FrancophonIA/ELRC3.0 huggingface dataset:
English: Boxes containing 7, 28, 30 or 84 (multipack containing 3 packs of 28) patches, which are individually sealed in sachets.
Maltese: Kaxxili fihom 7, 14, 28, 30, or 84 (pakkett multiplu li fih 3 pakketti ta' 28) impjastru, li huma ssiġillati individwalment fi qratas.
English: pathological gambling, stereotypy/ punding, binge eating/eating disorder b, compulsive shopping c)
Maltese: Mhux magħruf patoloġiku, stereotypy/ punding, iffangar/ disturbi ta' kif tiekolb, xiri kompulsivc),
English: Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Maltese: L-għoti flimkien ta' omeprazole (inhibitur ta' CYP2C19), f'dożi ta' 40 mg/ġurnata, ma kellu l-ebda effett fuq il-farmakokinetika u l-metaboliżmu ta' rotigotine f'voluntiera f'saħħithom.
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Leganto
Maltese: Dan huwa magħruf bħala ‘sindromu ra' disregulazzjoni ta' dopamine' u jista' jwassal tal-użu żejjed ta' Leganto
English: Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson's disease and Restless Legs Syndrome.
Maltese: Rotigotine hu agonist ta' dopamine mhux ergoliniku, li jintuża għal-kura tas-sinjali u s-sintomi talmarda ta' Parkinson u s-sindromu ta' Restless Legs.
English: In a multicenter, double-blind, randomized, 2-way, crossover study in 52 outpatients, the skin adhesion of the improved room temperature patch formulation was compared to the cold storage formulation, using the 8 mg/24 h rotigotine patch.
Maltese: F'studju cross-over, 2-way, randomizzat, double-blind, multiċentrali f' 52 pazjenti barra mill-isptar, ittwaħħil mal-ġilda tal-formulazzjoni mtejjba tal-impjastru tat-temperatura tal-ambjent kienet mqabbla mal-formulazzjoni tal-ħażna fil-kesħa, billi ntuża l-impjasstru rotigotine 8 mg/24 siegħa.
English: In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
Maltese: dopamine marbuta ma' l-effetti farmakodinamiċi u t-tnaqqis konsegwenti tat-tnixxija ta' prolactin.
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Maltese: Reazzjonijiet avversi tal-mediċina (ADRs) irrappurtati f'iktar minn 10% tal-pazjenti kkurati bil-garża Leganto li tipprovdi mediċina li tgħaddi minn ġol-ġilda huma dardir, rimettar, reazzjonijiet fis-sit tatteħid, nagħas tqil, sturdament u uġigħ ta' ras.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għall- preżentazzjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan ilprodott huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew talmediċini.
English: • hiccups
Maltese: • inkubi
English: Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).
Maltese: 03mg ethinylestradiol, 0.15mg levonorgestrel).
English: • increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles)
Maltese: • Żieda fil-livelli ta' creatine phosphokinase (CPK) fid-demm ta' pazjenti Ġiappuniżi (CPK huwa enżim li ssibu prinċiparjament fil-muskoli skeletali)
English: After 6 months of maintenance treatment in patients with moderate to severe RLS, the baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for rotigotine.
Maltese: Wara sitt xhur ta' trattament ta' manteniment f'pazjenti b'RLS moderat sa sever, il-punteġġ tal-linja bażi IRLS tjiebet minn 30.7 għal 20.7 għal plaċebo u minn 30.2 għal 13.8 għal rotigotine.
English: The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions and other signs of central dopaminergic stimulation.
Maltese: Ir- reazzjonijiet avversi li huma l-aktar mistennija li jseħħu x'aktarx li jkunu dawk marbuta mal-profil farmakodinamiku ta' agonist ta' dopamine, li jinkludu dardir, rimettar, pressjoni tad-demm baxxa ħafna, movimenti involontarji, alluċinazzjonijiet, konfużjoni, konvulżjonijiet u sinjali oħrajn ta' stimulazzjoni dopaminerġika ċentrali.
English: AST, ALT, GGT), weight increased, heart rate increased, CPK increased d
Maltese: AST, ALT, GGT), żieda filpiże, żieda firrata tal qalbe, żieda fis-CPKd,e
English: Rotigotine significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 for placebo (p<0.0001).
Maltese: F'studju kontrollat mill-plaċebo li dam 7 ġimgħat kienu investigati parametriċi polysomnografiċi. rotigotine naqqas sinifikament l-indiċi ta' moviment tar-riġlejn perjodiku (PLMI) minn 50.9 għal 7.7 meta mqabbel ma' 37.4 għal 32.7 bil-plaċebo (p<0.
English: • feeling of heartbeat (palpitation)
Maltese: • sensazzjoni ta' taħbit tal-qalb (palpitazzjoni)
English: It belongs to a group of medicines called ‘dopamine agonists'.
Maltese: Jappartjeni għal grupp ta' mediċini msejħa agonisti ta' dopamine.
English: Component of a multipack, can't be sold separately
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament
English: What Leganto is Leganto contains the active substance rotigotine.
Maltese: X'inhu Leganto Leganto fih is-sustanza attiva rotigotine.
English: In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Maltese: Riżultati in vitro jindikaw li isoformi differenti tasCYP jistgħu jikkatalizzaw l-N-dealkylation ta' rotigotine.
English: The box contains 7, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.
Maltese: Kaxxi li fihom 7, 28, 30 jew 84 (pakkett multiplu li fih 3 pakketi ta' 28) impjastru, li huma ssiġillati individwalment fi qratas.
English: • Release liner: Transparent fluoropolymer coated polyester film.
Maltese: • Inforra tar-rilaxx: Saff ta' polyester miksi b'fluoropolimer trasparenti
English: Observed in open-label studies c
Maltese: Lista f'tabella tar-reazzjonijiet avversi
English: Fall a
Maltese: Irritibilit a`
English: In a randomized, open-label study (SP825) in patients with early-stage Parkinson's disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole.
Maltese: Fi studju randomizzat (SP825), open-label li sar f'pazjenti fl-istadji bikrija tal-marda ta'Parkinson, 25 pazjent ingħataw rotigotine u 26 ropinirole mingħajr ma ġew magħżula.
English: At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001).
Maltese: Titjib ta' 20% kien osservat fi 48% tal-pazjenti li kienu qed jirċievu rotigotine u f'19% tal-pazjenti li kienu qed jirċievu l-plaċebo (differenza ta' 29% CI95% 18%; 39%, p<0.0001).
English: The mean improvement in the UPDRS score (Parts II + III) was 6.83 points (baseline 33.2 points) in the rotigotine arm, 10.78 points in the ropinirole arm (baseline 32.2 points) and 2.33 points in the placebo arm (baseline 31.3 points).
Maltese: Il-medja tat-titjib fil-punteġġ UPDRS (Partijiet II + III) kienet ta' 6.83 punti (linja bażi 33.2 punti) fil-parti ta' l-istudju dwar rotigotine, 10.
English: • blurry vision
Maltese: • vista mċajpra
English: The maximum dose is 8 mg per day.
Maltese: Id-doża massima hi ta' 8 mg kuljum.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-immaniġġjar tar-riskju (RMP)
English: Ophthalmologic monitoring
Maltese: Monitoraġġ oftalmoloġiku
English: Multipack: 84 (3 packs of 28) transdermal patches
Maltese: U KONTENUT Pakkett multiplu: 84 (3 pakketti ta' 28) garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease.
Maltese: L-effettività ta' rotigotine fit-trattament tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson kienet evalwata fi programm multinazzjonali dwar l-iżvilupp tal-mediċina li kien jikkonsisti f'erba' studji importanti ħafna, paralleli, randomized, double-blind, ikkontrollati bil-plaċebo u tlett studji li jinvestigaw aspetti tal-Marda ta' Parkinson.
English: • high blood pressure
Maltese: • pressjoni għolja
English: Main metabolites are sulfates and glucuronide conjugates of the parent compound as well as N-desalkyl-metabolites, which are biologically inactive.
Maltese: Il-metaboliti ewlenin huma sulfates u konjugati ta' glucuronide tal-kompost prinċipali kif ukoll metaboliti
English: Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse Lymphoma Assay with metabolic activation and weaker effects without metabolic activation.
Maltese: Rotigotine ma kkawżax mutazzjonijiet tal-ġeni fit-test ta' Ames, iżda wera effetti fl-Analiżi taċ-Ċelluli tal-Limfoma tal-Ġrieden in vitro ma' attivazzjoni metabolika u effetti iktar dgħajfa mingħajr attivazzjoni metabolika.
English: Fibrotic complications
Maltese: Komplikazzjonijiet fibrotiċi
English: Peel off sachet in a cardboard carton: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.
Maltese: Naħa minnhom hi magħmula minn ethylene copolymer (is-saff ta' ġewwanett), fojl ta' l-aluminju, rita tal-polyethylene b'densità baxxa u karta; in-naħa l-oħra hi magħmula minn polyethylene (is-saff ta' ġewwanett), aluminju, ethylene copolymer u karta.
English: The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson's disease.
Maltese: Id-dożi huma ta 2 mg/24 h, 4 mg/24 h, 6 mg/24 h u 8 mg/24 h għat-trattament tal-marda ta' Parkinson.
English: • Thigh or hip.
Maltese: • Telf ta' piż
English: These occurred in 3.4% of Japanese subjects on rotigotine compared to 1.9% on placebo in double-blind Parkinson's disease and RLS studies.
Maltese: Dawn seħħew f' 3.4% tal-pazjenti Ġappuniżi fuq rotigotine meta mqabbla ma' 1.9% fuq placebo f'studji double-blind bil-marda ta' Parkinson's u RLS.
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Leganto in 7.2% of subjects.
Maltese: Il-maġġoranza tar-reazzjonijiet fis-sit ta' applikazzjoni kienu ħfief jew moderati fl-intensità, limitati għal-post mnejn jittieħed u rriżultaw fit-twaqqif tal-kura b'Leganto f'7.2% tal-pazjenti.
English: INTERMEDIATE BOX (WITHOUT BLUE BOX) BOX OF 28 PATCHES
Maltese: KAXXA TAN-NOFS (MINGĦAJR IL-BLUE BOX) KAXXA TA' 28 IMPJASTRU
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Legantoand 214 placebo-treated patients, 65.5% of the patients on Leganto and 33.2% 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' 748 pazjent li kienu ikkurati b'Leganto u 214 pazjent kkurati bil-plaċebo, 65. 5% tal-pazjenti fuq Leganto u 33.2% ta' pazjenti fuq il-plaċebo irrappurtaw mill-inqas reazzjoni avversa waħda.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)
Maltese: (li tinkludi eritema, ħakk, irritazzjoni, raxx, dermatite, bżieżaq żgħar, uġigħ, ekżema, infjammazzjoni, nefħa, diskolorazzjoni, infafet, esfoljazzjoni, urtikarja, sensittività eċċessiva), Kondizzjonijiet asteniċi inklużi għeja, astenja, u telqa)
English: Special populations)
Maltese: Popolazzjonijiet speċjali)
English: Very common Common Uncommon
Maltese: Komuni ħafna Komuni
English: Ear and labyrinth disorders
Maltese: Mard tal-widna u s-sistema labirintika
English: Adverse reactions of increased creatine phosphokinase (CPK) were observed with rotigotine in clinical studies conducted in Japan.
Maltese: Reazzjonijiet avversi ta' żieda fil creatinine phosphokinase (CPK) kienu osservati b'rotigotine f'studji kliniċi li saru l-Ġappun.
English: OUTER LABEL (WITH BLUE BOX) BOX OF 84 PATCHES CONTAINING 3 BOXES OF 28 PATCHES
Maltese: TIKKETTA TA' BARRA (BIL-BLUE BOX) KAXXA TA' 84 GARZA LI FIHA 3 KAXXI TA' 28 IMPJASTRU
English: Dopaminergic adverse reactions
Maltese: • reazzjoni allerġika
English: Each patch releases 6 mg of rotigotine per 24 hours.
Maltese: Each Kull impjastru jerħi 6 mg ta' rotigotine kull 24 siegħa.
English: • You may get redness and itching on the skin where the patch has been - these reactions are usually mild or moderate.
Maltese: • Jista' jkollok ħmura u ħakk fil-ġilda fejn kien hemm l-impjastru - dawn ir-reazzjonijiet normalment ikunu ħfief jew moderati.
English: For both primary endpoints statistically significant differences have been observed for the doses 1 mg/24 h, 2 mg/24 h and 3 mg/24 h in comparison to placebo.
Maltese: Għaż-żewġ punti ta' l-aħħar primarji ġew osservati differenzi statistikament sinifikattivi għad-dożi 1 mg/24 siegħa, 2 mg/24siegħa u 3 mg/24siegħa meta mqabbla mal-plaċebo.
English: Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
Maltese: Leganto fih sodium metabisulphite, sulphite li jista' jikkawża reazzjonijiet tat-tip allerġiċi inklużi sintomi anafilattiċi u episodji fejn ikun hemm periklu tal-mewt, jew episodji ażżmatiċi anqas severi, f'persuni suxxettibbli.
English: Treatment of Restless Legs Syndrome
Maltese: Trattament tas-Sindromu ta' Restless Legs
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: Comparable skin tolerability was reported for both formulations.
Maltese: It-tollerabbilta` tal-ġilda kienet simili fiż-żewġ formolazzjonijiet.
English: Hypertension Orthostatic hypotension
Maltese: Pressjoni baxxa ortostatika
English: Atrial fibrillation Supraventricular tachycardia
Maltese: Palpitazzjonijie te, fibrillazzjoni atrijalie, supraventrikula ri takikardjae
English: Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirolegroup after 4 weeks of maintenance.
Maltese: Iż-żewġ studji wrew titjib fil-funzjoni tal-muskoli kmieni filgħodu, Sintomi motorili (UPDRS Part III) tjiebu b'6.3 ± 1.3 punti u b' 5.9 ± 1.3 punti fil-grupp ta' ropinirole wara 4 ġimgħat ta' manteniment.
English: If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)
Maltese: Jekk pazjent bil-marda ta' Parkinson ma jkunx ikkontrollat biżżejjed waqt li jkun fuq trattament b'rotigotine, jekk jaqleb għal agonist ieħor ta' dopamine, dan jista' jipprovdi benefiċċju addizzjonali (ara sezzjoni 5.1)
English: See ‘Changes to your behaviour and abnormal thinking' in section 4 for more information.
Maltese: Ara ‘ Tibdiliet fl-aġir tieghek u ħsibijiet abnormali' f'sezzjoni 4 għal aktar informazzjoni.
English: MedDRA
Maltese: Dardir
English: Palpitations e,
Maltese: Palpitazzjoniji et
English: The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 4 mg/24 h to a maximum dose of 16 mg/24 h. In the pramipexole group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/day.
Maltese: Fil-grupp ta' pramipexole, il-pazjenti rċivew 0.375 mg fl-ewwel ġimgħa, 0.75 mg fit-tieni ġimgħa u kienu ttitrati mill-ġdid f'inkrementi ta' kull ġimgħa ta' 0.75 mg għall-aħjar doża tagħhom sa massimu ta' 4.5 mg/kuljum.
English: The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall elimination half-life is 5 to 7 hours.
Maltese: It-tneħħija ta' rotigotine wara l-għoti transdermali hi ta' madwar 10 l/min u b'kollox l-half-life ta' leliminazzjoni tiegħu hi minn 5 sa 7 sigħat.
English: In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.
Maltese: F'istudji SP824 u SP825 li saru minn wara l-prova inizjali komparattiva, rotigotine u ropinirole kienu murija li kellhom effikaċja komparibli f'dożi ekwivalenti.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni ta' Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS).
Maltese: L-evalwazzjoni tar-riżultat primarju kien il-punteġġ għallkomponent Activities of Daily Living (ADL) (Parti II) flimkien mal-komponent Motor Examination
English: With rotigotine, the mean reductions in “off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
Maltese: B'rotigotine, il-medja tat-tnaqqis fil-ħin “off” kien ta' 2.7 u 2.1 sigħat rispettivament, filwaqt li fil-parti ta' l-istudju fejn il-pazjenti kienu kkurati bil-plaċebo, tnaqqis ta' 0.9 ta' siegħa kien osservat.
English: Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09
Maltese: Mediċina ta' kontra il-Parkinson, agonisti ta' dopamine:
English: Nausea
Maltese: delirju
English: How to store Leganto
Maltese: X'fih Leganto
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiku
English: ANNEX I
Maltese: MANIFATTUR(I) RESPONSABBLI
English: B. PACKAGE LEAFLET
Maltese: Komponent ta' pakkett multiplu
English: • For most patients, the right dose is between 8 mg and 16 mg each day.
Maltese: • Għall-biċċa l-kbira tal-pazjenti, id-doża korretta hija ta' bejn 8 mg u 16 mg kuljum.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: (≥1/10,000 sa <1/1,000); rari ħafna: (<1/10,000) mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Leganto.
Maltese: Dan huwa magħruf bħala ‘sindromu ta' disregulazzjoni ta' dopamine' u jista' jwassal tal-użu żejjed ta' Leganto
English: Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Leganto, and co-administration should be avoided.
Maltese: Minħabba li rotigotine hu agonist ta' dopamine, hu ssoponut li l-antagonisti ta' dopamine, bħal newroleptiċi (eż. phenothiazines, butyrophenones, thioxanthenes) jew metoclopramide, jistgħu jnaqqsu l-effettività ta' Leganto, u l-għoti flimkien għandu jiġi evitat.
English: Leganto 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Maltese: Leganto 2 mg/24 siegħa 4 mg/24 siegħa 6 mg/24 siegħa 8 mg/24 siegħa
English: Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal function.
Maltese: Il-livelli tal-konjugati ta' rotigotine fil-plażma u l-metaboliti desalkyl tiegħu, jiżdiedu ma lindeboliment tal-funzjoni tal-kliewi.
English: • rash over larger parts of the body • involuntary muscle spasms (convulsion)
Maltese: • spażmi tal-muskoli involontarji (konvulżjoni)
English: The treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, individually sealed in sachets.
Maltese: Pakkett wieħed tal-bidu tal-kura fih 28 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda f'4 kaxxi tal-kartun b'7 impjastri ta' 2 mg, 4 mg, 6 mg, u 8 mg kull waħda, li huma ssiġillati individwalment fi qratas.
English: Leganto 8 mg/24 h transdermal patch EU/1/11/695/046
Maltese: Leganto 8 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/11/695/046
English: Fall e a
Maltese: Ġimgħa 3
English: The absolute bioavailability after transdermal application is approximately 37%.
Maltese: Il-bijodisponibilità assoluta wara l-għoti minn fuq il-ġilda hi ta' madwar 37%.
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia e,
Maltese: sinkope, sinkope vażovagali, telf ta' koxxjenza),
English: Leganto 1 mg/24 h transdermal patch EU/1/11/695/001
Maltese: Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda EU/1/11/695/001
English: SACHET LABEL - WEEK 1
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-QARTAS - ĠIMGĦA 1
English: Leganto 2 mg/24 h
Maltese: Leganto 2 mg/24 siegħa
English: Leganto 8 mg/24 h
Maltese: Leganto 8 mg/24 siegħa
English: Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
Maltese: Mediċini newroleptiċi mogħtija bħala antiemetiċi (mediċini ta' kontra d-dardir u r-rimettar) m'għandhomx jingħataw lil pazjenti li jkunu qed jieħdu agonisti ta' dopamine (ara wkoll sezzjoni 4.5).
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Leganto are nausea, application site reactions, asthenic conditions and headache.
Maltese: Reazzjonijiet avversi tal-mediċina (ADRs) irrappurtati f'iktar minn 10% tal-pazjenti ttrattati b'Leganto huma dardir, reazzjonijiet fil-post mnejn jittieħed, kondizzjonijiet asteniċi u uġigħ ta' ras.
English: • sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
Maltese: • mediċini sedattivi bħal benzodiazepine jew mediċini biex tikkura mard mentali u mediċini biex tikkura d-dipressjoni.
English: Leganto 6 mg/24 h
Maltese: Leganto 6 mg/24 siegħa
English: Currently available data are described in section 5.2 but no recommendation on a posology in children with RLS can be made.
Maltese: Id-dejta disponibbli bħalissa huma deskritti f'sezzjoni 5.2 imma ma jistgħux isiru rekommandazzjonijiet dwar pożoloġija f'tfal b'RLS.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Maltese: Id-dejta disponibbli bħalissa huma deskritti f'sezzjoni 5.2 imma ma jistgħux isiru rekommandazzjonijiet dwar pożoloġija.