FrancophonIA/ELRC3.0 huggingface dataset:
English: P value2 Vaso-occlusive crises 12.13 ± 8.56 0.6 ± 1.37 11.46 ± 3.01 10.2 ± 3.24 0.10 <0.001 Blood transfusions 2.43 ± 0.69 0.13 ± 0.43 2.13 ± 0.98 1.98 ± 0.82 0.25 <0.001 Hospitalisations P value is for comparison between hydroxycarbamide and placebo groups at baseline P value is for comparison between hydroxycarbamide and placebo groups at 18 months Primary stroke prevention (TWiTCH study) Transcranial Doppler (TCD) with Transfusions Changing to Hydroxycarbamide (TWiTCH) was an
Croatian: Pvrijednost2 Vazookluzivne krize 12,13 ± 8,56 0,6 ± 1,37 11,46 ± 3,01 10,2 ± 3,24 0,10 < 0,001 Transfuzije krvi Hospitalizacije 10,13 ± 6,56 0,70 ± 1,28 9,56 ± 2,91 9,59 ± 2,94
English: Push the tip of the dosing syringe into the hole in the adaptor (figure 3).
Croatian: Vrh štrcaljke za doziranje gurnite u otvor nastavka za bočicu (slika 3).
English: - Skin cancers in elderly patients - Viral infection with Parvovirus B19 - Stomach pain or heartburn - Gastrointestinal ulcer - Fever - Absence of menstrual cycles (amenorrhoea) - Weight gain
Croatian: Rak kože u starijih bolesnika Virusna infekcija parvovirusom B19 Bol u želudcu ili žgaravica
English: In keeping with the mechanism of action of hydroxycarbamide, the MSH study also showed a statistically significant increase in HbF (mean difference 3.9% (95% CI 2.69 to 5.11 (p < 0.0001)) and haemoglobin levels (mean difference 0.6 g/dL (95% CI 0.28 to 0.92, p < 0.0014) and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Croatian: U skladu s mehanizmom djelovanja hidroksikarbamida, MSH ispitivanje također je pokazalo statistički značajno povećanje razine HbF (srednja vrijednost razlike 3,9 % (95 % CI 2,69 do 5,11
English: It is recommended that the healthcare professional advises the patient or carer which syringe to use to ensure that the correct volume is administered.
Croatian: Kako bi se osiguralo davanje ispravnog volumena, preporučuje se da zdravstveni radnik savjetuje bolesniku ili njegovatelju koju štrcaljku treba koristiti.
English: Bone marrow depression including neutropenia, reticulocytopenia, macrocytosis
Croatian: Depresija koštane srži uključujući neutropeniju,
English: Erythrocytic abnormalities; megaloblastic erythropoiesis, which is selflimiting, is often seen early in the course of hydroxycarbamide therapy.
Croatian: Abnormalnosti eritrocita; u ranoj fazi liječenja hidroksikarbamidom česta je megaloblastična eritropoeza, koja je samoograničavajuća.
English: If dose escalation is warranted based on clinical and laboratory findings, the following steps should be taken:
Croatian: Ako je povećanje doze opravdano na temelju kliničkih i laboratorijskih nalaza, treba poduzeti sljedeće korake: • svakih osam tjedana treba povećati dozu za 5 mg/kg/dan.
English: This is to check the number and type of cells in your blood and to check your liver and kidney.
Croatian: - Tijekom uzimanja lijeka Xromi liječnik će redovito provoditi krvne pretrage kako bi provjerio broj i vrstu stanica u vašoj krvi te rad vaše jetre i bubrega.
English: Hepatic impairment
Croatian: - Teška infekcija
English: - Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Xromi - Lijek čuvajte izvan pogleda i dohvata djece.
English: Hydroxycarbamide can cause foetal harm when administered to a pregnant woman.
Croatian: Primjena hidroksikarbamida u trudnica može uzrokovati oštećenje fetusa.
English: The active substance is hydroxycarbamide.
Croatian: Djelatna tvar je hidroksikarbamid.
English: 2,000/μL to 4,000/μL) is achieved, up to a maximum of 35 mg/kg/day.
Croatian: • Treba nastaviti s povećavanjem doze sve dok se ne postigne blaga mijelosupresija (apsolutni broj neutrofila od 2000/μl do 4000/μl), do najveće doze od 35 mg/kg/dan.
English: If you forget to take Xromi Tell your doctor.
Croatian: Ako ste zaboravili uzeti Xromi
English: - if you suffer from severe liver disease - if you suffer from severe kidney disease - if you have decreased production of red, white, or coagulating blood cells (‘myelosuppressed') as described in section 3 “How to take Xromi, Treatment follow-up” - if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
Croatian: („mijelosupresija”) kako je opisano u dijelu 3. „Kako uzimati Xromi, Praćenje tijekom liječenja” - ako ste trudni ili dojite (pogledajte dio „Trudnoća, dojenje i plodnost”) - ako uzimate antiretrovirusne lijekove za liječenje virusa humane imunodeficijencije (HIV), virusa koji uzrokuje AIDS
English: Leg ulcers
Croatian: Ulkusi nogu
English: - if you have extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells (anaemia).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Xromi: - ako osjećate ekstremni umor, slabost i nedostatak zraka, koji mogu biti simptomi nedostatka crvenih krvnih stanica (anemija) - ako imate krvarenja ili vam se lako stvaraju modrice, što mogu biti simptomi niskih razina stanica u krvi poznatih pod nazivom trombociti
English: Hydroxycarbamide is cytotoxic.
Croatian: Hidroksikarbamid je citotoksičan lijek.
English: Hydroxycarbamide did not reduce rates of hepatic or splenic sequestration when compared with placebo.
Croatian: U usporedbi s placebom, primjenom hidroksikarbamida nije smanjena stopa sekvestracije u jetri ili u slezeni.
English: - Indication; - Instructions for proper and safe use of the product, including clear instructions on the use of two different dosing syringes to avoid the risk of medication error; - Follow-up of patients treated with Xromi: o Need for periodic blood counts; Other medicines that suppress the bone marrow and radiation therapy; o Concomitant use of anti-retroviral medicines; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer);
Croatian: o Istodobna primjena antiretrovirusnih lijekova; o Kožni ulkus i vaskulitis, ulkusi nogu; o Dugoročna sigurnost, osobito razvoj malignih bolesti (leukemija, rak kože); o Oštećenje funkcije jetre i/ili bubrega; o Teratogenost i plodnost u muškaraca; Potreba za kontracepcijom;
English: The recovery from myelosuppression is rapid when hydroxycarbamide therapy is interrupted.
Croatian: Nakon što se liječenje hidroksikarbamidom prekine, oporavak od mijelosupresije je brz.
English: Hydroxycarbamide Therapy (mean ± SD)
Croatian: Prije terapije hidroksikarbamidom (srednja vrijednost ± SD)
English: Evidence for the efficacy of hydroxycarbamide in reducing the vaso-occlusive complications of Sickle Cell Disease in patients older than 2 years comes from four randomised controlled trials (Charache et al 1995 [MSH Study]; Jain et al 2012, Ferster et al 1996; Ware et al 2015 [TWiTCH]).
Croatian: [MSH ispitivanje]; Jain et al 2012.; Ferster et al 1996.; Ware et al 2015.
English: Two dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml) are provided for accurate measurement of the prescribed dose of the oral solution.
Croatian: Za točno mjerenje propisane doze oralne otopine predviđene su dvije štrcaljke za doziranje (crvena štrcaljka graduirana do 3 ml i bijela štrcaljka graduirana do 12 ml).
English: WBC (×109/L) HbF (%) Reticulocytes (%)
Croatian: HbF (%)
English: Range
Croatian: Nuspojava
English: If bone marrow function is depressed, treatment with hydroxycarbamide should not be initiated.
Croatian: Liječenje hidroksikarbamidom ne smije se započeti ako je funkcija koštane srži smanjena.
English: Use in elderly
Croatian: Ulysses House
English: Patients who have received irradiation therapy in the past may have an exacerbation of post irradiation erythema when hydroxycarbamide is given.
Croatian: Pri primjeni hidroksikarbamida u bolesnika koji su prethodno liječeni zračenjem moguće je pogoršanje eritema izazvanog zračenjem.
English: - Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Croatian: Vrlo rijetke nuspojave: mogu se javiti u do 1 na 10 000 osoba - Upala kože koja uzrokuje crvene ljuskave mrlje i može se pojaviti zajedno s boli u zglobovima.
English: As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of hydroxycarbamide in patients with renal impairment.
Croatian: Oštećenje funkcije bubrega Budući da je put eliminacije bubrežno izlučivanje, u bolesnika s oštećenom funkcijom bubrega treba razmotriti smanjenje doze hidroksikarbamida.
English: Nausea, constipation
Croatian: - Vrućica ili zimica
English: - Ulcers or wounds on your legs Very rare: may affect up to 1 in 10,000 people
Croatian: Rijetke nuspojave: mogu se javiti u do 1 na 1000 osoba - Ulkusi ili rane na nogama
English: Therefore it must not be administered to patients who are pregnant.
Croatian: Stoga se hidroksikarbamid ne smije primjenjivati u trudnica.
English: Bone marrow suppression
Croatian: Prijavljivanje nuspojava
English: If the solution comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water (see section 6.6).
Croatian: Ako otopina dođe u kontakt s kožom ili sluznicom, treba je odmah temeljito oprati vodom i sapunom
English: In all clinical studies, there was a significant increase in
Croatian: U svim kliničkim ispitivanjima nakon primjene hidroksikarbamida nastupilo je značajno povećanje razine HbF u odnosu na početnu vrijednost.
English: An increase in HbF and a decrease in absolute neutrophil count were reported in the hydroxycarbamide group.
Croatian: U skupini koja je primala hidroksikarbamid zabilježen je porast u razini HbF i smanjenje apsolutnog broja neutrofila.
English: Skin cancer has been reported in patients receiving long term hydroxycarbamide.
Croatian: U bolesnika koji primaju dugotrajnu terapiju hidroksikarbamidom zabilježena je pojava raka kože.
English: 3rd Floor
Croatian: PRILOG III.
English: • Patient information leaflet
Croatian: • Sažetak opisa svojstava lijeka
English: • Guide for healthcare professionals
Croatian: • Vodič za zdravstvene radnike Vodič za zdravstvene radnike mora sadržavati sljedeće ključne elemente:
English: Excipients
Croatian: Cijepljenja
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: NALJEPNICA NA BOČICI
English: Talk to your doctor, pharmacist or nurse before taking Xromi:
Croatian: - Praćenje bolesnika liječenih lijekom Xromi:
English: Hydroxycarbamide must not be administered to patients with severe renal impairment (CrCl < 30 ml/min) (see sections 4.3, 4.4, and 5.2).
Croatian: < 30 ml/min) (vidjeti dijelove 4.3., 4.4. i 5.2.).
English: See package leaflet for further information.
Croatian: Dodatne informacije potražite u uputi o lijeku.
English: Hydroxycarbamide should be used with caution in patients with marked renal dysfunction.
Croatian: Savjetuje se oprez pri primjeni hidroksikarbamida u bolesnika s ulkusima nogu.
English: Package leaflet: Information for the user Xromi 100 mg/ml oral solution hydroxycarbamide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži vama važne podatke.
English: You will not have to store this product.
Croatian: Nećete trebati čuvati ovaj proizvod.
English: It will only be administered as a combination.
Croatian: Primjenjivat će se samo kao kombinacija.
English: Target Organ
Croatian: Ciljni organ
English: Intravenous administration should not be protracted over more than 2 hours.
Croatian: Intravensku primjenu lijeka ne bi trebalo odgoditi za više od 2 sata.
English: This could potentially result in osteosarcomas.
Croatian: To bi potencijalno moglo dovesti do razvoja osteosarkoma.
English: The use of television monitor systems to monitor the patients is recommended.
Croatian: Preporučuje se upotreba televizijskih sustava za nadzor bolesnika.
English: However, in case of an overdose, you will receive the appropriate treatment.
Croatian: Međutim, u slučaju predoziranja dobit ćete odgovarajuću terapiju.
English: Precautions with respect to relatives, carers and hospital staff are provided in section 6.6.
Croatian: Mjere predostrožnosti vezane uz rodbinu, njegovatelje i bolničko osoblje su navedene u dijelu 6.6.
English: The ART is defined as the end of production.
Croatian: Vrijeme umjeravanja aktivnosti definirano je kao kraj proizvodnje.
English: The following information is intended for the specialist only.
Croatian: Sljedeće informacije namijenjene su samo specijalistu.
English: This is below the threshold considered acceptable for discharge from the clinic (20 µSv/h).
Croatian: To je ispod donje granice koja se smatra prihvatljivom za otpuštanje iz klinike (20 µSv/h).
English: Destination:
Croatian: Odredište:
English: Also low gamma energy is emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Croatian: Također se emitira gama zračenje niske energije, primjerice 113 keV (6,2 %) i 208 keV (11 %).
English: It appeared that more than 78% of the doses was distributed into liver, bone and spleen.
Croatian: Ispostavilo se da je više od 78 % doza distriburirano u jetru, kosti i slezenu.
English: Effects of the respiration were slight and variable.
Croatian: Učinci na disanje bili su blagi i promjenljivi.
English: These people will take special care for the safe use of this product and will keep you informed of their actions.
Croatian: Te će osobe posebnu pozornost obratiti sigurnoj uporabi ovog proizvoda te će vas obavještavati o svojim radnjama.
English: What Lumark is and what it is used for
Croatian: Što je Lumark i za što se koristi
English: Activity may be measured using an ionisation chamber.
Croatian: Aktivnost se može izmjeriti upotrebom ionizacijske komore.
English: Electrocardiograms showed no irregularities in cardiac rhythm or conduction.
Croatian: Elektrokardiogrami nisu pokazali nepravilnosti srčanog ritma ili provodljivosti.
English: very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No special storage condition required.
Croatian: Nisu potrebni posebni uvjeti čuvanja.
English: For single use only
Croatian: Samo za jednokratnu upotrebu
English: The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Croatian: Djelotvornost kelacije najveća je neposredno nakon ili unutar jednoga sata od izlaganja kada je radionuklid u cirkulaciji ili je dostupan u tkivnim tekućinama i plazmi.
English: Activity (at ART): {Y} GBq
Croatian: Aktivnost (pri ART-u): {Y} GBq
English: Appropriate aseptic precautions should be taken.
Croatian: Valja poduzeti aseptičke mjere predostrožnosti.
English: Client code:
Croatian: Kôd naručitelja:
English: Lumark is not a medicine and it is not intended to be used on its own.
Croatian: Lumark nije lijek i nije namijenjen samostalnoj uporabi.
English: Holland B.V.
Croatian: I.D.B Holland B.V.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc.
Croatian: Primjena radiofarmaceutika stvara rizik za ostale osobe od vanjskog zračenja ili kontaminacije prolijevanjem urina, povraćanjem itd.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovim proizvodom će rukovati i davati vam ga samo osobe koje su osposobljene i kvalificirane za njegovu sigurnu upotrebu.
English: No gross differentiating changes were found of the tissues demonstrating no evidence of acute damage resulting from the experiment.
Croatian: Nisu pronađene makroskopske razlike u tkivu, što znači da nema dokaza o akutnom oštećenju nastalom zbog eksperimenta.
English: With respect to the distribution pattern in blood it appeared that 2 h after administration 15% of the Lutetium as being present in blood, had entered the blood cells with the remaining 85% still being present in the serum.
Croatian: U odnosu na uzorak distribucije u krvi, ispostavilo se da je 2 sata nakon primjene 15 % lutecija prisutno u krvi ušlo u krvne stanice, a preostalih 85 % ostalo je prisutno u serumu.
English: Children and adolescents Medicines radiolabelled with Lumark should not be used in children and adolescents below 18 years of age.
Croatian: Lijekovi koji su radioaktivno označeni Lumarkom ne smiju se primjenjivati u djece i adolescenata mlađih od 18 godina.
English: The European Medicines Agency has waived the obligation to submit the results of the studies with Lumark in all subsets of the paediatric population on grounds that the specific medicinal product is likely to be ineffective or unsafe in part or all of the paediatric population and on grounds that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for the paediatric patients.
Croatian: Pedijatrijska populacija Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja s lijekom Lumark u svim podskupinama pedijatrijske populacije na temelju činjenice da će konkretan lijek vjerojatno biti neučinkovit ili nesiguran u dijelu ili cjelokupnoj pedijatrijskoj populaciji te činjenice da konkretan lijek ne predstavlja znatnu terapijsku korist u odnosu na postojeće terapije koje se daju pedijatrijskim bolesnicima.
English: For minimising radiation exposure resulting from repeated exposure, there is no specific recommendation except the strict observance of the above ones.
Croatian: Kako bi se izloženost zračenju kod ponavljanog izlaganja svela na najmanju moguću mjeru, ne postoje određene preporuke, osim strogog pridržavanja gore navedenih preporuka.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Croatian: Postoje strogi zakoni o uporabi radiofarmaceutskih proizvoda, rukovanju njima i njihovu zbrinjavanju.
English: How to store Lumark
Croatian: Kako čuvati Lumark
English: In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
Croatian: U svakom slučaju potrebno je pratiti krvne parametre bolesnika te odmah poduzeti odgovarajuće mjere ako postoji dokaz o oštećenju koštane srži.
English: Activity measurements using an ionization chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Croatian: Mjerenja aktivnosti upotrebom ionizacijske komore izrazito su osjetljiva na geometrijske faktore, stoga ih treba obavljati samo u prikladno validiranim geometrijskim uvjetima.
English: Please read the package leaflet of that medicine carefully.
Croatian: Pozorno pročitajte uputu o tom lijeku.
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Croatian: - Ustanovljena trudnoća, sumnja na trudnoću ili u slučaju kada trudnoća nije isključena (vidjeti dio 4.6).
English: Pharmacokinetic data on Lumark related to free Lutetium:
Croatian: Farmakokinetički podaci o lijeku Lumark povezani sa slobodnim lutecijem:
English: The vial should never be opened and must be kept inside its lead shielding.
Croatian: Bočica se nikada ne smije otvarati i mora se čuvati unutar olovnog spremnika.
English: Lutetium (177Lu) is a beta(-)/gamma emitter.
Croatian: Lutecij (177Lu) jest beta(-)/gama emiter.
English: Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff.
Croatian: Mjerenja na lokaciji i tijekom rada od ključne su važnosti i trebalo bi ih provoditi u svrhu preciznijeg i upućenijeg određivanja ukupne doze zračenja koju primi osoblje.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Croatian: U svim je slučajevima neophodno osigurati da su rizici od zračenja manji od rizika same bolesti koja se liječi.
English: Storing Lumark is the responsibility of the specialist and will be done in appropriate premises.
Croatian: Čuvanje Lumarka odgovornost je specijalista i vršit će se u odgovarajućim prostorima.
English: These medicines can then be used in medical procedures to carry radioactivity to where it is needed in the body such as sites of tumour cells.
Croatian: Ti se lijekovi potom mogu koristiti u medicinskim postupcima za prijenos radioaktivnosti do mjesta u tijelu na kojem je potrebna, poput tumorskih stanica.
English: For a person in the vicinity of the patient, assuming continuous exposure at 2 m and infinite biological half-life (no disposal by the patient after discharge from the hospital), this dose rate will result in an overall dose of approximately 0.6 mSv, which is approximately one half of the dose limit set for general public (1 mSv/year).
Croatian: Za osobu koja se nalazi u blizini bolesnika, pod pretpostavkom stalne izloženosti na 2 m i beskonačnog biološkog vremena poluraspada (bez eliminacije od strane bolesnika nakon otpuštanja iz bolnice), ova stopa doze će dovesti do ukupne doze od otprilike 0,6 mSv, što odgovara približno polovici doze dozvoljene za opću populaciju (1 mSv/godinu).
English: Medicines radiolabelled with Lumark will only be used in special, controlled areas.
Croatian: Lijekovi koji su radioaktivno označeni Lumarkom upotrebljavat će se samo u posebnim, kontroliranim prostorima.
English: Lumark is a type of product called a radiopharmaceutical precursor.
Croatian: Lumark je vrsta proizvoda koja se naziva radiofarmaceutskim prekursorom.
English: The complete Summary of Product Characteristics (SmPC) of Lumark is provided as a separate document in the pack of the medicinal product, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this product.
Croatian: Potpun Sažetak opisa svojstava lijeka za Lumark priložen je kao zaseban dokument u pakiranju medicinskog proizvoda, s ciljem pružanja dodatnih znanstvenih i praktičnih informacija zdravstvenim radnicima o uporabi ovog proizvoda.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official authorities.
Croatian: Prijem, skladištenje, uporaba, prijenos i odlaganje moraju se obavljati sukladno propisima i/ili odgovarajućim dozvolama nadležnih tijela.
English: 8 days from the date of ART (= end of production).
Croatian: 6.3 Rok valjanosti 8 dana od datuma vremena umjeravanja aktivnosti (= kraja proizvodnje).
English: In the absence of compatibility studies, this medicinal product must not be mixed with medicinal products other than the medicinal products to be radiolabelled.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj se lijek ne smije miješati s lijekovima koji nisu lijekovi koji se radioaktivno označavaju.
English: The dosimetry estimates are based on biodistribution data provided by ICRP-30, showing bone, liver and kidneys as the significant target organs for the biodistribution of lutetium.
Croatian: Dozimetrijske procjene temelje se na podacima o biološkoj distribuciji prema ICRP-30, koje pokazuju da su kosti, jetra i bubrezi važni ciljni organi za biološku distribuciju lutecija.
English: - if you are pregnant or believe you may be pregnant Warnings and precautions
Croatian: - ako ste trudni ili vjerujete da biste mogli biti trudni.
English: It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.
Croatian: To će biti najmanja količina potrebna da se postigne odgovarajući ishod, ovisno o lijeku koji se daje uz ovaj i o njegovoj namjeni.
English: It is not intended for direct use in patients.
Croatian: Nije namijenjen za izravnu primjenu bolesnicima.
English: • a reduced number of red blood cells (anaemia)
Croatian: - smanjeni broj crvenih krvnih stanica (anemija)