natgillin/translations-raw huggingface dataset:
The nuclear medicine doctor supervising the procedure will decide on the quantity of SomaKit TOC to be used in your case. 
Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila SomaKit TOC, ki bo uporabljena pri vas.
A single injection is sufficient to conduct the test that your doctor needs. 
Za izvedbo preiskave, ki jo potrebuje vaš zdravnik, zadostuje eno samo injiciranje.
You should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the procedure to ensure that SomaKit TOC is removed as quickly as possible from the body. 
Pred začetkom preiskave pijte veliko vode, da boste v prvih urah po postopku čim več urinirali in tako zagotovili, da bo zdravilo SomaKit TOC čim prej izločeno iz telesa.
Turn the button by 90° to loading position then wait 10 seconds before turning the button back to initial position, according to the generator's instructions for use. 
Obrnite gumb za 90° v položaj za polnjenje, počakajte 10 sekund in nato gumb obrnite nazaj v prvotni položaj skladno z navodili za uporabo proizvajalca generatorja.
The quantity to be administered usually recommended for an adult ranges from 100 MBq to 200 MBq (megabecquerel, the unit used to express radioactivity). 
Uporabljena količina, navadno priporočena za odrasle, je od 100 do 200 MBq (megabekerel, enota, ki se uporablja za izražanje radioaktivnosti).
The use of SomaKit TOC involves exposure to small amounts of radioactivity. 
Uporaba zdravila SomaKit TOC vključuje izpostavljenost majhnim količinam radioaktivnosti.
Splenectomy should also be considered as a relevant factor when reporting the outcome of somatostatin receptor targeted diagnostics. 
Splenektomijo je treba pav tako obravnavati kot pomemben dejavnik pri poročanju o izidu diagnostike, ki cilja na somatostatinske receptorje.
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. 
Bolnik mora biti pred začetkom preiskave dobro hidriran in naročiti mu je treba, da v prvih urah po preiskavi čim pogosteje urinira, saj bo to zmanjšalo njegovo izpostavljenost sevanju.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine. 
Nosečnost in dojenje Če ste noseči ali če dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vzamete to zdravilo.
Local tolerance assessment resulted in mild to moderate inflammation signs in the perivascular region of some animals which can be attributed to the acidic pH of the solution. 
Ocena lokalne tolerance je pokazala blage do zmerne znake vnetja v perivaskularnem območju nekaterih živali, kar je mogoče pripisati kislemu pH raztopine.
If you are breast-feeding the nuclear medicine doctor may either delay the medical procedure until you no longer breast-feed or ask you to stop breastfeeding and to discard this milk until there is no radioactivity in your body (8 hours after the administration of SomaKit TOC). 
Če dojite, bo zdravnik nuklearne medicine postopek prestavil, dokler ne boste več dojili, ali pa vam naročil, da prenehate dojiti in da zavržete mleko, dokler v vašem telesu ne bo več radioaktivnosti (8 ur po uporabi zdravila SomaKit TOC).
Therefore, the radiolabelled solution can be used within 4 hours after preparation according to the radioactivity required for the administration. 
Zato je treba radioaktivno označeno raztopino uporabiti v 4 urah po pripravi glede na radioaktivnost, potrebno pri dajanju.
For storage conditions after radiolabelling of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po radioaktivnem označevanju zdravila glejte poglavje 6.3.
However, it is recommended that the vial be prepared as instructed and used for a single patient dose, based on the activity to be injected; any remaining material should be discarded after radiolabelling and use. 
Vendar je priporočljivo, da se viala pripravi skladno z navodili in da se uporabi za enkratni odmerek pri bolniku glede na injicirano aktivnost; ves preostali material je treba po radioaktivnem označevanju in uporabi zavreči.
Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. 
Možnost preobčutljivostnih ali anafilaktičnih reakcij Če se pojavijo preobčutljivostne ali anafilaktične reakcije je treba dajanje zdravila takoj prekiniti in po potrebi takoj uvesti intravensko zdravljenje.
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical. 
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero koli sestavino označenega radiofarmaka.
After 7 minutes, remove the vial from the dry bath, place it in an appropriately labelled lead shield and let it cool down at room temperature for approximately 10 minutes. 
Po 7 minutah vialo vzemite iz suhe kopeli, postavite jo v svinčeni ščit z ustrezno oznako in jo pustite, da se približno 10 minut ohlaja pri sobni temperaturi.
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including somatostatin analogues, glucocorticoids (also called corticosteroids), since they may interfere with the interpretation of the images. 
Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z analogi somatostatina in glukokortikoidi (imenovanimi tudi kortikosteroidi), ki bi lahko vplivali na interpretacijo slik.
01630 Saint Genis Pouilly France tel: +33 4 50 99 30 70 fax: +33 4 50 99 30 71 e-mail: info@adacap.com 
01630 Saint Genis Pouilly France tel: +33 4 50 99 30 70 faks: +33 4 50 99 30 71
• Mobile phase: 77 g/L solution of ammonium acetate in water /Methanol 50:50 V/V 
• Mobilna faza: Raztopina amonijevega acetata v vodi 77 g/l / metanol 50:50 V/V
There is no data if the intravenous administration of edotreotide produces variation of serum gastrin and serum glucagon levels. 
Ni podatkov o tem, ali intravensko dajanje edotreotida povzroči spremembo ravni gastrina in glukagona v serumu.
This medicine is a radiopharmaceutical product for diagnostic use only. 
To zdravilo je radiofarmak, ki je namenjen le diagnostični uporabi.
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. 
Galij-68 razpada z razpolovnim časom 68 min na stabilni cink-68, 89 % z emisijo pozitronov s povprečno energijo 836 keV, čemur sledi fotonsko anihilacijsko sevanje s 511 keV (178 %), 10 % z orbitalnim zajemanjem elektronov (rentgenske emisije ali emisije Auger) in 3 % prek 13 gama prehodov s 5 ravni vzbujenosti.
Calibration time: ________ Time/Date 
Čas umerjanja: ________ ura/datum
After radiolabelling, SomaKit TOC should be used within 4 hours. 
Po radioaktivnem označevanju je treba zdravilo SomaKit TOC uporabiti v 4 urah.
Gallium (68Ga) edotreotide contains a small amount of radioactivity. 
Galijev (68Ga) edotreotid vsebuje majhno količino radioaktivnosti.
The medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine diagnostic agents and only in a designated nuclear medicine facility. 
Zdravilo smejo uporabljati samo usposobljeni zdravstveni delavci s tehničnim znanjem o uporabi in ravnanju z diagnostičnimi sredstvi za nuklearno medicino in to le v objektu, namenjenem nuklearni medicini.
The effective dose resulting from the administration of an activity of 200 MBq to an adult weighing 70 kg is about 4.2 mSv. 
Efektivni odmerek pri obsevanju z 200 MBq aktivnosti za odraslo osebo, ki tehta 70 kg, je približno 4,2 mSv.
Total body Effective dose mSv/MBq 
Maternica Celotno telo Efektivni odmerek mSv/MBq
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionizing radiation (if there are any) should be offered to the patient. 
Če obstaja dvom glede nosečnosti (če je ženski izostala menstruacija, je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi druge tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
• Galli Ad, 0.74 - 1.85 GBq, radionuclide generator (IRE-Elit). 
• Galli Ad, 0,74-1,85 GBq, radionuklidni generator (IRE-Elit).
For instructions on extemporaneous preparation of the medicinal product before administration, see sections 6.6 and 12. 
Za navodila glede sprotne priprave zdravila pred dajanjem glejte poglavji 6.6 in 12.
Radiopharmaceuticals should be used by or under the control of healthcare professionals who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radionuclides. 
Radiofarmake smejo uporabljati zdravstveni delavci, ki so bili posebej usposobljeni in imajo izkušnje na področju varne uporabe radionuklidov ter ravnanja z njimi, katerih usposabljanje in izkušnje je odobrila ustrezna vladna agencija, pooblaščena za izdajanje licenc za uporabo radionuklidov.
This medicinal product must not be mixed with other products except those mentioned in section 12. 
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 12. 6.3 Rok uporabnosti
In case of extravasation, the injection must be stopped, the site of injection must be changed and the affected area should be irrigated with sodium chloride solution. 
V primeru ekstravazacije je treba injiciranje ustaviti, mesto injiciranja je treba zamenjati, prizadeta območja pa sprati z raztopino natrijevega klorida.
SomaKit TOC must not be used after the expiry date which is stated on the carton. 
Zdravila SomaKit TOC ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
The peptide is excreted via kidneys as intact compound. 
Peptid se izloča preko ledvic kot nespremenjena spojina.
Elute the generator directly into the Vial 1 (through the needle). 
Generator eluirajte neposredno v vialo 1 (skozi iglo).
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. 
Somatostatin je nevrotransmitor v osrednjem živčevju in hormon, ki se veže na celice nevroendokrinega izvora in zavira sproščanje rastnega hormona, inzulina, glukagona in gastrina.
The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection. 
Priporočeni razpon aktivnosti pri odraslih, ki tehtajo 70 kg, je od 100 do 200 MBq z neposredno počasno intravensko injekcijo.
• GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator (Eckert & Ziegler Radiopharma GmbH), 
• GalliaPharm, 0,74-1,85 GBq, radionuklidni generator (Eckert & Ziegler Radiopharma GmbH),
After radiolabelling with the correct volume of reaction buffer and generator eluate, any further dilution with any diluent is prohibited. 
Po radioaktivnem označevanju z ustrezno količino pufra za reakcijo in eluata iz generatorja je prepovedano nadaljnje redčenje s kakršnim koli redčilom.
The labelling efficiency is calculated by integration of peak with Rf = 0.9 to 1.0 that must be ≤ 2%. 
Učinkovitost označevanje se izračuna z integracijo vrha z Rf = 0,9-1,0, ki mora biti ≤ 2 %.
Precautions to be taken before handling or administration of the medicinal product For instructions on radiolabelling of the medicinal product before administration, see section 12. 
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede radioaktivnega označevanja zdravila pred dajanjem glejte poglavje 12.
The labelling efficiency is calculated by integration of peak with Rf = 0 to 0.1 that must be ≤ 3%. 
Učinkovitost označevanja se izračuna z integracijo vrha z Rf = 0-0,1, ki mora biti ≤ 3 %.
Half-life Given that the elimination rate is substantially slower than the physical half-life of gallium (68Ga) 
Razpolovni čas Glede na to, da je hitrost izločanja bistveno počasnejša kot fizikalni razpolovni čas 68Ga galija
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. 
Zdravnik nuklearne medicine vas bo obvestil, če boste po uporabi tega zdravila morali upoštevati kakršne koli posebne previdnostne ukrepe.
Reaction buffer 
Pufer za reakcijo
Gallbladder wall Lower large intestine wall Small intestine Stomach wall Upper large intestine wall Heart wall 
Stena spodnjega debelega črevesa Tanko črevo
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities. 
Ta radiofarmak dovede majhne količine ionizirajočega sevanja, povezanega z zelo majhnim tveganjem za raka in prirojene nepravilnosti.
It contains the active substance edotreotide. 
Vsebuje učinkovino edotreotid.
c. Place the ITLC strip in the developing tank and allow it to develop for a distance of 9 cm from the point of application. 
c. Trak ITLC položite v razvijalno posodo in pustite, da se razvije do razdalje 9 cm od točke nanosa.
However, even taking as worst case reference the limits for genotoxic and carcinogenic impurities, the risk related to the trace amounts of 1,10-phenanthroline in SomaKit TOC formulation is considered negligible at the dose to be administered in patients: the exposure to 1,10-phenanthroline (5 µg/dose) is 24 fold lower than the acceptable daily intake for a genotoxic impurity (120 µg/day for exposures <1 month). 
Vendar pa je tudi v najslabšem referenčnem primeru mejnih vrednosti za genotoksične in rakotvorne nečistoče tveganje, povezano z sledovi 1,10-fenantrolina v formulaciji SomaKit TOC pri odmerku za bolnike zanemarljivo: izpostavljenost 1,10-fenantrolinu (5 µg/odmerek) je 24-krat nižja od sprejemljivega dnevnega vnosa za genotoksično nečistočo (120 µg/dan za izpostavljenost <1 meseca).
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and fœtus. 
Med nosečnostjo je zato treba izvajati samo nujne preiskave, pri katerih je verjetna korist precej večja od tveganja za mater in plod.
At the chemical concentrations used for diagnostic examinations, gallium (68Ga) edotreotide does not appear to have any clinically relevant pharmacodynamic effect. 
Pri kemičnih koncentracijah, ki se uporabljajo za diagnostične preiskave, se zdi, da [68Ga]galijedotreotid nima nobenih klinično pomembnih farmakodinamičnih učinkov.
Take this into consideration if you are on a controlled sodium diet. 
To je treba upoštevati, če imate dieto z nadzorovanim vnosom natrija.
Elute the generator directly into the Vial 1 (through the needle) according to the generator manufacturer instructions for use, in order to reconstitute the powder with the eluate. 
Generator eluirajte neposredno v vialo 1 (skozi iglo) skladno z navodili za uporabo proizvajalca generatorja, da prašek rekonstituirate z eluatom.
Clear solutions free of visible particles 
Bistra raztopina brez vidnih delcev
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.