FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, within this dose range, the kinetics of gadoversetamide appear to be linear.
Croatian: Stoga izgleda da je, unutar ovog raspona doze, kinetika gadoversetamida linearna.
English: Therapeutic indications
Croatian: Terapijske indikacije
English: Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose).
Croatian: U istraživanjima na ljudima gadoversetamid je primjenjivan u dozama do 700 mikromola/kg (sedam puta više od uobičajene doze).
English: • in neonates up to 4 weeks of age (see section 4.4).
Croatian: • kod novorođenčadi do 4 tjedna starosti (vidjeti dio 4.4).
English: The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly.
Croatian: Sigurnost ovih ponavljanih doza nije potvrđena kod djece i adolescenata (od 2 godine i starije), kod bolesnika s oštećenjem bubrega niti kod starijih osoba.
English: Gadoversetamide, an extracellular gadolinium chelate, after intravenous administration, equilibrates rapidly within the extracellular fluid/space and is eliminated primarily by glomerular filtration.
Croatian: Gadoversetamid, izvanstanični gadolinijski kelat, se nakon intravenske primjene brzo raspodjeljuje unutar izvanstanične tekućine/prostora i primarno eliminira glomerulskom filtracijom.
English: For liver metastases, the signal difference between the tumour and surrounding liver tissue is significantly improved during the first 90 seconds after an extracellular gadolinium contrast agent is administered.
Croatian: Za metastaze u jetri razlika u signalu između tumora i okolnog tkiva jetre značajno se povećava tijekom prvih 90 sekundi po primjeni izvanstaničnog gadolinijskog kontrastnog sredstva.
English: NSF may result in debilitating joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life-threatening.
Croatian: Posljedice NSF-a mogu biti nepokretnost zglobova, mišićna slabost ili utjecaj na rad unutrašnjih organa koje potencijalno mogu ugroziti život.
English: Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use as described in section 6.6.
Croatian: Mjere opreza koje treba osigurati prije rukovanja ili primjene ovog lijeka Spremnik i otopinu treba prekontrolirati prije uporabe, kao što je to opisano u dijelu 6.6.
English: Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders.
Croatian: Zabilježene su ozbiljne nuspojave koje uključuju anafilaktičke reakcije, kardiovaskularne reakcije i alergijske respiratorne poremećaje.
English: Optimark must not be administered with an autoinjector to children of 2 to 11 years (see section 4.4).
Croatian: Optimark se ne smije primjenjivati pomoću auto-injektora djeci od 2 do 11 godina (vidjeti dio 4.4).
English: Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
Croatian: Liječenje treba biti simptomatsko, a lijekovi i oprema za hitno zbrinjavanje bolesnika moraju biti dostupni u slučaju da dođe do nekog od ozbiljnih događaja.
English: To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Croatian: Kako bi se osiguralo potpuno injiciranje kontrastnog sredstva, potrebno je nakon kontrasta injicirati 5 ml natrijevog klorida 9 mg/ml (0,9%) otopine za injekciju radi ispiranja.
English: As a result, these agents have been referred to as markers for sites of abnormal BBB breakdown.
Croatian: Ove tvari smatraju se markerima za obilježavanje abnormalnih prekida KMB.
English: Optimark is contraindicated in these patients (see section Contraindications).
Croatian: Optimark je kontraindiciran u ovih bolesnika (vidjeti dio Kontraindikacije).
English: As a result of these characteristics, the timing of the image acquisition after contrast administration is critical in liver imaging.
Croatian: Zbog ovih karakteristika, vrijeme snimanja nakon primjene kontrasta od izuzetne je važnosti kod prikaza jetre.
English: In general, the addition of contrast to MRI, at the standard clinical dose of 100 micromol/kg, has led to a significantly improved lesion detection, sensitivity and diagnostic accuracy.
Croatian: Općenito, dodatak kontrasta prikazu magnetskom rezonancijom u standardnoj kliničkoj dozi od 100 mikromola/kg doveo je do značajnog poboljšanja pri otkrivanju lezija, osjetljivosti i dijagnostičkoj točnosti.
English: Since the hepatic artery and portal venous system supply approximately 20% and 80% of the hepatic blood supply, respectively, the earlier (hepatic arterial phase) images provide optimal lesion conspicuity for hypervascular lesions and the portal venous phase images are useful for hypovascular lesions (most metastatic lesions are relatively hypovascular and are better demonstrated during the portal venous phase, manifesting as areas of lower signal intensity compared with the markedly enhanced liver).
Croatian: S obzirom da hepatičke arterije nose 20% opskrbe jetre krvlju, a preko sustava vene porte dolazi ostalih 80% krvi, rani prikazi (faza hepatičkih arterija) omogućuju optimalno isticanje dobro prokrvljenih lezija, dok su prikazi u fazi portalne vene prikladni za prikaz slabije prokrvljenih lezija (većina metastatskih patoloških promjena su relativno slabo prokrvljene i bolje se prikazuju tijekom faze portalne vene, u vidu područja slabijeg intenziteta signala u usporedbi sa značajno pojačanim signalom jetre).
English: There is insufficient information on the excretion of gadoversetamide in animal milk.
Croatian: Nema dovoljno podataka o izlučivanju gadoversetamida u mlijeko životinja.
English: Gadoversetamide does not undergo protein binding in vitro.
Croatian: Gadoversetamid se nije vezao na proteine u in vitro istraživanjima.
English: There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Croatian: Nema dokaza koji bi poduprli uvođenje hemodijalize za prevenciju ili liječenje NSF-a kod bolesnika koji inače nisu na hemodijalizi.
English: • you are on a controlled sodium diet
Croatian: • ste na dijeti s ograničenim unosom natrija
English: Cases of gadolinium associated skin plaques, with demonstrated sclerotic bodies on histology, have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis.
Croatian: Slučajevi kožnih plakova povezanih s gadolinijem, s histološki dokazanim sklerotičnim tjelešcima, zabilježeni su kod primjene nekih kontrastnih sredstava koja sadrže gadolinij u bolesnika koji inače nemaju simptome i znakove nefrogene sistemske fibroze.
English: The MAH shall conduct a study evaluating the potential for long-term accumulation of gadolinium in the bone based on a CHMP agreed protocol.
Croatian: Nositelj odobrenja provest će ispitivanje za procjenu mogućnosti dugotrajnog nakupljanja gadolinija u kostima na temelju plana ispitivanja dogovorenog s CHMP-om.
English: • to other gadolinium contrast agents.
Croatian: • na druga kontrastna sredstva koja sadrže gadolinij
English: At the 100 micromol/kg dose, the mean distribution half life in normal subjects calculated by the method of residuals in 12 normal volunteers is 13.3 ± 6.8 min.
Croatian: Pri dozi od 100 mikromola/kg srednje poluvrijeme distribucije u zdravih ispitanika, izračunato metodom određivanja ostatka u 12 zdravih dobrovoljaca, bilo je 13,3 ± 6,8 min.
English: Therefore, a rapid imaging sequence should be initiated 20 seconds after bolus injection of the contrast agent when the agent is predominately in the hepatic arteries and then again at 60 seconds after injection during the dominant portal venous phase.
Croatian: Zato treba započeti s brzim sekvencijskim snimanjem 20 sekundi nakon intravenskog bolusa kontrastnog sredstva kada je kontrast najvećim dijelom u hepatičkim arterijama, i ponovo 60 sekundi nakon injiciranja kada je najvećim dijelom u veni porte.
English: Non-clinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja reproduktivne toksičnosti.
English: Nevertheless, because of reported cases of NSF that may be associated with renal impairment for other gadolinium containing contrast agents and for gadoversetamide, Optimark should not be used in these patients.
Croatian: Ipak, zbog opisanih slučajeva NSF-a koji su moguće bili povezani s oštećenjem bubrega kod primjena drugih kontrastnih sredstava koja sadrže gadolinij ili gadoversetamid, Optimark ne bi trebalo primjenjivati kod ovih bolesnika.
English: If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.
Croatian: U slučaju pojave reakcije preosjetljivosti, primjena kontrastnog sredstva mora se odmah prekinuti i, ukoliko je to potrebno, odmah započeti s intravenskim liječenjem.
English: Optimark is for diagnostic use, only.
Croatian: Optimark je namijenjen samo za dijagnostičke svrhe.
English: Please see package leaflet for further information.
Croatian: Molimo vidjeti uputu o lijeku za dodatne informacije.
English: Similar results are obtained in normal subjects and patients with various combinations of liver, CNS and renal dysfunctions with renal clearance of gadoversetamide being approximately 95% of the total plasma clearance.
Croatian: Slični su rezultati kod zdravih ispitanika i bolesnika s različitim kombinacijama disfunkcije jetre, SŽS-a i bubrega, a renalni klirens gadoversetamida bio je otprilike 95% ukupnog klirensa plazme.
English: If you are an ambulant patient and plan to drive or use tools or machines, take into account that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark.
Croatian: Ako ste bolesnik koji se liječi ambulantno i planirate upravljati vozilom ili raditi na strojevima, uzmite u obzir mogućnost da se nakon injekcije Optimarka ponekad iznenada može javiti omaglica.
English: Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
Croatian: Preporučuje se uvođenje savitljive intravenske kanile, vidjeti dio 4.4.
English: Delayed post-contrast or equilibrium images (> 5 minutes after dosing) assist in the characterization of lesions, e.g. the centre of a metastasis may accumulate contrast in the interstitial space of the lesion and become hyperintense to the normal liver.
Croatian: Odgođeni post-kontrastni ili prikazi nakon raspodjele kontrasta (> 5 minuta nakon doziranja) pomažu pri karakterizaciji lezija, npr. središte metastaze može nakupljati kontrast u intersticijskom prostoru i izgledati puno izraženije u odnosu na normalnu jetru.
English: Before the examination, care must be taken that patients are sufficiently hydrated.
Croatian: Prije pretrage mora se voditi brigu o tome da je bolesnik primjereno hidriran.
English: However, these were not evident from clinical trials with Optimark.
Croatian: Ipak, takvi slučajevi nisu zabilježeni u kliničkim istraživanjima Optimarka.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak s obzirom na reproduktivnu toksičnost.
English: After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the grey piston rotates freely.
Croatian: Nakon što ste navinuli klip u čep klipa koji je ugrađen u štrcaljku, važno je da okrenete klip još dodatnih pola kruga tako da se sivi ugrađeni čep klipa može slobodno okretati.
English: Clinical consequences of an overdose have not been reported.
Croatian: Nisu zabilježene kliničke posljedice predoziranja.
English: Before the injection of contrast media, patients should be asked whether they have any allergies (e.g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma.
Croatian: Prije injiciranja kontrastnog sredstva bolesnike treba pitati jesu li alergični na bilo što (npr. alergija na morske plodove, lijekove, peludna groznica, urtikarija), jesu li preosjetljivi na kontrastna sredstva i boluju li od bronhijalne astme.
English: It would account for 14 ml for a 70 kg individual, and this volume would be injected over about 7-14 seconds into a vein, usually a vein in an arm.
Croatian: Otprilike iznosi 14 ml za osobu težine 70 kg, a taj volumen treba ubrizgati u venu kroz 7-14 sekundi,
English: Optimark has been shown to cause interference in the measurement of serum calcium using the orthocresolphthalein complexone (OCP) colorimetric method.
Croatian: Pokazalo se da Optimark interferira s određivanjem serumskog kalcija korištenjem orto-krezolftalein komplekson (OCP) kolorimetrijske metode.
English: 6.6 Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Optimark je namijenjen samo za jednokratnu primjenu; sav neiskorišteni sadržaj treba zbrinuti.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Croatian: Farmakovigilancijskom planu, kako je dogovoreno u RMP-u prikazanom u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim nadopunama RMP-a dogovorenima od strane
English: Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I).
Croatian: Optimark je napunjen u bočice izrađene od bezbojnog, visokootpornog borosilikatnog stakla (EP Tip
English: Optimark must not be administered with an autoinjector to children of 2 to 11 years.
Croatian: Optimark se ne smije primjenjivati pomoću auto-injektora djeci od 2 do 11 godina.
English: Prior to the launch, the MAA shall provide to all potential prescribers a copy of the SPC with a cover letter highlighting the safety information included in Sections 4.3 and 4.4.
Croatian: Prije stavljanja lijeka u promet, nositelj odobrenja za stavljanje lijeka u promet osigurat će svim liječnicima koji bi mogli propisivati lijek primjerak Sažetka opisa svojstava lijeka uz popratno pismo u kojem će biti istaknute informacije o sigurnosti primjene iz dijelova 4.3 i 4.4.
English: It provides contrast enhancement and facilitates visualization and helps with characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.
Croatian: Poboljšava kontrast, olakšava vizualizaciju i pomaže pri karakteriziranju žarišnih lezija i abnormalnih struktura u SŽS-u i jetri kod odraslih bolesnika i djece od dvije godine i starije s poznatom bolešću ili izrazitom sumnjom na postojanje bolesti.
English: The high accountability for the dose as intact complex in urine suggests that no significant metabolism of gadoversetamide occurs in humans.
Croatian: Visoka koncentracija nepromijenjenog lijeka u urinu ukazuje da kod ljudi nema značajnog metabolizma gadoversetamida.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, ispuniti sljedeće mjere:
English: • you suffer from allergies (e.g. medicinal products, seafood, hay fever, hives) or asthma
Croatian: • bolujete od alergije (npr. na lijekove, morske plodove, peludne groznice, koprivnjače) ili astme
English: The injection is then flushed through with a saline injection to make sure none is left in the needle or tube used for the injection.
Croatian: Injekcija se potom ispere fiziološkom otopinom da bi se osiguralo da kontrastno sredstvo ne zaostane u igli ili cjevčici kroz koju se dala injekcija.
English: • Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Croatian: • Ne preporučuje se primjena Optimarka u djece mlađe od dvije godine budući da njegova sigurnost, djelotvornost i učinak na još nerazvijenu bubrežnu funkciju u toj dobnoj skupini nisu ispitani.
English: During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended.
Croatian: Tijekom ove pretrage je potreban nadzor liječnika, a preporučuje se i uvođenje savitljive intravenske kanile.
English: When looking at certain abnormalities in the brain, Optimark may need to be used at three times the usual dose in one injection in adults.
Croatian: Kada se traže određene abnormalnosti u mozgu, kod odraslih će možda biti potrebno primijeniti jednu injekciju s trostruko većom dozom
English: Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions (see section 4.8).
Croatian: Reakcije nalik alergijskim i druge idiosinkrazijske reakcije mogu se pojaviti uz primjenu gadoversetamida, a mogu se manifestirati u obliku kardiovaskularnih, respiratornih ili kožnih reakcija (vidjeti dio 4.8).
English: • Optimark is contraindicated in patients with severe renal impairment (GFR
Croatian: • Optimark je kontraindiciran kod bolesnika s teškim oštećenjem funkcije bubrega (GFR
English: Gadoversetamide is used as a ‘contrast agent' in magnetic resonance imaging.
Croatian: Gadoversetamid se koristi kao kontrastno sredstvo za prikaz magnetskom rezonancijom.
English: The product must be examined before use to confirm that all solids are dissolved and that the container and closure are undamaged.
Croatian: Prije primjene lijek se mora pregledati kako bi se utvrdilo da su sve krute čestice otopljene i da spremnik i zatvarač nisu oštećeni.
English: Rare (≥1/10,000 to <1/1,000)
Croatian: Rijetko (≥1/10 000 i <1/1000)
English: Gadoversetamide does not affect other methods of measuring serum calcium, such as the arsenazo III colorimetric method, atomic absorption spectroscopy, and inductively coupled plasma mass spectroscopy.
Croatian: Gadoversetamid ne utječe na druge metode određivanja serumskog kalcija, kao što su arsenazo III kolorimetrijska metoda, atomska apsorpcijska spektroskopija i induktivno vezana plazmatska masena spektroskopija.
English: Optimark is contraindicated
Croatian: Optimark je kontraindiciran:
English: The MAH shall submit annual cumulative reviews on nephrogenic systemic fibrosis (NSF) cases.
Croatian: Nositelj odobrenja podnijet će godišnje kumulativne preglede slučajeva nefrogene sistemske fibroze (NSF).
English: Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na gadoversetamid, na druge pripravke koji sadrže gadolinij ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Optimark can be removed by haemodialysis.
Croatian: Optimark se može odstraniti hemodijalizom.
English: Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Croatian: Injekcije Optimarka ne treba ponovno primjenjivati, ukoliko vremenski razmak između injekcija nije barem 7 dana.
English: Most of the side effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
Croatian: Većina nuspojava opaženih nakon primjene Optimarka bila je blagog do umjerenog intenziteta i bile su prolazne.
English: pH: 6.0 - 7.5
Croatian: Bistra, bezbojna do blijedožuta otopina. pH: 6,0 - 7,5
English: The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Croatian: Najčešće nuspojave bile su neobičan okus u ustima, osjećaj vrućine, glavobolja i omaglica.
English: Gadolinium containing MRI contrast agents (gadolinium-based chelates) are designed to act indirectly on the local magnetic environment by altering proton T1 (spin-lattice) and T2 (spin-spin) relaxation times and at the usual concentration of 100 micromol/kg, the T1 shortening predominates, and the T2 shortening is not significant using T1-weighted sequences.
Croatian: Kontrastna sredstva za magnetsku rezonanciju koja sadrže gadolinij (kelati na bazi gadolinija) djeluju posredno na lokalno magnetsko okruženje mijenjajući vremena relaksacije protona T1 (spin-lattice) i T2 (spin-spin), te pri prosječnoj koncentraciji od 100 mikromola/kg, prevladava T1 skraćenje, dok T2
English: In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan.
Croatian: Kod bolesnika s umjerenim oštećenjem bubrega, ne smije se primijeniti više od jedne doze Optimarka tijekom snimanja.
English: For electronic records: enter product name, batch no. and dose.
Croatian: Za elektroničke kartone: unesite ime lijeka, broj serije i dozu.
English: To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Croatian: Kako bi se omogućilo trenutačno reagiranje u hitnim slučajevima, potrebni lijekovi (npr. epinefrin/adrenalin, teofilin, antihistaminici, kortikosteroidi i atropin), endotrahealni tubus i balon za ventilaciju moraju biti neposredno dostupni.
English: Acute toxicity symptoms are unlikely to occur in patients with normal renal function.
Croatian: Nije vjerojatna pojava znakova akutne toksičnosti kod bolesnika s normalnom bubrežnom funkcijom.
English: When corrected for body weight, the total body clearance of gadoversetamide is greater in the 2 to 11 year age group (143 ± 27.9 ml/h/kg) than that observed in the 12 to 18 year age group (117 ± 26.1
Croatian: Kada se u obzir uzme ukupna tjelesna težina, ukupni tjelesni klirens gadoversetamida veći je u skupini djece u dobi između 2 i 11 godina (143 ± 27,9 ml/h/kg) nego u skupini djece u dobi između 12 i 18
English: The risk of hypersensitivity reactions is increased in the following cases: - patients with allergic predisposition - patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased - patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents
Croatian: Rizik pojave reakcija preosjetljivosti povećan je u sljedećim slučajevima: - kod bolesnika s alergijskom predispozicijom - kod bolesnika s bronhijalnom astmom; kod tih bolesnika posebno je povećan rizik nastanka bronhospazma - kod bolesnika s anamnezom reakcije preosjetljivosti na kontrastna sredstva, uključujući reakcije na jodna kontrastna sredstva.
English: The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:
Croatian: Učestalost i simptomi navedeni niže temelje se na podacima kliničkih istraživanja i na iskustvu kliničke primjene Optimarka nakon dolaska na tržište:
English: No dose adjustment is considered necessary.
Croatian: Nije potrebna prilagodba doze.
English: There are no data from the use of gadoversetamide in pregnant women.
Croatian: Nema podataka o primjeni gadoversetamida u trudnica.
English: There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/kg).
Croatian: Ni kod kojeg kinetičkog parametra nije bilo sustavne razlike u odnosu na visinu doze (100 do 700
English: Patients with cardiovascular disease
Croatian: Bolesnici sa srčano-žilnim bolestima