FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva:
Croatian: Ako se na Vas odnosi bilo koje od dolje navedenih stanja morate obavijestiti liječnika, prije nego što uzmete Klopidogrel Teva: • ako postoji opasnost od krvarenja poput
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Croatian: Klopidogrel, također, inhibira agregaciju trombocita induciranu drugim agonistima, pored ADP-a, i to blokiranjem pojačavanja aktivacije trombocita oslobođenim ADP-om.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Croatian: izloženost aktivnom metabolitu bila je veća nego kod režima doziranja od 300 mg/75 mg.
English: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Croatian: • odraslih bolesnika koji boluju od akutnog koronarnog sindroma: - Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda), uključujući bolesnike koji se podvrgavaju ugradnji stenta nakon perkutane koronarne intervencije, u kombinaciji s acetilsalicilatnom kiselinom (ASK).
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a
Croatian: Kounisov sindrom (alergijska vazospastična angina
English: EU/1/09/540/010 14x1 film-coated tablets EU/1/09/540/011 28x1 film-coated tablets EU/1/09/540/012 30x1 film-coated tablets EU/1/09/540/013 50x1 film-coated tablets EU/1/09/540/014 84x1 film-coated tablets EU/1/09/540/015 90x1 film-coated tablets EU/1/09/540/016
Croatian: EU/1/09/540/010 14x1 filmom obloženih tableta EU/1/09/540/011 28x1 filmom obloženih tableta EU/1/09/540/012 30x1 filmom obloženih tableta EU/1/09/540/013 50x1 filmom obloženih tableta EU/1/09/540/014 84x1 filmom obloženih tableta EU/1/09/540/015 90x1 filmom obloženih tableta EU/1/09/540/016 100x1 filmom obloženih tableta EU/1/09/540/017 28x1 filmom obloženih tableta
English: Rare side effect (may affect up to 1 in 1000 people):
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
English: EU/1/09/540/001 14x1 film-coated tablets EU/1/09/540/002 28x1 film-coated tablets EU/1/09/540/003 30x1 film-coated tablets EU/1/09/540/004 50x1 film-coated tablets EU/1/09/540/005 84x1 film-coated tablets EU/1/09/540/006 90x1 film-coated tablets EU/1/09/540/007 100x1 film-coated tablets
Croatian: EU/1/09/540/001 14x1 filmom obloženih tableta EU/1/09/540/002 28x1 filmom obloženih tableta EU/1/09/540/003 30x1 filmom obloženih tableta EU/1/09/540/004 50x1 filmom obloženih tableta EU/1/09/540/005 84x1 filmom obloženih tableta EU/1/09/540/006 90x1 filmom obloženih tableta EU/1/09/540/007 100x1 filmom obloženih tableta
English: Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Croatian: Upute o vađenju tableta iz blistera nalaze se na kutiji u kojoj su blisteri s odvojivom folijom.
English: 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.
Croatian: Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 5 dvostrukoslijepih studija koje su uključivale više od 88 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te
English: (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka):
English: − Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets
Croatian: − Aluminijskim perforiranim blisterima u kalendarskom pakovanju koje sadrži 28x1 tabletu.
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet TEVA Pharmaceutical Works Private Limited Company Pallagi út 13
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Croatian: 2% za bijelce, 4% za crnce i 14% za Kineze.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Croatian: Pretrage produljeno vrijeme krvarenja, smanjen broj neutrofila, smanjen broj trombocita
English: hypersensitivity reaction due to clopidogrel*
Croatian: / alergijski infarkt miokarda) u kontekstu reakcije preosjetljivosti na klopidogrel*
English: TEVA GmbH Tel: (49) 731 402 08
Croatian: Tel: (49) 731 402 08
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulfate).
Croatian: Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata).
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Croatian: Rezultati kliničkih ispitivanja podupiru trajanje liječenja do 12 mjeseci, a najveći učinak zabilježen je u trećem mjesecu liječenja
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: 5) bila je 9% (114 događaja) u skupini s vođenom de-eskalacijom u odnosu na 11% (137 događaja) u kontrolnoj skupini (p=0,14).
English: Tel: +(39) 028917981
Croatian: Teva Italia S.r.l. Tel: +(39) 0289179805
English: Vertigo, enlarged breasts in males.
Croatian: Vrtoglavica, povećanje grudi u muškaraca.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Croatian: 104 tjedna u dozama do 77 mg/kg dnevno (što predstavlja barem 25 puta veću izloženost nego u ljudi koji primaju kliničku dozu od 75 mg/dan).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PRILOG II A. PROIZVOĐAČ ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Croatian: mjeseca te s rizikom od tromboze (PICOLO), procijenjen je učinak klopidogrela u konsekutivnim dozama od 0,01, 0,1 i 0,2 mg/kg u novorođenčadi i dojenčadi te u dozi od 0,15 mg/kg samo u novorođenčadi.
English: • Swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Croatian: • oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Croatian: U tzv. post-hoc analizi 2.172 bolesnika (17% ukupne CURE populacije) koji su se podvrgli ugradnji stenta (Stent-CURE), podaci su pokazali da je klopidogrel u usporedbi s placebom pokazao značajno smanjenje relativnog rizika od 26,2% za koprimarni ishod
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Croatian: Nisu opažene značajne razlike u izloženosti aktivnom metabolitu i prosječnoj vrijednosti inhibicije agregacije trombocita
English: Fri
Croatian: Ut
English: Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Croatian: Film-ovojnica: laktoza hidrat hipromeloza (E464) titanijev dioksid (E171) makrogol 4000 željezov oksid, crveni (E172) željezo oksid, žuti (E172) Indigo carmine aluminium lake (E132)
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 za prijavu nuspojava navedenog u. nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: − Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil and sodium laurilsulfate.
Croatian: • Pomoćne tvari su (vidjeti dio 2 „Klopidogrel Teva sadrži laktozu“): Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, hidroksipropilceluloza (E463), krospovidon (tip A), hidrogenizirano biljno ulje i natrijev laurilsulfat.
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Croatian: Zbog opreza se ne preporučuje istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori CYP2C19 (vidjeti dio 4.4. i 5.2.).
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR=23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR=7.3%; CI: -5.7 to 18.7 [p=0.258]).
Croatian: U analizi podskupina sačinjenih prema stanju (infarkt miokarda, ishemijski moždani udar, BPA) najveću su korist od liječenja (postignuta statistička značajnost pri p = 0,003) imali bolesnici s bolešću perifernih arterija (BPA), posebno oni koji su u anamnezi imali infarkt miokarda (RRR = 23,7%; CI:
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba):
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Croatian: Ovo randomizirano, otvoreno ispitivanje uključivalo je bolesnike s akutnim koronarnim sindromom u kojih je bila potrebna perkutana koronarna intervencija (PCI).
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Croatian: Klopidogrel Teva 75 mg filmom obložene tablete klopidogrel
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
English: Clopidogrel Teva 75 mg film-coated tablets
Croatian: Klopidogrel Teva 75 mg filmom obložene tablete
English: - 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), - poremećaja krvi zbog čega ste skloni unutrašnjim krvarenjima (krvarenje u tkivima, organima ili zglobovima), - nedavne teške ozljede,
English: Clopidogrel Teva contains lactose
Croatian: Teva sadrži laktozu
English: Fertility Clopidogrel was not shown to alter fertility in animal studies.
Croatian: U ispitivanjima na životinjama, klopidogrel nije pokazao utjecaj na plodnost.
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Croatian: Incidencija klinički značajnog krvarenja bila je slična onoj zamijećenoj pri istodobnoj primjeni trombolitika i heparina s
English: Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Croatian: Klopidogrel je indiciran u:
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: - 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).
Croatian: - ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
English: • The film-coated tablets are light pink to pink, film coated, capsule shaped tablets.
Croatian: • Filmom obložene tablete su svjetlo ružičaste do ružičaste filmom obložene tablete u obliku kapsula, s utisnutom oznakom „93“ na jednoj i „7314“ na drugoj strani.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Croatian: Klopidogrel Teva u kombinaciji s acetilsalicilatnom kiselinom, tvari prisutnom u mnogim lijekovima za ublažavanje boli i snižavanje temperature.
English: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA)
Croatian: Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda): liječenje klopidogrelom treba započeti s jednokratnom udarnom dozom od 300
English: Clopidogrel Teva contains sodium
Croatian: Teva sadrži natrij
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Croatian: (najprije udarnu dozu od 300 mg, a nakon toga dozu od 75 mg na dan, n=1752) ili placebo (n=1739), oboje u kombinaciji s ASK (150 do 325 mg kao udarna doza nakon čega je slijedila doza od 75 do 162
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg.
Croatian: Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva per day to be taken orally with or without food, and at the same time each day.
Croatian: Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta Klopidogrela
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Croatian: umjereni i slabi), procijenjen je farmakokinetički i antitrombocitni odgovor primjenom doze od 300 mg, nakon čega je slijedila doza od 75 mg/dan te primjenom doze od 600 mg, nakon čega je slijedila doza od 150 mg/dan, u trajanju od ukupno 5 dana (stanje dinamičke ravnoteže).
English: Gynaecomastia
Croatian: Klopidogrel
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Croatian: Primjenu ASK (75-100 mg na dan) treba započeti i nastaviti davati u kombinaciji s klopidogrelom (vidjeti dio
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Croatian: Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio
English: Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Croatian: Perforirani blisteri sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 filmom obloženih tableta.
English: Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it.
Croatian: Laganim potezom uzduž perforacije odvojiti jediničnu dozu od ostatka blistera.
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 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Croatian: [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
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 filmom obloženih tableta)
English: Thur
Croatian: Čet
English: INSTRUCTIONS ON USE.
Croatian: NAVOĐENJE DJELATNE/IH
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Croatian: + ASK i 0,7% u skupini placebo + ASK) i hemoragijskog moždanog udara (0,8% naspram 0,6%).
English: − Peelable perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
Croatian: Aluminijskim perforiranim blisterima s jediničnim dozama koji sadržavaju 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ili 100x1 tableta
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR=-4.0%; CI: -22.5 to 11.7 [p=0.639]).
Croatian: ASK (RRR = -4,0%; CI: -22,5 do 11,7 [p=0,639]).
English: Package leaflet: Information for the user Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Croatian: Uputa o lijeku: Informacije za korisnika Klopidogrel
English: 75 mg-325 mg daily).
Croatian: mg, a zatim nastaviti sa 75 mg jedanput na dan (uz acetilsalicilnu kiselinu (ASK) 75 mg do 325 mg na dan).
English: If you take more Clopidogrel Teva than you should
Croatian: Teva nego što ste trebali
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: reakcije preosjetljivosti s bolovima u prsnom košu ili trbuhu, simptomi niske razine šećera u krvi koji ne prolaze.
English: Thrombocytopenia, leucopenia, eosinophilia
Croatian: pancitopenija, agranulocitoza, teška trombocitopenija,
English: NN:
Croatian: Dodatno,
English: BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in
Croatian: Kumulativna incidencija svih događaja krvarenja (BARC stupanj krvarenja od 1 do
English: 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Croatian: Bleeding Academic Reasearch Consortium) stupnja krvarenja ≥ 2 u prvoj godini nakon akutnog koronarnog sindroma dogodio se u 43 bolesnika (13,4%) u skupini sa de-eskaliranim DAPT-om i u 85 bolesnika (26,3%) u skupini s nepromijenjenim DAPT-om.
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Croatian: COMMIT ispitivanje faktorskog dizajna 2x2 uključivalo je 45 852 bolesnika koji su unutar posljednja
English: Contact our press officer Monika Benstetter
Croatian: Obratite se našem djelatniku za medije Monika Benstetter
English: Healthcare professionals should follow these recommendations:
Croatian: Zdravstveni se djelatnici trebaju pridržavati sljedećih preporuka:
English: The EMA will evaluate the results of this study as soon as they are available.
Croatian: EMA će ocijeniti rezultate ispitivanja čim oni postanu dostupni.
English: Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day.
Croatian: Stoga, preporučena početna doza lijeka Iclusig treba ostati 45 mg jednom na dan.
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Croatian: • Ako imate bilo kakvih dodatnih pitanja ili nedoumica, obratite se svojem liječniku ili drugom zdravstvenom djelatniku.
English: • chronic myeloid leukaemia (CML);
Croatian: • kroničnom mijeloidnom leukemijom (KML);
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 October 2014 EMA/641476/2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The review of Iclusig was initiated on 27 November 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Pregled lijeka Iclusig pokrenut je 27. studenog 2013. na zahtjev Europske komisije sukladno članku 20.
English: • Before starting treatment, your doctor will assess your risk of heart and circulatory problems, and will continue to check your condition at regular intervals during your treatment with Iclusig.
Croatian: • Prije početka terapije, vaš će liječnik ocijeniti vaš rizik od srčanih i cirkulacijskih problema, te će nastaviti provjeravati vaše stanje u redovitim intervalima tijekom vaše terapije lijekom Iclusig.
English: • If a reduced dose of Iclusig is used, doctors should monitor patients for maintenance of therapeutic response.
Croatian: • Ako se koristi smanjena doza lijeka Iclusig, liječnici trebaju nadzirati bolesnike da bi se održao terapijski odgovor.
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Croatian: Blokirajući Bcr-Abl, Iclusig pomaže pri kontroli rasta i širenju stanica leukemije.
English: • Educational material will be provided to healthcare professionals, highlighting important risks for which monitoring and/or dose adjustments are recommended.
Croatian: • Zdravstvenim djelatnicima dostavit će se edukacijski materijali u kojima se naglašavaju važni rizici za koje se preporuča praćenje i/ili podešavanje doze.
English: • The benefit-risk balance of Iclusig remains positive in all authorised indications, and the starting dose remains 45 mg per day.
Croatian: • Omjer koristi i rizika za lijek Iclusig ostaje pozitivan u svim odobrenim indikacijama, a početna doza ostaje 45 mg na dan.
English: • Treatment with Iclusig should be stopped if a complete haematologic response has not occurred by three months.
Croatian: • Terapiju lijekom Iclusig treba zaustaviti ako nije nastupio potpuni hematološki odgovor unutar tri mjeseca.
English: Iclusig was authorised as an orphan medicine (a medicine to treat rare diseases) in the EU in July
Croatian: Iclusig je odobren kao lijek za liječenje rijetkih bolesti u EU-u u srpnju 2013.
English: The review of Iclusig was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled lijeka Iclusig prvi je put proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC) pri Agenciji.