FrancophonIA/ELRC3.0 huggingface dataset:
English: 15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
Danish: 15 mg pulver i et hætteglas (type I glas) med prop (butylgummi) dækket med en film (fluoropolymer) på produktsiden og 0,5 ml solvens i en ampul (type I glas).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5ml of water for injections with 3% (w/v) of mannitol
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,5 ml vand til injektionsvæske med 3 % (v/v) mannitol.
English: White powder and clear, colourless solvent for solution for injection
Danish: Hvidt pulver og klar, farveløs solvens til injektionsvæske, opløsning
English: If necessary, therapy with desirudin should be interrupted until aPTT returns to less than twice the control value at which time treatment with desirudin can be resumed at a reduced dose.
Danish: Om nødvendigt bør behandlingen med desirudin afbrydes, indtil aPTT vender tilbage til mindre end 2 gange kontrolværdien, hvorpå behandling med desirudin kan genoptages med lavere dosering.
English: If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Danish: Hvis De har en nyre- eller leversygdom, vil lægen eller sygeplejersken følge, hvorledes Deres blod størkner og vil derefter måske ændre Deres dosis eller Deres doseringsskema.
English: 4.7 Effects on ability to drive and use machines Revasc has no or negligible influence on the ability to drive and use machines.
Danish: Revasc har ingen eller ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
English: If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Danish: Hvis samtidig behandling ikke kan undgås, bør patienten nøje monitoreres, både klinisk og med laboratorieprøver (se pkt.
English: Your risk of bleeding may also be increased: - if you have recently given birth, fallen, or suffered a blow to the body or head - if you are already taking medicines, especially blood-thinners (see below).
Danish: - hvis De for nylig har født, er faldet eller har fået et slag på kroppen eller i hovedet - hvis De allerede tager medicin, især blodfortyndende medicin (se nedenfor).
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig:
English: Ask you pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket hvordan De skal aflevere medicinrester.
English: The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
Danish: Desirudin og ikke-fraktionerede hepariner har en additiv effekt på forlængelsen af aPTT (se pkt.
English: Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000
Danish: Hvert hætteglas indeholder 15 mg desirudin med 18.000 ATU/mg svarende til omtrent 270.000 ATU pr. hætteglas.
English: Treatment with desirudin is then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient is fully ambulant, whichever occurs first.
Danish: Behandling med desirudin fortsættes herefter to gange daglig post-operativt i 9 dage, maksimalt 12 dage, eller indtil patienten er fuldt oppegående afhængig af, hvilken situation der først indfinder sig.
English: Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement
Danish: Forebyggelse af dyb venetrombose hos patienter, som gennemgår planlagte operationer med udskiftning af hofte eller knæ.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revasc 15 mg/0.5 ml
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Revasc; 15 mg/0,5 ml
English: Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions.
Danish: Usædvanlig træthed eller svaghed (blodmangel), kvalme, væskesiven fra sår, lavt blodtryk, feber, årebetændelse, sommetider ledsaget af en blodprop, buler på injektionsstederne, blå mærker, hævelse af benene på grund af væskeophobning, ikke dødelige overfølsomhedsreaktioner.
English: In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.
Danish: Hos patienter med let til moderat nedsat leverfunktion anbefales monitorering af aPTT (se pkt.
English: Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):
Danish: Ikke almindelige bivirkninger (rammer sandsynligvis mellem 1 ud af 100 og 1 ud af 1.000 patienter).
English: Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first.
Danish: Behandling med desirudin fortsættes derefter 2 gange daglig efter operationen i 9 til højst 12 dage, eller til patienten er helt oppegående, alt efter hvilken situation, der først opstår.
English: Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery:
Danish: Informer hurtigst muligt lægen eller sygeplejersken, hvis en af nedenstående bivirkninger opstår.
English: However, the in-use stability has been demonstrated for 24 hours between 2°C and 8°C (in a refrigerator).
Danish: Dog er stabilitet under anvendelse demonstreret i 24 timer ved temperaturer mellem 2 °C og 8 °C (i køleskab).
English: If necessary, therapy with desirudin should be interrupted until aPTT falls to less than twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
Danish: Om nødvendigt bør behandlingen med desirudin afbrydes, indtil aPTT vender tilbage til mindre end 2 gange kontrolværdien, hvor behandling med desirudin kan genoptages med reduceret dosis (se også pkt.
English: Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs,
Danish: Stigning af leverenzymer, svimmelhed, søvnløshed, konfusion, følelse af at være forpustet, opkastning (med eller uden blod), forstoppelse, blod i urinen, vandladningsbesvær, udslæt, kløe (urtikaria), lavt indhold af kalium i blodet, brændende fornemmelse ved vandladning sammen med en øget vandladningshyppighed, langsom sårheling, næseblod, højt blodtryk, smerter (herunder smerter i benene, maven og/eller brystet).
English: Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
Danish: Allergiske reaktioner er i kliniske undersøgelser rapporteret hos samme mængde (1,6 %) patienter, der blev behandlet med desirudin (N=2.367) eller ufraktioneret
English: The total urinary excretion of unchanged desirudin amounts to 40-50 % of the administered dose.
Danish: Af den administrerede dosis udskilles 40-50 % uforandret i urinen.
English: Patients with liver impairment
Danish: Patienter med nedsat nyrefunktion
English: However, the in-use stability has been demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator).
Danish: Dog er stabilitet under anvendelse demonstreret i 24 timer ved temperaturer mellem 2 og 8 °C (i køleskab).
English: Desirudin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients - with active bleeding and/or irreversible coagulation disorders - with severe renal and hepatic impairment
Danish: Desirudin er kontraindiceret til patienter med: - overfølsomhed over for det aktive eller over for et eller flere af hjælpestofferne, - aktiv blødning og/eller irreversible koagulationsforstyrrelser, - svær nedsat lever- og nyrefunktion, - under graviditet (se pkt.
English: In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.
Danish: De fleste af de bivirkninger, der er rapporteret i kontrollerede kliniske undersøgelser af desirudin 15 mg to gange daglig og en standarddosis af ufraktioneret heparin, kan tilskrives selve hofteoperationen og virkningsmekanismen for de to produkter, der er undersøgt.
English: Keep the vial and ampoule in the outer carton in order to protect from light.
Danish: Opbevar hætteglas og ampul i den ydre karton for at beskytte mod lys.
English: However, lactating mothers should be advised to avoid breast feeding or alternative
Danish: Imidlertid bør det frarådes at amme, eller der bør anvendes alternativ lægemidler.
English: NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN Revasc 15 mg/0,5 ml pulver og solvens til injektionsvæske, opløsning
English: A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d.
Danish: En gennemsnitlig forlængelse af maksimum aPTT på ca. 1,4 gange basisværdien er observeret efter subkutan (s.c.) injektion af 15 mg desirudin 2 gange daglig.
English: Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.
Danish: I kliniske forsøg var bivirkninger, der blev rapporteret uanset forbindelse til forsøgslægemidlet, blødningsepisoder, oliguri, hyperpyrexi og luksation af led.
English: As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (abciximab, eptifibatide,
Danish: Disse lægemidler omfatter acetylsalicylsyre og NSAID præparater ticlopidin og clopidogrel, glycoprotein IIb/IIIa-antagonister (abciximab, eptifibatid, tirofiban) og iloprost.
English: (N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p<0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p<0.0001).
Danish: I to kontrollerede dobbeltblinde kliniske undersøgelser var den totale hyppighed af tromboemboliske hændelser hos patienter behandlet med desirudin 15 mg s.c. 2 gange daglig (N=370) det halve i forhold til patienter behandlet med en standarddosis af ikke-fraktioneret heparin (N=396) (p < 0,0001); hyppigheden af proksimal dyb venetrombose var kun en femtedel af den ved heparin (p < 0,0001) observerede.
English: 6.6 Special precautions for disposal and other handling To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection.
Danish: For at tilberede den færdige opløsning tilsættes 0,5 ml af den medfølgende mannitol solvens under aseptiske forhold til hætteglasset med pulveret til injektionsvæske.
English: What Revasc looks like and contents of the pack Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless
Danish: Revasc består af et hætteglas, der indeholder et hvidt pulver og en ampul, der indeholder et klart, farveløst solvens til injektionsvæske, opløsning.
English: A slower terminal elimination phase follows with a dose-independent mean terminal elimination half life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Danish: «Mean residence time» er 1,7- 2 timer og 6-7 timer efter henholdsvis i.v.
English: As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk.
Danish: Patienter, som tidligere har været behandlet med hirudin eller hirudinanaloger, kan have forøget risiko, da disse reaktioner er immunmedierede.
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Danish: Indehaveren af markedsføringstilladelsen og fremstiller
English: Nervous system disorders Uncommon:
Danish: Immunsystemet Almindelig:
English: Keep the vial and ampoule in the outer carton.
Danish: Opbevar hætteglas og ampul i den ydre karton.
English: Absorption is complete based on mean area under
Danish: Absorptionen er fuldstændig og vurderet på areal under kurve- (AUC) værdierne.
English: Investigations Uncommon:
Danish: Sjælden:
English: - If you have any further questions, ask your doctor, nurse or your pharmacist.
Danish: - Spørg lægen, sygeplejersken eller på apoteket, hvis der er mere, De vil vide.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01
Danish: ATC-kode: B01AE01
English: Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
Danish: Desirudin er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: TIL 1 HÆTTEGLAS (15 mg/hætteglas) OG 1 AMPUL
English: If a dose is missed
Danish: Hvis De har glemt at få Revasc
English: Dizziness, insomnia, confusion Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Luftveje, thorax og mediastinum Ikke almindelig: Dyspnø
English: General disorders and administration site conditions Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
Danish: Feber, hævelse på injektionsstedet, hæmatom, ødem af benene, Ikke almindelig: Smerter i benene, smerter, abdominal- og brystsmerter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: 10 HÆTTEGLAS (15 mg/hætteglas) OG 10 AMPULLER
English: - if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the - if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia) - if you have serious kidney or liver disease
Danish: - hvis De er overfor naturlig eller syntetisk hirudin, inklusive desirudin eller et af de øvrige
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: 2 HÆTTEGLAS (15 mg hætteglas) OG 2 AMPULLER
English: In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
Danish: Aktiveret partiel tromboplastintid (aPTT) skal monitoreres hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance mellem 31 og 90 ml/min; se pkt.
English: Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e.g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary
Danish: Desirudin bør anvendes med forsigtighed under omstændigheder med øget risiko for blødninger, som ved store operationer, biopsi eller punktur af et ikke kompressibelt blodkar indenfor de seneste måneder; tidligere tilfælde af hjerneblødning, intrakraniel eller intraokulær blødning inkl.
English: injection of 15mg desirudin.
Danish: Revasc 15 mg /0,5 ml Pulver til injektionsvæske Desirudin
English: Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning 15 mg pulver i et hætteglas og 0,5 ml solvens i en ampul
English: Total clearance of desirudin has been found to be in the same range following either SC or IV administration (ca 1.95-2.20ml/min/kg) and was dose-independent.
Danish: administration (ca. 1,95-2,20 ml/min/kg) og var uafhængig af dosis.
English: In the solvent the
Danish: Solvens:
English: If you are given more than you should
Danish: Hvis De har fået for meget Revasc
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin Read all of this leaflet carefully before you start using this medicine.
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Revasc 15 mg/0,5 ml pulver og solvens til injektionsvæske, opløsning Desirudin
English: Always take Revasc exactly as your doctor has instructed you.
Danish: Tag altid Revasc nøjagtig som Deres læge har fortalt Dem. Spørg lægen eller apoteket, hvis der er noget De er i tvivl om..
English: Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had: - bleeding disorders or a family history of bleeding disorder - stomach ulcers or any other bleeding disease of the gut - history of a stroke, or bleeding within the brain or eye - a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last month - recently a brief shortage of blood supply to a part of the brain within the last six months
Danish: - en nylig operation (inklusive tandkirurgi) eller biopsi eller hul på blodkar indenfor for den seneste måned - en nylig kortvarig mangel af blodforsyningen til dele af hjernen indenfor de seneste 6 måneder - tilfælde af blødning i tarmen eller lungerne indenfor de seneste tre måneder
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL: 15mg
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL: 0.5ml SOLVENT
Danish: Ampul etiket: 0,5 ml solvens
English: FURTHER INFORMATION
Danish: • ANDRE BETINGELSER
English: Powder for injection
Danish: Oversigt over indlægssedlen:
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jfr.
English: The dose
Danish: LÆGEMIDLETS NAVN
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Ikke almindelig: Udslæt, urtikaria
English: What Revasc contains
Danish: INFORMATION I BRAILLE-SKRIFT
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 15 mg desirudin
English: EU/1/19/1382/001 Azacitidine Celgene 25 mg/ml
Danish: EU/1/19/1382/001
English: Powder for suspension for injection
Danish: 25 mg/ml Pulver til injektionsvæske, suspension
English: Subcutaneous use vial (glass) 100 mg
Danish: Hætteglas 100 mg
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Danish: Gennemførelse af aftalen i medlemsstaterne (indsendelse af ændringsansøgningen fra indehaveren af markedsføringstilladelsen):
English: 24 July 2013
Danish: 24. juli 2013
English: 01 October 2013
Danish: 1. oktober 2013
English: June 2013 CMDh meeting
Danish: CMDh's møde i juni 2013
English: The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede godkendelsen anerkendt i Belgien, Bulgarien, Cypern, Tyrkiet, Danmark, Estland, Grækenland, Frankrig, Ungarn, Irland, Island, Litauen, Luxembourg, Letland, Malta, Nederlandene, Norge, Polen, Rumænien, Slovenien, Slovakiet og Det Forenede Kongerige ("de berørte medlemsstater").
English: What is Priligy?
Danish: Hvad er Priligy?
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultatet af en procedure i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer
English: Why was Priligy reviewed?
Danish: Hvorfor blev Priligy revurderet?
English: Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.
Danish: Priligy er et lægemiddel, der anvendes til behandling af for tidlig sædafgang hos mænd i alderen 18 til 64 år.
English: The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable.
Danish: CHMP konkluderede desuden, at den potentielle øgede risiko for synkope er påvist at være kontrollerbar.
English: Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells.
Danish: Priligy antages at forøge tiden til sædafgang ved at øge mængden af en neurotransmitter mellem nervecellerne.
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 24 February 2011.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den svenske lægemiddelstyrelse henviste sagen til CHMP med henblik på voldgift den 24. februar 2011.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af Priligy tabletter.
English: Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope.
Danish: Patienterne bør ikke sættes i behandling med 60 mg tabletter og må kun overgå til 60 mg, hvis de ikke har responderet tilfredsstillende på 30 mg tabletterne og ikke har haft moderate eller svære bivirkninger eller symptomer, der kan være tegn på synkope.
English: The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009.
Danish: Virksomheden, der markedsfører Priligy i Sverige, Janssen-Cilag AB, indgav en ansøgning om markedsføringstilladelse for Priligy (30 mg og 60 mg tabletter) via den gensidige anerkendelsesprocedure på grundlag af den indledende godkendelse, der var udstedt af Sverige den 6. februar 2009.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets)
Danish: Spørgsmål og svar om Priligy (dapoxetin, tabletter, 30 mg og 60 mg)
English: The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells.
Danish: Den virker ved at forhindre genoptagelse af neurotransmitteren 5-hydroxytryptamin (der også kaldes serotonin) i nervecellerne i hjernen og rygmarven, og øger derved mængden af serotonin mellem cellerne.