FrancophonIA/ELRC3.0 huggingface dataset:
English: During its 13-15 January 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the use of the product as recommended does not constitute a risk for the environment and therefore the points of disagreement raised by Germany should not prevent the granting of a Marketing Authorisation.
Slovenian: Med svojim zasedanjem 13.-15. januarja 2009 je CVMP na podlagi celotnih predloženih podatkov in znanstvene razprave znotraj Odbora soglasno sprejel mnenje, da priporočena uporaba zdravila ne predstavlja tveganja za okolje, zato ugovori, ki jih je izpostavila Nemčija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.
English: ENRO-K 10% ORAL SOLUTION
Slovenian: ENRO-K 10% PERORALNA RAZTOPINA
English: • Identification of a potential serious risks to blue-green algae and terrestrial plants arising from the use of Enro-K 10% Oral solution.
Slovenian: • ugotavljanje morebitnih resnih tveganj za modrozelene alge in kopenske rastline, ki izhajajo iz uporabe zdravila Enro-K 10 % peroralna raztopina.
English: The applicant, Laboratorios Karizoo S.A., submitted an application for a decentralised procedure for Enro-K 10% Oral Solution, indicated for chickens and turkeys and for oral administration via the drinking water.
Slovenian: Predlagatelj, družba Laboratorios Karizoo S.A., je vlogo za zdravilo Enro-K 10% peroralna raztopina, indicirano za kokoši in purane ter peroralno uživanje s pitno vodo, predložil v presojo po decentraliziranem postopku.
English: 4 hours.
Slovenian: 4 ure.
English: It might be helpful to estimate the effective dose that was applied.
Slovenian: Morda bi bilo koristno oceniti efektivni uporabljeni odmerek.
English: Only generators that have been authorised as medicinal products in the EU should be used.
Slovenian: Uporabiti se sme le generatorje, ki so bili odobreni kot zdravila v EU.
English: Visual inspection pH
Slovenian: Vizualni pregled pH
English: This medicine is not recommended in patients under 18 years of age because its safety and efficacy have not been established in this patient population.
Slovenian: Uporaba tega zdravila ni priporočljiv pri bolnikih, mlajših od 18 let, saj varnost in učinkovitost pri tej populaciji bolnikov nista bili dokazani.
English: No studies on fertility, embryology, mutagenicity or long-term carcinogenicity have been conducted.
Slovenian: Študije o plodnosti, embriologiji, mutagenosti ali dolgoročni kancerogenosti niso bile izvedene.
English: Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organization.
Slovenian: Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezne licence pristojnega organa.
English: Elderly population No special dosage regimen for elderly patients is required.
Slovenian: Pri starejših bolnikih poseben režim odmerjanja ni potreben.
English: The elution can be performed either manually or by means of a pump.
Slovenian: Eluacijo je mogoče izvesti ročno ali s črpalko.
English: Leave the vial at 95°C for at least 7 minutes (do not exceed 10 minutes heating) without agitation or stirring.
Slovenian: Vialo pustite pri temperaturi 95 °C vsaj 7 minut (vendar je ne segrevajte več kot 10 minut) brez agitacije ali mešanja.
English: In case of allergic reactions you will receive the appropriate treatment from your medical staff.
Slovenian: V primeru alergijskih reakcij boste od zdravstvenega osebja prejeli ustrezno zdravljenje.
English: The recommended time for imaging is 40 to 90 minutes post injection.
Slovenian: Priporočeni čas za slikanje je od 40 do 90 minut po injiciranju.
English: There is no information about the safety and the efficacy of the use of this medicine during pregnancy.
Slovenian: O varnosti in učinkovitosti uporabe tega zdravila med nosečnostjo ni razpoložljivih informacij.
English: Perform the quality control according to the recommended methods in order to check the compliance to the specifications (see section, “Quality control”).
Slovenian: Opravite postopek nadzora kakovosti po priporočenih metodah, da preverite skladnost s tehničnimi zahtevami (glejte poglavje »Nadzor kakovosti«).
English: This medical procedure obtains images of your organs, to help locate the abnormal cells or tumours giving valuable information about your disease.
Slovenian: Ta medicinski postopek pridobi slike vaših organov in tako pomaga najti nenormalne celice ali tumorje ter s tem zagotavlja dragocene informacije o vaši bolezni.
English: Osteogenic cells Skin
Slovenian: Osteogenetske celice Koža
English: Moreover, the in vivo binding of gallium (
Slovenian: Nadzor kakovosti Preglednica 2: Specifikacije [
English: If you are taking somatostatin analogues you might be asked to stop your treatment for a short period of time.
Slovenian: Če jemljete analoge somatostatina, vam bodo morda naročili, da zdravljenje z njimi za kratek čas prekinete.
English: See section 4.5.
Slovenian: Glejte poglavje 4,5.
English: After injection, you will be offered something to drink and asked to urinate immediately preceding the test.
Slovenian: Po injiciranju vam bodo ponudili pijačo in naročili, da urinirate tik pred preiskavo.
English: Five studies have been submitted, one of them prospective (Gabriel et al. 2009) and four retrospective studies (Kroiss et al. 2013, Ezziddin et al. 2012, Kratochwil et al. 2015 and Luboldt et al.2010a).
Slovenian: Predloženih je bilo pet študij, od katerih je ena prospektivna (Gabriel et al. 2009), štiri pa so retrospektivne študije (Kroiss et al. 2013, Ezziddin et al. 2012, Kratochwil et al. 2015 in Luboldt et al.2010a).
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube must be immediately available.
Slovenian: Za takojšnje ukrepanje v nujnih primerih morajo biti na takojšnjem dosegu zdravila in oprema, kot je endotrahealna cev.
English: Precautions with respect to environmental hazard are in section 6.6.
Slovenian: Previdnostni ukrepi glede nevarnosti za okolje so navedeni v poglavju 6.6.
English: For information on the use in paediatric population, see section 4.2.
Slovenian: Za informacijo o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Product administration data should also be recorded.
Slovenian: Podatke glede dajanja zdravila je treba tudi zabeležiti.
English: (68 min), the biological half-life will have little impact on the effective half-life of the product which then would be expected to be somewhat less than 68 minutes.
Slovenian: (68 min), bo biološki razpolovni čas le malo vplival na efektivni razpolovni čas zdravila, za katerega se pričakuje, da bo nekoliko krajši od 68 minut.
English: Labelling efficiency
Slovenian: Učinkovitost označevanja
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Slovenian: Vaš osebni zdravnik in zdravnik nuklearne medicine sta presodila, da klinične koristi tega postopka z radiofarmakom pri vas odtehtajo tveganje zaradi sevanja.
English: This medicine contains 1.5 mmol (or 32.5 mg) sodium per dose.
Slovenian: To zdravilo vsebuje 1,5 mmol natrija (ali 32,5 mg) na odmerek.
English: Organs
Slovenian: Organi
English: There is no recommendation for use of SomaKit TOC in paediatric patients.
Slovenian: Ni priporočil za uporabo zdravila SomaKit TOC pri pediatričnih bolnikih.
English: Drinking and emptying your bladder frequently will help remove the radioactive substance from your body more quickly.
Slovenian: Pitje in pogosto praznjenje mehurja vam bo pomagalo hitreje izločiti radioaktivno snov iz telesa.
English: OLINDA/EXM 1.1 software (table 1).
Slovenian: OLINDA/EXM 1.1 (preglednica 1).
English: After injection into a vein, it can make parts of the body areas visible to doctors during a medical imaging procedure called positron emission tomography (PET).
Slovenian: Po injiciranju v veno lahko napravi dele telesa vidne zdravnikom v postopku medicinskega slikanja imenovanem pozitronska emisijska tomografija (PET).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: Imaging acquisition start time and duration should be adapted according to the equipment used, the patient and the tumour characteristics in order to obtain the best image quality possible.
Slovenian: Čas začetka in zajemanja slik in trajanje je treba prilagoditi glede na uporabljeno opremo, lastnosti bolnika in tumorja, da pridobimo najboljšo mogočo kakovost slike.
English: Fertility No studies were conducted to assess the impact on fertility.
Slovenian: Študij za oceno vpliva na plodnost niso izvedli.
English: SomaKit TOC will only be used in special controlled areas.
Slovenian: Zdravilo SomaKit TOC se bo uporabljalo samo v posebno nadzorovanih prostorih.
English: Manufacturer Gipharma S. r.l.
Slovenian: Proizvajalec Gipharma S. r.l.
English: Positive results require evaluating the possibility that another disease, characterised by high local somatostatin receptor concentrations, may be present.
Slovenian: Pozitivni rezultati zahtevajo ovrednotenje možnosti, da je lahko prisotna druga bolezen z značilnostjo visokih koncentracij lokalnih somatostatinskih receptorjev.
English: The radioactive substance is not part of the kit and should be added during the preparation steps before injection.
Slovenian: Radioaktivna snov ni del kompleta in jo je treba dodati v korakih priprave pred injiciranjem.
English: Edotreotide is a somatostatin analogue.
Slovenian: Edotreotid je analog somatostatina.
English: In vitro, this radiopharmaceutical binds with high affinity mainly to SSTR2 but also, to a lesser extent, to SSTR5.
Slovenian: Ta radiofarmak se in vitro z veliko afiniteto veže predvsem na SSTR2, v manjšem obsegu pa tudi na SSTR5.
English: Total volume: ________mL
Slovenian: Skupna prostornina: ________ ml
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, blood, etc.
Slovenian: Dajanje radiofarmakov predstavlja tveganje za druge osebe zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja, krvi itd.
English: • Radiometric ITLC scanner
Slovenian: • Radiometrični bralnik ITLC
English: The content of the kit before radiolabelling is not radioactive.
Slovenian: Vsebina kompleta pred radioaktivnim označevanjem ni radioaktivna.
English: Absorbed dose in selected organs mGy/MBq
Slovenian: Absorbirani odmerek v posameznih organih mGy/MBq
English: Pharmacotherapeutic group: Other diagnostic radiopharmaceuticals for tumour detection, ATC code: V09IX09.
Slovenian: Farmakoterapevtska skupina: Drugi radiodiagnostiki za tumorje, oznaka ATC: V09IX09.
English: The activity will be adapted to patient characteristics, the type of PET camera used and acquisition mode.
Slovenian: Aktivnost je treba prilagoditi lastnostim bolnika, vrsti uporabljene kamere PET in načinu zajemanja slike.
English: Although no side effects have been reported, a potential risk of allergic reactions (hypersensitivity) exists with SomaKit TOC.
Slovenian: Čeprav o stranskih učinkih niso poročali, pri zdravilu SomaKit TOC obstaja potencialno tveganje za alergijske reakcije (preobčutljivost).
English: This should be taken into account in patient on low sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z malo natrija.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of SomaKit TOC to be used in your case.
Slovenian: Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila SomaKit TOC, ki bo uporabljena pri vas.
English: A single injection is sufficient to conduct the test that your doctor needs.
Slovenian: Za izvedbo preiskave, ki jo potrebuje vaš zdravnik, zadostuje eno samo injiciranje.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The quantity to be administered usually recommended for an adult ranges from 100 MBq to 200 MBq (megabecquerel, the unit used to express radioactivity).
Slovenian: Uporabljena količina, navadno priporočena za odrasle, je od 100 do 200 MBq (megabekerel, enota, ki se uporablja za izražanje radioaktivnosti).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1141/001
Slovenian: EU/1/16/1141/001
English: The use of SomaKit TOC involves exposure to small amounts of radioactivity.
Slovenian: Uporaba zdravila SomaKit TOC vključuje izpostavljenost majhnim količinam radioaktivnosti.
English: Splenectomy should also be considered as a relevant factor when reporting the outcome of somatostatin receptor targeted diagnostics.
Slovenian: Splenektomijo je treba pav tako obravnavati kot pomemben dejavnik pri poročanju o izidu diagnostike, ki cilja na somatostatinske receptorje.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ocena lokalne tolerance je pokazala blage do zmerne znake vnetja v perivaskularnem območju nekaterih živali, kar je mogoče pripisati kislemu pH raztopine.
English: 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).
Slovenian: 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).
English: Therefore, the radiolabelled solution can be used within 4 hours after preparation according to the radioactivity required for the administration.
Slovenian: Zato je treba radioaktivno označeno raztopino uporabiti v 4 urah po pripravi glede na radioaktivnost, potrebno pri dajanju.
English: For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po radioaktivnem označevanju zdravila glejte poglavje 6.3.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali na katero koli sestavino označenega radiofarmaka.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 01630 Saint Genis Pouilly France tel: +33 4 50 99 30 70 fax: +33 4 50 99 30 71 e-mail: info@adacap.com
Slovenian: 01630 Saint Genis Pouilly France tel: +33 4 50 99 30 70 faks: +33 4 50 99 30 71
English: • Mobile phase: 77 g/L solution of ammonium acetate in water /Methanol 50:50 V/V
Slovenian: • Mobilna faza: Raztopina amonijevega acetata v vodi 77 g/l / metanol 50:50 V/V
English: There is no data if the intravenous administration of edotreotide produces variation of serum gastrin and serum glucagon levels.
Slovenian: Ni podatkov o tem, ali intravensko dajanje edotreotida povzroči spremembo ravni gastrina in glukagona v serumu.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Slovenian: To zdravilo je radiofarmak, ki je namenjen le diagnostični uporabi.
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.
Slovenian: 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.
English: Calibration time: ________ Time/Date
Slovenian: Čas umerjanja: ________ ura/datum
English: After radiolabelling, SomaKit TOC should be used within 4 hours.
Slovenian: Po radioaktivnem označevanju je treba zdravilo SomaKit TOC uporabiti v 4 urah.
English: Gallium (68Ga) edotreotide contains a small amount of radioactivity.
Slovenian: Galijev (68Ga) edotreotid vsebuje majhno količino radioaktivnosti.
English: 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.
Slovenian: 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.
English: The effective dose resulting from the administration of an activity of 200 MBq to an adult weighing 70 kg is about 4.2 mSv.
Slovenian: Efektivni odmerek pri obsevanju z 200 MBq aktivnosti za odraslo osebo, ki tehta 70 kg, je približno 4,2 mSv.
English: Total body Effective dose mSv/MBq
Slovenian: Maternica Celotno telo Efektivni odmerek mSv/MBq
English: 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.
Slovenian: 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).
English: • Galli Ad, 0.74 - 1.85 GBq, radionuclide generator (IRE-Elit).
Slovenian: • Galli Ad, 0,74-1,85 GBq, radionuklidni generator (IRE-Elit).
English: For instructions on extemporaneous preparation of the medicinal product before administration, see sections 6.6 and 12.
Slovenian: Za navodila glede sprotne priprave zdravila pred dajanjem glejte poglavji 6.6 in 12.
English: 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.
Slovenian: 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.
English: This medicinal product must not be mixed with other products except those mentioned in section 12.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 12. 6.3 Rok uporabnosti
English: 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.
Slovenian: V primeru ekstravazacije je treba injiciranje ustaviti, mesto injiciranja je treba zamenjati, prizadeta območja pa sprati z raztopino natrijevega klorida.
English: SomaKit TOC must not be used after the expiry date which is stated on the carton.
Slovenian: Zdravila SomaKit TOC ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: The peptide is excreted via kidneys as intact compound.
Slovenian: Peptid se izloča preko ledvic kot nespremenjena spojina.
English: Elute the generator directly into the Vial 1 (through the needle).
Slovenian: Generator eluirajte neposredno v vialo 1 (skozi iglo).
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.
Slovenian: Somatostatin je nevrotransmitor v osrednjem živčevju in hormon, ki se veže na celice nevroendokrinega izvora in zavira sproščanje rastnega hormona, inzulina, glukagona in gastrina.
English: The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection.
Slovenian: Priporočeni razpon aktivnosti pri odraslih, ki tehtajo 70 kg, je od 100 do 200 MBq z neposredno počasno intravensko injekcijo.
English: • GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator (Eckert & Ziegler Radiopharma GmbH),
Slovenian: • GalliaPharm, 0,74-1,85 GBq, radionuklidni generator (Eckert & Ziegler Radiopharma GmbH),