FrancophonIA/ELRC3.0 huggingface dataset:
English: Typically, a fall in the platelet count will be observed within 14 to 21 days of starting treatment and in most patients an adequate therapeutic response will be observed and maintained at a dose of 1 to 3 mg/day (for further information on the clinical effects refer to section 5.1).
Croatian: Obično se pad broja trombocita opaža unutar 14 do 21 dan od početka liječenja i u većine bolesnika odgovarajući terapijski odgovor bit će primijećen i održan pri dozi od 1 do 3 mg/dan (za više podataka o kliničkim učincima vidjeti dio 5.1).
English: Very limited data are available on the use of anagrelide in the paediatric population and anagrelide should be used in this patient group with caution (see sections 4.2, 4.8, 5.1 and 5.2).
Croatian: Dostupni su vrlo ograničeni podaci o primjeni anagrelida u pedijatrijskoj populaciji pa se u toj skupini bolesnika anagrelid treba primjenjivati s oprezom (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2).
English: Treatment with anagrelide should be initiated by a clinician with experience in the management of essential thrombocythaemia.
Croatian: Liječenje anagrelidom treba započeti kliničar s iskustvom u liječenju esencijalne trombocitemije.
English: Diagnostic guidelines for essential thrombocythaemia should be followed carefully and diagnosis reassessed periodically in cases of uncertainty, with effort made to distinguish from hereditary or secondary thrombocytosis, which may include genetic analysis and bone marrow biopsy.
Croatian: Treba se pažljivo pridržavati dijagnostičkih smjernica za esencijalnu trombocitemiju, a u slučaju nesigurnosti, dijagnozu ponovno periodički procjenjivati, uz posebno nastojanje da se esencijalna trombocitemija razluči od hereditarne ili sekundarne trombocitoze, što može uključiti genetsku analizu i biopsiju koštane srži.
English: The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4).
Croatian: Učinke liječenja anagrelidom treba redovito nadzirati (vidjeti dio 4.4).
English: In male rats, anagrelide at oral doses up to 240 mg/kg/day (> 1,000 times a 2 mg/day dose, based on body surface area) was found to have no effect on fertility and reproductive performance.
Croatian: U mužjaka štakora, nađeno je da anagrelid u peroralnim dozama do 240 mg/kg na dan (> 1000 puta doza od 2 mg na dan, na temelju površine tijela) nema učinka na plodnost i reproduktivnu sposobnost.
English: Each capsule contains approximately 119 mg lactose.
Croatian: Jedna kapsula sadrži približno 119 mg laktoze.
English: • Potentially life-threatening, irregular heart beat (torsade de pointes);
Croatian: • nepravilni otkucaji srca koji mogu biti opasni po život (torsade de pointes);
English: • At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function e.g. acetylsalicylic acid.
Croatian: • U dozama preporučenim za primjenu u liječenju esencijalne trombocitemije anagrelid može pojačati učinke drugih lijekova koji inhibiraju ili mijenjaju funkciju trombocita, npr. acetilsalicilne kiseline.
English: The effect of two dose levels of anagrelide (0.5 mg and 2.5 mg single doses) on the heart rate and QTc interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adult men and women.
Croatian: Učinak dvije različite doze anagrelida (jednostruke doze od 0,5 mg i 2,5 mg) na brzinu otkucaja srca i QTc interval bio je procijenjen u dvostruko slijepom, randomiziranom, placebom i djelatnom tvari kontroliranom ukriženom ispitivanju u zdravih odraslih muškaraca i žena.
English: Do not crush the capsules or dilute the contents in a liquid.
Croatian: Nemojte drobiti kapsule niti otapati njihov sadržaj u tekućini.
English: In cell culture studies, anagrelide suppressed expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.
Croatian: U ispitivanjima provedenim na staničnim kulturama, anagrelid je potisnuo ekspresiju čimbenika transkripcije, uključujući GATA-1 i FOG-1 koji su potrebni za megakariocitopoezu, što konačno dovodi do smanjene proizvodnje trombocita.
English: The capsule size is approximately 14.3 x 5.3 mm.
Croatian: Veličina kapsule je približno 14,3 × 5,3 mm.
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for Anagrelide Mylan, such as this leaflet.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o referentnom lijeku te će se sve izmjene za referentni lijek također odgovarajuće uključiti u informacije o lijeku za Anagrelid Mylan, kao što je ova uputa o lijeku.
English: In fasted subjects, peak plasma levels occur about 1 hour after administration.
Croatian: U primjeni natašte, vršne vrijednosti u plazmi pojavljuju se u bolesnika otprilike 1 sat nakon primjene.
English: 4.4 Special warnings and precautions for use Hepatic impairment
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Oštećenje funkcije jetre
English: Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets.
Croatian: Esencijalna trombocitemija je stanje koje nastaje kada koštana srž stvara previše krvnih stanica poznatih kao krvne pločice.
English: Anagrelide, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
Croatian: Pokazalo se da anagrelid u dozama višim od preporučenih snižava krvni tlak uz povremene pojave hipotenzije.
English: The platelet count will increase within 4 days of stopping treatment with anagrelide and will return to pre-treatment levels within 10 to 14 days, possibly rebounding above baseline values.
Croatian: Broj trombocita će se povećati unutar 4 dana nakon prestanka liječenja anagrelidom i vratit će se na razine prije liječenja unutar 10 do 14 dana, s tim da se mogu vratiti na razine iznad početnih vrijednosti.
English: - If you have further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: • Theophylline, used to treat severe asthma and breathing problems;
Croatian: • teofilin, primjenjuje se za liječenje teške astme i poteškoća s disanjem;
English: The consequences on the safety and efficacy profile of anagrelide are not established.
Croatian: Posljedice za profil sigurnosti i djelotvornosti anagrelida nisu ustanovljene.
English: Serious cardiovascular adverse reactions including cases of torsade de pointes, ventricular tachycardia, cardiomyopathy, cardiomegaly and congestive heart failure have been reported (see section 4.8).
Croatian: Prijavljene su ozbiljne kardiovaskularne nuspojave uključujući slučajeve torsade de pointes, ventrikularne tahikardije, kardiomiopatije, kardiomegalije i kongestivnog zatajenja srca (vidjeti dio 4.8).
English: Anagrelide is primarily metabolised by CYP1A2 to form, 3-hydroxy anagrelide, which is further metabolised via CYP1A2 to the inactive metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline.
Croatian: Anagrelid se prvenstveno metabolizira putem CYP1A2 te nastaje 3-hidroksianagrelid koji se dalje metabolizira putem CYP1A2 do neaktivnog metabolita 2-amino-5,6-dikloro-3,4-dihidrokinazolina.
English: In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk of major haemorrhages (bleeding) (see section “Other medicines and Anagrelide Mylan”).
Croatian: U kombinaciji s acetilsalicilnom kiselinom (tvar prisutna u mnogim lijekovima koja se primjenjuje za ublažavanje bolova i snižavanje temperature, a također i za sprječavanje zgrušavanja krvi, poznata i kao aspirin), postoji povećani rizik za obilne hemoragije (krvarenja) (pogledajte dio „Drugi lijekovi i Anagrelid Mylan“).
English: The average total daily dose of anagrelide across all studies in paediatric ET patients was highly variable, but overall the data suggest that adolescents could follow similar starting and maintenance doses to adults and that a lower starting dose of 0.5 mg/day would be more appropriate for children over 6 years (see sections 4.2, 4.4, 4.8, 5.2).
Croatian: Prosječna ukupna dnevna doza anagrelida u svim ispitivanjima esencijalne trombocitemije u pedijatrijskih bolesnika bila je visoko promjenjiva, ali sveukupni podaci pokazuju da adolescenti mogu primati početne doze i doze održavanja za odrasle, i da je za djecu stariju od 6 godina prikladnija niža početna doza od 0,5 mg na dan (vidjeti dijelove 4.2, 4.4, 4.8, 5.2).
English: The observed pharmacokinetic differences between elderly and young patients with ET (see section 5.2) do not warrant using a different starting regimen or different dose titration step to achieve an individual patient-optimised anagrelide regimen.
Croatian: Farmakokinetičke razlike opažene između starijih i mlađih bolesnika s esencijalnom trombocitemijom (vidjeti dio 5.2) ne nalažu primjenu različitog početnog režima ili različitog postupka pri titraciji doze kako bi se postigao režim anagrelida najbolji za pojedinog bolesnika.
English: As with the adult population, a full blood count and assessment of cardiac, hepatic and renal function should be undertaken before treatment and regularly during treatment.
Croatian: Kao i u slučaju odrasle populacije, potrebno je prije liječenja napraviti kompletnu krvnu sliku i procjenu funkcije srca, jetre i bubrega, a zatim provoditi te pretrage redovito tijekom liječenja.
English: • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Croatian: • Anagrelid može prouzročiti crijevne tegobe u nekih bolesnica i oslabiti apsorpciju oralne hormonske kontracepcije.
English: • Medicines that can alter your heart rhythm e.g. sotalol, amiodarone;
Croatian: • lijekove koji mogu promijeniti srčani ritam, npr. sotalol, amiodaron;
English: Use of concomitant anagrelide and acetylsalicylic acid has been associated with major haemorrhagic events (see section 4.5).
Croatian: Istovremena primjena anagrelida i acetilsalicilne kiseline povezana je s velikim hemoragijskim događajima (vidjeti dio 4.5).
English: The most commonly reported adverse reactions associated with anagrelide were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6% and diarrhoea occurring at 5%.
Croatian: Najčešće prijavljene nuspojave povezane s anagrelidom bile su: glavobolja zabilježena u otprilike 14% ispitanika, palpitacije zabilježene u otprilike 9%, zadržavanje tekućine i mučnina, obje nuspojave javile su se u približno 6% ispitanika i proljev koji se javio u 5% ispitanika.
English: Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well.
Croatian: Vaš liječnik će zatražiti da u redovitim vremenskim razmacima radite krvne pretrage kako bi se provjerilo ostvaruje li lijek učinak i rade li dobro
English: A specific antidote for anagrelide has not been identified.
Croatian: Specifični antidot za anagrelid nije ustanovljen.
English: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, France
Croatian: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, Francuska
English: The reference medicine for Anagrelide Mylan has been authorised under ‘exceptional circumstances'
Croatian: Referentni lijek za Anagrelid Mylan odobren je u „iznimnim okolnostima“.
English: Anagrelide should only be used if the potential benefits of therapy outweigh the potential risks.
Croatian: Anagrelid se smije primjenjivati samo ako su moguće koristi terapije veće od mogućih rizika.
English: Each capsule contains approximately 59.5 mg lactose.
Croatian: Jedna kapsula sadrži približno 59,5 mg laktoze.
English: Care should also be taken in populations that may have a higher maximum plasma concentration (Cmax) of anagrelide or its active metabolite, 3-hydroxy-anagrelide, e.g. hepatic impairment or use with CYP1A2 inhibitors (see section 4.5).
Croatian: Potreban je oprez i u populacija koje mogu imati više maksimalne koncentracije (Cmax) anagrelida ili njegovog djelatnog metabolita u plazmi, 3-hidroksianagrelida, npr. oštećenje funkcije jetre ili primjena s inhibitorima CYP1A2 (vidjeti dio 4.5).
English: In case of overdose, close clinical supervision of the patient is required; this includes monitoring of the platelet count for thrombocytopenia.
Croatian: U slučaju predoziranja, potreban je strogi klinički nadzor bolesnika; to uključuje praćenje broja trombocita zbog trombocitopenije.
English: Less than 1% is recovered in the urine as anagrelide.
Croatian: Manje od 1% otkrije se u mokraći kao anagrelid.
English: If treatment is initiated, the benefits and risks of treatment with anagrelide must be monitored regularly and the need for ongoing treatment evaluated periodically.
Croatian: Ako se liječenje započne, koristi i rizike liječenja anagrelidom mora se redovito nadzirati, a potrebu za nastavkom liječenja periodički procjenjivati.
English: Effects of anagrelide on other active substances
Croatian: Učinci anagrelida na druge djelatne tvari
English: In an open-label clinical study in 8 children and 10 adolescents (including patients who were anagrelide treatment naïve or who had been receiving anagrelide for up to 5 years pre-study), median platelet counts were decreased to controlled levels after 12 weeks of treatment.
Croatian: U otvorenom kliničkom ispitivanju provedenom u 8 djece i 10 adolescenata (uključujući bolesnike koji prethodno nisu bili liječeni anagrelidom ili koji su prije ispitivanja primali anagrelid do 5 godina), medijan broja trombocita smanjio se na kontrolirane razine nakon 12 tjedana liječenja.
English: Evidence of similar in vivo actions was observed in bone marrow biopsy samples from treated patients.
Croatian: Dokazi sličnih djelovanja in vivo opaženi su u bioptatima koštane srži liječenih bolesnika.
English: Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), assessment of liver function (ALT and AST), renal function (serum creatinine and urea) and electrolytes (potassium, magnesium and calcium).
Croatian: Terapija zahtijeva strogi klinički nadzor bolesnika, što uključuje kompletnu krvnu sliku (vrijednosti hemoglobina i broja leukocita te trombocita), procjenu funkcije jetre (ALT i AST), funkcije bubrega (kreatinin u serumu i urea) i elektrolite (kalij, magnezij i kalcij).
English: In vitro studies of human megakaryocytopoiesis established that anagrelide's inhibitory actions on platelet formation in man are mediated via retardation of maturation of megakaryocytes, and reducing their size and ploidy.
Croatian: Ispitivanjem ljudske megakariocitopoeze in vitro ustanovljeno je da su inhibicijska djelovanja anagrelida na stvaranje trombocita u čovjeka posredovana usporavanjem sazrijevanja megakariocita i smanjenjem njihove veličine i ploidnosti.
English: • Inflammation of the kidneys (tubulointerstitial nephritis).
Croatian: • upala bubrega (tubulointersticijski nefritis).
English: What you need to know before you take Anagrelide Mylan
Croatian: Što morate znati prije nego počnete uzimati Anagrelid Mylan
English: In these studies 22 patients received anagrelide for up to 4 years.
Croatian: U ovim ispitivanjima 22 bolesnika primala su anagrelid do 4 godine.
English: Anagrelide Mylan should not be taken by pregnant women.
Croatian: Anagrelid Mylan ne smiju uzimati trudnice.
English: Effects on heart rate and QTc interval
Croatian: Učinci na brzinu otkucaja srca i QTc interval
English: • Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e.g. theophylline.
Croatian: • Anagrelid pokazuje određeno ograničeno inhibicijsko djelovanje na CYP1A2, što može predstavljati teorijsku mogućnost za interakciju s drugim istovremeno primijenjenim lijekovima jednakog mehanizma klirensa, npr. teofilin.
English: • Acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin);
Croatian: • acetilsalicilnu kiselinu (tvar prisutna u mnogim lijekovima koja se primjenjuje za ublažavanje bolova i snižavanje temperature, a također i za sprječavanje zgrušavanja krvi, poznata je i kao aspirin);
English: In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x 109/l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Croatian: U bolesnika s esencijalnom trombocitemijom potpuni odgovor definiran je kao smanjenje broja trombocita na ≤ 600 x 109/l ili smanjenje ≥ 50% u odnosu na početnu vrijednost te održavanje smanjenog broja tijekom još najmanje 4 tjedna.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti“.
English: In female rats increases in pre- and post-implantation losses and a decrease in the mean number of live embryos was observed at 30 mg/kg/day.
Croatian: U ženki štakora, povećanje u gubicima prije i poslije implantacije te smanjenje prosječnog broja živih embrija opaženo je pri dozi od 30 mg/kg na dan.
English: Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1 mg/kg/day or higher in males and females with males being more sensitive.
Croatian: Nakon ponovljene peroralne primjene anagrelida u pasa, subendokardijalna hemoragija i fokalna nekroza miokarda opažene su u mužjaka i ženki kod doza od 1 mg/kg na dan ili viših, s tim da su mužjaci bili osjetljiviji.
English: Among them, the incidence of adrenal phaeochromocytomas was increased relative to control in males at all dose levels (≥ 3 mg/kg/day) and in females receiving 10 mg/kg/day and above.
Croatian: Među njima je incidencija adrenalnog feokromocitoma u odnosu na kontrolne životinje bila povećana u mužjaka pri svim razinama doze (≥ 3 mg/kg na dan), a u ženki pri dozi od 10 mg/kg na dan ili višoj.
English: These adverse drug reactions are expected based on the pharmacology of anagrelide (inhibition of PDE III).
Croatian: Te su nuspojave očekivane s obzirom na farmakologiju anagrelida (inhibicija PDE III).
English: • In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Croatian: • In vivo ispitivanja interakcija u ljudi dokazala su da digoksin i varfarin ne utječu na farmakokinetička svojstva anagrelida.
English: A transient increase in mean QTc was observed for both doses during periods of increasing heart rate and the maximum change in mean QTcF (Fridericia correction) was +5.0 msec occurring at 2 hours for 0.5 mg and +10.0 msec occurring at 1 hour for 2.5 mg.
Croatian: Prolazno povećanje srednje vrijednosti QTc bilo je opaženo kod obje doze tijekom razdoblja povećavanja brzine otkucaja srca, a najveća promjena u srednjoj vrijednosti QTcF (Fridericijina korekcija) bila je +5,0 ms i nastala je 2 sata nakon doze od 0,5 mg te +10,0 ms i nastala je 1 sat nakon doze od 2,5 mg.
English: • Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g. condom).
Croatian: • oralne kontraceptive: ako Vam se pojavi teški proljev dok uzimate ovaj lijek, to bi moglo smanjiti djelovanje tableta za sprječavanje trudnoće pa se preporučuje upotreba još jedne metode zaštite od trudnoće (npr. kondom).
English: In male rats, there was no effect on fertility or reproductive performance with anagrelide.
Croatian: U mužjaka štakora nije bilo učinka anagrelida na plodnost ili reproduktivnu sposobnost.
English: 117 Allée des Parcs Saint-Priest
Croatian: 117 Allée des Parcs
English: It is unknown whether anagrelide/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se anagrelid/metaboliti u majčino mlijeko.
English: • Anagrelide is an inhibitor of PDE III.
Croatian: • Anagrelid je inhibitor PDE III.
English: Show them the pack of Anagrelide Mylan.
Croatian: Pokažite im pakiranje lijeka Anagrelid Mylan.
English: There are no adequate data from the use of anagrelide in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni anagrelida u trudnica.
English: If you are not sure, speak to your doctor or pharmacist for advice.
Croatian: Ako niste sigurni, potražite savjet liječnika ili ljekarnika.
English: Anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Croatian: Anagrelid je indiciran za smanjenje povećanog broja trombocita u rizičnih bolesnika s esencijalnom trombocitemijom (ET) koji ne podnose dobro trenutno primjenjivanu terapiju ili kojima se primjenjivanom terapijom povećani broj trombocita nije smanjio na prihvatljivu razinu.
English: Marketing Authorisation Holder Mylan S.A.S
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Mylan S.A.S
English: Pharmacokinetic data from exposed fasting children and adolescents (age range 7 - 16 years) with essential thrombocythaemia indicate that dose normalised exposure, Cmax and AUC, of anagrelide tended to be higher in children/adolescents compared with adults.
Croatian: Farmakokinetički podaci za izloženost anagrelidu uzimanom natašte u djece i adolescenata s esencijalnom trombocitemijom (dobni raspon od 7 do 16 godina) pokazuju da su izloženost, Cmax i AUC anagrelida normalizirani za dozu obično bili viši u djece/adolescenata nego u odraslih bolesnika.
English: There is limited information on the use of anagrelide in children and adolescents and therefore this medicine should be used with caution.
Croatian: Budući da su podaci o primjeni anagrelida u djece i adolescenata ograničeni, ovaj lijek treba primjenjivati s oprezom.
English: Anagrelide Mylan is available in plastic bottles of 30 ml or 75 ml with a tamper evident, child-resistant closure and a desiccant.
Croatian: Anagrelid Mylan dostupan je u plastičnim bočicama od 30 ml ili 75 ml sa sigurnosnim zatvaračem za djecu s evidencijom otvaranja i sredstvom za sušenje.
English: In the absence of specific paediatric guidelines, WHO diagnostic criteria for adult diagnosis of ET are considered to be of relevance to the paediatric population.
Croatian: U nedostatku smjernica namijenjenih posebno pedijatrijskoj populaciji, za postavljanje dijagnoze esencijalne trombocitemije u pedijatrijskoj populaciji smatraju se primjenjivima dijagnostički kriteriji Svjetske zdravstvene organizacije za odrasle.
English: The disease may progress to myelofibrosis or AML.
Croatian: Bolest može napredovati u mijelofibrozu ili akutnu mijeloičnu leukemiju (AML).
English: • Lung inflammation (signs include fever, coughing, difficulty breathing, wheezing; which causes scaring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonitis);
Croatian: • upala pluća (znakovi uključuju vrućicu, kašalj, teškoće s disanjem, piskanje pri disanju; koja uzrokuje stvaranje ožiljaka na plućima) (alergijski alveolitis, uključujući intersticijsku bolest pluća, pneumonitis);
English: A capsule size 4 (approximately 14.3 x 5.3 mm) with a grey body and cap.
Croatian: Kapsula veličine 4 (približno 14,3 x 5,3 mm) sa sivim tijelom i kapicom.
English: If you forget to take Anagrelide Mylan
Croatian: Ako ste zaboravili uzeti Anagrelid Mylan