FrancophonIA/ELRC3.0 huggingface dataset:
English: JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
Croatian: JCV granule cell neuronopathy) koja je prijavljena u bolesnika liječenih TYSABRIJEM.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA
English: Symptoms of JCV GCN are similar to PML.
Croatian: Simptomi JCV GCN su slični simptomima
English: Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Croatian: Liječnik će nakon pretraga krvi odlučiti je li TYSABRI djelotvoran te će po potrebi prekinuti liječenje
English: • Inspect the TYSABRI vial for particles prior to dilution and administration.
Croatian: • Provjerite sadrži li TYSABRI bočica čestice prije razrjeđivanja i primjene.
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.
Croatian: Liječenje TYSABRIJEM trebaju započeti i neprekidno nadgledati specijalizirani liječnici s iskustvom u dijagnozi i liječenju neuroloških stanja, u ustanovama gdje postoji stalan pristup uređaju za snimanje magnetskom rezonancom (MR).
English: • Urinary tract infection
Croatian: • infekcija mokraćnog sustava
English: Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
Croatian: Pojave koje su češće zabilježene kod uzimanja natalizumaba nego placeba uključuju omaglicu, mučninu, urtikariju i tresavicu.
English: • Do not breast-feed whilst using TYSABRI.
Croatian: • Nemojte dojiti tijekom primjene TYSABRIJA.
English: If you miss your dose of TYSABRI
Croatian: Ako ste zaboravili primijeniti TYSABRI
English: Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median (range)
Croatian: Medijan dobi (raspon) Medijan trajanja MS u godinama (raspon)
English: Each vial contains 2.3 mmol (or 52 mg) sodium.
Croatian: Jedna bočica sadrži 2,3 mmol (ili 52 mg) natrija.
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Croatian: Omjer stope relapsa 0,33 CI95% 0,26 ; 0,41
English: o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Possibility of other opportunistic infections o The need to inform the National Competent Authority about any cases of PML
Croatian: Karticu s upozorenjima za bolesnika koja uključuje dogovoreni tekst od strane CHMP-a o Ako bi se liječenje nastavilo u trajanju duljem od 24 mjeseca, bolesnike je potrebno obavijestiti o povećanom riziku od PML-a i dati im primjerak obrasca za nastavak liječenja o Mogućnost oportunističkih infekcija o Nacionalno regulatorno tijelo treba obavijestiti o svakom slučaju PML-a
English: Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that you speak to your doctor as soon as possible.
Croatian: Stoga ako smatrate da se Vaša MS pogoršava ili ako primijetite neke nove simptome, dok ste na liječenju
English: Nervous system disorders
Croatian: Poremečaji živčanog sustava Glavobolja
English: When diluted, the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Croatian: Kada je razrijeđena, otopina za infuziju sadrži približno 2,6 mg/ml natalizumaba.
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA TYSABRI 300 mg koncentrat za otopinu za infuziju
English: Secondary endpoints
Croatian: Sekundarni ishodi ispitivanja
English: Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Croatian: Drugi sastojci su: natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev klorid (vidi dio 2 'TYSABRI sadrži natrij'). polisorbat 80 (E433) voda za injekcije
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Po završetku infuzije isperite intravensku liniju 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekcije.
English: − Listlessness
Croatian: − bezvoljnost
English: In 2-year controlled clinical trials in MS patients TYSABRI treatment was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells.
Croatian: TYSABRIJEM bilo je povezano s povećanjem broja limfocita, monocita, eozinofila, bazofila i crvenih krvnih stanica s jezgrom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TYSABRI 300 mg concentrate for solution for infusion natalizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA TYSABRI 300 mg koncentrat za otopinu za infuziju natalizumab
English: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Croatian: Jedna bočica TYSABRIJA sadrži 2,3 mmola (ili 52 mg) natrija.
English: Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Croatian: Simptomi neuronopatije granularnih stanica uzrokovane JC virusom su slični simptomima PML-a (tj. cerebelarnom sindromu).
English: After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Croatian: ovaj lijek sadrži 17,7 mmol (ili 406 mg) natrija po dozi.
English: What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Croatian: TYSABRI je bistra, bezbojna do blago zamućena tekućina.
English: • Chest pain or discomfort
Croatian: • bol ili nelagoda u prsištu
English: • Feeling sick (nausea)
Croatian: • osip praćen svrbežom (koprivnjača)
English: See section 4.8 for how to report adverse reactions
Croatian: Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
English: This should be carefully considered on a case-by-case basis, and a wash-out period of natalizumab might be appropriate.
Croatian: To treba pažljivo razmotriti za svakog bolesnika ponaosob te ostaviti neko razdoblje da se natalizumab ukloni iz organizma.
English: Magyarország Biogen Hungary Kft. Tel.: +36 (1) 899 9883
Croatian: Tel.: +36 (1) 899 9883
English: The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Croatian: Nuspojave su navedene u skladu s MedDRA nazivljem i klasifikacijom organskih sustava prema MedDRA-i.
English: VCAM-1, CS-1 and osteopontin that mediates the firm adhesion and transmigration of leukocytes into the brain parenchyma and may perpetuate the inflammatory cascade in CNS tissue.
Croatian: Za pojavu upale središnjeg živčanog sustava u multiploj sklerozi odgovorna je interakcija α4β1 s VCAM-1, CS-1 i osteopontinom koja dovodi do snažne adhezije i prodora leukocita u parenhim mozga te može pokrenuti upalni proces u tkivu središnjeg živčanog sustava.
English: Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3).
Croatian: Liječnici moraju promotriti svakog bolesnika zasebno kako bi utvrdili da li je stanje bolesnika imunokompromitirano prije početka liječenja TYSABRIJEM
English: Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
Croatian: Češća snimanja MR-om (npr. svakih 3 do 6 mjeseci) za bolesnike s većim rizikom od PML-a.
English: PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
Croatian: OBLIK I SADRŽAJ koncentrat za otopinu za infuziju
English: Marketing Authorisation Holder Biogen Idec Limited Innovation House 70 Norden Road
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Biogen Idec Limited
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
Croatian: o Da rizik za PML raste s produljenjem trajanja liječenja te da liječenje u trajanju duljem od 24 mjeseca nosi dodatni rizik i ostale čimbenike povezane s povećanim rizikom za PML
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Croatian: • Bolesnike s visokim indeksom anti-JCV protutijela koji su primali terapiju TYSABRIJEM dulje od 2 godine i bez prethodne imunosupresivne terapije u anamnezi.
English: België/Belgique/Belgien Biogen Belgium N.V./S.A.
Croatian: België/Belgique/Belgien Biogen Belgium N.V./S.A. Tél/Tel: +32 2 219 12 18
English: Discontinue administration of TYSABRI and initiate appropriate therapy at the first symptoms or signs of hypersensitivity.
Croatian: Kod prvih znakova preosjetljivosti treba prekinuti primjenu TYSABRIJA i započeti s odgovarajućom terapijom.
English: PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation.
Croatian: U bolesnika čiji nalazi nisu ukazivali na PML u vrijeme prekida, zabilježena je pojava PML-a nakon prekida primjene TYSABRIJA.
English: Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium-enhancing lesion.
Croatian: hiperintenzivnih lezija u T2 na magnetskoj rezonanci mozga (MR) ili barem 1 leziju koja se bolje uočava primjenom gadolinija.
English: No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
Croatian: Podaci o istovremenoj izloženosti imunosupresivima u bolesnika s multiplom sklerozom nisu dostupni.
English: Blockade of the molecular interactions of α4β1 with its targets reduces inflammatory activity present in the brain in
Croatian: Prekid molekulskih interakcija α4β1 s njegovim metama smanjuje upalnu aktivnost prisutnu u mozgu kod multiple skleroze i inhibira daljnji prodor imunih stanica u upaljeno tkivo, čime smanjuje nastanak i povećanje lezija u multiploj sklerozi.
English: A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Croatian: U sklopu kliničkih ispitivanja multiple skleroze zabilježen je slučaj dijareje uzrokovane protozoom roda Cryptosporidium.
English: − Shortness of breath
Croatian: − nedostatak zraka
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Croatian: Kod bolesnika koji imaju sva tri čimbenika rizika za PML (npr., koji su pozitivni na anti-JCV protutijela i primali su TYSABRI više od 2 godine,
English: • Being sick (vomiting)
Croatian: • mučnina • povraćanje
English: Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Croatian: Prije primjene vizualno provjerite da li razrijeđeni lijek sadrži čestice ili je promijenio boju.
English: You should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment.
Croatian: Morate obratiti pažnju na simptome koji se mogu pojaviti do 6
English: • Tiredness
Croatian: • drhtanje
English: EXP
Croatian: EDSS
English: The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Croatian: Razrijeđena otopina daje se putem intravenske infuzije tijekom 1 sata brzinom od oko
English: How to store TYSABRI
Croatian: Moguće nuspojave Kako čuvati TYSABRI
English: Subjects
Croatian: Ispitanici
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Croatian: Tel: +353 (0)1 463 7799
English: In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Croatian: Osim ove Upute dobit ćete i Karticu s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije u koje morate biti upućeni prije nego
English: Randomised
Croatian: Randomizacija
English: • Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Croatian: • progresivna multifokalna leukoencefalopatija (PML)
English: Tel: +420 255 706 200
Croatian: Biogen (Czech Republic) s.r.o. Tel: +420 255 706 200
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion natalizumab
Croatian: Uputa o lijeku: Informacije za bolesnika TYSABRI 300 mg koncentrat za otopinu za infuziju natalizumab
English: However, observation over longer treatment periods is required before any effect of natalizumab on malignancies can be excluded.
Croatian: Međutim, utjecaj natalizumaba na zloćudne bolesti nije moguće isključiti bez praćenja bolesnika kroz dulje razdoblje.
English: Biogen Netherlands B.V. Tel: +31 20 542 2000
Croatian: Biogen Italia s.r.l. Tel: +39 02 584 9901
English: Luxembourg/Luxemburg Biogen Belgium N.V./S.A.
Croatian: Luxembourg/Luxemburg Biogen Belgium N.V./S.A. Tél/Tel: +32 2 219 12 18
English: Tel: +386 1 511 02 90
Croatian: Biogen Pharma d.o.o. Tel: +386 1 511 02 90
English: Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML.
Croatian: i liječeni su imunosupresivima prije primanja TYSABRIJA), rizik za PML je znatno viši.
English: Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
Croatian: Nakon stavljanja lijeka u promet zabilježene su spontane prijave ozbiljnih nuspojava, povezanih s oštećenjem jetre.
English: Mean number of Gd-enhancing lesions
Croatian: Srednji broj lezija utvrđenih gadolinijem
English: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Croatian: Preporučuje se primijeniti otopinu odmah nakon razrjeđivanja 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekciju.
English: − Severe diarrhoea
Croatian: Zloćudne bolesti
English: • Treatment discontinuation form
Croatian: NAČIN PRIMJENE LIJEKA
English: Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
Croatian: U bolesnika koji su liječeni TYSABRIJEM u opservacijskim ispitivanjima nakon stavljanja lijeka u promet, zabilježeni su rijetki, ozbiljni slučajevi anemije i hemolitičke anemije.
English: Optimark gadoversetamide
Croatian: Optimark gadoversetamid
English: The recommended dose is 0.2 ml per kilogram body weight.
Croatian: Preporučena doza jest 0,2 ml po kilogramu tjelesne težine.
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.
Croatian: Cjeloviti EPAR za lijek Optimark nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: NSF causes thickening of the skin and connective tissues.
Croatian: NSF uzrokuje zadebljanje kože i vezivnih tkiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Optimark na snazi u Europskoj uniji od 23. srpnja 2007.
English: As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Croatian: Kao rezultat te interakcije, molekule vode šalju jači signal što pomaže u dobivanju jasnije slike.
English: Other information about Optimark:
Croatian: Ostale informacije o lijeku Optimark:
English: What measures are being taken to ensure the safe and effective use of Optimark?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Optimark?
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.
Croatian: Optimark omogućuje da se snimanje obavlja do jednog sata nakon ubrizgavanja iako najbolje vrijeme za provedbu pretrage ovisi o lokaciji i vrsti abnormalnosti koja se pregledava.
English: The radiologists did not know what treatment the patient had received beforehand, to make sure that the studies' findings were as accurate as possible.
Croatian: Radiolozi nisu znali koju je terapiju bolesnik prethodno primio kako bi se osigurali što točniji rezultati ispitivanja.
English: When looking at certain abnormalities in the brain, Optimark may need to be used at a higher dose, or the dose may need to be repeated.
Croatian: Pri promatranju određenih abnormalnosti mozga, lijek Optimark možda će trebati primijeniti u većoj dozi ili će se doza trebati ponoviti.
English: In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped' until it is eliminated from the body in the urine.
Croatian: U lijeku Optimark gadolinij se veže za drugu kemijsku tvar i stoga se metal ne ispušta u tijelo nego ostaje „zarobljen” dok se ne ukloni iz tijela putem mokraće.
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.
Croatian: Tvrtka koja lijek Optimark stavlja u promet osigurat će da su svi zdravstveni radnici od kojih se očekuje da će primjenjivati ovaj lijek obaviješteni o tome da se lijek ne smije primjenjivati u djece mlađe od dvije godine jer učinak lijeka u toj dobnoj skupini, primjerice učinak na nedovoljno razvijene bubrege, nije ispitan.
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.
Croatian: Osim toga, tvrtka će osigurati godišnja izvješća o slučajevima NSF-a te će provesti ispitivanje o nakupljanju gadolinija u kostima.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Optimark.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Optimark.
English: Optimark is for diagnostic use.
Croatian: Optimark je namijenjen za dijagnostičke svrhe.
English: Each scan's clarity was scored on a four-point scale.
Croatian: Jasnoća svakog prikaza ocjenjivala se na ljestvici od jedan do četiri.
English: This is a summary of the European public assessment report (EPAR) for Optimark.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Optimark.
English: It is used in adults and in children from two years of age who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Croatian: Primjenjuje se u odraslih osoba i djece starije od dvije godine pri pretrazi magnetskom rezonancijom (MRI), vrstom pretrage snimanjem s pomoću koje se dobiva prikaz unutarnjih organa.
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).
Croatian: Lijek Optimark ispitivan je u četirima glavnim ispitivanjima na ukupno 804 bolesnika koji su imali ili kod kojih je postojala sumnja na poremećaje mozga ili kralježnice (dva ispitivanja na 401 bolesniku) ili jetre (dva ispitivanja na 403 bolesnika).
English: MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
Croatian: Magnetska rezonancija je metoda snimanja koja se temelji na sitnim magnetskim poljima koja proizvode molekule vode u tijelu.
English: It must not be used in patients who have severely reduced kidney function, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF).
Croatian: Ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji trebaju biti podvrgnuti transplantaciji jetre ili u novorođenčadi mlađe od četiri tjedna zbog rizika od pojave stanja koje se naziva nefrogena sistemska fibroza (NSF).
English: These patients should receive no more than one dose of Optimark during each MRI scan, and there should be a gap of at least a week between each Optimark injection.
Croatian: Takvi bolesnici smiju primiti samo jednu dozu lijeka Optimark tijekom svake pretrage magnetskom rezonancijom i mora postojati razmak od najmanje jednog tjedna između svake injekcije lijeka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Optimark have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati radi sigurne i učinkovite uporabe lijeka Optimark također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Croatian: To je uspoređeno s povećanjem od 0,66 boda pri primjeni usporednog kontrastnog sredstva u odnosu na osnovnu vrijednost od 1,60 bodova.
English: It is given as an injection into a vein, usually a vein in an arm.
Croatian: Lijek se primjenjuje ubrizgavanjem injekcije u venu, obično u venu na ruci.
English: Optimark must not be used in people who are hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
Croatian: Optimark se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na gadoversetamid, bilo koji drugi sastojak lijeka ili na bilo koje druge lijekove koji sadrže gadolinij.
English: In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
Croatian: U ispitivanjima abnormalnosti jetre, oba su lijeka povećala rezultat za prosječno 0,38 bodova u odnosu na osnovnu vrijednost od 1,82 boda.
English: Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.
Croatian: Optimark se primjenjuje da bi se dobio jasniji prikaz kod bolesnika koji imaju ili kod kojih postoji sumnja na poremećaje mozga, kralježnice ili jetre.
English: Once injected, gadolinium interacts with the water molecules.
Croatian: Nakon ubrizgavanja lijeka, dolazi do interakcije gadolinija i molekula vode.
English: The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Optimark nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).
Croatian: Tri su radiologa (liječnici specijalizirani za obavljanje ovakvih pregleda i tumačenje prikaza tijela) analizirala prikaze.