FrancophonIA/ELRC3.0 huggingface dataset:
English: - Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Dura contains hydrogenated castor oil') - Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Croatian: Jezgra tablete: mikrokristalinična celuloza, silicijev dioksid, koloidni, bezvodni, krospovidon (tip A), makrogol 6000, hidrogenizirano ricinusovo ulje Filmska ovojnica: polivinilni alkohol, titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172), talk i makrogol 3000.
English: Pink, round and slightly convex film-coated tablets.
Croatian: Ružičaste, okrugle i blago zaobljene filmom obložene tablete.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors.
Croatian: Kao i u slučaju drugih antitrombocitnih lijekova, klopidogrel s oprezom treba davati bolesnicima koji su izloženi povećanom riziku od krvarenja zbog povrede, kirurških zahvata ili drugih patoloških stanja te bolesnicima koji se liječe s ASK, heparinom, inhibitorima glikoproteina IIb/IIIa ili nesteroidnim protuupalnim lijekovima (NSAIL), uključujući Cox-2 inhibitore.
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Clopidogrel 75 mg/day.
Croatian: S dozom od 0,2 mg/kg postignut je prosječni postotak inhibicije od 49,3% (5 µM ADP-om inducirane agregacije trombocita), što je usporedivo s postotkom u odraslih koji uzimaju klopidogrela u dozi od 75 mg/dnevno.
English: If you stop taking Clopidogrel dura:
Croatian: Ako prestanete uzimati Clopidogrel dura:
English: • if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain;
Croatian: • ako imate poremećaj koji izaziva krvarenje, kao što je, primjerice, želučani čir ili krvarenje u mozgu.
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Croatian: Preporučuje se praćenje eventualne pojave preosjetljivosti u bolesnika u kojih je zabilježena alergija na tienopiridine.
English: In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Croatian: Potrebno je razmotriti dijagnozu stečene hemofilije u slučajevima potvrđenog izoliranog, aktiviranog parcijalno tromboplastinskog vremena (aPTT) s krvarenjem ili bez njega.
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Croatian: Međutim, bolesnici koji su sudjelovali u kliničkim ispitivanjima s klopidogrelom istodobno su primali niz lijekova, među kojima su bili diuretici, beta blokatori, ACE inhibitori, antagonisti kalcija, lijekovi za snižavanje kolesterola, koronarni vazodilatatori, antidijabetici (uključujući inzulin), antiepileptici te antagonisti glikoproteina IIb/IIIa, bez znakova klinički značajnih štetnih interakcija.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Croatian: retroperitonealno krvarenje gastrointestinalno i retroperitonealno krvarenje s fatalnim ishodom, pankreatitis, kolitis (uključujući ulcerozni ili limfocitni kolitis), stomatitis
English: If you forget to take Clopidogrel dura:
Croatian: Ako ste zaboravili uzeti Clopidogrel dura:
English: Blood and the lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija,
English: Common side effects(may affect up to 1 in 10 people) : Diarrhoea, abdominal pain, indigestion or heartburn.
Croatian: Česte nuspojave: (mogu se javiti u manje od 1 na 10 osoba): proljev, bol u trbuhu, loša probava ili žgaravica.
English: Mylan AB Tlf: + 46 8-555 227 50 (Sverige)
Croatian: Tlf: + 46 8-555 227 50 (Sverige)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrel hidroklorida).
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Croatian: Nakon ponovljenih doza od 75 mg klopidogrela dnevno, inhibicija ADP-om inducirane agregacije trombocita bila je niža (25%) u ispitanika s teško narušenom funkcijom bubrega (klirens kreatinina od 5 do 15 ml/min), u usporedbi sa zdravim ispitanicima, iako je produljenje vremena krvarenja bilo slično onom zabilježenom u zdravih bolesnika koji su primali 75 mg klopidogrela dnevno.
English: - a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days
Croatian: - poremećaja krvi zbog čega ste skloni unutrašnjim krvarenjima (krvarenje u tkivima, organima ili zglobovima), - nedavne teške ozljede, - nedavnog kirurškog zahvata (uključujući stomatološke zahvate), - planiranog kirurškog zahvata (uključujući stomatološke zahvate) u sljedećih sedam dana.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4
Croatian: Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. "Moguće nuspojave").
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Croatian: mikrokristalinična celuloza silicijev dioksid, koloidni, bezvodni krospovidon (tip A) makrogol 6000 ricinusovo ulje, hidrogenirano
English: While you are taking Clopidogrel dura:
Croatian: Dok uzimate Clopidogrel dura:
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Croatian: U analizi ITT (engl. 'intention to treat') zabilježeno je 939 slučajeva u skupini koja je primala klopidogrel, a 1020 u skupini koja je primala ASK (realtivno smanjenje rizika, RRR - engl. relative risk reduction = 8,7% [95% CI: 0,2 do 16,4]; p = 0,045) što, odgovara broju od dodatnih 10 bolesnika kojima je spriječen novi ishemijski događaj, na svakih 1000 bolesnika liječenih 2 godine [CI: 0 do 20]. Analiza ukupne smrtnosti, sekundarnog ishoda studije, nije pokazala značajnu razliku između klopidogrela (5,8%) i ASK (6,0%).
English: Tablet core:
Croatian: Jezgra:
English: Therefore, concomitant use should be undertaken with caution (see section 4.4).
Croatian: Zbog toga, kod istodobne uporabe potreban je oprez (vidjeti dio 4.4).
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Croatian: Kao mjera opreza, ne preporučuje se istodobna primjena lijekova koji su jaki ili umjereni inhibitori enzima CYP2C19 nije preporučena (za popis inhibitora CYP2C19 vidjeti dio 4.5, također vidjeti dio 5.2).
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Croatian: neutropenija, uključujući tešku neutropeniju trombotična trombocitopenična purpura (TTP) (vidjeti dio 4.4), aplastična anemija, panciopenija, agranulocitoza, teška trombocitopenija, stečena hemofilija A, granulocitopenija, anemija
English: Clopidogrel dura 75 mg film-coated tablets clopidogrel
Croatian: Clopidogrel dura 75 mg filmom obložene tablete klopidogrel
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Croatian: Klinički značajne nuspojave uočene u ispitivanjima CAPRIE, CURE, CLARITY i COMMIT opisane su u nastavku.
English: Hydrogenated castor oil
Croatian: Clopidogrel dura hidrogenirano ricinusovo ulju
English: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Croatian: Propuštena doza: - Ako je prošlo manje od 12 sati nakon uobičajenog termina uzimanja lijeka: bolesnik treba odmah uzeti dozu, a sljedeću dozu treba uzeti prema uobičajenom rasporedu.
English: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Croatian: Terapijsko iskustvo u bolesnika s umjereno narušenom funkcijom jetre koji mogu imati hemoragičnu dijatezu je ograničeno (vidjeti dio 4.4).
English: EU/1/09/560/001-009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/560/001-009
English: As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4).
Croatian: Kao mjera opreza, ne preporučuje se istodobna primjena s omeprazolom i esomeprozolom (vidjeti dio 4.4).
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous, urticaria, eczema, lichen planus
Croatian: Poremećaji kože i potkožnog tkiva bulozni dermatitis (toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrel hidroklorida).
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel dura 75 mg film-coated tablets
Croatian: NAZIV LIJEKA Clopidogrel dura 75 mg filmom obložene tablete
English: After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Croatian: Nakon režima doziranja od 300 mg/75 mg, antitrombocitni odgovor bio je smanjen u slabih metabolizatora sa srednjom vrijednosti IPA (5 μM ADP) od 24% (nakon 24 sata) te 37% (na dan 5), u usporedbi s vrijednostima
English: Each film-coated tablet contains 13 mg hydrogenated castor oil.
Croatian: Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta sadrži 13 mg hidrogeniziranog ricinusovog ulja.
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa krvarenje u dišnom sustavu (hemoptiza, krvarenje u plućima), bronhospazam, intersticijski pneumonitis, eozinofilna pneumonija
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Croatian: U studiji CLARITY, uočeno je ukupno povećanje krvarenja u grupi klopidogrel uz ASK u odnosu na skupinu koja je uzimala placebo uz ASK.
English: Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Croatian: Nositelj odobrenja: Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Njemačka
English: Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Croatian: Oštećenje funkcije bubrega Terapijsko iskustvo u bolesnika s narušenom funkcijom bubrega je ograničeno (vidjeti dio 4.4).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Njemačka
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): glavobolja, ulkus želuca, povraćanje, mučnina, zatvor, povećano stvaranje plinova u želucu ili crijevima, osip, svrbež, omaglica, osjećaj trnaca i utrnulosti.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel dura.
Croatian: Ako se bilo što od navedenog odnosi na Vas, ili niste sigurni, obratite se svom liječniku prije uzimanja lijeka Clopidogrel dura.
English: Marketing Authorisation Holder Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Germany
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan dura GmbH, Wittichstraße 6, D-64295 Darmstadt, Njemačka
English: Serum sickness, anaphylactoid reactions, cross reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Croatian: Poremećaji imunološkog sustava serumska bolest, anafilaktoidne reakcije, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridinima (kao što su tiklopidin, prasugrel) (vidjeti dio
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time
Croatian: - Ako je prošlo više od 12 sati: bolesnik treba sljedeću dozu uzeti prema uobičajenom rasporedu i ne smije uzeti dvostruku dozu.
English: Taste disturbances
Croatian: Moguće nuspojave
English: C. AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Croatian: Kao mjera opreza, ne preporučuje se istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori enzima CYP2C19 nije preporučena (vidjeti dio 4.4 i 5.2).
English: What Clopidogrel dura looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Croatian: Filmom obložene tablete su ružičaste, okrugle i blago zaobljene.
English: Film coating:
Croatian: BROJ SERIJE Serija:
English: Tel: +33 4 37 25 75 00
Croatian: Mylan SAS Tel: +33 4 37 25 75 00
English: Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Croatian: Poremećaji živčanog sustava slučajevi s fatalnim ishodom) glavobolja, parestezija, omaglica poremećaj okusa
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: Odmah kontaktirajte svog liječnika ako primijetite: - vrućicu, znakove infekcije ili teškog umora; ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica; - znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2 "Upozorenja i mjere opreza"); - oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: You should not breast-feed while taking this medicine.
Croatian: Ovaj lijek se ne bi trebao primjenjivati tijekom dojenja.
English: Method of administration For oral use
Croatian: 15. UPUTE ZA UPORABU
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I DJELOTVORNU PRIMJENU LIJEKA
English: The most common side effect reported is bleeding.
Croatian: Najčešća nuspojava lijeka Clopidogrel dura jest krvarenje.
English: - heparin, or any other injectable medicine used to reduce blood clotting, - omeprazole, esomeprazole or cimetidine, medicines to treat for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and
Croatian: Posebno je važno obavijestiti liječnika ako uzimate - oralne antikoagulanse, lijekove koji smanjuju zgrušavanje krvi, - nesteroidne protuupalne lijekove, koji se obično primjenjuju za liječenje bolnih i/ili upalnih stanja mišića ili zglobova, - heparin ili bilo koji drugi lijek koji se daje putem injekcije za smanjivanje zgrušavanja krvi, - omeprazol, esomeprazol ili cimetidin, lijekove za smanjenje želučanih tegoba, - flukonazol, vorikonazol, ciprofloksacin ili kloramfenikol, lijekovi koji se primjenjuju za liječenje bakterijskih i gljivičnih infekcija, - fluoksetin, fluvoksamin ili moklobemid, lijekovi koji se primjenjuju za liječenje depresije, - karbamazepin ili okskarbazepin, lijekovi koji se primjenjuju za liječenje nekih oblika epilepsije, - tiklopidin ili druge antitrombocitne lijekove.
English: Acquired haemophilia has been reported following use of clopidogrel.
Croatian: Uz upotrebu klopidogrela prijavljena je stečena hemofilija.
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
English: Vertigo
Croatian: Ltd
English: If you get any side effects, talk to your doctor or pharmacist .
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Haematoma
Croatian: Dojenje
English: Hrvatska
Croatian: Norge
English: Gastrointestinal disorders
Croatian: Poremećaji probavnog sustava gastrointestinalno krvarenje,
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Croatian: - medicinskih stanja kod kojih postoji opasnost od unutrašnjeg krvarenja (kao što je želučani čir),
English: Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy .
Croatian: Ne preporučuje se uzimanje lijeka Clopidogrel dura za vrijeme trudnoće.
English: België/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 0032 2 658 61 00
Croatian: Hrvatska sanofi-aventis Croatia d.o.o. Tel: +385 1 600 34 00
English: Str. Dr. Victor Babeş nr. 50 Baia Mare
Croatian: Dr. Victor Babeş nr. 50 Baia Mare
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Croatian: Prilog I Popis naziva, farmaceutskih oblika, doza lijeka, puteva primjene, nositelja odobrenja za stavljanje lijeka u promet u zemljama članicama
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
Croatian: Velika Britanija Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe
English: Terapia SA Str. Fabricii nr. 124 Cluj-Napoca Romania
Croatian: Fabricii nr. 124 Cluj-Napoca Romania
English: 821 08 Bratislava
Croatian: 821 08 Bratislava Slovak Republic
English: Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti
Croatian: S.C. Arena Group S.A. Str. Ştefan Mihăileanu nr. 31 Sector 2, Bucureşti România
English: Luxembourg Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
Croatian: Luksemburg Janssen Cilag NV 15-17 Antwerpseweg B-2340 Beerse
English: S.C. Magistra C&C Str. Aurel Vlaicu nr. 82A 8700 Constanţa România
Croatian: Aurel Vlaicu nr. 82A 8700 Constanţa România
English: 1-10 Constantinoupoleos street 3505 Lemesos
Croatian: Medochemie ltd 1-10 Constantinoupoleos street 3505 Lemesos
English: Karla Engliše 3201/6
Croatian: Janssen-Cilag s.r.o. Karla Engliše 3201/6 15000 Praha 5
English: Slovak Republic Johnson & Johnson s.r.o.
Croatian: Johnson & Johnson s.r.o. Karadžičova 12
English: Belgium Janssen-Cilag NV Antwerpseweg 15-17
Croatian: Janssen-Cilag NV Antwerpseweg 15-17 2340 Beerse Belgium
English: The Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150
Croatian: Dr. Paul Janssenweg 150
English: Czech Republic Janssen-Cilag s.r.o.
Croatian: Nizozemska Janssen-Cilag B.V.
English: FUNGAREST comprimidos 200mg
Croatian: TABLETS 200mg
English: S.C.
Croatian: Str.
English: Recovery* > 21 days
Croatian: Oporavak* > 21 dana
English: Also contains mannitol.
Croatian: Također sadrži manitol.
English: Your doctor will decide your dose of this medicine, depending on your general condition, height and weight.
Croatian: Liječnik će odrediti dozu ovog lijeka ovisno o Vašem općem stanju, visini i težini.
English: 9/l) prior to the first treatment
Croatian: 9/L) prije prvog liječenja
English: Unopened powder vial: 4 years
Croatian: Neotvorena bočica praška: 4 godine
English: Dose mg/m (% of recommended starting dose)
Croatian: Doza mg/m (% preporučene početne doze)
English: You should not use Azacitidine Celgene during pregnancy as it may be harmful to the baby.
Croatian: Ne smijete uzimati Azacitidin Celgene tijekom trudnoće jer može biti štetan za dijete.
English: Powder for suspension for injection.
Croatian: Prašak za suspenziju za injekciju.
English: The safety and efficacy of Azacitidine Celgene in children aged 0-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost Azacitidina Celgene u djece u dobi od 0 do 17 godina nisu još ustanovljene.
English: They are also responsible for preparing and disposing of any unused Azacitidine Celgene correctly.
Croatian: Također su odgovorni za pravilnu pripremu i zbrinjavanje neiskorištenog Azacitidina Celgene.
English: KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval; HR = hazard ratio
Croatian: KRATICE: AZA = azacitidin; CCR = režim konvencionalne skrbi; CI = interval pouzdanosti; HR = omjer hazarda
English: While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with azacitidine.
Croatian: Iako su u analizi postojala ograničenja, dostupni podaci pokazuju da bolesnici nemaju značajno pogoršanje kvalitete života tijekom liječenja azacitidinom.
English: • Azacitidine Celgene is given every day for one week, followed by a rest period of 3 weeks.
Croatian: • Azacitidin Celgene se primjenjuje svakoga dana tijekom jednog tjedna, nakon čega slijedi razdoblje stanke od 3 tjedna.
English: The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m
Croatian: Sljedeća tablica služi samo kao primjer kako se računaju pojedinačne doze azacitidina prema prosječnoj vrijednosti PT-a od 1,8 m
English: • The recommended dose is 75 mg per m body surface area.
Croatian: • Preporučena doza je 75 mg/m površine tijela.
English: • Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
Croatian: • infekcija dubljih slojeva kože koja se bržo širi, oštećuje kožu i tkivo što može biti opasno po život (nekrotizirajući fasciitis).