FrancophonIA/ELRC3.0 huggingface dataset:
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden boste prejeli zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: This corresponds to the administration of 0.25 to 1 mg of besilesomab.
Slovenian: To ustreza uporabi 0,25 do 1 mg besilesomaba.
English: Patients who are HAMA positive may have a greater risk for hypersensitivity reactions.
Slovenian: Preiskovanci, ki so pozitivni za HAMA, imajo večje tveganje preobčutljivostne reakcije.
English: The low renal clearance of activity (0.2 L/h for a glomerular filtration rate around 7 L/h) indicates that the kidney is not the major route of besilesomab elimination.
Slovenian: Majhen ledvični očistek aktivnosti (0,2 l/h pri hitrosti glomerulne filtracije približno 7 l/h) kaže, da ledvice niso poglavitna pot izločanja besilesomaba.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: Z zdravilom bodo ravnale in vam ga dale samo osebe, usposobljene za njegovo varno uporabo.
English: If you wish, you can express and store your breast milk before your injection.
Slovenian: Če želite, si lahko mleko iztisnete in shranite pred injiciranjem.
English: These three days correspond to 10 half-lives of technetium (99mTc) (60 hours).
Slovenian: Ti trije dnevi ustrezajo 10 razpolovnim dobam tehnecija (99mTc) (60 ur).
English: After 1 min, check that the content of the vial of Scintimun has completely dissolved.
Slovenian: Po 1 min preverite, ali se je vsebina viale z oznako Scintimun popolnoma raztopila.
English: • Serious allergic reaction which causes difficulty in breathing or dizziness
Slovenian: • resna alergijska reakcija, ki povzroči oteženo dihanje ali omotico, • bolečine v mišicah ali sklepih
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Radiofarmake lahko sprejmejo, uporabljajo in dajejo le pooblaščene osebe v odobrenih kliničnih ustanovah.
English: Whole blood concentration-time radioactivity curves show a two-phase course, which can be subdivided into an early phase (0-2 h) and a late phase (5-24 h).
Slovenian: Krivulje odvisnosti koncentracije radioaktivnosti v polni krvi od časa kažejo dvofazni potek, ki ga lahko razdelimo v zgodnjo fazo (0-2 h) in pozno fazo (5-24 h).
English: For repeated use, see section 4.4.
Slovenian: Glede ponavljajoče se uporabe glejte poglavje 4.4.
English: Scintimun images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations.
Slovenian: Slike, dobljene z zdravilom Scintimun, je treba interpretirati ob upoštevanju ustreznih anatomskih in/ali funkcijskih preiskav.
English: Images acquisition should start 3 to 6 hours after administration.
Slovenian: Zajem slik naj se začne od 3 do 6 ur po uporabi zdravila.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may interfere with the interpretation of the images.
Slovenian: Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, saj lahko vplivajo na interpretacijo slik.
English: The use of Scintimun does involve exposure to small amounts of radioactivity.
Slovenian: Uporaba zdravila Scintimun vključuje izpostavljenost majhnim količinam radioaktivnosti.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.82 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,82 mg
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Slovenian: Ženske z izostalo menstruacijo morate obravnavati kot noseče, dokler ne dokažete drugače.
English: Only clear solutions, free of visible particles should be used.
Slovenian: Uporabite lahko le bistre raztopine, brez vidnih delcev.
English: Non pathological unusual accumulations may be observed in the spleen (up to 6 % of the patients), in the bowel (up to 4 % of the patients), in the liver and bone marrow (up to 3 % of the patients), and in the thyroid and kidneys (up to 2 % of patients).
Slovenian: Nepatološka nenavadna kopičenja lahko najdemo v vranici (pri do 6 % preiskovancev), v črevesju (pri do 4 % preiskovancev), v jetrih in kostnem mozgu (pri do 3 % preiskovancev) ter v ščitnici in ledvicah (pri do 2 % preiskovancev).
English: If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.
Slovenian: Če je kadarkoli med pripravo zdravila integriteta viale ogrožena, je ne smete uporabiti.
English: For patient preparation, see section 4.4.
Slovenian: Za pripravo bolnika glejte poglavje 4.4.
English: Specific warnings
Slovenian: Posebna opozorila
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavitev ionizirajočemu sevanju je povezana z indukcijo raka in potencialom za razvoj dednih okvar.
English: As the effective dose is about 6.9 mSv when the maximal recommended activity of 800 MBq is administered these adverse reactions are expected to occur with a low probability.
Slovenian: Ker je efektivni odmerek približno 6,9 mSv, ko je uporabljena največja priporočena 800 MBq, se predvideva, da je verjetnost za pojav teh neželenih učinkov majhna.
English: After injection into your vein, your doctor can obtain pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection.
Slovenian: Po injiciranju v veno lahko zdravnik pridobi slike vaših organov, s katerim zaznavamo mesta vnetja in/ali okužbe.
English: Fill in the enclosed label and fix it to the radiolabelled solution.
Slovenian: Izpolnite priloženo nalepko in jo namestite na radioaktivno označeno raztopino.
English: This medicine is a radiopharmaceutical product for diagnostic use only in adults.
Slovenian: Zdravilo je radiofarmak samo za diagnostične namene pri odraslih.
English: If you have been given more Scintimun than you should An overdose is unlikely because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions.
Slovenian: Če ste prejeli večji odmerek zdravila Scintimun, kot bi smeli Ker injekcijo pripravi bolnišnično osebje kot en odmerek v strogo nadzorovanih pogojih, ni verjetno, da bi prejeli prevelik odmerek.
English: The complete SmPC of Scintimun is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Slovenian: Celoten povzetek glavnih značilnosti zdravila (SmPC)je na voljo kot del, ki ga odtrgate, na koncu tiskanega navodila v pakiranju zdravila, njegov cilj pa je zdravstvenim delavcem ponuditi druge dodatne znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
English: - The final radiolabelled injection solution must be protected from oxygen.
Slovenian: - Končno radioaktivno označeno raztopino za injiciranje morate varovati pred kisikom.
English: False positive findings in patients with CEA expressing tumours cannot be excluded.
Slovenian: Ne moremo izključiti lažno pozitivnih rezultatov pri bolnikih s tumorji, ki izražajo CEA.
English: When the solvent has reached the top of the strip (about 10 minutes), use the forceps to remove the strip and dry in the air.
Slovenian: Ko topilo doseže zgornji konec traku (po približno 10 minutah), s pinceto izvlecite trak in ga posušite na zraku.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Slovenian: Za takojšnje ukrepanje v nujnih primerih morajo biti na razpolago nujno potrebna zdravila in medicinski pripomočki, kot sta endotrahealna cevka in naprava za predihavanje.
English: 1/1000 of the initial activity in the body.
Slovenian: Takrat preostala aktivnost predstavlja približno 1/1000 izhodiščne aktivnosti v telesu.
English: After correcting for the decay of radionuclide, the calculated half-life of the early phase is 0.5 h whereas the late phase shows a half-life of elimination of 16 h.
Slovenian: Po korekciji za razpad radionuklida je izračunana razpolovna doba zgodnje faze 0,5 h, medtem ko pozna faza kaže razpolovno dobo eliminacije 16 h.
English: The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.
Slovenian: Efektivni odmerek, ki nastane zaradi odmerjanja aktivnosti 800 MBq za odraslo osebo z maso 70 kg, je za to zdravilo 6,9 mSv.
English: If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Slovenian: Če niste prepričani glede morebitne nosečnosti (če je ženski izostala menstruacija ali je menstruacija zelo neredna ipd.), je treba bolnici ponuditi alternativne tehnike, ki ne vključujejo ionizacijskega sevanja (če obstajajo).
English: However, due to the nature of the molecule and the short half-life of technetium (99mTc) besilesomab, dose adjustment is not necessary in such patients.
Slovenian: Vendar zaradi narave molekule in kratke razpolovne dobe tehnecijevega (99mTc) besilesomaba prilagajanje odmerka pri teh bolnikih ni potrebno.
English: Besilesomab cross-reacts with tumours expressing carcinoembryonic antigen (CEA).
Slovenian: Besilesomab navzkrižno reagira s tumorji, ki izražajo karcinoembrionalni antigen (CEA).
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation.
Slovenian: Vaš osebni zdravnik in zdravnik nuklearne medicine sta pretehtala, da klinične koristi tega postopka z radiofarmakom odtehtajo tveganja zaradi izpostavitve majhnim količinam sevanja.
English: Since allergic reactions to the murine protein cannot be excluded, cardiovascular treatment, corticosteroids, and antihistamines must be available during administration of the product.
Slovenian: Ker alergijskih reakcij na mišje beljakovine ne moremo izključiti, morajo biti med uporabo zdravila na voljo kardiovaskularna zdravila, kortikosteroidi in antihistaminiki
English: The other ingredients are (see section 2 “Scintimun contains sorbitol and sodium”):
Slovenian: - Pomožne snovi so (Glejte poglavje 2 “Zdravilo Scintimun vsebuje sorbitol in natrij”):
English: The Marketing Authorisation Holder shall ensure that, at launch, all physicians experienced in nuclear medicine who are expected to prescribe/use Scintimun are provided with a Direct Healthcare Professional Communication (DHPC), which includes information regarding potential risks of human anti-mouse antibody (HAMA) generation, hypersensitivity reactions and risks of acute hypotension, as agreed by CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob začetku dajanja zdravila v promet vsi zdravniki z izkušnjami v nuklearni medicini, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Scintimun, prejeli neposredno obvestilo za zdravstvene delavce (DHPC), ki bo vsebovalo podatke o možnem tveganju za pojav humanih protiteles proti mišjim protitelesom (HAMA) in preobčutljivostnih reakcij ter tveganju akutne hipotenzije, kot je bilo dogovorjeno z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Materials and reagents
Slovenian: Materiali in reagenti
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Slovenian: Ženske v rodni dobi Kadar je indicirana uporaba radiofarmakov pri ženski v rodni dobi, je pomembno, da se prepričate ali je noseča ali ne.
English: Besilesomab is a murine immunoglobulin of IgG1 isotype that specifically binds to NCA-95 (non specific cross-reacting antigen 95), an epitope expressed at the cell membrane of granulocytes and granulocyte precursors.
Slovenian: Mehanizem delovanja Besilesomab je mišji imunoglobulin izotipa IgG1, ki se specifično veže na NCA-95 (nespecifični navzkrižno reaktivni antigen 95), epitop, ki se izraža na celični membrani granulocitov in granulocitnih prednikov.
English: False results may be obtained in patients with diseases involving neutrophil defects and to patients with haematological malignancies including myeloma.
Slovenian: Rezultati so lahko lažno pozitivni pri bolnikih z boleznimi z okvarami nevtrofilcev in pri bolnikih s hematološkimi malignimi boleznimi, vključno z mielomom.
English: Such substances should therefore not be administered together with, or a short time before the injection of Scintimun.
Slovenian: Takšnih snovi zato ne morete dajati sočasno z zdravilom Scintimun ali v kratkem času pred injiciranjem tega zdravila.
English: Swirl carefully; the content of the vial of Scintimun will dissolve within one minute (DO NOT shake).
Slovenian: Previdno vrtinčite, da se vsebina viale z oznako Scintimun raztopi v roku ene minute (NE
English: The activity must be between 400 and 1800 MBq depending on the volume of pertechnetate (99mTc).
Slovenian: Aktivnost mora biti med 400 in 1800 MBq, odvisno od volumna pertehnetata (99mTc).
English: Method Instant thin layer chromatography or paper chromatography.
Slovenian: Metoda Hitra tankoplastna kromatografija ali papirno kromatografijo
English: Data on repeated dosing of Scintimun are very limited.
Slovenian: Podatkov o ponavljajočem se odmerjanju zdravila Scintimun je zelo malo.
English: What Scintimun is and what it is used for What you need to know before you are given Scintimun How Scintimun is given
Slovenian: Kaj je zdravilo Scintimun in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Scintimun Kako boste prejeli zdravilo Scintimun
English: Twenty-four hours after injection, the percentages of radioactivity are 1.6 % in the liver and 2.3 % in the spleen.
Slovenian: Štiriindvajset ur po injiciranju je v jetrih 1,6 % radioaktivnosti, v vranici pa 2,3 %.
English: Cut the strip in two separate parts at Rf = 0.5.
Slovenian: Na Rf = 0,5 prerežite trak v dva ločena dela.
English: However, based on the investigator's diagnosis after one month of follow-up, Scintimun had a slightly lower specificity (71.8 %) than 99mTc-WBCs (79.5 %).
Slovenian: Vendar je imelo zdravilo Scintimun na osnovi diagnoze raziskovalcev po enem mesecu sledenja nekoliko manjšo specifičnost (71,8 %) kot s 99mTc označeni levkociti (79,5 %).
English: Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.
Slovenian: Besilesomab je monoklonsko protitelo proti granulocitom (BW 250/183), izdelano v mišjih celicah.
English: Calculations
Slovenian: Izračuni
English: Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction
Slovenian: nastajanje človeških protiteles proti mišjim protitelesom, ki reagirajo proti protitelesom v zdravilu Scintimun (protitelesom iz mišjih celic), s tveganjem alergijske reakcije.
English: Without removing the needle, withdraw an equivalent volume of air in order to avoid excess pressure in the vial.
Slovenian: Igle ne izvlecite, ampak v brizgo povlecite enak volumen zraka, da ohranite atmosferski tlak v viali.
English: Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable.
Slovenian: Tehnecij (99mTc) nastaja v generatorju (99Mo/99mTc) in razpada z emisijo gama sevanja s povprečno energijo 140 keV in razpolovno dobo 6,02 ur v tehnecij (99Tc), ki se šteje za kvazistabilnega glede na dolgo razpolovno dobo 2,13 x 105 let.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Slovenian: Možnost preobčutljivostnih ali anafilaktičnih reakcij V primeru preobčutljivostnih ali anafilaktičnih reakcij je treba takoj prekiniti dajanje zdravila in po potrebi uvesti intravensko zdravljenje.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of technetium(99mTc)- besilesomab to be used in your case.
Slovenian: Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino uporabljenega tehnecijevega (99m Tc) besilomaba v vašem primeru.
English: Technetium(99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.
Slovenian: Tehnecij (99mTc) je radioaktivni element, ki omogoča, da so organi z nakopičenim besilesomabom, vidni s posebno kamero.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je treba pripraviti v skladu z varnostjo pred sevanjem in zahtevami za kakovost farmacevtskega izdelka.
English: Hypersensitivity to the active substance, to other murine antibodies, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
Slovenian: Preobčutljivost na zdravilno učinkovino, druga mišja protitelesa, katero koli pomožno snov, navedeno v poglavju 6.1, ali katere koli sestavine označenega radiofarmaka
English: Six hours after injection, about 1.5 % of the whole body radioactivity is found in the liver whereas about 3.0 % is found in the spleen.
Slovenian: Šest ur po injiciranju najdemo približno 1,5 % radioaktivnosti iz polne krvi v jetrih, približno 3,0 % pa v vranici.
English: Duration of the procedure Your Nuclear medicine doctor will inform you about the usual duration of the procedure.
Slovenian: O običajni dolžini postopka vas obvesti zdravnik nuklearne medicine.
English: After disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Slovenian: raztopino pa morate odvzeti prek zamaška z enoodmerno injekcijsko brizgo, opremljeno z ustrezno zaščito in sterilno iglo za enkratno uporabo, ali z uporabo odobrenega avtomatskega sistema apliciranja.
English: After the procedure
Slovenian: Po postopku
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Slovenian: Postopke dajanja je treba izvajati tako, da se čim bolj zmanjša tveganje za okužbo zdravila in obsevanje osebja.
English: DO NOT let the spot dry.
Slovenian: PAZITE, da se nanos ne posuši.
English: After complete dissolution, disinfect the septum and allow drying.
Slovenian: Po popolni raztopitvi septum razkužite in počakajte, da se posuši.
English: - If you have any further questions, ask your doctor or the nuclear medicine specialist who will supervise the procedure.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali specialistom nuklearne medicine, ki bo nadzoroval postopek.
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Slovenian: Pred uporabo radiofarmakov pri doječi materi morate ugotoviti, ali je možno dajanje radionuklida odložiti, dokler preiskovanka ne preneha z dojenjem oz. kateri so najbolj primerni radiofarmaki ob upoštevanju izločanja aktivnosti v materinem mleku.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da je v bistvu „brez natrija“.
English: Preclinical data obtained with the non-radioactive compound reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose and repeated-dose toxicity, although antimurine antibodies were found in all dose groups (including controls) in a repeated-dose study in monkeys.
Slovenian: Predklinični podatki, dobljeni z neradioaktivno spojino, na osnovi običajnih študij farmakološke varnosti ter toksičnosti enega odmerka in pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka, čeprav so v študiji s ponavljajočimi se odmerki pri opicah odkrili protitelesa proti mišjim protitelesom v vseh skupinah z različnimi odmerki (tudi v kontrolni skupini).
English: Contents of the vial are intended only for use in the preparation of technetium(99mTc) besilesomab and are not to be administered directly to the patient without first undergoing the preparative procedure.
Slovenian: Vsebina viale je indicirana samo za uporabo pri pripravi tehnecijevega (99mTc) besilesomaba in ni primerna za neposredno dajanje brez predhodne priprave bolnika.
English: However, in the case of an overdose, you will be asked to drink plenty of water and to take laxatives to increase the elimination of the product from your body.
Slovenian: Če pa prejmete prevelik odmerek, vam bodo naročili pitje obilo vode ter uporabo odvajal, da se bo povečalo odstranjevanje zdravila iz telesa.
English: In the event of administration of a radiation overdose with technetium (99mTc) besilesomab, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding, and by the use of laxatives to promote faecal excretion.
Slovenian: V primeru uporabe prevelikega odmerka sevanja s tehnecijevim (99mTc) besilesomabom je treba odmerek, ki ga je absorbiral preiskovanec, če je mogoče čimbolj zmanjšati, s povečanjem izločanja radionuklida iz telesa s prisilno diurezo in pogostim praznjenjem mehurja ter uporabo odvajal za pospeševanje izločanja blata.
English: Elderly No dose adjustment is required.
Slovenian: Starostniki Prilagajanje odmerka ni potrebno.
English: Besilesomab has no effect on activation of complement, granulocyte function or platelets.
Slovenian: Besilesomab nima učinka na aktivacijo komplementa, na funkcijo granulocitov in trombocite.
English: Dispose of radioactive waste in accordance with local regulations.
Slovenian: Radioaktivni odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Using a hypodermic syringe, introduce through the rubber seal 2-7 mL of pertechnetate (99mTc) (the eluate complies with the requirements of current Eur.
Slovenian: S hipodermijsko brizgo skozi zamašek iz kavčuka vnesite 2-7 ml pertehnetata (99mTc) (izpirek ustreza zahtevam veljavne Eur.