FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC JAR and LEAD CONTAINER
Croatian: PLASTIČNA POSUDA i OLOVNI SPREMNIK
English: For information concerning interactions associated with the use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.
Croatian: Za informacije o interakcijama prilikom primjene lijekova radioaktivno označenih lutecijem (177Lu) pogledajte Sažetak opisa svojstava lijeka/uputu priloženu uz lijek koji se radioaktivno označava.
English: Treatment with Lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells.
Croatian: Lu) može uzrokovati sindrom lize tumora zbog brzog razaranja tumorskih stanica.
English: Take special care with the medicine that is radiolabelled with Lumark: - If you are breast-feeding
Croatian: Posebno pripazite kad je riječ o lijeku koji je radioaktivno označen Lumarkom:
English: ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: The toxicological properties of Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with
Croatian: Nuspojave nakon intravenske primjene lijekova radioaktivno označenih lutecijem (177Lu) pomoću lijeka
English: How Lumark is stored
Croatian: Kako Lumark izgleda i sadržaj pakiranja
English: Anaemia, thrombocytopenia, leucopenia, lymphopenia, and less commonly neutropenia may occur during radioligand therapy with Lutetium (177Lu).
Croatian: Mijelosupresija Tijekom radioligandne terapije lutecijem (177Lu) može se pojaviti anemija, trombocitopenija, leukopenija,
English: leading to a rapid renal clearance of Lutetium (177Lu).
Croatian: povezanih s radioligandnom terapijom lutecijem (Lu-177).
English: Lu), if present,
Croatian: OD LIJEKA, AKO JE POTREBNO
English: Spleen
Croatian: Slezena
English: Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq (at ART) The volume depends on the quantity of medicines combined with Lumark required for administration by the nuclear medicine doctor.
Croatian: Svaka bočica sadrži volumen u rasponu od 0,1 do 5 ml, što odgovara aktivnosti u rasponu od 8 do 400 GBq (pri ART-u).
English: Gastrointestinal disorders: very common: Nausea and vomiting
Croatian: Vrlo često: mučnina, povraćanje Poremećaji metabolizma i prehrane:
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte vašeg ljekarnika kako baciti lijekove koje više ne koristite.
English: Date of latest renewal: 15 June 2012
Croatian: Datum posljednje obnove: 15. lipnja 2012.
English: The repeat dose is not recommended in these populations.
Croatian: Stoga se ponovljena doza ne preporučuje kod ovih populacija.
English: The text shall be agreed by the CHMP and shall also contain the following key element:
Croatian: Tekst će biti dogovoren s CHMP-om te će također sadržavati sljedeći ključni element:
English: Other medicines and Optimark
Croatian: Drugi lijekovi i Optimark
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući one koji se mogu dobiti bez liječničkog recepta.
English: • to any of the other ingredients of Optimark (see section 6), or
Croatian: • na bilo koji drugi sastojak Optimarka (vidjeti dio 6), ili
English: July of each year until the results of the study in bone have been submitted.
Croatian: U srpnju svake godine sve dok ne budu podneseni rezultati ispitivanja za kosti.
English: Patients taking beta-blockers
Croatian: Bolesnici koji uzimaju beta-blokatore
English: Read all of this leaflet carefully before you are being given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Talk to your doctor before Optimark is used, if:
Croatian: Razgovarajte sa svojim liječnikom prije primjene Optimarka ako:
English: The number of elderly patients in whom the pharmacokinetics were determined was limited (over 65 years, N=3).
Croatian: Broj ispitanika starije dobi kod kojih je farmakokinetika određivana bio je ograničen (preko 65 godina, N=3).
English: If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Croatian: Ako se bilo što od navedenog odnosi na Vas, liječnik će odlučiti je li planirana pretraga moguća ili nije.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C.
Croatian: Dokazana kemijska i fizikalna stabilnost lijeka u primjeni je 24 sata na temperaturi do 25°C.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: Administer the lowest dose possible for adequate imaging.
Croatian: Primijenite najnižu moguću dozu za odgovarajuće oslikavanje.
English: • Risk Management Plan (RMP)
Croatian: LIJEKA ● Plan upravljanja rizikom (RMP)
English: Osmolality (37°C): 1000 - 1200 mOsm/kg
Croatian: Osmolalnost (37°C): 1000 - 1200 mOsm/kg
English: Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
Croatian: Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija.
English: The dose used should also be recorded.
Croatian: Također, treba zabilježiti i primijenjenu dozu.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: System Organ Class (MedDRA)
Croatian: Klasifikacija organskih sustava (MedDRA)
English: Confusion and disorientation
Croatian: konfuzija i dezorijentacija
English: Safety and efficacy have not been studied in this age group.
Croatian: Sigurnost i djelotvornost nisu ispitani u ovoj dobnoj skupini.
English: The medicine should be used immediately.
Croatian: Lijek se mora odmah primijeniti.
English: What Optimark is and what it is used for
Croatian: Što je Optimark i za što se koristi
English: Repeat dose
Croatian: Ponovljena doza
English: In this group of patients hypersensitivity reactions may be severe.
Croatian: Kod ove skupine bolesnika reakcije preosjetljivosti mogu biti teške.
English: Elderly (aged 65 years and above)
Croatian: Stariji bolesnici (65 godina i više)
English: The pharmacokinetics of gadoversetamide conforms to a two compartment open-model.
Croatian: Farmakokinetika gadoversetamida u skladu je s otvorenim modelom dva odjeljka.
English: It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.
Croatian: Treba uzeti u obzir mogućnost da bolesnici liječeni beta-blokatorima možda neće nužno reagirati na primjenu beta-agonista koji se obično koriste u liječenju reakcija preosjetljivosti.
English: The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older.
Croatian: Uobičajena doza od 0,2 ml/kg tjelesne težine ista je za odrasle bolesnike i djecu od 2 godine i stariju.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može izazvati nuspojave, iako se one neće javiti kod svakoga.
English: Nephrogenic systemic fibrosis (NSF)
Croatian: Nefrogena sistemska fibroza (NSF)
English: Optimark has no or negligible influence on the ability to drive and use machines.
Croatian: Optimark ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2007
Croatian: Datum prvog odobrenja: 23. srpnja 2007.
English: Premedication with antihistamines and/or glucocorticoids may be considered.
Croatian: Može se razmotriti premedikacija antihistaminicima i/ili glukokortikoidima.
English: The use of a contrast agent may therefore reduce the threshold for lesion detection and visualization.
Croatian: Na taj način kontrastno sredstvo može sniziti prag za detekciju i vizualizaciju lezije.
English: 15, rue des Vanesses 93420 Villepinte France
Croatian: 15, rue des Vanesses 93420 Villepinte Francuska
English: Not all package sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: Not known (frequency cannot be estimated from the available data)
Croatian: (učestalost se ne može procijeniti iz dostupnih podataka)
English: • you are feeling thirsty and/or if you have only had small quantities or nothing to drink before the examination
Croatian: • ste žedni i/ili ste pili malo tekućine ili uopće niste pili tekućinu prije pretrage
English: No carcinogenicity studies were performed.
Croatian: Nisu provedena istraživanja karcinogenosti.
English: What Optimark is and what it is used for What you need to know before you are given Optimark How Optimark is given
Croatian: Što je Optimark i za što se koristi Što morate znati prije nego počnete primjenjivati Optimark Kako primjenjivati Optimark
English: • you suffer from epilepsy or brain lesions
Croatian: • bolujete od epilepsije ili druge bolesti mozga
English: Possible side effects are described in greater detail below.
Croatian: Moguće nuspojave opisane su detaljnije dalje u tekstu.
English: Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.
Croatian: Optimark se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva primjenu gadoversetamida.
English: Adult male and female subjects were enrolled in two pharmacokinetic studies.
Croatian: Učinak spola: Odrasli ispitanici oba spola bili su uključeni u dva farmakokinetička istraživanja.
English: The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.
Croatian: Potrebnu dozu djetetu od 2 do 11 godina treba dati ručno kako bi se izbjeglo predoziranje radi pogreške.
English: No significant differences in pharmacokinetics based on gender were identified.
Croatian: Nisu uočene značajne farmakokinetičke razlike s obzirom na spol.
English: NSF is a disease involving thickening of the skin and connective tissues.
Croatian: NSF je bolest kod koje dolazi do zadebljanja kože i vezivnog tkiva.
English: You must tell the doctor or nurse/technologist immediately if you feel pain around the area where the needle is placed.
Croatian: Odmah morate obavijestiti liječnika ili medicinsku sestru/tehničara ako osjetite bol u području gdje je postavljena igla.
English: Elderly (aged 65 years and above) No dosage adjustment is considered necessary.
Croatian: Stariji bolesnici (65 godina i više) Nije potrebna prilagodba doze.
English: In adults, a second dose may be given within 30 minutes of the first injection.
Croatian: Kod odraslih, može se primijeniti druga doza u roku od 30 min nakon prve injekcije.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora upotrijebiti odmah.
English: • you have heart disease
Croatian: • bolujete od srčane bolesti
English: As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials.
Croatian: Kao i kod drugih kontrastnih sredstava iz iste skupine moguće su i kasne reakcije (pojavljuju se par sati ili dana nakon primjene), ali samo u rijetkim slučajevima.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne iskoristi odmah, vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika.
English: Serum iron and zinc
Croatian: Serumsko željezo i cink
English: Dosage in special patient groups
Croatian: Doziranje kod posebnih skupina bolesnika
English: Dose level has no consistent effect on the volume of distribution in any of the studies.
Croatian: Visina doze nije iskazivala konzistentan učinak na volumen distribucije u istraživanjima.
English: • you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker
Croatian: • se liječite određenom vrstom lijeka protiv povišenog krvnog tlaka, tj. beta-blokatorom
English: Optimark must not be administered with an autoinjector.
Croatian: Optimark se ne smije primjenjivati auto-injektorom.
English: Optimark should be drawn into the syringe and used immediately.
Croatian: Optimark treba uvući u štrcaljku i odmah primijeniti.
English: Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.
Croatian: Tijekom pretrage takvih bolesnika potreban je oprez (npr. nadzor bolesnika), a oprema i lijekovi potrebni za brzo liječenje mogućih konvulzija trebaju biti pripravni.
English: This difference in enhancement pattern is useful in formulating a differential diagnosis based on lesion characterization and diagnostic confidence.
Croatian: Razlika u jakosti prikaza struktura korisna je pri diferencijalnoj dijagnozi temeljenoj na karakterizaciji lezija i doprinosi dijagnostičkoj pouzdanosti.
English: headache, strange taste in the mouth, feeling hot
Croatian: glavobolja, neobičan okus u ustima, osjećaj vrućine
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Croatian: Opisani su slučajevi nefrogene sistemske fibroze (koja uzrokuje zadebljanje kože a može utjecati i na meko tkivo i unutarnje organe).
English: In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Croatian: Kod bolesnika koji boluju od epilepsije ili lezija mozga mogućnost pojave konvulzija tijekom pretrage je povećana.
English: Optimark should not be used during pregnancy unless strictly necessary.
Croatian: Optimark se ne smije primjenjivati tijekom trudnoće, osim ako to nije neophodno.
English: However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Croatian: Međutim, nema dokaza da je hemodijaliza prikladna za prevenciju nefrogene sistemske fibroze (NSF).
English: The elimination of Optimark in dogs younger than 3 months of age was significantly delayed because of immature renal function and resulted in a high systemic exposure to Optimark.
Croatian: Eliminacija Optimarka kod pasa mlađih od 3 mjeseca bila je značajno usporena zbog nerazvijene funkcije bubrega, što je dovelo do visoke sistemske izloženosti Optimarku.
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 se misli da imaju poremećaje mozga, kralježnice ili jetre.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak s obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja lijeka nakon prvog otvaranja vidjeti u dijelu 6.3.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Guerbet, 15, rue des Vanesses, 93420 Villepinte, France
Croatian: IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Guerbet, 15, rue des Vanesses, 93420 Villepinte, Francuska
English: If your kidneys are working normally it is unlikely you will have any problems.
Croatian: Ako Vam je bubrežna funkcija uredna, vjerojatno nećete imati nikakvih problema.
English: Do not use if leakage is observed.
Croatian: Ne koristite ako primijetite da curi.
English: What Optimark contains
Croatian: Što Optimark sadrži
English: hardening of the skin which may affect also soft tissue and internal organs (nephrogenic systemic fibrosis), feeling unwell
Croatian: zadebljanje kože koje može utjecati na meka tkiva i unutarnje organe (nefrogena sistemska fibroza), općenito loše osjećanje
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Croatian: Prema smjernicama CHMP-a za Sustave upravljanja rizicima za lijekove za humanu uporabu, svaka dopuna RMPa mora se podnijeti u isto vrijeme kao i odgovarajuće Periodičko izvješće o neškodljivosti lijeka (PSUR).
English: If you are given more Optimark than you should have been If too much Optimark was injected it is unlikely that it will do you much harm, as much higher doses did not lead to any problems when some people received them.
Croatian: Ako je injicirano previše Optimarka nije vjerojatno da će Vam škoditi, budući da nije bilo problema kod pojedinih ljudi koji su primili puno veće doze.
English: Repeated-dose toxicity studies in rats and dogs revealed vacuolation of the tubular cells of the kidneys, with strong evidence for reversibility of the effect.
Croatian: Istraživanja toksičnosti ponovljenih doza u štakora i pasa ukazala su na vakuolizaciju stanica tubula bubrega, uz jake dokaze o reverzibilnosti ovog učinka.
English: Local reactions have occurred at the injection site and may lead to local irritation type reactions.
Croatian: Na mjestu primjene se mogu pojaviti lokalne reakcije koje mogu poprimiti oblik lokalnih iritacijskih reakcija.
English: Pharmacotherapeutic Group: MRI contrast media, ATC code: V08CA06
Croatian: Farmakoterapijska skupina: Kontrastna sredstva za prikaz magnetskom rezonancijom, ATK oznaka: V08CA06
English: Since gadoversetamide is only administered as a single dose this will lead to a longer and higher exposure for a limited duration.
Croatian: S obzirom na to da se gadoversetamid primjenjuje samo jednokratnim doziranjem, to će dovesti do dulje i veće izloženosti samo kroz određeno vrijeme.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja farmakologije, akutne toksičnosti, reproduktivne toksičnosti, lokalne podnošljivosti, imunogenosti i genotoksičnosti.
English: However, the administration of gadoversetamide does not cause a true decrease in serum calcium.
Croatian: Međutim, primjena gadoversetamida ne dovodi do stvarnog sniženja kalcija u serumu.
English: When the BBB is disrupted, the gadoversetamide molecules diffuse into the interstitial compartment thereby producing the characteristic paramagnetic effect of T1 and T2 shortening.
Croatian: Pri oštećenju KMB, molekule gadoversetamida šire se u intersticijski odjeljak i time stvaraju karakteristični paramagnetski učinak skraćivanja T1 i T2.
English: In the absence of compatibility studies, Optimark should not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: • you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents
Croatian: • ste ranije imali reakcije na injekcije kontrastnih sredstava, uključujući prethodnu reakciju na jodna kontrastna sredstva
English: The purpose of an MRI contrast agent is to induce signal intensity changes within the lesion thereby facilitating its recognition from the surrounding normal structures.
Croatian: Svrha kontrastnog sredstva pri prikazu magnetskom rezonancijom je pojačati intenzitet promjena signala unutar lezije i na taj način olakšati njeno prepoznavanje u odnosu na okolne normalne strukture.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Syringe is now ready for needle or infusion tubing attachment.
Croatian: Štrcaljka je sada spremna za stavljanje igle ili nastavka za infuziju.
English: Weekly repeated dosing of two to twenty times the clinical dose from one week of age through maturation resulted in extensive mineralization of tissues, which produced localized effects, such as ulcerative dermatitis, compromised circulation and hepatic dysfunction.
Croatian: Tjedno ponovljeno doziranje s dozama od dva do dvadeset puta većim od kliničke doze od jednog tjedna starosti tijekom sazrijevanja rezultiralo je opsežnom mineralizacijom tkiva, koja je uzrokovala lokalizirane učinke, poput ulceroznog dermatitisa, oslabljene cirkulacije i disfunkcije jetre.
English: Still, after 72 hours even in patients with severe renal impairment nearly the whole dose is recovered in the urine and in healthy populations up to 500 micromol/kg doses were administered without safety issues.
Croatian: Ipak, nakon 72 sata će se i kod bolesnika s teškim renalnim oštećenjem urinom izlučiti skoro cijela doza, a u zdrave populacije primjenjivane su doze do 500 mikromola/kg bez narušene sigurnosti.
English: Most of these reactions occur within half an hour after administering the contrast medium.
Croatian: Najveći broj tih reakcija javlja se unutar pola sata nakon primjene kontrastnog sredstva.
English: Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Croatian: Dijagnostički postupci koji uključuju primjenu kontrastnih sredstava trebaju biti provedeni pod nadzorom liječnika koji je ranije obavezno prošao obuku i potpuno je upoznat s postupkom koji treba provesti.
English: The risk of acute kidney injury may increase with an increased dose of the contrast agent.
Croatian: Rizik od akutne ozljede bubrega može biti povećan kod povišene doze tog kontrastnog sredstva.
English: Assembly and Inspection
Croatian: Sklapanje i pregled
English: It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Croatian: Primjenjuje se kod odraslih i djece u dobi od 2 godine i starije, koji se trebaju podvrći pretrazi magnetskom rezonancijom (MRI), vrsti pretrage pomoću koje se dobije prikaz unutarnjih organa.
English: This volume of distribution (approximately 10-15 l for a body weight of 70 kg) is consistent with a medicinal product which distributes into the extracellular fluid.
Croatian: Ovaj volumen distribucije (približno 10 do 15 litara na tjelesnu težinu od 70 kg) odgovara onom volumenu distribucije lijekova koji se raspodjeljuju u izvanstaničnu tekućinu.
English: If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.
Croatian: Ako sumnjate da Vam je injicirano više Optimarka nego što je potrebno, odmah o tome izvijestite liječnika ili medicinsku sestru/tehničara.
English: The magnitude of this measurement artefact is proportional to the concentration of gadoversetamide in the blood, and in patients with normal renal clearance accurate values can be obtained approximately 90 minutes following injection.
Croatian: Veličina ove mjerne pogreške proporcionalna je koncentraciji gadoversetamida u krvi, i kod bolesnika s normalnim bubrežnim klirensom točne vrijednosti mogu se odrediti 90 minuta nakon davanja injekcije.