FrancophonIA/ELRC3.0 huggingface dataset:
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: The contents of the vial of Yttriga 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: Vsebine viale radiofarmacevtskega predhodnika Yttriga se ne sme dajati direktno bolniku, temveč jo je treba uporabiti za radioaktivno označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi ali drugi substrati.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavljanje ionizirajočemu sevanju je povezano s povzročitvijo raka in predstavlja potencial za razvoj dednih okvar.
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Slovenian: Jetra 5 minut po injekciji sprejmejo 18 % injicirane aktivnosti.
English: Therefore, in case of an inadvertent administration of Yttriga, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like CaDTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.
Slovenian: Zaradi tega je potrebno, v primeru nenamernega vnosa radiofarmacevtskega predhodnika Yttriga, radiotoksičnost za bolnika zmanjšati s takojšnjim (tj. v roku 1 ure) dajanjem preparatov, ki vsebujejo kelatorje, kot sta Ca-DTPA ali Ca-EDTA, da se pospeši odstranjevanje radionuklidov iz telesa.
English: Radiopharmaceutical precursor - Not intended for direct use in patients.
Slovenian: Radiofarmacevtski predhodnik - Ni namenjen za direktno uporabo na bolnikih.
English: When the target is reached, Yttriga gives tiny radiation doses to these specific sites.
Slovenian: Ko se doseže tarča, zdravilo Yttriga sprošča zelo majhne odmerke sevanja na določena mesta.
English: Fax +49- 30-941084-470 e-mail: radiopharma@ezag.de
Slovenian: Faks +49- 30-941084-470 e-pošta: radiopharma@ezag.de
English: - Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga will always be used in a hospital or a similar setting.
Slovenian: Ker obstajajo strogi zakoni za uporabo, ravnanje in odstranjevanje radiofarmakov, se radiofarmacevtski predhodnik Yttriga vedno uporablja v zdravstvenih ustanovah.
English: Do not use Yttriga:
Slovenian: Ne uporabljajte radiofarmacevtski predhodnik Yttriga:
English: Gastro-intestinal content
Slovenian: vsebina gastrointestinalne ga trakta
English: The vial may contain high pressure due to radiolysis.
Slovenian: V viali je zaradi radiolize lahko visok pritisk.
English: If the administration cannot be delayed, a lactating mother should be advised to stop breast-feeding.
Slovenian: Če dajanje radiofarmaka ne more biti odloženo, je treba doječi materi svetovati, naj preneha z dojenjem.
English: Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Slovenian: Uporablja se lahko samo igle za brizge (na primer nekovinske), z dokazano odpornostjo na razredčene kisline, da se zmanjša raven nečistot v obliki kovin v sledovih.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IZDELOVALCA
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 kalcijevih ionov in itrija, na podlagi zmožnosti itrija, da z ligandi za kelatiranje (DTPA, EDTA) tvori v vodi topne komplekse.
English: Colourless clear sterile solution.
Slovenian: Brezbarvna, bistra sterilna raztopina
English: In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood.
Slovenian: Pri podganah se, po intravenskem dajanju, itrijev (90Y) klorid hitro očisti iz krvi.
English: Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Slovenian: Radioaktivno označevanje zdravil, kot so monoklonska protitelesa, peptidi ali drugi substrati, z itrijevim (90Y) kloridom, je zelo občutljivo na prisotnost nečistot v obliki kovin v sledovih.
English: Heart
Slovenian: srce
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 se daje s počasno intravensko injekcijo v času 3-4 minut ali z infuzijo (1 g v 100-250 ml dekstroze ali fiziološke raztopine).
English: Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Slovenian: Itrijev (90Y) klorid nastane z razpadom svojega radioaktivnega predhodnika stroncija (90Sr).
English: Adult (70 kg)
Slovenian: Odrasli (70 kg)
English: Pregnancy Yttrium (90Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Slovenian: Z itrijem (90Y) označena zdravila so kontraindicirana pri ugotovljeni nosečnosti ali sumu nanjo ali kadar nosečnost ni bila izključena (glejte poglavje 4.3).
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: Dana radioaktivnost mora biti najnižja možna ob upoštevanju dejstva, da je treba doseči nameravani rezultat zdravljenja.
English: Do not use Yttriga after the expiry date and time which is stated on the label after EXP.
Slovenian: Zdravila Yttriga ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake Uporabno do.
English: The theoretical specific activity is 20 GBq/microgram of Yttrium (90Y) (see section 6.5).
Slovenian: 20 GBq/mikrogram itrija (90Y) (glejte poglavje 6.5).
English: Like all medicines, Yttriga can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi radiofarmacevtski predhodnik Yttriga neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Storage should be in accordance with local regulations for radioactive substances.
Slovenian: Shranjevanje mora biti v skladu z lokalnimi predpisi za radioaktivne snovi.
English: Stomach
Slovenian: želodec
English: For further information regarding the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used as combination partner.
Slovenian: Za dodatne informacije o zdravljenju in morebitnih učinkih, ki jih povzroča radioaktivno označeno zdravilo, si oglejte navodilo za uporabo zdravila, ki se uporablja kot drugo zdravilo v kombinaciji.
English: It is not intended for direct use in patients.
Slovenian: Ni namenjeno neposredni uporabi pri bolnikih.
English: Yttriga is a radioactive medicine used in combination with another medicine which targets specific body cells.
Slovenian: Yttriga je radioaktivno zdravilo, ki se uporablja v kombinaciji s še enim zdravilom, in je usmerjeno na posebne telesne celice.
English: What Yttriga is and what it is used for Before you use Yttriga How to use Yttriga.
Slovenian: Kaj je radiofarmacevtski predhodnik Yttriga in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili radiofarmacevtski predhodnik Yttriga Kako uporabljati radiofarmacevtski predhodnik Yttriga
English: Yttriga is only to be used by specialists experienced with in vitro radiolabelling.
Slovenian: Radiofarmacevtski predhodnik Yttriga smejo uporabljati samo specialisti, izkušeni na področju radioaktivnega označevanja in vitro.
English: WHAT YTTRIGA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE RADIOFARMACEVTSKI PREDHODNIK YTTRIGA IN ZA KAJ GA UPORABLJAMO
English: Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal.
Slovenian: Brezbarvna steklena viala tip I, volumna 3 ml, z dnom v obliki črke V, ali brezbarvna steklena viala tip 1, volumna 10 ml, z ravnim dnom, z zaporko iz silikona, zaprto z aluminijastim pokrovčkom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/322/001 (3 ml V-shaped vial) EU/1/05/322/002 (10 ml flat bottom vial)
Slovenian: EU/1/05/322/001 (3 ml viala z dnom v obliki črke V) EU/1/05/322/002 (10 ml viala z dnom v obliki črke V)
English: Yttriga is contraindicated in the following cases: - Hypersensitivity to Yttrium (90Y) chloride or to any of the excipients
Slovenian: Yttriga je kontraindicirana v naslednjih primerih: - preobčutljivost za itrijev (90Y) klorid ali katerokoli pomožno snov.
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 telesu med terapijo, se lahko zmanjša z naknadnim dajanjem kelatorjev.
English: Colon
Slovenian: kolon
English: The product should be aseptically withdrawn through the stopper using sterilised single use needle and syringe after disinfecting the stopper.
Slovenian: Izdelek je treba, po dezinfekciji zaporke, z uporabo sterilne igle in brizge za enkratno uporabo aseptično odvzeti skozi zaporko.
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of Yttriga.
Slovenian: Spodnja tabela dozimetrije predstavlja ocenjevanje prispevka nekonjugiranega itrija (90Y) k prejeti dozi sevanja, ki sledi dajanju z itrijem (90Y) označenega zdravila ali kot rezultat radioaktivno označene naključne intravenske injekcije radiofarmacevtskega predhodnika Yttriga.
English: The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga will lead to increased bone marrow toxicity and haematopoietic stern cell damage.
Slovenian: 4.9 Preveliko odmerjanje Prisotnost prostega itrijevega (90Y) klorida v telesu, po nenamernem dajanju zdravila Yttriga, bo povzročila povečano toksičnost za kostni mozeg in okvaro hematopoetskih matičnih celic.
English: Yttrium (90Y) chloride
Slovenian: itrijev (90Y) klorid
English: Storage should be in accordance with national regulation on radioactive material.
Slovenian: Shranjevanje mora biti v skladu z nacionalnimi določili za radioaktivne materiale.
English: PHARMACEUTICAL FORM AND CONTENTS Radiopharmaceutical precursor, solution.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBNOST Radiofarmacevtski predhodnik, raztopina.
English: Yttrium (90Y) is a beta pure emitter.
Slovenian: Itrij (90Y) je čisti beta sevalec.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: DODATEK II A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
English: Store in accordance with local regulations for radioactive substances.
Slovenian: Shranjujte v skladu z lokalnimi predpisi za radioaktivne snovi.
English: Liver uptake decreases then to 8.4 % 24 hours after injection.
Slovenian: 24 ur po dajanju se vrednost v jetrih zmanjša na 8,4 %.
English: Take special care with Yttriga - Yttriga is a radioactive medicine and is only used in combination with another medicinal product.
Slovenian: Yttriga je radioaktivno zdravilo in se uporablja samo v kombinaciji s še enim zdravilom.
English: - if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of
Slovenian: - če ste alergični na (preobčutljivi za) itrijev (90Y) klorid ali katerokoli sestavino radiofarmacevtskega predhodnika Yttriga.
English: The quantity of Yttriga required for radiolabelling and the quantity of Yttrium (90Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.
Slovenian: Količina radiofarmacevtskega predhodnika Yttriga, potrebna za radioaktivno označevanje, in količina z itrijem (90Y) označenega zdravila, ki je nato dejansko dana, bo odvisna od radiaktivno označenega zdravila in njegove načrtovane uporabe.
English: No interactions of Yttrium (90Y) chloride with other medicines are known as no clinical studies are available.
Slovenian: Medsebojno delovanje itrijevega (90Y) klorida z drugimi zdravili ni poznano.
English: Name and address of the manufacturer responsible for batch release
Slovenian: SPROŠČANJE SERIJE Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Ovaries
Slovenian: ovariji
English: - The other ingredient is hydrochloric acid (0.04 M).
Slovenian: - Pomožna snov je klorovodikova kislina (0,04 M).
English: NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS
Slovenian: NI NAMENJENO ZA DIREKTNO UPORABO NA BOLNIKIH
English: 15 years (50 kg)
Slovenian: 15 let (50 kg)
English: 5 years (17 kg)
Slovenian: 5 let (17 kg)
English: Pancreas
Slovenian: pankreas
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Takšne informacije bodo zbrane v povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki bo radioaktivno označevano.
English: The volume is 0.02-5 ml.
Slovenian: Volumen znaša 0,02-5 ml. Teoretična specifična aktivnost je
English: 10 years (30 kg)
Slovenian: 10 let (30 kg)
English: METHOD OF ADMINISTRATION in vitro labelling
Slovenian: označevanje in vitro
English: METHOD AND ROUTE(S) OF ADMINISTRATION For in vitro radiolabelling.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za radioaktivno označevanje in vitro.
English: Imaging Equipment Limited The Barn, Manor Farm, Church Lane Chilcompton, Somerset BA3 4 HP SalesAdmin@imagingequipment.co.uk
Slovenian: Chilcompton, Somerset BA3 4 HP SalesAdmin@imagingequipment.co.uk
English: METHOD OF ADMINISTRATION For in vitro radiolabelling.
Slovenian: Za radioaktivno označevanje in vitro.
English: Do not administer Yttriga directly to the patient.
Slovenian: Radiofarmacevtskega predhodnika Yttriga ne dajajte direktno bolniku.
English: What Yttriga looks like and contents of the pack
Slovenian: Izgled radiofarmacevtskega predhodnika Yttriga in vsebina pakiranja
English: 1 year (10 kg)
Slovenian: 1 leto (10 kg)
English: 7.90 E-02 1.18 E-01 2.76 E-01 3.95 E-01 7.90 E-01 2.37 E+00 Skeletal muscle 6.12 E-04 9.17 E-04 2.14 E-03 3.06 E-03 6.12 E-03 1.83 E-02 Skin
Slovenian: 7,90 E-02 1,18 E-01 2,76 E-01 3,95 E-01 7,90 E-01 2,37 E+00 skeletne mišice 6,12 E-04 9,17 E-04 2,14 E-03 3,06 E-03 6,12 E-03 1,83 E-02 koža
English: Store in the original package.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalnem pakiranju.
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Informacije o dozimetriji sevanja vsakega različnega zdravila po dajanju radioaktivno označenega zdravila, bodo na voljo v povzetku glavnih značilnosti zdravila/navodilu za uporabo določenega zdravila, ki bo radioaktivno označevano.
English: Hydrochloric acid (0.04 M)
Slovenian: SEZNAM POMOŽNIH SNOVI klorovodikova kislina (0,04 M)
English: Yttriga is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.
Slovenian: Yttriga je namenjena za in vitro označevanje zdravil (kompletov za pripravo radiofarmakov), ki se jih nato daje v skladu z odobreno potjo uporabe.
English: Liver
Slovenian: jetra
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hydrochloric acid (0.04 M) 6.2 Incompatibilities
Slovenian: 6.1 Seznam pomožnih snovi klorovodikova kislina (0,04 M)
English: Act.: (Y) GBq/vial
Slovenian: : (Y) GBq/viala Kal.
English: If Yttriga is administered inadvertently
Slovenian: Če so vam zdravilo Yttriga dali pomotoma
English: EXPIRY DATE EXP (12h CET) BATCH NUMBER
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (12h CET)
English: Read all of this leaflet carefully before you start using this medicine.
Slovenian: Pred uporabo natančno preberite navodilo.
English: Yttriga is administered after being combined with another medicine by your doctor under strictly controlled conditions.
Slovenian: Zdravilo Yttriga daje samo zdravnik pod strogo nadzorovanimi pogoji in v kombinaciji z drugim zdravilom.
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6)
Slovenian: Z itrijem (90Y) označena zdravila so kontraindicirana v naslednjem primeru: - ugotovljena nosečnost ali sum nanjo ali kadar nosečnost ni bila izključena (glejte poglavje 4.6).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
Slovenian: 1 ml sterilne raztopine vsebuje 0,1-300 GBq itrija (90Y) ob referenčnem datumu in času (ustreza 0,005-15 mikrogramom itrija [90Y]) (kot itrijev [90Y] klorid).
English: The following preparations must be available in medical institutions, which use Yttriga for labelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Slovenian: - Ca-DTPA (trinatrijev kalcijev dietilentriamin pentaacetat) ali - Ca-EDTA (kalcijev dinatrijev etilendiamin tetraacetat)
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Za več informacij upoštevajte povzetek glavnih značilnosti zdravila določenega zdravila, ki bo radioaktivno označevano.
English: Your doctor will not administer Yttriga directly.
Slovenian: KAKO UPORABLJATI RADIOFARMACEVTSKI PREDHODNIK YTTRIGA Zdravnik vam zdravila Yttriga ne bo dal neposredno.
English: Further information concerning the use of a Yttrium (90Y)-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Slovenian: Dodatne informacije, ki zadevajo uporabo z itrijem (90Y) označenih zdravil v času nosečnosti in dojenja, so podrobno opisane v povzetku glavnih značilnosti zdravila, ki bo radioaktivno označevano.
English: 4.20 E-02 6.29 E-02 1.47 E-01 2.10 E-01 4.19 E-01 1.26 E+00 Bone marrow 2.58 E+00 3.88 E+00 9.05 E+00 1.29 E+01 2.58 E+01 7.75 E+01 Brain
Slovenian: 4,20 E-02 6,29 E-02 1,47 E-01 2,10 E-01 4,19 E-01 1,26 E+00 kostni mozeg 2,58 E+00 3,88 E+00 9,05 E+00 1,29 E+01 2,58 E+01 7,75 E+01 možgani
English: Possible adverse reactions following the intravenous administration of a Yttrium (90Y)-labelled medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used.
Slovenian: Morebitni neželeni učinki, ki so posledica intravenskega dajanja zdravila, označenega z itrijem (90Y) in pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga, bodo odvisni od specifičnega zdravila, ki bo uporabljeno.
English: Yttriga radiopharmaceutical precursor, solution.
Slovenian: NAVODILO ZA UPORABO Yttriga radiofarmacevtski predhodnik, raztopina.
English: 4.7 Effects on ability to drive and use machines Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Vplivi na sposobnost vožnje in upravljanje s stroji po zdravljenju z zdravilom, označenim z itrijem (90Y), bodo natančno opisani v povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki bo radioaktivno označevano.
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetične lastnosti z itrijem (90
English: Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Slovenian: Ena 10-militrska viala vsebuje 0,1-300 GBq, kar ustreza 0,005-15 mikrogramom itrija (90Y) ob referenčnem datumu in času.
English: Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Slovenian: Ena 3-mililitrska viala vsebuje 0,1-300 GBq, kar ustreza 0,005-15 mikrogramom itrija (90Y) ob referenčnem datumu in času.
English: NAME OF THE MEDICINAL PRODUCT Yttriga radiopharmaceutical precursor, solution.
Slovenian: IME ZDRAVILA Yttriga radiofarmacevtski predhodnik, raztopina
English: BEFORE YOU USE YTTRIGA
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI RADIOFARMACEVTSKI PREDHODNIK YTTRIGA
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Upoštevati je treba povzetek glavnih značilnosti zdravila/navodilo za uporabo določenega zdravila, ki bo radioaktivno označevano.
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga refer the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Za informacije o kontraindikacijah z itrijem (90Y) označenega določenega zdravila, pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga, poglejte povzetek glavnih značilnosti zdravila/navodilo za uporabo določenega zdravila, ki bo radioaktivno označevano.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Further information concerning the use of a Yttrium (90Y)-labelled medicinal concerning fertility is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Slovenian: Plodnost Dodatne informacije, ki zadevajo uporabo z itrijem (90Y) označenih zdravil v času plodnosti, so podrobno opisane v povzetku glavnih značilnosti zdravila, ki bo radioaktivno označevano.
English: The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: Toksikološke lastnosti z itrijem (90Y) označenega zdravila, pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označevano.
English: For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Za informacije, ki zadevajo medsebojno delovanje, povezano z uporabo z itrijem (90Y) označenega zdravila, poglejte povzetek glavnih značilnosti zdravila/navodilo za uporabo zdravila, ki bo radioaktivno označevano.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovenian: PLOČEVINKA IN SVINČENA POSODA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL ON PERSPEX SHIELD
Slovenian: OZNAKA VIALE NA PLOŠČI PERSPEX
English: STATEMENT OF ACTIVE SUBSTANCE(S) Yttrium (90Y) chloride
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Yttriga raztopina itrijev (90Y) klorid
English: Thymus
Slovenian: timus
English: Possible side effects How to store Yttriga Further information
Slovenian: Shranjevanje radiofarmacevtski predhodnik Yttriga Dodatne informacije