natgillin/translations-raw huggingface dataset:
Mechanism of action Gallium (68Ga) edotreotide binds to somatostatin receptors.
Mehanizem delovanja Galijev (68Ga) edotreotid se veže na somatostatinske receptorje.
• Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips
• Papir iz steklenih vlaken ITLC (na primer Agilent ITLC SGI001), predhodno razrezan na trakove velikosti 1 x 12 cm
Interpretation of gallium (68Ga) edotreotide images and limitations of use PET images with gallium (68Ga) edotreotide reflect the presence of somatostatin receptors in the tissues.
Interpretacija slik [68Ga]galij-edotreotida in omejitve uporabe Slike PET [68Ga]galij-edotreotida odražajo prisotnost somatostatinskih receptorjev v tkivih.
PET images with gallium (68Ga) edotreotide should be interpreted visually, and semiquantitative measurement of gallium (68Ga) edotreotide uptake should not be used for clinical interpretation of images.
Slike PET [68Ga]galij-edotreotida je treba interpretirati vizualno, semikvantitativnega merjenja privzema [68Ga]galij-edotreotida pa ne smemo uporabljati za klinično interpretacijo slik.
After radiolabelling
po radioaktivnem označevanju
What SomaKit TOC is and what it is used for
Kaj je zdravilo SomaKit TOC in za kaj ga uporabljamo
Other medicines and SomaKit TOC
Druga zdravila in zdravilo SomaKit TOC
In GEP-NET, a more intense gallium (68Ga) edotreotide uptake than normal background is a consistent finding.
V GEP-NET je dosledno ugotovljen intenzivnejši privzem [68Ga]galij-edotreotida kot pri običajnem ozadju.
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.
V primeru Cushingovega sindroma lahko dolgoročna izpostavljenost endogenemu hiperkortizolizmu negativno regulira izražanje somatostatinskih receptorjev in negativno vpliva na rezultate slikanja somatostatinskih receptorjev z [68Ga]galij-edotreotidom.
One vial of powder contains 40 µg of edotreotide.
Ena viala praška vsebuje 40 µg edotreotida.
Organ uptake The organ with the highest physiological uptake of gallium (68Ga) edotreotide is the spleen, followed by the kidneys.
Privzem v organih Organ z najvišjim fiziološkim privzemom [68Ga]galij-edotreotida je vranica, sledijo pa ledvice.
Close contact with infants and pregnant women should be restricted during the first 8 hours after administration.
V 8 urah po dajanju je treba omejiti tesne stike z dojenčki in nosečnicami.
(70%) and discrepancies in 14 patients (30%) presenting 9 with progressive disease and 5 with remission.
PET in CT z [68Ga]galij-edotreotidom sta dala skladne rezultate pri 32 bolnikih (70 %) in neskladnosti pri 14 bolnikih (30 %), pri čemer jih je 9 bilo s progresivno boleznijo in 5 z remisijo.
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).
2009 so primerjali uporabo [68Ga]galij-edotreotida pred PRRT s CT ali MRI po merilih za vrednotenje odziva pri solidnih tumorjih (merila RECIST).
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration.
Odmerek za bolnika je treba tik pred dajanjem izmeriti z ustreznim sistemom za umerjanje radioaktivnosti.
With a low dead space 1 ml sterile syringe carefully withdraw 100 µl and keep the reaction buffer in syringe for step “g”.
S sterilno 1-ml injekcijsko brizgo z majhnim volumnom mrtvega prostora previdno povlecite 100 µl in ohranite pufer za reakcijo v injekcijski brizgi za korak »g«.
The organs with high physiological uptake of gallium (68Ga) edotreotide include spleen, kidneys, liver, pituitary gland, thyroid gland and adrenals.
Organi z visokim fiziološkim privzemom [68Ga]galij-edotreotida vključujejo vranico, ledvice, jetra, hipofizo, ščitnico in nadledvične žleze.
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.
Za radioaktivno označevanje s pufrom za reakcijo in raztopino galija-68 (68 Ga) v HCl iz generatorja germanija (68Ge)/galija (68Ga).
The quality controls should be performed under a shielded screen for radioprotection purposes.
Nadzor kakovosti je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
Before administering radiopharmaceuticals to a mother who is breastfeeding, 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.
dokler mati ne neha dojiti, in o najustreznejši izbiri radiofarmakov, pri čemer je treba upoštevati izločanje aktivnosti sevanja v materino mleko.
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).
Podatki, ki podpirajo učinkovitost [68Ga]galij-edotreotida pri predvidevanju in spremljanju terapevtskega odziva na radionuklidno terapijo s peptidnimi receptorji (PRRT, peptide receptor radionuclide therapy) v histološko potrjenem metastatskem NET, so omejeni (glejte poglavje 5.1).
Each 40 microgram vial contains an excess of product.
Ena viala s 40 mikrogrami vsebuje čezmerno količino zdravila.
In vivo, semiquantitative correlation was not assessed between gallium (68Ga) edotreotide uptake in tumours and the density of SSTR in histopathological samples neither in GEP-NET patients nor in normal organs.
Semikvantitativna korelacija med privzemom [68Ga]galij-edotreotida v tumorjih in gostoto SSTR v histopatoloških vzorcih ni bila ocenjena in vivo, niti pri bolnikih z GEP-NET niti pri normalnih organih.
pH-indicator strips
Indikatorski trakovi za pH
EXP: ________ Time/Date
Uporabno do: ________ ura/datum
Gallium (68Ga) edotreotide has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Galijev (68Ga) edotreotid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Thus, in patients with GEP-NET and Cushing syndrome, normalisation of hypercortisolism should be suggested before performing PET with gallium (68Ga)
Pri bolnikih z GEP NET in Cushingovim sindromom je treba torej pred izvedbo PET z [68Ga]galij-edotreotidom predlagati normalizacijo hiperkortizolizma.
After radiolabelling, the solution obtained also contains, as excipient, hydrochloric acid from the generator eluate.
Po radioaktivnem označevanju dobljena raztopino kot pomožno snov vsebuje tudi klorovodikovo kislino iz eluata iz generatorja.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC
IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC
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)
Dolgoročna izpostavljenost endogenemu hiperkortizolizmu lahko negativno regulira izražanje somatostatinskih receptorjev in negativno vpliva na rezultate slikanja somatostatinskih receptorjev z [68Ga]galij-edotreotidom.
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.
Odprite zaporko (tipa »flip-off«) na viali praška in obrišite vrh viale z ustreznim antiseptičnim sredstvom za razkuževanje površine, nato pa pustite, da se zamašek posuši.
The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Varnost in učinkovitost [68Ga]galij-edotreotida pri pediatrični populaciji nista bili dokazani, učinkoviti odmerek pa je lahko drugačen kot pri odraslih.
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”.
S sterilno 1-ml injekcijsko brizgo z majhnim volumnom mrtvega prostora previdno povlecite 0,5 ml pufra za reakcijo in ohranite pufer za reakcijo v injekcijski brizgi za korak »i«.
Individual benefit/risk justification
Presoja razmerja med tveganji in koristmi pri posameznem bolniku
Connect the male luer of the outlet line of the 68Ge/68Ga generator with a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity tracenot supplied).
Moški del konice Luer odvoda generatorja 68Ge/68Ga povežite s sterilno iglo (prevlečeno s silikonom ali drugega ustreznim materialom za zmanjšanje sledov kovinskih nečistoč ta ni priložena zdravilu).
Non-clinical data did not reveal any special hazard for gallium (68Ga) edotreotide in humans.
5.3 Predklinični podatki o varnosti Neklinični podatki ne kažejo nobenega posebnega tveganja za uporabo [68Ga]galij-edotreotida pri ljudeh.
Depending on the time when you administer the injection, the content of sodium may in some cases be greater than 1 mmol.
Vsebnost natrija je lahko v nekaterih primerih večja od 1 mmol, kar je odvisno od časa injiciranja.
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.
Na koncu odstranite 0,2-µm sterilni odzračevalni filter ter vialo s kleščami prestavite na odprtino suhe kopeli pri 95 °C.
Connect the Vial 1 to the outlet line of the generator by pushing the needle through the rubber septum.
Povežite vialo 1 z odvodom generatorja, tako da iglo potisnete skozi gumijasto tesnilo.
After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
[68Ga]galij-edotreotida indicirana za slikanje čezmerne ekspresije somatostatinskih receptorjev s pozitronsko emisijsko tomografijo (PET) pri odraslih bolnikih s potrjenimi ali domnevnimi dobro diferenciranimi gastroenteropankreatičnimi nevroendokrinimi tumorji (GEP-NET) za lokalizacijo primarnih tumorjev in njihovih metastaz.
d. Scan the ITLC with a radiometric ITLC scanner e. The retention factor (Rf) specifications are as follows: Not complexed gallium (68Ga) = 0 to 0.1 gallium (68Ga) edotreotide = 0.8 to 1
e. Lastnosti retencijskega faktorja (Rf) so naslednje: Nekompleksiran galij (68Ga) = 0-0,1 [68Ga]galij-edotreotid = 0,8-1
Urinary bladder wall Uterus
Ščitnica Stena sečnega mehurja
Table 1: Dosimetry of gallium (68Ga) edotreotide
Preglednica 1: Dozimetrija [68Ga]galij-edotreotida
Connect Vial 1 through the 0.2 µm sterile vent filter to a vacuum vial or to a pump to start the elution.
Vialo 1 preko 0,2-µm sterilnega odzračevalnega filtra povežite z vakuumsko vialo ali črpalko, da začnete z eluacijo.
High physiological uptake of gallium (68Ga) edotreotide by the pancreas uncinate process can also be observed.
Visok fiziološki privzem [68Ga]galij-edotreotida je opazen tudi v uncinatnem procesusu trebušne slinavke.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the fœtus.
Podatki o uporabi tega zdravila med nosečnostjo ni. Radionuklidni postopki, opravljeni na nosečnicah, vključujejo tudi odmerke sevanja na plod.
monograph 2464 Gallium (68Ga) chloride solution for radiolabelling and that, in addition, is sterile and has been tested for compatibility with SomaKit TOC.
Namenjen je radioaktivnemu označevanju z raztopino [68Ga]galijevega klorida, skladno z monografijo Ph. Eur št. 2464 - raztopina [68Ga]galijevega klorida za radioaktivno označevanje, poleg tega mora biti sterilna ter preskušeno združljiva z zdravilom SomaKit TOC.
In the study of Kowalski et al. 2003 in 4 patients with GEP-NET, gallium (68Ga) edotreotide showed better patient-based detection rate (100%) than indium (111In) pentetreotide (50%).
V študiji Kowalski et al. 2003 s 4 bolniki z GEP NET je bila stopnja odkrivanja pri posameznem bolniku pri [68Ga]galij-edotreotidu boljša (100 %) kot pri [111In]indij-pentetreotidu (50 %).
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Radiofarmake bodo shranjevali v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
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).
Izkazalo se je, da je privzem v organih neodvisen od starosti in tudi pretežno neodvisen od spola
• One vial of buffer: 10 ml cyclic olefin polymer vial closed with a teflon stopper and sealed with a flip-off cap. Each vial contains 1 ml of reaction buffer.
• Ena viala s pufrom: 10-mililitrska steklena viala iz cikličnega olefin polimera s teflonskim zamaškom, zatesnjenim z zaporko (tipa »flip-off«).
b. Apply a drop of the gallium (68Ga) edotreotide solution on a pencil line 1 cm from the bottom of the ITLC strip.
b. Kapljo raztopine [68Ga]galij-edotreotida nanesite na črto svinčnika 1 cm od spodnjega roba traka ITLC.
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;
- če imate težave z ledvicami ali jetri (ledvično ali jetrno bolezen); - če ste mlajši od 18 let; - če imate znake dehidracije pred in po pregledu;
Symptoms may include: warm flush, redness of the skin, swelling, itching, nausea and difficulty breathing.
Simptomi lahko vključujejo: vročinske oblive, pordelost kože,
Paediatric population The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Varnost in učinkovitost [68Ga]galij-edotreotida pri pediatrični populaciji nista bili dokazani, učinkoviti odmerek pa je lahko drugačen, kot pri odraslih.
With a 5 mL sterile syringe and a sterile needle (coated with silicone or other appropriate material able to reduce metal impurity trace - not supplied) carefully withdraw 4 mL of water for injections (not supplied) and reconstitute the powder in Vial 1.
S sterilno 5-ml injekcijsko brizgo in sterilno iglo (prevlečeno s silikonom ali drugim ustreznim materialom za zmanjšanje sledov kovinskih nečistoč - ta ni priložena zdravilu)
EXP After radiolabelling, use within 4 hours.
Po radioaktivnem označevanju porabit v 4 urah.
Reconstitution with GalliaPharm generator: a.
Rekonstitucija z generatorjem GalliaPharm:
Therefore, when treating patients with somatostatin analogues, it is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) preceding the next administration of a somatostatin analogue.
Zato je treba pri zdravljenju bolnikov s somatostatinskimi analogi slikanje z [68Ga]galij-edotreotidom po možnosti opraviti dan (nekaj dni) pred naslednjim dajanjem analoga somatostatina.
A low dead space 1 ml plastic syringe must be used in order to precisely measure the adequate volume of reaction buffer to be added during the preparation.
Za natančno merjenje zadostne količine pufra za reakcijo, ki ga je treba dodati med pripravo, je treba uporabiti 1-ml plastično injekcijsko brizgo z majhnim volumnom mrtvega prostora.
However, after gallium (68Ga) chloride solution is added, adequate shielding of the final preparation must be maintained.
[68Ga]galijevega klorida, pa je treba ves čas uporabljati ustrezno zaščito pred sevanjem končnega pripravka.
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.
Razpoložljivi podatki glede klinične učinkovitosti [68Ga]galij-edotreotida za indikacijo predvidevanja in spremljanja terapevtskega odziva na radionuklidno terapijo s peptidnimi receptorji (PRRT) v histološko potrjenem metastatskem NET, so omejeni (glejte poglavje 5.1).
As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas).
neoplazije pljuč (drobnocelični karcinom), meningiomi, karcinomi dojk, limfoproliferativna bolezen (npr. Hodgkinova bolezen in ne-Hodgkinovi limfomi) in tumorji, ki izhajajo iz tkiva, ki embriološko izhaja iz nevralnega grebena (npr. paragangliomi, medularni karcinomi ščitnice, nevroblastomi, feokromocitomi).
For radiolabelling with gallium (68Ga) chloride solution.
Za radioaktivno označevanje z raztopino [68Ga]galijevega klorida.
The visual inspection should be performed under a shielded screen for radioprotection purposes.
Pregled je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
How SomaKit TOC is stored 6.
Shranjevanje zdravila SomaKit TOC 6.
If possible, for more convenience in the preparation of radiolabelled SomaKit TOC, the heating platform should be placed right beside the generator.
SomaKit TOC grelno platformo postavite neposredno ob generator.
Before administration of SomaKit TOC
Pred uporabo zdravila SomaKit TOC
Close contact with infants should be restricted during the initial 8 hours following injection.
V prvih 8 urah po dajanju tega zdravila je treba omejiti tesne stike z dojenčkom.
Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment.
Varnosti in učinkovitosti [68Ga]galij-edotreotida niso preučevali pri bolnikih z okvaro ledvic ali jeter.
Lesion-detection rate was 75% (3/4) in the subgroup of patients with unknown primary tumour site of the prospective study of Frilling et al. 2010.
V prospektivni študiji Frilling et al. 2010 je bila stopnja odkrivanja lezij 75 % (3/4) za podskupino bolnikov z neznanim mestom primarnega tumorja.
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.
Izvlecite injekcijsko brizgo in 0,2-µm sterilni odzračevalni filter ter vialo s kleščami prestavite na odprtino suhe kopeli pri 95 °C.
b. Apply a drop of the gallium (68Ga) edotreotide on a pencil line 1 cm from the bottom of the
b. Kapljo [68Ga]galij-edotreotida nanesite na črto svinčnika 1 cm od spodnjega roba traka
Administration of SomaKit TOC and conduct of the procedure After radiolabelling, SomaKit TOC is administered by intravenous injection.
Zdravilo SomaKit TOC se po radioaktivnem označevanju daje z intravensko injekcijo.
• One vial of powder for solution for injection: 10 ml Type I glass vial closed with a bromobutyl rubber stopper and sealed with a flip-off cap. Each vial contains 40 micrograms of edotreotide.
• Ena viala s praškom za raztopino za injiciranje: 10-mililitrska steklena viala (steklo tipa I) z zamaškom iz bromobutilne gume, zatesnjenim z zaporko (tipa »flip-off«).
m. The solution should be visually inspected prior to use.
m. Raztopino je treba pred uporabo pregledati.
In the study of Lee et al. 2015 in 13 GEP-NET patients, a total of 35 positive lesions were detected in 10 patients on either gallium (68Ga) edotreotide PET/CT or indium (111In) pentetreotide
V študiji Lee et al. 2015 je bilo pri 13 bolnikih z GEP NET odkritih skupno 35 pozitivnih lezij pri 10 bolnikih, tako s PET/CT z [68Ga]galij-edotreotidom kot tudi s SPECT/CT z [111In]indij-pentetreotidom, medtem ko pri 3 bolnikih niso odkrili nobene pozitivne lezije z nobeno od metod slikanja.
Figure 1: Radiolabelling procedure when using GalliaPharm generator Reconstitution with Galli Ad generator:
Slika 1: Postopek radioaktivnega označevanja pri uporabi generatorja GalliaPharm
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.
Izgled zdravila SomaKit TOC in vsebina pakiranja SomaKit TOC je komplet za pripravo radiofarmaka, ki vsebuje:
SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation Edotreotide
SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka edotreotid
Renal / Hepatic impairment
Bolniki z ledvično ali jetrno okvaro
After radiolabelling, store below 25°C.
Po radioaktivnem označevanju shranjujte pri temperaturi do 25 ºC.
NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
IME ZDRAVILA SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka
Radiolabelled SomaKit TOC is suitable for PET medical imaging.
Radioaktivno označeno zdravilo SomaKit TOC je primerno za medicinsko slikanje s PET. Zajemanje mora vključevati celo telo od lobanje do sredine stegen.
Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68
Učinkovitost označevanja vzorec koloidnega galija-68
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba skrbno pretehtati razmerje med koristmi in tveganji .
No adverse reactions related to gallium (68Ga) edotreotide have been reported.
4.8 Neželeni učinki O neželenih učinkih, povezanih z [68Ga]galij-edotreotidom, niso poročali.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide
IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC 40 mikrogramov raztopina za injiciranje [68Ga]galij-edotreotid intravenska uporaba
The three remaining retrospective studies recruited small samples (ranging from 20 to 28 GEP-NET patients or those with cancer of unknown origin) and found that semiquantitative uptake in the pre-PRRT gallium (68Ga)
Preostale tri retrospektivne študije so uporabljale majhne vzorce (v razponu od 20 do 28 bolnikov z GEP NET ali bolnikov z rakom neznanega izvora) in so ugotovile, da je bil semikvantitativni privzem pri slikanju PET z [68Ga]galij edotreotidom pred PRRT povezan z odmerki, ki jih tumor absorbira ob vbrizganju v naslednjem prvem ciklu zdravljenja, da je pomagal pri razlikovanju med lezijami, opredeljenimi kot odzivnimi in neodzivnimi po treh ciklih PRRT, ter da je pomagal razlikovati metastaze v jetrih od normalnega jetrnega tkiva.
No radioactive metabolites were detected in serum within 4 hours after intravenous injection of gallium (68Ga) edotreotide.
V 4 urah po intravenskem injiciranju [68Ga]galij-edotreotida niso odkrili readioaktivnih presnovkov v serumu.
How SomaKit TOC is used
Kako uporabljati zdravilo SomaKit TOC
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.
V študiji Hofmann et al. 2001, ki je obravnavala bolnike s histološko dokazanimi NET bronhijev (n=2) in srednjega črevesa (n=6), so zaznali stopnjo odkrivanja lezij 100 % (40/40) v primerjavi s 85 % (34/40).
Store the vial containing the gallium (68Ga) edotreotide solution below 25°C until use.
Vialo z [68Ga]galij-edotreotidom do uporabe hranite pri temperaturi do 25 °C.
What you need to know before SomaKit TOC is used
Kaj morate vedeti, preden boste uporabili zdravilo SomaKit TOC Zdravila SomaKit TOC se ne sme uporabljati:
ITLC strip.
ITLC.