FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Voriconazole Hikma, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Voriconazole Hikma nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: This is because voriconazole is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: Razlog tome je činjenica da se vorikonazol daje intravenskom infuzijom i djelatna tvar odmah ulazi u krvotok.
English: The Committee recommended that Voriconazole Hikma be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za lijek Voriconazole Hikma za primjenu u EU-u.
English: This means that Voriconazole Hikma is similar to a ‘reference medicine' already authorised in the European Union
Croatian: To znači da je lijek Voriconazole Hikma sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Vfend.
English: The dose of Voriconazole Hikma depends on the weight of the patient.
Croatian: Doza lijeka Voriconazole Hikma ovisi o tjelesnoj težini bolesnika.
English: For more information about treatment with Voriconazole Hikma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekom Voriconazole Hikma pročitajte uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Voriconazole Hikma is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Voriconazole Hikma dostupan je kao prašak za otopinu za infuziju (drip) u venu.
English: A risk management plan has been developed to ensure that Voriconazole Hikma is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Voriconazole Hikma.
English: What measures are being taken to ensure the safe and effective use of Voriconazole Hikma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Voriconazole Hikma?
English: What is Voriconazole Hikma and what is it used for?
Croatian: Što je Voriconazole Hikma i za što se koristi?
English: Voriconazole Hikma voriconazole
Croatian: Voriconazole Hikma vorikonazol
English: The active substance in Voriconazole Hikma, voriconazole, belongs to the ‘triazole' class of antifungal medicines.
Croatian: Djelatna tvar lijeka Voriconazole Hikma, vorikonazol, ubraja se u kategoriju „triazola” antifungalnih lijekova.
English: For practical information about using Voriconazole Hikma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Voriconazole Hikma bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti se svojem liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Voriconazole Hikma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Voriconazole Hikma.
English: What are the benefits and risks of Voriconazole Hikma?
Croatian: Koje su koristi i rizici lijeka Voriconazole Hikma?
English: The list of fungi against which Voriconazole Hikma is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis gljivica protiv kojih lijek Voriconazole Hikma djeluje dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za lijek Voriconazole Hikma nalazi se na internetskim stranicama Agencije.
English: Other information about Voriconazole Hikma
Croatian: Ostale informacije o lijeku Voriconazole Hikma
English: Why is Voriconazole Hikma approved?
Croatian: Zašto je lijek Voriconazole Hikma odobren?
English: How is Voriconazole Hikma used?
Croatian: Kako se Voriconazole Hikma koristi?
English: Voriconazole Hikma contains the active substance voriconazole.
Croatian: Lijek Voriconazole Hikma sadrži djelatnu tvar vorikonazol.
English: How does Voriconazole Hikma work?
Croatian: Kako djeluje Voriconazole Hikma?
English: How has Voriconazole Hikma been studied?
Croatian: Kako je Voriconazole Hikma ispitivan?
English: The median follow-up for both groups was 359 days.
Croatian: Srednje vrijeme praćenja za obje skupine iznosilo je 359 dana.
English: This leaflet was last revised in {MM/YYYY} .
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: All patients were continued on aspirin and were followed for one year.
Croatian: Svi bolesnici su nastavili liječenje aspirinom i praćeni su godinu dana.
English: anti-retroviral medicines (medicines to treat HIV infections).
Croatian: - antiretrovirusne lijekove (lijekovi za liječenje infekcije HIV-om).
English: Do not take a double dose to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet :
English: Excipients with a known effect:
Croatian: Pomoćne tvari s poznatim učinkom:
English: Date of first authorisation: 16.10.2009 Date of latest renewal: 18.09.2014
Croatian: Datum posljednje obnove: 18.09.2014
English: EU/1/09/568/001 Cartons of 7 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/002 Cartons of 14 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/003 Cartons of 28 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/004 Cartons of 30 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/005 Cartons of 50 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/006 Cartons of 56 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/007 Cartons of 84 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/008 Cartons of 90 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/009 Cartons of 100 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/010 Cartons of 7 film-coated tablets in PA/ALL/PVDC/Alu blisters EU/1/09/568/011 Cartons of 14 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/012 Cartons of 28 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/013 Cartons of 30 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/014 Cartons of 50 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/015 Cartons of 56 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/016 Cartons of 84 film-coated tablets in PA/ALL/PVDC /Alu blisters
Croatian: EU/1/09/568/001 kutija sa 7 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/002 kutija s 14 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/003 kutija s 28 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/004 kutija s 30 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/005 kutija s 50 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/006 kutija s 56 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/008 kutija s 90 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/009 kutija sa 100 filmom obloženih tableta u PVC/PE/PVDC/Al blisterima EU/1/09/568/010 kutija sa 7 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/011 kutija s 14 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/012 kutija s 28 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/013 kutija s 30 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/014 kutija s 50 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/015 kutija s 56 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/016 kutija s 84 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/017 kutija s 90 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima EU/1/09/568/018 kutija sa 100 filmom obloženih tableta u PA/ALL/PVDC/Al blisterima
English: 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).
Croatian: 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).
English: At Day 14, platelet function testing (PFT) was performed.
Croatian: Na 14. dan obavljeno je testiranje funkcije trombocita (PFT).
English: The characteristics of the studied cohort were similar in the 2 groups.
Croatian: Karakteristike ispitivane kohorte bile su slične u obje skupine.
English: You should take Clopidogrel Apotex for as long as your doctor continues to prescribe it.
Croatian: Apotex trebate uzimati sve dok Vam ga liječnik propisuje.
English: You have been prescribed Clopidogrel Apotex to help prevent blood clots and reduce the risk of these severe events because:
Croatian: Clopidogrel Apotex Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer:
English: Risk Management Plan(RMP)
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo
English: An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Croatian: Povremeno uzimanje acetilsalicilatne kiseline (ne više od 1000 mg u periodu unutar 24 sata) općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
English: The mean CHADS2 score was 2.0 (range 0-6).
Croatian: Srednja vrijednost CHADS2 skora iznosila je 2,0 (raspon 0-6).
English: • If you suffer from severe liver disease.
Croatian: • ako patite od teške bolesti jetre.
English: Some other medicines may influence the use of Clopidogrel Apotex or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje Clopidogrel Apotexa i obratno.
English: Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Croatian: Iako je ishemijska korist bila dosljedna tijekom prve godine, veće smanjenje ponavljanja ishemijskih događaja nakon ACS-a zabilježeno je tijekom prvih dana nakon početka liječenja.
English: 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 post-ACS.
Croatian: Za razliku od toga, post-hoc analize pokazale su statistički značajno povećanje rizika od krvarenja kod jačih inhibitora P2Y12, koje se većinom javljalo tijekom faze održavanja, nakon prvog mjeseca poslije ASC-a.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje „oralni antikoagulansi“ učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene klopidogrela i acetilsalicilatne kiseline.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: This randomized, open-label trial included 2,610 biomarker-positive ACS patients after successful PCI.
Croatian: Ovo randomizirano, otvoreno ispitivanje uključivalo je 2.610 bolesnika s ACS-om pozitivnim na biomarkere nakon uspješnog PCI-ja.
English: Core:
Croatian: Jezgra:
English: Secondary prevention of atherothrombotic events
Croatian: Sekundarna prevencija aterotrombotičkih događaja
English: Marketing Authorisation Holder and Manufacturers:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođači:
English: In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years.
Croatian: Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤75 godina.
English: • Your doctor may order blood tests.
Croatian: • Liječnik će možda odrediti da Vam se naprave pretrage krvi.
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Croatian: Ispitivanja TOPIC i TROPICAL-ACS osmišljena su da ispitaju kako se pojava krvarenja može ublažiti uz zadržavanje djelotvornosti.
English: 4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Klopidogrel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Clopidogrel Apotex contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Clopidogrel Apotex sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: Your doctor should have prescribed Clopidogrel plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Croatian: Liječnik Vam treba propisati klopidogrela i acetilsalicilatnu kiselinu ako ne možete uzimati oralne antikoagulanse te nemate rizik od velikog krvarenja.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Croatian: Farmakoterapijska skupina: inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Croatian: Detalijne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies,and showed no genotoxic activity.
Croatian: Klopidogrel je testiran u mnogim genotoksičnim studijama in vivo i in vitro i nije pokazao genotoksičnu aktivnost.
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Croatian: • Odrasli i starije osobe Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2 CYP2B6 and CYP3A4.
Croatian: Aktivni metabolit nastaje većinom putem CYP2C19 uz sudjelovanje nekoliko drugih CYP enzima, uključujući CYP1A2, CYP2B6 i CYP3A4.
English: The de-escalated patients underwent high platelet reactivity (HPR) testing.
Croatian: Deeskalirani bolesnici podvrgnuti su testiranju visoke reaktivnosti trombocita (HPR).
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Apotex.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Clopidogrel Apotexom.
English: If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Croatian: Ako je HPR bio ≥46 jedinica, bolesnici su ponovno eskalirani na prasugrel od 5 ili 10 mg/dan tijekom 11,5 mjeseci; ako je HPR bio <46 jedinica, bolesnici su nastavili liječenje klopidogrelom od 75 mg/dan tijekom 11,5 mjeseci.
English: If you forget to take a dose of Clopidogrel Apotex, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Clopidogrel Apotexa, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: If you become pregnant while taking Clopidogrel Apotex, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Croatian: Ako zatrudnite za vrijeme uzimanja Clopidogrel Apotexa, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
English: Apotex Polska Sp. z o.o.
Croatian: Apotex Polska Sp. z o.o. Polsce
English: You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
Croatian: imate nepravilne otkucaje srca, stanje koje se zove "fibrilacija atrija", a ne možete uzimati lijekove poznate kao 'oralni antikoagulansi' (antagonisti vitamina K), koji sprječavaju stvaranje novih ugrušaka te rast postojećih ugrušaka.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Apotex in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Croatian: Ako ste imali jaku bol u prsištu (nestabilna angina ili srčani udar), liječnik Vam može propisati Clopidogrel Apotex u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
English: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
Croatian: hipromeloza (E464) laktoza hidrat triacetin (E1518) titanijev dioksid (E171) željezov oksid, crveni (E172)
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Croatian: U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa slučajeva temeljena na metabolizatorskom statusu.
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Croatian: Prema tome, u grupi s kontroliranom deeskalacijom bili su bolesnici na prasugrelu (40 %) ili klopidogrelu (60 %).
English: Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Greece
Croatian: Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Grčka
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Croatian: U studiji CHARISMA i jednoj kohortnoj studiji (Simon), povećana stopa događaja bila je zapažena samo u slabih metabolizatora, u sporedbi s brzim metabolizatorima.
English: If you have any further questions, ask your doctor or your pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: 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).
Croatian: Kumulativna učestalost svih događaja krvarenja (BARC kategorija od 1 do 5) bila je 9 % (114 događaja) u skupini s kontroliranom deeskalacijom u odnosu na 11 % (137 događaja) u kontrolnoj skupini (p=0,14).
English: Blisters of white PVC/PE/PVDC-aluminium foil or PA/ALL/PVC-aluminium foil.
Croatian: Blisteri s bijelom PVC/PE/PVDC-aluminijskom folijom ili PA/ALL/PVC-aluminijskom folijom.
English: What Clopidogrel Apotex is and what it is used for
Croatian: Što je Clopidogrel Apotex i za što se koristi
English: not known*
Croatian: Vrlo rijetko, nepoznato*
English: If Clopidogrel Apotex is supplied in all aluminium blisters, it does not require any special storage conditions.
Croatian: Ako je Clopidogrel Apotex opremljen u aluminijske blistere, lijek ne zahtijeva posebne uvjete čuvanja.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Apotex.
Croatian: Ako ste trudni ili sumnjate na trudnoću, obavjestite svog liječnika ili ljekarnika prije nego što uzmete Clopidogrel Apotex.
English: Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Greece
Croatian: Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Grčka ili
English: The prasugrel-only patients were continued on prasugrel for 11.5 months.
Croatian: Bolesnici koji su primali samo prasugrel nastavili su liječenje prasugrelom tijekom 11,5 mjeseci.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Apotex (4 tablets of 75 mg) once at the start of treatment.
Croatian: Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Clopidogrel Apotexa (4 tablete od po 75 mg).
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon "Rok valjanosti".
English: Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Croatian: Nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka): reakcije preosjetljivosti s bolovima u prsnom košuištuma ili trbuhu, trajni simptomi niskog šećera u krvi).
English: Store below 25°C (for PVC/PE/PVDC/aluminium blisters)
Croatian: Čuvati na temperaturi ispod 25°C (za PVC/PE/PVDC/aluminij blistere)
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes 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) (see section 4 ‘Possible side effects').
Croatian: • Također, odmah obavijestite svog liječnika ukoliko se pojavi medicinsko stanje (koje se naziva trombotična trombocitopenična purpura ili "TTP") sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (pogledajte dio 4. "Moguće nuspojave").
English: Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT).
Croatian: Bolesnici na aspirinu i jačem blokatoru P2Y12 bez nuspojava nakon mjesec dana raspoređeni su za prebacivanje na fiksnu dozu aspirina plus klopidogrel (deeskalirana dualna antitrombocitna terapija (DAPT)) ili za nastavak svog režima lijeka (neizmijenjeni DAPT).
English: In all aluminium blisters, this medicinal product does not require any special storage conditions.
Croatian: Aluminijski blisteri: lijek ne zahtijeva posebne uvjete čuvanja.