qanastek/EMEA-V3 huggingface dataset:
Neupro is used for to treat the symptoms of the following diseases in adults: • Parkinson’ s disease.
Neupro jintuża għat- trattament tas- sintomi ta 'dan il- mard li ġej fl- adulti: • marda ta' Parkinson.
Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson’ s disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective. • 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.
Neupro bħala monoterapija jintuża fit- trattament ta 'din il- marda fl- istadju inizjali, jew flimkien mal- levodopa (mediċina oħra użata għall- marda ta' Parkinson) fl- istadji kollha tal- marda, inklużi l- aħħar stadji meta l- levodopa tibda titlef l- effikaċja tagħha. • sindromu tar- riġlejn mingħajr mistrieħ (restless legs syndrome) minn moderat għal gravi li huwa disturb li bih il- pazjent mhuwiex kapaċi jieqaf milli jċaqlaq riġlejh biex iwaqqaf sensazzjoni strambi, ta 'skumdità jew ta' wġigħ jew fil- ġisem, normalment matul il- lejl.
Neupro is used when a specific cause for the disorder cannot be identified.
Neupro jintuża meta ma tistax tiġi identifikata kawża speċifika għad- disturb.
How is Neupro used?
Kif jintuża Neupro?
Neupro is applied once a day at about the same time every day.
Neupro huwa applikat darba kuljum bejn wieħed u ieħor fl- istess ħin tal- ġurnata.
The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
L- istikk jiġi applikat fuq ġilda xotta, nadifa u b' saħħitha fuq l- addome (żaqq), il- koxxa, il- ġenbejn, il- ġenb, l- ispalla jew fil - parti ta 'fuq tad- driegħ.
The patch remains on the skin for 24 hours and is then replaced by a new one in a different place.
L- istikk jibqa 'fuq il- ġilda għal 24 siegħa u mbagħad dan għandu tinbidel b' wieħed ġdida mqiegħed f' post differenti.
The same place must not be used again until two weeks later.
Għandha tiġi evitata l- applikazzjoni mill- ġdid fl- istess post sa ġimagħtejn wara.
In early-stage Parkinson’ s disease, the starting dose is 2 mg/ 24 h, which is increased every week by 2 mg/ 24 h until an effective dose is reached or up to a maximum dose of 8 mg/ 24 h.
Fl- istadju inizjali tal- marda ta 'Parkinson, id- doża inizjali hija 2 mg/ 24 siegħa u mbagħad din tiżdied kull ġimgħa b' 2 mg/ 24 siegħa sakemm tintlaħaq doża effikaċi jew sa doża massima ta' 8 mg/ 24 siegħa.
For most patients, an effective dose is reached within three or four weeks.
Għal ħafna mill- pazjenti d- doża effikaċi tintlaħaq fi żmien 3 jew 4 ġimgħat.
A special pack with patches of four different strengths is available to help when starting treatment.
Għall- pazjenti li jibdew it- terapija tħejja pakkett speċjali li fih l- erba 'dożaġġi differenti.
If the control of the disease is not sufficient, patients may benefit from switching to another similar medicine.
Jekk il- mediċina mhijiex biżżejjed biex tikkontrolla l- marda, il- pazjenti jistgħu jieħdu benefiċċju jekk jgħaddu għal mediċina oħra simili.
In advanced disease, the starting dose is 4 mg/ 24 h, which is increased every week by 2 mg/ 24 h until an effective dose is reached or up to a maximum dose of 16 mg/ 24 h.
Fi stadju avvanzat tal- marda, id- doża inizjali hija 4 mg/ 24 siegħa li mbagħad tiżdied kull ġimgħa b' 2 mg/ 24 siegħa sakemm tintlaħaq doża effikaċi jew sa doża massima ta '16 mg/ 24 siegħa.
Some doses may need the application of more than one patch.
L - applikazzjoni ta 'ċerti stikks tista' teħtieġ iktar minn stikk wieħed.
In restless legs syndrome, the starting dose is 1 mg/ 24 h.
Fis- sindromu tar- riġlejn bla mistrieħ, id- doża inizjali hija 1 mg/ 24 siegħa.
Depending on the patient’ s response, the dose can be increased every week by 1 mg/ 24 h until an effective dose is reached or up to a maximum dose of 3 mg/ 24 h.
Id- doża tista 'tiżdied kull ġimgħa b' 1 mg/ 24 siegħa, skond ir- rispons tal- pazjent, sakemm tintlaħaq id- doża effikaċi jew sa doża
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. massima ta '3 mg/ 24 siegħa.
How does Neupro work?
Kif jaħdem Neupro?
The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Is- sustanza attiva f' Neupro, rotigotina, hija agonista tad- dopamina li jfisser li timita l- azzjoni tad - dopamina.
Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Id- dopamina hija sustanza li taħdem bħala messaġġiera fil- partijiet tal- moħħ li jikkontrollaw il- moviment u l- koordinazzjoni.
In patients with Parkinson’ s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Fil- pazjenti li jbatu mill- marda ta 'Parkinson, iċ- ċelluli li jipproduċu d- dopamina jibdew imutu u b' hekk l- ammont ta' dopamina fil- moħħ jonqos.
The patients then lose their ability to control their movements reliably.
Għalhekk il - pazjenti jitilfu l- kapaċità li jikkontrollaw il- movimenti tagħhom b' mod affidabbli.
Neupro delivers a constant supply of rotigotine through the skin into the bloodstream.
Neupro jittrasferixxi fid- demm kwantità ta 'rotigotina minn ġol- ġilda.
Rotigotine then 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 stiffness and slowness of movement.
Ir- rotigotina mbagħad tistimola l- moħħ hekk kif tagħmel id- dopamina, biex b' hekk il- pazjenti jikkontrollaw il- movimenti tagħhom u jkollhom inqas sinjali u sintomi tal- marda ta 'Parkinson, bħall- ebusija u d- dewmien fil- movimenti.
The way rotigotine works in restless legs syndrome is not fully understood.
Għadu mhuwiex kompletament mifhum il- mod kif ir- rotigotina taħdem fis- sindromu tal- riġlejn bla mistrieħ.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Huwa maħsub li s- sindromu huwa kkawżat minn problemi fil- mod kif id- dopamina taħdem fil- moħħ li jista 'jitjieb permezz tar- rotigotina.
How has Neupro been studied?
Kif ġie studjat Neupro?
The effectiveness of Neupro in the treatment of early-stage Parkinson’ s disease was studied in a total of 830 patients in two studies.
L- effikaċja ta 'Neupro fit- trattament ta' l- istadji inizjali tal- marda ta 'Parkinson ġiet studjata fuq total ta' 830 pazjent f' żewġ studji.
The studies measured the scores before and after treatment obtained with a standard questionnaire called the Unified Parkinson’ s Disease Rating Scale (UPDRS).
L- istudji kejlu l- punteġġi miksubin qabel u wara t- trattament fi kwestjonarju standard (Unified Parkinson' s Disease Rating Scale, UPDRS).
An improvement of 20% in the score after treatment was taken as a measure of a benefit that would be relevant for patients.
Titjib ta '20% fil- punteġġ wara t- trattament tqies bħala kejl ta' benefiċċju li jkun rilevanti għall- pazjenti.
In the first study, the effectiveness of Neupro was compared with that of placebo (a dummy treatment) and in the second, it was compared with ropinirole (another dopamine agonist) and with placebo.
Fl- ewwel studju, l - effikaċja ta 'Neupro tqabblet ma' dik ta 'plaċebo (trattament finta) u fit- tieni studji, tqabblet ma' ropinirole (agonista tad- dopamina ieħor) u mal- plaċebo.
In advanced Parkinson’ s disease, Neupro was studied in a total of 842 patients in two studies.
Fl- istadju avvanzat tal- marda ta 'Parkinson, Neupro ġie studjat fuq total ta' 842 pazjent f' żewġ studji.
The measure of effectiveness was the length of time during the day that the patients recorded as ‘ off’ (when they had too many Parkinson’ s disease symptoms to be able to live normally).
Il- kejl ta 'l- effikaċja kien rappreżentat mill - perjodu ta' żmien fil- ġurnata li fih il- pazjenti qiesu lilhom infushom bħala 'off' (meta kellhom wisq sintomi tal- marda ta 'Parkinson biex ikunu jistgħu jgħixu normalment).
In the first study, the effectiveness of two different doses of Neupro was compared with that of placebo and in the second, it was compared with pramipexole (another dopamine agonist) and with placebo.
Fl- ewwel studju, l- effikaċja ta 'żewġ dożi differenti ta' Neupro tqabblet ma 'dik ta' plaċebo u fit- tieni studji, tqabblet ma 'pramipexole (agonista tad- dopamina ieħor) u mal- plaċebo.
For restless legs syndrome, Neupro has been studied in two main studies involving a total of 963 patients with moderate to severe disease.
Fis- sindromu tar- riġlejn bla mistrieħ, Neupro ġie studjat f' żewġ studji ewlenin li involvew total ta '963 pazjent b' marda minn moderata għal gravi.
The effectiveness of Neupro at doses between 0.5 and 3 mg/ 24 h was compared with that of placebo.
L- effikaċja ta 'Neupro f' dożi bejn 0. 5 u 3 mg/ 24 siegħa tqabblet ma' dik tal- plaċebo.
The main measure of effectiveness was the change in symptoms between the start of the study and after six months of treatment with a stable dose, measured using two standard scales.
Il- kejl ewlieni ta 'l- effikaċja kien il- bidla fis- sintomi bejn il- bidu ta' l - istudju u wara sitt xhur ta 'trattament b' doża stabbli, imkejjel permezz ta' żewġ skali standard.
What benefit has Neupro shown during the studies?
X' benefiċċju wera Neupro matul l- istudji mwettqu?
Neupro was more effective than placebo in treating Parkinson’ s disease.
Neupro rriżulta aktar effikaċi mill- plaċebo fit- trattament tal- marda ta 'Parkinson.
In early-stage disease, the scores obtained with Neupro showed an improvement compared with placebo in the UPDRS.
Fl- istadju inizjali tal - marda, il- punteġġi miksubin fil- UPDRS b' Neupro wrew titjib meta mqabbel mal- plaċebo.
A 20% improvement in scores was seen in 48 to 52% of the patients using Neupro and in 19 to 30% of those using placebo.
F' 48 sa 52% tal- pazjenti ttrattati b' Neupro ġie osservat titjib ta '20% fil- punteġġi kif ukoll fi 19 sa 30% ta' dawk ittrattati bil- plaċebo.
Neupro was less effective than ropinirole: a 20% improvement was seen in 68% of the subjects receiving ropinirole.
Fi 68% ta 'dawk ittrattati b' ropinirole, ġie osservat titjib ta' 20%.
In advanced Parkinson’ s disease, patients using Neupro had a greater decrease in their ‘ off ’ time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Fil- marda ta 'Parkinson fl- istadju avvanzat, il- pazjenti ttrattati b' Neupro esperjenzaw tnaqqis akbar fil- perjodu li tqiesu bħala' off 'minn dawk ittrattati bil- plaċebo (tnaqqis ta' 2. 1 sa 2. 7 siegħa b' Neupro meta mqabbel ma '0. 9 sigħat bil- plaċebo).
The decrease with pramipexole was 2.8 h.
It- tnaqqis bi pramipexole kien 2. 8 sigħat.
In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/ 24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Fis- sindromu tar- riġlejn bla mistrieħ, il- pazjenti ttrattati b' dożaġġi ta 'Neupro ta' bejn 1 u 3 mg/ 24 siegħa esperienzaw titjib akbar minn dawk ittrattati bil- plaċebo fiż- żewġ studi, hekk kif imkejjel fiż- żewġ skali tas- sintomi.
What is the risk associated with Neupro?
X' inhu r- riskju assoċjat ma 'Neupro?
The most common side effects with Neupro in patients with Parkinson’ s disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, nausea (feeling sick) and application site reactions such as irritation and burning of the skin.
L- effetti sekondarji l- aktar komuni b' Neupro fil- pazjenti li jbatu mill- marda ta 'Parkinson (li dehru f' aktar minn pazjent 1 minn 10) huma ħedla tan- ngħas, sturdament, nawżea (dardir) u reazzjonijiet fil - punt ta' applikazzjoni bħal irritazzjoni u ħruq tal- ġilda.
In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, fatigue (tiredness) and headache.
Fil- pazjenti li jbatu mis- sindromu tar- riġlejn bla mistrieħ, l- effetti sekondarji l- aktar komuni (li dehru f' aktar minn pazjent 1 minn 10) kienu nawżea, reazzjonijiet fil- punt ta 'applikazzjoni, għeja u wġigħ ta' ras.
It is important to use the patch as instructed to limit skin reactions.
Biex jiġu limitati r- reazzjonijiet tal- ġilda, huwa importanti li l- istikk jintuża skond l- istruzzjonijiet.
Somnolence can affect the ability of the patient to drive.
Il- ħedla tan- ngħas tista 'tikkomprometti l - kapaċità tal- pazjent li jsuq.
For the full list of all side effects reported with Neupro, see the Package Leaflet.
Għal lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Neupro, ara l - Fuljett ta' Tagħrif.
Neupro should not be used in people who may be hypersensitive (allergic) to rotigotine or any of the other ingredients.
Neupro ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għar- rotigotina jew għal xi ingredjenti oħra.
The backing layer of Neupro contains aluminium.
Is- saff ta 'rinforz ta' Neupro fih l- aluminju.
To avoid skin burns, Neupro should be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart’ s normal rhythm).
Biex tevita ħruq tal- ġilda, Neupro 2/ 3 għandu jitneħħa jekk il- pazjent għandu jiġi sottopost għal magnetic resonance imaging (MRI) jew għal kardjoverżjoni (proċess li jerġa 'jġib ir- ritmu tat- taħbit tal- qalb għan- normal).
2/ 3 Why has Neupro been approved?
Għaliex ġie approvat Neupro?
The Committee for Medicinal Products for Human Use (CHMP) decided that Neupro’ s benefits are greater than its risks for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, and the treatment of the signs and symptoms of idiopathic Parkinson’ s disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Neupro huma ogħla mir- riskji tiegħu għat- trattament sintomatiku tas- sindromu idjopatiku tar- riġlejn bla mistrieħ minn moderat għal gravi fl- adulti kif ukoll għat- trattament tas- sinjali u tas- sintomi tal - marda ta' Parkinson idjopatika.
The Committee recommended that Neupro be given marketing authorisation.
Il- Kumitat irrakkomanda li Neupro jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Neupro?
Liema miżuri qegħdin jittieħdu sabiex jiżguraw l- użu sikur ta 'Neupro?
The company that makes Neupro is studying some of the side effects that have been seen with similar medicines (sleep attacks and development of hard tissue in the valves of the heart).
Il- kumpanija li tipproduċi Neupro qiegħda tistudja wħud mill- effetti sekondarji li ġew osservati f' mediċini analogi (attakki ta 'rqad u żvilupp ta' tessut iebes fil- valvoli tal- qalb).
Other information about Neupro:
Aktar tagħrif dwar Neupro:
The European Commission granted a marketing authorisation valid throughout the European Union for Neupro to Schwarz Pharma Ltd. on 15 February 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Neupro lil Schwarz Pharma Ltd. fil- 15 ta 'Frar 2006.
The full EPAR for Neupro can be found here.
L- EPAR sħiħ għal Neupro jista 'jiġi kkonsultat hawn.
Neupro 1 mg/ 24 h transdermal patch
Neupro 1 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Each patch releases 1 mg of rotigotine per 24 hours.
Kull impjastru jerħi 1 mg ta ’ rotigotine kull 24 siegħa.
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Kull impjastru ta ’ 5 cm2 fih 2. 25 mg ta ’ rotigotine.
Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.
Irqiqa, matrix- type, b’ forma kwadra bi truf jagħtu fit- tond, li tikkonsisti fi tliet saffi.
The outside of the backing layer is tan-coloured and imprinted with Neupro 1 mg/ 24 h.
In- naħa ta ’ barra tas- saff ta ’ wara hi ta ’ kulur kannella ċar u għandha l- kliem Neupro 1mg/ 24 h. stampat fuqha.
Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Neupro huwa indikat għat- trattament tas- sintomi tas- sindromu ta ’ Restless Legs idjopatiku moderat għal sever fl- adulti.
Neupro is applied once a day.
Neupro jiġi applikat darba kuljum.
The patch should be applied at approximately the same time every day.
L- impjastru għandu jiġi applikat bejn wieħed u ieħor fl- istess ħin kuljum.
The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
L- impjastru jibqa ’ fuq il- ġilda għal 24 siegħa u mbagħad jinbidel ma ’ wieħed ġdid f’ zona ta ’ l- applikazzjoni differenti.
If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day.
Jekk il- pazjent jinsa japplika l- impjastru fil- ħin tas- soltu tal- jum jew jekk l- impjastru jinqala ’, għandu jiġi applikat impjastru ieħor għall- bqija tal- jum.
Dosage The dose recommendations made are in nominal dose.
Dożaġġ Ir- rakkomandazzjonijiet tad- doża mogħtija huma skond id- doża nominali.
A single daily dose should be initiated at 1 mg/ 24 h.
Doża singola kuljum għandha tinbeda b ’ 1 mg/ 24 siegħa.
Depending on the individual patient response, the dose may be increased in weekly increments of 1 mg/ 24 h to a maximal dose of 3 mg/ 24 h.
Id- doża tista ’ tiżdied b’ żiediet ta ’ 1 mg/ 24 siegħa kull ġimgħa għal doża massima ta ’ 3 mg/ 24 siegħa, skond ir- rispons individwali tal- pazjent.
The need for treatment continuation should be reconsidered every 6 months.
Il - bżonn tal- kontinwazzjoni tat- trattament għandu jerġa jiġi kunsidrat kull 6 xhur.
Treatment discontinuation Neupro should be discontinued gradually.
Twaqqif tal- kura Neupro għandu jitwaqqaf gradwalment.
The daily dose should be reduced in steps of 1 mg/ 24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Id- doża ta ’ kuljum għandha titnaqqas f’ inkrementi ta ’ 1 mg/ 24 siegħa bi tnaqqis tad- doża preferibbilment darba kull jumejn, sakemm Neupro jitwaqqaf għal kollox (ara sezzjoni 4. 4).
Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) was not observed.
Wara din il- proċedura, ma ġiex osservat l- effett rebound (meta s- sintomi jiggravaw wara l’ intensita` iniżjali wara li jitwaqqaf it- trattament).
Hepatic and renal impairment:
Indeboliment tal- fwied u tal- kliewi:
Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment or in patients with mild to severe renal impairment including those requiring dialysis.
L- aġġustament tad- doża mhuwiex meħtieġ f’ pazjenti li għandhom indeboliment tal- fwied li jkun minn ħafif sa moderat jew f’ pazjenti b’ indeboliment tal- kliewi li jkun minn ħafif sa sever, li jinkludi dawk li jeħtieġu d- dijaliżi.
Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Hu rakkomandat li tingħata attenzjoni fi trattament ta ’ pazjenti b ’ indeboliment sever tal- fwied, li jista ’ jwassal għal tneħħija mnaqqsa ta ’ rotigotine.
Neupro has not been investigated in this patient group.
Neupro ma ġiex studjat f’ dan il- grupp ta ’ pazjenti.
A dose reduction might be needed in case of worsening of the hepatic impairment.
Jista ’ jkun hemm bżonn tnaqqis fid- doża f’ każ li jiggrava l- indeboliment tal- fwied.
Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Jista ’ jkun hemm ukoll livelli akkumulati ta ’ rotigotine mhux mistennija meta jiggrava b’ mod akut il- funzjoni tal- kliewi.
2 Children and adolescents:
2 Tfal u adolexxenti:
Neupro is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Neupro mhux rakkomandat għall- użu fit- tfal u fl- adolexxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Method of administration The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
Kif jingħata L- impjastru għandu jiġi applikat fuq ġilda nadifa, xotta, intatta u f’ saħħitha fuq l- addome, il- koxxa, il - ġenbejn, il- ġenb tal- ġisem, l- ispallejn, jew fuq in- naħa ta ’ fuq tad- driegħ.
Reapplication to the same site within 14 days should be avoided.
L- applikazzjoni mill- ġdid fl - istess zona fi żmien 14- il jum għandha tiġi evitata.
Neupro should not be placed on skin that is red, irritated or damaged.
Neupro m’ għandux jitpoġġa fuq il- ġilda jekk din tkun ħamra, irritata jew fiha xi ferita.
Use and handling:
Użu u mmaniġġjar:
Each patch is packed in a sachet and should be applied directly after the sachet has been opened.
Kull impjastru hu ppakkjat f’ qartas u għandu jiġi applikat direttament wara li l- qartas ikun infetaħ.
One half of the protective liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Nofs l- inforra protettiva għandha titneħħa u n- naħa li teħel għandha titpoġġa fuq il- ġilda u tingħafas.
Then, the patch is fold back and the second part of the release liner is removed.
Imbagħad, l- impjastru jintewa lura u t- tieni parti ta ’ l- inforra li terħi titneħħa.
The sticky side of the patch should not be touched.
In- naħa li teħel tal - impjastru m’ għandhiex tintmess.
The patch should be pressed down firmly with the palm of the hand for about 20 to 30 seconds, so that it sticks well.
L- impjastru għandu jingħafas b’ mod sod bil- keffa ta ’ l- id għal madwar 20 sa 30 sekonda, biex jeħel sewwa.
In the event that a patch should fall off, a new patch should be applied for the remainder of the 24 hour dosing interval.
Fil- każ li l- impjastru jaqa ’, għandu jiġi applikat impjastru ġdid għall- bqija tal- perjodu tad- dożaġġ ta ’ 24 siegħa.
The patch should not be cut into pieces.
L- impjastru m’ għandhux jitqatta ’ f’ biċċiet.
Magnetic resonance imaging or cardioversion (see section 4.4).
Immaġni bir- riżonanza manjetika jew kardjoverżjoni (ara sezzjoni 4. 4).
The backing layer of Neupro contains aluminium.
Is- saff ta ’ wara ta ’ Neupro fih l- aluminju.
To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Biex tevita ħruq tal- ġilda, Neupro għandu jitneħħa jekk il - pazjent ikun jeħtieġ li ssirlu immaġni bir- riżonanza manjetika (MRI) jew kardjoverżjoni.
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/ orthostatic hypotension.
Agonisti ta ’ dopamine huma magħrufa li jindebolixxu r- regolazzjoni sistemika tal- pressjoni tad- demm li tirriżulta fil- pressjoni tad- demm baxxa ħafna meta wieħed iqum bilwieqfa/ ikun bilwieqfa.
These events were also observed during treatment with Neupro, however the incidence was similar to that in placebo-treated patients.
Dawn l - avvenimenti kienu wkoll osservati matul t- trattament b’ Neupro, madankollu l- inċidenza kienet bħal dik ta ’ pazjenti li kienu kkurati bil- plaċebo.
Syncope was observed in association with Neupro, but also at a similar rate in patients treated with placebo.
Is- sinkope kien osservat b’ rabta ma ’ Neupro, iżda wkoll kellu rata simili f’ pazjenti li kienu kkurati bil - plaċebo.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Hu rakkomandat li jsir monitoraġġ tal- pressjoni tad- demm, b’ mod speċjali fil- bidu tat- trattament, minħabba r- riskju ġenerali ta ’ pressjoni tad- demm baxxa ħafna meta wieħed ikun bilwieqfa, assoċjata mat- terapija dopaminerġika.
Neupro has been associated with somnolence and episodes of sudden sleep onset.
Neupro kien assoċjat man- ngħas u episodji ta ’ rqad li jiġi f’ daqqa.
Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Irqad li jiġi f’ daqqa waqt l - attivitajiet ta ’ kuljum, f’ xi każijiet mingħajr ma dak li jkun ikollu xi sinjali ta ’ twissija, kien irrappurtat.
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
Dawk li jagħtu r- riċetta għal din il- mediċina għandhom jevalwaw mill- ġdid il- pazjenti b’ mod kontinwu għal ngħas jew irqad, għax il- pazjenti jistgħu ma jirrikonoxxux li jkollhom ngħas jew ħedla sakemm wieħed jistaqsihom b’ mod dirett.
A reduction of dosage or termination of therapy should be carefully considered.
Tnaqqis fid- dożaġġ jew it- twaqqif tat- terapija għandhom ikunu kkunsidrati bl- attenzjoni.
Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
Logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità kienu rrappurtati f’ pazjenti kkurati b’ agonisti ta ’ dopamine, li jinkludu rotigotine.
Although not reported with Neupro, symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Għalkemm ma kienux irrappurtati b’ Neupro, sintomi li jissuġġerixxu sindrome malinn newroleptiku kienu rrappurtati mat- twaqqif f’ daqqa tat- terapija dopaminerġika.
Therefore it is recommended to taper treatment (see section 4.2).
Għalhekk hu rakkomandat li t - trattament jitwaqqaf ftit ftit (ara sezzjoni 4. 2).
Hallucinations have been reported and patients should be informed that hallucinations can occur.
L- alluċinazzjonijiet kienu rrappurtati u l- pazjenti għandhom ikunu infurmati li l- alluċinazzjonijiet jistgħu jseħħu.
Fibrotic complications:
3 Komplikazzjonijiet fibrotiċi:
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Każijiet ta ’ fibrożi retroperitonali, infiltrati pulmonari, effużjonijiet mill - plewra, plewra li teħxien, perikardite u valvulopatija kardijaka kienu rrappurtati f’ xi pazjenti kkurati b’ sustanzi dopaminerġiċi li ġejjin mill- ergot.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Filwaqt li dawn il- komplikazzjonijiet jistgħu jfiequ meta t- trattament jitwaqqaf, ir- riżoluzjoni sħiħ mhux dejjem iseħħ.
3 Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
Għalkemm dawn ir- reazzjonijiet avversi huma maħsuba li huma marbuta ma ’ l- istruttura ergolina ta ’ dawn is- sustanzi, mhux magħruf jekk agonisti oħrajn ta ’ dopamine li ġejjin min- nonergots jistgħux jikkawżawhom.
Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists (see also section 4.5).
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).
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Monitoraġġ oftalmoloġiku hu rakkomandat f’ intervalli regolari jew jekk iseħħu anormalitajiet fil- vista.
Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Rapporti fil- literatura jindikaw li t- trattament tas- sindrome ta ’ Restless legs b’ prodotti mediċinali dopaminerġiċi jistgħu jwasslu għal awmentazzjoni.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
Awmentazzjoni jirreferi għal bidu aktar kmieni tas - sintomi filgħaxija (jew anke wara nofsinhar), żieda fis- severita ’ tas- sintomi, u l- firxa tas- sintomi biex jonvolvu partijiet oħra tal- ġisem.
External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Sħana esterna (dawl tax- xemx eċċessiv, heating pads u sorsi ta ’ sħana oħrajn, bħal sawna u banju sħun) m’ għandhomx jiġu applikati fiz- zona tal- impjastru.
Application site skin reactions may occur and are usually mild or moderate in intensity.
Reazzjonijiet tal- ġilda fiz- zona ta ’ l- applikazzjoni jistgħu jseħħu u normalment dawn ikunu ħfief jew moderati fl- intensità.
It is recommended that the application site should be rotated on a daily basis (e. g. from the right side to the left side and from the upper body to the lower body).
Hu rakkomandat li z- zona ta ’ l- applikazzjoni tinbidel ta ’ kuljum (eż. min- naħa tal- lemin għan- naħa tax- xellug u min- naħa ta ’ fuq għan- naħa t’ isfel tal- ġisem).
The same site should not be used within 14 days.
L- istess zona m’ għandiex tintuża fi żmien 14- il jum.
If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/ benefit balance for the individual patient should be conducted.
Jekk iseħħu reazzjonijiet fiz- zona ta ’ l- applikazzjoni li jdumu iktar minn ftit jiem jew li jkunu persistenti, jekk ikun hemm żieda fis- severità, jew jekk ir- reazzjoni tal- ġilda tinfirex ’ il barra miz- zona ta ’ l- applikazzjoni, għandha ssir evalwazzjoni tal- bilanċ tar - riskju/ benefiċċju għall- pazjent individwali.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Jekk ikun hemm raxx jew irritazzjoni tal- ġilda mis- sistema li tgħaddi l- mediċina minn ġol- ġilda, ix - xemx diretta fuq iz- zona għandha tiġi evitata sakemm il- ġilda tfieq.
Exposure could lead to changes in the skin color.
L- espożizzjoni tista ’ twassal għal tibdil fil- kulur tal- ġilda.
If a generalised skin reaction (e. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Jekk reazzjoni ġeneralizzata tal- ġilda (eż. raxx allerġiku, li jinkludi raxx jew ħakk eritematuż, makulari jew papulari) marbuta ma ’ l- użu ta ’ Neupro tkun osservata, Neupro għandu jitwaqqaf.
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 Neupro, and co-administration should be avoided.
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 ’ Neupro, u l- għoti flimkien għandu jiġi evitat.
Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e. g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
Minħabba l- possibbiltà ta ’ effetti addittivi, il- pazjenti għandhom jingħataw parir biex joqogħdu attenti meta jkunu jieħu prodotti mediċinali li huma sedattivi jew anti- dipressanti tas- CNS (central nervous system) oħrajn (eż. benzodiazepines, mediċini antipsikotiċi, anti- dipressanti) jew alkoħol flimkien ma ’ rotigotine.
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.
L- għoti flimkien ta ’ L- dopa u carbidopa ma ’ rotigotine ma kellu l- ebda effett fuq il- farmakokinetiċi ta ’ rotigotine, u rotigotine ma kellu l- ebda effett fuq il- farmakokinetiċi ta ’ L- dopa u carbidopa.
Co-administration of domperidone with rotigotine had no effect on the pharmacokinetics of rotigotine.
L- għoti flimkien ta ’ domperidone ma ’ rotigotine ma kellu l- ebda effett fuq il- farmakokinetika ta ’ rotigotine.
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.
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.
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).
L- għoti flimkien ta ’ rotigotine (3 mg/ 24 siegħa) ma kellu l- ebda effett fuq il- farmakodinamika u l - farmakokinetika ta ’ kontraċettivi orali (0. 03mg ethinylestradiol, 0. 15mg levonorgestrel).
Interactions with other forms of hormonal contraception have not been investigated.
4 Interazzjonijiet ma ’ forom oħra ta ’ kontraċezzjoni ormonali ma ġewx investigati.
4.6 Pregnancy and lactation
4. 6 Tqala u treddigh
There are no adequate data from the use of Neupro in pregnant women.
M’ hemmx dejta biżżejjed dwar l- użu ta ’ Neupro waqt it- tqala.
The potential risk for humans is unknown.
Studji fuq l- annimali ma jindikaw l - ebda effetti teratoġeniċi fil- firien u fil- fniek, iżda tossiċità ta ’ l- embriju kienet osservata fil- firien u fil - ġrieden f’ dożi materno- tossiċi (ara sezzjoni 5. 3). Mhux magħruf ir- riskju potenzjali fuq il- bniedem.
Rotigotine should not be used during pregnancy.
Rotigotine m’ għandux jintuża waqt it- tqala.
4 Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Minħabba li rotigotine jnaqqas it- tnixxija ta ’ prolactin fil- bnedmin, l- inibizzjoni tat- treddigħ hi mistennija.
Studies in rats have shown that rotigotine and/ or its metabolite(s) is excreted in breast milk.
Studji fil- firien urew li rotigotine u/ jew il- metabolit( i) tiegħu jitneħħew fil- ħalib tas- sider.
In the absence of human data, breast-feeding should be discontinued.
Fl- assenza ta ’ dejta dwar rotigotine fil- bnedmin, it- treddigħ għandu jitwaqqaf.
Rotigotine may have major influence on the ability to drive and use machines.
Rotigotine jista ’ jkollu influenza maġġura fuq il- ħila tas- sewqan u l- użu ta ’ magni.
Patients being treated with rotigotine and presenting with somnolence and/ or sudden sleep episodes must be informed not to drive or engage in activities (e. g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).
Pazjenti li qed jiġu kkurati b’ rotigotine u li jkollhom ngħas u/ jew episjodi ta ’ rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet (eż. jħaddmu l- magni) fejn in- nuqqas ta ’ attenzjoni jista ’ jpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt, sakemm dawn l- episodji rikorrenti u ngħas jiġu riżoluti (ara wkoll sezzjonijiet 4. 4 u 4. 5).
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.0% of the patients on Neupro and 32.7% of patients on placebo reported at least one adverse reaction.
Ibbażat fuq l- analiżi miġbura minn ġabra ta ’ provi kliniċi kkontrollati bil- plaċebo li kienu jinkludu total ta ’ 748 pazjent li kienu ikkurati b’ Neupro u 214 pazjent kkurati bil- plaċebo, 65. 0% tal- pazjenti fuq Neupro u 32. 7% ta ’ pazjenti fuq il- plaċebo irrappurtaw mill- inqas reazzjoni avversa waħda.
At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur.
Fil- bidu tat- terapija, jistgħu jseħħu reazzjonijiet avversi dopaminerġiċi bħal dardir u rimettar.
These are usually mild or moderate in intensity and transient even if treatment is continued.
Normalment dawn ikunu ħfief jew moderati fl- intensità u li jgħaddu malajr, anki jekk titkompla l- kura.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, fatigue and headache.
Reazzjonijiet avversi tal- mediċina (ADRs) irrappurtati f’ iktar minn 10% tal- pazjenti trattati b’ Neupro huma dardir, reazzjonijiet fil- post mnejn jittieħed, għajja u uġigħ ta ’ ras.
In trials where the application sites were rotated as reflected in the instructions provided in the SPC and package leaflet, 34.2% of 748 patients using Neupro, experienced application site reactions.
Fi provi fejn il- post mnejn jittieħed inbidel kif indikat fl- istruzzjonijiet ipprovduti fl- SPC u fil- fuljett ta ’ tagħrif, 34. 2% tas- 748 pazjent li kienu jużaw Neupro ġarrbu reazzjonijiet fil- post mnejn jittieħed.
The majority of these reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet kienu ħfief jew moderati fl- intensità, limitati għal- post mnejn jittieħed u rriżultaw fit- twaqqif tal- kura b’ Neupro f’ 7. 2% tal- pazjenti.
The following table covers adverse drug reactions from all studies in patients with Restless Legs Syndrome.
It- tabella li jmiss tkopri r- reazzjonijiet avversi tal- mediċina mill- istudji kollha f’ pazjenti bis- sindromu ta ’ Restless Legs.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond il - gravita` tagħhom.
classes acc. to MedDRA
Sistema tal - klassifika/ tal - organi skond MedDRA
≥ 1/ 10
Komuni ħafna > 1/ 10
≥ 1/ 100, < 1/ 10
Komuni > 1/ 100, ≤1/ 10
≥ 1/ 1,000, < 1/ 100
Mhux komuni > 1/ 1, 000, ≤1/ 100
≥ 1/ 10,000, ≤ 1/ 1,000
Rari ≤1/ 1, 000
Nausea
dardir
Vomiting, Dyspepsia
rimettar, dispepsja
General disorders and administration
5 Sistema tal -
Application and instillation site a
Komuni ħafna
Irritability
Komuni
site conditions
Mhux komuni
reactions (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, excoriation, urticaria, hypersensitivity) Fatigue
Rari
Immune system disorders
klassifika/ tal - organi skond MedDRA
Hypersensitivity
> 1/ 100, ≤1/ 10
Nervous system
> 1/ 1, 000, ≤1/ 100
Headache
≤1/ 1, 000
Somnolence
reazzjonijiet fiz - zona ta ’ l - a
disorders
Irritabilità
5
applikazzjoni (li tinkludi eritema, ħakk, irritazzjoni, raxx, dermatite, bżieżaq żgħar, uġigħ, ekżema, infjammazzjoni, nef ħa, diskolorazzjoni, infafet, escoriation, urtikarja, sensittività eċċessiva) għajja
Psychiatric
sensittività eċċessiva
Sleep attacks,
Disturbi fis- sistema nervuża
Impulse
uġigħ ta ’ ras
control a
nagħas
Obsessive
a
disorders
Disturbi psikjatriċi
Sexual desire a
Attakki ta ’ rqad, disturbi fil- ġibda a
disorder (incl.
Mard kompulsivi (li jinkludu l -
compulsive
Mard kumpulsiv ossessiv
disorder (incl. hypersexuality, libido increased), Insomnia, Sleep disorder, Abnormal dreams
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
pathological gambling, punding)
sesswali (li jinkludu l - ipersesswalità, żieda fil- libido), Insomnja, mard ta ’ l- irqad, ħolm abnormali Ħakk
disorder
logħob ta ’ l- ażżard patoloġiku, prużunterija jew punding)
Skin and subcutaneous tissue disorders
Pressjoni tad- demm Pressjoni tad- demm Disturbi vaskulari
Pruritus
għolja
Vascular disorders a) High Level Term
baxxa ħafna meta wieħed iqum bilwieqfa/ ikun bilwieqfa
Hypertension
a)
Orthostatic hypotension
Terminu ta ’ Livell Għoli
Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Neupro kien assoċjat ma ’ ngħas li jinkludi ngħas eċċessiv matul il- jum, u episodji fejn il- pazjent jorqod għal għarrieda.
In isolated cases “ sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents.
F’ każijiet iżolati, “ l- irqad li jiġi f’ daqqa ” seħħ meta l- pazjent kien qed isuq, u dan irriżulta f’ inċidenti tat- traffiku.
See also section 4.4 and 4.7.
Ara wkoll sezzjoni 4. 4 u 4. 7.
Patients treated with dopamine agonists including Neupro, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Il- pazjenti kkurati b’ agonisti ta ’ dopamine, li jinkludu Neupro, kienu rrappurtati li wrew sinjali logħob ta ’ l- azzard patoloġiku, żieda fil- libido u ipersesswalità, li huma ġeneralment riversibbli malli titnaqqas id- doża jew titwaqqaf il- kura.
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.
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.
There is no known antidote for overdose of dopamine agonists.
M’ hemm l- ebda antidot magħruf għal doża eċċessiva ta ’ agonisti ta ’ dopamine.
In case of suspected overdose, the patch(es) should immediately be removed from the patient.
F’ każ ta ’ suspett ta ’ 6 doża eċċessiva, l- impjastru( i) għandu jitneħħa immedjatament mill- pazjent.
Levels of rotigotine decrease after patch removal.
Il- livelli ta ’ rotigotine jonqsu wara li l- impjastru jitneħħa.
Before stopping use of rotigotine completely see section 4.2.
Qabel twaqqaf l- użu ta ’ rotigotine kompletament, ara sezzjoni 4. 2.
The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Il- pazjent għandu jkun immonitorjat mill- qrib, u dan jinkludi r- rata tat- taħbit tal- qalb, ir- rittmu tal- qalb u l- pressjoni tad- demm.
Because rotigotine is over 90% protein bound, dialysis would not be expected to be beneficial.
Minħabba li rotigotine jeħel mal- proteini b’ aktar minn 90%, id- dijaliżi mhux mistennija li tkun ta ’ benefiċċju.
Treatment of overdose may require general supportive measures to maintain the vital signs.
Il- kura ta ’ doża eċċessiva jista ’ jkollha bżonn ta ’ miżuri ġenerali ta ’ appoġġ biex jinżammu s- sinjali vitali.
Pharmacotherapeutic group:
Agonisti ta ’ dopamine:
Dopamine agonists; ATC code:
Kodiċi ATC:
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
Rotigotine hu agonist ta ’ dopamine D3/ D2/ D1 mhux ergoliniku, li jintuża għa- kura tal- marda ta ’ Parkinson.
It is believed to elicit its beneficial effect by activation of the D3, D2 and D1 receptors of the caudate- putamen in the brain.
Hu maħsub li rotigotine jikkawża l- effett utli tiegħu bl- attivazzjoni tar- riċetturi D3, D2 u D1 tal- caudate- putamen fil- moħħ.
Rotigotine alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Rotigotine jtaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
Clinical studies:
Studji Kliniċi:
The efficacy of Neupro was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
L- effikaċja ta ’ Neupro kienet mkejla f’ 5 studji kontrollati minn plaċebo b’ iżjed minn 1, 400 pazjent bis- Sindromu ta ’ Restless Legs idjopatiku (RLS).
Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
L- Effikaċja ntweriet f’ studji kontrollati f’ pazjenti trattati għal mhux iżjed minn 29 ġimgħa.
The effect was maintained over a 6 months period.
L- effett ġie miżmun fuq perjodu ta ’ 6 xhur.
For both primary endpoints statistically significant
It- tibdil mill- linja bażi fl- Iskala ta ’ Punteġġ Internazzjonali RLS (IRLS) u CGI- item 1 (is- severita` tal - marda) kienu parametri tal- effikaċja primarji.
6 differences have been observed for the doses 1 mg/ 24 h, 2 mg/ 24 h and 3 mg/ 24 h in comparison to placebo.
Għaż- żewġt punti ta ’ l- aħħar primarji ġew osservati differenzi statistikament sinifikattivi għad- dożi 1 mg/ 24siegħa, 2 mg/ 24siegħa u 3 mg/ 24siegħa meta mqabbla mal- plaċebo.
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 Neupro.
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 Neupro.
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p < 0.0001).
Id- differenza medja aġġustata kienet ta ’ - 6. 5 punti (CI95% - 8. 7; - 4. 4, p < 0. 0001).
CGI-I responder rates (much improved, very much improved) were 43.0% and 67.5% for placebo and Neupro respectively (difference 24.5% CI 95%:
Ir- rati CGI- responder (tjieb sew, tjieb ħafna) kienu ta ’ 43. 0% u 67. 5% għal plaċebo u Neupro rispettivament (differenza 24. 5% CI 95%:
14.2%; 34.8%, p < 0.0001).
14. 2%; 34. 8%, p < 0. 0001).
In a placebo-controlled, 7-week trial polysomnographic parameters were investigated.
F’ studju kontrollat mill- plaċebo li dam 7 ġimgħat kienu investigate parametric polysomnografiċi.
Neupro 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).
Neupro 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. 0001).
Absorption Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Assorbiment Wara l- applikazzjoni, rotigotine jintreħa kontinwament mill- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda, u jiġi assorbit minn ġol- ġilda.
Steady-state concentrations are reached after one to two days of patch application and are maintained at a stable level by once daily application in which the patch is worn for 24 hours.
Il- konċentrazzjonijiet fl- istat fiss jintlaħqu wara minn jum sa jumejn minn meta jitpoġġa l- impjastru u jinżammu f’ livell stabbli bl- applikazzjoni ta ’ kuljum fejn l- impjastru jkun fuq il- ġilda għal 24 siegħa.
Rotigotine plasma concentrations increase dose-proportionally over a dose range of 1 mg/ 24 h to 24 mg/ 24 h.
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.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
Madwar 45% tas- sustanza attiva fl- impjastru tintreħa fil- ġilda fi żmien 24 siegħa.
The absolute bioavailability after transdermal application is approximately 37%.
Il- bijodisponibilità assoluta wara l- għoti minn fuq il- ġilda hi ta ’ madwar 37%.
Rotating the site of patch application may result in day-to-day differences in plasma levels.
It- tibdil taz- zona fejn jitpoġġa l- impjastru jista ’ jirriżulta f’ differenzi fil- livelli fil- plażma minn jum għall- ieħor.
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Id- differenzi fil- bijodisponibilità ta ’ rotigotine varjaw minn 2% (dirgħajn ta ’ fuq meta mqabbla mal- ġenbejn) għal 46% (l- ispallejn meta mqabbla mal- koxox).
However, there is no indication of a relevant impact on the clinical outcome.
Madankollu, m’ hemm l- ebda indikazzjoni ta ’ impatt rilevanti fuq il- riżultat kliniku.
Distribution The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Distribuzzjoni It- twaħħil in vitro ta ’ rotigotine mal- proteini tal- plażma hu ta ’ madwar 92%.
The apparent volume of distribution in humans is approximately 84 l/ kg.
7 Il- volum apparenti tad- distribuzzjoni fil- bnedmin hu ta ’ madwar 84 l/ kg.
Metabolism Rotigotine is metabolised to a great extent.
Metaboliżmu Il- biċċa l- kbira ta ’ rotigotine hu mmetabolat.
Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
Rotigotine hu mmetabolat permezz ta ’ N- dealkylation kif ukoll bħala konjugazzjoni diretta u sekondarja.
In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Riżultati in vitro jindikaw li isoformi differenti tas - CYP jistgħu jikkatalizzaw l- N- dealkylation ta ’ rotigotine.