FrancophonIA/ELRC3.0 huggingface dataset:
English: Palpitations, AV block first Tachycardia, Arrhythmia
Croatian: Srčani poremećaji palpitacije, AV blok prvog stupnja, ekstrasistole, tahikardija,
English: The enhancement of brain tumours using a gadolinium (or iodine) containing contrast agent depends on the disruption of the blood brain barrier (BBB).
Croatian: Pojačanje prikaza tumora mozga primjenom kontrastnih sredstava koja sadrže gadolinij (ili jod) ovisi o prijelazu krvno-moždane barijere (KMB).
English: Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Croatian: Zbog nedostatka podataka o ponovljenoj primjeni, injekcije Optimarka ne treba ponovno primjenjivati, ukoliko razmak među injekcijama nije barem 7 dana.
English: Central nervous system disorders
Croatian: Poremećaji središnjeg živčanog sustava
English: Gadoversetamide is dialysable.
Croatian: Gadoversetamid je dijalizibilan.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
English: Such results (ratio renal clearance/total plasma clearance close to 1) indicate that gadoversetamide is essentially cleared through the kidneys.
Croatian: Ti rezultati ukazuju (omjer - renalni klirens/ukupni klirens plazme blizu 1) da se gadoversetamid u biti izlučuje putem bubrega.
English: Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Croatian: Posebne mjere za zbrinjavanje i druga rukovanja lijekom Optimark je namijenjen samo za jednokratnu primjenu; neiskorišteni sadržaj treba zbrinuti.
English: When Optimark was used in children aged 2 or older they had similar side effects as in adults.
Croatian: Kod primjene Optimarka u djece od 2 godine ili starije, nuspojave su bile slične onima kod odraslih.
English: In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium.
Croatian: U prisutnosti gadoversetamida, OCP metoda mjeri pogrešnu, sniženu vrijednost kalcija u plazmi.
English: How to store Optimark
Croatian: Kako čuvati Optimark
English: Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.
Croatian: Prije nego što počnete primjenjivati Optimark, morate napraviti pretragu krvi, kako bi Vam se provjerila bubrežna funkcija.
English: • The active substance is gadoversetamide.
Croatian: • Djelatna tvar je gadoversetamid.
English: • The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Croatian: • Drugi sastojci su: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid i/ili kloridna kiselina, voda za injekcije.
English: More than one dose should not be used during a scan.
Croatian: Tijekom snimanja ne smije se primijeniti više od jedne doze sredstva.
English: Hypotension, Hypertension
Croatian: Krvožilni poremećaji hipotenzija, hipertenzija
English: Insertion of a flexible in-dwelling venous catheter is recommended.
Croatian: Preporučuje se uvođenje savitljive intravenske kanile.
English: If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Croatian: Ako se koristi pribor za višekratnu upotrebu, zahtijeva se poseban oprez kako bi se spriječilo onečišćenje zaostatkom sredstva za čišćenje.
English: Optimark contains sodium
Croatian: Optimark sadrži natrij
English: • your kidneys do not work properly
Croatian: • Vaša bubrežna funkcija nije uredna
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i.e. it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi do 17 ml, tj. zanemarive količine natrija.
English: Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
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.
English: Gadoversetamide is a chelate containing gadolinium - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand versetamide.
Croatian: Gadoversetamid je kelat koji sadrži gadolinij (koji ima paramagnetska svojstva temeljem kojih pojačava kontrast kod prikaza magnetskom rezonancijom) i ligand versetamid.
English: Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl<30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Croatian: Koncentracija gadoversetamida u plazmi raste linearno u odnosu na slabljenje renalne funkcije; kod bolesnika s teškim bubrežnim oštećenjem (CrCl<30 ml/min) to može dovesti do šesterostrukog pada klirensa gadoversetamida i odgovarajućeg šesterostrukog povećanja AUC i t½.
English: If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Croatian: Ako se koriste elektronički kartoni bolesnika, u njih je potrebno unijeti ime lijeka, broj serije i dozu.
English: Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use.
Croatian: Mjere opreza koje treba osigurati prije rukovanja ili primjene ovog lijeka Spremnik i otopinu treba prekontrolirati prije uporabe.
English: Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Croatian: Istraživanja provedena u djece od 2 godine i starije pokazala su sigurnosni profil sličan onom u populaciji odraslih.
English: The imaging procedure should be completed within 1 hour of administration of the contrast medium.
Croatian: Dijagnostičko prikazivanje treba završiti unutar sat vremena od primjene kontrastnog sredstva.
English: (≥1/100 to
Croatian: (≥1/100 i <1/10)
English: No formal interaction studies have been performed.
Croatian: Nisu provedena ispitivanja interakcija.
English: It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.
Croatian: Ukoliko imate 65 godina ili ste stariji, nije neophodno da Vam se prilagodi doza, ali napravit će Vam se krvne pretrage kako bi Vam se provjerila bubrežna funkcija.
English: The elimination half life at the 100 micromol/kg dose ranges from 1.49 ± 0.15 h in healthy volunteers to 2.11 ± 0.62 h in non-renally impaired patients (including normal subjects and patients with CNS or liver pathology).
Croatian: Eliminacija Poluvrijeme eliminacije pri dozi od 100 mikromola/kg je u rasponu od 1,49 ± 0,15 sati u zdravih dobrovoljaca do 2,11 ± 0,62 sati u bolesnika s urednom bubrežnom funkcijom (uključujući zdrave ispitanike i bolesnike s bolestima SŽS-a ili jetre).
English: Mean volume of distribution at the 100 micromol/kg dose in non-renally impaired patients (including both normal subjects and patients with CNS or liver pathology) was 158.7 ± 29.0 to 214.3 (range 116.4 to 295.0) ml/kg.
Croatian: Srednji volumen distribucije pri dozi od 100 mikromola/kg, u osoba s urednom bubrežnom funkcijom (uključujući zdrave ispitanike i bolesnike s bolestima SŽS-a i jetre), bio je 158,7 ± 29,0 do 214,3 (raspon od 116,45 do 295,0) ml/kg.
English: Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
Croatian: Pogotovo se to odnosi na bolesnike s ozbiljnim srčanim bolestima (npr. teško srčano popuštanje, koronarna bolest srca) kod kojih može doći do značajnog pogoršanja njihove bolesti.
English: Discard syringe and unused portion of the solution after use.
Croatian: Štrcaljku i neiskorišteni dio otopine treba zbrinuti nakon primjene.
English: Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body.
Croatian: Hemodijaliza primijenjena u kratkom vremenskom razdoblju nakon primjene Optimarka može biti korisna za odstranjivanje
English: Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Croatian: Bolesnici kod kojih je transplantirana jetra, odnosno koji će biti podvrgnuti transplantaciji jetre su posebno ugroženi, budući da je u toj skupini visoka incidencija akutnog zatajenja bubrega.
English: Optimark is contraindicated in neonates up to 4 weeks of age.
Croatian: Optimark je kontraindiciran u novorođenčadi do uključivo 4 tjedna starosti.
English: Optimark should not be used in children below the age of two years.
Croatian: Optimark se ne smije primjenjivati kod djece mlađe od 2 godine.
English: allergic/hypersensitivity reaction, dizziness, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, itching, rash, chest discomfort, chest pain, feeling cold including cold feeling in extremities, administration site reactions, changes in blood calcium levels
Croatian: alergijske/reakcije preosjetljivosti, omaglica, osjećaj trnaca, utrnulost, oslabljen osjet mirisa, toplina i crvenilo kože, začepljen nos, grlobolja, mučnina, proljev, svrbež, osip, neugoda u prsima, bol u prsima, osjećaj hladnoće uključujući osjećaj hladnoće u ekstremitetima, reakcije na mjestu injiciranja, promjene u razini kalcija u krvi.
English: Do not use Optimark if you are allergic
Croatian: Što morate znati prije nego počnete primjenjivati Optimark Nemojte primjenjivati Optimark ako ste alergični
English: The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/kg (100 micromol/kg) body weight.
Croatian: Pripravak treba primijeniti intravenskom injekcijom u obliku bolusa u perifernu venu u dozi od 0,2 ml/kg (100 mikromola/kg) tjelesne težine.
English: • Optimark must not be used in newborn babies up to the age of 4 weeks.
Croatian: • Optimark se ne smije primjenjivati u novorođenčadi do uključivo 4 tjedna života.
English: Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly (≥1/1,000 to <1/100) occur (see section 4.8).
Croatian: Ambulantni bolesnici moraju uzeti u obzir mogućnost da se manje često (≥1/1000 do <1/100) prilikom upravljanja vozilima ili rada sa strojevima može javiti akutna omaglica (vidjeti dio 4.8).
English: • you have recently had, or soon expect to have, a liver transplant
Croatian: • Vam je nedavno presađena jetra ili ukoliko se trebate podvrći presađivanju jetre
English: The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness.
Croatian: Najčešće nuspojave su disgeuzija, osjećaj vrućine, glavobolja i omaglica.
English: The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.
Croatian: Većina nuspojava zabilježena nakon primjene gadoversetamida pripada poremećajima živčanog sustava, potom slijede opći poremećaji, poremećaji probavnog sustava te poremećaji kože i potkožnog tkiva.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: The doctor will decide how much Optimark is needed for your examination.
Croatian: Optimarka potrebnoj za Vaš pregled.
English: swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting
Croatian: oticanje područja oko očiju, abnormalni nalaz EKG-a, nesvjestica, povraćanje
English: Optimark is contraindicated in neonates up to 4 weeks of age (see section 4.3).
Croatian: Optimark je kontraindiciran u novorođenčadi do uključivo 4 tjedna starosti (vidjeti dio 4.3).
English: Neonates and infants
Croatian: Novorođenčad i dojenčad
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury.
Croatian: Postoje izvješća o pojavi nefrogene sistemske fibroze (NSF) povezane s primjenom Optimarka i nekih gadolinijskih kontrastnih sredstava kod bolesnika s akutnim ili kroničnim teškim oštećenjem bubrežne funkcije (GFR <30ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
English: Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Croatian: Optimark je indiciran za primjenu kod prikaza središnjeg živčanog sustava (SŽS) i jetre magnetskom rezonancijom (MR).
English: No functional impairment was observed.
Croatian: Nisu uočena funkcijska oštećenja.
English: Effect of Gender:
Croatian: Učinak dobi:
English: Do not use the solution if it is discoloured or particulate matter is present.
Croatian: Nemojte koristiti otopinu ako je došlo do promjene boje ili ako sadrži vidljive čestice.
English: Optimark can be removed using dialysis.
Croatian: Optimark se može izlučiti iz tijela dijalizom.
English: Clinical studies on fertility have not been performed.
Croatian: Nisu provedena klinička ispitivanja vezano uz plodnost.
English: In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrastenhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Croatian: Kod prikaza kranijalnih struktura magnetskom rezonancijom, ukoliko je jako izražena klinička sumnja na postojanje lezije usprkos učinjenoj snimci MR praćenoj jednokratnom primjenom kontrastnog sredstva ili kada točniji podaci o broju, veličini ili proširenosti lezija mogu utjecati na zbrinjavanje ili liječenje bolesnika, može se kod osoba s normalnom funkcijom bubrega primijeniti i druga bolus injekcija od 0,2 ml/kg (100 mikromola/kg) unutar 30 minuta nakon prve injekcije kako bi se proširilo dijagnostičko područje ispitivanja.
English: Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Croatian: Treba biti oprezan, jer su u kliničkim istraživanjima opažena prolazna sniženja koncentracije željeza i cinka u serumu.
English: Solution for injection in pre-filled syringe 10 ml (1, 10 syringes)
Croatian: Otopina za injekciju u napunjenoj štrcaljki 10 ml (1, 10 štrcaljki)
English: • you suffer from severe and/or acute kidney impairment, or
Croatian: Ne smijete primati Optimark ako: • bolujete od teškog i/ili akutnog oštećenja bubrega, ili
English: • in patients who have had liver transplantation or
Croatian: • kod bolesnika kojima je transplantirana jetra ili
English: The clinical significance of this is unknown.
Croatian: Nije poznato ima li to kakvog kliničkog značaja.
English: Lesion conspicuity of hypo- and hypervascular lesions may be reduced if imaging is delayed more than 3 minutes due to the diffusion of the contrast agent into the interstitial spaces of both the liver parenchyma and lesion (e.g. metastasis) making the lesion isointense with the normal liver parenchyma.
Croatian: Uočljivost slabo i dobro prokrvljenih lezija smanjuje se kada se s prikazom čeka dulje od 3 minute zbog difuzije kontrastnog sredstva u intersticijske prostore jetrenog parenhima i lezije (npr. metastaze) što dovodi do prikaza lezije i normalnog jetrenog parenhima istim intenzitetom.
English: No dose adjustment is considered necessary in children more than 2 years of age.
Croatian: Smatra se da nije potrebna prilagodba doze kod djece starije od 2 godine.
English: As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions.
Croatian: Kao i kod ostalih paramagnetskih kontrastnih sredstava, pojačanje magnetske rezonancije gadoversetamidom može pogoršati prikaz postojećih lezija.
English: Patients with impaired renal function
Croatian: Bolesnici s oštećenjem funkcije bubrega
English: < 30ml/min/1.73 m²) and/or acute kidney injury, in
Croatian: <30ml/min/1,73m²) i/ili akutnom ozljedom bubrega, kod
English: Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.
Croatian: Zbog toga treba biti oprezan pri tumačenju nalaza magnetske rezonancije pojačane kontrastom, bez usporedbe s nalazom magnetske rezonancije bez pojačanja kontrasta.
English: Syringe tip cap and piston are made of bromobutyl rubber.
Croatian: Zatvarač vrha štrcaljke i čep klipa napravljeni su od bromobutilne gume.
English: Metabolism and Nutrition Disorders
Croatian: Poremećaji metabolizma i prehrane smanjenje apetita
English: ml/h/kg) and the two adult populations (82.1 ± 16.8 and 56.5 ± 9.7 ml/h/kg in the 19 to 64 and ≥ 65
Croatian: godina (117 ± 26,1 ml/h/kg) i dvije skupine odraslih (82,1 ± 16,8 i 56,5 ± 9,7 ml/h/kg u skupini od 19
English: Optimark contains the active substance gadoversetamide.
Croatian: Optimark sadrži djelatnu tvar gadoversetamid.
English: • in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury,
Croatian: • kod bolesnika s teškim oštećenjem funkcije bubrega (GFR <30ml/min/1,73m²) i/ili akutnom ozljedom bubrega,
English: GENERAL CLASSIFICATION FOR SUPPLY Subject to medical prescription.
Croatian: NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
English: Optimark is filled in pre-filled syringes made of polypropylene.
Croatian: Optimark je napunjen u štrcaljke od polipropilena.
English: Fertility, pregnancy and lactation
Croatian: Plodnost, trudnoća i dojenje Trudnoća
English: If solids remain, the vial must be discarded.
Croatian: Ako sadrži krute čestice, bočica se mora baciti.
English: In patients with compromised renal function, clearance of gadoversetamide will be slowed and the interference with calcium determination by OCP prolonged.
Croatian: Kod bolesnika s oštećenom bubrežnom funkcijom, klirens gadoversetamida biti će usporen, a smetnje pri određivanju serumskog kalcija OCP metodom trajat će produljeno.
English: 30 ml of the solution contain 43.13 mg sodium.
Croatian: 30 ml otopine sadrži 43,13 mg natrija.
English: Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Croatian: Optimark je dostupan u bočicama s čepom od bromobutilne gume i aluminijskim prstenom.
English: Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid i/ili kloridna kiselina, voda za injekcije.
English: • to the active substance gadoversetamide or
Croatian: • na djelatnu tvar gadoversetamid ili
English: The vials are fitted with bromobutyl rubber closures, aluminium cap seals, and plastic flip caps.
Croatian: Bočice su zatvorene čepovima od bromobutilne gume, aluminijskim prstenom i plastičnim poklopcem.
English: Very rare (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetko (mogu se javiti kod do 1 na 10 000 osoba)
English: Optimark should only be administered by physicians experienced in clinical MRI practice.
Croatian: Doziranje i način primjene Optimark smiju primjenjivati samo liječnici koji posjeduju odgovarajuće kliničko iskustvo u korištenju magnetske rezonancije.
English: Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Croatian: Ne preporučuje se primjena Optimarka kod djece mlađe od 2 godine budući u toj dobnoj skupini nisu ispitivani njegova sigurnost, djelotvornost ni učinak na još nerazvijenu bubrežnu funkciju.
English: Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Croatian: Ograničeni podaci dobiveni iz primjene drugih gadolinijskih kontrastnih sredstava upućuju da bi za isključivanje dodatnih kranijalnih metastaza u bolesnika s dokazanom operabilnom solitarnom metastazom, dijagnostički pouzdaniji mogao biti MR pregled uz injiciranje Optimarka u dozi od 300 mikromola/kg tjelesne težine.
English: Caution should be exercised in elderly patients (see section 4.4).
Croatian: Kod starijih bolesnika ovaj lijek treba primjenjivati s oprezom (vidjeti dio 4.4).
English: • patients who have had liver transplantation or in
Croatian: • bolesnika kojima je transplantirana jetra ili kod
English: Some of these lesions may be seen on unenhanced, non-contrast MRI.
Croatian: Neke od tih lezija moguće je uočiti magnetskom rezonancijom bez pojčanja kontrasta.
English: decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning sensation, a sensation of movement or spinning, ringing in the ears, eyelid redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath, hoarseness, runny nose, throat constriction, mouth watering, abdominal pain, constipation, dry mouth, hives, cold sweat, redness, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, face swollen, weakness and similar symptoms like fatigue and general feeling of being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, protein in urine, heart and muscle enzyme increased, decreased haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat, high blood pressure, tightening of the airways, swollen throat or voice box, raw throat, cough, itchy nose, sneezing, sweating
Croatian: povišena koncentracija u krvi tvari (kreatinin) koja se izlučuje bubrezima, krv u urinu, otečenost lica, slabost i slični simptomi poput umora i općenito lošeg osjećanja, vrućica, otečenost udova, zimica, bol, osjećaj hladnoće u udovima, povišenje jetrenih enzima, poremećeni nalazi analize mokraće, povišene vrijednosti minerala u mokraći, proteini u mokraći, povišeni srčani i mišićni enzimi, sniženje hemoglobina, osjećaj smetenosti i dezorijentacije, tresavica, konvulzije, ružičasta boja očiju, ubrzani otkucaji srca, visoki krvni tlak, suženje dišnih puteva, otečenost grla ili grkljana, suhoća grla, kašalj, svrbež nosa, kihanje,
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Croatian: Prije primjene Optimarka, potrebno je kod svih bolesnika laboratorijskim testovima isključiti bubrežnu disfunkciju.
English: 10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
Croatian: Bočice sa 10 ml i 15 ml sadrže manje od 1 mmol natrija; tj. zanemarive količine natrija.
English: Inspect the syringe for signs of leakage.
Croatian: Provjerite da iz štrcaljke ne curi otopina.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i naljepnici štrcaljke iza „Rok valjanosti“.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contrast medium for magnetic resonance imaging For recording: stick the peel-off tracking label onto the patient record.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Kontrastno sredstvo za snimanje magnetskom rezonancijom