natgillin/translations-raw huggingface dataset:
The following information is intended for healthcare professionals only: The complete SmPC of SomaKit TOC is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Celoten povzetek glavnih značilnosti zdravila SomaKit TOC je na voljo kot odtrgljivi del na koncu tiskanega navodila v pakiranju zdravila, njegov cilj pa je zdravstvenim delavcem ponuditi druge dodatne znanstvene in praktične informacije o injiciranju in uporabi tega radiofarmaka.
Report the activity value, the calibration time, the batch number and the expiry time on the shield label included in the pack to be applied on the lead shielding container after radiolabelling.
Vrednost aktivnosti, čas umerjanja, številko serije in rok uporabe zabeležite na nalepko za ščit, ki je priložena kompletu in ki jo je treba namestiti na posodo svinčenega ščita po radioaktivnem označevanju.
Should you have any further questions on the use of SomaKit TOC, please ask the nuclear medicine doctor who supervises the procedure.
Če imate kakršna koli dodatna vprašanja o uporabi zdravila SomaKit TOC, se posvetujte z zdravnikom nuklearne medicine, ki nadzoruje postopek.
OTHER SPECIAL WARNING(S), IF NECESSARY Medicinal product radioactive after radiolabelling.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravilo je po radioaktivnem označevanju radioaktivno.
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.
Analiza vzorca a. Razvijalno posodo TLC pripravimo z vlivanjem mobilne faze do globine 3 do 4 mm. Posodo pokrijemo in pustimo, da se uravnovesi.
Intravenous use after radiolabelling.
Intravenska uporaba po radioaktivnem označevanju.
1,10-phenanthroline Gentisic acid Mannitol (E421)
1,10-fenantrolin gentizinska kislina manitol (E421)
Approximately 16% of gallium (68Ga) edotreotide activity is removed from the body in the urine within 2 to 4 hours.
Približno 16 % aktivnosti [68Ga]galij-edotreotida se iz telesa odstrani s sečem v 2 do 4 urah.
Method of preparation
Način priprave
The gallium (68Ga) edotreotide solution must be prepared in accordance with radioprotection and pharmaceutical quality standards, especially concerning aseptic technique.
Raztopino [68Ga]galij-edotreotida je treba pripraviti skladno s standardi za radioaktivno zaščito in farmacevtsko kakovost, zlasti glede aseptične tehnike.
Only essential investigations should be carried out during pregnancy, when the likely benefit far exceeds any risk to the mother and foetus.
Med nosečnostjo je treba izvajati samo nujne preiskave, pri katerih je verjetna korist precej večja od tveganja za mater in plod.
Acceptance Criteria Method
Merila sprejemljivosti
For administration, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Za dajanje je treba raztopino povleči skozi zamašek z uporabo injekcijske brizge za enkratni odmerek, ki je opremljena z zaščitnim ščit, in sterilno iglo za enkratno uporabo ali odobren avtomatizirani sistem za apliciranje.
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.
Pri obsevanju z 200 MBq je tipična doza obsevanja kritičnih organov, torej stene sečnega mehurja, vranice, ledvic in nadledvične žleze, 24, 22, 16 oziroma 15 mGy.
The vial of buffer contains approximately 32.5 mg of sodium.
Viala s pufrom vsebuje približno 32,5 mg natrija.
Distribution After intravenous injection, gallium (68Ga) edotreotide is rapidly cleared from the blood following bi exponential elimination of activity with half-lives of 2.0 ± 0.3 min and 48 ± 7 min respectively.
Porazdelitev Po intravenskem injiciranju se je [68Ga]galij-edotreotid hitro izločil iz krvi po dvoeksponentni odstranitvi aktivnosti z razpolovnima časoma 2,0 ± 0,3 min oziroma 48 ± 7 min.
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.
Vsebina vial je namenjena samo za uporabo pri pripravi raztopine [68Ga]galij-edotreotida za injiciranje in se ne sme dajati neposredno bolniku, preden se opravi postopek priprave.
The gallium (68Ga) edotreotide solution for intravenous injection must be prepared according to aseptic procedure, local regulation and the following instructions.
Raztopino [68Ga]galij-edotreotida za intravensko injiciranje je treba pripraviti skladno z aseptičnim postopkom, lokalnimi predpisi in naslednjimi navodili.
Wait for the level of radioactivity to decay adequately before throwing away radioactive products.
Pred odstranjevanjem radioaktivnih izdelkov počakajte, da se stopnja radioaktivnosti ustrezno zniža.
The dosimetry of gallium (68Ga) edotreotide was calculated by Sandstrom et al. (2013), using
Dozimetrijo [68Ga]galij-edotreotida so izračunali Sandstrom et al. (2013) s programsko opremo
Glass syringe must not be used.
Ne uporabljajte steklene injekcijske brizge.
Regarding the novel excipient (1,10-phenanthroline), during the toxicity study conducted with the kit formulation of SomaKit TOC including 1,10-phenanthroline at a dose 400 fold higher than the human dose, no toxicity signs were observed.
Kar zadeva novo pomožno snov (1,10-fenantrolin) v študiji toksičnosti, ki so jo izvedli s formulacijo kompleta zdravila SomaKit TOC, ki je vsebovala 1,10-fenantrolin 400-krat večjem odmerku od človeškega, niso opazili nobenih znakov toksičnosti.
6.5 Nature and contents of container and special equipment for use
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo Vsako pakiranje vsebuje:
Genotoxicity studies on 1,10-phenanthroline available in the literature show negative results in bacterial mutation assay (Ames test), while in a mouse lymphoma assay an indication of possible genotoxicity was obtained at concentrations 750 times higher than the maximum 1,10-phenanthroline blood concentration achievable in patients.
Študije genotoksičnosti za 1,10-fenantrolin, ki so na voljo v literaturi, kažejo negativne rezultate pri testu mutacij pri bakterijah (Amesov test), medtem ko so se je v testu mišjega limfoma znaki morebitne genotoksičnosti pojavili pri koncentracijah, 750-krat višjih od najvišje koncentracije
SomaKit TOC is for intravenous use and for single use only.
Zdravilo SomaKit TOC To je samo za intravensko in enkratno uporabo.
The retrospective study of Kroiss et al. 2013 in 249 NET patients showed that PRRT does not significantly influence semiquantitative uptake of gallium (68Ga) edotreotide PET, except in liver metastases of patients with NET, but the study lacked histological confirmation.
V retrospektivni študiji Kroiss et al. 2013 so pri 249 bolnikih z NET ugotovili, da PRRT ne vpliva bistveno na semikvantitivnimi privzem pri PET z [68Ga]galij-edotreotidom, razen pri metastazah v jetrih pri bolnikih z NET, vendar študija nima histološke potrditve.
A schematic representation of the radiolabelling procedure is shown in Figure 2.
Shematski prikaz postopka radioaktivnega označevanja je prikazan na sliki 2.
Kit for radiopharmaceutical preparation containing: - Powder for solution for injection: the vial contains a white lyophilised powder.
Komplet za pripravo radiofarmaka, ki vsebuje: - Prašek za raztopino za injiciranje: viala vsebuje bel liofilizirani prašek.
In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and by frequent micturition.
4.9 Preveliko odmerjanje V primeru uporabe prevelikega odmerka sevanja je treba absorbirani odmerek zmanjšati, kadar je to mogoče, tako da povečate izločanje radionuklida iz telesa s povečano hidracijo bolnika in pogostim uriniranjem.
If at any time in the preparation of this product the integrity of the vials is compromised it should not be used.
Če je kadar koli med pripravo ogrožena integriteta viale, zdravila ne smete uporabiti.
Administration procedures should be carried out in a way to minimize risk of contamination of the medicinal product and irradiation of the operators.
Postopke dajanja je treba izvajati tako, da se čim bolj zmanjša tveganje za kontaminacijo zdravila in obsevanje osebja.
Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Zdravnik nuklearne medicine vas bo seznanil z običajnim časom za izvedbo postopka.
SomaKit TOC is supplied as a kit containing two vials.
Zdravilo SomaKit TOC je dobavljeno v kompletu, ki vsebuje dve viali.
If you have been given more SomaKit TOC than you should An overdose is unlikely because you will only receive a single dose under controlled conditions by the nuclear medicine doctor supervising the procedure.
Preveliko odmerjanje ni verjetno, saj boste prejeli le en odmerek zdravila pod nadzorovanimi pogoji s strani zdravnika nuklearne medicine, ki bo nadzoroval postopek.
An increased uptake of gallium (68Ga) edotreotide is not specific for GEP-NET.
Povečan privzem [68Ga]galij-edotreotida ni specifičen za GEP NET.
Gallium (68Ga) edotreotide solution is stable up to 4 hours after preparation.
Raztopina [68Ga]galij-edotreotida je stabilna 4 ure po pripravi.
Radiopharmaceuticals should be received, used and administered only by authorized persons in designated clinical settings.
Radiofarmake sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v pooblaščenih zdravstvenih ustanovah.
At the time of administration, the product must be aseptically withdrawn and the radioprotection standards must be followed.
V času dajanja je treba zdravilo izvleči na aseptičen način in pri tem upoštevati standarde za zaščito pred sevanjem.
- The other ingredients are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections.
- pomožne snovi so: 1,10-fenantrolin, gentizinska kislina, manitol, mravljinčna kislina, natrijev hidroksid, voda za injekcije.
SomaKit TOC contains sodium (see section 2).
Zdravilo SomaKit TOC vsebuje natrij (glejte poglavje 2).
Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling the radiolabelled SomaKit TOC to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
učinkovito zaščito pred sevanjem in ustrezne varnostne ukrepe, da preprečite nepotrebno izpostavljenost bolnika, delavcev, kliničnega osebja in drugih oseb sevanju.
Add the reaction buffer previously dosed in the 1 ml sterile syringe.
Dodajte pufer za reakcijo, ki ste ga predhodno pripravili v 1-ml sterilno injekcijsko brizgo.
PHARMACEUTICAL FORM AND CONTENTS Kit for radiopharmaceutical preparation The box contains: - 1 vial of powder - 1 vial of buffer
Komplet za pripravo radiofarmaka Škatla vsebuje: - 1 vialo praška - 1 vialo pufra
Figure 2: Radiolabelling procedure when using Galli Ad generator
Slika 2: Postopek radioaktivnega označevanja pri uporabi generatorja Galli Ad
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.
Prebodite tesnilo viale 1 s sterilnim odzračevalnim filtrom 0,2 µm, da se med postopkom radioaktivnega označevanja v viali ohrani atmosferski tlak.
Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
Izmerite radioaktivnost viale z ustreznim sistemom za umerjanje radioaktivnosti in rezultat zabeležite.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 micrograms
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mikrogramov
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/12/2016
Datum prve odobritve: 08/12/2016 10.
The injection of gallium (68Ga) edotreotide must be administered intravenously in order to avoid local extravasation resulting in inadvertent radiation to the patient and imaging artefacts.
Injekcijo [68Ga]galij-edotreotida je treba dajati intravensko, da se izognemo lokalni ekstravazaciji, ki bi povzročila nehoteno obsevanje bolnika in artefakte pri slikanju.
Refer to the Summary of Product Characteristics of the particular generator for more information.
Za več informacij glejte povzetek glavnih značilnosti zdravila posameznega generatorja.
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%).
V retrospektivnem članku Schreiter et al. 2014 je primerjava posameznikov v podskupini 20 bolnikov pokazala, da je [68Ga]galij edotreotid omogočil lokalizacijo primarnega tumorja pri 9/20 (45 %) bolnikov, medtem ko je [111In]indij-pentetreotid to omogočil pri 2/20 bolnikih (10 %).
Recommended method for determining labelling efficiency of gallium (68Ga) edotreotide:
Priporočena metoda za ugotavljanje učinkovitosti označevanja [68Ga]galij-edotreotida:
SomaKit TOC must not be used if there are visible signs of deterioration.
Zdravila SomaKit TOC ne uporabljajte, če opazite vidne znake kvarjenja.
Radiolabelling of carrier molecules with gallium (68Ga) chloride is very sensitive to the presence of trace metal impurities.
Radioaktivno označevanje nosilnih molekul z [68Ga]galijevim kloridom je zelo občutljivo na prisotnost sledov kovinskih nečistoč.
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.
Uporabljati je treba samo injekcijske brizge in igle, ki lahko zmanjšajo raven sledi kovinskih nečistoč, na primer, nekovinske ali s silikonom prevlečene igle - te zdravilu niso priložene).
If the administration is considered necessary, breastfeeding should be interrupted for 8 hours and the expressed feeds discarded.
Če je uporaba nujna, je treba dojenje po injiciranju prekiniti za 8 ur, izločeno mleko pa zavreči.
After administration of SomaKit TOC, you should: - avoid any close contact with young children and pregnant women for 8 hours after the injection - urinate frequently in order to eliminate the product from your body.
Po uporabi zdravila SomaKit TOC: - se izogibajte tesnemu stiku z majhnimi otroci in nosečnicami še 8 ur po injiciranju;
However, lesions of GEP-NET not expressing sufficient density of somatostatin receptors cannot be visualised with gallium (68Ga) edotreotide.
Vseeno lezij GEP NET, ki ne izražajo zadostne gostote somatostatinskih receptorjev, ni mogoče vizualizirati s [68Ga]galij-edotreotidom.
The solution should be visually inspected prior to use.
Raztopino je treba pred uporabo pregledati.
Sodium hydroxide (E524) Water for injections
Pufer mravljinčna kislina natrijev hidroksid (E524) voda za injekcije
In patients with Cushing syndrome, the normalisation of hypercortisolism should be considered before performing PET with SomaKit TOC.
Pri bolnikih s Cushingovim sindromom je treba pred izvedbo PET z zdravilom SomaKit TOC razmisliti o normalizaciji hiperkortizolizma.
Gallium (68Ga) edotreotide detected 35/35 (100%) lesions vs 19/35=54% for indium (111In) pentetreotide SPECT/CT.
Z [68Ga]galij-edotreotidom so odkrili 35/35 (100 %) lezij v primerjavi z 19/35 = 54 % pri SPECT/CT z [111In]indij-pentetreotidom.
The uptake in the liver and in the pituitary, thyroid and adrenal glands is lower.
Privzem v jetrih in v hipofizi, ščitnici in nadledvičnih žlezah je nižji.
- Reaction buffer: the vial contains a clear, colourless solution.
- Pufer za reakcijo: viala vsebuje bistro, brezbarvno raztopino.
Radiation safety - Product handling
NAVODILA ZA PRIPRAVO RADIOFARMAKOV Varnost pri sevanju - ravnanje z zdravilom
What SomaKit TOC is and what it is used for 2.
Kaj je zdravilo SomaKit TOC in za kaj ga uporabljamo 2.
Set the temperature of the shielded dry bath at 95°C and wait for the temperature to reach the set point and stabilize.
Temperaturo zaščitene suhe kopeli nastavite na 95 °C in počakajte, da se stabilizira pri nastavljeni točki.
m. Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
m. Izmerite radioaktivnost viale z ustreznim sistemom za umerjanje radioaktivnosti in rezultat zabeležite.
Somatostatin and its analogues are probably competing to bind to the same somatostatin receptors.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Somatostatin in njegovi analogi verjetno tekmujejo za vezavo na iste somatostatinske receptorje.
Only clear solutions, free from visible particles should be used.
Uporabiti smete le bistro raztopino brez vidnih delcev.
MARKETING AUTHORISATION HOLDER Advanced Accelerator Applications 20 rue Diesel
Imetnik dovoljenja za promet Advanced Accelerator Applications 20 rue Diesel
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.
študiji Van Binnebeek et al. 2015 je bila stopnja odkrivanja lezij pri 53 bolnikih z metastatskim GEPNET (večinoma GEP-NET (n=39) ali NET neznanega izvora (n=6)) z [68Ga]galij-edotreotidom 99,9 % (1098/1099) v primerjavi z 60-% (660/1099) stopnjo odkrivanja z [111In]indij-pentetreotidom na podlagi nadaljnjih slikanj.
Your nuclear medicine doctor will inform you if you need to take any other special precaution before or after using SomaKit TOC.
Zdravnik nuklearne medicine vas bo obvestil, če boste pred ali po uporabi zdravila SomaKit TOC
At the end of the elution, first withdraw the needle from the vacuum vial in order to establish atmospheric pressure into Vial 1, then disconnect Vial 1 from the generator by removing the needle from the rubber septum.
Po eluaciji najprej povlecite iglo iz vakuumske viale, da v viali 1 vzpostavite atmosferski tlak, in nato vialo 1 odklopite z generatorja, tako da iglo povlečete iz gumijastega tesnila.
As the effective dose is about 4.5 mSv when the maximal recommended activity of 200 MBq is administered, these adverse reactions are expected to occur with a low probability.
Ker je učinkovit odmerek približno 4,5 mSv, kadar je največja priporočena aktivnost 200 MBq,
• Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips Mobile phase: sodium Citrate 0.1 M (pH 5) in water
• Papir iz steklenih vlaken ITLC (na primer Agilent ITLC SGI001), predhodno razrezan na trakove velikosti 1 x 12 cm Mobilna faza: natrijev citrat 0,1 M (pH 5) v vodi
The following authorised generators have shown to be compatible with SomaKit TOC:
Z zdravilom SomaKit TOC so dokazano združljivi naslednji odobreni generatorji:
SomaKit TOC must not be used - if you are allergic to edotreotide or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na edotreotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
A prospective intra-individual comparison showed that gallium (68Ga) edotreotide is able to detect lesions better than indium (111In) pentetreotide.
Prospektivna primerjava posameznikov je pokazala, da [68Ga]galij-edotreotid omogoča odkrivanje lezij bolje kot [111In]indij-pentetreotid.
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.
V študiji Buchmann et al. 2007, ki je bila izvedena s 27 bolniki, večinoma z GEP-NET (59 %) ali z NET neznanega izvora (30 %), so z [68Ga]galijedotreotidom odkrili 279 lezij v primerjavi s 157 lezijami, odkritimi z [111In]indij-pentetreotidom.
Driving and using machines It is considered unlikely that SomaKit TOC will affect your ability to drive or to use machines.
Ni verjetno, da bo imelo zdravilo SomaKit TOC vpliv na sposobnost vožnje ali upravljanja strojev.
What you need to know before SomaKit TOC is used 3.
Kaj morate vedeti, preden boste uporabili zdravilo SomaKit TOC 3.
Thin layer chromatography (ITLC2, see details below)
Tankoplastna kromatografija (ITLC2, glejte podrobnosti spodaj)
The activity of gallium (68Ga) edotreotide has to be measured with an activimeter immediately prior to injection.
Aktivnost [68Ga]galij-edotreotida je treba tik pred injiciranjem izmeriti z merilnikom aktivnosti.
About 50 minutes after intravenous administration, gallium (68Ga) edotreotide accumulation shows plateauing in all organs.
Približno 50 minut po intravenskem dajanju akumulacija [68Ga]galij-edotreotida v vseh organih doseže plato.
After radiolabelling, the solution obtained also contains hydrochloric acid.
Po radioaktivnem označevanju dobljena raztopina vsebuje tudi klorovodikovo kislino.
Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium (68Ga) chloride to make gallium (68Ga) edotreotide (this procedure is called radiolabelling).
Pred uporabo se prašek v viali zmeša z radioaktivno snovjo, imenovano [68Ga]galijev klorid, s čimer se pridobi snov, imenovana [68Ga]galij-edotreotid (ta postopek se imenuje radioaktivno označevanje).
Radioactive waste must be disposed of in accordance with relevant national regulations.
Radioaktivne odpadke je treba zavreči skladno z nacionalnimi predpisi.
Thin layer chromatography (ITLC1, see details below)
Tankoplastna kromatografija (ITLC1, glejte podrobnosti spodaj)
• Developing tank
• Razvijalna posoda
At the end of the elution, disconnect the generator from the Vial 1 withdrawing the needle from the rubber septum and immediately add the reaction buffer previously dosed in the 1 ml sterile syringe.
Po eluaciji odklopite generator z viale 1, tako da iglo povlečete iz gumijastega tesnila, in takoj dodajte pufer za reakcijo, ki ste ga predhodno pripravili v 1-ml sterilno injekcijsko brizgo.
Test
Preizkus
- A glass vial with yellow flip-off cap containing a clear and colourless solution.
- Stekleno vialo z rumeno zaporko (tipa »flip-off«), ki vsebuje bistro in brezbarvno raztopino.
Due to the acidic pH of the radiolabelled gallium (68Ga) edotreotide solution, accidental extravasation may cause local irritation.
Zaradi kislega pH radioaktivno označene raztopine z [68Ga]galij-edotreotidom lahko nenamerna ekstravazacija povzroči lokalno draženje.
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.
Odprite zaporko (tipa »flip-off«) na viali 2 (pufra za reakcijo) in obrišite vrh viale z ustreznim antiseptičnim sredstvom za razkuževanje površine, nato pa pustite, da se zamašek posuši.
- if you have others medical conditions, such as high level of cortisol in the body (Cushing syndrome), inflammation, thyroid disease, other type of tumour (of pituitary gland, lung, brain, breast, immune system, thyroid, adrenal gland or others) or disease of spleen that may affect the interpretation of the images; - if you have been taking other medicines, such as somatostatin analogues and glucocorticoids, which may interact with SomaKit TOC; - if you are pregnant or believe you may be pregnant; - If you are breast-feeding.
- če imate kakršna koli druga zdravstvena stanja, kot so visoka raven kortizola v telesu (Cushingov sindrom), vnetje, bolezen ščitnice, druge vrste tumorja (hipofize, pljuč, možganov, dojk, imunskega sistema, ščitnice, nadledvične žleze ali drugega) ali bolezen vranice, ki lahko vplivajo na interpretacijo slik;
Renal/Hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment has not been characterized.
Ledvična in jetrna okvara Farmakokinetičnih značilnosti pri bolnikih z ledvično ali jetrno okvaro niso preučevali.