FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Odmerka se ne sme povečevati za več kot 0,5 mg dnevno v katerem koli tednu, priporočen največji enkratni odmerek pa ne sme preseči 2,5 mg (glejte poglavje 4.9).
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.
Slovenian: Otroke je treba redno spremljati glede napredovanja bolezni v skladu s standardnimi kliničnimi praksami, kot so telesni pregled, ocenjevanje relevantnih označevalcev bolezni in biopsija kostnega mozga.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORE OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Slovenian: Sorazmernost odmerka so ugotovili v razponu odmerkov od 0,5 mg do 2 mg.
English: Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Slovenian: Farmakokinetični podatki, pridobljeni od zdravih oseb, dokazujejo, da hrana zmanjša Cmax anagrelida za 14 %, vendar pa zveča AUC za 20 %.
English: Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.
Slovenian: Veliko število krvnih ploščic v krvi lahko povzroči hude težave pri kroženju krvi in koagulaciji.
English: 48 patients aged 6-17 years (19 children and 29 adolescents) have received anagrelide for up to 6.5 years either in clinical studies or as part of a disease registry (see section 5.1).
Slovenian: 48 bolnikov, starih 6-17 let (19 otrok in 29 mladostnikov), je prejemalo anagrelid do 6,5 let dolgo bodisi v kliničnih študijah bodisi v okviru registra bolezni (glejte poglavje 5.1).
English: However, as expected, patients in this age group had twice the incidence of serious adverse events (mainly cardiac).
Slovenian: Kot je bilo pričakovano, so se v tej starostni skupini resni neželeni učinki pojavljali dvakrat pogosteje (v glavnem povezani s srcem).
English: POL. Las Salinas Sant Boi de Llobregat 08830 Barcelona Spain
Slovenian: Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Španija
English: Anagrelide should only be used if the potential benefits of therapy outweigh the potential risks.
Slovenian: Anagrelid naj se uporablja samo, kadar so potencialne koristi zdravljenja večje od potencialnega tveganja.
English: In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
Slovenian: V dvoletni raziskavi karcinogenosti pri podganah, so opazovali ne-neoplastične in neoplastične spremembe ter jih povezali ali pripisali prekomernemu farmakološkemu učinku.
English: • Certain types of antibiotic, such as enoxacin, used to treat infections;
Slovenian: • nekatere vrste antibiotikov, na primer enoksacin, za zdravljenje okužb;
English: 4.7 Effects on ability to drive and use machines In clinical development, dizziness was commonly reported.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Pri kliničnem razvoju so pogosto poročali o omotici.
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.
Slovenian: Pri vseh bolnikih je treba med zdravljenjem redno spremljati (npr. z EKG ali ehokardiografijo) znake kardiovaskularnih učinkov, zaradi katerih bi utegnila biti potrebna nadaljnja kardiovaskularna preiskava in pregled.
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.
Slovenian: Razpolovni čas anagrelida v plazmi je kratek, približno 1,3 ure, in v skladu s pričakovanji zaradi njegovega razpolovnega časa ni znakov, da bi se anagrelid kopičil v plazmi.
English: There are no adequate data from the use of anagrelide in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi anagrelida pri nosečnicah.
English: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, France
Slovenian: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, Francija
English: It is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal) (see sections 4.2 and 4.3).
Slovenian: Zdravljenje ni priporočljivo pri bolnikih s povišanimi ravnmi transaminaz (> 5-krat večje od zgornje meje normale) (glejte poglavji 4.2 in 4.3).
English: Effects on heart rate and QTc interval
Slovenian: Učinki na srčni utrip in interval QTc
English: There is limited information on the use of anagrelide in children and adolescents and therefore this medicine should be used with caution.
Slovenian: O uporabi anagrelida pri otrocih in mladostnikih je podatkov malo, zato je treba to zdravilo uporabljati previdno.
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.
Slovenian: Ob odsotnosti posebnih pediatričnih smernic velja, da so za pediatrično populacijo pomembna diagnostična merila SZO za diagnozo ET pri odraslih.
English: The experience in children and adolescents is very limited; anagrelide should be used in this patient group with caution.
Slovenian: Izkušenj pri otrocih in mladostnikih je zelo malo; v tej skupini bolnikov naj se anagrelid uporablja previdno.
English: The reference medicinal product containing anagrelide has been authorised under “exceptional circumstances”.
Slovenian: Referenčno zdravilo, ki vsebuje anagrelid, je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: In all paediatric patients, careful titration to a patientspecific daily dose is needed.
Slovenian: Pri vseh pediatričnih bolnikih je potrebna skrbna titracija dnevnega odmerka, specifičenga za posameznega bolnika.
English: There was also a trend to higher dose-normalised exposure to the active metabolite.
Slovenian: Obstajal je tudi trend k večji izpostavljenosti aktivnemu presnovku, normalizirani na odmerek.
English: Less than 1% is recovered in the urine as anagrelide.
Slovenian: Manj kot 1 % se ga izloči v urin v obliki anagrelida.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX35.
Slovenian: Farmakoterapevtska skupina: Druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX35.
English: Moreover, serious cardiovascular adverse events have also occurred in patients without suspected heart disease and with normal pre-treatment cardiovascular examination.
Slovenian: Poleg tega so se resni kardiovaskularni neželeni učinki pojavili tudi pri bolnikih brez domnevne bolezni srca in z normalnim izvidom kardiovaskularnega pregleda pred začetkom zdravljenja.
English: • Food delays the absorption of anagrelide, but does not significantly alter systemic exposure.
Slovenian: • Hrana upočasni absorpcijo anagrelida, a ne spremeni bistveno sistemske izpostavljenosti.
English: • Potentially life-threatening, irregular heart beat (torsade de pointes);
Slovenian: • potencialno smrtno nevaren nereden srčni ritem (torsade de pointes);
English: • Anagrelide is primarily metabolised by CYP1A2.
Slovenian: • Anagrelid se v glavnem metabolizira s CYP1A2.
English: These differences were likely to be caused by lower presystemic metabolism of anagrelide to 3-hydroxy anagrelide in the elderly patients.
Slovenian: Te razlike so najverjetneje posledica manjše predsistemske presnove anagrelida v 3-hidroksi anagrelid pri starejših bolnikih.
English: Additionally these results show no evidence of auto-induction of the anagrelide clearance.
Slovenian: Dodatno ti rezultati ne kažejo znakov avtoindukcije očistka anagrelida.
English: C/ Castello, nº1, Pol. Las Salinas
Slovenian: C/ Castello, nº1, Pol.
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.
Slovenian: Po enem tednu se odmerek lahko titrira pri vsakem bolniku posamezno, da se doseže najnižji učinkovit odmerek za zmanjšanje in/ali ohranitev števila trombocitov pod 600 × 109/l in v idealnih razmerah v vrednostih med 150 × 109/l in 400 x 109/l.
English: If you are worried, speak to your doctor.
Slovenian: Če vas skrbi, se posvetujte s svojim zdravnikom.
English: Available data in animals have shown excretion of anagrelide/metabolites in milk.
Slovenian: Razpoložljivi podatki pri živalih kažejo na izločanje anagrelida/presnovkov v mleko.
English: Adverse reactions arising from clinical studies, post-authorisation safety studies and spontaneous reports are presented in the table below.
Slovenian: Neželeni učinki zdravila, opisani v kliničnih študijah, študijah varnosti v obdobju trženja zdravila in spontanih poročilih, so predstavljeni v spodnji preglednici.
English: Name and address of the manufacturers responsible for batch release SYNTHON HISPANIA, S.L.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij SYNTHON HISPANIA, S.L.
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).
Slovenian: Varnost in učinkovitost anagrelida kot učinkovine za zniževanja trombocitov so ovrednotili v štirih odprtih, nenadzorovanih preskušanjih (številke študij 700-012, 700-014, 700-999 in 13970-301), ki so vključevale več kot 4.000 bolnikov z mieloproliferativnimi neoplazmami (MPN).
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.
Slovenian: Med kliničnim razvojem je bilo približno 50 % bolnikov, zdravljenih z anagrelidom, starejših od 60 let in za te bolnike ni bilo treba posebej spreminjati odmerka zaradi njihove starosti.
English: Limited pharmacokinetic and/or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Slovenian: Opravili so malo število farmakokinetičnih in/ali farmakodinamičnih študij, v katerih so preiskovali možna medsebojna delovanja anagrelida in drugih zdravil.
English: • Theophylline, used to treat severe asthma and breathing problems;
Slovenian: • teofilin, ki se uporablja za zdravljenje hude astme in težav z dihanjem;
English: The safety and efficacy of anagrelide in children has not been established.
Slovenian: Varnost in učinkovitost anagrelida pri otrocih nista bili dokazani.
English: For this reason it is used to treat patients with essential thrombocythaemia.
Slovenian: Zato se uporablja za zdravljenje bolnikov z esencialno trombocitemijo.
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).
Slovenian: Običajno opazimo padec števila trombocitov v 14 do 21 dneh od začetka zdravljenja, pri večini bolnikov pa bo ustrezen terapevtski odziv opazen in ga bo mogoče vzdrževati pri odmerku od 1 do 3 mg/dan (za dodatne informacije o kliničnih učinkih glejte poglavje 5.1).
English: Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Slovenian: Pri raziskavah genotoksičnega potenciala anagrelida niso odkrili mutagenih ali klastogenih učinkov.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Slovenian: • Anagrelid utegne pri nekaterih bolnikih povzročiti črevesne motnje in poslabšati absorpcijo hormonskih peroralnih kontracepcijskih sredstev.
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.
Slovenian: Če ste vzeli večji odmerek zdravila Anagrelid Mylan, kot bi smeli Če ste vzeli večji odmerek zdravila Anagrelid Mylan, kot bi smeli, ali če je zdravilo vzel kdo drug, o tem takoj obvestite zdravnika ali farmacevta.
English: Patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Slovenian: Bolniki z zmerno ali močno oslabljenim delovanjem ledvic (očistek kreatinina < 50 ml v minuti).
English: An at risk essential thrombocythaemia patient is defined by one or more of the following features:
Slovenian: Bolnika, ki je izpostavljen tveganju za pojav esencialne trombocitemije, določa ena ali več naslednjih lastnosti:
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.
Slovenian: Znano je, da CYP1A2 zavirajo številna zdravila, med drugim tudi fluvoksamin in enoksacin, in ta zdravila utegnejo teoretično neugodno vplivati na očistek anagrelida.
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.
Slovenian: Ugotovljene farmakokinetične razlike med starejšimi in mlajšimi bolniki z ET (glejte poglavje 5.2) ne upravičujejo uporabe drugačnega začetnega režima ali drugačne stopnje titriranja odmerka, da bi dosegli za posameznega bolnika optimiziran režim anagrelida.
English: A single 5 mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Slovenian: Enkraten 5 mg odmerek anagrelida utegne povzročiti padec krvnega tlaka, ki ga ponavadi spremlja omotica.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco na nekatere sladkorje, se posvetujte z zdravnikom, preden vzamete to zdravilo.
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.
Slovenian: V prvih 12 urah so opazili od odmerka odvisno pospešitev srčnega utripa, največja pospešitev se je pojavila približno ob času najvišje koncentracije.
English: Manufacturer Synthon Hispania SL C/ Castelló no1
Slovenian: Izdelovalec Synthon Hispania SL, C/ Castelló no1, POL.
English: Anagrelide or these medicines may not work properly if taken together.
Slovenian: Anagrelid ali zgoraj našteta zdravila morda ne bodo imela pravega učinka, če jih boste jemali skupaj.
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).
Slovenian: Povprečni celotni dnevni odmerek anagrelida v vseh študijah pri pediatričnih bolnikih z ET se je močno spreminjal, v celoti gledano pa podatki kažejo, da bi lahko mladostniki prejemali podobne začetne in vzdrževalne odmerke kot odrasli in da bi bil manjši začetni odmerek, 0,5 mg/dan, za otroke, starejše od 6 let, primernejši (glejte poglavja 4.2, 4.4, 4.8, 5.2).
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.
Slovenian: Zmanjšuje število krvnih ploščic, ki jih proizvaja kostni mozeg, posledica tega pa je zmanjšanje števila krvnih ploščic v krvi in približanje normalnim vrednostim.
English: • Fluvoxamine, used to treat depression;
Slovenian: • fluvoksamin, ki se uporablja za zdravljenje depresij;
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).
Slovenian: O uporabi anagrelida pri pediatrični populaciji je na voljo zelo malo podatkov, zato ga je pri tej skupini bolnikov treba uporabljati previdno (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
English: The capsule is filled with white to off-white powder.
Slovenian: Kapsula je napolnjena s praškom bele do skoraj bele barve.
English: This medicinal product does not require any special temperature storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
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.
Slovenian: V študijah na celičnih kulturah je anagrelid zaviral ekspresijo transkripcijskih faktorjev, vključno z GATA-1 in FOG-1, ki sta potrebna za megakariocitopoezo, kar je na koncu privedlo do zmanjšanega nastajanja trombocitov.
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.
Slovenian: Anagrelid je zaviralec ciklične AMP fosfodiesteraze III in ga moramo zaradi pozitivnih inotropnih in kronotropnih učinkov previdno uporabljati pri bolnikih katerekoli starosti z znano ali domnevno boleznijo srca.
English: 117 Allée des Parcs Saint-Priest
Slovenian: 117 Allée des Parcs,
English: It is unknown whether anagrelide/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se anagrelid/presnovki izločajo v materino mleko.
English: The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4).
Slovenian: Učinke zdravljenja z anagrelidom je treba redno spremljati (glejte poglavje 4.4).
English: There are limited pharmacokinetic data for this patient population.
Slovenian: Za to skupino bolnikov je na voljo malo farmakokinetičnih podatkov.
English: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking anagrelide.
Slovenian: Ženske, pri katerih obstaja tveganje, da zanosijo, morajo poskrbeti za uporabo učinkovite kontracepcije, ko jemljejo anagrelid.
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
Slovenian: Kaj je zdravilo Anagrelid Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Anagrelid Mylan Kako jemati zdravilo Anagrelid Mylan Možni neželeni učinki
English: The majority of adverse events observed were among those listed in the SmPC.
Slovenian: Večina opaženih neželenih učinkov je bila med tistimi, ki so navedeni v povzetku glavnih značilnosti.
English: Dose should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Slovenian: Odmerek je treba zmanjšati ali prekiniti dajanje, kot je primernejše, dokler se število trombocitov ne povrne v normalno območje.
English: Maternally toxic doses of anagrelide in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Slovenian: Toksični odmerki anagrelida pri brejih podganah in kuncih so povezani s povečano resorpcijo pri zarodku in zvišano umrljivostjo ploda.
English: Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Slovenian: Po peroralni uporabi anagrelida pri človeku se iz prebavnega trakta absorbira vsaj 70 %.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to anagrelide administration and should be monitored periodically during therapy.
Slovenian: Hipokaliemijo ali hipomagnezemijo je treba popraviti pred začetkom dajanja anagrelida, med zdravljenjem pa jo je treba spremljati v rednih presledkih.
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.
Slovenian: Učinek dveh različnih odmerkov anagrelida (enkratni odmerki 0,5 mg in 2,5 mg) na srčni utrip in interval QTc so ocenjevali v dvojno slepi, randomizirani, s placebom in aktivno nadzorovani primerjalni študiji pri zdravih odraslih moških in ženskah.
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.
Slovenian: Skrbno je treba upoštevati diagnostične smernice za esencialno trombocitemijo in v negotovih primerih redno ponovno ocenjevati diagnozo, pri čemer se je treba truditi za njeno razlikovanje od dedne ali sekundarne trombocitoze, kar je mogoče storiti med drugim z genetsko analizo in biopsijo kostnega mozga.
English: The capsules must be swallowed whole.
Slovenian: Bolnik mora kapsule pogoltniti cele.
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.
Slovenian: Podobno kot pri odrasli populaciji je treba narediti celoten hemogram in oceniti delovanje srca, jeter in ledvic pred zdravljenjem in v rednih presledkih med njim.
English: Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Slovenian: Adenokarcinom maternice epigenetskega izvora bi lahko bil povezan z indukcijo encima iz družine CYP1.
English: • CYP1A2 inducers (such as omeprazole) could decrease the exposure of anagrelide increasing its main active metabolite.
Slovenian: • Spodbujevalci CYP1A2 (npr. omeprazol) bi lahko zmanjšali izpostavljenost anagrelidu, tako da bi zvečali njegov glavni aktivni presnovek.
English: The capsule size is approximately 14.3 x 5.3 mm.
Slovenian: Velikost kapsule je približno 14,3 × 5,3 mm.
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.
Slovenian: Pri bolnikih z esencialno trombocitemijo je bil popoln odziv opredeljen kot zmanjšanje števila trombocitov na ≤ 600 × 109/l ali ≥ 50 % zmanjšanje od prvotne vrednosti in vzdrževanje zmanjšanega števila vsaj štiri tedne.
English: • Inflammation of the kidneys (tubulointerstitial nephritis).
Slovenian: • vnetje ledvic (tubulointersticijski nefritis).
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.
Slovenian: In vitro študije človeške megakariocitopoeze so pokazale, da se zaviralno delovanje anagrelida na tvorbo trombocitov pri ljudeh odvija prek upočasnitve razvoja megakariocitov ter zmanjšanja njihove velikosti in ploidnosti.
English: A specific antidote for anagrelide has not been identified.
Slovenian: Posebnega antidota za anagrelid ne poznamo.