FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly (aged 65 years and above)
Maltese: Anzjani (età minn 65 sena 'l fuq)
English: CZ - Czech Republic
Maltese: Ir-Repubblika Ċeka
English: The CHMP also recognised that according to their risk for NSF, GdCAs can be classified in 3 risk categories: high, medium and low risk.
Maltese: Il-CHMP irrikonoxxa wkoll li abbażi tar-riskju tagħhom għal NSF, il-GdCAs jistgħu jiġu kklassifikati fi 3 kategoriji ta' riskju: riskju għoli, medju u baxx.
English: Bracco ALTANA Pharma GmbH Max-Stromeyer-Str. 116
Maltese: Pharma GmbH Max-Stromeyer-Str. 116
English: IS - Iceland
Maltese: L-islanda
English: BG - Bulgaria
Maltese: Il-Bulgarija
English: GR-Greece
Maltese: Il-Greċja
English: NSF may result in severe joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life threatening.
Maltese: NSF tista' twassal għal tnaqqis sever filmobilità tal-ġogi, indebboliment tal-muskoli jew tista' taffettwa l-funzjoni normali ta' organi interni b'potenzjal ta' periklu għall-ħajja.
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section
Maltese: Każijiet iżolati ta' fibrosi sistemika nefroġenika (NSF) ġew rapportati b'{Isem inventat} (ara sezzjoni jew
English: 28 D-20097 Hamburg Germany
Maltese: Helm AG Nordkanalstr. 28 D-20097 Hamburg Germany
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for gadolinium containing contrast agents (GdCAs) initiated by Denmark.
Maltese: - Il-Kumitat ikkunsidra r-riferiment magħmul skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għas-sustanzi ta' kuntrast li fihom gadolinium (GdCAs), mibdi mid-Danimarka.
English: On 6 November 2008 Denmark asked the CHMP, under Article 31 of Directive 2001/83/EC, to give its opinion on whether the marketing authorisations for GdCAs should be varied in relation to its use in special patient's population more at risk to develop nephrogenic systemic fibrosis (NSF).
Maltese: Fis-6 ta' Novembru 2008, id-Danimarka talbet lill-CHMP, skont l-Artikolu 31 tad-Direttiva 2001/83/KE, biex jagħti l-opinjoni tiegħu dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq talGdCAs għandhomx ikunu differenti fir-rigward tal-użu tagħhom f'popolazzjoni speċjali ta' pazjenti li jkunu aktar f'riskju li jiżviluppaw fibrożi sistemika nefroġenika (NSF).
English: - The Committee assessed the grounds for re-examination submitted by the MAH of Omniscan (gadodiamide) on 25 January 2010 and the scientific discussion within the Committee;
Maltese: - il-Kumitat ivvaluta r-raġunijiet għal eżami mill-ġdid sottomessi mill-MAH ta' Omniscan (gadodiamide) fil-25 ta' Jannar 2010 u d-diskussjoni xjentifika fi ħdan il-Kumitat;
English: All GdCAs are chelate complexes containing Gd3+, the highly toxic gadolinium ion, which potentially may be released through transmetallation in vivo.
Maltese: Il-GdCAs kollha huma kumplessi kelati li fihom Gd3+, il-jone tossiku ħafna gadolinium, li potenzjalment jista' jintreħa permezz ta' transmetallation in vivo.
English: Therefore and considering the overall benefit/risk, the CHMP agreed that for all patients to be administered with high NSF-risk GdCAs mandatory screening by laboratory tests should be performed.
Maltese: Għaldaqstant, u fid-dawl tal-benefiċċju/riskju globali, il-CHMP qabel li biex il-pazjenti kollha jingħataw GdCAs b'riskju għoli ta' NSF, għandu jitwettaq skrining obbligatorju permezz ta' testijiet fil-laboratorju.
English: 19 B D-69115 Heidelberg Germany
Maltese: 19 B D-69115
English: 287 mg/ml (0,5 mmol/ml) solution for injection intravenous use
Maltese: 287 mg/ml (0,5 mmol/ml) Soluzzjoni għallinjezzjoni
English: Dotarem 279.32mg/ml Solution for Injection, glass pre-filled syringes
Maltese: 32mg/ml Solution for Injection, glass pre-filled syringes
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2).
Maltese: Kien hemm rapporti ta' fibrosi sistemika nefroġenika (NSF) assoċjati mal-użu ta' xi sustanzi ta' kuntrast li fihom gadolinju f'pazjenti li għandhom indeboliment renali sever akut jew kroniku (GFR < 30 ml/min/1.73m2).
English: {Invented name} is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Maltese: {Isem ivvintat} huwa kontra-indikat fi trabi tat-twelid b'età sa 4 ġimgħat (ara sezzjoni 4.3).
English: Mommaertslaan 14 1831 Diegem Belgium
Maltese: Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem Belgium
English: [If use is not authorised for infants below the age of 1 year a statement in section 4.4 is not necessary.
Maltese: [Jekk l-użu mhux awtorizzat għal trabi b'età inqas minn sena, stqarrija f'sezzjoni 4.4 mhux neċessarja.
English: RO-Romania
Maltese: Ir-Rumanija
English: In order to have a harmonised traceability method across Europe for the effective monitoring of the use of GdCAs the National Competent Authorities, coordinated by the Reference Member State (where applicable) should ensure the implementation by the MAHs of detachable (“sticky”) labels on the vials and syringes of the GdCAs.
Maltese: Sabiex ikun hemm metodu ta' traċċabilità armonizzat madwar l-Ewropa kollha għall-monitoraġġ effettiv tal-użu ta' GdCAs, l-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza (fejn applikabbli), għandhom jassiguraw l-implimentazzjoni ta' tikketti (“iwaħħlu”) li jistgħu jinqalgħu fuq il-kunjetti u s-siringi tal-GdCAs mid-Detenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq.
English: Dotarem 279.32mg/ml Solution for Injection, glass vials
Maltese: 32mg/ml Solution for Injection, glass vials
English: GdCAs were first associated with nephrogenic systemic fibrosis (NSF) in January 2006 when five end-stage renal failure patients undergoing MRA developed signs of NSF two to four weeks after GdCAs administration.
Maltese: Il-GdCAs ġew assoċjati l-ewwel darba ma' fibrożi sistemika nefroġenika (NSF) f'Jannar 2006 meta ħames pazjenti b'indeboliment renali tal-aħħar stadju sottoposti għal MRA żviluppaw sinjali ta' NSF ġimagħtejn sa erba' ġimgħat wara l-għodi ta' GdCAs.
English: {Invented name} should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m2) at a dose not exceeding {x} mmol/kg body weight (see section 4.4).
Maltese: {Isem ivvintat} għandu jintuża biss wara valutazzjoni b'attenzjoni tar-riskju/benefiċċju f'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73m2) b'doża li ma taqbisx {x} mmol/kg ta' piż tal-ġisem (ara sezzjoni 4.4).
English: INSIGHT AGENTS GmbH Ringstrasse.
Maltese: Insights Agents GmbH Ringstrasse 19B
English: Based on the above the CHMP recognised that there are different categories of NSF-risk for GdCAs:
Maltese: Fuq il-bażi ta' dan ta' hawn fuq, il-CHMP irrikonoxxa li hemm kategoriji differenti ta' riskju ta' NSF għall-GdCAs:
English: Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva wara għoti ripetut ta' dożi għolja (ara sezzjoni 5.3).
English: 0.5 mmol/ml and 0.5 mmol/litre
Maltese: Omniscan injection 0.5 mmol/ml and 0.5 mmol/litre
English: HOW TO USE {Invented name}
Maltese: QABEL MA TINGĦATA {Isem inventat}
English: The use of the high risk category of GdCAs in neonates up to 4 weeks of age is contra-indicated.
Maltese: L-użu tal-kategorija ta' riskju għoli ta' GdCAs fi trabi għadhom jitwieldu sal-età ta' 4 ġimgħat huwa kontra-indikat.
English: DOTAREM 0,5 mmol/ml injection 100ml injection intravenous use
Maltese: DOTAREM 0,5 mmol/ml injection 100ml
English: solution for injection (syringe and cartridge)
Maltese: Soluzzjoni għallinjezzjoni (siringa, skartoċċ)
English: [Use currently approved text with the addition of information on NSF]
Maltese: [Uża t-test attwalment approvat biż-żieda ta' informazzjoni fuq NSF]
English: 287 mg/ml Gadodiamid
Maltese: 287 mg/ml Gadodiamid Soluzzjoni għallinjezzjoni
English: {Invented name} is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period (see section 4.3).
Maltese: {Isem ivvintat} huwa kontra-indikat f'pazjenti b'indeboliment sever tal-kliewi (GFR < 30 ml/min/1.73m2) u f'pazjenti fil-perijodu ta' qabel u wara operazzjoni ta' trapjant tal-fwied (ara sezzjoni 4.3).
English: DE - Germany
Maltese: Jena Germany
English: DE - Germany be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10 D-76534 Baden-Baden Germany
Maltese: Il-Ġermanja be imaging GmbH Dr.-Rudolf-Eberle-Str. 8-10
English: This risk minimisation was applied in accordance with the three different categories of NSF-risk for GdCAs recognised by the CHMP based on their thermodynamic and kinetic properties.
Maltese: Din il-minimizzazzjoni tar-riskju ġiet applikata skont it-tliet kategoriji differenti ta' riskju ta' NSF għall-GdCAs rikonoxxuti mill-CHMP abbażi tal-kwalitajiet termodinamiċi u kinetiċi tagħhom.
English: Gadovist 1.0 mmol/ml Solution for Injection in prefilled cartridge solution for injection, in prefilled cartridge intravenous use
Maltese: Gadovist 1.0 mmol/ml Solution for Injection in prefilled cartridge
English: Primovist 0.25 mmol/ml Sol for Injection, prefilled syringe solution for injection, prefilled syringe intravenous use
Maltese: Primovist 0.25 mmol/ml Sol for Injection, prefilled syringe
English: Primovist 0,25 mmol/ ml, injekčný roztok
Maltese: Primovist 0,25 mmol/ ml, injekčný roztok 0,25 mmol/ml
English: 19 B, 69115 HEIDELBERG Germany
Maltese: 19 B, 69115
English: Strong warnings are included in the GdCAs of medium and low NSF risk as regards use in patients with severe renal impairment but subject to dose restriction to a minimum during a scan and with a minimum 7 day interval between administrations.
Maltese: Huma inklużi twissijiet qawwija fil-GdCAs ta' riskju medju u baxx għal NSF fir-rigward tal-użu f'pazjenti b'indeboliment sever tal-kliewi iżda suġġett għal restrizzjoni tad-doża għal minimu waqt skansjoni u b'intervall minimu ta' 7 ijiem bejn għotja u oħra.
English: Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} in patients co-administered other gadolinium-containing contrast agents (see section 4.4).
Maltese: Każijiet iżolati ta' fibrosi sistemika nefroġenika (NSF) ġew rapportati b'sustanzi oħra ta' kuntrast li fihom gadolinju (ara sezzjoni 4.4).
English: {Invented name} is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2), in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
Maltese: {Isem ivvintat} huwa kontra-indikat f'pazjenti b'indeboliment sever tal-kliewi (GFR <30ml/min/1.73m2), f'pazjenti fil-perijodu ta' qabel u wara operazzjoni ta' trapjant tal-fwied u fi trabi tat-twelid b'età sa 4 ġimgħat (ara sezzjoni 4.4).
English: Screening for renal dysfunction
Maltese: Funzjoni tal-kliewi indebolita
English: LULuxembourg
Maltese: Il-Lussemburgu
English: NO - Norway
Maltese: In-Norveġja
English: Box 4220 Nydalen, N-0401 Oslo Norway
Maltese: P.O. Box 4220 Nydalen, N-0401 Oslo Norway
English: Via Emilio Folli, 50 20134 Milano Italy
Maltese: Via Emilio Folli, 50 20134
English: Omniscan 0.5mmol/ml solution for injection, prefilled syringe solution for injection, prefilled syringe intravenous use
Maltese: Omniscan 0.5mmol/ml solution for injection, prefilled syringe
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) is unknown, therefore, {Invented name} should be only used after careful risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding {x} mmol/kg body weight.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi (GFR 30-59 ml/min/1.73 m2) ir-riskju ta' żvilupp ta' NSF mhux magħruf, għalhekk, f'pazjenti b'indeboliment moderat tal-kliewi {Isem ivvintat} għandhu jintuża biss wara valutazzjoni b'attenzjoni tar-riskju u l-benefiċċju.
English: The use of “sticky labels” detachable from the vials and syringes are considered an appropriate method to be implemented for all GdCAs.
Maltese: L-użu ta' “sticky labels” li jistgħu jinqalgħu minn mal-kunjetti u s-siringi huwa kkunsidrat bħala metodu adattat biex jiġi implimentat għall-GdCAs kollha.
English: Because of the lack of information on repeated administration, {Invented name} injections should not be repeated unless the interval between injections is at least 7 days.
Maltese: Minħabba n-nuqqas ta' informazzjoni dwar amministrazzjoni ripetuta, l-injezzjonijiet {Isem inventat} m'għandhomx jiġu ripetuti sakemm l-intervall bejn linjezzjonijiet ikun tal-anqas ta' 7 ijiem.
English: However, screening should only require laboratory testing following evaluation of the patient's medical history and the minimisation measure should be the same for all GdCAs.
Maltese: Madankollu, l-iskrining għandu jeħtieġ testijiet fil-laboratorju biss wara evalwazzjoni tal-istorja medika tal-pazjent u l-miżura ta' minimizzazzjoni għandha tkun l-istess għall-GdCAs kollha.
English: BEFORE YOU ARE GIVEN {Invented name}
Maltese: {Isem inventat} [sustanza attiva]
English: For patients with moderate renal impairment, since the risk is unknown for the high risk category of GdCAs it was agreed that use should only be considered after careful consideration of the benefit-risk, subject to dose restriction to not more than one injection of the minimum dose during a scan with a minimum 7 day interval between administrations.
Maltese: Fil-każ ta' pazjenti b'indeboliment renali moderat, billi mhuwiex magħruf ir-riskju għall-kategorija ta' GdCAs b'riskju għoli, ġie maqbul li l-użu għandu jiġi kkunsidrat biss wara konsiderazzjoni bir-reqqa tal-benefiċċju-riskju, suġġett għal restrizzjoni tad-doża għal mhux aktar minn injezzjoni waħda taddoża minima waqt skansjoni b'intervall minimu ta' 7 ijiem bejn għotja u oħra.
English: - The Committee, concluded that gadolinium contrast agents are associated with NSF and that the risk is increased in renal impaired patients, liver transplant patients, the paediatric population, during pregnancy and lactation and in the elderly.
Maltese: - Il-Kumitat ikkonkluda li s-sustanzi ta' kuntrast li fihom gadolinium huma assoċjati ma' NSF u li r-riskju jiżdied f'pazjenti b'indeboliment tal-kliewi, pazjenti bi trapjant tal-fwied, ilpopolazzjoni pedjatrika, waqt it-tqala u t-treddigħ u fl-anzjani.
English: As the renal clearance of {active substance} may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Maltese: Peress li t-tneħħija ta'{sustanza attiva} tista' tiġi indebolita fl-anzjani, huwa partikolarment importanti li l-pazjenti li għandhom 65 sena jew aktar jiġu skrinjati għal funzjoni mhux tajba tal-kliewi.
English: Omniscan 0,5 mmol/ml raztopina za injiciranje
Maltese: Omniscan 0,5 mmol/ml raztopina za injiciranje 0,5 mmol/ml
English: Since June 2006 there have been reports of NSF associated with other GdCAs and this issue has been subject to close regulatory reviews leading to risk minimisation measures at the national level.
Maltese: Minn Ġunju 2006 'l hawn kien hemm rapporti ta' NSF assoċjati ma' GdCAs oħra u din il-kwistjoni kienet soġġetta għal valutazzjonijiet regolatorji bir-reqqa li wasslu għal miżuri ta' tnaqqis tar-riskju fil-livell nazzjonali.
English: FR - France
Maltese: VILLEPINTE France
English: Box 4220 Nydalen, Oslo N-0401
Maltese: P.O. Box 4220 Nydalen, Oslo N-0401
English: Gadovist 1.0 mmol/ml Solution for Injection in prefilled syringe solution for injection, in prefilled syringe intravenous use
Maltese: Gadovist 1.0 mmol/ml Solution for Injection in prefilled syringe
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDIUM RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadoxetic acid, gadobenic acid)
Maltese: TAL-PRODOTT GĦAL SUSTANZI TA' KUNTRAST TA' RISKJU GĦOLI LI FIHOM GADOLINIUM (gadodiamide, gadopentetic acid)
English: {Invented name} should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with noncontrast enhanced MRI (see section 4.4).
Maltese: {Isem inventat} għandu jintuża biss f'pazjenti li għandhom indeboliment renali sever (GFR < 30 ml/min/1.73m2) u f'pazjenti li qegħdin fil-perijodu perioperattiv ta' trapjant tal-fwied wara analiżi birreqqa tar-riskju/s-siwi u jekk l-informazzjoni dijanjostika hi essenzjali u mhix disponibbli b'MRI mhux imtejjeb b'kuntrast (ara sezzjoni 4.4).
English: Co-factors that may increase the risk of NSF such as serum calcium and phosphate levels at the time of administration of a GdCA should be studied and biomarkers evaluated.
Maltese: Għandhom jiġu studjati kofatturi li jistgħu jżidu r-riskju ta' NSF, bħalma huma l-livelli ta' kalċju u fosfat fis-serum fil-ħin tal-għoti ta' GdCA, u jiġu evalwati l-bijomarkers.
English: DOTAREM 0,5 mmol/ml injection 60ml injection intravenous use
Maltese: DOTAREM 0,5 mmol/ml injection 60ml 0,5 mmol/ml
English: Multihance 0.5 M solution for injection
Maltese: Multihance 0.5 M solution for injection 529 mg/ml
English: DOTAREM 0,5 mmol/ml injection 15ml injection intravenous use
Maltese: DOTAREM 0,5 mmol/ml injection 15ml 0,5 mmol/ml
English: Insight Agents GmbH Ringstr.19 B D-69115 Heidelberg Germany
Maltese: Insight Agents GmbH Ringstr.19 B D-69115
English: POSSIBLE SIDE EFFECTS [Use currently approved text with the addition of information on NSF]
Maltese: [Uża t-test attwalment approvat biż-żieda ta' informazzjoni dwar NSF]
English: Due to the immature renal function of infants below 1 year of age the use of all GdCAs should be subject to careful consideration and to dose and interval administration restrictions to not more than one injection of the minimum dose during a scan with a minimum 7 day interval between dose administrations.
Maltese: Minħabba l-funzjoni renali immatura tat-trabi ta' inqas minn sena, l-użu tal-GdCAs kollha għandu jkun suġġett għal konsiderazzjoni bir-reqqa u għal restrizzjonijiet fuq id-doża u l-intervall tal-għoti għal mhux aktar minn injezzjoni waħda tad-doża minima waqt skansjoni b'intervall minimu ta' 7 ijiem bejn għotja u oħra.
English: DK - Denmark
Maltese: Id-Danimarka
English: As there is a possibility that NSF may occur with {Invented name}, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI.
Maltese: Peress li hemm possibilità li jista' jkun hemm NSF {Isem inventat}, għalhekk għandu jiġi evitat f'pazjenti b'indeboliment talkliewi sever u f'pazjenti fil-perijodu perioperattiv ta' trapjant tal-fwied wara analiżi bir-reqqa tarriskju/is-siwi u jekk l-informazzjoni dijanjostika hija essenzjali u mhix disponibbli b'MRI mhux imtejjeb b'kuntrast.
English: This information is reflected in all GdCAs' product information.
Maltese: Din l-informazzjoni hija riflessa fl-informazzjoni dwar ilprodott għall-GdCAs kollha.
English: The MAH for Omniscan (gadodiamide) disagreed with the proposed labelling warnings with respect to screening patients for renal dysfunction and requested a re-examination of the opinion.
Maltese: It-testijiet tal-laboratorju huma aktar effettivi biex tiġi valutata l-funzjoni renali fil-pazjenti kollha f'riskju, billi l-bidliet fil-funzjoni tal-kliewi ħafna drabi ma jiġux riflessi b'mod sintomatiku jew kliniku.
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) in patients who received {Invented name} together with other gadolinium-containing contrast agents.
Maltese: Kien hemm rapporti ta' fibrosi sistemika nefroġenika (li tikkawża twebbis tal-ġilda u tista' taffettwa wkoll it-tessut artab u l-organi interni) li l-maġġoranza tagħhom kienu f'pazjenti li rċevew {Isem inventat} flimkien ma' sustanzi oħra ta' kuntrast li fihom gadolinju.
English: Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with {Invented name} (see section 4.4).
Maltese: Każijiet iżolati ta' fibrosi sistemika nefroġenika (NSF) ġew rapportati b'{Isem inventat}, li l-maġġoranza tagħhom kienu f'pazjenti li ngħataw sustanzi ta' kuntrast oħra li fihom gadolinju (ara sezjoni 4.4). jew
English: DOTAREM 0,5 mmol/ml injection 20ml injection intravenous use
Maltese: DOTAREM 0,5 mmol/ml injection 20ml 0,5 mmol/ml
English: Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3).
Maltese: Sustanzi ta' kuntrast li fihom gadolinium jiġu eliminati fil-ħalib tas-sider fi kwantitajiet żgħar ħafna (ara sezzjoni 5.3).
English: Neonates and infants
Maltese: ANNESS I LISTA
English: Impaired renal function
Maltese: Pazjenti b'indeboliment renali u l-emodijalisi
English: - The CHMP concluded that the Product Information of all GdCAs should include safety information to minimise the risk of NSF and therefore recommended the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets in accordance to the risk category.
Maltese: - Il-CHMP ikkonkluda li l-Informazzjoni dwar il-Prodott tal-GdCAs kollha għandha tinkludi informazzjoni dwar is-sigurtà sabiex jitnaqqas ir-riskju ta' NSF u għalhekk irrakkomanda lemendi għas-sezzjonijiet rilevanti tas-Sommarji tal-Karatteristiċi tal-Prodott u l-Fuljetti ta' Tagħrif skont il-kategorija tar-riskju.
English: Primovist 0,25 mmol/ ml solution for injection
Maltese: Primovist 0,25 mmol/ ml solution for injection 0,25 mmol/ml
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR HIGH RISK GADOLINIUM-CONTAINING CONTRAST AGENTS (gadodiamide, gadopentetic acid)
Maltese: TALFULJETT TA' TAGĦRIF GĦAL SUSTANZI TA' KUNTRAST TA' RISKJU GĦOLI LI FIHOM GADOLINIUM (gadodiamide, gadopentetic acid)
English: HU - Hungary
Maltese: L-Ungerija
English: POSSIBLE SIDE EFFECTS [Use currently approved text with the addition of information on NSF] There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Maltese: SEKONDARJI LI JISTA' JKOLLU [Uża l-kitba approvata bħalissa b'żjieda ta' tagħrif dwar NSF] Kien hemm rapporti ta' fibrożi nefroġenika sistemika (li tikkawża twebbis tal-ġilda u tista' taffettwa wkoll it-tessut artab u l-organi interni).
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
Maltese: Kien hemm rapporti ta' fibrosi sistemika nefroġenika (li tikkawża twebbis tal-ġilda u tista' taffettwa wkoll it-tessut artab u l-organi interni) li kien assoċjat mal-użu ta' sustanzi oħra ta' kuntrast li fihom gadolinju.
English: IT - Italy
Maltese: L-Italja
English: Infants
Maltese: Miżuri
English: Insight Agents GmbH Ringstraat 19 B 69115 Heidelberg Germany
Maltese: Insight Agents GmbH Ringstraat 19 B 69115
English: The MAH supported the CHMP proposed risk minimisation for all patients to be screened for renal dysfunction irrespectively of the GdCAs.
Maltese: Barra minn hekk, huma rakkomandati Miżuri ta' Minimizzazzjoni tar-Riskju dwar ittraċċabilità kif ukoll l-effetti fit-tul ta' dawn il-prodotti fl-Ewropa.
English: National Competent Authorities should ensure that prescribers will be informed of the measures agreed by CHMP to minimise the risk of NSF.
Maltese: L-Awtoritajiet Nazzjonali Kompetenti għandhom jassiguraw li l-preskritturi jkunu infurmati dwar ilmiżuri maqbula mill-CHMP sabiex jitnaqqas ir-riskju ta' NSF.