FrancophonIA/ELRC3.0 huggingface dataset:
English: Xagrid or these medicines may not work properly if taken together.
Croatian: Xagrid ili ti lijekovi možda neće pravilno djelovati ako se uzmu zajedno.
English: Keep the sealed container in the bottle.
Croatian: Ostavite zatvoreni spremnik u bočici.
English: Talk to your doctor before taking Xagrid:
Croatian: Obratite se svom liječniku prije nego uzmete Xagrid:
English: They are marked with ‘S 063'.
Croatian: Na njima je utisnuta oznaka 'S 063'.
English: • a platelet count > 1000 x 10
Croatian: • broj trombocita > 1000 x 10
English: What Xagrid is and what it is used for
Croatian: Što je Xagrid i za što se koristi
English: The capsules are provided in bottles containing 100 hard capsules.
Croatian: Kapsule se nalaze u bočicama koje sadrže 100 tvrdih kapsula.
English: Show them the pack of Xagrid.
Croatian: Pokažite im pakiranje lijeka Xagrid.
English: Lactose is an ingredient in this medicine.
Croatian: Laktoza je sastojak ovog lijeka.
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: Other medicines and Xagrid
Croatian: Drugi lijekovi i Xagrid
English: If you take more Xagrid than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Croatian: Ako uzmete više lijeka Xagrid nego što ste trebali ili ako je netko drugi uzeo Vaš lijek, odmah obavijestite liječnika ili ljekarnika.
English: What Xagrid looks like and contents of the pack
Croatian: Kako Xagrid izgleda i sadržaj pakiranja
English: Like all medicines, Xagrid can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Xagrid može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Date of first authorisation: 16 November 2004 Date of latest renewal: 18 July 2014
Croatian: Datum posljednje obnove odobrenja: 18. srpnja 2014.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxyanagrelide, 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: What Xagrid is and what it is used for What you need to know before you take Xagrid How to take Xagrid
Croatian: Što je Xagrid i za što se koristi Što morate znati prije nego počnete uzimati Xagrid Kako uzimati Xagrid
English: If you take more Xagrid than you should
Croatian: Ako uzmete više lijeka Xagrid nego što ste trebali
English: An opaque white hard capsule imprinted with S 063.
Croatian: Neprozirna, bijela, tvrda kapsula s utisnutom oznakom S 063.
English: Xagrid is supplied as opaque, white, hard capsules.
Croatian: Xagrid dolazi u obliku neprozirnih, bijelih, tvrdih kapsula.
English: If you forget to take Xagrid
Croatian: Ako ste zaboravili uzeti Xagrid
English: Therefore platelets should be monitored frequently.
Croatian: Stoga treba često pratiti trombocite.
English: 9/l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Croatian: 9/l ili smanjenje ≥ 50% u odnosu na početnu vrijednost te održavanje smanjenog broja tijekom još najmanje 4 tjedna.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC Code: L01XX35.
Croatian: Farmakoterapijska skupina: Drugi antineoplastični lijekovi, ATK oznaka: L01XX35.
English: Mutagenic and carcinogenic potential Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Croatian: Mutageni i karcinogeni potencijal Ispitivanja genotoksičnog potencijala anagrelida nisu pokazala mutagene ili klastogene učinke.
English: Linearity Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Croatian: Linearnost Proporcionalnost dozi ustanovljena je u rasponu doze od 0,5 mg do 2 mg.
English: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je rečeno da ne podnosite neke šećere, obratite se svom liječniku prije nego što uzmete ovaj lijek.
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 daha;
English: • If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na anagrelid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.
Croatian: Bočice od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračima za djecu i sredstvom za sušenje koje sadrže 100 kapsula.
English: Treatment with Xagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia.
Croatian: Liječenje lijekom Xagrid treba započeti kliničar s iskustvom u liječenju esencijalne trombocitemije.
English: Therefore Xagrid is not recommended during pregnancy.
Croatian: Stoga se primjena lijeka Xagrid ne preporučuje tijekom trudnoće.
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 4000 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: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking Xagrid.
Croatian: Žene u kojih postoji mogućnost da zatrudne moraju provjeriti primjenjuju li djelotvornu kontracepciju dok uzimaju Xagrid.
English: Hypersensitivity to anagrelide or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na anagrelid ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Serious cardiovascular adverse events 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: In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x
Croatian: U bolesnika s esencijalnom trombocitemijom potpuni odgovor definiran je kao smanjenje broja trombocita na ≤ 600 x 10
English: Weight gain
Croatian: Porast težine
English: In male rats, anagrelide at oral doses up to 240 mg/kg/day (>1000 times a 2mg/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: Gastrointestinal disorder
Croatian: Gastrointestinalni poremećaj
English: Xagrid should not be taken by pregnant women.
Croatian: Xagrid ne smiju uzimati trudnice.
English: Diagnostic guidelines for essential thrombocythemia 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: • 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. acetilsalicilna kiselina.
English: Tubulointerstitial nephritis
Croatian: Tubulointersticijski nefritis
English: • If you have further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
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 “Other medicines and Xagrid”);
Croatian: • ako ste rođeni s produljenim QT intervalom ili je netko u obitelji imao produljeni QT interval (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 Xagrid“);
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 početne vrijednosti.
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 Xagrid”).
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 Xagrid“).
English: EU/1/04/295/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/295/001
English: Oedema Weight loss
Croatian: Edem Gubitak težine
English: Interstitial lung disease including pneumonitis and allergic alveolitis
Croatian: Plućni infiltrati Intersticijska bolest pluća, uključujući pneumonitis i alergijski alveolitis
English: Diarrhoea Vomiting Abdominal pain
Croatian: Proljev Povraćanje Abdominalna bol
English: Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1mg/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: Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg).
Croatian: Jedna tvrda kapsula sadrži laktozu hidrat (53,7 mg) i bezvodnu laktozu (65,8 mg).
English: Very common side effects: may affect more than 1 in 10 people
Croatian: Vrlo česte nuspojave: mogu se javiti u više od 1 na 10 osoba Glavobolja.
English: Angina pectoris Postural hypotension Vasodilatation
Croatian: Angina pektoris Posturalna hipotenzija Vazodilatacija
English: Xagrid 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: Xagrid 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: Hepatic enzymes increased
Croatian: Povećani jetreni enzimi
English: Xagrid (on the outer carton only)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Xagrid (samo na vanjskoj kutiji)
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, medicinal products that can prolong QTc interval and hypokalaemia.
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: The usual starting dose of Xagrid 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: How to store Xagrid
Croatian: Kako čuvati Xagrid
English: Name and address of the manufacturer(s) responsible for batch release Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, Ireland
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, Irska
English: Capsule shell: gelatin and titanium dioxide (E171).
Croatian: Ovojnica kapsule: želatina i titanijev dioksid (E171).
English: Dizziness has been reported by some patients taking Xagrid.
Croatian: Neki bolesnici koji su uzimali Xagrid prijavili su omaglicu.
English: There is limited information on the use of Xagrid in children and adolescents and therefore this medicine should be used with caution.
Croatian: Budući da su podaci o primjeni lijeka Xagrid u djece i adolescenata ograničeni, ovaj lijek treba primjenjivati s oprezom.
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: 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: Capsule contents: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460) and magnesium stearate.
Croatian: Sadržaj kapsule: povidon (E1201); krospovidon; laktoza, bezvodna; laktoza hidrat; celuloza, mikrokristalična (E460) i magnezijev stearat.
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, 3-hydroxy 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% više u starijih bolesnika, ali su za djelatni metabolit, 3-hidroksi anagrelid, vrijednosti Cmax bile za 42% i AUC za 37% niže u starijih bolesnika.
English: Do not crush or dilute the contents in a liquid.
Croatian: Nemojte ih drobiti ili otapati njihov sadržaj u tekućini.
English: Pulmonary hypertension Pneumonia Pleural effusion Dyspnoea Epistaxis
Croatian: Plućna hipertenzija Pneumonija Pleuralni izljev Dispneja
English: • Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol;
Croatian: • lijekove za liječenje srčanih poremećaja, primjerice milrinon, enoksimon, amrinon, olprinon i cilostazol;
English: Xagrid is a medicine which interferes with the development of platelets.
Croatian: Xagrid je lijek koji ometa razvoj krvnih pločica (trombocita).
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: Myocardial infarction Cardiomyopathy Cardiomegaly Pericardial effusion
Croatian: Infarkt miokarda Kardiomiopatija Kardiomegalija
English: Gastrointestinal haemorrhage Pancreatitis Anorexia Dyspepsia Constipation
Croatian: Gastrointestinalna hemoragija Pankreatitis Anoreksija Dispepsija Konstipacija
English: What you need to know before you take Xagrid Do not take Xagrid
Croatian: Što morate znati prije nego počnete uzimati Xagrid
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 10
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 x 10 9/l, a idealno na razinama između 150 x 10 9/l i 400 x 10 9/l.
English: Nausea Flatulence
Croatian: Mučnina Flatulencija
English: You must stop breast-feeding if you are taking Xagrid.
Croatian: Ako uzimate Xagrid morate prestati dojiti.
English: How to take Xagrid
Croatian: Kako uzimati Xagrid
English: Dry mouth
Croatian: Nervoza Suha usta
English: Do not remove or eat the drying agent.
Croatian: Nemojte izvaditi ili progutati sredstvo za sušenje.
English: Package leaflet: Information for the patient Xagrid 0.5 mg hard capsules anagrelide
Croatian: Uputa o lijeku: Informacije za bolesnika Xagrid 0,5 mg tvrde kapsule anagrelid
English: Xagrid contains the active substance, anagrelide.
Croatian: Xagrid sadrži djelatnu tvar, anagrelid.
English: Xagrid should not be taken while breast-feeding.
Croatian: Xagrid se ne smije uzimati za vrijeme dojenja.
English: Xagrid contains lactose.
Croatian: Xagrid sadrži laktozu.
English: In the later study 3660 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: Povidone (E1201) Lactose, anhydrous Lactose monohydrate Cellulose, microcrystalline (E460) Crospovidone
Croatian: Sadržaj kapsule povidon (E1201) laktoza, bezvodna laktoza hidrat celuloza, mikrokristalična (E460) krospovidon magnezijev stearat
English: Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
Croatian: Tinta za označavanje šelak jaka otopina amonijaka kalijev hidroksid (E525) željezov oksid, crni (E127)
English: This contains a drying agent to keep the capsules dry.
Croatian: U bočici se nalazi i mali zatvoren spremnik sa sredstvom za sušenje koji kapsule održava suhima.
English: Printing ink: shellac; strong ammonium solution; potassium hydroxide (E525); black iron oxide (E172).
Croatian: Tinta za označavanje: šelak; jaka otopina amonijaka; kalijev hidroksid (E525); crni željezov oksid (E127).
English: In clinical development, dizziness was commonly reported.
Croatian: U kliničkim ispitivanjima često je prijavljivana omaglica.
English: Xagrid 0.5 mg hard capsules.
Croatian: NAZIV LIJEKA Xagrid 0,5 mg tvrde kapsule
English: Xagrid contains lactose
Croatian: Xagrid sadrži laktozu
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: 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), pulmonary hypertension (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), plućna hipertenzija (znakovi uključuju nedostatak zraka, oticanje nogu ili gležnjeva, a usne i koža mogu poprimiti plavkastu boju).
English: Flu-like syndrome Pain
Croatian: Sindrom sličan gripi
English: 100 hard capsules
Croatian: OBLIK I SADRŽAJ 100 tvrdih kapsula