qanastek/EMEA-V3 huggingface dataset:
The MAH must ensure that the system of pharmacovigilance, as described in version 3 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.
Id- Detentur ta ’ l- Awtorizzazjoni għat- Tqegħid fuq is- Suq (MAH) għandu jassigura li s- sistema ta ’ Farmakoviġilanza, kif dettaljata fil- verżjoni 3 ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għal l - Awtorizzazjoni għat- Tqegħid fis- Suq, qegħdha f’ postha u qed taħdem qabel u waqt li l- prodott qiegħed fuq is- suq.
Risk Management Plan
Pjan ta ’ Mmaniġġjar ta ’ Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version of 9 November 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazjoni għat- Tqegħid fuq is- Suq (MAH) jikkommetti ruħu li jwettaq l- istudji u l- attivitajiet miżjuda ta ’ farmakoviġilanza kif dettaljat fil- Pjan ta ’ Famakoviġilanza, kif miftiehem fil- verżjoni tad- 9 ta ’ Novembru 2007 tal- Pjan ta ’ Mmaniġġjar ta ’ Riskju (RMP) ippreżentata f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni għal l- Awtorizzazjoni għat- Tqegħid fis- Suq u kull tiġdid sussegwenti ta ’ l - RMP kif miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskju għall- prodotti mediċinali għal użu fil- bniedem, l- RMP aġġornat għandu jingħata fl- istess ħin tar- Rapport Perjodiku aġġornat dwar is- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted
Barra minn hekk, RMP aġġornat għandu jingħata:
- When new information is received that may impact on the current Safety Specification,
- Meta jiġi rċevut tagħrif ġdid li jista ’ jaffettwa l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, l- Pjan
Pharmacovigilance Plan or risk minimisation activities
ta ’ Farmakoviġilanza jew l- attivitajiet li jnaqqsu r- riskju
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- F’ 60 ġurnata minn meta tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju)
- At the request of the EMEA
- Meta mitlub mill- EMEA
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FOLJA
Mimpara 30 mg film-coated tablets Cinacalcet
Mimpara 30 mg pilloli miksija b’ rita Cinacalcet
Each tablet contains 30 mg of cinacalcet (as hydrochloride)
Kull pillola fiha 30 mg ta ’ cinacalcet (bħala hydrochloride)
14 tablets 28 tablets 84 tablets
14- il pillola 28 pillola 84 pillola
For oral use Read the package leaflet before use.
Għall- użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EU/ 1/ 04/ 292/ 001 – carton of 14 tablets EU/ 1/ 04/ 292/ 002 – carton of 28 tablets EU/ 1/ 04/ 292/ 003 – carton of 84 tablets
EU/ 1/ 04/ 292/ 001 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 002 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 003 - Kaxxa bi 84 pillola
Mimpara 30 mg tablet Cinacalcet
Mimpara 30 mg pillola Cinacalcet
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FLIXKUN
30 tablets
30 pillola
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FLIXKUN
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FOLJA
Mimpara 60 mg film-coated tablets Cinacalcet
Mimpara 60 mg pilloli miksija b’ rita Cinacalcet
Each tablet contains 60 mg of cinacalcet (as hydrochloride)
Kull pillola fiha 60 mg ta ’ cinacalcet (bħala hydrochloride)
EU/ 1/ 04/ 292/ 005 – carton of 14 tablets EU/ 1/ 04/ 292/ 006 – carton of 28 tablets EU/ 1/ 04/ 292/ 007 – carton of 84 tablets
EU/ 1/ 04/ 292/ 005 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 006 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 007 - Kaxxa bi 84 pillola
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Mimpara 60 mg tablet Cinacalcet
Mimpara 60 mg pillola Cinacalcet
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FLIXKUN
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FLIXKUN
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FOLJA
Mimpara 90 mg film-coated tablets Cinacalcet
Mimpara 90 mg pilloli miksija b’ rita Cinacalcet
Each tablet contains 90 mg of cinacalcet (as hydrochloride)
Kull pillola fiha 90 mg ta ’ cinacalcet (bħala hydrochloride)
EU/ 1/ 04/ 292/ 009 – carton of 14 tablets EU/ 1/ 04/ 292/ 010 – carton of 28 tablets EU/ 1/ 04/ 292/ 011 – carton of 84 tablets
EU/ 1/ 04/ 292/ 009 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 010 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 011 - Kaxxa bi 84 pillola
51 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Mimpara 90 mg tablet Cinacalcet
Mimpara 90 mg pillola Cinacalcet
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FLIXKUN
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TAL- FLIXKUN
Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets Cinacalcet
Mimpara 30 mg pilloli miksija b’ rita Mimpara 60 mg pilloli miksija b’ rita Mimpara 90 mg pilloli miksija b’ rita Cinacalcet
If you have further questions, please ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Mimpara is and what it is used for 2.
X’ inhu Mimpara u għalxiex jintuża 2.
Before you take Mimpara 3.
Qabel ma tieħu Mimpara 3.
How to take Mimpara 4.
Kif għandek tieħu Mimpara 4.
Possible side effects 5 How to store Mimpara 6.
Kif taħżen Mimpara 6.
WHAT MIMPARA IS AND WHAT IT IS USED FOR
X’ INHU MIMPARA U GĦALXIEX JINTUŻA
Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Mimpara jaħdem billi jikkontrolla l- livelli ta ’ l- ormon tal- paratirojde (PHT), tal- kalċju u tal- fosforu fil- ġisem tiegħek.
It is used to treat problems with organs called parathyroid glands.
Jintuża biex jikkura problemi ta ’ organi magħrufa bħala glandoli paratirojdi.
The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Il - paratirojdi huma erba ’ glandoli żgħar fl- għonq, ħdejn il- glandola tat- tirojde li jipproduċu l- ormon tal - paratirojde (PTH).
Mimpara is used: • to treat secondary hyperparathyroidism in patients with kidney disease on dialysis. • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer. • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.
Mimpara jintuża: • għall- kura ta ’ iperparatirojdiżmu sekondarju f’ pazjenti b’ mard tal- kliewi fuq dijalisi. • biex inaqqas livelli għolja ta ’ kalċju fid- demm (iperkalċimja) f’ pazjenti b’ kanċer tal- paratirojde • biex inqqas livelli għolja ta ’ kalċju fid- demm (iperkalċimja) f’ pazjenti b’ iperparatirojdiżmu primarju li għad għandhom livelli għolja ta ’ kalċju fid- demm wara t- tneħħija tal- glandola tal - paratirojde jew meta tneħħija tal- glandola mhix possibbli.
In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroids.
F’ iperparatirojdiżmu primarju u sekondarju jiġi magħmul wisq PHT mill- paratirojdi.
This can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Dan jista ’ jikkawża telf ta ’ kalċju mill- għadam, li jista ’ jwassal għall- uġigħ fl- għadam u ksur, problemi bil- kanali tad- demm u tal- qalb, ġebel fil- kliewi, mard mentali u koma.
BEFORE YOU TAKE MIMPARA
QABEL MA TIEĦU MIMPARA
Do not take Mimpara:
Tieħux Mimpara
• DO NOT take Mimpara if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Mimpara.
• TIEĦUX Mimpara jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal cinacalcet jew sustanzi oħra ta ’ Mimpara.
58 Take special care with Mimpara:
58 Oqgħod attent ħafna b’ Mimpara
Before you start taking Mimpara, tell your doctor if you have or have ever had
Qabel ma tibda tieħu Mimpara, għid lit- tabib tiegħek jekk għandek jew jekk qatt kellek
• seizures (fits or convulsions).
• aċċessjonijiet (attakk epilettiku jew konvulżjonijiet).
The risk of having seizures is higher if you have had them before; • liver problems.
Ir- riskju li jkollok aċċessjonijiet huwa akbar jekk kellek minnhom qabel; • problemi tal- fwied
During treatment with Mimpara, tell your doctor: • if you start or stop smoking, as this may affect the way Mimpara works.
Waqt kura b’ Mimpara, għid lit- tabib tiegħek: • jekk tibda jew tieqaf tpejjep, minħabba li dan jista ’ jaffettwa il- mod kif taħdem Mimpara.
Please tell your doctor if you are taking the following medicines.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu l- mediċini li ġejjin:
These can affect how Mimpara works: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole, voriconazole); • antibiotics used to treat bacterial infections (telithromycin, rifampicin); • medicine used to treat HIV infection and AIDS (ritonavir).
• mediċini wżati għall- kura ta ’ infezzjonijiet tal- ġilda u tal- fungu (ketoconazole, itraconazole, voriconazole); • anti- bijotiċi wżati għall- kura ta ’ infezzjonijiet ikkawżati mill- batterji (telithromycin, rifampicin); • mediċina wżata għall- kura ta ’ infezzjoni tal- HIV u AIDS (ritanovir),
Mimpara may affect how the following work: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline, clomipramine and fluvoxamine); • medicines used to treat changes in heart rate (flecainide and propafenone); • medicine used to treat high blood pressure (metoprolol when given in heart failure); • antibiotic used to treat bacterial infections (ciprofloxacin).
Mimpara jista ’ jaffettwa kif jaħdmu dawn li ġejjin: • mediċini wżati għall- kura tad- depressjoni (amitriptyline, desipramine, nortriptyline, clomipramine u fluvoxamine); • mediċini wżati għall- kura ta ’ tibdil fir- rata tal- qalb (flecainide u propafenone); • mediċini wżati għall- kura ta ’ pressjoni għolja tad- demm (metoprolol meta mogħti għall - insuffiċjenza tal- qalb); • anti- bijotiċi wżati għall- kura ta ’ infezzjonijiet ikkawżati mill- batterji (ciprofloxacin).
Taking Mimpara with food and drink
Meta tieħu Mimpara ma ’ l- ikel u max- xorb
Mimpara should be taken with or shortly after food.
Mimpara għandu jittieħed ma ’ l- ikel jew eżatt wara l- ikel.
Always tell your doctor if you are pregnant or planning to become pregnant.
Dejjem għid lit- tabib tiegħek jekk inti tqila jew qed tippjana li toħroġ tqila.
Mimpara has not been tested in pregnant women.
Mimpara ma ġiex studjat f’ nisa tqal.
In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the foetus.
F’ każ ta ’ tqala, it- tabib tiegħek jista ’ jiddeċidi li jimmodifika il- kura tiegħek, minħabba li Mimpara tista ’ tagħmel ħsara lill- fetu.
It is not known whether Mimpara is excreted in human milk.
Mhux magħruf jekk Mimpara joħroġx fil- ħalib uman.
Your doctor will discuss with if you should discontinue either breast-feeding or treatment with Mimpara.
It- tabib tiegħek ser jiddiskuti miegħek jekk għandekx twaqqaf it- treddigħ jew il- kura b’ Mimpara.
Mimpara should not affect your ability to drive and use machines.
Mimpara m’ għandux jaffettwa l- ħila tiegħek biex issuq u tħaddem magni.
However, it is advisable to wait and see how you feel after taking Mimpara and before driving or operating machinery.
Madanakollu huwa rrakkomandat li tistenna u tara kif tħossok wara li tieħu Mimpara, qabel ma issuq jew tħaddem magni.
If you have an intolerance to some sugars
59 Jekk għandek intolleranza għal xi zokkrijiet
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal ċerti tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE MIMPARA
KIF GĦANDEK TIEĦU MIMPARA
Children under the age of 18 must not take Mimpara.
Tfal taħt l- età ta ’ 18- il sena m’ għandhomx jieħdu Mimpara.
Always take Mimpara exactly as your doctor has told you.
Dejjem għandek tieħu Mimpara skond il- parir tat- tabib.
Your doctor will tell you how much Mimpara you must take.
It- tabib tiegħek ser jgħidlek kemm għandek tieħu Mimpara.
Mimpara must be taken orally, with or shortly after food.
Mimpara għandu jittieħed mill- ħalq, ma ’ l- ikel jew ftit wara l- ikel.
The tablets must be taken whole and are not to be divided.
Il- pilloli għandhom jittieħdu sħaħ u m’ għandhomx jinqasmu.
Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.
It- tabib tiegħek se jieħu kampjuni tad- demm regolari waqt il- kura biex jissorvelja l- progress tiegħek u ser jaġġusta id- doża tiegħek skond il- bżonn
If you are being treated for secondary hyperparathyroidism
Jekk qed tiġi kkrat għall- iperparatirojdiżmu sekondarju
The usual starting dose for Mimpara is 30 mg (one tablet) once per day.
Ġeneralment id- doża tal- bidu ta ’ Mimpara hija 30 mg (pillola waħda) darba kuljum.
If you are being treated for parathyroid cancer or primary hyperparathyroidism
Jekk qed tiġi kkurat għall- kanċer fil- paratirojde jew għall- iperparatirojdiżmu primarju
The usual starting dose for Mimpara is 30 mg (one tablet) twice per day.
Ġeneralment id- doża tal- bidu ta ’ Mimpara hija 30 mg (pillola waħda) darbtejn kuljum.
If you take more Mimpara than you should
Jekk tieħu Mimpara aktar milli suppost
If you take more Mimpara than you should you must contact your doctor immediately.
Jekk tieħu aktar Mimpara milli suppost għandek tkellem lit- tabib tiegħek minnufih.
If you forget to take Mimpara
Jekk tinsa tieħu Mimpara
Do not take a double dose to make up for forgotten doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you have forgotten a dose of Mimpara, you should take your next dose as normal.
Jekk insejt doża ta ’ Mimpara, għandek tieħu d- doża li jmiss bħas- soltu.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek xi mistoqsijiet oħra dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Mimpara can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Mimpara jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (seen in more than 1 in 10 people taking Mimpara): • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Effetti sekondarji komuni ħafna (osservati f’ aktar minn 1 minn kull 10 persuni li jieħdu Mimpara): • tqalligħ u rimettar, dawn l- effetti sekondarji normalment huma ħfief u ma jdumux ħafna.
Common side effects (seen in more than 1 in 100 people taking Mimpara): • dizziness • numbness or tingling sensation (paraesthesia) • loss of appetite (anorexia) • muscle pain (myalgia) • weakness (asthenia) • rash • reduced testosterone levels
Effetti sekondarji komuni (osservati f’ aktar minn 1 minn kull 100 persuna li jieħdu Mimpara): • sturdament • sensazzjoni ta ’ tnemnim jew tingiż (parasteżija) • telf ta ’ l- aptit (anoressija) • uġigħ fil- muskoli (majalġja) • debbulizza (astenja) • raxx • tnaqqis fil- livelli ta ’ testosterone
Uncommon side effects (seen in more than 1 in 1000 people taking Mimpara): • seizures • indigestion (dyspepsia) • diarrhoea • allergic reaction (hypersensitivity)
60 Effetti sekondarji mhux komuni (osservati f’ aktar minn 1 minn kull 1000 persuna li jieħdu Mimpara): • aċċessjoniiet • indiġestjoni (dispepsja) • dijarea • reazzjoni allerġika (sensittività eċċessiva)
60 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should tell you doctor immediately.
Jekk jibda jkollok tnemnim jew tingiż madwar il- ħalq, uġigħ fil- muskoli jew bugħawwiġ u aċcessjonijiet għandek tgħid lit- tabib tiegħek immedjatament.
These may be signs that your calcium levels are too low (hypocalcaemia).
Dawn jistgħu jkunu sinjali li l- livelli tal- kalċju tiegħek huma baxxi wisq (ipokalċimja).
After taking Mimpara a very small number of patients with heart failure had worsening of their condition.
Wara li ħadu Mimpara numru żgħir ħafna ta ’ pazjenti b 'insuffiċjenza tal- qalb kellhom irkadar tal - kundizzjoni.
Low blood pressure (hypotension) has also been seen in a very small number of these patients.
Pressjoni baxxa (ipotensjoni) ġiet osservata ukoll f 'numru żgħir ħafna ta' dawn il - pazjenti.
As so few cases have been seen it is not known whether they are due to Mimpara, or not.
Peress li ġew osservati numru hekk żgħir ta ’ każijiet, mhux magħruf jekk dawn humiex minħabba Mimpara, jew le.
HOW TO STORE MIMPARA
KIF TAĦŻEN MIMPARA
Do not use Mimpara after the expiry date which is stated on the outer carton and on the blister.
Tużax Mimpara wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u fuq il- folja wara JIS.
The expiry date refers to the last day of that month.
Id - Data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
(or) Do not use Mimpara after the expiry date which is stated on the outer carton and on the bottle.
(jew) Tużax Mimpara wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u fuq il- flixkun
What Mimpara contains
X’ fih Mimpara:
The active substance is cinacalcet.
Is- sustanza attiva hi cinacalcet.
Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Kull pillola miksija b’ rita fiha 30 mg, 60 mg jew 90 mg ta ’ cinacalcet (bħala hydrochloride).
The other ingredients are: • Pre-gelatinised maize starch • Microcrystalline cellulose • Povidone • Crospovidone • Magnesium stearate • Colloidal anhydrous silica
Is- sustanzi l- oħra huma: • Pre- gelatinised maize starch • Microcrystalline cellulose • Povidone • Crospovidone • Magnesium stearate • Colloidal anhydrous silica.
The tablets are coated with: • Carnauba wax • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD & C Blue (E132), iron oxide yellow (E172)) • Opadry clear (containing hypromellose, macrogol)
Il- pilloli huma miksija b ’: • Carnauba wax • Opadry aħdar (li fih lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD & C Blu (E132), iron oxide isfar (E172)) • Opadry ċar (fih hypromellose, macrogol)
The printing ink contains: shellac glaze, iron oxide black (E172).
61 Il- linka għall- istampar fiha: shellac glaze, iron oxide iswed (E172).
What Mimpara looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Mimpara is a light green film-coated tablet.
Mimpara hija pillola ħadra ċara, miksija b’ rita.
They are oval-shaped and have “ 30”, “ 60” or “ 90” printed on one side and “ Amgen” on the other side.
Għandhom għamla ovali u “ 30 ”, “ 60 ” jew “ 90 ” stampat fuq naħa u “ Amgen ” fuq in- naħa l- oħra.
Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Mimpara huwa disponibbli f’ folji b’ pilloli miksija b’ rita ta ’ 30 mg, 60 mg jew 90 mg.
Each blister pack contains either 14, 28 or 84 tablets in a carton.
Kull pakkett ta ’ folji fih 14, 28 jew 84 pillola f’ kartuna.
61 Mimpara is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Mimpara huwa disponibbli fi fliexken b’ pilloli miksija b’ rita ta ’ 30 mg, 60 mg jew 90 mg, ġo kartuna.
Each bottle holds 30 tablets.
Kull flixkun fih 30 pillola.
España Amgen S. A.
62 España Amgen S. A.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Dan id- dokument huwa sommarju tar- Rapport ta 'Valutazzjoni Pubblika Ewropew (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek. Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta' CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Mirapexin?
X' inhu Mirapexin?
Mirapexin is a medicine containing the active substance pramipexole base.
Mirapexin hu mediċina li fiha s- sustanza attiva pramipexole base.
It is available as white tablets (round:
Hija disponibbli f' pilloli bojod (tondi:
0.088, 0.7 and 1.1 mg; oval:
0. 088, 0. 7 u 1. 1 mg; ovali:
0.18 and 0.35 mg).
0. 18 u 0. 35 mg).
What is Mirapexin used for?
Għal xiex jintuża Mirapexin?
Mirapexin is used to treat the symptoms of the following diseases: • Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Mirapexin jintuża fit- trattament tas- sintomi ta 'dan il- mard: • il- marda ta' Parkinson, disturb progressiv tal- moħħ li jikkawża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
Mirapexin can be used either on its own or in combination with levodopa (another medicine for Parkinson’ s disease), at any stage of disease including the later stages when levodopa starts becoming less effective; • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Mirapexin jista 'jintuża waħdu jew flimkien ma' levodopa (mediċina oħra għall- marda ta 'Parkinson), fi kwalunkwe stadju tal- marda inkluż l- istadji avvanzati meta levodopa tibda jkollha inqas effett; • Sindromu tar- riġlejn li ma għandhomx kwiet (restless legs syndrome) minn moderat għal gravi, disturb li jġiegħel il- pazjent iċaqlaq riġlejh u dirgħajh bla kontroll biex itaffi sensazzjonijiet ta' skumdità, ta 'wġigħ jew sensazzjonijiet strambi fil- ġisem, ġeneralment bil- lejl.
Mirapexin is used when a specific cause for the disorder cannot be identified.
Mirapexin jintuża meta ma tkunx tista 'tiġi identifikata xi kawża speċifika għad- disturb.
How is Mirapexin used?
Kif jintuża Mirapexin?
Mirapexin tablets should be swallowed with water, with or without food.
Il- pilloli ta 'Mirapexin għandhom jinbelgħu ma' l- ilma, ma 'l- ikel jew mingħajru.
For Parkinson’ s disease, the starting dose is 0.088 mg three times per day.
Għall- marda ta 'Parkinson, id- doża inizjali hi ta' 0. 088 mg tliet darbiet kuljum.
The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Id- doża għandha tiżdied kull ħamsa u sebat ijiem sakemm is- sintomi jkunu kkontrollati mingħajr ma jkunu kkawżati xi effetti sekondarji li ma jkunux jistgħu jiġu ttollerati.
The maximum daily dose is 1.1 mg three times per day.
Id- doża massima hi 1. 1 mg tliet darbiet kuljum.
Mirapexin must be given less frequently in patients who have problems with their kidneys.
Mirapexin għandu jingħata inqas frekwentement f' pazjenti li jkollhom problemi bil- kliewi.
If treatment is stopped for any reason, the dose should be decreased gradually.
Jekk għal xi raġuni it- trattament jitwaqqaf, id- doża għandha titnaqqas gradwalment.
For restless legs syndrome, Mirapexin should be taken once a day, two to three hours before going to bed.
Għas- sindromu tar- riġlejn li ma għandhomx kwiet, Mirapexin għandu jittieħed darba kuljum, bejn sagħtejn u tliet sigħat qabel l- irqad.
The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg.
Id- doża inizjali rakkomandata hi 0. 088 mg, iżda, jekk ikun hemm bżonn, din tista 'tiżdied sa massimu ta' 0. 54 mg.
The patient’ s response and the need for further treatment should be evaluated after three months.
Ir- rispons tal- pazjent u l- ħtieġa għal iktar trattament għandha tiġi evalwata wara tliet xhur.
How does Mirapexin work?
Kif jaħdem Mirapexin?
The active substance in Mirapexin, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Is- sustanza attiva f' Mirapexin, pramipexole, hi agonista tad- dopamina, li timita l- azzjoni tad - dopamina.
In patients with Parkinson’ s disease, the cells that produce dopamine begin to die and 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Id- dopamina hi sustanza messaġġiera f' partijiet mill- moħħ li jikkontrollaw iċ- ċaqliq u l - 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. the amount of dopamine in the brain decreases.
Reproduction is authorised provided the source is acknowledged. koordinazzjoni.
The patients then lose their ability to control their movements reliably.
Fil- pazjenti bil- marda ta 'Parkinson, iċ- ċelluli li jipproduċu d- dopamina jibdew imutu u l- ammont ta' dopamina fil- moħħ jonqos.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as shaking, stiffness and slowness of movement.
Pramipexole jistimula l- moħħ bħad- dopamina, u b' hekk il- pazjenti jkunu jistgħu jikkontrollaw il- moviment tagħhom u jkollhom inqas sinjali u sintomi tal - marda ta 'Parkinson, bħar- rogħda, l- ebusija u t- tnaqqis fil- ħeffa taċ- ċaqliq.
The way pramipexole works in restless legs syndrome is not fully understood.
Mhux magħruf għal kollox kif jaħdem pramipexole fis- sindromu tar- riġlejn li ma għandhomx kwiet.
The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.
Hu maħsub li s- sindromu jiġi kkawżat minn problemi fil- mod kif id- dopamina taħdem fil- moħħ, li jista 'jiġi rranġat b' pramipexole.
How has Mirapexin been studied?
Kif ġie studjat Mirapexin?
In Parkinson’ s disease, Mirapexin has been studied in five main studies involving 1,546 patients.
Fil- marda ta 'Parkinson, Mirapexin ġie studjat f' ħames studji ewlenin li fihom ħadu sehem 1, 546 pazjent.
Four studies compared the effects of Mirapexin with those of placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Erba 'studji qabblu l- effetti ta' Mirapexin ma 'dawk tal- plaċebo (trattament finta): studju wieħed bi 360 pazjent bil- marda fi stadju avvanzat li kienu diġà qed jieħdu levodopa li kienet bdiet ikollha inqas effett, u tliet studji b' total ta' 886 pazjenti bil- marda f' fażi bikrija li ma kinux qed jieħdu levodopa.
The main measure of effectiveness was the change in scores before and after treatment obtained with a standard questionnaire used to measure the severity of Parkinson’ s disease.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- punteġġi qabel u wara t- trattament miksuba minn kwestjonarju standard li jkejjel il- gravità tal- marda tal- Parkinson’ s.
The fifth study compared the effects of Mirapexin with those of levodopa in 300 patients with early disease.
Il- ħames studju qabbel l- effetti ta 'Mirapexin ma' dawk ta 'levodopa fi 300 pazjent bil- marda f' fażi bikrija.
Its main measure of effectiveness was the proportion of patients who had movement symptoms.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien il- proporzjon ta' pazjenti li kellhom sintomi relatati maċ- ċaqliq.
In all studies, Mirapexin doses were increased gradually over six to ten weeks before being maintained at a stable dose.
Fl - istudji kollha, id- dożi ta 'Mirapexin żdiedu gradwalment matul bejn sitta u għaxar ġimgħat qabel ma nżammu fuq doża stabbli.
Mirapexin has also been studied in two main studies of patients with restless legs syndrome.
Mirapexin ġie studjat ukoll f' żewġ studji ewlenin ta 'pazjenti bis- sindromu tar- riġlejn li ma għandhomx kwiet.
The first included 344 patients and compared the effects of three doses of Mirapexin with those of placebo.
Fl- ewwel studju ħadu sehem 344 pazjent u fih tqabblu l- effetti tat- tliet dożi ta 'Mirapexin ma' dawk tal- plaċebo.
The main measure of effectiveness was the improvement in symptoms between the start and end of the study, measured using two standard scales.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- titjib fis- sintomi bejn il - bidu u t- tmiem ta' l- istudju, imkejjel fuq żewġ skali standard.
The other study included 150 patients who took Mirapexin for six months, and compared the effects of remaining on Mirapexin or switching to placebo.
Fl- istudju l- ieħor ħadu sehem 150 pazjent li ħadu Mirapexin għal sitt xhur, u qabblu l- effetti ta 'meta wieħed jibqa' jieħu Mirapexin jew li minflok jibda jieħu l- plaċebo.
The main measure of effectiveness was the time until symptoms got worse.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien iż- żmien sa ma s- sintomi marru għall- agħar.
What benefit has Mirapexin shown during the studies?
X' kienu l- benefiċċji ta 'Mirapexin li ntwerew f' dawn l- istudji?
In the study of patients with advanced Parkinson’ s disease, patients taking Mirapexin had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
Fl- istudju f' pazjenti bil- marda ta 'Parkinson fi stadju avvanzat, il- pazjenti li kienu qed jieħdu Mirapexin kellhom titjib ikbar wara 24 ġimgħa ta' trattament b' doża fissa meta mqabbla ma 'dawk li kienu qed jieħdu l- plaċebo.
Similar results were seen in the first three studies of early Parkinson’ s disease, with greater improvements after four or 24 weeks.
Dehru riżultati simili fl- ewwel tliet studji tal- marda ta 'Parkinson f' fażi bikrija, b' titjib ikbar wara erbgħa sa 24 ġimgħa.
When compared with levodopa, fewer of the patients taking Mirapexin had movement symptoms after 21 months:
Meta mqabbel ma 'levodopa, inqas pazjenti li kienu qed jieħdu Mirapexin kellhom sintomi taċ- ċaqliq wara 21 xahar:
28% of the patients taking Mirapexin had symptoms (42 out of 151) compared with 51% of the patients taking levodopa (76 out of 150).
28% fost dawk il- pazjenti li kienu qed jieħdu Mirapexin kellhom is- sintomi (42 mill- 151) mqabbla ma '51% fost dawk il- pazjenti li kienu qed jieħdu levodopa (76 minn 150).
In the first study of restless legs syndrome, symptom scores fell by between 12.8 and 14.0 points after 12 weeks in patients taking Mirapexin, compared with a fall of 9.3 points in the patients taking placebo.
Fl- ewwel studju b' pazjenti bis- sindromu tar- riġlejn li ma għandhomx kwiet, il- pazjenti li kienu qed jieħdu Mirapexin wara 12 – il ġimgħa kellhom tnaqqis fil- punteġġi tas- sintomi ta 'bejn 12. 8 u 14. 0- il punt, minn madwar 23 punt fil- bidu ta' l- istudju.
Scores were around 23 points at the start of the study.
Il- punteġġi kienu madwar 23 meta beda l- istudju.
The difference between placebo and Mirapexin was greatest after four weeks before getting smaller.
L- ikbar differenza bejn il- plaċebo u Mirapexin dehret wara erba 'ġimgħat u mbagħad ċkienet.
More patients taking Mirapexin also had an improvement in symptoms.
Kien hemm iktar pazjenti li kienu qed jieħdu Mirapexin li kellhom titjib fis- sintomi.
The results of the other study were insufficient to prove the long- term effectiveness of Mirapexin.
Ir- riżultati ta 'l- istudju l- ieħor ma kinux biżżejjed biex jippruvaw l- effikaċja fit- tul ta' Mirapexin.
What is the risk associated with Mirapexin?
X' inhu r- riskju assoċjat ma 'Mirapexin?
The most common side effect with Mirapexin (seen in more than 1 patient in 10) is nausea (feeling sick).
L- iktar effetti sekondarji komuni ma 'Mirapexin (li dehru f' iktar minn pazjent wieħed minn għaxra) huma nawsea (tħossok ma tiflaħx).
In patients with Parkinson’ s disease, the other side effects seen in more than 1 patient in 10 are dizziness, dyskinesia (difficulty controlling movement), somnolence (sleepiness) and hypotension (low blood pressure).
F’ pazjenti bil- marda tal- Parkinson’ s, l- effetti sekondarji li dehru f’ pazjent minn kull 10 huma sturdament u diskinesija (diffikultà biex wieħed jikkontrolla l- moviment), somnolenza (ngħas) u ipotensjoni (pressjoni tad- demm baxxa).
For the full list of all side effects reported with Mirapexin, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Mirapexin, ara l- Fuljett ta 'Tagħrif.
Mirapexin should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Mirapexin m' għandux jintuża minn persuni li aktarx ikunu ipersensittivi (allerġiċi) għal pramipexole jew għal kwalunkwe mill- ingredjenti l- oħra.
Why has Mirapexin been approved?
Għaliex ġie approvat Mirapexin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mirapexin’ s benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson’ s disease alone or in combination with levodopa, and for the treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Mirapexin għandu iktar benefiċċji milli riskji meta użat fit- trattament tas- sinjali u s- sintomi tal- marda ta 'Parkinson idjopatika, waħdu jew flimkien ma' levodopa, u għat- trattament tas- sindromu tar- riġlejn li ma 2/ 3 għandhomx kwiet idjopatiku minn moderat għal gravi b' dożi sa 0. 54 mg tal- bażi.
The Committee recommended that Mirapexin be given marketing authorisation.
Il- Kumitat irrakkomanda li Mirapexin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Mirapexin:
Tagħrif ieħor dwar Mirapexin:
The European Commission granted a marketing authorisation valid throughout the European Union for Mirapexin on 23 February 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Mirapexin fit- 23 ta 'Frar 1998.
The marketing authorisation was renewed on 23 February 2003 and on 23 February 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 23 ta 'Frar 2003 u fit- 23 ta' Frar 2008.
The marketing authorisation holder is Boehringer Ingelheim International GmbH.
Sid l- awtorizzazzjoni għat- tqegħid fis- suq hija Boehringer Ingelheim International GmbH.
The full EPAR for Mirapexin can be found here.
L- EPAR sħiħ għal Mirapexin jista 'jiġi kkonsultat hawn.
This summary was last updated in 09-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU/ 1/ 97/ 051/ 001
Numru ta ’ l- UE EU/ 1/ 97/ 051/ 001
Mirapexin
Isem inventat Mirapexin
0.088 mg
Qawwa 0. 088 mg
Tablet
Għamla farmaċewtika Pillola
Oral use
Mnejn jingħata Użu orali
Blister (polyamide/ aluminium/ PVC)
Il- pakkett Folja (polyamide/ aluminju/ PVC)
30 tablets
Daqs tal- pakkett 30 pillola
Blister (polyamide/ aluminium/ PVC)
Folja (polyamide/ aluminju/ PVC)
100 tablets
100 pillola
MIRAPEXIN 0.088 mg tablets
MIRAPEXIN 0. 088 mg pilloli
MIRAPEXIN 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Pilloli MIRAPEXIN 0. 088 mg fihom 0. 088 mg ta ’ bażi ta ’ pramipexole (bħala 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate).
Pramipexole doses as published in the literature refer to the salt form.
Id- dożi ta ’ pramipexole kif ippubblikati fil- letteratura jirreferu għas- sura tal- melħ.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Għalhekk, id- dożi ser ikunu espressi f’ termini kemm ta ’ bażi ta ’ pramipexole u ta ’ melħ ta ’ pramipexole (fil- parentesi).
All tablets are white and have a code embossed.
Il- pilloli kollha huma bojod u għandhom kodiċi mnaqqax fuqhom.
Strength (mg salt) 0.125 0.25 0.5 1.0 1.5
Qawwa (mg ta ’ melħ) 0. 125 0. 25 0. 5 1. 0 1. 5
Appearance flat, round, 6 mm diameter, no score flat, oval, 7.86 x 5.63 mm, scores on both sides flat, oval, 10.59 x 7.59 mm, scores on both sides flat, round, 9 mm diameter, scores on both sides flat, round, 11 mm diameter, scores on both sides
Dehra ċatti, tondi, dijametru ta ’ 6 mm, l- ebda ferq ċatti, ovali, 7. 86 x 5. 63 mm, ferq fuq iż- żewġ naħat ċatti, ovali, 10. 59 x 7. 59 mm, ferq fuq iż- żewġ naħat ċatti, tondi, dijametru ta ’ 9 mm, ferq fuq iż- żewġ naħat ċatti, tondi, dijametru ta ’ 11 mm, ferq fuq iż- żewġ naħat
All tablets can be divided into equal halves (with the exception of the 0.088/ 0.125 mg tablet).
Il- pilloli kollha jistgħu jinqasmu min- nofs (bl- eċċezzjoni tal- pillola ta ’ 0. 088/ 0. 125 mg)
MIRAPEXIN 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).
MIRAPEXIN hu indikat għall- kura tas- sinjali u tas- sintomi tal- marda idjopatika ta ’ Parkinson, waħidhom (i. e. mingħajr levodopa) jew flimkien ma ’ levodopa, i. e. matul il- kors tal- marda, sa l- istadji aħħarin fejn l- effett ta ’ levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet ta ’ l- effett terapewtiku (fl- aħħar tad- doża jew fluttwazzjonijiet “ on off ”).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (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.).
Parkinson’ s disease
Il- marda ta ’ Parkinson
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Il- pilloli għandhom jittieħdu mill- ħalq, jinbelgħu ma ’ l- ilma, u jistgħu jittieħdu ma ’ l- ikel jew mingħajr l- ikel.
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.
-2- Initial treatment:
Kura inizjali:
Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Id- dożaġġi għandhom jiżdiedu gradwalment minn doża tal- bidu ta ’ 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) kuljum u mbagħad jiżdiedu kull 5 - 7 ijiem.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
2 li ma jkunux jistgħu jittolleraw, id- dożaġġ għandu jkun ittitrat biex iwettaq l- effett terapewtiku massimu.
Ascending – Dose Schedule of MIRAPEXIN
Skeda ta ’ Doża li Tiżdied ta ’ MIRAPEXIN
Week
Ġimgħa
Dosage (mg of base)
Dożaġġ (mg ta ’ bażi)
Total Daily Dose (mg of base)
Doża Totali ta ’ Kuljum (mg ta ’ bażi)
Dosage (mg of salt)
Dożaġġ (mg ta ’ melħ)
Total Daily Dose (mg of salt)
Doża Totali ta ’ Kuljum (mg ta ’ melħ)
3 x 0.088 3 x 0.18 3 x 0.35
3 x 0. 088 3 x 0. 18 3 x 0. 35
0.264 0.54 1.1
0. 264 0. 54 1. 1
3 x 0.125 3 x 0.25 3 x 0.5
3 x 0. 125 3 x 0. 25 3 x 0. 5
0.375 0.75 1.50
0. 375 0. 75 1. 50
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.
Jekk ikun hemm bżonn ta ’ żieda addizzjonali fid- doża, id- doża ta ’ kuljum għandha tiżdied b’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) f’ intervalli ta ’ darba f’ ġimgħa sa 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 tan- ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
Maintenance treatment:
Kura tal- manteniment:
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Id- doża individwali għandha tkun fil- medda ta ’ 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) sa massimu ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
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 studji importanti ħafna, l- effikaċja bdiet tkun osservata f’ doża ta ’ kuljum ta ’ 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 undesirable effects.
Aġġustamenti addizzjonali fid- doża għandhom isiru skond ir- rispons kliniku u l- okkorrenza ta ’ effetti mhux mixtieqa.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
Fil- provi kliniċi, madwar 5% tal- pazjenti kienu kkurati b’ dożi li kienu taħt 1. 1 mg (1. 5 mg ta ’ melħ).
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Fil- marda ta ’ Parkinson fl- istadju avvanzat, dożi ogħla minn 1. 1 mg (1. 5 mg ta ’ melħ) kuljum jistgħu jkunu utli f’ pazjenti fejn it- tnaqqis tat- terapija ta ’ levodopa jkun intenzjonat.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, depending on reactions in individual patients.
Hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas kemm matul il- perjodu meta d- doża tkun qed tiżdied, kif ukoll matul il- kura tal- manteniment b’ MIRAPEXIN, skond ir- reazzjonijiet fil- pazjenti individwali.
Treatment discontinuation:
It- twaqqif tal- kura:
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
It- twaqqif f’ daqqa tat- terapija dopaminerġika jista ’ jwassal għall- iżvilupp ta ’ sindrome malinn newroleptiku.
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Għalhekk, pramipexole għandu jitwaqqaf gradwalment b’ rata ta ’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) kuljum sakemm id- doża ta ’ kuljum tkun tnaqqset għal 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ).
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Wara dak il- perjodu, id- doża għandha titnaqqas b’ 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) kuljum (ara sezzjoni 4. 4).
Dosing in patients with renal impairment:
Id- dożaġġ f’ pazjenti b’ indeboliment renali:
The elimination of pramipexole is dependent on renal function.
L- eliminazzjoni ta ’ pramipexole tiddependi fuq il- funzjoni renali.
The following dosage schedule is suggested for initiation of therapy:
L- iskeda tad- dożaġġ li ġejja hi ssuġġerita għall- bidu tat- terapija:
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Pazjenti bi tneħħija tal- krejatinina ta ’ iktar minn 50 ml/ min ma jeħtieġu l- ebda tnaqqis fid- doża ta ’ kuljum.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of MIRAPEXIN should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
F’ pazjenti bi tneħħija tal- krejatinina bejn 20 u 50 ml/ min, id- doża inizjali ta ’ kuljum ta ’ MIRAPEXIN għandha tingħata f’ żewġ dożi maqsumin, li jibdew minn 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) darbtejn kuljum (0. 176 mg ta ’ bażi/ 0. 25 mg ta ’ melħ kuljum).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of MIRAPEXIN should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
F’ pazjenti bi tneħħija tal- krejatinina ta ’ inqas minn 20 ml/ min, id- doża ta ’ kuljum ta ’ MIRAPEXIN għandha tingħata f’ doża waħda, li tibda b’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) kuljum.
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%.
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 maqsumin jekk it- tneħħija tal- krejatinina tkun bejn 20 u 50 ml/ min, u bħala doża waħda kuljum jekk it- tneħħija tal- krejatinina tkun inqas minn 20 ml/ min.
-3- Dosing in patients with hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.
3 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, għax madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
However, the potential influence of hepatic insufficiency on MIRAPEXIN pharmacokinetics has not been investigated.
Madankollu, l- influwenza potenzjali ta ’ insuffiċjenza epatika fuq il- farmakokinetiċi ta ’ MIRAPEXIN ma kinitx investigtaa.
Restless Legs Syndrome
Is- Sindrome tas- Saqajn Bla Kwiet (Restless Legs Syndrome - RLS)
The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Id- doża tal- bidu rakkomandata ta ’ MIRAPEXIN hi ta ’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) li tittieħed darba kuljum 2- 3 sigħat qabel ħin l- irqad.
For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as shown in the table below).
Għal pazjenti li jkunu jeħtieġu solliev sintomatiku addizzjonali, id- doża tista ’ tiżdied kull 4- 7 ijiem sa massimu ta ’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) kuljum (kif muri fit- tabella hawn taħt).
Dose Schedule of MIRAPEXIN
L- Iskeda tad- Doża ta ’ MIRAPEXIN
Titration Step
Pass tat - Titrazzjoni
Once Daily Evening Dose (mg of base)
Doża Filgħaxija Darba Kuljum (mg ta ’ bażi)
Once Daily Evening Dose (mg of salt)
Doża Filgħaxija Darba Kuljum (mg ta ’ melħ)
1 2* 3* 4* * if needed
1 2 * 3 * 4 * * jekk meħtieġ