FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Latvian: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Danish: Via E. Folli, 50 20134 Milano Italy
Latvian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
Danish: Laboratoires S.M.B.
Latvian: Laboratoires SMB S.A.
Danish: Tyskland TAD Pharma GmbH Postfach 720
Latvian: TAD Pharma GmbH Postfach 720
Danish: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Latvian: Portugāle Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
Danish: Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Latvian: Andersens Boulevard 2, DK-1780 København V, Denmark
Danish: GenRx B.V.
Latvian: Nīderlande GenRx B.V.
Danish: Tolvon, tablets 10 mg 10 mg
Latvian: Tolvon, tablets 10 mg
Danish: Via Tor Sapienza, 138 00155 Roma Italy
Latvian: Polifarma S.p.A. Via Tor Sapienza, 138 00155 Roma Italy
Danish: GlaxoSmithKline B.V.
Latvian: Nīderlande GlaxoSmithKline B.V.
Danish: Koncentrat til injektionsvœske til opløsning
Latvian: Koncentrāts injekciju šķīduma pagatavošanai
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Latvian: Uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību (pašnāvības mēģinājumiem un domām par pašnāvību), kā arī naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedību un dusmas) biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi.
Danish: ZOLOFT OC 20mg/ml 20mg/ml
Latvian: ZOLOFT OC 20mg/ml
Danish: Cipramil Infusionsloesungskonzentrat 20 mg
Latvian: Infusionsloesungskonzentrat 20 mg
Danish: Inpharmco-Mianserin10mg-Tabletten
Latvian: Inpharmco-Mianserin-10mgTabletten
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Latvian: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Latvian: Norvēģija Farmagon AS, P.O.Box 35, 1332
Danish: Desiflu voxamin 50 mg 50 mg
Latvian: Desiflu voxamin 50 mg
Danish: BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
Latvian: IV PIELIKUMS GROZĪJUMI, KAS ATTIECAS UZ LIETOŠANAS INSTRUKCIJU
Danish: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Latvian: Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Danish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Latvian: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: 67, 02631 Espoo, Finland
Latvian: Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Latvian: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Latvian: 2696-901 Bobadela Portugal
Danish: Mutan 20mgFilmtabletten
Latvian: Mutan 20mg-Filmtabletten
Danish: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Latvian: Nīderlande KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Danish: Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Latvian: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Felixsan 50mgFilmtabletten
Latvian: Felixsan 50mg-Filmtabletten
Danish: Poligono Can Calderon, Viladecans 08840, Spain
Latvian: SUMOL PHARMA, S.A., Andorra, 64. Poligono Can Calderon, Viladecans 08840, Spain
Danish: Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Latvian: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Danish: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Latvian: SOLVAY PHARMA, 3 Avenue du Bourgmestre, E.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
Latvian: Turklāt šobrīd nav pierādīts tas, cik nekaitīgs ir [piešķirtais nosaukums] ilgstošā laikā, tostarp ietekme uz augšanu, nobriešanu, kognitīvo un uzvedības attīstību.
Danish: Paroxetin "Merckle" 20mg-Filmtabletten
Latvian: Paroxetin "Merckle" 20mgFilmtabletten
Danish: Paroxetin "Sandoz" 20mg-Tabletten
Latvian: Paroxetin "Sandoz" 20mgTabletten
Danish: Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Latvian: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Latvian: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Danish: Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Latvian: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Mianserin 30mg Holsten 30 mg
Latvian: Mianserin 30mg Holsten
Danish: Mianserin Organon 10mg 10 mg
Latvian: Mianserin Organon 10mg
Danish: Pol. Ind. Urtinsa II 28923 Alcorcón, Spain
Latvian: Urtinsa II 28923 Alcorcón, Spain
Danish: CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Latvian: CHMP secināja, ka citalopramu, escitalopramu, fluoksetīnu, fluvoksamīnu, mianserīnu, milnacipranu, mirtazapīnu, paroksetīnu, reboksetīnu, sertralīnu un venlafaksīnu saturošo zāļu aprakstā un attiecīgajā lietošanas instrukciju iedaļā ir jāiekļauj brīdinājums par to, ka uzvedības pazīmes, kuras liecina par tieksmi uz pašnāvību (pašnāvības mēģinājumiem un domām par pašnāvību), kā arī naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedība un dusmas) biežāk novēroja klīniskās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi.
Danish: Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Latvian: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression.
Latvian: Tāpēc CHMP uzskata, ka atomoksetīnu saturošo zāļu aprakstā, kā arī attiecīgajā lietošanas instrukciju iedaļā ir jāiekļauj brīdinājums par to, ka naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedību un dusmas), kā arī emocionālo labilitāti biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, ko ārstēja, izmantojot placebo metodi, kā arī brīdinājums, ka zāles nav iedarbīgas pret depresiju.
Danish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Latvian: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co.
Danish: LABORATORIO FARMACEUTICO C.T.
Latvian: LABORATORIO FARMACEUTICO C.T. S.R.L.
Danish: Via G. Richard, 7 20143 Milano Italy
Latvian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
Danish: Citalopram-Hormosan 10mg
Latvian: Citalopram-Hormosan 10mg 10 mg
Danish: KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Latvian: Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Danish: MedochemieLtd., p.o. box 51409, Limassol, CY - 3505, Constantinoupoleos Str., 3011 Limassol, Cyprus
Latvian: box 51409, Limassol, CY - 3505, Constantinoupoleos Str., 3011 Limassol, Cyprus
Danish: Efexor Modified Release XL
Latvian: Efexor Modified Release XL 150 mg
Danish: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 A
Latvian: Bexal Produtos Farmacêuticos S.A., Rua Prof.
Danish: Mianserin Organon 60mg 60 mg
Latvian: Mianserin Organon 60mg
Danish: Citalopram-Hormosan 40mg
Latvian: Citalopram-Hormosan 40mg 40 mg
Danish: Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Latvian: UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danish: Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
Latvian: Sandoz Pharmaceuticals GmbH Dieselstr. 5
Danish: Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Latvian: Athlone Laboratories Limited, Ballymurray, Co.
Danish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
Latvian: BC Biochemie Pharma GmbH Dieselstr. 5
Danish: Hexal B.V.
Latvian: Nīderlande Hexal B.V.
Danish: SERTRALIN IREX 100 MG
Latvian: SERTRALIN IREX 100 MG 100 mg
Danish: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Latvian: Rue du Tilleul 13, 1332 GENVAL, Belgium
Danish: SEROXAT 30 MG 30 mg
Latvian: SEROXAT 30 MG
Danish: PAROXETINA APOTEX-FARMA
Latvian: PAROXETINA APOTEXFARMA
Danish: Mianserin „Arcana" 30mg-Filmtabletten
Latvian: Mianserin „Arcana" 30mgFilmtabletten
Danish: Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Latvian: Portugāle Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
Danish: - Udvalget konkluderede på baggrund af de tilgængelige data fra kliniske undersøgelser, at der er signaler på selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd, f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med selektive serotonin-genoptagelseshæmmere og serotonin-noradrenalingenoptagelseshæmmere, såsom de ovennævnte lægemidler.
Latvian: - Komiteja, ņemot vērā esošos klīniskās izpētes datus secināja, ka bērniem un pusaudžiem, ko ārstēja ar selektīvajiem serotonīna atpakaļuzņemšanas inhibitoriem un serotonīnanoradrenalīna atpakaļuzņemšanas inhibitoriem, kādas ir iepriekš minētās zāles, konstatēja uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību, tostarp pašnāvības mēģinājumiem, domām par pašnāvību, kā arī/vai ar to saistītu uzvedību, piemēram, pašsakropļošanos, naidīgumu un emocionālo labilitāti;
Danish: Organon, P.O. Box 20, Oss, Netherland
Latvian: Box 20, Oss, Netherland
Danish: Tyskland Synthon B.V.
Latvian: Synthon B.V.
Danish: Citalopram-Hormosan 20mg
Latvian: Citalopram-Hormosan 20mg 20 mg
Danish: Paroxetin "Arcana" 20mg-Filmtabletten
Latvian: Paroxetin "Arcana" 20mgFilmtabletten
Danish: Storbritannien Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Latvian: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Danish: Tolvon, tablets 3 mg 30 mg
Latvian: Tolvon, tablets 3 mg
Danish: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Latvian: Portugāle Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Danish: EDRONAX 4 MG N
Latvian: EDRONAX 4 MG
Danish: SERTRALIN IREX 50 MG
Latvian: SERTRALIN IREX 50 MG 50 mg
Danish: Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Latvian: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: Grœkenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Latvian: FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Danish: Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Latvian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Danish: Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Latvian: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Danish: Fluoxetin „Lannacher" 20mg-Kapseln
Latvian: Fluoxetin „Lannacher" 20mgKapseln
Danish: Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Latvian: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: B-1080 Bruxelles
Latvian: Moliére B-1050 Bruxelles
Danish: Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131 Algés Portugal
Latvian: Portugāle Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Danish: Tolvon 60 mg, tablets 60 mg
Latvian: Tolvon 60 mg, tablets
Danish: Paroxetin beta 20mg 20 mg
Latvian: Paroxetin beta 20mg
Danish: Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal
Latvian: Portugāle Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
Danish: Danmark
Latvian: Dānia
Danish: Niche Generics Ltd.
Latvian: Generics UK Ltd.
Danish: Mianserin 10mg Holsten 10 mg
Latvian: Mianserin 10mg Holsten
Danish: Fluvoxamine-maleaat 50 A, tablets
Latvian: Fluvoxamine-maleaat 50 A, tablets 50 mg
Danish: Danmark N.V.
Latvian: Nīderlande N.V.
Danish: Ljubljana, Slovenia
Latvian: Niklaas, Belgium
Danish: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Latvian: Bld de la Plaine 17 1050 Bruxelles, Belgium
Danish: LAREQ PHARMA S.L., Laguna, 4244.
Latvian: LAREQ PHARMA S.L., Laguna, 4244. Polígono Industrial Urtinsa II.
Danish: Mianserin „Arcana" 10mg-Filmtabletten
Latvian: Mianserin „Arcana" 10mgFilmtabletten
Danish: Flux „Hexal" Tabs 40mgTabletten
Latvian: Flux „Hexal" Tabs 40mg-Tabletten 40mg
Danish: Via Della Libertà, 30 10095 Grugliasco - Torino Italy
Latvian: Solvay Pharma S.p.A. Via Della Libertà, 30 10095 Grugliasco - Torino Italy
Danish: Storbritannien Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Latvian: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Danish: Storbritannien Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Latvian: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: Du bør underrette din læge, hvis nogle af de ovennævnte symptomer opstår eller forværres, når patienter under 18 år indtager [særnavn].
Latvian: Ja kāda no iepriekš uzskaitītajām pazīmēm pastiprinās vai tā kļūst izteiktāka, kamēr pacienti, kas ir jaunāki par 18 gadiem, lieto [piešķirtais nosaukums], informējiet savu ārstu.
Danish: Mianserin-TEVA 30 mg 30 mg
Latvian: Mianserin-TEVA 30 mg
Danish: Fluoxenorm "Genericon" 40mg-Kapseln
Latvian: Fluoxenorm "Genericon" 40mgKapseln
Danish: Fluoxenorm "Genericon" 20mg-Filmtabletten
Latvian: Fluoxenorm "Genericon" 20mgFilmtabletten
Danish: Grœkenland PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Latvian: PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Danish: LERIVON 30MG 30 mg
Latvian: LERIVON 30MG
Danish: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland
Latvian: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co.
Danish: Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Latvian: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Sertralin AWD 50 mg 50 mg
Latvian: Sertralin AWD 50 mg
Danish: ADOFEN 20 mg oral solution
Latvian: ADOFEN 20 mg oral solution 20 mg
Danish: RENEURON 20 mg oral solution
Latvian: RENEURON 20 mg oral solution 20 mg
Danish: Tyskland Lundbeck GmbH Postfach 900662
Latvian: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Danish: Fevarin Tabs 100 mg 100 mg
Latvian: Fevarin Tabs 100 mg
Danish: LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Latvian: ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Danish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Latvian: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
Danish: ZOLOFT 20 mg/ml oldat 20mg/ml
Latvian: ZOLOFT 20 mg/ml oldat
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Latvian: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Latvian: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Danish: LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Latvian: ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Danish: Mianserin-neuraxpharm 60mg
Latvian: Mianserin-neuraxpharm 60mg 60 mg
Danish: Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland
Latvian: Clonmel Healthcare Limited Waterford Road, Clonmel, Co.
Danish: NV. Organon, PO Box 20 5340 HB Oss, Holland
Latvian: Organon, PO Box 20 5340 HB Oss, Holland
Danish: Trevilor retard 75 mg 75 mg
Latvian: Trevilor retard 75 mg
Danish: Flux „Hexal" Tabs 10mgTabletten
Latvian: Flux „Hexal" Tabs 10mg-Tabletten 10mg
Danish: Tyskland Biomo pharma GmbH Josef-Dietzgen-Str. 3
Latvian: Vācija biomo pharma GmbH Josef-Dietzgen-Str.
Danish: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
Latvian: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Danish: Fluoxetin "Genericon" 20mg-Filmtabletten
Latvian: Fluoxetin "Genericon" 20mgFilmtabletten
Danish: Synthon BV, Microweg 22, P.O. Box 7071
Latvian: Synthon BV, Microweg 22, P.O.
Danish: Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
Latvian: Norvēģija Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
Danish: QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed 20 mg
Latvian: QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed
Danish: D-53773 Hennef paroxetin-biomo 20mg 20 mg
Latvian: 3 D-53773 Hennef paroxetin-biomo 20mg
Danish: EFEXOR 37,5 MG 37.5mg
Latvian: EFEXOR 37,5 MG
Danish: Euro-Labor, Laboratórios de Síntese Química e Especialidades Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
Latvian: Farmacêuticas, S.A., Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
Danish: Tolvon 60mgFilmtabletten
Latvian: Tolvon 60mg-Filmtabletten
Danish: Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Latvian: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Mirtazapine Sandoz 15 mg
Latvian: MIRTAZAPINA SANDOZ 15 mg
Danish: Tolvon 30mgFilmtabletten
Latvian: Tolvon 30mg-Filmtabletten
Danish: Fluoxetin-TEVA 10 mg Tabletten
Latvian: Fluoxetin-TEVA 10 mg Tabletten 10 mg
Danish: Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
Latvian: Biomo pharma GmbH Josef-Dietzgen-Str.
Danish: - CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Latvian: - Komiteja tāpēc secināja, ka citalopramu, escitalopramu, fluoksetīnu, fluvoksamīnu, mianserīnu, milnacipranu, mirtazapīnu, paroksetīnu, reboksetīnu, sertralīnu un venlafaksīnu saturošo zāļu aprakstā un attiecīgajā lietošanas instrukciju iedaļā ir jāiekļauj brīdinājums attiecībā uz uzvedības pazīmēm, kuras liecina par tieksmi uz pašnāvību (pašnāvības mēģinājumiem un domām par pašnāvību), kā arī naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedību un dusmas), un ka šīs pazīmes biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi;
Danish: 90 breve (med en måleske)
Latvian: 90 paciņas (ar dozēšanas karoti)
Danish: Denne oversigt blev sidst ajourført i 04-2019.
Latvian: Šis kopsavilkums pēdējo reizi atjaunināts 2019. gada aprīlī.
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Renvela i 2009 ("informeret samtykke").
Latvian: Šī reģistrācijas apliecība ir izsniegta, pamatojoties uz 2009. gadā izsniegto Renvela reģistrācijas apliecību ("informētu piekrišanu").
Danish: • voksne og børn fra 6 år og opefter med kronisk (langvarig) nyresygdom.
Latvian: • pieaugušiem un bērniem no 6 gadu vecuma ar hronisku (ilg-termiņa) nieru slimību.
Danish: • voksne patienter i dialyse (en teknik, hvor man fjerner uønskede stoffer fra blodet)
Latvian: • pieaugušiem pacientiem, kuriem veic dialīzi (procedūru nevēlamu vielu izvadīšanai no asinīm);
Danish: Yderligere information om Sevelamer carbonate Winthrop findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Latvian: Sīkāka informācija par Sevelamer carbonate Winthrop ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/pelmeg.
Danish: Sevelamer carbonate Winthrop fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015.
Latvian: Sevelamer carbonate Winthrop 2015. gada 15. janvārī saņēma reģistrācijas apliecību, kas derīga visā ES.
Danish: De hyppigste bivirkninger ved Sevelamer carbonate Winthrop (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning, smerter i den øvre del af maven og forstoppelse.
Latvian: Visbiežākās Sevelamer carbonate Winthrop blakusparādības (kas var rasties vairāk nekā 1 no 10 cilvēkiem) ir slikta dūša (nelabums), vemšana, sāpes vēdera augšdaļā un aizcietējums.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Sevelamer carbonate Winthrop løbende overvåget.
Latvian: Tāpat kā par visām zālēm, dati par Sevelamer carbonate Winthrop lietošanu tiek pastāvīgi uzraudzīti.
Danish: Sevelamer carbonate Winthrop fås som tabletter (800 mg) og som pulver (800 mg og 2,4 g), som skal tages tre gange om dagen sammen med et måltid.
Latvian: Sevelamer carbonate Winthrop ir pieejamas tabletēs (800 mg) un pulvera veidā (800 mg un 2,4 g) lietošanai 3 reizes dienā ēšanas laikā.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Sevelamer carbonate Winthrop.
Latvian: Zāļu aprakstā un lietošanas instrukcijā tika ietverti ieteikumi un piesardzības pasākumi, kas jāievēro veselības aprūpes speciālistiem un pacientiem, lai garantētu drošu un efektīvu Sevelamer carbonate Winthrop lietošanu.
Danish: I to hovedstudier hos 110 voksne med nyresygdom, som var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet til ca. 1,5-1,6 mmol/l (hvilket er inden for eller tæt på normalområdet), og det var lige så effektivt som et andet godkendt lægemiddel, Renagel.
Latvian: Divos pamatpētījumos 110 pieaugušajiem ar nieru slimību, kuriem veica dialīzi, Sevelamer carbonate Winthrop pazemināja fosfātu līmeni līdz aptuveni 1,5-1,6 mmol/l (kas atbilst normai vai ir tuvu tai) un bija tikpat efektīvas kā citas reģistrētās zāles Renagel.
Danish: I et tredje hovedstudie hos 49 voksne, som ikke var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet fra 2,0 mmol/l til 1,6 mmol/l.
Latvian: Trešajā pamatpētījumā ar 49 pieaugušajiem, kuriem neveica dialīzi, Sevelamer carbonate Winthrop pazemināja fosfātu līmeni no 2,0 mmol/l līdz 1,6 mmol/l.