FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 30x1, 50x1, 90x1 and 100x1 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER / 30, 30x1, 50x1, 90x1 og 100x1 tabletter
English: Aluminium perforated unit-dose blisters in cardboard cartons containing 30x1, 50x1, 90x1 and 100x1 film-coated tablet.
Danish: Perforerede enkeltdosisblistere af aluminium i kartonæsker indeholdende 30x1, 50x1, 90x1 og 100x1 filmovertrukne tabletter.
English: EU/1/10/619/008 14 film-coated tablets EU/1/10/619/009 28 film-coated tablets EU/1/10/619/010 30x1 film-coated tablet EU/1/10/619/011 50x1 film-coated tablet EU/1/10/619/012 84 film-coated tablets EU/1/10/619/013 90x1 film-coated tablet EU/1/10/619/014 100x1 film-coated tablet
Danish: EU/1/10/619/008 14 filmovertrukne tabletter EU/1/10/619/009 28 filmovertrukne tabletter EU/1/10/619/010 30x1 filmovertrukne tabletter EU/1/10/619/011 50x1 filmovertrukne tabletter EU/1/10/619/012 84 filmovertrukne tabletter EU/1/10/619/013 90x1 filmovertrukne tabletter EU/1/10/619/014 100x1 filmovertrukne tabletter
English: In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet efter administration af en prostaglandinsyntesehæmmer (se pkt.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Red iron oxide (E172)
Danish: Lactosemonohydrat Hypromellose (E464) Titandioxid (E171) Triacetin (E1518) Jernoxid, rød (E172)
English: EU/1/10/619/001 14 film-coated tablets EU/1/10/619/002 28 film-coated tablets EU/1/10/619/003 30x1 film-coated tablet EU/1/10/619/004 50x1 film-coated tablet EU/1/10/619/005 84 film-coated tablets EU/1/10/619/006 90x1 film-coated tablet EU/1/10/619/007 100x1 film-coated tablet EU/1/10/619/015 30 film-coated tablets
Danish: EU/1/10/619/001 14 filmovertrukne tabletter EU/1/10/619/002 28 filmovertrukne tabletter EU/1/10/619/003 30x1 filmovertrukne tabletter EU/1/10/619/004 50x1 filmovertrukne tabletter EU/1/10/619/005 84 filmovertrukne tabletter EU/1/10/619/006 90x1 filmovertrukne tabletter EU/1/10/619/007 100x1 filmovertrukne tabletter EU/1/10/619/015 30 filmovertrukne tabletter
English: What DuoPlavin contains
Danish: DuoPlavin indeholder:
English: No clinical data on exposure to DuoPlavin during pregnancy are available.
Danish: Der er ingen data fra anvendelse af DuoPlavin til gravide kvinder.
English: DuoPlavin is supplied in cardboard cartons containing: - 14, 28 and 84 tablets in all-aluminium blisters - 30x1, 50x1, 90x1 and 100x1 tablet in all-aluminium perforated unit-dose blisters.
Danish: DuoPlavin udleveres i pakninger, der indeholder: - 14, 28 og 84 tabletter i aluminiumblister, - 30x1, 50x1, 90x1 eller 100x1 tabletter i perforerede enkeltdosisblister i aluminium.
English: How to take DuoPlavin
Danish: Sådan skal du tage DuoPlavin
English: Each film-coated tablet contains 8 mg of lactose and 3.3 mg of hydrogenated castor oil.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 8 mg lactose og 3,3 mg hydrogeneret ricinusolie.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med DuoPlavin Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nyligt.
English: DuoPlavin is supplied in cardboard cartons containing: - 14, 28, 30 and 84 tablets in all-aluminium blisters - 30x1, 50x1, 90x1 and 100x1 tablet in all-aluminium perforated unit-dose blisters.
Danish: DuoPlavin udleveres i pakninger, der indeholder - 14, 28, 30 og 84 tabletter i aluminiumblister, - 30x1, 50x1, 90x1 eller 100x1 tabletter i perforerede enkeltdosisblister i aluminium.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Yellow iron oxide (E172)
Danish: Lactosemonohydrat Hypromellose (E464) Titandioxid (E171) Triacetin (E1518) Jernoxid, gul (E172)
English: Each film-coated tablet contains 7 mg of lactose and 3.3 mg of hydrogenated castor oil.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 7 mg lactose og 3,3 mg hydrogeneret ricinusolie.
English: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Danish: Erfaring med behandling af patienter med moderat alvorlige leversygdomme, hvor der kan være disposition for blødning, er begrænset.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30x1, 50x1, 90x1 and 100x1 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT BLISTER / 30x1, 50x1, 90x1 og 100x1 tabletter
English: DuoPlavin 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow, engraved on one side with ‘C75' and ‘A75'on the other side.
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter (tabletter) er ovale, let bikonvekse, gule og er præget på den ene side med "C75" og på den anden side med "A75".
English: Patients should inform physicians and dentists that they are taking DuoPlavin before any surgery is scheduled and before any new medicinal product is taken.
Danish: Før kirurgi planlægges, og før ordination af nye lægemidler bør patienterne informere læge og tandlæge om, at de tager DuoPlavin.
English: You should not breast-feed while using this medicine.
Danish: Du bør ikke amme, mens du tager DuoPlavin.
English: DuoPlavin 75 mg/75 mg film-coated tablets
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter
English: DuoPlavin 75 mg/100 mg film-coated tablets
Danish: DuoPlavin 75 mg/100 mg filmovertrukne tabletter
English: DuoPlavin 75 mg/100 mg film-coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75' and ‘A100'on the other side.
Danish: DuoPlavin 75 mg/100 mg filmovertrukne tabletter Lys pink, oval, lettere bikonveks, med "C75" præget på den ene side og ”A100” på den anden side.
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter DuoPlavin 75 mg/100 mg filmovertrukne tabletter
English: Bleeding at the puncture site
Danish: Blødning ved injektionsstedet
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter DuoPlavin 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: DuoPlavin 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: DuoPlavin 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
English: concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Danish: Som forholdsregel frarådes samtidig anvendelse af potente eller moderate CYP2C19-hæmmere (se også pkt.
English: What DuoPlavin is and what it is used for What you need to know before you take DuoPlavin How to take DuoPlavin
Danish: Det skal du vide, før du begynder at tage DuoPlavin Sådan skal du tage DuoPlavin Bivirkninger
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin should be given as a single daily 75 mg/75 mg dose.
Danish: DuoPlavin bør gives som en enkelt daglig dosis på 75 mg/75 mg.
English: Each tablet contains: 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Danish: Hver tablet indeholder: 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre.
English: NAME OF THE MEDICINAL PRODUCT DuoPlavin 75 mg/75 mg tablets clopidogrel/acetylsalicylic acid
Danish: LÆGEMIDLETS NAVN DuoPlavin 75 mg/75 mg tabletter clopidogrel/acetylsalicylsyre
English: DuoPlavin is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Blodpropper kan føre til f.eks. slagtilfælde, hjerteanfald og død (aterotrombotiske hændelser).
English: NAME OF THE MEDICINAL PRODUCT DuoPlavin 75 mg/100 mg tablets clopidogrel/acetylsalicylic acid
Danish: LÆGEMIDLETS NAVN DuoPlavin 75 mg/100 mg tabletter clopidogrel/acetylsalicylsyre
English: (psoriasis),
Danish: (se pkt.
English: • medicines that may increase your risk of bleeding such as: - oral anticoagulants, medicines used to reduce blood clotting, - ASA or another non-steroidal anti-inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other injectable medicine used to reduce blood clotting, - ticlopidine, other antiplatelet agent,
Danish: • medicin, der kan øge risikoen for blødning såsom: o medicin, som modvirker blodets størkning (blodfortyndende medicin, orale antikoagulantia) gennem munden.
English: • omeprazole or esomeprazole, medicines to treat upset stomach,
Danish: • omeprazol eller esomeprazol til behandling af for meget mavesyre.
English: Vascular disorders Haematoma
Danish: Silica, kolloid vandfri
English: MA (EU) number (Invented) name
Danish: MF (EU) -number
English: Concentrate for solution for
Danish: Koncentrat til infusionsvæske,
English: Pack size
Danish: Indhold Pakningsstørrelse
English: Conte nt
Danish: EMA's procedurenr.
English: for up to 24 and 9 weeks, respectively.
Danish: i op til henholdsvis 24 og 9 uger.
English: The countries involved in the first wave were Austria, Germany, Spain, Finland, Italy, Portugal.
Danish: Landene i den første bølge var Østrig, Tyskland, Spanien, Finland, Italien og Portugal.
English: • The Committee considered the notification of the referral triggered by Sweden under Article 29(4) of Council Directive 2001/83/EC.
Danish: • Udvalget vurderede meddelelsen om, at Sverige havde indbragt sagen i henhold til artikel 29, stk. 4, i Rådets direktiv 2001/83/EF.
English: The approved indication in the EU is for the treatment of PE in men 18 to 64 years of age.
Danish: Den godkendte indikation i EU er behandling af PE hos mænd på mellem 18 og 64 år.
English: They are all included in the 5 PSURs mentioned above.
Danish: De er alle inkluderet i de 5 ovennævnte PSUR'er.
English: Overall discussion and benefit/risk assessment
Danish: Samlet drøftelse og benefit/risk-vurdering
English: Overall summary of the scientific evaluation of Priligy and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Priligy og relaterede navne (se bilag I)
English: Design and dosage
Danish: Undersøgelse Design og dosering
English: • Safety issues
Danish: • Sikkerhedsaspekter
English: It has been granted marketing authorisation in 25 countries worldwide, including 7 countries in the European Union which were part of a decentralised procedure with Sweden acting as reference Member State.
Danish: Den har fået markedsføringstilladelse i 25 lande verden over, herunder 7 lande i EU, som var en del af en decentral procedure med Sverige som referencemedlemsstat.
English: As an agreement could not be reached the procedure was subsequently referred to CHMP.
Danish: Da man ikke kunne nå til enighed, blev sagen efterfølgende indbragt for CHMP.
English: Typical syncope episodes are brief and usually last no longer than 20 seconds.
Danish: Typiske synkopeepisoder er korte og varer normalt ikke mere end 20 sekunder.
English: Subsequently, Janssen Cilag submitted an application for mutual recognition of Priligy, 30 mg and 60 mg film-coated tablets in the following Member States: Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom.
Danish: Efterfølgende indsendte Janssen Cilag en ansøgning om gensidig anerkendelse af Priligy 30 mg og 60 mg filmovertrukne tabletter i følgende medlemsstater: Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Grækenland, Frankrig, Ungarn, Irland, Island, Litauen, Luxembourg, Letland, Malta, Nederlandene, Norge, Polen, Rumænien, Slovenien, Slovakiet og Det Forenede Kongerige.
English: Priligy is a pharmacologic treatment approved for men with Premature Ejaculation (PE).
Danish: Priligy er en farmakologisk behandling, som er godkendt til mænd med præmatur ejakulation (PE).
English: This difference was not noted for mean average IELT.
Danish: Denne forskel blev ikke noteret for gennemsnitlig middelværdi for IELT.
English: Five of these events were medically confirmed and four events were unconfirmed.
Danish: Fem af disse hændelser var medicinsk bekræftet, og fire var ubekræftede.
English: The amended labelling and package leaflet of the reference Member State are set out in Annex III.
Danish: Den ændrede etikettering og indlægsseddel fra referencemedlemsstaten er anført i bilag III.
English: Evidence on the safety profile of Priligy in clinical practice is available from 2 complementary data sources, including
Danish: Dokumentation for Priligys sikkerhedsprofil i klinisk praksis fås fra 2 komplementære datakilder, herunder
English: Half of them were considered as medically confirmed (adjudicated syncope).
Danish: Halvdelen af dem blev betragtet som medicinsk bekræftede (bedømt som synkope).
English: Syncope occurrence during Post-authorisation
Danish: Forekomst af synkope efter godkendelse
English: − No events of syncope have been reported.
Danish: − Der er ikke rapporteret nogen hændelser med synkope.
English: The CHMP having reviewed the above available data on safety noted the following:
Danish: CHMP udtalte efter gennemgang af ovenstående tilgængelige sikkerhedsdata følgende:
English: Ventricular tachycardia (VT) or other serious dysrhythmias were not observed in any of these 7 subjects during the events.
Danish: Der blev ikke observeret ventrikulær takykardi (VT) eller andre alvorlige dysrytmier hos nogen af disse 7 forsøgspersoner under hændelserne.
English: No event of syncope has been spontaneously reported in association with the administration of Priligy since February 2011.
Danish: Der har ikke været nogen spontane indberetninger om synkope i forbindelse med administration af Priligy siden februar 2011.
English: Four of these events were associated with the 30 mg dose and the other five were associated with the 60 mg dose.
Danish: Fire af disse hændelser var relateret til dosen på 30 mg, og de øvrige fem var relateret til dosen på 60 mg.
English: Given that IELT data is not expected to be normally distributed, the geometric mean IELT has been proposed as a more appropriate summary statistic than the mean IELT.
Danish: Da IELT-dataene ikke forventes at være normalfordelt, er den geometriske middelværdi af IELT foreslået som en mere passende opsummerende statistisk værdi end middel-IELT.
English: Similar results for the geometric mean average IELT at Week 12 were seen in each Phase III study in which IELT was measured.
Danish: Tilsvarende resultater for den geometriske gennemsnitlige middelværdi af IELT ved uge 12 sås i hver fase III-undersøgelse, hvor IELT blev målt.
English: The severity of the adverse events has generally been reported as mild or perhaps moderate, resulting in limited discontinuation from the study by patients.
Danish: Alvorsgraden af de uønskede hændelser er generelt rapporteret som mild eller måske moderat, hvilket har resulteret i begrænset udtræden af forsøgspersoner fra undersøgelsen.
English: All of these events were of short duration and spontaneously resolved.
Danish: Alle disse hændelser var korte af varighed og forsvandt spontant.
English: and 60 mg q.d (once daily) as well as another open-label 9-month extension study (see summary table below).
Danish: og 60 mg q.d (en gang dagligt) samt en ublindet 9-måneders forlængelsesundersøgelse (se resumé i tabellen nedenfor).
English: − 92% of patients were prescribed treatment according to the SmPC, i.e. initiation of treatment with 30 mg.
Danish: − 92 % af patienterne fik ordineret behandling ifølge produktresuméet, dvs. behandlingen indledes med 30 mg.
English: Of these the strict medical definition requiring loss of consciousness was fulfilled for 8 cases, including one case with sinus arrest (with an associated 28-second period of asystole).
Danish: Af disse var den strenge medicinske definition, som kræver bevidsthedstab, opfyldt i 8 tilfælde, herunder et tilfælde med sinusstop (med associeret 28-sekunders asystoli).
English: In this study, no events of “syncope” or “syncope vasovagal” have been reported in any patient prescribed with Priligy.
Danish: I denne undersøgelse er der ikke rapporteret nogen hændelser med "synkope" eller "synkope vasovagal" hos nogen patient, som har fået ordineret Priligy.
English: A total of 30 syncope cases (cases of interest) were observed during the clinical studies.
Danish: Der blev observeret i alt 30 synkopetilfælde (tilfælde af interesse) under de kliniske undersøgelser.
English: Sensitivity analyses: Sensitivity analyses were conducted for the key efficacy variables, each representing more conservative assumptions than the originally planned analyses, which included the intent-to-treat (ITT) population with last postbaseline observation carried forward (LPOCF).
Danish: Sensitivitetsanalyser: Der blev udført sensitivitetsundersøgelser for de vigtigste virkningsvariabler, som hver især repræsenterer mere konservative antagelser end de oprindeligt planlagte analyser, der inkluderede intent-to-treat-populationen (ITT) med LPOCF ("last postbaseline observation carried forward").
English: Regarding the 60 mg strength a more or less pronounced dose-response is observed in all analyses.
Danish: For styrken 60 mg observeres der en mere eller mindre udtalt dosisrespons i alle analyser.
English: The active substance of Priligy is dapoxetine hydrochloride that belongs to the class of selective serotonin reuptake inhibitors (SSRIs), originally developed as a potential treatment of pain, obesity and depression.
Danish: Det aktive stof i Priligy er dapoxetinhydroklorid, som tilhører stofgruppen selektive serotoninreuptake-inhibitorer (SSRI'er), der oprindeligt blev udviklet som en potentiel behandling af smerter, svær overvægt og depression.
English: After occurrence of infrequent cases of syncope in the early phases of the clinical development program Holter monitoring was introduced in the phase III program.
Danish: Efter forekomst af sjældne tilfælde af synkope i de tidlige faser af det kliniske udviklingsprogram blev der indført Holter-monitorering i fase III-programmet.
English: The available evidence shows that the risk minimisation measures put in place have been effective in the management of syncope events:
Danish: Den foreliggende dokumentation viser, at de risikominimeringsforanstaltninger, som blev iværksat, har været effektive til at håndtere hændelser med synkope:
English: Nine spontaneously reported events of syncope in the post-approval setting are included in the PSURs summarizing safety from 17 December 2008 to 17 June 2011, of which 5 events are medically confirmed and 4 events are unconfirmed.
Danish: Ni spontant rapporterede hændelser med synkope efter godkendelse er inkluderet i PSUR'erne, som resumerer sikkerheden fra 17. december 2008 til 17. juni 2011, hvoraf 5 hændelser er medicinsk bekræftet, og 4 hændelser ikke er bekræftet.
English: Seventeen patients in the study have reported a serious adverse event (11 patients taking Priligy, 6 patients taking alternate care/non Priligy), all of which were considered to be “not related to treatment” by the treating health care provider.
Danish: 17 patienter i undersøgelsen har rapporteret en alvorlig uønsket hændelse (11 patienter, som tog Priligy, 6 patienter, som tog anden behandling/ikke-Priligy), hvor alle af den behandlende sundhedsudbyder blev betragtet som "ikke relateret til behandling".
English: It was concluded that Priligy 30 mg shows greater efficacy versus placebo.
Danish: Det blev konkluderet, at Priligy 30 mg viser større virkning end placebo.
English: It can also be concluded that up to about 10% more patients responds to 60 mg compared to 30 mg.
Danish: Det kan også konkluderes, at op til 10 % flere patienter responderer på 60 mg sammenlignet med 30 mg.
English: These include many of the safety concerns associated with marketed antidepressant SSRIs, such as treatment-emergent suicidality, clinically important moodrelated adverse events (including depression and anxiety), akathisia, SSRI discontinuation syndrome, and sexual function adverse effects, which were measured using broadly accepted and validated rating scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) and Beck Depression Inventory-II (BDI-II) (mood), Hamilton Anxiety Scale (HAM-A) (anxiety), Barnes Akathisia Scale (BARS) (akathisia), discontinuation-emergent signs and symptoms (DESS) (withdrawal syndrome), and International Index of Erectile Function (IIEF) (sexual function effects) and methods (Columbia Classification Algorithm of Suicide Assessment [C-CASA] for suicidality).
Danish: Disse omfatter mange af de betænkeligheder ved sikkerheden af markedsførte antidepressive SSRI'er, f.eks. behandlingsrelateret selvmordstrang, klinisk vigtige humørrelaterede uønskede hændelser (herunder depression og angst), akatisi, SSRI-seponeringssyndrom og uønskede hændelser i forbindelse med seksuel funktion, som blev målt med bredt accepterede og validerede vurderingsskalaer, herunder Montgomery-Asberg Depression Rating Scale (MADRS) og Beck Depression Inventory-II (BDI-II) (humør), Hamilton Anxiety Scale (HAM-A) (angst), Barnes Akathisia Scale (BARS) (akatisi), seponeringsrelaterede tegn og symptomer (DESS) (abstinenssyndrom) og International Index of Erectile Function (IIEF) (virkninger på seksuel funktion) og metoder (Columbia Classification Algorithm of Suicide Assessment [C-CASA] for selvmordstrang).
English: • Some of the risk minimisation measures (e.g. patient instructions, exclusion of orthostatic manoeuvres) were introduced already during the course of Phase III program with no further episodes of syncope reported in the clinical program following that.
Danish: • Nogle af de risikominimerende foranstaltninger (f.eks. patientvejledning, udelukkelse af ortostatiske manøvrer) blev indført allerede under fase III-programmet, og herefter var der ingen yderligere episoder med synkope i det kliniske program.
English: Those analyses assume that all subjects with missing data, irrespective of the reason for discontinuation, experienced no benefit from treatment with dapoxetine.
Danish: Disse analyser forudsætter, at alle forsøgspersoner med manglende data, uanset årsag til udtræden, ikke oplevede nogen gavnlig virkning af behandling med dapoxetin.
English: This conclusion has been further strengthen with no cases of syncope in the postmarketing safety study and an estimated post-marketing exposure of 850,000 patients with only 5 medically confirmed spontaneous reports of syncope, all of short duration and spontaneously resolved.
Danish: Denne konklusion er yderligere styrket, idet der ikke har været nogen tilfælde af synkope i sikkerhedsundersøgelsen efter markedsføring med en estimeret eksponering af 850.000 patienter efter markedsføring med kun 5 medicinsk bekræftede spontane rapporter om synkope, alle af kort varighed og spontant forsvundet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG II VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR POSITIV UDTALELSE OG ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMA
English: Some of the required procedures in the dapoxetine clinical development program (e.g., venipuncture and orthostatic challenge) that may have contributed to the occurrence of syncope are not expected in routine clinical practice.
Danish: Nogle af de krævede procedurer i det kliniske udviklingsprogram for dapoxetin (f.eks. venepunktur og ortostatisk udfordring), som kan have bidraget til forekomsten af synkope, forventes ikke i almindelig klinisk praksis.