FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Prasugrel Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Prasugrel Mylan Vsebina pakiranja in dodatne informacije
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Slovenian: f Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl, vendar < 5 g/dl.
English: Do not eat or remove the desiccant contained in the bottle Not all pack sizes may be marketed.
Slovenian: Ne jejte ali odstranjujte sušilnega sredstva v plastenki.
English: e Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Slovenian: e Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl, vendar < 5 g/dl.
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is a colouring agent, which may cause allergic reactions.
Slovenian: Prasugrel Mylan 10 mg vsebuje sončno rumeno barvilo FCF (E110) in natrij Sončno rumeno barvilo FCF je barvilo, ki lahko povzroči alergijske reakcije.
English: Prasugrel + ASA
Slovenian: Izidi prasugrel + ASK
English: ≥75 years (N=2060)**
Slovenian: ≥ 75 let (N=2060)**
English: Non-fatal stroke
Slovenian: Ne-smrtna možganska kap
English: Only take other medicines while you are on Prasugrel Mylan if your doctor tells you that you can.
Slovenian: Medtem ko jemljete zdravilo Prasugrel Mylan, vzemite druga zdravila samo, če vam zdravnik pove, da jih smete.
English: Effects of other medicinal products on Prasugrel Mylan
Slovenian: Učinki drugih zdravil na zdravilo Prasugrel Mylan
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Slovenian: V 30­dnevni študiji (ACCOAST) s 4033 bolniki z NSTEMI s povišanim troponinom, pri katerih je bila predvidena koronarna angiografija, ki ji je sledila perkutana koronarna intervencija v obdobju 2 do 48 ur po randomizaciji, so bolniki, ki so prejeli 30-miligramski polnilni odmerek prasugrela v povprečju 4 ure pred koronarno angiografijo, ki mu je sledil 30-miligramski polnilni odmerek v času perkutane koronarne intervencije (n = 2037), imeli povečano tveganje za krvavitev ob postopku, ki ni bila povezana z aortokoronarnim obvodom, in nobenih dodatnih koristi v primerjavi z bolniki, ki so prejeli 60-mg polnilni odmerek v času perkutane koronarne intervencije (n = 1996).
English: Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days.
Slovenian: Po dajanju 900 mg polnilnega odmerka klopidogrela (z ASK) je bilo 56 preiskovancev z ACS 14 dni zdravljenih s prasugrelom 10 mg enkrat na dan ali klopidogrelom 150 mg enkrat na dan, nato pa so nadaljnjih 14 dni zdravljenje nadaljevali s klopidogrelom 150 mg ali prasugrelom 10 mg. Močnejše zaviranje agregacije trombocitov so opazili pri bolnikih, ki so jim zdravljenje zamenjali na zdravljenje s prasugrelom 10 mg v primerjavi s tistimi, ki so bili zdravljeni s klopidogrelom 150 mg.
English: Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Slovenian: Prasugrel je predzdravilo, ki se hitro presnavlja in vivo v aktivni presnovek in neaktivne presnovke.
English: Take your dose at around the same time every day.
Slovenian: Odmerek vzemite ob približno istem času vsak dan. Tablet ne lomite in ne drobite.
English: • Fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice).
Slovenian: • vročino, podkožne modrice, ki lahko izgledajo kot rdeče pike, z ali brez nepojasnjene hude utrujenosti, zmedenosti, porumenitve kože in oči (zlatenica) (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Prasugrel Mylan«)
English: Contains sunset yellow FCF aluminium lake (E110).
Slovenian: Vsebuje sončno rumeno barvilo FCF (E110).
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev je pri sočasni uporabi NSAID (vključno z zaviralci COX-2) in zdravila Prasugrel Mylan (glejte poglavje 4.4) potrebna previdnost.
English: Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) and prasugrel should be co-administered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev moramo previdno dajati sočasno varfarin (ali druge kumarinske derivate) in prasugrel (glejte poglavje 4.4).
English: Contact your doctor immediately if you notice any of the following:
Slovenian: Svojega zdravnika nemudoma obvestite, če opazite kar koli od naslednjega:
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions.
Slovenian: Zdravilo Prasugrel Mylan 10 mg vsebuje sončno rumeno barvilo FCF (E110) in natrij Sončno rumeno barvilo FCF je azo barvilo, ki lahko povzroči alergijske reakcije.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Slovenian: Imetnik dovoljenja za promet z zdravilom Mylan S.A.S.
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor periprocedural bleeding compared with a prasugrel loading dose at the time of PCI.
Slovenian: Tveganje za krvavitve, povezano z izbiro časa za dajanje polnilnega odmerka pri NSTEMI Pri kliničnem preskušanju bolnikov z NSTEMI (študija ACCOAST), pri katerem je bila za bolnike predvidena koronarna angiografija v obdobju 2 do 48 ur po randomizaciji, je polnilni odmerek prasugrela, dan v povprečju 4 ure pred koronarno angiografijo, povečal tveganje za večjo ali manjšo krvavitev ob postopku v primerjavi s polnilnim odmerkom prasugrela v času perkutane koronarne intervencije.
English: Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Slovenian: nestabilna angina pektoris, miokardni infarkt brez elevacije ST spojnice [non-ST segment elevation myocardial infarction, UA/NSTEMI] ali miokardni infarkt z elevacijo ST spojnice [ST segment elevation myocardial infarction, STEMI], ki imajo primarno ali odloženo perkutano koronarno intervencijo (percutaneous coronary intervention, PCI).
English: - have ever had a stroke or a transient ischaemic attack (TIA).
Slovenian: - če ste kadar koli imeli možgansko kap ali tranzitorno ishemično atako.
English: 2D barcode carrying the unique identifier included.
Slovenian: Samo na škatli: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: * ICH = intracranial haemorrhage.
Slovenian: * ICH = intrakranialna krvavitev (intracranial haemorrhage).
English: d ICH = intracranial haemorrhage.
Slovenian: d ICH = intrakranialna krvavitev (intracranial haemorrhage).
English: e ICH = intracranial haemorrhage.
Slovenian: e ICH = intrakranialna krvavitev (intracranial haemorrhage).
English: Patients taking Prasugrel Mylan should also take ASA daily (75 mg to 325 mg).
Slovenian: Bolniki, ki jemljejo zdravilo Prasugrel Mylan, morajo dnevno jemati tudi ASK (75 mg do 325 mg).
English: • If you have an increased risk of bleeding such as: - age of 75 years or older.
Slovenian: • Če imate povečano tveganje za krvavitev, kot je: - starost 75 let ali več, Vaš zdravnik vam mora predpisati dnevni odmerek 5 mg, ker obstaja večje tveganje za krvavitev pri bolnikih, starejših od 75 let.
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Prasugrela ne smemo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: UA/NSTEMI Primary Composite Outcome Events
Slovenian: Primarni sestavljeni izidi UA/NSTEMI
English: No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to greater than 75 times the recommended therapeutic exposures in humans (based on plasma exposures to the active and major circulating human metabolites).
Slovenian: V 2­letni študiji pri podganah pri izpostavitvah prasugrelu v obsegu do več kot 75­kratnim priporočenim terapevtskim odmerkom pri ljudeh (na osnovi plazemske izpostavitve aktivnemu in pomembnejšim krožečim humanim presnovkom), niso opazili tumorjev, povezanih z zdravilno učinkovino.
English: This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and in blister packs containing 28, 30, 84 or 98 film-coated tablets.
Slovenian: Zdravilo je na voljo v plastenkah s sušilnim sredstvom in 28 ali 30 filmsko obloženimi tabletami in v pretisnih omotih, ki vsebujejo 28, 30, 84 ali 98 filmsko obloženih tablet.
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Slovenian: Tveganje za krvavitve, povezano z izbiro časa za dajanje polnilnega odmerka pri NSTEMI V kliničnem preskušanju bolnikov z NSTEMI (študija ACCOAST), v katerem je bila za bolnike predvidena koronarna angiografija v obdobju 2 do 48 ur po randomizaciji, so bolniki, ki so prejeli 30-miligramski polnilni odmerek v povprečju 4 ure pred koronarno angiografijo, ki mu je sledil 30-miligramski polnilni odmerek v času perkutane koronarne intervencije, imeli povečano tveganje za krvavitev ob postopku, ki ni bila povezana z aortokoronarnim obvodom, in nobenih dodatnih koristi v primerjavi z bolniki, ki so prejeli 60-miligramski polnilni odmerek v času perkutane koronarne intervencije (glejte poglavji 4.2 in 4.4).
English: What Prasugrel Mylan looks like and contents of the pack
Slovenian: Izgled zdravila Prasugrel Mylan in vsebina pakiranja
English: Do not stop taking Prasugrel Mylan without consulting your doctor; if you stop taking Prasugrel Mylan too soon, your risk of a heart attack may be higher.
Slovenian: Če zdravilo Prasugrel Mylan prenehate jemati prezgodaj, je lahko pri vas tveganje za srčno kap večje.
English: Fatal
Slovenian: Smrtna
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epitaksa hemoptiza
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 or 90 x 1 film-coated tablets.
Slovenian: Pakiranja v perforiranih enoodmernih pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 30 x 1 ali 90 x 1 filmsko obloženo tableto.
English: What Prasugrel Mylan contains - The active substance is prasugrel.
Slovenian: Kaj vsebuje zdravilo Prasugrel Mylan - Učinkovina je prasugrel.
English: Sunset yellow FCF aluminium lake (E110) [only Prasugrel Mylan 10 mg]
Slovenian: Sončno rumeno barvilo FCF (E110) [samo Prasugrel Mylan 10 mg] Rdeči železov oksid (E172) [samo Prasugrel Mylan 10 mg]
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih udarnina pooperacijska krvavitev podkožni hematom
English: • Before you take Prasugrel Mylan:
Slovenian: • Preden vzamete zdravilo Prasugrel Mylan:
English: Prasugrel was administered without regard to food in TRITON.
Slovenian: Prasugrel so v študiji TRITON dajali neodvisno od hrane.
English: Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) body weight of less than 60 kg.
Slovenian: - nedavna resna poškodba, - nedavni kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi), - nedavna ali ponovna krvavitev iz želodca ali črevesja (npr. želodčni ulkus ali polipi debelega črevesja), telesna masa nižja od 60 kg.
English: Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
Slovenian: V obdobju 7 dni po prekinitvi prasugrela se pri bolnikih, ki so imeli kirurški poseg aortokoronarnega obvoda (Coronary Artery Bypass Graft, CABG), lahko pojavita povečana pogostnost (3-kratna) in resnost krvavitve (glejte poglavje 4.8).
English: Because of the potential for increased risk of bleeding, warfarin and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev moramo previdno dajati sočasno varfarin in zdravilo Prasugrel Mylan (glejte poglavje 4.4).
English: Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see section 4.5).
Slovenian: Pri bolnikih, ki so sočasno prejemali prasugrel in morfin, so opazili zmanjšano učinkovitost prasugrela (glejte poglavje 4.5).
English: b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Slovenian: b Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina
English: If you forget to take Prasugrel Mylan
Slovenian: Če ste pozabili vzeti zdravilo Prasugrel Mylan
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 filmcoated tablets.
Slovenian: Pakiranja v pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
English: This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight <60 kg when given a 10 mg once daily dose compared with patients ≥60 kg (see sections 4.4, 4.8 and
Slovenian: Odmerjanje zdravila Prasugrel Mylan je treba začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati s 5 mg enkrat na dan. 10 mg vzdrževalni odmerek ni priporočljiv, in sicer zaradi večje izpostavljenosti aktivnemu presnovku prasugrela in povečanemu tveganju za krvavitev ob prejemanju 10 mg odmerka enkrat na dan pri bolnikih, ki tehtajo < 60 kg, v primerjavi z bolniki ≥ 60 kg (glejte poglavja 4.4, 4.8 in 5.2).
English: • Bleeding from a needle puncture site
Slovenian: • Krvavitev iz mesta vboda igle
English: CV death, nonfatal MI, or nonfatal stroke
Slovenian: Srčno-žilna smrt, ne-smrtni miokardni infarkt ali ne-smrtna možganska kap
English: If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Slovenian: Če je po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja (glejte poglavje 4.4) zdravljenje v starostni skupini bolnikov ≥ 75 let potrebno, mora biti po enkratnemu 60 mg polnilnemu odmerku predpisan nižji vzdrževalni odmerek 5 mg. Bolniki ≥ 75 let so bolj nagnjeni h krvavitvi in bolj izpostavljeni aktivnemu presnovku prasugrela (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Slovenian: Pri bolnikih, pri katerih srčna anatomija ni določena in je možen nujni aortokoronarni obvod, je treba skrbno razmisliti o koristih in tveganjih prasugrela.
English: Thrombocytopaenia
Slovenian: Krospovidon
English: • While you are taking Prasugrel Mylan:
Slovenian: • Med jemanjem zdravila Prasugrel Mylan:
English: Eye haemorrhage
Slovenian: Okvara ledvic
English: Prasugrel Mylan is for oral use.
Slovenian: Zdravilo Prasugrel Mylan je za peroralno uporabo.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated tablets.
Slovenian: Pakiranja v pretisnih omotih iz OPA/Al/PE/sušilno sredstvo/PE-Al, ki vsebujejo 28, 30, 84 ali 98 filmsko obloženih tablet.
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Slovenian: c Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina
English: EU/1/18/1273/004
Slovenian: EU/1/18/1273/002 EU/1/18/1273/004
English: Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side of the tablet and ‘M' on the other side.
Slovenian: Prasugrel Mylan 5 mg: filmsko obložene tablete so rumene barve, v obliki kapsule, bikonveksne, velikosti 8,15 mm × 4,15 mm, z vtisnjenim »PH3« na eni strani in »M« na drugi strani.
English: Prasugrel Mylan 5 mg: Do not store above 30°C.
Slovenian: Prasugrel Mylan 5 mg: Shranjujte pri temperaturi do 30 °C.
English: • ‘non-steroidal anti-inflammatory drugs' for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Slovenian: Še posebej je pomembno, da poveste svojemu zdravniku, če se zdravite s/z: klopidogrelom (zdravilom proti trombocitom), varfarinom (antikoagulantom), »nesteroidnimi protivnetnimi zdravili« za bolečino in vročino (kot je ibuprofen, naproksen, etorikoksib).
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Slovenian: Pakiranja v pretisnih omotih: Shranjujte pri temperaturi do 30 °C.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of <60 kg compared to those weighing ≥60 kg.
Slovenian: Srednja izpostavljenost (AUC) aktivnemu presnovku prasugrela je približno 30-40 % višja pri zdravih osebah in bolnikih s telesno maso < 60 kg, v primerjavi s tistimi, ki tehtajo ≥ 60 kg. Prasugrel moramo uporabljati previdno pri bolnikih s telesno maso < 60 kg, zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavje 4.4).
English: Prasugrel
Slovenian: Smukec
English: Thrombotic thrombocytopaenic purpura (TTP)
Slovenian: Trombotična trombocitopenična purpura (TTP) Pri uporabi prasugrela so poročali o TTP.
English: Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel
Slovenian: Prasugrel Mylan 5 mg filmsko obložene tablete Prasugrel Mylan 10 mg filmsko obložene tablete prasugrel
English: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Slovenian: Ena tableta vsebuje prasugrel besilat, kar ustreza 10 mg prasugrela.
English: Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side and ‘M' on the other side.
Slovenian: Rumena bikonveksna filmsko obložena tableta v obliki kapsule, velikosti 8,15 mm × 4,15 mm, z vtisnjeno oznako »PH3« na eni in »M« na drugi strani.
English: Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side of the tablet and ‘M' on the other side.
Slovenian: Prasugrel Mylan 10 mg: filmsko obložene tablete so bež barve, v obliki kapsule, bikonveksne, velikosti 11,15 mm × 5,15 mm, z vtisnjenim »PH4« na eni strani in »M« na drugi strani.
English: BOTTLE CARTON AND BOTTLE LABEL OF 10 MG FILM-COATED TABLETS
Slovenian: ŠKATLA ZA PLASTENKO IN NALEPKA NA PLASTENKI 10 MG FILMSKO OBLOŽENIH TABLET
English: • Bruising
Slovenian: • Modrice
English: BOTTLE CARTON AND BOTTLE LABEL OF 5 MG FILM-COATED TABLETS
Slovenian: ŠKATLA ZA PLASTENKO IN NALEPKA NA PLASTENKI 5 MG FILMSKO OBLOŽENIH TABLET
English: Sodium lauryl sulfate
Slovenian: Gliceril monokaprilat monokaprinat Natrijev lavril sulfat
English: Prasugrel Mylan 5 mg film-coated tablets prasugrel
Slovenian: Prasugrel Mylan 5 mg filmsko obložene tablete prasugrel
English: Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Slovenian: Prasugrel Mylan 10 mg: Ena tableta vsebuje prasugrel besilat v količini, ki ustreza 10 mg prasugrela.
English: Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Slovenian: Prasugrel Mylan 5 mg: Ena tableta vsebuje prasugrel besilat v količini, ki ustreza 5 mg prasugrela.
English: How to store Prasugrel Mylan
Slovenian: Kako jemati zdravilo Prasugrel Mylan
English: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Slovenian: Ena tableta vsebuje prasugrel besilat, kar ustreza 5 mg prasugrela.
English: Always take Prasugrel Mylan exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila Prasugrel Mylan natančno upoštevajte navodila zdravnika.
English: Prasugrel Mylan 10 mg film-coated tablets prasugrel
Slovenian: Prasugrel Mylan 10 mg filmsko obložene tablete prasugrel
English: Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side and ‘M' on the other side.
Slovenian: Bež bikonveksna filmsko obložena tableta v obliki kapsule, velikosti 11,15 mm × 5,15 mm, z vtisnjeno oznako »PH4« na eni in »M« na drugi strani.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Non-fatal MI
Slovenian: Smrtno nevarna d
English: BLISTER CARTON OF 5 MG FILM-COATED TABLETS
Slovenian: PRETISNI OMOT 5 MG FILMSKO OBLOŽENIH TABLET
English: Blister packs only: Do not store above 30°C.
Slovenian: Samo za pretisne omote: Shranjujte pri temperaturi do 30 °C.
English: Prasugrelb + ASA (N=6741)
Slovenian: ASK (N = 6741)
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥4 units) TIMI minor bleedingf a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study
Slovenian: f a Centralno določeni dogodki, definirani po kriterijih preiskovane skupine za trombolizo pri miokardnem infarktu (Thrombolysis in Myocardial Infarction, TIMI).
English: BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Slovenian: PRETISNI OMOT 10 MG FILMSKO OBLOŽENIH TABLET
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets
Slovenian: Prasugrel Mylan 5 mg filmsko obložene tablete Prasugrel Mylan 10 mg filmsko obložene tablete
English: Non-CABG-related TIMI major or minor bleeding rates: Weight
Slovenian: Bolniki < 60 kg Stopnje večjih in manjših krvavitev po TIMI, nepovezanih z aortokoronarnim obvodom:
English: Prasugrel Mylan 10 mg: Do not store above 25°C.
Slovenian: Prasugrel Mylan 10 mg: Shranjujte pri temperaturi do 25 °C.