FrancophonIA/ELRC3.0 huggingface dataset:
English: Ergotam-CT 2,5mg Retardkapseln
Maltese: Ergotam-CT 2,5mg Retardkapseln kapsula li terħi lmediċina b'mod modifikat
English: Pharmaceutical Form Route of administration
Maltese: Għamla farmaċewtika
English: Packaging Content
Maltese: Kontenut (konċentrazzjoni)
English: EU number
Maltese: Numru ta' Proċedura ta' lEU
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa
English: Powder for solution for injection/infusion
Maltese: Soluzzjoni għallinjezzjoni/infużjoni
English: EMA/409425/2019 EMEA/H/C/001037
Maltese: EMA/454049/2019 EMA/H/C/001037
English: Further information on Cimzia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cimzia.
Maltese: Aktar informazzjoni dwar Cimzia tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/cimzia.
English: The most common side effects with Cimzia (affecting up to 1 in 10 people) are bacterial infections including abscesses (a swollen area where pus has collected), viral infections (including herpes, papillomavirus and influenza), eosinophilic disorders (disorders of eosinophils, a type of white blood cell), leucopenia (low white blood cell counts), nausea (feeling sick), headaches (including migraine), sensory abnormalities (such as numbness, tingling and burning sensation), high blood pressure, hepatitis (liver inflammation) including increased levels of liver enzymes, rash, fever, pain, weakness, itching and reactions at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Cimzia (li jaffettwaw sa persuna 1 minn 10) huma infezzjonijiet batterjali inkluż axxessi (ħofor li fihom il-materja), infezzjonijiet virali (inklużi ħerpes, papillomavirus, u influwenza), disturbi ejosinofiliċi (disturbi tal-ejosinofili, tip ta' ċellola bajda tad-demm), lewkopenja (għadd baxx ta' ċelloli bojod tad-demm), nawżja (tħossok ma tiflaħx), uġigħ ta' ras (inkluż emigranja), anormalitajiet sensorjali (bħal tirżiħ, textix u sensazzjoni ta' ħruq), pressjoni tad-demm għolja, epatite (infjammazzjoni tal-fwied) inklużi livelli ogħla ta' enzimi tal-fwied, raxx, deni, uġigħ, debbulizza, ħakk u reazzjonijiet fis-sit tal-injezzjoni.
English: Other information about Cimzia
Maltese: Informazzjoni oħra dwar Cimzia
English: The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis:
Maltese: L-istudji kienu jinvolvu adulti bl-artrite rewmatojde attiva, spondiloartrite assjali, artrite psorjatika u psorijażi bil-qoxra moderata sa gravi:
English: What are the risks associated with Cimzia?
Maltese: X'inhuma r-riskji assoċjati ma' Cimzia?
English: Cimzia received a marketing authorisation valid throughout the EU on 1 October 2009.
Maltese: Cimzia ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-1 ta' Ottubru 2009.
English: After 12 weeks of treatment, Cimzia 200 mg every two weeks led to 61% of patients responding and 67% responding with Cimzia 400 mg every two weeks compared with 53% of patients receiving etanercept and 5% of patients receiving placebo.
Maltese: Wara 12-il ġimgħa ta' kura, 61 % tal-pazjenti rrispondew għal Cimzia 200 mg kull ġimagħtejn u 67 % irrispondew għal Cimzia 400 mg kull ġimagħtejn, meta mqabbel ma' 53 % tal-pazjenti li ngħataw etanercept u 5 % tal-pazjenti li ngħataw plaċebo.
English: In a study in 879 patients who had never received DMARDs, treatment with Cimzia and methotrexate led to remission in almost 29% of patients (189 out of 655), compared with 15% (32 out of 213) of patients receiving placebo with methotrexate.
Maltese: Fi studju bi 879 pazjent li qatt ma ngħataw DMARDs, il-kura b'Cimzia u b'metotressat wasslet għal remissjoni fi kważi 29 % tal-pazjenti (189 minn 655), meta mqabbla ma' 15 % (32 minn 213) tal-pazjenti li ngħataw plaċebo ma' metotressat.
English: In the first study, symptoms were reduced by at least 20% in 57% of patients who received Cimzia (141 out of 246) compared with 9% of patients who received placebo (11 out of 127).
Maltese: Fl-ewwel studju, is-sintomi tnaqqsu b'talanqas 20 % f'57 % tal-pazjenti li ngħataw Cimzia (141 minn 246) meta mqabbla ma' 9 % talpazjenti li ngħataw plaċebo (11 minn 127).
English: The active substance in Cimzia, certolizumab pegol, reduces the activity of the immune system (the body's defences).
Maltese: Is-sustanza attiva f'Cimzia, iċ-ċertoliżumab pegol, tnaqqas l-attività tas-sistema immunitarja (id-difiżi tal-ġisem).
English: Nine main studies involving over 3,000 patients have found Cimzia effective for reducing symptoms of inflammatory conditions.
Maltese: Disa' studji ewlenin li jinvolvu 3,000 pazjent sabu li Cimzia huwa effettiv għat-tnaqqis ta' sintomi ta' kundizzjonijiet infjammatorji.
English: In the other main study, symptoms were reduced by at least 20% in 59% of patients who received Cimzia (228 out of 388) compared with 14% of patients who received placebo (27 out of 198).
Maltese: Fl-istudju ewlieni l-ieħor, is-sintomi tnaqqsu b'tal-anqas 20 % f'59 % tal-pazjenti li ngħataw Cimzia (228 minn 388) meta mqabbla ma' 14 % tal-pazjenti li ngħataw plaċebo (27 minn 198).
English: It is made up of a monoclonal antibody, certolizumab, which has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Hija magħmula minn antikorp monoklonali, iċ-ċertoliżumab, li ġie ‘pegilat' (jeħel ma' kimika msejħa polietilin glikol).
English: Cimzia contains the active substance certolizumab pegol.
Maltese: Cimzia fih is-sustanza attiva ċertoliżumab pegol.
English: • For psoriatic arthritis, symptoms improved by at least 20% in 58% of patients treated with Cimzia 200 mg every two weeks compared with 24% of patients receiving placebo.
Maltese: • Għall-artrite psorjatika, is-sintomi tjiebu b'tal-anqas 20 % fi 58 % tal-pazjenti kkurati b'Cimzia 200 mg kull ġimagħtejn meta mqabbla ma' 24 % tal-pazjenti li ngħataw plaċebo.
English: • For active rheumatoid arthritis that had not improved adequately with disease-modifying antirheumatic drug (DMARD) treatment, two main studies found Cimzia effective when used with methotrexate when compared with placebo (dummy treatment).
Maltese: • Għal artrite rewmatojde attiva li ma tkunx tjiebet b'mod adegwat b'kura b'mediċini antirewmatiċi li jimmodifikaw il-marda (DMARD), żewġ studji ewlenin sabu li Cimzia huwa effettiv meta jintuża mal-metotressat meta mqabbel ma' plaċebo (kura finta).
English: As for all medicines, data on the use of Cimzia are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Cimzia hija ssorveljata kontinwament.
English: Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha (TNF-alpha).
Maltese: Iċ-ċertoliżumab pegol tfassal biex jeħel ma' messaġġier talproteina fil-ġisem magħruf bħala fattur alfa tan-nekrożi minn tumur (TNF-alfa).
English: For patients receiving Cimzia 400 mg every four weeks 52% saw an improvement.
Maltese: Għall-pazjenti li ngħataw Cimzia 400 mg kull erba' ġimgħat, 52 % minnhom raw titjib.
English: Treatment with Cimzia 200 mg every two weeks in the two studies led to 66.5% and 52.6% of patients responding compared with 6.5% and 4.5% of patients receiving placebo.
Maltese: Dan ifisser li l-punteġġ tas-sintomi tjieb b'75 % jew aktar. 66.5 % u 52.6 % tal-pazjenti rrispondew għall-kura b'Cimzia 200 mg kull ġimagħtejn fiż-żewġ studji, meta mqabbel ma' 6.5 % u 4.5 % talpazjenti li ngħataw plaċebo. 75.8 % u 55.4 % tal-pazjenti irrispondew għal Cimzia 400 mg kull ġimagħtejn.
English: For the full list of side effects of Cimzia, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Cimzia, ara l-fuljett ta' tagħrif.
English: • A study in patients with axial spondyloarthritis showed that symptoms improved by at least 20% after 12 weeks in around 60% of patients treated with Cimzia compared with around 40% of patients receiving placebo.
Maltese: • Studju f'pazjenti bi spondiloartrite assjali wera li s-sintomi tjiebu b'tal-anqas 20 % wara 12il ġimgħa f'madwar 60 % tal-pazjenti kkurati b'Cimzia, meta mqabbel ma' madwar 40 % talpazjenti li ngħataw plaċebo.
English: How does Cimzia work?
Maltese: Kif jintuża Cimzia?
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Ħarsa ġenerali lejn Cimzia u għalfejn huwa awtorizzat fl-UE
English: Cimzia must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure (inability of the heart to pump enough blood around the body).
Maltese: Cimzia m'għandux jintuża f'pazjenti morda bit-tuberkolożi attiva, infezzjonijiet gravi oħra, jew insuffiċjenza kardijaka minn moderata sa gravi (inabbiltà tal-qalb li tippompja biżżejjed demm madwar il-ġisem).
English: In patients with active rheumatoid arthritis who had never received DMARDs, treatment with Cimzia led to sustained remission (no detectable disease activity) after 52 weeks of treatment.
Maltese: Fil-pazjenti b'artrite rewmatojde attiva li qatt ma ngħataw DMARDs, il-kura b'Cimzia wasslet għal remissjoni sostnuta (ma dehret l-ebda attività ta' mard) wara 52 ġimgħa ta' kura.
English: Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Cimzia huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Patients will be given a reminder card with safety information that they should carry with them.
Maltese: Il-kumpanija li tqiegħed Cimzia fis-suq ser tipprovdi wkoll pakketti edukattivi għat-tobba li jippreskrivu Cimzia.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints)
Maltese: • psorjażi bil-qoxra (marda li tikkawża rqajja' ħomor, bil-qoxra fuq il-ġilda).
English: By blocking TNF-alpha, certolizumab pegol reduces inflammation and other symptoms of the diseases.
Maltese: Dawn il-pakketti ser jinkludu informazzjoni dwar is-sigurtà tal-mediċina.
English: Treatment starts with a 400-mg dose given as two injections, followed by a further 400-mg dose 2 and 4 weeks later.
Maltese: Il-kura tibda b'doża ta' 400 mg mogħtija bħala żewġ injezzjonijiet, segwita b'doża oħra ta' 400 mg ġimagħtejn u erba' ġimgħat wara.
English: Organ Adult male 70 kg
Maltese: Organu Raāel adult 70 kg
English: 7 days from the date/hour of manufacture.
Maltese: 7 ijiem mid-data/siegħa ta' manifattura.
English: Date of the last renewal: 24/03/2008
Maltese: Data ta' l-aħħar reviŜjoni: 24/03/2008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/250/001
Maltese: FIS-SUQ EU/1/03/250/001
English: Timepoints for measurements were 5 minutes, 1 hour, 6 hours, 1 day, 4 days and 15 days.
Maltese: Il-kejl tad-doŜi ttieħdu wara 5 minuti, siegħa 1, 6 sigħat, jum 1, 4t'ijiem u 15-il jum.
English: It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr).
Maltese: Huwa jiddegrada bl-emissjoni ta' radjazzjoni beta ta' 2.281 MeV (99.98 %) ta' enerāija massima lil Zirconium (90Zr) stabbli.
English: Y) chloride 1.850 GBq/ml
Maltese: Yttrium chloride (90Y) 1.850 GBq/ml
English: Effective dose (Sv/1 GBq administered) Adult male Adult female 15 years 10 years 5 years
Maltese: DoŜa effettiva (Sv/1 GBq mogħtija) Raāel adult Mara adulta 15-il sena 10 snin 5 snin Sena 1 Tarbija tattwelid
English: Hydrochloric acid 30%, water for injections.
Maltese: Hydrochloric acid 30%, ilma għall-injezzjoni.
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Maltese: Fil-fwied, 18 % ta' l-attività injettata hija assorbita 5 min wara t-titqiba.
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terapewtiëi
English: Pharmacovigilance system
Maltese: Sistema ta' Farmakoviāilanza
English: Adult female 57 kg 15 years 10 years 5 years
Maltese: Mara adulta 57 kg 15-il sena 10 snin 5 snin Sena 1 Tarbija tattwelid
English: Hydrochloric acid 30 %
Maltese: Hydrochloric acid 30 % Ilma għall-injezzjoni
English: 90Y-yttrium has a half-life of 2.67 days (64.1 hours).
Maltese: Il-half-life ta' 90Y-Yttrium huwa ta' 2.67 jum (64.1 sigħat).
English: Yttrium (90Y) is a beta pure emitter.
Maltese: Yttrium (90Y) huwa emettur pur tar-raāāi beta.
English: For this product, the effective dose resulting from an intravenously injected activity of 1 GBq is 700 mSv for a 57-kg female adult and 650 mSv for a 70-kg male adult.
Maltese: Għal dan il-prodott, id-doŜa effettiva li tirriŜulta minn attività injettata āol-vina ta' 1 GBq hija ta' 700 mSv għal mara adulta ta' 57 kg u 650 mSv għal raāel adult ta' 70 kg.
English: The toxicological properties of Yttrium (
Maltese: Il-kwantità ta' YTRACIS meħtieāa biex jiāi radjutikkettat, u l-kwantità ta' prodott mediëinali li jiāi radjutikkettat b'Yttrium (
English: In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
Maltese: Fl-għadam, il-perëentwali ta' l-attività injettata tiŜdied minn 3.1 % f'5 min għal 18 % f'6 sigħat u mbagħad tonqos mal-ħin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of sterile solution contains 1.850 GBq Yttrium (90Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium.
Maltese: U KWANTITATTIVA 1ml ta' soluzzjoni sterili fih 1.850 GBq Yttirium (90Y) chloride, fid-data ta' kalibrazzjoni, li tikkorrispondi għal 92 ng ta' Yttrium.
English: Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Maltese: Yttrium chloride (90Y) huwa r-riŜultat tad-degradazzjoni tal-prekursur radjuattiv Strontium (90Sr).
English: At 1 and 24 hours, blood radioactivity decreases from 11 % to 0.14 % of the administered activity.
Maltese: Bejn 1 u 24 siegħa, ir-radjuattività fid-demm tonqos minn 11. % għal 0.14 % ta' l-attività mogħtija.
English: 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).
Maltese: Āramma waħda ta' l- agenti kelanti, għandha tkun mogħtija minn injezzjoni āol-vina bil-mod fi Ŝmien ta' 3-4 minuti, jew permezz ta' infuŜjoni (1 g f'100-250 ml ta' destrosju, jew soluzzjoni normali ta' melħ).
English: For in vitro radiolabelling.
Maltese: Għal radjutikkettar in vitro.
English: - The active substance is Yttrium (90Y) chloride.
Maltese: - Is-sustanza attiva hi l-Yttrium (90Y) chloride.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 24/03/2003
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĀDID TA' L-AWTORIśśAZZJONI Data ta' l-ewwel awtorizzazzjoni: 24/03/2003
English: Each millilitre of solution contains 1.850 GBq of Yttrium (90Y) chloride at the date of calibration.
Maltese: - Kull millilitru ta' soluzzjoni fih 1.850 GBq ta' Yttrium (90Y) chloride fid-data ta' 'kalibrazzjoni,
English: In this leaflet:
Maltese: TuŜax YTRACIS:
English: Batch N°: {XXXXX}
Maltese: Vol.: {Z} ml
English: NOT INTENDED FOR DIRECT APPLICATION TO PATIENTS
Maltese: MHUX INTENZJONAT GĦAL APPLIKAZZJONI DIRETTA FUQ ILPAZJENTI
English: Radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Maltese: Radjutikkettar ta' molekuli portaturi, bħal antikorpi monoklonali, peptidi jew substrata oħra, b' Yttrium chloride (90Y) huwa sensittiv ħafna għall-preŜenza ta' impuritajiet ta' metalli traëëi.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraāā kontinwu tal-bilanë bejn il-benefiëëju u r-riskju tal-prodott mediëinali.
English: A.LABELLING
Maltese: A.TIKKETTA
English: Kidneys Liver Bladder Ovaries Uterus Spleen 0.85 Bone Heart Lungs Intestines Muscles Testes
Maltese: Qalb Pulmuni Intestini Muskoli Testikoli
English: Faecal and urinary elimination is slow: about 13 % of the administered activity is eliminated in 15 days.
Maltese: L-eliminazzjoni fil-purgar u flawrina hija bil-mod: madwar 13 % ta' l-attività mogħtija hija eliminata fi Ŝmien 15-il āurnata.
English: PHARMACEUTICAL PARTICULARS
Maltese: FARMAKOLOĀIKU
English: OTHER
Maltese: TALLOTT
English: 1 vial
Maltese: 11 DOśIMETRIJA
English: The following preparations must be available in medical institutions, which use Ytracis for radiolabelling of carrier molecules for therapeutic purposes: Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Maltese: Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
English: Yttrium (90Y) chloride.
Maltese: Yttrium chloride (90Y).
English: INSTRUCTIONS ON USE
Maltese: PREKAWZJONIJIET SPEêJALI
English: 4.9 Overdose
Maltese: .9 DoŜa eëëessiva
English: Vol.: {Z} ml Act.: {Y} GBq/vial
Maltese: {Y} GBq/kunjett Kal : {ĀĀ/XX/YYYY} (12 h CET) Att.: {Y} GBq/ml
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Maltese: INFORMAZZJONI BIL-BRAILLE <Il-Āustifikazzjoni biex ma jkunx inkluŜ il-Braille hija aëëettata.>
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediëina tinsab fuq is-sit elettroniku tal-Aāenzija Ewropea għallMediëini http://www.ema.europa.eu/.
English: LIST OF EXCIPIENTS
Maltese: KLASSIFIKAZZJONI ĀENERALI
English: Absorbed dose per unit activity administered (mGy/MBq)
Maltese: DoŜi fl-organi (mGy/MBq injettati) u doŜa effettiva (Sv/GBq injettata) DoŜa assorbita għal kull unità t'attività waħda mogħtija (mGy/MBq) (mGy/MBq)
English: A vial contains 0.5 ml (0.925 GBq at calibration) to 2 ml (3.700 GBq at calibration).
Maltese: Kunjett 1 jista jkun fih minn 0.5 sa 2 ml (jikkorrespondi għal 0.925 sa 3.700
English: Liver uptake decreases then to 8.4 % 24 hours after injection.
Maltese: L-assorbiment mill-fwied imbagħad jonqos għal 8.4% 24 siegħa wara t-titqiba.
English: One vial contains 0.925 to 3.700 GBq (see section 6.5).
Maltese: Kunjett wieħed fih minn 0.925 sa 3.700
English: YTRACIS is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by approved route.
Maltese: YTRACIS huwa maħsub biex jigu radjutikkettati prodotti mediëinali in vitro, li wara jigħataw bilmetodu approvat.
English: EXP {DD/MM/YYYY} (12h CET)
Maltese: DATA META JISKADI JIS {ĀĀ/XX/SSSS} (12h CET)
English: Pharmacotherapeutic group: Not applicable ATC code: Not applicable
Maltese: Kodiëi ATC:
English: B.PACKAGE LEAFLET
Maltese: 2. QABEL MA TUśA YTRACIS
English: Cal : {DD/MM/YYYY} (12 h CET)
Maltese: DATA TA' META JISKADI JIS {ĀĀ/XX/SSSS} (12h CET)
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Maltese: GĦAMLA FARMAêEWTIKA Prekursur radjufarmaëewtiku, soluzzjoni.
English: YTRACIS is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3 Contraindications).
Maltese: YTRACIS huwa kontra-indikat għal waqt tqala stabbilita jew meta jkun hemm suspett ta' tqala jew meta t-tqala tkun għadha ma āietx eskluŜa (ara sezzjoni 4.3 Kontra-indikazzjonijiet).
English: The content of the vial of YTRACIS is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Maltese: Il-kontenut tal-kunjett ta' YTRACIS ma għandux jingħata direttament lill-pazjent iŜda għandu jintuŜa għar- radju-labiling ta' molekuli portaturi, bħal anti-korpi monoklonali, peptidi u sustrati oħra.
English: YTRACIS radiopharmaceutical precursor, solution.
Maltese: Prekursur Radjufarmaëewtiku, soluzzjoni.
English: 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.
Maltese: It-tossiëità ta' Yttrium (90Y) ħieles hija minħabba li joħroā in-vivo mill-bijomolekoli radjutikkettati fil-āisem matul it-terapija.
English: Store in the original package.
Maltese: AħŜen fil-pakkett oriāinali tiegħu.
English: What YTRACIS looks like and contents of the pack
Maltese: Id-Dehra ta' YTRACIS u l-kontenuti tal-pakkett:
English: PHARMACOLOGICAL PROPERTIES
Maltese: GĦAMLA FARMAêEWTIKA
English: The MAH must ensure that the system of pharmacovigilance, as described in version 7 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.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiŜgura li s-sistema ta' farmakoviāilanza, kif deskritta fil-verŜjoni 7 ippreŜentata f'Modulu 1.8.1. tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq .
English: HOW TO USE YTRACIS
Maltese: Kunjett wieħed
English: Colourless Type I glass 2-ml vial, closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
Maltese: Kunjett tal-ħāieā tat-Tip 1 ta' 2 ml, mingħajr kulur, magħluq b'tapp tal-gomma bromobjutajl, miksi bit-Teflon u b'siāill ta' l-aluminju.
English: YTRACIS is contraindicated in the following cases: - Hypersensitivity to the active substance or to any of the excipients.
Maltese: YTRACIS ma ghandux jintuŜa fil-kaŜijiet li āejjin: - Sensittività eëëessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi.
English: (GBq : GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
Maltese: (GBq: GigaBecquerel hi l-junit li jkejjel l-ammont ta' radjuattività) - Is-sustanzi l-oħra huma hydrochloric acid u ilma għall-injezzjoni
English: 91192 GIF-SUR-YVETTE Cedex France
Maltese: 91192 GIF-SUR-YVETTE Cedex Franza
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Maltese: Għal informazzjoni dwar twissijiet speëjali u prekawzjonijiet għall-uŜu ta' prodotti mediëinali radjutikkettati b'Yttrium (90Y) irreferi għall-Karatteristiëi tal-Prodott fil-Qosor/fuljett tal-pakkett tal prodott mediëinali li sejjer jiāi radjutikkettat.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Maltese: • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL-FORNIMENT U L-UśU IMPOSTI FUQ ID-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FISSUQ
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of YTRACIS.
Maltese: Id-doŜa assorbita mill-utru wara għoti ta' prodotti mediëinali radjutikkettati b'Yttrium (90Y),
English: BATCH NUMBER
Maltese: Mhux applikabbli
English: 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).
Maltese: Dawn l-agenti kelanti iraŜŜnu ir-radjutossiëità ta' Yttrium permezz ta' bdil bejn l-jone tal-kalëju u Yttrium, bil-ħila li għandhom li jiffurmaw kumplessi li jinħallu fl-ilma mal-ligand kelanti (DTPA, EDTA).
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Maltese: F-91192 GIF-SUR-YVETTE Cedex Franza
English: F-91192 GIF-SUR-YVETTE CEDEX FRANCE
Maltese: F-91192 GIF-SUR-YVETTE CEDEX FRANZA
English: HOW TO STORE YTRACIS
Maltese: Metodu ta' kif jintuŜa
English: Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, will be dependent on the specific medicinal product being used.
Maltese: Effetti possibbli li mhux mixtieqa wara l-għoti āol-vina ta' prodotti mediëinali radjutikkettati b'Yttrium (90Y); ippreparati billi āew radjutikkettati b'YTRACIS; huma dipendenti fuq il-prodott mediëinali speëifiku li jkun qiegħed jintuŜa.