natgillin/translations-raw huggingface dataset:
In patients at risk of acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Pri bolnikih s tveganjem akutne ledvične odpovedi je treba zdravila i.v.
Solutions that are cloudy or have deposits should not be used.
Ne uporabljajte motnih raztopin ali raztopin z usedlinami.
Proteinuria, increased blood creatinine
Bolezni sečil proteinurija, povečan kreatinin v krvi občasni akutna odpoved ledvic neznana
Live attenuated virus vaccines
Shranjevanje zdravila Privigen
2 g/kg bw every 4 to 8 weeks over 2 to 5 days
2 g/kg tm vzdrževalni odmerek: 1g/kg tm ali 2g/kg tm v obdobju 2 do 5 zaporednih dni vsake 2 do 4 tedne ali vsakih 4 do 8 tednov v obdobju 2 do 5 dni
Noncardiogenic pulmonary edema may very rarely occur following treatment with IVIg products, including Privigen.
Zelo redko se lahko po zdravljenju z zdravili i.v.
Skin and subcutaneous tissue disorders
eritem, eksfoliacijo kože)
Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding.
Če ste noseči, nameravate zanositi ali dojite, o tem obvestite zdravnika ali zdravstvenega delavca.
Aseptic meningitis
Infekcijske in parazitske bolezni aseptični meningitis občasni
- if you are pregnant.
- če ste noseči.
It will be the smallest quantity necessary to get the desired information.
To bo najmanjša potrebna količina, da se dobijo želene informacije.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 12.
F-91192 Gif-sur-Yvette Cedex France
F-91192 Gif-sur-Yvette Cedex Francija
Withdrawals should be performed under aseptic conditions.
Odvzeme je treba opravljati v aseptičnih pogojih.
After radiolabelling: 3 hours.
Po radioaktivnem označevanju: 3 ure.
After radiolabelling with sodium pertechnetate (
- Prvega izpirka iz generatorja tehnecija (
- if you have any blood disease.
- če imate kakršnokoli bolezen krvi, - če dojite.
This medicine is not recommended for use in patients below 18 years of age because the safety and efficacy of the product have not been established.
Zdravilo ni priporočeno bolnikom, mlajšim od 18 let, ker varnost in učinkovitost zdravila nista bili dokazani.
Under nitrogen atmosphere
V dušikovi atmosferi
A single injection into a vein in your arm is sufficient to conduct the test your doctor needs.
Ena injekcija v veno v vaši roki zadostuje za izvedbo preiskave, ki jo zdravnik potrebuje.
The DHPC also includes 3 copies of a Patient Alert Card completed by the Healthcare Professional and provided to each patient.
DHPC vključuje tudi 3 kopije opozorilne kartice za bolnika, ki jo izpolni zdravstveni delavec in prejme vsak bolnik.
Appropriate aseptic precautions should be taken.
Potrebni so ustrezni aseptični previdnostni ukrepi.
This may increase the risk of allergic reactions in case of repeated administration of Scintimun.
To lahko poveča tveganje alergijskih reakcij v primeru ponavljajoče se uporabe zdravila Scintimun.
This will protect your child from the radiation that may be present in your breast milk.
Tako boste zaščitili svojega otroka pred sevanjem, ki bo morda prisotno v vašem mleku.
The safety and efficacy of Scintimun in children and adolescents have not yet been established.
Varnost in učinkovitost zdravila Scintimun pri otrocih in mladostnikih še nista bili dokazani.
Date of latest renewal: 26 August 2014
Datum prve odobritve: 11. januar 2010 Datum zadnjega podaljšanja: 26. avgusta 2014
In case of allergic reaction you will receive appropriate treatment from your doctor.
V primeru alergijske reakcije vas bo zdravnik ustrezno zdravil.
A risk to a breast-fed child cannot be excluded.
Tveganja za dojenega otroka ni možno izključiti.
EXP Use within 3 hours after radiolabelling.
EXP Uporabite v 3 urah po radioaktivnem označenju.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Prejem, shranjevanje, uporaba, prenos in odstranjevanje radiofarmakov je urejeno s predpisi in/ali ustreznimi licencami pristojnih organov.
Scintimun will only be used in special controlled areas.
Zdravilo Scintimun se bo uporabljalo samo v posebno nadzorovanih prostorih.
Genotoxicity studies conducted to test for potentially genotoxic impurities were also negative.
Študije genotoksičnosti, opravljene za preskus potencialno genotoksičnih nečistoč, so tudi bile negativne.
If you are pregnant you must not be given Scintimun.
Če ste noseči, ne smete prejeti zdravila Scintimun.
Table 1: Values of the absorbed doses calculated for the individual male and female of reference.
Tabela 1: Vrednosti absorbiranih odmerkov, izračunanih za referenčnega moškega in žensko.
The content of the kit before reconstitution is not radioactive.
Vsebina kompleta pred rekonstitucijo ni radioaktivna.
METHOD OF ADMINISTRATION Not intended for direct application to patients.
POSTOPEK UPORABE Ni namenjeno neposredni uporabi pri bolniku.
Pregnancy (see section 4.6).
Nosečnost (glejte poglavje 4.6).
For diagnostic nuclear medicine investigations the frequency of these adverse reactions is not known.
Pri diagnostičnih preiskavah v nuklearni medicini pogostnost teh neželenih učinkov ni znana.
BATCH NUMBER Lot:
ŠTEVILKA SERIJE Lot :
Swirl carefully to mix the whole solution (DO NOT shake).
Previdno vrtinčite, da premešate celotno raztopino (NE stresajte).
Effective Dose 0.00863 mSv / MBq
Celotno telo Efektivni odmerek 0,00863 mSv/MBq
You can also report side effects directly via directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
An additional acquisition 24 hours after initial injection is recommended.
Priporočljiv je dodaten zajem 24 ur po prvotnem injiciranju.
Pharmacodynamic effects At the recommended activities, it does not exert any clinically relevant pharmacodynamic effects.
Farmakodinamični učinki Priporočene aktivnosti te učinkovine nimajo klinično relevantnih farmakodinamičnih učinkov.
MBq ml hour/date
MBq ml ura/datum
There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging.
Trenutno ni kriterijev za razlikovanje okužbe in vnetja s pomočjo slikanja z zdravilom Scintimun.
Adequate shielding is mandatory.
Ustrezna zaščita je obvezna.
If you have an intolerance to some sugars (for example fructose or sorbitol), tell your doctor before you are given Scintimun.
Če ne prenašate določenih sladkorjev (na primer fruktozo ali sorbitol), obvestite zdravnika, preden boste prejeli zdravilo Scintimun.
The effective dose has been calculated by using the absorbed doses determined for each individual organ, taking into account the weighting factors (radiation and tissue) to use according to the recommendations of the ICRP (International Commission of Radiological Protection, Publication 103).
Efektivni odmerek so izračunali z absorbiranimi odmerki, določenimi za vsak posamezen organ, ob upoštevanju uteži (sevanja in tkiva) za uporabo skladno s priporočili ICRP (International Commission of Radiological Protection, publikacija 103).
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Pri uporabi radiofarmakov nastane tveganje za druge osebe zaradi zunanjega sevanja ali kontaminacije zaradi razlitja urina, bruhanja itd.
Investigations in nuclear medicine may involve a risk to the unborn.
Preiskave v nuklearni medicini so lahko nevarne za nerojenega otroka.
Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3).
Uporaba besilesomaba je kontraindicirana v nosečnosti (glejte poglavje 4.3).
It is not known if the product is excreted in human milk.
Ni znano, ali se zdravilo izloča v materino mleko.
Acquisition can be performed using planar imaging.
Zajem lahko opravite s planarnim slikanjem.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Long-term carcinogenicity studies and toxicity to reproduction have not been carried out.
Dolgoročnih študij karcinogenosti niso izvajali.
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Zdravnik nuklearne medicine vas bo obvestil, ali morate po prejemu tega zdravila upoštevati posebne varnostne ukrepe.
The quantity to be administered usually recommended for an adult ranges from 400 to 800 MBq (megabecquerel, the unit used to express radioactivity).
Uporabljena količina, navadno priporočena za odrasle, je od 400 do 800 MBq (megabekerel je enota, ki se uporablja za izražanje radioaktivnosti).
Separately count each cut part of the strip and record the obtained values (use an appropriate detection apparatus with a constant counting time, and known geometry and background noise).
Ločeno preštejte vsak del prerezanega traku in zabeležite vrednosti (uporabite ustrezno detekcijsko opremo s stalnim števnim časom, znano geometrijo in izhodiščnim šumom).
About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun.
Pri približno 14 od 100 bolnikov, ki so prejeli to injekcijo, so odkrili nastajanje protiteles v krvi, ki reagirajo proti protitelesom, ki so prisotna v zdravilu Scintimun.
The radiochemical purity of the final radiolabelled preparation can be tested according to the following procedure:
Radioaktivno čistoto končnega radioaktivnega pripravka lahko preverite po naslednjem postopku:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000)
Spodaj navedena pogostnost je opredeljena v skladu z naslednjimi dogovorjenimi skupinami: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1000 do < 1/100); redki (≥ 1/10 000 do < 1/1 000); zelo redki (< 1/10 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Individual benefit/risk justification
Individualna utemeljite razmerja med koristmi in tveganji
These persons will take special care for the safe use of this product and will keep you informed of their actions.
Te bodo posebej pozorne na varno uporabo zdravila in vas bodo sproti obveščale o svojem ravnanju.
Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is excreted via the bladder during the 24 h post-injection.
Meritve ravni radioaktivnosti v urinu so pokazale, da se do 14 % uporabljene aktivnost izloči skozi sečni mehur v 24 h po injiciranju.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden boste prejeli zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
This corresponds to the administration of 0.25 to 1 mg of besilesomab.
To ustreza uporabi 0,25 do 1 mg besilesomaba.
Patients who are HAMA positive may have a greater risk for hypersensitivity reactions.
Preiskovanci, ki so pozitivni za HAMA, imajo večje tveganje preobčutljivostne reakcije.
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.
Majhen ledvični očistek aktivnosti (0,2 l/h pri hitrosti glomerulne filtracije približno 7 l/h) kaže, da ledvice niso poglavitna pot izločanja besilesomaba.
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).
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).
This product will only be handled and given to you by people who are trained and qualified to use it safely.
Z zdravilom bodo ravnale in vam ga dale samo osebe, usposobljene za njegovo varno uporabo.
If you wish, you can express and store your breast milk before your injection.
Če želite, si lahko mleko iztisnete in shranite pred injiciranjem.
These three days correspond to 10 half-lives of technetium (99mTc) (60 hours).
Ti trije dnevi ustrezajo 10 razpolovnim dobam tehnecija (99mTc) (60 ur).
After 1 min, check that the content of the vial of Scintimun has completely dissolved.
Po 1 min preverite, ali se je vsebina viale z oznako Scintimun popolnoma raztopila.
• Serious allergic reaction which causes difficulty in breathing or dizziness
• resna alergijska reakcija, ki povzroči oteženo dihanje ali omotico, • bolečine v mišicah ali sklepih
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Radiofarmake lahko sprejmejo, uporabljajo in dajejo le pooblaščene osebe v odobrenih kliničnih ustanovah.
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).
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).
For repeated use, see section 4.4.
Glede ponavljajoče se uporabe glejte poglavje 4.4.
Scintimun images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations.
Slike, dobljene z zdravilom Scintimun, je treba interpretirati ob upoštevanju ustreznih anatomskih in/ali funkcijskih preiskav.
Images acquisition should start 3 to 6 hours after administration.
Zajem slik naj se začne od 3 do 6 ur po uporabi zdravila.
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.
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.
The use of Scintimun does involve exposure to small amounts of radioactivity.
Uporaba zdravila Scintimun vključuje izpostavljenost majhnim količinam radioaktivnosti.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.82 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,82 mg
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Ženske z izostalo menstruacijo morate obravnavati kot noseče, dokler ne dokažete drugače.
Only clear solutions, free of visible particles should be used.
Uporabite lahko le bistre raztopine, brez vidnih delcev.
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).
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).
If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.
Če je kadarkoli med pripravo zdravila integriteta viale ogrožena, je ne smete uporabiti.
For patient preparation, see section 4.4.
Za pripravo bolnika glejte poglavje 4.4.
Specific warnings
Posebna opozorila
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Izpostavitev ionizirajočemu sevanju je povezana z indukcijo raka in potencialom za razvoj dednih okvar.
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.
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.
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.
Po injiciranju v veno lahko zdravnik pridobi slike vaših organov, s katerim zaznavamo mesta vnetja in/ali okužbe.
Fill in the enclosed label and fix it to the radiolabelled solution.
Izpolnite priloženo nalepko in jo namestite na radioaktivno označeno raztopino.
This medicine is a radiopharmaceutical product for diagnostic use only in adults.
Zdravilo je radiofarmak samo za diagnostične namene pri odraslih.
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.
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.
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.
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.
- The final radiolabelled injection solution must be protected from oxygen.
- Končno radioaktivno označeno raztopino za injiciranje morate varovati pred kisikom.
False positive findings in patients with CEA expressing tumours cannot be excluded.
Ne moremo izključiti lažno pozitivnih rezultatov pri bolnikih s tumorji, ki izražajo CEA.
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.
Ko topilo doseže zgornji konec traku (po približno 10 minutah), s pinceto izvlecite trak in ga posušite na zraku.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Za takojšnje ukrepanje v nujnih primerih morajo biti na razpolago nujno potrebna zdravila in medicinski pripomočki, kot sta endotrahealna cevka in naprava za predihavanje.
1/1000 of the initial activity in the body.
Takrat preostala aktivnost predstavlja približno 1/1000 izhodiščne aktivnosti v telesu.
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.
Po korekciji za razpad radionuklida je izračunana razpolovna doba zgodnje faze 0,5 h, medtem ko pozna faza kaže razpolovno dobo eliminacije 16 h.
The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.
Efektivni odmerek, ki nastane zaradi odmerjanja aktivnosti 800 MBq za odraslo osebo z maso 70 kg, je za to zdravilo 6,9 mSv.
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.
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).
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.
Vendar zaradi narave molekule in kratke razpolovne dobe tehnecijevega (99mTc) besilesomaba prilagajanje odmerka pri teh bolnikih ni potrebno.
Besilesomab cross-reacts with tumours expressing carcinoembryonic antigen (CEA).
Besilesomab navzkrižno reagira s tumorji, ki izražajo karcinoembrionalni antigen (CEA).
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.
Vaš osebni zdravnik in zdravnik nuklearne medicine sta pretehtala, da klinične koristi tega postopka z radiofarmakom odtehtajo tveganja zaradi izpostavitve majhnim količinam sevanja.
Since allergic reactions to the murine protein cannot be excluded, cardiovascular treatment, corticosteroids, and antihistamines must be available during administration of the product.
Ker alergijskih reakcij na mišje beljakovine ne moremo izključiti, morajo biti med uporabo zdravila na voljo kardiovaskularna zdravila, kortikosteroidi in antihistaminiki
The other ingredients are (see section 2 “Scintimun contains sorbitol and sodium”):
- Pomožne snovi so (Glejte poglavje 2 “Zdravilo Scintimun vsebuje sorbitol in natrij”):
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.
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).
Materials and reagents
Materiali in reagenti
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Ženske v rodni dobi Kadar je indicirana uporaba radiofarmakov pri ženski v rodni dobi, je pomembno, da se prepričate ali je noseča ali ne.
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.
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.
False results may be obtained in patients with diseases involving neutrophil defects and to patients with haematological malignancies including myeloma.
Rezultati so lahko lažno pozitivni pri bolnikih z boleznimi z okvarami nevtrofilcev in pri bolnikih s hematološkimi malignimi boleznimi, vključno z mielomom.
Such substances should therefore not be administered together with, or a short time before the injection of Scintimun.
Takšnih snovi zato ne morete dajati sočasno z zdravilom Scintimun ali v kratkem času pred injiciranjem tega zdravila.
Swirl carefully; the content of the vial of Scintimun will dissolve within one minute (DO NOT shake).
Previdno vrtinčite, da se vsebina viale z oznako Scintimun raztopi v roku ene minute (NE
The activity must be between 400 and 1800 MBq depending on the volume of pertechnetate (99mTc).
Aktivnost mora biti med 400 in 1800 MBq, odvisno od volumna pertehnetata (99mTc).
Method Instant thin layer chromatography or paper chromatography.
Metoda Hitra tankoplastna kromatografija ali papirno kromatografijo
Data on repeated dosing of Scintimun are very limited.
Podatkov o ponavljajočem se odmerjanju zdravila Scintimun je zelo malo.