FrancophonIA/ELRC3.0 huggingface dataset:
English: With these assumptions the estimated dose for a person in close contact with the patient is 0.46 mSv, which is less than one half of the limit of not exposed people (1 mSv/year).
Croatian: S tim pretpostavkama procijenjena doza za osobe u bliskom kontaktu s bolesnikom je 0,46 mSv, što je manje od jedne polovine granične doze za osobe neizložene radioaktivnom zračenju (1 mSv/godina).
English: This volume depends on the quantity of medicine combined with Cuprymina required for administration by the nuclear medicine doctor.
Croatian: Ovaj volumen ovisi o količini lijeka kombiniranog s Cupryminom potrebnog za primjenu od strane specijaliste nuklearne medicine.
English: Therefore, based upon the safety profile of Cuprymina, which requires the submission of a yearly PSUR, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Croatian: Stoga, na temelju sigurnosnog profila Cuprymine, zbog čega se zahtijeva podnošenje godišnjih PSUR-ova, CHMP je zaključio da nositelj odobrenja mora podnijeti zahtjev za jednu dodatnu obnovu u roku od 5 godina.
English: In all cases, the risks of the radiation should be less than from the disease itself.
Croatian: U svim slučajevima, rizici od zračenja trebaju biti manji od rizika same bolesti.
English: For instruction on preparation of the medicinal product, see section 12.
Croatian: Za uputu o pripremi lijeka, vidjeti dio 12.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Volume: {Z} mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Volumen: {Z} mL
English: If you are pregnant Medicines radiolabelled with Cuprymina must not be administered if you are pregnant.
Croatian: Ako ste trudni Lijekovi radioobilježeni Cupryminom ne smiju se davati ako ste trudni.
English: Copper-64 is a radioactive form of the chemical element copper, which emits the radiation needed for certain procedures that may be carried out on you.
Croatian: Bakar-64 je radioaktivni oblik kemijskog elementa bakra koji emitira zračenje potrebno za određene postupke koji se mogu provoditi kod Vas.
English: Table 1 - Condition of negligible radioactivity in the patients Days after injection (2,770 MBq)
Croatian: Tablica 1 - Stanje zanemarive radioaktivnosti u bolesnikâ Dani nakon injekcije (2770 MBq)
English: If at any time in the preparation of this medicinal product the integrity of this container is compromised it should not be used.
Croatian: Ako se u bilo kojem trenutku tijekom pripreme ovog lijeka ošteti spremnik, ne smijete ga koristiti.
English: It is not known whether copper (64Cu) chloride may interact with other medicines as specific studies have not been carried out.
Croatian: Nije poznato da li bakrov (64Cu) klorid može stupiti u interakciju s drugim lijekovima s obzirom da nisu provedena posebna ispitivanja.
English: EXP {DD/MM/YYYY} hh:mm CET
Croatian: EXP {DD/MM/GGGG} hh:mm CET
English: Following intravenous administration, at the beginning most organs contained an amount of radioactivity which represented their content of Copper-64-laden blood.
Croatian: Nakon intravenske primjene, na početku je većina organa sadržavala količinu radioaktivnosti koja je predstavljala količinu bakra-64 u krvi.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Croatian: Njihov prijem, skladištenje, korištenje, prijenos i odlaganje podliježu propisima i/ili odgovarajućim dozvolama nadležne službene organizacije.
English: These chelating agents help elimination of copper radiotoxicity by an exchange between the calcium ion and the copper due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA).
Croatian: Ovi kelirajući agensi pomažu u eliminaciji radiotoksičnosti bakra i to posredstvom razmjene između iona kalcija i bakra zbog njihove sposobnosti formiranja kompleksa s kelirajućim ligandima (DTPA, EDTA) topivih u vodi.
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 damages.
Croatian: U svakom slučaju u takvog bolesnika treba pratiti hematološke parametre i u slučaju postojanja znakova oštećenja odmah poduzeti odgovarajuće mjere.
English: This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Croatian: Ovaj lijek se smije koristiti samo za radioobilježavanje molekula nosača, koje su posebno razvijene i odobrene za radioobilježavanje s ovim radionuklidom.
English: For this medicinal product, the effective dose resulting from an intravenously injected activity of 925 MBq is 65.86 mSv for a 60-kg female adult and 88.99 mSv for a 70-kg male adult.
Croatian: Za ovaj lijek, efektivna doza koja proizlazi iz intravenski injicirane radioaktivnosti od 925 MBq je 65,86 mSv za odraslu ženu od 60 kg i 88,99 mSv za odraslog muškarca od 70 kg.
English: PHARMACEUTICAL FORM AND CONTENTS Volume: {Z} mL
Croatian: OBLIK I SADRŽAJ Volumen: {Z} ml
English: Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Croatian: Prije korištenja lijekova obilježenih bakrom-64, potrebno je isključiti trudnoću pomoću odgovarajućeg/ validiranog testa.
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 druge osobe od vanjskog zračenja ili kontaminacije od prolivenog urina, povraćanja, itd.
English: Radiolabelling of carrier molecules, such as peptides, monoclonal antibodies, or other substrates, with Copper (64Cu) chloride is very sensitive to the presence of trace metal impurities.
Croatian: Radioaktivno označavanje molekula nosača, kao što su peptidi, monoklonska antitijela ili drugi supstrati, bakrenim (64Cu) kloridom vrlo je osjetljivo na prisutnost onečišćenja u obliku metala u tragovima.
English: Like all medicines, the medicine radiolabelled with Cuprymina can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, i lijekovi radioobilježeni Cupryminom mogu izazvati nuspojave, iako se one neće javiti kod svih osoba.
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 slučajevima, potrebno je osigurati da je rizik od zračenja manji od rizika same bolesti.
English: Cuprymina is used to label certain medicines that have been specially developed for use with the active substance copper (64Cu) chloride.
Croatian: Cuprymina se koristi za obilježavanje određenih lijekova koji su posebno razvijeni za primjenu s djelatnom tvari bakrenim (64Cu) kloridom.
English: The use of Copper-64-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Croatian: Primjena lijekova obilježenih bakrom-64 je kontraindicirana tijekom ustanovljene trudnoće, ili u slučajevima sumnje na trudnoću, odnosno kada trudnoća nije isključena (vidjeti dio 4.3).
English: If the administration is considered necessary, a breast-feeding mother should be advised to stop breast-feeding.
Croatian: Ako se primjena smatra neophodnom, majkama dojiljama mora se savjetovati da prestanu sa dojenjem.
English: Assuming the worst case that the whole maximum activity (2,770 MBq) is injected to the patient and Copper-64 is labelled to a molecule with infinite biological half-life (no disposal by the patient) the person is continuously exposed at a distance of 2 meters.
Croatian: Pod pretpostavkom najgoreg slučaja da se cijela maksimalna aktivnost (2770 MBq) injicira u bolesnika i da bakar-64 obilježiva molekulu s beskonačnim biološkim poluvijekom (bez uklanjanja u organizmu bolesnika) osoba je neprestano izložena na udaljenosti od 2 metra od bolesnika.
English: Copper-64-labelled medicinal products should not be used in children and adolescents up to 18 years.
Croatian: Lijekovi obilježeni bakrom-64 ne smiju se koristiti kod djece i adolescenata do 18 godina starosti.
English: This waiver does however not extend to any diagnostic or therapeutic uses of the medicinal product when linked to a carrier molecule.
Croatian: Ovo se izuzeće međutim ne odnosi na bilo koju dijagnostičku ili terapijsku primjenu lijeka kad je vezan na molekulu koja je nosač.
English: Please read the package leaflet of that medicine carefully.
Croatian: Molimo pažljivo pročitajte uputu o lijeku za taj lijek.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 august 2012
Croatian: Datum prvog odobrenja: 23. kolovoza 2012.
English: Part of the decrease can be attributed to excretion of Copper-64 into the bile, urine and faeces.
Croatian: Dio smanjenja može se pripisati izlučivanju bakra-64 u žuči, mokraći i stolici.
English: No animal toxicity studies were conducted with Cuprymina.
Croatian: Nisu rađena toksikološka ispitivanja na životinjama za Cupryminu.
English: Liver, gastrointestinal tract and kidney are the target organs for copper toxicity after single and repeated doses administration.
Croatian: Jetra, gastrointestinalni trakt i bubrezi su ciljni organi za toksičnost bakra nakon primjene jedne i ponovljenih doza.
English: This medicinal product will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovim lijekom će rukovati i primjenjivati ga samo djelatnici kvalificirani i obučeni za njegovu sigurnu primjenu.
English: Liver, kidney and the intestinal tract reached their maximal content of Copper-64 within the first few hours, and then radioactivity steadily diminished.
Croatian: bubrezima i intestinalnom traktu postignuta je maksimalna koncentracija bakra-64 unutar prvih nekoliko sati, a potom se radioaktivnost stalno smanjivala.
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti u skladu s nacionalnim propisima.
English: absorbed dose per unit activity administered (mGy/MBq)
Croatian: apsorbirana doza po jedinici primijenjene radioaktivnosti (mGy/MBq)
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to the choice of the most appropriate radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Croatian: Prije primjene radiofarmaceutika u majke koja doji, nužno je razmotriti mogućnost odgađanja primjene radionuklida sve dok majka ne prestane dojiti, i izabrati najprikladniji radiofarmaceutik, uzimajući u obzir da i majčino mlijeko postaje radioaktivno.
English: Clear, colourless solution, free of particulate matter.
Croatian: Bistra, bezbojna otopina, bez čestica.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: Regarding the dose for a person in close contact with the patient, this is entirely due to the gamma rays (Cuprymina emits 2 gamma rays at 511.0 Kev and 1,345.77 Kev), because β+ and β- emissions have no role due to their very short range.
Croatian: Što se tiče doze zračenja za osobe u bliskom kontaktu s bolesnikom, ona isključivo ovisi o gama zrakama (Cuprymina emitira 2 gama zrake na 511,0 keV i 1345,77 keV), budući da su β + i β-emisija zbog svog kratkog dometa zanemarive.
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Croatian: Molimo pitajte svog liječnika specijalistu nuklearne medicine kada možete nastaviti s dojenjem.
English: Administration of the medicine radiolabelled with Cuprymina and conduct of the procedure Cuprymina must be used only in combination with another medicine which has been specifically developed and authorised for being combined with Cuprymina, and will be administered subsequently.
Croatian: Primjena lijeka radioobilježenog Cupryminom i provedba postupka Cuprymina se smije koristiti samo u kombinaciji s drugim lijekom koji je posebno razvijen i odobren za kombinaciju s Cupryminom, a koji će se primijeniti naknadno.
English: However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator, even if with reduced efficiency.
Croatian: Međutim, izloženost radionuklidu dulje od jednog sata ne isključuje primjenu kelirajuće terapije i njeno učinkovito djelovanje, čak i ako uz smanjenu učinkovitost.
English: The dosimetry estimates were based on a mouse distribution study and the calculations were effected using OLINDA (Organ Level INternal Dose Assessment Code) (see Table 2).
Croatian: Dozimetrijske procjene temelje se na ispitivanjima distribucije kod miševa te su izračuni izvršeni pomoću OLINDA procjene - Organ Level INternal Dose Assessment Code (program procjene doze zračenja unutarnjih organa nakon sistemske primjene radionuklida) (vidjeti Tablicu 2).
English: Specific activity ≥ 3,700 MBq Cu-64/micrograms of copper.
Croatian: Specifična aktivnost ≥ 3700 MBq Cu-64/mikrogram bakra.
English: Table 2: Absorbed dose per unit activity administered
Croatian: Tablica 2: Apsorbirana doza po jedinici primijenjene radioaktivnosti
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3 - 4 minutes or by infusion (1 g in 100-250 mL of glucose, or sodium chloride 9 mg/mL (0.9 %) solution for injection).
Croatian: Kelirajuće agense u dozi od 1 g treba primijeniti sporom intravenskom injekcijom tijekom 3-4 minute ili infuzijom (1 g u 100-250 ml otopine glukoze ili otopine 0,9 % natrijevog klorida (9 mg/ml) za injekciju).
English: When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Croatian: Kada se namjerava primjeniti radioaktivni lijek u žena u reproduktivnoj dobi, važno je utvrditi da li je riječ o trudnici ili ne.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given medicines radiolabelled with Cuprymina.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se specijalistu nuklearne medicine za savjet prije nego
English: After the medicine radiolabelled with Cuprymina is administered, it will deliver certain amounts of ionising radiation (radioactivity) which can induce a certain risk of cancer and development of hereditary defects.
Croatian: Nakon primjene lijeka radioobilježenog Cupryminom doći će do isporuke određene količine ionizirajućeg zračenja (radioaktivnosti) koje nosi određeni rizik od raka i razvoja nasljednih mana.
English: Copper-64 decays by an emission of β+ (17.6 %) with a maximum energy of 0.66 MeV, an emission of β- (38.5 %) with a maximum energy of 0.58 MeV and electronic capture (43.9 %).
Croatian: Bakar-64 se raspada emisijom β+ čestica (17,6%), uz maksimalnu energiju od 0,66 MeV, emisijom β čestica (38,5%), uz maksimalnu energiju od 0,58 MeV i elektronskim zahvatom (43,9%).
English: Cuprymina should not be administered directly to the patient.
Croatian: Cuprymina se ne smije primijenjivati izravno bolesniku.
English: Cuprymina is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound.
Croatian: Cuprymina se koristi za radioobilježavanje, tehniku u kojoj se tvar označava (radioobilježava) s radioaktivnim spojem.
English: Assuming that the environmental background value is of 150 nSv/h, and requiring that the dose rate due to Copper-64 is lower than the environmental background the condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection (dose rate 132 nSv/h) as shown in table 1.
Croatian: Uz pretpostavku da vrijednost pozadinske doze zračenja okoliša iznosi 150 nSv/h, i uz zahtjev da je doza zračenja porijeklom od bakra-64 niža od pozadinske doze zračenja okoliša, u bolesnika se postiže stanje zanemarive radioaktivnosti, u praksi, 4 dana nakon injekcije (doza zračenja od 132 nSv/h), kako je prikazano u tablici 1.
English: Dose rate (nSv/h)
Croatian: (nSv/h)
English: The radiopharmaceutical precursor solution is packaged in a colourless, type I glass 10 mL vial, closed with bromobutyl rubber stopper and aluminium overseal.
Croatian: Otopina radiofarmaceutskog prekursora je pakirana u bočice od bezbojnog stakla tipa I, volumena 10 ml, zatvorene bromobutilnim gumenim čepom i aluminijskim zaštitnim zatvaračem.
English: Calibration time: {DD/MM/YYYY} 01h00 a.m. CET
Croatian: Vrijeme kalibracije: {DD/MM/GGGG} 01h00 CET
English: It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled compound are thoroughly cleaned to ensure freedom from such trace metal impurities.
Croatian: Važno je da se sav stakleni pribor, igle za štrcaljke itd., koji se koristi za pripremu radioaktivno označenog lijeka temeljito očisti kako bi se osiguralo da nema onečišćenja u obliku metala u tragovima.
English: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - Italy
Croatian: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - Italija
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of medicine radiolabelled with Cuprymina to be used in your case.
Croatian: Specijalist nuklearne medicine koji nadzire sam postupak će odlučiti o količini lijeka radioobilježenog Cupryminom koji će se koristiti u Vašem slučaju.
English: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE) Italy
Croatian: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE) Italija
English: Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Croatian: Potrebno je koristiti samo igle za štrcaljke (na primjer, nemetalne) za koje je dokazano da su otporne na razrijeđenu kiselinu kako bi se smanjila razina onečišćenja metalima u tragovima.
English: No interactions studies of Copper-64 chloride with other medicinal products have been performed.
Croatian: Nisu sprovedena ispitivanja interakcije bakrovog-64 klorida s drugim lijekovima.
English: The radiation dose to the patient resulting from exposure after administration may result in higher incidence of cancer and mutations.
Croatian: Doza zračenja za bolesnika nastala usljed izloženosti zračenju nakon primjene radiofarmaceutika može rezultirati većom incidencijom raka i mutacijâ.
English: It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons.
Croatian: Mora se uzeti u obzir i činjenica da radioobilježeni lijek emitira Augerove elektrone visokog intenziteta.
English: Tel: 0039.388.8735530 or 0039.0733.560354 Fax: 0039.0836.1975111 or 0039.0733.560376 E-mail: info@sparklepet.it
Croatian: Tel: 0039.388. 8735530 ili 0039.0733.560354 Fax: 0039.0836.1975111 ili 0039.0733.560376 E-mail: info@sparklepet.it
English: Children and adolescents Medicines radiolabelled with Cuprymina should not be used in children and adolescents up to 18 years.
Croatian: Lijekovi radioaktivno označeni Cupryminom ne smiju se koristi kod djece i adolescenata do 18 godina starosti.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Croatian: Izloženost ionizirajućem zračenju povezana je s indukcijom raka i mogućnošću razvoja nasljednih anomalija.
English: Pharmacokinetic data on Cuprymina relate to free copper
Croatian: Farmakokinetički podaci o Cuprymini u odnosu na slobodni bakar
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Croatian: Kada ste u nedoumici, važno je da konzultirate svog liječnika, specijalistu nuklearne medicine koji će nadgledati postupak.
English: Each pack contains 1 vial in a tungsten or lead container.
Croatian: Svako pakiranje sadrži 1 bočicu u volframskom ili olovnom spremniku.
English: If you have been given more medicine radiolabelled with Cuprymina than you should Since the medicine radiolabelled with Cuprymina is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose.
Croatian: Budući da lijekom radioobilježenim Cupryminom rukuje specijalist nuklearne medicine pod strogo kontroliranim uvjetima, postoji vrlo mala šansa za moguće predoziranje.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Stoga se moraju poduzeti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: The toxicity of the free Copper-64 due to in vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.
Croatian: Toksičnost slobodnog bakra-64 koji se in vivo oslobađa iz obilježene biomolekule u organizmu tijekom terapije mogla bi biti smanjena nakon primjene kelirajućih agensa.
English: Pharmacokinetics of Cuprymina was investigated in mice.
Croatian: Farmakokinetika Cuprymine je ispitivana u miševa.
English: Hydrochloric acid (0.1 N).
Croatian: Kloridna kiselina (0,1 M).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept. (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: The following information is intended for medical or healthcare professionals only: The complete Summary of Product Characteristics (SmPC) of Cuprymina is provided as a separate document in the medicinal product pack, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this medicinal product.
Croatian: Cjeloviti Sažetak opisa svojstava za Cupryminu dostupan je kao zaseban dokument u pakiranju lijeka, s ciljem da zdravstvenim radnicima pruži druge dodatne znanstvene i praktične informacije o korištenju ovog lijeka.
English: Other medicines and medicines radiolabelled with Cuprymina Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images.
Croatian: Obavijestite svog liječnika, specijalistu nuklearne medicine ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koji drugi lijek, jer oni mogu ometati tumačenje snimki.
English: Cuprymina is a sterile solution.
Croatian: Cuprymina je sterilna otopina.
English: Cuprymina is a type of medicinal product called a radiopharmaceutical precursor.
Croatian: Cuprymina je vrsta pripravka pod nazivom radiofarmaceutski prekursor.
English: Copper-64 decays in stable Nickel 64Ni (61 %) by an emission of β+ (18 %) or by an electronic capture (43 %).
Croatian: Bakar-64 se raspada u stabilni nikal 64Ni (61%) emisijom β+ čestica (18%) ili elektronskim zahvatom (43%).
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Croatian: - Ako imate bilo kakvih dodatnih pitanja, upitajte svog liječnika, specijalistu nuklearne medicine koji će nadgledati postupak.
English: The use of Copper-64-labelled medicines involves exposure to small amounts of radioactivity.
Croatian: Primjena lijekova obilježenih bakrom-64 podrazumjeva izloženost malim količinama radioaktivnosti.
English: The minimal specific activity is 3,700 MBq Copper-64/micrograms of Copper at the expiry date and time.
Croatian: Minimalna specifična aktivnost je 3700 MBq bakra-64/mikrogram bakra na datum i vrijeme isteka rokaupotrebe.