qanastek/EMEA-V3 huggingface dataset:
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
Iftaħ is- siringa mimlja għal- lest billi tkisser is- siġill li hi magħluqa bih u neħħi t- tapp abjad flimkien mat- tapp bit- tarf tal- gomma li hemm fih.
Press the syringe tip into the vial access device and twist in a clockwise motion to ensure that the syringe is securely attached to the white luer cap of the vial access device.
Agħfas il- ponta tas- siringa ġo l- apparat ta ’ aċċess għall- kunjett u dawwar b’ ċaqliqa lejn il- lemin biex tiżgura li s- siringa weħlet b’ mod sod mat- tapp abjad luer ta ’ l- apparat ta ’ aċċess għall - kunjett.
Hold the skirt of the vial access device during attachment to prevent spinning.
Żomm l- għata ta ’ l- apparat ta ’ aċċess għall- kunjett waqt li tkun qed twaħħlu biex tevita li jdur fuqu nnifsu.
Holding the plunger rod down with the thumb, shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Filwaqt li żomm il- planġer l- isfel b’ sebgħek il- kbir, ħawwad il- kunjett bis- saħħa għal mill - anqas 10 sekondi sakemm tikseb suspensjoni omoġena.
Mixing is complete when the suspension appears uniform, thick, and milky in color and all the powder is fully dispersed.
It- taħlit ikun komplut meta s- suspensjoni tidher uniformi, magħquda u kulur il- ħalib u t- trab kollu jkun xtered kompletament fit- taħlita.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
TAĦŻINX IL- KUNJETT WARA R- RIKOSTITUZZJONI GĦAX INKELLA S- SUSPENSJONI TISTA ’ TISSEPARA U T- TRAB JINŻEL FIL- QIEGĦ.
For identification purposes, tear section of the vial label at the perforation and apply detached section to the syringe.
Għal skopijiet ta’ identifikazzjoni, qatta parti mit- tikketta tal- kunjett minn fejn hemm it- toqob żgħar u waħħal il- parti mqatta ’ mas- siringa.
Prepare the patient for injection.
Ipprepara l- pazjent għall- injezzjoni.
RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
IS- SUSPENSJONI MILL- ĠDID TA ’ RISPERDAL CONSTA TINĦTIEĠ QABEL MA ’ DAN JINGĦATA MINĦABBA LI T- TRAB JINŻEL FIL- Q EGĦ MAL- ĦIN LADARBA L- PRODOTT JIĠI RIKOSTITWIT.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
FERREX IL- MIKROSFERI MILL- ĠDID FIS- SUSPENSJONI ĠOS- SIRINGA BILLI TĦAWWAD BIS- SAĦĦA.
Pull sheath away from the needle -do not twist sheath as needle may be loosened from Needle- Pro device.
Iġbed l- għant minn madwar il- labra – iddawwarx l- għant minħabba li l- labra tista ’ tinħall minn ma ’ l - apparat Needle- Pro.
DO NOT ADMINISTER INTRAVENOUSLY.
TAGĦTIHX ĠOL- VINA.
WARNING:
67 TWISSIJA:
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it.
Biex tevita li titniggeż bil- labra kkontaminata, tippruvax: • Taqla intenzjonalment l- apparat Needle- Pro • Tipprova tiddritta l- labra jew twaħħal l- apparat Needle- Pro jekk il- labra hija mgħawwġa jew mhix tajba • Taqbad l- apparat ta ’ protezzjoni tal- labra b’ mod goff li jista ’ jwassal biex il- labra toħroġ minnu
After procedure is completed, press the needle into the needle protection device.
Wara l- proċedura titlesta, agħfas il- labra ġo l- apparat ta ’ protezzjoni tal- labra.
As the needle protection device is pressed, the needle is firmly engaged into it.
Kif l - apparat ta ’ protezzjoni tal- labra jingħafas, il- labra tidħol b’ mod sod fih.
Instructions for Three Needle System RISPERDAL CONSTA come in a form of a powder that must be mixed with only the solution in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Struzzjonijiet għas- Sistema ta ’ Tliet Labriet Mikrosferi RISPERDAL CONSTA li jintreħew bil- mod li qegħdin fil- kunjett għandhom jiġu rikostitwiti biss fid- dilwent ta ’ ġos- siringa pprovduta fil- pakkett tad- doża, u għandu jingħata biss bil - labra ta ’ sigurtà Needle- Pro pprovduta fil- pakkett tad- doża.
Contents of the dose pack: • One vial containing RISPERDAL CONSTA extended release microspheres • Two Hypoint 20G 2” TW needles for reconstitution • One prefilled syringe containing 2 ml solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle with needle protection device).
Kontenut tal- pakkett tad- doża: • Kunjett wieħed li fih mikrosferi ta ’ RISPERDAL CONSTA li jintreħew bil- mod • Żewġ labriet Hypoint 20G 2 "TW għar- rikostituzzjoni • Siringa waħda mimlija għal- lest li fiha 2 ml ta ’ solvent għal RISPERDAL CONSTA • Labra Needle- Pro waħda għall- injezzjoni ġol- muskolu (labra ta ’ sigurtà 20G 2" TW b’ apparat ta ’ protezzjoni għal- labra)
Flip off the plastic colored cap from the vial
Aqla l- għatu tal- plastik ikkulurit mill- kunjett.
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside
Iftaħ is- siringa mimlja għal- lest billi tkisser is- siġill li hi magħluqa bih u neħħi it- tapp abjad flimkien mat- tapp bit- tarf tal- gomma li hemm fih.
3 Open the cover of one reconstitution needle.
Iftaħ it- tgeżwira ta ’ labra waħda tar- rikostituzzjoni.
65 Keeping the syringe and needle aligned, attach the needle with an easy clockwise twisting motion to the luer connection of the syringe.
Filwaqt li żżomm is- siringa u l- labra bi dritt xulxin, waħħal il- labra, billi ddawwar lejn il- lemin b’ ċaqliqa ħafifa, mal- konnessjoni luer tas- siringa.
Pull sheath away from the needle - do not twist.
Iġbed l- għant minn madwar il- labra – iddawwarx.
Inject the entire contents (solvent) of the syringe into the vial
Injetta l- kontenut kollu (solvent) tas- siringa fil- kunjett.
Unscrew the needle from the syringe and discard the needle appropriately.
Ħoll il- labra minn mas- siringa u armi il- labra kif xieraq.
Mixing is complete when the suspension appears uniform, thick, and milky in color, and all the powder is fully dispersed.
It- taħlit ikun komplut meta s- suspensjoni tidher uniformi, magħquda u kulur il- ħalib u t- trab kollu jkun xtered kompletament fit- taħlita.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE
69 TAĦŻINX IL- KUNJETT WARA R- RIKOSTITUZZJONI GĦAX INKELLA IS - SUSPENSJONI TISTA ’ TISSEPARA U T- TRAB JINŻEL FIL- QIEGĦ.
Take the syringe and pull sheath away from the reconstitution needle - donot twist.
Ħu s- siringa u iġbed l- għant minn madwar il- labra ta’ rikostituzzjoni – iddawwarx.
Insert the reconstitution needle into the upright vial.
Daħħal il- labra ta’ rikostituzzjoni fil- kunjett wieqaf.
Slowly withdraw the suspension from the vial in an upright, but slightly angled position as indicated in the picture to ensure that the entire contents are drawn up into the syringe
Bil- mod iġbed is- suspensjoni mill- kunjett li jinżamm wieqaf iżda ftit angolat kif indikat fl - istampa biex tiżgura li l- kontenut kollu inġibed għal ġos- siringa
Discard the vial appropriately.
Armi l- kunjett kif xieraq.
Prepare the patient for injection
Ipprepara l- pazjent għall- injezzjoni.
RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
IS- SUSPENSJONI MILL- ĠDID TA ’ RISPERDAL CONSTA TINĦTIEĠ QABEL MA ’ DAN JINGĦATA MINĦABBA LI T- TRAB JINŻEL FIL- Q EGĦ MAL- ĦIN LADARBA L - PRODOTT JIĠI RIKOSTITWIT.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
FERREX IL- MIKROSFERI MILL- ĠDID FIS - SUSPENSJONI ĠOS- SIRINGA BILLI TĦAWWAD BIS- SAĦĦA.
Pull sheath away from the needle - do not twist sheath as needle may be loosened from Needle- Pro® device.
Iġbed l- għant minn madwar il- labra – iddawwarx l- għant minħabba li l- labra tista ’ tinħall minn ma ’ l - apparat Needle- Pro.
WARNING:
70 TWISSIJA:
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it.
Biex tevita li titniggeż bil- labra kkontaminata, tippruvax: • Taqla intenzjonalment l- apparat Needle- Pro • Tipprova tiddritta l- labra jew twaħħal l- apparat Needle- Pro jekk il- labra hija mgħawwġa jew mhix tajba • Taqbad l- apparat ta ’ protezzjoni tal- labra b’ mod goff li jista ’ jwassal biex il- labra toħroġ minnu.
After procedure is completed, press the needle into the needle protection device.
Wara l- proċedura titlesta, agħfas il- labra ġo l- apparat ta ’ protezzjoni.
Perform a one- handed technique by GENTLY pressing the needle protection device against a flat surface.
Agħmel dan b’ id waħda billi BIL- ĦLEWWA tagħfas l- apparat ta ’ protezzjoni tal- labra ma ’ wiċċ ta’ oġġett ċatt.
Visually confirm
Kif l - apparat ta ’ protezzjoni tal- labra jingħafas, il- labra tidħol b’ mod sod fiha.
67 that the needle is fully engaged into the needle protection device.
Ikkonferma viżwalment li l- labra daħlet sewwa fl- apparat ta ’ protezzjoni tal- labra.
London, 8 October 2008 Doc.
Londra, 8 ta ’ Ottubru 2008 Dok.
EMEA/ CHMP/ 384879/ 2008
EMEA/ CHMP/ 554685/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 30 GĦAL Risperdal Consta u ismijiet assoċjati
International Non-Proprietary Name (INN): risperidone
Denominazzjoni Komuni Internazzjonali (DKI): risperidone
Risperdal Consta and associated names is an anti-psychotic, indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Risperdal Consta u ismijiet assoċjati huwa antipsikotiku, indikat għat- trattament ta ’ manutenzjoni ta ’ skizofrenija f’ pazjenti li fil- preżent huma stabbilizzati b’ antipsikotiċi orali.
It is available as prolonged release powder and solvent for suspension for intramuscular use.
Jiġi bħala trab b’ rilaxx prolungat u bħala solvent għal sospensjoni sabiex jingħata fil- muskoli.
On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal Consta and associated names.
Fl- 24 ta ’ Lulju 2007, il- Kummissjoni Ewropea ppreżentat riferiment lill- EMEA skont l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex jiġu armonizzati s- Sommarji tal- Karatteristiċi tal- Prodott (SPC), it- Tikketta u l- Fuljett ta ’ Tagħrif awtorizzati fuq livell nazzjonali, tal- prodott mediċinali Risperdal Consta u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal Consta and associated names approved across EU Member States, with respect to the indication, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Il- bażi għar- riferiment kien li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Risperdal Consta u ismijiet assoċjati approvati madwar l- Istati Membri tal- UE, fir- rigward tal - indikazzjoni, it- twissijiet speċjali u l- prekawzjonijiet għall- użu u l- interazzjoni ma ’ prodotti mediċinali oħrajn u ma ’ forom ta ’ interazzjoni oħrajn.
This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Dan il- prodott mediċinali jappartjeni għal- lista ta ’ prodotti identifikati fl- 2007 għall- armonizzazzjoni tal - SPC.
The procedure started on 20 September 2007.
Il- proċedura nbdiet fl- 20 ta ’ Settembru 2007.
The Marketing Authorisation Holder provided supplementary information on 28 January 2008 and 28 April 2008.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta informazzjoni supplimentari fit- 28 ta ’ Jannar 2008 u fit- 28 ta ’ April 2008.
During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Matul il- laqgħa tiegħu ta ’ Lulju 2008, is- CHMP, fid- dawl tad- dejta ġenerali ppreżentata u tad- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, it- Tikketta u l - Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal Consta and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ Lulju 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif għal Risperdal Consta u l- ismijiet assoċjati.
A Decision was issued by the European Commission on 7 October 2008.
Inħarġet Deċiżjoni mill- Kummissjoni Ewropea fis- 7 ta ’ Ottubru 2008.
ANNEX I
1 Stat Membru
Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien L- Awstrija
Orodispersible tablet Oral use
Pillola li tinħall fil - ħalq
Film-coated tablet Oral use
Użu Orali
Risperdal 1 mg - Filmtabletten
Risperdal 0, 5 mg - 0, 5 mg Filmtabletten
Film-coated tablet Oral use
Pillola miksija b’ rita Użu Orali
2
2 Stat Membru
Pharmaceutical Route of Form administration
Mnejn jingħata
Film-coated tablet
Pillola miksija b’ rita Użu Orali
Oral use
L- Awstrija
Pfarrgasse 75 A-1232 Wien Austria
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien L- Awstrija
Filmtabletten
Risperdal 3 mg - 3 mg Filmtabletten
Oral use
Soluzzjoni Orali Użu Orali
Orodispersible tablet Oral use
Pillola li tinħall fil - Użu Orali ħalq
Rispolin 4 mg - 4 mg Filmtabletten
4
Film-coated tablet Oral use
Il- Kontenut (Konċentrat)
Rispolin 6 mg - 6 mg Filmtabletten
6 mg - 6 mg
Oral solution Oral use
Soluzzjoni Orali
1 mg/ 1 ml
Użu Orali
Belgium
Il - Belġju
Roderveldlaan 1 B-2600 Berchem Belgium
Roderveldlaan 1 B- 2600 Berchem Il - Belġju
Roderveldlaan 1 B-2600 Berchem, Belgium
Roderveldlaan 1 B- 2600 Berchem, Il - Belġju
1 mg
Soluzzjoni Orali
Oral solution Oral use
Użu Orali
Roderveldlaan 1 B-2600
Roderveldlaan 1 B- 2600 Berchem, Il - Belġju
Member State
Użu Orali
Oral use
Qawwa
Bulgaria
Il - Bulgarija
Smartinska cesta 53 1000 Ljubljana Slovenia
Smartinska cesta 53 1000 Ljubljana Slovenja
Oral solution Oral use
Soluzzjoni Orali Użu Orali
Smartinska cesta 53, 1000 Ljubljana, Slovenia
Smartinska cesta 53, 1000 Ljubljana, Slovenja
Film coated tablet
Pillola miksija b’ rita Użu Orali
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Il - Belġju
Film-coated tablets
Pillola miksija b’ rita Użu Orali
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340,
J Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
J Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Il - Belġju
Czech Republic
Ir - Repubblika Ċeka
Karla Engliš e 3201/ 6 150 00 Praha 5 Czech Republic
Karla Engliše 3201/ 6 150 00 Praha 5 Ir - Repubblika Ċeka
Film-coated tablet
1 mg
oral use
Pillola miksija b’ rita Użu Orali
Karla Engliš e 3201/ 6
Karla Engliše 3201/ 6 150 00 Praha 5, Ir - Repubblika Ċeka
Pharmaceutical Form
Ir - Repubblika Ċeka
Karla Engliš e 3201/ 6 150 00 Praha 5
Karla Engliše 3201/ 6 150 00 Praha 5, Ir - Repubblika Ċeka
Karla Engliš e 3201/ 6 150 00 Praha 5
Karla Engliše 3201/ 6 150 00 Praha 5, Ir - Repubblika
Oral solution
Soluzzjoni Orali Użu Orali
oral use
1 mg / 1 ml
1 mg/ 1 ml
Qawwa
Czech Republic
Mnejn jingħata
Orodispersible tablet oral use
Pillola li tinħall fil - ħalq
Orodispersible tablet
Pillola li tinħall fil - ħalq
Janssen-Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Denmark
Janssen- Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Danimarka
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Danimarka
Film-coated Oral use
Pillola miksija b’ rita Użu Orali
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Danimarka
Film-coated
Pillola miksija b’ rita Użu Orali
Oral lyophilisate
Lajofiliżejt orali Użu Orali
Estonia
L - Estonja
1A LT-09312 Vilnius Lithuania
1A LT- 09312 Vilnius Il - Litwanja
Invented Name Strength
Isem Ivvintat
Finland
Il - Finlandja
Jansen-Cilag Oy Metsänneidonkuja 8 02130 Espoo Finland
Jansen- Cilag Oy Metsänneidonkuja 8 02130 Espoo Il - Finlandja
Strength
Użu Orali
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Franza
Scored tablet Oral use
Użu Orali
France
Cedex 9, Franza
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Franza
Film coatedtablet Oral use
Pillola miksija b’ rita Użu Orali
Laboratoires Janssen Cilag 1 rue Desmoulins
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Franza
TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Pillola mnaqqxa Użu Orali minn fejn tinqasam fin- nofs
Half-Scored tablet
Pillola mnaqqxa Użu Orali minn fejn tinqasam fin- nofs
Orodispersible Tablet
Pillola li tinħall fil - ħalq
Oral use
Użu Orali
Germany
Il - Ġermanja
Janssen-Cilag GmbH 41457 Neuss or Janssen-Cilag GmbH Raiffeisenstr.
Janssen- Cilag GmbH 41457 Neuss or
8 41470 Neuss, Germany
8 41470 Neuss, Il - Ġermanja
Film-coated tablet
Soluzzjoni Orali Użu Orali
Risperdal Lösung 1 mg/ ml
Risperdal Quicklet 1 mg
Oral solution
Pillola li tinħall fil - Użu Orali ħalq
Oral use
Risperidon
1 mg/ 1 ml
2 mg
Risperdal Quicklet 1 mg 1 mg
Risperdal Quicklet 3 mg
Member State
17 Stat Membru
Risperdal Quicklet 2 mg 2 mg
Risperdal Quicklet 4 mg 4 mg
Risperdal Quicklet 3 mg 3 mg
Risperidon- Janssen 6 mg Filmtabletten 6 mg
Orodispersible tablet Oral use
Pillola miksija b’ rita Użu Orali
Risperdal Quicklet 4 mg 4 mg
Risperidon- Janssen 1 mg Loesung 1 mg/ ml
Orodispersible tablet Oral use
Soluzzjoni Orali Użu Orali
Risperidon-Janssen 6 mg Filmtabletten 6 mg
Belivon 0, 5 mg 0. 5 mg Filmtabletten
Risperidon-Janssen 1 mg Loesung 1 mg/ ml
Belivon 1 mg 1 mg Filmtabletten
Oral solution Oral use
Pillola miksija b’ rita Użu Orali
Member State
18 Stat Membru
Belivon 0,5 mg Filmtabletten
Belivon 1mg/ ml Lösung
Film-coated tablet
Soluzzjoni Orali
Belivon 1mg/ ml Lösung
Belivon 3 mg 3 mg Filmtabletten
Oral solution
Pillola miksija b’ rita Użu Orali
Belivon 2 mg Filmtabletten
Belivon 4 mg 4 mg Filmtabletten
Belivon 3 mg Filmtabletten
Belivon 6 mg 6 mg Filmtabletten
17 Member State
19 Stat Membru
Belivon 4 mg Filmtabletten
Rehablit
4 mg
1 mg 1 mg
8 41470 Neuss, Germany
Il - Ġermanja
Belivon 6 mg Filmtabletten
Rehablit
6 mg
2 mg 2 mg
Rehablit 1 mg
Rehablit
Germany
8 41470 Neuss, Il - Ġermanja
2 mg
4 mg 4 mg
Janssen-Cilag GmbH 41457 Neuss
41457 Neuss
Rehablit 4 mg
Filmtabletten 6 mg
18 Member State
20 Stat Membru
8 41470 Neuss, Germany
Janssen- Cilag GmbH 41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
Oral solution
Soluzzjoni Orali
Greece
Il - Greċja
Janssen-Cilag Pharmaceutical S. A. C. I 56 Eirinis Avenue 56 Pefki, 15121 Greece
Janssen- Cilag Pharmaceutical S. A. C. I 56 Eirinis Avenue 56 Pefki, 15121 Il - Greċja
Oral use
Pillola miksija b’ rita Użu Orali
Janssen-Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Greece
Janssen- Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Il - Greċja
Lingual tablet
Pillola għall- ilsien
Hungary
L - Ungerija
2045 Törökbálint Tó park Hungary
2045 Törökbálint Tó park L - Ungerija
Film coated tablet
Pillola miksija b’ rita
2045 Törökbálint Tó park, Hungary
2045 Törökbálint Tó park, L - Ungerija
Iceland
L - islanda
Janssen-Cilag AB Box 7073 192 07 Sollentuna Sverige
Janssen- Cilag AB Box 7073 192 07 Sollentuna L- Isvezja
Oral lyophilisate Oral use
Lajofiliżejt orali
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, L- Isvezja
Film coated tablet Oral use
Pillola miksija b’ rita Użu Orali
Film Coated tablet Oral use
Pillola miksija b’ rita Użu Orali
Ireland
L - Irlanda
Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ir - Renju Unit
Film Coated Tablet
Isem Ivvintat
Janssen-Cilag Ltd Saunderton High Wycombe
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ir - Renju Unit
Orodispersible tablet
Pillola li tinħall fil -
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Saunderton High Wycombe Buckinghamshire HP14 4HJ Ir - Renju Unit
Italy
L - Italja
23 Cologno Monzese 20093, Milano Italy
23 Cologno Monzese 20093, Milano L - Italja
23 Cologno Monzese, 20093, Milano, Italy
23 Cologno Monzese, 20093, Milano, L - Italja
Oral use
Pillola Użu Orali
Orodispersible tablet Oral
Pillola li tinħall fil - Oral ħalq
Orodispersible tablet Oral use
Pillola li tinħall fil -
23 Cologno Monzese
23 Cologno Monzese 20093 Milano L - Italja
Oral use
Il - Latvja
UAB Johnson & Johnson Š eimyniš kių g.1A LT-09312 Vilnius Lithuania
UAB Johnson & Johnson Šeimyniškių g. 1A LT- 09312 Vilnius Il - Litwanja
Tablets
Pilloli Użu Orali
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312 Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Il - Litwanja
UAB Johnson & Johnson, Š eimyniš kių g.1A, Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, Vilnius, Il - Litwanja
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Il - Litwanja
27 Member State
30 Stat Membru
Vilnius, Lithuania
Vilnius, Il - Litwanja
Risperidone
Il - Latvja
1A, LT-09312 Vilnius, Lithuania
1A, LT- 09312 Vilnius, Il - Litwanja
Orodispersible tablets
Pillola li tinħall fil - ħalq
Latvia
Il - Latvja
Lithuania
Il - Litwanja
Orodispersible tablets
Pillola li tinħall fil - Użu Orali ħalq
28 Member State
31 Stat Membru
Luxemburg
Il - Lussemburgu
Roderveldlaan 1 2600 Berchem Belgium
Roderveldlaan 1 2600 Berchem Il - Belġju
Luxemburg
Użu Orali
Luxemburg
Lussemburgu Roderveldlaan 1 2600 Berchem, Il - Belġju Il - Lussemburgu
Roderveldlaan 1 2600 Berchem, Belgium
Roderveldlaan 1 2600 Berchem, Il - Belġju
Orodispersible tablet Oral use
Użu Orali
Risperdal Instasolv 2 mg
Risperdal Instasolv 1 mg
29
Użu Orali
Member State
32 Stat Membru
Luxemburg
33 Stat Membru
Janssen Cilag N. V.
Isem Ivvintat
Roderveldlaan 1 2600 Berchem, Belgium
Għamla Farmaċewtika
Risperidone
Mnejn jingħata
Risperidone Instasolv
Il- Kontenut (Konċentrat)
J-C
Risperidone J- C
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Il - Belġju
Tablets Oral use
Pilloli
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse
Filmcoated talbets
0. 5 mg
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The L- Olanda
6 mg
35
Filmcoated tablets
Id- Detentur ta ’ l -
Oral use
Il- Kontenut
Dr.
Risperidon Dr.
Orodisperable tablet
Pillola li tinħall fil - ħalq
Paul Janssenweg 150 PO Box 90240
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The L- Olanda
Quicklet 4 mg Quicklet
Pillola li tinħall fil - ħalq
Orodisperable tablet
Użu Orali
Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo Norveġja
Janssen-Cilag AS Hoffsveien 1D
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo Norveġja
Strength
Norveġja
0275 Oslo Norway
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo Norveġja
Norway
Qawwa
Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
0275 Oslo Norveġja
Poland
Il - Polonja
Turnhauseveg 30 B-2340 Beerse Belgium
Turnhauseveg 30 B- 2340 Beerse Il - Belġju
Turnhauseveg 30
Turnhauseveg 30 B- 2340 Beerse Il - Belġju
B-2340 Beerse Belgium Poland
Il - Polonja
Portugal
Użu Orali
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734- 503 Barcarena Il - Portugall
Portugal
Il - Portugall
Janssen Farmacêutica Portugal, Lda.
Janssen Farmacêutica Il - Portugall, Lda.
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Il - Portugall
Portugal
Stat Membru
38
42
A - Queluz de Baixo 2734-503 Barcarena Portugal
A - Queluz de Baixo 2734- 503 Barcarena Il - Portugall Il - Portugall
Janssen Farmacêutica Portugal, Risperidona Lda.
Janssen Farmacêutica Il - Portugall, Lda.
Romania
Ir - Rumanija
Risperidone Turnhoutseweg 30 2340 Beerse Belgium
Turnhoutseweg 30 2340 Beerse Il - Belġju
Risperidone Turnhoutseweg 30, 2340 Beerse, Belgium
Turnhoutseweg 30, 2340 Beerse, Il - Belġju
Dispersible tablets
Pillola li tinħall fil - ħalq
Johnson & Johnson s. r. o.
Pillola li tinħall fil - ħalq
Slovak Republic
Is - Slovakkja
Plynárenská 7/ B 824 78 Bratislava Slovak Republic
Plynárenská 7/ B 824 78 Bratislava Is - Slovakkja
Plynárenská 7/ B 824 78 Bratislava
Plynárenská 7/ B 824 78 Bratislava Is - Slovakkja
Š martinska 53 Ljubljana Slovenia
Šmartinska 53 Ljubljana Slovenja
1 mg
45
Orodispersible tablets
Id- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid
Janssen Cilag, SA Paseo de las Doce Estrellas 5- 7 28042 Madrid Spanja
Orodispersable tablet
Pillola li tinħall fil - ħalq
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 7 28042 Madrid, Spanja
Janssen Cilag, SA Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las DoceEstrellas, 5- 7 28042 Madrid, Spanja
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 728042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas, 5 - 728042 Madrid, Spanja
Film coated tablets
Id- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid Spain
Janssen Cilag, SA Paseo de las Doce Estrellas 5- 7 28042 Madrid Spanja
Janssen-Cilag AB Box 7073 192 07 Sollentuna
Janssen- Cilag AB Box 7073 192 07 Sollentuna L- Isvezja
Sverige
L- Isvezja
Oral use
L- Isvezja
Strength
L- Isvezja
United Kingdom
Ir - Renju Unit
Coated Tablet
Isem Ivvintat
United Kingdom
Buckinghamshire HP14 4HJ Ir - Renju Unit Ir - Renju Unit
Saunderton High Wycombe Buckinghamshire HP14 4HJ
Saunderton High Wycombe Buckinghamshire HP14 4HJ Ir - Renju Unit
United
Ir - Renju Unit
Orodispersible
Pillola li tinħall fil - ħalq
46 ANNEX II
50 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTTI, IT- TIKKETTI U L- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
47 SCIENTIFIC CONCLUSIONS
51 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ RISPERDAL U TAL - ISMIJIET ASSOĊJATI (ARA ANNESS I)
Risperdal (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Risperdal (risperidone) huwa derivattiv ta ’ benzisoxazole b’ karatteristiċi kombinati qawwija li jimblokka r- riċetturi ta ’ serotonin 5HT2A u dopamine D2.
Adrenergic α 1 and, to a lesser extent, histamine H1 and adrenergic α 2 receptors are also antagonised by risperidone.
Ir- riċetturi adrenerġiċi α1 u, f’ miżura inqas, ir - riċetturi tal- istamina H1 u adrenerġiċi α2 huma wkoll antagonizzati minn risperidone.
Authorised formulations of oral risperidone include oral film-coated tablets, orodispersible tablets and an oral solution.
Il - formulazzjonijiet awtorizzati ta ’ risperidone orali jinkludu pilloli orali miksijin b’ rita, pilloli li jinħallu fil- ħalq u soluzzjoni orali.
The Referral procedure under Article 30 of Directive 2001/ 83/ EC, as amended for Risperdal was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to the sections on indication, posology and method of administration, contraindications, special warnings and precautions for use and interactions with other medicinal products or other forms of interactions.
Il- proċedura ta ’ Referenza skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendat, għal Risperdal inbdiet bil- għan li jiġu solvuti d- diverġenzi bejn it- testi ta ’ Fuljett ta ’ Tagħrif awtorizzati b’ mod nazzjonali fl- Istati Membri tal- UE u taż- ŻEE, b’ mod partikolari fir- rigward tas- sezzjonijiet dwar l - indikazzjoni, il- pożoloġija u l- metodu ta ’ kif jingħata, il- kontraindikazzjonijiet, it- twissijiet speċjali u l- prekawzjonijiet għall- użu u reazzjonijiet ma ’ prodotti mediċinali oħra jew forom oħra ta ’ reazzjoni - prodott.
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
Is- CHMP evalwa l- kitba proposta pprovduta mill- MAH, u ngħatat attenzjoni partikolari għall- kwistjonijiet li ġejjin:
For the indication in Schizophrenia, the CHMP assessed the proposed dosing, and was of the opinion that although the 8 mg dose could be considered as a treatment option for particular patients with schizophrenia, treating physicians should individualise treatment and use the lowest efficacious dose for each patient with a target dose of 4 to 6 mg/ day.
Għall- indikazzjoni fis- Skizofrenija, is- CHMP evalwa d- dożaġġ propost, u kien tal- opinjoni li għalkemm id- doża ta ’ 8 mg tista ’ tiġi kkunsidrata bħala opzjoni ta ’ trattament għal pazjenti partikolari bis- skiżofrenija, it- tobba li jagħtu trattament għandhom jagħmlu dan billi jindividwalizzaw każ b’ każ u jużaw id- doża effikaċi l- aktar baxxa għal kull pazjent b’ doża fil- mira ta ’ 4 sa 6 mg/ kuljum.
Regarding the posology in elderly with schizophrenia, the CHMP considered that the data in elderly patients is limited but suggests that a lower starting dose with a more conservative dose titration than in younger adults is recommended and adopted the following wording:
Rigward il- pożoloġija f’ persuni anzjani bi skizofrenija, is- CHMP ħass li l- informazzjoni dwar pazjenti anzjani hija limitata iżda ssuġġerixxa li hija rakkomandata doża inizjali aktar baxxa b’ titrazzjoni tad- doża iżjed konservattiva milli f’ persuni adulti ta ’ età iżgħar u adotta l- kitba li ġejja:
“ A starting dose of 0.5 mg twice daily is recommended.
“ Hija rakkomandata doża inizjali ta ’ 0. 5 mg darbtejn kuljum.
This dosage can be individually adjusted with 0.5 mg twice-daily increments to 1 to 2 mg twice daily .”
Dan id- dożaġġ jista ’ jiġi aġġustat b’ mod individwali b’ żidiet ta ’ 0. 5 mg darbtejn kuljum għal 1 sa 2 mg darbtejn kuljum. ”
For the indication in Manic episodes associated with Bipolar Disorders, the CHMP assessed the safety and efficacy of the proposed 2 mg and 3 mg starting doses and noted that no comparisons on the change in efficacy measurements in the first days of treatment were made.
Għall- indikazzjoni f’ episodji ta ’ manija assoċjati ma ’ Disturbi Bipolari, is- CHMP evalwa s- sigurtà u l- effikaċja tad- dożi inizjali proposti ta ’ 2 mg u 3 mg u nnota li ma sar l- ebda tqabbil dwar it- tibdil fil - kejl tal- effikaċja l- ewwel ġranet tat- trattament.
Therefore the CHMP was of the opinion that starting doses should be restricted to 2 mg for the first day in bipolar mania.
Għaldaqstant is- CHMP kien tal- opinjoni li d- dożi inizjali għandhom jiġu limitati għal 2 mg għall- ewwel jum f’ manija bipolari.
The CHMP also assessed the optimal, recommended dose range for bipolar mania and considered, based on the submitted efficacy analysis of risperidone patients, grouped according to their mode daily dose during the study, that efficacy was demonstrated over the recommended dose range 1 to 6 mg/ day, and that some patients can effectively be treated at doses in the lower end of this dose range.
Is- CHMP evalwa wkoll il- medda ta ’ dożi rakkomandata, ottimali għall- manija bipolari u ħass, abbażi tal- analiżi sottomessa dwar l- effikaċja f’ pazjenti li ħadu risperidone, raggruppati skont id- doża modali tagħhom ta ’ kuljum matul l- istudju, li ġiet murija effikaċja tul il- medda ta ’ dożi rakkomandata ta ’ 1 sa 6 mg/ kuljum, u li xi pazjenti jistgħu effettivament jiġu ttrattati b’ dożi fin- naħa ta ’ isfel ta ’ din il- medda ta ’ dożi.
The CHMP also assessed the efficacy data for bipolar mania in elderly patients.
Is- CHMP evalwa wkoll l- informazzjoni dwar l- effikaċja għall- manija bipolari f’ pazjenti anzjani.
Due to the low number of patients and based on the limited data available, the CHMP did not consider it justified to treat elderly with bipolar mania with the posology recommended in adults.
Minħabba n- numru baxx ta ’ pazjenti u abbażi tal- informazzjoni limitata disponibbli, is- CHMP ħass li ma kienx ġustifikat li persuni anzjani b’ manija bipolari jiġu ttrattati bil- pożoloġija rakkomandata fl - adulti.
The CHMP concluded that the upper limit of dosage should be restricted and adopted the following dosage recommendations:
Is- CHMP ikkonkluda li l- limitu ta ’ fuq tad- dożaġġ għandu jiġi limitat u adotta r - rakkomandazzjonijiet li ġejjin dwar id- dożaġġ:
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Dan id- dożaġġ jista ’ jiġi aġġustat b’ mod individwali b’ żidiet ta ’ 0. 5 mg darbtejn kuljum għal 1 sa 2 mg darbtejn kuljum.
Since clinical experience in elderly is limited, caution should be exercised .”
Billi l - esperjenza klinika fl- anzjani hija limitata, għandha tintuża kawtela. ”
Finally, the CHMP assessed the data submitted on the use of risperidone in the treatment of mild forms of mania.
Fl- aħħar nett, is- CHMP evalwa l- informazzjoni sottomessa dwar l- użu ta ’ risperidone fit- trattament ta ’ forom ħfief ta ’ manija.
Given the small number of patients with mild mania in clinical trials and the limited data available, the CHMP could not guarantee that the balance between efficacy and safety in patients with mild mania is the same as in patients with moderate to severe mania.
Minħabba n- numru żgħir ta ’ pazjenti b’ manija ħafifa fil- provi kliniċi u l - informazzjoni limitata disponibbli, is- CHMP ma setax jiggarantixxi li l- bilanċ bejn l- effikaċja u s - sigurtà f’ pazjenti b’ manija ħafifa huwa l- istess bħal fil- pazjenti b’ manija moderata għal severa.
The CHMP therefore adopted the following wording in line with the indication for other approved antipsychotics:
Is - CHMP għalhekk adotta l- kitba segwenti li taqbel mal- indikazzjoni għal antipsikotiċi oħra approvati:
“ Risperdal is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders .”
52 “ Risperdal huwa indikat għat- trattament ta ’ episodji moderati għal severi ta ’ manija assoċjati ma ’ disturbi bipolari. ”
For the indication in Severe Aggression in Alzheimer’ s Dementia the CHMP assessed the provided data on
Għall- indikazzjoni f’ Aggressjoni Severa fid- Dimenzja ta ’ Alzheimer, is- CHMP evalwa l - informazzjoni pprovduta dwar l- aħjar tul tat- trattament, fid- dawl tal- ħtieġa li jiġu bbilanċjati l - kwistjonijiet sinjifikanti tas- sigurtà kontra s- severità tas- sintomi fil- popolazzjoni fil- mira (aggressjoni severa).
The CHMP decided to restrict the duration of the short-term therapy to 6 weeks, due to safety considerations.
Is- CHMP iddeċieda li jillimita t- tul tat- terapija fuq perjodu qasir għal 6 ġimgħat, minħabba konsiderazzjonijiet ta ’ sigurtà.
Regarding the qualification of “ severe aggression”, the CHMP considered that rating scales were not practical in clinical settings and that the most important clinical criteria to be met before treatment is initiated is that the aggression places the person or carer at risk of harm and that the behaviour is persistent.
Dwar il- kwalifika ta ’ “ aggressjoni severa ”, is- CHMP ħass li l- iskali ta ’ punteġġ ma kinux prattiċi f’ sitwazzjonijiet kliniċi u li l- iżjed kriterji kliniċi importanti li għandhom jiġu sodisfatti qabel ma jinbeda t- trattament huma li l- aggressjoni tpoġġi lill- persuna jew lil min jieħu ħsiebha f’ riskju li ssirilhom ħsara u li l- imġiba hija persistenti.
Accordingly, the following wording was adopted:
Għalhekk, ġiet adottata l- kitba segwenti:
“ Risperdal is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’ s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others .”
“ Risperdal huwa indikat għat- trattament fuq perjodu qasir (sa 6 ġimgħat) ta ’ aggressjoni persistenti f’ pazjenti b’ dimenzja ta ’ Alzheimer moderata għal severa li ma jkunux qegħdin iwieġbu għal approċċi mhux farmakoloġiċi u meta jkun hemm riskju li ssir ħsara lill- pazjent innifsu jew lil persuni oħra. ”
The CHMP was of the opinion that the efficacy in Alzheimer’ s dementia was similar compared to efficacy in vascular/ mixed dementias and that patients with severe aggression in vascular/ mixed dementias should be excluded from treatment with risperidone because of safety concerns.
Is- CHMP kien tal- opinjoni li l- effikaċja fid- dimenzja ta ’ Alzheimer kienet simili meta mqabbla mal - effikaċja f’ dimenzji vaskulari / imħallta u li l- pazjenti b’ aggressjoni severa f’ dimenzji vaskulari / imħallta għandhom jiġu esklużi mit- trattament b’ risperidone minħabba tħassib dwar is- sigurtà.
Restriction of the indication to patients with Alzheimer’ s dementia is also correct in view of efficacy.
Ir - restrizzjoni tal- indikazzjoni għal pazjenti b’ dimenzja ta ’ Alzheimer hija korretta wkoll fid- dawl tal - effikaċja.
The CHMP decided to limit the indication to AD, however the CHMP amended the warning in the SPC, regarding the magnitude of the risk for CVAEs in patients with MD/ VD to the following wording:
Is- CHMP iddeċieda li jillimita l- indikazzjoni għall- AD, madankollu s- CHMP emenda t - twissija fl- SPC, rigward il- kobor tar- riskju ta ’ CVAEs f’ pazjenti b’ MD/ VD għall- kitba segwenti:
“ The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer dementia.
“ Ir- riskju ta ’ CVAEs kien konsiderevolment ogħla f’ pazjenti li kellhom tip ta ’ dimenzja mħallta jew vaskulari meta mqabbel mad- dimenzja ta ’ Alzheimer.
Therefore, patients with other types of dementias than Alzheimer’ s should not be treated with risperidone .”
Għalhekk, pazjenti li jkollhom tipi ta ’ dimenzja differenti minn ta ’ Alzheimer ma għandhomx jiġu ttrattati b’ risperidone. ”
In addition, the CHMP assessed the safety and efficacy of risperidone and implemented warning and precaution texts in section 4.4 of the SPC, to address the increased risk for CVAE and the increased mortality with atypical antipsychotics in patients with dementia.
Barra minn hekk, is- CHMP evalwa s- sigurtà u l- effikaċja ta ’ risperidone u implimenta kitbiet ta ’ twissija u prekawzjoni fis- sezzjoni 4. 4 tal- SPC, biex jindirizza r- riskju akbar ta ’ CVAE u ż- żieda fil - mortalità b’ antipsikotiċi atipiċi f’ pazjenti bid- dimenzja.
Further warnings were implemented with regards to patients with mixed or vascular type of dementia and to the need for close monitoring of patients with Alzheimer’ s dementia.
Ġew implimentati iżjed twissijiet fir- rigward tat- tip ta ’ dimenzja mħallta jew vaskulari u għall- bżonn ta ’ monitoraġġ mill- qrib tal- pazjenti morda bid - dimenzja ta ’ Alzheimer.
The CHMP also adopted wordings further restricting the target population and the treatment duration.
Is- CHMP adotta wkoll kitbiet li jillimitaw aktar il- popolazzjoni fil- mira u t- tul tat- trattament.
In conclusion, the CHMP was of the opinion that the current weight of evidence is that the benefit-risk assessment remains favourable in this restricted target population indication of persistent aggression in Alzheimer’ s dementia for short-term treatment only (6 weeks) and with all restrictions and conditions indicated in the SPC.
Bħala konklużjoni, is- CHMP kien tal- opinjoni li l- piż attwali tal- evidenza huwa li l - evalwazzjoni tal- benefiċċju u r- riskju għadu favorevoli f’ din l- indikazzjoni ristretta fil- popolazzjoni fil - mira ta ’ aggressjoni persistenti fid- dimenzja ta ’ Alzheimer għal trattament fuq perjodu qasir biss (6 ġimgħat) u bir- restrizzjonijiet u l- kundizzjonijiet kollha indikati fl- SPC.
Finally, the CHMP noted the data and the responses submitted by the MAH with regards to safety signals, both in normal and elderly patients and agreed with the revised and corrected tables on CVAEs and ADRs.
Fl- aħħar nett, is- CHMP innota l- informazzjoni u t- tweġibiet sottomessi mill- MAH fir- rigward tas - sinjali tas- sigurtà, kemm f’ pazjenti normali kif ukoll anzjani u qabel mat- tabelli riveduti u korretti dwar is- CVAEs u l- ADRs.
For the indication in Severe Aggression in Children/ Adolescents with Conduct Disorder, the CHMP assessed the safety profile in children/ adolescents, requesting further clarifications, especially with regards to the Contradictions and discrepancies between the actual Safety Overview (April 2008) and the previous Safety Overview (January 2008) in children/ adolescents with Disruptive Behaviour Disorder (DBD).
Għall- indikazzjoni f’ Aggressjoni Severa fit- Tfal/ Adolexxenti b’ Disturb tal- Imġiba, is- CHMP evalwa l- profil tas- sigurtà fit- tfal/ adolexxenti, u talab iżjed kjarifiki, speċjalment fir- rigward tal - Kontraindikazzjonijiet u d- diskrepanzi bejn il- Ħarsa ġenerali attwali dwar is- Sigurtà (April 2008) u l - Ħarsa ġenerali preċedenti dwar is- Sigurtà (Jannar 2008) fi tfal/ adolexxenti b’ Disturb tal- Imġiba li jikkawża Diżintegrazzjoni (Disruptive Behaviour Disorder - DBD).
The CHMP also assessed the consistency of the Extrapyramidal Symptoms and the evidence suggesting regression in sexual maturation.
Is- CHMP evalwa wkoll il - konsistenza tas- Sintomi Ekstrapiramidali u l- evidenza li tissuġġerixxi regressjoni fil- maturazzjoni sesswali.
The CHMP considered that while regression of sexual maturation was not supported, the SPC states that ” the effects of long-term treatment on sexual maturation and height have not been adequately studied” and as a consequence, the sentence “ Treatment with risperidone for up to 1 year showed no adverse effects on sexual maturation” in section 4.4 should be deleted.
Is- CHMP ħass li filwaqt li r- regressjoni tal- maturazzjoni sesswali ma kinetx appoġġjata, l - SPC jiddikjara li “ l- effetti ta ’ trattament għal żmien twil fuq il- maturazzjoni sesswali u t- tul tal - persuna ma ġewx studjati adegwatament ” u minħabba f’ hekk, is- sentenza “ It- trattament b’ risperidone għal perjodu sa sena ma wera l- ebda effetti avversi fuq il- maturazzjoni sesswali ” f’ sezzjoni 4. 4 għandha titħassar.
The CHMP assessed the “ Relapse Prevention Study” (12 weeks of open-label and single-blind risperidone treatment followed by a 6-month double-blind) and was of the opinion that it may only be considered as supportive, due to the fact that only responders entered the double-blind phase.
53 biss bħala ta ’ sostenn, minħabba l- fatt li dawk li wrew reazzjoni (responders) biss daħlu fil- fażi double- blind.
The two 6 week- short term studies are considered as the main efficacy studies and the treatment should be restricted to short-term treatment (6 weeks) as the safety profile in children/ adolescents appears worse than in adults.
Iż- żewġ studji fuq perjodu qasir ta ’ 6 ġimgħat huma kkunsidrati bħala l- istudji prinċipali dwar l- effikaċja u t- trattament għandu jiġi limitat għal trattament fuq perjodu qasir (6 ġimgħat) peress li l- profil tas- sigurtà fit- tfal/ adolexxenti jidher agħar milli fl- adulti.
The CHMP also discussed the use of risperidone in children with normal intellectual functioning, noting that the controlled trials are predominantly conducted in children with borderline IQ or mental retardation.
Is- CHMP iddiskuta wkoll l- użu ta ’ risperidone fi tfal b’ kapaċità intellettwali normali, fejn innota li l - provi kkontrollati jitwettqu l- aktar fuq tfal b’ IQ fix- xifer jew ritard mentali.
According to the safety profile of risperidone in children, the population of use should not be expanded to children and adolescents with a normal IQ, since due to the structural differences between the brains of
Skont il- profil tas- sigurtà ta ’ risperidone fit- tfal, il- popolazzjoni tal- użu m’ għandhiex tiġi estiża għal tfal u adolexxenti b’ IQ normali, billi minħabba d- differenzi strutturali bejn l- imħuħ tat- tfal u l- adolexxenti b’ IQ normali u dawk b’ ritard mentali, wieħed ma jistax jassumi li ż- żewġ popolazzjonijiet se jirrispondu għall - medikazzjoni antipsikotika b’ mod identiku.
However, the CHMP decided to adopt an indication without restriction to specific IQ.
Madankollu, is- CHMP iddeċieda li jadotta indikazzjoni mingħajr restrizzjoni għal IQ speċifiku.
The CHMP further discussed efficacy in Children and Adolescents with Autistic Disorder, a Pervasive Developmental Disorder that is different from Conduct Disorder which is a Disruptive Behaviour Disorder.
Is- CHMP iddiskuta wkoll l- effikaċja fit- Tfal u l- Adolexxenti b’ Disturb Awtistiku, Disturb Pervażiv tal- Iżvilupp li huwa differenti minn Disturb tal- Imġiba li huwa Disturb tal- Imġiba li jikkawża Diżintegrazzjoni.
As a consequence, children with autistic disorders are not included in the proposed indication.
Minħabba f’ hekk, tfal b’ disturbi awtistiċi mhumiex inklużi fl- indikazzjoni proposta.
This exclusion is supported by the fact that the primary symptoms of the autism disorder cannot successfully be treated with Risperdal because the target symptoms in autism for which Risperdal has demonstrated its most robust efficacy are associated symptoms rather than a broad spectrum of symptoms of the disease.
Din l- esklużjoni hija sostnuta mill- fatt li s- sintomi primarji tad- disturb tal- awtiżmu ma jistgħux jiġu ttrattati b’ suċċess b’ Risperdal minħabba li s- sintomi fil- mira tal- awtiżmu li għalihom Risperdal wera l- iżjed effikaċja b’ saħħitha tiegħu huma sintomi assoċjati pjuttost milli spettru wiesa ’ ta ’ sintomi tal - marda.
Because of the lack of specificity and the availability of other treatment options, the CHMP did not considered the indication in Autistic Disorder as supported.
Minħabba n- nuqqas ta ’ speċifiċità u d- disponibilità ta ’ opzjonijiet oħra ta ’ trattament, is - CHMP ma kkunsidrax l- indikazzjoni f’ Disturb Awtistiku bħala appoġġjata.
In conclusion, the CHMP adopted the following indication:
Bħala konklużjoni, is - CHMP adotta l- indikazzjoni li ġejja:
“ Risperdal is indicated for the short-term symptomatic treatment (up to 6 weeks) of severe persistent aggression in conduct or other disruptive behaviour disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment.
“ Risperdal huwa indikat għat- trattament sintomatiku fuq perjodu qasir (sa 6 ġimgħat) ta ’ disturb tal - imġiba b’ aggressjoni persistenti severa jew disturb ieħor ta ’ imġiba li jikkawża diżintegrazzjoni fit - tfal mill- età ta ’ 5 snin u adolexxenti b’ kapaċità intellettwali taħt il- medja jew ritard mentali ddijanjostikati skont kriterji DSM- IV, li fihom is- severità tal- imġiba aggressiva jew ta ’ imġiba li tikkawża diżintegrazzjoni oħra tkun teħtieġ trattament farmakoloġiku.
Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention.
It- trattament farmakoloġiku għandu jkun parti integrali minn programm ta ’ trattament aktar intensiv, li jinkludi intervent psikosoċjali u edukattiv.