FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Lamivudine Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Lamivudine Teva Pharma B.V. huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji jitqiesu li kienu l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Lamivudine Teva Pharma B.V.?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Lamivudine Teva Pharma B.V.?
English: What is Lamivudine Teva Pharma B.V.?
Maltese: Kif ġie studjat Lamivudine Teva Pharma B.V.?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lamivudine Teva Pharma B.V. have been included in the summary of product characteristics and the package leaflet.
Maltese: Ir-rakkomandazzjonijiet u l-prekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam talkura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Lamivudine Teva Pharma B.V. ġew inklużi fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif.
English: adult female (60 kg)
Maltese: (70 kg)
English: Hydrochloric acid (0.1 N).
Maltese: Aċidu idrokloriku (0.1 N).
English: Date of latest renewal: 19 july 2017
Maltese: Data tal-aħħar tiġdid: 19 lulju 2017
English: Time points for measurements were 2 minutes, 30 minutes, 1 hour, 4 hours, 6 hours, 12 hours, 24 hours, 2 days, 4 days, 6 days.
Maltese: siegħa, 4 sigħat, 6 sigħat, 12-il siegħa, 24 siegħa, jumejn, 4 ijiem, 6 ijiem.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 august 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 awissu 2012
English: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE) Italy
Maltese: SPARKLE S.r.l Contrada Calò, snc IT-73042 Casarano (LE)
English: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - Italy
Maltese: SPARKLE S.r.l Contrada Calò, snc 73042 Casarano (LE) - L-Italja
English: Cuprymina is a sterile solution.
Maltese: Cuprymina huwa soluzzjoni sterili.
English: The Copper-64 gamma dose constant is 3.6 x 10-5 mSv x MBq-1 x h at a distance of 1 meter.
Maltese: Il-kostant tad-doża gamma Ram-64 huwa 3.6 x 10-5 mSv x MBq-1 x h f'distanza ta' metru.
English: MARKETING AUTHORISATION NUMBER EU/1/12/784/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ UE/1/12/784/001
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 glucose, or sodium chloride 9 mg/mL (0.9 %) solution for injection).
Maltese: 1 g tas-sustanzi kelanti għandha tingħata permezz ta' injezzjoni bil-mod minn ġol-vina fuq 3 - 4 minuti jew permezz ta' infużjoni (1 g f'100 - 250 mL ta' glukosju, jew klorur tas-sodju 9 mg/mL (0.9 %) soluzzjoni għall-injezzjoni).
English: Dose rate (nSv/h)
Maltese: doża(nSv/h) 4.5
English: Copper-64 is a beta emitter.
Maltese: Ram-64 jarmi l-beta.
English: For in vitro radiolabelling.
Maltese: Għar-radjutikkettar in vitro.
English: Ref. N°
Maltese: U MNEJN GĦANDU JINGĦATA
English: EXP {DD/MM/YYYY} hh:mm CET
Maltese: JIS { JJ/XX/SSSS } hh:mm CET
English: Copper-64 decays also in stable Zinc (64Zn) by emission of β- (39 %).
Maltese: Ir-Ram-64 jiddegrada wkoll fiż-Żingu (64Zn) stabbli b'emissjoni ta' β- (39 %).
English: Specific activity ≥ 3,700 MBq Cu-64/micrograms of copper.
Maltese: Attività speċifika ≥ 3,700 MBq ta' Ram-64/mikrogrammi ta' Ram.
English: The volume varies from 1 to 3 mL.
Maltese: Il-volum ivarja minn 1 sa 3 mL.
English: Località Cavallino 62010 Montecosaro (MC) - Italy
Maltese: Località Cavallino 62010 Montecosaro (MC) - L-Italja
English: Copper-64 has a half-life of 12.7 hours.
Maltese: Ir-Ram-64 għandu half-life ta' 12.7 sigħat.
English: MAH:
Maltese: Volum:
English: Central European Time [CET]), corresponding to at least 0.25 micrograms of Copper-64.
Maltese: Ċentrali Ewropew [Central European Time - CET]), li jikkorrispondi għal mill-inqas 0.25 mikrogramma ta' Ram-64.
English: Table 1 - Condition of negligible radioactivity in the patients Days after injection (2,770 MBq)
Maltese: Tabella 1 - Kondizzjoni ta' radjuattività negliġibbli fil-pazjenti Ġranet wara linjezzjoni (2,770 MBq)
English: ULI wall heart wall kidneys liver lungs muscle ovaries pancreas red marrow 0.00581 0.00565 0.00670 0.0118 0.0242 0.0586 0.198 osteogenic cells skin spleen testes thymus thyroid urinary bladder wall 0.00 uterus effective dose ( Sv/1 GBq administered) adult male adult female 15 years 10 years 5 years 1 years newborn
Maltese: Ħajt tal-qalb kliewi fwied pulmuni muskolu ovarji frixa mudullun aħmar ċelloli osteoġeniċi ġilda milsa testikoli timu tirojde ħajt tal-bużżieqa tal-awrina 0.00 0.00 0.00 0.00 0.00 0.00 0.00 utru doża effettiva ( Sv/1 GBq mogħtija) raġel mara 15 il sena 10 snin 5 snin sena tarbija tattwelid
English: Cuprymina is a radiopharmaceutical precursor.
Maltese: Cuprymina huwa prekursur radjufarmaċewtiku.
English: Pharmacokinetics of Cuprymina was investigated in mice.
Maltese: Il-farmakokinetika ta' Cuprymina ġiet investigata fil-ġrieden.
English: Activity: {Y}________MBq Cal.: {DD/MM/YYYY} 01h00 a.m. CET
Maltese: (Y) MBq tal-kal: {JJ/XX/SSSS} 01h00 a.m. CET
English: Marketing Authorisation Holder SPARKLE S.r.l.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq SPARKLE S.r.l.
English: Table 2: Absorbed dose per unit activity administered
Maltese: Tabella 2: Doża assorbita għal kull attività ta' unità mogħtija
English: Tel: 0039.388.8735530 or 0039.0733.560354 Fax: 0039.0836.1975111 or 0039.0733.560376 E-mail: info@sparklepet.it
Maltese: Fax: 0039.0836.1975111 jew 0039.
English: Relevant data is included in the Summary of Product Characteristics of the labelled medicinal products.
Maltese: Data rilevanti hija inkluża fis-Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali ttikkettati.
English: PHARMACEUTICAL FORM AND CONTENTS Volume: {Z} mL
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: It contains the active substance copper (64Cu) chloride.
Maltese: Fih is-sustanza attiva klorur tar-ram (64Cu).
English: Pharmacotherapeutic group: various diagnostic radiopharmaceuticals, ATC code: Not yet assigned
Maltese: Kategorija farmakoterapewtika: radjofarmaċewtiċi dijanjostiċi varji, Kodiċi ATC:
English: Copper-64 decays by an emission of β+ (17.6 %) with a maximum energy of 0.66 MeV, an emission of β- (38.5 %) with a maximum energy of 0.58 MeV and electronic capture (43.9 %).
Maltese: (38.5 %) b'enerġija massima ta' 0.58 MeV u qbid elettroniku (43.9 %).
English: Calibration time: {DD/MM/YYYY} 01h00 a.m. CET
Maltese: (Y) MBq ħin tal-kalibrar: {JJ/XX/SSSS} 01h00 a.m. CET
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: <Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Blood radioactivity decreased from 60.3 % to 3.4 % after 1 hour, and then it decreased of 1 % after 6 hours, and increased to 5.6 % and 4.9 % after 12-24 hours.
Maltese: Ir-radjuattività fid-demm naqset minn 60.3 % għal 3.4 % wara siegħa, u mbagħad naqset b'1 % wara 6
English: For this medicinal product, the effective dose resulting from an intravenously injected activity of 925 MBq is 65.86 mSv for a 60-kg female adult and 88.99 mSv for a 70-kg male adult.
Maltese: MBq injettata minn ġol-vini hija ta' 65.86 mSv għal mara ta' 60 kg u 88.99 mSv għal raġel ta' 70 kg.
English: Copper-64 decays in stable Nickel 64Ni (61 %) by an emission of β+ (18 %) or by an electronic capture (43 %).
Maltese: Ir-Ram-64 jiddegrada fin-Nikil 64Ni (61 %) stabbli b'emissjoni ta' β+ (18 %) jew bi qbid elettroniku
English: 8735530 or 0039.0733.560354 Fax: 0039.0836.1975111 or 0039.0733.560376 E-mail: info@sparklepet.it
Maltese: 0733.560376 Email:
English: - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Maltese: - Tqala stabbilita jew maħsuba jew meta t-tqala ma tkunx ġiet eskluża (ara sezzjoni 4.6).
English: 62010 Montecosaro (MC) - Italy Tel: 0039.388.
Maltese: Montecosaro (MC) - L-Italja Tel: 0039.388.8735530 jew 0039.
English: The following preparations must be available in medical institutions, which use Cuprymina for labelling of carrier molecules: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Maltese: It-tħejjijiet li ġejjin għandhom ikunu disponibbli fl-istituzzjonijiet mediċi li jużaw Cuprymina għat tikkettar ta' molekuli trasportaturi: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
English: One vial contains from 925 to 2,770 MBq (corresponding to 0.250.75 micrograms of copper-64).
Maltese: MBq sa 2,770 MBq (fil-ħin ta' kalibrar) li tikkorrispondi għal ammont ta' 0.25 sa 0.75 mikrogramma ta' Ram-64.
English: Considering that each MBq of Copper-64 causes a dose rate of 9 nSv/h (at a distance of 2 meters) and that the maximum injected activity is of 2,770 MBq, the initial dose rate is 24,930 nSv/h.
Maltese: u li l-attività massima injettata hija ta' 2,770 MBq, ir-rata inizjali tad-doża hija 24,930 nSv/h.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Copper (64Cu) chloride, 925 MBq/mL at calibration time (01h00 a.m. CET), corresponding to 0.25 micrograms (
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Klorur tar-ram (64Cu), 925 MBq/mL fil-ħin tal-kalibrar (01h00 a.m. CET), li jikkorrispondi għal 0.25 mikrogramma ta' (64Cu).
English: Copper (64Cu) chloride
Maltese: Klorur tar-ram (64Cu)
English: It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons.
Maltese: Wieħed għandu jiftakar li l-prodott mediċinali radjutikkettat jarmi elettroni Auger ta' intensità għolja.
English: Activity: (Y) MBq
Maltese: NUMRU(I)
English: According to literature reports, it may be considered that both spermatogenetic and genetic damage in male test is are unlikely at the dose of 1,000 MBq.
Maltese: Skont ir-rapporti tad-dokumentazzjoni, wieħed jista' jqis li aktarx ma jkunx hemm ħsara spermatoġenetika u lanqas ġenetika fit-testikoli maskili f'doża ta' 1,000 MBq.
English: Each mL of solution contains 925 MBq of copper (64Cu) chloride at calibration time (01h00 a.m.
Maltese: MBq ta' klorur tar-ram (64Cu) fil-ħin tal-kalibrar (01h00 a.m. Ħin
English: What Cuprymina contains - The active substance is copper (64Cu) chloride.
Maltese: X'fih Cuprymina - Is-sustanza attiva hija l-klorur tar-ram (64Cu).
English: Manufacturer: ACOM S.r.l.
Maltese: Manifattur ACOM S.r.l L-Italja
English: EXPIRY DATE EXP {DD/MM/YYYY} (hh:mm CET)
Maltese: DATA TA' SKADENZA JIS {JJ/XX/SSSS} (ss:mm CET)
English: The dosimetry estimates were based on a mouse distribution study and the calculations were effected using OLINDA (Organ Level INternal Dose Assessment Code) (see Table 2).
Maltese: L-istimi tad-dożimetrija kienu bbażati fuq studju tad-distribuzzjoni fil-ġrieden u l-kalkoli saru permezz tal-Kodiċi tal-Valutazzjoni tad-Doża Interna fil-Livell tal-Organi (OLINDA - Organ Level INternal Dose Assessment Code) (ara Tabella 2).
English: The possible use of chelating therapies could interfere with the use of Copper-64-labelled medicinal products.
Maltese: L-użu possibbli ta' terapiji kelanti jista' jfixkel l-użu ta' prodotti mediċinali ttikkettati b' Ram-64.
English: Assuming the worst case that the whole maximum activity (2,770 MBq) is injected to the patient and Copper-64 is labelled to a molecule with infinite biological half-life (no disposal by the patient) the person is continuously exposed at a distance of 2 meters.
Maltese: Jekk wieħed jassumi l-agħar każ fejn l-attività massima sħiħa (2,770 MBq) tiġi injettata lill-pazjent u Ram-64 jiġi ttikkettat ma' molekula b'half-life bijoloġika infinita (l-ebda rimi mill-pazjent) il-persuna tkun esposta kontinwament f'distanza ta' żewġ metri.
English: The following information is intended for medical or healthcare professionals only: The complete Summary of Product Characteristics (SmPC) of Cuprymina is provided as a separate document in the medicinal product pack, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this medicinal product.
Maltese: Is-Sommarju sħiħ tal-Karatteristiċi tal-Prodott (SmPC) ta' Cuprymina huwa pprovdut bħala dokument separat fil-pakkett tal-prodott mediċinali, bl-għan li jipprovdi lill-professjonisti tas-saħħa b'aktar informazzjoni xjentifika u prattika dwar l-użu ta' dan il-prodott mediċinali.
English: Pharmacokinetic data on Cuprymina relate to free copper
Maltese: Kif jidher Cuprymina u l-kontenut tal-pakkett
English: NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution.
Maltese: Cuprymina 925 MBq/mL prekursur radjufarmaċewtiku, soluzzjoni.
English: Copper-64 is a radioactive form of the chemical element copper, which emits the radiation needed for certain procedures that may be carried out on you.
Maltese: Ir-ram-64 huwa forma radjuattiva tal-element kimiku ram, li jarmi r-radjazzjoni meħtieġa għal ċerti proċeduri li jistgħu jsiru fuqek.
English: For instruction on preparation of the medicinal product, see section 12.
Maltese: Għal struzzjonijiet dwar it-tħejjija tal-prodott mediċinali, ara sezzjoni 12.
English: How to store Cuprymina
Maltese: Kif taħżen Cuprymina
English: No interactions studies of Copper-64 chloride with other medicinal products have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni tal-klorur tar-Ram-64 ma' prodotti mediċinali oħrajn.
English: 62010 Montecosaro (MC) - Italy
Maltese: Montecosaro (MC) -L- Italja
English: PACKAGE LEAFLET
Maltese: Tul tal-proċedura
English: Batch Ref. N°
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA
English: Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution Copper (64Cu) chloride
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: Cuprymina is a type of medicinal product called a radiopharmaceutical precursor.
Maltese: Cuprymina huwa tip ta' prodott mediċinali imsejjaħ prekursur radjufarmaċewtiku.
English: The radiation dose received by the various organs following intravenous administration of a Copper-64labelled medicinal product is dependent on the specific molecule being radiolabelled.
Maltese: DOŻIMETRIJA Id-doża ta' radjazzjoni li jirċievu d-diversi organi wara l-għoti minn ġol-vini ta' prodott mediċinali ttikkettat b' Ram-64 tiddependi mill-molekula speċifika li tkun qiegħda tiġi radjutikkettata.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: ACOM S.r.l.
Maltese: S.r.l.
English: Cuprymina 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: Ir-radjutikkettar ta' molekuli trasportaturi, bħall-peptidi, antikorpi monoklonali, jew substrati oħrajn,
English: BATCH NUMBER
Maltese: Numru ta 'referenza
English: 15 years 10 years 5 years 1 years newborn adrenals brain breasts gallbladder wall
Maltese: (60 kg) 15 il sena 10 snin 5 snin sena tarbija tattwelid adrenali moħħ sider ħajt tal-marrara ħajt tal-LLI
English: LIST OF EXCIPIENTS Hydrochloric acid (0.1 N).
Maltese: - Is-sustanzi l-oħra huma aċidu idrokloriku (0,1 N) u ilma għall-injezzjonijiet.
English: Cuprymina is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by the approved route.
Maltese: Metodu ta' kif għandu jingħata Cuprymina huwa maħsub għar-radjutikkettar in vitro ta' prodotti mediċinali, li sussegwentement jingħataw mnejn ikun approvat.
English: BATCH NUMBER Batch
Maltese: Lott Numru ta 'referenza
English: The radiopharmaceutical precursor solution is packaged in a colourless, type I glass 10 mL vial, closed with bromobutyl rubber stopper and aluminium overseal.
Maltese: 10 mL, magħluq b'tapp tal-lastiku bromobutyl u siġill tal-aluminju.
English: 48 hours from date and time of End of Synthesis (EOS).
Maltese: 48 siegħa mid-data u l-ħin tat-Tmiem tas-Sinteżi.
English: Appropriate aseptic precautions should be taken.
Maltese: Għandhom jittieħdu prekawzjonijiet asettiċi adattati.
English: Each mL of solution contains 925 MBq at calibration time (01h00 a.m. CET Central European Time), corresponding to at least 0.25 micrograms of copper-64.
Maltese: (01h00 a.m. CET Ħin Ċentrali Ewropew), li jikkorrispondi għal mill-inqas 0.25 mikrogramma ta'
English: The use of Copper-64-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Maltese: L-użu ta' prodotti mediċinali ttikkettati b' Ram-64 huwa kontraindikat wara tqala stabbilita jew maħsuba jew meta t-tqala ma tkunx ġiet eskluża (ara sezzjoni 4.3).
English: Assuming that the environmental background value is of 150 nSv/h, and requiring that the dose rate due to Copper-64 is lower than the environmental background the condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection (dose rate 132 nSv/h) as shown in table 1.
Maltese: doża minħabba Ram-64 tkun aktar baxxa mill-isfond ambjentali l-kondizzjoni ta' radjuattività negliġibbli fil-pazjent tintlaħaq, prattikament, erbat ijiem wara l-injezzjoni (rata ta' doża 132 nSv/h) kif jidher fit-tabella 1.
English: EXPIRY DATE Shelf-life: 48 hours from date/time of EOS.
Maltese: Żmien kemm idum tajjeb il-prodott mediċinali: 48 siegħa mid-data u l-ħin ta' Tmiem is-Sinteżi.
English: For information on contraindications to particular Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.
Maltese: Aktar tagħrif dwar l-użu ta' prodotti mediċinali ttikkettati b' Ram-64 waqt it-tqala u t-treddigħ huwa speċifikat fis-Sommarju tal-Karatteristiċi tal-Prodott tal-prodott mediċinali li jkun ser jiġi radjutikkettat.
English: If you have been given more medicine radiolabelled with Cuprymina than you should Since the medicine radiolabelled with Cuprymina is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose.
Maltese: Jekk tkun ingħatajt mediċina radjutikkettata b'Cuprymina aktar milli suppost Peress li l-mediċina radjutikkettata b'Cuprymina hija mmaniġġjata minn tabib tal-mediċina nukleari taħt kundizzjonijiet strettament ikkontrollati, hemm biss ċans żgħir ħafna li tingħata doża eċċessiva.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Maltese: Il-proċeduri tal-għoti għandhom isiru b'mod li jitnaqqas ir-riskju ta' kontaminazzjoni tal-prodott mediċinali u ta' irradjazzjoni tal-operaturi.
English: NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution
Maltese: IL-PRODOTT MEDIĊINALI Cuprymina 925
English: The toxicity of the free Copper-64 due to in vivo release from the labelled biomolecule in the body during therapy could be reduced by post-administration of chelating agents.
Maltese: Ram-64 li jingħata sussegwentement jiddependi mill-prodott mediċinali radjutikkettat u l-użu li jkun maħsub għalih.
English: absorbed dose per unit activity administered (mGy/MBq)
Maltese: doża assorbita għal kull attività ta' unità mogħtija
English: The very limited exposure to Cuprymina (cumulative total sales of 152 vials in the EU) is considered to constitute grounds for requiring an additional five-year renewal.
Maltese: L-espożizzjoni limitata ħafna li Cuprymina (bejgħ totali kumulattivi ta '152 kunjetti fl-UE) huwa meqjus li jikkostitwixxi bażi għall-ħtieġa ta' tiġdid addizzjonali ta 'ħames snin.
English: Many international bodies assessed copper genotoxicity and carcinogenicity concluding that there is no conclusive evidence that copper may be mutagenic or carcinogenic The Scientific Committee on Food of the European Commission (2003) recommend a Dietary Allowances of 0.9 mg copper/day in adult males and females and established a Tolerable Upper Uptake level of 5 mg/day, allowing a huge safety margin in comparison to copper amount administered by Cuprymina.
Maltese: Il-Kumitat Xjentifiku dwar l-Ikel tal-Kummissjoni Ewropea (2003) irrakkomanda Kwoti tad-Dieta ta' 0.9 mg ram/kuljum fl-irġiel u nisa adulti u stabbilixxa livell ta' Teħid
English: Radiolabelling of carrier molecules, such as peptides, monoclonal antibodies, or other substrates, with Copper (64Cu) chloride is very sensitive to the presence of trace metal impurities.
Maltese: bil-klorur tar-Ram (64Cu) huwa sensittiv ħafna għall-preżenza ta' traċċi ta' impuritajiet tal-metall.
English: Copper chloride (64CuCl2) is distributed mainly in the liver and kidney and the pattern of radioactivity in the blood parallels the pattern of radioactivity in the liver.
Maltese: Il-klorur tar-ram (64CuCl2) huwa distribwit l-aktar fil-fwied u fil-kliewi u l-mudell ta'radjuattività fiddemm huwa parallel mal-mudell ta' radjuattività fil-fwied.
English: Maximum liver uptake was 4 hours after injection with 57.7 %.
Maltese: It-teħid massimu mill-fwied seħħ 4 sigħat wara l-injezzjoni b'57.7 %.
English: Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Maltese: Qabel ma wieħed juża prodotti mediċinali ttikkettati b' Ram-64, it-tqala għandha tkun eskluża permezz ta' test adegwat/ivvalidat.
English: These chelating agents help elimination of copper radiotoxicity by an exchange between the calcium ion and the copper due to their capacity of forming water soluble complexes with the chelating ligands (DTPA, EDTA).
Maltese: Dan se jippermetti lġenerazzjoni ta 'aktar dejta ta' farmakoviġilanza li se jipprovdu assigurazzjoni li r-riskji għal dan il prodott huma skoperti u kkaratterizzati b'mod adegwat fl-istabbiliment wara l-bejgħ.
English: 62010 Montecosaro (MC) Italy
Maltese: MONTECOSARO (MC) L-Italja
English: The presence of free copper (64Cu) chloride in the body after an inadvertent administration of
Maltese: Il-preżenza ta' klorur tar-ram (64Cu) liberu fil-ġisem wara l-għoti involontarju ta' Cuprymina twassal għal żieda fl-epatotossiċità.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Maltese: L-espożizzjoni għar-radjazzjoni jonizzanti hija marbuta mal-induzzjoni tal-kanċer u mal-possibbiltà li jiżviluppaw difetti ereditarji.
English: If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Maltese: Jekk ikun hemm xi dubju dwar il-possibbiltà ta' tqala tagħha (jekk il-mara qabżet mestrwazzjoni, jekk il-mestrwazzjoni tagħha tkun irregolari, eċċ.), wieħed għandu joffri lill-pazjenti tekniki alternattivi li ma jużawx radjazzjoni jonizzanti (jekk dawn ikunu jeżistu).
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
Maltese: Pakketti ta' 14, 28, 30, 50, 56, 60, 90, 98, 112, 180.
English: GFR mL/min Metformin
Maltese: GFR mL/min
English: EU/1/06/354/011 2x98 tablets
Maltese: EU/1/06/354/011 2x98 pillola