natgillin/translations-raw huggingface dataset:
In long term safety studies, an analysis of data from 867 paediatric patients (mean age 7.3 years, range 0 to17) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
V dolgoročnih študijah varnosti so se rezultati o učinkovitosti in varnosti iz analize podatkov 867 pediatričnih bolnikov ( povprečna starost 7,3 let), ki so dobivali razburikazo v odmerku 0,20 mg/kg/dan od 1 do 24 dni (v glavnem od 1 do 4 dni), skladali z izsledki ključnih kliničnih študij.
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Dodajte ampulo vehikla v vialo z razburikazo in nežno mešajte z vrtenjem v validiranih aseptičnih pogojih.
Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
Razburikazo proizvaja mikroorganizem po imenu Saccharomyces cerevisiae v gensko-tehnološkem postopku.
Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Prašek: alanin manitol natrijev hidrogenfosfat dodekahidrat natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat
Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section
Fasturtec se uporablja kot ena intravenska infuzija dnevno v trajanju 30 minut, in sicer v 50 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) (glejte poglavje 6.6).
Respiratory, thoracic and mediastinal disorders
Boolezni dihal, prsnega koša in mediastinalneg a prostora
G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Pomanjkanje glukoza-6-fosfat dehidrogenaze in vse ostale okvare celičnega metabolizma, ki povzročajo hemolitično anemijo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Fasturtec je rekombinantni encim urat-oksidaza, ki ga proizvaja gensko spremenjen sev kvasovke Saccharomyces cerevisiae.
Tabulated list of adverse reactions MedDRA Organ system classes
Preglednica neželenih učinkov MedDRA Organski sistemi
Fasturtec is supplied as a pack of:
Fasturtec je pakiran v škatlice, ki vsebujejo:
- Anaphylaxis - Anaphylactic shock*
- anafilaksija - anafilaktični šok*
METHODS AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001-002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/170/001-002
- The other ingredients of the solvent are: poloxamer 188, water for injection.
- Pomožne snovi vehikla so: poloksamer 188, voda za injekcije.
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Po rekonstituciji vsebuje 1 ml koncentrata Fasturteca 1,5 mg razburikaze.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/170/001
Reconstitution required with the entire contents of the 5 ml solvent ampoule Intravenous use
Za rekonstitucijo morate porabiti celotno vsebino 5 ml ampule z vehiklom Intravenska uporaba
When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Rakaste celice, ki se razkrojijo med kemoterapijo, v krvni obtok sproščajo velike količine sečne kisline.
Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
Izločanje skozi ledvice je manj pomembna pot očistka razburikaze.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/002
ŠTEVILKA(E) DOVOLJENJA ZA PROMET EU/1/00/170/002
Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Pri bolnikih, pri katerih se razvije methemoglobinemija, morate takoj ukiniti zdravljenje in uporabiti ustrezne ukrepe (glejte poglavje 4.8).
In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec.
V kliničnih preskušanjih Fasturtec občasno povzroča hematološke motnje, kot sta hemoliza, hemolitična anemija in methemoglobinemija.
NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
IME ZDRAVILA Fasturtec 1,5 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje.
Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Fasturtec je potrebno rekonstituirati s celotnim volumnom priloženega vehikla (npr. vialo z 1,5 mg razburikaze morate rekonstituirati z 1 ml ampulo vehikla; vialo s 7,5 mg razburikaze morate rekonstituirati s 5 ml ampulo vehikla).
Dilution before infusion:
Redčenje pred uporabo:
Do not use any glucose solution for dilution due to potential incompatibility.
Zaradi morebitne nezdružljivosti, za redčenje ne uporabljajte raztopin glukoze.
Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Pri bolnikih, ki so prejemali razburikazo in pri zdravih prostovoljcih so našli protitelesa proti razburikazi.
If you have any further questions on the use of this medicine, ask your doctor, nurse or hospital pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, medicinsko sestro ali bolnišničnim farmacevtom.
Haemolysis has been reported in patients receiving Fasturtec.
Pri bolnikih, ki so prejemali Fasturtec, so poročali o hemolizi.
- The active substance is rasburicase 1.5 mg/ml.
- Zdravilna učinkovina je razburikaza 1.5 mg/ml.
Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Prašek vsebuje tudi: alanin, manitol, natrijev hidrogenfosfat dodekahidrat, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 7.5 mg
IME ZDRAVILA IN POT(I) UPORABE Vehikel za razburikazo 7,5 mg
STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 7.5 mg/5 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN razburikaza 7,5 mg/5 ml razburikaza, ki jo je v gensko-tehnološkem postopku proizvedel sev kvasovke Saccharomyces cerevisiae
Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.
Razburikaza, tudi sama encim, naj ne bi imela interakcij z drugimi zdravili.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE 1 VIALE PRAŠKA in 1 AMPULE VEHIKLA
Rasburicase must be reconstituted with the entire volume of the supplied solvent ampoule (1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Razburikazo morate rekonstituirati s celotnim volumnom priložene ampule z vehiklom (1,5 mg vialo razburikaze morate rekonstituirati z 1 ml ampulo vehikla; 7,5 mg vialo razburikaze morate rekonstituirati s 5 ml ampulo vehikla).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Navedba smiselno ni potrebna.
What Fasturtec contains
Kaj vsebuje zdravilo Fasturtec
- If you have any further questions, ask your doctor, nurse or hospital pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali z bolnišničnim farmacevtom.
Reconstitution results in a solution with a concentration of 1.5 mg/ml to be further diluted with sodium chloride 9 mg/ml (0.9%).
Z rekonstitucijo dobite raztopino s koncentracijo 1,5 mg/ml, ki jo nato razredčite z 9 mg/ml (0,9%) raztopino natrijevega klorida.
- Haemolysis - Haemolytic anaemia
- hemoliza - hemolitična anemija methemoglobine mija
STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 1.5 mg/1 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN razburikaza 1,5 mg/1 ml razburikaza, ki jo je v gensko-tehnološkem postopku proizvedel sev kvasovke Saccharomyces cerevisiae
Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Pri bolnikih s hiperurikemijo kot posledico mieloproliferativnih obolenj niso raziskovali vloge zdravila Fasturtec.
Very common side effects (may affect more than 1 in 10 people): - diarrhoea - vomiting - nausea
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - driska - bruhanje - slabost - glavobol - povišana telesna temperatura
Reconstitution results in a solution with a concentration of 1.5 mg/ml rasburicase to be further diluted with sodium chloride 9 mg/ml (0.9%) intravenous solution.
Z rekonstitucijo dobite raztopino s koncentracijo 1,5 mg/ml razburikaze, ki jo nato razredčite z raztopino natrijevega klorida za intravensko uporabo, 9 mg/ml (0,9 % raztopina natrijevega klorida).
The increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients.
Povečano tveganje hemolize obstaja le pri bolnikih s pomanjkanjem glukoza-6-fosfat dehidrogenaze in bolnikih s prirojeno anemijo.
The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ml (0.9%) solution to make a total volume of 50 ml.
Potrebni volumen rekonstituirane raztopine, ki ste jo dobili iz ene ali več vial, morate razredčiti z raztopino natrijevega klorida 9 mg/ml (0,9%), tako da dobite skupni volumen 50 ml. Koncentracija razburikaze v končni raztopini za infuzijo je odvisna od telesne mase bolnika.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fasturtec 1.5 mg/ml powder for sterile concentrate rasburicase
IME ZDRAVILA IN POT(I) UPORABE Fasturtec 1,5 mg/ml prašek za sterilni koncentrat razburikaza i.v.
Rasburicase solution should be infused over 30 minutes.
Infuzija raztopine razburikaze mora trajati 30 minut.
Therapeutic indications
4.1 Terapevtske indikacije
If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agent infusions and rasburicase.
Če uporaba druge cevke ni možna, morate cevko po uporabi kemoterapevtske učinkovine in pred uporabo razburikaze izprati s fiziološko raztopino.
The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.
Prašek je pakiran v 10 ml viali iz prozornega stekla z gumijastim zamaškom in vehikel v 5 ml ampuli iz prozornega stekla .
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
1 vialo po 7,5 mg razburikaze in 1 ampulo s 5 ml vehikla.
Methaemoglobinaemia has been reported in patients receiving Fasturtec.
Pri bolnikih, ki so prejemali Fasturtec, so poročali o methemoglobinemiji.
How to store Fasturtec
Shranjevanje zdravila Fasturtec
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 1.5 mg
IME ZDRAVILA IN POT(I) UPORABE Vehikel za razburikazo 1,5 mg
The powder is supplied in 3 ml clear glass vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule.
Prašek je pakiran v 3 ml viali iz prozornega stekla z gumijastim zamaškom in vehikel v 2 ml ampuli iz prozornega stekla.
Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility.
Da bi preprečili morebitno nezdružljivost zdravil, morate infundirati raztopino razburikaze po drugi cevki in ne po tisti, ki jo uporabljate za infuzijo kemoterapevtskih učinkovin.
3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
3 viale po 1,5 mg razburikaze in 3 ampule po 1 ml vehikla.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 3 POWDER VIALS and 3 SOLVENT AMPOULES
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE 3 VIAL PRAŠKA in 3 AMPUL VEHIKLA
If you notice any of these, tell your doctor, nurse or hospital pharmacist.
Če opazite katerega koli od navedenih neželenih učinkov, o tem obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta
If you get any side effects, talk to your doctor, nurse or hospital pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, medicinsko sestro ali z bolnišničnim farmacevtom.
Reconstitution of the solution:
Rekonstitucija raztopine:
Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
Bolnike, za katere sumite, da so prejeli prevelik odmerek, morate nadzorovati zaradi morebitne hemolize.
Reconstitution required with the entire contents of the 1 ml solvent ampoule Intravenous use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo Za rekonstitucijo morate porabiti celotno vsebino 1 ml ampule z vehiklom Intravenska uporaba
Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
Neželeni pojavi so lahko posledica izvirne bolezni in njenega zdravljenja, zato je težko oceniti katere neželene učinke povzroča Fasturtec.
Fasturtec contains the active ingredient rasburicase.
Fasturtec vsebuje zdravilno učinkovino razburikazo.
Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Pakiranje 3 vial, ki vsebujejo 1,5 mg razburikaze in 3 ampul, ki vsebujejo 1 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER/VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
- Fever++
- povišana telesna temperatura+
- The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate,
- Pomožne snovi praška so: alanin, manitol, natrijev hidrogenfosfat dodekahidrat, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat.
Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Pakiranje 1 viale, ki vsebuje 7,5 mg razburikaze in 1 ampule, ki vsebuje 5 ml vehikla.
NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Fasturtec 1,5 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje razburikaza
The concentration of rasburicase in the final solution for infusion depends on the patient's body weight.
Potreben volumen rekonstituirane raztopine je odvisen od telesne mase bolnika.
Not applicable.
Samo za enkratno uporabo.
The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
Prašek je pakiran v prozorne viale (tipa I) s prostornino 3 ml z gumijastim zamaškom.
The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Zato so pri rizičnih skupinah, kot so bolniki s pomanjkanjem glukoza-6-fosfat dehidrogenaze, opazili hemolitično anemijo in methemoglobinemijo.
The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Prašek je pakiran v prozorne viale (tipa I) s prostornino 10 ml z gumijastim zamaškom.
Methaemoglobina emia
VEHIKEL/AMPULA
Intravenous administration should not be protracted over more than 2 hours.
Z intravenskim dajanjem se ne sme odlašati več kot 2 uri.
Date of renewal: 06/01/2011
Datum podaljšanja: 06/01/2011
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
V vseh primerih je treba zagotoviti, da so tveganja zaradi sevanja manjša od same bolezni.
The risk to receive a possible overdose is small.
Tveganje za morebiten prevelik odmerek je majhno.
Please tell your doctor if there is any possibility that you are pregnant.
Zdravniku povejte, če obstaja kakršnakoli verjetnost, da ste noseči.
However, should this occur, you will receive appropriate treatment from your doctor.
Če pa se to vseeno zgodi, vam bo zdravnik nudil primerno zdravljenje.
Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.
Časi meritev so bili 5 minut, 1 ura, 6, 24, 96 in 360 ur.
Faecal and urinary elimination is slow: about 31 % of the administered activity is eliminated in 15 days.
Izločanje z blatom in urinom je počasno: okrog 31 % dane aktivnosti se izloči po 15 dneh.
Further information on the preparation of the product is given in section 12.
Dodatne informacije o pripravi zdravila so v poglavju 12.
The vial should never be opened and must be kept inside its lead shielding.
Viale se ne sme nikoli odpreti, ostati mora znotraj svinčene zaščite.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/01/2006
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja: 19/01/2006
Activity measurements using an ionisation chamber are very sensitive to geometric factors and, therefore, should be performed only under geometric conditions which have been appropriately validated.
Meritve aktivnosti z uporabo ionizacijske celice so zelo občutljive na geometrične faktorje in jih je zaradi tega treba izvajati samo pod geometričnimi pogoji, ki so bili primerno validirani.
Up to 12 days from the date of manufacture.
6.3 Rok uporabnosti Do 12 dni od datuma izdelave.
Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).
Itrij (90Y) ima razpolovno dobo 2,67 dni (64,1 ure).
Your doctor will consider alternative techniques which do not involve ionising radiation.
Zdravnik bo razmislil o uporabi drugih tehnik, ki ne vključujejo ionizirajočega sevanja.
In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
V vsakem primeru je treba opazovati bolnikove krvne parametre in takoj ustrezno ukrepati, če se pokažejo znaki okvare kostnega mozga.
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.
Radiofarmacevtske izdelke sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v izbranih kliničnih ustanovah, njihovo prejemanje, shranjevanje, uporaba, prenos in odstranjevanje pa so predmet predpisov in ustreznih licenc s strani pristojnih organov.
However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator with reduced efficiency.
Vseeno, pa interval > 1 ure po izpostavljenosti ne izključuje dajanja in uspešnega delovanja kelatorja z zmanjšano učinkovitostjo.
Usual precautions regarding sterility and radioactivity should be respected.
Upoštevati je treba običajne varnostne ukrepe glede sterilnosti in radioaktivnosti.
The dosimetry estimates were based on a rat distribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations.
Dozimetrične ocene temeljijo na študiji porazdelitve pri podganah, izračuni pa so bili izvedeni v skladu s priporočili MIRD/ICRP 60.
Activity may be measured using an ionisation chamber.
Aktivnost se lahko meri z uporabo ionizacijske celice.
Your doctor will ask you to stop breast-feeding.
Zdravnik vam bo naročil, da prenehajte dojiti.
There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
Ni podatkov o toksičnosti itrijevega (90Y) klorida in tudi ne o njegovih učinkih na razmnoževanje pri živalih ali o njegovem mutagenem ali karcinogene potencialu.
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Učinkovitost keliranja je največja takoj ali eno uro po izpostavljenosti, ko radionuklid kroži ali se nahaja v tkivni tekočini in plazmi.
In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
V kosteh odstotek injicirane aktivnosti naraste s 3,1 %, po 5 minutah, na 18 %, po 6 urah, in se nato sčasoma zmanjšuje.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
Za vsakega bolnika mora biti izpostavljanje ionizirajočemu sevanju upravičeno na podlagi predvidenih kliničnih koristi.
If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative.
Če vam zamuja menstruacija, predpostavljajte, da ste noseči, dokler ne opravite testa za ugotavljanje nosečnosti, katerega rezultat je negativen.
Effective Dose (mSv/MBq)
učinkovit odmerek (mSv/MBq)
Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).
Posebna previdnost je potrebna pri dajanju radiofarmakov otrokom in mladostnikom (starih od 2 do 16 let).
At 1 and 24 hours, blood radioactivity decreases from 11.0 % to 0.14 % of the administered activity.
Po 1 uri in 24 urah se radioaktivnost krvi zmanjša z 11,0 % na 0,14 % dane aktivnosti.
Yttriga is contraindicated in Pregnancy.
Uporaba zdravila Yttriga je kontraindicirana v obdobju nosečnosti.
The volume is 0.02-3 ml.
Volumen znaša 0,02-3 ml.
Women of childbearing potential should use effective contraception during and after treatment.
Ženske v rodni dobi morajo med zdravljenjem in po njem uporabljati učinkovito kontracepcijo.
Specific activity at calibration: (Y) GBq/vial
Specifična aktivnost pri kalibraciji: (Y) GBq/viala
Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding.
Pred dajanjem radiofarmaka doječi materi je treba razmisliti, ali je mogoče s preiskavo upravičeno odlašati, dokler mati ne preneha z dojenjem.
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Before use, packaging and radioactivity should be checked.
NAVODILA ZA PRIPRAVO RADIOFARMAKOV Pred uporabo je treba preveriti pakiranje in radioaktivnost.
Any unused product or waste material should be disposed of in accordance with local requirements.
Vsa neuporabljena zdravila ali odpadni material je treba odvreči skladno z lokalnimi predpisi.
For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 1 GBq is 665 mSv.
Efektivna doza sevanja za 70 kg težko odraslo osebo po intravenskem dajanju 1 GBq tega izdelka je 665 mSv.
It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Z njim naj ravnajo in ga uporabljajo samo osebe, ki so usposobljene in kvalificirane za varno ravnanje z radioaktivnimi materiali.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Prejeta doza sevanja, kot rezultat terapevtske izpostavljenosti, lahko povzroči povečano incidenco raka in mutacij.