qanastek/EMEA-V3 huggingface dataset:
A further study looked at the long-term effects of Invega in preventing new symptoms for up to 35 weeks in 207 patients who had initially been treated for symptoms of schizophrenia over a 14-week period.
Studju ieħor ħares lejn l- effetti fit- tul ta 'Invega fil- prevenzjoni ta' sintomi ġodda għal 35 ġimgħa f' 207 pazjenti li fil- bidu kienu ġew ittrattati għas- sintomi tal- iskiżofrenija matul perjodu ta '14- il ġimgħa.
What benefit has Invega shown during the studies?
X' benefiċċji ta 'Invega intwerew f' dawn l- istudji?
Invega was more effective than placebo and as effective as olanzapine in reducing the symptoms of schizophrenia.
Invega kien iktar effettiv mill- plaċebo u kien effettiv daqs olanzapine fit- tnaqqis tas- sintomi tal - iskiżofrenija.
In the first short-term study, patients taking placebo had an average fall in their symptom score of 4.1 points, compared with an average fall of between 17.9 and 23.3 points in those taking Invega and of 19.9 in those taking olanzapine.
Fl- ewwel studju li ħares lejn l- effetti fil- futur qrib, il- pazjenti li kienu qed jieħdu l - plaċebo kellhom medja ta 'tnaqqis fil- punteġġ tas- sintomi ta' 4. 1 punti, meta mqabbla ma 'tnaqqis medju ta' bejn 17. 9 u 23. 3 punti f' dawk il- pazjenti li kienu qed jieħdu Invega u ta '19. 9 f' dawk li kienu qed jieħdu olanzapine.
Similar results were seen in the other two short- term studies.
Fiż- żewġ studji l- oħra li ħarsu lejn l- effetti sal- futur qrib, dehru riżultati simili.
Across all three studies, higher doses of Invega were more effective than lower doses in reducing symptoms.
Fit- tliet studji, dożi ogħla ta 'Invega kienu iktar effettivi minn dożi iktar baxxi fit- tnaqqis ta' sintomi.
Invega was also more effective than placebo in preventing the occurrence of new symptoms of schizophrenia in the long-term study.
Invega kien ukoll iktar effettiv mill- plaċebo fil- prevenzjoni ta 'sintomi ġodda tal- iskiżofrenija fl - istudju li ħares fit- tul.
What is the risk associated with Invega?
X' inhu r- riskju assoċjat ma 'Invega?
The most common side effect with Invega (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarju komuni mat- teħid ta 'Invega (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu l- uġigħ fir- ras.
For the full list of all side effects reported with Invega, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Invega, ara l- Fuljett ta 'Tagħrif.
Invega should not be taken by people who may be hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Invega m' għandux jintuża minn persuni li huma allerġiċi għal paliperidone jew għal xi sustanza oħra tiegħu.
Why has Invega been approved?
Għaliex ġie approvat Invega?
The Committee for Medicinal Products for Human Use (CHMP) decided that, at doses of between 3 and 12 mg a day, Invega’ s benefits are greater than its risks for the treatment of schizophrenia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem iddeċieda li, f' dożi ta 'bejn 3 u 12- il mg kuljum, il- benefiċċji ta' Invega fit- trattament tal- iskiżofrenija huma ikbar mir- riskji tiegħu.
The Committee also concluded that 6 mg once a day was a reasonable starting dose, based on the balance of benefits and risks of the different doses studied.
Il- kumitat ikkonkluda li 6 mg darba kuljum kienet doża inizjali raġonevoli, abbażi tal- bilanċ bejn il- benefiċċji u r- riskji tad- dożi differenti li ġew studjati.
The Committee recommended that Invega be given marketing authorisation.
Il- Kumitat irrakkomanda li Invega jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Invega:
Tagħrif ieħor dwar Invega:
The European Commission granted a marketing authorisation valid throughout the European Union for Invega to Janssen-Cilag International NV on 25 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Invega, valida fl- Unjoni Ewropea kollha, lil Janssen- Cilag International NV fil- 25 ta 'Ġunju 2007.
The full EPAR for Invega can be found here.
L- EPAR sħiħ għal Invega jinsab hawn.
This summary was last updated in 02-2009.
Dan is- sommarju ġie aġġornat l- aħħar f ': 02- 2009.
Pharmaceutical Form Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet
Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (PVC/ PCTFE/ alu) asdf blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu)
folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu)
Package size 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 28 tablets
28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 28 pillola
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EU/ 1/ 07/ 395/ 042 EU/ 1/ 07/ 395/ 043 EU/ 1/ 07/ 395/ 044 EU/ 1/ 07/ 395/ 045 EU/ 1/ 07/ 395/ 046 EU/ 1/ 07/ 395/ 047 EU/ 1/ 07/ 395/ 048 EU/ 1/ 07/ 395/ 049 EU/ 1/ 07/ 395/ 050 EU/ 1/ 07/ 395/ 051 EU/ 1/ 07/ 395/ 052 EU/ 1/ 07/ 395/ 053 EU/ 1/ 07/ 395/ 054 EU/ 1/ 07/ 395/ 055 EU/ 1/ 07/ 395/ 056 EU/ 1/ 07/ 395/ 057 EU/ 1/ 07/ 395/ 058 EU/ 1/ 07/ 395/ 059 EU/ 1/ 07/ 395/ 060 EU/ 1/ 07/ 395/ 061 EU/ 1/ 07/ 395/ 062 EU/ 1/ 07/ 395/ 063 EU/ 1/ 07/ 395/ 064 EU/ 1/ 07/ 395/ 065 EU/ 1/ 07/ 395/ 066 EU/ 1/ 07/ 395/ 067 EU/ 1/ 07/ 395/ 068 EU/ 1/ 07/ 395/ 069 EU/ 1/ 07/ 395/ 070 EU/ 1/ 07/ 395/ 071 EU/ 1/ 07/ 395/ 072 EU/ 1/ 07/ 395/ 073 EU/ 1/ 07/ 395/ 074 EU/ 1/ 07/ 395/ 075 EU/ 1/ 07/ 395/ 076 EU/ 1/ 07/ 395/ 077 EU/ 1/ 07/ 395/ 078 EU/ 1/ 07/ 395/ 079 EU/ 1/ 07/ 395/ 080 EU/ 1/ 07/ 395/ 081 EU/ 1/ 07/ 395/ 082 EU/ 1/ 07/ 395/ 083
12 mg 12 mg 12 mg 12 mg 3 mg 3 mg 3 mg 3 mg 6 mg 6 mg 6 mg 6 mg 9 mg 9 mg 9 mg 9 mg 12 mg 12 mg 12 mg 12 mg 3 mg 3 mg 6 mg 6 mg 9 mg 9 mg 12 mg 12 mg 3 mg 3 mg 3 mg 6 mg 6 mg 6 mg 9 mg 9 mg 9 mg
3 mg 3 mg 3 mg 6 mg 6 mg 6 mg 6 mg 9 mg 9 mg 9 mg 9 mg 12 mg 12 mg 12 mg 12 mg 3 mg 3 mg 6 mg 6 mg 9 mg 9 mg 12 mg 12 mg 3 mg 3 mg 3 mg 6 mg 6 mg 6 mg 9 mg 9 mg 9 mg 12 mg 12 mg 12 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg
Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet
Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-alu-PVC/ alu) blister (OPA-alu-PVC/ alu) - blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) Bottle (HDPE/ PP) blister (PVC/ PCTFE/ alu) asdf blister (white PVC/ PCTFE/ alu) blister (OPA-alu-PVC/ alu) blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu) blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu)
folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu) folja (PVC/ PCTFE/ alu abjad)
30 tablets 49 tablets 56 tablets 98 tablets 28 tablets 49 tablets 56 tablets 98 tablets 28 tablets 49 tablets 56 tablets 98 tablets 28 tablets 49 tablets 56 tablets 98 tablets 28 tablets 49 tablets 56 tablets 98 tablets 30 tablets 350 tablets 30 tablets 350 tablets 30 tablets 350 tablets 30 tablets 350 tablets 14 tablets 14 tablets 14 tablets 14 tablets 14 tablets 14 tablets 14 tablets 14 tablets 14 tablets
49 pillola 56 pillola 98 pillola 28 pillola 49 pillola 56 pillola 98 pillola 28 pillola 49 pillola 56 pillola 98 pillola 28 pillola 49 pillola 56 pillola 98 pillola 30 pillola 350 pillola 30 pillola 350 pillola 30 pillola 350 pillola 30 pillola 350 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 14 pillola 28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 14 pillola
EU/ 1/ 07/ 395/ 074 EU/ 1/ 07/ 395/ 075 EU/ 1/ 07/ 395/ 076 EU/ 1/ 07/ 395/ 077 EU/ 1/ 07/ 395/ 078 EU/ 1/ 07/ 395/ 079 EU/ 1/ 07/ 395/ 080 EU/ 1/ 07/ 395/ 081 EU/ 1/ 07/ 395/ 082 EU/ 1/ 07/ 395/ 083 EU/ 1/ 07/ 395/ 084 EU/ 1/ 07/ 395/ 085 EU/ 1/ 07/ 395/ 086 EU/ 1/ 07/ 395/ 087 EU/ 1/ 07/ 395/ 088 EU/ 1/ 07/ 395/ 089 EU/ 1/ 07/ 395/ 090 EU/ 1/ 07/ 395/ 091 EU/ 1/ 07/ 395/ 092 EU/ 1/ 07/ 395/ 093 EU/ 1/ 07/ 395/ 094 EU/ 1/ 07/ 395/ 095
EU/ 1/ 07/ 395/ 084 EU/ 1/ 07/ 395/ 085 EU/ 1/ 07/ 395/ 086 EU/ 1/ 07/ 395/ 087 EU/ 1/ 07/ 395/ 088 EU/ 1/ 07/ 395/ 089 EU/ 1/ 07/ 395/ 090 EU/ 1/ 07/ 395/ 091 EU/ 1/ 07/ 395/ 092 EU/ 1/ 07/ 395/ 093 EU/ 1/ 07/ 395/ 094 EU/ 1/ 07/ 395/ 095
Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega
Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega Invega
12 mg 12 mg 12 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg 1.5 mg
1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg 1. 5 mg
Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet
Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod Pillola li terħi l- mediċina bil- mod
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (white PVC/ PCTFE/ alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) blister (OPA-Alu-PVC/ Alu) Bottle (HDPE/ PP) Bottle (HDPE/ PP)
folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (PVC/ PCTFE/ alu abjad) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) folja (OPA- Alu- PVC/ Alu) Flixkun (HDPE/ PP) Flixkun (HDPE/ PP)
14 tablets 14 tablets 14 tablets 14 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 14 tablets 28 tablets 30 tablets 49 tablets 56 tablets 98 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets 30 tablets 350 tablets
28 pillola 30 pillola 49 pillola 56 pillola 98 pillola 14 pillola 28 pillola 49 pillola 56 pillola 98 pillola 30 pillola 350pillola
INVEGA 1.5 mg prolonged-release tablets
INVEGA pilloli tal- 1. 5 mg li jerħu l- mediċina bil- mod
Each prolonged-release tablet contains 1.5 mg of paliperidone.
Kull pillola li terħi l- mediċina bil- mod fiha 1. 5 mg ta ’ paliperidone.
Prolonged-release tablet
Pillola li terħi l- mediċina bil- mod.
Trilayer capsule-shaped orange brown tablets printed with “ PAL 1.5”
Pilloli b’ forma ta ’ kapsula kannella fl- oranġjo bi tliet saffi stampati b ’ “ PAL 1. 5 ”
INVEGA is indicated for the treatment of schizophrenia.
INVEGA huwa indikat għall- kura ta ’ l- iskiżofrenja.
Adults INVEGA is for oral administration.
Adulti INVEGA jittieħed mill- ħalq.
The recommended dose of INVEGA is 6 mg once daily, administered in the morning.
Id- doża rakkomandata ta ’ INVEGA hija 6 mg darba kuljum, u tingħata filgħodu.
The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
(ara sezzjoni 5. 2).
The patient should be instructed to always take INVEGA in the fasting state or always take it together with breakfast and not to alternate between administration in the fasting state or in the fed state.
Lill- pazjent għandhom jingħataw istruzzjonijiet li għandu dejjem jieħu INVEGA waqt li hu sajjem jew dejjem mal- kolazzjon, u ma jbiddilx bejn amministrazzjoni waqt li hu sajjem u waqt l- ikel.
Initial dose titration is not required.
M’ hemmx bżonn doża titrata inizjali.
Some patients may benefit from lower or higher doses within the recommended range of 3 to 12 mg once daily.
Xi pazjenti jistgħu jibbenefikaw minn dożi iktar baxxi jew ogħla fil- medda rakkomandata ta ’ bejn 3 u 12- il mg darba kuljum.
Dosage adjustment, if indicated, should occur only after clinical reassessment.
Il- bidla fid - dożaġġ, jekk hu indikat, għandu jsir biss wara assessjar kliniku mill- ġdid.
When dose increases are indicated, increments of 3 mg/ day are recommended and generally should occur at intervals of more than 5 days.
Meta hija indikata żieda fid - doża, żidiet ta ’ 3mg/ jum huma rrakkomandati u ġeneralment dawn għandhom iseħħu b’ intervali ta ’ iktar minn 5 ijiem.
INVEGA must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
INVEGA għandu jinbela ’ sħiħ ma ’ likwidu, u m’ għandiex tiġi magħmuda, maqsuma jew imfarrka.
The active substance is contained within a non absorbable shell designed to release the active substance at a controlled rate.
Is - sustanza attiva tinsab f’ qoxra li ma tiġix assorbita, u li hi maħduma biex is- sustanza attivi tintreħa b’ rata kontrollata.
The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Il- qoxra tal- pillola, flimkien mal- komponenti tal- qalba li ma jdubux, jiġu eliminati mill- ġisem; il- pazjenti m’ għandhomx jinkwetaw jekk xi kultant jaraw xi ħaġa qisha pillola fl- ippurgar.
Patients with hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku M’ hemmx għalfejn bidla fid- doża għal pazjenti b’ indeboliment epatiku ħafif jew moderat.
As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
Billi INVEGA ma ġietx studjata f’ pazjenti b’ indeboliment epatiku qawwi, l- amministrazzjoni f’ dawn il - pazjenti għandha ssir b’ kawtela.
Patients with renal impairment For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 ml/ min), the recommended initial dose is 3 mg once daily.
Pazjenti b’ indeboliment renali Għal pazjenti b’ indeboliment renali ħafif (tneħħija tal- kreatinina ≥ 50 sa < 80 ml/ min), id- doża inizzjali rakkomandata hi ta ’ 3 mg darba kuljum.
The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Id- doża tista ’ tiżdied sa 6mg darba kuljum skond ir - rispons kliniku u t- tollerabilità.
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/ min), the recommended initial dose of INVEGA is 1.5 mg every day, which may be increased to 3 mg once daily after clinical reassessment.
Għal pazjenti b’ indeboliment renali moderat għal qawwi (tneħħija tal- kreatinina ≥ 10 sa < 50 ml/ min), id- doża rakkomandata ta ’ INVEGA hija 1. 5 mg darba kuljum li tista tiżdied sa 3mg darba kuljum wara evalwazzjoni klinika mill- ġdid.
As INVEGA has not been studied in patients with creatinine clearance below 10 ml/ min, use is not recommended in such patients.
Billi INVEGA ma ġiex studjat f’ pazjenti bi tneħħija tal- kreatinina taħt l- 10 ml/ min, l- amministrazzjoni f’ dawn il- pazjenti mhux rakkomandata.
2 Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
2 Anzjani Ir- rakkomandazzjoni għad- dożaġġ għal pazjenti anzjani li għandhom funzjoni renali normali (≥ 80 ml/ min) hija l- istess għall- adulti b’ funzjoni renali normali.
However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Patients with Renal Impairment above).
(Ara Pazjenti b’ Indeboliment Renali iktar ‘ il fuq).
INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4).
INVEGA għandu jintuża b’ kawtela f’ pazjenti anzjani b’ dimenzja b’ fatturi ta ’ riskju ta ’ aċċessjoni (ara sezzjoni 4. 4).
Paediatric population Safety and efficacy of INVEGA in patients < 18 years of age have not been studied.
Popolazzjoni pedjatrika Ma ġietx studjata s- sigurtà u l- effikaċja ta ’ INVEGA f’ pazjenti < 18- il sena.
There is no experience in children.
M’ hemmx esperjenza dwar l- użu fit- tfal.
Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Popolazzjonijiet speċjali oħra Mhux rakkomandata bidla fid- doża ta ’ INVEGA skond is- sess, razza jew jekk il- pazjent ipejjipx jew le.
(For pregnant women and breast-feeding mothers, see section 4.6)
(Għal nisa tqal u ommijiet li qed ireddgħu, ara sezzjoni 4. 6)
Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products.
Qlib għal prodotti mediċinali oħra antipsikotiċi M’ hemmx tagħrif miġbur sistematikament speċifikament dwar pazjenti li jaqilbu minn INVEGA għal prodotti mediċinali oħra antipsikotiċi.
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Minħabba l- profili farmakodinamiċi u farmakokinetiċi differenti fost prodotti mediċinali antipsikotiċi, hija meħtieġa s- superviżjoni ta ’ tabib meta l- qlib għal prodott antipsikotiku ieħor jitqies xieraq mill- aspett mediku.
Hypersensitivity to the active substance, risperidone, or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva, risperidone, jew għal xi sustanzi mhux attivi.
QT interval As with other antipsychotics, caution should be exercised when INVEGA is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicines thought to prolong the QT interval.
Intervall QT Bħal fil- każ ta ’ antipsikotiċi oħra, għanda tintuża l- kawtela meta INVEGA jiġi miktub lil pazjenti li għandhom mard kardjovaskulari jew storja medika fil- familja ta ’ prolongament ta ’ QT u f’ użu konkomitanti flimkien ma ’ mediċini oħrajn maħsuba li jtawwlu l- intervall QT.
Neuroleptic malignant syndrome Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics, including paliperidone.
Sindromu malinn newrolettiku Is- Sindromu malinn newrolettiku (NMS), li hu karatterizzat minn ipertermja, twebbis tal- muskoli, instabilità awtonomika, perċezzjoni mibdula, u livelli elevati ta ’ serum creatine phosphokinase, ġie rrapurtat li jseħħ bl- antipsikotiċi, inkluż paliperidone.
Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Sinjali kliniċi oħrajn jistgħu jinkludu majoglobinurja (rabdomajoliżi) u insuffiċjenza renali akuta.
If a patient develops signs or symptoms indicative of NMS, all antipsychotics, including INVEGA, should be discontinued.
Jekk pazjent jiżviluppa sinjali jew sintomi li jindikaw NMS, l- antipsikotiċi kollha, inkluż INVEGA, għandhom jitwaqqfu.
Tardive dyskinesia Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/ or face.
Diskajneżja Tardiva Mediċini bi proprjetajiet antagonistiċi għal riċetturi tad- dopamina ġew assoċjati ma ’ l- induzzjoni ta ’ diskajneżja tardiva karatterizzata minn ċaqlieq ritmiku involontarju, l- iktar ta ’ l- ilsien u/ jew tal- wiċċ.
If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including INVEGA, should be considered.
Jekk jixirfu s- sinjali u s- sintomi ta ’ diskajneżja tardiva, għandu jitqies it- twaqqif ta ’ l- antipsikotiċi kollha, inkluż INVEGA.
Hyperglycemia Rare cases of glucose related adverse reactions, e. g., increase in blood glucose, have been reported in clinical trials with INVEGA.
Ipergliċemija Fi provi kliniċi ta ’ INVEGA ġew irrapurtati każijiet rari avversi marbuta mal- glucose, e. ż., żieda fil - glukosju tad- demm.
As with other antipsychotics, appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Bħal fil- każ ta ’ antipsikotiċi oħrajn, jaqbel li jkun hemm monitoraġġ kliniku xieraq f’ pazjenti dijabetiċi u f’ pazjenti b’ fatturi ta ’ riskju li jiżviluppaw dijabete mellitus.
Orthostatic hypotension Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity.
Ipotensjoni ortostatika F’ xi pazjenti, paliperidone jista ’ jinduċi ipotensjoni ortostatika minħabba l- attività tagħha ta ’ mblokkar ta ’ l- alfa.
Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
Skond t- tagħrif meqjus flimkien minn tliet provi kontrollati bi plaċebo, ta ’ sitt ġimgħat b’ doża fissa ta ’ INVEGA (3, 6, 9, u 12- il mg), ġiet irrapurtata ipotensjoni ortostatika f’ 2. 5% tas- suġġetti trattati b’ INVEGA meta mqabbel ma ’ 0. 8% tas- suġġeti ttrattati bi plaċebo.
INVEGA should be used with caution in patients with known cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities),
INVEGA għandu jintuża b’ kawtela f’ pazjenti li għandhom mard kardjovaskolari magħruf (e. ż., insuffiċjenza tal- qalb, infart
3 cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
3 mijokardijaku jew iskemija, anormalitajiet fil- konduzzjoni), mard ċerebrovaskulari, jew kundizzjonijiet li jippredisponu lill- pazjent għall- ipotensjoni (e. ż., id- deidratazzjoni u l- ipovolemija).
Seizures INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Aċċessjonijiet INVEGA għandu jintuża b’ mod kawt ma ’ pazjenti bi storja ta ’ aċċessjonijiet jew kundizzjonijiet oħra li għandhom il- potenzjal li jkabbru l- possibiltà ta ’ aċċessjoni.
Potential for gastrointestinal obstruction Because the INVEGA tablet is non-deformable and does not appreciably change shape in the gastrointestinal tract, INVEGA should not ordinarily be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets.
Potenzjal għal ostruzzjoni gastrointestinali Billi l- pillola INVEGA ma tistax tiġi deformata u ma tbiddilx l- għamla tagħha b’ mod sinjifikanti fl- apparat gastrointestinali, INVEGA normalment m’ għandux jiġi amministrat lill - pazjenti li diġà għandhom djuq gastrointestinali sever (patoloġiku jew jatroġeniku) jew f’ pazjenti b’ disfaġja jew diffikultà sinjifikanti biex jibilgħu l- pilloli.
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.
Kien hemm rapporti rari ta ’ sintomi ta ’ ostruzzjoni f’ pazjenti li kellhom problemi magħrufa ta ’ diffikulta` biex jibilgħu l- mediċina fil- formulazzjonijiet non- deformabbli u li jerħu l- mediċina bil- mod.
Due to the controlled-release design of the dosage form, INVEGA should only be used in patients who are able to swallow the tablet whole.
Minħabba d- disinn tal- forma tad- dożaġġ li jerħi l - mediċina bil- mod, INVEGA għandu jintuża biss f’ pazjenti li jistgħu jibilgħu il- pillola sħiħa.
Conditions with decreased gastro-intestinal transit time Conditions leading to shorter gastrointestinal transit time, e. g., diseases associated with chronic severe diarrhoea, may result in a reduced absorption of paliperidone.
Kundizzjonijiet bi - żmien ta ’ traġitt mill- apparat gastro- intestinali imqassar Kundizzjonijiet li jwasslu għal żmien iqsar tat- traġitt mill- apparat gastro- intestinali, e. ż., mard assoċjat ma ’ dijarea qawwija kronika, jista ’ jirriżulta f’ inqas assorbiment ta ’ paliperidone.
Renal impairment The plasma concentrations of paliperidone are increased in patients with renal impairment and, therefore, dosage adjustment may be required in some patients (see section 4.2 and 5.2).
Indeboliment renali Il- konċentrazzjonijiet ta ’ paliperidone fil- plażma jiżdiedu f’ pazjenti b’ insuffiċjenza renali u, għalhekk, jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ xi pazjenti (ara sezzjoni 4. 2 u 5. 2).
No data are available in patients with a creatinine clearance below 10 ml/ min.
M’ hemmx tagħrif dwar pazjenti bi tneħħija ta ’ kreatinina taħt l- 10 ml/ min.
Paliperidone should not be used in patients with creatinine clearance below 10 ml/ min.
Paliperidone m’ għandux jintuża ma ’ pazjenti bi tneħħija ta ’ kreatinina taħt l- 10 ml/ min.
Hepatic impairment No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Indeboliment epatiku M’ hemmx tagħrif dwar pazjenti b’ indeboliment epatiku qawwi (Child- Pugh Klassi C).
Caution is recommended if paliperidone is used in such patients.
Hija rakkomandata l- kawtela fl- użu ta ’ paliperidone ma ’ dawn il- pazjenti.
Elderly patients with dementia INVEGA has not been studied in elderly patients with dementia.
Pazjenti anzjani b’ dimenzja INVEGA ma ġiex studjat f’ pazjenti anzjani bid- dimenzja.
Hence, until data demonstrate otherwise the experience from risperidone is considered valid also for paliperidone.
Għalhekk, sakemm ikun hemm tagħrif li juri mod ieħor, l- esperjenza minn risperidone għandha titqies valida wkoll għal paliperidone.
Overall mortality In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Mortalità ġenerali F’ meta- analiżi ta ’ 17- il prova klinika kkontrollata, pazjenti anzjani bid- dimenzja kkurati b’ antipsikotiċi atipiċi oħrajn, inkluż risperidone, aripiprazole, olanzapine, u quetiapine kellhom riskju ogħla ta ’ mortalità meta mqabbla ma ’ dawk li ħadu plaċebo.
Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Fost dawk ikkurati b’ risperidone, il- mortalità kienet 4% meta mqabbel ma ’ 3. 1% bil- plaċebo.
Cerebrovascular adverse reactions An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Reazzjonijiet ċerebrovaskulari avversi Ġiet innutat żieda fir- riskju madwar 3 darbiet aktar ta ’ reazzjonijiet ċerebrovaskulari avversi fi provi kliniċi randomised ikkontrollati bi plaċebo fil- popolazzjoni bid- dimenzja b’ xi antipsikotiċi atipiċi, inkluż risperidone, aripiprazole, u olanzapine.
The mechanism for this increased risk is not known.
Il- mekkaniżmu għaż- żieda fir- riskju mhux magħruf.
INVEGA should be used with caution in elderly patients with dementia who have risk factors for stroke.
INVEGA għandu jintuża b’ kawtela f’ pazjenti anzjani b’ dimenzja b’ fatturi ta ’ riskju ta ’ aċċessjoni
Parkinson’ s disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing antipsychotic medicinal products, including INVEGA, to patients with Parkinson’ s Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
Mard tal- Parkinson u dimenzja b’ Lewy bodies It- tobba għandhom iqisu r- riskji u l- benefiċċji meta jagħtu prodotti mediċinali antipsikotiċi, inkluż INVEGA, lil pazjenti bil- mard tal- Parkinson jew Dimenzja b’ Lewy Bodies (DLB) billi dawn iż- żewġ gruppi jista ’ jkollhom riskju ogħla tas- Sindromu Malinn Newrolettiku, kif ukoll sensittività ogħla għall- antipsikotiċi.
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Manifestazzjoni ta ’ din is- sensittività ogħla tista tinkludi konfużjoni, tmewwit, instabilità fil- qagħda li twassal għal waqgħat frekwenti, flimkien ma ’ sintomi extrapiramidali.
4 Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
4 Mediċini b’ effetti ta ’ mblukkar alfa- adrenerġiċi ġew irrapurati li jinduċu l- priapiżmu.
Although no cases of priapism have been reported in clinical trials with INVEGA, paliperidone shares this pharmacologic activity and, therefore, may be associated with this risk.
Għalkemm ma ġewx irrapurtati każijiet ta ’ priapiżmu fi provi kliniċi bi INVEGA, paliperidone għandu wkoll din l - attività farmakoloġika u, għalhekk, jista ’ jkun assoċjat ma ’ dan ir- riskju.
Body temperature regulation Disruption of the body’ s ability to reduce core body temperature has been attributed to antipsychotic medicines.
Regolazzjoni tat- temperatura tal- ġisem Disturbi fil- ħila tal- ġisem li jnaqqas it- temperatura tal- ġisem ġew attribwiti għall- mediċini antipsikotiċi.
Appropriate care is advised when prescribing INVEGA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e. g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Għandha ssir attenzjoni xierqa meta tingħata INVEGA lil pazjenti li se jkollhom kundizzjonijiet li jistgħu jikkontribwixxu għal żieda fit- temperatura tal- ġisem, e. ż., eżerċizzju qawwi, espożizzjoni għal sħana estrema, meta tittieħed ma ’ mediċina b’ attività antikolinerġika, jew li tkun suġġett għal deidratazzjoni.
Antiemetic effect An antiemetic effect was observed in preclinical studies with paliperidone.
Effett antiemitiku Ġie osservat effett antiemitiku fi studji pre- kliniċi b’ paliperidone.
This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines or of conditions such as intestinal obstruction, Reye’ s syndrome, and brain tumour.
Dan l- effett, jekk iseħħ fil- bnedmin, jista ’ jostor sinjali u sintomi ta ’ doża eċċessiva b’ ċerti mediċini jew ta ’ kundizzjonijiet bħal ostruzzjoni intestinali, sindromu ta ’ Reye u tumur fil- moħħ.
Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e. g., class IA antiarrhythmics (e. g., quinidine, disopyramide) and class III antiarrhythmics (e. g., amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e. g., mefloquine).
Għandha tintuża kawtela meta jingħata INVEGA ma ’ mediċini li huma magħrufa li jtawlu l- intervall QT, e. ż. antiarritmijaċi tal- klassi IA, (e. ż. quinidine, disopyramide) u antiarritmijaċi tal- klassi III (e. ż. amiodarone, sotalol), xi antistaminiċi, xi antipsikotiċi oħrajn, u xi mediċini kontra l- malarja (e. ż. mefloquine).
Potential for INVEGA to affect other medicines Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicines that are metabolised by cytochrome P-450 isozymes.
Il- potenzjal ta ’ INVEGA li jaffettwa mediċini oħrajn Paliperidone mhux mistenni li jikkawża interazzjonijiet farmakokinetiċi klinikament importanti ma ’ mediċini li huma metabolizzati bl- isożimi cytochrome P- 450.
Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e. g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Meta wieħed iqis l- effetti primarji CNS ta ’ paliperidone (ara sezzjoni 4. 8), INVEGA għandu jintuża b’ kawtela meta jittieħed flimkien ma ’ mediċini oħra li għandhom azzjoni ċentrali e. ż. anksjolitiċi, il - biċċa l- kbira ta ’ l- antipsikotiċi, ipnotiċi, opjejts, etc. jew l- alkoħol.
Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Paliperidone jista ’ jantagonizza l- effett ta ’ levodopa u agonisti oħra tad- dopamina.
If this combination is deemed necessary, particularly in end-stage Parkinson’ s disease, the lowest effective dose of each treatment should be prescribed.
Jekk dan it- teħid flimkien jitqies neċessarju, speċjalment fl- aħħar fażi tal- marda tal- Parkinson, għandha tingħata l- iktar doża baxxa effettiva ta ’ kull trattament.
Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e. g., other antipsychotics, tricyclics.
Minħabba l- potenzjal li għandha li tinduċi l- ipotensjoni ortostatika (ara sezzjoni 4. 4) jista ’ jiġi osservat effett kumulattiv meta INVEGA jiġi amministrat ma ’ aġenti terapewtiċi oħrajn li għandhom dan il - potenzjal e. ż antipsikotiċi oħrajn, triċikliċi.
Caution is advised if paliperidone is combined with other medicines know to lower the seizure threshold (i. e., phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Għandha tintuża l- kawtela jekk paliperidone jittieħed ma ’ mediċini oħrajn li huma magħrufin li jkabbru l- possibiltà ta ’ attakk ta ’ aċċessjoni (bħal, e. ż., phenothiazines jew butyrophenones, triċikliċi jew SSRIs, tramadol, mefloquine eċċ.)
Potential for other medicines to affect INVEGA In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Il- potenzjal li mediċini oħrajn jaffettwaw INVEGA Studji in vitro jindikaw li CYP2D6 u CYP3A4 jistgħu ikun involuti b’ mod minimu fil- metaboliżmu ta ’ paliperidone, imma ma hemm l- ebda indikazzjoni in vitro jew in vivo li dawn l- isożimi għandhom sehem sinjifikanti fil- metaboliżmu ta ’ paliperidone.
Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
L- amministrazzjoni konkomitanti ta ’ INVEGA ma ’ paroxetine, inibitur qawwi ta ’ CYP2D6, ma wera ebda effett klinikament sinifikanti fuq il - farmakokinetika ta ’ paliperidone.
In vitro studies have shown that paliperidone is a P-glycoprotein (P-gp) substrate.
Studji in vitro wrew li paliperidone huwa sustrat ta ’ P- glycoprotein (P- gp).
Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
5 Meta INVEGA ġie ko- amministrat darba kuljum flimkien ma ’ 200 mg ta ’ carbamazepine darbtejn kuljum, dan wassal għal tnaqqis ta ’ madwar 37% fil- medja ta ’ stat fiss ta ’ Cmax u l- AUC ta ’ paliperidone.
This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Dan it- tnaqqis huwa kkawżat fil- parti l- kbira, minn żieda ta ’ 35% tat- tneħħija renali ta ’ paliperidone aktarx minħabba l- induzzjoni ta ’ P- gp renali b’ carbamazepine.
A minor decrease in the amount of active substance excreted unchanged in the urine suggests that there was little effect on the CYP metabolism or bioavailability of paliperidone during carbamazepine co-administration.
Tnaqqis żgħir fl- ammont tas- sustanza attiva li toħroġ ma ’ l- urina mhux mibdula tissuġġerixxi li ftit kien hemm effett fuq il - metaboliżmu ta ’ CYP jew il- bijodisponibilità ta ’ paliperidone waqt il- ko- amministrazzjoni b’ carbamazepine.
Larger decreases in plasma concentrations of paliperidone could occur with higher doses of carbamazepine.
Jista ’ jkun hemm tnaqqis ikbar fil- konċentrazzjonijiet ta ’ paliperidone fil- plażma b’ dożi ikbar ta ’ carbamazepine.
On initiation of carbamazepine, the dose of INVEGA should 5 be re-evaluated and increased if necessary.
Kif jibda jittieħed carbamazepine, id- doża ta ’ INVEGA għandha tiġi evalwata mill- ġdid u jekk hemm bżonn għandha tiżdied.
Conversely, on discontinuation of carbamazepine, the dose of INVEGA should be re-evaluated and decreased if necessary.
Bil- maqlub, meta carbamazepine jitwaqqaf, id- doża ta ’ INVEGA għandha tiġi evalwata mill- ġdid u jekk hemm bżonn għandha titnaqqas.
It takes 2-3 weeks for full induction to be achieved and upon discontinuation of the inducer the effect wears off over a similar time period.
L - induzzjoni sħiħa sseħħ fi 2- 3 ġimgħat, u wara li l- induċitur jitwaqqaf l- effett jispiċċa wara perjodu ta ’ żmien simili.