FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receive an injection of the contrast agent just before or during the scan.
Estonian: Patsientidele süstitakse kontrastainet vahetult enne skaneerimist või skaneerimise ajal.
English: In addition, the prescribing information of all gadolinium-containing contrast agents should include:
Estonian: Lisaks sellele peaks kõikide gadoliiniumi sisaldavate kontrastainete määramist puudutav teave sisaldama:
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;
Estonian: • hoiatust, et eakatel võib NSFi risk olla tavapärasest suurem, sest nende neerud ei väljuta gadoliiniumi organismist nii tõhusalt;
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.
Estonian: Gadoliiniumi sisaldavate kontrastainete kasutamise ja NSFi tekke seost täheldati esimest korda 2006. aasta jaanuaris, mil Taanis ja Austrias avastati NSFi juhud nende neeruprobleemidega patsientide seas, kellele tehti MRI.
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.
Estonian: Need ained sisaldavad haruldast muldmetalli gadoliiniumi, mida kasutatakse kontrastsuse suurendamiseks, et muuta organismi sisemus skaneerimise ajal paremini nähtavaks.
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised agents.
Estonian: Samal ajal tegi Euroopa Komisjon inimravimite komiteele ülesandeks hinnata samal moel tsentraliseeritud korras müügiloa saanud aineid
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.
Estonian: Teadusnõuanderühm tõi samuti välja vajaduse ühtlustada nende ainete kasutamise teave, eelkõige kõrge riskiastmega rühmade seas, nagu näiteks rasedad ja imetavad naised, lapsed, eakad ja patsiendid, kellele tehakse maksasiirdamine.
English: NSF is a rare disease that causes thickening of the skin and connective tissues in patients with severe kidney problems.
Estonian: NSF on harvaesinev haigus, mis põhjustab tõsiste neeruprobleemidega patsientidel naha ja sidekoe paksenemist.
English: • warnings should be added to the prescribing information for their use in patients with severe kidney problems and patients receiving a liver transplant;
Estonian: • nende määramist puudutavat teavet tuleks täiendada hoiatustega nende kasutamise kohta tõsiste neeruprobleemidega patsientidel ja patsientidel, kellele tehakse maksasiirdamine;
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.
Estonian: 2007. aasta jooksul avastati veel haigusjuhtusid ning inimravimite komitee ravimiohutuse järelevalve töörühm korraldas mitu arutelu, et teha kindlaks, kuidas oleks võimalik NSFi riski vähendada.
English: Gadolinium-containing contrast agents include nine different active substances: gadobenic acid, gadobutrol, gadodiamide, gadofosveset, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Estonian: Gadoliiniumi sisaldavate kontrastainete hulka kuulub üheksa toimeainet: gadobeenhape, gadobutrool, gadodiamiid, gadofosveset, gadopenteethape, gadoteerhape, gadoteridool, gadoversetamiid ja gadokseethape.
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.
Estonian: Ameti inimravimite komitee on jõudnud järeldusele, et nende ravimite määramise teavet tuleb täiendada mitme meetmega, et minimeerida nende kasutamisega seotud NSFi tekke riski.
English: Gadolinium-containing contrast agents are diagnostic agents used in patients undergoing a magnetic resonance imaging (MRI) scan.
Estonian: Gadoliiniumi sisaldavad kontrastained on diagnostilised ained, mida kasutatakse patsientidel, kellele tehakse magnetresonantstomograafia (MRI).
English: • as a precaution, breastfeeding should be discontinued for at least 24 hours after the patient has received a high-risk agent;
Estonian: • ettevaatusabinõuna tuleks imetamine katkestada vähemalt 24 tunniks alates suure riskiga aine manustamisest patsiendile;
English: In December 2007, the Scientific Advisory Group (SAG) for Diagnostics of the CHMP was convened to discuss the approach of the PhVWP.
Estonian: 2007. aasta detsembris kutsuti kokku inimravimite komitee diagnostika teadusnõuanderühm, et arutada ravimiohutuse järelevalve töörühma lähenemist.
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.
Estonian: 2008. aasta novembris palus Taani ravimiamet inimravimite komiteel korraldada mittetsentraliseeritud korras müügiloa saanud gadoliiniumi sisaldavate kontrastainete kasutamisega seotud NSFi riski hindamine ning soovitada meetmeid selle riski vähendamiseks.
English: What are gadolinium-containing contrast agents?
Estonian: Mis on gadoliiniumi sisaldavad kontrastained?
English: The European Medicines Agency has completed a review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents.
Estonian: Euroopa Ravimiamet on lõpetanud gadoliiniumi sisaldavaid kontrastaineid saavatel patsientidel esineva nefrogeense süsteemse fibroosi (NSFi) riski läbivaatamise.
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.
Estonian: Praeguseks kättesaadavate andmete hindamise ja komitees toimunud teadusliku arutelu põhjal nõustus inimravimite komitee teadusnõuanderühma soovitusega jagada gadoliiniumi sisaldavad kontrastained NSFi põhjustamise riski alusel suure, keskmise ja väikese riskiga aineteks.
English: • Doctors should record in the patient's notes the type and dose of contrast agent used.
Estonian: • Arstid peaksid märkima patsiendikaardile kasutatud kontrastaine tüübi ja annuse.
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.
Estonian: Inimravimite komitee hindas kõiki kättesaadavaid andmeid NSFi riski kohta gadoliiniumi sisaldavate kontrastainete kasutamisel, eelkõige seoses nende kasutamisega patsientidel, kellel on neeruprobleemid või kellele tehakse maksasiirdamine, vastsündinutel ja imikutel, eakatel ning rasedatel ja imetavatel naistel.
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.
Estonian: Lõpuks soovitas inimravimite komitee korraldada lisauuringud gadoliiniumi sisaldavatest kontrastainetest vabaneva gadoliiniumi pikaajalise püsimise kohta inimese kudedes (näiteks luukoes).
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;
Estonian: • otsuse imetamist jätkata või katkestada see vähemalt 24 tunniks alates suure riskiga aine manustamisest patsiendile peaksid tegema arst ja ema;
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.
Estonian: NSFi riski minimeerimiseks soovitas komitee teha nende ainete riskiklassi alusel nende määramise teabes mitu muudatust.
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;
Estonian: • neid ei tohi kasutada tõsiste neeruprobleemidega patsientidel, maksasiirdamise perioodil ja alla nelja nädala vanustel vastsündinutel, kelle neerud ei ole veel täielikult välja arenenud;
English: For medium- and low-risk agents the CHMP recommended that:
Estonian: Keskmise ja väikese riskiga kontrastainete korral olid inimravimite komitee soovitused järgmised:
English: Questions and answers on the review of gadolinium-containing contrast agents
Estonian: Teave gadoliiniumi sisaldavate kontrastainete läbivaatamise kohta
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:
Estonian: Teadusnõuanderühm nõustus ravimiohutuse järelevalve töörühma seisukohaga, et NSFi tekke risk sõltub kasutatava gadoliiniumi sisaldava kontrastaine tüübist, ning soovitas jagada need ained kolme rühma:
English: • low risk: gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Estonian: • väikese riskiga ained: gadoteerhape (Dotarem), gadoteridool (ProHance) ja gadobutrool (Gadovist).
English: For high-risk gadolinium-containing contrast agents, the CHMP recommended that:
Estonian: Gadoliiniumi sisaldavate suure riskiga kontrastainete korral olid inimravimite komitee soovitused järgmised:
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.
Estonian: Samas märkis inimravimite komitee, et füüsikalis-keemiliste omaduste, loomkatsete ja kogu maailmas täheldatud NSFi juhtude arvu põhjal otsustades näib NSFi risk olevat suure riskiga ainete rühmas gadoversetamiidi ja gadodiamiidi korral suurem kui gadopenteethappe korral.
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;
Estonian: • mõõdukate neeruprobleemidega patsientidele ja kuni aasta vanustele imikutele tuleks manustada väikseim soovitatav annus ning skaneerimiste vahele peaks jääma vähemalt seitse päeva;
English: Why were gadolinium-containing contrast agents reviewed?
Estonian: Mis oli gadoliiniumi sisaldavate kontrastainete läbivaatamise põhjus?
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;
Estonian: • tõsiste neeruprobleemidega patsientidele, patsientidele maksasiirdamise perioodil, vastsündinutele ja kuni aasta vanustele imikutele tuleks manustada väikseim soovitatav annus ning skaneerimiste vaheline periood peaks olema vähemalt seitse päeva;
English: • screening for kidney problems using laboratory tests is recommended for all patients before receiving these agents.
Estonian: • enne nende ainete manustamist on soovitatav kontrollida kõiki patsiente laborikatsete abil neeruprobleemide suhtes.
English: • high risk: gadoversetamide (OptiMARK), gadodiamide (Omniscan) and gadopentetic acid
Estonian: • suure riskiga ained: gadoversetamiid (OptiMARK), gadodiamiid (Omniscan) ja gadopenteethape (Magnevist, Magnegita ja Gado-MRT-ratiopharm);
English: • medium risk: gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid
Estonian: • keskmise riskiga ained: gadofosveset (Vasovist), gadokseethape (Primovist) ja gadobeenhape (MultiHance);
English: • all patients should be screened for kidney problems using laboratory tests before receiving these agents.
Estonian: • enne nende ainete manustamist tuleks laborikatsete abil kontrollida kõiki patsiente neeruprobleemide suhtes.
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;
Estonian: • hoiatust selle kohta, et puuduvad tõendid, mis toetaksid hemodialüüsi (vere puhastamistehnika)
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.
Estonian: kuid arstid peaksid olema teadlikud nendega seotud NSFi riskist, eelkõige neeruprobleemidega patsientide ja teiste kõrge riskiastmega rühmade puhul.
English: Tilt your head back.
Estonian: Painutage pea taha.
English: Carton containing 1 or 3 bottles.
Estonian: Karp sisaldab 1 või 3 pudelit.
English: Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Estonian: Müügiloa esmase väljastamise kuupäev: 18. juuli 2014 Müügiloa viimase uuendamise kuupäev: 20. veebruar 2019
English: Plasma concentrations are very low.
Estonian: Plasmakontsentratsioonid on väga madalad.
English: In rabbits, maximum ocular concentrations were achieved in less than one hour in most cases.
Estonian: Küülikutel saavutati maksimaalsed kontsentratsioonid enamikel juhtudel vähem kui tunniga.
English: 4 weeks after first opening.
Estonian: 4 nädalat pärast esmast avamist.
English: The only adverse reaction reported to date was hypotension.
Estonian: Ainus kõrvaltoime, millest seni on teatatud, on hüpotensioon.
English: Do not drive or use machines until the symptoms are cleared.
Estonian: Ärge juhtige autot ega kasutage masinaid enne, kui sümptomid on taandunud.
English: White-to-off-white uniform suspension, pH 6.5 (approximately).
Estonian: Valge kuni valkjas ühtlane suspensioon, pH 6,5 (ligikaudu).
English: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established.
Estonian: SIMBRINZA ohutus ja efektiivsus lastel ja noorukitel vanuses 2 kuni 17 aastat ei ole tõestatud.
English: Other medicines and SIMBRINZA
Estonian: Muud ravimid ja SIMBRINZA
English: SIMBRINZA with alcohol
Estonian: SIMBRINZA koos alkoholiga
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.
Estonian: On eriti oluline, et ravimit ei kasutataks alla 2-aastastel lastel (vt eespool lõiku „Ärge kasutage SIMBRINZA't“), sest tõenäoliselt ei ole see ohutu.
English: BE-2870 Puurs Belgium or
Estonian: BE-2870 Puurs Belgia või
English: You should also tell your doctor if the dose of any of your current medicines is changed.
Estonian: Teatage oma arstile ka seda, kui mõne teie kasutatava ravimi annust muudetakse.
English: All subjects were reported to have made a full recovery, usually within 6-24 hours.
Estonian: Kõikidel juhtudel teatati täielikust tervenemisest, enamasti 6...24 tunni jooksul.
English: All treatment differences (SIMBRINZA versus individual components) were statistically significant with p=0.0001 or less.
Estonian: Kõik erinevused (SIMBRINZA versus üksikkomponendid) olid statistiliselt olulised (p=0,0001 või väiksem).
English: Do not use more than one drop in the affected eye(s) two times a day.
Estonian: Ärge kasutage rohkem kui üks tilk kahjustatud silma(de) kohta kaks korda päevas.
English: The frequency of an allergic reaction to the medicine is not known (frequency cannot be estimated from the available data).
Estonian: Allergiliste reaktsioonide sagedus ei ole teada (sagedust ei saa hinnata olemasolevate andmete põhjal).
English: Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
Estonian: Ärge pigistage pudelit: see on disainitud nii, et kergest vajutusest põhjale piisab (joonis 2).
English: Maximum human plasma concentrations are <1 ng/mL and achieved within <1 hour.
Estonian: Maksimaalsed plasmakontsentratsioonid inimestel on <1 ng/ml ja need saavutatakse vähem kui tunniga.
English: Hold the bottle, pointing down, between your thumb and fingers.
Estonian: Hoidke pudelit suunaga allapoole pöidla ja sõrmede vahel.
English: If you stop using SIMBRINZA the pressure in your eye will not be controlled, which could lead to loss of sight.
Estonian: Kui te lõpetate SIMBRINZA kasutamise, pole rõhk silmas enam kontrolli all ning see võib põhjustada nägemise kaotuse.
English: Ask your optometrist (optician) or pharmacist how to throw away medicines you no longer use.
Estonian: Küsige oma optometristilt (optikult) või apteekrilt, kuidas visata ära ravimeid, mida te enam ei kasuta.
English: Do not use a double dose to make up for a forgotten dose.
Estonian: Ärge tilgutage topeltannust unustatu tasategemiseks.
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.
Estonian: Kui teil tekib mõni järgmistest kõrvaltoimetest, lõpetage ravimi kasutamine ja pöörduge kohe arsti poole, kuna need võivad olla ravimist põhjustatud reaktsiooni nähud.
English: How to store SIMBRINZA Contents of the pack and other information
Estonian: Kuidas SIMBRINZA't säilitada Pakendi sisu ja muu teave
English: If allergic reactions are observed, treatment should be discontinued.
Estonian: Allergiliste reaktsioonide ilmnemisel tuleb ravi katkestada.
English: If overdose with SIMBRINZA occurs treatment should be symptomatic and supportive.
Estonian: SIMBRINZA üleannustamise korral peab ravi olema sümptomaatiline ja toetav.
English: Pull down your lower eyelid with a clean finger, until there is a ‘pocket' between the eyelid and your eye.
Estonian: Tõmmake puhta sõrmega silma alalaug eemale, kuni tekib „tasku” silmalau ja silma vahele.
English: Do not use SIMBRINZA unless clearly indicated by your doctor.
Estonian: Ärge kasutage SIMBRINZA't, välja arvatud juhul, kui see on teie arsti poolt selgelt näidustatud.
English: There are no efficacy and safety data for adjunct therapy beyond 6 weeks.
Estonian: Üle 6 nädala kestva täiendava ravi kohta puuduvad efektiivsus- ja ohutusandmed.
English: For the full list of excipients, see section 6.1.
Estonian: Abiainete täielik loetelu vt 6.1.
English: Brinzolamide is moderately (about 60%) bound to human plasma proteins.
Estonian: Brinsolamiid seondub mõõdukalt (ligikaudu 60%) inimese plasmavalkudega.
English: The patient's airway should be maintained.
Estonian: Patsiendi hingamisteed tuleb lahti hoida.
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.
Estonian: SIMBRINZA ei ole mõeldud kasutamiseks lastele ega alla 18-aastastele noorukitele, sest antud vanuserühmades ei ole seda uuritud.
English: If you use drops in both eyes, repeat the steps for your other eye.
Estonian: Kui peate tilgutama ravimit mõlemasse silma, korrake samu võtteid teisel silmal.
English: • General side effects: fainting, increased blood pressure
Estonian: • Üldised kõrvaltoimed: minestamine, vererõhu tõus
English: A study of brinzolamide in Japanese versus non-Japanese subjects showed similar systemic pharmacokinetics between the two groups.
Estonian: Uuring brinsolamiidi kasutamise kohta jaapanlastel ja mittejaapanlastel näitas sarnast süsteemset farmakokineetikat mõlemal rühmal.
English: Throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle.
Estonian: Infektsioonide vältimiseks visake pudel ära 4 nädalat pärast esmakordset avamist ning avage uus pudel.
English: The potential effects following cessation of treatment with SIMBRINZA have not been studied.
Estonian: Võimalikke toimeid pärast SIMBRINZAga ravi lõpetamist ei ole uuritud.
English: The Cmax, AUC and elimination half-life of brimonidine are similar in elderly (>65 years of age) subjects compared to young adults.
Estonian: Brimonidiini Cmax, AUC ja eliminatsiooni poolväärtusaeg on eakatel (> 65-aastased) ja noortel täiskasvanutel sarnased.
English: 1, libido decreased
Estonian: 1, libiido vähenemine
English: Data in rats showed some biliary excretion (about 30%), primarily as metabolites.
Estonian: Rottidel tehtud uuringud näitasid mõningast (ligikaudu 30%) eritumist sapiga, peamiselt metaboliitidena.
English: Given the low systemic exposure to brimonidine following topical ocular administration, it is expected that changes in plasma exposure would not be clinically relevant.
Estonian: Arvestades seda, et pärast lokaalset silmasisest manustamist on brimonidiini süsteemne ekspositsioon madal, eeldatakse, et muutused plasmakontsentratsioonides ei ole kliiniliselt olulised.
English: Although both brinzolamide and brimonidine lower IOP by suppressing aqueous humour formation, their mechanisms of action are different.
Estonian: Kuigi nii brinsolamiid kui ka brimonidiin langetavad silmasisest rõhku vähendades vesivedeliku moodustumist, on nende toimemehhanismid erinevad.
English: Not known (frequency cannot be estimated from the available data)
Estonian: Teadmata kõrvaltoimed (esinemissagedust ei saa hinnata olemasolevate andmete alusel)
English: Only use SIMBRINZA for your eyes.
Estonian: Kasutage SIMBRINZA't ainult silma tilgutamiseks.
English: 3, miosis Not known: visual disturbances
Estonian: 3, mioos Teadmata: nägemishäired
English: Both substances work together to reduce pressure within the eye.
Estonian: Mõlemad toimeained langetavad silmasisest rõhku.
English: In rats and monkeys, urinary metabolites accounted for 60 to 75% of oral or intravenous doses.
Estonian: Rottidel ja ahvidel eritus metaboliitidena uriiniga 60% kuni 75% suukaudsest või intravenoossest annusest.
English: Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparations and miotics, ATC code: S01EC54
Estonian: Farmakoterapeutiline rühm: oftalmoloogias kasutatavad ained, glaukoomivastased preparaadid ja miootikumid, ATC-kood: S01EC54
English: 2, amnesia
Estonian: 2, amneesia
English: Tell your doctor, optometrist (optician) or pharmacist if you are using, have recently used, or might use any other medicines.
Estonian: Teatage oma arstile, optometristile (optikule) või apteekrile, kui te kasutate või olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: However, clinical and non-clinical safety data show it to be welltolerated and safe during chronic administration.
Estonian: Kliinilised ja mittekliinilised ohutusandmed aga näitavad, et see on pikaajalise manustamise korral hästi talutav ja ohutu.
English: Brimonidine is primarily eliminated in the urine as metabolites.
Estonian: Brimonidiin eritub peamiselt uriiniga metaboliitidena.
English: Patients must be instructed to remove contact lens prior to application of SIMBRINZA and wait at least 15 minutes before reinsertion.
Estonian: Patsiente tuleb juhendada, et SIMBRINZA manustamise ajaks tuleb kontaktläätsed silmast ära võtta ja enne tagasi panekut oodata vähemalt 15 minutit.
English: Eye drops, suspension (eye drops).
Estonian: Silmatilgad, suspensioon (silmatilgad).
English: Animal studies with oral brimonidine do not indicate direct harmful effects with respect to reproductive toxicity.
Estonian: Loomkatsed suukaudse brimonidiiniga ei näita otsest kahjulikku toimet reproduktiivsusele.
English: However, the combination product is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/minute).
Estonian: Sellegipoolest ei soovitata kombinatsioonravimit kasutada raske neerukahjustusega patsientidel (kreatiniini kliirens < 30 ml/minutis).