FrancophonIA/ELRC3.0 huggingface dataset:
English: (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2.)
English: The number of elderly patients in whom the pharmacokinetics were determined was limited (over 65 years, N=3).
Slovenian: Število starejših bolnikov, pri katerih so določali farmakokinetiko, je bilo omejeno (nad 65 let, n = 3).
English: System Organ Class (MedDRA)
Slovenian: Organski sistem (MedDRA)
English: If your kidneys are working normally it is unlikely you will have any problems.
Slovenian: Če vaše ledvice delujejo normalno, ni verjetno, da boste imeli kakršnekoli težave.
English: Date of latest renewal: 15 June 2012
Slovenian: Datum zadnjega podaljšanja: 15 junij 12
English: In this group of patients hypersensitivity reactions may be severe.
Slovenian: Pri tej skupini bolnikov so lahko preobčutljivostne reakcije hude.
English: The medicine should be used immediately.
Slovenian: Zdravilo je treba uporabiti takoj.
English: The doctor will decide how much Optimark is needed for your examination.
Slovenian: Zdravnik se bo odločil, koliko zdravila Optimark potrebujete za pregled.
English: 15, rue des Vanesses 93420 Villepinte France
Slovenian: 15, rue des Vanesses 93420 Villepinte Francija
English: No significant differences in pharmacokinetics based on gender were identified.
Slovenian: Pomembnih razlik pri farmakokinetiki na podlagi spola niso odkrili.
English: No functional impairment was observed.
Slovenian: Funkcionalnih okvar niso opazili.
English: The text shall be agreed by the CHMP and shall also contain the following key element:
Slovenian: Besedilo mora odobriti Odbor za zdravila za uporabo v humani medicini (CHMP) in mora vsebovati tudi naslednje ključne elemente:
English: This difference in enhancement pattern is useful in formulating a differential diagnosis based on lesion characterization and diagnostic confidence.
Slovenian: Ta razlika v vzorcih krepitve je uporabna pri formuliranju diferencialne diagnoze na podlagi karakterizacije lezij in diagnostični zanesljivosti.
English: • you are feeling thirsty and/or if you have only had small quantities or nothing to drink before the examination
Slovenian: • ste žejni in/ali ste pred pregledom pili zelo malo ali nič;
English: Effect of Gender:
Slovenian: Vpliv spola:
English: The repeat dose is not recommended in these populations.
Slovenian: Pri teh populacijah se ne priporoča dajanje ponavljajočih se odmerkov.
English: Osmolality (37°C): 1000 - 1200 mOsm/kg
Slovenian: Osmolalnost (37 °C): 1000-1200 mOsm/kg
English: The use of a contrast agent may therefore reduce the threshold for lesion detection and visualization.
Slovenian: Uporaba kontrastnega sredstva lahko torej zmanjša prag detekcije in vidnosti lezij.
English: The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older.
Slovenian: Običajni odmerek 0,2 ml/kg telesne mase je enak za odrasle in za otroke, stare 2 leti ali več.
English: • you have heart disease
Slovenian: • imate srčno bolezen;
English: The dose used should also be recorded.
Slovenian: Zabeležite tudi uporabljeni odmerek.
English: Elderly (aged 65 years and above)
Slovenian: Starejši (stari 65 in več let)
English: Safety and efficacy have not been studied in this age group.
Slovenian: Varnosti in učinkovitosti v tej starostni skupini niso raziskovali.
English: Possible side effects are described in greater detail below.
Slovenian: Možni neželeni učinki so natančneje opisani spodaj.
English: • you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker
Slovenian: • jemljete posebno vrsto zdravila proti zvišanem krvnem tlaku, tj. blokator beta;
English: The pharmacokinetics of gadoversetamide conforms to a two compartment open-model.
Slovenian: Porazdelitev Farmakokinetika gadoversetamida ustreza dvodelnemu odprtemu modelu.
English: Caution should be exercised in elderly patients.
Slovenian: Pri starejših bolnikih je potrebna previdnost.
English: Most of these reactions occur within half an hour after administering the contrast medium.
Slovenian: Večina teh reakcij se pojavi pol ure po injiciranju kontrastnega sredstva.
English: However, the administration of gadoversetamide does not cause a true decrease in serum calcium.
Slovenian: Vendar pa uporaba gadoversetamida ne povzroča resničnega znižanja kalcija v serumu.
English: Some of these lesions may be seen on unenhanced, non-contrast MRI.
Slovenian: Nekatere od teh lezij je mogoče videti na neokrepljeni, nekontrastni sliki MRI.
English: Before the examination, care must be taken that patients are sufficiently hydrated.
Slovenian: Pred slikanjem je treba paziti, da so bolniki dovolj hidrirani.
English: Up to 1 in 100 people may be affected.
Slovenian: Prizadene lahko do 1 od 100 bolnikov.
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.
Slovenian: NSF lahko povzroči nepremičnost zaradi oslabitve sklepov, šibkost mišic ali vpliva na normalno delovanje notranjih organov, ki je lahko tudi smrtno nevarno.
English: If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Slovenian: Če za vas velja karkoli od naštetega, se bo zdravnik odločil, ali bo nameravani pregled opravil.
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.
Slovenian: Kot pri drugih kontrastnih sredstvih istega razreda se lahko v redkih primerih pojavijo pozne reakcije (po več urah ali dneh); vendar pa pri končanih kliničnih preskušanjih o njih niso poročali.
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Slovenian: Poročali so o nefrogeni sistemski fibrozi (ki povzroča odebelitev kože in lahko vpliva tudi na mehko tkivo in notranje organe).
English: Patients with cardiovascular disease
Slovenian: Bolniki s kardiovaskularnimi boleznimi
English: • you suffer from severe and/or acute kidney impairment, or
Slovenian: • imate hudo in/ali akutno ledvično okvaro ali
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
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.
Slovenian: Če ste vzeli večji odmerek zdravila Optimark, kot bi smeli Če so vam injicirali preveč zdravila Optimark, ni verjetno, da bo to povzročilo veliko težav, ker tudi veliko večji odmerki niso povzročali težav, ko so jih dali nekaterim osebam.
English: Read all of this leaflet carefully before you are being given this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
English: In the absence of compatibility studies, Optimark should not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila Optimark ne smemo mešati z drugimi zdravili.
English: Other medicines and Optimark
Slovenian: Druga zdravila in zdravilo Optimark
English: Discard any remaining solution after first use.
Slovenian: Preostalo raztopino zavrzite po prvi uporabi.
English: If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.
Slovenian: Če mislite, da so vam injicirali preveč zdravila Optimark, takoj povejte zdravniku ali medicinski sestri/zdravstvenemu delavcu.
English: NSF is a disease involving thickening of the skin and connective tissues.
Slovenian: NSF je bolezen, pri kateri se odebelijo koža in vezivna tkiva.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Zaradi mikrobioloških razlogov je treba zdravilo porabiti takoj.
English: • Optimark is contraindicated in patients with severe renal impairment (GFR
Slovenian: • Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (GFR <
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.
Slovenian: Študije toksičnosti pri ponavljajočih se odmerkih pri podganah in psih so pokazale vakuolizacijo ledvičnih tubularnih celic z močnimi dokazi za reverzibilnost tega učinka.
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.
Slovenian: Pri pregledu teh bolnikov je treba biti previden (npr. bolnika nadzorovati), na voljo pa morajo biti oprema in zdravila za hitro zdravljenje morebitnih konvulzij.
English: Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja niso izvedli.
English: The risk of acute kidney injury may increase with an increased dose of the contrast agent.
Slovenian: Tveganje za akutno poškodbo ledvic lahko naraste s povečanjem odmerka kontrastnega sredstva.
English: If solids remain, the vial must be discarded.
Slovenian: Če so trdne snovi še vedno prisotne, morate vialo zavreči.
English: Clinical consequences of an overdose have not been reported.
Slovenian: O kliničnih posledicah prevelikega odmerjanja niso poročali.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C.
Slovenian: Raztopina ostane kemično in fizično stabilna 24 ur, če jo hranimo pri temperaturi do 25 °C.
English: There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/kg).
Slovenian: Ni bilo nikakršne sistematične razlike pri kateremkoli kinetičnem parametru, ki bi bila funkcija odmerka (od 100 do 700 mikromolov/kg).
English: You must not be given Optimark if
Slovenian: Zdravila Optimark vam ne smejo dati, če
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.
Slovenian: Velikost tega artefakta pri merjenju je sorazmerna s koncentracijo gadoversetamida v krvi, pri bolnikih z normalnim očistkom kreatinina pa je mogoče izmeriti natančne vrednosti približno 90 minut po injiciranju.
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.
Slovenian: Namen kontrastnega sredstva za slikanje MRI je spodbuditi spremembe jakosti signala v leziji in tako olajšati njeno ločevanje od bližnjih normalnih struktur.
English: Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.
Slovenian: Zdravila Optimark ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva uporabo gadoversetamida.
English: There are no data from the use of gadoversetamide in pregnant women.
Slovenian: Podatkov o uporabi gadoversetamida pri nosečnicah ni.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: Adult male and female subjects were enrolled in two pharmacokinetic studies.
Slovenian: V dveh farmakokinetičnih študijah so sodelovali odrasli moški in ženske.
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.
Slovenian: Izločanje zdravila Optimark pri psih, mlajših od 3 mesecev, je bilo močno zapoznelo zaradi nezrelega delovanja ledvic, in je povzročilo visoko sistemsko izpostavljenost zdravilu Optimark.
English: During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended.
Slovenian: Med preiskavo je nujna navzočnost zdravnika, priporoča pa se vstavitev prožnega stalnega katetra.
English: Hypotension, Hypertension
Slovenian: Hipotenzija, hipertenzija
English: What Optimark is and what it is used for What you need to know before you are given Optimark How Optimark is given
Slovenian: Kaj je zdravilo Optimark in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Optimark Kako se daje zdravilo Optimark
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu
English: No carcinogenicity studies were performed.
Slovenian: Raziskav kancerogenosti niso opravili.
English: The imaging procedure should be completed within 1 hour of administration of the contrast medium.
Slovenian: Postopek slikanja je treba končati v eni uri od injiciranja kontrastnega sredstva.
English: However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).
Slovenian: Vendar pa ni dokazov, da je hemodializa primerna za preprečevanje nefrogene sistemske fibroze (NSF),
English: Such results (ratio renal clearance/total plasma clearance close to 1) indicate that gadoversetamide is essentially cleared through the kidneys.
Slovenian: Taki rezultati (razmerje med ledvičnim in plazemskim očistkom blizu 1) pomenijo, da se gadoversetamid izloča predvsem skozi ledvice.
English: There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Slovenian: Ni dokazov, ki podpirajo uporabo hemodialize za preprečevanje ali zdravljenje NSF pri bolnikih, ki niso na hemodializi.
English: Optimark should be drawn into the syringe and used immediately.
Slovenian: Zdravilo Optimark je treba povleči v brizgo in uporabiti takoj.
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.
Slovenian: Diagnostične postopke, pri katerih se uporabijo kontrastna sredstva, je treba opraviti pod nadzorom ustrezno usposobljenega zdravnika, ki ima temeljito znanje, potrebno za izvajanje tega postopka.
English: In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Slovenian: Bolezni osrednjega živčevja Pri bolnikih z epilepsijo ali lezijami v možganih se lahko verjetnost konvulzij med preiskavo poveča.
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.
Slovenian: Tedensko ponavljajoče se odmerjanje dvakrat do dvajsetkrat višjih kliničnih odmerkov od enega tedna starosti do zrelosti je povzročilo obširno mineralizacijo tkiva s posledičnimi lokaliziranimi učinki, kot so ulcerozni dermatitis, ogrožena cirkulacija in disfunkcija jeter.
English: You must tell the doctor or nurse/technologist immediately if you feel pain around the area where the needle is placed.
Slovenian: Zdravniku ali medicinski sestri/zdravstvenemu delavcu morate takoj povedati, če začutite bolečino na mestu injiciranja.
English: Gadoversetamide does not undergo protein binding in vitro.
Slovenian: Gadoversetamid se in vitro ne veže na beljakovine.
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.
Slovenian: • Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
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).
Slovenian: Ambulantni bolniki morajo med vožnjo ali pri upravljanju s stroji upoštevati, da lahko občasno pride do akutne omotice (≥1/1.000 do <1/100) (glejte poglavje 4.8).
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvajal študijo, ki ocenjuje potencial za dolgoročno kopičenje gadolinija v kosteh na podlagi protokola v dogovoru s CHMP.
English: Local reactions have occurred at the injection site and may lead to local irritation type reactions.
Slovenian: Na mestu injiciranja so se pojavile lokalne reakcije, ki lahko povzročijo lokalno draženje.
English: Pharmacotherapeutic Group: MRI contrast media, ATC code: V08CA06
Slovenian: Farmakoterapevtska skupina: Kontrasti za jedrsko magnetno resonanco, oznaka ATC: V08CA06.
English: More than one dose should not be used during a scan.
Slovenian: Med slikanjem se ne sme uporabiti več kot en odmerek.
English: No dose adjustment is considered necessary.
Slovenian: Prilagoditev odmerka ni potrebna.
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.
Slovenian: Če ste ambulantni bolnik in nameravate voziti ali uporabljati orodja ali stroje, upoštevajte, da se lahko po postopku, pri katerem vam injicirajo zdravilo Optimark, pojavi omotica.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na sposobnost razmnoževanja (glejte poglavje 5.3).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in vial 15 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v viali 15 ml
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.
Slovenian: Pri jetrnih metastazah je razlika v jakosti signala med tumorjem in jetrnim tkivom močno izboljšana v prvih 90 sekundah po uporabi zunajceličnega gadolinijevega kontrastnega sredstva.
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.
Slovenian: To predstavlja 14 ml za 70-kilogramskega posameznika, ta volumen pa se injicira v 7-14 sekundah v veno, po navadi v veno na roki.
English: Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I).
Slovenian: Zdravilo Optimark je pakirano v viale, izdelane iz brezbarvnega, zelo odpornega borosilikatnega stekla (EP vrste I).
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.
Slovenian: Podobne rezultate so dobili pri normalnih osebah in bolnikih z različnimi kombinacijami okvare delovanja jeter, osrednjega živčevja in ledvic, pri čemer je bil ledvični očistek gadoversetamida približno 95 % skupnega očistka iz plazme.
English: As the renal clearance of gadoversetamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Slovenian: Ker je ledvični očistek gadofosveseta pri starejših lahko slabši, je pregled za ugotavljanje ledvične disfunkcije še zlasti pomemben pri bolnikih, starih več kot 65 let.
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.
Slovenian: Pri ogledovanju nekaterih abnormalnosti v možganih bo morda pri odraslih treba uporabiti trikratni običajni odmerek zdravila
English: If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.
Slovenian: Če pride do preobčutljivostne reakcije, je treba takoj prekiniti dajanje kontrastnega sredstva in po potrebi začeti intravensko zdravljenje.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na sposobnost razmnoževanja.
English: Feeling hot
Slovenian: Občutek vročine
English: (≥1/100 to
Slovenian: Pogosti (≥ 1/100 do
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Terapevtske indikacije
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.
Slovenian: Kljub temu so po 72 urah celotni odmerek zaznali v urinu, tudi pri bolnikih s hudo ledvično okvaro, pri zdravih populacijah pa so odmerke do 500 mikromolov/kg uporabljali brez varnostnih težav.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja), • na zahtevo Evropske agencije za zdravila.
English: Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders.
Slovenian: Poročali so o resnih neželenih učinkih, vključno z anafilaktičnimi reakcijami, kardiovaskularnimi reakcijami in alergijskimi boleznimi dihal.
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.
Slovenian: Gadoversetamid ne vpliva na druge metode merjenja kalcija v krvi, kot so arsenazo III kolorimetrična metoda, atomska absorpcijska spektroskopija in masna spektrometrija z induktivno sklopljeno plazmo.
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.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Vsebnik in raztopino je treba pred uporabo pregledati, kot je opisano v poglavju 6.6.
English: • in neonates up to 4 weeks of age (see section 4.4).
Slovenian: • pri novorojenčkih, starih do 4 tedne (glejte poglavje 4.4).
English: Please see package leaflet for further information.
Slovenian: Glejte navodilo za uporabo za več informacij.
English: Repeat dose
Slovenian: Ponavljajoči se odmerek