natgillin/translations-raw huggingface dataset:
55 Metformin passes into human milk in small amounts.
57 Metformin v majhnih količinah prehaja v materino mleko.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
59 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Each film -coated tablet contains 50 mg of
Vsaka filmsko obložena tableta
sitagliptin (as phosphate monohydrate) and 1000 mg of metformin hydrochloride.
vsebuje 50 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata) in 1. 000 mg metforminijevega klorida.
Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Rdeče filmsko obložene tablete v obliki kapsule, z oznako » 577 « na eni strani.
59 Κύπρος Merck Sharp & Dohme (Middle East) Limited.
61 Κύπρος Merck Sharp & Dohme (Middle East) Limited.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI MORAJO BITI IZVEDENI V DRŽAVAH ČLANICAH
The educational material should include: • A copy of the SPC • Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age. o If, after a careful individual benefit/ risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed. o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/ PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups.
Izobraževalno gradivo mora vključevati: • Izvod SPC- ja • S poudarkom na: o Hude krvavitve so pogostejše pri bolnikih starih ≥ 75 let (vključno s smrtnimi primeri) ali s telesno maso < 60 kg. o Zdravljenje s prasugrelom na splošno ni priporočeno za bolnike stare ≥ 75 let. o Če je po skrbni oceni lečečega zdravnika glede posameznikove koristi/ tveganja zdravljenje v starostni skupini ≥ 75 let potrebno, mora biti po enkratnemu 60 mg polnilnemu odmerku predpisan nižji vzdrževalni odmerek 5 mg. o Bolniki s telesno maso < 60 kg morajo jemati nižji vzdrževalni odmerek 5 mg. o Podatki za 5 mg odmerek so osnovani samo na farmakodinamičnih/ farmakokinetičnih analizah, saj trenutno ni na voljo kliničnih podatkov glede varnosti tega odmerka pri tveganih podskupinah bolnikov.
It is available as double-arrow- shaped tablets (yellow:
Na voljo je v obliki tablet v obliki dvojne puščice (rumene:
5 mg; beige:
5 mg; bež:
Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack.
Akutni koronarni sindrom je skupina stanj, ki zajema nestabilno angino (hudo obliko bolečine v prsih) in srčni infarkt.
Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).
Perkutana koronarna intervencija je operativni poseg, pri katerem odmašijo zožene koronarne arterije (krvne žile v srcu).
Efient treatment starts with one 60-mg dose.
Zdravljenje z zdravilom Efient začnemo z enim 60- miligramskim odmerkom.
This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Nato nadaljujemo z 10 mg enkrat na dan, razen pri bolnikih, ki tehtajo manj kot 60 kg, ki naj vzamejo 5 mg enkrat na dan.
The medicine can be taken with or without food.
Zdravilo se lahko vzame s hrano ali brez nje.
Patients taking Efient should also take aspirin at a dose prescribed by their doctors.
Bolniki, ki jemljejo zdravilo Efient, naj prav tako jemljejo aspirin, in sicer v odmerku, ki jim ga je predpisal zdravnik.
The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group.
Uporaba zdravila Efient pri bolnikih, mlajših od 18 let, zaradi nezadostnih podatkov o varnosti in učinkovitosti v tej starostni skupini ni priporočena.
Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary.
Njegova uporaba prav tako ni priporočena pri bolnikih, starejših od 75 let, razen če je zdravnik skrbno preučil njegove koristi in tveganja in je ocenil, da je zdravljenje z zdravilom Efient potrebno.
In this case, the 5-mg daily dose should be used following a 60-mg starting dose.
V tem primeru naj se po 60- miligramskem začetnem odmerku uporablja 5- miligramski dnevni odmerek.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Ko se kri strdi, je to posledica zlepljanja (agregacije) posebnih celic v krvi, imenovanih trombociti.
This stops the platelets becoming ‘ sticky’, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.
Tako se prepreči, da bi trombociti postali „ lepljivi “, kar zmanjša tveganje za tvorbo krvnega strdka in pomaga pri preprečevanju srčnega infarkta ali kapi.
The effects of Efient were first tested in experimental models before being studied in humans.
Učinki zdravila Efient so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘ maintenance’ doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
V eni glavni študiji so zdravilo Efient, ki so ga dajali v začetnem odmerku 60 mg in sledečih „ vzdrževalnih “ odmerkih po 10 mg, primerjali s klopidogrelom (drugim zaviralcem agregacije trombocitov), pri čemer so obe zdravili uporabljali v kombinaciji z aspirinom.
The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes.
Glavno merilo učinkovitosti je bilo zmanjšano skupno število srčnožilnih smrti (smrti zaradi težav s srcem ali krvnimi žilami), srčnih infarktov ali kapi.
The patients were followed up for an average of 14.5 months.
V povprečju so bolnike spremljali do 14, 5 meseca.
At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Ob koncu študije je 9% bolnikov, ki so jemali zdravilo Efient, umrlo zaradi srčnožilnih vzrokov ali doživelo srčni infarkt ali kap (643 bolnikov od 6 813) v primerjavi z 11% bolnikov, ki so jemali klopidogrel (781 bolnikov od 6 795).
The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising.
Najpogostejši neželeni učinki zdravila Efient (opaženi pri 1 do 10 bolnikih izmed 100) so anemija (nizko število rdečih krvnih celic), hematom (skupek krvi pod kožo ali v mišici), epistaksa (krvavitev iz nosu), gastrointestinalna krvavitev (krvavitev v želodec ali črevesje), izpuščaj, hematurija (kri v urinu), krvavitev iz mest vboda igle, hematom na mestih vboda in modrice.
For the full list of all side effects reported with Efient, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Efient, glejte navodilo za uporabo.
Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients.
Zdravila Efient ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) prasugrel ali katero koli drugo sestavino zdravila.
It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.
Ne smejo ga uporabljati bolniki z bolezenskim stanjem, ki povzroča prekomerno krvavitev, bolniki, ki so imeli kap ali tranzitorno ishemično atako (prehodno zmanjšan dotok krvi delu možganov) ali hude težave z jetri.
The Committee for Medicinal Products for Human Use (CHMP) decided that Efient’ s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Efient ob sočasni uporabi z aspirinom za preprečevanje aterotrombotičnih dogodkov pri bolnikih z akutnim koronarnim sindromom, ki so imeli primarno ali odloženo perkutano intervencijo, večje od z njim povezanih tveganj.
The Committee recommended that Efient be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Efient odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Efient?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Efient?
The company that makes Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine.
Družba, ki izdeluje zdravilo Efient, mora zagotoviti, da bo v vseh državah članicah zdravnikom, ki bodo zdravili bolnike z zdravilom, na voljo izobraževalno gradivo.
The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.
Gradivo bo vključevalo informacije o varnem predpisovanju zdravila in bo zdravnike opozarjalo, da uporaba zdravila pri bolnikih, starejših od 75 let, ni priporočena.
Other information about Efient:
Druge informacije o zdravilu Efient:
The European Commission granted a marketing authorisation valid throughout the European Union for Efient to Eli Lilly Nederland BV on 25 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Efient, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland BV dne 25. februarja 2009.
The full EPAR for Efient can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Efient je na voljo tukaj.
EU/ 1/ 08/ 503/ 001 EU/ 1/ 08/ 503/ 002 EU/ 1/ 08/ 503/ 003 EU/ 1/ 08/ 503/ 004 EU/ 1/ 08/ 503/ 005 EU/ 1/ 08/ 503/ 006 EU/ 1/ 08/ 503/ 007 EU/ 1/ 08/ 503/ 008 EU/ 1/ 08/ 503/ 009 EU/ 1/ 08/ 503/ 010 EU/ 1/ 08/ 503/ 011 EU/ 1/ 08/ 503/ 012 EU/ 1/ 08/ 503/ 013 EU/ 1/ 08/ 503/ 014
EU/ 1/ 08/ 503/ 001 EU/ 1/ 08/ 503/ 002 EU/ 1/ 08/ 503/ 003 EU/ 1/ 08/ 503/ 004 EU/ 1/ 08/ 503/ 005 EU/ 1/ 08/ 503/ 006 EU/ 1/ 08/ 503/ 007 EU/ 1/ 08/ 503/ 008 EU/ 1/ 08/ 503/ 009 EU/ 1/ 08/ 503/ 011 EU/ 1/ 08/ 503/ 012 EU/ 1/ 08/ 503/ 013 EU/ 1/ 08/ 503/ 014 EU/ 1/ 08/ 503/ 015
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo
blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu) blister (alu)
pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu) pretisni omot (alu)
14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets 14 tablets 28 tablets 30 x 1 tablet 56 tablets 84 tablets 90 x 1 tablet 98 tablets
14 tablet 28 tablet 30 x 1 tableta 56 tablet 84 tablet 90 x 1 tableta 98 tablet 14 tablet 28 tablet 30 x 1 tableta 56 tablet 84 tablet 90 x 1 tableta 98 tablet
Each tablet contains 2.7 mg lactose.
Ena tableta vsebuje 2, 7 mg laktoze.
Yellow and double-arrow-shaped tablets, debossed with “ 5 mg” on one side and “ 4760” on the other.
Rumene tablete v obliki dvojne puščice, z vtisnjenim “ 5 mg ” na eni strani in “ 4760 ” na drugi strani.
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in 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).
Zdravilo Efient, dano sočasno z acetilsalicilno kislino (ASK), je indicirano za preprečevanje aterotrombotičnih dogodkov pri bolnikih z akutnim koronarnim sindromom (t. j. 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 so imeli primarno ali odloženo perkutano koronarno intervencijo (percutaneous coronary intervention, PCI).
For further information please refer to section 5.1.
Za nadaljnje informacije glejte poglavje 5. 1.
Adults Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Odrasli Odmerjanje zdravila Efient moramo začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati z 10 mg enkrat na dan.
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’ s underlying disease.
Pri bolnikih z akutnim koronarnim sindromom (acute coronary syndrome, ACS), ki je zdravljen s PCI, lahko predhodna prekinitev kakršnegakoli zdravila proti trombocitom, vključno z zdravilom Efient, vodi v povečano tveganje za trombozo, miokardni infarkt ali smrt zaradi osnovne bolnikove bolezni.
A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Priporoča se zdravljenje do 12 mesecev, razen, če je prekinitev zdravila Efient klinično indicirana (glejte poglavji 4. 4 in 5. 1).
Patients ≥ 75 years old The use of Efient in patients ≥ 75 years of age is generally not recommended.
Bolniki, stari ≥ 75 let Uporaba zdravila Efient pri bolnikih, starih ≥ 75 let, na splošno ni priporočena.
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.
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.
Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
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).
The evidence for the 5 mg dose is based only on pharmacodynamic/ pharmacokinetic analyses and no clinical data currently exist on the safety of this dose in the patients age group ≥ 75 years.
Podatki za 5 mg odmerek so osnovani samo na farmakodinamičnih/ farmakokinetičnih analizah, saj trenutno ni na voljo kliničnih podatkov glede varnosti tega odmerka pri bolnikih starostne skupine ≥ 75 let.
Patients weighing < 60 kg Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
2 Bolniki, ki tehtajo < 60 kg Zdravilo Efient moramo dati kot enkratni 60 mg polnilni odmerek in nato nadaljevati s 5 mg odmerkom enkrat na dan.
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.
10 mg vzdrževalni odmerek ni priporočen, 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.
Efficacy and safety of the 5 mg dose have not been prospectively assessed (see sections 4.4, 4.8 and 5.2).
Učinkovitosti in varnosti 5 mg odmerka za ta namen niso ocenili (glejte poglavja 4. 4, 4. 8 in 5. 2).
Renal impairment No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Okvara ledvic Prilagoditev odmerka ni potrebna pri bolnikih z okvaro ledvic, vključno z bolniki s končno ledvično odpovedjo (glejte poglavje 5. 2).
There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4. 4).
Hepatic impairment No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Okvara jeter Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh- u) (glejte poglavje 5. 2).
There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Terapevtske izkušnje pri bolnikih z blago in zmerno okvaro jeter so omejene (glejte poglavje 4. 4).
Children and adolescents Efient is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Efient ne priporočamo za uporabo pri otrocih mlajših od 18 let.
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 v stanju stradanja lahko nudi najhitrejši začetek delovanja (glejte poglavje 5. 2).
History of stroke or transient ischaemic attack (TIA).
Kap ali tranzitorna ishemična ataka (TIA) v anamnezi.
Severe hepatic impairment (Child Pugh class C).
Huda jetrna okvara (razred C po Child Pugh- u).
Bleeding risk In the phase 3 clinical trial key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Tveganje za krvavitev V kliničnem preskušanju faze 3 so izključitveni kriteriji vključevali povečano tveganje za krvavitev; anemijo; trombocitopenijo; patološke intrakranialne ugotovitve v anamnezi.
This concern applies especially to patients: • ≥ 75 years of age (see below). • with a propensity to bleed (e. g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease) • with body weight < 60 kg (see sections 4.2 and 4.8).
Ta skrb velja zlasti za naslednje bolnike: • ≥ 75 let starosti (glejte spodaj). • z nagnjenostjo za krvavitev (npr. zaradi nedavne poškodbe, nedavnega kirurškega posega, nedavne ali ponovljene gastrointestinalne krvavitve ali aktivni peptični ulkus). • s telesno maso < 60 kg (glejte poglavji 4. 2 in 4. 8).
A 5 mg maintenance dose should be used. • 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.
Uporabiti moramo 5 mg vzdrževalni odmerek. • s sočasnim dajanjem zdravil, ki lahko povečajo tveganje za krvavitev, vključno s peroralnimi antikoagulanti, klopidogrelom, nesteroidnimi protivnetnimi zdravili (non- steroidal anti- inflammatory drugs, NSAIDs) in fibrinolitiki.
The use of Efient in patients ≥ 75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/ risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Uporaba zdravila Efient pri bolnikih ≥ 75 let starosti na splošno ni priporočena in mora biti opravljena 3 previdno, samo po skrbni oceni lečečega zdravnika glede posameznikove koristi/ tveganja, ki meni, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal 3 bleeding, compared to patients < 75 years of age.
V kliničnem preskušanju faze 3 so imeli ti bolniki večje tveganje za krvavitev, vključno s krvavitvijo s smrtnim izidom, v primerjavi z bolniki < 75 let starosti.
If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Če zdravilo predpišemo, moramo uporabiti nižji vzdrževalni odmerek 5 mg; 10 mg vzdrževalni odmerek ni priporočen (glejte poglavji 4. 2 in 4. 8).
Therapeutic experience with prasugrel is limited in Asian patients.
Terapevtske izkušnje s prasugrelom so omejene pri bolnikih azijske rase.
Surgery Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Kirurški poseg Bolnikom moramo svetovati, naj pred kakršnimkoli načrtovanim kirurškim posegom in preden začnejo jemati kakršnokoli novo zdravilo povedo zdravnikom in zobozdravnikom, da jemljejo prasugrel.
Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see 4.8).
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- krat) in resnost krvavitve (glejte poglavje 4. 8).
Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of other thienopyridines.
Trombotična trombocitopenična purpura (TTP) Pri uporabi z drugimi tienopiridini so poročali o TTP.
Efient was not associated with TTP in clinical trials supporting registration.
V kliničnih preskušanjih za registracijo zdravila Efient zdravilo ni bilo povezano s TTP.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take Efient.
Laktoza Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati zdravila Efient.
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).
Zaradi možnega povečanega tveganja za krvavitev, moramo previdno dajati sočasno varfarin (ali druge kumarinske derivate) in prasugrel (glejte poglavje 4. 4).