FrancophonIA/ELRC3.0 huggingface dataset:
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 načrtovani rezultat zdravljenja.
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 pripravka, bodo na voljo v povzetku glavnih značilnosti zdravila/navodilu za uporabo posameznega zdravila, ki bo radioaktivno označevano.
English: pregnancy should be excluded using an adequate/validated test.
Slovenian: Pred uporabo z lutecijem (177Lu) označenih zdravil je treba izključiti nosečnost z uporabo ustreznega/veljavnega testa.
English: The medicines used in combincation with Lumark could affect your ability to drive and to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravila, uporabljena v kombinaciji z radionuklidnim predhodnikom Lumark, lahko vplivajo na vašo sposobnost upravljanja vozil in strojev.
English: EXPIRY DATE Expiry date: {DD/MM/YYYY} hh:mm CET
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Datum izteka roka uporabnosti: {DD/MM/LLLL} uu:mm CET
English: There have been reports of carcinoid crisis and other syndromes associated with release of hormones from functional neuroendocrine tumours following 177Lu peptide receptor radionuclide therapy, which may be related to irradiation of tumour cells.
Slovenian: Sindromi sproščanja hormonov Obstajajo poročila o karcinoidni krizi in drugih sindromih, povezanih s sproščanjem hormonov iz funkcionalnih nevroendokrinih tumorjev po zdravljenju z radionuklidno terapijo s peptidnimi receptorji (PRRT) za lutecij (177Lu), ki so lahko povezani z obsevanjem tumorskih celic.
English: Activity (at ART): {Y} GBq
Slovenian: Prostornina: {Z} ml Aktivnost (v ART): {Y} GBq
English: One mL of solution contains 80 GBq Lutetium (177Lu) chloride at activity reference time (ART), corresponding to at most a maximum of 160 microgram of Lutetium.
Slovenian: En ml raztopine vsebuje 80 GBq lutecijevega (177Lu) klorida v referenčnem času aktivnosti (ART), kar ustreza največ 160 mikrogramom lutecija.
English: Administration of the medicine radiolabelled with Lumark and conduct of the procedure Lumark must be used only in combination with another medicine which has been specifically developed and authorised for being combined with Lumark.
Slovenian: Radionuklidni predhodnik Lumark se lahko uporablja le v kombinaciji z drugim zdravilom, ki je bilo posebej razvito in odobreno za uporabo z radionuklidnim predhodnikom Lumark.
English: Store in the original package that provides protection from radiation.
Slovenian: Shranjujte v originalni ovojnini, ki zagotavlja zaščito pred sevanjem.
English: The lower bound of the 95 % confidence interval of the reporting odds ratio for tumour lysis syndrome in EudraVigilance in association with Lu-177 is increased at 34.50, with 3 cases.
Slovenian: Na osnovi 3 poročanih primerov v bazi EudraVigilance je spodnja meja 95-% intervala zaupanja razmerja obetov poročanja (reporting odds ratio - ROR) za sindrom tumorske lize v povezavi z Lu-177 34,50.
English: Lumark is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by the approved route.
Slovenian: Radionuklidni predhodnik Lumark je namenjen za in vitro označevanje zdravil, ki se nato dajejo v skladu z odobreno potjo uporabe.
English: The radiation dose received by the various organs following administration of a Lutetium (177Lu)-labelled medicinal product will be dependent on the specific molecule being radiolabelled.
Slovenian: Odmerki sevanja, ki jih prejmejo različni organi po dajanju z lutecijem (177Lu) označenega zdravila, so odvisni od specifične molekule, ki se radioaktivno označuje.
English: The quantity of Lumark required for radiolabelling and the quantity of the product to be radiolabelled with Lutetium(177Lu) that is subsequently administered will depend on the medicinal product to be radiolabelled and its intended use.
Slovenian: Količina radionuklidnega predhodnika Lumark, potrebna za radioaktivno označevanje, in količina z lutecijem (177Lu) označenega zdravila, ki je nato dejansko dana, bo odvisna od radioaktivno označenega zdravila in njegove predvidene uporabe.
English: Hepatotoxicity:
Slovenian: Hepatotoksičnost
English: Bone marrow cancer (myelodysplastic syndrome and acute myeloid leukaemia) has been reported in patients several years after treatment with Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tumours.
Slovenian: O raku kostnega mozga (mielodisplastičnem sindromu in akutni mieloični levkemiji) so pri bolnikih poročali več let po radionuklidni terapiji z lutecijem (177Lu) s peptidnimi receptorji za nevroendokrine tumorje.
English: Treatment with Lutetium (177Lu) radioligand therapy may lead to the following side effects
Slovenian: Zdravljenje z radioligandno terapijo z lutecijem (177Lu) lahko privede do naslednjih neželenih učinkov:
English: Such information is supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Te informacije so zbrane v povzetku glavnih značilnosti zdravila/navodilu za uporabo zdravila, ki bo radioaktivno označevano.
English: • Bone marrow cancer (myelodysplastic syndrome)
Slovenian: − rak kostnega mozga (mielodisplastični sindrom)
English: Storage of radiopharmaceuticals should be in accordance with national regulations for radioactive materials.
Slovenian: Radiofarmake je treba shranjevati v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Slovenian: FARMACEVTSKA OBLIKA radionuklidni predhodnik, raztopina Bistra, brezbarvna raztopina.
English: Lumark is not a medicine and it is not intended to be used on its own.
Slovenian: Kaj je radionuklidni predhodnik Lumark in za kaj ga uporabljamo Lumark ni zdravilo in se ga ne sme uporabljati samega.
English: Therefore, in case of an inadvertent administration of Lumark, 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: v roku ene ure) dajanjem pripravkov, ki vsebujejo kelatorje, kot sta Ca-DTPA ali Ca-EDTA, da se pospeši odstranjevanje radionuklidov iz telesa.
English: Lutetium (177Lu) decays by β--emission to stable Hafnium (177Hf), with the most abundant β- (79.3%) having a maximum energy of 0.497 MeV.
Slovenian: Z emisijo β-sevanja maksimalne energije 0,497 MeV z največjo količino β-sevanja (79,3 %) lutecij (177Lu) razpade v stabilni hafnij (177Hf).
English: NAME OF THE MEDICINAL PRODUCT Lumark 80 GBq/mL radiopharmaceutical precursor, solution
Slovenian: IME ZDRAVILA Lumark 80 GBq/ml radionuklidni predhodnik, raztopina
English: - Keep this leaflet.
Slovenian: da nehate dojiti.
English: The product should be aseptically withdrawn through the stopper using sterilized single use needle and syringe after disinfection of the stopper.
Slovenian: Po dezinfekciji zaporke je treba radionuklidni predhodnik aseptično odvzeti skozi zaporko z uporabo sterilizirane igle in brizge za enkratno uporabo.
English: Manufacturer I.D.B.
Slovenian: Izdelovalec I.D.B Holland B.V.
English: For more information, refer to the package leaflet of the particular medicine to be radiolabelled.
Slovenian: Za več informacij glejte navodilo za uporabo določenega zdravila, ki bo radioaktivno označevano.
English: Lumark is only to be used by specialists experienced with in vitro radiolabelling Posology
Slovenian: Radionuklidni predhodnik Lumark smejo uporabljati le zdravniki specialisti, ki imajo izkušnje na področju radioaktivnega označevanja in vitro.
English: Marketing Authorisation Holder I.D.B.
Slovenian: Imetnik dovoljenja za promet z zdravilom I.D.B Holland B.V.
English: If you are breast-feeding
Slovenian: Če dojite
English: A more detailed study of the biodistribution of Lutetium (177Lu) chloride in mice confirms the relatively high uptake in the liver, kidneys and bone marrow The results indicated that lutetium (177Lu) chloride is accumulated in the bone marrow and emphasizes the importance of all Lutetium (177Lu) to be peptide-bound at injection, as well as the in-vivo stability of the radionuclide-chelate-complex during therapy.
Slovenian: Rezultati so pokazali, da se lutecijev (177Lu) klorid kopiči v kostnem mozgu, in poudarili pomen vezave vseh oblik lutecija (177Lu) na peptid ob injiciranju, kot tudi stabilnost kompleksa radionuklida in kelata in vivo med zdravljenjem.
English: Please refer to the package leaflet of the medicine that is to be radiolabelled with Lumark.
Slovenian: Upoštevajte navodilo za uporabo zdravila, ki bo radiooznačeno z radionuklidnim predhodnikom Lumark.
English: Take special care with the medicine that is radiolabelled with Lumark: - If you are breast-feeding
Slovenian: Pri uporabi zdravila, označenega z radionuklidnim predhodnikom Lumark, bodite posebej previdni: - če dojite.
English: Skin and subcutaneous tissue disorders: very common: Alopecia
Slovenian: Zelo pogosti: alopecija
English: What you need to know before the medicine radiolabelled with Lumark is used 3.
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo, radiooznačeno z zdravilom Lumark
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Presoja razmerja med tveganji in koristmi pri posameznem bolniku
English: For information concerning special warnings and precautions for use of 177Lu-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Slovenian: Za informacije, ki zadevajo posebna opozorila in previdnostne ukrepe za uporabo z lutecijem 177označenih zdravil, glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo zdravila, ki bo radioaktivno označevano.
English: Effects on ability to drive or use machines following treatment by Lutetium (177Lu)-labelled medicinal products is specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Slovenian: Vplivi na sposobnost vožnje ali upravljanja s stroji po zdravljenju z zdravilom, označenim z lutecijem (177Lu), so podrobno opisani v povzetku glavnih značilnosti zdravila/navodilu za uporabo posameznega zdravila, ki bo radioaktivno označevano.
English: Storage must be in accordance with local regulations for radioactive substances 10.
Slovenian: Shranjujte v skladu z lokalnimi predpisi o radioaktivnih snoveh.
English: Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq at the ART.
Slovenian: Ena viala vsebuje prostornino, ki obsega od 0,1 do 5 ml raztopine, ki ustreza aktivnosti v obsegu od 8 do
English: Store in the original package to protect from radiation.
Slovenian: Shranjujte v originalni ovojnini za zaščito pred sevanjem.
English: Store in the original package in order to protect from radiation.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred sevanjem.
English: Lumark is a radiopharmaceutical precursor.
Slovenian: 4.1 Terapevtske indikacije Lumark je radionuklidni predhodnik.
English: Gastrointestinal disorders: very common: Nausea and vomiting
Slovenian: Zelo pogosti: navzea, bruhanje
English: • Reduction in blood cell counts (platelets, red or white blood cells)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - zmanjšanje števila krvnih celic (krvnih ploščic, rdečih ali belih krvnih celic)
English: What Lumark contains - The active substance is Lutetium (177Lu) chloride.
Slovenian: Kaj vsebuje radionuklidni predhodnik Lumark - Zdravilna učinkovina je lutecijev (177Lu) klorid.
English: microgram of Lutetium.
Slovenian: Vsebuje zdravilno učinkovino lutecijev
English: For information on contraindications to particular Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with Lumark, refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.
Slovenian: Za informacije o kontraindikacijah posameznih, z lutecijem (177Lu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radionuklidnim predhodnikom Lumark, glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo posameznega zdravila, ki bo radioaktivno označevano.
English: Lumark 80 GBq/mL radiopharmaceutical precursor, solution Lutetium (177Lu) chloride
Slovenian: Lumark 80 GBq/ml radionuklidni predhodnik, raztopina lutecijev (177Lu) klorid
English: Ovaries
Slovenian: VIALA
English: Neoplasms benign, malignant and unspecified (including cysts and polyps): common: Refractory cytopenia with multilineage dysplasia (Myelodysplastic syndrome) (see section 4.4) uncommon: Acute myeloid leukaemia (see section 4.4)
Slovenian: Pogosti: refraktarna citopenija z displazijo več celičnih linij (mielodisplastični sindrom) (glejte poglavje 4.4)
English: Hormone release syndromes:
Slovenian: Bolezni prebavil:
English: The following preparations must be available in medical institutions, which use Lumark for radiolabelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Slovenian: - Ca-DTPA (trinatrijev kalcijev dietilentriaminpentaacetat) ali - Ca-EDTA (kalcijev dinatrijev etilendiamintetraacetat)
English: Adverse reactions following the intravenous administration of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with Lumark, will be dependent on the specific medicinal product being used.
Slovenian: Neželeni učinki, ki so posledica intravenskega dajanja zdravil, označenih z lutecijem (177Lu) in pripravljenih z radioaktivnim označevanjem z radionuklidnim predhodnikom Lumark, bodo odvisni od specifičnega zdravila, ki bo uporabljeno.
English: EXPIRY DATE EXP: {DD/MM/YYYY} BATCH NUMBER
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {DD/MM/LLLL}
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lumark 80 GBq/mL radiopharmaceutical precursor, solution Lutetium (177Lu) chloride
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Lumark 80 GBq/ml radionuklidni predhodnik, raztopina lutecijev (177Lu) klorid
English: Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) have been observed after treatment with Lutetium (177 Lu) peptide receptor radionuclide therapy for neuroendocrine tumours (see section 4.8).
Slovenian: Po radionuklidni terapiji z lutecijem (177 Lu) s peptidnimi receptorji za nevroendokrine tumorje so poročali o mielodisplastičnem sindromu (MDS) in akutni mieloični levkemiji (AML) (glejte poglavje 4.8).
English: Myelosuppression
Slovenian: Ekstravazacija
English: It decays by emission of beta radiation of maximal 498 keV to 177Hf-Hafnium.
Slovenian: Lutecijev klorid razpade v hafnij (177Hf) z emisijo beta sevanja maksimalne energije 498 keV.
English: Cases of hepatotoxicity have been reported in the post-marketing setting and in the literature in patients with liver metastases undergoing treatment with 177Lu peptide receptor radionuclide therapy for neuroendocrine tumours.
Slovenian: Po prihodu zdravila na trg in v literaturi, pri bolnikih z metastazami jeter, ki prejemajo radionuklidno terapijo s peptidnimi receptorji (PRRT) za lutecij (177Lu) za zdravljenje nevroendokrinih tumorjev, so poročali o primerih hepatotoksičnosti.
English: For more information concerning the paediatric use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Products Characteristics/package leaflet of the the particular medicinal product to be radiolabelled.
Slovenian: Za več informacij v zvezi s pediatrično uporabo zdravil, označenih z lutecijem (177Lu), glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo določenega zdravila, ki bo radioaktivno označevano.
English: The radiopharmaceutical precursor solution is packaged in colourless type I glass vial of 10 mL, closed with a bromobutylrubber stopper and aluminium overseal.
Slovenian: ki je zaprta z zaporko iz bromobutilne gume in z aluminijastim pokrovčkom.
English: No interaction studies of Lutetium (177Lu) with other medicinal products have been performed.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja lutecija (177Lu) z drugimi zdravili niso izvedli.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER I.D.B.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Dry mouth has been reported among patients with prostate cancer receiving treatment with Lutetium (177Lu)
Slovenian: Pri bolnikih z metastatskim na kastracijo odpornim rakom prostate, ki so prejemali z lutecijem (177Lu)
English: The pharmacodynamic properties of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with Lumark, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: Farmakodinamične lastnosti z lutecijem (177Lu) označenega zdravila, pripravljenega z radioaktivnim označevanjem z radionuklidnim predhodnikom Lumark pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označevano.
English: Lumark is used for radiolabelling medicines, a technique in which medicines are tagged (radiolabelled) with a radioactive form of the element lutetium, known as lutetium (177Lu).
Slovenian: z radioaktivno obliko elementa lutecija, imenovanega lutecij (177Lu).
English: 1 vial contains
Slovenian: radionuklidni predhodnik, raztopina 1 viala vsebuje
English: Destination:
Slovenian: Naslov za dostavo:
English: Extravasation: There have been reports of extravasation of Lutetium (177Lu) labelled ligands in the post-marketing setting.
Slovenian: V obdobju trženja zdravila so poročali o ekstravazaciji ligandov, označenih z lutecijem (177Lu).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The pharmacokinetic properties of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with Lumark, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetične lastnosti z lutecijem (177Lu) označenih zdravil, pripravljenih z radioaktivnim označevanjem z radionuklidnim predhodnikom Lumark pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označevano.
English: Anaemia, thrombocytopenia, leucopenia, lymphopenia, and less commonly neutropenia may occur during radioligand therapy with Lutetium (177Lu).
Slovenian: Mielosupresija Pri radioligandni terapiji z lutecijem (177Lu) se lahko pojavi anemija, trombocitopenija, levkopenija,
English: Testes
Slovenian: Odmerjanje
English: For information concerning interactions associated with the use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Slovenian: Za informacije o medsebojnem delovanju, povezanem z uporabo z lutecijem (177Lu) označenih zdravil, glejte povzetek glavnih značilnosti zdravila/navodilo za uporabo zdravila, ki bo radioaktivno označevano.
English: The presence of free Lutetium (177Lu) chloride in the body after an inadvertent administration of Lumark will lead to increased bone marrow toxicity and haematopoetic stem cell damage.
Slovenian: Prisotnost prostega lutecijevega (177Lu) klorida v telesu po nenamernem dajanju radionuklidnega predhodnika
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC JAR and LEAD CONTAINER
Slovenian: PLASTIČNI LONČEK in SVINČENI VSEBNIK
English: Radiopharmaceutical precursor, solution.
Slovenian: Shranjevanje radionuklidnega predhodnika Lumark 6.
English: EU/1/15/1013/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 177Lu-Lutetium has a half-life of 6.647 days.
Slovenian: Lutecij 177Lu ima razpolovni čas
English: Product Characteristics of the medicinal product to be radiolabelled.
Slovenian: To je tehnika, pri kateri se zdravila označijo (radiooznačijo)
English: Clear, colourless solution.
Slovenian: limfopenija in, manj pogosto, nevtropenija.
English: • Mild temporary hair loss Common (may affect up to 1 in 10 people):
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih, pri katerih so zdravili nevroendokrine tumorje: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - blaga, začasna izguba las
English: Educational material shall consist of information aiming to minimise adverse events and support effective use through adequate education about:
Slovenian: Izobraževalna gradiva morajo vsebovati informacije, namenjene minimizaciji neželenih dogodkov in bodo pripomogla k učinkoviti uporabi z ustreznim informiranjem o:
English: The Member States must ensure that the Marketing Authorisation Holder will provide healthcare professionals with educational materials for healthcare professionals and patients.
Slovenian: Države članice morajo zagotoviti, da bo imetnik dovoljenja za promet z zdravilom zdravnikom zagotovil izobraževalna gradiva za zdravnike in bolnike.
English: The educational materials are aimed at risk minimisation and will support safe and effective use of the product by the patient.
Slovenian: Namen izobraževalnih gradiv je minimizacija tveganja ter podpora varni in učinkoviti uporabi zdravila med bolniki.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH JE TREBA NASLOVITI NA DRŽAVE ČLANICE
English: a) The need for consistent and standard inhalation technique to ensure both optimal and consistent b) Special precaution with the insulin inhaler e) Magnitude of titration steps and resulting precautions f) The change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics j) Recommendation for special populations; underlying lung diseases such as asthma and COPD, congestive heart failure, pregnancy, children and adolescent
Slovenian: e) velikosti titracijskih korakov in posledičnih previdnostnih ukrepih, f) spremembah delovanja pljuč in potrebi po nadziranju pljučnega delovanja, g) kajenju v zvezi s povzročenimi spremembami farmakokinetike,
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ZDRAVILOM, KI JIH MORAJO IMPLEMENTIRATI DRŽAVE
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: July of each year until the results of the study in bone have been submitted.
Slovenian: Julij vsakega leta do predložitve rezultatov študije na kosteh.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2007
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23. julij 2007
English: • your kidneys do not work properly
Slovenian: • vaše ledvice ne delujejo ustrezno;
English: Dose level has no consistent effect on the volume of distribution in any of the studies.
Slovenian: Raven odmerka ni imela doslednega učinka na volumen porazdelitve pri nobeni izmed študij.
English: Administer the lowest dose possible for adequate imaging.
Slovenian: Dajte najnižji možni odmerek za ustrezno slikanje.