qanastek/EMEA-V3 huggingface dataset:
More information on the restrictions for the medicines radiolabelled with Ytracis will be given in the Package Leaflet of the particular medicine that is radiolabelled with Ytracis.
Aktar informazzjoni dwar ir- restrizzjonijiet għall- mediċini radjuttikkettati b’ Ytracis sejra tingħata fil- Fuljett ta ’ Tagħrif tal- mediċina partikolari li hija radjuttikkettata b’ Ytracis.
Why has Ytracis been approved?
Għalfejn Ytracis ġie approvat?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ytracis’ s benefits are greater than its risks for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Ytracis huma ikbar mir- riskji tiegħu għar- radjutikkettar ta ’ molekuli ġarriera li ġew speċifikament żviluppati u awtorizzati għar- radjutikkettar b’ dan ir- radjunuklide.
The Committee recommended that Ytracis be given marketing authorisation.
Il- Kumitat irrakkomanda li Ytracis jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ytracis:
Informazzjoni oħra dwar Ytracis:
The European Commission granted a marketing authorisation valid throughout the European Union for Ytracis to CIS bio international on 24 March 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Ytracis lil CIS bio international fl- 24 ta ’ Marzu 2003.
The marketing authorisation was renewed on 24 March 2008.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 24 ta ’ Marzu 2008.
The full EPAR for Ytracis is available here.
L- EPAR sħiħ għal Ytracis jista ’ jinkiseb minn hawn.
EU/ 1/ 03/ 250/ 001
Daqs tal - pakkett
1.850 GBq/ ml
1. 850 GBq/ ml
Radiopharmaceutical precursor
Prekursur radjufarmaċewtiku
YTRACIS radiopharmaceutical precursor, solution.
Prekursur radjufarmaċewtiku YTRACIS, soluzzjoni.
1ml of sterile solution contains 1.850 GBq Yttrium (90Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium.
1ml ta 'soluzzjoni sterili fih 1. 850 GBq Yttirium (90Y) chloride, fid- data ta ’ kalibrazzjoni, li tikkorrispondi għal 92 ng ta' Yttrium.
One vial contains 0.925 to 3.700 GBq (see section 6.5).
Kunjett wieħed fih minn 0. 925 sa 3. 700 GBq (ara sezzjoni 6. 5).
Radiopharmaceutical precursor, solution.
Prekursur radjufarmaċewtiku, soluzzjoni.
Clear, colourless solution, free of particulate matter.
Soluzzjoni ċara u bla kulur, u mingħajr frak.
To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Għandu jintuża biss biex jiġu radjutikkettati molekuli portaturi li ġew żviluppati speċifikament u ġew awtoriżżati biex jiġu radjutikkettati b' dan ir- radjunuklidu.
Radiopharmaceutical precursor - Not intended for direct application to patients.
Prekursur radjufarmaċewtiku - Mhuwiex maħsub sabiex jingħata direttament lill- pazjenti.
YTRACIS is only to be used by specialists with the appropriate experience.
YTRACIS għandu jintuża biss minn speċjalisti li għandhom l- esperjenza xierqa.
The quantity of YTRACIS required for radiolabelling and the quantity of Yttrium (90Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.
Il- kwantità ta 'YTRACIS meħtieġa biex jiġi radjutikkettat, u l- kwantità ta' prodott mediċinali li jiġi radjutikkettat b' Yttrium (90Y) li se jingħata lill- pazjent, jiddependi mill- prodott mediċinali li jiġi radjutikketat u l- użu li huwa maħsub għalih.
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Irreferi għall- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali partikolari li sejjer jiġi radjutikkettat.
YTRACIS is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by approved route.
YTRACIS huwa maħsub biex jigu radjutikkettati prodotti mediċinali in vitro, li wara jigħataw bil - metodu approvat.
Do not administer YTRACIS directly to the patient.
Tagħtix YTRACIS direttament lill- pazjent.
YTRACIS is contraindicated in the following cases:
YTRACIS ma ghandux jintuża fil- każijiet li ġejjin:
- Hypersensitivity to the the active substance or to any of the excipients.
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
- Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
- Tqala magħrufa jew suspettata, jew meta t- tqala tkun għadha ma ġietx eskluża (ara sezzjoni
For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Għal informazzjoni dwar kontraindikazzjonijiet ta 'prodotti mediċinali partikolari radjutikkettati b' Yttrium (90Y) billi ġew radjutikkettati b' YTRACIS, irreferi għall- Karatteristiċi tal- Prodott fil - Qosor/ fuljett tal- pakkett tal- prodott mediċinali li sejrin jiġu radjutikkettati.
The content of the vial of YTRACIS is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Il- kontenut tal- kunjett ta ’ YTRACIS ma għandux jingħata direttament lill- pazjent iżda għandu jintuża għar - radju- labiling ta 'molekuli portaturi, bħal anti- korpi monoklonali, peptidi u sustrati oħra.
Radioactive medicinal products 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.
Prodotti mediċinali radjuattivi għandhom jintlaqgħu, jintużaw u jiġu mogħtija biss minn persuni awtoriżżati f' ambjenti kliniċi nnominati u l- ilqugħ, l- użu, t- trasferiment u r- rimi huma suġġetti għar - regolamenti u liċenzji xierqa ta 'l- awtoritajiet kompetenti.
Radioactive medicinal products should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Prodotti mediċinali radjuattivi għandhom jiġu ppreparati minn min se jużah b' mod li jissodisfa kemm il- ħtiġijiet tas- sigurtà ta 'radjazzjoni kif ukoll dawk ta' kwalità farmaċewtika.
For information concerning special warnings and precautions for use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Għal informazzjoni dwar twissijiet speċjali u prekawzjonijiet għall- użu ta 'prodotti mediċinali radjutikkettati b' Yttrium (90Y) irreferi għall- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal - prodott mediċinali li sejjer jiġi radjutikkettat.
Particular care should be taken when administering radioactive medicinal products to children and adolescents.
Għandha tingħata attenzjoni speċjali meta jingħataw prodotti mediċinali radjuattivi lit- tfal u lill - adoloxxenti.
No interaction studies have been performed..
Ma sarux studji dwar l- interazzjonijiet.
For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Għal informazzjoni dwar interazzjonijiet assoċjati ma 'l- użu ta' prodotti mediċinali radjutikkettati b' Yttrium (90Y) irreferi għall- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali li sejjer jiġi radjuttikkettjat.
YTRACIS is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3 Contraindications).
YTRACIS huwa kontra- indikat għal waqt tqala stabbilita jew meta jkun hemm suspett ta ’ tqala jew meta t- tqala tkun għadha ma ġietx eskluża (ara sezzjoni 4. 3 Kontra- indikazzjonijiet).
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Meta jkun meħtieġ li jingħataw prodotti mediċinali radjuattivi lil nisa li jistgħu jkollhom it- tfal, dejjem għandha tkun investigata l- possibilita ta ’ tqala.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Mara li ma jiġihiex il- pirjid darba, għandha tkun meqjusa tqila qabel ma jiġi ppruvat mod ieħor.
Alternative techniques which do not involve ionising radiation should always be considered.
Tekniki alternattivi li ma jinvolvux radjazzjoni jonizzanti għandhom dejjem jiġu kkunsidrati.
Radionuclide procedures carried out in pregnant women also involve radiation doses to the foetus.
Proċeduri b’ radjunuklidi li jsiru fuq nisa tqal, jinvolvu wkoll dożi ta 'radjazzjoni fuq il- fetu.
The absorbed dose to the uterus following administration of Yttrium (90Y)-labelled medicinal products is dependent on the specific medicinal product being radiolabelled and is to be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Id- doża assorbita mill- utru wara għoti ta 'prodotti mediċinali radjutikkettati b' Yttrium (90Y), tiddependi fuq il- prodott mediċinali li qiegħed jiġi radjutikkettat u għandha tkun speċifikata fil- Karatteristiċi tal - Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali li sejjer jiġi radjutikkettat.
Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the administration could be reasonably delayed until the mother has ceased breastfeeding.
Qabel ma jingħata prodott mediċinali radjuattiv lil omm li qiegħda tredda ', għandu jiġi kkunsidrat jekk jistax ma jigħatax sa wara li l- omm tkun waqfet tredda'.
If the administration cannot be delayed, a lactating mother should be advised to stop breastfeeding.
Jekk ma jistax ikun hemm dewmien fl- għoti, omm li qegħda tredda 'għandha tingħata l- parir li tieqaf tredda'.
For information concerning the use of Yttrium (90Y)-labelled medicinal products in pregnancy and lactation refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Għal informazzjoni dwar l- użu ta 'prodotti mediċinali radjutikkettati b' Yttrium (90Y) waqt it- tqala u t - tirdigħ, irreferi għall- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali li sejjer jiġi radjutikkettat.
3 4.7 Effects on ability to drive or use machines
3 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effects on the ability to drive and use machines have been performed.
Ma sar ebda studju dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Effects on ability to drive or use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
L- effetti fuq il- ħila biex issuq jew tħaddem magni wara kura bi prodotti mediċinali radjutikkettati b’ Yttrium (90Y), ikunu speċifikati fit- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali partikolari li għandu jiġi radjutikkettat.
Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, will be dependent on the specific medicinal product being used.
Effetti possibbli li mhux mixtieqa wara l- għoti ġol- vina ta ’ prodotti mediċinali radjutikkettati b’ Yttrium (90Y); ippreparati billi ġew radjutikkettati b’ YTRACIS; huma dipendenti fuq il- prodott mediċinali speċifiku li jkun qiegħed jintuża.
Such information will be supplied in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Għal kull pazjent, l- espożizzjoni għal radjazzjoni jonizzanti għandha tkun ġustifikata fuq il- bażi tal - benefiċċju kliniku li x’ aktarx għandu.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
L- attività mogħtija għandha tkun tali, li d- doża ta ’ radjazzjoni, għandha tkun kemm jista ’ jkun baxxa.
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.
Fl- istess ħin, li wieħed għandu jżomm f’ moħħu l- ħtieġa li jinkiseb ir- riżultat terapewtiku maħsub.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Id- doża ta ’ radjazzjoni li tirriżulta minn espożizzjoni terapewtika, tista ’ iżżid l’ inċidenza ta ’ kanċer u mutazzjonijiet.
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Fil- każijiet kollha, hemm il- ħtieġa li jiġi żgurat, li r- riskji tar- radjazzjoni jkunu inqas mill- marda minnha nfisha.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
L- espożizzjoni għal radjazzjoni jonizzanti hija marbuta mal- fatt li tista ’ tikkawża kanċer u tkun ta ’ potenzjal għal żvilupp ta ’ difetti ereditarji.
The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Ytracis will lead to increase bone marrow toxicity and haematopoetic stem cell damage.
Il- preżenza ta ’ Yttrium chloride (90Y) ħieles fil- ġisem wara għoti bi żvista ta ’ YTRACIS iwassal għal żjieda fit- tossiċità fil- mudullun u mard fiċ- ċelloli stem ematopojetiċi.
Therefore, in case of an inadvertent administration of Ytracis, 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.
Għalhekk, fil- każ ta ’ għoti bi żvista, ir- radjutossiċità għall- pazjent għandha titnaqqas billi jingħata minnufiħ (jiġifieri fi żmien siegħa) prodotti li fihom kelanti bħal Ca- DTPA jew Ca- EDTA sabiex tiżdied l- eliminazzjoni tar - radjunuklidu minn ġol- ġisem.
The following preparations must be available in medical institutions, which use Ytracis for radiolabelling of carrier molecules for therapeutic purposes:
Il- prodotti li ġejjin għandhom ikunu disponibbli f' istituzzjonijiet mediċi, li jużaw YTRACIS biex jiġu radjutikkettati molekoli portaturi għal skopijiet terapewtiċi:
Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Ca- DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew Ca- EDTA (Calcium disodium ethylenediaminetetraacetate)
These chelating agents suppress yttrium radiotoxicity by an exchange between the calcium ion and the yttrium due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA).
Dawn l- agenti kelanti irażżnu ir- radjutossiċità ta 'Yttrium permezz ta' bdil bejn l- jone tal- kalċju u Yttrium, bil- ħila li għandhom li jiffurmaw kumplessi li jinħallu fl- ilma mal- ligand kelanti (DTPA, EDTA).
These complexes are rapidly eliminated by the kidneys.
Dawn il- kumplessi huma mneħħija malajr mill- kliewi.
1 g of the chelating agents should be administered by slow intravenous injection over 3-4 minutes or by infusion (1 g in 100-250 ml of dextrose, or normal saline).
Ġramma waħda ta ’ l - agenti kelanti, għandha tkun mogħtija minn injezzjoni ġol- vina bil- mod fi żmien ta '3- 4 minuti, jew permezz ta' infużjoni (1 g f' 100- 250 ml ta 'destrosju, jew soluzzjoni normali ta' melħ).
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.
L- efficjenza kelanti hija l- aktar għolja eżatt wara, jew sa żmien siegħa mill- espożizzjoni, meta r - radjunuklidu ikun qiegħed jiċċirkola, jew ikun disponibbli għal fluwidi tat- tessut u tal- plażma.
However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator with reduced efficiency.
Iżda, intervall ta ’ wara l- espożizzjoni > minn siegħa, ma għandux iwaqqaf l- għotja u l- azzjoni effettiva tal - kelant pero ’ b’ inqas effiċjenza.
Intravenous administration should not be protracted over more than 2 hours.
L- għoti ġol- vina ma għandux idum iktar minn sagħtejn.
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.
4 Fi kwalunkwe każ, il- parametri tad- demm tal- pazjent għandhom jiġu osservati u għandhom jittieħdu l - azzjonijiet xierqa b’ mod immedjat jekk ikun hemm evidenza ta ’ ħsara fil- mudullun tad- demm.
The toxicity of the free Yttrium (90Y) due to in-vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents
Dan jista ’ jitnaqqas billi wara jingħataw agenti kelanti.
Not applicable ATC code:
Kodiċi ATC:
Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Yttrium chloride (90Y) huwa r- riżultat tad- degradazzjoni tal- prekursur radjuattiv Strontium (90Sr).
It decays by emission of beta radiation of 2.281 MeV (99.98%) of maximal energy to stable Zirconium (90Zr).
Huwa jiddegrada bl- emissjoni ta ’ radjazzjoni beta ta ’ 2. 281 MeV (99. 98%) ta ’ enerġija massima lil Zirconium (90Zr) stabbli.
90 Y-yttrium has a half-life of 2.67 days (64.1 hours).
Il- half- life ta ’ 90Y- Yttrium huwa ta ’ 2. 67 jum (64. 1 sigħat).
The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Qabel ma jingħataw, il- karatteristiċi farmakodinamiċi ta ’ prodotti mediċinali radjutikkettati b’ Yttrium (90Y), ippreparati billi jiġu radjutikkettati b’ YTRACIS, jiddependu fuq in- natura tal- prodott mediċinali nnifsu.
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Irreferi għall- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal- pakkett tal- prodott mediċinali partikolari li għandu jiġi radjutikkettat.
The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Qabel ma jingħataw, il- karatteristiċi farmakokinetiċi ta ’ prodotti mediċinali radjutikkettati b’ Yttrium (90Y) ippreparati billi jiġu radjutikkettati b’ YTRACIS, jiddependu fuq in- natura tal- prodott mediċinali innifsu.
In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood.
Fil- far, wara li jingħata ġol- vina, Yttrium chloride (90Y) jitneħħa malajr mid- demm.
At 1 and 24 hours, blood radioactivity decreases from 11.% to 0.14% of the administered activity.
Bejn 1 u 24 siegħa, ir- radjuattività fid- demm tonqos minn 11.% għal 0. 14% ta ’ l- attività mogħtija.
The two main organs where Yttrium (90Y) chloride distributes are the liver and bones.
Iż- żewġ organi prinċipali fejn Yttrium chloride (90Y) jiddistribwixxi ruħu, huma l- fwied u l- għadam.
In the liver, 18% of the injected activity is taken up 5 min after injection.
Fil- fwied, 18% ta ’ l- attività injettata hija assorbita 5 min wara t- titqiba.
Liver uptake decreases then to 8.4% 24 hours after injection.
L- assorbiment mill- fwied imbagħad jonqos għal 8. 4% 24 siegħa wara t- titqiba.
In bone, percentage of injected activity increases from 3.1% at 5 min to 18% at 6 hours and then decreases with time.
Fl- għadam, il- perċentwali ta ’ l- attività injettata tiżdied minn 3. 1% f’ 5 min għal 18% f’ 6 sigħat u mbagħad tonqos mal- ħin.
Faecal and urinary elimination is slow: about 13% of the administered activity is eliminated in 15 days.
L- eliminazzjoni fil- purgar u fl- awrina hija bil- mod: madwar 13% ta ’ l- attività mogħtija hija eliminata fi żmien 15- il ġurnata.
The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Qabel ma jingħataw, il- karatteristiċi tossikoloġiċi ta ’ prodotti mediċinali radjutikkettati b’ Yttrium (90Y) ippreparati billi jiġu radjutikkettati b’ YTRACIS, jiddependu fuq in- natura tal- prodott mediċinali nnifsu.
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.
Ma hemm l- ebda nformazzjoni jew studji dwar it- tossiċità ta’ Yttrium chloride (90Y) u lanqas dwar l - effetti tiegħu fuq ir- riproduzzjoni fl- annimali jew il- potenzjal mutaġeniku jew karċenoġeniku tiegħu.
Hydrochloric acid 30% Water for injections
Hydrochloric acid 30% Ilma għall- injezzjoni
Radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Radjutikkettar ta ’ molekuli portaturi, bħal antikorpi monoklonali, peptidi jew substrata oħra, b ’ Yttrium chloride (90Y) huwa sensittiv ħafna għall- preżenza ta ’ impuritajiet ta ’ metalli traċċi.
It is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities.
Huwa mportanti li l- oġġetti kolla tal- ħġieġ, labar tas- siringi eċċ, wżati għall- preparazzjoni tal- prodott mediċinali biex jiġi radjutikkettat, jiġu mnaddfa tajjeb sabiex jiġi żgurat li ma jkunx hemm impuritajiet ta ’ metalli traċċi.
Only syringe needles (for example non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Għandhom jintużaw labar tas- siringi (per eżempju mhux metalliċi) b’ reżistenza ppruvata għal aċidu dilwit sabiex jiġu minimizzati l- livelli ta ’ impurità ta ’ metalli traċċi.
7 days from the date/ hour of manufacture.
7 ijiem mid- data/ siegħa ta ’ manifattura.
Storage should be in accordance with local regulations for radioactive substances.
Il- ħżin għandu jsir b’ mod konformi mar- regolamenti lokali għal sostanzi radjuattivi.
Colourless Type I glass 2-ml vial, closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
Kunjett tal- ħġieġ tat- Tip 1 ta ’ 2 ml, mingħajr kulur, magħluq b’ tapp tal- gomma bromobjutajl, miksi bit- Teflon u b’ siġill ta ’ l- aluminju.
1 vial contains 0.5 to 2 ml (corresponding to 0.925 to 3.700 GBq calibrated three or four days after the manufacturing date) depending on the ordered radioactivity.
Dan jiddependi fuq ir- radjuattività ordnata.
The vial is supplied in a lead pot of appropriate thickness.
Il- kunjett jiġi mogħti f’ reċipjent taċ- ċomb ta ’ ħxuna xierqa.
The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
L- għoti ta ’ prodotti mediċinali radjuattivi joħloq riskji għal persuni oħra minn radjazzjoni esterna jew kontaminazzjoni minn tixrid ta ’ l- awrina, remettar, eċċ.
See section 12, for detailed instructions of product preparation.
Ara sezzjoni 12, għal struzzjonijiet dettaljati sabiex tipprepara l- prodott.
24/ 03/ 2003 Date of the last renewal:
24/ 03/ 2003 Data ta ’ l- aħħar reviżjoni:
DOSIMETRY
11 DOŻIMETRIJA
The radiation dose received by the various organs following administration of a Yttrium (90Y)-labelled medicinal product will be dependent on the specific pharmaceutical being radiolabelled.
Id- doża ta ’ radjazzjoni li jirċievu l- organi differenti wara l- għoti ta ’ prodott mediċinali radjutikkettat b’ Yttrium (90Y) tiddependi fuq il- prodott mediċinali speċifiku li jkun qiegħed jiġi radjutikkettat.
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.
L- informazzjoni dwar id- dożimetrija tar- radjazzjoni ta ’ kull prodott mediċinali differenti wara l- għoti ta ’ prodott radjutikkettat, għandha tkun disponibbli fit- Karatteristiċi tal- Prodott fil- Qosor/ fuljett tal - pakkett tal- prodott mediċinali partikolari li għandu jiġi radjutikkettat.
The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of YTRACIS.
It- tabella ta ’ dożimetrija ta ’ hawn taħt, ġiet inkluża biex tivvaluta l- kontribuzzjoni ta ’ Yttrium (90Y) mhux konjugat għad- doża ta ’ radjazzjoni wara l- għoti ta ’ prodott mediċinali radjutikkettati b’ Yttrium (90Y), jew li jirriżulta minn injezzjoni aċċidentali ġol- vina ta ’ YTRACIS.
The dosimetry estimates were based on a rat biodistribution study and the calculations were effected in accordance with MIRD/ ICRP 60 recommendations.
L- istimi tad- dożimetrija kienu bbażati fuq studju tal- bijodistribuzzjoni fil- far, u l- kalkoli ġew magħmulin b’ mod konformi mar- rakkommandazzjoni tal- MIRD/ ICRP 60.
Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 days, 4 days and 15 days.
Il- kejl tad- dożi ttieħdu wara 5 minuti, siegħa 1, 6 sigħat, jum 1, 4t’ ijiem u 15- il jum.
Organ doses (mGy/ MBq injected) and effective dose (Sv/ GBq injected).
7 Dożi fl- organi (mGy/ MBq injettati) u doża effettiva (Sv/ GBq injettata)
Absorbed dose per unit activity administered (mGy/ MBq) Adult male Adult female
Doża assorbita għal kull unità t’ attività waħda mogħtija (mGy/ MBq) (mGy/ MBq)
Organ
Tarbija tat -
70 kg
Organu
1
10 snin
1 year
Sena 1
New Born
twelid
Kidneys Liver Bladder Ovaries Uterus Spleen Bone Heart Lungs
Kliewi Fwied
5.06 2.41 2.11 --- --- 0.85 0.30 0.26 0.11
5. 06 5. 50 2. 41 3. 29
5.50 3.29 2.78 0.88 0.29 1.04 0.29 0.33 0.14
6. 10 3. 29
6.10 3.29 2.78 0.92 0.3 1.27 0.29 0.34 0.17
8. 75 5. 20
8.75 5.20 4.31 3.1 5.7 2.02 0.53 0.54 0.24
13. 0 7. 89
13.0 7.89 6.87 5.6 8.8 3.23 0.98 0.87 0.37
24. 1 15. 8
24.1 15.8 13.5 13.6 16.3 6.12 1.37 1.60 0.75
66. 1 38. 1
66.1 38.1 35.8 29.6 6.15 17.1 2.41 3.18 2.13
Bużżieqa ta ’ l- awrina
Intestines Muscles Testes
2. 11
0.10 0.05 0.01
2. 78
0.11 0.08 ---
2. 78
0.13 0.09 0.03
4. 31
0.23 0.20 0.23
6. 87
0.39 0.68 0.26
13. 5
0.78 1.36 0.36
35. 8
2.02 1.79 0.51
--- --- 0. 85 0. 30 0. 26 0. 11 0. 10 0. 05 0. 01
Effective dose (Sv/ 1 GBq administered)
3. 1 5. 7 2. 02 0. 53 0. 54 0. 24 0. 23 0. 20 0. 23
Adult male Adult female
5. 6 8. 8 3. 23 0. 98 0. 87 0. 37 0. 39 0. 68 0. 26
1
Doża effettiva (Sv/ 1 GBq mogħtija) Tarbija tat -
5
5 snin
0.65 0.70
0. 65 0. 70 0. 74
2.50
1. 50
5.42
2. 50
12.8
5. 42
8 12.
12. 8
Before use, packaging and radioactivity should be checked.
Qabel l- użu, l- ippakkjar u r- radjuattività għandhom jiġu ikkontrollati.
Activity may be measured using an ionisation chamber.
L- attività tista ’ tiġi mkejla billi jintuża kompartiment ta ’ jonizzazzjoni.
Yttrium (90Y) is a beta pure emitter.
Yttrium (90Y) huwa emettur pur tar- raġġi beta.
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.
Il- kejl ta ’ l - attività bl- użu ta ’ kompartiment ta ’ jonizzazzjoni huwa sensittiv ħafna għal fatturi ġejometriċi u għalhekk għandu jsir taħt kondizzjonijiet ġejometriċi li qabel kienu ġew validati b’ mod xieraq.
Usual precautions regarding sterility and radioactivity should be respected.
Għandhom jiġu rispettati l- prekawzjonijiet dwar l- isterilità u r- radjuattività.
The vial should never be opened and must be kept inside its lead shielding.
Il- kunjett qatt ma għandhu tinfetaħ u għandhu jinżamm fl- ilqugħ taċ- ċomb tagħha.
The product should be aseptically withdrawn through the stopper using sterilised single use needle and syringe after disinfection of the stopper.
Dan għandu jsir wara d- disinfettar tat- tapp.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Pharmaceutical Manufacturing Practice, in order to maintain the sterility of YTRACIS and to maintain sterility throughout the labelling procedures.
Għandhom jittieħdu prekawzjonijiet asettiċi xierqa, li jikkonformaw mal- ħtiġiet ta ’ Prattika ta ’ Manifattura Farmaċewtika Tajba, sabiex tinżamm l- isterilità ta’ YTRACIS u sabiex tinżamm l- isterilità matul il- proċeduri ta ’ mmarkar radjuattiv kollha.
10 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CIS bio international Boîte Postale 32 91192 GIF-SUR-YVETTE Cedex France
CIS bio international Boîte Postale 32 91192 GIF- SUR- YVETTE Cedex Franza
Not applicable
10 ANNESS III
11 ANNEX III
11 A. TIKKETTA
12 A. LABELLING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA JEW, FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
METALLIC BOX / LEAD POT
KAXXA METALLIKA / KONTENITUR TAĊ- ĊOMB
YTRACIS Radiopharmaceutical precursor, solution.
Prekursur Radjufarmaċewtiku YTRACIS, Soluzzjoni.
Yttrium (90Y) chloride
Yttrium chloride (90Y)
Yttrium (90Y) chloride 1.850 GBq/ ml
Yttrium chloride (90Y) 1. 850 GBq/ ml
Hydrochloric acid 30%, water for injections.
Hydrochloric acid 30%, ilma għall- injezzjoni.
Radiopharmaceutical precursor, solution.
Prekursur Radjufarmaċewtiku, soluzzjoni.
1 vial Vol.:
Kunjett wieħed Vol.:
{Y} GBq/ vial Act.:
{Y} GBq/ kunjett Att.:
Cal:
Kal:
{DD/ MM/ YYYY} (12 h CET) Cal:
{ĠĠ/ XX/ YYYY} (12 h CET) Kal:
{DD/ MM/ YYYY} (12 h CET)
{ĠĠ/ XX/ YYYY} (12 h CET)
For in vitro radiolabelling.
MHUX INTENZJONAT GĦAL APPLIKAZZJONI DIRETTA FUQ IL- PAZJENTI Għal immarkar radjuattiv in vitro.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAM FEJN MA JINTALĦAQX U MA JIDĦIRX MIT- TFAL
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXP {DD/ MM/ YYYY} (12h CET)
JIS {ĠĠ/ XX/ SSSS} (12h CET)
Store in the original package.
Aħżen fil- pakkett oriġinali tiegħu.
Storage should be in accordance with local regulations for radioactive substances.
Il- ħażna għandha tkun skond ir- regolamenti lokali dwar sustanzi radjuattivi.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA 'PRODOTT MEDIĊINALI MHUX UŻAT JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
CIS bio international BP 32 F-91192 GIF-SUR-YVETTE Cedex France
CIS bio international BP 32 F- 91192 GIF- SUR- YVETTE Cedex Franza
Batch N°:
Lott:
Medical product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
GLASS VIAL
KUNJETT TAL- ĦĠIEĠ
YTRACIS Yttrium (90Y) chloride
Yttrium (90Y) chloride
For in vitro radiolabelling.
Għal radjutikkettar in vitro.
NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS
MHUX INTENZJONAT GĦAL APPLIKAZZJONI DIRETTA FUQ IL - PAZJENTI
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI NDIVIDWALI
{Y}________GBq/ vial
{Y} ________ GBq/ kunjett Kal.:
{DD/ MM/ AAAA} (12h CET)
{ĠĠ/ XX/ SSSS} (12h CET)
16 B. PACKAGE LEAFLET
16 FULJETT TA ’ TAGĦRIF:
YTRACIS radiopharmaceutical precursor, solution.
YTRACIS prekursur radjufarmaċewtiku, soluzzjoni.
Yttrium (90Y) chloride.
Yttrium chloride (90Y).
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel ma tibda 'tieħu din il- mediċina.
please tell your doctor or pharmacist
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew tiegħek
What YTRACIS is and what it is used for 2.
X' inhu YTRACIS u għalxiex jintuża 2.
Before you use YTRACIS 3.
Qabel ma tuża YTRACIS 3.
How to use YTRACIS 4.
Kif għandek tuża YTRACIS 4.
Possible side effects 5 How to store YTRACIS 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen YTRACIS 6.
WHAT YTRACIS IS AND WHAT IT IS USED FOR
X' INHU YTRACIS U GĦALXIEX JINTUŻA
YTRACIS is a radioactive medicine used in combination with another medicine product which targets specific body cells.
YTRACIS hija mediċina radjuattiva li tintuża flimkien ma ’ prodott mediċinali ieħor li huma mmirati għal ċelloli speċifiċi tal- ġisem.
When the target is reached, Ytracis gives tiny radiation doses to these specific sites.
Meta t- tragward jintlaħaq, Ytarcis jitfa dożi ċkejknin ta ’ radjazzjoni f’ dawn is- siti speċifiċi.
For further information regarding the treatment and possible effects caused by the medicinal product to be radiolabelled please refer to the package leaflet of the medicinal product to be radiolabelled.
Għal aktar informazzjoni dwar il- kura u l- effetti possibbli kkawżati mill- prodott mediċinali li sejjer jiġi radjutikkettat, jekk jogħġbok irreferi għall- fuljett ta ’ tagħrif tal- prodott mediċinali li sejjer jiġi radjutikkettat.
BEFORE YOU USE YTRACIS
QABEL MA TUŻA YTRACIS
- if you are hypersensitive (allergic) to Yttrium (90Y) chloride or any of the other ingredients of
Tużax YTRACIS: jekk inti tbati minn sensittività eċċessiva (allerġiku) għall- Yttrium chloride (90Y) jew sustanzi l -
YTRACIS.
oħra ta 'YTRACIS.
- if you are pregnant or if there is a possibility that you might be pregnant (see below).
- jekk inti tqila jew jekk hemm il- possibilità li inti tqila (ara hawn taħt).
YTRACIS is not to be administered directly to the patient.
Oqgħod attent ħafna b’ YTRACIS YTRACIS ma għandux jiġi mogħti direttament lill- pazjent.
Because there are strict laws covering the use, handling and disposal of radioactivity, YTRACIS will always be used in a hospital or a similar setting.
Minħabba li jeżistu liġijiet stretti dwar l- użu, l- immaniġġjar u r- rimi tar- radjuattività, YTRACIS għandu jintuża biss fi sptar jew f’ postijiet simili.
It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Għandu jkun immaniġġjat u mogħti minn nies imħarrġa u kkwalifikati fl- immanniġġjar sikur ta 'materjal radjuattiv.
18 Pregnancy:
17 Tqala:
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu kwalunkwe mediċina.
It is important to tell your doctor if there is any possibility that you are pregnant.
Huwa mporatanti li tgħid lit- tabib tiegħek jekk hemm xi possibilità li inti tqila.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Mara li ma jiġihiex il - pirjid darba għandha titqies tqila qabel ma jiġi ppruvat mod ieħor.
Alternative techniques which do not involve radioactive medicines should always be considered.
Tekniki alternattivi li ma jinvolvux mediċini radjuattivi għandhom dejjem jiġu kkunsidrati.
Breast-feeding:
Jekk qed tredda ’:
Ask your doctor or pharmacist for advice before taking any medicine.
Saqsi lit- tabib jew lill- ispiżjar tiegħek qabel ma tieħu kwalunkwe mediċina.
You will be asked to stop breast-feeding.
Se tkun mitluba sabiex tieqaf tredda '.
Driving and using machines:
Sewqan u t- tħaddim ta ’ magni:
No studies on the effects on the ability to drive and use machines have been performed.
Ma saru ebda studji fuq il- ħila li ssuq u li tħaddem magni.
No interactions of Yttrium (90Y) chloride with other medicinal products are known because no studies have investigated this issue.
Mhux magħruf jekk hemmx interazzjonijiet ta ’ Yttrium (90Y) chloride ma ’ prodotti mediċinali oħra peress li għad ma kienx hemm studji li stħarrġu dan.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anke dawk mingħajr riċetta.
HOW TO USE YTRACIS
KIF GĦANDEK TUŻA L- YTRACIS
YTRACIS is not to be administered directly to the patient.
YTRACIS ma għandux jiġi mogħti direttament lill- pazjent.
Dosage Your physician will decide on the amount of YTRACIS to be used in your case.
Dożaġġ It- tabib tiegħek jiddeċidi dwar l- ammont ta 'YTRACIS li għandu jintuża fil- każ tiegħek.
Method of Administration YTRACIS is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Metodu ta 'kif jintuża YTRACIS huwa maħsub għar - radjo- labiling ta' prodotti mediċinali li jikkuraw mard speċifiku, li wara jigħataw skond il- mod approvat.
If you use more YTRACIS than you should Since YTRACIS is administered by a doctor under strictly controlled conditions there is little chance of possible overdose.
Jekk tuża YTRACIS aktar milli suppost għandek Minħabba li l- YTRACIS jiġi mogħti minn tabib taħt kundizzjonijiet ikkontrallati b' mod strett, il - possibbiltà li tittieħed doża eċċessiva hija żgħira.
However, should this occur, you will receive appropriate treatment from your doctor.
Madankollu, jekk dan jiġri, inti tirċievi l- kura li jkollok bżonn mit- tabib tiegħek.
Like all medicines, YTRACIS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, YTRACIS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Għal aktar informazzjoni, irreferi għall- fuljett ta ’ tagħrif tal- prodott mediċinali li sejjer jiġi radjuttikkettjat.
HOW TO STORE YTRACIS
KIF TAĦŻEN YTRACIS
Do not use after the expiry date and time stated on the label.
Ma għandekx tuża wara d- data w l- ħin li jidhru fuq it- tikketta.
Store in accordance with local regulations for radioactive substances.
Aħżen skond ir- regolamenti lokali dwar is- sustanzi radjuattivi.
The product label includes the appropriate storage conditions and the expiry date for the batch of product.
It- tikketta tal- prodott tinkludi kundizzjonijiet ta ’ ħażna xierqa u d- data ta ’ skadenza għal- lott tal - prodott.
Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Il- personel ta ’ l- isptar għandu jiżgura li l- prodott jiġi maħżun korrettament u ma jiġix mogħti lilek wara d- dtat ta ’ skadenza dikjarata.
What YTRACIS contains
X’ fih YTRACIS:
- The active substance is Yttrium (90Y) chloride.
Is- sustanza attiva hi l- Yttrium (90Y) chloride.
Each millilitre of solution contains 1.850 GBq of Yttrium (90Y) chloride at the date of calibration. (GBq:
Kull millilitru ta ’ soluzzjoni fih 1. 850 GBq ta ’ Yttrium (90Y) chloride fid- data ta ’ 'kalibrazzjoni,
GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
GigaBecquerel hi l- junit li jkejjel l- ammont ta ’ radjuattività)
- The other ingredients are hydrochloric acid and water for injections.
- Is- sustanzi l- oħra huma hydrochloric acid u ilma għall- injezzjoni
What YTRACIS looks like and contents of the pack
Id- Dehra ta ’ YTRACIS u l- kontenuti tal- pakkett:
YTRACIS is a radiopharmaceutical precursor.
YTRACIS hu prekursur radjufarmaċewtiku
This medicine is a clear and colourless solution which is packed in a colourless Type I glass 2-ml vial closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
Din il- mediċina tikkonsisti minn soluzzjoni ċara u mingħajr kulur u hi ppakkjata f’ kunjetti tal- ħġieġ mingħajr kulur ta ’ Tip I magħluqin b’ lastku tal- bromobutyl miksi bit- Teflon u b’ siġill li jgħatti ta ’ l - aluminju
A vial contains 0.5 ml (0.925 GBq at calibration) to 2 ml (3.700 GBq at calibration).
5 (0. 925 GBq malli jiġi kkalbrat) sa 2 ml (3. 700 Gbq malli jiġi kkalibrat)
CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette Cedex FRANCE
CIS bio international Boîte Postale 32 F- 91192 Gif- sur- Yvette Cedex FRANZA
20 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
19 Għall- kull tagħrif dwar din il- mediċina, jekk jogħġbok agħmel kuntatt mar- rappreżentant lokali tad - Detenetur ta ’ lAwtorizzazzjoni għat- tqegħid fis- Suq.
This leaflet was last approved on ().
Dan il- fuljett kien approvat l- aħħar f ’ {}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
For detailed information refer to the Summary of Product Characteristics of YTRACIS.
Għal tagħrif dettaljat irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott ta 'YTRACIS.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Yttriga?
X' inhu Yttriga?
Yttriga is a radioactive liquid, which contains the active substance yttrium (90Y) chloride.
Yttriga huwa likwidu radjuattiv, li fih is- sustanza attiva yttrium (90Y) chloride.
90Y, yttrium-90, is a radioactive form of the chemical element yttrium.
90Y, yttrium- 90 huwa forma radjuattiv ta ’ l- element kimiku yttrium.
What is Yttriga used for?
Għal x' hiex jintuża Yttriga?
Yttriga is used for radiolabelling.
Yttriga jintuża għal- radju- tikkettjar.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Radju- tikkettjar huwa teknika fejn sustanza tiġi ttikkettjata b’ sustanza radjuattiva.
In the case of Yttriga, the product is used to label medicines that have been specially developed for use with the active substance yttrium (90Y) chloride.
Fil- każ ta ’ Yttriga, il- prodott jintuża bħala tikketta għall- mediċini li ġew żviluppati speċifikament biex jintużaw mas- sustanza attiva yttrium (90Y) chloride.
These medicines act as carrier to take the radioactivity to where it is needed.
Dawn il- mediċini jaġixxu bħala ġarriera tar- radjuattività għal fejn ikun hemm bżonn.
These may be substances such as antibodies that have been designed to recognise a particular type of cells in the body, including tumour cells.
Dawn jistgħu ikunu sustanzi bħal antikorpi li ġew imfasslin biex jagħrfu tip ta ċelloli partikolari tal- ġisem, inkluż ċelloli tat- tumur.
The effects of the medicine that is radiolabelled with Yttriga will be fully explained in its Package Leaflet.
L - effetti tal- mediċina li hija radju- tikkettjata bħala Yttriga ser jiġu spjegati bis- sħiħ fil- Fuljett ta ’ Tagħrif.
How is Yttriga used?
Kif jintuża Yttriga?
Yttriga will only be handled and given by people who have experience in the safe handling of radioactive material.
Yttriga jintmess biss u jingħata biss minn nies li huma esperjenzati fl- immaniġjar ta ’ materjal radjuattiv.
Yttriga is never given on its own.
Yttriga qatt ma jingħata waħdu.
It must be mixed outside the body, usually in a laboratory, with the medicine that needs radiolabelling.
Jeħtieġ jiġi mħallat barra mill- ġisem, ġeneralment f’ xi laboratorju, mal- mediċina li għandha bżonn radju- tikkettjar.
The yttrium-90 contained in Yttriga then attaches itself to the carrier medicine and the resulting mixture is given according to the Package Leaflet of the carrier medicine.
Imbagħad, Yttrium- 90 li hemm f’ Yttriga jeħel mal - mediċina ġarriera u t- taħlita li tirriżulta tingħata skond il- Fuljett ta ’ Tagħrif tal- mediċina ġarriera.
The quantity of Yttriga needed for radiolabelling and the dose of the radiolabelled medicine that is then given will depend on the medicine that is radiolabelled and the disease that is being treated.
Il - kwantità ta ’ Yttriga meħtieġa għar- radju- tikkettjar, u d- doża tal- mediċina radju- tikkettjata li mbagħad għandha tingħata jiddependu fuq il- mediċina li qed tiġi radju- tikkettjata u l- marda li qed tiġi trattata.
How does Yttriga work?
Kif jaħdem Yttriga?
The active substance in Yttriga, yttrium (90Y) chloride, is a radioactive compound.
Is- sustanza attiva f’ Yttriga, yttrium (90Y) chloride, hija sustanza radjuattiva.
It emits beta radiation.
Hija tarmi radjazzjoni tat - tip beta.
The effect of Yttriga depends on the nature of the carrier medicine that is radiolabelled with Yttriga.
L- effett ta ’ Yttriga jiddependi fuq in- natura tal- mediċina ġarriera li ġiet radju- tikkettjata b’ Yttriga.
An example of its use is the treatment of some type of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour.
Eżempju ta ’ l- użu tagħha huwa fit- trattament ta ’ xi tipi ta ’ tumuri, fejn il- mediċina radju - tikkettjata ġġorr ir- radjuattività għas- sit tat- tumur.
Once there, the radioactivity from Yttriga helps to destroy the tumour.
Ladarba tkun hemm, ir- radjuattività minn Yttriga tgħin biex teqred it- tumur.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Yttriga been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Yttriga?
As Yttriga is a ‘ precursor’ and will not be given on its own, no studies have been done in humans.
Minħabba li Yttriga huwa ‘ prekursur ’ u ma jingħatax waħdu, ma sar ebda studju fuq in- nies.
The company presented information from scientific articles already published on 90Y.
Il - kumpanija ppreżentat informazzjoni minn artikli xjentifiċi fuq 90Y li diġà kienu ġew ippubblikati.
The company also presented published information showing the utility of 90Y to radiolabel other medicines, including one study of non-Hodgkin’ s lymphoma (a cancer of the lymph tissue, part of the immune system).
Il - kumpanija ippreżentat ukoll informazzjoni li turi l- utilità ta ’ 90Y biex tittikkettja r- radjuttività għall - mediċini oħra, inkluż studju wieħed fuq il- limfoma non- Hodgkins (kanċer tat- tessut limfatiku, parti mis- sistema imuni).
What benefit has Yttriga shown during the studies?
X' benefiċċji ta 'Yttriga intwerew f' dawn l- istudji?
The information supplied by the company shows the utility of Yttriga as a precursor to radiolabel medicines with 90Y.
L- informazzjoni li ġiet ipprovduta mill- kumpanija turi li Yttriga hija utili bħala prekursur għal radju - tikkettjar ta ’ mediċini b’ 90Y.
What is the risk associated with Yttriga?
X' inhu r- riskju assoċjat ma 'Yttriga?
As Yttriga is a precursor and will not be given on its own, it has no side effects.
Minħabba li Yttriga huwa prekursur u ma jingħatax waħdu, m’ għandux effetti sekondarji.
Patients may experience side effects following the injection of a medicine radiolabelled with Yttriga.
Pazjenti jistgħu jesperjenzaw xi effetti sekondarji wara l- injezzjoni ta ’ mediċina radju- ttikkettjata b’ Yttriga.
These side effects will depend on the medicine being used, and they will be described in the Package Leaflet of the medicine labelled with Yttriga.
Dawn l- effetti sekondarji jiddependu fuq il- mediċina li qed tintuża, u ser jiġu deskritti fil- Fuljett ta ’ Tagħrif tal- mediċina b’ tikketta ta ’ Yttriga.
Yttriga is radioactive and its use may carry a risk of cancer and hereditary defects.
Yttriga huwa radjuattiv u l- użu tiegħu jista ’ jġorr riskju ta ’ kanċer u difetti ereditarji.
The doctor who prescribes Yttriga must ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
It- tabib li jippriskrivilek Yttriga għandu jiżgura li r- riskji assoċjati ma ’ l - espożizzjoni għar- radjuattività huma iżgħar mill- marda nfisha.
Yttriga must not be given directly to any patient.
Yttiga m’ għandux jingħata direttament lill- pazjent.