qanastek/EMEA-V3 huggingface dataset:
Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Polyethylene oxide 200K Sodium chloride Povidone (K29- 32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Ferric oxide (red) (E172) Carnauba wax
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (isfar) (E172) Ferric oxide (aħmar) (E172) Carnauba wax
• Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
• Oriented polyamide (OPA) - aluminium- polyvinyl chloride (PVC) / aluminju li tinbotta b’ subgħajk.
EU/ 1/ 07/ 395/ 6-10 EU/ 1/ 07/ 395/ 26-30 EU/ 1/ 07/ 395/ 45-48 EU/ 1/ 07/ 395/ 59-60 EU/ 1/ 07/ 395/ 68-70
EU/ 1/ 07/ 395/ 6- 10 EU/ 1/ 07/ 395/ 26- 30 EU/ 1/ 07/ 395/ 45- 48 EU/ 1/ 07/ 356/ 59- 60 EU/ 1/ 07/ 395/ 68- 70
INVEGA 9 mg prolonged-release tablets
INVEGA pilloli tad- 9 mg li jerħu l- mediċina bil- mod
Each prolonged-release tablet contains 9 mg of paliperidone.
Kull pillola li terħi l- mediċina bil- mod fiha 9 mg ta ’ paliperidone.
Trilayer capsule-shaped pink tablets printed with “ PAL 9”
Pilloli b’ forma ta ’ kapsula roża bi tliet saffi stampati b ’ “ PAL 9 ”
Adults INVEGA is for oral administration.
Adulti INVEGA tittieħed mill- ħalq.
INVEGA must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
INVEGA għandu jinbela ’ sħiħ ma ’ likwidu, u m’ għandux jiġi magħmud, maqsum jew imfarrak.
The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Id- doża tista ’ tiżdied għal 6mg darba kuljum skond ir- respons u t- tollerabilità klinika.
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 inizzjali rakkomandata ta ’ INVEGA hija 1. 5 mg kuljum, li tista ’ tiżdied għal 3 mg kuljum wara evalwazzjoni klinika mill- ġdid.
42 Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
44 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.
There is no experience in children.
M’ hemmx esperjenza fit - tfal.
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 bi INVEGA ta ’ sitt ġimgħat b’ doża fissa (3, 6, 9, U 12- il mg) u bl- użu ta ’ plaċebo ma ’ grupp ta ’ kontroll, l- ipotensjoni ortostatika ġiet irrapurtata fi 2. 5% tal- pazjenti kkurati bi INVEGA meta mqabbla ma ’ 0. 8% ta ’ suġġetti kkurati bil- plaċebo.
INVEGA should be used with caution in patients with known
INVEGA għandu jintuża b’ kawtela f’ pazjenti li għandhom mard kardjovaskolari (e. ż., insuffiċjenza
43 cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
45 tal- qalb, infart mijokardijaku jew iskemija, anormalitajiet fil- konduzzjoni), mard ċerebrovaskulari, jew kondizzjonijiet li jippredisponu lill- pazjent għall- ipotensjoni (e. ż., id- deidrazzjoni u l- ipovolemija).
44 Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
46 Mediċini b’ effetti ta ’ mblukkar alfa- adrenerġiċi ġew irrapurati li jinduċu l- prijapiżmu.
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 oħra, triċikliċi.
On initiation of carbamazepine, the dose of INVEGA should 45 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.
Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone e. g. metoclopramide.
Prodotti mediċinali li jaffettwaw iż- żmien ta ’ tranżitu gastrointestinali jistgħu jaffettwaw l- assorbiment ta ’ paliperidone, e. ż. metoclopramide.
46 System Organ Class
48 Klassifikazzjoni tas - Sistema ta ’ l- Organi Disturbi fis- sistema immuni
grand mal convulsion, syncope, dyskinesia, dizziness postural,
konvulżjonijiet tal- grand mal, sinkope, diskajneżja, sturdament skond il - pożizzjoni,
amenorrhoea, galactorrhoea, erectile dysfunction, gynaecomastia, breast discharge,, menstruation irregular
amenorrea, galactorea, nuqqas ta ’ erezzjoni normali, ġinekomastija, tnixxija mis- sider, mestrwazzjoni irregulari,
hyperprolactaemia, inappropriate antidiuretic hormone secretion
49 Disturbi fil- metaboliżmu u n- nutrizzjoni
47 Psychiatric disorders
Disturbi psikjatriċi
48 Investigations
50 Investigazzjonijiet
5.1 Pharmacodynamic properties
51 5. 1 Tagħrif farmakodinamiku
Pharmacologic group: other antipsychotics ATC code:
Kodiċi ATC:
Pharmacodynamic Effects
Efetti farmakodinamiċi
The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Il- kejl aħħari primarju ta ’ effiċjenza kien iddefinit bħala t- tnaqqis fl- iSkala totali ta ’ Sindromi Pożittivi u Negattivi (PANSS) kif muri fit- tabelli li ġejja.
50 Note:
Nota:
Distribution Paliperidone is rapidly distributed.
53 Paliperidone jiġi distribwit malajr.
51 Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
Indeboliment epatika Paliperidone mhux metabolizzat b’ mod estensiv fil- fwied.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
It- tneħħija totali ta ’ paliperidone naqset bi 32% f’ suġġetti b’ indeboliment renali ħafif (tneħħija tal- kreatinina [CrCl] = 50 to < 80 ml/ min), b’ 64% f’ indeboliment moderat (CrCl = 30 to < 50 ml/ min), u 71% f’ indeboliment sever (CrCl = < 30 ml/ min).
Race Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
54 Razza Analiżi farmakokinetika tal- popolazzjoni ma uriet l- ebda xiehda ta ’ differenzi marbuta mar- razza fil - karatteristiċi farmakokinetiċi ta ’ paliperidone wara l- amministrazzjoni ta ’ INVEGA.
Smoking Status Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Tipjip Fuq il- bażi ta ’ studji in vitro li użaw enżimi tal- fwied uman, paliperidone mhux sustrat għal CYP1A2; għalhekk, it- tipjip mhux suppost ikollu effett fuq il- karatteristiċi farmakokinetiċi ta ’ paliperidone.
For the 9 mg tablet:
Għall- pillola tad- 9 mg::
52 Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Iron oxide (black) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Polyethylene oxide 200K Sodium chloride Povidone (K29- 32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Iron oxide (iswed) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Colour overcoat:
55 Il- kulur tal- kisja ta ’ barra:
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (red) (E172) Carnauba wax
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (aħmar) (E172) Carnauba wax
53 Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Pakketti ta ’ 14, 28, 30, 49, 56, u 98 pillola li jerħu l- mediċina bil- mod.
6.6 Special precautions for disposal
56 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema < u għal immaniġġar ieħor >
EU/ 1/ 07/ 395/ 011-015 EU/ 1/ 07/ 395/ 031-035 EU/ 1/ 07/ 395/ 049-052 EU/ 1/ 07/ 395/ 061-062 EU/ 1/ 07/ 395/ 071-073
EU/ 1/ 07/ 395/ 11- 15 EU/ 1/ 07/ 395/ 31- 35 EU/ 1/ 07/ 395/ 49- 52 EU/ 1/ 07/ 395/ 61- 62 EU/ 1/ 07/ 395/ 71- 73
NAME OF THE MEDICINAL PRODUCT
57 1 ISEM TAL- PRODOTT MEDIĊINALI
INVEGA 12 mg prolonged-release tablets
INVEGA pilloli tat- 12- il mg li jerħu l- mediċina bil- mod
Each prolonged-release tablet contains 12 mg of paliperidone.
Kull pillola li terħi l- mediċina bil- mod fiha 12- il mg ta ’ paliperidone.
Trilayer capsule-shaped yellow tablets printed with “ PAL 12”
Pilloli b’ forma ta ’ kapsula sofor bi tliet saffi stampati b ’ “ PAL 12 ”
When dose increases are indicated, increments of 3 mg/ day are recommended and generally should occur at intervals of more than 5 days.
Meta jiġu indikati żidiet fid - dożi, huma rrakkomandati żidiet ta ’ 3 mg/ kuljum u ġeneralment dawn għandhom iseħħu b’ intervalli ta ’ iktar minn 5 ijiem.
55 Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
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.
INVEGA should be used with caution in patients with known
59 fi 2. 5% tal- pazjenti kkurati bi INVEGA meta mqabbla ma ’ 0. 8% ta ’ suġġetti kkurati bil- plaċebo.
56 cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
INVEGA għandu jintuża b’ kawtela f’ pazjenti li għandhom mard kardjovaskolari (e. ż., insuffiċjenza tal- qalb, infart mijokardijaku jew iskemija, anormalitajiet fil- konduzzjoni), mard ċerebrovaskulari, jew kondizzjonijiet li jippredisponu lill- pazjent għall- ipotensjoni (e. ż., id- deidrazzjoni u l- ipovolemija).
57 Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
60 Mediċini b’ effetti ta ’ mblukkar alfa- adrenerġiċi ġew irrapurati li jinduċu l- prijapiżmu.
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 oħra, triċikliċi.
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.
61 metaboliżmu ta ’ CYP jew il- bijodisponibiltà ta ’ paliperidone waqt il- ko- amministrazzjoni b’ carbamazepine.
On initiation of carbamazepine, the dose of INVEGA should 58 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.
59 System Organ Class
62 Klassifikazzjoni tas - Sistema ta ’ l- Organi Disturbi fis- sistema immuni
hyperprolactaemia, inappropriate antidiuretic hormone secretion
63 Disturbi fil- metaboliżmu u n- nutrizzjoni
60 Psychiatric disorders
Disturbi psikjatriċi
61 Investigations
64 Investigazzjonijiet
In clinical trials, the proportions of subjects meeting a weight gain criterion of ≥ 7% of body weight were compared, revealing a similar incidence of weight gain for INVEGA 3 mg and 6 mg compared with placebo, and a higher incidence of weight gain for INVEGA 9 mg and 12 mg compared with placebo.
Fi provi kliniċi, tqabblu l- proporzjon ta ’ suġġetti li laħqu l- kriterju ta ’ żieda fil- piż ta ’ ≥ 7% tal- piż tal- ġisem, u dan wera żieda simili fil- piż għal INVEGA tat- 3 mg u tas- 6 mg meta mqabbla mal- plaċebo, u inċidenza ogħla ta ’ żieda fil- piż għal INVEGA tad- 9 mg u tat- 12- il mg mal- plaċebo.
5.1 Pharmacodynamic properties
65 5. 1 Tagħrif farmakodinamiku
Paliperidone also blocks alfa1-adrenergic receptors and, blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Paliperidone jimblokka wkoll riċetturi alfa1- adrenerġiċi u jimblokka, inqas, riċetturi istaminerġiċi H1 u adrenerġiċi alfa2.
The 1-7 version of the PANSS
Intużat il- verżjoni 1- 7 ta ’
63 was used.
66 PANSS.
Distribution Paliperidone is rapidly distributed.
Distribuzzjoni Paliperidone jiġi distribwit malajr.
In Vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
67 Studji in vitro urew li paliperidone huwa sustrat ta ’ P- gp u inibitur dgħajjef ta ’ P- gp f’ konċentrazzjonijiet għolja.
64 Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
Indeboliment epatika Paliperidone mhux metabolizzat b’ mod estensiv fil- fwied.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
It- tneħħija totali ta ’ paliperidone naqset bi 32% f’ suġġetti b’ indeboliment renali ħafif (Tneħħija ta; - kreatinina [CrCl] = 50 to < 80 ml/ min), b’ 64% f’ indeboliment moderat (CrCl = 30 to < 50 ml/ min), u 71% f’ indeboliment sever (CrCl = < 30 ml/ min).
For the 12 mg tablet:
Għall- pillola tat- 12- il mg:
Polyethylene oxide 200K 65 Sodium chloride Povidone (K29-32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Ferric oxide (yellow) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Polyethylene oxide 200K Sodium chloride Povidone (K29- 32) Stearic acid Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (aħmar) (E172) Ferrix Oxide (isfar) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Carnauba wax
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (isfar) (E172) Carnauba wax
• Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
69 • Polyvinyl chloride (PVC) laminat b’ saff ta ’ polychloro- trifluoroethylene (PCTFE) / aluminju li tinbotta b’ subgħajk.
66 Or
Jew
EU/ 1/ 07/ 395/ 16-20 EU/ 1/ 07/ 395/ 36-40 EU/ 1/ 07/ 395/ 53-56 EU/ 1/ 07/ 395/ 63-64 EU/ 1/ 07/ 395/ 74-76
EU/ 1/ 07/ 395/ 16- 20 EU/ 1/ 07/ 395/ 36- 40 EU/ 1/ 07/ 395/ 53- 56 EU/ 1/ 07/ 395/ 63- 64 EU/ 1/ 07/ 395/ 74- 76
67 ANNEX II
70 ANNESS II
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Janssen IT-04010 Borgo San Michele Latina Italy
Janssen IT- 04010 Borgo San Michele Latina L- Italja
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata b ’ riċetta tat- tabib.
Pharmacovigilance system
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni v. 003/ 20071203 ippreżentata f’ Modulu 1. 8. 1 tal - Applikazzjoni tal- Awtorizzazzjoni għat- tqegħid fis- Suq, qegħda fis- seħħ u tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
The MAH must ensure that the system of pharmacovigilance, as described in version v.003/ 20071203 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.
Pjan ta ’ l- immaniggjar tar- riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jintrabat li jagħmel l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali kif ddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni EDMA- PSDB- 5361639: 3. 0 tas- 7 ta ’ Diċembru 2007 fil- Pjan għall - Immaniġġar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2 tal- Applikazzjoni għall - Awtorizzazzjoni għat- tqegħid fis- Suq u kull aġġornamenti sussegwenti tal- RMP miftiehem mas- CHMP.
Risk Management plan
Barra dan, pjan ta ’ l- immaniġġar tar- riskju aġġornat għandu jiġi sottomess
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version EDMS-PSDB-5361639:
Meta informazzjoni ġdida tinkiseb illi jkollha impatt fuq l -
3.0 dated 7 December 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.
ispeċifikazzjonijiet tas- sigurta ’ kurrenti, fuq il- pjan ta ’ farmakoviġilanza few fl- attivitajiet ta ’ minimizzazzjoni tar- riskji
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Fi żmien 60 ġurnata minn meta tintlaħaq ġrajja importanti (ta ’
69 ANNEX III
72 ANNESS III
CARTON FOR PVC-PCTFE/ ALUMINIUM BLISTER (for white and clear blister)
KARTUNA GĦALL - FOLJA PVC- PCTFE/ ALUMINJU (għall- folji bojod u ċari)
INVEGA 1.5 mg prolonged-release tablets paliperidone
INVEGA pilloli ta ’ 1. 5 mg li jerħu l- mediċina bil- mod paliperidone
Each prolonged-release tablet contains 1.5 mg paliperidone
Kull pillola li terħi l- mediċina bil- mod fiha 1. 5 mg paliperidone
14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
14 pillola li jerħu l- mediċina bil- mod 28 pillola li jerħu l- mediċina bil- mod 30 pillola li jerħu l- mediċina bil- mod 49 pillola li jerħu l- mediċina bil- mod 56 pillola li jerħu l- mediċina bil- mod 98 pillola li jerħu l- mediċina bil- mod
Oral use Swallow whole, do not chew, divide or crush Read the package leaflet before use.
Għall- użu orali Ibla ’ sħiħa, tomgħodx, taqsamx u tfarrakx Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Do not store above 30oC Store in the original package in order to protect from moisture.
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340 Beerse, Il- Belġju
INVEGA 1.5 mg
INVEGA 1. 5 mg
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
7 & 10 TABLET PVC-PTFE/ ALU BLISTER (for white and clear blister)
FOLJA TAL- PVC- PTFE/ ALU B’ 7 & 10 PILLOLI (għall- folji bojod u ċari)
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR OPA-ALUMINIUM-PVC/ ALUMINIUM BLISTER
KARTUNA GĦALL - FOLJA OPA- ALUMINJU- PVC / ALUMINJU
14 prolonged-release tablets 28 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
14 pillola li jerħu l- mediċina bil- mod 28 pillola li jerħu l- mediċina bil- mod 49 pillola li jerħu l- mediċina bil- mod 56 pillola li jerħu l- mediċina bil- mod 98 pillola li jerħu l- mediċina bil- mod
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
7 TABLET OPA-ALU-PVC/ ALU BLISTER
FOLJA TA ’ L- OPA- ALU- PVC/ ALU B’ 7 PILLOLI
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BOTTLE CARTON
KARTUNA TAL- FLIXKUN
30 prolonged-release tablets 350 prolonged-release tablets
30 pillola li jerħu l- mediċina bil- mod 350 pillola li jerħu l- mediċina bil- mod
Do not store above 30oC Keep the bottle tightly closed in order to protect from moisture
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM
79 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
PHARMACEUTICAL FORM AND CONTENT
GĦAMLA FARMAĊEWTIKA U KONTENUT
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INVEGA 3 mg prolonged-release tablets paliperidone
INVEGA pilloli ta ’ 3 mg li jerħu l- mediċina bil- mod paliperidone
Each prolonged-release tablet contains 3 mg paliperidone
Kull pillola li terħi l- mediċina bil- mod fiha 3 mg paliperidone
82 9.
85 9.
Do not store above 30oC Store in the original package in order to protect from moisture.
Taħżinx f’ temperatura ogħla minn 30oC Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdità.
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 065 - CLEAR 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 001 - CLEAR 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 002 - CLEAR 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 003 - CLEAR 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 004 - CLEAR 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 005 - CLEAR
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 065 - ĊARI 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 001 - ĊARI 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 002 - ĊARI 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 003 - ĊARI 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 004 - ĊARI 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 005 - ĊARI
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 066 - WHITE 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 021 - WHITE 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 022 - WHITE 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 023 - WHITE 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 024 - WHITE 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 025 - WHITE
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 066 - BOJOD 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 021 - BOJOD 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 022 - BOJOD 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 023 - BOJOD 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 024 - BOJOD 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 025 - BOJOD
83 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 067 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 041 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 042 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 043 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 044
14 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 067 28 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 041 49 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 042 56 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 043 98 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 044
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
90 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Do not store above 30oC Keep the bottle tightly closed in order to protect from moisture 88 10.
Taħżinx f’ temperatura ogħla minn 30oC Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdità.
30 prolonged-release tablets - EU/ 1/ 07/ 395/ 057 350 prolonged-release tablets - EU/ 1/ 07/ 395/ 058
30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 057 350 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 058
89 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Do not store above 30oC Keep the bottle tightly closed in order to protect from moisture
Taħżinx f’ temperatura ogħla minn 30oC Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdità.
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR PVC-PCTFE/ ALUMINIUM BLISTER (for white and clear blister)
KARTUNA GĦALL- FOLJA TAL- PVC- PCTFE/ ALUMINJU (għall- folji bojod u ċari)
INVEGA 6 mg prolonged-release tablets paliperidone
INVEGA pilloli ta ’ 6 mg li jerħu l- mediċina bil- mod paliperidone
Each prolonged-release tablet contains 6 mg paliperidone
Kull pillola li terħi l- mediċina bil- mod fiha 6 mg paliperidone
14 prolonged release tablets 28 prolonged-release tablets 30 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
14 pillola li jerħu l- mediċina bil- mod 28 pillola li jerħu l- mediċina bil- mod 30 pillola li jerħu l- mediċina bil- mod 49 pillola li jerħu l- mediċina bil- mod 56 pillola li jerħu l- mediċina bil- mod 98 pillola li jerħu l- mediċina bil- mod
Read the package leaflet before use.
Għall- użu orali Ibla ’ sħiħa, tomgħodx, taqsamx u tfarrakx Aqra l- fuljett ta ’ tagħrif qabel l- użu.
92 9.
95 9.
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 068 - CLEAR 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 006 - CLEAR 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 007 - CLEAR 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 008 - CLEAR 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 009 - CLEAR 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 010 - CLEAR
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 068 - ĊARI 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 006 - ĊARI 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 007 - ĊARI 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 008 - ĊARI 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 009 - ĊARI 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 010 - ĊARI
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 069 - WHITE 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 026 - WHITE 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 027 - WHITE 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 028 - WHITE 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 029 - WHITE 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 030 - WHITE
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 069 - BOJOD 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 026 - BOJOD 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 027 - BOJOD 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 028 - BOJOD 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 029 - BOJOD 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 030 - BOJOD
93 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
96 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
7 & 10 TABLET PVC-PCTFE/ ALU BLISTER (for white and clear blister)
FOLJA TAL- PVC- PCTFE/ ALU B’ 7 & 10 PILLOLI (għall- folji bojod u ċari)
EXP MM/ YYYY
JIS {XX/ SSSS}
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
95 9.
98 9.
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 070 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 045 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 046 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 047 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 048
14 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 070 28 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 045 49 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 046 56 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 047 98 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 048
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
7 TABLET OPA-ALU-PVC/ ALU BLISTER
FOLJA TAL - OPA- ALU- PVC / ALU B’ 7 PILLOLI
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Do not store above 30oC Keep the bottle tightly closed in order to protect from moisture
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN [For storage conditions statements see Appendix III] Taħżinx f’ temperatura ogħla minn 30oC Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdità.
MARKETING AUTHORISATION NUMBER(S) 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 059 350 prolonged-release tablets - EU/ 1/ 07/ 395/ 060
30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 059 350 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 060
99 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
30 prolonged-release tablets - EU/ 1/ 07/ 395/ 059 350 prolonged-release tablets - EU/ 1/ 07/ 395/ 060
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 059 350 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 060
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKATTJAR TA ’ BARRA
INVEGA 9 mg prolonged-release tablets paliperidone
INVEGA pilloli ta ’ 9 mg li jerħu l- mediċina bil- mod paliperidone
Each prolonged-release tablet contains 9 mg paliperidone
Kull pillola li terħi l- mediċina bil- mod fiha 9 mg paliperidone
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 071 - CLEAR 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 011 - CLEAR 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 012 - CLEAR 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 013 - CLEAR 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 014 - CLEAR 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 015 - CLEAR
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 071 - ĊARI 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 011 - ĊARI 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 012 - ĊARI 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 013 - ĊARI 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 014 - ĊARI 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 015 - ĊARI
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 072 - WHITE 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 031 - WHITE 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 032 - WHITE 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 033 - WHITE 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 034 - WHITE 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 035 - WHITE
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 072 - BOJOD 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 031 - BOJOD 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 032 - BOJOD 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 033 - BOJOD 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 034 - BOJOD 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 035 - BOJOD
103 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 073 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 049 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 050 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 051 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 052
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 14 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 073 28 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 049 49 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 050 56 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 051 98 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 052
106 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
INVEGA 9 mg prolonged-release tablets
INVEGA pilloli ta ’ 9 mg li jerħu l- mediċina bil- mod paliperidone
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
30 prolonged-release tablets - EU/ 1/ 07/ 395/ 061 350 prolonged-release tablets - EU/ 1/ 07/ 395/ 062
30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 061 350 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 062
109 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMIS MAL- PRODOTT
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKATTJAR TA ’ BARRA
INVEGA 12 mg prolonged-release tablets paliperidone
INVEGA pilloli ta ’ 12- il mg li jerħu l- mediċina bil- mod paliperidone
Each prolonged-release tablet contains 12 mg paliperidone
Kull pillola li terħi l- mediċina bil- mod fiha 12- il mg paliperidone
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 074 - CLEAR 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 016 - CLEAR 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 017 - CLEAR 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 018 - CLEAR 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 019 - CLEAR 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 020 - CLEAR
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 074 - ĊARI 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 016 - ĊARI 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 017 - ĊARI 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 018 - ĊARI 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 019 - ĊARI 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 020 - ĊARI
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 075 - WHITE 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 036 - WHITE 30 prolonged-release tablets - EU/ 1/ 07/ 395/ 037 - WHITE 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 038 - WHITE 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 039 - WHITE 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 040 - WHITE
14 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 075 - BOJOD 28 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 036 - BOJOD 30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 037 - BOJOD 49 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 038 - BOJOD 56 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 039 - BOJOD 98 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 040 - BOJOD
INVEGA 12 mg
INVEGA 12- il mg
113 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
116 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
114 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
14 prolonged release tablets 28 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
14 pillola li jerħu l- mediċina bil- mod 28 pillola li jerħu l- mediċina bil- mod 49 pillola li jerħu l- mediċina bil- mod 56 pillola li jerħu l- mediċina bil- mod 98 pillola li jerħu l- mediċina bil- mod
115 9.
118 9.
14 prolonged-release tablets - EU/ 1/ 07/ 395/ 076 28 prolonged-release tablets - EU/ 1/ 07/ 395/ 053 49 prolonged-release tablets - EU/ 1/ 07/ 395/ 054 56 prolonged-release tablets - EU/ 1/ 07/ 395/ 055 98 prolonged-release tablets - EU/ 1/ 07/ 395/ 056
14 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 076 28 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 053 49 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 054 56 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 055 98 pillola li jerħu l- mediċina bil- mod EU/ 1/ 07/ 395/ 056
116 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
30 prolonged-release tablets - EU/ 1/ 07/ 395/ 063 350 prolonged-release tablets - EU/ 1/ 07/ 395/ 064
30 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 063 350 pillola li jerħu l- mediċina bil- mod - EU/ 1/ 07/ 395/ 064
119 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMIS MAL- PRODOTT
122 PACKAGE LEAFLET:
125 FULJETT TA ’ TAGĦRIF:
INVEGA 1.5 mg prolonged-release tablets INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets
INVEGA Pilloli li jerħu l- mediċina bil- mod ta1- 1. 5 mg INVEGA Pilloli li jerħu l- mediċina bil- mod tat- 3 mg INVEGA Pilloli li jerħu l- mediċina bil- mod tas- 6 mg INVEGA Pilloli li jerħu l- mediċina bil- mod tad- 9 mg INVEGA Pilloli li jerħu l- mediċina bil- mod tat- 12 mg Paliperidone
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What INVEGA is and what it is used for 2.
X’ inhu INVEGA u għalxiex jintuża 2.
Before you take INVEGA 3.
Qabel ma tieħu INVEGA 3.
How to take INVEGA 4.
Kif għandek tieħu INVEGA 4.
How to store INVEGA 6.
Kif taħżen INVEGA 6.
WHAT INVEGA IS AND WHAT IT IS USED FOR
X’ INHU INVEGA U GĦALXIEX JINTUŻA
INVEGA belongs to the class of antipsychotic medicines and is used to treat schizophrenia.
INVEGA jagħmel parti minn klassi ta ’ mediċini antipsikotiċi u huwa użat għall- kura ta ’ l- iskiżofrenja.
Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness.
L- iskiżofrenja huwa disturb b’ sintomi li jinkludu li wieħed jibda tisma ’ l- affarijiet, jara jew iħoss affarijiet li m’ humiex hemm, ikollu konvinzjonijiet żbaljati, jibda jissuspetta mix- xejn, jinqata ’ għalih waħdu, jitkellem b’ mod li ma jinftiehemx, ikollu emozzjonijiet u mġieba ċassi.
People with this disorder may also feel depressed, anxious, guilty, or tense.
Min ikollu dan id - disturb jista ’ jħossu wkoll imdejjaq, anzjuż, ħati jew tens.
BEFORE YOU TAKE INVEGA
QABEL MA TIEĦU INVEGA
Do not take INVEGA
Tieħux INVEGA
- if you are allergic (hypersensitive) to paliperidone, any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal paliperidone, sustanzi oħra ta ’
INVEGA, or risperidone.
INVEGA, jew risperidone.
Take special care with INVEGA -INVEGA has not been studied in elderly patients with dementia.
- INVEGA ma ġiex studjat f’ pazjenti anzjani b’ dimenzja.
However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Madankollu, pazjenti anzjani
(see section 4, possible side effects)
b’ dimenzja li huma kkurati b’ mediċina simili jista ’ jkollhom riskju ogħla ta ’ aċċessjoni jew mewt (ara Sezzjoni 4 effetti sekondarji li jista ’ jkollu).
- if you have Parkinson’ s disease or Dementia.
- Jekk għandek il- marda ta ’ Parkinson jew Dimenzja.
- if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle
- Jekk qatt kellek djanjosi b’ kondizzjoni li s- sintomi tagħha jinkludu temperatura għolja u ebusija
stiffness (also known as Neuroleptic Malignant Syndrome).
tal- muskoli (magħrufa wkoll bħala s- Sindromu Newrolettiku Malinn).
- if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).
- Jekk qatt esperjenzajt muvimenti anormali ta ’ l- ilsien jew il- wiċċ (Diskajneżja Tardiva).
You should be aware that both of these conditions may be caused by this type of medicine.
Għandek tkun taf li dawn iż- żewġ kondizzjonijiet jistgħu jkunu kkawżati minn din it- tip ta ’ mediċina.
- if you are diabetic or prone to diabetes.
- Jekk għandek id- dijabete jew għandek it- tendenza li jkollok id- dijabete.
- if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
- Jekk għandek mard tal- qalb jew kura għall- mard tal- qalb li tbaxxilek il- pressjoni tad- demm.
- if you have epilepsy.
- Jekk tbati minn epilessija.
- if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass
- Jekk għandek mard li tbati biex tibla, ta ’ l- istonku jew ta ’ l- intestini li jnaqqaslek il- ħila li tibla
foods by normal bowel movements.
jew tipporga b’ mod normali meta tiekol.
- if you have diseases associated with diarrhoea
- Jekk għandek mard assoċjat mad- dijarea.
- if you have a loss of kidney function.
- Jekk il- kliewi ma jaħdmux sew.
- if you have a loss of liver function.
- Jekk il- fwied ma jaħdimx sew.
- if you have prolonged and/ or painful erection.
- Jekk għandek erezzjoni li titwal u/ jew li tweġġgħak.
- if you have difficulty controlling core body temperature or overheating.
- Jekk għandek diffikultà tikkontrolla t- temperatura tal- ġisem jew tisħon wisq.
If you have any of these conditions, please talk to your doctor as he/ she may want to adjust your dose or monitor you for a while.
Jekk għandek xi waħda minn dawn il- kondizzjonijiet, jekk jogħġbok kellem lit- tabib billi jista ’ jkun li jkun irid jirranġa d- doża tiegħek jew li jżommok għal ftit taħt osservazzjoni.
Since INVEGA works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.
Billi INVEGA jaħdem primarjament fil- moħħ, jista ’ jkun hemm interferenza minn mediċini oħrajn (jew alkoħol) li jaħdmu fuq il- moħħ minħabba l- effett kumulattiv fuq il- funzjoni tal- moħħ..
Since INVEGA can lower blood pressure, care should be taken when INVEGA is taken with other medicines that lower blood pressure.
Billi INVEGA jista ’ jbaxxi l- pressjoni tad- demm, għandha ssir attenzjoni meta jittieħed INVEGA ma ’ mediċini oħrajn li jbaxxu l- pressjoni tad- demm.
INVEGA can reduce the effect of medicines against Parkinson’ s disease and restless legs syndrome (e. g., levodopa).
INVEGA jista ’ jnaqqas l- effett tal- mediċini kontra l- marda tal- Parkinson u s- sindromu ta ’ riġlejn bla kwiet (e. ż. levodopa).
Taking INVEGA with food and drink Alcohol should be avoided when taking INVEGA.
Meta tieħu INVEGA ma ’ l- ikel u max- xorb M’ għandux jittieħed l- alkoħol meta jittieħed INVEGA.
INVEGA should be taken every morning with breakfast or without breakfast, but in the same way every day.
INVEGA għandu jittieħed kull filgħodu waqt il- kolazzjon jew mingħajr kolazzjon, imma bl- istess mod kuljum.
Do not alternate between taking INVEGA with breakfast one day and without having breakfast the next day.
Tbiddilx bejn tieħu INVEGA waqt il- kolazzjon f’ jum wieħed u mingħajr kolazzjon il - jum ta ’ wara.
Pregnancy and breast-feeding Tell your doctor if you are pregnant or think you are pregnant.
Tqala u treddigħ Informa lit- tabib tiegħek jekk int tqila jew taħseb li tista ’ tkun tqila.
You should not take INVEGA during pregnancy unless this has been discussed with your doctor.
M’ għandekx tieħu INVEGA waqt it- tqala jekk ma tkunx tkellimt mat- tabib tiegħek.
You should not breastfeed when taking INVEGA.
M’ għandekx tredda ’ meta qed tieħu INVEGA.
This should be considered in cases where full alertness is required, e. g., when driving a car or handling machinery.
Sewqan u tħaddim ta ’ magni Meta tieħu INVEGA jista ’ jkun li jkollok problemi ta ’ sturdament u vista (ara sezzjoni 4, effetti sekondarji li jista ’ jkollu) Dan għandu jiġi kkonsidrat fil- każijiet fejn hemm bżonn attenzjoni sħiħa, e. ż., is- sewqan ta ’ karozza jew it- tħaddim ta ’ magni.
Important information about some of the ingredients of INVEGA The 3 mg tablet of INVEGA contains lactose, a type of sugar.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ INVEGA Il- pillola tat- 3 mg ta ’ INVEGA fiha lactose, li hi tip ta ’ zokkor.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
You should not take the 3 mg tablet of INVEGA because it contains lactose.
M’ għandekx tieħu pillola ta ’ 3 mg ta ’ INVEGA billi għandha lactose.
However, the 1.5, 6 mg, 9 mg, or 12 mg INVEGA tablets can be taken as these do not contain lactose monohydrate.
Madanakollu tista ’ tieħu l- pilloli tal- 1. 5 mg, 6 mg, 9 mg jew it- 12- il mg ta ’ INVEGA billi dawn ma fihomx lactose monohydrate.
HOW TO TAKE INVEGA
KIF GĦANDEK TIEĦU INVEGA
Always take INVEGA exactly as your doctor has told you.
Dejjem għandek tieħu INVEGA skond il- parir eżatt tat- tabib.
The usual dose is 6 mg taken in the morning, but the dose may be increased or decreased by your doctor.
Id- doża li ssoltu tingħata hija 6 mg li tittieħed filgħodu, imma d- doża tista ’ tiżdied jew titnaqqas mit- tabib tiegħek.
INVEGA must be taken by mouth, swallowed whole with water or other liquids.
INVEGA irid jittieħed bilfors mill- ħalq, u tinbela ’ sħiħa bl- ilma jew xi likwidu ieħor.
It must not be chewed, broken, or crushed.
M’ għandekx tomgħodha, tiksirha jew tfarrakha.
The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is passed out of the body as waste.
L- ingredjent attiv, paliperidone, idub ladarba jinbela ’ u l- qoxra tal- pillola tgħaddi mill- ġisem ma ’ l - ippurgar.
If you take more INVEGA than you should Contact your doctor right away.
127 Jekk tieħu INVEGA aktar milli suppost Ikkuntattja mal- ewwel lit- tabib tiegħek.
If you forget to take INVEGA
Tista ’ tħossok imħeddel, għajjien, ikollok ċaqlieq tal- ġisem mhux normali, problemi biex tqum u timxi, sturdament minħabba pressjoni baxxa tad- demm, u taħbit mhux normali tal- qalb.
124 Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu INVEGA M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If you miss one dose, take your next dose on the day following the missed dose.
Jekk tinsa tieħu doża waħda, ħu d- doża li jmiss fil- jum ta ’ wara d- doża l- maqbuża.
If you miss two or more doses, contact your doctor.
Jekk titlef żewġ dożi jew iktar, ikkuntattja lit - tabib tiegħek.
If you stop INVEGA You will lose the effects of the medicine.
Jekk tieqaf tieħu INVEGA titlef l- effetti tal- mediċina.
You should not stop this medicine told to do so by your doctor as your symptoms may return.
M’ għandekx twaqqaf din il- mediċina sakemm jordnalek it- tabib billi s - sintomi tiegħek jistgħu jerġgħu jiġu.
Like all medicines, INVEGA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, INVEGA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Uncommonly, you may experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘ anaphylactic reaction’).
Għalkemm mhux komuni, jista ’ jkollok reazzjoni allerġika severa karatterizzata b’ deni, ħalq, wiċċ, xoffa jew lsien minfuħ, qtugħ ta ’ nifs, ħakk, raxx tal- ġilda u xi kultant tnaqqis fil- pressjoni tad- demm (li tista ’ titqies ‘ reazzjoni anafilattika).
If this occurs, seek medical attention immediately.
Jekk dan iseħħ, għandek tfittex attenzjoni medika mal - ewwel.