FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zdravilo Vibativ so z vankomicinom primerjali tudi v dveh glavnih študijah, v katerih je sodelovalo skupno 1 897 odraslih z zapletenimi okužbami kože in mehkih podkožnih tkiv, ki so jih povzročile grampozitivne bakterije, zdravili pa so dajali do 14 dni.
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.
Slovenian: Kljub temu je odbor menil, da bi bilo zdravilo Vibativ lahko koristno pri zdravljenju bolnikov z bolnišnično pljučnico, za katero je znano oziroma se sumi, da jo je povzročila bakterija MRSA, in pri katerih zdravljenje z drugimi zdravili ni primerno.
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).
Slovenian: Zdravilo Vibativ so primerjali z vankomicinom (drugim antibiotikom) v dveh glavnih študijah, v katerih je sodelovalo skupno 1 503 odraslih z bolnišnično pljučnico, ki jo povzročajo grampozitivne bakterije (vrste bakterij, ki vključujejo MRSA).
English: The company will carry out a study to assess side effects that are experienced by patients using Vibativ and another to monitor for the development of bacteria resistant to the medicine.
Slovenian: Družba bo izvedla študijo za oceno neželenih učinkov pri bolnikih, ki jemljejo Vibativ, in drugo študijo za spremljanje razvoja na zdravilo odpornih bakterij.
English: Vibativ is a medicine that contains the active substance telavancin.
Slovenian: Vibativ je zdravilo, ki vsebuje zdravilno učinkovino telavancin.
English: How does Vibativ work?
Slovenian: Kako zdravilo Vibativ deluje?
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.
Slovenian: Zdravilo Vibativ se uporablja samo v primerih, ko je znano ali se sumi, da je okužbo povzročila „na meticilin odporna bakterija Staphylococcus aureus“(MRSA) in kadar zdravljenje z drugimi zdravili (na primer
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.
Slovenian: Pri tem je treba spremljati delovanje ledvic: pri bolnikih z manjšimi težavami z ledvicami bo morda treba zmanjšati začetni odmerek in nadaljnje odmerke; če se delovanje ledvic občutno poslabša, pa bo zdravljenje morda treba prekiniti.
English: How has Vibativ been studied?
Slovenian: Kako je bilo zdravilo Vibativ raziskano?
English: Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%).
Slovenian: Študije so pokazale, da so se pri bolnikih, ki so se zdravili z zdravilom Vibativ, po zdravljenju pogosteje pojavile težave z ledvicami kot pri bolnikih, ki so jemali vankomicin (3,8 % v primerjavi z 2,2 %).
English: For the full list of restrictions with Vibativ, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Vibativ glejte navodilo za uporabo.
English: For the full list of all side effects reported with Vibativ, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vibativ, glejte navodilo za uporabo.
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
Slovenian: V povzetek glavnih značilnosti zdravila in navodila za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito
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).
Slovenian: V prvi študiji zdravljenja zapletenih okužb kože in mehkih tkiv je bilo ob koncu terapije ozdravljenih 76 % (323 od 426) bolnikov, ki so se zdravili z zdravilom Vibativ, v primerjavi s 75 % (321 od 429) bolnikov, ki so jih zdravili z vankomicinom.
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).
Slovenian: V prvi študiji zdravljenja bolnišnične pljučnice je bilo ob koncu terapije ozdravljenih 58 % (214 od 372) bolnikov, ki so se zdravili z zdravilom Vibativ, v primerjavi z 59 % (221 od 374) bolnikov, ki so jih zdravili z vankomicinom.
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).
Slovenian: V drugi študiji je bilo ob koncu terapije ozdravljenih 77 % bolnikov (387 od 502), ki so se zdravili z zdravilom Vibativ, v primerjavi s 74 % (376 od 510) bolnikov,
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
Slovenian: V drugi študiji je bilo ob koncu terapije ozdravljenih 60 % (227 od 377) bolnikov, ki so se zdravili z zdravilom Vibativ, v primerjavi s 60 % (228 od 380 bolnikov) bolnikov, ki so jih zdravili z vankomicinom.
English: Vibativ is given as a drip into a vein lasting one hour.
Slovenian: Zdravilo Vibativ se daje kot enourna kapalna infuzija v veno.
English: Low risk:
Slovenian: Nizko tveganje:
English: Annual cumulative safety review
Slovenian: Letni kumulativni varnostni pregled
English: The dose used should also be recorded.
Slovenian: Zabeležiti je treba tudi uporabljen odmerek.
English: The communication should be based on the “key message document” agreed by CHMP.
Slovenian: Obveščanje mora temeljiti na „ključnem dokumentu o obveščanju“, ki ga je sprejel CHMP.
English: Long-term effects study
Slovenian: Študija dolgoročne učinkovitosti
English: Furthermore, Risk Minimisation Measures on the traceability as well as the long-term effects of these products in Europe are recommended.
Slovenian: Poleg tega so priporočljivi ukrepi za zmanjševanje tveganja o sledljivosti ter dolgoročna učinkovitost teh zdravil v Evropi.
English: Medium risk:
Slovenian: Srednje visoko tveganje:
English: However, medical history alone could not be relied on, as it will not be sufficient to identify all at-risk patients.
Slovenian: Vendar pa se zgolj na zdravstveno anamnezo ni mogoče zanesti, saj ne zadošča za opredelitev vseh bolnikov, pri katerih obstaja tveganje.
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.
Slovenian: Od junija 2006 so poročali o primerih NSF, povezanih z drugimi GdCA, to vprašanje pa je bilo predmet podrobnih regulativnih pregledov, ki so privedli do ukrepov za zmanjševanje tveganja na nacionalni ravni.
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;
Slovenian: - Odbor je ocenil razloge za ponovni pregled, ki jih je predložil imetnik dovoljenja za promet z zdravilom Omniscan (gadodiamid) dne 25. januarja 2010, in znanstveno razpravo v Odboru;
English: Other precautionary measures
Slovenian: Drugi previdnostni ukrepi
English: The CHMP reviewed all the information made available by the Marketing Authorisation Holders.
Slovenian: CHMP je pregledal vse informacije, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
English: The need to have a harmonised traceability method across Europe for effective monitoring of the use of GdCAs was agreed.
Slovenian: Izpostavljena je bila potreba po usklajeni metodi sledljivosti po Evropi, da se zagotovi učinkovito spremljanje uporabe GdCA.
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).
Slovenian: Dne 6. novembra 2008 je Danska v skladu s členom 31 Direktive 2001/83/ES pozvala CHMP, naj poda svoje mnenje o tem, ali je treba dovoljenja za promet z GdCA spremeniti z vidika njihove uporabe pri posebni populaciji bolnikov, pri katerih je prisotno večje tveganje pojava nefrogene sistemske fibroze (NSF).
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.
Slovenian: Temu je sledilo 25 primerov NSF (20 na Danskem in 5 v Avstriji) pri bolnikih s hudo okvaro ledvic, ki so prejemali gadodiamid.
English: [The following statement should be added]
Slovenian: [Doda se naslednja izjava]
English: National Competent Authorities should ensure that prescribers will be informed of the measures agreed by CHMP to minimise the risk of NSF.
Slovenian: Nacionalni pristojni organi morajo zagotoviti, da so zdravniki, ki predpisujejo zdravila, obveščeni o ukrepih, ki jih je CHMP sprejel za zmanjševanje tveganja NSF.
English: This should be submitted to the CHMP within 3 months of the Commission Decision on this Referral procedure.
Slovenian: Te podatke je treba CHMP predložiti v 3 mesecih po odločbi Komisije o tem postopku napotitve.
English: At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.
Slovenian: V kliničnih odmerkih se ne pričakuje učinkov na dojenčka zaradi majhne količine, ki se izloči v mleku ter majhne absorpcije iz prebavil.
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.
Slovenian: - Odbor je proučil vse razpoložljive podatke, ki so bili predloženi o varnosti kontrastnih sredstev, ki vsebujejo gadolinij, v zvezi s tveganjem NSF;
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.
Slovenian: CHMP je ugotovil tudi, da je GdCA glede na tveganje NSF mogoče razvrstiti v 3 kategorije tveganja: visoko, srednje in nizko tveganje;
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.
Slovenian: Ta ukrep za zmanjševanje tveganja je bil uporabljen v skladu s tremi različnimi kategorijami tveganj NSF pri GdCA, ki jih je ugotovil CHMP na osnovi njihovih termodinamičnih in kinetičnih lastnosti.
English: Other factors such as renal impairment would likely increase the toxicity of the complexes by slowing the clearance of Gd3+.
Slovenian: Drugi dejavniki, npr. okvara ledvic, utegnejo povečati toksičnost kompleksov z upočasnitvijo nastajanja očistka Gd3+.
English: Tell your doctor if: [Use currently approved text]
Slovenian: Obvestite svojega zdravnika, če [odobreno besedilo]
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.
Slovenian: Za zagotovitev usklajene metode sledljivosti po Evropi za učinkovito spremljanje uporabe GdCA morajo pristojni nacionalni organi, ki jih usklajuje referenčna država članica (kjer je ustrezno), zagotoviti, da imetniki dovoljenj za promet z zdravilom na vialah in injekcijskih brizgah z GdCA uporabljajo nalepke, ki jih je mogoče odstraniti.
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.
Slovenian: - Odbor je upošteval napotitev, ki jo je sprožila Danska v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za kontrastna sredstva, ki vsebujejo gadolinij (GdCA-ji);
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom Omniscan (gadodiamid) se ni strinjal s predlaganimi opozorili za označevanje v zvezi s presejanjem bolnikov glede ledvične disfunkcije in je zahteval ponovno presojo mnenja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GADOLINIUMCONTAINING CONTRAST AGENTS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA KONTRASTNIH SREDSTEV, KI VSEBUJEJO GADOLINIJ (glejte Dodatek I)
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.
Slovenian: Ocenjeno relativno tveganje NSF, izračunano na osnovi števila primerov brez vpliva begavih spremenljivk in GdCA, je višje pri gadodiamidu (100 %), gadoversetamidu (94 %) in gadopentetski kislini (10 %) ter < 1 % pri gadoteridolu in gadoterski kislini.
English: No dosage adjustment is considered necessary.
Slovenian: Prilagajanje odmerkov ni potrebno.
English: Based on the above the CHMP recognised that there are different categories of NSF-risk for GdCAs:
Slovenian: Na osnovi zgoraj navedenega je CHMP zaključil, da obstajajo različne kategorije tveganja NSF pri GdCA:
English: However there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Slovenian: Vendar ni dokazov, da je hemodializa primerna za preprečevanje nefrogene sistemske fibroze (NSF).
English: Encouraging appropriate testing of renal function should ensure identification of patients at risk and ensure use of appropriate diagnostic agents.
Slovenian: Spodbujanje ustreznih preizkusov delovanja ledvic mora pomagati pri opredelitvi bolnikov, pri katerih obstaja tveganje, in uporabi ustreznih diagnostičnih sredstev.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The use of “sticky labels” detachable from the vials and syringes are considered an appropriate method to be implemented for all GdCAs.
Slovenian: Uporaba nalepk, ki jih je mogoče odstraniti z vial in injekcijskih brizg, je ustrezna metoda, ki se bo uporabljala za vse GdCA.
English: Therefore the use of high-risk GdCAs is contraindicated in this population.
Slovenian: Uporaba GdCA z visokim tveganjem je zato pri tej populaciji kontraindicirana.
English: You must tell your doctor if you think you are or might become pregnant as {Invented name} should not be used during pregnancy unless strictly necessary.
Slovenian: Zdravnika morate obvestiti, če menite, da ste ali bi lahko bili noseči, saj se zdravilo {lastniško ime} ne sme uporabljati med nosečnostjo, razen če je nujno potrebno.
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.
Slovenian: - CHMP je zaključil, da morajo podatki o zdravilu za vse GdCA vključevati informacije o varnosti za zmanjševanje tveganja NSF, zato je priporočil spremembe zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo v skladu s kategorijo tveganja.
English: GE Healthcare Via Galeno 36, 20126 Milano
Slovenian: GE Healthcare Via Galeno 36, 20126 Milano Italy
English: The use of the high risk category of GdCAs in neonates up to 4 weeks of age is contra-indicated.
Slovenian: Uporaba kategorije GdCA z visokim tveganjem pri novorojenčkih do starosti 4 tednov je kontraindicirana.
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.
Slovenian: - Odbor je zaključil, da so kontrastna sredstva, ki vsebujejo gadolinij, povezana z NSF, ter da je tveganje povečano pri bolnikih z okvaro ledvic, bolnikih s presaditvijo jeter, otrocih, nosečnicah in doječih materah ter pri starejših.
English: However as the risk with gadopentetic acid remains substantially higher than the NSF risk with the other lower risk contrast agents, the CHMP recommended that gadopentetic acid should be retained in the high risk group and be subject to the same risk minimisation measures.
Slovenian: Ker je tveganje pri gadopentetski kislini še vedno bistveno večje od tveganja NSF pri drugih kontrastnih sredstvih z manjšim tveganjem, je CHMP priporočil, da se gadopentetska kislina v skupini z visokim tveganjem še naprej uporablja in da zanjo veljajo isti ukrepi za zmanjševanje tveganja.
English: The following information is intended for medical or healthcare professionals only: [Use currently approved text with the addition of information on NSF] Prior to administration of {Invented name}, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: [Uporabi se trenutno odobreno besedilo z dodatkom informacije o NSF] Pred uporabo zdravila {izmišljeno ime} je priporočljivo pri vseh bolnikih preveriti delovanje ledvic z laboratorijskimi preiskavami.
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.
Slovenian: Obseg transmetilacije je bistveno drugačen pri kompleksih z linearnimi helati, pri katerih obstaja večja verjetnost sproščanja Gd3+ kot pri cikličnih helatih, kjer je gadolinijev ion ujet v ciklu.
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.
Slovenian: Po oceni podrobnih razlogov za ponovni pregled, ki jih je imetnik dovoljenja za promet z zdravilom pisno predložil, se je CHMP strinjal, da zdravstvena anamneza omogoča opredelitev bolnikov z morebitno ledvično disfunkcijo.
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
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: b) Linear ionic chelate: gadopentetic acid (Magnevist, Gado-MRT-ratiopharm, Magnegita).
Slovenian: b) Linearni ionski helat: gadopentetska kislina (Magnevist, Gado-MRT-ratiopharm, Magnegita).
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).
Slovenian: Kontrastna sredstva, ki vsebujejo gadolinij (GdCA) - gadoversetamid, gadodiamid, gadopentetska kislina, gadobenska kislina, gadofosveset, gadoksetna kislina, gadoteridol, gadobutrol in gadoterska kislina - so intravenska sredstva, ki se uporabljajo za izboljšavo kontrasta pri magnetnoresonančnem slikanju (MRI) in magnetnoresonančni angiografiji (MRA).
English: There is insufficient information on the excretion of {active substance} in animal milk.
Slovenian: Ni dovolj podatkov o izločanju {zdravilne učinkovine} v živalsko mleko.
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.
Slovenian: Na osnovi zgoraj navedenega je CHMP zaključil, da ohrani svoje mnenje z dne 19. novembra 2009 s priporočenimi predlogi sprememb zadevnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo, kot je navedeno v Dodatku III k mnenju.
English: Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3).
Slovenian: Kontrastna sredstva, ki vsebujejo gadolinij, se izločajo v materino mleko v zelo majhnih količinah (glejte poglavje 5.3).
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.
Slovenian: NSF povzroči hudo prizadetost sklepov, mišično oslabelost in lahko prizadene delovanje notranjih organov, kar je lahko življensko ogrožujoče.
English: This screening is recommended for all patients who will receive medium and low NSF-risk GdCAs.
Slovenian: To presejanje je priporočljivo za vse bolnike, ki bodo prejeli GdCA s srednje visokim in nizkim tveganjem NSF.
English: No relative risk was estimated for the other GdCAs as their usage is too low.
Slovenian: Za druge GdCA relativno tveganje ni bilo ocenjeno, saj njihova uporaba ni dovolj pogosta.
English: Although only small amounts of gadolinium are excreted into human breast milk, the immaturity of foetal kidneys could delay the excretion of gadolinium leading to the possibility of long-term accumulation of gadolinium in tissues.
Slovenian: Čeprav se le majhna količina gadolinija izloči v materino mleko, lahko nezrelost ledvic pri plodu podaljša izločanje gadolinija, kar lahko vodi do dolgoročne akumulacije gadolinija v tkivih.
English: • your kidneys do not work properly • you have recently had, or soon expect to have, a liver transplant
Slovenian: • vaše ledvice ne delujejo pravilno • ste pred kratkim imeli ali v kratkem pričakujete presaditev jeter
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
Slovenian: DODATEK IV POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM
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.
Slovenian: Laboratorijski testi so učinkovitejši način za oceno delovanja ledvic pri vseh bolnikih, pri katerih obstaja tveganje, saj se spremembe delovanja ledvic pogosto ne kažejo s simptomi ali kliničnimi znaki.
English: The testing of bone samples from patients undergoing hip and knee replacement surgery is recommended.
Slovenian: Priporočljivo je testiranje vzorcev kosti pri bolnikih, pri katerih se izvede zamenjava kolka in kolena.
English: In order to minimise the recognised risk associated with GdCAs and the development of NSF, the CHMP agreed on the following measures for the following at risk patient groups:
Slovenian: Za zmanjšanje znanih tveganj, povezanih z GdCA, in pojava NSF je CHMP sprejel naslednje ukrepe za naslednje skupine bolnikov, pri katerih obstaja tveganje: