qanastek/EMEA-V3 huggingface dataset:
Uncommon Gastrointestinal disorders
Mhux komuni Disturbi gastrointestinali
hypotension
Pressjoni baxxa
Skin and subcutaneous tissue disorders 6
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
hypersensitivity, pruritus, rash
Sensittività eċċessiva, ħakk, raxx
fatigue peripheral oedema
għeja Edema periferali
weight increase
Żieda fil- piż
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipexole jista ’ jkun assoċjat ma ’ disturbi fil- ħajra sesswali (żieda (0. 1%) jew tnaqqis (0. 4%)).
Patients treated with dopamine agonists for Parkison’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti trattati b ’ agonisti tad- dopamine għal marda ta ’ Parkinson, li jinkludu pramipexole, speċjalment f’ dożi għoljin, ġew rapportati li wrew sinjali ta ’ logħob patoloġiku tal- azzard, żieda fil- ħajra sesswali u ipersesswalità, li ġeneralment hija riversibbli ma ’ tnaqqis fid- doża jew mat- twaqqif tat- trattament.
See also section 4.4.
Ara wkoll 4. 4.
The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Ir- reazzjonijiet avversi mistennija għandhom ikunu dawk relatati mal- profil farmakodinamiku ta ’ agonista ta ’ dopamine, li jinkludi tqalligħ, remettar, iperkinesja, alluċinazzjonijiet, aġitazzjoni u pressjoni tad- demm baxxa.
There is no established antidote for overdose of a dopamine agonist.
M’ hemm l - ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
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 D 3 receptors, and has full intrinsic activity.
Pramipexole hu agonist qawwi ta ’ dopamine li jeħel b’ mod silettiv u speċifiku mas- sottofamilja ta ’ riċettaturi ta ’ dopamine D 2 li magħha għandu affinità preferenzjali għar- riċettaturi D 3 u li magħhom għandu attività intrinsika sħiħa.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipexole jtaffi n- nuqqasijiet tal- moviment kawżati bil- marda ta ’ Parkinson permezz ta ’ stimulazzjoni tar- riċettaturi ta ’ dopamine fl- istrajatum.
Clinical trials in Parkinson’ s disease In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Fil- pazjenti pramipexole jtaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
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 avvanzati, u rċevew terapija konkomitanti b’ levodopa, u ġarrbu kumplikazzjonijiet fil- moviment.
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 ghandu jkun bilanċjat b’ titjib aktar fil- funzjoni tal- moviment b’ levodopa (kif imkejjel bil- bidla medja fil- punetġġ UPDRS).
However there
L- inċidenza globali ta ’ alluċinazzjonijiet u ngħas kienu ġeneralment ogħla fil - fażi ta ’ eskalazzjoni fil- grupp ta ’ pramipexole.
7 was no significant difference during the maintenance phase.
Madankollu ma kien hemm ebda differenza sinifikanti matul il- fażi ta ’ manteniment.
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Dawn il- punti għandhom jiġu kkonsidrati meta jinbeda kura b’ pramipexole f’ pazjenti bil- marda ta ’ Parkinson.
In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the number of periodic limb movements during time in bed.
Fi studju polisonmografiku b’ kontrolli bil- plaċebo fuq 3 ġimgħat pramipexole sinifikament naqqas l - għadd ta ’ movimenti perijodiċi tar- riġlejn/ dirgħajn waqt il- ħin fis- sodda.
Pramipexole is rapidly and completely absorbed following oral administration.
Pramipexole jiġi assorbit malajr u b’ mod komplet wara l- għoti orali.
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
L- għoti fl- istess hin mal- ikel ma naqqasx il- grad tal- assorbiment ta ’ pramipexole, izda r- rata tal- assorbiment tnaqqset.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipexole juri kinetiċi lineari u varjazzjoni zghira fil- livelli tal- plażma bejn pazjenti.
8-fold compared to plasma).
Konċentrazzjonijiet għolja fit- tessut tal- moħħ kienu osservati fil- firien (madwar 8 darbiet aktar meta mqabbel mal- plażma).
Approximately 90% of 14ºC-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Madwar 90% ta ’ doża tikkettata b’ 14C hi eliminata mill- kliewi waqt li inqas minn 2% jiġi eliminat ma ’ l- ippurgar.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Il- half- life ta ’ eliminazzjoni (t ½) tvarja minn 8 sigħat fiż- żgħar sa 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 ripetuta wrew li pramipexole ssensitizza effetti funzjonali, li prinċipalment kienu jinvolvu s- SNĊ u s- sistema riproduttiva tan- nisa, u probabilment rriżulta minn effett farmakoloġiku eżaġerat ta ’ pramipexole.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a hypotensive effect was discerned in the monkey.
Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata ta ’ taħbit tal- qalb kienu nnutati fil- qazuż ċkejken, u tendenza għal effett ta ’ pressjoni baxxa kienu osservati fix- xadina.
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 l- fniek imma kien embrijotossiku fil- far f’ dożi maternali tossiċi.
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 kien assoċjat ma ’ deġenerazzjoni retinali fil- firien
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Dan ir- riżultat tal- aħħar ma kienx osservat f’ firien bil- pigmentazzjoni, u lanqas fl- istudju ta ’ sentejn fuq il- ġurdien albino jew f’ kull speċi oħra mistħarrġa.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium stearyl fumarate Colloidal silicon dioxide.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium monostearyl fumarate Colloidal silicon dioxide.
8 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Aluminium/ Aluminium Blister Pack sizes:
Strixxi Folji tal- Aluminju/ Aluminju Daqsijiet ta ’ pakketti:
30, 50 x 1 and 100 tablets
30, 50 x 1 u 100 pillola
Polyethylene tablet container with CRC polypropylene cap.
Kontenitur tal- polyethylene tal- pilloli b’ għatu tal - CRC Polypropylene:
Pack sizes:
Daqs tal- pakkett:
90 tablets.
90 pillola,.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 7.
Computerweg 10, 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht L- Olanda
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
Pramipexole Teva 0.18 mg tablets
Pramipexole Teva 0. 18 mg pilloli
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 18 mg bażi ta ’ pramipexole( bħala 0. 25 mg pramipexole dihydrochloride monohydrate) 0..
Tablets.
Pilloli.
White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the scored side and "93" on the other side.
Pillola tonda wiċċ ċatt b’ xifer imżerżaq, b’ dijametru ta ’ 7. 00 mm, intaljat b ’ "P2" fuq "P2" fuq in- naħa bil- ferq u "93" fuq in- naħa l- oħra.
The tablet can be divided into equal halves.
Din il- pillola tista ’ tinqasam f’ nofsijiet indaqs.
Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off ” fluctuations).
Pramipexole Teva hu indikat għal trattament tas- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson, meta jingħata waħdu (mingħajr levodopa) jew f’ kombinazzjoni ma ’ levodopa, i. e. matul il- kors tal - marda, sal- istadji tardivi meta l- effett ta ’ levodopa jonqos ħafna jew isir inkonsistenti u jseħħu varjazzjonijiet tal- effett terapewtiku (fl- aħar tad- doża jew varjazzjonijiet “ on off ”).
Ascending – Dose schedule of Pramipexole Teva Week
Skeda fejn id- Doża Tiżdied għal Pramipexole Teva Ġimgħa
Dosage (mg of base)
Doża Totali ta ’ Kuljum
Total Daily Dose (mg of base)
(mg ta ’ bażi)
Dosage (mg of salt)
(mg ta ’ bażi)
Total Daily Dose (mg of salt)
(mg ta ’ bażi)
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
11 Jekk żieda fid- doża hi meħtieġa, id- doża ta ’ kuljum għandha tiżdied b’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) f’ intervalli ta ’ ġimgħa sakemm tilħaq doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
10 Maintenance treatment:
Trattament ta ’ manteniment:
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Fi tliet studjital- pern, l- effikaċja kienet osservata b’ doża ta ’ kuljum li tibda b’ 1. 1 mg ta ’ bażi (1. 5 mg ta ’ melħ).
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions..
Aġġustamenti oħra fid- doża għandhom isiru skont ir- rispons kliniku tal- okkorrenza ta ’ reazzjonijiet avversi.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Id- doża ta ’ kuljum tista ’ tingħata f’ żewġ dożi kondiviżi jekk it- tneħħija tal- kreatinina tkun ta ’ bejn 20 u 50 ml/ min, u bħala doża waħda kuljum jekk it- tneħħija tal- kreatinina tkun inqas minn 20 ml/ min..
Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
Id- dożaġġ f’ pazjenti b’ indeboliment epatiku.
90% of absorbed active substance is excreted through the kidneys.
L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ peress li madwar 90% tas- sustanza attiva assorbita tiġi eliminata minn ġol- kliewi.
Hypersensitivity to the active substance or to any of the excipients.
12 Sensittività eċċessiva għas- sustanza( i) attiva( i) jew għal xi sustanzi mhux attivi.
When prescribing Pramipexole Teva 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 pilloli Pramipexole Teva f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skont kif spjegat f’ sezzjoni 4. 2
Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
L- alluċinazzjonijiet huma magħrufa bħala effett avvers magħruf tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
If they occur, the dose of levodopa should be decreased.
Fi stadju avvanzat ta ’ Parkinson, flimkien ma ’ kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it - titrazzjoni inizjali ta ’ Pramipexole Teva. Jekk din iseħħ, id- doża ta ’ levodopa għandha titnaqqas.
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, il- kawtela hija rakkomandata meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma ’ pramipexole (ara sezzjoni 4. 7 u sezzjoni 4. 8).
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Barra minn hekk pazjenti u persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li bidliet fl- imġieba jistgħu jseħħu.
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Rapporti fil- letteratura medika jindikaw li t- trattament għal indikazzjoni oħra bi prodotti mediċinali dopominerġiċi jista ’ jirriżulta fi tiżjid.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat- tħarriex wara użu aktar fit- tul ta ’ pramipexole u l- immaniġġjar xieraq ta ’ dawn l - avvenimenti ma kienux evalwati fil- provi kliniċi b’ kontrolli.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
13 ir- rabta ta ’ proteini ma ’ plażma jew eliminazzjoni bijotrasformazzjoni mhumiex probabbli.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz tal- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
12 When Pramipexole Teva 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 Pramipexole Teva.
Meta Pramipexole Teva 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 ’ Pramipexole Teva tiżdied.
Pramipexole Teva can have a major influence on the ability to drive and use machines.
Pramipexole Teva jista ’ jkollu influwenza ewlenija fuq il- ħila biex issuq jew tħaddem magni.
Patients being treated with Pramipexole Teva 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 ttrattati bi Pramipexole Teva u li jkollhom episodji ta ’ ngħas u/ jew ta ’ rqad li jiġi għal għarrieda għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn viġilanza indebolita tista ’ tpoġġi lilhom jew lil persuni oħra f’ riskju ta ’ ferriment serju jew mewt (eż. tħaddim ta ’ magni) sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4, 4. 5, u 4. 8).
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behavious, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Ir- reazzjonijiet avversi li ġejjin mistennija li jseħħu meta jintuża Pramipexole Teva: ħolm abnormali, konfużjoni, stitikezza, sturdament, delużjoni, diskinesja, għeja, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesja, pressjoni baxxa, żieda fit- teħid tal- ikel (tiekol bl- addoċċ, iperfaġja), nuqqas ta ’ rqad, problemi ta ’ tqanqil sesswali, tqalligħ, edema periferika, paranojja, logħob patoloġiku tal- ażżard, ipersesswalità u mġieba abnormali oħra, ngħas, żieda fil- piż, l- irqad jiġi f’ daqqa, ħakk u raxx, u sensittività eċċessiva oħra 14 Minn analiżi bbażżata fuq provi miġbura li saru fi provi bi plaċebo bħala kontroll, li kienu jinkludu total ta ’ 1, 923 pazjent fuq pramipexole u 1, 354 pazjent fuq il- plaċebo, reazzjonijiet avversi tal - mediċina kienu rrappurtati b’ mod frekwenti fiż- żewġ gruppi.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
63% ta ’ pazjenti fuq pramipexole u 52% ta ’ pazjenti fuq il- plaċebo rrappurtaw minn ta ’ lanqas reazzjoni avversa waħda.
13 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).
Fi ħdan il- klassi tas- sistema tal- organi, effetti mhux mixtieqa huma elenkati taħt titli ta ’ frekwenza, taħt il- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 to < 1/ 10); mhux komuni (≥1/ 1, 000 to ≤ 1/ 100); rari (≥1/ 10, 000 to ≤1/ 1, 000); rari ħafna (≤1/ 10, 000),
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Reazzjonijiet avversa aktar frekwenti f’ kombinazzjoni ma ’ levodopa kienet diskinesjasi.
The most commonly (≥ 5%) reported adverse drug reactions in patients with other indication treated with pramipexole were nausea, headache, dizziness and fatigue.
L- aktar reazzjonijiet avversi komuni (≥ 5%) irraportati f’ pazjenti li għandhom l- indikazzjoni l- oħra kurati bi pramipexole kienu tqalligħ, uġigħ ta ’ ras, stordament u għeja.
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
It- tqalligħ u l- għeja kienu aktar rapportati ta ’ spiss f’ pazjenti nisa ttrattati bi pramipexole (20. 8% u 10. 5%, rispettivament) meta mqabbla mal- irġiel (6. 7% u 7. 3%, rispettivament).
Other Indication System Organ Class Psychiatric disorders
Indikazzjoni oħra Sistema tal- Klassifika tal- Organi
Common Uncommon Not known Nervous system disorders
Komuni Mhux komuni Mhux magħruf
abnormal dreams, insomnia confusion, hallucination, libido disorder abnormal behaviour, delusion, hypersexuality, increased eating, paranoia, pathological gambling
ħolm abnormali, nuqqas ta ’ rqad konfużjoni, alluċinazzjoni, problemi fix- xewqa sesswali mġieba abnormali, delużjoni, ipersesswalità, tiekol aktar, paranojja, logħob patoloġiku tal- ażżard
Common Uncommon Not known Vascular disorders
Komuni Mhux komuni Mhux magħruf
Uncommon Gastrointestinal disorders
Mhux komuni
Skin and subcutaneous tissue disorders 14
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Investigations
Stħarriġ:
Patients treated with dopamine agonists for Parkinson’ s disease, including, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti trattati b’ agonisti tad- dopamine għal marda ta ’ Parkinson, li jinkludu pramipexole, speċjalment f’ dożi għoljin, ġew rapportati li wrew sinjali ta ’ logħob patoloġiku tal- azzard, żieda fil- ħajra sesswali u ipersesswalità, li ġeneralment hija riversibbli ma ’ tnaqqis fid- doża jew mat- twaqqif tat- trattament.
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 D 3 receptors, and has full intrinsic activity.
Pramipexole hu agonist qawwi ta ’ dopamine li jeħel b’ mod silettiv u speċifiku qawwi mas- sottofamilja ta ’ riċettaturi ta ’ dopamine D 2 li magħha għandu affinità preferenzjali għar- riċettaturi D 3 u li magħhom għandu attività intrinsika sħiħa.
In human volunteers, a dose-dependent decrease in prolactin was observed.
16 F’ voluntiera umani, kien osservat tnaqqis li jiddependi mid- doża fil- prolactin.
15 was no significant difference during the maintenance phase.
Madankollu ma kien hemm ebda differenza sinifikanti matul il- fażi ta ’ manteniment.
Pramipexole was not genotoxic.
17 Pramipexole ma kienx ġenotossiku.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium stearyl fumarate Colloidal silicon dioxide.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25, Magnesium stearate Sodium monostearyl fumarate Colloidal silicon dioxide.
16 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Aluminium/ Aluminium Blister Strips Pack sizes:
Strixxi Folji tal- Aluminju/ Aluminju Daqsijiet ta ’ pakketti:
Polyethylene tablet container with CRC polypropylene cap.
Kontenitur tal- polyethylene tal- pilloli b’ għatu ta ’ CRC Polypropylene:
90 tablets.
90 pillola.
Pramipexole Teva 0.35 mg tablets
Pramipexole Teva 0. 35 mg pilloli
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 35 mg bażi ta ’ pramipexole (bħala 0. 5 mg pramipexole dihydrochloride monohydrate)
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8023" over "8023" on the scored side and "93" on the other side.
Pillola tonda, wiċċ ċatt b’ xifer imżerżaq, b’ dijametru ta ’ 8. 82 mm, intaljat b ’ "8023" fuq "8023" fuq in - naħa bil- ferq u "93" fuq in- naħa l- oħra.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ nofsijiet indaqs.
The daily dosage is administered in equally divided doses 3 times a day.
Id- dożaġġ ta ’ kuljum jingħata f’ dożi maqsumin indaqs 3 darbiet kuljum
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Kemm- il darba pazjenti ma jkollhomx effetti mhux mixtieqa intollerabbli, id- dożaġġ għandu jkun ittitrat biex jilħaq l- ogħla effett terapewtiku
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
20 Jekk żieda fid- doża hi meħtieġa, id- doża ta ’ kuljum għandha tiżdied b’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) f’ intervalli ta ’ ġimgħa sakemm tilħaq doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
18 Maintenance treatment:
Trattament ta ’ manteniment:
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Id- doża ta ’ kuljum tista ’ tingħata f’ żewġ dożi kondiviżi jekk it- tneħħija tal- kreatinina tkun bejn 20 u 50 ml/ min, u bħala doża waħda kuljum jekk it- tneħħija tal- kreatinina tkun inqas minn 20 ml/ min.
Hypersensitivity to the active substance or to any of the excipients.
21 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
When prescribing Pramipexole Teva 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 pilloli Pramipexole Teva f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skont kif spjegat f’ sezzjoni 4. 2
19 Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
L- alluċinazzjonijiet huma magħrufa bħala effett avvers tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
Fi stadju avvanzat ta ’ Parkinson, flimkien ma ’ kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it - titrazzjoni inizjali ta ’ Pramipexole Teva.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Peress li
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
22 antikolinerġiċi huma prinċipalment eliminati b’ bijotransformazzjoni, il- potenzjal għal interazzjoni hu limitat, għalkemm l- interazzjoni ma ’ antikolinerġiċi ma ġiex mistħarrġa.
20 When Pramipexole Teva is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medication is kept constant while increasing the dose of Pramipexole Teva.
Meta Pramipexole Teva 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 ’ Pramipexole Teva tiżdied.
Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with pramipexole.
Minħabba l- possibilità ta ’ effetti addittivi, kawtela hija rakkomandata meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma ’ pramipexole.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole ghandu jkun evitat (ara sezzjoni 4. 4), jekk hu mistenni li jkun hemm effetti antagonistiċi.
In rats, the concentration ofactive 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.
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behavious, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Ir- reazzjonijiet avversi li ġejjin mistennija li jseħħu meta jintuża Pramipexole Teva: ħolm abnormali, konfużjoni, stitikezza, delużjoni, sturdament, diskinesja, għeja, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesja, pressjoni baxxa, żieda fit- teħid tal- ikel (tiekol bl- addoċċ, iperfaġja), nuqqas ta ’ rqad, problemi ta ’ tqanqil sesswali, tqalligħ, edema periferika, paranojja, logħob patoloġiku tal- ażżard, ipersesswalità u mġieba abnormali oħra, ngħas, żieda fil- piż, l- irqad jiġi f’ daqqa, ħakk u raxx, u sensittività eċċessiva oħra
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
23 Minn analiżi bbażżata fuq provi miġbura li saru fi provi bi plaċebo bħala kontroll, li kienu jinkludu total ta ’ 1, 923 pazjent fuq pramipexole u 1, 354 pazjent fuq il- plaċebo, reazzjonijiet avversi tal - mediċina kienu rrappurtati b’ mod frekwenti fiż- żewġ gruppi.
21 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).
Fi ħdan il- klassi tas- sistema tal- organi, effetti mhux mixtieqa huma elenkati taħt titli ta ’ frekwenza, taħt il- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 to < 1/ 10); mhux komuni (≥1/ 1, 000 to ≤ 1/ 100); rari (≥1/ 10, 000 to ≤1/ 1, 000); rari ħafna (≤1/ 10, 000)
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
L- aktar reazzjonijiet komuni (≥ 5%) avversi rapportati għal mediċina f’ pazjenti bil- marda ta ’ Parkinson li ngħataw trattament aktar ta ’ spiss b’ pramipexole milli bil- plaċebo kienu tqalligħ, diskinesja, pressjoni baxxa, ngħas, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Reazzjoni avversa aktar frekwenti għal mediċina meta tingħata flimkien ma ’ levodopa kienet diskinesja.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Il- pressjoni baxxa tista ’ sseħħ fil - bidu tat- trattament, speċjalment jekk prampexole jiġi ttitrat malajr wisq.
The most commonly (≥ 5%) reported adverse drug reactions in patients with other indication treated with pramipexole were nausea, headache, dizziness and fatigue.
L- aktar reazzjonijiet avversi komuni (≥ 5%) irrapportati f’ pazjenti li għandhom l- indikazzjoni l- oħra kurati bi pramipexole kienu tqalligħ, uġigħ ta ’ ras, stordament u għeja.
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
It- tqalligħ u l- għeja kienu aktar rapportati ta ’ spiss f’ pazjenti nisa trattati bi pramipexole (20. 8% u 10. 5% rispettivament) meta mqabbla ma ’ rġiel (6. 7% u 7. 3% rispettivament).
Common Uncommon Not known Nervous system disorders
Komuni Mhux komuni Mhux magħruf Disturbi fis- sistema nervuża
nausea constipation 22
tqalligħ stitikezza
Patients treated with dopamine agonists for Parkison’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti trattati bi pramipexole, speċjalment f’ dożi għoljin, ġew rapportati li wrew sinjali ta ’ logħob patoloġiku tal- azzard, żieda fil- ħajra sesswali u ipersesswalità, li ġeneralment hija riversibbli mat - twaqqif tat- trattament.
Clinical trials in Parkinson’ s disease In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
25 Provi kliniċi fil- marda ta ’ Parkinson Fil- pazjenti pramipexole jtaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
The overall incidence of hallucinations and
L- inċidenza globali ta ’ alluċinazzjonijiet u ngħas kienu ġeneralment ogħla fil - fażi ta ’ eskalazzjoni fil- grupp ta ’ pramipexole.
However there was no significant difference during the maintenance phase.
Madankollu ma kien hemm ebda differenza sinifikanti matul il- fażi ta ’ manteniment.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Il- bijodisponibilità assoluta hi ogħla minn 90% u l- konċentrazzjonijiet massimi fil- plażma jsehhu bejn 1 u 3 sigħat wara.
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.
26 f’ dożi ta ’ 2 mg/ kg (ta ’ melħ) u ogħla, pramipexole kien assoċjat ma ’ deġenerazzjoni retinali fil- firien albini.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium stearyl fumarate Colloidal silicon dioxide.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium monostearyl fumarate Colloidal silicon dioxide
30, 50 x 1 and 100 tablets
30, 50 x1 u 100 pillola
Polyethylene tablet container with CRC polypropylene cap.
Kontenitur tal- polyethylene għal pilloli b’ għatu ta ’ CRC Polypropylene:
6.6 Instructions for use and handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor L- ebda ħtiġijiet speċjali
Pramipexole Teva 0.7 mg tablets
Pramipexole Teva 0. 7 mg pilloli
Tablets.
Pillola.
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the scored side and "93" on the other side.
Pillola tonda, wiċċ ċatt b’ xifer imżerżaq, b’ dijametru ta ’ 8. 82 mm, intaljat b ’ "8023" fuq "8023" fuq in - naħa bil- ferq u "93" fuq in- naħa l- oħra.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Kemm- il darba pazjenti ma jkollhomx effetti mhux mixtieqa intollerabbli, id- dożaġġ għandu jkun ittitrat biex jilħaq l- ogħla effett terapewtiku massimu.
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
29 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 26 3.3 mg of base (4.5 mg of salt) per day.
Id- doża individwali għandha tkun fil- medda ta ’ bejn 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) sa doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
When prescribing Pramipexole Teva tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
30 Meta tingħata riċetta għal pilloli Pramipexole Teva f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skont kif spjegat f’ sezzjoni 4. 2
27 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
Fi stadju avvanzat ta ’ Parkinson, flimkien ma ’ kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it - titrazzjoni inizjali ta ’ Pramipexole Teva.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Barra minn hekk persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li bidliet fl- imġieba jistgħu jseħħu.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2.)
Sintomi li jissuġerixxu sindromu newrolettiku mallinn kienu rapportati mat- twaqqif f’ daqqa tat- terapija dopaminerġika (ara sezzjoni 4. 2).
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Għalhekk, effetti ma ’ prodotti mediċinali oħra li jaffettwaw ir- rabta ta ’ proteini ma ’ plażma jew eliminazzjoni bijotrasformazzjoni mhumiex probabbli.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Peress li antikolinerġiċi huma prinċipalment eliminati b’ bijotransformazzjoni, il- potenzjal għal interazzjoni hu
28 When Pramipexole Teva 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 Pramipexole Teva.
Meta Pramipexole Teva 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 ’ Pramipexole Teva tiżdied.
Pramipexole Teva can have a major influence on the ability to drive an use machines.
Pramipexole Teva jista ’ jkollu influwenza ewlenija fuq il- ħila biex issuq jew tħaddem magni
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Ir- reazzjonijiet avversi li ġejjin mistennija li jseħħu meta jintuża Pramipexole Teva: ħolm abnormali, konfużjoni, stitikezza, delużjoni, sturdament, diskinesja, għeja, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesja, pressjoni baxxa, żieda fit- teħid tal- ikel (tiekol bl- addoċċ, iperfaġja), nuqqas ta ’ rqad, problemi ta ’ tqanqil sesswali, tqalligħ, edema periferika, paranojja, logħob patoloġiku tal- ażżard, ipersesswalità u mġieba abnormali oħra, ngħas, żieda fil- piż, l- irqad jiġi f’ daqqa, ħakk u raxx, u sensittività eċċessiva oħra.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
32 Minn analiżi bbażżata fuq provi miġbura li saru fi provi bi plaċebo bħala kontroll, li kienu jinkludu total ta ’ 1, 923 pazjent fuq pramipexole u 1, 354 pazjent fuq il- plaċebo, reazzjonijiet avversi tal - mediċina kienu rrappurtati b’ mod frekwenti fiż- żewġ gruppi.
29 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).
Fi ħdan il- klassi tas- sistema tal- organi, effetti mhux mixtieqa huma elenkati taħt titli ta ’ frekwenza, taħt il- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 to < 1/ 10); mhux komuni (≥1/ 1, 000 to ≤ 1/ 100); rari (≥1/ 10, 000 to ≤1/ 1, 000); rari ħafna (≤1/ 10, 000),
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
It- tqalligħ u l- għeja kienu aktar rapportati ta ’ spiss f’ pazjenti nisa trattati b’ pramipexole (20. 8% u 10. 5% rispettivament) meta mqabbla ma ’ rġiel (6. 7% u 7. 3% rispettivament)
Skin and subcutaneous tissue disorders 30
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Patients treated with dopamine agonists for Parkison’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti trattati b’ agonisti tad- dopamine għal marda ta ’ Parkinson, li jinkludu pramipexole, speċjalment f’ dożi għoljin, ġew rapportati li wrew sinjali ta ’ logħob patoloġiku tal- azzard, żieda fil- ħajra sesswali u ipersesswalità, li ġeneralment hija riversibbli ma ’ tnaqqis fid- doża jew mat- twaqqif tat- trattament.
31 was no significant difference during the maintenance phase.
Madankollu ma kien hemm ebda differenza sinifikanti matul il- fażi ta ’ manteniment.
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 l- fniek imma kien embrijotossiku fil- far f’ dożi
32 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
30, 50 x 1 and 100 tablets
30 50 x1 u 100 pillola
Polyethylene tablet container with CRC polypropylene cap.
Konteniturtal- polyethylene għal pilloli b’ għatu ta ’ CRC Polypropylene:
6.6 Instructions for use and handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
DATE OF REVISION OF THE TEXT
DA TA TA ’ META ĠIET RIVEDUTA L- KITBA
33 ANNEX II
37 ANNESS II
Teva Pharmaceutical Works Co.
TEVA Pharmaceutical Works Co.
Pallagi Street 13 H-4042 Debrecen Hungary
Pallagi út 13, Debrecen H- 4142 L- Ungerija
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöll ő, Táncsics Mihály út 82 Hungary
TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő, Táncsics Mihály út 82 L- Ungerija
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir- Renju Unit
Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Swensweg 5, Postbus 552, 2003 RN Haarlem L- Olanda
TEVA Santé Sa, Rue Bellocier, 89107, Sens, France
TEVA Santé Sa, Rue Bellocier, 89107, Sens, Franza
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib.
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 November 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 4. 0, iddatata Novembru 2007 ippreżentata f’ Moduli 1. 8. 1 ta ’ l- Applikazzjoni dwar l- Awtorizzazjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
The PSUR submission schedule for Pramipexole Teva tablets should follow PSURs submission schedule for the reference medicinal product.
PSUR Is- sottomissjoni ta ’ l- iskeda tal- PSUR għal pilloli ta ’ Pramipexole Teva għandhom isegwu l- iskeda tal- PSUR għall- prodott mediċinali ta ’ riferiment
36 ANNEX III
40 ANNESS III
Carton – Pramipexole Teva 0.088 mg Tablets
Kartuna – Pramipexole Teva 0. 088 mg Pillola
Pramipexole Teva 0.088 mg tablets Pramipexole
Pramipexole Teva 0. 088 mg pilloli Pramipexole
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 088 mg ta ’ pramipexole li hu ekwivalenti għal 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate.
Tablet container:
Kontenitur tal- pilloli:
39 Store in the original package in order to protect from light and moisture.
43 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità
Blister - Pramipexole Teva 0.088 mg Tablets
Folja - Pramipexole Teva 0. 088 mg Pilloli
41 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Self-adhesive, paper label -Pramipexole Teva 0.088 mg Tablets
Tikketta tal- karti li titwaħħal waħedha - Pramipexole Teva 0. 088 mg Pilloli
Store in the original package in order to protect from light and moisture.
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton – Pramipexole Teva 0.18 mg tablets
Kartuna – Pramipexole Teva 0. 18 mg pillola
Pramipexole Teva 0.18 mg tablets Pramipexole
Pramipexole Teva 0. 18 mg pilloli Pramipexole
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 18 mg ta ’ pramipexole li hu ekwivalenti għal 0. 25 mg ta ’ pramipexole dihydrochloride monohydrate.
44 Store in the original package in order to protect from light and moisture
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità
Blister – Pramipexole Teva 0.18 mg tablets
Folja – Pramipexole Teva 0. 18 mg pilloli
46 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
self-adhesive, paper label - Pramipexole Teva 0.18 mg tablets
Tikketta tal- karti li titwaħħal waħedha - Pramipexole Teva 0. 18 mg pilloli
Store in the original package in order to protect from light and moisture
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton – Pramipexole Teva 0.35 mg Tablets
Kartuna – Pramipexole Teva 0. 35 mg Pilloli
Pramipexole Teva 0.35 mg tablets Pramipexole
Pramipexole Teva 0. 35 mg pilloli Pramipexole
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 35 mg ta ’ pramipexole li hu ekwivalenti għal 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate.
49 Store in the original package in order to protect from light and moisture.
53 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
50 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister – Pramipexole Teva 0.35 mg Tablets
Folja – Pramipexole Teva 0. 35 mg Pilloli
51 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Self-adhesive, paper label – Pramipexole Teva 0.35 mg Tablets
Tikketta tal- karti li titwaħħal – Pramipexole Teva 0. 35 mg Pilloli
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton – Pramipexole Teva 0.7 mg tablets
Kartuna – Pramipexole Teva 0. 7 mg pilloli
Pramipexole Teva 0.7 mg tablets Pramipexole
Pramipexole Teva 0. 7 mg pilloli Pramipexole
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 7 mg ta ’ pramipexole li hu ekwivalenti għal 1 mg ta ’ pramipexole dihydrochloride monohydrate.
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister – Pramipexole Teva 0.7 mg tablets
Folja – Pramipexole Teva 0. 7 mg pilloli
56 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
self-adhesive, paper label - Pramipexole Teva 0.7 mg tablets
Tikketta tal- karti li titwaħħal - Pramipexole Teva 0. 7 mg pilloli
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
Kull pillola fiha 0. 7 mg ta ’ pramipexole li hu ekwivalenti għal 1. 00 mg ta ’ pramipexole dihydrochloride monohydrate).
Do not store above 25 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Store in the original package in order to protect from light and moisture
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità
59 PACKAGE LEAFLET:
63 FULJETT TA ’ TAGĦRIF:
PRAMIPEXOLE TEVA 0.088 MG TABLETS PRAMIPEXOLE TEVA 0.18 MG TABLETS PRAMIPEXOLE TEVA 0.35 MG TABLETS PRAMIPEXOLE TEVA 0.7 MG TABLETS Pramipexole
PRAMIPEXOLE TEVA 0. 088 MG PILLOLI PRAMIPEXOLE TEVA 0. 18 MG PILLOLI PRAMIPEXOLE TEVA 0. 35 MG PILLOLI PRAMIPEXOLE TEVA 0. 7 MG PILLOLI Pramipexole
It may harm them, even if their symptoms are the same as yours.  If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.  Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Pramipexole Teva is and what it is used for 2.
X’ inhi Pramipexole Teva u għalxiex tintuża 2.
Before you take Pramipexole Teva 3.
Qabel ma tieħu Pramipexole Teva 3.
How to take Pramipexole Teva 4.
Kif għandek tieħu Pramipexole Teva 4.
How to store Pramipexole Teva 6.
Kif taħżen Pramipexole Teva 6.
WHAT PRAMIPEXOLE TEVA IS AND WHAT IT IS USED FOR
X’ INHI PRAMIPEXOLE TEVA U GĦALXIEX TINTUŻA 1.
Pramipexole Teva is a dopamine agonist and works by stimulating dopamine receptors in the brain.
Pramipexole Teva hu agonista u jaġixxi billi jistimula r- riċettaturi ta ’ dopamine fil- moħħ.