natgillin/translations-raw huggingface dataset:
The European Medicines Agency has waived the obligation to submit the results of studies with Ledaga in all subsets of the paediatric population in cutaneous T-cell lymphoma (see section 4.2 for information on paediatric use). 
Ledaga za vse podskupine pediatrične populacije s kožnim T-celičnim limfomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
- Allow the area to dry for 5 to 10 minutes after applying your medicine and before covering with clothing. 
- Predel kože naj se po nanosu suši od 5 do 10 minut, preden ga pokrijete z obleko.
Each gram of gel contains 160 micrograms of chlormethine. 
En gram gela vsebuje 160 mikrogramov klormetina.
Diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, butylhydroxytoluene. 
Dietilenglikolmonoetileter, propilenglikol, izopropilni alkohol, glicerol, mlečna kislina, hidroksipropilceluloza, natrijev klorid, racemni mentol, dinatrijev edetat, butilhidroksitoluen.
Ledaga 160 micrograms/g gel chlormethine 
Ledaga 160 mikrogramov/g gel klormetin
In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed: 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje dodatne ukrepe za zmanjševanje tveganj v vseh državah članicah, kjer je v prometu zdravilo Ledaga, za zmanjšanje pomembnega ugotovljenega tveganja »toksičnost za sluznice/oči« in pomembnega potencialnega tveganja »sekundarne izpostavljenosti drugih oseb, razen bolnika«:
Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel. 
Zdravilo Ledaga prejmete v beli aluminijasti tubi z notranjim lakom in aluminijastim tesnilom ter belim polipropilenskim navojnim pokrovčkom.
• Patients must wash hands thoroughly with soap and water immediately after handling or applying Ledaga. 
• Bolniki si morajo takoj po nanašanju zdravila Ledaga dobro umiti roke z milom in vodo.
- For patients applying the gel, wash your hands with soap and water immediately after applying. 
- Za bolnike, ki sami nanašajo gel: po nanosu si roke takoj umijte z milom in vodo.
- Apply Ledaga to affected areas of the skin. 
- Zdravilo Ledaga nanesite na prizadete površine kože.
- Ledaga is supplied within a child-resistant transparent, sealable, plastic bag. 
- Zdravilo Ledaga je dobavljeno v prozorni plastični vrečki, ki jo je mogoče zapreti in je varna za otroke.
- Until Ledaga has dried on the skin, avoid contact with an open flame or a lit cigarette. 
- Izogibajte se stiku z odprtim plamenom ali prižgano cigareto, dokler se zdravilo Ledaga na koži ne posuši.
- Use Ledaga exactly as your doctor or pharmacist tells you. 
- Pri uporabi zdravila Ledaga natančno upoštevajte navodila zdravnika ali farmacevta.
Contact your doctor or seek immediate medical attention if you experience allergic reactions to Ledaga (see section 
Če opazite alergijske reakcije na zdravilo Ledaga, se posvetujte z zdravnikom ali poiščite takojšnjo medicinsko oskrbo (glejte poglavje 4).
STATEMENT OF ACTIVE SUBSTANCE(S) 
Popolni odziv (PO) Delni odziv (DO)
These reactions may include some or all of the following symptoms: - Swelling of the lips, face, throat or tongue 
Reakcije lahko vključujejo naslednje simptome (nekatere od njih ali vse):
See end of section 2 for further information on propylene glycol and butylhydroxytoluene. 
Za nadaljnje informacije o propilenglikolu in butilhidroksitoluenu glejte na koncu poglavja 2.
Ledaga is for topical application to the skin. 
Zdravilo Ledaga je za lokalno nanašanje na kožo.
Ledaga contains propylene glycol and butylhydroxytoluene 
Zdravilo Ledaga vsebuje propilenglikol in butilhidroksitoluen.
Occlusive (air- or water-tight) dressings should not be used on areas of the skin where Ledaga was applied. 
Na delih kože, na katere je bilo naneseno zdravilo Ledaga, se ne sme uporabljati okluzivnih (za zrako ali vodo neprepustnih) povojev ali oblek.
In case of Ledaga exposure to non-affected areas of the skin, patients should wash the exposed area with soap and water. 
Če so zdravilu Ledaga izpostavljeni neprizadeti deli kože, jih mora bolnik umiti z milom in vodo.
Talk to your doctor or pharmacist before using Ledaga. 
Pred začetkom uporabe zdravila Ledaga se posvetujte z zdravnikom ali farmacevtom.
- With clean hands, place Ledaga back in the box it came in and the box in the plastic bag. 
- Zdravilo Ledaga s čistimi rokami vstavite nazaj v škatlo, iz katere ste ga vzeli, in v prozorno plastično vrečko, ki jo je mogoče zapreti.
The tube should not be used and the pharmacist should be contacted if the seal is missing, punctured, or lifted. 
Če tesnilo manjka, je predrto ali odprto, se tube ne sme uporabiti in posvetovati se je treba s farmacevtom.
The MAH must agree about the content and format of the text prior to the launch of Ledaga in each MS with the National Competent Authority (NCA). 
Pred začetkom sprostitve zdravila Ledaga v promet v vsaki od držav članic se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom o vsebini in obliki tega besedila.
In case of Ledaga exposure to non-affected areas of the skin, wash the exposed area with soap and water. 
Če so zdravilu Ledaga izpostavljeni neprizadeti deli kože, jih umijte z milom in vodo.
Therefore, it is not recommended to breast-feed while taking this medicine.You should talk to your doctor before breast-feeding to determine whether or not it is best to breast-feed or to use Ledaga. 
Pred dojenjem se posvetujte z zdravnikom, da ugotovite, ali je bolje, da dojite ali da uporabljate zdravilo Ledaga.
• The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene. 
• Druge pomožne snovi so: dietilenglikolmonoetileter, propilenglikol, izopropilni alkohol, glicerol,
What you need to know before you use Ledaga Do not use Ledaga 
Kaj morate vedeti, preden boste uporabili zdravilo Ledaga Ne uporabljajte zdravila Ledaga
Very common side effects on the treatment area (may affect more than 1 in 10 people): - Skin inflammation - Infections of the skin - Itching (pruritus) 
Zelo pogosti neželeni učinki na zdravljenem delu (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Panel 3 
Preglednica 1.
STOP taking Ledaga and tell your doctor immediately if you experience allergic reactions (hypersensitivity). 
Če opazite alergijske reakcije (preobčutljivost), takoj PRENEHAJTE uporabljati zdravilo Ledaga in o tem obvestite zdravnika.
How to store Ledaga 
Shranjevanje zdravila Ledaga
Studies in animals have shown reproductive toxicity after systemic administration (see section 5.3). 
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja po sistemski uporabi
Your doctor will check your skin for skin cancers during and after your treatment with Ledaga. 
Zdravnik bo med zdravljenjem z zdravilom Ledaga in po njem pregledal, ali se je na koži pojavil kožni rak.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 60 g TUBE 
OVOJNINAH 60 g TUBA
- Do not cover the treated area with air- or water-tight bandages after you have applied this medicine. 
- Zdravljenega predela kože ne ovijte s povojem, ki je neprepusten za zrak ali vodo.
Package leaflet: Information for the patient Ledaga 160 micrograms/g gel chlormethine 
Navodilo za uporabo Ledaga 160 mikrogramov/g gel klormetin
Sodium chloride Menthol racemic Disodium edetate Butylhydroxytoluene 
hidroksipropilceluloza, natrijev klorid, racemni mentol, dinatrijev edetat, butilhidroksitoluen.
Topical use. 
Način uporabe
Common side effects on the treatment area (may affect up to 1 in 10 people): - Skin ulcers - Blisters - Darkening of the skin 
Pogosti neželeni učinki na zdravljenem delu (pojavijo se lahko pri največ 1 od 10 bolnikov):
The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine. 
Tveganje za reakcije na koži zaradi lokalnega klormetina je povečano pri uporabi na obrazu, spolovilih, danki in intertriginozni koži.
Ratio 95% CI 
Razmerje odstotni IZ
Your doctor may stop your treatment if you develop severe inflammation of the skin (i.e., redness and swelling), blisters and ulcers. 
Zdravnik bo morda prekinil vaše zdravljenje, če dobite hudo vnetje kože (t.j.
Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below. 
Drugi neželeni učinki lahko vključujejo: Obvestite zdravnika ali farmacevta, če opazite katerega od neželenih učinkov,
- Direct skin contact with Ledaga should be avoided in individuals other than the patient, such as caregivers. 
- Posamezniki, ki niso bolniki, na primer negovalci, naj se izogibajo neposrednemu stiku zdravila
Each carton contains 1 bottle. 
Vsaka škatla vsebuje 1 plastenko.
• Sudden difficulty in walking or loss of balance or co-ordination 
• nenadne težave pri hoji ali izguba ravnotežja ali koordinacije,
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Table 3: Patients with outcome events in TRITON primary analysis 
Preglednica 3: Bolniki z izidi v primarni analizi TRITON
It may be administered with or without food. 
Lahko se daje s hrano ali brez hrane.
The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state. 
Rezultati dogovora ter gradivo (kjer je ustrezno) morajo biti dogovorjeni s pristojnim nacionalnim organom in morajo biti na voljo v vsaki državi članici pred prihodom zdravila na trg.
• Sudden confusion, difficulty speaking or understanding others 
• nenadna zmedenost, težave z govorom ali razumevanjem drugih,
• ≥75 years of age (see below). 
• ≥ 75 let starosti (glejte spodaj).
Use of any thienopyridine within 5 days before enrolment was an exclusion criterion. 
Uporaba katerega koli tienopiridina v 5 dneh pred vključitvijo je bila izključitveni kriterij.
No significant difference was seen in the STEMI population. 
V populacijah STEMI niso opazili značilne razlike.
TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study. 
TRITON s 13.608 bolniki je bila multicentrična, mednarodna, randomizirana, dvojno slepa študija s paralelno skupino.
The patient population was 92% Caucasian, 26% female, and 39% ≥65 years of age. 
Populacija bolnikov je bila 92 % belcev, 26 % žensk in 39 % ≥ 65 let starosti.
Primary Individual Outcome Events 
Primarni posamezni izidi
• Sudden dizziness or sudden severe headache with no known cause 
• nenadna omotica ali nenaden hud glavobol brez znanega vzroka.
The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours). 
Aktivni presnovek ima razpolovni čas izločanja približno 7,4 ure (razpon 2-15 ur).
These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Prasugrel Mylan') 
To so lahko znaki hude alergijske reakcije (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Prasugrel Mylan«)
For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab. 
Za vse bolnike je bil polnilni odmerek lahko dan kadar koli med randomizacijo in 1 uro po tem, ko je bolnik zapustil kateterizacijski laboratorij.
Date of first authorisation: 16 May 2018 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. maj 2018
• Small red bruises on the skin (ecchymoses) 
• Majhne rdeče modrice na koži (ekhimoza)
All ACS population 
Celotna ACS populacija
Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician. 
Bolnikom je treba povedati, da bo morda trajalo dlje kot običajno, da se ustavi krvavitev, kadar jemljejo prasugrel (v kombinaciji z ASK), ter da morajo svojemu zdravniku sporočiti vsako neobičajno krvavitev (mesto ali trajanje).
• Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body 
• nenadna odrevenelost ali šibkost rok, nog ali obraza, zlasti če je to samo na eni strani telesa,
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake »EXP«.
The format and means of dissemination, of this material should be discussed with the appropriate learned societies. 
Oblika in način razdeljevanja tega gradiva morata biti dogovorjena z ustreznimi strokovnimi združenji.
No (N=13090) 
Ne (N = 13090)
Mylan utca 1, Komárom, 2900, Hungary 
Mylan utca 1, 2900 Komárom, Madžarska
Children and adolescents Prasugrel Mylan should not be used in children and adolescents below 18 years of age. 
Otroci in mladostniki Zdravilo Prasugrel Mylan se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Medicinal products that elevate gastric pH 
Zdravila, ki višajo želodčni pH
Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints. 
Osebe z diabetesom so imele občutno znižanje primarnih in vseh sekundarnih sestavljenih ciljev študije.
• with body weight <60 kg (see sections 4.2 and 4.8). 
• s telesno maso < 60 kg (glejte poglavji 4.2 in 4.8).
You should use Prasugrel Mylan only after discussing with your doctor the potential benefits and any potential risks to your unborn child. 
Zdravilo Prasugrel Mylan lahko jemljete samo po posvetu z vašim zdravnikom glede možnih koristi in kakršnih koli možnih tveganjih za vašega nerojenega otroka.
Pharmacokinetic in special populations 
Farmakokinetika pri posebnih populacijah
Do not take Prasugrel Mylan if you - are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Prasugrel Mylan - če ste alergični na prasugrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Polyvinyl alcohol 
Polivinil alkohol
Prasugrel prior to coronary angiographya (N=2037) % 
Prasugrel pred koronarno angiografijo (N = 2037) %
It is important that you tell your doctor, dentist and pharmacist, that you are taking Prasugrel Mylan. 
Pomembno je, da poveste svojemu zdravniku, zobozdravniku in farmacevtu, da jemljete zdravilo Prasugrel Mylan.
Hazard Ratio (HR) (95% CI) 
Razmerje tveganja (RT) (95 % IZ)
You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. 
Morda imate tudi eno ali več žilnih opornic, ki razširjajo zamašeno ali zožano arterijo, ki oskrbuje srce s krvjo.
Inhibitors of CYP3A 
Zaviralci CYP3A
Because animal reproduction studies are not always predictive of a human response, Prasugrel Mylan should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus. 
Ker študije razmnoževanja pri živalih vedno ne napovedo odgovora pri ljudeh, lahko uporabljamo zdravilo Prasugrel Mylan med nosečnostjo samo, če možna korist za mater upraviči možno tveganje za zarodek.
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p<0.001) for prasugrel versus clopidogrel. 
V celotni populaciji ACS je analiza vsakega od sekundarnih ciljev kazala pomembno korist (p < 0,001) za prasugrel v primerjavi s klopidogrelom.
- have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines. 
- če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je krvavitev iz želodca ali črevesja.
Bleeding risk 
Tveganje za krvavitev
Patients ≥75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events. 
Bolniki ≥ 75 let, pri katerih je bila korist zdravljenja s prasugrelom bolj očitna, so vključevali tiste z diabetesom, s STEMI, večjim tveganjem za trombozo žilne opornice ali ponovljenimi dogodki.
If you take more Prasugrel Mylan than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding. 
Če ste vzeli večji odmerek zdravila Prasugrel Mylan, kot bi smeli Nemudoma se obrnite na svojega zdravnika ali bolnišnico, saj imate morda tveganje za prekomerno krvavitev.
A 5 mg maintenance dose should be used. 
Uporabiti je treba 5 mg vzdrževalni odmerek.
If you are pregant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Patients ≥75 years old 
Bolniki, stari ≥ 75 let
The use of Prasugrel Mylan in patients ≥75 years of age is generally not recommended. 
Uporaba zdravila Prasugrel Mylan pri bolnikih, starih ≥ 75 let, na splošno ni priporočena.
You may take Prasugrel Mylan with or without food. 
Zdravilo Prasugrel Mylan lahko jemljete s hrano ali brez nje.
You have been prescribed Prasugrel Mylan because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart. 
Zdravilo Prasugrel Mylan so vam predpisali, ker ste že imeli srčni infarkt ali nestabilno angino pektoris in so vas zdravili s postopkom, s katerim so odprli zamašene arterije v srcu.
At a very high dose (>240 times the recommended daily human maintenance dose on a mg/m² basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls). 
Pri zelo visokem odmerku (> 240-kratnik priporočenega dnevnega vzdrževalnega odmerka za ljudi na osnovi mg/m²), ki je povzročil učinke na telesno maso breje samice in/ali uživanje hrane, je bil opazen rahel upad telesne mase mladičev (glede na kontrolo).
Your doctor will also tell you to take acetylsalicylic acid, and (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily). 
Vaš zdravnik vam bo tudi naročil, da jemljite acetilsalicilno kislino in vam povedal natančen odmerek, ki ga morate vzeti (običajno med 75 mg in 325 mg dnevno).
• Uncontrollable bleeding, for example from a cut 
• Nenadzorovana krvavitev, na primer od ureza
• Low haemoglobin or red blood cell count (anaemia) 
• Nizek hemoglobin ali nizko število rdečih krvnih celic (anemija)
No dose adjustment is recommended based on ethnicity alone. 
Prilagoditev odmerka na osnovi etnične pripadnosti ni potrebna.
Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain). 
Strdki v arterijah, ki oskrbujejo srce s krvjo, lahko tudi zmanjšajo dotok krvi, s čimer povzročijo nestabilno angino pektoris (huda bolečina v prsih).
McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland 
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
The safety and efficacy of Prasugrel Mylan in children below age 18 has not been established. 
Varnost in učinkovitost zdravila Prasugrel Mylan pri otrocih, mlajših od 18 let, nista bili dokazani.
If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Prasugrel Mylan should be discontinued at least 7 days prior to surgery. 
Če ima bolnik predviden nenujen kirurški poseg in če antitrombotični učinek ni zaželen, mora z jemanjem zdravila Prasugrel Mylan prekiniti najmanj 7 dni pred kirurškim posegom.
Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI. 
Približno 98 % bolnikov (v vsaki skupini zdravljenja) je prejelo antitrombine (heparin, nizko molekularni heparin, bivalirudin ali druga zdravila) neposredno kot podporo PCI.
• with concomitant administration of medicinal products that may increase the risk of bleeding, including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics. 
• s sočasnim dajanjem zdravil, ki lahko povečajo tveganje za krvavitev, vključno s peroralnimi antikoagulanti, klopidogrelom, nesteroidnimi protivnetnimi zdravili (non-steroidal anti inflammatory drugs, NSAID) in fibrinolitiki.
Prasugrel has no or negligible influence on the ability to drive and use machines. 
Prasugrel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC22. 
Farmakoterapevtska skupina: Antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC22.
The observed benefit of prasugrel in patients ≥75 years was less than that observed in patients <75 years. 
Opazovane koristi prasugrela pri bolnikih ≥ 75 let so bile manjše kot pri bolnikih < 75 let.
The tablets should not be crushed or broken. 
Tablet ne drobite in ne lomite.
Patients ≥60 kg and age <75 years 
Bolniki ≥ 60 kg in < 75 let
More than 98% of subjects had ≥20% inhibition of platelet aggregation during maintenance dosing. 
Več kot 98 % oseb je imelo ≥ 20 % zaviranje agregacije trombocitov med vzdrževalnim odmerjanjem.
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Prasugrel Mylan. 
Povejte svojemu zdravniku, če zanosite ali poskušate zanositi, medtem ko jemljete zdravilo Prasugrel Mylan.
Prasugrel showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3). 
Prasugrel je pokazal superiorno učinkovitost v primerjavi s klopidogrelom pri znižanju primarnih sestavljenih izidov kot tudi vnaprej določenih sekundarnih izidov, vključno s trombozo žilne opornice (glejte Preglednico 3).
Inducers of cytochromes P450 
Induktorji citokroma P450
Microcrystalline cellulose Mannitol 
Mikrokristalna celuloza Manitol
The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug. 
Večje tveganje za krvavitve pri osebah, zdravljenih s prasugrelom, je bilo prisotno še do 7 dni od zadnjega odmerka preiskovanega zdravila.
The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3). 
Korist je bila primarno posledica občutnega znižanja ne-smrtnega miokardnega infarkta (glejte Preglednico 3).
• Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs 
• Spontana krvavitev iz očesa, danke, dlesni ali v trebuh okrog notranjih organov
Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel. 
Toksikološke študije razvoja ploda/zarodka pri podganah in zajcih niso podale dokazov o malformacijah zaradi prasugrela.
Iron oxide yellow (E172) 
Rumeni železov oksid (E172)
Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2). 
Dajanje 60 mg polnilnega odmerka prasugrela na tešče lahko nudi najhitrejši začetek delovanja (glejte poglavje 5.2).