FrancophonIA/ELRC3.0 huggingface dataset:
English: This included information from preclinical and clinical studies, as well as information provided by the companies that make the medicines.
Slovenian: Ocenil je tudi informacije iz predkliničnih in kliničnih študij ter informacije, ki so jih predložile družbe, ki izdelujejo zdravila.
English: The review was carried out under ‘Article 31'1 and ‘Article 20'2 referrals.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom po členu 311 in členu 202.
English: • information on the cases of NSF reported for each agent.
Slovenian: • informacije o poročanih primerih NSF za posamezno kontrastno sredstvo.
English: The Committee also concluded that an additional factor that may contribute to the risk of NSF is the way these medicines are used (such as the dose, how often they are given and for how long).
Slovenian: Odbor je zaključil tudi, da je dodatni dejavnik, ki lahko prispeva k tveganju NSF, način uporabe teh zdravil (npr. odmerek, pogostost in trajanje dajanja).
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised agents.
Slovenian: Hkrati je Evropska komisija pozvala CHMP, naj izvede enako oceno za sredstva, odobrena po centraliziranem postopku.
English: Two of these products - OptiMARK (gadoversetamide) and Vasovist (gadofosveset) - have received a marketing authorisation that is valid throughout the European Union (EU).
Slovenian: Dve izmed teh zdravil - OptiMARK (gadoversetamid) in Vasovist (gadofosveset) - sta prejeli dovoljenje za promet, ki je veljavno v Evropski uniji (EU).
English: • a warning that the elderly may be at particular risk of NSF, because their kidneys are less able to remove gadolinium from the body;
Slovenian: • opozorilo, da so starejše osebe še posebej izpostavljene tveganju NSF, ker so njihove ledvice manj sposobne odstranjevati gadolinij iz telesa;
English: For medium- and low-risk agents the CHMP recommended that:
Slovenian: Za sredstva s srednjim in nizkim tveganjem je CHMP priporočil, da:
English: In December 2007, the Scientific Advisory Group (SAG) for Diagnostics of the CHMP was convened to discuss the approach of the PhVWP.
Slovenian: Decembra 2007 je bila sklicana znanstvena svetovalna skupina (SAG) za diagnostiko odbora CHMP, da bi razpravljala o pristopu PhVWP.
English: Questions and answers on the review of gadolinium-containing contrast agents
Slovenian: Vprašanja in odgovori v zvezi s pregledom kontrastnih sredstev, ki vsebujejo gadolinij
English: They contain gadolinium, a ‘rare earth' metal, which is used as a ‘contrast enhancer' to help make the inside of the body more visible on the scan.
Slovenian: Vsebujejo gadolinij, „redko zemeljsko“ kovino, ki se uporablja kot „ojačevalec kontrasta“ za izboljšanje vidnosti telesa pri slikanju.
English: • a statement that there is no evidence to support the initiation of haemodialysis (a blood clearance technique) to prevent or treat NSF in patients not already undergoing haemodialysis;
Slovenian: • izjavo, da ni dokazov v podporo iniciaciji hemodialize (tehnike čiščenja krvi) za preprečevanje ali zdravljenje NSF pri bolnikih, pri katerih se hemodializa še ne izvaja;
English: • Doctors should record in the patient's notes the type and dose of contrast agent used.
Slovenian: • Zdravniki morajo v bolnikovo kartoteko zabeležiti vrsto in odmerek uporabljenega kontrastnega sredstva.
English: An association between the use of gadolinium-containing contrast agents and NSF was first observed in January 2006, when cases of the disease were reported in Denmark and Austria in patients with kidney problems undergoing MRI scans.
Slovenian: Povezava med uporabo kontrastnih sredstev, ki vsebujejo gadolinij, in NSF je bila najprej opažena januarja 2006, ko so o primerih bolezni poročali na Danskem in v Avstriji pri bolnikih s težavami z ledvicami, pri katerih se izvede slikanje MRI.
English: In addition, the prescribing information of all gadolinium-containing contrast agents should include:
Slovenian: Poleg tega morajo informacije o predpisovanju vseh kontrastnih sredstev, ki vsebujejo gadolinij, vsebovati:
English: NSF is a rare disease that causes thickening of the skin and connective tissues in patients with severe kidney problems.
Slovenian: NSF je redka bolezen, ki povzroči odebelitev kože in veznih tkiv pri bolnikih s hudimi težavami z ledvicami.
English: Consequently, in November 2008 the Danish medicines regulatory agency asked the CHMP to carry out an assessment of the risk of NSF for the non-centrally authorised gadolinium-containing contrast agents, and to recommend measures that could be taken to reduce this risk.
Slovenian: Novembra 2008 je zato danska regulatorna agencija za zdravila pozvala CHMP, naj izvede oceno tveganja NSF pri kontrastnih sredstvih, ki vsebujejo gadolinij, ki niso bila odobrena po centraliziranem postopku, in priporoča ukrepe, ki lahko prispevajo k zmanjšanju tega tveganja.
English: Finally, the CHMP recommended that further studies should be carried out on the long-term retention of gadolinium in human tissues (such as bone) released from gadolinium-containing contrast agents.
Slovenian: Končno je CHMP priporočil, da se izvedejo nadaljnje študije v zvezi z dolgoročnim zadrževanjem gadolinija v človeških tkivih (npr. v kosteh); ta gadolinij se sprošča iz kontrastnih sredstev, ki vsebujejo gadolinij.
English: Gadolinium-containing contrast agents include nine different active substances: gadobenic acid, gadobutrol, gadodiamide, gadofosveset, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Slovenian: Kontrastna sredstva, ki vsebujejo gadolinij, so sestavljena iz devetih različnih zdravilnih učinkovin: gadobenska kislina, gadobutrol, gadodiamid, gadofosveset, gadopentetska kislina, gadoterna kislina, gadoteridol, gadoversetamid in gadoksetna kislina.
English: • as a precaution, breastfeeding should be discontinued for at least 24 hours after the patient has received a high-risk agent;
Slovenian: • je kot preventivni ukrep treba prekiniti dojenje za najmanj 24 ur po tem, ko je bolnica prejela sredstvo z visokim tveganjem;
English: Why were gadolinium-containing contrast agents reviewed?
Slovenian: Zakaj so bila kontrastna sredstva, ki vsebujejo gadolinij, pregledana?
English: During 2007, more cases of the disease were reported and the CHMP's Pharmacovigilance Working Party (PhVWP) held several discussions to establish how the risk of NSF could be reduced.
Slovenian: Leta 2007 so poročali o več primerih bolezni, delovna skupina za farmakovigilanco (PhVWP) odbora CHMP pa je imela različne razprave v zvezi s tem, kako bi bilo mogoče zmanjšati tveganje NSF.
English: The SAG also highlighted the need to harmonise the prescribing information regarding the use of these agents particularly in high-risk groups, such as pregnant and breast-feeding women, children, the elderly and patients undergoing liver transplant.
Slovenian: Skupina SAG je poudarila tudi potrebo po uskladitvi informacij o predpisovanju v zvezi z uporabo teh sredstev predvsem v skupini z visokim tveganjem, kot so noseče in doječe ženske, otroci, starejše osebe in bolniki, pri katerih se izvede presaditev jeter.
English: However, the CHMP recognised that within the high-risk group the risk of NSF with gadoversetamide and gadodiamide appears higher than with gadopentetic acid, based on physicochemical properties, studies in animals and the number of cases of NSF reported worldwide.
Slovenian: Vendar pa je CHMP ugotovil, da je v skupini z visokim tveganjem tveganje NSF pri uporabi gadoversetamida in gadodiamida večje kot pri gadopentetski kislini, pri čemer je upošteval fizikalno-kemijske lastnosti, študije pri živalih in število primerov NSF, o katerih so poročali po vsem svetu.
English: The European Medicines Agency has completed a review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents.
Slovenian: Evropska agencija za zdravila je zaključila pregled tveganja za nefrogeno sistemsko fibrozo (NSF) pri bolnikih, ki prejemajo kontrastna sredstva, ki vsebujejo gadolinij.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed with the SAG classification of gadolinium-containing contrast agents into high-, medium- and low-risk agents based on their risk of causing NSF.
Slovenian: CHMP se je na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih razprav v okviru Odbora strinjal s predlogom skupine SAG za razvrstitev kontrastnih sredstev, ki vsebujejo gadolinij, na sredstva z visokim, srednjim in nizkim tveganjem glede na tveganje za pojav NSF.
English: The SAG agreed with the PhVWP that the risk of developing NSF depends on the type of gadolinium-containing contrast agent used, and advised that these agents should be categorised into three groups:
Slovenian: Skupna SAG se je strinjala s PhVWP, da je tveganje nastanka NSF odvisno od vrste uporabljenega kontrastnega sredstva, ki vsebuje gadolinij, in predlagala razvrstitev teh sredstev v tri skupine:
English: • Gadolinium-containing contrast agents remain suitable diagnostic agents for use in patients undergoing an MRI scan, but doctors should be aware of the associated risk of NSF especially in patients with kidney problems, and other high-risk groups.
Slovenian: • Kontrastna sredstva, ki vsebujejo gadolinij, ostanejo še naprej primerna diagnostična sredstva za uporabo pri bolnikih, pri katerih se izvede slikanje MRI, vendar se morajo zdravniki zavedati povezanih tveganj za NSF, zlasti pri bolnikih s težavami z ledvicami in drugih skupinah z visokim tveganjem.
English: Gadolinium-containing contrast agents are diagnostic agents used in patients undergoing a magnetic resonance imaging (MRI) scan.
Slovenian: Kontrastna sredstva, ki vsebujejo gadolinij, so diagnostična sredstva, ki se uporabljajo pri bolnikih, pri katerih se izvede magnetno resonančno slikanje (MRI).
English: • the decision to continue or suspend breastfeeding for at least 24 hours after a scan should be taken by the doctor and the mother;
Slovenian: • morata odločitev o tem, ali se dojenje nadaljuje ali prekine za najmanj 24 ur po slikanju, sprejeti zdravnik in mati;
English: To minimise the risk of NSF the Committee recommended a number of changes to the prescribing information of these medicines, depending on the risk classification of the agents.
Slovenian: Za zmanjšanje tveganja NSF je Odbor priporočil številne spremembe informacij o predpisovanju teh zdravil, pri čemer se upošteva razvrstitev teh sredstev glede na tveganje.
English: The CHMP has assessed all of the available information on the risks of NSF associated with the use of gadolinium-containing contrast agents, particularly those used in patients with kidney problems and patients receiving a liver transplant, in neonates and infants, the elderly and women who are pregnant or breastfeeding.
Slovenian: CHMP je ocenil vse razpoložljive informacije o tveganju NSF zaradi uporabe kontrastnih sredstev, ki vsebujejo gadolinij, zlasti tistih, ki se uporabljajo pri bolnikih s težavami z ledvicami in pri bolnikih, pri katerih se izvede presaditev jeter, pri novorojenčkih in dojenčkih, starejših osebah in ženskah, ki so noseče ali dojijo.
English: For high-risk gadolinium-containing contrast agents, the CHMP recommended that:
Slovenian: Za kontrastna sredstva, ki vsebujejo gadolinij, z visokim tveganjem je CHMP priporočil, da:
English: • warnings should be added to the prescribing information for their use in patients with severe kidney problems and patients receiving a liver transplant;
Slovenian: • se k informacijam o predpisovanju doda opozorilo glede njihove uporabe pri bolnikih s hudimi težavami z ledvicami in bolnikih, pri katerih se izvede presaditev jeter;
English: What are gadolinium-containing contrast agents?
Slovenian: Kaj so kontrastna sredstva, ki vsebujejo gadolinij?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risk of NSF associated with their use.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba k informacijam o predpisovanju teh zdravil dodati številne ukrepe za zmanjšanje tveganja NSF, povezanega z njihovo uporabo.
English: • they must not be used in patients with severe kidney problems, in patients around the time of liver transplantation, and in newborn babies less than four weeks of age, who are known to have immature kidneys;
Slovenian: • se ne smejo uporabljati pri bolnikih s hudimi težavami z ledvicami, pri bolnikih okoli trenutka presaditve jeter in pri novorojenčkih, mlajših od štirih tednov, za katere je znano, da imajo nerazvite ledvice;
English: The medicines are only used by MR specialists.
Slovenian: Zdravilo uporabljajo le strokovnjaki za magnetno resonanco (MR).
English: • low risk: gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Slovenian: • nizko tveganje: gadoterna kislina (Dotarem), gadoteridol (ProHance) in gadobutrol (Gadovist).
English: • their dose should be restricted to the minimum recommended dose in patients with moderate kidney problems and infants up to one year of age, and there should be at least a period of seven days between scans;
Slovenian: • se njihov odmerek omeji na minimalni priporočljiv odmerek pri bolnikih z zmernimi težavami z ledvicami in dojenčkih, starih do enega leta, poleg tega morata biti slikanji v razmiku najmanj sedmih dni;
English: • their dose should be restricted to the minimum recommended dose in patients with severe kidney problems, patients around the time of liver transplantation and neonates and infants up to one year of age, and there should be at least a period of seven days between scans;
Slovenian: • se njihov odmerek omeji na minimalni priporočljiv odmerek pri bolnikih s hudimi težavami z ledvicami, bolnikih okoli trenutka presaditve jeter ter novorojenčkih in dojenčkih, starih do enega leta, poleg tega morata biti slikanji v razmiku najmanj sedmih dni;
English: • medium risk: gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid
Slovenian: • srednje tveganje: gadofosveset (Vasovist), gadoksetna kislina (Primovist) in gadobenska kislina (MultiHance);
English: • high risk: gadoversetamide (OptiMARK), gadodiamide (Omniscan) and gadopentetic acid
Slovenian: • visoko tveganje: gadoversetamid (OptiMARK), gadodiamid (Omniscan) in gadopentetska kislina (Magnevist, Magnegita in Gado-MRT-ratiopharm);
English: • all patients should be screened for kidney problems using laboratory tests before receiving these agents.
Slovenian: • je treba pred prejetjem teh sredstev pri vseh bolnikih z laboratorijskimi preiskavami izvesti presejanje, da se ugotovi, ali so pri njih morda prisotne težave z ledvicami.
English: • screening for kidney problems using laboratory tests is recommended for all patients before receiving these agents.
Slovenian: • je pred prejetjem teh sredstev priporočljivo presejanje vseh bolnikov, da se ugotovi, ali so pri njih morda prisotne težave z ledvicami.
English: Tilt your head back.
Slovenian: Nagnite glavo nazaj.
English: Use at the same time each day.
Slovenian: Zdravilo uporabljajte vsak dan ob istem času.
English: Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Slovenian: Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja: 20. februar 2019
English: Wash your hands before you start.
Slovenian: Preden začnete, si umijte roke.
English: Plasma concentrations are very low.
Slovenian: Njene plazemske koncentracije so zelo nizke.
English: All subjects were reported to have made a full recovery, usually within 6-24 hours.
Slovenian: Poročali so, da so vsi preiskovanci popolnoma okrevali, običajno v 6 do 24 urah.
English: Do not drive or use machines until the symptoms are cleared.
Slovenian: Ne vozite in ne upravljajte strojev, dokler simptomi ne minejo.
English: Carton containing 1 or 3 bottles.
Slovenian: Škatla z 1 ali 3 kapalnimi vsebniki.
English: If you use drops in both eyes, repeat the steps for your other eye.
Slovenian: Če uporabljate kapljice na obeh očesih, ponovite te korake tudi na drugem očesu.
English: The only adverse reaction reported to date was hypotension.
Slovenian: Edini neželeni učinek, ki so ga prijavili doslej, je bil hipotenzija.
English: In rabbits, maximum ocular concentrations were achieved in less than one hour in most cases.
Slovenian: Pri kuncih so bile največje očesne koncentracije v večini primerov dosežene v manj kot eni uri.
English: They are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).
Slovenian: Razvrščeni so v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) ali pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established.
Slovenian: Varnost in učinkovitost zdravila SIMBRINZA pri otrocih in mladostnikih, starih od 2 do 17 let, še nista bili dokazani.
English: Should this happen, contact your doctor immediately.
Slovenian: Če se to zgodi, se nemudoma posvetujte s svojim zdravnikom.
English: You should also tell your doctor if the dose of any of your current medicines is changed.
Slovenian: Posvetujte se z zdravnikom tudi, če se spremeni odmerek katerega koli od zdravil, ki jih trenutno jemljete.
English: If you experience any of the following side effects, please stop using this medicine and seek immediate medical attention as these could be signs of a reaction to the medicine.
Slovenian: Če se pri vas pojavi kateri koli od naslednji neželenih učinkov, prenehajte z uporabo tega zdravila in nemudoma poiščite medicinsko pomoč, ker so to lahko znaki reakcije na zdravilo.
English: There are no efficacy and safety data for adjunct therapy beyond 6 weeks.
Slovenian: O učinkovitosti in varnosti več kot 6-tedenske uporabe dodatne terapije ni podatkov.
English: Plasma levels decline with a half-life of approximately 2-3 hours.
Slovenian: Plazemske koncentracije upadajo z razpolovnim časom približno 2 do 3 ur.
English: It is particularly important that the medicine is not used in children under the age of 2 years (see section ‘Do not use SIMBRINZA' above) because it is unlikely to be safe.
Slovenian: Še posebej je pomembno, da se zdravilo ne uporablja pri otrocih, mlajših od 2 let (glejte poglavje ‘Ne uporabljajte zdravila SIMBRINZA' zgoraj), ker pri njih verjetno ni varno.
English: Throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle.
Slovenian: Kapalni vsebnik zavrzite 4 tedne po prvem odprtju, da boste preprečili okužbe, in potem uporabite nov vsebnik.
English: The frequency of an allergic reaction to the medicine is not known (frequency cannot be estimated from the available data).
Slovenian: Pogostnost alergijskih reakcij na zdravilo ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: SIMBRINZA is not intended for use by children and adolescents aged below 18 years because it has not been studied in this age group.
Slovenian: Zdravilo SIMBRINZA ni namenjeno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let, ker ga v tej starostni skupini še niso preskušali.
English: All treatment differences (SIMBRINZA versus individual components) were statistically significant with p=0.0001 or less.
Slovenian: Vse razlike v zdravljenju (zdravilo SIMBRINZA v primerjavi s posameznimi učinkovinami) so bile statistično značilne z vrednostjo p=0,0001 ali manj.
English: 1, motor dysfunction
Slovenian: 1, motorična disfunkcija
English: Uncommon: hypotension Very rare: hypertension
Slovenian: Občasni: hipotenzija Zelo redki: hipertenzija
English: White-to-off-white uniform suspension, pH 6.5 (approximately).
Slovenian: bela do belkasta, enakomerna suspenzija, pH 6,5 (približno)
English: To reduce the amount of medicine that could come into the rest of the body after application of the eye drop, close your eye and apply gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
Slovenian: Da bi zmanjšali količino zdravila, ki bi lahko prišlo v druge dele telesa, po uporabi kapljic za oko zaprite oko in rahlo pritisnite s prstom na očesni kot ob nosu za najmanj 2 minuti.
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kapalnem vsebniku in na škatli poleg oznake „EXP“.
English: Patients with hyperchloraemic acidosis.
Slovenian: Bolniki s hiperkloremično acidozo.
English: Only use SIMBRINZA for your eyes.
Slovenian: Zdravilo SIMBRINZA smete uporabljati samo za oči.
English: Brinzolamide is moderately (about 60%) bound to human plasma proteins.
Slovenian: Brinzolamid se zmerno (približno 60 %) veže na plazemske proteine pri človeku.
English: The Cmax, AUC and elimination half-life of brimonidine are similar in elderly (>65 years of age) subjects compared to young adults.
Slovenian: Vrednosti Cmax, AUC in razpolovni čas izločanja brimonidina pri starostnikih (>65 let starosti) so podobne kot pri mlajših odraslih.
English: Do not use more than one drop in the affected eye(s) two times a day.
Slovenian: Ne vkapajte več kot eno kapljico v prizadeto oko (oči) dvakrat na dan.
English: Visit
Slovenian: Obisk
English: A study of brinzolamide in Japanese versus non-Japanese subjects showed similar systemic pharmacokinetics between the two groups.
Slovenian: Študija uporabe brinzolamida pri japonskih preiskovancih v primerjavi z nejaponskimi je pokazala podobno sistemsko farmakokinetiko pri obeh skupinah.
English: Do not swallow or inject.
Slovenian: Ne smete ga zaužiti ali injicirati.
English: Maximum human plasma concentrations are <1 ng/mL and achieved within <1 hour.
Slovenian: Največje plazemske koncentracije pri človeku znašajo <1 ng/ml in so tudi dosežene v manj kot eni uri.
English: The recommended dose is one drop in the affected eye or eyes two times a day.
Slovenian: Priporočeni odmerek je ena kapljica v prizadeto oko ali očesi dvakrat na dan.
English: Women who may become pregnant are advised to use effective contraception during SIMBRINZA treatment.
Slovenian: Ženskam, ki bi lahko zanosile, svetujemo uporabo učinkovite kontracepcije med zdravljenjem z zdravilom SIMBRINZA.
English: What you need to know before you use SIMBRINZA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo SIMBRINZA
English: 2, paraesthesia Very rare: syncope Not known: tremor
Slovenian: 2, parestezija Zelo redki: sinkopa Neznana: tremor
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Dysgeusia was the most common systemic adverse reaction associated with the use of SIMBRINZA (3.4%).
Slovenian: Disgevzija je bila najpogostejši sistemski neželeni učinek, povezan z uporabo zdravila SIMBRINZA (3,4 %).