FrancophonIA/ELRC3.0 huggingface dataset:
English: In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damages.
Slovenian: V vsakem primeru je treba opazovati bolnikove krvne parametre in takoj ustrezno ukrepati, če se pokažejo znaki okvar.
English: Activity: (Y) MBq
Slovenian: Aktivnost: (Y) MBq
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 august 2012
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23 avgust 2012
English: rates and the accumulated dose depend on many factors.
Slovenian: Površinski odmerki in akumuliran odmerek so odvisni od mnogo dejavnikov.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Slovenian: Pri vsaki ženski, ki ni dobila menstruacije, je treba predpostavljati, da je noseča, dokler ni dokazano nasprotno.
English: The use of television monitor systems to monitor the patients is recommended.
Slovenian: Prav tako se za spremljanje bolnikov priporoča uporaba sistema televizijskih zaslonov.
English: The volume varies from 1 to 3 mL.
Slovenian: Prostornina se spreminja od 1 do 3 ml.
English: These complexes are rapidly eliminated by the kidneys.
Slovenian: Ti kompleksi se hitro izločijo prek ledvic.
English: Copper-64 has a half-life of 12.7 hours.
Slovenian: Baker-64 ima razpolovni čas 12,7 ure.
English: Activity measurements using an ionisation chamber are very sensitive to geometric factors and, therefore, should be performed only under geometric conditions which have been appropriately validated.
Slovenian: Meritve aktivnosti z uporabo ionizacijske celice so zelo občutljive za geometrične faktorje in jih je zaradi tega treba izvajati samo pod geometričnimi pogoji, ki so bili primerno potrjeni.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Slovenian: PRILOGA IV RAZLOGI ZA DODATNO PODALJŠANJE
English: Toxicity of copper compounds has been extensively investigated both in human and in animals.
Slovenian: Toksičnost bakrovih spojin je bila obširno raziskana na ljudeh in tudi na živalih.
English: These medicines act as a carrier to take the radioactivity to where it is needed.
Slovenian: Ta zdravila delujejo kot prenašalci, ki prenesejo radioaktivnost tja, kjer je potrebna.
English: Dispose in accordance with local requirements.
Slovenian: Odstranjevanje v skladu z lokalnimi predpisi.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Slovenian: V vsakem primeru je treba zagotoviti, da so tveganja zaradi sevanja manjša od same bolezni.
English: Blood radioactivity decreased from 60.3 % to 3.4 % after 1 hour, and then it decreased of 1 % after 6 hours, and increased to 5.6 % and 4.9 % after 12-24 hours.
Slovenian: Radioaktivnost krvi se je po 1 uri zmanjšala s 60,3 % na 3,4 % ter po 6 urah še za 1 %, nato je po 1224 urah narasla na 5,6 % in 4,9 %.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Slovenian: Njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje urejajo predpisi in/ali ustrezna dovoljenja pristojnih organov.
English: Then copper re-emerges in plasma and is distributed to other organs.
Slovenian: Baker se ponovno pojavi v plazmi in se porazdeli v druge organe.
English: Disappearance of radioactivity
Slovenian: Pojemanje radioaktivnosti
English: The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Slovenian: Učinkovitost keliranja je največja takoj ali eno uro po izpostavljenosti, ko radionuklid kroži ali je v tkivni tekočini in plazmi.
English: Usual precautions regarding sterility and radioactivity must be respected.
Slovenian: Treba je upoštevati običajne varnostne ukrepe glede sterilnosti in radioaktivnosti.
English: The very limited exposure to Cuprymina (cumulative total sales of 152 vials in the EU) is considered to constitute grounds for requiring an additional five-year renewal.
Slovenian: Zelo majhna izpostavljenost zdravilu Cuprymina (kumulativna vsota prodaje v EU je 152 vial), je razlog za zahtevo za dodatno petletno podaljšanje.
English: MARKETING AUTHORISATION NUMBER EU/1/12/784/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/12/784/001
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Slovenian: − Ugotovljena nosečnost ali sum nanjo ali kadar nosečnost ni bila izključena (glejte poglavje 4.6).
English: For instruction on preparation of the medicinal product, see section 12.
Slovenian: Za navodila glede priprave zdravila glejte poglavje 12.
English: The dosimetry estimates were based on a mouse distribution study and the calculations were effected using OLINDA (Organ Level INternal Dose Assessment Code) (see Table 2).
Slovenian: Dozimetrične ocene temeljijo na študiji porazdelitve pri miših, izračuni pa so bili izvedeni z ocenjevalnim kodeksom OLINDA (Organ Level INternal Dose Assessment Code) (glejte preglednico 2).
English: If at any time in the preparation of this medicinal product the integrity of this container is compromised it should not be used.
Slovenian: Če je neoporečnost vsebnika kadar koli med pripravo zdravila ogrožena, se ne sme uporabiti.
English: Pharmacotherapeutic group: various diagnostic radiopharmaceuticals, ATC code: Not yet assigned
Slovenian: Farmakoterapevtska skupina: Razni radiodiagnostiki, oznaka ATC: še ni bila dodeljena
English: These persons will take special care for the safe use of this medicinal product and will keep you informed of their actions.
Slovenian: Ti bodo zlasti pozorni na varno uporabo zdravila in vas bodo sproti obveščali o svojem ravnanju.
English: The vial should never be opened and must be kept inside its shielded container.
Slovenian: Viala se ne sme nikoli odpreti, ostati mora znotraj zaščite.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Slovenian: Cuprymina Obstajajo strogi zakoni za uporabo, ravnanje in odstranjevanje radiofarmakov.
English: These may be substances that have been designed to recognise a particular type of cell in the body, including tumour cells.
Slovenian: Lahko so to učinkovine, ki so bile razvite zato, da v telesu prepoznajo določene vrste celice, med njimi tudi rakave.
English: With these assumptions the estimated dose for a person in close contact with the patient is 0.46 mSv, which is less than one half of the limit of not exposed people (1 mSv/year).
Slovenian: S temi predpostavkami je ocenjeni odmerek za osebo v tesnem stiku z bolnikom 0,46 mSv, kar je manj kot polovica dovoljene količine za ljudi, ki sevanju niso bili izpostavljeni (1 mSv/leto).
English: For minimising radiation exposure with repeated exposition there is no recommendation except the strict observance of the above ones.
Slovenian: Za zmanjšanje izpostavljenosti sevanju pri večkratni izpostavljenosti ni drugih priporočil kot strogo upoštevanje navedenega.
English: This medicinal product will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: Z zdravilom bodo ravnali in vam ga dajali le strokovnjaki, usposobljeni za njegovo varno uporabo.
English: PHARMACEUTICAL FORM AND CONTENTS Volume: {Z} mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prostornina: {Z} ml
English: The following information is intended for the specialist only.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju.
English: Table 2: Absorbed dose per unit activity administered
Slovenian: Preglednica 2: Absorbiran odmerek na enoto dane aktivnosti
English: Table 1 - Condition of negligible radioactivity in the patients Days after injection (2,770 MBq)
Slovenian: Preglednica 1 - Stanje zanemarljive radioaktivnosti pri bolnikih Dnevi po injiciranju (2 770 MBq)
English: Based upon the data that have become available since the granting of the initial Marketing authorisation, the CHMP considers that the benefit-risk balance of Cuprymina remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Slovenian: Na podlagi podatkov, ki so bili zbrani po prvi pridobitvi dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da razmerje med koristmi in tveganji za zdravilo Cuprymina ostaja pozitivno, vendar ocenjuje, da je varnostni profil zdravila treba skrbno spremljati zaradi naslednjih razlogov:
English: The condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection.
Slovenian: V praksi je pri bolniku doseženo stanje zanemarljive radioaktivnosti 4 dni po injiciranju.
English: Maximum liver uptake was 4 hours after injection with 57.7 %.
Slovenian: Največji privzem v jetrih je bil 57,7 % 4 ure po injiciranju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/784/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/784/001
English: Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Slovenian: Pred uporabo z bakrom (64Cu) označenih zdravil je treba nosečnost izključiti z uporabo primernega/validiranega testa.
English: Given the long half-life of Copper-64 it is specially recommended to avoid internal contamination.
Slovenian: Zaradi dolge razpolovne dobe bakra (64Cu) se je še zlasti treba izogibati notranji kontaminaciji.
English: The European Medicines Agency has waived the obligation to submit the results of the studies with Cuprymina in all subsets of the paediatric population on grounds of lack of significant therapeutic benefit over existing treatments.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z radiofarmacevtskim predhodnikom Cuprymina za vse podskupine pediatrične populacije zaradi pomanjkanja pomembnih terapevtskih koristi v okviru obstoječih zdravljenj.
English: Grounds for one additional renewal
Slovenian: Razlogi za dodatno podaljšanje
English: It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.
Slovenian: To bo najmanjša količina, potrebna za doseganje primernega izida, glede na sočasno uporabljano zdravilo in njegovo uporabo.
English: Dose rate (nSv/h)
Slovenian: Odmerek (nSv/h)
English: Therefore, based upon the safety profile of Cuprymina, which requires the submission of a yearly PSUR, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Slovenian: Na podlagi varnostnega profila zdravila Cuprymina, ki zahteva predložitev letne PSUR, je CHMP sklenil, da mora imetnik dovoljenja za promet predložiti dodatno vlogo za podaljšanje čez 5 let.
English: Healthcare personnel are advised to limit the time of close contact with patients injected with Copper-64-radiopharmaceuticals.
Slovenian: Priporočljivo je, da zdravstveno osebje omeji čas tesnega stika z bolniki, injiciranimi z bakrovim (64Cu) radiofarmakom.
English: It is not intended for direct use in patients.
Slovenian: Ni namenjeno za neposredno uporabo pri bolnikih.
English: However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator, even if with reduced efficiency.
Slovenian: Čeprav od izpostavljenosti poteče več kot 1 ura, to ne izključuje dajanja in uspešnega delovanja kelatorja, četudi z zmanjšano učinkovitostjo.
English: Appropriate aseptic precautions must be taken, in order to maintain the sterility of Cuprymina and to maintain sterility throughout the labelling procedures.
Slovenian: Treba je poskrbeti za primerne aseptične varnostne ukrepe, da se vzdržujeta sterilnost radiofarmacevtskega predhodnika Cuprymina in sterilnost med postopki označevanja.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: − Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Slovenian: Vprašajte zdravnika nuklearne medicine, kdaj lahko nadaljujete dojenje.
English: Copper-64-labelled medicinal products should not be used in children and adolescents up to 18 years.
Slovenian: Z bakrom (64Cu) označena zdravila se ne smejo uporabljati pri otrocih in mladostnikih, starih do 18 let.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Slovenian: Administrativne postopke je treba izvajati tako, da se čim bolj zmanjša tveganje za okužbo zdravila in obsevanje operaterjev.
English: If the administration is considered necessary, a breast-feeding mother should be advised to stop breast-feeding.
Slovenian: Če je uporaba nujna, je treba doječi materi svetovati, naj prekine dojenje.
English: Radiolabelling of carrier molecules, such as peptides, monoclonal antibodies, or other substrates, with Copper (64Cu) chloride is very sensitive to the presence of trace metal impurities.
Slovenian: Radioaktivno označevanje nosilnih molekul, kot so peptidi, monoklonska protitelesa ali drugi substrati, z bakrovim (64Cu) kloridom je zelo občutljivo za prisotnost sledov kovinskih nečistot.
English: Please read the package leaflet of that medicine carefully.
Slovenian: Pozorno preberite navodilo za uporabo tega zdravila.
English: It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled compound are thoroughly cleaned to ensure freedom from such trace metal impurities.
Slovenian: Pomembno je, da so vsa steklovina, igle za brizge itd., ki se uporabljajo za pripravo radioaktivno označenih zdravil, temeljito očiščeni, da se zagotovi odsotnost sledov kovinskih nečistot.
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 ionising radiation (if there are any) should be offered to the patient.
Slovenian: Če obstaja negotovost glede nosečnosti (če ni dobila menstruacije, če je menstruacija zelo neredna itd.), je treba bolnici ponuditi uporabo kakšne druge metode (če so na voljo), ki ne vključujejo uporabe ionizirajočega sevanja.
English: This waiver does however not extend to any diagnostic or therapeutic uses of the medicinal product when linked to a carrier molecule.
Slovenian: Opustitev se ne nanaša na nobeno od diagnostičnih ali terapevtskih uporab radiofarmacevtskega predhodnika, kadar je vezan na nosilno molekulo.
English: Considering that each MBq of Copper-64 causes a dose rate of 9 nSv/h (at a distance of 2 meters) and that the maximum injected activity is of 2,770 MBq, the initial dose rate is 24,930 nSv/h.
Slovenian: Ob upoštevanju, da en MBq bakra (64Cu) povzroči odmerek 9 nSv/h (na razdalji 2 metra) in da je maksimalna injicirana aktivnost 2.770 MBq, je začetni odmerek 24.930 nSv/h.
English: Cuprymina is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Slovenian: Radionukleotidni predhodnik Cuprymina se ne sme dajati neposredno bolniku, temveč ga je treba uporabiti za radioaktivno označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi ali drugi substrati.
English: SPECIAL STORAGE CONDITIONS Store in the original package that provides protection from radiation, according to local regulation.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini, ki ščiti pred sevanjem, v skladu z lokalnimi predpisi.
English: Each pack contains 1 vial in a tungsten or lead container.
Slovenian: Vsako pakiranje vsebuje 1 vialo v volframovem ali svinčevem vsebniku.
English: The possible use of chelating therapies could interfere with the use of Copper-64-labelled medicinal products.
Slovenian: Morebitna uporaba kelatnih terapij lahko ovira uporabo z bakrom (64Cu) označenih zdravil.
English: According to literature reports, it may be considered that both spermatogenetic and genetic damage in male test is are unlikely at the dose of 1,000 MBq.
Slovenian: Glede na poročila iz strokovne literature se lahko sklepa, da je pri odmerku 1.000 MBq le majhna verjetnost za spermatogenetske in genetske okvare v moških testisih.
English: The duration of stopping will depend on the particular radiolabelled medicinal product.
Slovenian: Trajanje prekinitve bo odvisno od posameznega radioaktivno označenega zdravila.
English: Therefore, in case of an inadvertent administration of Cuprymina, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) intravenous administration of preparations containing chelators like Ca-DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.
Slovenian: Zato je treba ob nenamernem vnosu radiofarmacevtskega predhodnika Cuprymina radiotoksičnost pri bolniku zmanjšati s takojšnjo (tj. v roku 1 ure) intravensko uporabo pripravkov, ki vsebujejo kelatorje, kot sta Ca-DTPA ali Ca-EDTA, da bi tako pospešili odstranjevanje radionuklidov iz telesa.
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to the choice of the most appropriate radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Slovenian: Pred uporabo radiofarmaka na ženski, ki doji, je treba razmisliti o možni prestavitvi dajanja radionuklida, dokler mati ne neha dojiti, in izbrati najustreznejši radiofarmak, ob upoštevanju njegovega izločanja v materino mleko.
English: Appropriate aseptic precautions should be taken.
Slovenian: Treba je upoštevati ustrezne varstvene ukrepe za zagotavljanje aseptičnih pogojev.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Slovenian: Če se to vseeno zgodi, vam bo zdravnik uvedel primerno zdravljenje.
English: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE) Italy
Slovenian: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE) Italija
English: Following intravenous administration, at the beginning most organs contained an amount of radioactivity which represented their content of Copper-64-laden blood.
Slovenian: Po intravenskem dajanju je na začetku večina organov vsebovala količino radioaktivnosti, enako njihovi vsebnosti bakra (64Cu) v krvi.
English: Before use, packaging and radioactivity must be checked.
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV Pred uporabo je treba preveriti pakiranje in radioaktivnost.
English: 48 hours from date and time of End of Synthesis (EOS).
Slovenian: 48 ur od datuma in časa konca sinteze.
English: Liver, kidney and the intestinal tract reached their maximal content of Copper-64 within the first few hours, and then radioactivity steadily diminished.
Slovenian: Jetra, ledvice in črevesje so dosegli največjo vsebnost bakra (64Cu) v prvih nekaj urah, nato se je radioaktivnost enakomerno zmanjševala.
English: Almost the entire 64CuCl2 rapidly leaves the blood and enters the liver and kidney.
Slovenian: Skoraj ves bakrov klorid (64CuCl2) se hitro očisti iz krvi ter vstopi v jetra in ledvice.
English: This will enable the generation of further pharmacovigilance data which will provide assurance that risks for this product are detected and adequately characterised in the post-marketing setting.
Slovenian: S tem se bodo pridobili nadaljnji farmakovigilančni podatki in tako se bo zagotovilo, da so tveganja povezana z zdravilom v obdobju trženja zdravila odkrita in ustrezno opisana.
English: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - Italy
Slovenian: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - Italija
English: It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons.
Slovenian: Treba je upoštevati, da radioaktivno označeno zdravilo oddaja Augerjeve elektrone visokih intenzivnosti.
English: The minimal specific activity is 3,700 MBq Copper-64/micrograms of Copper at the expiry date and time.
Slovenian: Minimalna specifična aktivnost je 3.700 MBq bakra-64/mikrogram bakra na datum in čas izteka roka uporabnosti.
English: The use of Copper-64-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Slovenian: Uporaba z bakrom (64Cu) označenih zdravil je kontraindicirana ob ugotovljeni nosečnosti ali sumu nanjo ali kadar nosečnost ni bila izključena (glejte poglavje 4. 3).
English: This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Slovenian: To zdravilo se sme uporabljati samo za radioaktivno označevanje nosilnih molekul, ki so bile posebej razvite in odobrene za radioaktivno označevanje s tem radionuklidom.
English: Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff.
Slovenian: Pomembno je, da se izvajajo meritve na kraju dela in med delom, saj se s tem lahko natančneje in bolj poučno določi skupni odmerek sevanja za osebje.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Slovenian: Shranjevanje radiofarmakov mora biti v skladu z nacionalnimi določili za radioaktivne materiale.
English: Copper chloride (64CuCl2) is distributed mainly in the liver and kidney and the pattern of radioactivity in the blood parallels the pattern of radioactivity in the liver.
Slovenian: Bakrov klorid (64CuCl2) se porazdeli predvsem v jetra in ledvice, torej je vzorec radioaktivnosti v krvi vzporeden z vzorcem radioaktivnosti v jetrih.
English: Cuprymina is stored under the responsibility of the specialist in appropriate premises.
Slovenian: Radionukleotidni predhodnik Cuprymina se shranjuje v pristojnosti strokovnjaka v za to ustreznih prostorih.
English: These chelating agents help elimination of copper radiotoxicity by an exchange between the calcium ion and the copper due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA).
Slovenian: Ti kelatorji zavirajo radiotoksičnost bakra z izmenjavo kalcijevih ionov in bakrom na podlagi zmožnosti bakra, da z ligandi za kelatiranje (DTPA, EDTA) tvori v vodi topne komplekse.
English: Non-clinical data reveal no special hazard for humans based on available published data.
Slovenian: Predklinični podatki na podlagi razpoložljivih objavljenih podatkov ne kažejo posebnega tveganja za človeka.
English: When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Slovenian: Pri načrtovanem dajanju radiofarmaka ženskam v rodni dobi je pomembno ugotoviti, ali je ženska noseča.
English: Copper-64 decays by an emission of β+ (17.6 %) with a maximum energy of 0.66 MeV, an emission of β- (38.5 %) with a maximum energy of 0.58 MeV and electronic capture (43.9 %).
Slovenian: Baker-64 razpada z oddajanjem delcev β+ (17,6 %) z najvišjo energijo 0,66 MeV, oddajanjem delcev β- (38,5 %) z najvišjo energijo 0,58 MeV in zajetjem elektronov (43,9 %).
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Slovenian: Če ste v dvomih, je pomembno, da se posvetujete s specialistom nuklearne medicine, ki bo postopek nadzoroval.
English: Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Slovenian: Uporabljajo se lahko samo igle za brizge (npr. nekovinske) z dokazano odpornostjo proti razredčenim kislinam, s čimer se zmanjša stopnja prisotnosti sledov kovinskih nečistot.
English: For in vitro radiolabelling.
Slovenian: Za radioaktivno označevanje in vitro.