FrancophonIA/ELRC3.0 huggingface dataset:
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Croatian: Pogledajte što je navedeno u uputama priloženim uz kontracepcijske tablete koje uzimate.
English: Discontinuation of treatment should be considered in paediatric patients who do not have a satisfactory treatment response after approximately 3 months.
Croatian: Prestanak liječenja treba razmotriti u pedijatrijskih bolesnika koji ne postignu zadovoljavajući odgovor na terapiju nakon otprilike 3 mjeseca.
English: Each bottle contains 100 hard capsules.
Croatian: Svaka bočica sadrži 100 tvrdih kapsula.
English: Clinical benefit in terms of thrombohaemorrhagic events has not been convincingly demonstrated.
Croatian: Klinička korist u smislu trombohemoragijskih događaja nije bila uvjerljivo dokazana.
English: Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Croatian: Anagrelid Mylan sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek“ već odobren u EU.
English: Your capsules should be swallowed whole with a glass of water.
Croatian: Kapsule morate progutati cijele uz čašu vode.
English: A dose-related increase in heart rate was observed during the first 12 hours, with the maximum increase occurring around the time of maximal concentrations.
Croatian: Povećanje brzine otkucaja srca povezano s dozom bilo je opaženo tijekom prvih 12 sati, s time da je najveće povećanje nastalo oko vremena najviše koncentracije.
English: Within the system organ classes they are listed under the following headings: Very common (≥ 1/10); 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: Unutar klasifikacije organskih sustava nuspojave su navedene prema sljedećim naslovima: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor if you are taking any of the following medicines:
Croatian: Obavijestite liječnika ako uzimate neki od ovih lijekova:
English: Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Croatian: Nakon peroralne primjene anagrelida u čovjeka, najmanje 70% apsorbira se iz gastrointestinalnog trakta.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxy-anagrelide, by 29%, although it had no effect on the AUC.
Croatian: Hrana je snizila i Cmax aktivnog metabolita 3-hidroksianagrelida za 29%, iako to nije imalo učinka na AUC.
English: • If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na anagrelid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Therefore anagrelide is not recommended during pregnancy.
Croatian: Stoga se primjena anagrelida ne preporučuje tijekom trudnoće.
English: In all paediatric patients, careful titration to a patientspecific daily dose is needed.
Croatian: U svih pedijatrijskih bolesnika potrebna je pažljiva titracija doze na dnevnu dozu specifičnu za bolesnika.
English: There are limited pharmacokinetic data for this patient population.
Croatian: Za ovu populaciju bolesnika postoje ograničeni farmakokinetički podaci.
English: However, safety data are limited and do not allow a meaningful comparison between adult and paediatric patients to be made (see section 4.4).
Croatian: Međutim, kako su podaci o sigurnosti ograničeni, nije moguća pouzdana usporedba između odraslih i pedijatrijskih bolesnika (vidjeti dio 4.4).
English: Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.
Croatian: Velik broj krvnih pločica u krvi može prouzročiti ozbiljne tegobe s cirkulacijom i zgrušavanjem krvi.
English: Do not drive or use machines if you feel dizzy.
Croatian: Ne upravljajte vozilima ili strojevima ako osjećate omaglicu.
English: • a platelet count > 1,000 x 109/l or
Croatian: • broj trombocita > 1000 × 109/l ili
English: If you take more Anagrelide Mylan than you should If you take more Anagrelide Mylan than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Croatian: Ako uzmete više lijeka Anagrelid Mylan nego što ste trebali ili ako je netko drugi uzeo Vaš lijek, odmah obavijestite liječnika ili ljekarnika.
English: Talk to your doctor before taking Anagrelide Mylan:
Croatian: Obratite se svom liječniku prije nego uzmete Anagrelid Mylan:
English: • Certain types of antibiotic, such as enoxacin, used to treat infections;
Croatian: • određene vrste antibiotika, kao što je enoksacin, koji se primjenjuju za liječenje infekcija;
English: However, as expected, patients in this age group had twice the incidence of serious adverse events (mainly cardiac).
Croatian: Međutim, kao što se i očekivalo, incidencija ozbiljnih štetnih događaja u bolesnika te dobne skupine bila je dvostruko veća (uglavnom sa srcem).
English: In studies 700-012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Croatian: U ispitivanjima 700-012, 700-014, 700-999 i ispitivanju 13970-301 vrijeme do potpunog odgovora bilo je u rasponu od 4 do 12 tjedana.
English: Symptoms resolved with conservative management.
Croatian: Simptomi su se povukli uz konzervativno liječenje.
English: Manufacturer Synthon Hispania SL C/ Castelló no1
Croatian: Proizvođač Synthon Hispania SL C/ Castello, no1
English: During clinical development doses of 10 mg/day have been used.
Croatian: Tijekom kliničkog razvoja primjenjivane su doze od 10 mg/dan.
English: Although the rate of such progression is not known, children have a longer disease course and may, therefore, be at increased risk for malignant transformation, relative to adults.
Croatian: Iako brzina tog napredovanja nije poznata, budući da je u djece tijek bolesti dulji, za njih može postojati veći rizik od zloćudne transformacije u odnosu na odrasle.
English: Limited pharmacokinetic and/or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Croatian: Provedena su ograničena farmakokinetička i/ili farmakodinamička ispitivanja koja su istraživala moguće interakcije anagrelida i drugih lijekova.
English: The capsule is filled with white to off-white powder.
Croatian: Kapsula je napunjena bijelim do bjelkastim praškom.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Pacijenti s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: UNIQUE IDENTIFIER - 2D BARCODE Carton only:
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Samo na kutiji:
English: The plasma half-life of anagrelide is short, approximately 1.3 hours and as expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Croatian: Anagrelid ima kratki poluvijek u plazmi, približno 1,3 sata i kao što se i očekuje s obzirom na poluvijek, nema dokaza za akumulaciju anagrelida u plazmi.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX35.
Croatian: Farmakoterapijska skupina: Drugi antineoplastični lijekovi, ATK oznaka: L01XX35.
English: Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Croatian: Farmakokinetički podaci u zdravih ispitanika pokazali su da hrana smanjuje Cmax anagrelida za 14%, ali povećava AUC za 20%.
English: It is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal) (see sections 4.2 and 4.3).
Croatian: Liječenje se ne preporučuje u bolesnika s povišenim transaminazama (> 5 puta iznad gornje granice normalnih vrijednosti) (vidjeti dijelove 4.2 i 4.3).
English: Clinically relevant interactions
Croatian: Klinički važne interakcije
English: Additionally these results show no evidence of auto-induction of the anagrelide clearance.
Croatian: Osim toga, ti rezultati ne daju dokaz o samoindukciji klirensa anagrelida.
English: Any abnormalities should be evaluated promptly and appropriate measures taken, which may also include dose reduction, interruption or discontinuation.
Croatian: Svaki poremećaj normalnih vrijednosti treba smjesta procijeniti i poduzeti odgovarajuće mjere, što može uključiti i snižavanje doze, privremenu obustavu ili prekid liječenja.
English: The dose increment must not exceed more than 0.5 mg/day in any one-week and the recommended maximum single dose should not exceed 2.5 mg (see section 4.9).
Croatian: Povećanje doze ne smije prelaziti više od 0,5 mg/dan u bilo kojem tjednu, a preporučena najviša jednokratna doza ne smije prelaziti 2,5 mg (vidjeti dio 4.9).
English: These differences were likely to be caused by lower presystemic metabolism of anagrelide to 3-hydroxy anagrelide in the elderly patients.
Croatian: Te su razlike vjerojatno posljedica slabijeg predsistemskog metabolizma anagrelida u 3-hidroksianagrelid u starijih bolesnika.
English: An at risk patient
Croatian: Rizični bolesnik
English: Therefore, platelets should be monitored frequently.
Croatian: Stoga treba često pratiti trombocite.
English: The safety of anagrelide has been examined in 4 open label clinical studies.
Croatian: Sigurnost primjene anagrelida ispitivana je u 4 otvorena klinička ispitivanja.
English: • The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Croatian: • Učinci hrane na bioraspoloživost ne smatraju se klinički važnima za primjenu anagrelida.
English: All patients should be monitored regularly during treatment (e.g. ECG or echocardiography) for evidence of cardiovascular effects that may require further cardiovascular examination and investigation.
Croatian: Sve bolesnike treba redovito pratiti za vrijeme liječenja (npr. EKG ili ehokardiografija) zbog dokaza o kardiovaskularnim učincima koji mogu zahtijevati daljnje kardiovaskularne preglede i pretrage.
English: Name and address of the manufacturers responsible for batch release SYNTHON HISPANIA, S.L.
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet SYNTHON HISPANIA, S.L.
English: • Omeprazole, used to reduce the amount of acid produced in the stomach;
Croatian: • omeprazol, primjenjuje se za smanjenje količine kiseline koju proizvodi želudac;
English: Adverse reactions arising from clinical studies, post-authorisation safety studies and spontaneous reports are presented in the table below.
Croatian: Nuspojave koje su se pojavile u kliničkim ispitivanjima, sigurnosnim ispitivanjima poslije odobrenja i u spontanim prijavama, navedene su u tablici ispod.
English: Embryofoetal development studies
Croatian: Ispitivanja embriofetalnog razvoja
English: The safety and efficacy of anagrelide in children has not been established.
Croatian: Sigurnost i djelotvornost anagrelida u djece nisu ustanovljene.
English: Maternally toxic doses of anagrelide in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Croatian: Maternalno toksične doze anagrelida bile su u štakora i kunića povezane s povećanom resorpcijom embrija i fetalnom smrtnošću.
English: During clinical development approximately 50% of the patients treated with anagrelide were over 60 years of age and no age specific alterations in dose were required in these patients.
Croatian: Tijekom kliničkog razvoja približno je 50% bolesnika liječenih anagrelidom bilo starije od 60 godina i za te bolesnike nije bilo potrebno mijenjati dozu zbog njihove dobi.
English: Dose should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Croatian: Dozu treba smanjiti ili obustaviti, kako je odgovarajuće, sve dok se broj trombocita ne vrati u raspon normalnih vrijednosti.
English: Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Croatian: Ispitivanja genotoksičnog potencijala anagrelida nisu pokazala mutagene ili klastogene učinke.
English: Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Croatian: Proporcionalnost dozi ustanovljena je u rasponu doze od 0,5 mg do 2 mg.
English: This means that due to the rarity of this disease it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da zbog male učestalosti ove bolesti nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: If the starting dose is > 1 mg/day platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until a stable maintenance dose is reached.
Croatian: Ako je početna doza > 1 mg/dan, broj trombocita treba kontrolirati svaka dva dana u prvom tjednu liječenja te poslije toga barem jedanput tjedno, sve dok se ne dosegne stabilna doza održavanja.
English: Repeated dose toxicity
Croatian: Toksičnost ponovljene doze
English: After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 109/l and ideally at levels between 150 x 109/l and 400 x 109/l.
Croatian: Nakon jednog tjedna doza se može titrirati u svakog bolesnika pojedinačno, kako bi se postigla najniža učinkovita doza koja je potrebna da se broj trombocita smanji i/ili održi ispod 600 × 109/l, a idealno na razinama između 150 x 109/l i 400 x 109/l.
English: Patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Croatian: Bolesnici s umjerenim ili teškim oštećenjem funkcije bubrega (klirens kreatinina < 50 ml/min).
English: Rare: Kidney failure (when you pass little or no urine), heart attack.
Croatian: Rijetke: zatajenje bubrega (kada mokrite malo ili uopće ne mokrite), srčani udar.
English: What Anagrelide Mylan is and what it is used for
Croatian: Što je Anagrelid Mylan i za što se koristi
English: How to take Anagrelide Mylan Always take Anagrelide Mylan exactly as your doctor has told you.
Croatian: Uvijek uzmite Anagrelid Mylan točno onako kako Vam je rekao liječnik.
English: The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four openlabel, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4,000 patients with myeloproliferative neoplasms (MPNs).
Croatian: Sigurnost i djelotvornost anagrelida kao sredstva za smanjenje broja trombocita procijenjene su u četiri otvorena nekontrolirana klinička ispitivanja (ispitivanja broj 700-012, 700-014, 700-999 i 13970-301) koja su uključila više od 4000 bolesnika s mijeloproliferativnim neoplazmama.
English: • Other medicines used to treat conditions affecting the platelets in your blood, e.g. clopidogrel;
Croatian: • druge lijekove za liječenje stanja koja utječu na krvne pločice u Vašoj krvi, npr. klopidogrel;
English: Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Croatian: Adenokarcinomi uterusa epigenetskog podrijetla mogu se povezati s indukcijom enzima iz CYP1 obitelji.
English: The experience in children and adolescents is very limited; anagrelide should be used in this patient group with caution.
Croatian: U djece i adolescenata iskustva su vrlo ograničena; u toj skupini bolesnika anagrelid treba primjenjivati s oprezom.
English: CARTON AND BOTTLE LABEL
Croatian: KUTIJA I NALJEPNICA BOČICE
English: An at risk essential thrombocythaemia patient is defined by one or more of the following features:
Croatian: Rizičnog bolesnika s esencijalnom trombocitemijom određuje jedno ili više od sljedećih obilježja:
English: In earlier, open-label studies, median platelet count reductions were observed in 7 children and 9 adolescents treated for between 3 months and 6.5 years.
Croatian: U prethodnim, otvorenim ispitivanjima, smanjenja medijana broja trombocita opažena su u 7 djece i 9 adolescenata liječenih između 3 mjeseca i 6,5 godina.
English: A single 5 mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Croatian: Jedna doza od 5 mg anagrelida može dovesti do pada krvnog tlaka obično popraćenog omaglicom.
English: If anagrelide is used during pregnancy, or if the patient becomes pregnant while using the medicinal product, she should be advised of the potential risk to the foetus.
Croatian: Ako se anagrelid primjenjuje u trudnoći ili ako bolesnica zatrudni tijekom primjene ovog lijeka, treba je upozoriti na mogući rizik za fetus.
English: It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level.
Croatian: Smanjuje broj krvnih pločica koje stvara koštana srž, a posljedica je smanjenje broja krvnih pločica u krvi prema normalnijoj razini.
English: • Food delays the absorption of anagrelide, but does not significantly alter systemic exposure.
Croatian: • Hrana odgađa apsorpciju anagrelida, ali ne mijenja značajno sistemsku izloženost.
English: • Fluvoxamine, used to treat depression;
Croatian: • fluvoksamin, primjenjuje se za liječenje depresije;
English: Reported symptoms include sinus tachycardia and vomiting.
Croatian: Prijavljeni simptomi uključuju sinusnu tahikardiju i povraćanje.
English: POL. Las Salinas Sant Boi de Llobregat 08830 Barcelona Spain
Croatian: Las Salinas Sant Boi de Llobregat 08830 Barcelona
English: Anagrelide treatment should only be initiated when the patient shows signs of disease progression or suffers from thrombosis.
Croatian: Liječenje anagrelidom smije se započeti samo kada bolesnik pokazuje znakove napredovanja bolesti ili boluje od tromboze.
English: The reference medicinal product containing anagrelide has been authorised under “exceptional circumstances”.
Croatian: Referentni lijek koji sadrži anagrelid odobren je u „iznimnim okolnostima“.
English: • A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1 mg once daily and acetylsalicylic acid 75 mg once daily may enhance the anti-platelet aggregation effects of each active substance compared with administration of acetylsalicylic acid alone.
Croatian: • Kliničko ispitivanje interakcija provedeno u zdravih ispitanika pokazalo je da istovremena ponovna primjena doze anagrelida 1 mg jedanput na dan i acetilsalicilne kiseline 75 mg jedanput na dan može povećati antiagregacijske učinke svake djelatne tvari u usporedbi s primjenom samo acetilsalicilne kiseline.
English: In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
Croatian: U dvogodišnjem ispitivanju kancerogenosti u štakora, opaženi su i neoplastični nalazi i oni koji nisu bili neoplastični, a povezuju se ili pripisuju pretjeranom farmakološkom učinku.
English: Therefore, clinical and biological monitoring is recommended in patients taking concomitant CYP1A2 inducers.
Croatian: Stoga se preporučuje kliničko i biološko praćenje bolesnika koji istodobno uzimaju induktore CYP1A2.
English: C/ Castello, nº1, Pol. Las Salinas
Croatian: C/ Castello, nº1, Pol.
English: If you notice any of these side effects, contact your doctor immediately.
Croatian: Ako primijetite bilo koju od tih nuspojava, odmah se obratite liječniku.
English: • Anagrelide is primarily metabolised by CYP1A2.
Croatian: • Anagrelid se prvenstveno metabolizira putem CYP1A2.
English: An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath;
Croatian: Alergijska reakcija može se prepoznati kao osip, svrbež, otečenost lica ili usana ili nedostatak zraka;
English: What Anagrelide Mylan is and what it is used for What you need to know before you take Anagrelide Mylan How to take Anagrelide Mylan Possible side effects
Croatian: Što je Anagrelid Mylan i za što se koristi Što morate znati prije nego počnete uzimati Anagrelid Mylan Kako uzimati Anagrelid Mylan Moguće nuspojave
English: However, hepatic metabolism represents the major route of anagrelide clearance and liver function may therefore be expected to influence this process.
Croatian: Međutim, budući da jetreni metabolizam predstavlja glavni put klirensa anagrelida, može se očekivati da jetrena funkcija utječe na taj proces.
English: • If you have any problems with your liver or kidneys.
Croatian: • ako imate bilo kakvih tegoba s jetrom ili bubrezima.
English: The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Croatian: Prosječna količina otkrivenog 2-amino-5,6-dikloro-3,4-dihidrokinazolina u mokraći čini približno 18-35% primijenjene doze.
English: It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and enoxacin, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Croatian: Poznato je da CYP1A2 inhibira nekoliko lijekova, uključujući fluvoksamin i enoksacin, i takvi bi lijekovi u teoriji mogli štetno utjecati na klirens anagrelida.
English: The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose).
Croatian: Preporučena početna doza anagrelida je 1 mg/dan, a treba je primjenjivati peroralno podijeljeno u dvije odvojene doze (0,5 mg/dozi).
English: Moreover, serious cardiovascular adverse events have also occurred in patients without suspected heart disease and with normal pre-treatment cardiovascular examination.
Croatian: Štoviše, ozbiljne kardiovaskularne nuspojave nastale su i u bolesnika bez sumnje na srčanu bolest te s normalnim nalazom na kardiovaskularnom pregledu prije liječenja.
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic and chronotropic effects, anagrelide should be used with caution in patients of any age with known or suspected heart disease.
Croatian: Anagrelid je inhibitor cikličke AMP fosfodiesteraze III pa ga zbog njegovih pozitivnih inotropnih i kronotropnih učinaka treba primjenjivati s oprezom u bolesnika bilo koje dobi s potvrdom ili sumnjom na srčanu bolest.
English: • CYP1A2 inducers (such as omeprazole) could decrease the exposure of anagrelide increasing its main active metabolite.
Croatian: • Induktori CYP1A2 (kao što je omeprazol) mogu smanjiti izloženost anagrelidu i povećati njegov glavni djelatni metabolit.
English: Children should be monitored regularly for disease progression according to standard clinical practices, such as physical examination, assessment of relevant disease markers and bone marrow biopsy.
Croatian: Djecu treba redovito nadzirati zbog napredovanja bolesti prema standardima kliničke prakse, kao što su liječnički pregled, procjena relevantnih biljega bolesti i biopsija koštane srži.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to anagrelide administration and should be monitored periodically during therapy.
Croatian: Hipokalemija ili hipomagnezemija moraju biti korigirane prije primjene anagrelida i mora ih se povremeno nadzirati tijekom terapije.
English: Available data in animals have shown excretion of anagrelide/metabolites in milk.
Croatian: Dostupni podaci u životinja pokazuju da se anagrelid/metaboliti izlučuju u mlijeko.
English: Close monitoring for an effect on the QTc interval is advisable.
Croatian: Savjetuje se pažljivo pratiti učinak na QTc interval.