FrancophonIA/ELRC3.0 huggingface dataset:
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips
Croatian: • ITCL papir od staklenog vlakna (npr. Agilent ITLC SGI001) koji je prethodno narezan na trakice od 1 cm x 12 cm
English: Quality control Table 2: Specifications of the gallium (68Ga) edotreotide
Croatian: Kontrola kvalitete Tabela 2.: Specifikacije galijevog [68Ga] edotreotida
English: The visual inspection should be performed under a shielded screen for radioprotection purposes.
Croatian: Vizualni pregled trebalo bi izvesti sa zaštitnom maskom radi zaštite od zračenja.
English: For an administered activity of 200 MBq the typical radiation dose to the critical organs, which are the urinary bladder wall, the spleen, the kidneys and the adrenals, are about 24, 22, 16 and 15 mGy, respectively.
Croatian: Uobičajene doze zračenja kritičnih organa, a to su stijenka mokraćnog mjehura, slezena, bubrezi i nadbubrežne žlijezde, iznose 24, 22, 16 i 15 mGy, navedenim redoslijedom, za primijenjenu aktivnost od 200 MBq.
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 examination in order to reduce radiation.
Croatian: Prije početka pretrage bolesnici moraju biti dobro hidrirani, a tijekom prvih nekoliko sati nakon pretrage potrebno ih je poticati na učestalo mokrenje radi smanjenja izlaganja zračenju.
English: In the retrospective paper of Schreiter et al. 2014, the intra-individual comparison in a subgroup of 20 patients showed that gallium (68Ga) edotreotide permitted to localise the primary tumour in 9/20 (45%) patients while indium (111In) pentetreotide did in 2/20 (10%).
Croatian: U retrospektivnom ispitivanju Schreitera i sur. 2014., intraindividualna usporedba u podskupini od 20 bolesnika pokazala je da galijev [68Ga] edotreotid lokalizira primarni tumor u 9/20 (45 %) bolesnika, a indij (111In) pentetreotid u 2/20 (10 %) bolesnika.
English: Only syringe and syringe needles able to minimise trace metal impurity levels (for example, non-metallic or coated with silicone needles - not supplied -) should be used.
Croatian: Potrebno je koristiti samo štrcaljku i igle za štrcaljku koje mogu svesti na najmanju moguću razinu metalna onečišćenja u tragovima (primjerice, nemetalne igle ili igle presvučene silikonom - nisu isporučene).
English: Somatostatin is a neurotransmitter in the central nervous system, but also a hormone which binds to cells of neuroendocrine origin and inhibits the release of growth hormone, insulin, glucagon, and gastrin.
Croatian: ali i hormon koji se veže za stanice neuroendokrinog podrijetla i inhibira otpuštanje hormona rasta, inzulina, glukagona i gastrina.
English: In the study of Buchmann et al. 2007, conducted in 27 patients mostly with GEP-NET (59%) or NETs of unknown primary (30%), gallium (68Ga) edotreotide identified 279 lesions versus 157 lesions seen with indium (111In) pentetreotide.
Croatian: U ispitivanju koje su proveli Buchmann i sur. 2007., koje je provedeno na 27 bolesnika većinom s GEP-NET-om (59 %) ili NET-ima nepoznatog primarnog sijela (30 %), galijev [68Ga] edotreotid identificirao je 279 tumora u usporedbi sa 157 tumora otkrivenih s indijevim (111In) pentetreotidom.
English: About 50 minutes after intravenous administration, gallium (68Ga) edotreotide accumulation shows plateauing in all organs.
Croatian: Otprilike 50 minuta nakon intravenske primjene, nakupljanje galijevog [68Ga] edotreotida doseže plato u svim organima.
English: The uptake in the liver and in the pituitary, thyroid and adrenal glands is lower.
Croatian: Apsorpcija u jetri, hipofizi, štitnoj žlijezdi i nadbubrežnim žlijezdama je niža.
English: Contents of the vials are intended only for use in the preparation of gallium (68Ga) edotreotide solution for injection and are not to be administered directly to the patient without first undergoing the preparative procedure.
Croatian: Sadržaj bočica predviđen je isključivo za pripremu otopine galijevog [68Ga] edotreotida za injekciju te se ne smije primjenjivati izravno u bolesnika bez prethodnog pripremnog postupka.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SHIELD LABEL TO BE APPLIED AFTER RADIOLABELLING
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZAŠTITNOG SPREMNIKA KOJA SE POSTAVLJA NAKON RADIOAKTIVNOG OBILJEŽAVANJA
English: After radiolabelling, the solution obtained also contains hydrochloric acid.
Croatian: Nakon radioaktivnog obilježavanja dobivena otopina sadržava i kloridnu kiselinu.
English: Powder: 1,10-phenanthroline, gentisic acid, mannitol (E421) Buffer: formic acid, sodium hydroxide (E524), water for injections See leaflet for further information.
Croatian: Prašak: 1,10-fenantrolin, gentizinska kiselina, manitol (E421) Pufer: mravlja kiselina, natrijev hidroksid (E524), voda za injekcije
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6. Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: In the study of Van Binnebeek et al. 2015 in 53 patients with metastatic GEP-NET [mostly GEP-NET (n=39) or NET of unknown origin (n=6)], the lesion-based detection rate of gallium (68Ga) edotreotide was 99.9% (1098/1099) versus 60% (660/1099) for indium (111In) pentetreotide based on the follow-up scans.
Croatian: U ispitivanju koje su proveli Van Binnebeek i sur. 2015., na 53 bolesnika s metastatskim GEP-NET-om [uglavnom GEPNET (n=39) ili NET nepoznatog podrijetla (n=6)], stopa otkrivanja tumora za galijev [68Ga] edotreotid bila je 99,9% (1098/1099) naspram 60% (660/1099) za indijev (111In) pentetreotid na temelju kontrolnih snimanja.
English: Flip off cap from the Vial 2 (Reaction buffer) and swab the top of the vial closure with an appropriate antiseptic to disinfect the surface, and then allow the stopper to dry.
Croatian: Uklonite zatvarač s bočice 2 (reakcijski pufer) i obrišite vrh bočice odgovarajućim antiseptikom da biste dezinficirali površinu, zatim pustite da se čep osuši.
English: In patients with Cushing syndrome, the normalisation of hypercortisolism should be considered before performing PET with SomaKit TOC.
Croatian: U bolesnika s Cushingovim sindromom potrebno je normalizirati razinu kortizola prije izvođenja PET-a uz primjenu lijeka SomaKit TOC.
English: The organ uptake has been shown to be age-independent in normal adult human tissues and also predominantly gender-independent (except for the thyroid and head of pancreas).
Croatian: Uočeno je da apsorpcija u organima u tkivima zdravih odraslih osoba ovisi o dobi te da pretežno ne ovisi o spolu (osim u slučaju štitne žlijezde i glave gušterače).
English: Figure 2: Radiolabelling procedure when using Galli Ad generator
Croatian: Slika 1: Postupak radioaktivnog obilježavanja pri korištenju generatora GalliaPharm
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika trebalo bi biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
English: The acquisition must include a whole body acquisition from skull to mid-thigh.
Croatian: Oslikavanje mora obuhvaćati cijelo tijelo, od lubanje do sredine bedara.
English: Thin layer chromatography (ITLC1, see details below)
Croatian: Tankoslojna kromatografija (ITLC1, vidjeti pojedinosti u nastavku)
English: With a low dead space 1 ml sterile syringe carefully withdraw 0.5 ml reaction buffer, and keep the reaction buffer in syringe for step “i”.
Croatian: Sterilnom štrcaljkom s malo mrtvog prostora od 1 ml pažljivo izvucite 0,5 ml reakcijskog pufera i zadržite reakcijski pufer u štrcaljki za potrebe koraka „i”.
English: MARKETING AUTHORISATION HOLDER Advanced Accelerator Applications 20 rue Diesel
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Advanced Accelerator Applications 20 rue Diesel
English: Each pack contains:
Croatian: Svaka bočica sadržava
English: m. The solution should be visually inspected prior to use.
Croatian: m. Prije uporabe potrebno je vizualno pregledati otopinu.
English: Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment.
Croatian: Oštećenje funkcije bubrega / oštećenje funkcije jetre Sigurnost i djelotvornost galijevog [68Ga] edotreotida nisu ispitivane u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: SomaKit TOC is supplied as a kit containing two vials.
Croatian: Način pripreme SomaKit TOC isporučuje se kao set koji sadržava dvije bočice.
English: Pierce the Vial 1 septum with a 0.2 µm sterile vent filter in order to maintain atmospheric pressure within the vial during the radiolabelling process.
Croatian: Probušite čep bočice 1 sterilnim filtrom zraka od 0,2 µm radi održavanja atmosferskog tlaka unutar bočice tijekom postupka radioaktivnog obilježavanja.
English: Somatostatin and its analogues are probably competing to bind to the same somatostatin receptors.
Croatian: 4.5. Interakcije s drugim lijekovima i drugi oblici interakcija Somatostatin i njegovi analozi vjerojatno se nastoje vezati za iste somatostatinske receptore.
English: This medicinal product should be radiolabelled before administration to the patient.
Croatian: Ovaj lijek potrebno je radioaktivno obilježiti prije primjene u bolesnika.
English: However, lesions of GEP-NET not expressing sufficient density of somatostatin receptors cannot be visualised with gallium (68Ga) edotreotide.
Croatian: Međutim, GEP NET-i s nedovoljno gusto izraženim somatostatinskim receptorima ne mogu se prikazati galijevim [68Ga] edotreotidom.
English: Intravenous use after radiolabelling.
Croatian: Primjena u venu nakon radioaktivnog obilježavanja.
English: The vial of buffer contains approximately 32.5 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom Bočica pufera sadržava približno 32,5 mg natrija.
English: With a low dead space 1 ml sterile syringe carefully withdraw 100 µl and keep the reaction buffer in syringe for step “g”.
Croatian: Sterilnom štrcaljkom s malo mrtvog prostora od 1 ml pažljivo izvucite 100 µl reakcijskog pufera i zadržite reakcijski pufer u štrcaljki za potrebe koraka „g”.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be radiolabelled with the reaction buffer and a solution of Gallium-68 (68Ga) in HCl provided by a germanium (68Ge)/gallium (68Ga) generator.
Croatian: Za radioaktivno obilježavanje reakcijskim puferom i otopinom galija-68 [68Ga] u HCl koja se dobiva germanij [68Ga]/galij [68Ga] generatorom.
English: 6.5 Nature and contents of container and special equipment for use
Croatian: Vrsta i sadržaj spremnika i posebna oprema za uporabu Svako pakiranje sadržava:
English: Kit for radiopharmaceutical preparation containing: - Powder for solution for injection: the vial contains a white lyophilised powder.
Croatian: - prašak za otopinu za injekciju: bočica sadržava bijeli liofilizirani prašak.
English: Finally remove the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Croatian: Konačno uklonite sterilni filtar zraka od 0,2 µm te premjestite bočicu u otvor suhe kupelji na 95°C, koristeći hvataljke.
English: Thin layer chromatography (ITLC2, see details below)
Croatian: Tankoslojna kromatografija (ITLC2, vidjeti pojedinosti u nastavku)
English: In case of Cushing syndrome, a long-term exposure to endogenous hypercortisolism may down regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga) edotreotide.
Croatian: U slučaju Cushingovog sindroma, dugotrajna izloženost endogenom hiperkortizolizmu može smanjiti ekspresiju somatostatinskih receptora i negativno utjecati na rezultate oslikavanja somatostatinskih receptora galijevim [68Ga] edotreotidom.
English: In the study by Gabriel et al. 2009 pre-PRRT gallium (68Ga) edotreotide was compared with CT or MRI using the Response Evaluation Criteria in Solid Tumors (RECIST).
Croatian: 2009., galijev [68Ga] edotreotid prije PRRT-a uspoređen je s CT-om ili MR-om primjenom kriterija za procjenu odgovora solidnih tumora (RECIST).
English: ITLC1:
Croatian: ITLC1: Materijal
English: After radiolabelling, SomaKit TOC should be used within 4 hours.
Croatian: SomaKit TOC trebalo upotrijebiti u roku od 4 sata nakon radioaktivnog obilježavanja.
English: Gallium (68Ga) edotreotide detected 35/35 (100%) lesions vs 19/35=54% for indium (111In) pentetreotide SPECT/CT.
Croatian: edotreotid otkrio je 35/35 (100%) tumora u usporedbi s 19/35=54% za SPECT/CT sliku dobivenu primjenom indijevog (111In) pentetreotida.
English: Flip off cap from the vial of powder and swab the top of the vial closure with an appropriate antiseptic to disinfect the surface, and then allow the stopper to dry.
Croatian: Uklonite zatvarač s bočice s praškom i obrišite vrh bočice odgovarajućim antiseptikom da biste dezinficirali površinu, zatim pustite da se čep osuši.
English: Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68
Croatian: Djelotvornost obilježavanja % slobodni galij-68
English: Talk to your nuclear medicine specialist before you are given SomaKit TOC: - if you experience any signs of allergic reaction (listed in section 4) after previous administration of SomaKit TOC; - if you have kidney or liver problems (renal or hepatic disease); - if you are under 18 years of age; - if you have signs of dehydration before and after the examination;
Croatian: TOC: - ako osjetite bilo kakve znakove alergijske reakcije (navedene u dijelu 4.) nakon prethodne primjene lijeka SomaKit TOC; - ako imate problema s bubrezima ili jetrom (bolest bubrega ili jetre);
English: Data supporting efficacy of gallium (68Ga) edotreotide for predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited (see section 5.1).
Croatian: Podaci koji podupiru djelotvornost galijevog [68Ga] edotreotida u predviđanju i praćenju terapijskog odgovora na radionuklidnu terapiju usmjerenu na peptidne receptore (PRRT, engl. peptide receptor radionuclide therapy) u histološki potvrđenom metastatskom NET-u su ograničeni (vidjeti dio 5.1.).
English: Data available on clinical efficacy of gallium (68Ga) edotreotide for the indication of predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited.
Croatian: Podaci koji su dostupni o kliničkoj djelotvornosti galijevog [68Ga] edotreotida za indikaciju predviđanja i praćenja terapijskog odgovora na radionuklidnu terapiju usmjerenu na peptidne receptore (PRRT) u histološki potvrđenom metastatskom NET-u su ograničeni.
English: Organ uptake The organ with the highest physiological uptake of gallium (68Ga) edotreotide is the spleen, followed by the kidneys.
Croatian: Apsorpcija u organima Organ s najvišom razinom fiziološke apsorpcije galijevog [68Ga] edotreotida je slezena, a slijede je bubrezi.
English: For radiolabelling with gallium (68Ga) chloride solution.
Croatian: Za radioaktivno obilježavanje otopinom galijevog [68Ga] klorida.
English: If the administration is considered necessary, breastfeeding should be interrupted for 8 hours and the expressed feeds discarded.
Croatian: potrebno je prekinuti dojenje na osam sati, a izdojeno mlijeko baciti.
English: A long-term exposure to endogenous hypercortisolism may down-regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga)
Croatian: Dugotrajna izloženost endogenom hiperkortizolizmu može smanjiti ekspresiju somatostatinskih receptora i negativno utjecati na rezultate oslikavanja somatostatinskih receptora galijevim [68Ga]
English: Thus, in patients with GEP-NET and Cushing syndrome, normalisation of hypercortisolism should be suggested before performing PET with gallium (68Ga)
Croatian: Stoga je u bolesnika s GEP-NET-om i Cushingovim sindromom potrebna normalizacija vrijednosti kortizola prije PET-e uz primjenu galijevog [68Ga]
English: Kit as packaged for sale 12 months.
Croatian: Set zapakiran kao za prodaju
English: Sample Analysis a. The TLC developing tank is prepared by pouring the mobile phase to a depth of 3 to 4 mm. Cover the tank and allow to equilibrate.
Croatian: TLC spremnik za razvijanje priprema se ulijevanjem mobilne faze na dubinu od 3 do 4 mm.
English: b. Apply a drop of the gallium (68Ga) edotreotide on a pencil line 1 cm from the bottom of the
Croatian: b. Nanesite kap galijevog [68Ga] edotreotida na liniju iscrtanu olovkom na 1 cm od kraja
English: Connect Vial 1 through the 0.2 µm sterile vent filter to a vacuum vial or to a pump to start the elution.
Croatian: Kroz sterilni filtar zraka od 0,2 µm spojite bočicu 1 na vakuumsku bočicu ili pumpu kako biste započeli eluaciju.
English: For the detection of the primary GEP-NET site in case of rising levels of a relevant biochemical tumour marker or in case of proven NET metastasis, patient-based sensitivity and specificity of gallium (68Ga) edotreotide PET were 100% (4/4) and 89% (8/9), respectively, in the prospective study of Gabriel et al. 2007.
Croatian: Za otkrivanje primarnog GEP-NET-a u slučaju povećanih razina relevantnog biokemijskog tumorskog markera ili u slučaju dokazanih metastaza NET-a, osjetljivost s obzirom na pojedinog bolesnika i specifičnost PET-a primjenom galijevog [68Ga] edotreotida bili su 100 % (4/4), odnosno 89 % (8/9) u prospektivnom ispitivanju koje su proveli Gabriel i sur. 2007. Stopa otkrivanja tumora bila je 75% (3/4) u podskupini bolesnika s nepoznatim primarnim tumorom u prospektivnom ispitivanju koje su proveli Frilling i sur. 2010.
English: If at any time in the preparation of this product the integrity of the vials is compromised, the product should not be used.
Croatian: Ako se u bilo kojem trenutku tijekom pripreme lijeka bočica ošteti, lijek se ne smije koristiti.
English: At the time of administration, the product must be aseptically withdrawn and the radioprotection standards must be followed.
Croatian: U trenutku primjene lijek se mora aseptički izvući te je potrebno pridržavanje standarda zaštite od zračenja.
English: SomaKit TOC is for intravenous use and for single use only.
Croatian: Način primjene Somakit TOC namijenjen je isključivo za intravensku, jednokratnu primjenu.
English: After radiolabelling, the solution obtained also contains, as excipient, hydrochloric acid from the generator eluate.
Croatian: Nakon radioaktivnog obilježavanja, dobivena otopina kao pomoćnu tvar sadržava i kloridnu kiselinu iz eluensa generatora.
English: Withdraw the syringe and the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Croatian: Izvucite štrcaljku i sterilni filtar zraka od 0,2 µm te premjestite bočicu u otvor suhe kupelji na 95°C, koristeći hvataljke.
English: Excipients:
Croatian: Proizvođač:
English: Approximately 16% of gallium (68Ga) edotreotide activity is removed from the body in the urine within 2 to 4 hours.
Croatian: Unutar 2 do 4 sata približno 16 % aktivnosti galijevog [68Ga] edotreotida eliminira se iz tijela mokrenjem.
English: After radiolabelling with the correct volume of reaction buffer and generator eluate, any further dilution with any diluent is prohibited.
Croatian: Nakon radioaktivnog obilježavanja ispravnim volumenom reakcijskog pufera i eluensa generatora,
English: Connect the Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum.
Croatian: Spojite bočicu 1 s odvodom generatora ubadanjem igle kroz gumeni čep.
English: For instructions on extemporaneous preparation of the medicinal product before administration, see sections 6.6 and 12.
Croatian: Za upute o magistralnoj pripremi lijeka prije primjene pogledajte dijelove 6.6. i 12. Za upute o pripremi bolesnika pogledajte dio 4.4.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA SomaKit TOC
English: Reconstitution with GalliaPharm generator: a.
Croatian: Rekonstitucija pomoću generatora GalliaPharm:
English: Close contact with infants should be restricted during the initial 8 hours following injection.
Croatian: Prvih osam sati nakon injekcije potrebno je ograničiti bliski kontakt s dojenčadi.
English: Gallium-68 decays with a half-life of 68 min to stable zinc-68, 89% through positron emission with a mean energy of 836 keV followed by photonic annihilation radiations of 511 keV (178%), 10% through orbital electron capture (X-ray or Auger emissions), and 3% through 13 gamma transitions from 5 excited levels.
Croatian: Galij-68 raspada se uz poluvijek od 68 minuta na stabilni cink-68, u 89 % slučajeva pozitronskom emisijom prosječne energije od 836 keV, nakon čega slijedi fotonsko anihilacijsko zračenje od
English: - If you get any side effects, talk to your nuclear medicine doctor.
Croatian: Ako primijetite bilo koju nuspojavu, obratite se svom liječniku specijalistu nuklearne medicine.
English: This should be taken into account in patient on low sodium diet.
Croatian: O tome treba voditi računa u bolesnika s ograničenim unosom natrija u prehrani.
English: The solution should be visually inspected prior to use.
Croatian: Prije uporabe potrebno je vizualno pregledati otopinu.
English: Before administration of SomaKit TOC
Croatian: Prije primjene lijeka SomaKit TOC
English: In GEP-NET, a more intense gallium (68Ga) edotreotide uptake than normal background is a consistent finding.
Croatian: U slučaju GEP-NET-a, uobičajena je intenzivnija apsorpcija galijevog [68Ga] edotreotida nego u zdravom tkivu.
English: A lesion detection rate of 100% (40/40) versus 85% (34/40) was observed in the study of Hofmann et al. 2001 recruiting patients with histologically proven bronchial (n=2) or midgut (n=6) NETs.
Croatian: (34/40) uočena je u ispitivanju koje su proveli Hofmann i sur. 2001. u kojem su sudjelovali bolesnici s histološki dokazanim bronhijalnim (n=2) NET-om ili NET-om srednjeg crijeva (n=6).
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the fœtus.
Croatian: Postupci koji uključuju primjenu radionuklida u trudnica uzrokuju i ozračivanje fetusa.
English: What you need to know before SomaKit TOC is used
Croatian: Što morate znati prije primjene lijeka SomaKit TOC SomaKit TOC se ne smije primijeniti
English: Store the vial containing the gallium (68Ga) edotreotide solution below 25°C until use.
Croatian: Bočicu s otopinom galijevog [68Ga] edotreotida čuvajte na temperaturi ispod 25°C do uporabe.
English: What SomaKit TOC looks like and contents of the pack SomaKit TOC is a kit for radiopharmaceutical preparation containing: - A glass vial with black flip-off cap containing a white powder.
Croatian: Kako SomaKit TOC izgleda i sadržaj pakiranja SomaKit TOC je set za pripravu radiofarmaceutika koji sadržava:
English: Mechanism of action Gallium (68Ga) edotreotide binds to somatostatin receptors.
Croatian: Galijev [68Ga] edotreotid veže se za somatostatinske receptore.
English: SomaKit TOC contains sodium
Croatian: SomaKit TOC sadržava natrij
English: Image acquisition
Croatian: Dobivanje slika
English: Administration procedures should be carried out in a way to minimize risk of contamination of the medicinal product and irradiation of the operators.
Croatian: Postupci primjene moraju se provesti tako da se rizik od kontaminacije lijeka i ozračivanja osoblja svede na najmanju moguću mjeru.
English: Each 40 microgram vial contains an excess of product.
Croatian: Svaka bočica od 40 mikrograma sadržava suvišak lijeka.
English: One vial of powder contains 40 µg of edotreotide.
Croatian: Jedna bočica praška sadržava 40 mikrograma edotreotida.
English: Close contact with infants and pregnant women should be restricted during the first 8 hours after administration.
Croatian: Tijekom prvih 8 sati nakon primjene potrebno je ograničiti bliski kontakt s dojenčadi i trudnicama.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA SomaKit TOC 40 mikrograma otopina za injekciju galijev [68Ga] edotreotid