FrancophonIA/ELRC3.0 huggingface dataset:
English: Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Estonian: Ägenemiste puhul lühiajalise kortikosteroidikuuri kasutamisel ei ole kliinilistes uuringutes täheldatud infektsioonide sagenemist.
English: In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body.
Estonian: PML-iga patsientidel võib tekkida pärast PML-i ravimist TYSABRI eemaldamisel teie kehast reaktsioon IRIS (immuunsuse taastumise põletikuline sündroom).
English: After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Estonian: Pärast kasutamiseks lahjendamist sisaldab ravim 17,7 mmol (ehk 406 mg) naatriumi ühes annuses.
English: Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Estonian: Ühealuseline naatriumfosfaatmonohüdraat Kahealuseline naatriumfosfaatheptahüdraat Naatriumkloriid (vt lõik 2 „TYSABRI sisaldab naatriumi“) Polüsorbaat 80 (E433)
English: In MS, lesions are believed to occur when activated T-lymphocytes cross the blood-brain barrier (BBB).
Estonian: Arvatakse, et sclerosis multiplex'i kahjustused tekivad, kui aktiveeritud T-lümfotsüüdid läbivad hematoentsefaalbarjääri.
English: In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Estonian: Hiirtega tehtud uuringutes ei suurendanud natalizumabi manustamine melanoomi metastaaside ja lümfoblastilise leukeemia kasvajarakkude kasvu.
English: Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
Estonian: Turuletulekujärgsetes jälgimisuuringutes on harva teatatud aneemia ja hemolüütilise aneemia tõsistest juhtudest TYSABRI'ga ravitud patsientidel.
English: When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Estonian: Lahjendatuna (vt lõik 6.6) sisaldab infusioonilahus ligikaudu 2,6 mg/ml natalizumabi.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.
Estonian: Pärast lahjendamist 100 ml naatriumkloriidi 9 mg/ml (0,9%) lahuses sisaldab ravim 17,7 mmol (ehk 406 mg) naatriumi.
English: Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Estonian: JC-viiruse GCN-i sümptomid sarnanevad PML-i (s.t tserebellaarse sündroomi) sümptomitega.
English: The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
Estonian: Sclerosis multiplex'iga patsientidel platseebo-kontrollitud uuringutes natalizumabi kasutamisel soovitatud annuses kõige sagedamini teatatud kõrvaltoimed on pearinglus, iiveldus, nõgestõbi ja vappekülm seoses infusioonidega.
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Estonian: Sclerosis multiplex'i põdevatel patsientidel, keda raviti TYSABRI'ga, on turuletulekujärgselt teatatud rasketest, eluohtlikest ja mõnel juhul surmaga lõppenud juhtumitest (vt lõik 4.8).
English: − Headache
Estonian: − peavalu
English: TYSABRI stops the cells that cause inflammation from going into your brain.
Estonian: TYSABRI takistab põletikku põhjustavate rakkude minekut ajju, mis vähendab SM-i põhjustatud närvikahjustusi.
English: Mean number of Gd-enhancing lesions
Estonian: Gd-kontrasteeruvate kollete keskmine arv
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Estonian: Kordajate suhe 0,33 CI95% 0,26 ; 0,41
English: − Prolonged dizziness
Estonian: − pikaajaline pearinglus
English: More frequent MRIs (e.g. on a 3 to 6 monthly basis) using an abbreviated protocol should be considered for patients at higher risk of PML.
Estonian: Suurema PML-i riskiga patsientide puhul tuleb kaaluda sagedasemate MRT-uuringute tegemist (nt iga 3 või 6 kuu tagant), kasutades lühendatud protokolli.
English: In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals.
Estonian: Osadel sünnituseni natalizumabi saanud cynomolgus ahvidel tuvastati rinnapiimas väike toimeaine sisaldus.
English: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride
Estonian: Ühealuseline naatriumfosfaatmonohüdraat Kahealuseline naatriumfosfaatheptahüdraat Naatriumkloriid
English: Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
Estonian: Turuletulekujärgses faasis on teatatud spontaansetest tõsistest maksakahjustusega seotud kõrvaltoimetest.
English: Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Estonian: Kontrollige lahjendatud ravimit enne manustamist visuaalselt osakeste ja värvimuutuste suhtes.
English: Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML.
Estonian: Kui patsient on saanud immunosupressante, on suurenenud PML-i tekke oht.
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Estonian: TYSABRI turuletulekujärgse kasutamise käigus on teatatud ka JC-viiruse GCN-i juhtudest.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Estonian: Lahjendatud lahuse kõlblikkusaja ja säilitustingimuste järgimise eest vastutab kasutaja.
English: Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Estonian: Annustamisperioodi keskmine tasakaalukontsentratsioon vahetult enne järgmise annuse manustamist jäi vahemikku 23 μg/ml kuni
English: Marketing Authorisation Holder Biogen Idec Limited Innovation House 70 Norden Road
Estonian: Müügiloa hoidja Biogen Idec Limited Innovation House 70 Norden Road Maidenhead Berkshire
English: • Being sick (vomiting)
Estonian: • sügelev lööve (nõgestõbi)
English: Gently invert the TYSABRI solution to mix completely.
Estonian: Pöörake TYSABRI lahusega viaali ülemine pool ettevaatlikult allapoole, et lahus täielikult seguneks.
English: Platelet counts were also reduced in offspring born to mothers treated with natalizumab until parturition, however there was no evidence of anaemia in these offspring.
Estonian: Trombotsüütide arv oli vähenenud ka nende emade järeltulijatel, kellele manustati natalizumabi kuni sünnituseni; see toime taandus natalizumabi kliirensiga.
English: No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
Estonian: Natalizumabi ja platseeboga ravitud patsientidel, keda jälgiti kahe-aastase ravi jooksul, ei ilmnenud erinevusi pahaloomuliste kasvajate liigi ega sageduse vahel.
English: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Estonian: Üks TYSABRI viaal sisaldab 2,3 mmol (või 52 mg) naatriumi.
English: How to store TYSABRI
Estonian: Kuidas TYSABRI't säilitada
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: • Lisage 15 ml infusioonilahuse kontsentraati 100 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahusele.
English: When diluted the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Estonian: Lahjendatud infusioonilahus sisaldab ligikaudu 2,6 mg/ml natalizumabi.
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Estonian: • kõrge JC-viiruse vastaste antikehade indeksiga patsiendid, kes on saanud TYSABRI-ravi kauem kui 2 aastat ja pole saanud varem immunosupressantravi.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Estonian: Pärast lahjendamist 100 ml naatriumkloriidi 9 mg/ml (0,9%) lahuses sisaldab ravim 17,7 mmol (ehk 406 mg) naatriumi ühes annuses.
English: When diluted, the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Estonian: Lahjendatuna sisaldab infusioonilahus ligikaudu 2,6 mg/ml natalizumabi.
English: Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: Lisage 15 ml infusioonilahuse kontsentraati 100 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahusele.
English: Special populations
Estonian: Vanemad inimesed
English: Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients.
Estonian: Raviarstid peavad vaatama lisateavet PML-i riskijuhtimise kohta TYSABRI'ga ravitud patsientidel juhendist „Arstidele suunatud teave ja ravijuhis“.
English: In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
Estonian: SM patsientidel tehtud kahe-aastastes kliinilistes uuringutes tekkisid 10% patsientidest püsivad natalizumabivastased antikehad.
English: 4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section
Estonian: TYSABRI on vastunäidustatud kasutamiseks kombinatsioonis koos beeta-interferoonide või glatirameeratsetaadiga (vt lõik 4.3).
English: In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
Estonian: Neil juhtudel tuleb määrata antikehi ning kui testi tulemus püsib positiivsena ka vähemalt kuue nädala möödudes, tuleb ravi katkestada, kuna antikehade püsimine on seotud
English: TYSABRI must not be administered as a bolus injection.
Estonian: Ärge manustage TYSABRI't boolussüstena.
English: There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Estonian: TYSABRI-ravi saanud patsientidel on üksikjuhtudel esinenud harvaesinevat ajuinfektsiooni, mille nimetus on PML - progresseeruv multifokaalne leukoentsefalopaatia.
English: TYSABRI 300 mg concentrate for solution for infusion natalizumab
Estonian: TYSABRI 300 mg infusioonilahuse kontsentraat natalizumab (natalizumabum)
English: Relapse rate derived variables / MRI-derived variables
Estonian: Ägenemistega seotud muutujad / MRT-uuringuga seotud muutujad
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Estonian: Natalizumab on selektiivne adhesioonimolekuli inhibiitor, mis seondub inimese integriinide α4-alaühikuga.
English: Due to this increased risk of developing PML, the benefits and risks of TYSABRI treatment should be individually reconsidered by the specialist physician and the patient; patients must be monitored at regular intervals throughout and should be instructed together with their caregivers on early signs and symptoms of PML.
Estonian: Selle PML-i tekkimise suurenenud riski tõttu peab eriarst TYSABRI'ga ravimise kasulikkust ja sellega kaasnevaid riske koos patsiendiga uuesti individuaalselt hindama.
English: In post marketing experience,serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
Estonian: Sclerosis multiplex'i põdevatel patsientidel, keda raviti TYSABRI'ga, on turuletulekujärgsel perioodil teatatud herpes simplex või varicella zoster viiruste poolt põhjustatud rasketest, eluohtlikest ja mõnel juhul surmaga lõppenud entsefaliidi ja meningiidi juhtumitest.
English: This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Estonian: Suurema tõenäosusega tekkis allergiline reaktsioon patsientidel, kes taasalustasid ravi, kui olid saanud ühe või kaks annust TYSABRI't ning seejärel ravi katkestati kolmeks kuuks või rohkem.
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS TYSABRI 300 mg infusioonilahuse kontsentraat
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Estonian: Neeru- või maksapuudulikkuse mõju ei ole uuritud.
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: Kui infusioon on lõppenud, voolutage veeniteed naatriumkloriidi 9 mg/ml (0,9%) süstelahusega.
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Estonian: • teave PML-i ja IRIS-e kohta, sealhulgas PML-i tekkeriski kohta TYSABRI-ravi ajal,
English: Each vial contains 2.3 mmol (or 52 mg) sodium.
Estonian: Üks viaal sisaldab 2,3 mmol (ehk 52 mg) naatriumi.
English: Discontinue administration of TYSABRI and initiate appropriate therapy at the first symptoms or signs of hypersensitivity.
Estonian: Esimeste ülitundlikkuse ilmingute tekkides lõpetage TYSABRI manustamine ja alustage asjakohast ravi.
English: • After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Estonian: • Kui infusioon on lõppenud, voolutage veeniteed naatriumkloriidi 9 mg/ml (0,9%) süstelahusega.
English: Stopping TYSABRI therapy
Estonian: TYSABRI-ravi lõpetamine
English: TYSABRI contains sodium
Estonian: TYSABRI sisaldab naatriumi
English: • Sore throat and runny or blocked up nose
Estonian: • kurguvalu ja nohu või ninakinnisus
English: Starting other therapies during this interval will result in a concomitant exposure to natalizumab.
Estonian: Kui sellel ajal hakata võtma muid ravimeid, tuleb arvestada natalizumabi olemasoluga veres.
English: TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Estonian: TYSABRI ravi peab alustama ja selle kulgu pidevalt jälgima ainult neuroloogiliste haiguste ravi kogemusega eriarst haiglas, kus on ettenähtud ajal võimalik teha MRT-uuringut.
English: Natalizumab is excreted in human milk.
Estonian: Natalizumab eritub inimese rinnapiima.
English: Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
Estonian: Leukotsüütide liikumisel läbi hematoentsefaalbarjääri on oma osa adhesioonimolekulide ja põletikurakkude ning veresoone seina endoteelirakkude vastastikuses mõjus.
English: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Estonian: • Teave järgmiste kõrvaltoimete kohta: o Infusioonireaktsioonid; o Ülitundlikkusreaktsioonid; o antikehade tekkimine.
English: A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Estonian: SM kliinilistes uuringutes on teatatud cryptosporidium kõhulahtisuse tekkest.
English: Following reconstitution of the immune system in immunocompromised patients with PML improved outcome has been seen.
Estonian: PML-iga immunosupresseeritud patsientidel on pärast immuunseisundi taastumist täheldatud seisundi paranemist.
English: If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Estonian: Kui teil jääb plaaniline TYSABRI annus saamata, leppige oma arstiga kokku aeg, et manustada see nii kiiresti kui võimalik.
English: Unopened vial 4 years
Estonian: Avamata viaal
English: Paediatric population
Estonian: Pahaloomulised kasvajad
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TYSABRI 300 mg concentrate for solution for infusion natalizumab
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) TYSABRI 300 mg infusioonilahuse kontsentraat natalizumabum
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion natalizumab
Estonian: RAVIMPREPARAADI NIMETUS TYSABRI 300 mg infusioonilahuse kontsentraat natalizumabum
English: • Urinary tract infection
Estonian: • kuseteede infektsioon
English: Randomised
Estonian: Püreksia
English: Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
Estonian: Mõningatel, haigusloos maksatesti kõrvalekalletega patsientidel on TYSABRI-ravi ajal esinenud maksatesti kõrvalekalde edasine suurenemine.
English: All physicians who intend to prescribe TYSABRI must ensure they are familiar with the Physician Information and Management Guidelines.
Estonian: Enne TYSABRI määramist peab arst tutvuma „Teabega arstile ja ravijuhistega“.
English: Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
Estonian: Platseebost sagedamini teatatud natalizumabi kõrvaltoimete hulka kuulusid pearinglus, iiveldus, urtikaaria ja külmavärinad.
English: • Shivering
Estonian: • pearinglus
English: BATCH NUMBER Lot
Estonian: PARTII NUMBER Partii nr
English: Symptoms of serious infections including:
Estonian: Tõsise ajuinfektsiooni põhjustatud sümptomite rühm, k.a:
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Estonian: Nende hulgas said 581 patsienti monoteraapiat fikseeritud annusega 300 mg. Keskmine tasakaaluoleku kliirens (standardhälbega) 13,1 ± 5,0 ml/h ja keskmine poolväärtusaeg (standardhälbega) 16 ± 4 päeva.
English: Inspect the TYSABRI vial for particles prior to dilution and administration.
Estonian: Enne lahjendust ja manustamist kontrollige TYSABRI viaali osakeste suhtes.
English: Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Estonian: Kui patsiendil on tekkinud ülitundlikkusreaktsioon, ei tohi TYSABRI't enam manustada.
English: Dizziness
Estonian: − hingeldus
English: Sodium content in TYSABRI
Estonian: TYSABRI naatriumisisaldus
English: • Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Estonian: • progresseeruv multifokaalne leukoentsefalopaatia (PML)
English: Rigors
Estonian: Ülitundlikkus
English: No information on the severity of the relapses before inclusion of patients in the study is available.
Estonian: Uuringueelse ägenemiste raskusastme kohta andmed puuduvad.
English: Mean number of T1-hypointense lesions
Estonian: T1-režiimis hüpointensiivse signaaliga kollete keskmine arv
English: Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months
Estonian: Kui kuuekuuline ravi pole andnud tulemusi, tuleb edasise ravi vajadus hoolikalt üle hinnata.
English: • Inspect the TYSABRI vial for particles prior to dilution and administration.
Estonian: • Enne lahjendust ja manustamist kontrollige TYSABRI viaali osakeste suhtes.
English: Blockade of the molecular interactions of α4β1 with its targets reduces inflammatory activity present in the brain in
Estonian: α4β1 ja selle sihtmärkide molekulaarsete koostoimete blokaad vähendab SM-ist tingitud põletikulisi muutusi ajus ja pärsib immuunrakkude edasist migratsiooni põletikulisse koesse, vähendades nii SM-i kahjustuskollete teket ja suurenemist.
English: • Dizziness
Estonian: • iiveldustunne
English: • Feeling sick (nausea)
Estonian: • raske allergia (ülitundlikkus)
English: If you miss your dose of TYSABRI
Estonian: Kui teil jääb TYSABRI annus saamata
English: Readministration
Estonian: Korduv manustamine
English: Relapse rate
Estonian: Maksa reaktsioonid
English: Subjects
Estonian: Teabematerjalid
English: − Listlessness
Estonian: • liigesevalu
English: Use aseptic technique when preparing TYSABRI solution for intravenous infusion.
Estonian: lahust valmistades aseptilist tehnikat.
English: Optimark gadoversetamide
Estonian: Optimark gadoversetamiid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Estonian: Euroopa Komisjon andis Optimarki müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. juulil 2007.
English: What measures are being taken to ensure the safe and effective use of Optimark?
Estonian: Mis meetmed võetakse, et tagada Optimarki ohutu ja efektiivne kasutamine?
English: The full EPAR for Optimark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Optimarki kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.
Estonian: Optimarki turustaja tagab, et kõiki seda ravimit eeldatavasti kasutavaid tervishoiutöötajaid teavitatakse, et ravimit ei tohi kasutada alla 2-aastastel lastel, sest selles vanuserühmas ei ole ravimi toimet uuritud, näiteks toimet väikelaste neerudele.
English: The recommended dose is 0.2 ml per kilogram body weight.
Estonian: Soovitatav annus on 0,2 ml kehamassi kg kohta.
English: The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Optimarki kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
English: Other information about Optimark:
Estonian: Muu teave Optimarki kohta
English: Each scan's clarity was scored on a four-point scale.
Estonian: Iga uuringu kontrastsust hinnati nelja punkti skaalal.
English: In addition, the company will provide annual reviews of cases of NSF and conduct a study on the accumulation of gadolinium in the bone.
Estonian: Lisaks koostab ettevõte igal aastal nefrogeense fibroosi juhtude ülevaated ja korraldab uuringu, mis käsitleb gadoliiniumi kogunemist luudesse.
English: A repeated dose is not recommended in children, in patients with kidney problems or in elderly patients.
Estonian: Manustamist ei soovitata korrata lastel, neeruprobleemidega ja eakatel patsientidel.
English: Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined.
Estonian: Optimark võimaldab saada kujutisi kuni tunni aja jooksul pärast süstimist, kuigi parim uuringuaeg sõltub uuritava häire kohast ja liigist.
English: It is given as an injection into a vein, usually a vein in an arm.
Estonian: Ravimit süstitakse veeni, tavaliselt käsivarre veeni.
English: Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients).
Estonian: Optimarki uuriti neljas põhiuuringus, milles osales kokku 804 patsienti, kellel olid aju- või lülisambahäired (kaks uuringut, 401 patsienti) või maksahäired (kaks uuringut, 403 patsienti) või nende kahtlus.