FrancophonIA/ELRC3.0 huggingface dataset:
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 liječniku specijalistu nuklearne medicine za savjet prije nego što Vam se da ovaj lijek.
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 potencijalom za razvoj nasljednih mana.
English: At the chemical concentrations used for diagnostic examinations, Striascan does not appear to have any pharmacodynamic activity.
Croatian: Čini se da pri koncentracijama koje se primjenjuju za dijagnostičke preglede Striascan nema nikakvu farmakodinamičku aktivnost.
English: • In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.
Croatian: • U odraslih bolesnika s klinički nesigurnim parkinsonizmom, na primjer u onih s ranim simptomima, kao pomoć u razlikovanju esencijalnog tremora od parkinsonizma povezanog s idiopatskom Parkinsonovom bolešću, multiplom sistemskom atrofijom i progresivnom supranuklearnom paralizom.
English: Route Nationale 306
Croatian: CIS bio international Route Nationale 306
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 obavijestit će Vas ako je potrebno poduzeti bilo kakve posebne mjere opreza nakon primanja ovog lijeka.
English: As the effective dose is 4.6 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
Croatian: S obzirom na to da je učinkovita doza 4,6 mSv kad se primjenjuje maksimalna preporučena aktivnost od 185 MBq, postoji mala vjerojatnost od pojave ovih štetnih događaja.
English: Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use.
Croatian: Eksperimentalna ispitivanja na modelu striatuma pokazuju da se optimalne snimke postižu veličinom matrice i faktorima povećanja odabranim kako bi dali veličinu piksela od 3,5-4,5 mm za sustave koji su trenutno u uporabi.
English: Activity in the liver is excreted according to the Publication 53 gallbladder model (ICRP, 1987), where 30% is eliminated via the gallbladder and the remainder passes directly into the small intestine.
Croatian: Aktivnost iz jetre izlučuje se u skladu s modelom žučnog mjehura iz ICRP Publikacije 53 (ICRP, 1987.), u kojem se 30 % eliminira preko žučnog mjehura, a ostatak prolazi izravno u tanko crijevo.
English: Animal reproductive toxicity studies have not been performed with this product.
Croatian: Ispitivanja reproduktivne toksičnosti na životinjama nisu provedena za ovaj lijek.
English: Striascan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
Croatian: Striascan je indiciran za detekciju gubitka funkcije završetaka dopaminergičnih neurona u striatumu:
English: In the absence of data, Striascan is not recommended in cases of moderate to severe renal or hepatic impairment.
Croatian: U nedostatku podataka, Striascan se ne preporučuje u slučajevima umjerenog do teškog oštećenja funkcije bubrega ili jetre.
English: The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Croatian: Pozitivna prediktivna vrijednost bila je u rasponu od 78,9 % do 84,4 %, a negativna prediktivna vrijednost od 86,1 % do 88,7 %.
English: Clinical efficacy has been demonstrated across the range 110 to 185 MBq.
Croatian: Klinička djelotvornost dokazana je za raspon od 110 do 185 MBq.
English: Talk to your nuclear medicine doctor before using this medicine if you have moderate or severe problems with your kidneys or liver.
Croatian: Obratite se svom liječniku specijalistu nuklearne medicine prije nego primite ovaj lijek ako imate umjerene ili teške probleme s bubrezima ili jetrom.
English: To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Croatian: To je potrebno uzeti u obzir kod visokorizičnih skupina poput bolesnika s bolešću jetre ili epilepsijom.
English: I) results in an absorbed dose to the uterus of 2.6 mGy.
Croatian: I) rezultira apsorbiranom dozom od 2,6 mGy za uterus.
English: Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with Striascan imaging and can therefore be continued if desired.
Croatian: Ne očekuje se da agonisti i antagonisti dopamina koji djeluju na postsinaptičke dopaminske receptore utječu na snimanje Striascanom te se stoga mogu nastaviti primjenjivati po želji.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Croatian: Radionuklidni postupci koji se provode u trudnice uključuju i određenu dozu zračenja fetusa.
English: Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.
Croatian: Snimke treba napraviti uz pomoć gama kamere opremljene kolimatorom visoke rezolucije i kalibrirane koristeći maksimalnu energiju od 159 keV i energetski prozor ± 10 %.
English: Uncommon: may affect up to 1 in 100 people - Increased appetite - Dizziness - Taste disturbance - Nausea - Dry mouth - Vertigo - A brief irritating feeling similar to ants crawling over your skin (formication) - Intense pain (or burning sensation) at the injection site.
Croatian: Manje često: mogu se javiti u do 1 na 100 osoba - Pojačan apetit - Omaglica - Poremećaj okusa - Mučnina - Suha usta - Vrtoglavica - Kratak iritirajući osjećaj kao da Vam mravi hodaju po koži (mravinjanje) - Intenzivna bol (ili osjećaj pečenja) na mjestu primjene injekcije.
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: Mogućnost preosjetljivosti ili anafilaktičkih reakcija Ako dođe do preosjetljivosti ili anafilaktičke reakcije, primjenu lijeka treba odmah prekinuti i po potrebi započeti intravensko liječenje.
English: The complete Summary of Product Characteristics (SmPC) of Striascan is provided as a separate document in the product packaging, 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 Striascan isporučen je kao zaseban dokument u pakiranju lijeka, s ciljem pružanja drugih dodatnih znanstvenih i praktičnih informacija o primjeni i upotrebi ovog radiofarmaceutika zdravstvenim radnicima.
English: For an administered activity of 185 MBq the typical radiation dose to the target organ (brain) is 3 mGy and the typical radiation doses to the critical organs: liver and colon wall are 16 mGy and 11 mGy, respectively.
Croatian: Za primijenjenu aktivnost od 185 MBq tipična doza zračenja za ciljni organ (mozak) je 3 mGy, a tipične doze zračenja za kritične organe: jetru i stijenku debelog crijeva su 16 mGy, odnosno 11 mGy.
English: What Striascan is and what it is used for What you need to know before Striascan is used How Striascan is used
Croatian: Što je Striascan i za što se koristi Što morate znati prije nego primite Striascan Kako se primjenjuje Striascan Moguće nuspojave
English: • In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's disease.
Croatian: • U odraslih bolesnika, kao pomoć u razlikovanju moguće demencije Lewyjevih tjelešaca od Alzheimerove bolesti.
English: At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
Croatian: 48 sati nakon injiciranja, oko 60 % injicirane radioaktivnosti izlučeno je putem urina, a izlučivanje putem fecesa izračunato je na otprilike 14 %.
English: Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of Striascan.
Croatian: Bolesnici moraju primiti odgovarajuću terapiju za blokadu štitne žlijezde prije injekcije, kako bi se minimalizirao unos radioaktivnog joda u štitnjaču, na primjer peroralnim uzimanjem otprilike 120 mg kalijevog jodida 1 do 4 sata prije injekcije Striascana.
English: I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.
Croatian: I) se nakon intravenske injekcije brzo uklanja iz krvi; 5 minuta nakon injekcije u svoj krvi preostaje samo 5 % primijenjene aktivnosti.
English: Marketing authorisation holder and manufacturer: CIS bio international
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač: CIS bio international
English: I): 74 MBq/mL at reference time
Croatian: I): 74 MBq/ml u referentnom vremenu.
English: The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter)
Croatian: Vrijednosti su izračunate uz pretpostavku pražnjenja mokraćnog mjehura u 4,8-satnim intervalima i uz odgovarajuću blokadu štitne žlijezde (Jod-123 je poznat kao emiter Augerovih elektrona).
English: If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding.
Croatian: Ako se primjena smatra neophodnom, dojenje se mora prekinuti na 3 dana i za to vrijeme koristiti zamjensko mlijeko.
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 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 dojilje potrebno je razmotriti mogućnost odgode primjene radionuklida do prestanka dojenja i provjeriti koji bi radiofarmaceutik bio najprikladniji imajući u vidu izlučivanje aktivnosti u majčino mlijeko.
English: Striascan should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia.
Croatian: Striascan se smije koristiti samo u odraslih bolesnika prema preporuci liječnika s iskustvom u liječenju poremećaja pokreta i/ili demencije.
English: Method of administration Striascan is for intravenous use.
Croatian: Način primjene Striascan je za intravensku primjenu.
English: Medicinal products shown in animal studies not to interfere with Striascan imaging include pergolide.
Croatian: Lijekovi za koje je u ispitivanjima na životinjama pokazano da ne utječu na snimanje Striascanom uključuju pergolid.
English: The effective dose (E) resulting from administration of 185 MBq of Striascan injection is 4.6 mSv (per 70 kg individual).
Croatian: Efektivna doza (E) nakon primjene 185 MBq Striascana je 4,6 mSv (po pojedincu tjelesne težine 70 kg).
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Striascan to be used in your case.
Croatian: Vaš liječnik specijalist nuklearne medicine koji nadgleda postupak odredit će količinu Striascana koja će se primijeniti u Vašem slučaju.
English: A minimum of 500 k counts should be collected for optimal images.
Croatian: Za optimalne slike potrebno je prikupiti broj od najmanje 500 k impulsa.
English: When renal or hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be increased.
Croatian: Kod oštećenja bubrežne ili jetrene funkcije, efektivna doza i apsorbirana doza zračenja organa mogu biti veće.
English: Very common (1/10) Common
Croatian: Vrlo često ( 1/10) Često
English: Injection site pain (intense pain or burning sensation following administration into small veins)
Croatian: Bol na mjestu injiciranja (jaka bol ili osjećaj pečenja nakon primjene u male vene)
English: Volume: 5 mL
Croatian: Volumen: 5 ml
English: These include: - amfetamine, - benzatropine, - bupropion, - cocaine, - mazindol, - methylphenidate, - phentermine and - sertraline.
Croatian: To uključuje: - amfetamin, - benzatropin, - bupropion, - kokain, - mazindol, - metilfenidat, - fentermin i - sertralin.
English: Precautions to be taken before handling or administering the medicinal product Striascan should be used without dilution.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Striascan se treba koristiti bez razrjeđivanja.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Croatian: Ovaj lijek je radiofarmaceutik i primjenjuje se samo u dijagnostičke svrhe.
English: I) images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Croatian: I) uspoređeni su s kliničkom dijagnozom postavljenom od strane liječnika s iskustvom u liječenju i dijagnosticiranju demencija.
English: Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.
Croatian: Striascanom nije moguće razlikovati demenciju Lewyjevih tjelešaca od demencije u Parkinsonovoj bolesti.
English: If you are breast-feeding, your nuclear medicine doctor may delay the use of this product or ask you to stop breast-feeding.
Croatian: Ako dojite, liječnik specijalist nuklearne medicine može odgoditi uporabu ovog lijeka ili od Vas zatražiti da prestanete dojiti.
English: Before administration of Striascan 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 study.
Croatian: Prije primjene Striascana i prije početka pretrage trebate piti puno vode kako biste što češće mokrili u prvim satima nakon pretrage.
English: E 1510 (see leaflet for further information), E 260, E 262, E 338, water for injections.
Croatian: E1510 (za dodatne informacije pogledajte uputu o lijeku), E260, E262, E338, voda za injekcije.
English: Active substances shown during clinical trials not to interfere with Striascan imaging include: - amantadine, - trihexyphenidyl, - budipine, - levodopa, - metoprolol, - primidone, - propranolol and - selegiline.
Croatian: Djelatne tvari za koje se tijekom kliničkih ispitivanja pokazalo da ne utječu na snimanje Striascanom uključuju: - amantadin, - triheksifenidil, - budipin, - levodopu, - metoprolol, - primidon, - propranolol i - selegilin.
English: The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.
Croatian: Bolesnike prije početka pregleda treba dobro hidrirati te poticati na što češće mokrenje u prvim satima nakon pregleda kako bi se smanjilo zračenje.
English: Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine.
Croatian: Liječnik specijalist nuklearne medicine preporučit će Vam da pijete puno tekućine kako bi se ubrzalo izlučivanje lijeka iz tijela.
English: Saclay BP 32
Croatian: Saclay B.P.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Croatian: Za čuvanje ovog lijeka u odgovarajućim uvjetima odgovoran je specijalist.
English: Contents of the pack and other information
Croatian: Kako se čuva Striascan Sadržaj pakiranja i druge informacije
English: Striascan is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.
Croatian: Striascanom nije moguće razlikovati Parkinsonovu bolest od multiple sistemske atrofije i progresivne supranuklearne paralize.
English: What you need to know before Striascan is used
Croatian: Što morate znati prije nego primite Striascan
English: Salivary glands Skin
Croatian: Žlijezde slinovnice Koža
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Croatian: Liječnik specijalist nuklearne medicine reći će Vam koliko dugo obično traje postupak.
English: Volume: 2.5 mL
Croatian: Volumen: 2,5 ml
English: Clinical studies in patients with dementia with Lewy bodies.
Croatian: Klinička ispitivanja u bolesnika s demencijom Lewyjevih tjelešaca.
English: Studies in animals have shown that ioflupane binds with high affinity to the presynaptic dopamine transporter and so radiolabelled ioflupane (
Croatian: Ispitivanja na životinjama pokazala su da ioflupan ima visok afinitet vezanja za presinaptičke prijenosnike dopamina te se radiooznačeni ioflupan (
English: Erythema, pruritus, rash, urticaria, hyperhidrosis
Croatian: Eritem, pruritus, osip, urtikarija, hiperhidroza
English: In the event of administration of a radiation overdose, frequent micturition and defaecation should be encouraged in order to minimise radiation dose to the patient.
Croatian: U slučaju primjene prekomjerne doze zračenja, potrebno je potaknuti učestalo mokrenje i defekaciju kako bi se smanjila doza zračenja bolesnika.
English: These stop the radioactivity building-up in your thyroid gland.
Croatian: To sprečava nakupljanje radioaktivnosti u Vašoj štitnoj žlijezdi.
English: • methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
Croatian: • metilfenidat (koristi se za liječenje hiperaktivnosti kod djece i narkolepsije (pretjerane pospanosti))
English: The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.
Croatian: Osjetljivost je bila u rasponu od 60,6 % do 63,4 %, a specifičnost od 88,6 % do 91,4 % kad su mogući bolesnici s DLT-om bili uključeni kao bolesnici s DLT-om.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Zbog toga je nužno je primijeniti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: Striascan is given to you as an injection, usually into a vein in your arm. A single injection is enough.
Croatian: Vam se daje injekcijom, obično u venu na ruci.
English: Striascan has no known influence on the ability to drive and use machines.
Croatian: Striascan ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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 liječnikom specijalistom nuklearne medicine koji će nadgledati postupak.
English: Precautions with respect to environmental hazard see section 6.6.
Croatian: Za mjere opreza koje se odnose na onečišćenje okoliša vidjeti dio 6.6.
English: Analyses in which both possible and probable DLB patients were compared with nonDLB dementia patients demonstrated values for the sensitivity of ioflupane (
Croatian: Analiza u kojoj su i mogući i vjerojatni bolesnici s DLT-om uspoređeni s bolesnicima s ne-DLT demencijom prikazuje osjetljivost ioflupana (
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Croatian: Potrebno je pažljivo donijeti odluku o aktivnosti koju je potrebno primijeniti jer je u takvih bolesnika moguća povećana izloženost zračenju.
English: Striascan must not be used
Croatian: Striascan se ne smije primijeniti:
English: EXP: DD/MM/YYYY xx h xx CET
Croatian: EXP: DD/MM/GGGG xx (sati):xx (minuta) po srednjoeuropskom vremenu
English: • bupropion (used to treat depression (sadness))
Croatian: • bupropion (koristi se za liječenje depresije (tuge))
English: Acetic acid, glacial (E 260) Sodium acetate, trihydrate (E 262) Ethanol, anhydrous (E 1510) Phosphoric acid, concentrated (E 338) Water for injections
Croatian: Acetatna kiselina, ledena (E260) Natrijev acetat, trihidrat (E262) Etanol, bezvodni (E1510) Fosfatna kiselina, koncentrirana (E338) Voda za injekcije
English: • parkinsonism (including Parkinson's disease) and
Croatian: • parkinsonizma (uključujući Parkinsonovu bolest) i • demencije Lewyjevih tjelešaca.
English: Active substances that bind to the dopamine transporter with high affinity may therefore interfere with Striascan diagnosis.
Croatian: Djelatne tvari s visokim afinitetom vezanja na prijenosnik dopamina stoga mogu ometati dijagnostiku Striascanom.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Croatian: Potrebno je pažljivo procijeniti omjer koristi i rizika jer je u takvih bolesnika moguća povećana izloženost zračenju.
English: - The other ingredients are acetic acid, glacial (E 260); sodium acetate trihydrate (E 262), ethanol, anhydrous (E 1510); phosphoric acid, concentrated (E 338) and water for injections.
Croatian: Drugi sastojci su acetatna kiselina, ledena (E260); natrijev acetat, trihidrat (E262); etanol, bezvodni (E1510); fosfatna kiselina, koncentrirana (E338) i voda za injekcije.
English: Administration of Striascan and conduct of the procedure Before you receive Striascan, your nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine.
Croatian: Prije nego primite Striascan, liječnik specijalist nuklearne medicine uputit će Vas da uzmete određene tablete ili tekućinu koji sadrže jod.
English: How Striascan is used
Croatian: Kako se primjenjuje Striascan
English: Uncommon (1/1,000 to <1/100) Rare
Croatian: Manje često ( 1/1000 i < 1/100) Rijetko ( 1/10 000 i < 1/1000) Vrlo rijetko (< 1/10 000)
English: 2.5 mL vial 35 hours from the end of synthesis (7 hours from the activity reference time stated on the label)
Croatian: 35 sati od završetka sinteze (7 sati od referentnog vremena aktivnosti navedenog na naljepnici) Bočica s 5 ml otopine
English: Pack size: 1 vial containing 2.5 mL or 5 mL.
Croatian: Pakiranje: 1 bočica koja sadrži 2,5 ml ili 5 ml.
English: - Hypersensitivity (allergic) - Shortness of breath - Redness of the skin - Itching - Rash - Hives (urticaria) - Excessive sweating - Vomiting - Low blood pressure - Feeling hot.
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka - Preosjetljivost (alergijska) - Nedostatak zraka - Crvenilo kože - Svrbež - Osip - Koprivnjača (urtikarija) - Prekomjerno znojenje - Povraćanje - Nizak krvni tlak - Osjećaj vrućine
English: For all organs and tissues, 80% is assumed to be excreted with a biological half-time of 58 h, and 20% with a half-time of 1.6 h. It is further assumed that 60% of the injected activity is excreted to the urine, and 40% is excreted to the gastrointestinal tract for all organs and tissues.
Croatian: Za sve organe i tkiva pretpostavlja se da se 80 % izluči s biološkim poluvremenom od 58 sati, a 20 % s poluvremenom od 1,6 h.
English: 15 mL amber glass vial sealed with a rubber closure and metal overseal.
Croatian: Bočica od smeđeg stakla od 15 ml zatvorena gumenim čepom i metalnim prstenom.
English: Striascan 74 MBq/mL solution for injection ioflupane (
Croatian: Striascan 74 MBq/ml otopina za injekciju ioflupan (
English: 185 MBq / vial at ref. (see outer label) 74 MBq / mL
Croatian: 185 MBq/bočica u ref. (vidjeti vanjsko pakiranje) 74 MBq/ml
English: 370 MBq / vial at ref. (see outer label) 74 MBq / mL
Croatian: 370 MBq/bočica u ref. (vidjeti vanjsko pakiranje) 74 MBq/ml
English: 5 mL vial 48 hours from the end of synthesis (20 hours from the activity reference time stated on the label)
Croatian: 48 sati od završetka sinteze (20 sati od referentnog vremena aktivnosti navedenog na naljepnici) 6.4 Posebne mjere pri čuvanju lijeka