FrancophonIA/ELRC3.0 huggingface dataset:
English: Miscellaneous: forceps, scissors, syringes, appropriate counting assembly.
Croatian: - Razno: Hvataljka, škare, štrcaljke, odgovarajući komplet za očitavanje.
English: For diagnostic nuclear medicine investigations the frequency of these adverse reactions is not known.
Croatian: Za dijagnostičke postupke u sklopu nuklearne medicine učestalost ovih nuspojava nije poznata.
English: However, after sodium pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained.
Croatian: Međutim, nakon što je dodan natrijev pertehnetat (99mTc), mora se održavati odgovarajuća zaštita konačnog pripravka.
English: Besilesomab has no effect on activation of complement, granulocyte function or platelets.
Croatian: Besilesomab ne utječe na aktivaciju komplementa, funkciju granulocita ili trombocita.
English: Notes on the instructions - Solvent for Scintimun must NEVER be radiolabelled first and then added to Scintimun.
Croatian: Napomene uz upute - NIKAD SE NE SMIJE najprije radioaktivno obilježiti Otapalo za Scintimun, a onda ga dodati
English: The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.
Croatian: Učinkovita doza kao posljedica primjene aktivnosti od 800 MBq odrasloj osobi tjelesne težine od 70 kg iznosi 6,9 mSv.
English: If you wish, you can express and store your breast milk before your injection.
Croatian: Ako želite, mlijeko možete izdojiti i pohraniti prije nego primite lijek.
English: Hypersensitivity to the active substance, to other murine antibodies, 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 druga mišja protutijela, na neku od pomoćnih tvari navedenih u dijelu 6.1 ili na neku komponentu obilježenog radiofarmaceutika.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Croatian: Svaku ženu kod koje je izostala menstruacija treba smatrati trudnom sve dok se trudnoća ne isključi.
English: Fill in the enclosed label and fix it to the radiolabelled solution.
Croatian: Ispunite priloženu naljepnicu i nalijepite je na radioaktivno obilježenu otopinu.
English: Containers: appropriate containers such as chromatography tank or 1 000 mL Erlenmeyer flasks.
Croatian: - Spremnici: Odgovarajući spremnici poput spremnika za kromatografiju ili Erlenmeyerove tikvice od 1000 ml.
English: Medicines reducing inflammation and medicines affecting the production of your blood cells (such as corticosteroids or antibiotics) may affect the results of your examination.
Croatian: Lijekovi koji smanjuju upalu i lijekovi koji djeluju na stvaranje krvnih stanica (poput kortikosteroida ili antibiotika) mogu utjecati na rezultat pretrage.
English: There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging.
Croatian: Trenutno ne postoje kriteriji za razlikovanje infekcije od upale na temelju slikovnih prikaza dobivenih pomoću Scintimuna.
English: The total volume in the vial of Scintimun equals 3 to 8 mL.
Croatian: Ukupni volumen u bočici Scintimuna iznosi 3 do 8 ml.
English: METHOD OF ADMINISTRATION Not intended for direct application to patients.
Croatian: Nije namijenjeno za izravnu primjenu bolesniku.
English: The radiochemical purity (the percentage of bound Technetium (99mTc)) must be more than or equal to 95 %.
Croatian: Radiokemijska čistoća (postotak vezanog tehnecija (99mTc)) mora biti jednaka ili veća od 95 %.
English: Method Instant thin layer chromatography or paper chromatography.
Croatian: Metoda Brza tankoslojna kromatografija ili kromatografija na papiru
English: Therefore you should not receive Scintimun a second time.
Croatian: Zato se Scintimun ne smije primijeniti dvaput.
English: Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction
Croatian: Razvoj ljudskih anti-mišjih protutijela koja reagiraju na protutijelo prisutno u Scintimunu (protutijelo mišjih stanica) uz rizik nastanka alergijske reakcije.
English: Twenty-four hours after injection, the percentages of radioactivity are 1.6 % in the liver and 2.3 % in the spleen.
Croatian: 24 sata nakon injiciranja postotak radioaktivnosti u jetri iznosi 1,6 %, a u slezeni 2,3 %.
English: If you have been given more Scintimun than you should An overdose is unlikely because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions.
Croatian: Predoziranje nije vjerojatno budući da injekciju lijeka priprema bolničko osoblje kao jednostruku dozu pod strogo kontroliranim uvjetima.
English: Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called granulocytes (a type of white blood cells involved in the inflammation process) in your body.
Croatian: Scintimun je lijek koji sadrži protutijelo (besilesomab) koje se veže na specifične stanice u Vašem tijelu zvane granulociti (to je vrsta bijelih krvnih stanica koje sudjeluju u upalnom procesu).
English: One mL of the radiolabelled solution contains less than 4 mg of sodium.
Croatian: Jedan ml radioaktivno obilježene otopine sadrži manje od 4 mg natrija.
English: Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.
Croatian: Besilesomab je monoklonsko protutijelo protiv granulocita (BW 250/183), proizvedeno na mišjim stanicama.
English: Technetium(99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.
Croatian: Tehnecij (99mTc) je radioaktivni element koji omogućuje da se organi u kojima se besilesomab nakuplja prikažu pomoću posebnih kamera.
English: Contents of the vial are intended only for use in the preparation of technetium(99mTc) besilesomab and are not to be administered directly to the patient without first undergoing the preparative procedure.
Croatian: Sadržaj bočice je namijenjen samo za primjenu prilikom pripreme tehnecijevog (99mTc) besilesomaba i ne smije se primijeniti direktno bolesniku bez prethodnog obavljanja postupka pripreme.
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 se posavjetujete s Vašim liječnikom nuklearne medicine koji će nadzirati postupak.
English: False results may be obtained in patients with diseases involving neutrophil defects and to patients with haematological malignancies including myeloma.
Croatian: Lažni rezultati mogu nastati i u bolesnika koji boluju od bolesti koje uključuju oštećenje neutrofila, te u bolesnika s malignim hematološkim bolestima uključujući mijelom.
English: The recommended activity of technetium (99mTc) besilesomab should be between 400 MBq and
Croatian: Preporučena aktivnost tehnecijevog (99mTc) besilesomaba treba biti između 400 MBq i 800 MBq.
English: However, due to the nature of the molecule and the short half-life of technetium (99mTc) besilesomab, dose adjustment is not necessary in such patients.
Croatian: Ipak, zbog svojstava molekule i kratkog poluvijeka tehnecijevog (99mTc) besilesomaba, prilagodba doze u tih bolesnika nije potrebna.
English: Disinfect the septum and allow drying.
Croatian: Dezinficirajte septum i pričekajte da se osuši.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Croatian: Čuvanje ovog lijeka u odgovarajućem prostoru je odgovornost specijaliste.
English: Whole blood concentration-time radioactivity curves show a two-phase course, which can be subdivided into an early phase (0-2 h) and a late phase (5-24 h).
Croatian: Krivulja ovisnosti koncentracije o vremenu radioaktivnosti u punoj krvi je bifazična, i može se podijeliti u ranu (0-2 h) i kasnu fazu (5-24 h).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: Talk to the nuclear medicine specialist before using Scintimun: - if you have previously been administered Scintimun, because you should only be administered
Croatian: Obratite se specijalistu nuklearne medicine prije nego primijenite Scintium: - ako ste ranije primili Scintimun, jer Scintimun se smije primiti samo jedanput u životu.
English: Duration of the procedure Your Nuclear medicine doctor will inform you about the usual duration of the procedure.
Croatian: Vaš liječnik nuklearne medicine će Vam reći koliko dugo obično traje postupak.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu strip of activity
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: 10 min after the addition of pertechnetate (99mTc) the solution is ready for injection.
Croatian: 10 minuta nakon dodavanja pertehnetata (99mTc) otopina je spremna za injiciranje.
English: If the administration is considered necessary, breast-feeding should be interrupted for three days and the expressed feeds discarded.
Croatian: Ako je primjena neophodna, dojenje je potrebno prekinuti na tri dana, a izdojeno mlijeko baciti.
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 what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Croatian: Prije primjene radiofarmaceutika majci koja doji, potrebno je razmotriti mogućnost odgode primjene radionuklida do prestanka dojenja i provjeriti je li izabran najprikladniji radiofarmaceutik, a imajući u vidu njegovu aktivnost u izlučenom majčinom mlijeku.
English: If you are not sure if you have been given this medicine before,
Croatian: Ako niste sigurni -jeste li ranije primili ovaj lijek, molimo recite to svom liječniku.
English: The activity must be between 400 and 1800 MBq depending on the volume of pertechnetate (99mTc).
Croatian: 400 i 1800 MBq ovisno o volumenu pertehnetata (99mTc).
English: The solution should be inspected visually prior to use.
Croatian: Prije uporabe otopinu je potrebno vizualno pregledati.
English: Possible side effects are listed in the order of their frequency below:
Croatian: Moguće nuspojave navedene su u nastavku prema svojoj učestalosti:
English: For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i radioaktivnog obilježavanja lijeka vidjeti u dijelu 6.3.
English: Genotoxicity studies conducted to test for potentially genotoxic impurities were also negative.
Croatian: Rezultati ispitivanja genotoksičnosti, provedena radi ispitivanja potencijalno genotoksičnih nečistoća,
English: You must inform the nuclear medicine doctor before the administration of Scintimun if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Croatian: Morate obavijestiti liječnika nuklearne medicine prije primjene Scintimuna ako postoji mogućnost da ste trudni ili ako Vam je izostala mjesečnica ili ako dojite.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/602/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/602/001
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2 °C - 8 °C).
English: After complete dissolution, disinfect the septum and allow drying.
Croatian: Nakon što ste pripremili otopinu dezinficirajte septum i pričekajte da se osuši.
English: The Marketing Authorisation Holder shall ensure that, at launch, all physicians experienced in nuclear medicine who are expected to prescribe/use Scintimun are provided with a Direct Healthcare Professional Communication (DHPC), which includes information regarding potential risks of human anti-mouse antibody (HAMA) generation, hypersensitivity reactions and risks of acute hypotension, as agreed by CHMP.
Croatian: • Dodatne mjere minimizacije rizika Nositelj odobrenja za stavljanje lijeka u promet treba osigurati da, u trenutku stavljanja lijeka u promet, svi liječnici s iskustvom iz nuklearne medicine od kojih se očekuje da će propisivati/primjenjivati Scintimun prime Pismo zdravstvenim djelatnicima (DHPC - Direct Healthcare Professional Communication), koje uključuje informacije o mogućem riziku stvaranja ljudskog protutijela na mišji antigen, reakcijama preosjetljivosti i rizicima za akutnu hipotenziju, kako je to odredilo Povjerenstvo za humane lijekove (CHMP).
English: Preclinical data obtained with the non-radioactive compound reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose and repeated-dose toxicity, although antimurine antibodies were found in all dose groups (including controls) in a repeated-dose study in monkeys.
Croatian: Pretklinički podaci prikupljeni konvencionalnim ispitivanjima farmakološke sigurnosti, ispitivanjima toksičnosti jednokratne doze i ponovljenih doza, korištenjem pripravka bez radioaktivnog djelovanja, nisu pokazali postojanje posebnog rizika za ljude, iako su anti-mišja protutijela pronađena u svim skupinama (uključujući i kontrolne skupine) prilikom ispitivanja ponovljene doze na majmunima.
English: If you are breast-feeding you must stop breast-feeding for 3 days after your injection and the expressed milk should be discarded.
Croatian: Ako dojite, morate prekinuti dojenje na 3 dana nakon ubrizgavanja lijeka, a da izdojeno mlijeko bacite.
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: Ako se pojave preosjetljivost ili anafilaktičke reakcije, primjenu lijeka treba odmah prekinuti i po potrebi započeti intravenozno liječenje.
English: Non pathological unusual accumulations may be observed in the spleen (up to 6 % of the patients), in the bowel (up to 4 % of the patients), in the liver and bone marrow (up to 3 % of the patients), and in the thyroid and kidneys (up to 2 % of patients).
Croatian: 4 % bolesnika), u jetri i koštanoj srži (do 3 % bolesnika), u štitnjači i u bubrezima (do 2 % bolesnika).
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Croatian: Procjena individualnog omjera koristi i rizika Kod svakog bolesnika izloženost zračenju mora biti opravdana vjerojatnom koristi.
English: Hypersensitivity, including angioedema, urticaria
Croatian: Preosjetljivost, uključujući angioedem,
English: Solvent: methyl ethyl ketone (MEK)
Croatian: - Otapalo: Metiletilketon (MEK)
English: Pack sizes:
Croatian: Veličina pakiranja:
English: Besilesomab cross-reacts with tumours expressing carcinoembryonic antigen (CEA).
Croatian: Besilesomab unakrsno reagira s tumorima koji eksprimiraju karcinoembrionalni antigen (CEA).
English: It is not known if the product is excreted in human milk.
Croatian: Nije poznato izlučuje li se lijek u majčino mlijeko.
English: Preclinical toxicity and safety studies were performed using commercial kits reconstituted with decayed technetium (99mTc) and thus the effect of radiation has not been assessed.
Croatian: Pretklinička ispitivanja toksičnosti i sigurnosti primjene provedena su pomoću komercijalnog pripravka rekonstituiranog s raspadnutim tehnecijem (99mTc) stoga učinak zračenja nije ispitan.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION (99mTc)- Scintimun
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA (99mTc)- Scintimun
English: - If you have any further questions, ask your doctor or the nuclear medicine specialist who will supervise the procedure.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku ili specijalistu nuklearne medicine koji će nadgledati postupak.
English: Using a syringe, introduce through the rubber seal 5 mL of 0.9% sodium chloride solution.
Croatian: Pomoću šprice kroz gumeni čep injicirajte 5 ml 0,9 %-tne otopine natrijeva klorida.
English: False positive findings in patients with CEA expressing tumours cannot be excluded.
Croatian: Ne mogu se isključiti lažno pozitivni nalazi u bolesnika s tumorima s ekspresijom CEA.
English: The table below reports adverse reactions by MedDRA system organ classes.
Croatian: U dolje prikazanoj tablici navedene su nuspojave prema MedDRA klasifikaciji organskih sustava.
English: Scintimun: white powder Solvent for Scintimun: white powder
Croatian: OBLIK Set za pripravu radiofarmaceutika Scintimun: bijeli prašak Otapalo za Scintimun: bijeli prašak
English: For instructions on reconstitution and radiolabelling of the medicinal product before administration, see sections 12.
Croatian: Za upute o rekonstituciji i radioaktivnom obilježavanju lijeka prije primjene vidjeti dio 12.
English: Administration of murine monoclonal antibodies can lead to the development of Human Anti-Mouse Antibodies (HAMA).
Croatian: Primjena mišjih monoklonalnih protutijela može dovesti do nastanka humanih anti-mišjih protutijela.
English: Cut the strip in two separate parts at Rf = 0.5.
Croatian: Na Rf = 0,5 prerežite traku na dva odvojena dijela.
English: Introduce the ITLC-SG or RBM-1 paper strip immediately into the chromatography tank using forceps to avoid formation of pertechnetate (99mTc) due to oxygen.
Croatian: Pomoću hvataljke odmah unesite ITLC-SG ili papirnate trake RBM-1 u spremnik za kromatografiju kako bi se izbjegao nastanak pertehnetata (99mTc) pod utjecajem kisika.
English: Heart
Croatian: Srce
English: Inquiry on possible previous exposure to murine monoclonal antibodies and a HAMA test should be made prior to administration of Scintimun; a positive response would contraindicate the administration of Scintimun (see section 4.3).
Croatian: Bolesnike je potrebno ispitati o mogućem ranijem izlaganju mišjim monoklonskim protutijelima, te je potrebno učiniti testiranje na humana antimišja protutijela prije primjene Scintimuna; pozitivan rezultat testa predstavlja kontraindikaciju za primjenu Scintimuna (vidjeti dio 4.3).
English: If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.
Croatian: Ako se u bilo kojem trenutku pripreme lijeka bočica ošteti, ne smije ju se koristiti.
English: Scintimun must not be used: - if you are allergic to besilesomab, to antibody from mouse origin or any other antibodies, or to sodium pertechnetate (99mTc) solution or any of the other ingredients of this medicine listed in section 6.
Croatian: Scintimun se ne smije primijeniti: - ako ste alergični na besilesomab, na protutijela mišjeg porijekla ili neka druga protutijela, ili na otopinu natrijevog pertehnetata (99mTc) ili na neki drugi sastojak ovog lijeka naveden u dijelu - ako Vam je rezultat testa na prisutnost ljudskih anti-mišjih protutijela pozitivan (HAMA test).
English: Human anti-mouse antibody positive
Croatian: Pozitivni humani anti-mišji antigen
English: In the event of administration of a radiation overdose with technetium (99mTc) besilesomab, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding, and by the use of laxatives to promote faecal excretion.
Croatian: U slučaju primjene prekomjerne doze zračenja s tehnicijem (99mTc) besilesomabom, apsorbiranu dozu u bolesnika treba smanjiti gdje je to moguće povećanjem eliminacije radionuklida iz tijela forsiranom diurezom i čestim pražnjenjem mjehura, te primjenom laksativa radi poticanja izlučivanja stolicom.
English: Driving and using machines It is considered unlikely that Scintimun will affect your ability to drive or to use machines.
Croatian: Smatra se da je malo vjerojatno da će Scintimun utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX contains Blue Box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: Do not let air enter the vial to be tested and store all vials containing radioactive solution in lead shielding.
Croatian: Spriječite da zrak prodre u bočicu koja se testira, a sve bočice koje sadrže radioaktivnu otopinu čuvajte u spremniku s olovnom zaštitom.
English: Scintimun is used for the preparation of a radioactive solution for injection of technetium(99mTc)besilesomab.
Croatian: Scintimun se koristi za pripremu radioaktivne otopine za ubrizgavanje tehnecijevog (99mTc)
English: 800 MBq.
Croatian: odnosno 16,8 mGy.
English: Swirl carefully; the content of the vial of Scintimun will dissolve within one minute (DO NOT shake).
Croatian: Scintimun će se otopiti unutar jedne minute (NE mućkati).
English: How Scintimun is given
Croatian: Kako se daje Scintimun
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu čuvati u kutiji radi zaštite od svjetlosti.
English: Close contact with infants and pregnant women should be restricted during the first 12 hours after the injection.
Croatian: Bliski kontakt s dojenčadi i trudnicama treba ograničiti tijekom prvih 12 sata nakon injekcije.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika treba biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
English: However Scintimun should not be used for the diagnosis of diabetic foot infection.
Croatian: Međutim, Scintimun se ne smije koristiti za dijagnozu infekcije dijabetičkog stopala.
English: Scintimun is a sterile powder containing 1 mg of besilesomab per vial Scintimun.
Croatian: Scintimun je sterilan prašak koji sadrži 1 mg besilesomaba po bočici Scintimuna.
English: Formal studies have not been performed in patients with renal or hepatic impairment.
Croatian: Službena ispitivanja na bolesnicima s oštećenom funkcijom bubrega i jetre nisu provedena.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/602/001 one multidose vial Scintimun and one vial solvent for Scintimun EU/1/09/602/002 two multidose vials Scintimun and two vials solvent for Scintimun
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/602/001 višedozna bočica Scintimuna i jedna bočica otapala za Scintimun
English: Uncommon (may affect up to 1 in 100 people): Allergic reaction, including swelling of the face, hives (urticaria)
Croatian: Rijetke (mogu se pojaviti u do 1 na 1000 osoba): • Ozbiljna alergijska reakcija koja uzrokuje poteškoće s disanjem ili omaglicu
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Manje česte (mogu se pojaviti u do 1 na 100 osoba):
English: In order to obtain images of best quality and to reduce the radiation exposure of the bladder, patients should be encouraged to drink sufficient amounts and to empty their bladder prior to and after the scintigraphic examination.
Croatian: U cilju dobivanja slikovnih prikaza najbolje kvalitete te radi smanjivanja izloženosti mokraćnog mjehura bolesnike je potrebno poticati da unose dovoljnu količinu tekućine te da isprazne mjehur prije i nakon scintigrafskog snimanja.
English: Close contact with infants should be restricted during the first 12 hours after the injection.
Croatian: Bliski kontakt s dojenčadi treba ograničiti tijekom prvih 12 sati nakon injekcije.
English: 4.5 Interaction with other medicinal products and other forms of interaction Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics and corticosteroids) may lead to false negative results.
Croatian: Djelatne tvari koje inhibiraju upalne procese ili utječu na hematopoetski sustav (poput antibiotika i kortikosteroida) mogu dovesti do lažno negativnog rezultata.
English: Should you have any further questions on the use of Scintimun, please ask the nuclear medicine doctor who supervises the procedure.
Croatian: Ako imate bilo kakvih pitanja u vezi s primjenom Scintimuna, obratite se liječniku nuklearne medicine koji nadzire postupak.