%).
English: Each patch of 40 cm contains 18.0 mg of rotigotine.
Maltese: Kull impjastru ta' 40 cm2 fih 18.0 mg ta' rotigotine.
English: Vision blurred, visual impairment, photopsia
Maltese: Viżjoni mċajpra, impediment tal-vista, fotopsija
English: In the double-blind study SP515, 201 patients received rotigotine, 200 received pramipexole and 100 patients received placebo.
Maltese: Fl istudju double-blind SP515, 201 pazjenti rċivew rotigotine, 200 irċivew pramipexole u 100 pazjenti rċivew il-plaċebo.
English: Week 3.
Maltese: siegħa.
English: The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Maltese: It-twaħħil in vitro ta' rotigotine mal-proteini tal-plażma hu ta' madwar 92%.
English: MULTIPACKS ONLY
Maltese: PAKKETTI MULTIPLI BISS
English: How to use the Leganto patches:
Maltese: Tużax Leganto jekk:
English: Contains E223.
Maltese: Fih E223. Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Take the patch out of the sachet.
Maltese: Hi rqiqa u fiha tliet saffi.
English: For information on fertility studies, please see section 5.3.
Maltese: Għal informazzjoni dwar studju dwar il-fertilita`, jekk jogħġbok ara sezzjoni 5.3.
English: Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Maltese: Id-differenzi fil-bijodisponibilità ta' rotigotine varjaw minn 2% (dirgħajn ta' fuq meta mqabbla mal-ġenbejn) għal 46% (l-ispallejn meta mqabbla mal-koxox).
English: With nondopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor.
Maltese: B'riċetturi mhux dopinerġiċi, rotigotine wera antagoniżmu f' riċetturi alpha2B u agoniżmu f' riċetturi 5HT1A, iżda ebda attivita` fuq riċetturi 5HT2B.
English: Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months.
Maltese: Żewġ provi importanti (SP512 Parti I and SP513 Parti I) li investigaw l-effettività ta' rotigotine fil-kura tas-sinjali u s-sintomi tal-marda idjopatika ta' Parkinson, twettqu f'pazjenti li ma kienux qed jirċievu terapija b'agonist ta' dopamine fl-istess ħin, u jew qatt ma kienu ħadu L-dopa qabel jew it-tul tal-kura b'L-dopa kienet ta' ≤ 6 xhur.
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Maltese: sinkope, sinkope vażovagali, telf ta' koxxjenza), diskinesjae, sturdament posturalie, letarġijae, konvulżjonie
English: A further multinational double-blind study (SP889) was conducted in 287 patients with early or advanced stages of Parkinson's disease who had unsatisfactory early morning motor symptom control.
Maltese: Studju multinazzjonali double-blind ieħor (SP889) sar f' 287 pazjent bi stadji tal-bidu jew avvanzati tal-marda ta' Parkinson li ma kellhomx kontrol sodisfaċenti tas-sintomu motorili ta' kmieni filgħodu.
English: Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Maltese: Jista' jkun hemm ukoll livelli akkumulati ta' rotigotine mhux mistennija meta jiggrava b'mod akut il-funzjoni tal-kliewi (ara sezzjoni 5.2).
English: With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points).
Maltese: B'rotigotine, il-medja tat-titjib fil-punteġġ UPDRS (Partijiet II + III) kienet ta' -3.98 punti (linja bażi 29.9 punti) filwaqt li fil-parti ta' l-istudju fejn il-pazjenti kienu kkurati bil-plaċebo, kien osservat li dawn marru għall-agħar b'1.31 punti (linja bażi 30.0 punt).
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups).
Maltese: Fit-tmiem tat-trattament tal-manteniment, titjib ta' mill-inqas 30% kien osservat f'57% u f'55% tal-pazjenti li kienu qed jirċievu rotigotine 8 mg/24 siegħa u 12 mg/24 siegħa, rispettivament u f'34% tal-pazjenti li kienu qed jirċievu l-plaċebo (differenza ta' 22% u 21%, rispettivament CI95% 10%; 35% u 8%; 33%, rispettivament, p<0.001 għażżewġ gruppi ta' rotigotine).
English: Patients should be regularly monitored for the development of impulse control disorders.
Maltese: Il-pazjenti għandhom jiġu regolarment immonitorjati għall-iżvillup ta' disturbi fil-kontrol tal-impulsi.
English: Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III).
Maltese: L-effikaċja kienet stabbilita mir-rispons tal-pazjent għat-terapija f'termini tat-titjib fil-punti tar-rispons u tal-punti assoluti fil-punteġġi kkombinati ta' ADL u l-Motor Examination (UPDRS Parti II+III).
English: In both arms treatment was titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively.
Maltese: F'dawn iż-żewġ gruppi ttrattament kien titrat għad-doża optimali jew doża massima ta' 8 mg/24 siegħa jew 9 mg/ġurnata, rispettivament.
English: • you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
Maltese: • ikollok bżonn li ssirlek immaġni bir-riżonanza manjetiku, scan MRI (stampi diagnostiċi tal organi u tessuti interni tal-ġisem, li jiġu kkrejati permezz ta' enerġija manjetiku minflok dik x ray)
English: Each patch of 20 cm contains 9.0 mg of rotigotine.
Maltese: Kull impjastru ta' 20 cm2 fih 9.0 mg ta' rotigotine.
English: Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/24 h to 24 mg/24 h.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' rotigotine jiżdiedu proporzjonalment mad-doża fuq il-medda tad-doża ta' 1 mg/24 siegħa sa 24 mg/24 siegħa.
English: The difference was 5.28 points and statistically significant (p<0.0001).
Maltese: Id-differenza kienet ta' 5.28 punti u kienet statistikament sinifikanti (p<0.
English: Convulsion Dropped head syndrome c,e
Maltese: Sindrome ta' Ras Baxxutac, e
English: At the end of maintenance, the mean UPDRS part III score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the placebo-group (baseline 32.0).
Maltese: III kienet tjiebet b'7.0 punti filpazjenti ttrattati b'rotigotine (linja bażi 29.6), u b'3.9 punti fil-grupp tal-plaċebo (linja bażi
English: In the double blind study SP650DB, 113 patients received rotigotine up to a maximum dose of 8 mg/24 h, 109 patients received rotigotine up to a maximum dose of 12 mg/24 h and 119 patients received placebo.
Maltese: Fl-istudju double blind SP650DB, 113 pazjenti rċivew rotigotine sa doża massima ta' 8 mg/24 siegħa, 109 pazjenti rċivew rotigotine sa doża massima ta' 12 mg/24 siegħa u 119-il pazjent irċivew il-plaċebo.
English: Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving concomitant levodopa therapy.
Maltese: Żewġ provi addizzjonali importanti (SP650DB u SP515) twettqu f'pazjenti li kienu qed jirċievu terapija fl-istess ħin b'levodopa.
English: Pruritus generalised, skin irritation, dermatitis contact
Maltese: Ħakk ġeneralizzat, irritazzjoni tal-ġilda, dermatite talkuntatt
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Legantoand 607 placebo-treated patients, 72.5% of the patients on Leganto and 58.0% of patients on placebo reported at least one adverse reaction.
Maltese: Ibbażat fuq l-analiżi miġbura minn ġabra ta' provi kliniċi kkontrollati bil-plaċebo li kienu jinkludu total ta' 1,307 pazjenti li kienu ikkurati b'Leganto u 607 pazjenti kkurati bil-plaċebo, 72.5% talpazjenti fuq Leganto u 58.0% ta' pazjenti fuq il-plaċebo irrappurtaw mill-inqas reazzjoni avversa waħda.
English: Transdermal patch
Maltese: Użu transdermali
English: The safety profile was unchanged from that observed in previous studies.
Maltese: Il-profil ta' sigurta` ma nbidilx minn dak osservat fl-istudji preċedenti.
English: Application and instillation site reactions a
Maltese: Reazzjonijiet fiż-żona ta' lapplikazzjoni u installazzjoni a
English: • movements you cannot control related to Parkinson's disease (dyskinesia)
Maltese: • movimenti ikontrollabli minħabba Parkinson's disease (diskinesija)
English: - Keep this leaflet.
Maltese: Disfunzjoni ta' erezzjoni
English: • The maximum dose is 8 mg each day.
Maltese: • Id-doża massima hi ta' 8 mg kuljum.
English: Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Maltese: Ħsibijiet u aġir anormali kienu rrappurtati u jistgħu jikkonsistu f'varjeta` ta' manifestazzjonijiet li jinkludu idejat paranojċi, delużjonijiet, alluċinazzjonijiet, konfużjoni, aġir qisu psikożi, diżorientazzjoni, aġir aggressiv, aġitazzjoni, u delirju.
English: The strengths are 1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h. The patches of 1 mg/24 h and 3 mg/24 h are used for the treatment of Restless Leg Syndrome, while the patches of 4 mg/24 h, 6 mg/24 h and 8 mg/24 h are used for the treatment of Parkinson's disease.
Maltese: L-impjastri ta' 1 mg/24h u 3 mg/24 h jintużaw għat-trattament ta Restless Leg Syndrome, waqt li limpjastri ta' 4 mg/24 h, 6mg/24 h u 8 mg/24 h jintużaw għat-trattament ta Parkinson's Disease.
English: In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo.
Maltese: Fl' studju double blind SP512 Parti I, 177 pazjent rċivew rotigotine u 96 pazjent irċivew il-plaċebo.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilita`, tqala u treddigh
English: • aggressive behaviour
Maltese: • tkun aggressiva
English: Clinical studies in Parkinson's disease
Maltese: Studji Kliniċi fil-Marda ta' Parkinson
English: Restless Legs Syndrome
Maltese: Sindromu ta' Restless Legs
English: Clinical studies in Restless Legs Syndrome
Maltese: Studji Kliniċi fis-Sindromu ta' Restless Legs
English: • generalised itching, skin irritation
Maltese: • ħakk ġeneralizzat, irritazzjoni fil-ġilda
English: Retinal degeneration was observed by transmission microscopy at a dose equivalent to 2.8 times the maximum recommended human dose on a mg/m² basis in a 3-month study in albino rats.
Maltese: Id-deġenerazzjoni tar-retina kienet osservata permezz ta' mikroskopija tat-trasmissjoni f'doża ekwivalenti għal 2.8 darbiet tal-massimu rakkomandat għad-doża umana fuq bażi ta' mg/m² fi studju li dam sejjer 3 xhur f'firien albini.
English: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).
Maltese: Film tal-polyester film, silikoniżżat, aluminiżżat, Miksi b'kulur permezzz ta saff ta pigment (titanium dioxide (E171), pigment isfar 95, pigment aħmar 166) u stampat (pigment aħmar 144, pigment isfar 95, pigment iswed 7).
English: Transdermal patch rotigotine
Maltese: Mhux magħru
English: In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo.
Maltese: Fl' studju double-blind SP513 Parti I, 213 pazjent irċivew rotigotine, 227 irċivew ropinirole u 117 pazjenti rċivew il-plaċebo.
English: Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off' fluctuations).
Maltese: Leganto hu indikat għall-kura tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson fl-istadju bikri bħala monoterapija (i.e. mingħajr levodopa) jew flimkien ma' levodopa, i.e. matul il-kors talmarda, sa l-istadji aħħarin fejn l-effett ta' levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet ta' l-effett terapewtiku (fluttwazzjonijiet fl-aħħar tad-dożaġġ jew ‘on-off').
English: Peripheral oedema has been observed in clinical trials conducted in patients with RLS.
Maltese: Edima periferali kienet osservata f'provi kliniċi li saru f'pazjenti bl'RLS.
English: Each patch of 10 cm contains 4.5 mg of rotigotine.
Maltese: Kull impjastru ta' 10 cm2 fih 4.5 mg ta' rotigotine.
English: • delusion
Maltese: • delirju
English: In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
Maltese: F'pazjenti b'indeboliment moderat tal-fwied u indeboliment sever tal-kliewi, ma ġietx osservati żieda fil-livelli ta' rotigoline fil-plażma.