FrancophonIA/ELRC3.0 huggingface dataset:
English: Care is also required when hydroxyzine is co-administered with drugs known to be potent inhibitors of alcohol dehydrogenase or CYP3A4/5.
Maltese: Hija meħtieġa wkoll kura meta hydroxyzine jingħata flimkien ma' mediċini magħrufin li huma inibituri qawwija ta' alkoħol dehydrogenase jew CYP3A4/5.
English: Recommendations for these new measures were originally made by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest (stopping of the heart).
Maltese: Ir-rakkomandazzjonijiet għal dawn il-miżuri kienu oriġinarjment saru mill-Kumitat għall-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza (PRAC) tal-EMA, li kkonferma riskju magħruf qabel ta' titwil fl-intervall QT u torsades de pointes, tibdil fl-attività elettrika tal-qalb li jista' jwassal għal ritmi tal-qalb anormali u arrest kardijaku (waqfien tal-qalb).
English: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
Maltese: Restrizzjonijiet ġodda biex jitnaqqsu r-riskji ta' effetti fuq ir-ritmu tal-qalb b'mediċini li fihom hydroxyzine
English: Elderly patients should not use these medicines, but if they do the maximum dose should be 50 mg a day.
Maltese: Il-pazjenti anzjani ma għandhomx jużaw dawn il-mediċini, iżda jekk jagħmlu dan, id-doża massima għandha tkun ta' 50 mg kuljum.
English: On 25 March 2015 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Maltese: Fil-25 ta' Marzu 2015, is-CMDh adotta l-pożizzjoni tiegħu b'kunsens, biex b'hekk il-miżuri rrakkomandati mill-PRAC ser jiġu implimentati mill-Istati Membri fejn il-mediċini huma awtorizzati skont skeda maqbula.
English: It was considered appropriate to restrict the maximum daily dose in adults, with corresponding changes in the paediatric and elderly populations based on pharmacokinetic data, in order to minimise exposure.
Maltese: Kien ikkunsidrat xieraq li tiġi ristretta d-doża massima ta' kuljum fl-adulti, b'bidliet korrispondenti fil-popolazzjoni pedjatrika u dik anzjana abbażi tad-data farmakokinetika, sabiex jitnaqqas l-esponiment.
English: • Use is not recommended in elderly patients, due to reduced elimination of hydroxyzine in these patients and greater vulnerability to anticholinergic effects and other adverse reactions.
Maltese: • L-użu mhuwiex irrakkomandat f'pazjenti adulti, minħabba t-tnaqqis fit-tneħħija ta' hydroxyzine f'dawn il-pazjenti u vulnerabbiltà akbar għal effetti antikolinerġiċi u reazzjonijiet avversi oħrajn.
English: • In countries where the medicines are approved for use in children, the maximum dose depends on their weight, and the daily total should not be more than 2 mg per kg of body weight in children weighing up to 40 kg (children over 40 kg should be given the adult dose).
Maltese: • F'pajjiżi fejn il-mediċini huma approvati għall-użu fi tfal, id-doża massima tiddependi fuq il-piż tagħhom, u t-total ta' kuljum ma għandux ikun aktar minn 2 mg għal kull kg ta' piż tal-ġisem fi tfal li jiżnu sa 40 kg (tfal li jiżnu aktar 40 kg għandhom jingħataw id-doża tal-adulti).
English: • The potential risk of QT interval prolongation and torsades de pointes can therefore be adequately minimised through measures targeting the identified risk factors and restricting the use of hydroxyzine to the lowest effective dose for the shortest possible duration.
Maltese: • Għalhekk, ir-riskju potenzjali ta' titwil fl-intervall QT u torsades de pointes jista' jitnaqqas b'mod adegwat permezz ta' miżuri li jimmiraw fatturi ta' riskju identifikati u li jillimitaw l-użu ta' hydroxyzine sad-doża effikaċi l-aktar baxxa għall-iqsar żmien possibbli.
English: • Medicines containing the antihistamine hydroxyzine are available in most EU countries.
Maltese: • Il-mediċini li fihom l-antistamina hydroxyzine huma disponibbli fil-biċċa l-kbira tal-pajjiżi tal-UE.
English: Approved uses vary between countries, but may include treatment of anxiety disorders, relief of pruritus (itching) including that due to urticaria, premedication before surgery, and treatment of sleep disorders.
Maltese: L-użi approvati jvarjaw bejn il-pajjiżi, iżda jistgħu jinkludu lkura ta' disturbi ta' ansjetà, serħan mill-prurite (ħakk) inkluż minħabba urtikarja, premedikazzjoni qabel operazzjoni u kura ta' problemi fl-irqad.
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: 1 Artiklu 29(4) tad-Direttiva 2001/83/KE kif emendat.
English: London, 30 July 2007 EMEA/CHMP/247760/2007
Maltese: Londra, 30 ta' Lulju 2007 EMEA/CHMP/247760/2007
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur(s) was Dr Jens Ersbøll.
Maltese: IrRapporteur kien Dr. Frits Lekkerkerker u l-Ko-Rapporteur(s) kien Dr Jens Ersbøll.
English: Vantas, 50 mg, implant, is a luteinizing hormone-releasing hormone (LHRH) agonist indicated for the palliative treatment of advanced prostate cancer.
Maltese: Vantas, impjant, 50 mg, huwa ormon li jirrilaxxa l-ormoni lutejinizzanti (LHRH) agonist indikat fittrattament palljattiv ta' kanċer tal-prostata avvanzat.
English: Valera Pharmaceuticals Ltd. submitted applications for mutual recognition of Vantas, 50 mg, implant, on the basis of the marketing authorisation granted by Denmark on 17 November 2005.
Maltese: Valera Pharmaceuticals Ltd. issottomettew applikazzjonijiet għar-rikonoxximent reċiproku tal-Vantas, impjant, 50 mg abbażi ta' l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija lid-Danimarka fis-17 ta' Novembru 2005.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Vantas International Non-Proprietary Name (INN): Histrelin acetate BACKGROUND INFORMATION
Maltese: GĦALL-UŻU MILL-BNIEDEM OPINJONI SKOND L-ARTIKOLU 29(4)1 REFERENZA GĦAL Vantas Denominazzjoni Komuni Internazzjonali (INN- International Non-proprietary Name ):
English: During their May 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Vantas, that the objections raised by Germany, Spain, Ireland, Italy and the United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Matul il-laqgħa tagħhom ta' Mejju 2007, is-CHMP issottometta fid-dawl tad-dejta globali u d-diskussjoni xjentifika fi ħdan il-Kumitat, ikkunsidra li l-proporzjon ta' benefiċċju/riskju huwa favorevoli għal Vantas, illi l-oġġezzjonijiet imqajjma mill-Ġermanja, Spanja, l-Irlanda, l-Italja u r-Renju Unit għandhom jipprevjenu lgħoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq u illi għandhom isiru l-emendi għas-Sommarju talKaratteristiċi tal-Prodott, tikketta u fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza.
English: Germany, Spain, Ireland, Italy and the United Kingdom referred the reasons for disagreement to the EMEA on 1 February 2007.
Maltese: Il-Ġermanja, Spanja, lIrlanda, l-Italja u r-Renju Unit rreferew ir-raġunijiet ta' nuqqas ta' qbil lill-EMEA fl-1 ta' Frar 2007.
English: The Reference Member State was Denmark and the Concerned Member States were Germany, Spain, Ireland, Italy and the United Kingdom.
Maltese: L-Istat Membru ta' Referenza kien id-Danimarka u l-Istati Membri konċernati kienu l-Ġermanja, Spanja, l-Irlanda, l-Italja u r-Renju Unit.
English: The Mutual Recognition Procedure started on 23 August 2006.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku bdiet fit-23 ta' Awwissu 2006.
English: The arbitration procedure started on 22 February 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' l-arbitraġġ bdiet fit-22 ta' Frar 2007 permezz ta' l-adozzjoni ta' lista ta' domandi.
English: The Marketing Authorisation Holder provided written explanations on 7 March 2007.
Maltese: Il-Pussessur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq ta' spjegazzjonijiet bil-miktub fis-7 ta' Marzu 2007.
English: A positive opinion was adopted by consensus on 24 May 2007.
Maltese: Ġiet adottata opinjoni pożittiva permezz ta' kunsens fl-24 ta' Mejju 2007.
English: The reasons for disagreement was that, according to some Member States, the efficacy of Vantas was not demonstrated in comparison to other approved, effective treatments and that the safety of Vantas also was not adequately demonstrated.
Maltese: Ir-raġunijiet ta' nuqqas ta' qbil kienu illi, skond xi Stati Membri l-effikaċja ta' Vantas ma kienitx murija a paragon ma' trattamenti oħra appruvati u effettivi u illi s-sigurtà ta' Vantas ma kienitx murija b'mod xieraq.
English: United Kingdom Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom
Maltese: Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1 DH, United Kingdom
English: Bristol-Myers Squibb AB BOX 1172, 171 23 Solna, Sweden
Maltese: BOX 1172, 171 23 Solna, Sweden
English: EMA/334151/2016 EMEA/H/C/001240
Maltese: EMA/334151/2016 EMA/H/C/001240
English: The full EPAR for Vibativ 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: Vibativ is a medicine that contains the active substance telavancin.
Maltese: Vibativ huwa mediċina li fiha s-sustanza attiva telavanċina.
English: This is a summary of the European public assessment report (EPAR) for Vibativ.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vibativ.
English: Why has Vibativ been approved?
Maltese: Għaliex ġie approvat Vibativ?
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 1,503 adults with nosocomial pneumonia caused by Gram-positive bacteria (types of bacteria that include MRSA).
Maltese: Vibativ tqabbel mal-vankomiċina (antibijotiku ieħor) f'żewġ studji ewlenin li fihom ħadu sehem total ta' 1,503 adulti bi pnewmonja nosokomijali kkawżata minn batterji Gram-pożittivi (tipi ta' batterji li jinkludu l-MRSA).
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Maltese: Is-sustanza attiva f'Vibativ, it-telavanċina, hija antibijotiku li jagħmel parti mill-grupp ta' ‘glikopeptidi'.
English: It is effective against MRSA bacteria, which are resistant to other commonly used groups of antibiotics such as penicillins (including methicillin and oxacillin) and cephalosporins.
Maltese: Hija effettiva kontra l-batterju MRSA,li huwa reżistenti għal gruppi ta' antibijotiċi oħra użati normalment bħallpeniċillini (inklużi l-metaċillina u l-oksaċillina) u ċ-ċefalosporini.
English: The recommended dose is 10 mg per kg body weight once every 24 hours, for seven to 21 days.
Maltese: Id-doża rrakkomandata hija 10 mg għal kull kg tal-piż tal-ġisem darba kull 24 siegħa, għal sebat ijiem sa 21 jum.
English: Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%).
Maltese: L-istudji wrew li kien hemm aktar pazjenti li żviluppawlhom problemi fil-kliewi wara l-kura b'Vibativ milli bil-vankomiċina (3.8% kontra 2.2%).
English: For obese patients, a lower dose of 7.5 mg per kg body weight once every 24 hours is recommended.
Maltese: Għal pazjenti obeżi, hija rakkomandata doża aktar baxxa ta' 7.5 mg għal kull kg tal-piż tal-ġisem darba kull 24 siegħa.
English: In the first study in complicated infections of the skin and soft tissue, 76% of patients treated with Vibativ (323 out of 426) were cured after treatment compared with 75% treated with vancomycin (321 out of 429).
Maltese: Fl-ewwel studju fuq infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab, 76% tal-pazjenti li rċevew kura b'Vibativ (323 minn 426) fiequ wara l-kura meta mqabbla ma' 75% li rċevew kura bilvankomiċina (321 minn 429).
English: In the second study, 77% of patients treated with Vibativ (387 out of 502) were cured after treatment compared with 74% of those treated with vancomycin (376 out of 510).
Maltese: Fit-tieni studju, 77% tal-pazjenti li rċevew kura b'Vibativ (387 minn 502) fiequ wara l-kura meta mqabbla ma' 74% ta' dawk li rċevew kura bil-vankomiċina (376 minn 510).
English: How does Vibativ work?
Maltese: Kif jaħdem Vibativ?
English: Vibativ was also compared with vancomycin in two main studies involving a total of 1,897 adults with complicated infections of the skin and soft tissue below the skin caused by Gram-positive bacteria, where the medicines were given for up to 14 days.
Maltese: Vibativ tqabbel ukoll malvankomiċina f'żewġ studji ewlenin li fihom ħadu sehem total ta' 1,897 adult b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab ta' taħt il-ġilda kkawżati minn batterji Gram-pożittivi, fejn il-mediċini ngħataw għal tul massimu ta' 14-il jum.
English: In the second study, 60% of patients treated with Vibativ (227 out of 377) were cured after treatment compared with 60% of patients treated with vancomycin (228 out of
Maltese: Fit-tieni studju, 60% tal-pazjenti li rċevew kura b'Vibativ (227 minn 377) fiequ wara l-kura meta mqabbla ma' 60% tal-pazjenti li rċevew kura bil
English: In the first study in nosocomial pneumonia, 58% of patients treated with Vibativ (214 out of 372) were cured after treatment compared with 59% of patients treated with vancomycin (221 out of 374).
Maltese: Fl-ewwel studju fuq il-pnewmonja nosokomijali, 58% talpazjenti li rċevew kura b'Vibativ (214 minn 372) fiequ wara l-kura meta mqabbla ma' 59% tal-pazjenti li rċevew kura bil-vankomiċina (221 minn 374).
English: The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Vibativ (li dehru f'aktar minn pazjent 1 minn kull 10) huma disġewsija (disturbi fit-togħma) u nawżja (tħossok ma tiflaħx).
English: Vibativ is used only when the infection is known or believed to be caused by bacteria called ‘methicillin-resistant Staphylococcus aureus' (MRSA) and when other treatments (such as other antibiotics) are not suitable.
Maltese: Vibativ jintuża biss meta linfezzjoni tkun magħrufa jew maħsuba li tkun ikkawżata minn batterju msejjaħ ‘Staphylococcus aureus reżistenti għal metaċillina' (MRSA) u meta kuri oħra (bħal antibijotiċi oħra) ma jkunux adegwati.
English: The company that markets Vibativ will ensure all doctors who are expected to prescribe or use Vibativ receive a letter and an educational pack containing the summary of product characteristics, package leaflet and a guide setting out important safety information on the correct use of Vibativ.
Maltese: Il-kumpanija li tqiegħed Vibativ fis-suq ser tiżgura li t-tobba kollha li huma mistennija jippreskrivu jew jużaw Vibativ jirċievu ittra u pakkett edukattiv li jinkludi s-sommarju tal-karatteristiċi tal-prodott, ilfuljett ta' tagħrif u gwida li tagħti informazzjoni importanti dwar is-sigurtà rigward l-użu korrett ta' Vibativ.
English: The antibiotics were given for up to 21 days.
Maltese: L-antibijotiċi ngħataw għal tul massimu ta' 21 jum.
English: The CHMP concluded that, although Vibativ had been shown to be effective in treating both nosocomial pneumonia and complicated infections of the skin and soft tissue, its toxic effect on the kidneys was an important safety concern.
Maltese: Is-CHMP ikkonkluda li, minkejja li ntwera li Vibativ kien effettiv fil-kura kemm tal-pnewmonja nosokomijali kif ukoll tal-infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab, l-effett tossiku tiegħu fuq il-kliewi kien ta' tħassib importanti fir-rigward tas-sigurtà.
English: Vibativ was as effective as vancomycin at curing nosocomial pneumonia and complicated infections of the skin and soft tissue.
Maltese: Vibativ kien effettiv daqs vancomycin fil-kura tal-pnewmonja nosokomijali u tal-infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab.
English: Vibativ must not be given to patients with severe kidney problems or acute (sudden) kidney failure.
Maltese: Vibativ m'għandux jingħata lil pazjenti li jkollhom problemi severi fil-kliewi jew insuffiċjenza akuta (f'daqqa) tal-kliewi.
English: What benefit has Vibativ shown during the studies?
Maltese: X'benefiċċji wera Vibativ waqt l-istudji?
English: In addition, care should be taken when giving Vibativ to patients taking other medicines that could cause kidney problems, those who already have kidney disease or have other diseases that make them more likely to have kidney problems, such as diabetes, congestive heart failure (a type of heart disease) and hypertension (high blood pressure).
Maltese: Barra minn hekk, jenħtieġ li tintuża kawtela meta Vibativ jingħata lil pazjenti li jkunu qed jieħdu mediċini oħra li jistgħu jikkawżaw problemi fil-kliewi, dawk li diġà għandhom mard tal-kliewi jew għandhom mard ieħor li jagħmilhom aktar suxxettibbli li jkollhom problemi fil-kliewi, bħad-dijabete, l-indeboliment konġestiv tal-qalb (tip ta' mard tal-qalb) u l-ipertensjoni (pressjoni taddemm għolja).
English: A. Martins & Fernandes S.A.
Maltese: Martins & Fernandes S.A.
English: Medium risk:
Maltese: Riskju medju:
English: Lusal - Produção QuímicoFarmacêutica Luso-Alemã Lda.
Maltese: Lusal - Produção QuímicoFarmacêutica Luso-Alemã
English: Guerbet Nederland B.V. Avelingen-West 3A 4202 MS GORINCHEM Netherlands
Maltese: Guerbet Nederland B.V. Avelingen-West 3A 4202 MS GORINCHEM
English: Av. Baix Llobregat 3-5 Sant Joan Despi Barcelona 08970
Maltese: Baix Llobregat 3-5 Sant Joan Despi Barcelona 08970
English: PHADISCO LTD 185 YIANNOU GRANIDIOTI AVE, 2235 LATSIA
Maltese: PHADISCO LTD 185 YIANNOU GRANIDIOTI AVE, 2235
English: GE Healthcare Via Galeno 36, 20126 Milano
Maltese: GE Healthcare Via Galeno 36, 20126 Milano Italy
English: de Europa 22 Alcobendas 28108 Madrid Spain
Maltese: GE HEALTHCARE BIO-SCIENCES S.A. Avda. de Europa 22 Alcobendas 28108 Madrid Spain
English: 15 rue des Vanesses Zone Paris Nord II F-83420 VILLEPINTE France
Maltese: 15 rue des Vanesses Zone Paris Nord II F-83420
English: b) Linear ionic chelate: gadopentetic acid (Magnevist, Gado-MRT-ratiopharm, Magnegita).
Maltese: b) Kelat joniku lineari: aċidu gadopentetiku (Magnevist, Gado-MRT-ratiopharm, Magnegita).
English: Avenue Henri Dunant 31 1140 Bruxelles Belgium
Maltese: Avenue Henri Dunant 31 1140
English: Marotrast GmbH Otto-Schott-Str. 15 D-07745 Jena Germany
Maltese: Marotrast GmbH Otto-Schott-Str. 15 D-07745
English: GE HEALTHCARE 11, avenue Morane Saulnier 78140 Vélizy Villacoublay France
Maltese: GE HEALTHCARE 11, avenue Morane Saulnier 78140
English: IE - Ireland
Maltese: L-Irlanda
English: PL - Poland
Maltese: Il-Polonja
English: 0.5mMol/ml (287 mg equiv.
Maltese: 0.5mMol/ml (287 mg equiv. 0.5 mmol)
English: High risk: a) Linear non-ionic chelates including gadoversetamide (OptiMARK) and gadodiamide (Omniscan).
Maltese: Riskju għoli: a) Kelati mhux joniċi lineari fosthom gadoversetamide (OptiMARK) u gadodiamide (Omniscan).
English: Macrocyclic chelates including gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Maltese: Kelati makroċikliċi fosthom l-aċidu gadoteriku (Dotarem), gadoteridol (ProHance) u gadobutrol (Gadovist).
English: The gadolinium-containing contrast agents (GdCAs) - gadoversetamide, gadodiamide, gadopentetic acid, gadobenic acid, gadofosveset, gadoxetic acid, gadoteridol, gadobutrol and gadoteric acid - are intravenous agents used for contrast enhancement with magnetic resonance imaging (MRI) and with magnetic resonance angiography (MRA).
Maltese: Is-sustanzi ta' kuntrast li fihom gadolinium (GdCAs) - gadoversetamide, gadodiamide, aċidu gadopentetiku, aċidu gadobeniku, gadofosveset, aċidu gadoksetiku, gadoteridol, gadobutrol u aċidu gadoteriku - huma sustanzi għal ġol-vini li jintużaw għal titjib tal-kuntrast ma' immaġni bir-riżonanza manjetika (MRI) u ma' anġjografija bir-riżonanza manjetika (MRA).
English: This followed a cluster of 25 cases of NSF (20 in Denmark and 5 in Austria) in patients with severe renal impairment, to whom gadodiamide had been administered.
Maltese: Dan segwa grupp ta' 25 każ ta' NSF (20 fidDanimarka u 5 fl-Awstrija) f'pazjenti b'indeboliment sever tal-kliewi, li ngħataw gadodiamide.
English: LV - Latvia
Maltese: Il-Latvja
English: EE - Estonia
Maltese: L-Estonja
English: The estimated relative risk for NSF calculated based on the number of unconfounded cases and GdCA is higher for gadodiamide (100%), gadoversetamide (94%), and gadopentetic acid (10%) and <1% for gadoteridol and gadoteric acid.
Maltese: L-istima tar-riskju relattiv għal NSF, ikkalkulata fuq il-bażi tan-numru ta' każijiet mhux imħawda u GdCA, hija ogħla għal gadodiamide (100%), gadoversetamide (94%), u l-aċidu gadopentetiku (10%) u <1% għal gadoteridol u l-aċidu gadoteriku.
English: Linear ionic chelates including gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid (MultiHance).
Maltese: Kelati joniċi lineari fosthom gadofosveset (Vasovist), aċidu gadoksetiku (Primovist) u aċidu gadobeniku (MultiHance).
English: SK - Slovakia
Maltese: Is-Slovakkja
English: GR-143 43, N. Chalkidona, Athens Greece
Maltese: Chalkidona, Athens Greece
English: GdCAs have been associated with nephrogenic systemic fibrosis (NSF), a rare, serious and lifethreatening syndrome involving fibrosis of the skin, joints and internal organs in patients with severe renal impairment.
Maltese: Il-GdCAs ġew assoċjati ma' fibrożi sistemika nefroġenika (NSF), sindrome serja, rari u ta' theddida għall-ħajja li tinvolvi fibrożi tal-ġilda, il-ġogi u l-organi interni f'pazjenti b'indeboliment sever talkliewi.
English: However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Maltese: Madankollu m'hemmx evidenza li emodijalisi hija xierqa għall-prevenzjoni ta' fibrosi nefroġenika sistemika (NSF).
English: Folli 50 I-20134 Milan Italy
Maltese: I-20134 Milan Italy
English: 6.6 Special precautions for disposal and other handling [Use currently approved text for information on disposal]
Maltese: [Uża t-test attwalment approvat for information on disposal]
English: Multihance 529 mg/ml solution for injection in prefiled syringe solution for injection in prefilled syringe intravenous use
Maltese: Multihance 529 mg/ml solution for injection in prefiled syringe
English: LT - Lithuania
Maltese: Il-Litwanja
English: On 19 November 2008, the European Commission triggered the corresponding procedure under Article 20 of Council Regulation (EC) 726/2004, for GdCAs which are centrally authorised (gadoversetamide and gadofosveset).
Maltese: Fid-19 ta' Novembru 2008, ilKummissjoni Ewropea bdiet il-proċedura korrispondenti skont l-Artikolu 20 tar-Regolament tal-Kunsill (KE) 726/2004, għal GdCAs li huma awtorizzati ċentralment (gadoversetamide u gadofosveset).
English: BE - Belgium
Maltese: Bruxelles Belgium
English: Bracco Imaging Italia Via Egidio Folli, 50 20134 Milano Italy
Maltese: Bracco Imaging Italia Via Egidio Folli, 50 20134
English: The communication should be based on the “key message document” agreed by CHMP.
Maltese: Il-komunikazzjoni għandha tkun ibbażata fuq id-“dokument ta' messaġġ prinċipali” maqbul mill-CHMP.
English: DE - Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: 3 D-89079 Ulm Germany
English: Gadovist 1,0 mmol/ml raztopina za injiciranje
Maltese: Gadovist 1,0 mmol/ml raztopina za injiciranje 1,0 mmol/ml