qanastek/EMEA-V3 huggingface dataset:
19 The table below displays the adverse reactions reported in ≥ 1% of patients according to the standard MedDRA system organ class.
It- tabella t’ hawn taħt turi r- reazzjonijiet avversi rapportati f’ ≥ 1% tal- pazjenti skond l- istandard MedDRA dwar is- sistema tal- klassifika ta ’ l- organi.
20 System Organ Class Investigations
20 Sistema tal- Klassifika ta ’ l- Organi
Very Common Vomiting, Nausea, Constipation Common Diarrhoea, Stomatitis, Abdominal pain, Dyspepsia, Upper abdominal pain
Komuni Ħafna Rimettar, Dardir, Stitikezza Komuni Dijarea, Stomatite, Uġigħ addominali, Dispepsja, Uġigħ addominali fil- parti ta ’ fuq
21 Most frequent adverse reactions
21 Reazzjonijiet avversi l- aktar frekwenti
Most transaminase elevations improved to grade 1 or to pre-retreatment levels within 15 days, and less than 2% of cycles had recovering times longer than 25 days.
Il - maġġoranza taż- żidiet fit- transaminases tjiebu għal- livelli ta ’ grad 1 jew ta ’ qabel il- kura mill- ġdid fi żmien 15- il jum, u anqas minn 2% taċ- ċikli kelhom żminijiet ta ’ rikupru itwal minn 25 jum.
Nausea, vomiting, diarrhoea and constipation:
Dardir, rimettar, dijarea u stitikezza:
Nausea and vomiting were reported in 63 and 38.5% of patients respectively.
Dardir u rimettar kienu irrapportati f ’ 63 u 38. 5% tal- pazjenti rispettivament.
Grade 3-4 nausea and vomiting were reported in 6% and 6.5% of patients, respectively.
Dardir u rimettar ta ‘ Grad 3- 4 kienu irrapportati f’ 6% u 6. 5% tal- pazjenti, rispettivament.
22 Dyspnoea:
22 Dispnea:
In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.
Fil- każ ta ’ doża eċċessiva, pazjenti għandhom ikun sorveljati mill- qrib u kura ta ’ appoġġ sintomatiku tinbeda skond il- ħtieġa
Trabectedin has been shown to exert antiproliferative in vitro and in vivo activity against a range of human tumour cell lines and experimental tumours, including malignancies such as sarcoma, breast, non-small cell lung, ovarian and melanoma.
Trabectedin ġie muri li jeżerċità attività antiproliferattiva in vitro u in vivo kontra varjetà ta ’ razez ta ’ tumur tal- bniedem, li jinkludu malinnitajiet bħalma huma sarkoma, sider, ċellola mhux żgħira tal- pulmun, ta ’ l- ovarju u melanoma.
The efficacy and safety of trabectedin is based in a randomised trial in patients with locally advanced or metastatic liposarcoma or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.
L- effikaċja u s- sigurtà ta ’ trabectedin hija bbażata fi prova randomised f’ pazjenti b’ liposarkoma jew lejomajosarkoma lokalizzata jew metastatika avvanzata, li l- marda tagħhom kienet avvanzat jew irkadiet wara l- kura b’ ta ’ lanqas anthracyclines u ifosfamide.
The protocol specified final time to progression (TTP) analysis showed a 26.6% reduction in the relative risk of progression for patients treated in the 24-h q3wk group (Hazard Ratio = 0.734 CI 0.554-0.974).
L- analiżi taż- żmien finali għal progressjoni (TTP) speċifikat fil- protokol wera tnaqqis ta ’ 2. 6% fir - riskju relattiv ta ’ progressjoni għal pazjenti kkurati fil- grupp ta ’ 24 siegħa kull 3 ġimgħat (Proporzjon ta ’ Riskju= 0. 734 CI 0. 554- 0. 974).
23 Systemic exposure after administration as a 24 hour constant rate intravenous infusion is dose proportional at doses up to and including 1.8 mg/ m2.
23 Esponiment sistemiku wara l- għoti bħala infużjoni intravenuża b’ rata kostanti fuq 24 siegħa hija proporzjonali f’ dożi sa u li tinkludu 1. 8 mg/ m2.
The terminal half-life is long (population value of the terminal elimination phase:
Il- half - life terminali hija twila (valur tal- popolazzjoni tal- fażi ta ’ eliminazzjoni terminali:
After a dose of radiolabelled trabectedin administered to cancer patients, faecal mean (SD) recovery of total radioactivity is 58% (17%), and urinary mean (SD) recovery is 5.8% (1.73%).
Wara doża ta ’ trabectedin radjutikketat mogħti lil pazjenti bil- kanċer, l- irkupru medju (SD) fl- ippurgar tar - radjuattività totali kien ta ’ 58% (17%), u l- irkupru medju (SD) awrinarju kien ta ’ 5. 8% (1. 73%).
A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Skeda ta ’ infużjoni ta ’ siegħa kienet magħżula biex tilħaq livelli massimi fil- plażma (valuri Cmax) fil- medda ta ’ dawk osservati fil- klinika.
The plasma trabectedin levels attained were 10.6 ± 5.4 (Cmax), higher than those reached in patients after infusion of 1500 μ g/ m2 for 24 (Cmax of 1.8 ± 1.1 ng/ ml) and similar to those reached after administration of the same dose by 3 hour infusion (Cmax of 10.8 ± 3.7 ng/ ml).
Il- livellu ta ’ trabectedin fil- plażma li intlaħqu kienu 10. 6 ± 5. 4 (Cmax), ogħla minn dawk milħuqa f’ pazjenti wara infuzjoni ta ’ 1500 μg/ m2 għal 24 (Cmax ta ’ 1. 8 ± 1. 1 ng/ ml) u simili għal dawk milħuqa wara amministrazzjoni ta ’ l- istess doża minn infużjoni ta ’ 3 sigħat (Cmax ta ’ 10. 8 ± 3. 7 ng/ ml).
24 Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
24 Majelosoppressjoni u epatossiċità kienu identifikati bħala tossiċità primarja għal trabectedin.
These findings were secondary to severe local reaction at the administration site, and therefore uncertainly attributable to trabectedin; however, caution must be guaranteed in the interpretation of these renal findings, and treatment-related toxicity cannot be excluded.
Dawn ir- riżultati kienu sekondarji għal reazzjoni lokali severa fis- sit ta ’ l- amministrazzjoni, u għaldaqstant mhux ċertament attribwiti għal trabectedin; madankollu, għandha tkun garantita l- kawtela fl- interpretazzjoni ta ’ dawn ir- riżultati renali, u tossiċità relatata mal- kura ma tistax tiġi eskluża.
25 Yondelis is supplied in a Type I colourless glass vial with a bromobutyl rubber stopper covered with an aluminium flip-off seal.
25 Yondelis huwa ipprovdut f’ kunjett tal- ħġieġ bla kulur Tip I b’ tapp tal- lastku bromobutyl mgħotti b’ siġill ta ’ l- aluminju li jgħola u jinqala ’ permezz ta ’ saba ’.
Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of sterile water for injections.
Kull kunjett li fih 1 mg ta ’ trabectedin huwa rikostitwit b’ 20 ml ilma għall- injezzjoni sterili.
Instructions for reconstitution
Struzzjonijiet għar- rikostituzzjoni
A syringe is used to inject 20 ml of sterile water for injections into the vial.
Siringa hija użata biex tinjetta 20 ml ta ’ ilma għall- injezzjoni sterili għal ġol- kunjett.
Shake the vial until complete dissolution.
Ċaqlaq il- kunjett sakemm ikun inħall kollox.
It requires further dilution and is for single-use only
Hija teħtieġ aktar dilwazzjoni u għandha tintuża darba biss
If administration is to be made through a central venous line the appropriate amount of reconstituted solution should be withdrawn from the vial and added to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion), being the concentration of trabectedin in the infusion solution ≤ 0.030 mg/ ml.
Jekk se jingħata permezz ta ’ linja ċentrali fil- vina, l- ammont adegwat ta ’ soluzzjoni rrikostitwita għandu jittieħed mill- kunjett u miżjud fil- borża ta ’ l- infużjoni li jkun fiha ≥ 50 ml tad- dilwent (soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- infużjoni ta ’ glucose 50 mg/ ml (5%)), biex b’ hekk il- konċentrazzjoni ta ’ trabectedin fis- soluzzjoni għall- infużjoni tkun ≤ 0. 030 mg/ ml.
Parenteral solutions should be inspected visually for particles prior to administration.
Soluzzjonijiet parenterali għandhom jiġu spezzjonati viżwalment għal frak qabel l- amministrazzjoni.
Once the infusion is prepared, it should be administered immediately.
La darba l- infużjoni hija ippreparata, hija għandha tiġi amministrata minnufih.
Personnel should be trained in the correct techniques to reconstitute and dilute the medicinal product and should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Personal għandhom jiġu mħarrġa fit- tekniċi korretti biex jirrikostitwixxu u jidilwu l- prodott mediċinali u għandhom jilbsu ħwejjeġ protettivi inklużi maskra, nuċċali u ingwanti waqt ir- rikostituzzjoni u d- dilwiment.
26 Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
26 Kuntatt aċċidentali mal- ġilda, l- għajnejn jew ir- riti mukożia għandu jiġi ttrattat minnufih b’ ammonti abbundanti ta ’ ilma.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
L- ebda inkompatibbilita ma ġiet osservata bejn Yondelis u fliexken ta ’ ħġieġ tip I, boroż u pajpijiet tal- polyvinylchloride (PVC) u polyethylene (PE), kontenituri għall- ħażna magħmula minn polyisoprene u sistemi ta ’ aċċess vaskulari impjantabbli tat- titanium.
Polígono Industrial La Mina Avda. de los Reyes, 1 E-28770 Colmenar Viejo Madrid Spain
Polígono Industrial La Mina Avda. de los Reyes, 1 E- 28770 Colmenar Viejo Madrid Spanja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ Farmakoviġilanza Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 1. 0 ippreżentata f’ Modulu 1. 8. 1. tal- applikazzjoni tal - Awtorizazzjoni għat- Tqegħid fis- Suq, hija f’ postha u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Mmaniġġjar ta ’ Riskji Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet ta ’ Farmakoviġilanza oħra kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 3. 0 tal- Pjan ta ’ Mmaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2. tal- applikazzjoni tal- Awtorizazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis - CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi sottomess RMP aġġornat • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha impatt fuq Speċifikazzjonijiet ta ’ Sigurtà attwali, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskji. • Fi żmien 60 ġurnata minn meta tintlaħaq mira mportanti (farmakoviġilanza jew tnaqqis ta ’ riskji). • Mat- talba ta ’ l- EMEA
29 C.
29 Ċ.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima mill- ġdid tal - profil bejn il- benefiċċju/ riskju li ssir kull sena.
To conduct further investigations in order to elucidate whether predictors of response to Yondelis in patients with soft tissue sarcoma can be identified.
Li jwettaq aktar investigazzjonijiet biex b’ hekk jiġi determinat jekk jistgħux jiġu identifikati fatturi ta ’ tbassir ta ’ respons għal Yondelis f’ pazjenti b’ sarkoma tat- tessut morbidu.
This should include a proposal to assess the efficacy and safety of Yondelis in a sub-group of patients with myxoid liposarcoma and will be submitted to the EMEA by 4Q 2007.
Dan għandu jinkludi proposta biex jiġu stmati l- effikaċja u s- sigurtà ta ’ Yondelis f’ sotto- grupp ta ’ pazjenti b’ liposarkoma myxoid u se tiġi sottomessa lill- EMEA sa 4Q 2007.
Outer carton – 0.25 mg vial
Kartuna ta ’ barra – Kunjett ta ’ 0. 25 mg
Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0. 25 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Trabectedin
1 ml of reconstituted solution contains 0.05 mg of trabectedin.
1 ml ta ’ soluzzjoni rikostitwita fiha 0. 05 mg ta ’ trabectedin.
Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Fih ukoll: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
Trab għal konċentrat għal soluzzjoni għall- infużjoni Kunjett 1 fih 0. 25 mg trabectedin
For intravenous use after reconstitution and further dilution.
Użu għal ġol- vina wara r- rikostituzzjoni u aktar dilwazzjoni.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA / (IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
For storage conditions for the reconstituted and diluted solutions, see the package leaflet.
Għal kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit u dilwit, ara l- fuljett tat- tagħrif.
Cytotoxic product.
Prodott ċitotossiku.
Discard any unused product or waste material in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
La Mina 28770 Colmenar Viejo (Madrid) Spain
La Mina 28770 Colmenar Viejo (Madrid) Spanja
Vial label – 0.25 mg vial
Tikketta tal- kunjett – Kunjett ta ’ 0. 25 mg
Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin IV use
Yondelis 0. 25 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Trabectedin Użu IV
0.25 mg trabectedin
0. 25 mg trabectedin
Outer carton – 1 mg vial
Kartuna ta ’ barra – Kunjett ta ’ 1 mg
Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 1 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Trabectedin
Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
Trab għal konċentrat għal soluzzjoni għall- infużjoni Kunjett 1 fih 0. 25 mg trabectedin
Vial label – 1 mg vial
Tikketta tal- kunjett – Kunjett ta ’ 1 mg
Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin IV use
Yondelis 1 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Trabectedin Użu IV
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN IRID JAGĦMEL UŻU MINNU
Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0. 25 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Yondelis 1 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Trabectedin
What Yondelis is and what it is used for 2.
X’ inhu Yondelis u għalxiex jintuża 2.
Before you are given Yondelis 3.
Qabel ma tieħu Yondelis 3.
How to use Yondelis 4.
Kif għandek tieħu Yondelis 4.
How to store Yondelis 6.
Kif taħżen Yondelis 6.
WHAT YONDELIS IS AND WHAT IT IS USED FOR
X’ INHU YONDELIS U GĦALXIEX JINTUŻA
Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying.
Yondelis huwa mediċina ta ’ kontra l- kanċer li jaħdem billi jimpedixxi ċ- ċelluli tat- tumuri milli jimmoltiplikaw.
Yondelis is used for the treatment of patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful or the patients are unsuited to receive them.
Yondelis jintuża għat- kura ta ’ pazjenti b’ sarkoma tat- tessuti morbidi avvanzata, wara li mediċini oħra ma jkunux ħadmu b’ suċċess jew il- pazjenti mhumiex adattati biex jirċevuhom.
Soft tissue sarcoma is a malignant disease that starts somewhere in the soft tissues, such as the muscles, fat or other tissues (for example cartilages or vessels).
Sarkoma tat- tessuti morbidi hija marda mallinna li tibda x’ imkien fit- tessuti rotob, bħal fil- muskoli, il- grass jew tessuti oħra (ġer eżempju qarquċċ jew vażi).
BEFORE YOU ARE GIVEN YONDELIS
QABEL MA TIEĦU YONDELIS
Do not use Yondelis:
Tieħux Yondelis:
- if you are allergic (hypersensitive) to trabectedin or any of the other ingredients of Yondelis
- jekk inti allerġiku/ allerġika (tbati minn sensittività eċċessiva) għal trabectedin jew sustanza oħra
- if you have any serious infections
- jekk għandek xi infezzjonijiet serji
- if you will receive yellow fever vaccine.
- jekk ser tirċievi l- vaċċin tad- deni l- isfar.
Take special care with Yondelis:
Oqgħod attent ħafna b’ Yondelis:
Yondelis must not be used if you have severe liver or kidney damage.
Yondelis m’ għandux jintuża jekk għandek problemi severi fil- fwied jew fil- kliewi tiegħek.
Tell your doctor if you know or suspect that you have any liver or kidney problems before starting the treatment with Yondelis.
Għid lit - tabib tiegħek jekk taf jew tissusspetta li għandek xi problemi fil- fwied jew fil- kliewi qabel tibda l- kura b’ Yondelis.
You should seek medical attention immediately if any of the following conditions appear:
Għandek tfittex l- attenzjoni medika minnufiħ jekk xi wieħed minn dawn il- kundizzjonijiet imsemmija hawn isfel jitfaċċa:
• If you develop a fever as Yondelis may cause side-effects affecting your blood and liver.
• Jekk tiżviluppa deni peress li Yondelis jista ’ jikkawża effetti sekondarji li jaffettwaw id- demm u l- fwied tiegħek.
• If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine despite being given anti-sickness medicines.
• Jekk tħossok ma tiflaħx, trid tirremetti jew ma tistax tixrob fluwidi u għalhekk tgħaddi inqas awrina minkejja li tingħata mediċini kontra d- dardir.
40 • If you experience severe muscle pain as it could be a sign of rhabdomyolysis (damage to the muscles, see section 4).
40 • Jekk tħoss uġigħ sever fil- muskoli peress li dan jista ’ jkun sinjal ta ’ rabdomajoliżi (ħsara lill- muskoli, ara sezzjoni 4).
Yondelis must not be used in children and adolescents since safety and efficacy have not yet been studied in this age group.
Yondelis m’ għandux jintuża minn tfal u adoloxxenti peress li s- sigurtà u l- effiċjenza għadhom ma ġiewx studjati f’ dan il- grupp ta ’ etajiet.
Please tell your doctor if you plan to take, are taking or have recently taken any other medicines, including medicines obtained without a prescription, vaccines and herbal medicines.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tippjana li tieħu, qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inklużi mediċini mingħajr riċetta, vaċċini u mediċini magħmula mill- ħxejjex.
You must not use Yondelis if you will receive yellow fever vaccine and it is not recommended that you use Yondelis if you will receive a vaccine containing live virus particles.
M’ għandekx tieħu Yondelis jekk ser tieħu l- vaċċin tad- deni l- isfar u mhux rakkomandat li tieħu Yondelis jekk ser tirċievi vaċċin li jkun fih partiċelli ħajjin ta ’ vajrus.
The effect of medicines containing phenytoin (for epilepsy) may be decreased if given together with Yondelis and this is therefore not recommended.
L- effett ta ’ mediċini li jkun fihom phenytoin (għal epilessija) jista ’ jitnaqqas jekk jingħata ma ’ Yondelis u għalhekk dan mhux rakkomandat li jsir.
If you use other medicines, you may need to be closely monitored as the effects of Yondelis might be decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John´s Wort (Hypericum perforatum, herbal medicine for depression)) or increased (examples are medicines containing ketoconazole or fluconazole (for fungal infections), ritonavir (for HIV infection), clarithromycin (for bacterial infections), ciclosporin (inhibit the defensive system of the body) or verapamil (for high blood pressure and heart conditions)) as a result.
Jekk qed tuża mediċini oħra, għandek mnejn ikollok bżonn tiġi monitorat mill- qrib, peress li l- effetti ta ’ Yondelis jistgħu jitnaqqsu (eżempju huma mediċini li fihom rifampicin (għal infezzjonijiet batteriċi), phenobarbital (għal epilessija) jew St. John´s Wort (Hypericum perforatum, mediċina magħmula mill- ħxejjex għad- dipressjoni)) jew jiżdiedu (eżempji huma mediċini li fihom ketoconazole jew fluconazole (għal infezzjonijiet fungali), ritonavir (għal infezzjoni b’ HIV), clarithromycin (għal infezzjonijiet batteriċi), ċiklosporin (jinpedixxi s- sistema ta ’ difiża tal- ġisem) jew verapamil (għal pressjoni għolja tad- demm u kundizzjonijiet tal- qalb)) bħala riżultat.
If you are given a medicine that might cause damage to the liver or to the muscles (rhabdomyolysis), you may need to be closely monitored when using Yondelis together with this medicine, as there could be an increased risk of damage.
Jekk tingħata mediċina li tista ’ tikkawża ħsara għall- fwied jew għall- muskoli (rabdomajolisi), għandek mnejn ikollok bżonn li tiġi monitorat mill- qrib meta tieħu Yondelis ma ’ din il- mediċina, peress li jista ’ jkun hemm riskju akbar ta ’ ħsara.
Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Mediċini li fihom statins (li jnaqqsu l- livelli ta ’ kolesterol u li jipprevjenu mard kardjovaskulari) huma eżempji ta ’ mediċini li jistgħu jagħmlu ħsara lil muskolu.
Using Yondelis with food and drink
Meta tieħu Yondelis ma ’ l- ikel u max- xorb
Alcohol consumption must be avoided during treatment with Yondelis as this may harm the liver.
Il- konsum ta ’ l- alkoħol għandu jiġi evitat waqt il- kura b’ Yondelis peress li dan jista ’ jagħmel ħsara lill- fwied.
Pregnancy You should not use Yondelis if you are pregnant or if you/ your partner are trying to become pregnant as Yondelis may harm the unborn baby.
Tqala M’ għandekx tuża Yondelis jekk inti / jew seħbitek qed tipprovaw għal tarbija peress li Yondelis jista ’ jagħmel ħsara lit- tarbija mhux mwielda.
If you are pregnant or you think you may be pregnant, you must tell your doctor immediately.
Jekk inti tqila, jew taħseb li nqbadt tqila, għandek tgħarraf lit- tabib tiegħek minnufih.
The doctor may prescribe Yondelis during pregnancy in certain circumstances.
It- tabib jista ’ jagħtik Yondelis waqt it- tqala f’ ċertu ċirkostanzi biss.
Adequate contraceptive precautions must be used by men in fertile age and women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment for women and 5 months following the end of treatment for men.
Prekawzjonijiet dwar kontraċezzjoni adegwata għandhom jintużaw f’ irġiel ta ’ età fertili u min- nisa li jista ’ jkollhom it- tfal meta jirċievu Yondelis u għal 3 xhur wara li tintemm il- kura għan- nisa u 5 xhur wara li tintemm il- kura fl- irġiel.
If a pregnancy should occur you must tell your doctor immediately and genetic counselling is recommended since Yondelis can cause genetic damage.
Jekk ikun hemm tqala, għarraf lit- tabib minnufih u konsultazzjoni ġenetika hija rakkomandata peress li Yondelis jista ’ jikkaġuna ħsara ġenetika.
Genetic counselling is also recommended for patients wishing to have children after therapy.
Konsulenza ġenetika hija rakkomandata wkoll għal pazjenti li jixtiequ li jkollhom it- tfal wara t - terapija.
Male patients should seek advice on conservation of sperm prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Pazjenti rġiel għandhom ifittxu parir għal konservazzjoni ta ’ l- isperma qabel il- kura minħabba r- riskju ta ’ infertilità irriversibbli minħabba t- terapija b’ Yondelis.
Breast-feeding Yondelis must not be given to patients who are breast-feeding.
Treddigħ Yondelis m’ għandux jingħata lil pazjenti li qed ireddgħu.
Therefore you must stop breast-feeding before you start your treatment and you must not begin breast-feeding again until your doctor has confirmed that it is safe to do so.
Għalhekk għandek tieqaf tredda ’ qabel ma tibda l- kura u m’ għandekx tibda tredda ’ sakemm it- tabib tiegħek ikun ikkonferma li jkun sikur li tagħmel hekk.
41 During your treatment with Yondelis you may feel tired and experience a loss of strength.
41 Sewqan u tħaddim ta ’ magni
Do not drive or use any tools or machines if you are experiencing any of these side effects.
M’ għandekx issuq jew tuża għodda jew magni jekk tħoss dawn l- effetti sekondarji.
Important information about some of the ingredients of Yondelis
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Yondelis
This medicine contains potassium, less than 1 mmol (39 mg) per vial, and can therefore be considered as essentially “ potassium-free”.
Din il- mediċina fiha l- potassium, inqas minn 1 mmol (39 mg) f’ kull kunjett, u għalhekk għandha tiġi kkunsidrata bħala essenzjalment “ mingħajr potassium ”.
HOW TO USE YONDELIS
KIF GĦANDEK TIEĦU YONDELIS
Yondelis is given to you under the supervision of a physician experienced in the use of chemotherapy.
Yondelis jingħata lilek taħt is- superviżjoni ta ’ tabib li għandu esperjenza fl- użu ta ’ kimoterapija.
Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic medicines.
L- użu tiegħu hu ristrett biss għal onkoloġisti kwalifikati jew professjonisti tas- saħħa oħrajn speċjalizzati fl - għoti ta ’ mediċini ċitotossiċi.
The usual dose is 1.5 mg/ m2 of body surface area.
Id- doża li ġeneralment tingħata hi ta’ 1. 5 mg/ m2 ta ’ erja superfiċjali tal- ġisem.
During the treatment period, your doctor will carefully monitor you and decide the most appropriate dosage of Yondelis to give to you.
Matul il- perijodu ta ’ kura it- tabib tiegħek ser jissorveljak mill- qrib u jiddeċiedi fuq l- aktar doża ta ’ Yodelis adattata għalik.
Before it is given to you, Yondelis is reconstituted and diluted for intravenous use.
Qabel ma tingħatalek, Yondelis hija rikostitwita u dilwita biex tittieħed ġol- vina.
Every time you are given Yondelis, it will take about 24 hours for all of the solution to enter your blood.
Kull darba li tingħata Yondelis, ikun hemm bżonn madwar 24 siegħa sabiex is- soluzzjoni tidħol fid- demm tiegħek.
In order to avoid irritation at the site of injection it is recommended that Yondelis is given to you through a central venous line.
Sabiex jiġi evitat li jkun hemm irritazzjoni fis- sit ta ’ l- injezzjoni huwa rakkomandat li Yondelis jingħata minn linja venuża ċentrali.
You will be given medicine before and as needed during the treatment with Yondelis in order to protect your liver and to reduce the risk of side effects such as feeling sick (nausea) and vomiting.
Inti ser tingħata mediċina qabel u kif meħtieġ waqt il- kura b’ Yondelis sabiex jiġi mħares il- fwied tiegħek u sabiex jitnaqqas ir- riskju ta ’ effetti sekondarji bħal meta jħossok mhux f’ sikktek (dardir) u rimettar.
The infusion is given to you every 3 weeks.
L- infużjoni ser tingħatalek kull 3 ġimgħat.
The length of your whole treatment period will depend on your progress and how well you feel.
Il- perijodu ta ’ kura kollu tiegħek ser jiddependi mill- progress u minn kif tħossok.
Your doctor will tell you how long your treatment may last.
It- tabib tiegħek jista ’ jgħidlek kemm ser idum sejjer it- tratatment tiegħek.
If you have any further questions on the use of this medicine, ask your doctor.
Jekk għandek aktar mistoqsijiet dwar fuq l- użu ta ’ dan il- prodott mediċinali, staqsi lit- tabib tiegħek.
Like all medicines, Yondelis can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Yondelis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you are not sure what the side effects below are, you should ask your doctor to explain them to you in more detail.
Jekk inti m’ intiex żgur x’ inhuma l- effetti sekondarji t’ hawn isfel, għandek tistaqsi lit- tabib tiegħek jispjegahomlok f’ aktar dettall.
Very common (occurring in at least 1 in 10 patients):
Komuni ħafna (iseħħu f’ ta ’ lanqas 1 minn kull 10 pazjenti):
• You may: • feel tired • feel short of breath (dyspnoea) • bruise more easily • have nose bleeds • be more prone to infections.
• Tista ’ tħossok: • għajjien/ a • nuqqas ta ’ nifs (dispnea) • titbenġel aktar faċilment • tinfaraġ • tkun suxxettibbli aktar għal infezzjonijiet.
An infection could also give you a raised temperature.
Infezzjoni tista ’ tgħollilek it- temperatura.
If you develop any of these symptoms you should seek medical attention immediately.
Jekk tiżviluppa xi wieħed minn dawn is- sintomi, għandek tfittex l- attenzjoni medika immedjatament.
• Your doctor may require blood tests in certain situations in order to avoid that you develop damage to the muscles (rhabdomyolysis).
• It- tabib tiegħek għandu mnejn ikun jeħtieġ li jsiru testijiet tad- demm f’ ċertu sitwazzjonijiet sabiex jiġi evitat li jiżviluppaw problemi fil- muskoli (rabdomajolisi).
In very severe cases this could lead to kidney failure.
F’ każijiet severi ħafna, 42 dan jista ’ jwassal għal falliment tal- kliewi.
If you experience severe muscle pain, you should seek medical attention immediately.
Jekk tesperjenza uġigħ sever fil- muskoli, għandek tfittex għall- attenzjoni medika minnufih.
• You could have increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes).
• Jista ’ jkollok livelli ogħla tal- pigment safrani bilirubin fid- demm tiegħek li jista ’ jikkaġuna s- suffejra (sfurija tal- ġilda, riti mukużi u l- għajnejn).
42 • You may experience headache and a loss of strength.
• Tista ’ tesperjenza uġigħ ta ’ ras u nuqqas ta ’ saħħa.
• You may also lose your appetite, feel sick (nausea) or vomit, and become constipated.
• Tista ’ ukoll titlef l- aptit tiegħek, tħossok ma tiflaħx (imdardar) jew tirremetti, u ssir stetiku.
If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medication, you should immediately seek medical help.
Jekk tħossok ma tiflaħx, tirremetti jew ma tistax tixriob fluwidi u għalhekk tgħaddi anqas awrina, minkejja li tingħata mediċini kontra d- dardir, għandek tfittex l- għajnuna medika.
• Your doctor will order regular blood tests to detect any abnormalities in the blood.
• It- tabib tiegħek ser jordnalek testijiet regolari tad- demm sabiex jara għal abnormalitajiet fid- demm.
Common (occurring in at least 1 in 100 patients):
Komuni (iseħħu f’ ta ’ lanqas f’ 1 minn kull 100 pazjent):
• You may have fever.
• Jista ’ jkollok id- deni.
If you have a raised temperature you should seek medical attention immediately.
Jekk ikollok temperatura għolja għandek tfittex għal għajnuna medika minnufih.
• You could also feel pain in your back, muscles and joints.
• Tista ’ wkoll tħoss l- uġigħ fid- dahar, il- muskoli u l- ġogi.
There could be damage to your nerves which may result in muscle pain, weakness and numbness.
Dan jista ’ jkun ħsara lin- nervituri li jistgħu jirriżultaw f’ uġigħ muskolari, indeboliment u tirżiħ.
You could experience general swelling or swelling of the limbs and a sensation of creeping on the skin.
Tista ’ tesperjenza infiħ ġenerali jew jintefħu r- riġlejn/ driegħ u sensazzjoni ta ’ tkexkix fuq il- ġilda.
• You may experience diarrhoea, loss of water from the body, inflammation of the mouth (stomatitis), pain in the abdomen, weight loss, digestive discomfort and a change in your sense of taste.
• Tista ’ tesperjenza dijarea, telf ta ’ ilma mill- ġisem, infjammazzjoni tal- ħalq (stomatite), uġigħ fl - addome, telf ta ’ piż, skumdità diġestiva u bidla fis- sens ta ’ togħma tiegħek.
• You could have coughing.
• Jista ’ jkollok is- sogħla.
• You may lose hair (alopecia).
• Tista ’ titlef ix- xagħar (alopeċja).
• You could also experience dizziness, sleeping problems, low blood pressure and flushing.
• Jista ’ jkollok sturdamenti, problemi bl- irqad, pressjoni baxxa tad- demm u fwawar.
• You may have a reaction at the site of injection
• Jista ’ jkollok reazzjoni fis- sit ta ’ l- injezzjoni
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek
HOW TO STORE YONDELIS
KIF TAĦŻEN YONDELIS
Do not use Yondelis after the expiry date which is stated on the carton and the vial label after EXP.
Tużax Yondelis wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- kunjett wara JIS.
Information on in-use stability of the reconstituted and diluted solutions is included in the section for medical and healthcare professionals.
Informazzjoni dwar l- istabbilità waqt l- użu tas- soluzzjonijiet rikostitwiti u dilwiti huma inklużi fis- sezzjoni medika għal professjonisti tal- kura tas- saħħa.
What Yondelis contains:
X’ fih Yondelis:
- The active substance is trabectedin.
- Is- sustanza attiva hi trabectedin.
Yondelis 0.25 mg:
43 Yondelis 0. 25 mg:
Each vial contains 0.25 mg of trabectedin Yondelis 1 mg:
Kull kunjett fih 0. 25 mg ta ’ trabectedin Yondelis 1 mg:
- The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for
- Is- sustanzi l- oħra huma sucrose, potassium dihydrogen phosphate, phosphoric acid (sabiex ikun
pH-adjustment) and potassium hydroxide (for pH-adjustment).
jista ’ jiġi aġġustat il- pH) u potassium hydroxide (sabiex ikun jista ’ jiġi aġġustat il- pH).
43 What Yondelis looks like and contents of the pack
Id- dehra ta ’ Yondelis u l- kontenut tal- pakkett
Yondelis is a powder for concentrate for solution for infusion.
Yondelis huwa trab għal konċentrat għal soluzzjoni għall- infużjoni.
The powder has a white to off-white colour and comes in a glass vial.
It- trab għandu kulur abjad għal abjad maħmuġ u jiġi f’ kunjett tal- ħġieġ.
Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Kull kartuna fiha kunjett 1 jew ta ’ 0. 25 mg jew 1 mg ta ’ trabectedin.
Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spanja
Tel: +34 91 846 60 00 Fax: +34 91 846 60 01
Tel: +34 91 846 60 00 Faks: +34 91 846 60 01
For any information about this medicine, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
This medicine has been authorised under “ Exceptional Circumstances”.
Dan il- prodott mediċinali kien awtorizzat taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari ma kienx possibbli li tinkiseb informazzjoni kompleta dwar il - benefiċċji u r- riskji ta ’ dan il- prodott mediċinali.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal- Prodott, skond il- bżonn.
Instructions for use – preparation, handling and disposal
Struzzjonijiet dwar l- użu – preparazzjoni, manipulazzjoni u rimi
Appropriate procedures for proper handling and disposal of cytotoxic medicines must be followed.
Proċeduri xierqa għal manipulazzjoni u r- rimi ta ’ mediċini ċitotossiċi għandhom jiġu segwiti.
Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
You should have received training on the correct techniques to reconstitute and dilute Yondelis and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Inti suppost irċevejt taħriġ dwar it- teknika korretta kif tirrikostitwixxi u tiddilwa Yondelis u għandek tilbes ilbies protettiv li jinkludu maskra, nuċċali protettiv u ingwanti waqt ir- rikostituzzjoni u d- dilwazzjoni.
Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
Kull kuntatt aċċidentali mal- ġilda, l- għajnejn jew ir- riti mukużi għandu jitlaħlaħ minnufiħ b’ ammonti kbar ta ’ ilma.
You should not work with this medicine if you are pregnant.
M’ għandekx taħdem b’ din il- mediċina jekk inti tqila.
Yondelis must be reconstituted and further diluted prior to infusion (see also section 3).
Yondelis għandu jiġi rikostitwit u dilwit aktar qabel l- infużjoni (ara wkoll sezzjoni 3).
Appropriate aseptic techniques must be used.
Għandhom jintużaw tekniċi asettiċi xierqa.
Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent.
Yondelis m’ għandux jingħata bħala taħlita ma ’ mediċini oħra fl- istess infużjoni ħlief mad- diluwent.
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Ma ġiet osservata ebda inkompatibilità bejn Yondelis u polyvinylchloride (PVC) u l- boroż tal- polyethylene (PE) u l- pajpijiet, u sistemi t’ aċċess vaskulari impjantabbli tat- titanju.
Instructions for reconstitution:
44 Struzzjonijiet għar- rikostituzzjoni:
Yondelis 0.25 mg:
Yondelis 0. 25 mg:
Inject 5 ml of sterile water for injections into the vial.
Injetta 5 ml ta ’ ilma sterili għall- injezzjonijiet ġol- kunjett.
Inject 20 ml of sterile water for injections into the vial.
Injetta 20 ml ta ’ ilma sterili għall- injezzjonijiet ġol- kunjett.
A syringe is used to inject the correct amount of sterile water for injections into the vial.
Siringa hija użata biex jiġi injettat l- ammont korrett ta ’ ilma sterili għal injezzjonijiet ġol- kunjett.
It requires further dilution and is for single-use only.
Hija teħtieġ aktar dilwazzjoni u għandha tintuża darba biss.
Instructions for dilution:
Struzzjonijiet għad- dilwazzjoni:
Dilute the reconstituted solution with sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion.
Is- soluzzjoni rikostitwita għandha tiġi dilwita b’ soluzzjoni għal infużjoni ta ’ sodium chloride 9mg/ ml (0. 9%) jew soluzzjoni ta ’ glucose għal infużjoni 50 mg/ ml (5%).
Calculate the required volume as follows:
Il- volum meħtieġ huwa ikkalkulat kif ġej:
If administration is to be made via a central venous line, add the reconstituted solution to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion), being the concentration of trabectedin in the infusion solution ≤ 0.030 mg/ ml.
L- ammont adattat tas- soluzzjoni rrikostitwita għandu jiġi miġbud mill- kunjett u miżjud fil- borża ta ’ l - infużjoni li jkun fiha ≥ 50 ml tad- dilwent (soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- infużjoni ta ’ glucose 50 mg/ ml (5%)) jekk l- amministrazzjoni tkun se tiġi magħmula minn ġo linja venuża ċentrali, biex b’ hekk il- konċentrazzjoni ta ’ trabectedin fis- soluzzjoni għall- infużjoni tkun ≤ 0. 030 mg/ ml.
If central venous access is not feasible and a peripheral venous line has to be used, add the reconstituted solution to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion).
Jekk aċċess venuż ċentrali mhux possibbli u trid tintuża linja venuża periferali, is- soluzzjoni rikostitwita għandha tiġi miżjuda ġo borża ta ’ l- infużjoni li fiha ≥ 1, 000 ml ta ’ dilwent (soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- infużjoni ta ’ glucose 50 mg/ ml (5%).
Inspect the parenteral solution visually for particles prior to administration.
Soluzzjonijiet parenterali għandhom jiġu spezzjonati viżwalment għal frak qabel l- amministrazzjoni.
In-use stability of the solutions:
Stabbilità waqt l- użu tas- soluzzjonijiet:
From a microbiological point of view, the reconstituted solution should be diluted and used immediately.
Mil - lat mikrobijoloġiku, is- soluzzjoni rikostitwita għandha tkun dilwita u użata minnufih.
If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted solution are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma tkunx dilwita u użata minnufih, il- ħinijiet ta ’ ħażna waqt l- użu u l- kondizzjonijiet qabel l- użu tal- prodott rikostitwit huma r- risponsibbilità ta ’ l- utent u normalment ikunu mhux itwal minn 24 sigħat f’ temperatura ta ’ bejn 2ºC sa 8ºC, sakemm ir- rikostituzzjoni ma tkunx saret f’ kondizzjonijiet asettiċi ikkontrollati u ivvalidati.
What is Ytracis?
X’ inhu Ytracis?
Ytracis is a solution containing the active substance yttrium (90Y) chloride.
Ytracis hija soluzzjoni li fiha s- sustanza attiva klorur ta ’ l- ittriju (yttrium) (90Y).
90Y, yttrium-90, is a radioactive form of the chemical element yttrium.
90Y, yttrium- 90, huwa forma radjuattiva ta ’ l- element kimiku ittriju.
What is Ytracis used for?
Għal x’ hiex jintuża Ytracis?
Ytracis is used for radiolabelling.
Ytracis jintuża għal radjutikkettar.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Ir- radjutikkettar hija teknika li fiha sustanza tiġi ittikkettata b’ kompost radjuattiv.
In the case of Ytracis, the product is used to label medicines that have been specially developed for use with the active ingredient yttrium (90Y) chloride.
Fil- każ ta ’ Ytracis, il- prodott jintuża sabiex jittikketta mediċini li ġew speċifikament żviluppati sabiex jintużaw bis- sustanza attiva klorur ra ’ l- ittriju (90Y).
These medicines act as carrier to take the radioactivity to where it is needed.
Dawn il- mediċini jaġixxu bħala ġarriera sabiex jieħdu r- radjuattività safejn tkun meħtieġa.
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 jkunu sustanzi bħal antikorpi li ġew imfasslin sabiex jirrikonoxxu tip partikolari ta ’ ċelloli fil- ġisem, inkluż ċelloli tat- tumuri.
The effects of the medicine that is radiolabelled with Ytracis will be fully explained in its Package Leaflet.
L- effetti tal- mediċina li hija radjutikkettata b’ Ytracis sejrin jiġu spjegati fid- dettall fil- Fuljett ta ’ Tagħrif tiegħu.
How is Ytracis used?
Kif jintuża Ytracis?
Ytracis will only be handled and given by people who have experience in the safe handling of radioactive material.
Ytracis jiġi ġestit u mogħti biss minn persuna b’ esperjenza ta ’ kif għandu jintuża b’ mod sigur materjal radjuattiv.
Ytracis is never given on its own.
Ytracis qatt ma jingħata waħdu.
It must be mixed outside the body, usually in a laboratory, with the medicine that needs radiolabelling.
Għandu jitħallat barra mill- ġisem, normalment f’ laboratorju, bil - mediċina li teħtieġ radjutikkettar.
The 90Y contained in Ytracis then attaches itself to the carrier medicine and the resulting mixture is given according to the instructions in the Package Leaflet of the carrier medicine.
Imbagħad 90Y f’ Ytracis jeħel mal- mediċina ġarriera u t- taħlita li tirriżulta tingħata skond l- istruzzjonijiet fil- Fuljett ta ’ Tagħrif tal- mediċina ġarriera.
The quantity of Ytracis needed for radiolabelling and the quantity of the radiolabelled medicine that is given will depend on the medicine that is radiolabelled and the disease that is being treated.
Il- kwantità ta ’ Ytracis meħtieġa għar- radjutikkettar u l- kwantità tal- mediċina radjutikkettata li mbagħad tingħata jiddependu fuq il- mediċina li hija radjutikkettata u fuq il- marda li tkun qiegħda tiġi kkurata.
How does Ytracis work?
Kif jaħdem Ytracis?
The active substance in Ytracis, yttrium (90Y) chloride, is a radioactive compound.
Is- sustanza attiva f’ Ytracis, klorur ta ’ l- ittriju (90Y), hija kompost radjuattiv.
It emits beta radiation.
Temetti radjazzjonijiet beta.
The effect of Ytracis depends on the nature of the carrier medicine that is radiolabelled with Ytracis.
L- effett ta ’ Ytracis jiddependi fuq in- natura tal- mediċina ġarriera li hija radjutikkettata b’ Ytracis.
An example of its use is the treatment of some types of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour.
Eżempju ta ’ l- użu tagħha huwa t- trattament ta ’ xi tipi ta ’ tumuri; fejn il- mediċina radjutikkettata ġġorr ir- radjuattività sas- sit tat- tumur.
Once there, the radioactivity from Ytracis helps to destroy the tumour.
Ladarba hemm, ir- radjuattività minn Ytracis tgħin biex teqred it - tumur.
How has Ytracis been studied?
Kif ġie studjat Ytracis?
As Ytracis is a ‘ precursor’ and will not be given on its own, no studies have been done in humans.
Minħabba li Ytracis huwa ‘ prekursur ’ u mhuwiex se jingħata waħdu, ma sar ebda studju fuq il - bniedem.
The company presented information from scientific articles already published on 90Y.
Il- kumpanija ppreżentat informazzjoni minn artikoli speċifiċi diġà ppubblikati fuq 90Y.
The company also presented published information supporting the use of 90Y in radiolabelling other medicines.
Il - kumpanija ppreżentat ukoll l- informazzjoni ppubblikata li tappoġġa l- użu ta ’ 90Y għar- radjutikkettar ta ’ mediċini oħra.
What benefit has Ytracis shown during the studies?
X’ benfiċċju wera Ytracis matul dawn l- istudji?
The information supplied by the company supports the use of Ytracis as a precursor for radiolabelling medicines with 90Y.
L- informazzjoni fornuta mill- kumpanija tappoġġa l- użu ta ’ Ytracis bħala prekursur għar- radjutikkettar ta ’ mediċini bi 90Y.
What is the risk associated with Ytracis?
X’ inhu r- riskju assoċjat ma ’ Ytracis?
As Ytracis is a precursor and will not be given on its own, it has no side effects.
Minħabba li Ytracis huwa ‘ prekursur ’ u mhuwiex se jingħata waħdu, m’ għandu ebda effetti sekondarji.
Patients may experience side effects following the injection of the medicine radiolabelled with Ytracis.
Il- pazjenti jistgħu jesperjenzaw effetti sekondarji wara l- injezzjoni tal- mediċina radjutikkettata b’ Ytracis.
These side effects will depend on the medicine being used, and they will be described in the Package Leaflet of the medicine labelled with Ytracis.
Dawn l- effetti sekondarji jiddependu fuq il- mediċina li tkun qiegħda tintuża, u jiġu deskritti fil- Fuljett ta ’ Tagħrif tal- mediċina ttikkettata b’ Ytracis.
Ytracis is radioactive and its use may carry a risk of cancer and hereditary defects.
Ytracis huwa radjuattiv u l- użu tiegħu jista ’ jġorr riskju ta ’ kanċer u ta ’ difetti ereditarji.
The doctor who prescribes Ytracis must ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
It- tabib li jippreskrivi Ytracis għandu jiżgura li r- riskji marbutin ma ’ l- esponiment radjuattiv uikunu inqas mir- riskji mill- marda nfisha.
Ytracis must not be given directly to any patient.
Ytracis ma għandux jingħata direttament lill- pazjent.
Medicines radiolabelled with Ytracis should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients.
Mediċini radjuttikkettati b’ Ytracis ma għandhomx jintużaw fuq nies li jkunu ipersensittivi (allerġiċi) għall- klorur ta ’ l- ittriju jew għal xi sustanzi oħra.
A medicine labelled with Ytracis should not be used in women who are or may be pregnant.
Mediċina ttikkettjata b’ Ytracis ma għandhiex tintuża f’ nisa li huma jew li jistgħu jinqabdu tqal.