FrancophonIA/ELRC3.0 huggingface dataset:
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Croatian: Odmah kontaktirajte svog liječnika ako primijetite: vrućicu, znakove infekcije ili teškog umora; ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica; znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću (vidjeti dio 2 "Upozorenja i mjere opreza"); oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži; ovi simptomi mogu biti znakovi alergijske reakcije.
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75 - 100 mg daily) should be initiated and continued in combination with clopidogrel (see section
Croatian: U kombinaciji s klopidogrelom potrebno je započeti i nastaviti doziranje acetilsalicilne kiseline (75100 mg dnevno) (vidjeti dio 5.1).
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation
Croatian: Nisu opažene značajne razlike u izloženosti aktivnom metabolitu i prosječnoj vrijednosti inhibicije agregacije trombocita (IPA) među ultrabrzim, brzim i umjerenim metabolizatorima.
English: 14 film-coated tablets: EU/1/09/559/002
Croatian: 14 filmom obloženih tableta: EU/1/09/559/002
English: 56 film-coated tablets: EU/1/09/559/006
Croatian: 56 filmom obloženih tableta: EU/1/09/559/006
English: 28 film-coated tablets: EU/1/09/559/003
Croatian: 28 filmom obloženih tableta: EU/1/09/559/003
English: 7 film-coated tablets: EU/1/09/559/001
Croatian: 7 filmom obloženih tableta: EU/1/09/559/001
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki ginekomastija
English: Bruising
Croatian: Doziranje
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Croatian: (N = 7554) u više centara i kontroliranom placebom uspoređivala se primjena klopidogrela u dozi od 75 mg na dan + ASA-e
English: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
Croatian: Clopidogrel Mylan Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer: imate otvrdnuće arterija (koje se još zove ateroskleroza) te ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija ili osjećate jake bolove u prsima koji se nazivaju "nestabilnom anginom" ili "infarktom miokarda" (srčanim udarom).
English: 30 film-coated tablets: EU/1/09/559/004
Croatian: 30 filmom obloženih tableta: EU/1/09/559/004
English: 100 film-coated tablets: EU/1/09/559/009
Croatian: 100 filmom obloženih tableta: EU/1/09/559/009
English: 50 film-coated tablets: EU/1/09/559/005
Croatian: 50 filmom obloženih tableta: EU/1/09/559/005
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Croatian: TVARI Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrel hidroklorida).
English: Secondary prevention of atherothrombotic events
Croatian: Prevencija aterotromboze i tromboembolije prilikom atrijske fibrilacije
English: Tel: + 34 900 102 712
Croatian: Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712
English: Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
Croatian: Sedamdeset i tri posto (73%) bolesnika uključenih u ispitivanje ACTIVE-A nije moglo uzimati antagoniste vitamina
English: • Bioequivalence vis-à-vis a valid EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Croatian: • Bioekvivalencija u odnosu na valjani referentni lijek odobren u EU-u dokazana je na temelju relevantnih podataka, sukladno sa zahtjevima iz članka 10.
English: For the suspension of the marketing authorisations to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holders
Croatian: Kako bi se ukinula obustava odobrenja za stavljanje lijeka u promet, nadležna tijela država članica omogućuju da nositelji odobrenja za stavljanje lijeka u promet ispune sljedeći uvjet:
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Croatian: Uvjeti za ukidanje obustave odobrenja za stavljanje lijeka u promet
English: Teva Ελλάς Α.Ε.
Croatian: Ελλάδα Teva Ελλάς Α.Ε.
English: Date of latest renewal: 19 July 2013.
Croatian: Datum posljednje obnove: 19. srpnja 2013.
English: • think you may be pregnant or
Croatian: • mislite da biste mogli biti trudni; ili
English: The following information is intended for healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima
English: Do not warm Ratiograstim in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Ne zagrijavajte Ratiograstim na bilo koji drugi način (na primjer, ne zagrijavajte ju u mikrovalnoj pećnici ili vrućoj vodi).
English: It is important to tell your doctor if you:
Croatian: Važno je da obavijestite liječnika:
English: Regular monitoring of blood counts is recommended (see above).
Croatian: Preporučuje se redovito praćenje krvne slike (vidjeti gore).
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Croatian: Morate razgovarati sa svojim liječnikom o rizicima od razvoja raka krvi i pretragama koje trebate obaviti.
English: These changes all reversed after discontinuation of treatment.
Croatian: Navedene promjene su se povukle nakon prekida liječenja.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Croatian: Faktori rasta su proteini koji se prirodno stvaraju u tijelu, ali se mogu proizvesti i primjenom biotehnologije za primjenu kao lijek.
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Croatian: Vaš liječnik će Vas možda željeti pažljivo pratiti, vidjeti dio 4. upute o lijeku.
English: Do not remove the cover from the syringe until you are ready to inject.
Croatian: 6. Ne uklanjajte poklopac sa štrcaljke dok ne bude spremna za injiciranje.
English: Injury, poisoning and procedural complicatio ns
Croatian: Ozljede, trovanja i proceduralne komplikacije
English: A risk to the breastfed newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojeno novorođenče/dojenče.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Croatian: Klinički značaj ovog nalaza za primjenu višestrukih doza nije jasan.
English: In other circumstances, additional leukapheresis are recommended.
Croatian: U drugim se okolnostima preporučuju dodatne leukafereze.
English: Before you inject Ratiograstim you must do the following:
Croatian: Prije nego primijenite Ratiograstim injekciju morate učiniti sljedeće:
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Croatian: Čini se da su prinosi veći od ovog povezani s bržim oporavkom, a manji sa sporijim oporavkom.
English: > 1.0 x 109/L for 3 consecutive days
Croatian: > 1,0 x 109/l tijekom 3 uzastopna dana
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Croatian: Ako ste propustili injekciju ili ubrizgali premalu količinu lijeka, obratite se liječniku čim je prije moguće.
English: Common (≥ 1/100 to
Croatian: Često (≥ 1/100 i
English: Your healthcare professional should always record the exact product you are using.
Croatian: Vaš liječnik treba uvijek zabilježiti točan naziv lijeka koji koristite.
English: This section contains information on how to give yourself an injection of Ratiograstim.
Croatian: Ovo poglavlje sadrži informacije o tome kako možete sami sebi davati injekcije lijeka Ratiograstim.
English: Ratiograstim is not recommended during pregnancy.
Croatian: Ratiograstim se ne preporučuje tijekom trudnoće.
English: Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Croatian: Potom ga treba nastaviti određivati najmanje dvaput tjedno tijekom prva dva tjedna, a nakon toga jedanput tjedno ili jedanput svaka dva tjedna tijekom primjene doze održavanja.
English: If you develop or are likely to develop cancers of the blood, you should not use Ratiograstim, unless instructed by your doctor.
Croatian: Ako razvijete ili ste skloni razvoju raka krvi, ne smijete primjenjivati Ratiograstim osim ako Vas tako nije uputio liječnik.
English: After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Croatian: Nakon jednog do dva tjedna primjene, početna se doza može udvostručiti, ili pak prepoloviti, ovisno o odgovoru.
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Croatian: Preporučuje se da centar za aferezu vodi sustavnu evidenciju i prati davatelje matičnih stanica tijekom barem 10 godina, kako bi se osiguralo dugoročno praćenje sigurnosti primjene.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Croatian: Moguće interakcije s drugim hematopoetskim faktorima rasta i citokinima u kliničkim ispitivanjima još nisu istražene.
English: Your doctor will tell you how much Ratiograstim you should take.
Croatian: Vaš liječnik će Vam reći koliko Ratiograstima trebate uzeti.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti neželjeni učinci prikazani su prema ozbiljnosti, padajućim redoslijedom.
English: The additive effect of concomitantly given products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Croatian: Treba uzeti u obzir aditivni učinak istodobno primjenjenih lijekova koji sadrže sorbitol (ili fruktozu) te unos sorbitola (ili fruktoze) prehranom.
English: • decreased feeling of sensitivity, especially in the skin (hypoaesthesia)
Croatian: • smanjen osjećaj osjeta, osobito na koži (hipoestezija)
English: If you become pregnant during Ratiograstim treatment, please inform your doctor..
Croatian: Ako ostanete trudni tijekom liječenja Ratiograstimom, obavijestite svog liječnika.
English: Other medicines and Ratiograstim
Croatian: Drugi lijekovi i Ratiograstim
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient population.
Croatian: Ne postoji prospektivna, randomizirana usporedba dviju preporučenih metoda mobilizacije (filgrastim sam ili u kombinaciji s mijelosupresivnom kemoterapijom) u istoj populaciji bolesnika.
English: The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics (t(8;21), t(15;17), and inv(16)) have not been established.
Croatian: Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML u dobi od < 55 godina s povoljnim citogenetskim nalazom (t(8;21), t(15;17), i inv(16)) nisu ustanovljene.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će PSUR-eve za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Ratiograstim.
Croatian: Slučajno izlaganje temperaturama zamrzavanja ne utječe štetno na stabilnost Ratiograstima.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Croatian: Nisu bili prijavljeni neželjeni učinci koji bi se mogli izravno pripisati leukocitozi tog stupnja.
English: Do not use any Ratiograstim that is left in the syringe.
Croatian: Ne primjenjujte Ratiograstim koji je ostao u štrcaljki.
English: Infants and young children (below 2 years of age) may not yet be diagnosed with HFI.
Croatian: Dojenčad i mala djeca (mlađa od 2 godine) možda još nemaju dijagnosticirano nasljedno nepodnošenje fruktoze.
English: 1995-2000b aAnalysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) bAnalysis includes patients receiving bone marrow transplant during this period
Croatian: 1995-2000b aAnaliza uključuje studije koje se odnose na presađivanje koštane srži u tome periodu; neke studije koristile su GM-CSF (faktor rasta granulocitnih-makrofagnih kolonija) bAnaliza uključuje bolesnika koji su u tome periodu podvrgnuti presađivanju koštane srži
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Croatian: Bolesnike koji razviju simptome sindroma povećane propusnosti kapilara treba pažljivo nadzirati i liječiti standardnom simptomatskom terapijom, koja može uključivati i potrebu za intenzivnom skrbi (vidjeti dio 4.8).
English: What Ratiograstim looks like and contents of the pack
Croatian: Kako Ratiograstim izgleda i sadržaj pakiranja
English: However, you should not attempt this unless you have been properly trained first by your health care provider.
Croatian: Međutim, ne smijete to pokušati prije nego što Vas zdravstveni radnik o tome temeljito poduči.
English: There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Croatian: Postoje dokazi iz ispitivanja primjene jednokratne doze prema kojima intravensko doziranje može skratiti trajanje učinka lijeka.
English: Teva UK Limited Tel: +44 1977 628500
Croatian: United Kingdom Teva UK Limited Tel: +44 1977 628500
English: How long will I have to take Ratiograstim?
Croatian: Koliko dugo moram uzimati Ratiograstim?
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Croatian: Može se također davati kao polagana dnevna injekcija u venu (poznata kao intravenska infuzija).
English: Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Croatian: Ratiograstim je indiciran i za mobilizaciju progenitorskih stanica periferne krvi (PBPC).
English: Medicinal products (containing sorbitol/fructose) given intravenously may be life-threatening and should not be given in this population unless there is an overwhelming clinical need and no alternatives are available.
Croatian: Lijekovi (koji sadrže sorbitol/fruktozu) koji se daju intravenski mogu biti opasni po život i moraju biti kontraindicirani u ovoj populaciji osim ako postoji velika klinička potreba te nema dostupnih zamjenskih lijekova.
English: Check the expiry date on the pre-filled syringe label (EXP).
Croatian: 3. Provjerite datum roka valjanosti na naljepnici napunjene štrcaljke (EXP).
English: Ratiograstim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Croatian: Ratiograstim se obično daje kao dnevna injekcija u tkivo neposredno ispod kože (poznata kao potkožna ili supkutana injekcija).
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Croatian: Preporuka o minimalnim prinosima od ≥ 2,0 x 106 CD34+ stanica/kg temelji se na dosad objavljenim iskustvima u postizanju primjerene hematološke rekonstitucije.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Croatian: Pri izboru metode mobilizacije valja uzeti u obzir ciljeve liječenja u pojedinog bolesnika.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Croatian: Liječnik će Vam možda redovito testirati mokraću ako primijetite tu nuspojavu ili ako su Vam u mokraći nađeni proteini (proteinurija).
English: Ratiograstim is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines called cytokines.
Croatian: Ratiograstim je faktor rasta bijelih krvnih stanica (faktor stimulacije kolonije granulocita) i pripada skupini lijekova zvanih citokini.
English: Rates of generation of antibodies against filgrastim is generally low.
Croatian: Stopa stvaranja protutijela protiv filgrastima uglavnom je niska.
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Croatian: • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
Croatian: Šezdeset pet posto bolesnika uključenih u program ispitivanja teške kronične neutropenije bilo je mlađe od 18 godina.
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Croatian: Relativni rizik (95 % CI) za GvHD i TRM nakon terapije G-CSF-om nakon transplantacije koštane srži
English: Overall, reports were more common after IV administration.
Croatian: Općenito, takvi su slučajevi bili češći nakon i.v. primjene.
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Croatian: Filgrastim nije utjecao na reproduktivnu sposobnost ili plodnost u mužjaka i ženki štakora (vidjeti dio 5.3).
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Croatian: Ukupne razlike u sigurnosti ili djelotvornosti nisu zabilježene u ispitanika starijih od 65 godina u usporedbi s mladim odraslim ispitanicima (> 18 godina starosti) koji su primali citotoksičnu kemoterapiju, a kliničko iskustvo nije utvrdilo razlike u odgovorima između starijih i mlađih odraslih bolesnika.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (blood uric acid increased)
Croatian: • visoke razine mokraćne kiseline u krvi, što može uzrokovati giht (hiperuricemija) (povišena razina mokraćne kiseline u krvi)
English: After dilution use within 24 hours.
Croatian: Nakon razrjeđivanja primijeniti unutar 24 sata.
English: Do not take a double dose to make up for any missed doses.
Croatian: Nemojte uzeti dvostruku dozu lijeka kako biste nadoknadili propuštenu dozu.
English: Ratiograstim contains sorbitol (E420).
Croatian: Ratiograstim sadrži sorbitol (E420).
English: Ratiograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Croatian: Ratiograstim, koji sadrži r-metHuG-CSF (filgrastim), uzrokuje izrazit porast broja neutrofila u perifernoj krvi unutar 24 sata, i neznatan porast broja monocita.
English: This medicine contains 50 mg sorbitol in each mL.
Croatian: Ovaj lijek sadrži 50 mg sorbitola u jednom mililitru (ml).
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/L prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/L.
Croatian: Ako je potrebno provesti više od jedne leukafereze, posebnu pozornost treba obratiti davateljima s trombocitima < 100 x 109/l prije leukafereze; aferezu općenito ne treba provoditi ako su trombociti < 75 x 109/l.
English: In view of the possible risk of microbial contamination, Ratiograstim syringes are for single use only.
Croatian: Imajući u vidu mogući rizik od mikrobiološke kontaminacije, štrcaljke s Ratiograstimom namijenjene su isključivo jednokratnoj uporabi.
English: What Ratiograstim is and what it is used for What you need to know before you use Ratiograstim How to use Ratiograstim
Croatian: Što je Ratiograstim i za što se koristi Što morate znati prije nego počnete primjenjivati Ratiograstim Kako primjenjivati Ratiograstim
English: Leukapheresis should be performed during the period when the ANC rises from < 0.5 x 109/L to > 5.0 x 109/L.
Croatian: Leukaferezu treba obavljati tijekom razdoblja u kojem ABN s < 0,5x109/l poraste na > 5,0 x 109/l.
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Croatian: Rezultati analize broja CD34+ stanica pomoću protočne citometrije se razlikuju ovisno o preciznosti korištene metodologije te stoga preporuke o broju stanica temeljene na ispitivanju u drugim laboratorijima treba tumačiti s oprezom.
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Croatian: Ako ste bolesnik s teškom kroničnom neutropenijom, možete biti u riziku od razvoja raka krvi (leukemije, mijelodisplastičnog sindroma (MDS)).
English: Congenital, idiopathic or cyclic neutropenia:
Croatian: Način primjene Kongenitalna, idiopatska ili ciklička neutropenija:
English: Sweets syndrome (acute febrile neutrophilic dermatosis)
Croatian: Sweetov sindrom (akutna febrilna neutrofilna dermatoza)
English: Splenomegaly and Splenic rupture
Croatian: Splenomegalija i ruptura slezene
English: Your doctor will tell you how long you will need to take Ratiograstim.
Croatian: Vaš liječnik će Vam reći koliko dugo trebate uzimati Ratiograstim.
English: If you use more Ratiograstim than you should, contact your doctor or pharmacist as soon as possible.
Croatian: Ako primijenite više lijeka Ratiograstim nego što ste trebali, javite se što prije Vašem liječniku ili ljekarniku.