FrancophonIA/ELRC3.0 huggingface dataset:
English: It might be helpful to estimate the effective dose that was applied.
Croatian: Moglo bi biti korisno procijeniti efektivnu dozu koja je primijenjena.
English: Total volume: ________mL
Croatian: Ukupni volumen: ________ml
English: This medicine is not recommended in patients under 18 years of age because its safety and efficacy have not been established in this patient population.
Croatian: Ovaj lijek ne preporučuje se bolesnicima mlađima od 18 godina jer njegova sigurnost i djelotvornost nisu ustanovljeni za ovu populaciju bolesnika.
English: The elution can be performed either manually or by means of a pump.
Croatian: Eluacija se može obaviti ručno ili pumpom.
English: 6.2 Incompatibilities
Croatian: 6.2. Inkompatibilnosti
English: OLINDA/EXM 1.1 software (table 1).
Croatian: OLINDA/EXM 1.1 (tabela 1.).
English: Perform the quality control according to the recommended methods in order to check the compliance to the specifications (see section, “Quality control”).
Croatian: Izvedite kontrolu kvalitete u skladu s preporučenim metodama kako biste provjerili sukladnost sa specifikacijama (vidjeti dio „Kontrola kvalitete”).
English: A single injection is sufficient to conduct the test that your doctor needs.
Croatian: Jedna je injekcija dovoljna kako bi vaš liječnik proveo potrebnu pretragu.
English: Visual inspection pH
Croatian: Vizualno ispitivanje pH
English: Free gallium-68 = 0.9 to 1
Croatian: Slobodni galij-68 = 0,9 do 1
English: Glass syringe must not be used.
Croatian: Ne smije se koristiti staklena štrcaljka.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube must be immediately available.
Croatian: Kako bi se omogućilo trenutno djelovanje u hitnim slučajevima, potrebni lijekovi i oprema poput endotrahealnog tubusa moraju biti trenutno dostupni.
English: Fertility No studies were conducted to assess the impact on fertility.
Croatian: Plodnost Nisu provedena ispitivanja za procjenu utjecaja na plodnost.
English: Calibration time: ________ Time/Date
Croatian: Vrijeme kalibracije: ________ vrijeme/datum
English: Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organization.
Croatian: Njihovo preuzimanje, čuvanje, uporaba, prijenos i zbrinjavanje podliježu propisima i/ili odgovarajućim dozvolama nadležnih službenih tijela.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja tijekom primjene i uvjeti prije primjene odgovornost su korisnika.
English: Only generators that have been authorised as medicinal products in the EU should be used.
Croatian: Smiju se koristiti samo generatori koji su odobreni kao lijekovi u Europskoj uniji.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Croatian: Za svakog bolesnika izlaganje zračenju mora biti opravdano vjerojatnom koristi.
English: Depending on the time when you administer the injection, the content of sodium may in some cases be greater than 1 mmol.
Croatian: Ovisno o vremenu primjene injekcije, sadržaj natrija u nekim slučajevima može biti viši od 1 mmol.
English: If you are taking somatostatin analogues you might be asked to stop your treatment for a short period of time.
Croatian: Ako uzimate somatostatinske analoge, možda ćete biti zamoljeni da nakratko prekinete terapiju.
English: There is no information about the safety and the efficacy of the use of this medicine during pregnancy.
Croatian: Nisu dostupne informacije o sigurnosti i djelotvornosti primjene ovog lijeka u trudnoći.
English: This medicine contains 1.5 mmol (or 32.5 mg) sodium per dose.
Croatian: Ovaj lijek sadržava 1,5 mmol (ili 32,5 mg) natrija po dozi.
English: This medical procedure obtains images of your organs, to help locate the abnormal cells or tumours giving valuable information about your disease.
Croatian: Ovim medicinskim postupkom dobivaju se slike vaših organa, kako bi se olakšalo pronalaženje abnormalnih stanica ili tumora, čime se dobivaju dragocjene informacije o vašoj bolesti.
English: SomaKit TOC will only be used in special controlled areas.
Croatian: SomaKit TOC se primjenjuje samo u posebno kontroliranim prostorima.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Croatian: Vaš liječnik i liječnik specijalist nuklearne medicine smatraju da je klinička korist od ovog postupka s primjenom radiofarmaceutika veća od rizika izlaganja zračenju.
English: ITLC2: Material
Croatian: ITLC2: Materijal
English: However, in the case of an overdose, you will receive the appropriate treatment.
Croatian: Međutim, u slučaju predoziranja bit će vam pruženo odgovarajuće liječenje.
English: Manufacturer Gipharma S. r.l.
Croatian: Gipharma S. r.l.
English: Wait for the level of radioactivity to decay adequately before throwing away radioactive products.
Croatian: Pričekajte odgovarajuću razinu raspada radioaktivnosti prije nego što bacite radioaktivne proizvode.
English: The following authorised generators have shown to be compatible with SomaKit TOC:
Croatian: Sljedeći su se odobreni generatori pokazali kompatibilnim sa setom SomaKit TOC:
English: Positive results require evaluating the possibility that another disease, characterised by high local somatostatin receptor concentrations, may be present.
Croatian: Pozitivni rezultati zahtijevaju procjenu moguće prisutnosti neke druge bolesti za koju su karakteristične visoke lokalne koncentracije somatostatinskih receptora.
English: Splenectomy should also be considered as a relevant factor when reporting the outcome of somatostatin receptor targeted diagnostics.
Croatian: Također bi trebalo razmotriti splenektomiju kao relevantni čimbenik pri izvještavanju o ishodu ciljane dijagnostike somatostatinskih receptora.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće pojaviti kod svakoga.
English: Five studies have been submitted, one of them prospective (Gabriel et al. 2009) and four retrospective studies (Kroiss et al. 2013, Ezziddin et al. 2012, Kratochwil et al. 2015 and Luboldt et al.2010a).
Croatian: Podneseno je pet ispitivanja, od kojih je jedno prospektivno (Gabriel i sur. 2009.) i četiri retrospektivna (Kroiss i sur. 2013., Ezziddin i sur. 2012., Kratochwil i sur. 2015. i Luboldt i sur. 2010.a).
English: The radioactive substance is not part of the kit and should be added during the preparation steps before injection.
Croatian: Radioaktivna tvar nije dio seta i potrebno ju je dodati tijekom koraka pripreme prije injekcije.
English: Organs
Croatian: Organi
English: The recommended time for imaging is 40 to 90 minutes post injection.
Croatian: Preporučeno vrijeme oslikavanja je 40 do 90 minuta nakon injekcije.
English: In vitro, this radiopharmaceutical binds with high affinity mainly to SSTR2 but also, to a lesser extent, to SSTR5.
Croatian: In vitro ovaj se radiofarmaceutik veže s visokim afinitetom uglavnom za SSTR2, ali i za SSTR5 u manjoj mjeri.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of SomaKit TOC to be used in your case.
Croatian: Specijalist nuklearne medicine koji nadgleda postupak odredit će količinu lijeka SomaKit TOC koja će se koristiti u vašem slučaju.
English: There is no recommendation for use of SomaKit TOC in paediatric patients.
Croatian: Nema preporuke za primjenu lijeka SomaKit TOC u pedijatrijskih bolesnika.
English: No studies on fertility, embryology, mutagenicity or long-term carcinogenicity have been conducted.
Croatian: Nisu provedena ispitivanja plodnosti, embriološka ispitivanja, ispitivanja mutagenosti ili dugoročne kancerogenosti.
English: Imaging acquisition start time and duration should be adapted according to the equipment used, the patient and the tumour characteristics in order to obtain the best image quality possible.
Croatian: Vrijeme početka i trajanje oslikavanja potrebno je prilagoditi upotrijebljenoj opremi, bolesniku i obilježjima tumora radi postizanja najbolje moguće kvalitete slike.
English: After injection into a vein, it can make parts of the body areas visible to doctors during a medical imaging procedure called positron emission tomography (PET).
Croatian: Nakon ubrizgavanja u venu može dijelove tijela učiniti vidljivima liječnicima za vrijeme postupka medicinskog oslikavanja pod nazivom pozitronska emisijska tomografija (PET).
English: Turn the button by 90° to loading position then wait 10 seconds before turning the button back to initial position, according to the generator's instructions for use.
Croatian: Okrenite gumb za 90° u položaj za punjenje, potom pričekajte 10 sekundi prije no što vratite gumb u početni položaj sukladno uputama za uporabu generatora.
English: Leave the vial at 95°C for at least 7 minutes (do not exceed 10 minutes heating) without agitation or stirring.
Croatian: Ostavite bočicu na temperaturi od 95°C najmanje sedam minuta (nemojte dopustiti da zagrijavanje traje dulje od 10 minuta) bez mućkanja ili miješanja.
English: For information on the use in paediatric population, see section 4.2.
Croatian: Za informacije o primjeni u pedijatrijskoj populaciji vidjeti dio 4.2.
English: Absorbed dose in selected organs mGy/MBq
Croatian: Apsorbirana doza u određenim organima mGy/MBq
English: In case of allergic reactions you will receive the appropriate treatment from your medical staff.
Croatian: U slučaju alergijske reakcije vaše medicinsko osoblje pružit će vam odgovarajuće liječenje.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Medicinal product radioactive after radiolabelling.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Lijek je radioaktivan nakon radioaktivnog obilježavanja.
English: The activity will be adapted to patient characteristics, the type of PET camera used and acquisition mode.
Croatian: Aktivnost će biti prilagođena fizičkim karakteristikama bolesnika, vrsti PET kamere koju se koristi i metodi dobivanja slike.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including somatostatin analogues, glucocorticoids (also called corticosteroids), since they may interfere with the interpretation of the images.
Croatian: Obavijestite liječnika specijalista nuklearne medicine ako uzimate, nedavno ste uzimali ili biste mogli uzimati bilo koje druge lijekove, uključujući somatostatinske analoge, glukortikoide (također se zovu kortikosteroidi), s obzirom na to da oni mogu ometati tumačenje slika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1141/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1141/001
English: Edotreotide is a somatostatin analogue.
Croatian: Edotreotid je somatostatinski analog.
English: After injection, you will be offered something to drink and asked to urinate immediately preceding the test.
Croatian: Nakon injekcije bit će vam ponuđeno piće te ćete biti upućeni na mokrenje neposredno prije pretrage.
English: The quantity to be administered usually recommended for an adult ranges from 100 MBq to 200 MBq (megabecquerel, the unit used to express radioactivity).
Croatian: Uobičajena preporučena količina koja se primjenjuje za odrasle u rasponu je od 100 MBq do 200 MBq (megabecquerel je jedinica kojom se izražava radioaktivnost).
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Croatian: Liječnik specijalist nuklearne medicine obavijest će vas ako morate poduzeti bilo kakve mjere opreza nakon primanja ovog lijeka.
English: c. Place the ITLC strip in the developing tank and allow it to develop for a distance of 9 cm from the point of application.
Croatian: c. Postavite ITLC traku u spremnik za razvijanje i ostavite da se razvija na udaljenosti od 9 cm od mjesta nanošenja.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
Croatian: Preosjetljivost na djelatnu tvar, na neku od pomoćnih tvari navedenih u dijelu 6.1. ili na bilo koju komponentu obilježenog radiofarmaceutika.
English: • Galli Ad, 0.74 - 1.85 GBq, radionuclide generator (IRE-Elit).
Croatian: • Galli Ad, 0,74 - 1,85 GBq, generator radionuklida (IRE-Elit).
English: 1,10-phenanthroline Gentisic acid Mannitol (E421)
Croatian: 1,10-fenantrolin Gentizinska kiselina Manitol (E421)
English: Therefore, the radiolabelled solution can be used within 4 hours after preparation according to the radioactivity required for the administration.
Croatian: Zato se radioaktivno obilježena otopina smije upotrijebiti unutar 4 sata nakon pripreme u skladu s radioaktivnosti potrebnom za primjenu.
English: After 7 minutes, remove the vial from the dry bath, place it in an appropriately labelled lead shield and let it cool down at room temperature for approximately 10 minutes.
Croatian: Nakon 7 minuta maknite bočicu iz suhe kupelji, postavite je u odgovarajuće označeni olovni zaštitni spremnik i ostavite da se hladi na sobnoj temperaturi približno 10 minuta.
English: ITLC strip.
Croatian: ITLC trake.
English: • Mobile phase: 77 g/L solution of ammonium acetate in water /Methanol 50:50 V/V
Croatian: • Mobilna faza: 77 g/L otopine amonijevog acetata u vodi /metanolu 50:50 V/V
English: However, it is recommended that the vial be prepared as instructed and used for a single patient dose, based on the activity to be injected; any remaining material should be discarded after radiolabelling and use.
Croatian: Međutim, preporučuje se bočicu pripremiti u skladu s uputom i primijeniti kao pojedinačnu dozu u bolesnika, ovisno o aktivnosti koja će se ubrizgati; sav preostali materijal treba zbrinuti nakon radioaktivnog obilježavanja i primjene.
English: Precautions with respect to environmental hazard are in section 6.6.
Croatian: Mjere opreza u vezi s opasnostima za okoliš dostupne su u dijelu 6.6.
English: You should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the procedure to ensure that SomaKit TOC is removed as quickly as possible from the body.
Croatian: Prije početka pretrage trebali biste popiti dovoljnu količinu vode kako biste prvih nekoliko sati nakon postupka učestalo mokrili te kako bi se SomaKit TOC što prije uklonio iz tijela.
English: pH-indicator strips
Croatian: pH indikatorske trake
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, blood, etc.
Croatian: Primjena radiofarmaceutika rizična je za druge osobe jer može doći do vanjskog zračenja ili kontaminacije uslijed prolijevanja mokraće, povraćanja, krvarenja itd.
English: Take this into consideration if you are on a controlled sodium diet.
Croatian: Uzmite to u obzir ako primjenjujete režim prehrane s kontroliranim unosom natrija.
English: This medicinal product is for diagnostic use only.
Croatian: Ovaj lijek upotrebljava se samo u dijagnostičke svrhe.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Croatian: Potrebno je pažljivo razmotriti omjer koristi i rizika u tih bolesnika s obzirom na to da je moguće pojačano izlaganje zračenju.
English: If you are breast-feeding the nuclear medicine doctor may either delay the medical procedure until you no longer breast-feed or ask you to stop breastfeeding and to discard this milk until there is no radioactivity in your body (8 hours after the administration of SomaKit TOC).
Croatian: Ako dojite, liječnik specijalist nuklearne medicine mogao bi odgoditi medicinski postupak dok ne prestanete dojiti ili vas zamoliti da prekinete dojenje i bacite izdojeno mlijeko sve dok radioaktivnost ne bude uklonjena iz vašeg organizma (8 sati nakon primjene lijeka SomaKit TOC).
English: • GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator (Eckert & Ziegler Radiopharma GmbH),
Croatian: • GalliaPharm, 0,74 - 1,85 GBq, generator radionuklida (Eckert & Ziegler Radiopharma GmbH),
English: • Radiometric ITLC scanner
Croatian: • Radiometrijski ITLC snimač
English: Sodium hydroxide (E524) Water for injections
Croatian: Mravlja kiselina Natrijev hidroksid (E524) Voda za injekcije
English: Total body Effective dose mSv/MBq
Croatian: Maternica Cijelo tijelo Efektivna doza mSv/MBq
English: The effective dose resulting from the administration of an activity of 200 MBq to an adult weighing 70 kg is about 4.2 mSv.
Croatian: Efektivna doza koja proizlazi iz primjene aktivnosti od 200 MBq u odrasle osobe težine 70 kg iznosi otprilike 4,2 mSv.
English: Radiopharmaceuticals should be used by or under the control of healthcare professionals who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radionuclides.
Croatian: Radiofarmaceutike smiju primjenjivati ili njihovu primjenu nadgledati samo kvalificirani zdravstveni radnici sa specifičnom obukom i iskustvom u sigurnoj primjeni i rukovanju radionuklidima, i čije su iskustvo i obuku odobrile odgovarajuće vladine agencije koje izdaju dozvole za primjenu radionuklida.
English: After administration of SomaKit TOC, you should: - avoid any close contact with young children and pregnant women for 8 hours after the injection - urinate frequently in order to eliminate the product from your body.
Croatian: Nakon primjene lijeka SomaKit TOC trebali biste: - izbjegavati bliski kontakt s malom djecom i trudnicama 8 sati nakon injekcije - učestalo mokriti radi uklanjanja lijeka iz svojeg tijela.
English: • Developing tank
Croatian: • Spremnik za razvijanje
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 ionizing radiation (if there are any) should be offered to the patient.
Croatian: Ako postoji sumnja na trudnoću (ako je u žene izostala mjesečnica, ako je mjesečnica vrlo neredovita, itd.), bolesnici je potrebno ponuditi druge metode koje ne uključuju primjenu ionizirajućeg zračenja (ako su dostupne).
English: edotreotide.
Croatian: edotreotida.
English: There is no data if the intravenous administration of edotreotide produces variation of serum gastrin and serum glucagon levels.
Croatian: Nema podataka o tome dovodi li intravenska primjena edotreotida do varijacije razina serumskog gastrina i serumskog glukagona.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Croatian: Moguća reakcija preosjetljivosti ili anafilaktičke reakcije Ako nastupi reakcija preosjetljivosti ili anafilaktička reakcija, mora se odmah prekinuti primjena lijeka i prema potrebi započeti intravensko liječenje.
English: Acceptance Criteria Method
Croatian: Kriteriji prihvatljivosti
English: Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Croatian: Specijalist nuklearne medicine obavijestit će vas o uobičajenom trajanju postupka.
English: Before administering radiopharmaceuticals to a mother who is breastfeeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Croatian: Prije primjene radiofarmaceutika u majke koja doji potrebno je razmotriti mogućnost odgode primjene radionuklida sve dok majka ne prekine dojenje, te izabrati najprikladniji radiofarmaceutik, imajući na umu količinu aktivnosti koja se izluči u majčino mlijeko.
English: In case of extravasation, the injection must be stopped, the site of injection must be changed and the affected area should be irrigated with sodium chloride solution.
Croatian: U slučaju ekstravazacije ubrizgavanje se mora prekinuti i promijeniti mjesto ubrizgavanja, a zahvaćeno područje isprati otopinom natrijevog klorida.
English: If possible, for more convenience in the preparation of radiolabelled SomaKit TOC, the heating platform should be placed right beside the generator.
Croatian: Ako je moguće, radi praktičnosti tijekom pripreme radioaktivno obilježenog lijeka SomaKit TOC, grijaću ploču treba postaviti neposredno pored generatora.
English: Elute the generator directly into the Vial 1 (through the needle).
Croatian: Eluirajte generator izravno u bočicu 1 (kroz iglu).
English: Do not store above 25°C after radiolabelling.
Croatian: Ne čuvati na temperaturi iznad 25°C nakon radioaktivnog obilježavanja.
English: As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas).
Croatian: Na primjer, povećanje gustoće somatostatinskih receptora može se pojaviti u sljedećim patološkim stanjima: subakutnim upalama (područja koncentracije limfocita), tiroidnim bolestima (npr. tiroidna autonomija i Hashimotova bolest), tumorima hipofize, karcinomu pluća (karcinomu malih stanica), meningeomima, karcinomima dojke, limfoproliferativnim bolestima (npr. Hodgkinovoj bolesti i non-Hodgkinovim limfomima) i tumorima koji nastaju iz tkiva koja embriološki potječu od neuralnog grebena (npr. paragangliomima, medularnim karcinomima štitne žlijezde, neuroblastomima, feokromocitomima).
English: At the chemical concentrations used for diagnostic examinations, gallium (68Ga) edotreotide does not appear to have any clinically relevant pharmacodynamic effect.
Croatian: U kemijskim koncentracijama koje se upotrebljavaju za dijagnostičke pretrage, ne čini se da galijev [68Ga] edotreotid ima ikakav klinički relevantan farmakodinamički učinak.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total activity: ________MBq
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Ukupna aktivnost: ________MBq
English: Genotoxicity studies on 1,10-phenanthroline available in the literature show negative results in bacterial mutation assay (Ames test), while in a mouse lymphoma assay an indication of possible genotoxicity was obtained at concentrations 750 times higher than the maximum 1,10-phenanthroline blood concentration achievable in patients.
Croatian: Ispitivanja genotoksičnosti provedena na 1,10-fenantrolinu dostupna u literaturi pokazuju negativne rezultate pri testiranju mutacija na bakteriji (Amesov test), a pri testiranju limfoma u miševa otkrivena je moguća genotoksičnost pri koncentracijama koje su 750 puta više od maksimalne koncentracije 1,10-fenantrolina koju je moguće postići u krvotoku bolesnika.
English: A low dead space 1 ml plastic syringe must be used in order to precisely measure the adequate volume of reaction buffer to be added during the preparation.
Croatian: Mora se koristiti plastična štrcaljka od 1 ml s malo mrtvog prostora radi preciznog mjerenja odgovarajućeg volumena reakcijskog pufera koji se dodaje tijekom pripreme.
English: Reaction buffer
Croatian: Reakcijski pufer
English: Elderly population No special dosage regimen for elderly patients is required.
Croatian: Za starije bolesnike nije potrebna nikakva prilagodba doze.
English: Gallium (68Ga) edotreotide contains a small amount of radioactivity.
Croatian: Galijev [68Ga] edotreotid sadržava malu količinu radioaktivnosti.