FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of renal impairment, IVIg discontinuation should be considered.
Slovenian: Pri ledvični okvari je treba pretehtati možnost prekinitve zdravljenja z i.v.
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Slovenian: Ig, ali bolniki, pri katerih je bil presledek od predhodnega infundiranja dolg, se spremljajo med prvim infundiranjem in še prvo uro po prvem infundiranju, da bi ugotovili morebitne neželene znake.
English: The median doses administered for the 3-week and 4-week treatment schedules were almost identical to each other (428.3 vs. 440.6 mg IgG/ kg bw).The PID extension study included a total of 55 patients aged between 4 and 81 years old.
Slovenian: Mediani odmerki, dani v 3-tedenskem in 4-tedenskem režimu zdravljenja so bili skoraj identični (428,3 oz. 440,6 mg IgG/kg telesne mase).
English: Dizziness (including vertigo)
Slovenian: zelo pogosti omotica (vključno z vrtoglavico)
English: For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Slovenian: Pogostnost spontano poročanih neželenih učinkov zdravila (ADR) iz obdobja trženja je ocenjena kot
English: Skin disorder (including rash, pruritus, urticaria, maculo-papular rash, erythema, skin exfoliation)
Slovenian: Bolezni kože in podkožja bolezni kože (vključno z izpuščajem, pruritusom, urtikarijo, makulo-papuloznim izpuščajem,
English: 50 or 100 ml of solution in a single vial (type I or II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
Slovenian: 50 ali 100 ml raztopine v eni viali (steklo vrste I ali II) z zamaškom (elastomernim), zaporko (z aluminijastim navojem), s tesnilom Flip Off (plastičnim), oznako z vgrajeno zanko.
English: - If you get any side effects, talk to your doctor or healthcare professional.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
English: Anaemia, haemolysis (including haemolytic anaemia), leukopenia
Slovenian: Bolezni krvi in limfatičnega sistema anemija, hemoliza (vključno s hemolitično anemijo), levkopenija pogosti anizocitoza (vključno z mikrocitozo),
English: 1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose.
Slovenian: Kawasakijeva bolezen V 2 do 5 dneh je treba dati od 1,6 do 2,0 g/kg tm v deljenih odmerkih ali 2,0 g/kg tm v enem odmerku.
English: IgG4 ......................... 2 %
Slovenian: IgG2 ....................... 26 % IgG3 ......................... 3 % IgG4 ......................... 2 %
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration.
Slovenian: Hemolitična anemija se lahko razvije po zdravljenju z i.v.
English: Stability after dilution:
Slovenian: Obstojnost po redčenju:
English: 25 ml of solution in a single vial (type I glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
Slovenian: 25 ml raztopine v eni viali (steklo vrste I) z zamaškom (elastomernim), zaporko (z aluminijastim navojem), s tesnilom Flip Off (plastičnim), oznako z vgrajeno zanko.
English: If you get any side effects, talk to your doctor or healthcare professional.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali zdravstvenim delavcem.
English: 0.4 g/kg bw/d for 5 days
Slovenian: 0,4 g/kg tm/dan
English: • You receive this medicine in high doses either on 1 day or over several days and you have a blood group A, B or AB and/or you have an underlying inflammatory condition.
Slovenian: Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte, če katere od naštetih okoliščin veljajo za vas: ● 1 dan ali več dni ste prejemali visoke odmerke tega zdravila, vaša krvna skupina pa je A, B ali
English: Dyspnoea (including chest pain, chest discomfort, painful respiration)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (vključno z bolečino v prsih, tiščanjem v prsih), boleče dihanje)
English: For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Slovenian: Za informacije o varnosti glede povzročiteljev nalezljivih bolezni glejte poglavje 4.4.
English: Certain adverse reactions may occur more frequently: - in case of high rate of infusion, - in patients with hypogammaglobulinaemia or agammaglobulinaemia, with or without IgA deficiency, - in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Slovenian: - pri bolnikih, ki prvič prejmejo humani polispecifični imunoglobulin, ali v redkih primerih, kadar se zdravilo s humanim polispecifičnim imunoglobulinom zamenja ali kadar obstaja dolg presledek od predhodnega infundiranja.
English: Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Slovenian: Začetni odmerek: 2 g/kg v obdobju 2 do 5 zaporednih dni Vzdrževalni odmerek: 1 g/kg vsake 2 do 4 tedne ali 2 g/kg vsakih 4 do 8 tednov.
English: Nervous system disorders
Slovenian: Organski sistem po MedDRA
English: A) to increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy):
Slovenian: A) Povečanje nenormalno nizkih ravni imunoglobulinov v vaši krvi na normalno raven (nadomestno zdravljenje): bolniki s prirojeno zmanjšano sposobnostjo ali nesposobnostjo proizvajanja imunoglobulinov (primarna imunska pomanjkljivost (PID - primary immunodeficiencies)).
English: If signs and/or symptoms of haemolysis develop during or after an IVIg infusion, discontinuation of the IVIg treatment should be considered by the treating physician (see also section 4.8).
Slovenian: Če se znaki in/ali simptomi hemolize pojavijo med infundiranjem i.v.
English: Hepatobiliary disorders Hyperbilirubinaemia
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija pogosti
English: How Privigen works
Slovenian: Kako deluje zdravilo Privigen
English: TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
Slovenian: Za TRALI so značilni huda dihalna stiska, pljučni edem, hipoksemija,
English: There are two alternative treatment schedules:
Slovenian: Primarna imunska trombocitopenija (ITP) Na voljo sta dva možna režima zdravljenja:
English: In the first CIDP study, a prospective multicenter open label trial (Privigen impact on mobility and autonomy PRIMA study), 28 patients (13 subjects who have previously received IVIG and 15 subjects not) were treated with a Privigen loading dose of 2g/kg bw given over 2-5 days followed by 6 maintenance doses of 1g/kg bw over 1-2 days every three weeks.
Slovenian: Ig in 15 preiskovancev, ki ga predhodno niso prejemali) zdravili z zdravilom Privigen s polnilnim odmerkom 2 g/kg tm 2-5 dni, ki mu je sledilo 6 vzdrževalnih odmerkov 1g /kg tm 1-2 dni vsake tri tedne.
English: Palpitations, tachycardia
Slovenian: Srčne bolezni palpitacije, tahikardija občasni
English: Do NOT take Privigen
Slovenian: NE uporabljate zdravila Privigen
English: CSL Behring AB
Slovenian: CSL Behring GmbH
English: - Multifocal motor neuropathy (MMN)
Slovenian: multifokalni motorični nevropatiji (MMN).
English: IgG3 3 %
Slovenian: Čistost IgG ≥ 98 %.
English: Other side effects presented in order of decreasing frequency:
Slovenian: Nekateri neželeni učinki se lahko pojavijo pogosteje:
English: starting dose: 2 g/kg bw in divided doses over 2 to 5 days maintenance dose: 1 g/kg bw every 3 weeks over 1 to 2 days
Slovenian: 2 g/kg tm vzdrževalni odmerek: 1g/kg tm v razdeljenih odmerkih v obdobju 2 do 5 dni vsake 3 tedne v obdobju 1 do 2 dni
English: Subjects all with IVIg pretreatment of at least 8 weeks and with an IVIg-dependence confirmed by clinically evident deterioration during an IVIg withdrawal phase of up to 12 weeks, received a Privigen loading dose of 2 g/kg bw followed by up to 4 Privigen maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks.
Slovenian: Vsi preiskovanci so predhodno vsaj 8 tednov prejemali intravenske imunoglobuline (IVIg) in so bili od njih odvisni; slednje je bilo potrjeno s klinično opaznim poslabšanjem med fazo do 12 tednov trajajoče odtegnitve IVIg.
English: In patients at risk, the use of IVIg products that do not contain sucrose should therefore be considered.
Slovenian: Pri bolnikih s tveganjem je treba pretehtati možnost uporabe zdravil i.v.
English: A vented infusion line should be used for the administration of Privigen.
Slovenian: Privigen je treba uporabiti prezračevano infuzijsko cevko.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
English: Hypertension, flushing (including hot flush, hyperaemia), hypotension
Slovenian: Žilne bolezni hipertenzija, navali vročine (vključno z vročinskimi oblivi, hiperemijo), hipotenzija pogosti trombembolični dogodki, vaskulitis (vključno s periferno žilno motnjo)
English: Tell your doctor or healthcare professional prior to treatment if any of the circumstances listed below applies to you:
Slovenian: Svojemu zdravniku ali zdravstvenemu delavcu takoj povejte, če imate katerega od zgornjih simptomov.
English: Previously treated patients were withdrawn from IVIG until confirmed deterioration before start of Privigen.
Slovenian: Ig, dokler niso potrdili poslabšanja stanja, nakar so začeli dobivati zdravilo Privigen.
English: Pain (including back pain, pain in extremity, arthralgia, neck pain, facial pain) pyrexia (including chills), influenza like illness (including nasopharyngitis, pharyngolaryngeal pain, oropharyngeal blistering, throat tightness)
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečine (vključno z bolečinami v hrbtu, bolečinami v okončinah, artralgijo, bolečinami v vratu, obrazno bolečino), pireksija (vključno z mrazenjem), gripi podobno obolenje (vključno z nazofaringitisom, bolečinami v žrelu in grlu,
English: Monitor patients for pulmonary adverse reactions.
Slovenian: Bolnike je treba nadzirati glede pojava neželenih učinkov na dihalih.
English: • chest pain, chest discomfort, painful respiration due to transfusion related lung injury (TRALI) Tell your doctor or healthcare professional immediately if you have any of the above symptoms.
Slovenian: • bolečina v prsnem košu, občutek neugodja v prsnem košu, boleče dihanje zaradi s transfuzijo povezane akutne okvare pljuč (TRALI).
English: Vomiting, diarrhoea, abdominal pain
Slovenian: zelo pogosti bruhanje, driska, bolečina v trebuhu pogosti
English: Privigen is presented as a solution for infusion.
Slovenian: Zdravilo Privigen je raztopina za infundiranje.
English: Please also refer to section 2 “What you need to know before you are given Privigen” for additional details on circumstances which increase the risk of side effects.
Slovenian: Za dodatne informacije o okoliščinah, ki povečujejo tveganje neželenih učinkov, glejte tudi poglavje 2
English: 1 ml contains: Human normal immunoglobulin 100 mg. IgG purity ≥ 98%.
Slovenian: humani polispecifični imunoglobulin 100 mg.
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Slovenian: Pri bolnikih s tveganjem trombemboličnih neželenih učinkov je treba zdravila z i.v.
English: In patients at risk of acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Slovenian: Pri bolnikih s tveganjem akutne ledvične odpovedi je treba zdravila i.v.
English: Solutions that are cloudy or have deposits should not be used.
Slovenian: Ne uporabljajte motnih raztopin ali raztopin z usedlinami.
English: Proteinuria, increased blood creatinine
Slovenian: Bolezni sečil proteinurija, povečan kreatinin v krvi občasni akutna odpoved ledvic neznana
English: Live attenuated virus vaccines
Slovenian: Shranjevanje zdravila Privigen
English: 2 g/kg bw every 4 to 8 weeks over 2 to 5 days
Slovenian: 2 g/kg tm vzdrževalni odmerek: 1g/kg tm ali 2g/kg tm v obdobju 2 do 5 zaporednih dni vsake 2 do 4 tedne ali vsakih 4 do 8 tednov v obdobju 2 do 5 dni
English: Noncardiogenic pulmonary edema may very rarely occur following treatment with IVIg products, including Privigen.
Slovenian: Zelo redko se lahko po zdravljenju z zdravili i.v.
English: Skin and subcutaneous tissue disorders
Slovenian: eritem, eksfoliacijo kože)
English: Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding.
Slovenian: Če ste noseči, nameravate zanositi ali dojite, o tem obvestite zdravnika ali zdravstvenega delavca.
English: Aseptic meningitis
Slovenian: Infekcijske in parazitske bolezni aseptični meningitis občasni
English: - if you are pregnant.
Slovenian: - če ste noseči.
English: It will be the smallest quantity necessary to get the desired information.
Slovenian: To bo najmanjša potrebna količina, da se dobijo želene informacije.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 12.
English: F-91192 Gif-sur-Yvette Cedex France
Slovenian: F-91192 Gif-sur-Yvette Cedex Francija
English: Withdrawals should be performed under aseptic conditions.
Slovenian: Odvzeme je treba opravljati v aseptičnih pogojih.
English: After radiolabelling: 3 hours.
Slovenian: Po radioaktivnem označevanju: 3 ure.
English: After radiolabelling with sodium pertechnetate (
Slovenian: - Prvega izpirka iz generatorja tehnecija (
English: - if you have any blood disease.
Slovenian: - če imate kakršnokoli bolezen krvi, - če dojite.
English: This medicine is not recommended for use in patients below 18 years of age because the safety and efficacy of the product have not been established.
Slovenian: Zdravilo ni priporočeno bolnikom, mlajšim od 18 let, ker varnost in učinkovitost zdravila nista bili dokazani.
English: Under nitrogen atmosphere
Slovenian: V dušikovi atmosferi
English: A single injection into a vein in your arm is sufficient to conduct the test your doctor needs.
Slovenian: Ena injekcija v veno v vaši roki zadostuje za izvedbo preiskave, ki jo zdravnik potrebuje.
English: The DHPC also includes 3 copies of a Patient Alert Card completed by the Healthcare Professional and provided to each patient.
Slovenian: DHPC vključuje tudi 3 kopije opozorilne kartice za bolnika, ki jo izpolni zdravstveni delavec in prejme vsak bolnik.
English: Appropriate aseptic precautions should be taken.
Slovenian: Potrebni so ustrezni aseptični previdnostni ukrepi.
English: This may increase the risk of allergic reactions in case of repeated administration of Scintimun.
Slovenian: To lahko poveča tveganje alergijskih reakcij v primeru ponavljajoče se uporabe zdravila Scintimun.
English: EU/1/09/602/002
Slovenian: EU/1/09/602/001 EU/1/09/602/002
English: This will protect your child from the radiation that may be present in your breast milk.
Slovenian: Tako boste zaščitili svojega otroka pred sevanjem, ki bo morda prisotno v vašem mleku.
English: The safety and efficacy of Scintimun in children and adolescents have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Scintimun pri otrocih in mladostnikih še nista bili dokazani.
English: Quality control
Slovenian: Kontrola kakovosti
English: Date of latest renewal: 26 August 2014
Slovenian: Datum prve odobritve: 11. januar 2010 Datum zadnjega podaljšanja: 26. avgusta 2014
English: In case of allergic reaction you will receive appropriate treatment from your doctor.
Slovenian: V primeru alergijske reakcije vas bo zdravnik ustrezno zdravil.
English: A risk to a breast-fed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni možno izključiti.
English: EXP Use within 3 hours after radiolabelling.
Slovenian: EXP Uporabite v 3 urah po radioaktivnem označenju.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Slovenian: Prejem, shranjevanje, uporaba, prenos in odstranjevanje radiofarmakov je urejeno s predpisi in/ali ustreznimi licencami pristojnih organov.
English: Scintimun will only be used in special controlled areas.
Slovenian: Zdravilo Scintimun se bo uporabljalo samo v posebno nadzorovanih prostorih.
English: Genotoxicity studies conducted to test for potentially genotoxic impurities were also negative.
Slovenian: Študije genotoksičnosti, opravljene za preskus potencialno genotoksičnih nečistoč, so tudi bile negativne.
English: If you are pregnant you must not be given Scintimun.
Slovenian: Če ste noseči, ne smete prejeti zdravila Scintimun.
English: Table 1: Values of the absorbed doses calculated for the individual male and female of reference.
Slovenian: Tabela 1: Vrednosti absorbiranih odmerkov, izračunanih za referenčnega moškega in žensko.
English: The content of the kit before reconstitution is not radioactive.
Slovenian: Vsebina kompleta pred rekonstitucijo ni radioaktivna.
English: METHOD OF ADMINISTRATION Not intended for direct application to patients.
Slovenian: POSTOPEK UPORABE Ni namenjeno neposredni uporabi pri bolniku.
English: Pregnancy (see section 4.6).
Slovenian: Nosečnost (glejte poglavje 4.6).
English: For diagnostic nuclear medicine investigations the frequency of these adverse reactions is not known.
Slovenian: Pri diagnostičnih preiskavah v nuklearni medicini pogostnost teh neželenih učinkov ni znana.
English: BATCH NUMBER Lot:
Slovenian: ŠTEVILKA SERIJE Lot :
English: Swirl carefully to mix the whole solution (DO NOT shake).
Slovenian: Previdno vrtinčite, da premešate celotno raztopino (NE stresajte).
English: Effective Dose 0.00863 mSv / MBq
Slovenian: Celotno telo Efektivni odmerek 0,00863 mSv/MBq
English: You can also report side effects directly via directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: An additional acquisition 24 hours after initial injection is recommended.
Slovenian: Priporočljiv je dodaten zajem 24 ur po prvotnem injiciranju.
English: Pharmacodynamic effects At the recommended activities, it does not exert any clinically relevant pharmacodynamic effects.
Slovenian: Farmakodinamični učinki Priporočene aktivnosti te učinkovine nimajo klinično relevantnih farmakodinamičnih učinkov.
English: MBq ml hour/date
Slovenian: MBq ml ura/datum
English: There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging.
Slovenian: Trenutno ni kriterijev za razlikovanje okužbe in vnetja s pomočjo slikanja z zdravilom Scintimun.
English: Adequate shielding is mandatory.
Slovenian: Ustrezna zaščita je obvezna.
English: If you have an intolerance to some sugars (for example fructose or sorbitol), tell your doctor before you are given Scintimun.
Slovenian: Če ne prenašate določenih sladkorjev (na primer fruktozo ali sorbitol), obvestite zdravnika, preden boste prejeli zdravilo Scintimun.
English: The effective dose has been calculated by using the absorbed doses determined for each individual organ, taking into account the weighting factors (radiation and tissue) to use according to the recommendations of the ICRP (International Commission of Radiological Protection, Publication 103).
Slovenian: Efektivni odmerek so izračunali z absorbiranimi odmerki, določenimi za vsak posamezen organ, ob upoštevanju uteži (sevanja in tkiva) za uporabo skladno s priporočili ICRP (International Commission of Radiological Protection, publikacija 103).
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Slovenian: Pri uporabi radiofarmakov nastane tveganje za druge osebe zaradi zunanjega sevanja ali kontaminacije zaradi razlitja urina, bruhanja itd.
English: Investigations in nuclear medicine may involve a risk to the unborn.
Slovenian: Preiskave v nuklearni medicini so lahko nevarne za nerojenega otroka.
English: Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3).
Slovenian: Uporaba besilesomaba je kontraindicirana v nosečnosti (glejte poglavje 4.3).
English: It is not known if the product is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo izloča v materino mleko.
English: Acquisition can be performed using planar imaging.
Slovenian: Zajem lahko opravite s planarnim slikanjem.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Long-term carcinogenicity studies and toxicity to reproduction have not been carried out.
Slovenian: Dolgoročnih študij karcinogenosti niso izvajali.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Slovenian: Zdravnik nuklearne medicine vas bo obvestil, ali morate po prejemu tega zdravila upoštevati posebne varnostne ukrepe.
English: The quantity to be administered usually recommended for an adult ranges from 400 to 800 MBq (megabecquerel, the unit used to express radioactivity).
Slovenian: Uporabljena količina, navadno priporočena za odrasle, je od 400 do 800 MBq (megabekerel je enota, ki se uporablja za izražanje radioaktivnosti).
English: Separately count each cut part of the strip and record the obtained values (use an appropriate detection apparatus with a constant counting time, and known geometry and background noise).
Slovenian: Ločeno preštejte vsak del prerezanega traku in zabeležite vrednosti (uporabite ustrezno detekcijsko opremo s stalnim števnim časom, znano geometrijo in izhodiščnim šumom).
English: About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun.
Slovenian: Pri približno 14 od 100 bolnikov, ki so prejeli to injekcijo, so odkrili nastajanje protiteles v krvi, ki reagirajo proti protitelesom, ki so prisotna v zdravilu Scintimun.
English: The radiochemical purity of the final radiolabelled preparation can be tested according to the following procedure:
Slovenian: Radioaktivno čistoto končnega radioaktivnega pripravka lahko preverite po naslednjem postopku:
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000)
Slovenian: Spodaj navedena pogostnost je opredeljena v skladu z naslednjimi dogovorjenimi skupinami: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1000 do < 1/100); redki (≥ 1/10 000 do < 1/1 000); zelo redki (< 1/10 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Individual benefit/risk justification
Slovenian: Individualna utemeljite razmerja med koristmi in tveganji
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Slovenian: Te bodo posebej pozorne na varno uporabo zdravila in vas bodo sproti obveščale o svojem ravnanju.
English: Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is excreted via the bladder during the 24 h post-injection.
Slovenian: Meritve ravni radioaktivnosti v urinu so pokazale, da se do 14 % uporabljene aktivnost izloči skozi sečni mehur v 24 h po injiciranju.