FrancophonIA/ELRC3.0 huggingface dataset:
English: In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium.
Slovenian: Tehnika OCP v prisotnosti gadoversetamida daje napačno, nizko vrednost kalcija v plazmi.
English: Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose).
Slovenian: Gadoversetamid so pri človeku preizkusili pri odmerkih do 700 mikromolov/kg (sedemkratni standardni odmerek).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Guerbet, 15, rue des Vanesses, 93420 Villepinte, France
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Guerbet, 15, rue des Vanesses, 93420 Villepinte, Francija
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.
Slovenian: Injekcijo nato sperejo s fiziološko raztopino, da zagotovijo, da v igli ali cevki, ki so ju uporabili za injiciranje, ni ostalo nič zdravila.
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.
Slovenian: Bolniki, ki jemljejo blokatorje beta Treba je biti pozoren na to, da ni nujno, da se bolniki, ki uporabljajo blokatorje beta, odzovejo na agoniste beta, ki se po navadi uporabljajo pri zdravljenju preobčutljivostnih reakcij.
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.
Slovenian: 100 mikromolov/kg je povprečni razpolovni čas porazdelitve pri normalnih osebah izračunan po metodi ostankov, pri 12 normalnih prostovoljcih 13,3 ± 6,8 min.
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.
Slovenian: Kadar je krvno-možganska pregrada prekinjena, molekule gadoversetamida difundirajo v intersticijski prostor in povzročajo značilni paramagnetni učinek krajšanja T1 in T2.
English: Haemodialysis shortly after Optimark administration may be useful at removing Optimark from the body.
Slovenian: Hemodializa kmalu po uporabi zdravila Optimark je lahko uporabna pri odstranjevanju zdravila Optimark iz telesa.
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.
Slovenian: Če ste stari 65 let ali več, ni treba prilagoditi odmerka, vendar bodo pri vas opravili krvne preiskave za ugotavljanje delovanja vaših ledvic.
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.
Slovenian: Zdravilo Optimark se uporablja za izdelavo jasnejših diagnostičnih slik pri bolnikih, ki imajo ali pri katerih se sumi na abnormalnosti v možganih, hrbtenjači in jetrih.
English: The product must be examined before use to confirm that all solids are dissolved and that the container and closure are undamaged.
Slovenian: Pred uporabo morate zdravilo pregledati in se prepričati, da so se vse trdne snovi raztopile in da sta posoda in pokrov nepoškodovana.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Guerbet 15, rue des Vanesses 93420 Villepinte France For any information about this medicine, please contact the Marketing Authorisation Holder.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Guerbet 15, rue des Vanesses 93420 Villepinte Francija Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če ga ne porabite takoj, je za čas in pogoje hranjenja pred uporabo odgovoren uporabnik.
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'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek do 17 ml, kar v bistvu pomeni "brez natrija".
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.
Slovenian: Zato je treba začeti hitri niz slikanj 20 sekund po bolusni injekciji kontrastnega sredstva, ko je sredstvo predvsem v hepatičnih arterijah, in nato 60 sekund po injiciranju, ko je sredstvo v portalnem venskem sistemu.
English: As a result of these characteristics, the timing of the image acquisition after contrast administration is critical in liver imaging.
Slovenian: Zaradi teh značilnosti je čas slikanja po uporabi kontrastnega sredstva ključen pri slikanju jeter.
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.
Slovenian: Zapoznelo pokontrastno ali ravnotežno slikanje (> 5 minut po odmerjanju) pomaga pri karakterizaciji lezij, na primer osrednji del metastaze lahko akumulira kontrast v intersticijskem prostoru lezije in postane krepkejši od normalnega jetrnega tkiva.
English: Premedication with antihistamines and/or glucocorticoids may be considered.
Slovenian: Treba je pretehtati možnost predhodnega zdravljenja z antihistaminiki in/ali glukokortikoidi.
English: Rare (≥1/10,000 to <1/1,000)
Slovenian: Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000)
English: There is insufficient information on the excretion of gadoversetamide in animal milk.
Slovenian: Ni dovolj podatkov o izločanju gadoversetamida v živalsko mleko.
English: Gadoversetamide, an extracellular gadolinium chelate, after intravenous administration, equilibrates rapidly within the extracellular fluid/space and is eliminated primarily by glomerular filtration.
Slovenian: Gadoversetamid, zunajcelični gadolinijev kelat, se po intravenski uporabi hitro uravnovesi v zunajcelični tekočini/zunajceličnem prostoru, izloča pa se predvsem z glomerularno filtracijo.
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.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA kontrastno sredstvo za magnetnoresonančno slikanje Za beleženje: odluščljivo sledilno oznako pritrdite na kartoteko bolnika.
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.
Slovenian: Na splošno dodajanje kontrastnega sredstva pri slikanju MRI pri standardnem kliničnem odmerku 100 mikromolov/kg bistveno izboljša odkrivanje lezij, občutljivost in diagnostično natančnost.
English: • Optimark must not be used in newborn babies up to the age of 4 weeks.
Slovenian: • Zdravila Optimark se ne sme uporabiti pri novorojenčkih do 4 tedne starosti.
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.
Slovenian: Zaradi primerov NSF, o katerih so poročali pri drugih kontrastnih sredstvih, ki vsebujejo gadolinij, in pri gadoversetamidu, ki so lahko povezani z ledvično okvaro, se zdravila Optimark pri teh bolnikih ne sme uporabljati.
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:
Slovenian: Navedeni simptomi in njihova pogostnost temeljijo na kliničnih preskušanjih in na izkušnjah pri uporabi zdravila Optimark na trgu:
English: Insertion of a flexible in-dwelling venous catheter is recommended.
Slovenian: Priporoča se vstavitev prožnega stalnega venskega katetra.
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).
Slovenian: Hepatična arterija prenaša približno 20 %, portalni venski sistem pa približno 80 % krvi v jetrih, zato zgodnje slike (v fazi hepatičnih arterij) omogočajo optimalno vidnost hipervaskularnih lezij, faza portalnega venskega sistema pa je uporabna za hipovaskularne lezije (večina metastatskih lezij je sorazmerno hipovaskularnih in so torej bolje vidne med fazo portalnega venskega sistema, videti pa so kot območja z manjšo gostoto signala v primerjavi z močno okrepljenimi jetri).
English: Clear, colourless to pale yellow solution.
Slovenian: Bistra, brezbarvna do bledo rumena raztopina.
English: Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Slovenian: Zdravilo Optimark je indicirano za uporabo pri magnetnoresonančnem slikanju (magnetic resonance imaging - MRI) osrednjega živčevja in jeter.
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.
Slovenian: Varnost ponavljajočih se odmerkov pri otrocih (starih 2 letih in več) in mladostnikih, pri bolnikih z ledvično okvaro ali starejših bolnikih ni bila ugotovljena.
English: Nephrogenic systemic fibrosis (NSF)
Slovenian: Periorbitalni edem Nefrogenična sistemska fibroza (NFS)
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na nalepki škatle in viale poleg oznake EXP.
English: ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin
Slovenian: Zvišanje ALT, nenormalni rezultati analize urina, nenormalne ravni elektrolitov v urinu, albumin v urinu, zvišanje CPK, znižanje hemoglobina
English: • you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents
Slovenian: • ste v preteklosti imeli reakcijo pri injiciranju kontrastnih sredstev, vključno z reakcijami na kontrastna sredstva na osnovi joda;
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe: Opis
English: headache, strange taste in the mouth, feeling hot
Slovenian: glavobol, nenavaden občutek v ustih, občutek vročine
English: Optimark must not be administered with an autoinjector.
Slovenian: Zdravilo Optimark se ne sme dajati z avtoinjektorjem.
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with Optimark (see section 4.4).
Slovenian: Z uporabo zdravila Optimark so poročali o primerih nefrogene sistemske fibroze (NSF) (glejte poglavje 4.4).
English: Optimark has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Optimark nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom.
English: • if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
Slovenian: • boste ali ste imeli presaditev jeter, saj je njegova uporaba pri bolnikih s temi boleznimi povezana z boleznijo, imenovano nefrogena sistemska fibroza (NSF).
English: Caution should be exercised in elderly patients (see section 4.4).
Slovenian: Pri starejših bolnikih je potrebna previdnost (glejte poglavje 4.4).
English: Electrocardiogram QT prolonged
Slovenian: Podaljšan interval QT pri elektrokardiogramu
English: Talk to your doctor before Optimark is used, if:
Slovenian: Pred začetkom uporabe zdravila Optimarku se pogovorite z zdravnikom, če:
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.
Slovenian: Ravni gadoversetamida v plazmi se linearno večajo z zmanjšanjem ledvične funkcije; pri bolnikih s hudo ledvično okvaro (CrCl < 30 ml/min) to lahko povzroči tudi šestkratno zmanjšanje očistka gadoversetamida in ustrezno šestkratno povečanje izpostavljenosti AUC in 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.
Slovenian: Če se uporablja elektronska kartoteka bolnika, je treba v kartoteko bolnika vnesti ime zdravila, številko serije in odmerek.
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.
Slovenian: Pred injiciranjem kontrastnega sredstva je treba bolnike vprašati, ali imajo kakršnekoli alergije (npr. alergije na morsko hrano ali zdravila, seneni nahod, urtikarijo) ali so preobčutljivi za kontrastna sredstva ali imajo bronhialno astmo.
English: Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI.
Slovenian: Zato je treba biti previden pri interpretaciji slike z okrepljenim kontrastom brez spremljajoče slike MRI z neokrepljenim kontrastom.
English: Since gadoversetamide is only administered as a single dose this will lead to a longer and higher exposure for a limited duration.
Slovenian: Gadoversetamid se uporablja v obliki enkratnega odmerka, zato je trajanje te podaljšane in večje izpostavljenosti omejeno.
English: Optimark is contraindicated in these patients (see section Contraindications).
Slovenian: Zdravilo Optimark je pri teh bolnikih kontraindicirano (glejte poglavje Kontraindikacije).
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.
Slovenian: Pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter je tveganje še zlasti veliko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
English: Do not use the solution if it is discoloured or particulate matter is present.
Slovenian: Raztopine ne uporabljajte, če je obarvana ali če so v njej delci.
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.
Slovenian: Kontrastna sredstva za slikanje MRI, ki vsebujejo gadolinij (kelati na osnovi gadolinija), delujejo neposredno na lokalno magnetno okolje, tako da spremenijo protonski relaksacijski čas T1 (spinsko mrežni) in T2 (spinsko spinski) ter pri običajni koncentraciji 100 mikromolov/kg prevladuje krajšanje časa T1, krajšanje časa T2 pa ni tako pomembno pri poudarjenih zaporedjih T1.
English: Clinical studies on fertility have not been performed.
Slovenian: Kliničnih študij plodnosti niso izvajali.
English: Optimark should not be used during pregnancy unless strictly necessary.
Slovenian: Uporaba zdravila Optimark med nosečnostjo ni dovoljena, razen če je nujno potrebna.
English: Therefore, within this dose range, the kinetics of gadoversetamide appear to be linear.
Slovenian: Zato je videti, da je v tem intervalu odmerkov kinetika gadoversetamida linearna.
English: However, these were not evident from clinical trials with Optimark.
Slovenian: Vendar pa teh reakcij v kliničnih preskušanjih z zdravilom Optimark ni bilo.
English: The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Slovenian: Najpogostejši neželeni učinki so bili nenavaden okus v ustih, občutek vročine, glavobol in omotica.
English: The agent should be administered as a bolus peripheral intravenous injection.
Slovenian: Kontrastno sredstvo se daje v obliki bolusne periferne intravenske injekcije.
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.
Slovenian: Da se zagotovi injiciranje celotne količine kontrastnega sredstva, mora injekciji slediti spiranje s 5 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje.
English: Gadoversetamide is dialysable.
Slovenian: Gadoversetamid se lahko dializira.
English: Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na gadoversetamid, druga zdravila, ki vsebujejo gadolinij, ali katero koli pomožno snov, navedeno v poglavju 6.1 .
English: When Optimark was used in children aged 2 or older they had similar side effects as in adults.
Slovenian: Pri uporabi zdravila Optimark pri otrocih, starih 2 leti ali več, so bili neželeni učinki podobni kot pri odraslih.
English: In adults, a second dose may be given within 30 minutes of the first injection.
Slovenian: V 30 minutah po prvem odmerku lahko odraslim dajo drugega.
English: For electronic records: enter product name, batch no. and dose.
Slovenian: Za elektronske kartoteke: vnesite ime zdravila, št. serije in odmerek.
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.
Slovenian: Gadoversetamid je gadolinij, ki vsebuje kelat, ki ima paramagnetne lastnosti in povzroča krepitev kontrasta pri slikanju MRI, in ligand versetamid.
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.
Slovenian: Ta volumen porazdelitve (približno 10-15 l pri telesni masi 70 kg) je skladen z zdravili,
English: Optimark should only be administered by physicians experienced in clinical MRI practice.
Slovenian: Zdravilo Optimark smejo uporabljati le zdravniki, izkušeni v klinični praksi magnetnoresonančnega slikanja.
English: The enhancement of brain tumours using a gadolinium (or iodine) containing contrast agent depends on the disruption of the blood brain barrier (BBB).
Slovenian: Krepitev vidnosti možganskih tumorjev s kontrastnimi sredstvi, ki vsebujejo gadolinij (ali jod), je odvisna od okvar krvno-možganske pregrade.
English: The high accountability for the dose as intact complex in urine suggests that no significant metabolism of gadoversetamide occurs in humans.
Slovenian: Velik del odmerka se izloči kot nedotaknjen kompleks v urinu, kar kaže na to, da pri človeku ne prihaja do pomembne presnove gadoversetamida.
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.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, sposobnosti razmnoževanja, lokalne tolerance, antigenosti in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
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).
Slovenian: Razpolovni čas izločanja pri odmerku 100 mikromolov/kg je od 1,49 ± 0,15 h pri zdravih prostovoljcih do 2,11 ± 0,62 h pri bolnikih brez ledvične okvare (vključno z normalnimi osebami in bolniki z boleznijo osrednjega živčevja ali jeter).
English: Discard syringe and unused portion of the solution after use.
Slovenian: Brizgo in neuporabljeno raztopino po uporabi zavrzite.
English: 6.6 Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Optimark je namenjeno enkratni uporabi; neuporabljeno zdravilo zavrzite.
English: If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Slovenian: Pri uporabi opreme za večkratno uporabo morate biti izjemno previdni, da preprečite kontaminacijo z ostanki čistil.
English: • in patients in the perioperative liver transplantation period and
Slovenian: • pri bolnikih v perioperativen obdobju presaditve jeter in
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na nalepki škatle in injekcijske brizge poleg oznaki EXP.
English: Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.
Slovenian: Preden pri vas uporabijo zdravilo Optimark, morate opraviti krvne preiskave, s katerimi ugotavljajo delovanje vaših ledvic.
English: Optimark is for diagnostic use, only.
Slovenian: Zdravilo Optimark je samo za diagnostične namene.
English: Psychiatric Disorders
Slovenian: Psihiatrične motnje
English: 10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
Slovenian: 10 ml viale in 15 ml viale vsebujejo manj kot 1 mmol natrija, kar v bistvu pomeni "brez natrija".
English: Blood creatinine increased, Haematuria
Slovenian: Zvišanje kreatinina v krvi, hematurija
English: Precautions to be taken before handling or administering the medicinal product The container and the solution should be inspected prior to use.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Vsebnik in raztopino je treba pred uporabo pregledati.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja niso izvedli.
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Slovenian: Zato se zdravilo Optimark pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter in pri novorojenčkih ne sme uporabljati (glejte poglavje 4.3).
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates.
Slovenian: Zato uporaba zdravila Optimark ni dovoljena pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter in pri novorojencih.
English: The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.
Slovenian: Otrokom, starim 2 do 11 let, je treba potrebni odmerek injicirati ročno, da se tako prepreči nenamerno preveliko odmerjanje.