natgillin/translations-raw huggingface dataset:
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.
· püüdke nõela sirgeks painutada või sulgeda Needle- Pro vahendit, kui nõel on paindunud või
67 that the needle is fully engaged into the needle protection device.
Kontrollige visuaalselt, kas nõel on kaitsekapslisse täielikult fikseerunud.
68
68 69
Ref.
London, 8. oktoober 2008 Viide:
EMEA/ CHMP/ 384879/ 2008
EMEA/ CHMP/ 554678/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names
ARVAMUS PÄRAST ARTIKLI 30 KOHAST ESILDIST Rispedal Consta ja sarnased nimetused Rahvusvaheline mittekaubanduslik nimetus (INN): risperidoon
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.
24. juulil 2007 esitas Euroopa Komisjon Euroopa Ravimiametile muudetud direktiivi 2001/ 83/ EÜ artikli 30 alusel esildise Risperdal Consta ja sarnaste nimetuste liikmesriikides heakskiidetud ravimi omaduste kokkuvõtete, pakendi infolehtede ja märgistuste ühtlustamiseks.
Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien Austria
Risperdal Quicklet 0,5 mg - Tabletten
Risperdal Quicklet 0, 5 mg - Tabletten
Orodispersible tablet Oral use
Suukaudne
Risperdal 0,5 mg - Filmtabletten
Risperdal 0, 5 mg - Filmtabletten
Film-coated tablet Oral use
Suukaudne
Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria
Janssen- Cilag Pharma GmbH Pfarrgasse 75
Marketing Authorisation Holder
Müügiloa hoidja A- 1232 Wien Austria
Pharmaceutical Route of Form administration
Manustamisviis
Janssen-Cilag Pharma GmbH
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien Austria
Risperdal
Risperdal 3 mg - Filmtabletten
3 mg - 3 mg
3 mg
Risperdal 4 mg - 4 mg Filmtabletten
Risperdal 4 mg - Filmtabletten
Risperdal 6 mg - 6 mg Filmtabletten
Risperdal 6 mg - Filmtabletten
1 mg/ 1 ml
1 mg / 1 ml
Rispolin Quicklet 0,5 mg 0,5 mg - Tabletten
Rispolin Quicklet 0, 5 mg 0, 5 mg - Tabletten
Orodispersible tablet Oral use
Suus dispergeeruv tablett
Rispolin Quicklet 4 4 mg mg - Tabletten
Rispolin Quicklet 3 mg - Tabletten
Rispolin 0,5 mg - 0,5 mg Filmtabletten
Rispolin Quicklet 4 mg - Tabletten
Rispolin 1 mg- 1 mg Filmtabletten
Rispolin 0, 5 mg - Filmtabletten
Rispolin 2 mg - 2 mg Filmtabletten
Rispolin 1 mg - Filmtabletten
Rispolin 3 mg - 3 mg Filmtabletten
Rispolin 2 mg - Filmtabletten
Rispolin 4 mg - 4 mg Filmtabletten
Rispolin 3 mg - Filmtabletten
Rispolin 6 mg - 6 mg Filmtabletten
Rispolin 4 mg - Filmtabletten
Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien Austria
Janssen- Cilag Pharma GmbH Pfarrgasse 75 A- 1232 Wien
Rispolin 1 mg/ ml - 1 mg orale Lösung
Rispolin 6 mg - Filmtabletten
Oral solution Oral use
Õhukese polümeerikattega tablett
1 mg/ 1 ml
Suukaudne
Marketing Authorisation Holder
Müügiloa hoidja Austria
Roderveldlaan 1 B-2600 Berchem Belgium
Roderveldlaan 1 B- 2600 Berchem Belgia
Risperidone J-C Instasolv
Risperidone J- C 0. 5 mg Instasolv
0.5 mg
Suus dispergeeruv tablett
Roderveldlaan 1 B-2600 Berchem, Belgium
Roderveldlaan 1 B- 2600 Berchem, Belgia
1 mg
Suukaudne lahus
Oral solution Oral use
Suukaudne
Risperdal
Risperdal 0. 5 mg
0.5 mg
Õhukese polümeerikattega tablett
1 mg
Õhukese polümeerikattega tablett
6 mg
Risperdal 6 mg
Risperdal Instasolv 0.5 mg
Risperdal Instasolv
Risperdal Instasolv 1 mg
Risperdal Instasolv
Roderveldlaan 1 B-2600
Roderveldlaan 1 B- 2600 Berchem, Belgia
Risperdal Instasolv 2 mg
2 mg
Member State
Suukaudne
Risperidone J-C
Risperidone J- C
Risperidone Instasolv
Risperidone J- C Instasolv
J-C
1 mg
1 mg
Suus dispergeeruv tablett
Smartinska cesta 53 1000 Ljubljana Slovenia
Smartinska cesta 53 1000 Ljubljana Sloveenia
Strength
1 mg / 1 ml
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Belgia
J Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
J Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340, Beerse, Belgia
Karla Engliš e 3201/ 6 150 00 Praha 5 Czech Republic
Karla Engliše 3201/ 6 150 00 Praha 5 Tšehhi Vabariik
Risperidonum
Risperidonum
Karla Engliš e 3201/ 6
Karla Engliše 3201/ 6 150 00 Praha 5
Karla Engliš e 3201/ 6 150 00 Praha 5
Karla Engliše 3201/ 6 150 00 Praha 5
Orodispersible tablet oral use
Suukaudne
Janssen-Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Denmark
Janssen- Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Taani
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Taani
Film-coated Oral use
Suukaudne
Belivon 2 mg
2 mg
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Taani
Belivon 3 mg
3 mg
Film-coated Oral use
Õhukese polümeerikattega tablett
Film-coated
Õhukese polümeerikattega tablett
Janssen-Cilag A/ S, Postboks 149, Hammerbakken 19, 3460 Birkerød, Denmark
Janssen- Cilag A/ S, Postboks 149, Hammerbakken 19, 3460
Film-coated tablets
Õhukese polümeerikattega
Oral lyophilisate
Suukaudne lüofilisaat Suukaudne
Janssen-Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød
Janssen- Cilag A/ S Postboks 149 Hammerbakken 19 3460 Birkerød Taani
Johnson & Johnson UAB Š eimyniš kių g.
Johnson & Johnson UAB Šeimyniškių g.
1A LT-09312 Vilnius Lithuania
1A LT- 09312 Vilnius Leedu
Film-coated tablet
Õhukese Suukaudne polümeerikattega tablett
1A LT-09312 Vilnius Lithuania
1A LT- 09312 Vilnius
Jansen-Cilag Oy Metsänneidonkuja 8 02130 Espoo
Jansen- Cilag Oy Metsänneidonkuja 8 02130 Espoo Soome
Finland
1 mg / 1 ml
Risperdal
Risperdal 0. 25 mg
Risperdal Instasolv 0.5 mg
Risperdal Instasolv 0. 5 mg
Laboratorires 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, Prantsusmaa
Scored tablet Oral use
Suukaudne
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Laboratoires Janssen Cilag 1 rue Desmoulins
France
12 Liikmesriik
Laboratorires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Müügiloa hoidja TSA 91003 92787 Issy les Moulineaux Cedex 9, Prantsusmaa
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, Prantsusmaa
Belivon 4 mg
4 mg
Risperdal 0.5 mg
Risperdal
Film coatedtablet Oral use
Suukaudne
Laboratoires Janssen Cilag 1 rue Desmoulins
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, Prantsusmaa
INN
1 mg
Invented Name
Poolitatav tablett
Half-Scored tablet
Poolitatav tablett
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9, France
Laboratoires Janssen Cilag 1 rue Desmoulins TSA 91003
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
Janssen-Cilag GmbH 41457 Neuss or Janssen-Cilag GmbH Raiffeisenstr.
Janssen- Cilag GmbH 41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
Risperdal Filmtabletten 0,25 mg
Risperdal Filmtabletten 0, 25 mg
Risperdal Filmtabletten 0,5 mg
Risperdal Filmtabletten 0, 5 mg
Janssen-Cilag GmbH 41457 Neuss or
Janssen- Cilag GmbH 41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
Risperdal Quicklet 1 mg 1 mg
Risperdal Quicklet 1 mg
15
Suukaudne
Member State
16 Liikmesriik
Risperdal Quicklet 2 mg 2 mg
Risperdal Quicklet 2 mg
Risperdal Quicklet 3 mg 3 mg
Risperdal Quicklet 3 mg
Risperdal Quicklet 4 mg 4 mg
Risperdal Quicklet 4 mg
Risperidon-Janssen 6 mg Filmtabletten 6 mg
Risperidon- Janssen Filmtabletten 6 mg
Risperidon-Janssen 1 mg Loesung 1 mg/ ml
Risperidon- Janssen Loesung 1 mg/ ml
16
1 mg / 1 ml
Member State
17 Liikmesriik
Belivon 0,5 mg Filmtabletten
Belivon 0, 5 mg Filmtabletten
17 Member State
18 Liikmesriik
Belivon 4 mg Filmtabletten
Belivon 4 mg Filmtabletten
Belivon 6 mg Filmtabletten
Belivon 6 mg Filmtabletten
Janssen-Cilag GmbH 41457 Neuss
Janssen- Cilag GmbH 41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
Janssen-Cilag GmbH
Janssen- Cilag GmbH
41457 Neuss or Janssen-Cilag GmbH Raiffeisenstr.
41457 Neuss or Janssen- Cilag GmbH Raiffeisenstr.
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 Kreeka
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, Kreeka
Janssen-Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue, Pefki, 15121, Greece
Janssen- Cilag Pharmaceutical S. A. C. I, 56 Eirinis Avenue,
Risperdal 6 mg
6 mg
Risperdal Quicklet 0.5 mg
Risperdal Quicklet 0. 5 mg
Lingual tablet
Keelealune tablett
Janssen- Cilag Kft.
Janssen - Cilag Kft.
2045 Törökbálint Tó park Hungary
2045 Törökbálint Tó park Ungari
2045 Törökbálint Tó park, Hungary
2045 Törökbálint Tó park, Ungari
Risperdal 2 mg
2 mg
Risperdal 3 mg
3 mg
Risperdal 4 mg
4 mg
Risperdal 1mg
Risperdal
Janssen-Cilag AB Box 7073 192 07 Sollentuna Sverige
Janssen- Cilag AB Box 7073 192 07 Sollentuna Rootsi
Risperdal 0,5 mg
0, 5 mg
Oral lyophilisate Oral use
Suukaudne lüofilisaat Suukaudne
Janssen-Cilag AB, Box 7073 192 07 Sollentuna, Sverige
Janssen- Cilag AB, Box 7073 192 07 Sollentuna, Rootsi
Film coated tablet Oral use
Suukaudne
Film Coated tablet Oral use
Suukaudne
Film Coated tablet Oral use
Õhukese polümeerikattega tablett
Ireland
Island
Film Coated Tablet
Õhukese polümeerikattega tablett
Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd Saunderton High Wycombe
Janssen-Cilag Ltd Saunderton High Wycombe
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ühendkuningriik
Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ
Ireland
Liikmesriik
Janssen-Cilag Ltd
Ravimi väljamõeldud nimetus
Risperidone
Ravimvorm
Risperdal 1 mg
Manustamisviis
Orodispersible tablet
Pakendi sisu (kontsentratsi oon)
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ühendkuningriik
Quicklet
Risperdal Quicklet
Janssen-Cilag Ltd
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ühendkuningriik
Quicklet
Risperidonum
Janssen-Cilag Ltd
Risperdal Quicklet
23 Cologno Monzese 20093, Milano Italy
23 Cologno Monzese 20093, Milano Itaalia
23 Cologno Monzese, 20093, Milano, Italy
23
0,25 mg
0, 25 mg
23 Cologno Monzese, 20093, Milano, Italy
23 Cologno Monzese, 20093,
Orodispersible tablet Oral
Suukaudne
23 Cologno Monzese
23 Cologno Monzese 20093 Milano Itaalia
Film coated tablet Oral use
Õhukese polümeerikattega tablett
Film coated tablet
Õhukese polümeerikattega
UAB Johnson & Johnson Š eimyniš kių g.1A LT-09312 Vilnius Lithuania
UAB Johnson & Johnson Šeimyniškių g. 1A LT- 09312 Vilnius Leedu
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312 Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Leedu
UAB Johnson & Johnson, Š eimyniš kių g.1A, Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškių g. 1A, Vilnius, Leedu
UAB Johnson & Johnson, Š eimyniš kių g.1A, LT-09312
UAB Johnson & Johnson, Šeimyniškių g. 1A, LT- 09312 Vilnius, Leedu
27 Member State
29 Liikmesriik
Vilnius, Lithuania
Pakendi sisu (kontsentratsi oon)
UAB Johnson & Johnson, Š eimyniš kių g.
UAB Johnson & Johnson, Šeimyniškių g.
Risperdal Quicklet 1
Risperdal Quicklet
mg
1 mg
Orodispersible tablets
Suus dispergeeruv tablett
Rispolept Quicklet 1
Rispolept Quicklet
Rispolept Quicklet 2
2 mg
28 Member State
30 Liikmesriik
Roderveldlaan 1 2600 Berchem Belgium
Roderveldlaan 1 2600 Berchem Belgia
Risperidone J-C Instasolv
Risperidone J- C Instasolv
Roderveldlaan 1 2600 Berchem, Belgium
Roderveldlaan 1 2600 Berchem, Belgia
Roderveldlaan 1 2600 Berchem,
Roderveldlaan 1 2600 Berchem, Belgia
Tablets Oral use
Suukaudne
Member State
32 Liikmesriik
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Belgia
Risperdal Quicklets 0.5mg
Risperdal Quicklets 0. 5mg
Janssen-Cilag B. V.
Janssen- Cilag B. V.
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The Netherlands
Paul Janssenweg 150 PO Box 90240
Risperdal 0.5 mg Risperdal omhulde tabletten 0,5 mg
Risperdal 0. 5 mg Risperdal omhulde tabletten 0, 5 mg
Risperdal Risperdal 1 mg omhulde tabletten 1 mg
Õhukese polümeerikattega tablett
Member State
33 Liikmesriik
Marketing Authorisation Holder
Müügiloa hoidja 5000 LT Tilburg Holland
Risperdal Risperdal omhulde tabletten 2 mg
Risperdal Risperdal 1 mg omhulde tabletten 1 mg
Filmcoated tablets
Õhukese polümeerikattega tablett
Risperdal Risperdal omhulde tabletten 3 mg
Risperdal 2 mg Risperdal omhulde tabletten 2 mg
Risperdal Risperdal omhulde tabletten 4 mg
Risperdal 3 mg Risperdal omhulde tabletten 3 mg
Risperdal Risperdal omhulde tabletten 6 mg
Risperdal 4 mg Risperdal omhulde tabletten 4 mg
Risperdal Risperdal omhulde tabletten 8 mg
Risperdal 6 mg Risperdal omhulde tabletten 6 mg
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The Netherlands
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg
Belivon Belivon omhulde tabletten 1 mg
Risperdal 8 mg Risperdal omhulde tabletten 8 mg
32 Member State
Liikmesriik
Marketing Authorisation Holder
Müügiloa hoidja Holland
Strength
Ravimi Tugevus väljamõeldud nimetus
Risperidon
Suukaudne
Oral use
1 mg / 1 ml
1 mg/ 1 ml
Tugevus
Risperdal Quicklet 0.5 mg Risperdal Quicklet 0,5 mg
Risperdal Quicklet 0. 5 mg Risperdal Quicklet 0, 5 mg
Orodisperable tablet
Suus dispergeeruv tablett
Paul Janssenweg 150 PO Box 90240
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg Holland
Risperdal Risperdal 2 mg
Risperdal Quicklet 2 mg Risperdal Quicklet 2 mg
Risperdal Risperdal 3 mg
Risperdal Quicklet 3 mg Risperdal Quicklet 3 mg
Risperdal Risperdal 4 mg
Risperdal Quicklet 4 mg Risperdal Quicklet 4 mg
Janssen-Cilag AS Hoffsveien 1D
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo Norra
Strength
Norra
0275 Oslo Norway
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo Norra
Turnhauseveg 30 B-2340 Beerse Belgium
Turnhoutseweg 30 B- 2340 Beerse Belgia
Turnhauseveg 30 B-2340 Beerse Belgium
Turnhoutseweg 30
Turnhauseveg 30 B-2340 Beerse Belgium
Turnhoutseweg 30 B- 2340 Beerse Belgium
Rispolept Quicklet 0,5 mg
Rispolept Quicklet 0, 5 mg
Turnhauseveg 30
Turnhoutseweg 30 B- 2340 Beerse Belgia
B-2340 Beerse Belgium Poland
Poola
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734- 503 Barcarena
Risperidona
Risperidonum
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503
Risperdal Quicklet 0.5 mg
Risperdal
Risperdal Quicklet 1 mg
Quicklet 1 mg
Risperdal Quicklet 2 mg
Quicklet 2 mg
Estrada Consiglieri Pedroso, 69
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734- 503 Barcarena Portugal
Risperdal Quicklet 3 mg
Quicklet 3 mg
Janssen Farmacêutica Portugal, Risperidona Lda.
Janssen Farmacêutica Portugal, Lda.
Risperidone Turnhoutseweg 30 2340 Beerse Belgium
Turnhoutseweg 30 2340 Beerse Belgia
Rispolept
Rispolept 2 mg
Risperidone Turnhoutseweg 30, 2340 Beerse, Belgium
Risperidonum
Rispolept
Rispolept 3 mg
Risperidone Turnhoutseweg 30, 2340 Beerse, Belgium
Turnhoutseweg 30, 2340 Beerse, Belgia
Rispolept
Risperidonum
Quicklet 1 mg
Rispolept Quicklet 1 mg
Oral use
Dispergeeruv tablett Suukaudne
Quicklet 2 mg
Rispolept Quicklet 2 mg
Risperidone Plynárenská 7/ B 824 78 Bratislava
Plynárenská 7/ B 824 78 Bratislava Slovaki Vabariik
Film coated tablet
Õhukese Suukaudne polümeerikattega tablett
Plynárenská 7/ B 824 78 Bratislava Slovak Republic
Plynárenská 7/ B 824 78 Bratislava Slovaki Vabariik
Risperdal Quicklet 2 mg
2 mg
Risperdal Quicklet 3 mg
3 mg
Plynárenská 7/ B 824 78 Bratislava
Plynárenská 7/ B 824 78 Bratislava Slovaki Vabariik
Risperdal Quicklet 4 mg
4 mg
Risperdal
Risperdal 1 mg filmsko obložene tablete
1 mg 1 mg
1 mg
Š martinska 53 Ljubljana Slovenia
Johnson & Johnson d. o. o., Šmartinska 53, Ljubljana, Sloveenia
filmsko oblož ene tablete
Risperdal Risperdal 2 mg 2 mg filmsko obložene tablete
Slovenia
Suukaudne
Johnson & Johnson d. o. o., Š martinska 53, Ljubljana, Slovenia
43 Liikmesriik
Risperidone
Müügiloa hoidja
Risperdal Risperdal 2 mg filmsko oblož ene tablete
Ravimi väljamõeldud nimetus
2 mg
Tugevus
Film-coated tablets
Ravimvorm
Risperdal 3 mg filmsko oblož ene tablete
Risperdal 3 mg filmsko obložene tablete
Risperdal 4 mg filmsko oblož ene tablete
Risperdal 4 mg filmsko obložene tablete
Risperdal 1 mg/ ml peroralna raztopina
Risperdal 1 mg/ ml peroralna raztopina
Risperdal Quicklet 0,5 mg orodisperzibilna tableta
Risperdal Quicklet 0, 5 mg orodisperzibilna tableta
Janssen Cilag, SA Paseo de las Doce Estrellas 5-7 28042 Madrid
Janssen Cilag, SA Paseo de las Doce Estrellas 5- 7 28042 Madrid Hispaania
Orodispersable tablet
Suus dispergeeruv tablett
Janssen Cilag, SA Paseo de las Doce Estrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA
Orodispersable tablet
Suus dispergeeruv
Spain
tablett
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, Hispaania
Janssen Cilag, SA Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 7 28042 Madrid, Hispaania
Film coated tablets
Õhukese polümeerikattega tablett
Janssen Cilag, SA Paseo de las Doce Estrellas, 5- 728042 Madrid, Spain
Janssen Cilag, SA Paseo de las Doce Estrellas, 5 - 728042 Madrid, Hispaania
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 Hispaania
Janssen-Cilag AB Box 7073 192 07 Sollentuna
Janssen- Cilag AB Box 7073 192 07 Sollentuna Rootsi
0.5mg
0. 5mg
Oral lyophilisate
Suukaudne lüofilisaat
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Saunderton High Wycombe Buckinghamshire HP14 4HJ Ühendkuningriik
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Saunderton
United Kingdom
47 Liikmesriik
Saunderton High Wycombe Buckinghamshire HP14 4HJ
Saunderton High Wycombe Buckinghamshire HP14 4HJ Ühendkuningriik
Pharmaceutical Form
Ühendkuningri ik
Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Saunderton High Wycombe
United Kingdom
Müügiloa hoidja Buckinghamshire HP14 4HJ Ühendkuningriik
3 mg
Risperdal Quicklet 3 mg
United
Ühendkuningri ik
Risperdal Quicklet
Risperdal Quicklet 4mg
Orodispersible
Suus dispergeeruv tablett
46 ANNEX II
49 II LISA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
EUROOPA RAVIMIAMETI ESITATUD TEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE KOKKUVÕTETE, MÄRGISTUSE JA PAKENDI INFOLEHE MUUTMISE ALUSED
47 SCIENTIFIC CONCLUSIONS
50 TEADUSLIKUD JÄRELDUSED
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL AND ASSOCIATED NAMES (SEE ANNEX I)
RISPERDALI JA SEOTUD NIMETUSTE (VT I LISA) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
Risperdal (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Risperdal (risperidoon) on bensisoksasooli derivaat, millel on tugevad serotoniini 5HT2A retseptoreid ja dopamiini D2 retseptoreid blokeerivad kombineeritud omadused.
Adrenergic α 1 and, to a lesser extent, histamine H1 and adrenergic α 2 receptors are also antagonised by risperidone.
Risperidoonil on antagonistlik toime ka adrenergiliste α1- retseptorite ning vähemal määral histamiini H1- retseptorite ja adrenergiliste α2- retseptorite suhtes.
Authorised formulations of oral risperidone include oral film-coated tablets, orodispersible tablets and an oral solution.
Risperidooni heaks kiidetud ravimvormideks on suukaudsed õhukese polümeerikattega tabletid, suus lahustuvad tabletid ja suukaudne lahus.
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.
Muudetud direktiivi 2001/ 83/ EÜ artikli 30 alusel algatati Risperdali suhtes esildismenetlus, et lahendada lahknevusi eri ELi liikmesriikides ja Euroopa Majanduspiirkonna riikides registreeritud ravimi omaduste kokkuvõtetes ning eelkõige nende näidustamist, annustamist ja manustamisviisi, vastunäidustusi, hoiatusi ja ettevaatusabinõusid ja teiste ravimitega koostoimeid käsitlevates punktides.
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.
Skisofreenia näidustuse puhul hindas inimravimite komitee pakutud annustamist ning oli seisukohal, et kuigi 8 mg annust võib pidada konkreetsete skisofreenia diagnoosiga patsientide puhul ravivõimaluseks, peaksid raviarstid ravi patsiendile kohandama ja kasutama iga patsiendi puhul madalaimat tõhusat annust, kasutades sihtannusena 4– 6 mg/ päevas.
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:
Seoses ravimi annustamisega eakatele skisofreeniat põdevatele patsientidele leidis inimravimite komitee, et eakaid patsiente puudutavad andmed on puudulikud, kuid tegi ettepaneku, et soovitatav on madalam algannus kui nooremaealiste täiskasvanute puhul ja konservatiivsem annuse tiitrimine, ning kiitis heaks järgmise sõnastuse:
“ A starting dose of 0.5 mg twice daily is recommended.
„ Soovitav algannus on 0, 5 mg 2 korda päevas.
This dosage can be individually adjusted with 0.5 mg twice-daily increments to 1 to 2 mg twice daily .”
Kõnealust annust võib individuaalselt kohandada ja suurendada annust 0, 5 mg kaupa 2 korda päevas kuni 1– 2 mg- ni 2 korda päevas. ”
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.
Bipolaarse häirega kaasuvate maniakaalsete episoodide näidustuse puhul hindas inimravimite komitee esitatud 2 mg ja 3 mg algannuste ohutust ja tõhusust ning märkis, et ei olnud tehtud võrdlusi tõhususe hindamise muudatuste vahel esimestel ravipäevadel.
Therefore the CHMP was of the opinion that starting doses should be restricted to 2 mg for the first day in bipolar mania.
Seetõttu oli inimravimite komitee seisukohal, et bipolaarse häire esimese ravipäeva annused peavad piirduma 2 mg- ga.