FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Slovenian: Upoštevati je treba ustrezne previdnostne ukrepe za zagotavljanje aseptičnosti, ki so v skladu z Dobro proizvodno prakso za zdravila.
English: In absence of clinical data, the injected activity should be adapted to the renal function.
Slovenian: Kadar ni na razpolago kliničnih podatkov, moramo injicirano aktivnost prilagoditi delovanju ledvične funkcije.
English: Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy.
Slovenian: Vaš zdravnik vam bo tedensko jemal vzorce krvi vsaj 8 tednov zapored, da bi spremljal število trombocitov ter belih in rdečih krvnih telesc, ki lahko zaradi zdravljenja nekoliko upade.
English: Storage procedures should be in accordance with local regulations for radioactive substances.
Slovenian: Postopki pri shranjevanju morajo biti v skladu z lokalnimi predpisi za radioaktivne snovi.
English: Total skeletal uptake of Quadramet in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5 % of the administered activity.
Slovenian: Skupno kopičenje Quadrameta v raziskavi na 453 bolnikih z različnimi primarnimi malignomi je znašalo 65,5 ± 15,5 % aplicirane radioaktivnosti.
English: Quadramet is a medicinal product for therapeutic use only.
Slovenian: Quadramet je zdravilo, namenjeno izključno za terapevtsko uporabo.
English: The same results were observed for Sm-EDTMP enriched with radiolysis degradants.
Slovenian: Enake rezultate navajajo za Sm-EDTMP, ki je bil obogaten z razgradnimi produkti radiolize.
English: Quadramet should be used within 6 hours of thawing.
Slovenian: Quadramet je treba uporabiti v 6 urah po odmrznjenju.
English: For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces 17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy.
Slovenian: Pri aplicirani radioaktivnosti 2590 MBq znaša tipična doza sevanja, ki jo prejme ciljni organ - kostne metastaze 86,5 Gy, tipične doze sevanja, ki jih prejmejo kritični organi, pa so naslednje: normalne kostne površine 17,5 Gy, rdeči kostni mozeg 4,0 Gy, stena sečnega mehurja 2,5 Gy, ledvice 0,047 Gy in jajčniki 0,021 Gy.
English: During 6 hours following the injection of Quadramet, your physician will encourage you to drink and void as often as possible.
Slovenian: V šestih urah po injekciji Quadrameta vam bo zdravnik svetoval, da kar se da veliko pijete in pogosto odvajajte vodo.
English: The estimated absorbed radiation doses to an average adult patient from an intravenous injection of Quadramet are shown in Table 2.
Slovenian: Ocenjene absorbirane doze sevanja, ki jih prejme povprečen odrasel bolnik po intravenski injekciji zdravila Quadramet, so navedene v tabeli 2.
English: The clearance of Quadramet being rapid, the precautions relating to the excreted urinary radioactivity need not be taken after 6-12 hours following administration.
Slovenian: Zaradi hitrega izločanja Quadrameta, previdnostni ukrepi v zvezi z radioaktivnostjo izločenega urina 6-12 ur po aplikaciji niso več potrebni.
English: For the other patients the urine should be collected for at least six (6) hours.
Slovenian: Pri ostalih bolnikih pa je treba zbirati urin vsaj šest (6) ur.
English: The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.
Slovenian: Ocenjene vrednosti prejetih doz sevanja temeljijo na študijah klinične porazdelitve s pomočjo metod, ki jih je za izračunavanje doz sevanja razvil Medical Internal Radiation Dose (MIRD) Committee pri Združenju za nuklearno medicino (Society of Nuclear Medicine).
English: The undesirable effects due to Quadramet administration are linked with a decrease of red and white blood cells, and platelets.
Slovenian: Neželeni učinki pri uporabi Quadrameta so povezani z zmanjšanjem števila rdečih in belih krvnih telesc ter trombocitov.
English: What Quadramet is and what it is used for
Slovenian: Kaj je zdravilo Quadramet in za kaj ga uporabljamo
English: This medicinal product is not intended to be injected on a regular or continuous basis.
Slovenian: QUADRAMET ni namenjen za redno ali trajno uporabo.
English: At 12 hours, 35.3 ± 13.6 % of the administered activity had been excreted into the urine.
Slovenian: Po 12 urah se je 35,3 ± 13,6 % aplicirane radioaktivnosti izločilo v urinu.
English: Children and adolescents Quadramet is not recommended for use in children below 18 years of age.
Slovenian: Otroci in mladostniki Uporaba zdravila Quadramet pri otrocih pod 18 let ni priporočljiva.
English: If your renal function is decreased, the amount of product will be adapted.
Slovenian: Če je zmogljivost vaših ledvic zmanjšana, bodo temu primerno prilagodili količino zdravila.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT ml
English: Radioactive Sm-EDTMP has not been tested for mutagenicity/carcinogenicity but due to the radiation dose resulting from therapeutic exposure it should be regarded as presenting a genotoxic/carcinogenic risk.
Slovenian: Radioaktivnega Sm-EDTMP niso preskušali na mutagenost/karcinogenost, vendar pa je treba upoštevati, da prejeta doza sevanja zaradi terapevtske izpostavljenosti lahko predstavlja določeno genotoksično /karcinogeno tveganje.
English: The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/kg.
Slovenian: Produkti radiolize Sm-EDTMP so pokazali toksičnost za ledvica pri podganah in psih, raven brez ugotovljenih neželenih učinkov je bila pri koncentraciji 2,5 mg/kg.
English: Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days).
Slovenian: Samarij-153 oddaja srednjeenergijske beta delce in gama foton, ki omogoča scintigrafijo ter ima razpolovni čas 46,3 ure (1,93 dneva).
English: Each vial contains 2-4 GBq at the reference date.
Slovenian: Vsaka viala vsebuje 2 - 4 GBq na referenčni datum.
English: A small number of patients have reported a transient increase in bone pain shortly after injection (flare reaction).
Slovenian: Majhno število bolnikov je navajalo, da so imeli kmalu po injekciji prehodno močnejše bolečine v kosteh (burna reakcija).
English: In the absence of genotoxic properties, these effects can be assigned to the EDTMP chelatant properties leading to osseous metabolism disturbances.
Slovenian: Glede na odsotnost genotoksičnih lastnosti lahko te učinke povežemo s kelatnimi lastnostmi EDTMP, ki privedejo do motenj v kostnem metabolizmu.
English: What you need to know before you take Quadramet
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Quadramet
English: Absorbed dose per injected activity (mGy/MBq)
Slovenian: Absorbirana doza na injicirano radioaktivnost (mGy/MBq)
English: If you have the impression that the effect of Quadramet is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Quadramet premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
Slovenian: Bistra, brezbarvna do svetlo jantarna raztopino, ki ima pH med 7,0 in 8,5.
English: Quadramet should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.
Slovenian: Quadramet smejo dajati le zdravniki, ki imajo izkušnje z uporabo radiofarmakov, ko je zdravnikspecialist podal celotno onkološko oceno bolnika.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Thus, areas of metastatic involvement can accumulate significantly greater amounts of Quadramet than surrounding normal bone.
Slovenian: Tako lahko področja metastatske rašče akumulirajo značilno večje količine Quadrameta kot okolno normalno kostno tkivo.
English: Patients who respond to Quadramet generally experience the onset of pain relief within 1 week after treatment.
Slovenian: Bolniki, ki se odzivajo na Quadramet, običajno začutijo olajšanje bolečine v prvem tednu po začetku terapije.
English: Thirty minutes after injection of the agent to 22 patients, only 9.6 ± 2.8 % of the administered activity remained in plasma.
Slovenian: 30 minut po tem, ko so 22 bolnikom injicirali QUADRAMET, je bilo v plazmi prisotno le še 9,6 ± 2,8 % aplicirane radioaktivnosti.
English: The occurrence of these events may be linked to the patients' disease evolution.
Slovenian: Naštete pojave bi lahko povezali z napredovanjem bolezni pri teh bolnikih.
English: When there are spinal metastases at the cervico-dorsal level, an increased risk of spinal cord compression cannot be excluded.
Slovenian: Kadar gre za metastaze v hrbtenici na cerviko-dorzalni ravni, ne moremo izključiti povečanega tveganja za kompresijo hrbtenjače.
English: The patient should be encouraged to ingest (or receive by intravenous administration) a minimum of 500 ml of fluids prior to injection and should be encouraged to void as often as possible after injection to minimise radiation exposure to the bladder.
Slovenian: Pred injiciranjem naj bolnik zaužije (ali prejme z intravensko aplikacijo) najmanj 500 ml tekočine, po aplikaciji pa naj kar se da pogosto odvaja vodo, s čimer se zmanjša izpostavljenost mehurja sevanju.
English: Use within 6 hours of thawing.
Slovenian: Uporabite v 6 urah po odmrznjenju.
English: Storage procedures should be in accordance with national regulations for radioactive materials.
Slovenian: Postopki pri shranjevanju morajo biti v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: Radiation dose to specific organs, which may not be the target organ of therapy, may be influenced significantly by pathophysiological changes induced by the disease process.
Slovenian: Na doze sevanja, ki jih prejmejo posamezni organi, ki niso ciljni organi zdravljenja, lahko značilno vplivajo patofiziološke spremembe, ki jih sproži bolezenski proces.
English: The possibility of pregnancy must strictly be ruled out.
Slovenian: Možnost zanositve moramo brezpogojno izključiti.
English: It should not be used concurrently with other biphosphonates if an interference is shown on the technetium (99mTc)-labelled biphosphonate bone scans.
Slovenian: Ne smemo ga uporabljati sočasno z drugimi bifosfonati, če je na scintigrafiji kosti s (99mTc)tehnecijem označenega bifosfonata vidna interferenca.
English: Studies in rats have demonstrated that Quadramet is cleared rapidly from the blood and localises to growing areas of bone matrix, specifically the layer of osteoid undergoing mineralisation.
Slovenian: Študije na podganah so pokazale, da se Quadramet hitro izloči iz krvi in se lokalizira v rastnih delih kostnega matriksa, zlasti v plasti osteoidov, kjer prihaja do mineralizacije.
English: If you take more Quadramet than you should
Slovenian: Če ste uporabili večji odmerek zdravila Quadramet, kot bi smeli
English: The product should only be administered by qualified personnel in authorised settings.
Slovenian: To zdravilo sme dajati le ustrezno usposobljeno osebje v pooblaščenih ustanovah.
English: Biotransformation Analysis of urine samples found the radioactivity to be present as the intact complex
Slovenian: Analiza vzorcev urina je pokazala, da je bila radioaktivnost prisotna v obliki nespremenjenega kompleksa.
English: Frequency of administration
Slovenian: Pogostnost aplikacije
English: (Corresponding to 20 to 80 µg/ml of samarium)
Slovenian: (odgovarja 20 - 80 µg/ml samarija)
English: The solution for injection should be visually inspected before use.
Slovenian: Pred uporabo morate raztopino za injiciranje vizualno pregledati.
English: For this product the effective dose resulting from an injected activity of 2 590 MBq is 796 mSv.
Slovenian: Pri tem zdravilu je efektivna doza sevanja po injicirani radioaktivnosti 2590 MBq enaka 796 mSv.
English: Because Quadramet is excreted in the urine, radiation exposure was based on a urinary voiding interval of 4.8 hours.
Slovenian: Ker se zdravilo Quadramet izloča v urinu, so pri izpostavljenosti sevanju upoštevali 4,8-urni interval pri odvajanju urina.
English: There are no available clinical data relating to the excretion of Quadramet in human milk.
Slovenian: Na razpolago ni kliničnih podatkov o izločanju Quadrameta v mleku doječih mater.
English: (corresponding to 20-80 µg/ml of samarium per vial).
Slovenian: (ustreza 20 - 80 µg/ml samarija na vialo)
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Slovenian: Prejeta doza sevanja zaradi terapevtske izpostavljenosti lahko povzroči večjo pojavnost rakavih obolenj in mutacij.
English: Posology The recommended dose of Quadramet is 37 MBq per kg body weight.
Slovenian: Odmerjanje Priporočeni odmerek Quadrameta znaša 37 MBq na kg telesne mase.
English: Special precautions, such as bladder catheterisation, should be taken during six hours following administration to incontinent patients to minimise the risk of radioactive contamination of clothing, bed linen, and the patient's environment.
Slovenian: Pri inkontinentnih bolnikih so v prvih šestih urah po aplikaciji potrebni posebni previdnostni ukrepi, kot je kateterizacija mehurja, s čimer zmanjšamo tveganje radioaktivne kontaminacije oblačil, posteljnega perila in bolnikovega okolja.
English: Use of Quadramet in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefit of the treatment outweighs its risks.
Slovenian: Pri bolnikih, ki imajo zaradi predhodne terapije ali bolezni zmanjšano rezervo kostnega mozga, uporabe Quadrameta ne priporočamo, razen če pričakovana korist zdravljenja odtehta tveganje.
English: Because Quadramet contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
Slovenian: Ker Quadramet vsebuje majhne količine radioaktivnega elementa samarija-153, je sevanje lokalno na kostne lezije, kjer ima paliativni učinek - lajša kostne bolečine.
English: The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with probable bone marrow involvement.
Slovenian: Redki bolniki, pri katerih se je pojavila toksičnost 3-4 stopnje za krvotvorne organe, so bili predhodno zdravljeni bodisi z obsevanjem ali kemoterapijo ali pa so imeli hitro napredujočo bolezen z verjetno razširitvijo v kostni mozeg.
English: Other medicines and Quadramet Tell your doctor if you are taking or have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: What Quadramet looks like and contents of the pack Quadramet is a solution for injection.
Slovenian: Izgled zdravila Quadramet in vsebina pakiranja Quadramet je raztopina za injiciranje.
English: Quadramet should not be diluted before use.
Slovenian: Quadrameta pred uporabo ne smete redčiti.
English: Gamma * Maximum energies are listed for the beta emissions, the average beta particle energy is
Slovenian: * Največje energije so navedene za sevanja beta, povprečna energija beta delcev je 233 keV.
English: The following information is intended for medical or healthcare professionals only: The complete SmPC of Quadramet 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.
Slovenian: Povzetek glavnih značilnosti zdravila Quadramet je v celoti podan kot ločen dokument navodil za uporabo zdravila, in sicer z namenom, da zdravstvenemu osebju nudi dodatne znanstvene in praktične informacije o uporabi tega radiofarmaka.
English: The possibility of pharmacological overdose is therefore remote.
Slovenian: Zato je možnost prevelikega odmerjanja zdravila manj verjetna.
English: A minimum interval of 8 weeks should be respected, subject to recovery of adequate bone marrow function.
Slovenian: Upoštevati moramo minimalen razmik 8 tednov, da se lahko funkcija kostnega mozga ustrezno popravi.
English: The risks to be expected are associated with the inadvertent administration of excess radioactivity.
Slovenian: Pričakovano tveganje je lahko torej povezano le z nenamerno aplikacijo prevelikega odmerka sevanja.
English: Quadramet is to be administered by slow intravenous route through an established intravenous line over a period of one minute.
Slovenian: Quadramet dajemo počasi intravensko v trajanju 1 minute po vzpostavljenem intravenskem kanalu.
English: Quadramet expires 1 day from the activity reference time stated on the label.
Slovenian: Zdravilu Quadramet izteče rok uporabnosti 1 dan po referenčnem datumu za aktivnost, ki je naveden na ovojnini.
English: If Quadramet administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Slovenian: Če je uporaba zdravila Quadramet pri ženskah v obdobju dojenja nujna, je treba z dojenjem prenehati.
English: Allow the product to thaw at room temperature before administration.
Slovenian: Pred uporabo pustite zdravilo odmrzniti pri sobni temperaturi.
English: Quadramet is used only as a palliative agent and should not be used concurrently with myelotoxic chemotherapy as this may enhance myelotoxicity.
Slovenian: Quadramet uporabljamo le kot paliativno sredstvo in ga ne smemo dajati sočasno z mielotoksično kemoterapijo, ker lahko poveča mielotoksični učinek.
English: What Quadramet is and what it is used for What you need to know before you take Quadramet How to take Quadramet
Slovenian: Kaj je zdravilo Quadramet in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Quadramet Kako jemati zdravilo Quadramet Možni neželeni učinki
English: Warnings and precautions Talk to your doctor before taking Quadramet.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Quadramet se posvetujte s svojim zdravnikom.
English: Because of potential bone marrow suppression after administration, blood counts should be monitored weekly for at least 8 weeks, beginning 2 weeks after administration of Quadramet, or until recovery of adequate bone marrow function.
Slovenian: Zaradi verjetnosti pojava supresije kostnega mozga po aplikaciji Quadrameta moramo 2 tedna po aplikaciji tedensko spremljati krvno sliko vsaj 8 tednov, ali do ponovne vzpostavitve ustrezne funkcije kostnega mozga.
English: (12 h CET) METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use
Slovenian: (12 h po srednjeevropskem času) POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: Quadramet has a high affinity for skeletal tissue.
Slovenian: Quadramet ima veliko afiniteto do kostnega tkiva.
English: Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.
Slovenian: Odmerek sevanja, ki ga prejme telo, lahko omejimo s povečanim vnosom tekočin in pogostim odvajanjem urina.
English: Your doctor will want to carry out a special scan before administering Quadramet to ascertain whether you are likely to benefit from Quadramet.
Slovenian: Preden vam bo dal Quadramet, bo vaš zdravnik želel opraviti posebno slikanje, da ugotovi, če vam zdravljenje s Quadrametom lahko koristi.
English: For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources.
Slovenian: Zaradi zagotavljanja varnosti pred sevanjem se mora zdravljenje izvajati v ustanovi, ki ima ustrezno pooblastilo za terapevtsko uporabo odprtih virov radioaktivnega sevanja.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: A few patients experienced cord/root compressions, disseminated intravascular coagulation and cerebrovascular accidents.
Slovenian: Nekaj bolnikov je imelo kompresijo hrbtenjače ali korenin, diseminirano intravaskularno koagulacijo in cerebrovaskularni insult.
English: This is the reason why your blood counts will be monitored strictly for a few weeks following Quadramet injection.
Slovenian: To je tudi razlog, zakaj bodo nekaj tednov po injekciji Quadrameta skrbno spremljali vašo krvno sliko.
English: This radiopharmaceutical is used for the treatment of bone pain due to your disease.
Slovenian: Quadramet se uporablja za zdravljenje bolečin v kosteh, ki jih povzroča vaša bolezen.
English: TABLE 1 : SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA Radiation
Slovenian: TABELA 1: GLAVNE EMISIJE SEVANJA SAMARIJA-153
English: EXPIRY DATE EXP: DD/MM/YYYY (12 h CET)
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: DD/MM/LLLL (12 h po srednjeevropskem času)
English: Quadramet may be given subsequent to either of these treatments after allowing for adequate marrow recovery.
Slovenian: Zdravilo Quadramet lahko dajemo po zaključku teh terapij, oziroma, ko se kostni mozeg ustrezno opomore.
English: Because of the potential for additive effects on bone marrow, the treatment should not be given concurrently with chemotherapy or external beam radiation therapy.
Slovenian: Zaradi možnega sinergističnega učinka na kostni mozeg zdravljenje ne sme potekati sočasno s kemoterapijo ali radioterapijo.
English: Postmarketing reports of thrombocytopenia have included isolated reports of intracranial haemorrhage, and cases in which the outcome was fatal.
Slovenian: Postmarketinška poročila o trombocitopeniji vključujejo posamezne primere intrakranialne krvavitve in primere s smrtnim izidom.
English: The activity should be measured by a dose calibrator immediately before administration.
Slovenian: Radioaktivnost morate izmeriti z radionuklidnim kalibratorjem neposredno pred aplikacijo.
English: If you experience back pain or sensory abnormalities, please inform your physician as soon as possible.
Slovenian: Če opazite, da imate bolečine v hrbtenici ali motnje v čutnih zaznavah, o tem čim prej ko je mogoče obvestite svojega zdravnika.
English: In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders, cerebrovascular accidents.
Slovenian: V redkih primerih so opažali naslednje neželene učinke: nevralgije, motnje strjevanja krvi in cerebrovaskularni insult.
English: Quadramet has an affinity for skeletal tissue and concentrates in areas of bone turnover in intimate association with hydroxyapatite.
Slovenian: Quadramet ima afiniteto do kostnega tkiva, se kopiči v področjih spremenjene zgradbe kosti in je v tesni zvezi s hidroksiapatitom.
English: Store at -10°C to -20°C in a freezer in its original packaging.
Slovenian: Shranjujte v zamrzovalniku pri temperaturi -10 °C do -20 °C v originalni ovojnini.
English: Do not use Quadramet after the expiry date which is stated on the label.
Slovenian: Zdravila Quadramet ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
Slovenian: Vsaka viala vsebuje 1,5 ml (2 GBq ob kalibraciji) do 3,1 ml (4 GBq ob kalibraciji) raztopine za injiciranje.