natgillin/translations-raw huggingface dataset:
- 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
Briviact 75 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172)
Briviact 10 mg/ml oral solution
Briviact 10 mg/ml oralna otopina
EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/008 168 (3 pakiranja od 56) filmom obloženih tableta
EU/1/15/1073/009 14 film-coated tablets EU/1/15/1073/010 56 film-coated tablets EU/1/15/1073/011 100 x 1 film-coated tablet EU/1/15/1073/025 14 x 1 film-coated tablet
EU/1/15/1073/009 14 filmom obloženih tableta EU/1/15/1073/010 56 filmom obloženih tableta EU/1/15/1073/011 100 x 1 filmom obložena tableta EU/1/15/1073/025 14 x 1 filmom obložena tableta
EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/020 168 (3 pakiranja od 56) filmom obloženih tableta
EU/1/15/1073/005 14 film-coated tablets EU/1/15/1073/006 56 film-coated tablets EU/1/15/1073/007 100 x 1 film-coated tablet EU/1/15/1073/024 14 x 1 film-coated tablet
EU/1/15/1073/005 14 filmom obloženih tableta EU/1/15/1073/006 56 filmom obloženih tableta EU/1/15/1073/007 100 x 1 filmom obložena tableta EU/1/15/1073/024 14 x 1 filmom obložena tableta
Two oral syringes will be provided in the carton.
Upute za uporabu za bolesnike ili njegovatelje: Dvije štrcaljke za usta bit će priložene u kutiju.
EU/1/15/1073/001 14 film-coated tablets EU/1/15/1073/002 56 film-coated tablets EU/1/15/1073/003 100 x 1 film-coated tablet EU/1/15/1073/023 14 x 1 film-coated tablet
EU/1/15/1073/001 14 filmom obloženih tableta EU/1/15/1073/002 56 filmom obloženih tableta EU/1/15/1073/003 100 x 1 filmom obložena tableta EU/1/15/1073/023 14 x 1 filmom obložena tableta
EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/012 168 (3 pakiranja od 56) filmom obloženih tableta
- 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Briviact 100 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crni (E172)
EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets
EU/1/15/1073/016 168 (3 pakiranja od 56) filmom obloženih tableta
Treatment with levetiracetam
Liječenje levetiracetamom
Coating
Dojenje
0.1 ml/kg/intake
0,1 ml/kg/unos
The table below provides examples of volumes of oral solution per intake depending on prescribed dose and body weight.
Pedijatrijska populacija Liječnik treba propisati najprimjereniju formulaciju i jačinu u skladu s tjelesnom težinom i dozom.
Clobazam
Klobazam
- 50 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).
Briviact 50 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crveni (E172)
- 25 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Briviact 25 mg filmom obložene tablete poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk željezov oksid, žuti (E172) željezov oksid, crni (E172)
Upper respiratory tract infections, cough
Poremećaji dišnog sustava, prsišta i sredoprsja često infekcije gornjih dišnih putova, kašalj
5260 Odense S, Denmark
5260 Odense S, Danska
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego počnete ovaj uzimati ovaj lijek jer sadrži Vama važne podatke.
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzmite ovaj lijek točno onako kako su Vam rekli Vas liječnik ili ljekarnik.
If you take more Grepid than you should
Ako uzmete više Grepida nego što ste trebali
Other medicines and Grepid
Drugi lijekovi i Grepid
While you are taking Grepid:
Dok uzimate Grepid:
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUG O(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
• if you have had an allergy or reaction to any medicine used to treat your disease
• Ako ste imali alergiju ili reakciju na bilo koji lijek koji ste koristili za liječenje Vaše bolesti.
What Grepid is and what it is used for
Što je Grepid i za što se koristi
Some other medicines may influence the use of Grepid or vice versa.
Neki lijekovi mogu utjecati na djelovanje Grepida i obratno.
No special storage conditions (for all aluminium blisters)
Nema posebnih uvjeta čuvanja (za aluminijske blistere)
You should take Grepid for as long as your doctor continues to prescribe it.
Grepid trebate uzimati sve dok Vam ga liječnik propisuje.
Date of first authorisation: 28 July 2009 Date of latest renewal: 11 April 2014
Datum posljednje obnove: 11. travanj 2014.
- if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na klopidogrel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
EU/1/09/535/001 14 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/002 28 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/003 30 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/004 50 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/005 84 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/006 90 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/007 100 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/008 14 Film-coated tablets blister (alu/alu) EU/1/09/535/009 28 Film-coated tablets blister (alu/alu) EU/1/09/535/010 30 Film-coated tablets blister (alu/alu) EU/1/09/535/011 50 Film-coated tablets blister (alu/alu) EU/1/09/535/012 84 Film-coated tablets blister (alu/alu) EU/1/09/535/013 90 Film-coated tablets blister (alu/alu) EU/1/09/535/014 100 Film-coated tablets blister (alu/alu) EU/1/09/535/015 10 Film-coated tablets blister (PVC/PE/PVDC/alu) EU/1/09/535/016 28 Film-coated tablets blister (PVC/PE/PVDC/alu), calendar
EU/1/09/535/001 14 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/002 28 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/003 30 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/004 50 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/005 84 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/006 90 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/007 100 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/008 14 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/009 28 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/010 30 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/011 50 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/012 84 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/013 90 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/014 100 Filmom obloženih tableta blister (Al/Al) EU/1/09/535/015 10 Filmom obloženih tableta blister (PVC/PE/PVDC/Al) EU/1/09/535/016 28 Filmom obloženih tableta blister (PVC/PE/PVDC/Al), kalendarski
What you need to know before you take Grepid
Što morate znati prije nego počnete uzimati Grepid
What Grepid is and what it is used for What you need to know before you take Grepid How to take Grepid
Što se nalazi u ovoj uputi Što je Grepid i za što se koristi Što morate znati prije nego počnete uzimati Grepid Kako uzimati Grepid
Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 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).
Njihova je učestalost definirana na sljedeći način: česte (≥1/100, <1/10), manje česte (≥1/1000, <1/100), rijetke (≥1/10 000, <1/1000), vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
This leaflet was last revised in <Month YYYY>.
Ova uputa je zadnji puta revidirana u<mjesec GGGG>:
Grepid contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Grepid sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
An occasional use of acetylsalicylic acid (not more than 1,000 mg in 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Povremeno uzimanje acetilsalicilatne kiseline (ne više od 1000 mg u 24 sata) općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Tijekom nekliničkih ispitivanja na štakorima i babunima najčešće zabilježeni učinci bile su promjene na jetri.
- if you suffer from severe liver disease.
• ako patite od teške bolesti jetre.
What Grepid looks like and contents of the pack
Kako Grepid izgleda i sadržaj pakiranja
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Grepid and acetylsalicylic acid for this condition.
Trebalo Vam je biti rečeno da su za ovo stanje ''oralni antikoagulansi'' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Grepida i acetilsalicilatne kiseline.
What Grepid contains
Što Grepid sadrži
As a precautionary measure, breast-feeding should not be continued during treatment with Grepid.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Grepidom.
If you stop taking Grepid
Ako prestanete uzimati Grepid
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
Your doctor should have prescribed Grepid plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik Vam treba propisati Grepid i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
10 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obložene tablete 50 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section
Korist kombinacije klopidogrela s ASK u trajanju dužem od 4 tjedna nije ispitivana u ovom stanju (vidjeti dio
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
• Pedijatrijska populacija Klopidogrel se ne primjenjuje u djece zbog nedovoljnih podataka o djelotvornosti (vidjeti dio 5.1).
If you become pregnant while taking Grepid, consult your doctor immediately as it is recommended not to take Grepid while you are pregnant.
Ako zatrudnite za vrijeme uzimanja Grepida, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati Grepid za vrijeme trudnoće.
Other concomitant therapy:
Ostala istodobna terapija:
• if you are allergic to other thienopyridines (such as prasugrel, ticlopidine).
• Ako ste alergični na druge tienopiridine (kao što su prasugrel, tiklopidin)
Each film-coated tablet contains 2.47 mg of lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 2,47 mg laktoze (u obliku hidrata).
Do not take Grepid
Nemojte uzimati Grepid
Grepid film-coated tablets are pink, round and biconvex.
Grepid filmom obložene tablete su ružičaste, okrugle i bikonveksne.
If you forget to take Grepid
Ako ste zaboravili uzeti Grepid
Pink, round, biconvex, film-coated tablets.
Ružičaste, okrugle, bikonveksne, filmom obložene tablete.
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Nakon oralne doze klopidogrela obilježenog s 14C u ljudi približno 50% doze izlučilo se u mokraću, a približno 46% u stolicu u intervalu od 120 sati nakon doziranja.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), obratite se liječniku prije uzimanja ovog lijeka.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Grepid per day to be taken orally with or without food, and at the same time each day.
Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta Grepida od 75 mg dnevno koja se uzima kroz usta, s obrokom ili bez obroka, i u isto vrijeme svaki dan.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Farmakoterapijska skupina: Antitrombotici, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Grepid in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Grepid u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
Then, the recommended dose is one 75 mg tablet of Grepid per day as described above.
Grepida je jedna tableta od 75 mg dnevno, kao što je opisano iznad.
There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2,721), CHARISMA (n=2,428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1,477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Međutim, postoji veći broj retrospektivnih analiza za procjenu ovog učinka u bolesnika liječenih klopidogrelom za koje postoje rezultati genotipizacije: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477) te ACTIVE-A (n=601), kao i određeni broj objavljenih kohortnih kliničkih studija.
In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month postACS.
Međutim, post-hoc analize pokazale su statistički značajno povećanje rizika od krvarenja kod potentnijih inhibitora P2Y12, koji se javlja pretežno tijekom faze održavanja, nakon prvog mjeseca od pojave akutnog koronarnog sindroma.
Store below 25°C (for PVC/PE/PVDC/aluminium blisters) Or
Čuvati na temperaturi ispod 25°C (za PVC/ PE /PVDC/aluminijske blistere) Ili
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Grepid (4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Grepida (4 tablete od po 75 mg).
If you are pregnant or suspect that you are pregnant, you should tell your doctor or pharmacist before taking Grepid.
Ako ste trudni ili sumnjate na trudnoću, obavijestite svog liječnika ili ljekarnika prije nego što uzmete Grepid.
A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Ostali lijekovi: određeni broj ostalih kliničkih studija provodio se s klopidogrelom i nekim drugim istodobno primjenjivanim lijekovima kako bi se ispitala mogućnost farmakodinamičkih i farmakokinetičkih interakcija.
Ninety five patients (7 %) in the guided de-escalation group and 118 patients (9 %) in the control group (p non-inferiority=0.0004) had an event.
95 bolesnika (7%) u skupini s vođenom de-eskalacijom i 118 bolesnika (9%) u kontrolnoj skupini (p neinferiornosti=0,0004) imalo je događaj.
If you forget to take a dose of Grepid, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu Grepida, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets.
Isporučuju se u PVC/PE/PVDC/Al blisterima ili u PA/ALL/PVC-Al blisterima pakiranima u kartonske kutije koje sadrže 10, 14, 28, 30, 50, 84, 90 ili 100 filmom obloženih tableta.
Grepid contains lactose.
Grepid sadrži laktozu.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Bolesnici randomizirani u programu ACTIVE imali su dokumentiranu fibrilaciju atrija (AF), tj. ili permanentnu AF ili najmanje 2 epizode intermitentne AF u zadnjih 6 mjeseci te su imali najmanje jedan od sljedećih faktora rizika: dob ≥75 godina ili 55 do 74 godine te ili dijabetes koji zahtijeva terapiju lijekovima ili dokumentirani prethodni infarkt miokarda ili dokumentiranu bolest koronarnih arterija; ako su primali terapiju za sistemsku hipertenziju; prethodni moždani udar, prolazni ishemijski napadaj (TIA) ili ne-CNS sistemska embolija; disfunkcija lijevog ventrikula s ejekcijskom frakcijom lijevog ventrikula <45% ili dokumentirana periferna vaskularna bolest.
However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
Međutim, istodobna primjena 500 mg ASK dva puta dnevno tijekom jednog dana nije značajno produljila vrijeme krvarenja koje je već produljeno uzimanjem klopidogrela.
The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9 % (114 events) in the guided de-escalation group versus 11 % (137 events) in the control group (p=0.14).
Kumulativna incidencija svih događaja krvarenja (BARC stupanj krvarenja od 1 do 5) bila je 9% (114 događaja) u skupini s vođenom de-eskalacijom u odnosu na 11% (137 događaja) u kontrolnoj skupini (p=0,14).
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 5 dvostruko slijepih studija koje su uključivale preko 88 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te CURE, CLARITY, COMMIT i ACTIVE-A studije, u kojima se uspoređivalo djelovanje klopidogrela prema placebu, s tim da su obje terapije davane u kombinaciji s ASK i drugom standardnom terapijom.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. " Moguće nuspojave ").
Blisters of white PVC/PE/PVDC-aluminium foil or PA/ALL/PVC-aluminium foil.
Blisteri od bijele PVC/ PE/ PVDC - aluminijske folije ili PA/ALL/PVC - aluminijske folije.
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Nakon ponovljene oralne doze od 75 mg dnevno, klopidogrel se brzo apsorbira.
Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Tako se, nakon 3 mjeseca, zabilježena korist liječenja kombinacijom klopidogrela + ASK nije dalje povećavala, dok je opasnost od krvarenja i dalje postojala (vidjeti dio 4.4.).
You have been prescribed Grepid to help prevent blood clots and reduce the risk of these severe events because: - you have a condition of hardening of arteries (also known as atherosclerosis), and - you have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Grepid Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer: - imate otvrdnuće arterija (koje se još zove ateroskleroza) te - ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija, ili - ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Ispitivanje CLARITY uključivalo je 3 491 bolesnika, koji su unutar 12 sati imali infarkt miokarda s elevacijom ST-spojnice i planirala im se trombolitička terapija.
The guided de-escalation did not result in an increased combined risk of ischemic events (2.5 % in the deescalation group vs 3.2 % in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥ 2 ((5 %) in the de-escalation group versus 6 % in the control group (p=0.23)).
Vođena de-eskalacija nije rezultirala povećanjem u kombiniranom riziku od ishemijskih događaja (2,5 % u skupini sa vođenom de-eskalacijom u odnosu na 3,2% u kontrolnoj skupini; p neinferiornosti=0,0115) niti u ključnoj sekundarnoj mjeri ishoda BARC stupnja krvarenja ≥ 2 ((5%) u skupini s vođenom de-eskalacijom nasuprot 6% u kontrolnoj skupini (p=0,23)).
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Studija ACTIVE-A (n=7554) bila je multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana studija u kojoj se uspoređivao učinak klopidogrela u dozi od 75 mg/dnevno uz ASK (n=3772) u odnosu na placebo uz ASK (n=3782).
• if you have kidney or liver disease
• Ako imate bolest bubrega ili jetre.
Film-coating Hypromellose (E464) Iron oxide red (E172) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171)
Film ovojnica hipromeloza (E464) željezov oksid, crveni (E172) laktoza hidrat triacetin (E1518) titanijev dioksid (E171)
Bleeding events defined as all BARC occurred in 30 patients (9.3 %) in the de-escalated DAPT group and in 76 patients (23.5 %) in the unchanged DAPT group (p<0.01).
Događaji krvarenja definirani kao svi BARC stupnjevi dogodili su se u 30 bolesnika (9,3%) u skupini s de-eskaliranim DAPT-om i u 76 bolesnika (23,5%) u skupini sa nepromijenjenim DAPT-om (p< 0,01).
- if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• ako imate poremećaj koji izaziva krvarenje, kao što je, primjerice, želučani čir ili krvarenje u mozgu
Follow-up at one year was performed for 316 patients (98.1 %) in the de-escalated DAPT group and 318 patients (98.5 %) in the unchanged DAPT group.
Nakon godine dana provedeno je praćenje 316 bolesnika (98,1%) u skupini sa de-eskaliranim DAPT-om i 318 bolesnika (98,5%) u skupini sa nepromijenjenim DAPT-om.