FrancophonIA/ELRC3.0 huggingface dataset:
English: Dilutions for subcutaneous administration (0.2 ml per dose) Number and content of vaccine vials:
Maltese: Dilwizzjonijiet għal għoti taħt il-ġilda (0.2 ml għal kull doża):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (lyophilisate vials)
Maltese: Kaxex tal-kartun (kunjetti tal-lijofiliżat)
English: The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Maltese: 5,100 unità ELISA fit-tifqis.
English: Lyophilisate: brown reddish colour.
Maltese: Solvent: soluzzjoni ċara bla kulur.
English: Do not use in flocks without MDAs against IBDV.
Maltese: Ilma għall-injezzjonijiet
English: This depletion does not cause immunosuppression in chickens.
Maltese: Dan it-tnaqqis ma jikkawżax immunosoppressjoni fit-tiġieġ.
English: la Selva, 135
Maltese: LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
English: EU/1/15/1056/001 Praxbind
Maltese: EU/1/15/1056/001
English: 2.5 g/50 mL
Maltese: Praxbind 2,5 g/50 mL Soluzzjoni għallinjezzjoni/infużjoni
English: Intravenous use Vial (glass)
Maltese: Isem (ivvintat)
English: Eviplera emtricitabine / rilpivirine / tenofovir disoproxil
Maltese: Eviplera emtriċitabina / rilpivirina / tenofovir disoproxil
English: The full EPAR for Eviplera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • rifampicin, rifapentine (antibiotics);
Maltese: • rifampiċina, rifapentina (antibijotiċi);
English: It is available as tablets.
Maltese: Jiġi bħala pilloli.
English: Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg).
Maltese: Eviplera huwa mediċina li fiha s-sustanzi attivi emtriċitabina (200 mg), rilpivirina (25 mg) u tenofovir disoproxil (245 mg).
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: Ittenofovir huwa inibitur nukleosidiku tat-transkrittażi inversa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eviplera on 28 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Eviplera valida fl-Unjoni Ewropea kollha fit-28 ta' Novembru 2011.
English: Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Eviplera jintuża fil-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Other information about Eviplera
Maltese: Informazzjoni oħra dwar Eviplera
English: Rarely, kidney problems may occur in patients taking tenofovir disoproxil.
Maltese: Rarament, jista' jkun hemm problemi fil-kliewi f'pazjenti li jieħdu tenofovir disoproxsil.
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Maltese: • omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (inibituri tal-pompa tal-proton għat tnaqqis tal-aċidu fl-istonku);
English: This is a summary of the European public assessment report (EPAR) for Eviplera.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Eviplera.
English: Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Eviplera fiha tliet sustanzi attivi: l-emitriċitabina, li hija inibutur nukleosidiku tat-transkrittażi inversa; ir-rilpivirina, li hija inibitur mhux nukleosidiku tat-transkrittażi inversa (NNRTI); u t-tenofovir disoproxil, li hija‘ prodroga' ta' tenofovir, jiġifieri li tinbidel fis-sustanza attiva tenofovir fil-ġisem.
English: Why has Eviplera been approved?
Maltese: Għaliex ġie approvat Eviplera?
English: In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz.
Maltese: Fl-ewwel studju fuq pazjenti li ma kinux ikkurati qabel, 83% tal-pazjenti li kienu qegħdin jieħdu l-kombinazzjoni ta' Eviplera rrispondew għall-kura meta mqabbla ma' 84% tal-pazjenti li kienu qegħdin jieħdu lkombinazzjoni bl-efavirenz.
English: It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Maltese: Jintuża biss f'pazjenti fejn il-virus ma jkunx żviluppa reżistenza għal ċerti medicini kontra l-HIV imsejħa inibituri mhux nukleosidiċi tat-transkrittażi inversa (NNRTIs), it-tenofovir jew l-emtriċitabina, u li għandhom livelli ta' HIV fid-demm (tagħbija virali) ta' mhux aktar minn 100,000 kopja/ml HIV-1 RNA.
English: Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera.
Maltese: Eviplera kien evalwat ukoll f'532 pazjent li nqalbu għal Eviplera mill-kura attwali tagħhom kontra l-HIV.
English: • St John's wort (a herbal medicine to treat depression and anxiety).
Maltese: • Fexfiex tar-raba' (St John's wort) (mediċina erbali għall-kura tad-depressjoni).
English: In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment.
Maltese: Fit-tieni studju, 87% tal-pazjenti fil-grupp tar-rilpivirina (li kien jinkludi pazjenti li kienu qegħdin jieħdu l-kombinazzjoni ta' Eviplera) rrispondew għall-kura.
English: • systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
Maltese: • dessametażon sistemiku (mediċina sterojdi antiinfjammatorja u immunosuppressiva) ħlief meta użat bħala kura b'doża unika;
English: This compared with 83% of patients in the efavirenz group.
Maltese: Dan tqabbel ma' 83% tal-pazjenti fil-grupp tal-efavirenz.
English: In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine.
Maltese: Fl-ewwel studju ewlieni li kien jinvolvi 690 pazjent, Eviplera tqabbel ma' kombinazzjoni simili li kienet tinkludi l-efavirenz minflok ir-rilpivirina.
English: The CHMP concluded that Eviplera was as effective as combinations containing efavirenz.
Maltese: Is-CHMP ikkonkluda li Eviplera kien effettiv daqs il-kombinazzjonijiet li fihom l-efavirenz.
English: How has Eviplera been studied?
Maltese: Kif ġie studjat Eviplera?
English: Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Maltese: HIV-1 RNA kopji/ml wara 48 ġimgħa ta' kura ġew kkunsidrati li kienu rrispondew għall-kura.
English: The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.
Maltese: It-tieni studju ewlieni li kien jinvolvi 678 pazjent qabbel ir-rilpivirina mal-efavirenz, li t-tnejn kienu qegħdin jittieħdu mal-emtriċitabina u t-tenofovir disoproxil jew ma' żewġ inibituri oħra nukleosidiċi tat-transkrittażi inversa.
English: What is Eviplera?
Maltese: X'inhu Eviplera?
English: For the full list of side effects and restrictions with Eviplera, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Eviplera, ara l-fuljett ta' tagħrif.
English: All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected.
Maltese: Dawn it-tliet sustanzi attivi jimblokkaw l-attività ta' tat-transkrittażi inversa, enzima tal-virus li tippermetti lill-HIV-1 jirreplika fiċ-ċelloli li jkun infetta.
English: All three active substances are already available in separate medicines in the EU.
Maltese: It-tliet sustanzi attivi kollha huma diġà disponibbli f'mediċini separati fl-UE.
English: What is the risk associated with Eviplera?
Maltese: Għal xiex jintuża Eviplera?
English: If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
Maltese: Jekk Eviplera jingħata flimkien mar-rifabutina, it-tabib għandu jippreskrivi 25 mg oħra tar-rilpivirina kuljum matul il-kura bir-rifabutina.
English: The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.
Maltese: Il-kumpanija ppreżentat ukoll studji li juru li l-pillola li fiha t-tliet sustanzi kollha tiġi assorbita fil-ġisem bl-istess mod bħall-pilloli separati mogħtija flimkien taħt kundizzjonijiet simili.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Maltese: Għaldaqstant, is-CHMP ikkunsidra li l-benefiċċji ta' Eviplera huma akbar mir-riskji tiegħu f'pazjenti b'tagħbija virali baxxa ta' HIV-1, u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq għal dan il-grupp ta' pazjenti.
English: Patient's previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla.
Maltese: Il-kura preċedenti tal-pazjenti kienet tikkonsisti minn wieħed miż-żewġ inibituri nukleosidi tattranskrittażi inversa u mediċina oħra kontra l-HIV imsejħa inibitur tal-proteażi msaħħaħ, jew il-mediċina Atripla.
English: The Eviplera combination compared well with combinations containing efavirenz.
Maltese: Il-kombinazzjoni ta' Eviplera tqabblet sew mal-kombinazzjonijet li kien fihom l-efavirenz.
English: The most common side effects with Eviplera in patients who had not received previous HIV treatment (seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams, headache, diarrhoea and insomnia.
Maltese: L-effetti sekondarji l-iktar komuni b'Eviplera f'pazjenti li ma rċevewx kura preċedenti tal-HIV (li dehru f'iktar minn 5 pazjenti minn kull 100) kienu n-nawżja (tħossok ma tiflaħx), sturdament, ħolm anormali, uġigħ ta' ras, dijarrea u insomnja.
English: In patients who had received previous HIV treatment, the most common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and insomnia.
Maltese: F'pazjenti li kienu ħadu kura qabel kontra l-HIV, l-effetti sekondarji laktar komuni (li dehru f'iktar minn 2 pazjenti minn kull 100) kienu l-għeja, dijarea, nawżja u insomnja.
English: Tel: +33 5 57 55 40 40 Fax: +33 5 57 55 41 98
Maltese: Tel: +33 5 57 55 40 40 Faks:
English: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Maltese: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANZA
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Water for injections
Maltese: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Ilma għall-injezzjonijiet
English: ATCvet code: QI02AB.
Maltese: QI02AB
English: {MM/YYYY}
Maltese: {xahar/sena}
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 °C).
English: > 72 QF Units/ml
Maltese: > 72 QF Unit / ml
English: Inactivated Coxiella burnetii, strain Nine Mile
Maltese: Coxiella burneti inattivat, razza Nine Mile
English: Onset of immunity: not established.
Maltese: Bidu tal-immunità: mhux stabilita.
English: Marketing authorisation holder: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne
English: EU/2/10/110/002
Maltese: EU/2/10/110/002 100 ml
English: Respect normal aseptic conditions.
Maltese: Irrispetta l-kundizzjonijiet normali assettiċi.
English: HUNGARY
Maltese: FRANZA
English: Carton box with 1 plastic (LDPE) bottle, containing 100 ml of suspension.
Maltese: Kaxxa tal-kartun bi flixkun 1 tal-plastik (LDPE), li fih 100 ml jew 100 ml ta' suspensjoni.
English: > 72 QF Units* *QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Maltese: > 72 Unità QF* *Unità QF (tad-deni Q): qawwa relattiva għall-antiġen ta' fażi I imkejjel b'ELISA meta mqabbel ma'
English: For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Maltese: Għall-immunizzazzjoni attiva tal-ifrat biex jonqos ir-riskju għal annimali mhux infettati vaċċinati meta ma jkunux tqal biex jistgħu jwaqqgħu (probabilità ta' 5 darbiet meta mqabbla ma' annimali li jirċievu l-plaċebo) u sabiex inaqqsu Coxiella burnetii f'dawn l-annimali permezz ta' ħalib u mukus vaġinali.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, il bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Duration of immunity: 280 days after completion of the primary vaccination course.
Maltese: Perjodu tal-immunità: 280 jum wara t-tlestija tal-kors ta' vaċċinazzjoni prinċipali.
English: It was very common to see in laboratory trials a palpable reaction of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Maltese: Kienet komuni ħafna li tara reazzjoni palpabbli ta' dijametru massimu ta' bejn 9 sa 10 ċm fil-post fejn ingħatat it-tilqima, li tista' ddum għal 17-il jum, fil-provi tal-laboratorju.
English: Suspension for injection.
Maltese: Suspensjoni għall-injezzjoni
English: With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days.
Maltese: B'doża doppja reazzjoni palpabbli b'dijametru massimu ta' 10 ċm ġiet osservata fil-post fejn ingħatat it-tilqima, li tista' ddum għal 16-il jum.
English: Cattle from 3 months of age:
Maltese: Mogħoż minn età ta' 3 xhur:
English: With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days.
Maltese: B'doża doppja reazzjoni moderata u palpabbli b'dijametru ta' bejn 4 sa 5 ċm diameter ġiet osservata fil-post fejn ingħatat it-tilqima, li tista' ddum għal 4 ijiem.
English: Manufacturer responsible for batch release: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott CEVA-Phylaxia Veterinary Biologicals Co.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: The vaccine contains phase I Coxiella burnetii as active ingredient inducing active immunity against Q fever in cattle and goats.
Maltese: Il-vaċċin fih Coxiella burnetii ta' fażi I bħala sustanza attiva li tinduċi immunità attiva kontra d-deni Q
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX for 40 ml or 100 ml plastic bottle
Maltese: Daqsijiet tal-pakkett: flixkun tal-plastik LDPE ta' 40 ml jew 100 ml .
English: CONTRAINDICATIONS
Maltese: MANIFATTURA
English: Carton box with 1 plastic (LDPE) bottle, containing 40 ml of suspension.
Maltese: In-natura u l-għamla tal-ewwel ippakkjar Kaxxa tal-kartun bi flixkun 1 tal-plastik (LDPE), li fih 40 ml ta' suspensjoni.
English: EU/2/10/110/001-002
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/10/110/001-002
English: Diarrhoea has been observed rarely in post marketing safety experience.
Maltese: Dijarrea ġiet osservata rarament f'esperjenza ta' sigurtà ta' wara t-tqegħid fis-suq.
English: For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Maltese: Għall-immunizzazzjoni mnaqqsa għal mogħoż sabiex jonqas l-abort ikkaġunat minn Coxiella burnetii u sabiex jonqos it-tixrid tal-organiżmu permezz tal-ħalib, mukus vaġinali, l-ippurgar u s-sekonda.
English: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq: CEVA-Phylaxia Veterinary Biologicals Co.
English: Each ml contains:
Maltese: Sustanzi mhux attivi:
English: EU/2/10/110/001 (40 ml) EU/2/10/110/002 (100 ml)
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/10/110/001 40 ml
English: Re-vaccination: Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Maltese: Il-vaċċinazzjoni mill-ġdid Kull 9 xhur, kif deskritt għall-vaċċinazzjoni prinċipali, skont it-tul tal-immunità ta' 280 jum.
English: It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Maltese: Kienet komuni ħafna li tara reazzjoni palpabbli ta' dijametru ta' bejn 3 sa 4 ċm fil-post fejn ingħatat ittilqima li tista' ddum għal 6 ijiem, fil-provi tal-laboratorju.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: <sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010> <jew> <huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju>.>
English: Whitish, opalescent, homogeneous suspension.
Maltese: Suspensjoni għall-injezzjoni Suspensjoni omoġenja, fl-abjad u opalexxenti,.
English: COXEVAC suspension for injection for cattle and goats
Maltese: VETERINARJU COXEVAC suspensjoni għall-injezzjoni għall-ifrat u mogħoż
English: Special precautions for use in animals:
Maltese: Ħtiġijiet ta' farmakoviġilanza:
English: None.
Maltese: ISEM
English: These measures should help to protect the environment.
Maltese: sigurtà ta' wara t-tqegħid fis-suq.
English: The manufacture, import, possession, sale, supply and/or use of COXEVAC may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' COXEVAC huwa pprojbit jew jista' jkun ipprojbit f'ċertu Stati Membri fit-territorju kollu tagħhom jew f'parti minnu taħt leġiżlazzjoni nazzjonali.
English: It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination .
Maltese: Kienet komuni ħafna li tara żieda żgħira fit-temperatura fir-rektum għal 4 ijiem wara l-vaċċinazzjoni, fil provi tal-laboratorju.
English: However, in safety laboratory trials, the use of COXEVAC in males proved to be safe.
Maltese: Madanakollu, fi provi tal-laboratorju dwar is-sigurtà, l-użu ta' COXEVAC fl-irġiel ġie ppruvat li hu sikur.
English: Cattle and goats
Maltese: ANNESS I KARATTERISTIĊI
English: There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.
Maltese: M'hemmx benefiċċji tal-vaċċin (kif deskritt fl-indikazzjonijiet għall-ifrat), meta jiġi użat f'baqar infettati u/jew tqal.
English: Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Maltese: Sinjali sistemiċi bħala letarġija, telqa u/jew anoressja ġew osservati b'mod mhux komuni fl-esperjenza ta'
English: MANUFACTURER'S BATCH NUMBER
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva CEVA-Phylaxia Veterinary Biologicals Co.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott lill-annimali tinterferixxi mal-implimentazzjoni ta' programm nazzjonali għad djanjosi, il-kontroll jew l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ ċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;
English: Fluodeoxyglucose (
Maltese: Il-fluwodeossiglukożju (
English: Dr Prieto Yerro (Spain)
Maltese: Dr Prieto Yerro (Spanja)
English: Ref. EMEA/CHMP/342694/2009 EMEA/H/A-29/1123
Maltese: EMEA/CHMP/356661/2009 EMEA/H/A-29/1123
English: Dr Lechat (France)
Maltese: Dr Lechat (Franza)
English: 19 March 2009
Maltese: 19 ta' Marzu 2009
English: F) 500MBq per ml
Maltese: F) 500MBq għal kull ml
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' riskju potenzjali serju għas-saħħa pubblika
English: What is Gluscan 500?
Maltese: X'inhu Gluscan 500?
English: Advanced Accelerator Applications submitted Gluscan 500 to the French medicines regulatory agency for a decentralised procedure.
Maltese: Advanced Accelerator Applications issottometta Gluscan 500 lill-agenzija ta' regolamentazzjoni talmediċini Franċiża għall-proċedura deċentrallizzata.
English: United Kingdom.
Maltese: Irlanda u fir-Renju Unit.
English: The active substance in Gluscan 500, fluodeoxyglucose (18F), is a diagnostic radiopharmaceutical.
Maltese: Is-sustanza attiva fi Gluscan 500, fluwodeossiglukożju (fluodeoxyglucose) (18F), hija radjufarmaċewtiku dijanjostiku.
English: It contains a substance, fluodeoxyglucose, that has been labelled with 18F (fluoride-18), a radioactive form of the chemical element fluorine.
Maltese: (fluworur-18 - [fluoride-18]), forma radjuattiva tal-element kimiku fluworu (fluorine).