FrancophonIA/ELRC3.0 huggingface dataset:
English: A capsule size 4 (approximately 14.3 x 5.3 mm) with an opaque white body and cap.
Croatian: Kapsula veličine 4 (približno 14,3 x 5,3 mm) s neprozirnim bijelim tijelom i kapicom.
English: Effects of other active substances on anagrelide
Croatian: Učinci drugih djelatnih tvari na anagrelid
English: Therefore, it is recommended that patients with moderate or severe hepatic impairment are not treated with anagrelide.
Croatian: Stoga se preporučuje da se bolesnike s umjerenim ili teškim oštećenjem funkcije jetre ne liječi anagrelidom.
English: In female rats, using doses in excess of the therapeutic range, anagrelide disrupted implantation (see section 5.3).
Croatian: U ženki štakora, primjenom doza izvan terapijskog raspona, anagrelid je prekinuo implantaciju (vidjeti dio 5.3).
English: • In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin.
Croatian: • In vivo ispitivanja interakcija u ljudi dokazala su da anagrelid ne utječe na farmakokinetička svojstva digoksina i varfarina.
English: In this study 34 patients received anagrelide for up to 5 years.
Croatian: U ovom ispitivanju 34 bolesnika primalo je anagrelid do 5 godina.
English: Pharmacokinetic data from fasting elderly patients with ET (age range 65 - 75 years) compared to fasting adult patients (age range 22 - 50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 3hydroxy anagrelide, were 42% and 37% lower respectively in the elderly patients.
Croatian: Farmakokinetički podaci za anagrelid uziman natašte u starijih bolesnika s esencijalnom trombocitemijom (dobni raspon od 65 do 75 godina) u usporedbi s odraslim bolesnicima natašte (dobni raspon od 22 do 50 godina) pokazuju da su za anagrelid vrijednosti Cmax bile za 36% više i AUC za 61% viši u starijih bolesnika, ali su za djelatni metabolit, 3-hidroksianagrelid, vrijednosti Cmax bile za 42% niže i AUC za 37% niži u starijih bolesnika.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORE OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking anagrelide.
Croatian: Žene u kojih postoji mogućnost da zatrudne moraju provjeriti primjenjuju li djelotvornu kontracepciju dok uzimaju anagrelid.
English: No human data on the effect of anagrelide on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju anagrelida na plodnost u ljudi.
English: A pre-treatment cardiovascular examination, including a baseline ECG and echocardiography is recommended for all patients prior to initiating therapy with anagrelide.
Croatian: Za sve bolesnike preporučuje se kardiovaskularni pregled, uključujući početni EKG i ehokardiografiju, prije započinjanja terapije anagrelidom.
English: Pack size: 100 hard capsules.
Croatian: Veličine pakiranja: 100 tvrdih kapsula.
English: The maximum change in mean heart rate occurred at 2 hours after administration and was +7.8 beats per minute (bpm) for 0.5 mg and +29.1 bpm for 2.5 mg.
Croatian: Najveća promjena srednje vrijednosti brzine otkucaja srca nastala je 2 sata nakon primjene i iznosila je +7,8 otkucaja u minuti kod doze od 0,5 mg, a +29,1 otkucaj u minuti kod doze od 2,5 mg.
English: They were observed in females receiving 30 mg/kg/day, corresponding to 572 times the human AUC exposure after a 1 mg twice daily dose.
Croatian: Opaženi su u ženki koje su primale 30 mg/kg na dan, što odgovara izloženosti 572 puta većoj od vrijednosti AUC-a u ljudi nakon doze od 1 mg dvaput na dan.
English: The lowest dose in males (3 mg/kg/day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Croatian: Najniža doza u mužjaka (3 mg/kg na dan) odgovara izloženosti 37 puta većoj od AUC-a u ljudi nakon doze od 1 mg dvaput na dan.
English: Blood creatinine increased
Croatian: Pretrage povišeni kreatinin u krvi
English: The precise mechanism by which anagrelide reduces blood platelet count is unknown.
Croatian: Točan mehanizam kojim anagrelid smanjuje broj trombocita u krvi nije poznat.
English: Other medicines and Anagrelide Mylan
Croatian: Drugi lijekovi i Anagrelid Mylan
English: In a pre- and post-natal development study in female rats, anagrelide at oral doses of ≥ 10 mg/kg produced a non-adverse increase in gestational duration.
Croatian: U ispitivanjima prenatalnog i postnatalnog razvoja u ženki štakora, anagrelid u peroralnim dozama od ≥ 10 mg/kg prouzročio je produljenje trajanja gestacije koje nije bilo štetno.
English: For this reason it is used to treat patients with essential thrombocythaemia.
Croatian: Zbog toga se primjenjuje za liječenje bolesnika s esencijalnom trobocitemijom.
English: Post-marketing case reports of intentional overdose with anagrelide have been received.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi namjernog predoziranja anagrelidom.
English: • If you have moderate or severe liver problems;
Croatian: • ako imate umjerene ili teške tegobe s jetrom;
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).
Croatian: U kliničkim ispitivanjima ili u okviru registra oboljelih, anagrelid je primalo 48 bolesnika u dobi od 6 do 17 godina (19 djece i 29 adolescenata) u trajanju do 6,5 godina (vidjeti dio 5.1).
English: The other ingredients are lactose (see section 2 ‘Anagrelide Mylan contains lactose'), croscarmellose sodium, povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E171) and iron oxide black (E172).
Croatian: Drugi sastojci su laktoza (pogledajte dio 2 „Anagrelid Mylan sadrži laktozu”), umrežena karmelozanatrij, povidon, mikrokristalična celuloza, magnezijev stearat, želatina, titanijev dioksid (E171) i crni željezov oksid (E172).
English: The other ingredients are lactose (see section 2 ‘Anagrelide Mylan contains lactose'), croscarmellose sodium, povidone, microcrystalline cellulose, magnesium stearate, gelatin and titanium dioxide(E171).
Croatian: Drugi sastojci su laktoza (pogledajte dio 2 „Anagrelid Mylan sadrži laktozu”), umrežena karmelozanatrij, povidon, mikrokristalična celuloza, magnezijev stearat, želatina i titanijev dioksid (E171).
English: If your doctor stops your medicine, do not keep any leftover capsules unless your doctor tells you to. Do not throw away any medicines via wastewater or household waste.
Croatian: Ako Vam liječnik obustavi liječenje ovim lijekom, ne čuvajte preostale kapsule osim ako Vam liječnik tako kaže.
English: LIST OF EXCIPIENTS Contains lactose and sodium.
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu i natrij.
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III (PDE III).
Croatian: Anagrelid je inhibitor cikličke AMP fosfodiesteraze III (PDE III).
English: • Inflammation of the liver, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, discoloration of stool and urine (hepatitis);
Croatian: • upala jetre, simptomi uključuju mučninu, povraćanje, svrbež, žutu boju kože i očiju, promjenu boje stolice i mokraće (hepatitis);
English: INFORMATION IN BRAILLE Carton only: anagrelide mylan 1 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Samo na kutiji: anagrelid mylan 1 mg
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
Croatian: Anagrelid je inhibitor cikličke AMP fosfodiesteraze III.
English: In some ET patients concomitantly treated by acetylsalicylic acid and anagrelide, major haemorrhages occurred.
Croatian: U nekih bolesnika s esencijalnom trombocitemijom istovremeno liječenih acetilsalicilnom kiselinom i anagrelidom nastupila su velika krvarenja.
English: Patients with moderate or severe hepatic impairment.
Croatian: Bolesnici s umjerenim ili teškim oštećenjem funkcije jetre.
English: What Anagrelide Mylan looks like and contents of the pack Anagrelide Mylan 1 mg hard capsules have a grey body and cap.
Croatian: Kako Anagrelid Mylan izgleda i sadržaj pakiranja Anagrelid Mylan 1 mg tvrde kapsule imaju sivo tijelo i kapicu.
English: The usual starting dose of this medicine is 1 mg. You take this dose as one capsule of 0.5 mg twice a day, for at least a week.
Croatian: Uzimajte tu dozu kao jednu kapsulu od 0,5 mg dvaput na dan najmanje tjedan dana.
English: INFORMATION IN BRAILLE Carton only: anagrelide mylan 0.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Samo na kutiji: anagrelid mylan 0,5 mg
English: In a paediatric registry study, median platelet counts were reduced from diagnosis and maintained for up to 18 months in 14 paediatric ET patients (4 children, 10 adolescents) with anagrelide treatment.
Croatian: U ispitivanju na temelju registra pedijatrijskih bolesnika, uz liječenje anagrelidom medijan broja trombocita smanjio se od postavljanja dijagnoze i održao se do 18 mjeseci u 14 pedijatrijskih bolesnika s esencijalnom trombocitemijom (4 djeteta, 10 adolescenata).
English: MedDRA System Organ Class
Croatian: MedDRAklasifikacija organskih sustava
English: 117 Allée des Parcs, Saint-Priest,
Croatian: 117 Allée des Parcs,
English: Concomitant use of anagrelide with other PDE III inhibitors such as milrinone, amrinone, enoximone, olprinone and cilostazol is not recommended.
Croatian: Ne preporučuje se istovremena primjena anagrelida s drugim inhibitorima PDE III kao što su milrinon, amrinon, enoksimon, olprinon i cilostazol.
English: Patients are advised not to drive or operate machinery while taking anagrelide if dizziness is experienced.
Croatian: U slučaju da osjete omaglicu, bolesnicima se savjetuje da ne voze ili ne upravljaju strojevima dok uzimaju anagrelid.
English: What Anagrelide Mylan looks like and contents of the pack Anagrelide Mylan 0.5 mg hard capsules have a white body and cap.
Croatian: Kako Anagrelid Mylan izgleda i sadržaj pakiranja Anagrelid Mylan 0,5 mg tvrde kapsule imaju bijelo tijelo i kapicu.
English: Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, such as congenital long QT syndrome, a known history of acquired QTc prolongation,
Croatian: Potreban je oprez kad se anagrelid primjenjuje u bolesnika s poznatim čimbenicima rizika za produljenje QT intervala, kao što je kongenitalni sindrom dugog QT intervala, stečeno produljenje QTc intervala u anamnezi, lijekovi koji mogu produljiti QTc interval i hipokalemija.
English: High-density polyethylene (HDPE) bottle of 30 ml or 75 ml with a tamper evident, child-resistant polypropylene (PP) closure with a desiccant.
Croatian: Bočica od polietilena visoke gustoće (HDPE) od 30 ml ili 75 ml s polipropilenskim sigurnosnim zatvaračem za djecu s evidencijom otvaranja i sredstvom za sušenje.
English: Do not take Anagrelide Mylan
Croatian: Nemojte uzimati Anagrelid Mylan
English: If needed, anagrelide dose adjustment could be made.
Croatian: Moguća je prilagodba doze anagrelida, ako je potrebno.
English: • a history of thrombo-haemorrhagic events.
Croatian: • trombohemoragijski događaji u anamnezi.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light and moisture.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.
English: In the later study 3,660 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
Croatian: U kasnijem ispitivanju, sigurnost je procjenjivana u 3660 bolesnika koji su primali anagrelid u prosječnoj dozi od približno 2 mg/dan.
English: Anagrelide Mylan should not be taken while breast-feeding.
Croatian: Anagrelid Mylan se ne smije uzimati za vrijeme dojenja.
English: Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide.
Croatian: Žene reproduktivne dobi moraju primjenjivati odgovarajuće metode sprječavanja trudnoće tijekom liječenja anagrelidom.
English: Therefore, the potential risks of the concomitant use of anagrelide with acetylsalicylic acid should be assessed, particularly in patients with a high risk profile for haemorrhage before treatment is initiated.
Croatian: Stoga treba, prije početka liječenja, procijeniti moguće rizike istovremene primjene anagrelida s acetilsalicilnom kiselinom a osobito u bolesnika s visokim rizikom od krvarenja.
English: Anagrelide Mylan contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Croatian: Anagrelid Mylan sadrži manje od 1 mmol natrija (23 mg) po kapsuli, tj. zanemarive količine natrija.
English: • If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes e.g. potassium, magnesium or calcium (see section
Croatian: (vidljiv na EKG-u, zapisu električne aktivnosti srca) ili uzimate druge lijekove koji dovode do abnormalnih promjena na EKG-u ili imate niske razine elektrolita, npr. kalija, magnezija ili kalcija (pogledajte dio „Drugi lijekovi i Anagrelid Mylan“);
English: • Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone,
Croatian: • lijekove za liječenje srčanih poremećaja, primjerice milrinon, enoksimon, amrinon, olprinon i cilostazol;
English: In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
Croatian: U 3 ispitivanja sigurnost je procjenjivana u 942 bolesnika koji su primali anagrelid u prosječnoj dozi od približno 2 mg/dan.
English: Breast-feeding should be discontinued during treatment with anagrelide.
Croatian: Dojenje treba prekinuti za vrijeme liječenja anagrelidom.
English: What Anagrelide Mylan contains
Croatian: Što Anagrelid Mylan sadrži
English: Platelet targets are assigned on an individual patient basis by the treating physician.
Croatian: Ciljne vrijednosti broja trombocita određuje nadležni liječnik za svakog bolesnika pojedinačno.
English: The potential risks and benefits of anagrelide therapy in a patient with mild impairment of hepatic function should be assessed before treatment is commenced.
Croatian: Moguće rizike i koristi terapije anagrelidom u bolesnika s blagim oštećenjem funkcije jetre treba procijeniti prije početka liječenja.
English: Anagrelide at ≥ 60 mg/kg increased parturition time and mortality in the dam and foetus respectively.
Croatian: Anagrelid u dozi ≥ 60 mg/kg produljio je trajanje okota u ženki i povećao smrtnost fetusa.
English: Anagrelide is a medicine which interferes with the development of platelets.
Croatian: Anagrelid je lijek koji ometa razvoj krvnih pločica (trombocita).
English: How to store Anagrelide Mylan
Croatian: Kako čuvati Anagrelid Mylan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Anagrelide Mylan 0.5 mg hard capsules
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Anagrelid Mylan 0,5 mg tvrde kapsule
English: The no observed effect level (NOEL) for male dogs (0.3 mg/kg/day) corresponds to 0.1, 0.1, and 1.6-fold the AUC in humans for anagrelide at 2 mg/day, and the metabolites BCH24426 and RL603, respectively.
Croatian: Razina izloženosti pri kojoj nisu opaženi učinci (engl. no-observed-effect level, NOEL) za mužjake (0,3 mg/kg na dan) odgovara izloženosti 0,1; 0,1 i 1,6 puta većoj od AUC-a u ljudi za anagrelid u dozi od 2 mg na dan odnosno za metabolite BCH24426 i RL603.
English: You must stop breast-feeding if you are taking Anagrelide Mylan.
Croatian: Ako uzimate Anagrelid Mylan morate prestati dojiti.
English: Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of the legs due to fluid build-up), severe problem with the rate or rhythm of the heart beat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas which causes severe abdominal and back pain (pancreatitis), vomiting blood or passing bloody or black stools, severe reduction in blood cells which can cause weakness, bruising, bleeding or infections (pancytopenia), increased pressure in the lung arteries (signs include shortness of breath, swelling in legs or ankles and lips and skin can turn bluish colour).
Croatian: Manje česte: zatajenje srca (znakovi uključuju nedostatak zraka, bol u prsnom košu, oticanje nogu zbog nakupljanja tekućine), teške tegobe s brzinom ili ritmom otkucaja srca (ventrikularna tahikardija, supraventrikularna tahikardija ili atrijska fibrilacija), upala gušterače koja uzrokuje jake bolove u trbuhu i u leđima (pankreatitis), povraćanje krvi ili krvava ili crna stolica, izrazito smanjenje broja krvnih stanica što može uzrokovati slabost, nastanak modrica, krvarenje ili infekcije (pancitopenija), povišen tlak u plućnim arterijama (znakovi uključuju nedostatak zraka, oticanje nogu ili gležnjeva, a usne i koža mogu poprimiti plavkastu boju).
English: Manufacturer Synthon Hispania SL, C/ Castelló no1, POL. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain.
Croatian: Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Španjolska
English: The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Croatian: Primjena anagrelida može pojačati učinke lijekova sličnih svojstava kao što su inotropni lijekovi milrinon, enoksimon, amrinon, olprinon i cilostazol.
English: At the NOEL dose (30 mg/kg/day), the AUCs for anagrelide and the metabolites BCH24426 and RL603 were 425-, 31- and 13-fold higher than the AUC in humans administered an oral dose of anagrelide 2 mg/day, respectively.
Croatian: Pri NOEL dozi (30 mg/kg na dan), vrijednosti AUC-a za anagrelid i metabolite BCH24426 i RL603 bile su 425, odnosno 31 i 13 puta veće od AUC-a u ljudi nakon primjene peroralne doze anagrelida od 2 mg na dan.
English: Rare side effects: may affect up to 1 in 1,000 people Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease, (signs include fatigue, chest pain and palpitations), enlarged heart, accumulation of fluid around the heart, loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness on standing up (especially when getting up from a sitting or lying position), increased need to pass water at night, pain, ‘flu-like' symptoms, sleepiness, widening of blood vessels, inflammation of the large bowel (signs include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (signs include: pain, nausea, vomiting), area of abnormal density in the lung, increased creatinine level in blood tests, which may be a sign of kidney problems.
Croatian: Rijetke nuspojave: mogu se javiti u do 1 na 1000 osoba Krvarenje iz desni, dobivanje na težini, teška bol u prsnom košu (angina pektoris), bolest srčanog mišića (znakovi uključuju umor, bol u prsnom košu i osjećaj lupanja srca), prošireno srce, nakupljanje tekućine oko srca, gubitak koordinacije, teškoće pri govoru, suha koža, migrena, poremećaj vida ili dvoslike, zvonjava u ušima, omaglica pri ustajanju (osobito pri ustajanju iz sjedećeg ili ležećeg položaja), povećana potreba za mokrenjem noću, bol, simptomi slični gripi, pospanost, širenje krvnih žila, upala debelog crijeva (znakovi uključuju proljev, obično uz prisutnost krvi i sluzi, bol u trbuhu, vrućicu), upala želuca (znakovi uključuju bol, mučninu, povraćanje), područje nenormalne gustoće u plućima, povišena razina kreatinina u pretragama krvi što može biti znak tegoba s bubrezima.
English: Cases of pulmonary hypertension have been reported in patients treated with anagrelide.
Croatian: U bolesnika liječenih anagrelidom zabilježeni su slučajevi plućne hipertenzije.
English: The NOEL (10 mg/kg/day) to this effect was 143, 12 and 11-fold higher than the AUC in humans administered a dose of anagrelide 2 mg/day, and the metabolites BCH24426 and RL603, respectively.
Croatian: Kod tog učinka, vrijednost NOEL-a (10 mg/kg na dan) bila je 143, 12 i 11 puta veća od AUC-a u ljudi nakon primjene doze anagrelida od 2 mg na dan i metabolita BCH24426 i RL603.
English: Iron oxide black (E172)
Croatian: Anagrelid Mylan 1 mg tvrde kapsule želatina titanijev dioksid (E171) crni željezov oksid (E172)
English: Common side effects: may affect up to 1 in 10 people Dizziness, tiredness, rapid heart beat, irregular or strong heartbeat (palpitations), feeling sick (nausea), diarrhoea, stomach pain, wind, being sick (vomiting), reduction in red blood cell count (anaemia), fluid retention or rash.
Croatian: Česte nuspojave: mogu se javiti u do 1 na 10 osoba Omaglica, umor, brzi otkucaji srca, nepravilan ili snažan osjećaj lupanja srca (palpitacije), mučnina, proljev, bol u želucu, vjetrovi, povraćanje, sniženje broja crvenih krvnih stanica (slabokrvnost), zadržavanje tekućine ili osip.
English: Typically cytoreductive therapy is considered in high risk paediatric patients.
Croatian: U visokorizičnih pedijatrijskih bolesnika obično se razmatra provedba citoredukcijske terapije.
English: The potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced (see sections 4.2 and 4.3).
Croatian: Moguće rizike i koristi terapije anagrelidom u bolesnika s oštećenjem funkcije bubrega treba procijeniti prije početka liječenja (vidjeti dijelove 4.2 i 4.3).
English: Dizziness has been reported by some patients taking anagrelide.
Croatian: Neki bolesnici koji su uzimali anagrelid prijavili su omaglicu.
English: At the NOEL dose (3 mg/kg/day), the AUCs for anagrelide and the metabolites BCH24426 and RL603 were 14, 2 and 2-fold higher than the AUC in humans administered an oral dose of anagrelide 2 mg/day.
Croatian: Pri NOEL dozi (3 mg/kg na dan), vrijednosti AUC-a za anagrelid i metabolite BCH24426 i RL603 bile su 14, 2 i 2 puta veće od AUC-a u ljudi nakon primjene peroralne doze anagrelida od 2 mg na dan.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po kaspuli, tj. sadrži zanemarive količine natrija.
English: The majority of adverse events observed were among those listed in the SmPC.
Croatian: Većina opaženih nuspojava već se nalazila na popisu nuspojava u Sažetku opisa svojstava lijeka.
English: The potential risks and benefits of anagrelide therapy in a patient with mild impairment of hepatic function should be assessed before treatment is commenced (see sections 4.3 and 4.4).
Croatian: Moguće rizike i koristi terapije anagrelidom u bolesnika s blagim oštećenjem jetrene funkcije treba procijeniti prije početka liječenja (vidjeti dijelove 4.3 i 4.4).
English: This medicine contains less than 1mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po kaspuli, tj. zanemarive količine natrija.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta tinitus
English: Fluid retention Oedema Weight loss
Croatian: Poremećaji metabolizma i prehrane zadržavanje tekućine edem, gubitak težine porast težine
English: Anagrelide Mylan contains lactose
Croatian: Anagrelid Mylan sadrži laktozu
English: Anagrelide 0.5 mg hard capsules
Croatian: Anagrelid 0,5 mg tvrde kapsule
English: Anagrelide Mylan 1 mg hard capsules
Croatian: Anagrelid Mylan 1 mg tvrde kapsule
English: • If you have moderate or severe kidney problems.
Croatian: • ako imate umjerene ili teške tegobe s bubrezima.
English: Anagrelide Mylan 0.5 mg hard capsules
Croatian: Anagrelid Mylan 0,5 mg tvrde kapsule
English: Anagrelide Mylan contains lactose.
Croatian: Anagrelid Mylan sadrži laktozu.
English: Anagrelide Mylan contains sodium
Croatian: Anagrelid Mylan sadrži natrij
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1256/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1256/001
English: METHOD AND ROUTE OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT PRIMJENE LIJEKA Kroz usta.