FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Ravim toimib MRSA bakteri vastu, mis on resistentne muude tavaliselt kasutatavate antibiootikumide penitsilliinide (sealhulgas metitsilliini ja oksatsilliini) ja tsefalosporiinide suhtes.
English: However, the Committee considered that Vibativ could be valuable for treating patients with nosocomial pneumonia known or believed to be caused by MRSA for whom other treatments are not suitable.
Estonian: Komitee oli siiski arvamusel, et Vibativ on kasulik teadaolevalt või arvatavalt MRSA põhjustatud nosokomiaalse kopsupõletikuga patsientidele, kellele muud ravimid ei sobi.
English: Vibativ must not be given to patients with severe kidney problems or acute (sudden) kidney failure.
Estonian: Vibativi ei tohi kasutada raskete neeruprobleemide või ägeda (äkki tekkinud) neerupuudulikkusega patsiendid.
English: It works by stopping the bacteria causing the infection from making their own cell walls and by disrupting their cell membranes, thereby killing the bacteria.
Estonian: See takistab infektsiooni põhjustavate bakterite rakuseina sünteesi ja lagundab nende rakumembraane, hävitades nii bakterid.
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.
Estonian: Vibativi võrreldi vankomütsiiniga ka kahes põhiuuringus, kus osales kokku 1897 grampositiivsete bakterite põhjustatud naha- ja nahaaluste pehmekudede tüsistunud infektsioonidega täiskasvanut, kellele anti ravimeid kuni 14 päeva.
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.
Estonian: Vibativi kasutatakse ainult juhul, kui infektsiooni põhjustajaks on teadaolevalt või arvatavalt metitsilliinresistentne Staphylococcus aureus (MRSA) ja kui muud ravivõimalused (nt muud
English: Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%).
Estonian: Uuringud näitasid, et pärast ravi Vibativiga tekkis neeruprobleeme suuremal arvul patsientidest kui pärast ravi vankomütsiiniga (vastavalt 3,8% ja 2,2%).
English: For the full list of restrictions with Vibativ, see the package leaflet.
Estonian: Vibativi kohta teatatud piirangute täielik loetelu on pakendi infolehel.
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).
Estonian: Vibativi võrreldi vankomütsiiniga (samuti antibiootikum) kahes põhiuuringus, kus osales kokku 1503 grampositiivsete bakterite (teatud tüüpi bakterid, sealhulgas MRSA) põhjustatud nosokomiaalse kopsupõletikuga täiskasvanut.
English: Kidney function should be monitored and the initial and subsequent doses may have to be lowered for patients with minor kidney problems, while treatment may need to be stopped if kidney function gets markedly worse.
Estonian: Neerufunktsiooni tuleb jälgida ja kergete neeruprobleemidega patsientidel võib olla vaja vähendada algannust ja järgmisi annuseid.
English: How has Vibativ been studied?
Estonian: Kuidas Vibativi uuriti?
English: What benefit has Vibativ shown during the studies?
Estonian: Milles seisneb uuringute põhjal Vibativi kasulikkus?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vibativ have also been included in the summary of product characteristics and the
Estonian: Vibativi omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: For the full list of all side effects reported with Vibativ, see the package leaflet.
Estonian: Vibativi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Vibativ is used to treat adults with nosocomial pneumonia (an infection of the lungs).
Estonian: Vibativi kasutatakse nosokomiaalse kopsupõletiku raviks täiskasvanutel.
English: Vibativ was as effective as vancomycin at curing nosocomial pneumonia and complicated infections of the skin and soft tissue.
Estonian: Vibativ oli nosokomiaalse kopsupõletiku ning naha- ja nahaaluste pehmete kudede tüsistunud infektsioonide ravis sama efektiivne kui vankomütsiin.
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).
Estonian: Naha- ja nahaaluste pehmekudede tüsistunud infektsioonide esimeses uuringus oli pärast ravi lõppu paranenud 76% Vibativiga ravitud patsientidest (323 patsienti 426-st) ning 75% vankomütsiiniga ravitud patsientidest (321 patsienti 429-st).
English: This includes pneumonia caused by the use of a ventilator (a machine used in hospitals that helps patients to breathe).
Estonian: Nosokomiaalne tähendab, et infektsioon tekkis haiglas, ning mõiste hõlmab ka ventilaatori (hingamisaparaadi) kasutamisest tingitud kopsupõletikku.
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).
Estonian: Nosokomiaalse kopsupõletiku esimeses uuringus oli Vibativi saanud patsientidest pärast ravi lõppu paranenud 58% (214 patsienti 372-st), vankomütsiini saanute hulgas oli sama näitaja 59% (221 patsienti 374-st).
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).
Estonian: Teises uuringus oli pärast ravi lõppu paranenud 77% Vibativiga ravitud patsientidest (387 patsienti 502-st) ning 74% vankomütsiiniga ravitud patsientidest
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Estonian: Seda turustatakse infusioonilahuse (veeni
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
Estonian: Teises uuringus paranes pärast ravi lõppu 60% Vibativi saanud patsientidest (227 patsienti 377-st), vankomütsiini saanud patsientide vastav näitaja oli 60% (228 patsienti 380-st).
English: • your kidneys do not work properly
Estonian: • teie neerud ei tööta korralikult
English: Tell your doctor if:
Estonian: Informeerige oma arsti kui:
English: Long-term effects study
Estonian: Pikaajaliste toimete uuring
English: The dose used should also be recorded.
Estonian: Kasutatud annus tuleb samuti registreerida.
English: A risk to the suckling child cannot be excluded.
Estonian: Riski rinnapiimatoidul olevale lapsele ei saa välistada.
English: Special Populations
Estonian: Spetsiaalsed populatsioonid
English: Other Minimisation Measures
Estonian: Teised minimeerimise meetmed
English: Furthermore, Risk Minimisation Measures on the traceability as well as the long-term effects of these products in Europe are recommended.
Estonian: Lisaks soovitatakse Euroopas riski minimeerimise meetodeid jälgitavuse ja samuti nende ravimite pikaajaliste toimete kohta.
English: However, medical history alone could not be relied on, as it will not be sufficient to identify all at-risk patients.
Estonian: Samas ei saa loota ainult terviseloole, sest see ei ole piisav kõigi riskiga patsientide tuvastamiseks.
English: No dosage adjustment is considered necessary.
Estonian: Annuse kohandamine ei ole vajalik.
English: Other precautionary measures
Estonian: Teised ettevaatusabinõud
English: This information is reflected in all GdCAs' product information.
Estonian: See teave on kajastatud ka kõigi GdCAde ravimi infolehtedes.
English: Neonates and infants
Estonian: Vastsündinud ja väikelapsed
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).
Estonian: 19. novembril 2008 algatas Euroopa Komisjon nõukogu määruse 726/2004/EÜ artikli 20 alusel menetluse GdCA-de kohta, millel on tsentraalne müügiluba (gadoversetamiid ja gadofosveset).
English: Medium risk:
Estonian: Keskmine risk
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;
Estonian: - komitee hindas Omniscani (gadodiamiid) müügiloa hoidja poolt 25. jaanuaril 2010 esitatud põhjendusi arvamuse taasläbivaatamiseks ja komitees toimunud teaduslikku arutelu;
English: Low risk:
Estonian: Väike risk
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).
Estonian: 6. novembril 2008 palus Taani, et inimravimite komitee esitaks määruse 2001/83/EÜ artikli 31 alusel oma arvamuse, kas GdCA-de müügilube tuleks muuta seoses nende kasutamisega spetsiaalsel patsientide populatsioonil, kellel on suurem risk nefrogeense süsteemse fibroosi tekkimiseks.
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.
Estonian: Alates 2006. aasta juunist on esitatud aruandeid NSF-i kohta, mida seostatakse teiste GdCA-de kasutamisega, ja küsimust on õiguslikult üksikasjalikult uuritud, mille järel on võetud riiklikul tasandil riski vähendamismeetmeid.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Estonian: I LISA RAVIMI NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE JA MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES
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.
Estonian: Selleks et kogu Euroopas oleks ühtne jälgimismeetod, mille abil teha GdCA-de kasutamise kohta efektiivset seiret, peavad pädevad riiklikud ametiasutused, keda vajaduse korral koordineerivad viiteliikmesriigid, tagama, et müügiloa hoidjad kasutaksid GdCA-de viaalidel ja süstaldel eemaldatavaid (liimuvaid) märgiseid.
English: Other factors such as renal impairment would likely increase the toxicity of the complexes by slowing the clearance of Gd3+.
Estonian: Teised tegurid, nagu neerukahjustus, suurendavad tõenäoliselt nende komplekside toksilisust, sest nad aeglustavad Gd3+ kliirensit.
English: The use of the high risk category of GdCAs in neonates up to 4 weeks of age is contra-indicated.
Estonian: Suure riski kategooriasse kuuluvate GdCA-de kasutamine kuni 4-nädalastel vastsündinutel on vastunäidustatud.
English: GE HEALTHCARE BIO-SCIENCES S.A. Avda.
Estonian: GE HEALTHCARE BIOSCIENCES S.A. Avda.
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.
Estonian: Hinnanguline NSF-i suhteline risk, mis on arvutatud selgitamata juhtumite arvu ja GdCA-de alusel, on suurem gadodiamiidi (100%), gadoversetamiidi (94%) ja gadopenteethappe (10%) kasutamisel ning < 1% gadoteridooli ja gadoteerhappe kasutamisel.
English: National Competent Authorities should ensure that prescribers will be informed of the measures agreed by CHMP to minimise the risk of NSF.
Estonian: Pädevad riiklikud ametiasutused peavad kindlaks tegema, et ravimit määravad arstid on kursis inimravimite komitee poolt kokku lepitud meetmetega NSF-i riski minimeerimiseks.
English: Use during pregnancy and lactation
Estonian: Kasutamine raseduse ja imetamise ajal
English: The CHMP reviewed all the information made available by the Marketing Authorisation Holders.
Estonian: Inimravimite komitee vaatas läbi kogu müügiloa hoidjate esitatud teabe.
English: Encouraging appropriate testing of renal function should ensure identification of patients at risk and ensure use of appropriate diagnostic agents.
Estonian: Neerutalitluse sobiva analüüsi soovitamine tagab riskiga patsientide tuvastamise ja kindlustab sobivate diagnostiliste ainete kasutamise.
English: The communication should be based on the “key message document” agreed by CHMP.
Estonian: Teabeedastus peab lähtuma inimravimite komitee poolt kokku lepitud põhilisest teatamisdokumendist.
English: Annual cumulative safety review
Estonian: Iga-aastane kogutud ohutusandmete ülevaade
English: Tell your doctor if: [Use currently approved text]
Estonian: Rääkige oma arstile, kui: [kooskõlastatud tekst]
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.
Estonian: - komitee vaatas läbi muudetud direktiivi 2001/83/EÜ artikli 31 kohaselt tehtud esildise gadoliiniumi sisaldavad kontrastainete (GdCA) kohta, mille algatas Taani;
English: This screening is recommended for all patients who will receive medium and low NSF-risk GdCAs.
Estonian: Selline sõeluuring soovitatakse teha kõigil patsientidel, kes saavad keskmise ja väikese NSF-i riskiga GdCA-sid.
English: No relative risk was estimated for the other GdCAs as their usage is too low.
Estonian: Teiste GdCA-de korral suhtelist riski ei hinnatud, sest neid kasutatakse liiga vähe.
English: GE Healthcare Via Galeno 36, 20126 Milano
Estonian: GE Healthcare Via Galeno 36, 20126 Milano Italy
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.
Estonian: Omniscani (gadodiamiid) müügiloa hoidja ei nõustunud pakendi märgistuse jaoks soovitatud hoiatusega korraldada neerutalitlushäirega patsientide sõeluuring ja palus arvamuse uuesti läbi vaadata.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Estonian: Eriti ohustatud on patsiendid, kellel toimub maksa transplantatsioon, kuna äge neerupuudulikkuse teke selles grupis on kõrge.
English: Use during pregnancy is not recommended for any GdCA due to the possibility of gadolinium accumulation in human tissues.
Estonian: Raseduse ajal ei soovitata kasutada ühtegi GdCA-d, sest esineb võimalus, et gadoliinium koguneb inimkudedesse.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GADOLINIUMCONTAINING CONTRAST AGENTS (see Annex I)
Estonian: GADOLIINIUMI SISALDAVATE KONTRASTAINETE (vt I lisa) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
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.
Estonian: Sellele järgnes 25-st nefrogeense süsteemse fibroosi juhtumist koosnev koondaruanne (20 juhtumit Taanis ja 5 Austrias) raske neerukahjustusega patsientide kohta, kellele manustati gadodiamiidi.
English: Caution should be exercised in elderly patients (see section 4.4).
Estonian: Eakate patsientide korral tuleb olla ettevaatlik (vt lõik 4.4).
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.
Estonian: Samas peab sõeluuringus kasutama laborianalüüse ainult pärast patsiendi terviseloo hindamist ja riski minimeerimise meetodid peavad kõigi GdCA-de korral olema ühesugused.
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.
Estonian: GdCA-de kasutamist seostati esimest korda nefrogeense süsteemse fibroosiga 2006. aasta jaanuaris, kui viiel lõppstaadiumis neerupuudulikkusega patsiendil (läbisid MRA-uuringu) tekkisid NSF-i nähud kaks kuni neli nädalat pärast GdCA-de manustamist.
English: Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use {Invented name}, especially if you are 65 years of age or older.
Estonian: Teie arst võib enne {Väljamõeldud nimetus} kasutamist teha teile vereanalüüsi, et kontrollida kui hästi teie neerud töötavad, eriti kui te olete 65-aastane või vanem.
English: The GdCAs are available for different types of MR scan varying from product to product, including liver, brain and whole body scan.
Estonian: Toote kaupa varieeruvaid GdCA-sid kasutatakse eri tüüpi magnetresonantsskaneerimiseks, sealhulgas maksa, aju ja kogu keha skaneerimiseks.
English: Communication
Estonian: Teabeedastus
English: The need to have a harmonised traceability method across Europe for effective monitoring of the use of GdCAs was agreed.
Estonian: Nõustuti, et GdCA-de kasutamise jälgimiseks on kogu Euroopa lõikes vaja kooskõlastatud jälgimismeetodit.
English: The extent of transmetallation differs significantly between the complexes with the linear chelates more likely to release Gd3+ than the cyclical chelates where the gadolinium ion is caged in a cavity.
Estonian: Transmetalleerimise ulatus on eri kompleksidel märkimisväärselt erinev ja lineaarsed kelaadid vabastavad Gd3+ suurema tõenäosusega kui tsüklilised kelaadid, kus gadoliiniumiioon on õõnsusesse suletud.
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.
Estonian: Seetõttu ja arvestades üldist kasulikkuse ja riski suhet, nõustus inimravimite komitee, et kõigile patsientidele, kellele manustatakse suure NSF-i riskiga GdCA-sid, tuleb teha kohustuslik sõeluuring laborianalüüside abil.
English: Laboratory tests are more effective to assess the renal function of all at-risk patients, since changes in renal function are often not reflected symptomatically or clinically.
Estonian: Kõigi riskiga patsientide efektiivseim neerutalitluse hindamise viis on laboriuuring, sest sageli ei kajastu neerutalitluse muutused ei sümptomaatiliselt ega kliiniliselt.
English: For all other GdCAs the continuation or suspension of breast feeding is left to the discretion of the mother in consultation with the doctor.
Estonian: Kõigi teiste GdCA-de korral jääb rinnaga toitmise jätkamine või katkestamine pärast nõu pidamist arstiga patsiendi otsustada.
English: More than one dose should not be used during a scan.
Estonian: Skaneerimisel ei tohi kasutada üle ühe annuse.
English: b) Linear ionic chelate: gadopentetic acid (Magnevist, Gado-MRT-ratiopharm, Magnegita).
Estonian: b) Lineaarsed ioonsed kelaadid: gadopenteethape (Magnevist, Gado-MRT-ratiopharm, Magnegita).
English: This should be submitted to the CHMP within 3 months of the Commission Decision on this Referral procedure.
Estonian: Andmed tuleb esitada inimravimite komiteele 3 kuu jooksul pärast komisjoni otsust selle esildismenetluse kohta.
English: HOW TO USE {Invented name}
Estonian: MIDA ON VAJA TEADA ENNE {VÄLJAMÕELDUD NIMETUS} KASUTAMIST
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).
Estonian: Gadoliiniumi sisaldavad kontrastained (ingl gadolinium-containing contrast agents, GdCA) gadoversetamiid, gadodiamiid, gadopenteethape, gadobeenhape, gadofosveset, gadokseethape, gadoteridool, gadobutrool ja gadoteerhape on intravenoosselt manustatavad ained, mida kasutatakse kontrastsuse suurendamiseks magnetresonantstomograafia (MRI)) ja magnetresonantsangiograafia (MRA) tegemisel.
English: NSF is a disease involving thickening of the skin and connective tissues.
Estonian: NSF on haigus, mis toob kaasa naha ja pehmekudede paksenemise.
English: Based on the above, the CHMP concluded that its Opinion of 19 November 2009 should be maintained with the recommended amendments to relevant sections of the Summary of Product Characteristics and Package Leaflet as set out in Annex III to the opinion.
Estonian: Ülaltoodust lähtudes järeldas inimravimite komitee, et 19. novembril 2009 esitatud arvamus jääb kehtima koos soovitatud muudatustega ravimi omaduste kokkuvõtte ja pakendi infolehe vastavates lõikudes, nagu sätestatud arvamuse III lisas.
English: {Invented name} can be removed by haemodialysis.
Estonian: {Väljamõeldud nimetus} saab eemaldada hemodialüüsiga.
English: - The Committee considered all the available data submitted on the safety of the gadolinium containing contrast agents, in relation to the risk of NSF.
Estonian: - komitee kaalus kõiki olemasolevaid andmeid, mida esitati gadoliiniumi sisaldavate kontrastainete ohutuse kohta seoses nefrogeense süsteemse fibroosi riskiga;
English: In addition, the MAHs should submit a cumulative review on NSF cases annually for 3 consecutive years commencing one year after the decision on this referral procedure.
Estonian: Lisaks peavad müügiloa hoidjad esitama kolmel järjestikusel aastal iga-aastase kumulatiivse ülevaate NSF-i juhtudest, alustades aasta jooksul pärast esildismenetluse kohta tehtud otsust.
English: DE - Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Estonian: Saksamaa ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: You should not be given {Invented name} if you suffer from severe kidney problems, or if you are a patient who is about to have or has recently had a liver transplant, as use of {Invented name} in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
Estonian: Te ei tohiks kasutada {Väljamõeldud nimetus} kui teil esineb raske neerukahjustus või kui teil on kohe tulemas või on hiljuti olnud maksasiirdamine, kuna selliste seisunditega patsientidel on {Väljamõeldud nimetus} kasutamisega seostatud süsteemse nefrogeense fibroosi (NSF) teket.
English: Having considered the detailed grounds for re-examination provided by the MAH in writing, the CHMP agrees that medical history could identify some patients with possible renal dysfunction.
Estonian: Pärast müügiloa hoidja kirjalikult esitatud taasläbivaatamise üksikasjalike põhjuste kaalumist nõustus inimravimite komitee, et mõnel patsiendil võib terviseloo põhjal tuvastada võimaliku neerutalitlushäire.
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.
Estonian: Riski minimeerimise meetodeid kasutati GdCA-de kolme eri NSF-i riskikategooria korral, mida on tunnustanud ka inimravimite komitee, lähtudes nende termodünaamilistest ja kineetilistest omadustest.
English: Guerbet Nederland B.V. Avelingen-West 3A 4202 MS GORINCHEM Netherlands
Estonian: Avelingen-West 3A 4202 MS GORINCHEM Netherlands
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.
Estonian: Inimravimite komitee nõustus ka sellega, et nefrogeense süsteemse fibroosi tekkeriski alusel võib GdCA-d klassifitseerida kolme riskikategooriasse: suur, keskmine ja väike;