FrancophonIA/ELRC3.0 huggingface dataset:
English: In the other main study, symptoms were reduced by at least 20% in 59% of patients who received Cimzia (228 out of 388) compared with 14% of patients who received placebo (27 out of 198).
Slovenian: V drugi glavni študiji je do vsaj 20-odstotnega zmanjšanja simptomov prišlo pri 59 % (228 od 388) bolnikov, ki so prejemali zdravilo Cimzia, in pri 14 % (27 od 198) bolnikov, ki so prejemali placebo.
English: How is Cimzia used?
Slovenian: Kako se zdravilo Cimzia uporablja?
English: Cimzia is available as pre-filled syringes, prefilled pens and dose-dispenser cartridge.
Slovenian: Zdravilo Cimzia je na voljo v obliki napolnjenih injekcijskih brizg in peresnikov ter odmernih vložkov.
English: Treatment with Cimzia 200 mg every two weeks in the two studies led to 66.5% and 52.6% of patients responding compared with 6.5% and 4.5% of patients receiving placebo.
Slovenian: V teh dveh študijah se je na zdravljenje odzvalo 66,5 % oziroma 52,6 % bolnikov, ki so prejemali 200-miligramski odmerek zdravila Cimzia vsaka dva tedna, in 6,5 % oziroma 4,5 % bolnikov, ki so prejemali placebo.
English: For the full list of side effects of Cimzia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cimzia, glejte navodilo za uporabo.
English: including ankylosing spondylitis and when the X-ray does not show disease but there are clear signs of inflammation.
Slovenian: • aksialnega spondiloartritisa (bolezni, ki povzroča vnetje in bolečine v sklepih v hrbtenici), vključno z ankilozirajočim spondilitisom, in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
English: 7 days from the date/hour of manufacture.
Slovenian: 7 dni od datuma/ure izdelave.
English: 1 year New Born
Slovenian: 1 leto novorojenec
English: Intravenous administration should not be protracted over more than 2 hours.
Slovenian: Intravenska aplikacija ne sme trajati več kot 2 uri.
English: Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 day, 4 days and 15 days.
Slovenian: Časovni intervali opravljanja meritev so bili: 5 minut, 1 ura, 6 ur, 1 dan, 4 dni in 15 dni.
English: It is important to tell your doctor if there is any possibility that you are pregnant.
Slovenian: Pomembno je, da svojemu zdravniku poveste, če obstaja kakršnakoli možnost, da ste noseči.
English: This leaflet was last revised in ().
Slovenian: Navodilo je bilo nazadnje revidirano dne ().
English: A.LABELLING
Slovenian: A.OZNAČEVANJE
English: YTRACIS is only to be used by specialists with the appropriate experience.
Slovenian: YTRACIS smejo uporabljati le specialisti z ustreznimi izkušnjami.
English: 4.8 Undesirable Effects
Slovenian: 4.8 Neželeni učinki
English: Faecal and urinary elimination is slow: about 13 % of the administered activity is eliminated in 15 days.
Slovenian: Izločanje preko blata in urina je počasno: približno 13 % aplicirane aktivnosti se izloči v 15 dneh.
English: However, should this occur, you will receive appropriate treatment from your doctor.
Slovenian: Če bi pa do tega vseeno prišlo, vam bo vaš zdravnik nudil ustrezno zdravljenje.
English: Date of the last renewal: 24/03/2008
Slovenian: Datum zadnjega podaljšanja: 24/03/2008
English: You will be asked to stop breast-feeding.
Slovenian: Od vas bodo zahtevali, da prenehate dojiti.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Slovenian: V vseh primerih je potrebno zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
English: The vial should never be opened and must be kept inside its lead shielding.
Slovenian: Viale ne smemo nikoli odpirati in mora ostati shranjena v svinčeni zaščiti.
English: Organ Adult male 70 kg
Slovenian: Odrasel moški 70 kg
English: 90Y-yttrium has a half-life of 2.67 days (64.1 hours).
Slovenian: 90Y-itrij ima razpolovno dobo 2,67 dneva (64,1 ure).
English: However, a post-exposure interval >1 hour does not preclude the administration and effective action of chelator with reduced efficiency.
Slovenian: Seveda pa časovni interval > 1 h po izpostavljenosti ne izključuje aplikacije in učinkovitega delovanja kelatorja z zmanjšano efektivnostjo.
English: In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
Slovenian: V kosteh odstotek injicirane aktivnosti naraste od 3,1 % po 5 minutah na 18% po 6 urah, nato pa v času zopet upada.
English: There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
Slovenian: Na razpolago ni podatkov o toksičnosti itrijevega (90Y) klorida kot tudi ne o njegovih učinkih na reprodukcijo pri živalih ali njegovem mutagenem ali karcinogenem potencialu.
English: At 1 and 24 hours, blood radioactivity decreases from 11 % to 0.14 % of the administered activity.
Slovenian: Po 1 in 24 urah radioaktivnost v krvi pade od 11% na 0,14 % aplicirane aktivnosti.
English: Dosage Your physician will decide on the amount of YTRACIS to be used in your case.
Slovenian: Odmerjanje Vaš zdravnik bo odločil, kolikšna količina YTRACISa naj se uporabi v vašem primeru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/250/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/03/250/001
English: Since YTRACIS is administered by a doctor under strictly controlled conditions there is little chance of possible overdose.
Slovenian: Ker YTRACIS daje zdravnik pod strogo določenimi pogoji, je verjetnost možnega prevelikega odmerjanja majhna.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Slovenian: PODATKI V BRAILLOVI PISAVI <Sprejeta je utemeljitev, da Braillova pisava ni potrebna>
English: Radiopharmaceutical precursor - Not intended for direct application to patients.
Slovenian: Radiofarmacevtski predhodnik - ni namenjen za neposredno aplikacijo pri bolnikih.
English: These complexes are rapidly eliminated by the kidneys.
Slovenian: Ti kompleksi se hitro izločijo preko ledvic.
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 s pomočjo radionuklidnega kalibratorja so zelo občutljive na geometrijske dejavnike, zato naj se izvajajo le v geometrijskih pogojih, ki so bili ustrezno validirani.
English: Storage should be in accordance with local regulations for radioactive substances.
Slovenian: Shranjevanje mora biti v skladu z lokalnimi predpisi o radioaktivnih snoveh.
English: For this product, the effective dose resulting from an intravenously injected activity of 1 GBq is 700 mSv for a 57-kg female adult and 650 mSv for a 70-kg male adult.
Slovenian: Pri tem zdravilu je efektivna doza po intravensko injicirani aktivnosti 1 GBq 700 mSv za 57 kg težko odraslo žensko in 650 mSv za 70 kg težkega odraslega moškega.
English: - If you have any further questions, ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 7 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 7 in predložen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila..
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Slovenian: Vsako žensko, ki ji je izostala menstruacija, moramo obravnavati kot da je noseča, dokler se ne dokaže nasprotno.
English: Usual precautions regarding sterility and radioactivity should be respected.
Slovenian: Upoštevati moramo ustaljene previdnostne ukrepe glede sterilnosti in radioaktivnosti.
English: Because there are strict laws covering the use, handling and disposal of radioactivity, YTRACIS will always be used in a hospital or a similar setting.
Slovenian: Zaradi stroge zakonodaje na področju uporabe, rokovanja in odlaganja radioaktivnih snovi, se zdravilo YTRACIS vedno uporablja le v bolnišnici ali podobni ustanovi.
English: The dosimetry estimates were based on a rat biodistribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations.
Slovenian: Ocene prejetih doz temeljijo na študiji porazdeljevanja pri podganah, preračuni so bili narejeni v skladu s priporočili MIRD/ICRP 60.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: DODATEK II A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: YTRACIS is contraindicated in the following cases: - Hypersensitivity to the active substance or to any of the excipients.
Slovenian: YTRACIS je kontraindiciran v naslednjih primerih: - preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
English: If the administration cannot be delayed, a lactating mother should be advised to stop breastfeeding.
Slovenian: Če aplikacije ne moremo odložiti, je treba doječi materi svetovati, da z dojenjem preneha.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
Slovenian: Pri vsakem posameznem bolniku mora biti izpostavljenost radioaktivnemu sevanju upravičena s potencialno klinično koristjo.
English: It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Slovenian: Z njim lahko rokujejo in ga dajejo le osebe, ki so usposobljene in pooblaščene za varno uporabo radioaktivnih snovi.
English: Cal: {DD/MM/YYYY} (12 h CET) METHOD AND ROUTE(S) OF ADMINISTRATION NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS.
Slovenian: : {DD/MM/LLLL} (12h po srednjeevropskem času) POSTOPEK IN POT(I) UPORABE ZDRAVILA NI NAMENJENO ZA NEPOSREDNO APLIKACIJO BOLNIKOM.
English: Before use, packaging and radioactivity should be checked.
Slovenian: Pred uporabo moramo preveriti ovojnino in radioaktivnost.
English: 4.7 Effects on ability to drive or use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
English: Radioactive medicinal products should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.
Slovenian: Prejemanje, uporaba in dajanje radiofarmacevtskih izdelkov lahko poteka le v za to določenih kliničnih ustanovah, poseg pa smejo izvajati le pooblaščene osebe; prevzem, shranjevanje, uporaba, premeščanje in odlaganje teh snovi pa mora potekati v skladu s predpisi in ustreznimi dovoljenji pristojnih organov.
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3-4 minutes or by infusion (1 g in 100-250 ml of dextrose, or normal saline).
Slovenian: 1 g kelatorja je treba aplicirati s pomočjo počasne intravenske injekcije v trajanju 3-4 minut ali preko infuzije (1 g v 100-250 ml dekstroze ali fiziološke raztopine).
English: YTRACIS is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3 Contraindications).
Slovenian: YTRACIS je kontraindiciran v primeru ugotovljene nosečnosti ali suma na nosečnost ali v primeru, da se nosečnosti ne more izključiti (glejte poglavje 4.3 Kontraindikacije).
English: It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr).
Slovenian: Z oddajanjem beta žarkov maksimalne energije 2,281 MeV (99.98 %) razpada v stabilni cirkonij (90Zr).
English: B CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Act.: {Y} GBq/ml
Slovenian: : {Y} GBq/ml
English: (GBq : GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
Slovenian: gigabekerel, bekerel je enota za merjenje radioaktivnosti).
English: Therefore, in case of an inadvertent administration of Ytracis, the radiotoxicity for the patient must be reduced by immediate (i.e. within 1 hour) 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 potrebno v primeru nenamerne aplikacije Ytracisa zmanjšati radiotoksičnost za bolnika s takojšnjo (tj. najkasneje v 1 uri) aplikacijo preparatov, ki vsebujejo kelatorje, kot so Ca-DTPA ali Ca- EDTA, da bi povečali izločanje radioaktivnega izotopa iz telesa.
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: Kelacijski učinek je največji takoj po ali v prvi uri izpostavljenosti, ko radioaktivni izotop kroži oz. vstopa v tkivne tekočine in plazmo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 24/03/2003
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 24/03/2003
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Slovenian: Prejeta doza sevanja zaradi terapevtske izpostavljenosti ima lahko za posledico večjo pojavnost rakavih obolenj in mutacij.
English: Kidneys Liver Bladder Ovaries Uterus Spleen 0.85 Bone Heart Lungs Intestines Muscles Testes
Slovenian: 1 leto Novorojenec ledvice jetra mehur jajčniki maternica vranica kosti srce pljuča črevesje mišice testisi
English: Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the administration could be reasonably delayed until the mother has ceased breastfeeding.
Slovenian: Pred aplikacijo radiofarmaka doječi materi moramo pretehtati, če se aplikacije morda ne bi dalo razumno odložiti, dokler mati ne preneha z dojenjem.
English: One vial contains 0.925 to 3.700 GBq (see section 6.5).
Slovenian: Ena viala vsebuje 0,925 do 3,700 GBq (glejte poglavje 6.5).
English: These chelating agents suppress yttrium radiotoxicity by an exchange between the calcium ion and the yttrium due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA).
Slovenian: Ti kelatorji zavirajo radiotoksičnost itrija z izmenjavo kalcijevega iona in itrija zaradi svoje sposobnosti tvorbe vodotopnih kompleksov s kelacijo ligandov (DTPA, EDTA).
English: Do not use YTRACIS: - if you are hypersensitive (allergic) to Yttrium (90Y) chloride or any of the other ingredients of
Slovenian: Ne uporabljajte zdravila YTRACIS: - če ste preobčutljivi (alergični) na itrijev (90Y) klorid ali katerokoli sestavino zdravila
English: The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.
Slovenian: Aplicirana aktivnost mora biti v takih mejah, da je posledična doza sevanja kar se da nizka, obenem pa omogoča dosego zastavljenega terapevtskega izida.
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 damage to the blood marrow.
Slovenian: V vsakem primeru je treba spremljati krvno sliko bolnika in če je prišlo do okvare kostnega mozga, takoj ustrezno ukrepati.
English: The vial is supplied in a lead pot of appropriate thickness.
Slovenian: Dostava viale je v svinčeni posodi primerne debeline.
English: Y) chloride with other medicinal products are known because no studies have investigated this issue.
Slovenian: Ne poznamo nobenih interakcij itrijevega (90Y) klorida z drugimi zdravili, ker s tem v zvezi niso opravili nobene študije.
English: Alternative techniques which do not involve radioactive medicines should always be considered.
Slovenian: Vedno je treba upoštevati možnost uporabe alternativnih metod, ki niso povezane z radioaktivnimi zdravili.
English: Pregnancy: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Nosečnost: Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
English: The following information is intended for medical or healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of YTRACIS.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Za podrobnejše informacije glejte Povzetek glavnih značilnosti zdravila YTRACIS.
English: Radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Slovenian: Označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi ali drugi substrati, z itrijevim (90Y) kloridom je zelo občutljivo na prisotnost sledov kovinskih nečistot.
English: To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Slovenian: Uporablja se le za radioaktivno označevanje nosilnih molekul, ki so bile razvite in odobrene posebej za označevanje s tem izotopom.
English: 1 vial contains 0.5 to 2 ml (corresponding to 0.925 to 3.700 GBq calibrated three or four days after the manufacturing date) depending on the ordered radioactivity.
Slovenian: 1 viala vsebuje 0,5 do 2 ml (kar odgovarja 0,925 do 3,700 GBq, kalibrirano tri ali štiri dni po datumu izdelave), glede na naročeno radioaktivnost.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: What YTRACIS looks like and contents of the pack
Slovenian: Izgled zdravila YTRACIS in vsebina pakiranja
English: Do not administer YTRACIS directly to the patient.
Slovenian: Ne aplicirajte YTRACISa neposredno bolnikom.
English: Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Slovenian: Itrijev (90Y) klorid nastaja z razpadom njegovega radioaktivnega predhodnika stroncija (90Sr).
English: DOSIMETRY
Slovenian: 11 DOZIMETRIJA
English: WHAT YTRACIS IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO YTRACIS IN ZA KAJ GA UPORABLJAMO
English: It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities.
Slovenian: Pomembno je, da vso steklovino, injekcijske igle ipd., kar uporabljamo za pripravo radiofarmaka, temeljito očistimo ter tako zagotovimo, da v njem ni sledov kovinskih nečistot.
English: This medicine is a clear and colourless solution which is packed in a colourless Type I glass 2-ml vial closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
Slovenian: To zdravilo je bistra in brezbarvna raztopina, pakirana v brezbarvni 2-ml viali iz stekla tipa I, ki je zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz gume in aluminijasto zaščitno zaporko.
English: Hydrochloric acid 30%, water for injections.
Slovenian: 30% klorovodikova kislina, voda za injekcije.
English: The following preparations must be available in medical institutions, which use Ytracis for radiolabelling of carrier molecules for therapeutic purposes: Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Slovenian: V medicinskih ustanovah, kjer za označevanje nosilnih molekul v terapevtske namene uporabljajo Ytracis, morajo biti na razpolago naslednji preparati: Ca-DTPA (trinatrij-kalcijev-dietilentriaminpentacetat) ali Ca-EDTA (kalcijev-dinatrijev-etilendiamintetracetat)
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Batch: {XXXXX}
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Slovenian: Kadar je potrebno aplicirati radiofarmak ženskam v rodni dobi, moramo vselej preveriti stanje glede morebitne nosečnosti.
English: Only syringe needles (for example non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Slovenian: Uporabljati smemo le injekcijske igle (npr. nekovinske) z dokazano odpornostjo na redčenje kislin, s čimer se zmanjša stopnja prisotnosti sledov kovinskih nečistot.
English: Organ doses (mGy/MBq injected) and effective dose (Sv/GBq injected).
Slovenian: Doze po organih (injicirana aktivnost mGy/MBq) in efektivna doza (injicirani Sv/GBq) Absorbirana doza na enoto aplicirane aktivnosti (mGy/MBq)
English: The content of the vial of YTRACIS 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: Vsebina viale z YTRACISom ni namenjena za direktno aplikacijo bolnikom; uporabljati se sme le za označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi ali drugi substrati, z radioaktivnim izotopom.
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Slovenian: - ugotovljena nosečnost ali sum na nosečnost ali če se nosečnosti ne da izključiti (glejte poglavje
English: The product label includes the appropriate storage conditions and the expiry date for the batch of product.
Slovenian: Na ovojnini zdravila so navedeni pogoji za pravilno shranjevanje ter datum izteka roka uporabnosti serije zdravila.
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: - The other ingredients are hydrochloric acid and water for injections.
Slovenian: - Pomožni snovi sta klorovodikova kislina in voda za injekcije.
English: The toxicity of the free Yttrium (90Y) due to in-vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.
Slovenian: Toksičnost prostega itrija (90Y) zaradi in-vivo sproščanja iz označene biomolekule v telo v času trajanja terapije lahko zmanjšamo z naknadno aplikacijo kelatorjev.
English: Store in accordance with local regulations for radioactive substances.
Slovenian: Shranjujte v skladu z lokalnimi predpisi o radioaktivnih snoveh.
English: Radioactive medicinal products should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji kot tudi zahteve glede farmacevtske kakovosti.
English: Do not use after the expiry date and time stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: YTRACIS is a radioactive medicine used in combination with another medicine product which targets specific body cells.
Slovenian: YTRACIS je radioaktivno zdravilo, ki ga kombinirano z drugim zdravilom, ki ciljano deluje na specifične celice v telesu.
English: Clear, colourless solution, free of particulate matter.
Slovenian: Bistra, brezbarvna raztopina brez vidnih delcev.
English: Pharmacotherapeutic group: Not applicable ATC code: Not applicable
Slovenian: Farmakoterapevtska skupina: navedba smiselno ni potrebna Oznaka ATC: navedba smiselno ni potrebna.
English: YTRACIS is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Slovenian: YTRACIS je namenjen za radioaktivno označevanje zdravil za zdravljenje specifičnih bolezni, ki se nato dajejo po odobrenem postopku.