FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy Clinical studies in patients with dementia with Lewy bodies
Croatian: Klinička djelotvornost Klinička ispitivanja u bolesnika s demencijom s Lewyjevim tjelešcima
English: Metabolism and nutrition disorders Uncommon: Appetite increased
Croatian: Poremećaji metabolizma i prehrane Manje često: Povećanje apetita
English: General warning Normal safety precautions for handling radioactive materials should be observed.
Croatian: Potrebno je pratiti uobičajene sigurnosne mjere opreza za rukovanje radioaktivnim materijalima.
English: The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.63 mSv (per 70 kg individual).
Croatian: Efektivna doza (E) nakon primjene 185 MBq DaTSCAN-a je 4,63 mSv (po pojedincu tjelesne težine 70 kg).
English: Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been performed.
Croatian: Ispitivanja o reproduktivnoj toksičnosti te kancerogenosti ioflupana nisu provedena.
English: Fertility No fertility studies have been performed.
Croatian: Plodnost Nisu provedena ispitivanja plodnosti.
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 će Vam preporučiti da pijete puno tekućine kako bi se ubrzalo izlučivanje lijeka iz tijela.
English: SPECT imaging should take place between three and six hours post-injection.
Croatian: SPECT snimanje potrebno je obaviti između tri i šest sati nakon davanja injekcije.
English: If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding.
Croatian: Ako se uporaba smatra neophodnom, dojenje se mora prekinuti na 3 dana i za to vrijeme koristiti zamjensku hranu.
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 povećane.
English: • benzatropine (used to treat Parkinson's disease)
Croatian: • benzatropin (koristi se za liječenje Parkinsonove bolesti)
English: • Do not store above 25C.
Croatian: • Ne čuvati na temperaturi iznad 25°C.
English: If you are breast-feeding, your nuclear medicine doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding.
Croatian: Ako dojite, Vaš liječnik specijalist nuklearne medicine može odgoditi uporabu DaTSCAN-a ili od Vas zatražiti da prestanete dojiti.
English: DaTSCAN should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia.
Croatian: DaTSCAN se smije koristiti samo u odraslih bolesnika prema preporuci liječnika s iskustvom u liječenju poremećaja pokreta i/ili demencije.
English: I) (specific activity range 2.5 to
Croatian: I) (specifični raspon aktivnosti
English: A minimum of 500k counts should be collected for optimal images.
Croatian: Za optimalne slike potrebno je prikupiti broj od najmanje 500k impulsa.
English: Uncommon: Dizziness, formication (paraesthesia), dysgeusia
Croatian: Manje često: Omaglica, mravinjanje (paraestezija), disgeuzija
English: I) Intravenous use
Croatian: I) Intravenska primjena
English: These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.
Croatian: To uključuje amfetamin, benzatropin, buproprion, kokain, mazindol, metilfenidat, fentermin i sertralin.
English: Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.
Croatian: Potrebno je potaknuti često pražnjenje mokraćnog mjehura nakon primjene kako bi se minimalizirala izloženost zračenju.
English: This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Ovaj radiofarmaceutski pripravak mogu primiti, koristiti i primjenjivati samo ovlaštene osobe u posebno opremljenom kliničkom okruženju.
English: Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.
Croatian: Bolničko osoblje osigurat će pravilno čuvanje i zbrinjavanje lijeka te da se lijek ne koristi nakon isteka roka valjanosti navedenog na naljepnici.
English: Alternative techniques which do not involve radioactivity should be considered.
Croatian: Tada se trebaju razmotriti druge tehnike koje ne uključuju radioaktivnost.
English: Skin and subcutaneous tissue disorders Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva Nepoznato: Eritem, pruritus, osip, urtikarija, hiperhidroza
English: DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.
Croatian: DaTSCAN-om nije moguće razlikovati demenciju s Lewyjevim tjelešcima od demencije u Parkinsonovoj bolesti.
English: Slovenská republika MGP, spol.
Croatian: Slovenská republika MGP, spol. s r. o.
English: These stop the radioactivity building-up in your thyroid gland.
Croatian: To zaustavlja nakupljanje radioaktivnosti u Vašoj štitnoj žlijezdi.
English: Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline.
Croatian: Lijekovi za koje se tijekom kliničkih ispitivanja pokazalo da ne utječu na snimanje DaTSCAN-om uključuju amantadin, triheksifenidil, budipin, levodopu, metoprolol, primidon, propranolol i selegilin.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstva lijeka, dio 4.2).
English: If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku specijalistu nuklearne medicine koji će nadgledati Vaš postupak.
English: • mazindol (reduces appetite, as a means to treat obesity)
Croatian: • mazindol (smanjuje apetit, kao sredstvo za liječenje pretilosti)
English: This leaflet was last revised in <{MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site; http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: • The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.
Croatian: • Pomoćne tvari su acetatna kiselina, natrijev acetat, etanol i voda za injekcije.
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 visoki afinitet vezanja za presinaptičke prijenosnike dopamina, te se radiooznačeni ioflupan (
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 DLT bolesnici bili uključeni kao DLT bolesnici.
English: Driving and using machines DaTSCAN has no known influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima DaTSCAN nema poznatog utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: 5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.
Croatian: POPIS POMOĆNIH TVARI 5% etanol (za dodatne informacije pogledajte uputu o lijeku), acetatna kiselina, natrijev acetat, voda za injekcije.
English: Vascular disorders Not known: Blood pressure decreased
Croatian: Krvožilni poremećaji Nepoznato: Sniženje krvnog tlaka
English: How DaTSCAN is used
Croatian: Kako se primjenjuje DaTSCAN
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i bočici iza oznake EXP.
English: This medicine is used for diagnostic use only.
Croatian: Ovaj lijek koristi se samo za dijagnostičku uporabu.
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Croatian: Ako se radionuklidni postupci provode na trudnim ženama oni uključuju i određenu dozu zračenja fetusa.
English: NAME OF THE MEDICINAL PRODUCT DaTSCAN 74 MBq/ml solution for injection
Croatian: NAZIV LIJEKA DaTSCAN 74 MBq/ml otopina za injekciju
English: DaTSCAN should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.
Croatian: DaTSCAN smije koristiti isključivo kvalificirano medicinsko osoblje s odgovarajućom službenom dozvolom za primjenu i rukovanje radionuklidima unutar posebno opremljenih kliničkih prostorija.
English: DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
Croatian: DaTSCAN-om nije moguće razlikovati Parkinsonovu bolest od multiple sistemske atrofije i progresivne supranuklearne paralize.
English: • methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
Croatian: • metilfenidat (koristi se za liječenje hiperaktivnosti kod djece i narkolepsije (pretjerana pospanost))
English: Analyses in which both possible and probable DLB patients were compared with non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0% to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients.
Croatian: Analiza u kojoj su mogući i vjerojatni DLT bolesnici uspoređeni s ne-DLT bolesnicima s demencijom prikazuje osjetljivost DaTSCAN-a u rasponu od 75,0% do 80,2%, a specifičnost od 81,3% do 83,9% kad su mogući DLT bolesnici bili uključeni kao ne-DLT bolesnici.
English: Česká republika M.G.P.
Croatian: Česká republika M.G.P. spol. s r.o.
English: GE Healthcare d.o.o.
Croatian: GE Healthcare A.E.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM Nije primjenjivo.
English: In cases of overdose of radioactivity, frequent micturition and defaecation should be encouraged in order to minimise radiation dose to the patient.
Croatian: U slučajevima predoziranja radioaktivnom tvari, potrebno je potaknuti učestalo mokrenje i defekaciju kako bi se smanjila doza zračenja bolesnika.
English: The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of ioflupane (
Croatian: Procijenjene apsorbirane doze zračenja u prosječnog odraslog bolesnika (70 kg) nakon intravenske primjene ioflupana (
English: 2.5 ml vial: 7 hours from the activity reference time stated on the label.
Croatian: Bočica s 2,5 ml otopine: 7 sati od referentnog vremena aktivnosti navedenog na naljepnici.
English: Immune system disorders Not known: Hypersensitivity
Croatian: Poremećaji imunološkog sustava Nepoznato: Preosjetljivost
English: • sertraline (used to treat depression (sadness))
Croatian: • sertralin (koristi se za liječenje depresije (tuge))
English: If you have any further questions on the use of this medicine, ask your nuclear medicine doctor who supervises the procedure.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: 5 ml vial: 20 hours from the activity reference time stated on the label.
Croatian: Bočica s 5 ml otopine: 20 sati od referentnog vremena aktivnosti navedenog na naljepnici.
English: 2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Croatian: 2,5 ili 5 ml otopine u pojedinačnoj bezbojnoj staklenoj bočici od 10 ml zatvorenoj gumenim čepom i metalnim prstenom.
English: Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis.
Croatian: Lijekovi s visokim afinitetom vezanja na prijenosnik dopamina mogu zbog toga ometati dijagnostiku DaTSCAN-om.
English: I) is passed into breast milk.
Croatian: I) u majčino mlijeko.
English: • buproprion (used to treat depression (sadness))
Croatian: • buproprion (koristi se za liječenje depresije (tuge))
English: Muscles
Croatian: Mišići
English: This medicinal product is for diagnostic use only.
Croatian: Ovaj lijek koristi se samo u dijagnostičke svrhe.
English: EU/1/00/135/001 (2.5 ml) EU/1/00/135/002 (5 ml)
Croatian: EU/1/00/135/002 (5 ml)
English: Clear colourless solution.
Croatian: Prozirna bezbojna otopina.
English: (Lower large intestine wall Heart wall
Croatian: (Stijenka završnog dijela debelog crijeva Stijenka srca
English: DaTSCAN has no known influence on the ability to drive and use machines.
Croatian: DaTSCAN ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The values for the sensitivity of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Croatian: Osjetljivost DaTSCAN-a u određivanju vjerojatnosti DLT-a ili ne-DLT-a bile su u rasponu od 75,0% do 80,2%, a specifičnost od 88,6% do 91,4%.
English: Formal studies have not been carried out in patients with significant renal or hepatic impairment.
Croatian: Ispitivanja na bolesnicima sa značajnim oštećenjem bubrega ili jetre nisu provedena.
English: • phentermine (reduces appetite, as a means to treat obesity)
Croatian: • fentermin (smanjuje apetit, koristi se kao sredstvo za liječenje pretilosti)
English: How DaTSCAN is stored
Croatian: Kako se čuva DaTSCAN
English: The frequencies of adverse reactions are defined as follows:
Croatian: Učestalost nuspojava definirana je na sljedeći način:
English: • Parkinsonism (including Parkinson's disease) and
Croatian: • Parkinsonizma (uključujući Parkinsonovu bolest) i • demencije s Lewyjevim tjelešcima.
English: Gastrointestinal disorders Uncommon: Nausea, dry mouth Not known: Vomiting
Croatian: Poremećaji probavnog sustava Manje često: Mučnina, suha usta Nepoznato: Povraćanje
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojava, prvo su navedene najozbiljnije nuspojave, nakon kojih slijede manje ozbiljne.
English: General disorders and administration site conditions Uncommon: Injection site pain (intense pain or burning sensation following administration into small veins)
Croatian: Opći poremećaji i reakcije na mjestu primjene Manje često: Bol na mjestu injiciranja (jaka bol ili osjećaj pečenja nakon primjene u male vene)
English: • Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
Croatian: Redovno se izdajajte i bacite svo mlijeko koje ste izdojili.
English: - Hypersensitivity (allergic) - Shortness of breath - Redness of the skin - Itching - Rash - Hives (urticaria) - Excessive sweating - Vomiting - Low blood pressure - Feeling hot
Croatian: - Prekomjerno znojenje - Povraćanje - Nizak krvni tlak - Osjećaj vrućine
English: DaTSCAN 74 MBq/ml solution for injection Ioflupane (
Croatian: DaTSCAN 74 MBq/ml otopina za injekciju ioflupan (
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA Nije primjenjivo.
English: • amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a drug of abuse)
Croatian: • amfetamin (koristi se za liječenje hiperaktivnosti kod djece i narkolepsije (pretjerana pospanost);
English: (Upper large intestine wall
Croatian: (Stijenka gornjeg dijela debelog crijeva
English: What you need to know before DaTSCAN is used DaTSCAN must not be used
Croatian: Što morate znati prije nego primite DaTSCAN
English: What DaTSCAN looks like and contents of the pack DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Croatian: DaTSCAN je bezbojna otopina za injekciju od 2,5 ili 5 ml, dostupna u pojedinačnoj, bezbojnoj staklenoj bočici od 10 ml zatvorenoj gumenim čepom i metalnim prstenom.
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY
Croatian: EXP: 7 sati nakon referentnog vremena aktivnosti Ref.: 185 MBq/2,5 ml u 12:00 CET dana DD/MM/GGGG
English: Distribution Ioflupane (
Croatian: Distribucija Ioflupan (
English: Handling and disposal - see package leaflet.
Croatian: Rukovanje i zbrinjavanje - vidjeti uputu o lijeku.
English: The following undesirable effects are recognised for DaTSCAN:
Croatian: Primijećene su sljedeće nuspojave s DaTSCAN-om:
English: Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant.
Croatian: Ne uzimajte DaTSCAN ako ste trudni ili mislite da biste mogli biti trudni, zato što je dijete izloženo određenoj količini radioaktivnosti.
English: Administration of 185 MBq of ioflupane (
Croatian: Uporaba 185 MBq ioflupana (
English: I) at 1200 CET on DD/MM/YYYY
Croatian: I) u 12:00 CET dana DD/MM/GGGG
English: GE Healthcare B.V. De Rondom 8
Croatian: GE Healthcare B.V.
English: Each 2.5 ml single dose vial contains 185 MBq ioflupane (
Croatian: Jedna jednodozna bočica s 2,5 ml otopine sadrži 185 MBq ioflupana (
English: Tell your doctor if any of these apply to you.
Croatian: Ako se bilo što od navedenog odnosi na Vas, recite to svom liječniku.
English: Salivary glands Skin
Croatian: Žlijezde slinovnice
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Pakiranje od 5 ml
English: GE Healthcare A.E. Τηλ: +30 210 8930600
Croatian: Τηλ: +30 210 8930600
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains ioflupane (
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 74 MBq ioflupana (
English: EXP: 20 h post-ref. Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY
Croatian: Ref.: 370 MBq/5 ml u 23:00 CET dana DD/MM/GGGG
English: If you get any side effects, talk to your nuclear medicine doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika specijalista nuklearne medicine.
English: Respiratory, thoracic and mediastinal disorders Not known: Dyspnea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Nepoznato: Dispneja
English: Gallbladder wall Gastrointestinal tract
Croatian: Stijenka žučnog mjehura Probavni sustav
English: Each 5 ml single dose vial contains 370 MBq ioflupane (
Croatian: Jedna jednodozna bočica s 5 ml otopine sadrži 370 MBq ioflupana (
English: Ear and labyrinth disorders Uncommon: Vertigo
Croatian: Poremećaji uha i labirinta Manje često: Vrtoglavica
English: Tel: +385 (0)1 61 70 280
Croatian: GE Healthcare d.o.o. Tel: +385 (0)1 61 70 280
English: EXP: 20 h post-ref. Ref.: 370 MBq/5 ml ioflupane (
Croatian: Ref.: 370 MBq/5 ml ioflupana (
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml ioflupane (
Croatian: Ref.: 185 MBq/2,5 ml ioflupana (
English: 5 ml presentation
Croatian: Pakiranje od 5 ml
English: Any ioflupane (
Croatian: Ostatak ioflupana (
English: 11 DOSIMETRY
Croatian: 11. DOZIMETRIJA
English: Small intestine wall
Croatian: Stijenka mokraćnog mjehura Maternica
English: • The active substance is ioflupane (
Croatian: • Djelatna tvar je ioflupan (
English: GE Healthcare B.V. Tel: +31 (0) 40 299 10 00
Croatian: Tel: +31 (0) 40 299 10 00
English: General Electric International Inc. Tel.: +370 68 726 753
Croatian: Tel.: +370 68 726 753
English: Tel: +39 02 26001 111
Croatian: GE Healthcare S.r.l. Tel: +39 02 26001 111
English: Renal and hepatic impairment
Croatian: Oštećenje bubrega i jetre
English: DaTSCAN contains the active substance ioflupane (
Croatian: Što je DaTSCAN i za što se koristi DaTSCAN sadrži djelatnu tvar ioflupan (
English: s r.o.
Croatian: Ref.:
English: GE Healthcare Buchler GmbH & Co. KG Tel: +49 (0) 5 307 93 00
Croatian: KG Tel: +49 (0) 5 307 93 00
English: GE Healthcare S.r.l.
Croatian: Pharma-Cos Ltd.
English: The frequency of side effects is:
Croatian: Učestalost nuspojava je:
English: Not known: frequency cannot be estimated from the available data.
Croatian: Nema dostupnih podataka o primjeni u djece.
English: Ga) chloride.
Croatian: Ga) klorid.
English: edotreotide
Croatian: edotreotid
English: The PET scan images are then taken 40 to 90 minutes later.
Croatian: PET slike snimaju se nakon 40 do 90 minuta.
English: The studies included data from 970 patients.
Croatian: Ispitivanja su sadržavala podatke o 970 bolesnika.
English: The tumours can then spread elsewhere in the body (metastasis).
Croatian: Tumori se zatim mogu proširiti drugdje u tijelu (metastaziranje).
English: This makes it possible to see where the tumours are and whether they have spread.
Croatian: Na taj se način može otkriti gdje se tumori nalaze i jesu li se proširili.
English: The substance that is used for radiolabelling SomaKit TOC is called gallium (
Croatian: Tvar koja se upotrebljava za radioaktivno obilježavanje lijeka SomaKit TOC zove se galijev (
English: A comparison using data from several of these studies (a meta-analysis) was also presented.
Croatian: Također je predstavljena usporedba podataka iz nekoliko ispitivanja (meta-analiza).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine had been demonstrated.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je dokazana tehnička i dijagnostička djelotvornost lijeka.
English: It is given as a single injection into a vein immediately after being radiolabelled.
Croatian: Primjenjuje se kao jedna injekcija u venu, odmah nakon radioaktivnog obilježavanja.
English: Because the number of patients with GEP-NETs is low, the disease is considered ‘rare', and SomaKit TOC was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 March 2015.
Croatian: Budući da je broj bolesnika s bolešću GEP-NET nizak, bolest se smatra „rijetkom”, a SomaKit TOC dobio je status „lijeka za liječenje rijetkih bolesti” 19. ožujka 2015.
English: The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.
Croatian: Tvrtka je stoga dostavila informacije iz niza ispitivanja, uglavnom malih, iz objavljene literature kako bi prikazala djelotvornost lijeka SomaKit TOC u otkrivanju tumora.
English: The medicine is not used directly, but must be ‘radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation.
Croatian: Lijek se ne primjenjuje izravno, nego se prije injiciranja radioaktivno obilježava, što znači da se označava zasebnom tvari koja emitira malu količinu zračenja.
English: This is a summary of the European public assessment report (EPAR) for SomaKit TOC.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka SomaKit TOC.
English: In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.
Croatian: Četiri druga usporedna ispitivanja zabilježila su da je djelatna tvar u lijeku SomaKit TOC otkrila više tumora nego indij (111In) pentetreotid u nekih bolesnika.
English: Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied.
Croatian: Uzeta zajedno, ispitivanja su bila dostatna za dokazivanje djelotvornosti lijeka SomaKit TOC u otkrivanju tumora, iako su se rezultati razlikovali.
English: What measures are being taken to ensure the safe and effective use of SomaKit TOC?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka SomaKit TOC?