FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, findings from these pivotal studies are supported by observational studies including some long-term follow up.
Croatian: Nadalje, nalazi iz ovih ključnih ispitivanja podržani su opservacijskim ispitivanjima, uključujući i dugoročno praćenje.
English: Xromi with food and drink
Croatian: Xromi s hranom i pićem
English: Do not shake the bottle.
Croatian: Nemojte tresti bočicu.
English: Please contact your doctor immediately if you think you may be pregnant.
Croatian: Odmah se obratite svojem liječniku ako mislite da ste trudni.
English: You can take this medicine with or after meals at any time of the day.
Croatian: Ovaj lijek možete uzimati uz obrok ili nakon njega u bilo koje doba dana.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzimati bilo koje druge lijekove.
English: Results are presented in Table 4.
Croatian: Rezultati su prikazani u tablici 4.
English: Do not stop taking your medicine unless advised by your doctor.
Croatian: Nemojte prestati uzimati lijek osim ako vam to ne savjetuje liječnik.
English: - Depending on the dose you take, these tests may be performed initially every two weeks and then every 2-3 months.
Croatian: - Ovisno o dozi koju uzimate, ove pretrage mogu se na početku liječenja provoditi svaka dva tjedna, a zatim svaka dva do tri mjeseca.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako vam je rekao liječnik ili ljekarnik.
English: Continuous follow-up of the growth of treated children and adolescents is recommended.
Croatian: Preporučuje se kontinuirano praćenje rasta liječene djece i adolescenata.
English: Open date: __________
Croatian: Datum otvaranja: __________
English: In adults without swallowing difficulties, solid oral formulations may be more appropriate and convenient.
Croatian: U odraslih osoba koje nemaju poteškoća s gutanjem, čvrste oralne formulacije mogu biti primjerenije i praktičnije.
English: The safety and efficacy of hydroxycarbamide in children from birth up to 2 years have not yet been established.
Croatian: Sigurnost i djelotvornost hidroksikarbamida u djece u dobi od rođenja do dvije godine još nisu utvrđene.
English: Your doctor will also inspect your skin during routine follow-up visits.
Croatian: Vaš liječnik će vam također pregledati kožu tijekom redovitih kontrolnih posjeta.
English: Speak to your doctor if you are concerned by any of these side effects.
Croatian: Obratite se svom liječniku ako ste zabrinuti zbog neke od tih nuspojava.
English: Results of this study are presented in Tables 2 and 3 below.
Croatian: Rezultati tog ispitivanja prikazani su u tablicama 2. i 3. u nastavku.
English: 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Croatian: manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients should be advised to protect skin from sun exposure.
Croatian: Bolesnike je potrebno savjetovati da zaštite kožu od izloženosti suncu.
English: The use of effective contraception is strongly recommended for both male and female patients.
Croatian: Upotreba učinkovite kontracepcije preporučuje se i u muških i u ženskih bolesnika.
English: Other medicines and Xromi
Croatian: Drugi lijekovi i Xromi
English: Discard 12 weeks after first opening.
Croatian: Bacite 12 tjedana nakon prvog otvaranja.
English: Leukaemia, skin cancers (in elderly patients)
Croatian: Leukemija, rak kože (u starijih bolesnika)
English: P value
Croatian: P-vrijednost
English: Syringes should be rinsed and washed with cold or warm water and dried completely before the next use.
Croatian: Štrcaljke treba isprati i oprati hladnom ili toplom vodom i potpuno osušiti prije sljedeće uporabe.
English: Your doctor may need to give you a lower dose.
Croatian: Liječnik će vam možda morati dati manju dozu lijeka.
English: Open date: ______
Croatian: Datum otvaranja: ______
English: Sometimes the doctor may change your dose of Xromi, for example as a result of different tests.
Croatian: Liječnik vam ponekad može promijeniti dozu lijeka Xromi, na primjer na temelju rezultata različitih pretraga.
English: The primary outcome was the decrease in the frequency of vasoocclusive crises per patient per year.
Croatian: Primarni ishod bilo je smanjenje učestalosti vazookluzivnih kriza po bolesniku godišnje.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove, http://www.ema.europa.eu
English: When you use the medicine follow the instructions below:
Croatian: Prilikom upotrebe lijeka slijedite upute u nastavku:
English: Your doctor will prescribe the correct dose for you.
Croatian: Vaš će vam liječnik propisati točnu dozu.
English: The posology should be based on the patient's body weight (kg).
Croatian: Doziranje Doziranje se treba temeljiti na tjelesnoj težini bolesnika (kg).
English: Xromi may be taken with or after meals at any time of the day but patients should standardise the method of administration and time of day.
Croatian: Lijek Xromi može se uzimati uz obrok ili nakon njega u bilo koje doba dana, ali bolesnici trebaju ujednačiti način i vrijeme primjene.
English: Xromi must not be used during pregnancy.
Croatian: Xromi se ne smije uzimati tijekom trudnoće.
English: Nova Laboratories Ireland Limited
Croatian: Nova Laboratories Ireland Limited 3. kat
English: You should not drive or operate any machinery unless it has been shown not to affect you and you have discussed it with your doctor.
Croatian: Ne smijete upravljati vozilima ili raditi sa strojevima, osim ako se pokazalo da lijek ne utječe na Vas te ste o tome razgovarali sa svojim liječnikom.
English: Weight gain, vitamin D deficiency
Croatian: Porast težine, nedostatak vitamina D
English: Let the syringe dry completely before you use that syringe again for dosing.
Croatian: Pustite da se štrcaljka potpuno osuši prije no što je ponovno upotrijebite za doziranje.
English: -9.60 (95% CI -10.86 to -8.34) (p < 0.00001).
Croatian: -9,60 (95 % CI -10,86 do -8,34) (p < 0,00001).
English: Peak plasma concentrations are reached within 2 hours and by 24 hours the serum concentrations are virtually zero.
Croatian: Vršne koncentracije u plazmi dosežu se unutar dva sata, a do 24 sata koncentracije u serumu gotovo su jednake nuli.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1366/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1366/001
English: In some species cardiovascular and haematological effects have also been observed.
Croatian: Kod nekih vrsta također su uočeni kardiovaskularni i hematološki učinci.
English: The respective value in children was similar, 0.22 L/h/kg.
Croatian: Odgovarajuća vrijednost u djece bila je slična, 0,22 l/h/kg.
English: Before
Croatian: Prije
English: Rarely leg ulcers and very rarely systemic lupus erythematosus have been reported.
Croatian: Rijetko su prijavljeni ulkusi nogu i vrlo rijetko sistemski eritemski lupus.
English: Remove the syringe from your mouth.
Croatian: 9. Izvadite štrcaljku iz usta.
English: What you need to know before you take Xromi
Croatian: Što morate znati prije nego počnete uzimati Xromi
English: There is an increased risk of severe or fatal infections with the concomitant use of live vaccines.
Croatian: Postoji povećan rizik od teških ili smrtonosnih infekcija kod istodobne primjene živih cjepiva.
English: Store in a refrigerator.
Croatian: Držati u hladnjaku.
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 rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist i rizika, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The patient should be instructed to immediately contact a doctor in case of suspected pregnancy.
Croatian: Bolesnika treba uputiti da u slučaju sumnje na trudnoću odmah obavijesti liječnika.
English: If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose.
Croatian: Ako ste roditelj ili njegovatelj koji daje lijek, operite ruke prije i nakon primjene doze.
English: What Xromi is and what it is used for
Croatian: Što je Xromi i za što se koristi
English: However, a lack of increase in MCV, HbF, or both, is not an indication to discontinue therapy if the patient responds clinically (e.g. decreased incidence of pain or hospitalisation).
Croatian: Međutim, izostanak povećanja vrijednosti MCV, HbF ili obiju vrijednosti nije indikacija za prekid liječenja ako je u bolesnika uočen klinički odgovor (npr. manja učestalost pojave boli ili hospitalizacija).
English: Gastrointestinal disturbances, gastrointestinal ulcer, severe hypomagnesaemia
Croatian: Gastrointestinalne smetnje, gastrointestinalni ulkus, teška hipomagnezemija
English: Number of hospitalisations
Croatian: Broj hospitalizacija
English: Suite 2, Stafford House Strand Road Portmarnock Co. Dublin
Croatian: MIAS Pharma Limited Suite 2, Stafford House Strand Road Portmarnock Co.
English: Wash the syringe with cold or warm tap water and rinse well.
Croatian: Operite štrcaljku hladnom ili toplom vodom iz slavine i dobro je isperite.
English: Haemoglobin (Hb) (g/dL)
Croatian: Hemoglobin (Hb) (g/dl)
English: There were no deaths reported in the study.
Croatian: ispitivanju nisu zabilježeni smrtni slučajevi.
English: Secondary leukaemia and skin cancer
Croatian: Sekundarna leukemija i rak kože
English: You should not take Xromi if you have severe kidney disease.
Croatian: Ne smijete uzimati Xromi ako imate tešku bolest bubrega.
English: Xromi should be stopped 3 to 6 months prior to becoming pregnant, if possible.
Croatian: Liječenje lijekom Xromi treba prekinuti tri do šest mjeseci prije trudnoće, ako je to moguće.
English: Severe hepatic impairment (Child-Pugh classification C).
Croatian: Teška oštećenja funkcije jetre (klasifikacija Child-Pugh C).
English: Overall, exposure to hydroxycarbamide produces abnormalities in several experimental animal species and affects the reproductive capacity of male and female animals.
Croatian: Općenito, izlaganje hidroksikarbamidu uzrokovalo je abnormalnosti u nekoliko ispitivanih životinjskih vrsta i utjecalo je na reproduktivnu sposobnost mužjaka i ženki.
English: Hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean.
Croatian: Držite štrcaljku pod vodom i nekoliko puta uvucite i izvucite klip kako biste bili sigurni da je unutrašnjost štrcaljke čista.
English: Prior to launch of Xromi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Xromi u svakoj državi članici nositelj odobrenja za stavljanje u promet (MAH) mora s nacionalnim regulatornim tijelom dogovoriti sadržaj i oblik programa obuke, uključujući sredstva komunikacije, načine distribucije i sve druge aspekte programa.
English: Xromi should only be given to you by a specialist doctor who is experienced in treating blood problems.
Croatian: Xromi vam smije dati samo liječnik specijalist koji ima iskustva u liječenju poremećaja krvi.
English: Parvovirus B19 infection
Croatian: Infekcija parvovirusom B19
English: The maximum dose is 35 mg/kg/day.
Croatian: Maksimalna doza iznosi 35 mg/kg/dan.
English: The dose was increased to 25 mg/kg per day if change in HbF was <2% after 2 months.
Croatian: 25 mg/kg/dan ako je promjena u razini HbF nakon dva mjeseca bila < 2 %.
English: The estimated volume of distribution of hydroxycarbamide approximates total body water.
Croatian: Procijenjeni volumen distribucije hidroksikarbamida približan je ukupnom volumenu tjelesne vode.
English: In children, the fraction of hydroxycarbamide excreted unchanged into the urine comprised about 50%.
Croatian: U djece je udio hidroksikarbamida koji se izlučio nepromijenjen u urin iznosio otprilike 50 %.
English: For male patients taking Xromi, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing using Xromi.
Croatian: S muškim bolesnicima koji uzimaju Xromi, a čije partnerice ostanu trudne ili planiraju zatrudnjeti, liječnik će raspraviti potencijalne koristi i rizike nastavka liječenja lijekom Xromi.
English: If you have kidney disease
Croatian: Ako imate bolest bubrega
English: HIV patients
Croatian: Bolesnici s HIV-om
English: If you take more Xromi than you should, tell your doctor or go to a hospital immediately.
Croatian: Ako uzmete više lijeka Xromi nego što ste trebali, odmah se obratite liječniku ili otiđite u bolnicu.
English: Swallow the dose of oral solution then drink some water, making sure no medicine is left in your mouth.
Croatian: Progutajte dozu oralne otopine i popijte malo vode, vodeći računa da nimalo lijeka ne ostane u ustima.
English: If you take more Xromi than you should
Croatian: Ako uzmete više lijeka Xromi nego što ste trebali
English: You may be more sensitive to the effects of Xromi and your doctor may need to give you a lower dose.
Croatian: Mogli biste biti osjetljiviji na učinke lijeka Xromi te će vam liječnik možda morati dati manju dozu lijeka.
English: These disorders are also associated with the underlying disease.
Croatian: Ovi se poremećaji povezuju i s osnovnom bolešću bolesnika.
English: The use of live vaccines should be avoided during treatment and for at least six months after treatment has finished and individual specialist advice sought (see section 4.5).
Croatian: Primjenu živih cjepiva treba izbjegavati tijekom liječenja i najmanje šest mjeseci nakon završetka liječenja te zatražiti savjet liječnika specijalista (vidjeti dio 4.5.).
English: It is recommended that the starting dose is reduced by 50% in patients with CrCl <60 ml/min (see sections 4.2 and 4.3).
Croatian: Preporučuje se smanjenje početne doze za 50 % u bolesnika u kojih je CrCl < 60 ml/min (vidjeti dijelove 4.2. i 4.3.).
English: - Depending on these results your doctor may change your dose of Xromi.
Croatian: - Ovisno o tim rezultatima liječnik može promijeniti dozu lijeka Xromi koju uzimate.
English: Turn the bottle upside down (figure 4).
Croatian: Okrenite bočicu naopako (slika 4).
English: Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anaemia.
Croatian: Neke stanice postaju abnormalne, krute i poprimaju oblik polumjeseca ili srpa što dovodi do anemije.
English: Low fixed dose hydroxycarbamide in children with Sickle Cell Disease (Jain et al 2012)
Croatian: Niska fiksna doza hidroksikarbamida u djece s bolešću srpastih stanica (Jain et al 2012.)
English: What Xromi contains
Croatian: Što Xromi sadrži
English: Live vaccines are not recommended in immunosuppressed patients.
Croatian: Ne preporučuje se primjena živih cjepiva u imunosuprimiranih bolesnika.
English: Oligospermia, azoospermia
Croatian: Oligospermija, azoospermija
English: What Xromi looks like and contents of the pack
Croatian: Kako Xromi izgleda i sadržaj pakiranja
English: The primary objective of this study was to examine if hydroxycarbamide could maintain TCD velocities after an initial period of transfusions as effectively as chronic blood transfusions.
Croatian: Primarni cilj ovog ispitivanja bio je ispitati mogu li se primjenom hidroksikarbamida održati brzine strujanja krvi utvrđene TCD pretragom nakon početnog razdoblja transfuzija jednako učinkovito kao i kroničnim transfuzijama krvi.
English: There is also a serious risk of leukaemia and in the elderly, skin cancer, although the frequency is not known.
Croatian: Također postoji ozbiljan rizik od leukemije te od raka kože u starijih osoba, iako učestalost nije poznata.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Trudnoća Ispitivanja provedena na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3.).
English: There was no difference in life-threatening neurological events between the treatment groups.
Croatian: Između ispitnih skupina nije bilo razlike u po život opasnim neurološkim događajima.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih se radnika traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: To assist accurate and consistent dose delivery to the stomach water should be taken after each dose of Xromi.
Croatian: Kako bi se osigurala točna i dosljedna isporuka doze u želudac, nakon svake doze lijeka Xromi treba popiti vodu.
English: Oligospermia and azoospermia caused by hydroxycarbamide are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
Croatian: Oligospermija i azoospermija uzrokovane primjenom hidroksikarbamida općenito su reverzibilne, ali ih je potrebno uzeti u obzir ako muškarac želi postati otac (vidjeti dio 5.3.).
English: A significant fraction of hydroxycarbamide is eliminated by nonrenal (mainly hepatic) mechanisms.
Croatian: Značajan dio hidroksikarbamida eliminira se nerenalnim (uglavnom jetrenim) mehanizmima.
English: Male patients should be informed by their healthcare professionals about the possibility of sperm conservation (cryopreservation) before the start of therapy.
Croatian: Zdravstveni radnici trebali bi prije početka terapije obavijestiti muške bolesnike o mogućnosti očuvanja sperme (krioprezervacija).
English: Table 2: Number of Hospitalisations and Number of Days in Hospital by Treatment (Both Periods Combined)(Ferster et al, 1996)
Croatian: Tablica 2.: Broj hospitalizacija i broj dana u bolnici prema liječenju (kombinacija oba razdoblja)
English: Although there is no evidence of an age effect on the pharmacokinetic-pharmacodynamic relationship, elderly patients may be more sensitive to the effects of hydroxycarbamide and therefore consideration should be given to starting with a lower initial dose and more cautious dose escalation.
Croatian: Iako nema dokaza o utjecaju dobi na farmakokinetičko-farmakodinamički odnos, stariji bolesnici mogu biti osjetljiviji na učinke hidroksikarbamida te stoga treba razmotriti liječenje nižom početnom dozom i opreznijim povećanjem doze.
English: Ask your doctor or pharmacist for advice.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet.
English: In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%.
Croatian: U bolesnika s klirensom kreatinina (CrCl) ≤ 60 ml/min početnu dozu hidroksikarbamida treba smanjiti za 50 %.
English: Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe.
Croatian: Povucite klip štrcaljke prema natrag, tako da lijek iz bočice ulazi u štrcaljku.
English: If you stop taking Xromi
Croatian: Ako prestanete uzimati Xromi
English: Non-inferiority (p = 8.82×10-16) and post-hoc superiority (p = 0.023) were met.
Croatian: Ispunjeni su kriteriji neinferiornosti (p = 8,82 × 10-16) i post hoc superiornosti
English: Women who are pregnant, planning to be or breast-feeding should not handle hydroxycarbamide.
Croatian: Trudnice, žene koje planiraju zatrudnjeti ili dojilje ne smiju rukovati hidroksikarbamidom.
English: Pull the plunger back to the point on the scale that corresponds to the dose prescribed (figure 4).
Croatian: Povucite klip štrcaljke natrag do oznake na ljestvici koja odgovara propisanoj dozi (slika 4).
English: - Low Vitamin D level in blood test - Low magnesium level in blood test
Croatian: Niska razina vitamina D u krvi Niska razina magnezija u krvi Krvarenje
English: Hydroxycarbamide affects spermatogenesis, and hence oligospermia and azoospermia are very commonly reported.
Croatian: Hidroksikarbamid utječe na spermatogenezu, stoga se vrlo često prijavljuju oligospermija i azoospermija.
English: Systemic and cutaneous lupus erythematosus
Croatian: Sistemski i kožni eritemski lupus
English: Similar decreases were seen in blood transfusion rates, a surrogate for life-threatening illness.
Croatian: Slična smanjenja zabilježena su kod stopa transfuzije krvi, surogata za životno ugrožavajuću bolest.
English: Ensure that the cap is tightly closed.
Croatian: Provjerite je li zatvarač čvrsto zatvoren.
English: Repeat the above for each dose as instructed by your doctor or pharmacist.
Croatian: Prethodno navedene upute ponovite za svaku dozu, prema uputama liječnika ili ljekarnika.
English: Gradual dose titration is recommended to avoid more severe bone marrow suppressions (see section 4.2).
Croatian: Preporučuje se postupna titracija doze kako bi se izbjegle teže supresije koštane srži (vidjeti dio 4.2.).
English: A clinical response to treatment with hydroxycarbamide may take 3-6 months and therefore, a 6month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure (whether due to lack of adherence or failure to respond to therapy).
Croatian: Za postizanje kliničkog odgovora na liječenje hidroksikarbamidom može trebati tri do šest mjeseci te stoga treba ispitivati najvišu podnošljivu dozu tijekom šest mjeseci prije no što se razmotri prekid zbog neuspjeha liječenja (bilo zbog nepridržavanja ili zbog izostanka odgovora na liječenje).
English: The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥
Croatian: Popis je prikazan prema klasifikaciji organskih sustava, MedDRA preporučenim pojmovima i učestalosti prema sljedećim kategorijama učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10),
English: Remove the bottle cap (figure 1) and push the adaptor firmly into the top of the bottle and leave in place for future doses (figure 2).
Croatian: Skinite zatvarač bočice (slika 1) i gurnite nastavak za bočicu čvrsto u vrh bočice te ga ostavite tamo za davanje budućih doza (slika 2).
English: You should use this one if the total amount you have to take is less than or equal to 3 ml
Croatian: Trebali biste je upotrijebiti ako je ukupna količina koju morate uzeti veća od 3 ml
English: The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended.
Croatian: Makrocitoza može prikriti usputni razvoj nedostatka folne kiseline; preporučuje se redovito utvrđivanje razine folne kiseline u serumu.
English: You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with hydroxycarbamide.
Croatian: Trebate zaštititi kožu od sunca i redovito pregledavati kožu tijekom liječenja i nakon prekida terapije hidroksikarbamidom.
English: Anyone handling hydroxycarbamide should wash their hands before and after administering a dose.
Croatian: Svaka osoba koja rukuje hidroksikarbamidom mora oprati ruke prije i poslije primjene doze.
English: In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal.
Croatian: Zabilježeno izlučivanje nepromijenjenog lijeka u urinu u odraslih osoba iznosi otprilike 37 % oralne doze kod normalne funkcije bubrega.