FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zdravilo DuoPlavin 75 mg/75 mg filmsko obložene tablete (tablete) so ovalne, rahlo bikonveksne, rumene, z vtisnjeno oznako «C75» na eni strani in «A75» na drugi strani.
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin should be given as a single daily 75 mg/75 mg dose.
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete Zdravilo DuoPlavin se mora dajati kot enkratni dnevni odmerek 75 mg/75 mg.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Slovenian: Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila DuoPlavin«).
English: This leaflet was last revised in <Month YYYY>.
Slovenian: Navodilo je bilo nazadnje revidirano
English: DuoPlavin 75 mg/100 mg film-coated tablets DuoPlavin should be given as a single daily 75 mg/100 mg dose.
Slovenian: DuoPlavin 75 mg/100 mg filmsko obložene tablete Zdravilo DuoPlavin se mora dajati kot enkratni dnevni odmerek 75 mg/100 mg.
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Slovenian: Aktivni presnovek nastane predvsem z delovanjem CYP2C19, k nastanku pa pripomorejo tudi drugi encimi CYP, vključno s CYP1A2, CYP2B6 in CYP3A4.In vitro izolirani aktivni tiolski presnovek se hitro in ireverzibilno veže na trombocitne receptorje in tako zavre agregacijo trombocitov.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 30x1, 50x1, 90x1 and 100x1 tablets
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot / 30, 30x1, 50x1, 90x1 in 100x1 tablet
English: Patients should also be told that it might take longer than usual to stop bleeding when they take DuoPlavin, and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Naročiti jim morate, naj o vsaki krvavitvi, ki je neobičajna (glede na mesto ali trajanje), obvestijo svojega zdravnika.
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.
Slovenian: DuoPlavin 75 mg/100 mg filmsko obložene tablete Svetlo rožnata, ovalna, rahlo bikonveksna, z vtisnjeno oznako "C75" na eni strani in "A100" na drugi strani.
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASArelated GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Slovenian: Krvavitev v prebavila in retroperitonealna krvavitev (opisani so primeri s smrtnim izidom), pankreatitis, bolezni zgornjih prebavil (ezophagitis (vnetje sluznice požiralnika), ulkus požiralnika (razjede v požiralniku), perforacija (predrtje), erozivni gastritis, erozivni duodenitis; razjede/perforacije na želodcu/dvanajstniku)*, bolezni spodnjih prebavil (ulkusi (peptične razjede) tankega [jejunum in ileum] in debelega črevesa [kolon in rektum (danka)], kolitis in perforacije prebavil) *, simptomi zgornjih prebavil*, npr. gastralgija (glejte poglavje 4.4), te, z acetilsalicilno kislino (ASA) povezane gastrointestinalne (GI) reakcije, so lahko ali pa tudi ne povezane s krvavitvijo.
English: Microcrystalline cellulose Low substituted hydroxypropylcellulose Maize starch
Slovenian: Jedro manitol (E421) makrogol 6000 mikrokristalna celuloza nizko substituirana hidroksipropilceluloza koruzni škrob hidrogenirano ricinusovo olje stearinska kislina brezvodni koloidni silicijev dioksid
English: Acetylsalicylic acid inhibits platelet aggregation by irreversible inhibition of prostaglandin cyclo-oxygenase and thus inhibits the generation of thromboxane A2, an inducer of platelet aggregation and vasoconstriction.
Slovenian: Acetilsalicilna kislina zavira agregacijo trombocitov z ireverzibilnim zavrtjem prostaglandinske ciklooksigenaze.
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Slovenian: sanofi-aventis groupe
English: Varicella vaccine
Slovenian: Žilne bolezni
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,
Slovenian: Zdravniku morate posebej povedati, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralne antikoagulanse, zdravila proti strjevanju krvi, o ASA ali kakšno drugo nesteroidno protivnetno zdravilo, ki jih ponavadi uporabljamo za zdravljenje bolečin in/ali vnetja mišic ali sklepov, o heparin ali drugo zdravilo v obliki injekcij proti strjevanju krvi, o tiklopidin, drugo antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (vključno a ne omejeno na fluoksetin ali fluvoksamin), zdravila, ki se običajno uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - metotreksat, zdravilo za zdravljenje hude bolezni sklepov (revmatoidnega artritisa) ali bolezni kože (luskavice),
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘DuoPlavin contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘DuoPlavin contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) - Polishing agent: carnauba wax
Slovenian: Pomožne snovi so: - Jedro tablete: manitol (E421), makrogol 6000, mikrokristalna celuloza, nizko substituirana hidroksipropilceluloza, koruzni škrob, hidrogenirano ricinusovo olje (glejte poglavje 2 ‘Zdravilo DuoPlavin vsebuje hidrogenirano ricinusovo olje'), stearinska kislina in brezvodni koloidni silicijev dioksid.
English: Bleeding at the puncture site
Slovenian: Krvavitve na mestu vboda
English: How to store DuoPlavin
Slovenian: Shranjevanje zdravila DuoPlavin
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete DuoPlavin 75 mg/100 mg filmsko obložene tablete
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
Slovenian: EU/1/10/619/008 14 filmsko obloženih tablet EU/1/10/619/009 28 filmsko obloženih tablet EU/1/10/619/010 30 x 1 filmsko obloženih tablet EU/1/10/619/011 50 x 1 filmsko obloženih tablet EU/1/10/619/012 84 filmsko obloženih tablet EU/1/10/619/013 90 x 1 filmsko obloženih tablet EU/1/10/619/014 100 x 1 filmsko obloženih tablet
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
Slovenian: EU/1/10/619/001 14 filmsko obloženih tablet EU/1/10/619/002 28 filmsko obloženih tablet EU/1/10/619/003 30 x 1 filmsko obloženih tablet EU/1/10/619/004 50 x 1 filmsko obloženih tablet EU/1/10/619/005 84 filmsko obloženih tablet EU/1/10/619/006 90 x 1 filmsko obloženih tablet EU/1/10/619/007 100 x 1 filmsko obloženih tablet EU/1/10/619/015 30 filmsko obloženih tablet
English: DuoPlavin 75 mg/75 mg film-coated tablets
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete
English: You should stop other clopidogrel treatment while you are taking DuoPlavin.
Slovenian: Če jemljete zdravilo DuoPlavin prenehajte jemati klopidogrel.
English: DuoPlavin 75 mg/75 mg film-coated tablets EU/1/10/619/001 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/619/002 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/619/003 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/619/004 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/619/005 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/619/006 - Cartons of 90x1film-coated tablet in aluminium blister packs EU/1/10/619/007 - Cartons of 100x1film-coated tablet in aluminium blister packs EU/1/10/619/015 - Cartons of 30 film-coated tablet in aluminium blister packs
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete EU/1/10/619/001 - Škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/002 - Škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/003 - Škatle s 30 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/004 - Škatle s 50 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/005 - Škatle s 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/006 - Škatle z 90 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/007 - Škatle s 100 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/015 - Škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
English: Hearing loss* or tinnitus*
Slovenian: Tinitus* ali poslabšanje sluha*
English: DuoPlavin 75 mg/100 mg film-coated tablets
Slovenian: DuoPlavin 75 mg/100 mg filmsko obložene tablete
English: DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in:
Slovenian: Zdravilo DuoPlavin je na voljo v kartonskih škatlah, ki vsebujejo:
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete DuoPlavin 75 mg/100 mg filmsko obložene tablete klopidogrel in acetilsalicilna kislina
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Slovenian: Oznaka ATC: B01AC30.
English: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
Slovenian: DuoPlavin je kombinirano zdravilo s stalnim odmerkom za nadaljevalno zdravljenje pri: - akutnem koronarnem sindromu brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bila vstavljena opornica po perkutani koronarni intervenciji, - akutnem miokardnem infarktu z elevacijo ST spojnice pri bolnikih, ki se zdravijo z zdravili in so primerni za trombolitično zdravljenje.
English: DuoPlavin 75 mg/100 mg film-coated tablets EU/1/10/619/008 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/619/009 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/619/010 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/619/011 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/619/012 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/619/013 - Cartons of 90x1 film-coated tablet in aluminium blister packs EU/1/10/619/014 - Cartons of 100x1 film-coated tablet in aluminium blister packs
Slovenian: DuoPlavin 75 mg/100 mg filmsko obložene tablete EU/1/10/619/008 - Škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/009 - Škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/010 - Škatle s 30 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/011 - Škatle s 50 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/012 - Škatle s 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/10/619/013 - Škatle z 90 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih EU/1/10/619/014 - Škatle s 100 x 1 filmsko obloženo tableto v aluminijastih pretisnih omotih
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (kot hidrogensulfata) in 75 mg acetilsalicilne kisline (ASA).
English: Colitis (including ulcerative or lymphocytic colitis), stomatitis, acute pancreatitis in the context of a hypersensitivity reaction due to acetylsalicylic acid*
Slovenian: Zelo redki ali ni znano stomatitis, akutni pankreatitis v okviru preobčutljivostne reakcije zaradi acetilsalicilne kisline *
English: DuoPlavin 75 mg/100 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28 and 84 film-coated tablets.
Slovenian: Aluminijasti pretisni omoti v kartonskih škatlah, ki vsebujejo 14, 28 in 84 filmsko obloženih tablet.
English: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘DuoPlavin contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘DuoPlavin contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172) - Polishing agent: carnauba wax
Slovenian: - Obloga tablete: laktoza monohidrat (glejte poglavje 2 ‘Zdravilo DuoPlavin vsebuje laktozo') , hipromeloza (E464), titanov dioksid (E171), triacetin (E1518) in rumeni železov oksid (E172) - Polirno sredstvo: karnauba vosek.
English: The safety of the concomitant administration of DuoPlavin with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Slovenian: Varnost sočasne uporabe zdravila DuoPlavin z drugimi trombolitiki ni formalno ugotovljena.
English: Therapeutic experience is limited in patients with mild to moderate renal impairment (see section 4.4).
Slovenian: Zdravilo DuoPlavin se ne sme uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavje 4.3).Terapevtskih izkušenj pri bolnikih z blago do zmerno okvaro ledvic je malo (glejte poglavje 4.4).
English: Sanofi S.p.A. Tel: 800.536 389
Slovenian: Tel: 800. 536 389
English: DuoPlavin 75 mg/75 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28, 30 and 84 film-coated tablets.
Slovenian: Aluminijasti pretisni omoti v kartonskih škatlah, ki vsebujejo 14, 28,30 in 84 filmsko obloženih tablet.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Slovenian: Ena tableta vsebuje 75 mg klopidogrela (kot hidrogensulfata) in 75 mg acetilsalicilne kisline.
English: Each tablet contains: 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Slovenian: Ena tableta vsebuje: 75 mg klopidogrela (kot hidrogensulfata) in 100 mg acetilsalicilne kisline.
English: Each tablet contains: 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Slovenian: Ena tableta vsebuje: 75 mg klopidogrela (kot hidrogensulfata) in 75 mg acetilsalicilne kisline.
English: What DuoPlavin contains
Slovenian: Kaj vsebuje zdravilo DuoPlavin
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Slovenian: Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov * Informacije, v literaturi navedene za ASA s pogostnostjo “ni znana”.
English: If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Slovenian: Če jemljete to zdravilo se o dojenju posvetujte s svojim zdravnikom.
English: Clopidogrel is extensively metabolised by the liver.
Slovenian: Salicilna kislina se v jetrih predvsem konjugira.
English: • if you have a risk of bleeding such as: - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če imate tveganje za krvavitev, kot je: - bolezen, zaradi katere ste v nevarnosti za notranjo krvavitev (npr. razjeda na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitvam v katerokoli tkivo, organ ali sklep v telesu), - nedavna huda poškodba, - nedaven kirurški poseg (vključno z zobozdravstvenimi posegi), - načrtovan kirurški poseg (vključno z zobozdravstvenimi posegi) v naslednjih sedmih dneh,
English: Cases of Reye's syndrome have occurred following the use of salicylates during varicella infections (see section 4.4).
Slovenian: Po uporabi salicilatov med okužbo z noricami so poročali o pojavu Reyevega sindroma (glejte poglavje
English: Hydrogenated castor oil Stearic acid
Slovenian: Glazura karnauba vosek
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: DuoPlavin 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: DuoPlavin 75 mg/75 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
English: DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Slovenian: DuoPlavin 75 mg/100 mg tablete klopidogrel/acetilsalicilna kislina
English: Vertigo
Slovenian: Trombolitiki
English: Concentrate for solution for
Slovenian: 20 mg/1ml koncentrat za raztopino za
English: The data submitted by the company are presented below.
Slovenian: Podatki, ki jih je družba predložila, so predstavljeni spodaj.
English: On the average the effects appears modest.
Slovenian: V povprečju je učinek skromen.
English: The countries involved in the first wave were Austria, Germany, Spain, Finland, Italy, Portugal.
Slovenian: Države v prvem valu so bile Avstrija, Nemčija, Španija, Finska, Italija in Portugalska.
English: • The Committee considered the notification of the referral triggered by Sweden under Article 29(4) of Council Directive 2001/83/EC.
Slovenian: • Odbor je obravnaval napotitveni postopek, ki ga je sprožila Švedska skladno s členom 29(4) Direktive Sveta 2001/83/ES.
English: Typical syncope episodes are brief and usually last no longer than 20 seconds.
Slovenian: Tipične epizode sinkope so kratke, običajno ne trajajo več kot 20 sekund.
English: As an agreement could not be reached the procedure was subsequently referred to CHMP.
Slovenian: Ker dogovor ni bil dosežen, je bil postopek napoten na CHMP.
English: The amended labelling and package leaflet of the reference Member State are set out in Annex III.
Slovenian: Revidirano označevanje in navodilo za uporabo za referenčno državo članico sta na voljo v Prilogi III.
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.
Slovenian: Za zdravilo je bilo pridobljeno dovoljenje za promet v 25 državah sveta, vključno s 7 državami v Evropski uniji, ki so bile del decentraliziranega postopka, v katerem je bila Švedska referenčna država članica.
English: The CHMP having reviewed the above available data on safety noted the following:
Slovenian: CHMP je po pregledu zgoraj navedenih podatkov o varnosti ugotovil naslednje:
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.
Slovenian: Zatem je družba Janssen Cilag predložila vlogo za postopek medsebojnega priznavanja za zdravilo Priligy 30 mg in 60 mg filmsko obložene tablete v naslednjih državah članicah: Belgiji, Bolgariji, na Cipru, v Češki republiki, na Danskem, v Estoniji, Grčiji, Franciji, na Madžarskem, Irskem, Islandiji, v Litvi, Luksemburgu, Latviji, na Malti, Nizozemskem, Norveškem, Poljskem, v Romuniji, Sloveniji, na Slovaškem in v Združenem kraljestvu.
English: • Safety issues
Slovenian: • Zadržki glede varnosti
English: Five of these events were medically confirmed and four events were unconfirmed.
Slovenian: Pet teh dogodkov je bilo medicinsko potrjenih, štirje pa so bili nepotrjeni.
English: Overall summary of the scientific evaluation of Priligy and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Priligy in povezana imena (glejte Prilogo I)
English: Design and dosage
Slovenian: Zasnova in odmerjanje
English: The approved indication in the EU is for the treatment of PE in men 18 to 64 years of age.
Slovenian: Odobrena indikacija v EU je zdravljenje prezgodnje ejakulacije pri moških, starih od 18 do 64 let.
English: Evidence on the safety profile of Priligy in clinical practice is available from 2 complementary data sources, including
Slovenian: Dokazi o varnostnem profilu zdravila Priligy v klinični praksi zagotavljata 2 dodatna vira podatkov, vključno s:
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNILO OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Overall discussion and benefit/risk assessment
Slovenian: Končna razprava in vrednotenje koristnih učinkov in tveganja
English: Those analyses assume that all subjects with missing data, irrespective of the reason for discontinuation, experienced no benefit from treatment with dapoxetine.
Slovenian: Te analize predpostavljajo, da preiskovanci z manjkajočimi podatki, ne glede na vzrok prekinitve, niso imeli koristi od zdravljenja z dapoksetinom.
English: All of these events were of short duration and spontaneously resolved.
Slovenian: Vsi primeri so bili kratkotrajni in so spontano izzveneli.
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).
Slovenian: Od teh je bila stroga medicinska definicija izgube zavesti izpolnjena pri 8 primerih, vključno z enim sinusnim zastojem (s povezanim 28-sekundnim obdobjem asistole).
English: Similar results for the geometric mean average IELT at Week 12 were seen in each Phase III study in which IELT was measured.
Slovenian: Podobne rezultate za geometrično sredino povprečne IELT v 12. tednu so ugotovili v vseh študijah III. faze, v katerih so merili IELT.
English: The available evidence shows that the risk minimisation measures put in place have been effective in the management of syncope events:
Slovenian: Razpoložljivi dokazi kažejo, da so uvedeni ukrepi za zmanjšanje tveganja učinkovito obvladali primere sinkope:
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.
Slovenian: Nekaj od postopkov, zahtevanih v kliničnem programu razvoja dapoksetina (npr. venipunkcija in ortostatski izziv) in ki so morda prispevali k pojavu sinkope, se v rutinski klinični praksi ne pričakujejo.
English: Priligy is a pharmacologic treatment approved for men with Premature Ejaculation (PE).
Slovenian: Zdravilo Priligy se uporablja za farmakološko zdravljenje in je odobreno za moške s prezgodnjo ejakulacijo (PE).