natgillin/translations-raw huggingface dataset:
• Inflammation of the nose and throat • Inflammation of the sinuses • Fungal infection • Anxiety • Sinus headache • High or increased blood pressure • Diarrhoea • Pain in the upper part of the abdomen • Dry mouth • Back pain • Pain • Changes in some blood tests (amount of glucose in blood or tests of liver function).
• Vnetje nosu in grla • Vnetje sinusov • Glivična infekcija • Anksioznost • Sinusni glavobol • Visok ali zvišan krvni tlak • Diareja • Bolečina v zgornjem delu trebuha • Suha usta • Bolečina v hrbtu • Bolečina • Spremembe pri nekaterih krvnih testih (količina glukoze v krvi ali testi jetrne funkcije).
Rare side effects The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Redki neželeni učinki Redki neželeni učinki, ki se lahko pojavijo (prizadenejo 1 do 10 uporabnikov na 10. 000 uporabnikov) med zdravljenjem z zdravilom ORACEA:
• Allergic (hypersensitivity) reaction throughout the body* • Changes in the number or type of certain blood cells • Increased pressure in the brain
• Alergijska (preobčutljivostna) reakcija po vsem telesu * • Spremembe v številu ali tipu določenih krvnih celic • Zvišan tlak v možganih • Vnetje membrane, ki obdaja srce
25 • Inflammation of the membrane surrounding the heart • Nausea, vomiting, anorexia • Liver damage • Skin rashes or hives • Abnormal reaction of the skin to sunlight • Increased level of urea in the blood
26 • Slabost, bruhanje, anoreksija • Jetrna poškodba • Kožni izpuščaji ali koprivnica • nenormalna reakcija kože na sončno svetlobo • Zvišan nivo sečnine v krvi
Very rare side effects The following side effects may occur very rarely (affects less than 1 user in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Zelo redki neželeni učinki Zelo redki neželeni učinki, ki se lahko pojavijo (prizadenejo manj kot 1 uporabnika na 10. 000 uporabnikov) med zdravljenjem z zdravilom ORACEA:
• Allergic reaction causing swelling of the eyes, lips or tongue* • Yeast infection around the anus or genitals • Damage to red blood cells (haemolytic anaemia) • Inflammation of the tongue • Difficulty in swallowing • Inflammation of the intestine • Inflammation or ulceration of the gullet • Inflammation of the skin causing flakiness • Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
• Alergijska reakcija, ki povzroči otekanje oči, ustnic ali jezika * • Infekcija s kvasovkami okoli anusa ali genitalij • Poškodbe rdečih krvnih celic (hemolitična anemija) • Vnetje jezika • Težave s požiranjem • Vnetje črevesja • Vnetje ali razjede požiralnika • Vnetje kože, ki povzroči luskavost • Poslabšanje bolezni imunskega sistema, ki je poznana kot sistemski eritematozni lupus (SLE)
Hypromellose[piq-qrd1], methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry beige YS-1-17274-A (hypromellose 3cP/ 6cP, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80), sugar spheres (maize starch, sucrose).
Pomožne snovi so: hipromeloza[ piq- qrd1], kopolimer metakrilna kislina- etil akrilat (1: 1), trietilcitrat, smukec, opadry beige YS- 1- 17274- A (hipromeloza 3cP/ 6cP, titanov dioksid, makrogol 400, rumeni železov oksid, rdeči železov oksid, polisorbat 80), sladkorji (koruzni škrob, saharoza).
26 Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no.
27 Tiskarsko črnilo: šelak, propilenglikol, črn železov oksid, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C rumen št.
10 aluminium lake, Opacode black S-1-8115, Opacode black S-1-8114.
10 aluminium lake, Opacode črn S- 1- 8115, Opacode črn S- 1- 8114.
The capsules are beige in colour and bear the marking “ CGPI 40”.
Kapsule so beige barve in imajo oznako “ CGPI 40 ”.
This medicinal product is authorised in the Member States of the EEA under the following names:
To zdravilo je odobreno v državah članicah EEA pod naslednjimi imeni:
SE - ORACEA 40 mg modified release hard capsules UK - ORACEA 40 mg modified release hard capsules DE - ORACEA 40 mg modified release hard capsules IE - ORACEA 40 mg modified release hard capsules AT - ORACEA 40 mg modified release hard capsules FI - ORACEA 40 mg modified release hard capsules LU - ORACEA 40 mg modified release hard capsules NL - ORACEA 40 mg modified release hard capsules IT - ORACEA 40 mg modified release hard capsules
SE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem UK - ORACEA 40 mg trde kapsule s prirejenim sproščanjem DE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem IE - ORACEA 40 mg trde kapsule s prirejenim sproščanjem AT - ORACEA 40 mg trde kapsule s prirejenim sproščanjem FI - ORACEA 40 mg trde kapsule s prirejenim sproščanjem LU - ORACEA 40 mg trde kapsule s prirejenim sproščanjem NL - ORACEA 40 mg trde kapsule s prirejenim sproščanjem IT - ORACEA 40 mg trde kapsule s prirejenim sproščanjem
27 ANNEX IV
28 DODATEK IV
CONDITIONS OF THE MARKETING AUTHORISATION(S)
POGOJI DOVOLJENJ( A) ZA PROMET
28 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
29 Pristojni nacionalni organi, ki jih koordinira referenčna država članica, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
The Applicant should further agree to complete this study and file a report within a reasonable period of time (e. g.
Predlagatelj se mora tudi strinjati, da opravi omenjeno študijo in vloži poročilo v primernem obdobju (npr.
London, 23 July 2008 EMEA/ CHMP/ 428671/ 2008
London, 23. julij 2008 EMEA/ 427601/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA ZDRAVILO Oracea
International Non-Proprietary Name (INN): doxycycline monohydrate
Mednarodno nelastniško ime (INN): doksiciklin monohidrat
The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
Decentralizirani postopek UK/ H/ 0892/ 01/ DC se je pričel 12. aprila 2006.
The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions.
Poročevalec je bil dr.
The Rapporteur was Dr Tomas Salmonson (SE) and Co-Rapporteur was Dr Ian Hudson (UK).
Ian Hudson (Združeno kraljestvo).
The list of the medicinal product names concerned is given in Annex I.
Seznam zadevnih imen zdravil je naveden v Dodatku I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
29 March 2005 CHMP/ 187488/ 2004
29. marec 2005 CHMP/ 187488/ 2004
Paroxetine is a phenylpiperidine derivative and is a selective inhibitor of the presynaptic 5- hydroxytryptamine (5-HT) reuptake.
Paroksetin je fenilpiperidinski derivat ter selektivni zaviralec presinaptičnega ponovnega privzema 5 - hidroksitriptamina (5- HT).
Paroxetine was first approved in 1990 as an antidepressant in the U. K.
Paroksetin so prvič odobrili leta 1990 v Združenem kraljestvu kot antidepresiv.
On 13 June 2003, UK referred the matter to the EMEA under Article Article 31 of Directive 2001/ 83/ EC, as amended, for paroxetine containing medicinal products.
Dne 13. junija 2003 je Združeno kraljestvo napotilo zadevo na EMEA po 31. členu Direktive 2001/ 83/ ES, kot je bila dopolnjena, za zdravila, vsebujoča paroksetin.
The Rapporteur and Co-Rapporteur appointed were:
Poročevalec (Rapporteur) in so- poročevalec (Co - rapporteur) sta bila dr.
Dr.
F.
Lekkerkerker and Dr.
Lekkerkerker in dr.
During the referral procedure Dr.
Med samim postopkom je dr.
B. van Zwieten Boot took over the Rapporteurship from Dr.
B. van Zwieten Boot prevzela poročevalsko nalogo od dr.
Lekkerkerker and Dr.
Lekkerkerkerja, dr.
Rotblat took over from Dr.
Rotblat pa je nadomestila dr.
Written explanations were provided by the Marketing Authorisation Holder by 1 September 2003, 13 February 2004, 2 April 2004 and 16 April 2004.
Pisne obrazložitve je imetnik dovoljenja za promet predložil do 1. septembra 2003, 13. februarja 2004, 2. aprila 2004 in 16. aprila 2004.
Oral explanations were given on 20 April 2004.
Ustna obrazložitev je bila podana dne 20. aprila 2004.
Based on evaluation of the available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of paroxetine containing medicinal products remains favourable.
Na podlagi ovrednotenja razpoložljivih podatkov in na podlagi poročil o oceni zdravila (Rapporteurs 'assesment reports), je CHMP menil, da razmerje med tveganji in koristmi za zdravila, vsebujoča paroksetin, ostaja ugodno.
The CHMP adopted an opinion on 22 April 2004.
CHMP je mnenje sprejel dne 22. aprila 2004.
The final CHMP opinion was adopted on 8 December 2004 recommending the variation of the Marketing Authorisations in accordance with the Summary of Product Characteristics for paroxetine containing medicinal products.
8. decembra 2004 pa je bilo sprejeto končno mnenje CHMP, ki priporoča spremembo dovoljenja za promet z zdravilom v skladu s Povzetkom glavnih značilnosti zdravila za zdravila, vsebujoča paroksetin.
Major depressive episode Obsessive compulsive disorder Panic disorder with and without agoraphobia Social anxiety disorders / social phobia Generalised anxiety disorder Post-traumatic stress disorder
velike depresivne epizode obsesivno kompulzivne motnje panične motnje z agorafobijo ali brez nje motenj socialne anksioznosti/ socialne fobije motnje generalizirane anksioznosti posttravmatske stresne motnje
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The list of product names concerned is given in the Annex I.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Seznam zadevnih imen proizvodov je naveden v Dodatku I.
The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Znanstveni zaključki so podani v Dodatku, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III ter pogoji dovoljenja za promet z zdravilom v Dodatku IV.
Notes:
* Opombe:
The information given in this document and Annexes reflect only the CHMP Opinion dated 8 December 2004.
Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP datirano z 8. decembrom 2004.
For more information please refer to: http: / /www. emea. eu. int/ pdfs/ human/ referral/ SSRIs/ 29783705en. pdf http: / /www. emea. eu. int/ pdfs/ human/ referral/ SSRIs/ EMEA-H-A-31-651-SSRIs-en. pdf
Za dodatne informacije glejte: http: // www. emea. eu. int/ pdfs/ human/ referral/ SSRIs/ 29783705en. pdf http: // www. emea. eu. int/ pdfs/ human/ referral/ SSRIs/ EMEA- H- A- 31- 651- SSRIs- en. pdf
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
20 mg
Filmsko obložena
Paroxetine Bexal 40 mg
Bexal
40 mg
Paroxetine Bexal 40 mg
 EMEA 2005
Suspension orale
Cyprus
Box 51407 3505 Lemesos Cyprus
7/ 72
7/ 73
 EMEA 2005
Peroralna uporaba
12/ 72
12/ 73 tableta
Paroxetinhexal 20
Paroxetinhexal
20 mg
Nemčija
Oral use
Paroxistad 20 mg
Oral use
Paroxetin AL 20 mg
Film-coated tablet
Alpharma- ISIS GmbH & Co. KG
CHMP/ 187488/ 2004
Paroxetin- Isis 20 mg
17/ 72
20 mg
 EMEA 2005
Filmsko obložena
Germany
Peroralna uporaba
20 mg 20 mg
Nemčija
Film-coated tablet
Paroxetin Sandoz 20 mg
Film-coated tablet
Paroxetin beta 20 mg
Film-coated tablet
Paroxetin beta 40 mg
Oral use
40 mg
40 mg 40 mg
tableta
Oral use
18/ 73
Paroxetin-biomo 20 mg
Nemčija
Paroc 20 mg Filmtabletten
Paroc
Germany
21/ 73
Paroxedura 20 mg Filmtabletten
Paroxedura 20 mg
Paretin
Paretin 20 mg
Oral use
23/ 73
 EMEA 2005
Madžarska
Rextine 20 mg filmtabletta
Rextine
Oral use
Filmsko obložena
Hungary
Peroralna uporaba
BV P. O. Box 75 6920 Ab Duiven The Netherlands
P. O. Box 75 6920 Ab Duiven The Netherlands
Oral use
33/ 73
Multipharma BV, Gemeenschapspolderweg 28 P. O. Box 216 1382 Gr Weesp The Netherlands
Multipharma BV,
MP-Paroxetine 20 mg
MP- Paroxetine
34/ 72
tableta
Poland
Homera 46, 04- 624 Warsaw Poland
Poland
Domaniewska 50C 02- 672 Warsaw Poland
Paroxetina Biara 20 mg Comprimidos Revestidos
20 mg Comprimidos Revestidos
Paroxetina APS 20 mg Comprimidos Revestidos
Paroxetina APS
Paroxetina Bexal 20 mg Comprimido revestido por película
Paroxetina Bexal 20 mg
Laboratórios Azevedos – Indústria Farmacêutica, S. A.
Instituto Luso- Fármaco, Lda.
20 mg
mg
 EMEA 2005
Portugalska
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
de Produtos Farmacêuticos, Lda.
Paroxetina Ratiopharm 20 mg Comprimidos
Ratiopharm 20 mg Comprimidos
Slovac Republic
Slovaška
A/ S GEA Farmaceutisk Fabrik Holger Danskaes Vej 89 2000 Fraderiksberg Denmark
A/ S GEA Farmaceutisk Fabrik
CHMP/ 187488/ 2004
Holger Danskaes Vej 89 2000 Fraderiksberg Denmark
38/ 72
tableta
20 mg tbl flm 20 mg
20 mg tbl flm
Slovac Republic
Peroralna uporaba
30 mg tbl flm 30 mg
30 mg tbl flm
Film-coated tablet
30 mg
CHMP/ 187488/ 2004
Peroralna uporaba
20 mg
mg Filmsko obložena
Film-coated tablet
mg Filmsko obložena
Ronda de Poniente 16 28760-Tres Cantos, Madrid Spain
Ronda de Poniente 16
Casbol 20 mg comprimidos con cubierta pelicular
comprimidos
Film-coated tablet
28760- Tres Cantos, Madrid Spain
Oral use
con cubierta pelicular
Ratiopharm España S. A.
Peroralna uporaba
Coated
Obložena tableta
tablet
Peroralna uporaba
Oral use
Tamarang
United Kingdom
Velika
United Kingdom
EMEA 2005 CHMP/ 187488/ 2004 Britanija
United Kingdom
Britanija
20 mg
Velika
46/ 72
Filmsko obložena
Oral use
47/ 73
CHMP/ 187488/ 2004
Stockley Park West
47/ 72
Hydrochloride
 EMEA 2005
ZA DOPOLNILO POVZETKOV GLAVNIH
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENO S STRANI EVROPSKE AGENCIJE ZA VREDNOTENJE ZDRAVIL (European Agency for Evaluation of Medicinal Products- EMEA)
CHMP/ 187488/ 2004 SCIENTIFIC CONCLUSIONS
EMEA 2005 CHMP/ 187488/ 2004 ZNANSTVENI ZAKLJUČKI
Paroxetine is a phenylpiperidine derivative and is a potent and selective inhibitor of the presynaptic 5- hydroxytryptamine (5-HT) reuptake.
Paroksetin je fenilpiperidinski derivat ter močan in selektivni zaviralec presinaptičnega ponovnega privzema 5- hidroksitriptamina (5- HT).
Paroxetine was first approved in 1990 as an antidepressant in the U. K.
Paroksetin so prvič odobrili leta 1990 kot antidepresiv v Veliki Britaniji.
The indications for which paroxetine is currently approved in EU includemajor depressive disorder (MDD), panic disorder, obsessive compulsive disorder (OCD), social phobia/ social anxiety disorder (SAD), generalised anxiety disorder (GAD) and post-traumatic stress disorder (PTSD).
Indikacije, za katere je paroksetin trenutno odobren v EU, vključujejo veliko depresivno motnjo (major depressive disorder, MDD), panično motnjo, obsesivno kompulzivno motnjo (obsessive compulsive disorder, OCD), socialno fobijo/ socialno anksiozno motnjo (social anxiety disorder, SAD), generalizirano anksiozno motnjo (generalised anxiety disorder, GAD) in posttravmatsko stresno motnjo (post- traumatic stress disorder, PTSD).
Clinical trials, which have included gradual dose reduction at the end of treatment, have found that 30% of patients developed symptoms following discontinuation of treatment with paroxetine compared to 20% among those stopping placebo.
V kliničnih preskušanjih, kjer so ob koncu zdravljenja postopoma nižali odmerke, so ugotovili, da so se pri 30% bolnikov po ukinitvi zdravljenja s paroksetinom pojavili simptomi v primerjavi z 20% tistih, ki so prejemali placebo.
The issue of suicidal behaviour among patients treated with paroxetine has been addressed in the past in literature and at national level in some Member States.
V preteklosti so se problema samomorilnega vedenja med bolniki, zdravljenimi s paroksetinom, v nekaterih državah članicah lotili v literaturi in na nacionalni ravni.
Various analyses suggested that the risk of these outcomes was between 1.5 and 3.2 times greater with paroxetine compared to placebo.
Različne analize so pokazale, da je tveganje za te izide 1, 5 - do 3, 2- krat večje pri paroksetinu v primerjavi s placebom.
On 13 June 2003, UK triggered a referral to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, to medicinal products containing paroxetine.
13. junija 2003 je Velika Britanija sprožila napotilo EMEA po 31. členu Direktive 2001/ 83/ ES, kot je bila dopolnjena, za zdravila, vsebujoča paroksetin.
Based on the above data concerning withdrawal reactions and suicidal behaviour, UK considered that there was Community interest to reassess the balance of risks and benefits of paroxetine and requested the CHMP to give an opinion on whether the marketing authorisations for paroxetine containing medicinal products should be maintained, varied or withdrawn.
Na podlagi zgoraj navedenih podatkov o odtegnitvenih reakcijah in samomorilnem vedenju, so v Veliki Britaniji ocenili, da naj se v Skupnosti ponovno oceni razmerje tveganj in koristi paroksetina in zaprosili Odbor za lastniška zdravila (CHMP
EFFICACY A discussion on the efficacy of paroxetine containing medicinal products took place in CHMP based on the Rapporteur´s and Co-Rapporteur´s Assessment Reports and the data presented by the Marketing Authorisation Holders (MAHs).
UČINKOVITOST V CHMP so na podlagi poročil o oceni zdravila (Rapporteur´s in Co- Rapporteur´s Assessment Reports) in podatkov, ki so jih predstavili imetniki dovoljenj za promet z zdravilom (Marketing Authorisation Holders, MAHs), razpravljali o učinkovitosti zdravil, vsebujočih paroksetin.
Major Depressive Episode The efficacy of paroxetine in treating major depression in adults is established and supported by numerous short and long-term trials.
Velika depresivna epizoda Učinkovitost paroksetina pri zdravljenju velike depresije pri odraslih ugotavljajo in potrjujejo številna kratkotrajna in dolgotrajna preskušanja.
The long-term efficacy of paroxetine in depression has been demonstrated in a 52 week maintenance study with relapse prevention design:
Dolgoročno učinkovitost paroksetina pri depresiji so dokazali v 52- tedenski vzdrževalni študiji z zasnovo preprečevanja relapsov:
12% of patients receiving paroxetine (20-40mg daily) relapsed, versus 28% of patients on placebo.
12% bolnikov, ki so prejemali paroksetin (20- 40 mg dnevno), je doživelo relaps v primerjavi z 28% bolnikov, ki so prejemali placebo.
Obsessive Compulsive Disorder The efficacy of paroxetine in treating OCD in adults was investigated in short-term and long-term studies.
Obsesivno kompulzivna motnja Učinkovitost paroksetina pri zdravljenju OCD pri odraslih so raziskovali v kratkotrajnih in dolgotrajnih študijah.
The long-term
V nekaterih kratkotrajnih študijah so dobili značilne in pomembne rezultate.
efficacy of paroxetine in treating OCD was examined in three 24 week maintenance studies with relapse prevention design.
Dolgoročno učinkovitost paroksetina pri zdravljenju OCD so preiskovali v treh 24- tedenskih vzdrževalnih študijah z zasnovo preprečevanja relapsa.
One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).
V eni od treh študij so dosegli značilno razliko v deležu bolnikov z relapsom med paroksetinom (38%) v primerjavi s placebom (59%).
Panic Disorder The efficacy of paroxetine in the treatment of panic disorders in adults was investigated in some short- term and long-term studies.
Panična motnja Učinkovitost paroksetina pri zdravljenju paničnih motenj pri odraslih so raziskovali v nekaterih kratkotrajnih in dolgotrajnih študijah.
The long-term efficacy of paroxetine in treating panic disorder was demonstrated in a 24 week maintenance study with relapse prevention design:
Dolgoročno učinkovitost paroksetina pri zdravljenju panične motnje so pokazali v 24 - tedenski vzdrževalni študiji z zasnovo preprečevanja relapsa:
5% of patients receiving paroxetine (10-40mg daily) relapsed, versus 30% of patients on placebo.
5% bolnikov, ki so prejemali paroksetin (10- 40 mg dnevno), je doživelo relaps v primerjavi s 30% bolnikov, ki so prejemali placebo.
This was supported by a 36 week maintenance study.
To so potrdili v 36- tedenski vzdrževalni študiji.
Social Anxiety Disorder / Social Phobia The efficacy of paroxetine in the treatment of social anxiety disorders in adults was investigated in some short-term and long-term studies.
Motnja socialne anksioznosti / socialna fobija Učinkovitost paroksetina pri zdravljenju motenj socialne anksioznosti pri odraslih so preiskovali v nekaterih kratkotrajnih in dolgotrajnih študijah.
Generalised Anxiety Disorder The efficacy of paroxetine in the treatment of GAD in adults was investigated in some short-term and long-term studies.
Motnja generalizirane anksioznosti Učinkovitost paroksetina pri zdravljenju GAD pri odraslih so raziskovali v nekaterih kratkotrajnih in dolgotrajnih študijah.
Significant and relevant results were obtained in the short-term but not in the long- term studies and therefore the CHMP concluded that the long-term efficacy has not been sufficiently demonstrated.
V kratkotrajnih študijah so dobili značilne in pomembne rezultate, ne pa tudi v dolgotrajnih študijah, zato so v CHMP zaključili, da dolgoročna učinkovitost ni bila zadostno dokazana.
Post-traumatic Stress Disorder The efficacy of paroxetine in the treatment of PTSD in adults was investigated in some short-term and long-term studies.
Posttravmatska stresna motnja Učinkovitost paroksetina pri zdravljenju PTSD pri odraslih so raziskovali v nekaterih kratkotrajnih in dolgotrajnih študijah.
On the basis of the assessed data the CHMP concluded that paroxetine is effective in the treatment of major depressive episode, obsessive compulsive disorder, panic disorder with and without agarophobia, social anxiety disorder/ social phobia, generalised anxiety disorder and post-traumatic stress disorder.
Na podlagi ocenjenih podatkov so v CHMP zaključili, da je paroksetin učinkovit pri zdravljenju velike depresivne epizode, obsesivno kompulzivne motnje, panične motnje z agorafobijo ali brez nje, motnje socialne anksioznosti/ socialne fobije, motnje generalizirane anksioznosti in posttravmatske stresne motnje.
The CHMP also agreed that the above-mentioned information with regards to long- term efficacy should be included in section 5.1 (Pharmacodynamic Properties) of the Summary of Product Characteristics (SPC).
V CHMP so tudi soglašali, da je treba zgoraj navedene podatke glede dolgoročne učinkovitosti vključiti v poglavje 5. 1 (Farmakodinamične lastnosti) v Povzetku glavnih značilnosti zdravila (Summary of Product Characteristics, SPC).
Posology The CHMP also considered the available data supporting the recommended posology for each of the above indications.
Odmerjanje V CHMP so upoštevali tudi razpoložljive podatke, potrjujoče priporočeno odmerjanje za vsako od zgornjih indikacij.
The recommended daily dose of paroxetine is 40mg/ day for OCD and panic disorder and 20mg/ day for the other indications.
Priporočeni dnevni odmerek paroksetina je 40 mg/ dan za OCD in panično motnjo ter 20 mg/ dan za druge indikacije.