natgillin/translations-raw huggingface dataset:
Indehaver af markedsføringstilladelse
1 Member State Marketing Authorisation Holder
Navn
(Invented)
Østrig
Route of administration
Wyeth- Lederle Pharma GmbH Storchengasse 1 1150 Wien Østrig
Austria Wyeth-Lederle Pharma GmbH Storchengasse 1 1150 Vienna Austria
Kapsler med modificeret udløsning, hårde
Modified-release capsule, hard
Wyeth Pharmaceuticals SA/ NV Rue du Bosquet, 15 1348 Louvain- la- Neuve Belgien
Wyeth Pharmaceuticals SA/ NV Rue du Bosquet,15 1348 Louvain-la-Neuve Belgium
Depotkapsler
Prolonged-release capsules
2 Belgien
Belgium
Wyeth- Lederle Pharma GmbH Storchengasse 1 A- 1150 Wien Østrig
Wyeth-Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Austria
Depotkapsler, hårde
Prolonged-release capsule, hard
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athen Grækenland
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens Greece
Wyeth- Lederle Pharma GmbH., Storchengasse 1 1150 Wien Østrig
Wyeth-Lederle Pharma GmbH., Storchengasse 1 1150 Vienna Austria
3 Danmark
3 Denmark
Box 1822 SE - 17124 Solna Sverige
Box 1822 SE - 17124 Solna Sweden
Wyeth Lederle Pharma GmbH Storchengasse 1 A- 1150 Wien Østrig
Wyeth Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Austria
Depotkapsler, hårde
Prolonged-release capsules, hard
Wyeth AB, Dalvägen 12, B. O. BOX 1822, 17124 Solna Sverige
Wyeth AB, Dalvägen 12, B. O. BOX 1822, 17124 Solna Sweden
4 Finland
4 Finland
Wyeth Pharmaceuticals France Coeur Défense - Tour A - La Défense 4 92931 Paris La Défense Cedex, Frankrig
Wyeth Pharmaceuticals France Coeur Défense - Tour A - La Défense 4 92931 Paris La Défense Cedex, France
Wyeth Pharma GmbH Wienburgstrasse 207, D- 48159 Münster Tyskland
Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
5 Tyskland
5 Germany
Depotkapsler
Prolonged-release capsule
6 Irland
6 Ireland
Depotkapsler
Prolonged release-Capsules
Depotkapsler, hårde
Prolonged-release hard capsules
7 Letland
7 Latvia
Box 255 2130 AG HOOFDDORP Holland
Box 255 2130 AG HOOFDDORP The Netherlands
Depotkapsler
Prolonged release capsules
9 Polen
9 Poland
António Loureiro Borges, 2 Arquiparque – Miraflores 1495- 131 Algés Portugal
António Loureiro Borges, 2 Arquiparque – Miraflores 1495-131 Algés Portugal
10 Rumænien
10 Romania
37, 5mg cps plg
37,5mg cps plg
37, 5mg
37.5mg
75 mg cps plg
75 mg cps plg
150 mg cps plg
150 mg cps plg
Wyeth Lederle Pharma GmbH
Wyeth Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Austria
EFECTIN ER
EFECTIN ER 150 mg trde 150 mg kapsule s podaljš anim sprošč anjem
VANDRAL RETARD
VANDRAL RETARD
75 mg 75 mg
75 mg 75 mg
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes, Spanien
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes, Spain
General Mitre, 151 08022 Barcelona Spanien
General Mitre, 151 08022 Barcelona Spain
Wyeth AB Box 1822 171 42 Solna, Sverige
Wyeth AB Box 1822 171 42 Solna, Sweden
Efexor Depot 37, 5 mg
Efexor Depot 37.5 mg
Efexor Depot 75 mg
Efexor Depot 75 mg
Efexor Depot 150 mg
Efexor Depot 150 mg
John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH Storbritanien
John Wyeth & Brother Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH United Kingdom
Efexor XL 75 mg
Efexor XL 75 mg
Kapsler med modificeret udløsning
Modified Release Capsule
12 Storbritanien
12 United Kingdom
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
14 FAGLIGE KONKLUSIONER
14 SCIENTIFIC CONCLUSIONS
Efexor depot er optaget på listen over produkter til harmonisering af produktresumé, der er opstillet af koordinationsgruppen for gensidig anerkendelse og decentrale procedurer – humanmedicinske anliggender (CMD( h)), i overensstemmelse med artikel 30, stk.
Efexor depot has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended.
Som følge af de divergerende nationale beslutninger, der er truffet af medlemsstaterne vedrørende godkendelsen af ovennævnte lægemiddel (og tilknyttede navne), har Europa- Kommissionen anmodet CHMP/ EMEA- sekretariatet om en officiel indbringelse i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, for at få afhjulpet forskellene mellem de nationalt godkendte produktresuméer og derved harmonisere de divergerende produktresuméer i hele EU Følgende afsnit i produktresuméet er blevet behandlet under denne harmoniseringsprocedure.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/ EMEA Secretariat of an official referral under Article 30 of Directive 2001/ 83/ EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Afsnit 4. 1 i produktresuméet - Terapeutiske indikationer Efter Europa- Kommissionens anmodning blev afsnit 4. 1 i produktresuméet harmoniseret, så følgende terapeutiske indikationer blev medtaget således som formuleret og beskrevet herunder:
SPC Section 4.1 - Therapeutic Indications Following the European Commission’ s request, Section 4.1 of the Summary of Product Characteristics was harmonized to include the following therapeutic indications as worded and described below:
- "Behandling af svære depressive episoder", uden henvisninger til hertil knyttet angst, da det af
- “ treatment of major depressive episodes”, with no inclusion of references to associated anxiety,
undersøgelserne, der er designet til at se nærmere på den anxiolytiske virkning af venlafaxin, fremgik, at det er vanskeligt at skelne mellem angsten og den samtidige depressionstilstand.
given that the studies designed to investigate the anxiolytic effect of venlafaxine revealed that it is difficult to distinguish anxiety from the concomitant depression disorder;
- "Forebyggelse af svære depressive episoder", som støttedes fyldestgørende af de fremlagte data.
- “ prevention of recurrence of major depressive episodes”, which was adequately supported by the
(Indikationen "forebyggelse af recidiv af depression" blev udelukket, da tilbagefaldsindikationen på basis af gældende EU- retningslinjer er omfattet, når indikationen svære depressive episoder godkendes).
(The “ prevention of relapse of depression” indication was excluded since, based on current EU guidelines, the relapse indication is encompassed when approval for the indication of major depressive episodes is granted).
Et mindretal af CHMP- medlemmerne var af den opfattelse, at denne indikation burde slettes fra afsnit 4. 1, og at der skulle medtages en erklæring i afsnit 4. 2 med angivelse af, at længerevarende behandling også kan være hensigtsmæssig til forebyggelse af recidiv af svære depressive episoder.
A minority of CHMP members were of the opinion that this indication should be deleted from section 4.1, and a statement should be included in section 4.2, to indicate that longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes.
- “ behandling af socialangst ” (tidligere socialfobi), når det tages i betragtning, at de fremlagte
- “ treatment of social anxiety disorder” (former social phobia), given that the studies presented
undersøgelsesresultater i tilstrækkelig grad underbyggede den kliniske effekt af Efexor depot til denne indikation,
adequately supported the clinical efficacy of Efexor depot in this indication;
- “ behandling af panikangst med eller uden agorafobi ”, når det tages i betragtning, at de fremlagte
- “ treatment of panic disorders with or without agoraphobia”, given that the data derived from the
undersøgelsesdata gav tilstrækkelig bevis for virkningen af og sikkerheden ved venlafaxin til denne indikation,
studies presented provided sufficient evidence for the efficacy and safety of venlafaxine in this indication;
- “ behandling af generaliseret angst ”, eksklusive “ behandling af specielle angsttilfælde ”, når det
- “ treatment of generalized anxiety disorder (GAD )” excluding “ treatment of special anxiety cases”,
tages i betragtning, at sidstnævnte ikke er en anerkendt DSM- indikation.
given that the latter is not a recognised DSM indication.
Afsnit 4. 2 i produktresuméet - Dosering og indgivelsesmåde Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere den følgende doseringstekst i produktresuméet:
SPC Section 4.2 - Posology and Method of Administration The MAH was asked to harmonise the following posology texts in the SPC:
- Begrænsninger af behandlingsvarighed til 4 uger for den maksimale daglige dosis på 375 mg
- limitations of treatment duration of the maximum daily dose of 375mg to 4 weeks;
- Forskelle i anbefalet maksimal daglig dosis.
- differences in maximum recommended daily dose.
CHMP mente, at en maksimal dosis Efexor depot på 375 mg/ dag er sikker og effektiv ved langtidsbehandling og anbefalede, at den godkendes uden tidsbegrænsninger i det harmoniserede produktresumé.
Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/ day Efexor depot is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonized SPC.
Der var enighed om, at langtidsvirkningen af venlafaxin som depottablet var underbygget af de fremlagte data til GAD- indikationen.
15 Generalised Anxiety Disorder (GAD): it was agreed that the long term efficacy of prolonged-release venlafaxine in the GAD indication was supported by the data provided.
Dokumentationen fra indehaveren af markedsføringstilladelsen blev anset for fyldestgørende til underbyggelse af doseringen til SAD- indikationen.
Social Anxiety Disorder (SAD): the MAH’ s documentation was considered adequate to support the posology of the SAD indication.
Der var ikke sikkerhedsproblemer forbundet med doser over 75 mg/ dag, som også kan være fordelagtige for nogle patienter.
No safety problems were associated with doses higher than 75mg/ day, which may also be beneficial for some patients.
Indehaveren af markedsføringstilladelsen blev anmodet om mere detaljeret analyse af benefit/ risk- forholdet for panik- indikationen, hvori sikkerheden og virkningen af dosen på 75 mg sammenlignes med dosen på 225 mg.
Panic Disorder:. the MAH was asked to discuss the risk/ benefit for the panic indication in more detail, comparing the safety and efficacy for the 75 mg dose with the suggested 225 mg dose.
CHMP var enig med indehaveren af markedsføringstilladelsen om, at patienter kan have nytte af, at dosen individualiseres inden for det effektive doseringsområde fra 75 til 225 mg.
The CHMP concurred with the MAH that patients may benefit from individualising the dose within the effective range of 75 to 225 mg.
Det blev desuden præciseret i produktresuméet, at dosisoptrapninger kun må ske efter en klinisk vurdering, og at den laveste effektive dosis skal opretholdes af hensyn til risikoen for dosisrelaterede bivirkninger.
It was also clarified in the SPC that dose increments should only be made after a clinical evaluation and that the lowest effective dose should be maintained, given the risk of dose- related adverse effects.
På basis af de offentliggjorte data, der rejser spørgsmålet om muligheden for nedsat nyrefunktion og potentielle ændringer i neurotransmitterfølsomhed og sammenhæng med aldring, enedes man om en ny formulering for anvendelse til ældre patienter i produktresuméet.
Use in elderly patients: based on published data raising the possibility of renal impairment and the potential for changes in neurotransmitter sensitivity and affinity with aging, a new wording for use in elderly patients was agreed in the SPC.
"Specifikke dosisjusteringer anses ikke for nødvendige på basis af patientens alder alene".
It was agreed that “ No specific dose adjustments are considered necessary based on patient age alone”.
"Det anbefales ikke at anvende Venlafaxin til børn og unge".
Use in children and adolescents under the age of 18 years: it was agreed that “ Venlafaxine is not recommended for use in children and adolescents”.
Endvidere blev der medtaget en erklæring i det harmoniserede produktresumé for at påpege, at kontrollerede undersøgelser af børn ikke påviste effekt af venlafaxin til indikationen "major depression".
Furthermore, a statement was included in the harmonized SPC to highlight that controlled studies in children did not demonstrate efficacy of venlafaxine in the “ major depressive disorder” indication.
Der var enighed om i produktresuméet at anbefale individualisering af dosis for at komme ud over clearance- afvigelighed mellem patienter med nedsat leverfunktion.
Use in patients with hepatic impairment: it was agreed to recommend in the SPC the individualization of dosage to overcome clearance variability between patients with hepatic impairment.
Der var enighed om, at individualisering af dosis kan være ønskelig, og dette begreb blev indført i teksten til harmonisering.
Use in patients with renal impairment: it was agreed that the individualisation of the dosage may be desirable, and this concept was introduced in the text for harmonization.
På basis af en påtænkt tekst til produktresumkéet for selektive serotoningenoptagelseshæmmere (SSRI' er) / selektive noraldrenalingenoptagelseshæmmere (SNRI' er) (afsnit 4. 2, 4. 4 og 4. 8) gennemgået af arbejdsgruppen vedrørende lægemiddelovervågning blev det vedtaget at medtage denne tekst i det harmoniserede produktresumé.
Withdrawal symptoms seen on discontinuation of venlafaxine: based on a proposed text for the SPC for for Selective Serotonin Reuptake Inhibitors (SSRIs) / Selective Norepinephrine Reuptake Inhibitors (SNRIs) (Sections 4.2, 4.4, and 4.8) reviewed by the Pharmacovigilance Working Party, it was agreed to incorporate this text into the harmonised SPC.
Afsnit 4. 3 i produktresuméet - kontraindikationer Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4. 3 i produktresuméet, hvori følgende forskelle mellem produktresuméerne skulle vurderes:
SPC Section 4.3 - Contraindications The MAH was asked to harmonise Section 4.3, for which the following differences between SPCs needed to be evaluated:
- Monoaminooxidasehæmmere (MAO- hæmmere)
- Monoamine oxidase inhibitors (MAOIs);
- Kardiovaskulær sikkerhed
- Cardiovascular safety
- Ukontrolleret hypertension
- Uncontrolled hypertension.
Indehaveren af markedsføringstilladelsen var af den opfattelse, at alle MAO- hæmmere skulle være kontraindicerede sammen med venlafaxin.
However, the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.4 and Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
CHMP mente dog, at kun non- selektive irreversible MAO - hæmmere skal være kontraindicerede, og at en kraftig advarsel i afsnit 4. 4 og afsnit 4. 5 i
With regards to cardiovascular safety, it was agreed that a contraindication was not warranted and that a revised wording for Section 4.4 was sufficient.
Produktresuméet blev ændret, så det afspejler CHMP' s opfattelse.
16 The MAH was of the view that a contraindication in patients with uncontrolled hypertension was not warranted.
Som følge heraf var CHMP enig i, at en kontraindikation for patienter med ukontrolleret hypertension ikke var berettiget.
Given that strong warnings recommending the monitoring of blood pressure for all patients prior to the initiation of treatment were included in Section 4.4, the CHMP agreed that a contraindication in patients with uncontrolled hypertension was not warranted.
Afsnit 4. 4 i produktresuméet - særlige advarsler og forsigtighedsregler vedrørende brugen Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere pkt.
SPC Section 4.4 - Special Warnings and Precautions for Use The MAH was asked to harmonise Section 4.4, for which the following differences between SPCs needed to be evaluated:
- Omtalen af indberetninger om aggression i relation til indledning og ophør af behandling
- the mentioning of reports of aggression in relation to starting and discontinuing treatment;
- Behandling af børn og unge under 18 år, som CHMP i 2005 anbefalede medtaget i afsnit 4. 4 i
- treatment of children and adolescents under the age of 18, which was recommended by the CHMP in
produktresuméet (Kommissionens beslutning af 19. august 2005) Med hensyn til de indberettede tilfælde af aggression enedes man om at indføre en tekst for at angive, at aggression kan forekomme under indledning, dosisændringer og seponering af behandling hos patienter, der får venlafaxin.
2005 to be included in Section 4.4 of the SPC (Commission Decision of 19-VIII-2005); With regards to the aggression reports, it was agreed to introduce a wording to indicate that aggression may occur in patients receiving venlafaxine, under initiation, dose changes and discontinuation of treatment.
En advarsel om brugen af Efexor depot til behandling af børn og unge under 18 år blev også vedtaget og indført i afsnit 4. 4.
A warning on the use of Efexor depot in the treatment of children and adolescents under the age of 18 years was also agreed upon and introduced in Section 4.4.
Afsnit 4. 5 i produktresuméet - interaktion med andre lægemidler og andre former for interaktion Indehaveren af markedsføringstilladelsen blev anmodet om at harmonisere afsnit 4. 5 i produktresuméet, hvori følgende forskelle mellem produktresuméerne skulle vurderes:
SPC Section 4.5 - Interaction with other medicinal products and other forms of interaction The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated:
- Monoaminooxidase- hæmmere.
- monoamine oxidase inhibitors.
Indehaveren af markedsføringstilladelsen ønskede at fastholde, at alle MAO- hæmmere skulle være kontraindicerede, mens CHMP mente, at kun non- selektive irreversible MAO- hæmmere skulle være kontraindicerede, og at en kraftig advarsel i afsnit 4. 5 i produktresuméet burde være tilstrækkelig for de reversible MAO- hæmmere.
The MAH wished to maintain that all MAOIs should be contraindicated whereas the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Produktresuméet blev ændret i overensstemmelse med CHMP' s opfattelse.
The SPC was amended according to the CHMP position.
I den harmoniserede tekst under afsnit 4. 4 anføres det, at non- selektive MAO- hæmmere ikke må gives samtidigt, og at reversible selektive MAO- hæmmere, såsom moclobemid, ikke anbefales i kombination med venlafaxin som følge af risikoen for serotoninsyndrom.
In the harmonized text of Section 4.4 it is indicated that non-selective MAOIs should not be given concomitantly, and that reversible, selective MAOIs such as moclobemide are not recommended in combination with venlafaxine, due to the risk of serotonin syndrome.
Afsnit 4. 8 i produktresuméet - bivirkninger Indehaveren af markedsføringstilladelsen blev anmodet om at identificere forskellene mellem de anførte bivirkninger i de nationalt godkendte produktresuméer og indehaverens CDS (Core Data Sheet) og om at organisere afsnit 4. 8 i overensstemmelse med MedDRA- systemets organklasser.
SPC Section 4.8 - Undesirable effects The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH’ s CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Indehaveren af markedsføringstilladelsen gennemførte vurderingen af urinvejssygdomme og forekomsten af gastrointestinal blødning og indvilligede i at føje dem til skemaet over bivirkninger.
The MAH completed both the assessment of urinary disorders and of occurrence of gastrointestinal haemorrhage, and agreed to add them to the adverse reaction table.
Indehaveren af markedsføringstilladelsen var ikke enig i den af PhVWP/ CMD( h) godkendte tekst til produktresuméet for alle antidepressiva til afsnit 4. 8, da selvmordstanker ikke anses for en bivirkning hos voksne patienter, indehaveren indvilligede dog i at overholde den obligatoriske klassemærkning.
The MAH did not agree with the PhVWP/ CMD(h) agreed SPC wording for all antidepressants for Section 4.8, since suicidal ideation is not considered an adverse reaction in adult patients, but agreed to comply with the mandated class labelling.
17 BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL
17
- Forslaget til produktresumé, etikettering og indlægsseddel fra indehaveren af
- the Summaries of Products Characteristic, labelling, package leaflet proposed by the Marketing
markedsføringstilladelsen blev vurderet på basis af den indsendte dokumentation og den faglige drøftelse i udvalget.
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
19 PRODUKTRESUME
19 SUMMARY OF PRODUCT CHARACTERISTICS
Efexor Depot og tilhørende navne (se bilag I) 37. 5 mg depotkapsler, hårde Efexor Depot og tilhørende navne (se bilag I) 75 mg depotkapsler, hårde Efexor Depot og tilhørende navne (se bilag I) 150 mg depotkapsler, hårde
Efexor depot and associated names (see Annex I) 37.5 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 75 mg hard prolonged-release capsules Efexor depot and associated names (see Annex I) 150 mg hard prolonged-release capsules
Depotkapsel, hård.
Hard prolonged-release capsule.
Behandling af Major Depression (ICD- 10 ” Moderat til svær depressiv episode ”).
Treatment of major depressive episodes.
Major Depression Den anbefalede startdosis for venlafaxin depotkapsler er 75 mg 1 gang dagligt.
The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily.
Patienter, som ikke responderer på startdosen på 75 mg dagligt, kan have fordel af forøgelser af dosis op til en maksimal dosis på 375 mg dagligt.
Patients not responding to the initial 75 mg/ day dose may benefit from dose increases up to a maximum dose of 375 mg/ day.
4. 4).
21 Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4).
21 Generaliseret angst Den anbefalede startdosis for venlafaxin depotkapsler er 75 mg 1 gang dagligt.
The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily.
Patienter, som ikke responderer på startdosen på 75 mg dagligt, kan have fordel af forøgelser af dosis til maksimalt 225 mg dagligt.
Patients not responding to the initial 75 mg/ day dose may benefit from dose increases up to a maximum dose of 225 mg/ day.
4. 4).
Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4).
Socialfobi Den anbefalede dosis for venlafaxin depotkapsler er 75 mg 1 gang dagligt.
The recommended dose for prolonged-release venlafaxine is 75 mg given once daily.
Til enkelte patienter, som ikke responderer på initialdosen på 75 mg dagligt, kan det overvejes at øge dosis op til en maksimal dosis på 225 mg/ dag.
However, in individual patients not responding to the initial 75 mg/ day, increases up to a maximum dose of 225 mg/ day may be considered.
Panikangst Det anbefales at anvende en dosis venlafaxin depotkapsel på 37, 5 mg dagligt i 7 dage.
It is recommended that a dose of 37.5 mg/ day of prolonged-release venlafaxine be used for 7 days.
Dosis skal derefter forøges til 75 mg dagligt.
Dosage should then be increased to 75 mg/ day.
Patienter, som ikke responderer på dosen på 75 mg dagligt, kan have fordel af forøgelser af dosis op til maksimalt 225 mg dagligt.
Patients not responding to the 75 mg/ day dose may benefit from dose increases up to a maximum dose of 225 mg/ day.
Anvendelse til ældre patienter Det anses ikke for nødvendigt med specifikke dosisjusteringer af venlafaxin alene på grundlag af patientens alder.
22 No specific dose adjustments of venlafaxine are considered necessary based on patient age alone.