qanastek/EMEA-V3 huggingface dataset:
As long-term efficacy of MIRAPEXIN in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Minħabba li l- effikaċja fit- tul ta ’ MIRAPEXIN fil- kura ta ’ RLS ma kinitx ittestjata suffiċjentement, ir - rispons tal- pazjent għandu jkun evalwat wara 3 xhur ta ’ kura, u l- ħtieġa għat- tkomplija tal- kura għandha tkun ikkunsidrata mill- ġdid.
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Jekk il- kura tkun interrotta għal aktar minn ftit ijiem, din għandha terġa ’ tinbeda mill- ġdid permezz ta ’ titrazzjoni tad- doża kif spjegat hawn fuq.
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Twaqqif tal- kura Minħabba li d- doża ta ’ kuljum għall- kura ta’ sindrome tas- Saqajn Bla Kwiet ma taqbiżx 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ), MIRAPEXIN jista ’ jitwaqqaf mingħajr ma jkun hemm twaqqif gradwali.
Rebound (worsening of symptoms after abrupt discontinuation of treatment) can not be excluded.
Ir- rebound (sintomi li jmorru għall- agħar wara t- twaqqif f’ daqqa tal- kura) ma tistax tkun eskluża.
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Id- dożaġġ f’ pazjenti b’ indeboliment renali L- eliminazzjoni ta ’ pramipexole tiddependi fuq il- funzjoni renali.
Patients with a creatinine clearance above 20 ml/ min require no reduction in daily dose.
Pazjenti bi tneħħija tal- krejatinina ta ’ iktar minn 20 ml/ min ma jeħtieġu l- ebda tnaqqis fid- doża ta ’ kuljum.
The use of MIRAPEXIN has not been studied in hemodialysis patients, or in patients with severe renal impairment.
L- użu ta ’ MIRAPEXIN ma kienx studjat f’ pazjenti fuq l- emodijalisi, jew f’ pazjenti b’ indeboliment renali sever.
90% of absorbed active substance is excreted through the kidneys.
Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment mhuwiex meħtieġ, għax madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
Dosing in children and adolescents MIRAPEXIN is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Id- dożaġġ fit- tfal u fl- adolexxenti MIRAPEXIN mhux rakkomandat għall- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena, minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
4.4 Special warnings and precautions for use
4 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
-4- When prescribing MIRAPEXIN in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal MIRAPEXIN lil pazjent bil- marda ta ’ Parkinson li jkollu indeboliment renali, doża mnaqqsa skond kif spjegat f’ sezzjoni 4. 2 hi ssuġġerita.
Hallucinations Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
Alluċinazzjonijiet L- alluċinazzjonijiet huma effett sekondarju magħruf tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
Patients should be informed that (mostly visual) hallucinations can occur.
Il- pazjenti għandhom ikunu infurmati li alluċinazzjonijiet (l- aktar viżwali) jistgħu jseħħu.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
Diskinesija Fl- istadju avvanzat tal- marda ta ’ Parkinson, flimkien mal- kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it- titrazzjoni inizjali ta ’ MIRAPEXIN.
If they occur, the dose of levodopa should be decreased.
Jekk din isseħħ, id- doża ta ’ levodopa għandha titnaqqas.
Sudden onset of sleep and somnolence MIRAPEXIN has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Irqad li jiġi għal għarrieda u ngħas MIRAPEXIN kien assoċjat man- ngħas u episodji ta ’ rqad li jiġi f’ daqqa, partikularment f’ pazjenti bil- marda ta ’ Parkinson.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
L- irqad li jiġi f’ daqqa waqt l- attivitajiet ta ’ kuljum, f’ xi każijiet mingħajr ma dak li jkun ikun konxju tiegħu jew ikollu xi sinjali ta ’ twissija, kien irrappurtat b’ mod mhux komuni.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with MIRAPEXIN.
Il- pazjenti jridu jkunu infurmati b’ dan u jkunu avżati biex joqogħdu attenti waqt is- sewqan jew waqt it- tħaddim tal- magni matul il- kura b’ MIRAPEXIN.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pazjenti li kellhom ngħas u/ jew episodju ta ’ rqad li jiġi f’ daqqa, m’ għandhomx isuqu jew iħaddmu magni.
Furthermore a reduction of dosage or termination of therapy may be considered.
Flimkien ma ’ dan, it- tnaqqis fid- dożaġġ jew it- twaqqif tat- terapija jistgħu jkunu kkunsidrati.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Minħabba l- possibbiltà ta ’ effetti addittivi, għandha tingħata attenzjoni meta l- pazjenti jkunu qed jieħdu prodotti mediċinali oħrajn jew l- alkoħol flimkien ma ’ pramipexole (ara sezzjoni 4. 7 u sezzjoni 4. 8).
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including MIRAPEXIN.
Disturbi fil- kontroll tal- impulsi u mġiba kompulsiva Logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità kienu rrappurtati f’ pazjenti kkurati b’ agonisti ta ’ dopamine għall- marda ta ’ Parkinson, li jinkludu MIRAPEXIN.
Furthermore, patients and caregivers should be aware of the fact that other behavioural symptoms of impulse control disorders and compulsions such as binge eating and compulsive shopping can occur.
Flimkien ma ’ dan, il - pazjenti u persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li sintomi oħrajn tal- imġiba ta ’ disturbi fil- kontroll tal- impulsi, u kompulsjonijiet bħal li wieħed jiekol bl- addoċċ u xiri kompulsiv, jistgħu jseħħu.
Dose reduction/ tapered discontinuation should be considered.
It- tnaqqis fid- doża/ it- twaqqif gradwali għandu jkun ikkunsidrat.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Pazjenti b’ disturbi psikotiċi Pazjenti b’ mard psikotiku għandhom ikunu kkurati b’ agonisti ta ’ dopamine biss jekk il- benefiċċju potenzjali jiżboq ir- riskji. L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole għandu jkun evitat (ara sezzjoni 4. 5).
Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Monitoraġġ oftalmoloġiku Monitoraġġ oftalmoloġiku hu rakkomandat f’ intervalli regolari jew jekk iseħħu anormalitajiet fil- vista.
Severe cardiovascular disease In case of severe cardiovascular disease, care should be taken.
Mard kardjovaskulari sever F’ każ ta ’ mard kardjovaskulari sever, għandha tingħata attenzjoni.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Hu rakkomandat li jsir monitoraġġ tal- pressjoni tad- demm, b’ mod speċjali fil- bidu tal- kura, minħabba r- riskju ġenerali ta ’ pressjoni tad- demm baxxa li tiddependi mill- qagħda, assoċjata mat- terapija dopaminerġika.
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Sindrome malinn newroleptiku Sintomi li jissuġġerixxu sindrome malinn newroleptiku kienu rrappurtati mat- twaqqif f’ daqqa tat - terapija dopaminerġika (ara sezzjoni 4. 2).
Augmentation Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Żieda Rapporti fil- letteratura jindikaw li l- kura tas- Sindrome tas- Saqajn Bla Kwiet bi prodotti mediċinali dopaminerġiċi tista ’ tirriżulta f’ żieda.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Din iż- żieda tirreferi għall- bidu iktar bikri tas- sintomi filgħaxija (jew anki wara nofsinhar), żieda fis- sintomi, u li s- sintomi jinfirxu u jinvolvu estremitajiet oħrajn.
The controlled trials of MIRAPEXIN in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Il - provi kkontrollati ta ’ MIRAPEXIN f’ pazjenti bis- Sindrome tas- Saqajn Bla Kwiet, ġeneralment ma kinux ta ’ tul ta ’ żmien biżżejjed biex il- fenomeni tat- tkabbir ikunu osservati b’ mod adegwat.
The frequency of augmentation after longer use of MIRAPEXIN and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il - frekwenza tat- tkabbir wara użu aktar fit- tul ta ’ MIRAPEXIN u l- immaniġġjar adattat ta ’ dawn l - avvenimenti, ma kinux evalwati fil- provi kliniċi kkontrollati.
4.5 Interaction with other medicinal products and other forms of interaction
5 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
-5- Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Twaħħil mal- proteini fil- plażma Pramipexole jeħel ftit ħafna mal- proteini fil- plażma (< 20%), u ftit bijotrasformazzjoni tkun osservata fil- bniedem.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Għalhekk, interazzjonijiet ma ’ prodotti mediċinali oħrajn li jaffettwaw it- twaħħil mal- proteini fil- plażma jew l- eliminazzjoni permezz tal- bijotrasformazzjoni, mhumiex mistennija.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Minħabba li l- antikolinerġiċi huma eliminati primarjament permezz tal- bijotrasformazzjoni, il- potenzjal għal interazzjoni hu limitat, għalkemm l- interazzjoni ma ’ l- antikolinerġiċi ma kinitx investigata.
There is no pharmacokinetic interaction with selegiline and levodopa.
M’ hemm l- ebda interazzjoni farmakokinetika b’ selegiline u b’ levodopa.
Inhibitors/ competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Inibituri/ kompetituri tal- passaġġ tal- eliminazzjoni renali attiv Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’ l- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passaġġ, bħal cimetidine u amantadine, jistgħu jinteraġixxu ma ’ pramipexole, u dan jirriżulta fi tneħħija mnaqqsa ta ’ waħda jew taż- żewġ prodotti mediċinali.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.
It- tnaqqis fid- doża ta ’ pramipexole għandu jkun ikkunsidrat meta dawn il- prodotti mediċinali jingħataw fl- istess ħin ma ’ MIRAPEXIN.
Combination with levodopa When MIRAPEXIN is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of MIRAPEXIN.
It- teħid flimkien ma ’ levodopa Meta MIRAPEXIN jingħata flimkien ma ’ levodopa, hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas u li d- dożaġġ ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d- doża ta ’ MIRAPEXIN tiżdied.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Minħabba l- possibbiltà ta ’ effetti addittivi, għandha tingħata attenzjoni meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew l- alkoħol flimkien ma ’ pramipexole.
Antipsychotic medicinal products Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Prodotti mediċinali antipsikotiċi L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole għandu jkun evitat (ara sezzjoni 4. 4), eż. jekk ikunu mistennija effetti antagonistiċi.
The effect on pregnancy and lactation has not been investigated in humans.
L- effett fuq it- tqala u t- treddigħ ma kienx investigat fil- bnedmin.
Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Pramipexole ma kienx teratoġeniku fil- firien u fil- fniek, iżda kien embrijotossiku fil- firien f’ dożi maternotossiċi (ara sezzjoni 5. 3).
MIRAPEXIN should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
MIRAPEXIN m’ għandux jintuża waqt it- tqala ħlief jekk ikun meħtieġ b’ mod ċar, i. e. li l- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
As MIRAPEXIN treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Minħabba li l- kura b’ MIRAPEXIN tinibixxi t- tnixxija ta ’ prolactin fil- bnedmin, l- inibizzjoni tat- treddigħ hi mistennija.
The excretion of MIRAPEXIN into breast milk has not been studied in women.
It- tneħħija ta ’ MIRAPEXIN fil- ħalib ma kinitx studjata fin- nisa.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Fil- firien, il- konċentrazzjoni ta ’ radjuattività marbuta mas- sustanza attiva kienet ogħla fil- ħalib tas- sider milli fil - plażma.
In the absence of human data, MIRAPEXIN should not be used during breast-feeding.
Fl- assenza ta ’ informazzjoni miksuba mill- bnedmin, MIRAPEXIN m’ għandux jintuża matul it- treddigħ.
However, if its use is unavoidable, breast-feeding should be discontinued.
Madankollu, jekk l- użu tiegħu ma jkunx jista ’ jiġi evitat, it- treddigħ għandu jitwaqqaf.
MIRAPEXIN can have a major influence on the ability to drive and use machines.
MIRAPEXIN jista ’ jkollu influwenza maġġuri fuq il- ħila biex issuq u biex tuża l- magni.
Hallucinations or somnolence can occur.
L- alluċinazzjonijiet jew in- ngħas jistgħu jseħħu.
Patients being treated with MIRAPEXIN and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Pazjenti li qed jiġu kkurati b’ MIRAPEXIN u li jkollhom ngħas u/ jew episjodi ta ’ rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn in- nuqqas ta ’ attenzjoni jista ’ jpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt (eż. jħaddmu l- magni), sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4, 4. 5 u 4. 8).
-6- 4.8 Undesirable effects
6 4. 8 Effetti mhux mixtieqa
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema; pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Avvenimenti avversi mistennija Ir- reazzjonijiet avversi li ġejjin huma mistennija waqt l- użu ta ’ MIRAPEXIN: ħolm anormali, amnesija, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl- addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja, edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on MIRAPEXIN and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Ibbażat fuq l- informazzjoni miġbura minn analiżi ta ’ provi kkontrollati bil- plaċebo, li kienu jinkludu total ta ’ 1923 pazjent fuq MIRAPEXIN u 1354 pazjent fuq il- plaċebo, ir- reazzjonijiet avversi tal- mediċina kienu rrappurtati b’ mod frekwenti għaż- żewġ gruppi.
63% of patients on MIRAPEXIN and 52% of patients on placebo reported at least one adverse drug reaction.
63% tal- pazjenti fuq MIRAPEXIN u 52% tal- pazjenti fuq il- plaċebo, irrappurtaw mill- anqas reazzjoni avversa waħda tal- mediċina.
Tables 1 and 2 display the frequency of adverse drug reactions from placebo-controlled clinical trials in Parkinson’ s disease and Restless Legs Syndrome.
Tabelli 1 u 2 juru l- frekwenza ta ’ reazzjonijiet avversi minħabba l- mediċina mill- provi kliniċi kkontrollati bil- plaċebo f’ pazjenti bil- marda ta ’ Parkinson u bis- Sindrome tas- Saqajn Bla Kwiet.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with MIRAPEXIN and were reported significantly more often in patients taking MIRAPEXIN than placebo, or where the event was considered clinically relevant.
Ir- reazzjonijiet avversi minħabba l- mediċina rrappurtati f’ dawn it- tabelli huma dawk l- avvenimenti li seħħew f’ 0. 1% jew aktar tal- pazjenti kkurati b’ MIRAPEXIN u li kienu rrappurtati aktar ta ’ spiss b’ mod sinifikanti f’ pazjenti li jkunu qed jieħdu MIRAPEXIN milli f’ dawk li kienu qed jużaw il - plaċebo, jew fejn l- avveniment kien ikkunsidrat li hu klinikament rilevanti.
However, the majority of common adverse drug reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Madankollu, il - maġġoranza tar- reazzjonijiet avversi komuni minħabba l- mediċina kienu minn ħfief sa moderati, u normalment bdew kmieni fit- terapija, u l- biċċa l- kbira tagħhom għabu anki jekk it- terapija tkompliet.
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, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Fil- kategoriji tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt titli ta ’ frekwenza (numru ta ’ pazjenti li huma mistennija li jkollhom ir- reazzjoni), bl- użu tal- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1, 000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħrufa (ma tistax tittieħed stima mid- dejta disponibbli).
Parkinson’ s disease, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with MIRAPEXIN treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Il- marda ta ’ Parkinson, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) minħabba l- mediċina rrappurtati b’ mod komuni f’ pazjenti bil - marda ta ’ Parkinson li kienu aktar frekwenti bil- kura b’ MIRAPEXIN milli bil- Plaċebo kienu nawseja, diskinesija, pressjoni tad- demm baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja kbira.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
L- inċidenza tan- ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 2).
More frequent adverse drug reactions in combination with levodopa were dyskinesia.
Reazzjonijiet avversi iktar frekwenti minħabba l- mediċina flimkien ma ’ levodopa kienet id- diskinesija.
Hypotension may occur at the beginning of treatment, especially if MIRAPEXIN is titrated too fast.
Pressjoni tad- demm baxxa tista ’ sseħħ fil- bidu tal- kura, speċjalment jekk MIRAPEXIN ikun ittitrat malajr wisq.
Parkinson’ s disease System Organ Class Psychiatric disorders
Il- marda ta ’ Parkinson Sistema tal- Klassi ta ’ l - Organi Disturbi psikjatriċi
Adverse Drug Reaction
Reazzjonijiet Avversi għall- Mediċina
abnormal dreams, behavioural symptoms of impulse control disorders and compulsions; confusion, hallucinations, insomnia, restlessness
ħolm anormali, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal - impulsi u kompulsjonijiet; konfużjoni, alluċinazzjonijiet, nuqqas ta ’ rqad, nuqqas ta ’ kwiet f’ ġismek
compulsive shopping, delusion, hypersexuality, libido disorder, paranoia, pathological gambling
xiri kompulsiv, delużjoni, ipersesswalità, disturb fil- libido, paranojja, logħob patoloġiku tal- azzard
Not known Nervous system disorders
Mhux magħrufa Disturbi fis- sistema nervuża
binge eating, hyperphagia
tiekol bl- addoċċ, iperfaġja
Very common Common Uncommon Eye disorders
Komuni ħafna Komuni Mhux Komuni Disturbi fl- għajnejn
dizziness, dyskinesia, somnolence amnesia, headache hyperkinesia, sudden onset of sleep, syncope
sturdament, diskinesija, ngħas amnesija, uġigħ ta ’ ras iperkinesija, irqad li jiġi għal għarrieda, sinkope
Common Vascular disorders
Komuni Disturbi vaskulari
visual disturbance including vision blurred and visual acuity reduced
disturb tal- vista li tinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal - vista 7
Very common Gastrointestinal disorders
Komuni ħafna Disturbi gastro- intestinali
hypotension
pressjoni baxxa
Very common Common Skin and subcutaneous tissue Uncommon
Komuni ħafna Komuni
nausea constipation, vomiting disorders hypersensitivity, pruritus, rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
fatigue, peripheral oedema
għeja, edema periferali
weight decrease weight increase
tnaqqis fil- piż żieda fil- piż
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
Sindrome tas- Saqajn Bla Kwiet, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) li kienu rrappurtati b’ mod komuni fil- pazjenti li kellhom is- Sindrome tas- Saqajn Bla Kwiet, ikkurati b’ MIRAPEXIN, kienu nawseja, uġigħ ta ’ ras, sturdament u għeja kbira.
Nausea and fatigue were more often reported in female patients treated with MIRAPEXIN (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
In- nawseja u għeja kbira kienu rrappurtati aktar ta ’ spiss f’ pazjenti nisa kkurati b’ MIRAPEXIN (20. 8% u 10. 5%, rispettivament) meta mqabbla ma ’ pazjenti rġiel (6. 7% u 7. 3% rispettivament).
Restless Legs Syndrome System Organ Class Psychiatric disorders
Sindrome tas- Saqajn Bla Kwiet Sistema tal- Klassi ta ’ l - Organi Disturbi psikjatriċi
Adverse Drug Reaction
Reazzjonijiet Avversi għall- mediċina
Common Uncommon Not known Nervous system disorders
Komuni Mhux Komuni
abnormal dreams, insomnia confusion, hallucinations, libido disorder, restlessness behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; delusion, hyperphagia, paranoia
sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl- addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; delużjoni, iperfaġja, paranojja
Common Uncommon Not known Eye disorders
Komuni Mhux Komuni Mhux magħrufa Disturbi fl- għajnejn
dizziness, headache, somnolence sudden onset of sleep, syncope amnesia, dyskinesia, hyperkinesia
sturdament, uġigħ ta ’ ras, ngħas irqad li jiġi għal għarrieda, sinkope amnesija, diskinesija, iperkinesija
Uncommon Vascular disorders
Mhux komuni Disturbi vaskulari
visual disturbance including vision blurred and visual acuity reduced
disturb tal- vista li tinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal - vista
Uncommon Gastrointestinal disorders
Mhux Komuni Disturbi gastro- intestinali
nausea constipation, vomiting
nawseja stitikezza, rimettar
hypersensitivity, pruritus, rash
sensittività eċċessiva, ħakk, raxx
fatigue peripheral oedema
għeja kbira edema periferali
weight decrease, weight increase
tnaqqis fil- piż, żieda fil- piż
Somnolence MIRAPEXIN is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
MIRAPEXIN hu assoċjat man- ngħas (8. 6%) u kien assoċjat b’ mod mhux komuni ma ’ ngħas eċċessiv matul il- jum u episodji ta ’ rqad li jiġi f’ daqqa (0. 1%).
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Disturbi fil- libido 8 MIRAPEXIN jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
Impulse control disorders and compulsive behaviours Patients treated with dopamine agonists for Parkinson’ s disease, including MIRAPEXIN, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Disturbi fil- kontroll tal- impulsi u mġiba kompulsiva Il- pazjenti kkurati b’ agonisti ta ’ dopamine għal kura tal- marda ta ’ Parkinson, li jinkludu MIRAPEXIN, speċjalment b' dożi qawwija, kienu rrappurtati li wrew sinjali ta ’ logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità, li huma ġeneralment riversibbli malli titnaqqas id- doża jew meta titwaqqaf il- kura.
In a cross-sectional, retrospective screening and case-control study including 3090 Parkinson’ s disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had symptoms of an impulse control disorder during the past six months.
Fi studju cross- sectional, screening retrospettiv u case- control li kien jinkludi 3090 pazjenti bil- marda ta ’ Parkinson, 13. 6% tal- pazjenti kollha li kienu qed jirċievu kura dopaminerġika jew mhux dopaminerġika, kellhom sintomi ta ’ disturb fil- kontroll tal- impulsi matul is- sitt xhur ta ’ qabel.
Manifestations observed include pathological gambling, compulsive shopping, binge eating, and compulsive sexual behaviour (hypersexuality).
Il - manifestazzjonijiet osservati kienu jinkudu logħob patoloġiku tal- azzard, xiri kompulsiv, li wieħed jiekol bl- addoċċ, u mġiba sesswali kompulsiva (ipersesswalità).
Possible independent risk factors for impulse control disorders included dopaminergic treatments and higher doses of dopaminergic treatment, younger age (≤ 65 years), not being married and self-reported family history of gambling behaviours.
Fatturi indipendenti possibbli ta ’ riskju għal disturbi fil- kontroll tal- impulsi kienu jinkludu kuri dopaminerġiċi u dożi ogħla ta ’ kura dopaminerġika, età iżgħar (≤ 65 sena), li ma tkunx miżżewweġ/ miżżewġa u storja tal- famija rrappurtata minn dak li jkun ta ’ logħob tal- azzard.
There is no clinical experience with massive overdosage.
M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting,
L- avvenimenti avversi mistennija ser ikunu dawk relatati mal- profil farmakodinamiku ta ’ agonist ta ’ dopamine, li jinkludu nawseja, rimettar, iperkinesija, alluċinazzjonijiet, aġitazzjoni u pressjoni tad- demm baxxa.
There is no established antidote for overdosage of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit għal doża eċċessiva ta ’ agonist ta ’ dopamine.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Jekk ikun hemm sinjali ta ’ stimulazzjoni tas- sistema nervuża ċentrali, jista ’ jkun hemm bżonn ta ’ mediċina newroleptika.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
L- immaniġġjar tad - doża eċċessiva jista ’ jkun jeħtieġ miżuri ta ’ sapport ġenerali, flimkien ma ’ ħasil gastriku, fluwidi ġol - vina, l- għoti ta ’ faħam attivat u monitoraġġ permezz ta ’ elettrokardjogramm.
Pharmacotherapeutic group: dopamine agonists, ATC code:
Kategorija farmakoterapewtika: agonisti ta ’ dopamine, Kodiċi ATC:
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
Pramipexole hu agonist ta ’ dopamine li jeħel b’ selettività u speċifiċità qawwija mas- sotto- familja D2 tar- riċetturi ta ’ dopamine, li minnhom għandu affinità preferenzjali għar- riċetturi D3, u għandu attività intrinsika sħiħa.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipexole jtaffi n- nuqqasijiet tal- moviment kkwawżati mill- marda ta ’ Parkinson permezz ta ’ l- istimulazzjoni tar- riċetturi ta ’ dopamine fl- istriatum.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Studji fuq l- annimali wrew li pramipexole jinibixxi s- sintesi, il- ħruġ u l- ammont ta ’ dopamine.
The mechanism of action of pramipexole as treatment for Restless Legs Syndrome is unknown.
Il- mekkaniżmu ta ’ l- azzjoni ta ’ pramipexole bħala kura għas- Sindrome tas- Saqajn Bla Kwiet, mhuwiex magħruf.
Neuropharmacological evidence suggests primary dopaminergic system involvement.
Evidenza newrofarmakoloġika tissuġġerixxi l- involviment tas- sistema dopaminerġika primarja.
In human volunteers, a dose-dependent decrease in prolactin was observed.
F’ voluntiera umani, kien osservat tnaqqis li jiddependi mid- doża fil- prolactin.
Clinical trials in Parkinson’ s disease
Provi kliniċi bil- marda ta ’ Parkinson
In patients MIRAPEXIN alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Fil- pazjenti, MIRAPEXIN itaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
Il- provi kliniċi kkontrollati inkludew madwar 2100 pazjent li kienu fi stadji I – IV ta ’ Hoehn u Yahr.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Minn dawn, madwar 900 kienu fi stadji aktar avvanzati, u rċivew terapija b’ levodopa fl- istess ħin, u ġarrbu kumplikazzjonijiet fil- moviment.
In early and advanced Parkinson’ s disease, efficacy of MIRAPEXIN in the controlled clinical trials was maintained for approximately six months.
Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ MIRAPEXIN fil- provi kliniċi kkontrollati, inżammet għal madwar sitt xhur.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
9 tliet snin, ma kien hemm l- ebda sinjali ta ’ tnaqqis fl- effikaċja.
In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
Fi prova klinika kkontrollata double blind li damet sentejn, il- kura inizjali bi pramipexole, ittardjat b’ mod sinifikanti l- bidu ta ’ kumplikazzjonijiet tal- moviment, u naqqset l- okkorrenza tagħhom meta mqabbla mal- kura inizjali b’ levodopa.
This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Dan id- dewmien fil- kumplikazzjonijiet tal- moviment b’ pramipexole għandu jkun bbilanċjat b’ titjib akbar fil- funzjoni tal- moviment b’ levodopa (kif imkejjel mill- bidla medja fil - punteġġ UPDRS).
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
L- inċidenza totali ta ’ alluċinazzjonijiet u ngħas kienet ġeneralment ogħla matul il- perjodu taż- żieda tad- doża bil- grupp ta ’ pramipexole.
However there was no significant difference during the maintenance phase.
Madankollu, ma kien hemm l- ebda differenza sinifikanti matul il- fażi tal- manteniment.
These points should be considered when initiating pramipexole treatment in patients with Parkinson’ s disease.
Dawn il- punti għandhom ikunu kkunsidrati meta tinbeda l- kura b’ pramipexole f’ pazjenti bil- marda ta ’ Parkinson.
Clinical trials in Restless Legs Syndrome
Provi kliniċi bis- sindrome tas- Saqajn Bla Kwiet
The efficacy of MIRAPEXIN was evaluated in four placebo-controlled clinical trials in approximately 1000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
L- effikaċja ta ’ MIRAPEXIN kienet evalwata f’ erba ’ provi kliniċi kkontrollati bil- plaċebo f’ madwar 1000 pazjent li kellhom Sindrome tas- Saqajn Bla Kwiet idjopatiku li kien minn moderat sa sever ħafna.
Efficacy was demonstrated in controlled trials in patients treated for up to 12 weeks.
L- effikaċja ntweriet fi provi kkontrollati f’ pazjenti li kienu kkurati sa perjodu ta ’ 12- il ġimgħa.
Maintenance of effect has not been sufficiently tested.
Il- manteniment ta ’ l- effett ma kienx ittestjat suffiċjentement.
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
Il- bidla medja mil- linja bażi fir- Restless Legs Syndrome Rating Scale (IRLS) u l- Clinical Global Impression- Improvement (CGI- I) kienu l- miżuri tar- riżultat ta ’ l- effikaċja primarja.
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
Għaż- żewġ riżultati aħħarin primarji, differenzi statistikament sinifikanti kienu osservati għall- gruppi tad- doża ta ’ 0. 25 mg, 0. 5 mg u 0. 75 mg ta ’ pramipexole, meta mqabbla mal- plaċebo.
After 12 weeks of treatment the baseline IRLS score improved from 23.5 to 14.1 points for placebo and from 23.4 to 9.4 points for pramipexole (doses combined).
Wara 12- il ġimgħa ta ’ kura, il- punteġġ IRLS tal- linja bażi tjieb minn 23. 5 għal 14. 1 punti għall- plaċebo, u minn 23. 4 għal 9. 4 punti għal pramipexole (dożi kombinati).
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1
Id- differenza medja aġġustata kienet - 4. 3 punti (CI 95% - 6. 4; - 2. 1 punti, valur p < 0. 0001).
CGI-I responder rates (improved, very much improved) were 51.2% and 72.0% for placebo and pramipexole respectively (difference 20% CI 95%:
Ir- rati ta ’ dawk li rrispondew tas- CGI- I (imtejba, imtejba ħafna) kienu 51. 2% u 72. 0% għall- plaċebo u pramipexole rispettivament (differenza ta ’ 20% CI 95%:
Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of treatment.
L- effikaċja kienet osservata b’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) kuljum wara l- ewwel ġimgħa tal- kura.
In a placebo-controlled polysomnography study over 3 weeks MIRAPEXIN significantly reduced the number of periodic limb movements during time in bed.
Fi studju kkontrollat bil- plaċebo dwar il- polisonografija fuq perjodu 3 ġimgħat, MIRAPEXIN naqqas b’ mod sinifikanti n- numru ta ’ movimenti perjodiċi tar- riġlejn/ dirgħajn matul il- ħin li l- pazjent kien fis- sodda.
Pramipexole is rapidly and completely absorbed following oral administration.
Pramipexole jiġi assorbit malajr u b’ mod komplet wara l- għoti mill- ħalq.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Il- bijodisponibilità assoluta hi aktar minn 90% u l- konċentrazzjonijiet massimi fil- plażma jseħħu wara bejn 1 u 3 sigħat.
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
L- għoti fl- istess ħin ma ’ l- ikel ma naqqasx il- grad ta ’ l- assorbiment ta ’ pramipexole, iżda r- rata ta ’ l - assorbiment naqset.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipexole juri kinetiċi lineari u varjazzjoni żgħira fil- livelli tal- plażma bejn il- pazjenti.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Fil- bnedmin, it- twaħħil mal- proteina ta ’ pramipexole hu baxx ħafna (< 20%) u l- volum tad - distribuzzjoni hu kbir (400 l).
8-fold compared to plasma).
Konċentrazzjonijiet qawwija fit- tessut tal- moħħ kienu osservati fil- firien (madwar 8 darbiet aktar meta mqabbla mal- plażma).
Pramipexole is metabolised in man only to a small extent.
Pramipexole hu metabolat fil- bniedem f’ ammonti żgħar biss.
Renal excretion of unchanged pramipexole is the major route of elimination.
It- tneħħija renali ta ’ pramipexole mhux mibdul hi r- rotta maġġuri ta ’ l- eliminazzjoni.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Madwar 90% tad- doża ttikkettata 14C titneħħa minn ġol- kliewi, filwaqt li inqas minn 2% tinstab fl- ippurgar.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
It- tneħħija totali ta ’ pramipexole hi ta ’ madwar 500 ml/ min u t- tneħħija renali hi ta ’ madwar 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Il- half- life (t½) ta ’ l- eliminazzjoni tvarja minn 8 sigħat fiż- żgħażagħ għal 12- il siegħa fl- anzjani.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Studji dwar it- tossiċità ta ’ doża ripetuti wrew li pramipexole ħoloq effetti funzjonali, li primarjament kienu jinvolvu s- CNS u s- sistema riproduttiva fin- nisa u probabbilment irriżultaw minn effett farmakodinamiku esaġerat ta ’ pramipexole.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to an hypotensive effect was discerned in the monkey.
10 Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata ta ’ taħbit tal- qalb kienu nnutati fil- minipig, u kienet osservata tendenza għal effett ipotensiv fix- xadini.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
L- effetti potenzjali ta ’ pramipexole fuq il- funzjoni riproduttiva kienu investigat fil- firien u fil- fniek.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Pramipexole ma kienx teratoġeniku fil- firien u fil- fniek, iżda kien embrijotossiku fil- firien f’ dożi maternotossiċi.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Minħabba l- għażla ta ’ speċi ta ’ annimali u l- parametri limitati li kienu investigati, l- effetti avversi ta ’ pramipexole fuq it- tqala u fuq il- fertilità ta ’ l- irġiel ma kinux spjegati b’ mod sħiħ.
Pramipexole was not genotoxic.
Pramipexole ma kienx ġenotossiku.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Fi studju dwar il- karċinoġeneċità, il- firien irġiel żviluppaw iperplasija u adenomi taċ- ċelluli ta ’ Leydig, u dawn kienu spjegati mill- effett li jinibixxi l- prolactin ta ’ pramipexole.
This finding is not clinically relevant to man.
Din is- sejba mhijiex klinikament rilevanti għall- bniedem.
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
L- istess studju wera wkoll li, f’ dożi ta ’ 2 mg/ kg (ta ’ melħ) u ogħla, pramipexole kienet assoċjat ma ’ deġenerazzjoni tar- retina fi firien albini.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Din is- sejba ta ’ l- aħħar ma kinitx osservata f’ firien bil- pigmentazzjoni, u lanqas fi studju li dam sentejn dwar il- karċinoġeneċità fil- ġrieden albini, jew fi kwalunkwe speċi oħra li kienet investigata.
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
10 tablets per aluminium blister strips Cartons containing 3 or 10 blister strips (30 or 100 tablets)
Kaxxi tal- kartun li fihom 3 jew 10 strixxi bil- folja (30 jew 100 pillola).
Not all pack sizes may be marketed
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim International GmbH D- 55216 Ingelheim am Rhein Il- Ġermanja
23 February 1998 Date of Renewal of the authorisation:
23 ta ’ Frar, 1998 Data tat- Tiġdid ta ’ l- awtorizzazzjoni:
23 February 2008
23 ta ’ Frar, 2008
MIRAPEXIN 0.18 mg tablets
MIRAPEXIN 0. 18 mg pilloli
MIRAPEXIN 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli MIRAPEXIN 18 mg fihom 0. 18 mg ta ’ bażi ta ’ pramipexole (bħala 0. 25 mg ta ’ pramipexole dihydrochloride monohydrate).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of vase (0.75 mg of salt) (see section 4.2).
MIRAPEXIN hu indikat għall- kura sintomatika tas- Sindrome tas- Saqajn Bla Kwiet idjopatiku li jkun minn moderat sa sever, f’ dożaġġi sa 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) (ara sezzjoni 4. 2).
- 13 -
Kura inizjali:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
13 li ma jkunux jistgħu jittolleraw, id- dożaġġ għandu jkun ittitrat biex iwettaq l- effett terapewtiku massimu.
Abrupt discontinuation of dopaminergic therapy can lead to the development of aneuroleptic malignant syndrome.
It- twaqqif f’ daqqa tat- terapija dopaminerġika jista ’ jwassal għall- iżvilupp ta ’ sindrome malinn newroleptiku.
If renal function declines during maintenance therapy, reduce MIRAPEXIN daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the MIRAPEXIN daily dose by 30%.
Jekk il- funzjoni renali tonqos matul it- terapija tal- manteniment, naqqas id- doża ta ’ kuljum ta ’ MIRAPEXIN bl- istess perċentwali bħat- tnaqqis fit- tneħħija tal- krejatinina, i. e. jekk it- tneħħija tal- krejatinina tonqos bi 30%, naqqas id- doża ta ’ kuljum ta ’ MIRAPEXIN bi 30%.
- 14 -
14 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku
As long-term efficacy of MIRAPEXIN in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Minħabba li l- effikaċja fit- tul ta ’ MIRAPEXIN fil- kura ta ’ RLS ma kinitx ittestjata suffiċjentement, ir- rispons tal- pazjent għandu jkun evalwat wara 3 xhur ta ’ kura, u l- ħtieġa għat- tkomplija tal- kura għandha tkun ikkunsidrata mill- ġdid.
If the treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Jekk il- kura tkun interrotta għal aktar minn ftit ijiem, din għandha terġa ’ tinbeda mill- ġdid permezz ta ’ titrazzjoni tad- doża kif spjegat hawn fuq.
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Twaqqif tal- kura Minħabba li d- doża ta ’ kuljum għall- kura tas- Sindrome tas- Saqajn Bla Kwiet ma taqbiżx 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ), MIRAPEXIN jista ’ jitwaqqaf mingħajr ma jkun hemm twaqqif gradwali.
Patients with a creatinine clearance above 20 mL/ min require no reduction in daily dose.
Pazjenti bi tneħħija tal- krejatinina ta ’ iktar minn 20 ml/ min ma jeħtieġu l- ebda tnaqqis fid- doża ta ’ kuljum.
4.4 Special warnings and precautions for use
15 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
When prescribing MIRAPEXIN tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal MIRAPEXIN lil pazjent bil- marda ta ’ Parkinson li jkollu indeboliment renali, doża mnaqqsa skond kif spjegat f’ sezzjoni 4. 2 hi ssuġġerita.
Patients with psychotic disorders Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Pazjenti b’ disturbi psikotiċi Pazjenti b’ mard psikotiku għandhom ikunu kkurati b’ agonisti ta ’ dopamine biss jekk il- benefiċċju potenzjali jiżboq ir- riskji.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole għandu jkun evitat (ara sezzjoni 4. 5).
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Sindrome malinn newroleptiku Sintomi li jissuġġerixxu sindrome malinn newroleptiku kienu rrappurtati mat- twaqqif f’ daqqa tat- terapija dopaminerġika (ara sezzjoni 4. 2).
Augmentation Reports in the literature indicate treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Żieda Rapporti fil- letteratura jindikaw li l- kura tas- Sindrome tas- Saqajn Bla Kwiet bi prodotti mediċinali dopaminerġiċi tista ’ tirriżulta f’ żieda.
4.5 Interaction with other medicinal products and other forms of interaction
16 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Twaħħil mal- proteini fil- plażma Pramipexole jeħel ftit ħafna mal- proteini fil- plażma (< 20%), u ftit bijotrasformazzjoni tkun osservata fil- bniedem.
Combination with levodopa When MIRAPEXIN is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of MIRAPEXIN.
It- teħid flimkien ma ’ levodopa Meta MIRAPEXIN jingħata flimkien ma ’ levodopa, hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas u li d- dożaġġ ta ’ prodotti mediċinali kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d- doża ta ’ MIRAPEXIN tiżdied.