FrancophonIA/ELRC3.0 huggingface dataset:
English: Scintimun images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations.
Croatian: Slike je potrebno interpretirati u kontekstu odgovarajućih anatomskih i/ili funkcionalnih slikovnih prikaza.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Croatian: Njihovo preuzimanje, čuvanje, primjena, prijenos i odlaganje podliježu propisima i/ili dozvolama nadležnih službenih tijela.
English: A single injection into a vein in your arm is sufficient to conduct the test your doctor needs.
Croatian: Dovoljna je jedna injekcija lijeka u venu na Vašoj ruci da se provede test potreban Vašem liječniku.
English: Trace a starting line 2.5 cm from the bottom of the paper strip.
Croatian: Označite početnu crtu 2,5 cm od dna papirnate trake.
English: The safety and efficacy of Scintimun in children and adolescents have not yet been established.
Croatian: Sigurnost i djelotvornost Scintimuna u djece i adolesenata nisu još ustanovljene.
English: Elderly No dose adjustment is required.
Croatian: Starije osobe Prilagodba doze nije potrebna.
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 this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku nuklearne medicine za savjet prije nego što Vam daju ovaj lijek.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation.
Croatian: Vaš liječnik i liječnik nuklearne medicine uzeli su u obzir da je klinička korist koju ćete dobiti od postupka s radiofarmaceutikom veća od rizika zbog zračenja.
English: Such substances should therefore not be administered together with, or a short time before the injection of Scintimun.
Croatian: Takve lijekove stoga ne treba primjenjivati zajedno s, ili kratko vrijeme prije injiciranja Scintimuna.
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Croatian: Ove osobe će voditi posebnu brigu za sigurnu upotrebu ovog lijeka, te će vas obavijestiti o svojim postupcima.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite lijek jer sadrži Vama važne podatke.
English: The DHPC also includes 3 copies of a Patient Alert Card completed by the Healthcare Professional and provided to each patient.
Croatian: DHPC također sadrži 3 kopije Kartice s upozorenjima za bolesnika koju popunjavaju zdravstveni djelatnici i koju trebaju uručiti svakom bolesniku.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may interfere with the interpretation of the images.
Croatian: Obavijestite svog liječnika nuklearne medicine ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta jer mogu interferirati s tumačenjem slikovnih prikaza.
English: After radiolabelling with sodium pertechnetate (
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Dodatna oznaka nakon rekonstitucije i radioaktivnog obilježavanja otopinom natrijevog pertehnetata (
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Croatian: Primjenom radiofarmaceutika nastaje rizik za druge ljude od vanjskog zračenja ili kontaminacije prolijevanjem urina, povraćanjem,itd..
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Croatian: Vaš liječnik nuklearne medicine će Vas obavijestiti ako je potrebno poduzeti bilo koje posebne mjere opreza nakon primitka ovog lijeka.
English: In case of allergic reaction you will receive appropriate treatment from your doctor.
Croatian: U slučaju alergijske reakcije liječnik će primijeniti odgovarajuće liječenje.
English: Acquisition can be performed using planar imaging.
Croatian: Snimanje može biti učinjeno planarnim prikazom.
English: After the procedure
Croatian: Nakon postupka
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Radiofarmaceutike treba pripremiti na način koji zadovoljava kako zahtjeve sigurnosti kod zračenja tako i farmaceutske zahtjeve kvalitete.
English: The other ingredients are (see section 2 “Scintimun contains sorbitol and sodium”):
Croatian: Ostali sastojci su (pogledajte dio 2 “Scintimun sadrži sorbitol i natrij“):
English: If you have an intolerance to some sugars (for example fructose or sorbitol), tell your doctor before you are given Scintimun.
Croatian: Ako ne podnosite neke vrste šećera (npr. fruktozu ili sorbitol), recite to svom liječniku prije nego primite Scintimun.
English: Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3).
Croatian: Primjena besilesomaba je kontraindicirana u trudnih žena (vidjeti dio 4.3).
English: Common (may affect up to 1 in 10 people): Low blood pressure
Croatian: Česte (mogu se pojaviti u do 1 na 10 osoba): Nizak krvni tlak
English: What Scintimun is and what it is used for What you need to know before you are given Scintimun How Scintimun is given
Croatian: Što je Scintimun i za što se koristi Što morate znati prije nego primite Scintimun Kako se daje Scintimun
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Croatian: Kako bi se omogućilo trenutno djelovanje u hitnim slučajevima, potrebni lijekovi i medicinska oprema, kao što su endotrahealni tubus i ventilator moraju biti odmah dostupni.
English: This will protect your child from the radiation that may be present in your breast milk.
Croatian: Na taj način ćete zaštititi dijete od radioaktivnosti koja može biti prisutna u mlijeku.
English: The content of the kit before reconstitution is not radioactive.
Croatian: Sadržaj seta prije rekonstitucije nije radioaktivan.
English: If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Croatian: Ako ste u nedoumici oko njezine potencijalne trudnoće (ako je ženi izostala menstruacija, ako je menstruacija vrlo neredovita, itd), bolesnici treba ponuditi alternativne tehnike koje ne koriste ionizirajuće zračenje (ako postoje)
English: Pregnancy (see section 4.6).
Croatian: Trudnoća (vidjeti dio 4.6)
English: Do not store above 25 °C after radiolabelling.
Croatian: Ne čuvati iznad 25 °C nakon radioaktivnog obilježavanja.
English: Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you should avoid close contact with young children and pregnant women during this period of time.
Croatian: Zato što biste mogli emitirati zračenje posebno štetno za malu djecu tijekom prvih 12 sata nakon injekcije, trebate izbjegavati bliski kontakt s malom djecom i trudnicama tijekom tog vremenskog razdoblja.
English: Contact your nuclear medicine doctor if you have any questions.
Croatian: Obratite se svom liječniku nuklearne medicine ako imate bilo kakvih pitanja.
English: Scintimun contains sorbitol therefore patients with rare hereditary problems of fructose intolerance should not be administered this product.
Croatian: Scintimun sadrži sorbitol, stoga bolesnici koji imaju rijedak nasljedni poremećaj intolerancije fruktoze ne smiju primiti ovaj lijek.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Croatian: Ovaj radiofarmaceutik će isporučiti male količine ionizirajućeg zračenja povezanog s najmanjim rizikom od raka i nasljednih abnormalnosti.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000)
Croatian: Navedena učestalost definirana je na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i
English: - The final radiolabelled injection solution must be protected from oxygen.
Croatian: - Konačnu radioaktivno obilježenu otopinu za injekcije potrebno je zaštititi od kisika.
English: Fructose intolerance
Croatian: Intolerancija fruktoze
English: The radionuclide is not part of the kit.
Croatian: Radionuklid nije sastavni dio seta.
English: Effective Dose 0.00863 mSv / MBq
Croatian: Cijelo tijelo Učinkovita doza 0,00863 mSv / MBq
English: Myalgia, arthralgia
Croatian: Mialgija, artralgija
English: What Scintimun is and what it is used for
Croatian: Što je Scintimun i za što se koristi
English: The radiochemical purity of the final radiolabelled preparation can be tested according to the following procedure:
Croatian: Radiokemijska čistoća radioaktivno obilježenog pripravka može se testirati na sljedeći način:
English: These three days correspond to 10 half-lives of technetium (99mTc) (60 hours).
Croatian: Ova tri dana odgovaraju 10 poluvijeka tehnecija (99mTc) (60 sati).
English: Interpretation of images
Croatian: Tumačenje slikovnih prikaza
English: As the effective dose is about 6.9 mSv when the maximal recommended activity of 800 MBq is administered these adverse reactions are expected to occur with a low probability.
Croatian: Budući da je učinkovita doza oko 6,9 mSv kada se primjeni maksimalno preporučena aktivnost od 800 MBq, očekuje se da će se ove nuspojave pojaviti s niskom vjerojatnošću.
English: The frequencies are based on the most recent clinical trial and non interventional safety survey.
Croatian: Učestalost se temelji na podacima dobivenim u najnovijem kliničkom ispitivanju i neintervencijskom ispitivanju sigurnosti primjene.
English: A risk to a breast-fed child cannot be excluded.
Croatian: Rizik za dijete koje se doji ne može se isključiti.
English: However, based on the investigator's diagnosis after one month of follow-up, Scintimun had a slightly lower specificity (71.8 %) than 99mTc-WBCs (79.5 %).
Croatian: Ipak, na temelju dijagnoze koju je postavio ispitivač nakon mjesec dana praćenja bolesnika, Scintimun je imao nešto nižu specifičnost (71,8 %) nego 99mTc-leukociti (79,5 %).
English: Data on repeated dosing of Scintimun are very limited.
Croatian: Podaci o primjeni ponovljenih doza Scintimuna vrlo su ograničeni.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene prema padajućoj ozbiljnosti.
English: EXP Use within 3 hours after radiolabelling.
Croatian: EXP Upotrijebiti unutar 3 sata od radioaktivnog obilježavanja.
English: What you need to know before you are given Scintimun
Croatian: Što morate znati prije nego primite Scintimun
English: Separately count each cut part of the strip and record the obtained values (use an appropriate detection apparatus with a constant counting time, and known geometry and background noise).
Croatian: Odvojeno očitajte svaki dio trake i zabilježite dobivene vrijednosti (koristite odgovarajući uređaj sa stalnim vremenom očitavanja, poznatom geometrijom i pozadinskim šumom).
English: For repeated use, see section 4.4.
Croatian: Za ponovljenu primjenu vidjeti dio 4.4.
English: Scintimun should only be used once in a patient's lifetime.
Croatian: Scintimun bi trebalo primijeniti samo jedanput tijekom života bolesnika.
English: An additional acquisition 24 hours after initial injection is recommended.
Croatian: Preporučuje se i dodatno snimanje 24 sata nakon prvotne injekcije lijeka.
English: In vitro, besilesomab cross-reacts with CEA.
Croatian: In vitro, besilesomab pokazuje unakrsnu reakciju s CEA.
English: Appropriate aseptic precautions should be taken.
Croatian: Treba poduzeti ogovarajuće aseptičke mjere opreza.
English: Investigations in nuclear medicine may involve a risk to the unborn.
Croatian: Pretrage u sklopu nuklearne medicine mogu imati utjecaja na nerođenu djecu.
English: The use of Scintimun does involve exposure to small amounts of radioactivity.
Croatian: Upotreba scintimuna uključuje izloženost malim količinama radioaktivnosti.
English: After injection into your vein, your doctor can obtain pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection.
Croatian: Nakon ubrizgavanja lijeka u venu, liječnik može dobiti slike (skenove) Vaših organa koje će mu dati više podataka za utvrđivanje mjesta upale i/ili infekcije.
English: Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is excreted via the bladder during the 24 h post-injection.
Croatian: Mjerenje razine radioaktivnosti u urinu pokazuje da se do 14 % primijenjene aktivnosti izlučuje kroz mokraćni mjehur tijekom 24 sata nakon injiciranja.
English: This 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 te će Vam ga dati samo osobe koje su obučene i kvalificirane da ga koriste na siguran način.
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Croatian: Kada se u žene reproduktivne dobi namjerava primjeniti radiofarmaceutik, važno je utvrditi je li ona trudna ili nije.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i i svim slijedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Other medicines and Scintimun
Croatian: Drugi lijekovi i Scintimun
English: After correcting for the decay of radionuclide, the calculated half-life of the early phase is 0.5 h whereas the late phase shows a half-life of elimination of 16 h.
Croatian: Nakon korekcije zbog raspadanja radionuklida, izračunati poluvijek u ranoj fazi iznosi 0,5 h, dok druga faza pokazuje poluvijek eliminacije od 16 h.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 January 2010
Croatian: Datum prvog odobrenja: 11. siječnja 2010.
English: However, in the case of an overdose, you will be asked to drink plenty of water and to take laxatives to increase the elimination of the product from your body.
Croatian: Ipak, u slučaju predoziranja, od Vas će se tražiti da pijete puno vode i da uzmete sredstva za čišćenje kako bi se pojačalo izlučivanje lijeka iz organizma.
English: This may increase the risk of allergic reactions in case of repeated administration of Scintimun.
Croatian: Ovo može povećati rizik od nastanka alergijskih reakcija kod ponovljene primjene Scintimuna.
English: The vials must not be opened.
Croatian: Bočice ne smiju biti otvorene.
English: After 1 min, check that the content of the vial of Scintimun has completely dissolved.
Croatian: Nakon 1 min. provjerite je li sadržaj bočice Scintimuna potpuno otopljen.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo česte (mogu se pojaviti kod više od 1 na 10 osoba):
English: Swirl carefully to mix the whole solution (DO NOT shake).
Croatian: Pažljivim kružnim pokretima pomiješajte svu otopinu (NE mućkati).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.82 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2,82 mg
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Croatian: Molimo Vas da pitate svojeg liječnika nuklearne medicine kada možete nastaviti s dojenjem.
English: When the solvent has reached the top of the strip (about 10 minutes), use the forceps to remove the strip and dry in the air.
Croatian: Kada otapalo dostigne vrh trake (nakon otprilike 10 minuta), pomoću hvataljke izvadite traku i ostavite da se osuši na zraku.
English: Pharmacodynamic effects At the recommended activities, it does not exert any clinically relevant pharmacodynamic effects.
Croatian: Pri preporučenoj aktivnosti ne pokazuje klinički značajne farmakodinamičke učinke.
English: The first eluate taken from a technetium (99mTc)-generator that has not been eluted over the weekend must NOT be used.
Croatian: - Prvi ispirak dobiven iz generatora tehnecija (99mTc) koji se nije upotrebljavao preko vikenda NE SMIJE se koristiti.
English: About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun.
Croatian: Utvrđeno je da oko 14 od 100 bolesnika koji prime ovu injekciju u tijelu razvijaju protutijela koja reagiraju s protutijelom prisutnim u Scintimunu.
English: The low renal clearance of activity (0.2 L/h for a glomerular filtration rate around 7 L/h) indicates that the kidney is not the major route of besilesomab elimination.
Croatian: Nizak klirens aktivnosti (0,2 l/h pri glomerularnoj filtraciji od oko 7 l/h) pokazuje da bubrezi nisu glavni put eliminacije besilesomaba.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike trebaju preuzimati, koristiti i primjenjivati samo ovlaštene osobe u za to određenim kliničkim uvjetima.
English: In the most recent clinical study in which 123 patients were administered Scintimun, the most commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14 % of the patients, after a single administration (16 positive over 116 assayed one and/or three months after the administration).
Croatian: U najnovijem kliničkom ispitivanju u kojem je u 123 bolesnika primijenjen Scintimun, najčešće prijavljene nuspojave bile su stvaranje anti-mišjih protutijela u 14 % bolesnika nakon jednokratne primjene (16 pozitivnih na 116 ispitanih jedan i/ili tri mjeseca nakon primjene).
English: This corresponds to the administration of 0.25 to 1 mg of besilesomab.
Croatian: To odgovara primjeni 0,25 do 1 mg besilesomaba.
English: Images acquisition should start 3 to 6 hours after administration.
Croatian: Snimanje je potrebno započeti 3 do 6 sati nakon primjene lijeka.
English: Long-term carcinogenicity studies and toxicity to reproduction have not been carried out.
Croatian: Dugoročna ispitivanja kancerogenosti nisu provedena.
English: The complete SmPC of Scintimun is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Croatian: Cjeloviti sažetak opisa svojstava lijeka za Scintimun dostupan je kao dio za otkidanje na kraju printane verzije upute priložene u pakiranju lijeka, s ciljem pružanja zdravstvenim radnicima drugih dodatnih znanstvenih i praktičnih informacija o primjeni i upotrebi ovog radiofarmaceutika.
English: Without removing the needle, withdraw an equivalent volume of air in order to avoid excess pressure in the vial.
Croatian: Bez vađenja igle povucite jednaki volumen zraka kako biste izjednačili tlak u bočici.
English: This medicine is a radiopharmaceutical product for diagnostic use only in adults.
Croatian: Ovaj lijek je radiofarmaceutik i primjenjuje se samo u dijagnostičke svrhe u odraslih.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Croatian: Primijenjena aktivnost treba u svakom slučaju biti najniža moguća aktivnost koja će osigurati dobivanje potrebne dijagnostičke informacije.
English: MedDRA System Organ Classes
Croatian: MedDRA klasifikacija organskih sustava
English: For an administered activity of 800 MBq the typical radiation dose to the target organ bone is 14.2 mGy and the typical radiation doses to the critical organs, bone marrow, spleen and kidneys are 19.4 mGy, 21.7 mGy, and 16.8 mGy respectively.
Croatian: Za primijenjenu aktivnost od 800 MBq tipična doza zračenja za ciljni organ kosti je 14,2 mGy a tipične doze zračenja za kritične organe, koštanu srž, slezenu i bubrege su 19,4 mGy, 21,7 mGy,
English: Table 1: Values of the absorbed doses calculated for the individual male and female of reference.
Croatian: Tablica 1: Vrijednosti apsorbiranih doza izračunatih za referentnu osobu muškog odnosno ženskog spola.
English: This medicinal product is for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel.
Croatian: Ovaj je lijek namijenjen za korištenje samo u odobrenim ustanovama za nuklearnu medicinu, a njime smije rukovati samo ovlašteno osoblje.
English: After disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Croatian: Nakon dezinfekcije čepa, otopinu treba izvući kroz čep pomoću jednodozne štrcaljke opremljene odgovarajućim zaštitnim štitnikom i jednokratnom sterilnom iglom ili pomoću odobrenog automatiziranog sustava za aplikaciju.
English: Eluates should only be taken from a technetium (99mTc)-generator that has been eluted within the past 24 hours (i.e. with less than 24 h in-grow).
Croatian: - Upotrijebiti treba samo ispirke iz generatora tehnecija (99mTc) učinjenih u zadnja 24 sata (tj. s prirastom kraćim od 24 sata).
English: Scintimun contains sorbitol and sodium
Croatian: Scintimun sadrži sorbitol i natrij
English: Do not store the reconstituted and radiolabelled product above 25 °C.
Croatian: Rekonstituirani i radioaktivno obilježeni pripravak ne čuvati na temperaturi iznad 25 °C.
English: Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable.
Croatian: Tehnecij (99mTc) nastaje pomoću (99Mo/99mTc)-generatora i raspada se uz emisiju gama zračenja sa srednjom energijom od 140 keV i poluvijekom od 6,02 sata na tehnecij (99Tc), koji se, obzirom na svoj dugi poluvijek od 2,13 x 105 godina, može smatrati stabilnim.
English: Procedure
Croatian: Postupak
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Croatian: Izlaganje ionizirajućem zračenju povezano je s nastankom raka i može uzrokovati nastanak nasljednih poremećaja.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of technetium(99mTc)- besilesomab to be used in your case.
Croatian: Liječnik nuklearne medicine koji nadzire postupak će odrediti količinu tehnecijevog (99mTc) besilesomaba koja će se primijeniti u Vašem slučaju.
English: Six hours after injection, about 1.5 % of the whole body radioactivity is found in the liver whereas about 3.0 % is found in the spleen.
Croatian: 6 sati nakon injiciranja oko 1,5 % ukupne tjelesne radioaktivnosti nalazi se u jetri, dok je oko 3,0 % u slezeni.
English: Patients who are HAMA positive may have a greater risk for hypersensitivity reactions.
Croatian: U bolesnika koji su pozitivni na navedena protutijela može postojati povećani rizik za nastanak reakcija preosjetljivosti.