qanastek/EMEA-V3 huggingface dataset:
Medicines radiolabelled with Yttriga should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients.
Mediċini radju- tikkettjati b’ Yttriga m’ għandhomx jintużaw f’ nies li jista ’ jkollhom sensitività eċċessiva (allerġija) għal yttrium chloride jew xi sustanza oħra tiegħu.
A medicine labelled with Yttriga should not be used in women who are or may be pregnant.
Mediċina ttikkettjata b’ Yttriga m’ għandhiex tintuża f’ nisa li huma jew li jistgħu jkunu tqal.
More information on the restrictions for the medicines radiolabelled with Yttriga will be given in the Package Leaflet of the medicine labelled with Yttriga.
Aktar informazzjoni dwar ir- restrizjonijiet fuq il- mediċini li huma radju- tikkettjati b’ Yttriga ser tingħata fil- Fuljett ta ’ Tagħrif tal- mediċina li għandha tikketta b’ Yttriga.
Why has Yttriga been approved?
Għaliex ġie approvat Yttriga?
The Committee for Medicinal products for Human Use (CHMP) decided that Yttriga’ s benefits are greater than its risks for the for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Il- Kumitat għall- prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Yttriga jisbqu r- riskji tiegħu għar- radju- tikkettjar ta ’ molekuli ġarriera, li kienu ġew żviluppati speċifikament u awtorizzati għal radju- tikkettjar b’ dan il- radionuclide.
They recommended that Yttriga be given marketing authorisation.
Irrikmanda li Yttriga jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Yttriga:
Tagħrif ieħor dwar Yttriga:
The European Commission granted a marketing authorisation valid throughout the European Union for Yttriga to QSA Global GmbH on 19 January 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Yttriga valida fl- Unjoni Ewropea kollha lil QSA Global GmbH fid- 19 ta ’ Jannar 2006.
The full EPAR for Yttriga is available here.
L- EPAR sħiħ għal Yttriga huwa disponibbli minn hawnhekk.
This summary was last updated in 01-2007
Dan is- sommarju ġie aġġornat l- aħħar f’ 01- 2007
Yttriga radiopharmaceutical precursor, solution.
Yttriga prekursur radjufarmaċewtiku, soluzzjoni
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
1 ml ta ’ soluzzjoni sterili fiha 0. 1- 300 GBq Yttrium (90Y) fid- data u l- ħin tar- referenza (li jikkorrispondu għal 0. 005- 15 mikrogrammi ta ’ Yttrium [90Y]) (bħala Yttrium [90Y] chloride).
Each vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Kull kunjett fih 0. 1- 300 GBq, li jikkorrispondi għal 0. 005- 15 mikrogrammi ta ’ Yttrium (90Y), fid- data u l- ħin tar- referenza.
The volume is 0.02-5 ml.
Il- volum hu 0. 02- 5 ml.
The theoretical specific activity is 20 GBq/ microgram of Yttrium (90Y) (see section 6.5).
L- attività speċifika teoretika hi 20 GBq/ mikrogrammi ta ’ Yttrium (90Y) (ara sezzjoni 6. 5).
Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Yttrium (90Y) chloride hu prodott bit- taħsir tal- prekursur radjuattiv tiegħu Strontium (90Sr).
It decay by emission of beta radiation of 2.281 MeV (99.98%) of maximal energy to stable Zirconium (90Zr).
Jinbidel bil- mod bir- radjuattività bl- emissjoni ta ’ radjazzjoni beta ta ’ 2. 281 MeV (99. 98%) ta ’ enerġija massimali għal Zirconium (90Zr) stabbli.
Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).
Yttrium (90Y) għandu half- life ta ’ 2. 67 ġranet (64. 1 siegħa).
Radiopharmaceutical precursor, solution.
Prekursur radjufarmaċewtiku, soluzzjoni
Clear colourless solution, free of particulate matter.
Solużżjoni ċara bla kulur, ħielsa minn materjal f’ sura ta ’ partikuli.
To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Biex jintuża biss għar- radjutikkettar tal- molekuli carrier, li kienu żviluppati speċifikament u awtorizzati għar- radjutikkettar ma ’ dan ir- radjunuklid.
Radiopharmaceutical precursor - Not intended for direct use in patients.
Prekursur radjufarmaċewtiku – Mhux intenzjonat għall- użu dirett fil- pazjenti
Yttriga is only to be used by specialists experienced with in vitro radiolabelling
Yttriga għandu jintuża biss minn speċjalisti li għandhom esperjenza ta ’ radjutikkettar in vitro.
The quantity of Yttriga 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 ’ Yttriga li hi meħtieġa għar- radjutikkettar u l- kwantità tal- prodott mediċinali Yttrium (90Y) - ittikkettat li hu sussegwentement mogħti ser tiddependi mill- prodott mediċinali radjutikkettat u l - użu intenzjonat tiegħu.
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal - prodott mediċinali partikulari li ser ikun radjutikkettat.
Method of administration
Kif għandu jingħata:
Yttriga is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.
L- għan ta ’ Yttriga hu l- ittikkettar in vitro tal- prodotti mediċinali li huma sussegwentement mogħtija mir- rotta approvata.
Do not administer Yttriga directly to the patient.
Tagħtix Yttriga direttament lill- pazjent.
Yttriga is contraindicated in the following cases:
Yttriga hu kontra- indikat f’ dawn il- każi li ġejjin:
2
2 Sensittività eċċessiva għal Yttrium (90Y) chloride jew għal xi sustanzi mhux attivi.
- Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6)
- Meta jkun stabbilit li hemm tqala jew suspett ta ’ tqala jew meta t- tqala ma tkunx eskluża (ara
For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga refer the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Għal tagħrif dwar il- kontra- indikazzjonijiet għall- prodotti mediċinali partikulari Yttrium (90Y) - ittikkettati u ppreparati permezz tar- radjutikkettar ma ’ Yttriga, irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal- prodotti mediċinali partikulari li ser ikun radjutikkettat.
The contents of the vial of Yttriga 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 ’ Yttriga m’ għandux jingħata direttament lill- pazjent imma jrid jintuża għar - radjutikkettar tal- molekuli carrier, bħal antikorpi monoklonali, peptidi jew sottostrati oħra.
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.
Ir- Radjufarmaċewtiċi għandhom ikunu rċevuti, użati u mogħtija minn persuni awtorizzati biss f’ ambjent kliniku għal ta ’ l- apposta, u l- irċevuta, l- ħażna, l- użu, it- trasferiment u r- rimi huma suġġetti għar- regolamenti u l- liċenzji adattati ta ’ l- awtoritajiet kompetenti.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Ir- radjufarmaċewtiċi għandhom ikunu ppreparati minn min juża l- prodott b’ mod li jissodisfa l - kundizzjonijiet tas- sigurtà tar- radjazzjoni u tal- kwalità farmaċewtika.
For information concerning special warnings and special 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 tagħrif dwar twissijiet speċjali u prekawzjonijiet speċjali għall- użu tal- prodotti mediċinali Yttrium (90Y) - ittikkettati, irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal - prodott mediċinali li ser ikun radjutikkettat.
Particular care should be taken when administering radioactive medicinal products to children and adolescents.
Għandha tingħata attenzjoni partikulari meta ikunu qed jingħataw prodotti mediċinali radjuattivi lit - tfal u lill- adoloxxenti.
No interaction studies of Yttrium (90Y) chloride with other medicinal products have been performed, because Yttriga is a precursor solution for radiolabelling medicinal products.
Ma sarux studji dwar l- effett ta ’ Yttrium (90Y) chloride fuq prodotti mediċinali oħra, għax Yttriga hu soluzzjoni prekursura għar- radjutikkettar ta ’ prodotti mediċinali.
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 tagħrif dwar l- effetti assoċjati ma ’ l- użu ta ’ Yttrium (90Y) - ittikkettat irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal- prodotti mediċinali li ser ikunu radjutikkettati.
Before administration of a Yttrium (90Y)-labelled medicinal product pregnancy has to be excluded.
Qabel l- għoti tal- prodott mediċinali Yttrium (90Y) - ittikkettat, it- tqala trid tkun eskluża.
Alternative techniques which do not involve ionising radiation should always be considered.
Tekniċi alternattivi li ma jinvolvux ir- radjazzjoni jonizzanti għandhom dejjem ikunu meqjusa.
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 breastfeeding.
Qabel l- għoti ta ’ prodott mediċinali radjuattiv lil omm li qed tredda ’, wieħed għandu jara jekk l - investigazzjoni tistax tkun posposta b’ mod raġjonevoli sakemm l- omm ma tibqax tredda ’ aktar.
If the administration cannot be delayed, a lactating mother should be advised to stop breastfeeding.
Jekk l - l- għoti ma jistax ikun pospost, omm li qed tredda ’ għandha tingħata l- parir li tieqaf tredda ’.
Further information concerning the use of a Yttrium (90Y)-labelled medicinal in pregnancy and lactation is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Aktar tagħrif dwar l- użu ta ’ prodott mediċinali Yttrium (90Y) - tikkettat fit- tqala u treddigħ hu speċifikat fis- Sommarju tal- Karatteristiċi tal- Prodott tal- prodott mediċinali li ser ikun radjutikkettat.
Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelIed.
L- effetti fuq il- ħila biex issuq u tħaddem magni wara t- trattament bil- prodotti mediċinali li huma Yttrium (90Y) - ittikkettati ser ikunu speċifikati fis- Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal- prodott mediċinali li ser ikun radjutikkettat.
Possible side effects following the intravenous administration of Yttrium (90Y)-labelled a medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used.
Effetti sekondarji li jistgħu jiġru wara l- għoti ġol- vini ta ’ prodott mediċinali Yttrium (90Y) - ittikkettat ippreparat bir- radjutikkettar ma ’ Yttriga, ser jiddependu fuq il- prodott mediċinali speċifiku li qed jintuża.
Such information will be supplied in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Dan it- tagħrif ser jingħata f’ Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal - prodott mediċinali li ser ikun radjutikkettat.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit.
Għal kull pazjent, l- esponiment għar- radjazzjoni jonizzanti trid ikun iġġustifikata skond il- benefiċċji kliniċi li x’ aktarx ser ikun hemm.
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.
L- attività mogħtija trid tkun tali li d- doża tar- radjazzjoni tirriżulta baxxa kemm jista ’ jkun b’ mod raġjonevoli u wieħed irid iżomm f’ moħħu il- bżonn li jinkiseb ir- riżultat terapewtiku mixtieq.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
L- esponiment għar- radjazzjoni jonizzanti hi marbuta ma ’ l- induzzjoni tal- kanċer u l- potenzjal għall - iżvilupp ta ’ difetti ereditarji.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Id- doża tar- radjazzjoni li tirriżulta minn esponiment terapewtika għandha mnejn tirriżulta f’ inċidenza ogħla 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- każi kollha, hemm bżonn li jiġu aċċertati r- riskji tar- radjazzjoni huma inqas mill- marda innifisha.
The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga will lead to increased bone marrow toxicity and haematopoetic stern cell damage.
Il- preżenza ta ’ Yttrium (90Y) chloride liberu fil- ġisem wara l- għoti bi żball ta ’ Yttriga ser iwassal għal żieda fit- tossiċità fil- mudullun ta ’ l- għadam u ħsara fiċ- ċelluli staminali ematopoetiċi.
Therefore, in case of an inadvertent administration of Yttriga, 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 ’ l- għoti bi żball ta ’ Yttriga, ir- radjutossiċità għall- pazjent trid titnaqqas bl- għoti immedjat (i. e. fi żmien siegħa) ta ’ preparazzjonijiet li fihom kelaturi bħal Ca- DTPA jew Ca- EDTA biex tiżdied l- eliminazzjoni tar- radjunuklid mill- ġisem.
The following preparations must be available in medical institutions, which use Yttriga for labelling of carrier molecules for therapeutic purposes:
Il- preparazzjonijiet li ġejjin iridu jkunu disponibbli f’ istituzzjonijiet mediċi, li jużaw Yttriga għall - ittikkettar tal- molekuli carrier għal raġunijiet terapewtiċi:
- Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or
- Ca- DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew
- Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
- 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 is- sustanzi kelaturi jrażżnu ir- radjutossiċità ta ’ yttrium permezz ta ’ skambju bejn il- jone tal - calcium u yttrium minħabba l- ħila tagħhom li jiffurmaw kumplessi li jinħallu fl- ilma mal- ligandi kelaturi (DTPA, EDTA).
These complexes are rapidly eliminated by the kidneys.
Dawn il- kumplessi jitneħħew 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).
1 g ta ’ sustanzi kelaturi għandu jingħata permezz ta ’ injezzjoni ġol- vina bil- mod fuq firxa ta ’ minn 3 sa 4 minuti jew bl- infużjoni (1 g f’ 100 – 250 ml ta ’ dextrose, jew ilma bil- melħ normal).
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- effikaċja kelatriċi tilħaq l- ogħla livell minnufih jew fi żmien siegħa mill- esponiment meta r - radjunuklid ikun qed jiċċirkola jew ikun disponibbli għall- fluwidi tat- tessuti u l- plażma.
However, a post-exposure interval > 1 hour does not preclude the administration and effective action of chelator with reduced efficiency.
Imma, intervall ta ’ wara l- esponiment ta ’ > 1 siegħa ma jeskludix l- għoti u l- azzjoni effettiva ta ’ kelaturi b’ effiċjenza mnaqqsa.
Intravenous administration should not be protracted over more than 2 hours.
L- għoti ġol- vini m’ għandux idum aktar 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.
Hu x’ inhu l- każ, il- parametri tad- demm tal- pazjent iridu jkunu mmonitorjati u jridu jittieħdu minnufih il- miżuri adattati jekk hemm evidenza ta ’ ħsara lill- 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.
It- tossiċità ta ’ Yttrium (90Y) liberu minħabba l- ħruġ in- vivo mill- bijomolekula ttikkettata fil- ġisem matul it- terapija tista ’ titnaqqas bl- għoti ta ’ sustanzi kelaturi wara.
{group}, ATC code:
{kategorija}, Kodiċi ATC:
{code} [pending]
{kodiċi} [pendenti]
The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Il- proprjetatijiet farmakodinamiċi ta ’ prodotti mediċinali Yttrium (90Y) - ittikkettati ppreparati bir - radjutikkettar b’ Yttriga, qabel l- għoti, ser jiddependu min- natura tal- prodott mediċinali li ser ikun radjutikkettat.
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal- prodott partikular mediċinali li ser ikun radjutikkettat.
The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
It- tagħrif farmakokinetiku tal- prodott mediċinali Yttrium (90Y) - ittikkettati ppreparati bir - radjutikkettar b’ Yttriga, qabel l- għoti, ser jiddependi min- natura tal- prodott mediċinali li ser ikun radjutikkettat.
In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood.
Fil- firien, wara l- għoti ġol- vini, Yttrium (90Y) chloride jitneħħa malajr minn ġod- demm.
At 1 and 24 hours, blood radioactivity decreases from 11.0% to 0.14% of the administered activity.
Wara siegħa u 24 siegħa, ir- radjuattività tad- demm tinżel minn 11. 0% sa 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 (90Y) chloride jinfirex 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 tkun assorbita f’ 5 minuti wara l- injezzjoni.
Liver uptake decreases then to 8.4% 24 hours after injection.
L- assorbiment tal- fwied imbagħad jonqos għal 8. 4% 24 siegħa wara l- injezzjoni.
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- persentaġġ ta ’ l- attività injettata tiżdied minn 3. 1% wara 5 minuti għal 18% wara 6 sigħat u mbagħad tonqos biż- żmien.
Faecal and urinary elimination is slow: about 31% of the administered activity is eliminated in 15 days.
L- eliminazzjoni permezz ta ’ l- ippurgar u l- awrina hi bil- mod: madwar 31% ta ’ l- attività mogħtija titneħħa fi 15- il ġurnata.
The toxicological properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Il- proprjetajiet tossikoloġiċi ta ’ prodotti mediċinali Yttrium (90Y) - ittikkettati ppreparati bir - radjutikkettar b’ Yttriga qabel l- għoti, ser jiddependu fuq in- natura tal- prodott mediċinali li ser ikun radjutikkettat.
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.
M’ hemm l- ebda tagħrif dwar it- tossiċità ta ’ Yttrium (90Y) chloride, u lanqas dwar l- effetti tiegħu fuq ir- riproduzzjoni fil- bhejjem jew tal- potenzjal mutaġeniku jew karkinoġeniku.
Hydrochloric acid (0.04 M)
Hydrochloric acid (0. 04 M)
Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Ir- radjutikkettar tal- prodotti mediċinali, bħal antikorpi monoklonali, peptidi jew sottostrati oħra, b’ Yttrium (90Y) chloride hu sensittiv ħafna għall- preżenza ta ’ impuritajiet ta ’ traċċi metalliċi.
1t 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.
Hu importanti ħafna li l- ħġieġ u l- labar tas- sirinġi kollha, eċċ, li jkunu ser jintużaw għall- preparazzjoni tal- prodott mediċinali radjutikkettati, ikunu mnaddfa sewwa biex jiġi żgurat li m’ hemm l- ebda impuritajiet ta ’ traċċi metalliċi.
Only syringe needles (for example, non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Labar tas- sirinġi (per eżempju, non- metalliċi) li għandhom reżistenza ppruvata għall- aċidu dilwit għandhom jintużaw biss, biex innaqqsu kemm jista ’ jkun il- livelli ta ’ l - impurità tat- traċċi metalliċi.
5 6.3 Shelf life
5 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Up to 12 days from the date of manufacture.
Sa 12- il ġurnata mid- data tal- manifattura.
No special storage conditions required.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
Storage should be in accordance with national regulation on radioactive material.
Il- ħażna għandha ssir skond ir- regolamenti nazzjonali dwar il- materjal radjuattiv.
Colourless type I glass vial of 3 ml with a V-shapped bottom or a 10 ml with a flat bottom with a PTFE faced chlorobytylrubber stopper or silicon stopper, closed with an aluminium seal.
Kunjett tal- ħġieġ ta ’ tip I trasparenti ta ’ 3 ml b’ qiegħ forma ta ’ V jew ta ’ 10 ml b’ qiegħ ċatt b’ tapp PTFE tal- chlorobytylrubber jew tapp tas- silikon, magħluq b’ siġill ta ’ l- aluminju.
The outer container is a lead container lined with synthetic material inside.
Il- kontenitur ta ’ barra hu kontenitur taċ- ċomb miksi b’ materjal sintetiku minn ġewwa.
1 vial containing 0.02-5 ml solution calibrated for a reference day/ time depending on the ordered radioactivity.
Kunjett wieħed fih 0. 02- 5 ml ta ’ soluzzjoni kkalibrata għal ġurnata/ ħin tar- referenza u dan jiddependi mir- radjuattività ordnata.
The vial may contain high pressure due to radiolysis.
Il- kunjett jista ’ jkun fih pressjoni għolja minħabba r- radjulisi.
nuclitec GmbH Gieselweg 1 D-38110 Braunschweig Germany
nuclitec GmbH Gieselweg 1 D- 38110 Braunschweig Il- Ġermanja
The radiation dose received by the various organs following intravenous administration of an Yttrium (90Y)-labelled medicinal product is dependent on the specific medicinal product being radiolabelled.
Id- doża ta ’ radjazzjoni li tingħata lill- organi varji wara l- għoti ġol- vini ta ’ prodott mediċinali Yttrium (90Y) - ittikkettat tiddependi mill- prodott mediċinali speċifiku li ser ikun 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.
Tagħrif dwar id - dożimetrija tar- radjazzjoni ta ’ kull prodott mediċinali differenti wara l- għoti tal- preparazzjoni radjutikkettata ser ikun disponibbli fis- Sommarju tal- Karatteristiċi tal- Prodott/ fuljett ta ’ tagħrif tal - prodott mediċinali partikulari li ser ikun radjutikkettat.
6 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 Yttriga.
6 It- tabella tad- dożimetrija li tidher hawn taħt hi ppreżentata biex tkun tista ’ tevalwa l- kontribuzzjoni ta ’ Yttrium (90Y) mhux konjugat għad- doża tar- radjazzjoni wara l- għoti tal- prodott mediċinali Yttrium (90Y) - ittikkettat jew li jirriżulta minn injezzjoni aċċidentali ġol- vini ta ’ Yttriga.
The dosimetry estimates were based on a rat distribution study and the calculations were effected in accordance with MIRD/ ICRP 60 recommendations.
L- istimi tad- dożimetrija kienu bbażati fuq studju tad- distribuzzjoni fil- firien u l- kalkoli kienu affettwati skond is- 60 rakkomandazzjoni ta ’ MIRD/ ICRP.
Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.
Il- punti tal- ħin għal kejl kienu 5 minuti, 1, 6, 24, 96 u 360 siegħa.
Absorbed dose per unit activity administered (mGy/ MBq)
Doża assorbita għal kull unit ta ’ attività mogħtija (mGy/ MBq)
Organ
Organu
Adult
Adult
15 years
15- il sena
10 years 5 years 1 year
10 snin
1 year
5 snin
Newborn
Għadu kif
(5 kg)
jitwieled (5 kg)
Adrenals Blood Bone marrow Brain Carcass Colon Femur Gastro-intestinal
Moħħ Karkassa Kolon Wirk Kontenut gastro -
7.23 E-01 4.20 E-02 2.58 E+00 8.60 E-03 5.82 E-01 2.30 E-02 7.76 E+00
8. 60 E- 03 5. 82 E- 01 2. 30 E- 02 7. 76 E+00
1.09 E+00 6.29 E-02 3.88 E+00 1.29 E-02 8.72 E-01 3.46 E-02 1.16 E+01
1. 29 E- 02 8. 72 E- 01 3. 46 E- 02 1. 16 E+01
2.53 E+00 1.47 E-01 9.05 E+00 3.01 E-02 2.04 E+00 8.06 E-02 2.72 E+01
3. 01 E- 02 2. 04 E+00 8. 06 E- 02 2. 72 E+01
3.62 E+00 2.10 E-01 1.29 E+01 4.30 E-02 2.91 E+00 1.15 E-01 3.88 E+01
4. 30 E- 02 2. 91 E+00 1. 15 E- 01 3. 88 E+01
7.23 E+00 4.19 E-01 2.58 E+01 8.60 E-02 5.82 E+00 2.30 E-01 7.76 E+01
8. 60 E- 02 5. 82 E+00 2. 30 E- 01 7. 76 E+01
2.17 E+01 1.26 E+00 7.75 E+01 2.58 E-01 1.75 E+01 6.91 E-01 2.33 E+02
2. 58 E- 01 1. 75 E+01 6. 91 E- 01 2. 33 E+02
content Heart Ileum Kidneys Liver Lungs Ovaries Pancreas Skeletal muscle Skin Spleen Stomach Thymus Thyroids Urinary bladder Uterus Effective Dose
intestinali Qalb Ileu Kliewi Fwied Pulmuni Ovarji Frixa Muskolu skeltrali Ġilda Milsa Stonku Timu Tirojdi Bużżieqa ta ’ l - awrina
1.22 E-01 2.53 E-01 1.16 E-02 2.35 E+00 1.27 E+00 4.23 E-01 3.33 E-01 7.90 E-02 6.12 E-04 1.02 E-01 4.90 E-01 6.47 E-02 7.34 E-02 9.99 E-01 3.62 E-01 1.51 E-02
1. 22 E- 01 2. 53 E- 01 1. 16 E- 02 2. 35 E+00 1. 27 E+00 4. 23 E- 01 3. 33 E- 01 7. 90 E- 02 6. 12 E- 04 1. 02 E- 01 4. 90 E- 01 6. 47 E- 02 7. 34 E- 02 9. 99 E- 01 3. 62 E- 01
1.83 E-01 3.79 E-01 1.74 E-02 3.53 E+00 1.91 E+00 6.34 E-01 4.99 E-01 1.18 E-01 9.17 E-04 1.53 E-01 7.36 E-01 9.70 E-02 1.10 E-01 1.50 E+00 5.44 E-01 2.26 E-02
1. 83 E- 01 3. 79 E- 01 1. 74 E- 02 3. 53 E+00 1. 91 E+00 6. 34 E- 01 4. 99 E- 01 1. 18 E- 01 9. 17 E- 04 1. 53 E- 01 7. 36 E- 01 9. 70 E- 02 1. 10 E- 01 1. 50 E+00 5. 44 E- 01
4.26 E-01 8.85 E-01 4.06 E-02 8.24 E+00 4.46 E+00 1.48 E+00 1.17 E+00 2.76 E-01 2.14 E-03 3.58 E-01 1.72 E+00 2.26 E-01 2.57 E-01 3.50 E+00 1.27 E+00 5.28 E-02
4. 26 E- 01 8. 85 E- 01 4. 06 E- 02 8. 24 E+00 4. 46 E+00 1. 48 E+00 1. 17 E+00 2. 76 E- 01 2. 14 E- 03 3. 58 E- 01 1. 72 E+00 2. 26 E- 01 2. 57 E- 01 3. 50 E+00 1. 27 E+00
6.09 E-01 1.26 E+00 5.81 E-02 1.18 E+01 6.37 E+00 2.11 E+00 1.66 E+00 3.95 E-01 3.06 E-03 5.11 E-01 2.45 E+00 3.23 E-01 3.67 E-01 5.00 E+00 1.81 E+00 7.55 E-02
6. 09 E- 01 1. 26 E+00 5. 81 E- 02 1. 18 E+01 6. 37 E+00 2. 11 E+00 1. 66 E+00 3. 95 E- 01 3. 06 E- 03 5. 11 E- 01 2. 45 E+00 3. 23 E- 01 3. 67 E- 01 5. 00 E+00 1. 81 E+00
1.22 E+00 2.53 E+00 1.16 E-01 2.35 E+01 1.27 E+01 4.23 E+00 3.33 E+00 7.90 E-01 6.12 E-03 1.02 E+00 4.90 E+00 6.47 E-01 7.34 E-01 9.99 E+00 3.62 E+00 1.51 E-01
1. 22 E+00 2. 53 E+00 1. 16 E- 01 2. 35 E+01 1. 27 E+01 4. 23 E+00 3. 33 E+00 7. 90 E- 01 6. 12 E- 03 1. 02 E+00 4. 90 E+00 6. 47 E- 01 7. 34 E- 01 9. 99 E+00 3. 62 E+00
3.66 E+00 7.59 E+00 3.48 E-01 7.06 E+01 3.82 E+01 1.27 E+01 9.99 E+00 2.37 E+00 1.83 E-02 3.06 E+00 1.47 E+01 1.94 E+00 2.20 E+00 3.00 E+01 1.09 E+01 4.53 E-01
3. 66 E+00 7. 59 E+00 3. 48 E- 01 7. 06 E+01 3. 82 E+01 1. 27 E+01 9. 99 E+00 2. 37 E+00 1. 83 E- 02 3. 06 E+00 1. 47 E+01 1. 94 E+00 2. 20 E+00 3. 00 E+01 1. 09 E+01
6.65 E-01
6. 65 E- 01
9.98 E-01
9. 98 E- 01
2.33 E+00
2. 33 E+00
3.33 E+00
3. 33 E+00
6.65 E+00
6. 65 E+00
For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 1 GBq is 665 mSv.
Għal dan il- prodott, id- doża effettiva għal adult li jiżen 70 kg li tirriżulta minn attività injettata ġol - vina ta ’ 1 GBq hi 665 mSv.
Before use, packaging and radioactivity should be checked.
Qabel l- użu, il- pakkett u r- radjuattività għandhom jiġu ċċekkjati.
Activity may be measured using an ionisation chamber.
L- attività tista ’ tkun imkejla permezz ta ’ l- użu tal- kamra ta ’ l- jonizzazzjoni.
Yttrium (90Y) is a beta pure emitter.
Yttrium (90Y) hu emittent pur beta.
Usual precautions regarding sterility and radioactivity should be respected.
Il- kejl ta ’ l- attività permezz ta ’ l- użu tal- kamra ta ’ l- jonizzazzjoni hu sensittiv ħafna għal fatturi ġeometriċi u, għalhekk, għandu jsiru biss skond kundizzjonijiet ġeometriċi li kienu vvalidati kif suppost.
7 The vial should never be opened and must be kept inside its lead shielding.
7 Għandhom jittieħdu l- prekawzjonijiet tas- soltu dwar l- isterilità u r- radjuattività.
The product should be aseptically withdrawn through the stopper using sterilised single use needle and syringe after disinfecting the stopper.
Il - prodott għandu jinħareġ b’ mod asettiku minn ġot- tapp permezz ta ’ l- użu ta ’ labra u sirinġa sterilizzati li jintużaw darba waħda biss wara li t- tapp ikun diżinfettat.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Pharmaceutical Manufacturing Practice, in order to maintain the sterility of Yttriga and to maintain sterility throughout the labelling procedures.
Wieħed għandu jieħu prekawzjonijiet adattati asettiċi, li jkunu konformi mal- ħtiġijiet tal- Prattika Tajba tal- Manifattura Farmaċewtika biex tinżamm l- isterilità ta ’ Yttriga u biex tinżamm l- isterilità matul il- proċeduri ta 'l- ittikkettar.
The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
L- għoti tal- prodotti mediċinali radjuattivi joħloq riskji għal persuni oħra mir- radjazzjoni esterna jew kontaminazzjoni minn tixrid ta ’ l- awrina, rimettar, eċċ.
Radiation protection precautions in accordance with national regulations must therefore be taken.
Għalhekk, għandhom jittieħdu prekawzjonijiet tal- protezzjoni kontra r- radjazzjoni skond ir- regolamenti nazzjonali.
nuclitec GmbH Gieselweg 1 38110 Braunschweig Germany
nuclitec GmbH Gieselweg 1 38110 Braunschweig Il- Ġermanja
TIN CAN AND LEAD POT
BOTT TAL- LANDA U KONTENITUR TAĊ- ĊOMB
Yttrium (90Y) chloride
Yttriga prekursur radjufarmaċewtiku, soluzzjoni Yttrium (90Y) chloride
(Y) GBq/ vial
(Y) GBq/ kunjett
{DD/ MM/ YYYY} (12h CET)
{JJ/ XX/ SSSS} (12h CET)
Specific activity at calibration:
Attività speċifika waqt il- kalibrazzjoni:
1 vial Vol.:
1 kunjett Vol.:
NOT INTENDED FOR DIRECT ADMINISTRATION TO PATIENTS
MHUX INTENZJONAT LI JINGĦATA DIRETTAMENT LILL- PAZJENTI
The vial may contain high pressure due to radiolysis.
Il- kunjett jista ’ jkun fih pressjoni għolja minħabba r - radjulisi.
EXP {MM/ YYYY} (12h CET)
JIS {XX/ SSSS} (12h CET)
Storage should be in accordance with local regulations for radioactive substances.
Il- ħażna għandha ssir skond ir- regolamenti lokali dwar il- materjal radjuattiv.
Batch N°:
Lott Nru.:
{XXXXX}
{XXXXX}:
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI ŻGĦAR EWLENIN
VIAL LABEL ON PERSPEX SHIELD
TIKKETTA TAL- KUNJETT FUQ L- LQUGĦ TAL- PERSPEX
NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS
Aqra l- fuljett ta ’ tagħrif qabel l- użu MHUX INTENZJONAT LI JINGĦATA DIRETTAMENT LILL- PAZJENTI
EXP {DD/ MM/ YYYY} (12h CET)
JIS {JJ/ XX/ SSSS} (12h CET)
{Y}________GBq/ vial
(Y) ________ GBq/ kunjett
Yttriga Yttrium (90Y) chloride solution for in-vitro labelling
Yttriga Soluzzjoni ta ’ Yttrium (90Y) chloride għal ittikkettar in- vitro
in vitro labelling
Ittikkettar in vitro
Yttrium (90Y) Chloride
Yttriga prekursur radjufarmaċewtiku, soluzzjoni Yttrium (90Y) chloride
What Yttriga is and what it is used for 2.
X’ inhu Yttriga u għalxiex jintuża 2.
Before you use Yttriga 3.
Qabel ma tuża Yttriga 3.
4.
Kif għandek tuża Yttriga 4.
How to store Yttriga 6.
Kif taħżen Yttriga 6.
The active substance is Yttrium (90Y) Chloride.
Is- sustanza attiva hi Yttrium (90Y) Chloride.
WHAT YTTRIGA IS AND WHAT IT IS USED FOR
X’ INHU YTTRIGA U GĦALXIEX JINTUŻA
1 vial contains 0.02 -5 ml sterile Yttrium (90Y) solution (as Yttrium [90Y] chloride).
Kunjett wieħed fih soluzzjoni ta ’ 0. 02 - 5 ml ta ’ Yttrium (90Y) sterili (bħala Yttrium [90Y] chloride).
Yttriga is a radiopharmaceutical precursor which is a clear and colourless solution.
Yttriga hu prekursur radjufarmaċewtiku li hu soluzzjoni ċara u bla kulur.
It comes in single vials containing 0.1-300 GBq (corresponding to 0.005-15 micrograms of (90Y) Yttrium calibrated at 12h00 at calibration date.
Jista ’ jinsab f’ kunjetti individwali li fihom 0. 1- 300 GBq (li jikkorrispondu għal 0. 005- 15 mikrogrammi ta ’ (90Y) Yttrium ikkalibrat f’ 12h00 fid- data tal- kalibrazzjoni.
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 tagħrif dwar it- trattament u l- effetti possibbli kkawżati mill- prodott mediċinali li ser ikun radjutikkettat, jekk jogħġbok irreferi għall- fuljett ta ’ tagħrif tal- prodott mediċinali li ser ikun radjutikkettat.
BEFORE YOU USE YTTRIGA
QABEL MA TUŻA L- YTTRIGA
Do not use Yttriga:
Tużax Yttriga:
- if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of
jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għall- Yttrium (90Y) chloride jew sustanzi
Yttriga.
oħra ta ’ Yttriga.
- if you are pregnant or if there is a possibility that you may be pregnant (see below).
- jekk inti tqila jew jekk hemm il- possibbilità li tista ’ tkun tqila (ara hawn taħt).
Take special care with Yttriga
Oqgħod attent ħafna b’ Yttriga:
Radiopharmaceutical precursor - Not intended for direct use in patients
Prekursur radjufarmaċewtiku – Mhux intenzjonat għall- użu dirett fil- pazjenti
Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga will always be used in a hospital or a similar setting.
18 Peress li hemm liġijiet stretti dwar l- użu, tbagħbis u r- rimi ta 'prodotti radjufarmaċewtiċi, Yttriga dejjem ser jintuża fi sptar jew f’ ambjent simili.
It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Ser ikun immaniġġjat u mogħti minn nies li huma mħarrġa u kkwalifikati fl- immaniġġjar sigur tal- materjal radjuattiv.
18 Particular care should be taken when administering radioactive medicinal products to children and adolescents.
Għandha tingħata attenzjoni partikulari meta jkunu qed jingħataw prodotti mediċinali radjuattivi lit - tfal u lill- adolexxenti.
Taking other medicines Please inform your doctor or pharmacist, if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar mediċini oħra, anki dawk mingħajr riċetta.
No interaction of Yttrium (90Y) chloride with other medicinal products are known, because no studies have investigated this issue.
L- ebda interazzjoni ta ’ Yttrium (90Y) chloride ma ’ prodotti mediċinali oħra mhi magħrufa, għax l- ebda studju ma investiga din it- tema.
Using Yttriga with food and drink No special care is needed.
Meta tuża Yttriga ma ’ l- ikel u max- xorb L- ebda attenzjoni partikualari mhi meħtieġa.
It is important to tell your doctor if there is any possibility that you are pregnant.
Hu importanti li tgħid lit- tabib tiegħek dwar kwalunkwe possibbilità li int tqila.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Kwalunkwe mara li ma jiġihiex il- pirjid għandha titqies li hi tqila sakemm ikun ippruvat mod ieħor.
Alternative techniques which do not involve ionising radiation should always be considered.
Tekniċi alternattivi li ma jinvolvux ir- radjazzjoni jonizzanti għandhom dejjem ikunu kkunsidrati.
You will be asked to stop breast-feeding.
Int ser tintalab biex tieqaf tredda ’
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma saru l- ebda studji fuq l- effetti fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
HOW TO USE YTTRIGA
KIF GĦANDEK TUŻA YTTRIGA
Yttriga is not be administered directly to the patient.
Yttriga m’ għandux jingħata direttament lill- pazjent.
Dosage Your physician will decide on the amount of Yttriga to be used in your case.
Dożaġġ It- tabib tiegħek ser jiddeċiedi kemm għandu jintuża Yttriga fil- każ tiegħek.
Method of administration Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Yttriga hu intenzjonat għar- radjutikkettar ta ’ prodotti mediċinali biex jikkura mard speċifiku, li huma sussegwentement mogħtija permezz tar- rotta approvata.
If Yttriga is administered inadvertently Since Yttriga is administered by a doctor under strictly controlled conditions there is little risk of possible overdose.
Jekk Yttriga jingħata bi żball Peress li Yttriga jingħata minn tabib skond kundizzjonijiet stretti kkontrollati, hemm riskju żgħir li tingħata doża eċċessiva.
However, should this occur, you will receive appropriate treatment from your doctor.
Imma, jekk dan jiġri, int ser tingħata trattament adattat mit- tabib tiegħek.
Like all medicines, Yttriga can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Yttriga 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 tagħrif, irreferi għall- fuljett ta ’ tagħrif tal- prodott partikulari mediċinali li ser ikun radjutikkettat.
HOW TO STORE YTTRIGA
KIF TAĦŻEN YTTRIGA
Store in accordance with local regulations for radioactive substances.
Aħżen skond ir- regolamenti lokali dwar sustanzi radjuattivi.
Do not use Yttriga after the expiry date and time which is stated on the label.
Tużax Yttriga wara d- data u l- ħin ta ’ skadenza li jidhrur fuq it- tikketta.
What Yttriga contains
X’ fih Yttriga
- The active substance is Yttrium (90Y) chloride.
Is- sustanza attiva hi Yttrium (90Y) chloride.
- The other ingredient is hydrochloric acid (0.04 M).
- Is- sustanza l- oħra hi hydrochloric acid (0. 04 M).
What Yttriga looks like and contents of the pack
Id- dehra ta ’ Yttriga u l- kontenuti tal- pakkett
The theoretical specific activity is 20 GBq/ micrograms of Yttrium (90Y)
L- attività speċifika teoretika hi 20 GBq/ mikrogrammi ta ’ Yttrium (90Y).
nuclitec GmbH Gieselweg 1, D-38110 Braunschweig Germany Tel +49- 05307-932262 Fax +49- 05307-932337 e-mail
nuclitec GmbH Gieselweg 1 D- 38110 Braunschweig Il- Ġermanja Tel +49 - 05307- 932262 Fax +49 - 05307- 932337 e- mail:
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l - Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Zalasta?
X' inhu Zalasta?
Zalasta is a medicine containing the active substance olanzapine.
Zalasta huwa mediċina li fiha s- sustanza attiva olanzapine.
It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘ orodispersible’ tablets (5, 7.5, 10, 15 and 20 mg).
Huwa disponibbli bħala pilloli tondi, sofor (2. 5, 5, 7. 5, 10, 15 u 20 mg) u bħala pilloli ‘ orodispersibbli ’ tondi u sofor (5, 7. 5, 10, 15 u 20 mg).
Orodispersible tablets are tablets that dissolve in the mouth.
Pilloli orodispersibbli huma pilloli li jinħallu fil- ħalq.
Zalasta is a ‘ generic medicine’.
Zalasta huwa ‘ mediċina ġenerika ’.
This means that Zalasta is similar to ‘ reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Dan ifisser li Zalasta huwa simili għall - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Ewropea (UE) li jisimhom Zyprexa u Zyprexa Velotab.
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċina ġenerika, ara d- dokument ta ’ mistoqsija u tweġiba tagħhom hawn.
What is Zalasta used for?
Għal xiex jintuża Zalasta?
Zalasta is used to treat adults with schizophrenia.
Zalasta jintuża fit- trattament ta ’ l- iskizofrenija.
Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
L- iskizofrenija hija marda mentali li għandha numru ta ’ sintomi, inkluż disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il- pazjent jisma ’ jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
Zalasta is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Zalasta huwa effikaċi wkoll sabiex iżomm it- titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizjali ta ’ trattament.
Zalasta is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Zalasta jintuża wkoll fit - trattament ta ’ każijiet moderati jew severi tal- manija (burdata tajba b’ mod estrem) fl- adulti.
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Jista ’ wkoll jintuża sabiex jipprevjeni li dawn l- episodji jerġgħu ifeġġu (meta jerġa ’ jitfaċċaw is- sintomi) f’ adulti b’ disturbi bipolari (marda mentali b’ perjodi li jalternaw bejn burdata tajba ħafna u depressjoni) u li jkunu rrispondew għal kors inizjali ta ’ trattament.
How is Zalasta used?
Kif jintuża Zalasta?
10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Id- doża tal- bidu rrakomandata ta ’ Zalasta tiddependi mill- marda li tkun qed tiġi ttrattata: doża ta ’ 10 mg kuljum tintuża għall- iskiżofrenija u fil- prevenzjoni ta ’ każijiet manijaċi, u 15- il mg kuljum fit - trattament ta ’ episodji manijaċi, sakemm ma tintużax ma ’ mediċini oħra, f’ liema każ id- doża tal- bidu tista ’ tkun ta ’ 10 mg kuljum.
The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Id- doża tiġi aġġustata skont kemm il- pazjent jirrispondi tajjeb għat - trattament u kemm ikun jittolerah.
Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Id- doża normali tvarja bejn 5 u 20 mg kuljum. Il- pilloli orodispersabbli (li jdubu fil- ħalq), li jistgħu jintużaw minflok il- pilloli, jittieħdu billi jitpoġġew fuq l - ilsien, fejn jiddiżintegraw malajr fil- bżieq, jew inkella billi tħallathom ma ’ l- ilma qabel tiblagħhom. Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil- fwied jew fil - kliewi tagħhom jista ’ jkollhom bżonn ta ’ doża inizjali iktar baxxa ta ’ 5 mg kuljum.
How does Zalasta work?
Kif jaħdem Zalasta?
The active substance in Zalasta, olanzapine, is an antipsychotic medicine.
Is- sustanza attiva f '’ Zalasta, olanzapine, hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Mhux magħruf l- mekkaniżmu ta ’ l- azzjoni eżatta tagħha, iżda teħel ma ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Reproduction is authorised provided the source is acknowledged diversi riċetturi differenti fuq is- superfiċje taċ- ċelloli tan- nervituri tal- moħħ.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is- sinjali trażmessi bejn iċ- ċelloli tal- moħħ permezz tan - 'newrotrasmettituri', sustanzi kimiċi li jippermettu liċ - ċelloli tal- moħħ jikkomunikaw ma 'xulxin.
Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Billi dawn in- newrotrażmettituri għandhom sehem fl - iskiżofrenija u fid- disturbi bipolari, olanzapine jgħin fin- normalizzazzjoni ta ’ l- attività tal- moħħ, u b’ hekk inaqqas is- sintomi ta ’ dawn il- mardiet.
How has Zalasta been studied?
Kif ġie studjat Zalasta?
Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i. e. that the medicines produce the same levels of the active substance in the body).
Minħabba li Zalasta huwa mediċina ġenerika, l- istudji ġew illimitati għall- testijiet biex jintwera illi huwa bijoekwivalenti għall- mediċini ta ’ referenza (jiġifieri li l- mediċini jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Zalasta?
X’ inhu il- benefiċċju u r- riskju ta ’ Zalasta?
Because Zalasta is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Minħabba li Zalasta huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċini ta ’ referenza, il - benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċini ta ’ referenza.
Why has Zalasta been approved?
Għaliex ġie approvat Zalasta?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zalasta has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet ta ’ l- UE, ġie muri li Zalasta għandu kwalità komparabbli ma ’ u li hu bijoekwivlent għall - Zyprexa u Zyprexa Velotab.
The Committee recommended that Zalasta be given marketing authorisation.
Il- Kumitat irrakkomanda li Zalasta jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zalasta:
Tagħrif ieħor dwar Zalasta:
The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d. d., Novo mesto on 27 September 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Zalasta lil KRKA, d. d., Novo mesto fit- 27 ta ’ Settembru 2007.
The full EPARs for the reference medicines can also be found on the EMEA’ s website.
L- EPAR sħiħ għal Zalasta jista ’ jiġi ikkonsultat hawn L- EPARs sħaħ għall- mediċini ta ’ referenza jistgħu jiġu kkonsultati fuq il- websajt ta ’ l- EMEA wkoll.