FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless opening has taken place in controlled and validated aseptic conditions.
Slovenian: Čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je odprtje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
English: What GADOVIST looks like and contents of the pack
Slovenian: Izgled zdravila GADOVIST in vsebina pakiranja
English: 1) The current indication does neither reflect the studied population in the two pivotal studies submitted for this variation of Gadovist nor the clinical context for which Gadovist has demonstrated to have the same diagnostic accuracy than its comparator.
Slovenian: Trenutna indikacija ne odraža niti preučevane populacije v dveh ključnih raziskavah, ki sta bili predloženi za variacijo dovoljenja za Gadograf, niti kliničnega konteksta, v katerem je bila za Gadograf dokazana enaka diagnostična natančnost kot za primerjalno zdravilo.
English: In rare cases anaphylactoid reactions ranging to shock may occur.
Slovenian: V redkih primerih se lahko pojavijo anafilaktoidne reakcije, tudi šok.
English: It is not clearly obvious that accurate diagnostic information per se is beneficial, so the application for authorisation should provide support that the information is clinically useful by direct evaluation of this aspect in the clinical trials provided or being drawn historically from published scientific evidence.
Slovenian: Ker ni očitno, ali je natančen diagnostični podatek sam po sebi koristen, mora vloga za podelitev dovoljenja na osnovi neposrednega vrednotenja tega vprašanja v okviru klinični preskušanj ali na osnovi objavljenih znanstvenih dokazov utemeljiti, da je podatek klinično koristen.
English: At a dose of 0.1 mmol gadobutrol/kg BW, an average of 0.59 mmol gadobutrol/l plasma was measured 2 minutes after the injection and 0.3 mmol gadobutrol/l plasma 60 minutes post injection.
Slovenian: Pri odmerku 0,1 mmol gadobutrola/kg TM so 2 minuti po injiciranju izmerili povprečno 0,59 mmol gadobutrola/l plazme, 60 minut po injiciranju pa 0,3 mmol gadobutrola/l plazme.
English: Gadovist is injected by a doctor via a small needle into a vein.
Slovenian: Zdravilo Gadovist zdravnik injicira z majhno iglo v veno.
English: Cardiovascular monitoring (including ECG) and control of renal function is recommended as a measure of precaution.
Slovenian: Priporočena previdnostna ukrepa sta kardiovaskularni nadzor (vključno z elektrokardiogramom) in nadzor delovanja ledvic.
English: With reference to Question 2) the MAH acknowledged that Gadovist has not been adequately studied for any of its approved indications (including the new indication “contrast-enhanced MRI of liver and kidneys”) in patients aged less than 18 years.
Slovenian: Glede drugega vprašanja se imetnik dovoljenja za promet z zdravilom strinja, da pri otrocih, mlajših od 18 let, zdravilo Gadograf ni bilo zadostno preučeno za nobeno odobreno indikacijo (vključno z novo indikacijo „MRI jeter in ledvic z izboljšanim kontrastom“).
English: In animal studies repeated dosing of gadobutrol only at maternally toxic dose levels (8 to 17 times the diagnostic dose) caused retardation of the embryonal development and embryolethality but no teratogenicity.
Slovenian: V študijah na živalih je ponavljajoče dajanje gadobutrola le v maternalno toksičnih odmerkih (8 do 17-kratni diagnostični odmerek) upočasnilo embrionalni razvoj in povzročilo embrioletalnost, ni pa imelo teratogenih učinkov.
English: It is provided as a solution for intravenous injection.
Slovenian: Na voljo je v obliki raztopine za intravensko injiciranje.
English: A total amount of 0.3 millilitre Gadovist per kg body weight may be administered at maximum.
Slovenian: Največ se lahko uporabi skupno 0,3 mililitre zdravila Gadovist na kg telesne mase.
English: At 0.47 T (20 MHz), pH 7 and 40°C the paramagnetic effect (relaxivity), as determined from the effect on spin-lattice relaxation time (T1) - is about 3.6 l mmol sec and the spin-spin relaxation time (T2) is about 4 l mmol sec
Slovenian: Pri 0,47 T (20 MHz), pH 7 in 40 °C je paramagnetni efekt(relaksativnost), določena z učinkom na spin-mrežni relaksacijski čas (T1), približno 3,6 I mmol s-1
English: Since contrast medium elimination is delayed in patients with severely impaired renal function, the benefits must be weighed very carefully against the risks in such cases.
Slovenian: Pri bolnikih s hudo ledvično okvaro je izločanje kontrastnega sredstva upočasnjeno, zato je treba v takih primerih pozorno pretehtati razmerje koristi in tveganja.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Prefilled syringes (5 ml, 7.5 ml, 10 ml)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Napolnjene injekcijske brizge (5 ml, 7,5 ml, 10 ml)
English: Section 4.2 (Posology): “Gadovist is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Slovenian: Poglavje 4.2 (Odmerjanje): “ Uporaba zdravila Gadovist se ne priporoča za uporabo pri populaciji mlajši od 18 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti.“
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 ml
English: At a dose of 0.1 mmol gadobutrol/kg BW, an average of 100.3 ± 2.6% of the dose was excreted within 72 h after administration.
Slovenian: Pri odmerku 0,1 mmol gadobutrola/kg TM se je 72 ur po uporabi izločilo povprečno 100,3 ± 2,6 % odmerka.
English: Cardiovascular safety pharmacology studies as well as clinical phase I studies gave indication for a potential of Gadovist to block cardiac potassium channels and an effect on cardiac repolarization when administered in doses 3 to 8fold higher than normally administered to patients.
Slovenian: Farmakološke študije kardiovaskularne varnosti in klinične študije I. faze so pokazale, da lahko zdravilo Gadovist pri odmerkih, ki so 3- do 8-krat večji od odmerkov, ki se po navadi uporabljajo pri bolnikih, zavre kalijeve kanale v srcu in vpliva na repolarizacijo srca.
English: No impairment of renal functions has been observed during clinical trials performed on a limited number of patients.
Slovenian: Med kliničnimi preskušanji, opravljenimi pri omejenem številu bolnikov, niso opazili okvare delovanja ledvic.
English: In patients with an allergic disposition the decision to use Gadovist must be made after particularly careful evaluation of the risk-benefit ratio.
Slovenian: Pri bolnikih, ki so nagnjeni k alergijskim reakcijam, je treba pred uporabo zdravila Gadovist posebno pozorno oceniti razmerje tveganja in koristi.
English: The increase in specificity from precontrast to combined pre and postcontrast MRI was 9% in the liver study (patient based analysis) while there was no increase in specificity in the kidney study (patient-based analysis as well as lesion-based analysis).
Slovenian: Povečanje specifičnosti od predkontrastnega do kombiniranega pred- in pokontrastnega slikanja z magnetno resonanco je bila 9 % v študiji na jetrih (analiza na temelju števila bolnikov), v študiji na ledvicah pa povečanja ni bilo (analiza na temelju števila bolnikov in analiza na temelju števila lezij).
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: The MAH must include in section 4.2 the following sentence “Gadovist is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v poglavje 4.2 vključiti naslednji stavek: “ Uporaba zdravila Gadovist se ne priporoča za uporabo pri populaciji mlajši od 18 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti.“
English: What GADOVIST contains
Slovenian: Kaj vsebuje zdravilo GADOVIST
English: This is equivalent to 0.1 ml/kg BW of the 1.0 M solution”.
Slovenian: To je enakovredno 0,1 ml/kg TM 1,0-M raztopine“.
English: Any solution for injection not used in one examination must be discarded.
Slovenian: Raztopino za injiciranje, ki ni porabljena pri eni preiskavi, je treba zavreči.
English: Do not use Gadovist after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila Gadovist ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Gadovist will be administered immediately before your MRI examination.
Slovenian: Zdravilo Gadovist vam bodo dali neposredno pred preiskavo MRS.
English: Rare: between 1 and 10 in every 10,000 patients are likely to get these.
Slovenian: Redki: verjetno se bodo pojavili pri manj kot 1 bolniku od 1.000 in več kot 1 bolniku od 10.000.
English: Cardiovascular effects seen in animals (dogs) at exposure levels similar (0.25 mmol/kg) and higher (1.25 mmol/kg), respectively, to maximum clinical exposure levels were a dose dependent transient increase in blood pressure (5% and 10%, above saline control) and myocardial contractility (5% and 16%, above saline control).
Slovenian: Kardiovaskularna učinka, ki sta se pojavila pri živalih (psih), ob izpostavljenosti, ki je bila podobna največji klinični izpostavljenosti (0,25 mmol/kg) ali večja od nje (1,25 mmol/kg), sta bila od odmerka odvisno prehodno zvišanje krvnega tlaka (pri 0,25 mmol/kg 5 %, pri 1,25 mmol/kg pa 10 % nad kontrolo s fiziološko raztopino) in krčljivost miokarda (pri 0,25 mmol/kg 5 %, pri 1,25 mmol/kg pa 16 % nad kontrolo s fiziološko raztopino).
English: 1 vial with 30 ml of the solution contains 18141 mg gadobutrol.
Slovenian: 1 viala s 30 ml raztopine vsebuje 18.141 mg gadobutrola.
English: Cardiac arrest, Tachycardia
Slovenian: Srčne bolezni srčni zastoj, tahikardija
English: Gadovist should not be drawn up into the syringe from the vial until immediately before use.
Slovenian: Zdravilo Gadovist smete povleči iz viale v injekcijsko brizgo šele tik pred uporabo.
English: Gadovist is a contrast medium for magnetic resonance imaging (MRI) of the brain, spine, vessels, liver and kidneys.
Slovenian: KAJ JE ZDRAVILO GADOVIST IN ZA KAJ GA UPORABLJAMO Zdravilo Gadovist je kontrastno sredstvo za magnetnoresonančno slikanje (MRI - magnetic resonance imaging) možganov, hrbtenjače, žil, jeter in ledvic.
English: Important information about some of the ingredients of X This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek (na podlagi povprečne količine, ki se daje osebi, ki tehta 70 kg), kar v bistvu pomeni "brez natrija".
English: 1 infusion bottle with 65 ml of the solution contains 39307 mg gadobutrol.
Slovenian: 1 infuzijska steklenica s 65 ml raztopine vsebuje 39.307 mg gadobutrola.
English: Contrast medium not used in one examination must be discarded.
Slovenian: Kontrastno sredstvo, ki ga pri pregledu ne porabite, morate zavreči.
English: Each ml contains 604.72 mg of gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
Slovenian: Vsak ml vsebuje 604,72 mg gadobutrola (kar ustreza 1,0 mmol gadobutrola, ki vsebuje 157,25 mg gadolinija).
English: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI).
Slovenian: Povečanje kontrasta pri slikanju lobanje in hrbtenice z magnetno resonanco (MRI - magnetic resonance imaging).
English: PHARMACEUTICAL FORM Solution for injection in prefilled syringe Clear, colourless to pale yellow liquid.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjeni injekcijski brizgi Bistra, brezbarvna do bledo rumena tekočina.
English: Tell your doctor if you are breast-feeding or intending to breast-feed.
Slovenian: Zdravniku povejte, če dojite ali nameravate dojiti.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 7.5 ml Vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH 7,5-mililitrska viala
English: Contrast enhancement in magnetic resonance angiography (CE-MRA).
Slovenian: Povečanje kontrasta pri magnetnoresonančni angiografiji (CE-MRA - contrast enhancement in magnetic resonance angiography).
English: This is equivalent to 0.1 ml/kg BW of the 1.0 M solution.
Slovenian: To ustreza 0,1 ml/kg TM za 1,0 M raztopino.
English: In renal pathologies, MRI techniques have become increasingly important, particularly in combination with a contrast agent that enables the assessment of different states of renal perfusion.
Slovenian: Tehnike MRI so čedalje pomembnejše pri boleznih ledvic, zlasti v kombinaciji s kontrastnimi sredstvi.
English: LIST OF EXCIPIENTS Excipients: Calcobutrol sodium, Trometamol, Hydrochloric acid, Water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: natrijev kalkobutrol, trometamol, klorovodikova kislina, voda za injekcije.
English: In its response the MAH addressed the issue of clinical utility by comparing Gadovist-enhanced with Magnevist-enhanced MRI and underlined the diagnostic efficacy of Gadovist.
Slovenian: V svojem odgovoru je imetnik dovoljenja za promet z zdravilom odgovoril na vprašanje o klinični uporabnost s primerjavo MRI, katerega kontrast je izboljšan z zdravilom Gadograf, in MRI, katerega kontrast je izboljšan z zdravilom Magnevist.
English: The increase of sensitivity from precontrast to combined pre and postcontrast MRI for Gadovisttreated patients was 33% in the liver study (patient-based analysis) and 18% in the kidney study (patient-based analysis as well as lesion-based analysis).
Slovenian: Povečanje občutljivosti od predkontrastnega do kombiniranega pred- in pokontrastnega slikanja z magnetno resonanco je bila pri bolnikih, ki so prejemali zdravilo Gadovist, 33 % v študiji na jetrih (analiza na temelju števila bolnikov) in 18 % v študiji na ledvicah (analiza na temelju števila bolnikov in analiza na temelju števila lezij).
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow liquid.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje Bistra, brezbarvna do bledo rumena tekočina.
English: Breast-feeding should be stopped for at least 24 hours following Gadovist administration.
Slovenian: Dojiti ne smete najmanj 24 ur po uporabi zdravila Gadovist.
English: 1 or 10 injection vials with 7.5, 15 or 30 ml solution for injection 1 or 10 infusion bottles with 65 ml solution for injection (in 100-ml infusion bottle)
Slovenian: Vsebina pakiranj je: 1 ali 10 vial za injiciranje s 7,5, 15 ali 30 ml raztopine za injiciranje 1 ali 10 infuzijskih steklenic s 65 ml raztopine za injiciranje (v 100-mililitrski infuzijski steklenici) Na trgu ni vseh navedenih pakiranj.
English: In case of an overdose, Gadovist can be removed from the body by extracorporeal dialysis.
Slovenian: Pri prevelikem odmerjanju se lahko zdravilo Gadovist odstrani iz telesa z zunajtelesno dializo.
English: In a pivotal phase III kidney study average sensitivity was 91% (patient-based analysis) and 85% (lesion-based analysis) for classification of malignant and benign renal lesions.
Slovenian: V ključni študiji III. faze na ledvicah je bila pri razvrstitvi malignih in benignih ledvičnih lezij povprečna občutljivost 91 % (analiza na temelju števila bolnikov) in 85 % (analiza na temelju števila lezij).
English: 1 vial with 7.5 ml of the solution contains 4535 mg gadobutrol.
Slovenian: 1 viala s 7,5 ml raztopine vsebuje 4535 mg gadobutrola.
English: Gadovist should not be prepared until immediately before use.
Slovenian: Zdravilo Gadovist smete pripraviti tik pred uporabo.
English: Imaging of >1 field of view (FOV): 15 ml for body weight below 75 kg; 20 m for body weight of 75 kg and higher (corresponding to 0.2-0.3 mmol/kg BW).
Slovenian: Slikanje > 1 vidnega polja (VP): 15 ml za telesno maso pod 75 kg; 20 ml za telesno maso 75 kg ali več (kar ustreza 0,2-0,3 mmol/kg TM).
English: In a pivotal phase III liver study average sensitivity in combined pre and postcontrast MRI for Gadovist-treated patients was 79% and specificity was 81% for lesion detection and classification of suspected malignant liver lesions (patientbased analysis).
Slovenian: V ključni študiji III. faze na jetrih je bila povprečna občutljivost pri kombiniranem pred- in pokontrastnem slikanju z magnetno resonanco pri bolnikih, pri katerih so uporabili zdravilo Gadovist, za detekcijo lezij in razvrstitev jetrnih lezij, pri katerih so sumili, da so maligne, 79 %, specifičnost pa 81 % (analiza na temelju števila bolnikov).
English: Respiratory arrest, Bronchospasm, Cyanosis, Oropharyngeal swelling, Cough, Sneezing
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja dihalni zastoj, bronhospazem, cianoza, otekanje ust in žrela, kašelj, kihanje
English: Imaging of 1 field of view (FOV): 7.5 ml for body weight below 75 kg; 10 ml for body weight of 75 kg and higher (corresponding to 0.1-0.15 mmol/kg BW).
Slovenian: Slikanje 1 vidnega polja (VP): 7,5 ml za telesno maso pod 75 kg; 10 ml za telesno maso 75 kg ali več (kar ustreza 0,1-0,15 mmol/kg TM).
English: Following intravenous bolus injection of Gadovist, important information on hyper- or hypoperfusion of the organ and lesions can be obtained with MRI, which allow a better differentiation of pathological processes and the characterization of the renal mass as well as staging of renal neoplasms.
Slovenian: Po intravenski bolusni injekciji sredstva Gadograf lahko z MRI pridobimo pomembne podatke o hiper- in hipoperfuziji organa ter lezijah.
English: D - 133 42 Berlin, Germany Telephone: +49 30 468-1111
Slovenian: Telefon: +49 30 468-1111
English: Delayed allergy-like reactions, hours to several days after the administration of Gadovist, have been observed in rare cases.
Slovenian: V redkih primerih so v več urah do več dneh po uporabi zdravila Gadovist opazili zapoznele reakcije, podobne alergijam.
English: - Allergy-like reactions may occur after use of Gadovist.
Slovenian: - Po uporabi zdravila Gadovist se lahko pojavijo reakcije, podobne alergijam.
English: 1 infusion bottle (type II glass) with a stopper (chlorobutyl elastomer) and a pure aluminium with internal and external lacquer flanged cap containing 65 ml solution for injection.
Slovenian: 1 infuzijska steklenica (steklo hidrolitične odpornosti tip II) z zamaškom (klorobutilni elastomer) ter obrobljeno aluminijasto zaporko iz čistega aluminija z notranjim in zunanjim lakiranjem vsebuje 65 ml raztopine za injiciranje.
English: Vials
Slovenian: Viale
English: “Contrast-enhanced magnetic resonance imaging (MRI) in patients with high suspicion or evidence of having a focal disease of liver or kidneys, obtained by other diagnostic tests or histopathology, to correctly localise malignant lesions of liver or kidney.”
Slovenian: “Magnetno resonančno slikanje (MRI) z izboljšanim kontrastom za pravilno lokalizacijo malignih lezij v jetrih ali ledvicah pri bolnikih, pri katerih obstaja močan sum ali dokaz za fokalno bolezen jeter ali ledvic, pridobljen na osnovi drugih diagnostičnih ali histopatoloških preiskav.“
English: The usual safety requirements for magnetic resonance imaging, especially the exclusion of ferromagnetic materials, also apply when using Gadovist.
Slovenian: Pri uporabi zdravila Gadovist je potrebno upoštevati običajne previdnostne ukrepe za magnetnoresonančno slikanje, zlasti izključitev feromagnetnih snovi.
English: Numbness and tingling Problems with sense of taste Nausea (feeling sick) Widening of blood vessels Injection site pain Injection site reaction
Slovenian: Redki glavobol omotica otrplost in mravljinčenje težave pri okušanju navzea (slabost) širjenje krvnih žil bolečina na mestu injiciranja reakcije na mestu injiciranja težave z vohom težave pri dihanju bruhanje koprivnica kožni izpuščaj znižan krvni tlak reakcija, podobna alergiji
English: 1 vial (type II glass) with a stopper (chlorobutyl elastomer) and a pure aluminium with internal and external lacquer flanged cap containing 7.5 ml, 15 ml or 30 ml solution for injection.
Slovenian: 1 viala (steklo hidrolitične odpornosti tip I) z zamaškom (klorobutilni elastomer) ter obrobljeno aluminijasto zaporko iz čistega aluminija z notranjim in zunanjim lakiranjem vsebuje 7,5 ml, 15 ml ali 30 ml raztopine za injiciranje.
English: Gadovist consists of nonspecific, low-molecular-weight, extracellular gadolinium-chelates and is presented in the formulation l.0 mmol gadolinium/ml and an osmolality of 1603 mosmol/kg H2O at 37°C.
Slovenian: Na voljo je farmacevtska oblika z 1,0 mmol gadolinija/ml in osmolalnostjo 1603 mosmol/kg H2O pri 37 °C.
English: 1 vial with 15 ml of the solution contains 9070 mg gadobutrol.
Slovenian: 1 viala s 15 ml raztopine vsebuje 9070 mg gadobutrola.
English: Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.
Slovenian: Povečanje kontrasta pri MRI jeter in ledvic pri bolnikih, pri katerih obstaja sum na fokalne lezije ali dokaz zanje, da se te lezije opredelijo kot benigne ali maligne.
English: Calcobutrol sodium Trometamol Hydrochloric acid Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev kalkobutrol trometamol klorovodikova kislina voda za injekcije
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Gadovist Navodilo je bilo odobreno {MM/LLLL}.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml vsebuje 604,72 mg gadobutrola (kar ustreza 1,0 mmol gadobutrola, ki vsebuje 157,25 mg gadolinija).
English: CE-MRI of liver and kidneys:
Slovenian: Slikanje CE-MRS jeter in ledvic:
English: Pack sizes of:
Slovenian: Velikosti pakiranja:
English: - the CHMP recommended that the following additional indication: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.” can be granted for Gadovist.
Slovenian: CHMP priporoča, da se za zdravilo Gadograf odobri naslednja dodatna indikacija: „MRI jeter ali ledvic z izboljšanim kontrastom pri bolnikih, pri katerih obstaja močan sum ali dokaz za fokalne lezije, z namenom opredelitve benignosti ali malignosti teh lezij.“
English: Short-lasting mild to moderate feelings of coldness, warmth or pain at the injection site have been uncommonly observed in association with the venous puncture or contrast medium injection.
Slovenian: V povezavi z vbodom v veno ali injiciranjem kontrastnega sredstva so občasno opazili kratkotrajne blage do zmerne občutke mraza, toplote ali bolečine na mestu injiciranja.
English: BEFORE YOU ARE GIVEN GADOVIST
Slovenian: KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO GADOVIST
English: Gadovist contains gadobutrol, a neutral macrocyclic gadolinium complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Slovenian: Zdravilo Gadograf vsebuje gadobutrol, ki je nevtralen makrociklični gadolinijev kompleks.
English: One 10-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 5 ml, 7.5 ml, 10 ml solution for injection.
Slovenian: Ena 10-mililitrska napolnjena injekcijska brizga (steklo hidrolitične odpornost tip I) z vsajenim zamaškom (klorobutilni elastomer) in koničastim zamaškom (klorobutilni elastomer) vsebuje 5 ml, 7,5 ml, 10 ml raztopine za injiciranje.
English: One 20-ml prefilled syringe (type I glass) with a plunger stopper (chlorobutyl elastomer) and a tip cap (chlorobutyl elastomer) contains 20 ml solution for injection.
Slovenian: Ena 20-mililitrska napolnjena injekcijska brizga (steklo hidrolitične odpornost tip I) z vsajenim zamaškom (klorobutilni elastomer) in koničastim zamaškom (klorobutilni elastomer) vsebuje 20 ml raztopine za injiciranje.