FrancophonIA/ELRC3.0 huggingface dataset:
English: In rabbits, an increased number of early resorptions and a slight but significant increase in the number of foetal anomalies (in particular hydrocephalus and malrotated limbs) were observed at doses at which no or slight maternal toxicity was observed (exposure was 2 and 5 times the expected human exposure, respectively).
Slovenian: Pri kuncih so opazili povečano število zgodnjih resorpcij in rahlo, vendar pomembno povečanje števila anomalij ploda (zlasti hidrocefalusa in nepravilne rotacije okončin) pri odmerkih, pri katerih niso opazili nobene ali pa le rahlo toksičnost za mater (izpostavljenost je bila 2 do 5-krat večja od pričakovane izpostavljenosti pri človeku).
English: What Ablavar looks like and contents of the pack
Slovenian: Izgled Ablavar in vsebina pakiranja
English: The mean dialysis clearance was between the range of 16-32 ml/h/kg.
Slovenian: Srednja vrednost očistka pri dializi je bila med 16 - 32 ml/h/kg.
English: The use of this medicine is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant.
Slovenian: Uporaba zdravila se ne priporoča pri bolnikih s hudimi težavami z ledvicami ali pri bolnikih, pri katerih je bila kratkim opravljena ali je v bližnji prihodnosti načrtovana presaditev jeter.
English: In the situation of elevated levels of gadofosveset or underlying QT prolongation the patient should be carefully observed including cardiac monitoring.
Slovenian: V primeru povečanih vrednosti gadofosveseta ali obstoječem podaljšanju QT intervala morate bolnika skrbno opazovati in nadzirati delovanje srca.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali radiologa.
English: The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, or cardiovascular reactions, or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, previous reaction of contrast media, a history of asthma, or other allergic disorders.
Slovenian: Vedno je treba upoštevati možnost reakcij, vključno z resnimi, življenjsko nevarnimi, smrtnimi anafilaktoidnimi ali kardiovaskularnimi reakcijami, ali drugih idiosinkratičnih reakcij, zlasti pri bolnikih z znano klinično preobčutljivostjo, predhodno reakcijo na kontrastno sredstvo, anamnezo astme ali drugo alergijsko boleznijo.
English: No clinical experience is yet available for patients younger than 18.
Slovenian: Za bolnike, mlajše od 18 let, še ni kliničnih izkušenj.
English: This medicine must not be used in pregnant women unless strictly necessary.
Slovenian: To zdravilo se ne sme uporabljati pri nosečnicah, razen kadar je nujno.
English: It is therefore advisable to use a flexible indwelling cannula for intravenous contrast medium administration.
Slovenian: Za dajanje kontrastnega sredstva je torej priporočljivo uporabiti prožno vstavljeno kanilo.
English: In human studies, gadofosveset substantially shortens blood T1 values for up to 4 hours after intravenous bolus injection.
Slovenian: V študijah pri človeku je gadofosveset po intravenski bolusni injekciji znatno skrajšal vrednost T1 v krvi, tudi do 4 ure.
English: Gadofosveset can be removed from the body by hemodialysis.
Slovenian: Gadofosveset lahko iz telesa odstranimo s hemodializo.
English: • breathing difficulties and/or heart/ pulse-rate/ blood pressure disturbances which may lead to consciousness disorders respiratory reactions, and /or cardiovascular manifestations
Slovenian: • težave pri dihanju in/ali motnje delovanja srca, srčnega utripa ali krvnega tlaka, ki lahko pripeljejo do motenj zavesti (kožnih ali dihalnih reakcij in/ali srčno-žilnih znakov, ki lahko
English: • you have recently had, or soon expect to have, a liver transplant
Slovenian: • če so vam pred kratkim presadili ali v bližnji prihodnosti načrtujejo presaditev jeter.
English: After bolus intravenous administration of 0.05 mmol/kg dose in patients requiring three times a week haemodialysis using high-flux filter, at the end of third dialysis session, the plasma concentration had declined to less than 15 % of the Cmax.
Slovenian: Po bolusni intravenski aplikaciji odmerka 0,05 mmol/kg bolnikom, ki potrebujejo hemodializo z visokopretočnim filtrom trikrat tedensko, je bila koncentracija v plazmi na koncu tretjega postopka dialize manjša od 15 % vrednosti Cmax.
English: Discard any unused medium after each investigation.
Slovenian: Po vsaki preiskavi zavrzite neuporabljen medij.
English: Imaging time points
Slovenian: Časovne točke pri slikanju:
English: Hepatic impairment Dose adjustments in hepatic impairment are not necessary (see section 5.2).
Slovenian: Okvara jeter Prilagajanje odmerka pri bolnikih z okvaro jeter ni potrebno (glejte poglavje 5.2).
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) associated with use of other gadolinium-containing contrast agents.
Slovenian: Poročali so o nefrogeni sistemski fibrozi (NSF) (bolezen, ki povzroči otrditev kože in lahko prizadene tudi mehka tkiva in notranje orgake), povezani z uporabo nekaterih drugih kontrastnih sredstev, ki vsebujejo gadolinij.
English: Most of the adverse reactions (80%) occurred within 2 hours.
Slovenian: Največ neželenih učinkov (80 %) se je pojavilo v prvih 2 urah.
English: In an animal study, it was shown that less than 1% of the dose of gadofosveset administered enters breast milk.
Slovenian: Študije na živalih se je pokazale, da v mleko prehaja manj kot 1 % odmerka gadofosveseta.
English: 10 and 20 ml colourless type I glass vials with chloro- or bromobutyl elastomer stopper and aluminium bordered cap (plastic disk).
Slovenian: 10- in 20-mililitrske viale iz stekla tipa I z zamaškom iz klorobutilnega ali bromobutilnega elastomera in aluminijasto zaporko (plastični disk).
English: No comparative studies with extracellular gadolinium contrast agents have been conducted.
Slovenian: Primerjalne študije z ekstracelularnimi kontrastnimi sredstvi, ki vsebujejo gadolinij, niso izvedli.
English: Intravenous use and diagnostic use only.
Slovenian: Samo za intravensko uporabo in diagnostične namene.
English: Since gadofosveset is cleared from the body primarily by urinary excretion, caution should be exercised in patients with impaired renal function (see section 4.2 and 5.2).
Slovenian: Gadofosveset se iz telesa izloči predvsem v urinu, zato je treba biti pri bolnikih z okvarjenim delovanjem ledvic previden (glejte poglavji 4.2 in 5.2).
English: In this leaflet: What Ablavar is and what it is used for
Slovenian: KAJ JE ABLAVAR IN ZA KAJ GA UPORABLJAMO
English: No clinical information is available about repeated use of this medicinal product.
Slovenian: Kliničnih podatkov o večkratni uporabi to zdravilo ni.
English: No functional impairment was observed and electron microscopic investigations of the rat kidneys indicated that the observed vacuolation was primarily a storage phenomenon.
Slovenian: Funkcionalnih okvar niso opazili, preiskave ledvic podgan z elektronskim mikroskopom pa so pokazale, da je šlo pri vakuolizaciji predvsem za pojav kopičenja.
English: As with other contrast enhanced diagnostic procedures, post-procedure observation of the patient is recommended, in particular in patients with a history of allergy, renal insufficiency, or adverse reaction.
Slovenian: Kot pri drugih diagnostičnih postopkih z uporabo kontrastnih sredstev se priporoča opazovanje bolnika po postopku, zlasti bolnikov z anamnezo alergij, oslabljenega delovanja ledvic ali neželenimi učinki.
English: A small portion of gadofosveset dose was recovered in the faeces (4.7%, range 1.1 - 9.3%), indicating a minor role of biliary excretion in the disposition of gadofosveset.
Slovenian: Majhen del odmerka gadofosveseta se izloči v blatu (4,7 %, interval 1,1 - 9,3 %), kar nakazuje nepomembno vlogo izločanja gadofosveseta v žolču.
English: Elevated levels of gadofosveset (e.g. repeated use in the short term [within 6-8 hours], or an inadvertent overdose > 0.05 mmol/kg) may be associated with mild QT prolongation (8.5 msec by Fridericia correction).
Slovenian: Povečane vrednosti gadofosveseta (npr. pri večkratnem odmerjanju v kratkem obdobju (v 6 - 8 urah) ali pri nenamernem prevelikem odmerjanju > 0,05 mmol/kg) so lahko povezane z blagim podaljšanjem QT intervala (8,5 msec s Fridericia korekcijo).
English: Ablavar is a formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate substituted with a diphenylcyclohexylphosphate group (gadofosveset trisodium), for use in magnetic resonance imaging (MRI).
Slovenian: Ablavar je formulacija stabilnega kelata gadolinijeve dietilenetriaminpentaocetne kisline (GdDTPA), substituirane z difenilcikloheksilfosfatno skupino (trinatrijev gadofosveset) namenjena za magnetnoresonančno slikanje (MRS).
English: It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
Slovenian: Če ste starejši kot 65 let, prilagoditev odmerka ni potrebna, vendar boste morda opravili krvne preiskave, s katerimi bodo ugotavljali delovanje vaših ledvic.
English: You will be asked to lie down on the MRI scanning bed.
Slovenian: Povedali vam bodo, da se ulezite na mizo za MR-slikanje.
English: If hypersensitivity reactions occur (see section 4.8), administration of the contrast medium must be discontinued immediately and - if necessary - specific therapy instituted via a venous access.
Slovenian: Če pride do preobčutljivostne reakcije (glejte poglavje 4.8), je treba takoj prekiniti dajanje kontrastnega sredstva in če je nujno, začeti ustrezno intravensko zdravljenje.
English: • you suffer from allergy (e.g. hay fever, hives) or asthma
Slovenian: • imate alergijo (na primer seneni nahod ali koprivnico) ali astmo,
English: After the injection you will be observed in case there might be any initial side effects.
Slovenian: Po injiciranju vas bodo opazovali zaradi morebitnih takojšnjih neželenih učinkov.
English: Due to the possibility of severe hypersensitivity reactions after intravenous contrast administration, preparedness for institution of emergency measures is necessary, e.g., appropriate medicinal products, an endotracheal tube, and a respirator should be at hand.
Slovenian: Zaradi možnosti hudih preobčutljivostnih reakcij po intravenskem dajanju kontrastnega sredstva je treba nujno pripraviti pogoje za urgentno ukrepanje, pri roki je treba imeti npr. ustrezna zdravila, endotrahealni tubus in respirator.
English: Like all medicines, Ablavar can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi Ablavar neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Diagnostic procedures involving the use of MRI contrast agents should be carried out under the supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Slovenian: Diagnostični postopki, pri katerih se uporabljajo kontrastna sredstva za MRS, morajo biti opravljeni pod nadzorom ustrezno usposobljenega zdravnika in ob dobrem poznavanju postopka.
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 bi podpirali uvedbo hemodialize za preprečevanje ali zdravljenje NSF pri bolnikih, ki se še ne zdravijo s hemodializo.
English: In a clinical study, it was shown that gadofosveset does not affect the unbound fraction of warfarin in plasma.
Slovenian: V eni klinični študiji so pokazali, da gadofosveset ne vpliva na nevezano frakcijo varfarina v plazmi.
English: As with other intravenous contrast agents, this medicinal product can be associated with anaphylactoid / hypersensitivity reactions characterised by cutaneous, respiratory and/or cardiovascular manifestations which may lead to shock.
Slovenian: Kot druga intravenska kontrastna sredstva je tudi to zdravila lahko povezano z anafilaktoidnimi/preobčutljivostnimi reakcijami, za katere so značilni kožni, respiratorni in/ali kardiovaskularni znaki, ki lahko pripeljejo do šoka.
English: Do not use this medicine if you notice severe discolouration, the occurrence of particulate matter or a defective container.
Slovenian: Ne uporabljajte zdravila, če opazite izrazito obarvanost raztopine, prisotnost delcev ali če je vsebnik poškodovan.
English: In monkeys, no renal effects were observed after single use even at a dose 100-times higher than the clinical dose.
Slovenian: Pri opicah po enkratni uporabi niso opazili učinkov na ledvice, tudi v odmerkih, ki so bili 100-krat večji od kliničnih.
English: Dose in special patient groups
Slovenian: Odmerek za posebne skupine bolnikov
English: Take special care with Ablavar
Slovenian: Bodite posebno pozorni pri uporabi Ablavar
English: The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Slovenian: Neželeni učinki v spodnji preglednici so navedeni glede na organski sistem po MedDRA klasifikaciji (MedDRA SOCs).
English: Because of the lack of information on repeated administration, Ablavar injections should not be repeated unless the interval between injections is at least 7 days.
Slovenian: Zaradi pomanjkanja podatkov o ponavljajočem odmerjanju je ponovno dajanje injekcij Ablavar dovoljeno šele po poteku časovnega presledka 7 dni.
English: This medicinal product should only be used by physicians experienced in the field of diagnostic imaging.
Slovenian: To zdravilo lahko uporablja le zdravnik z izkušnjami pri diagnostičnem slikanju.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje s kontrastnim sredstvom
English: Vials are not intended for the withdrawal of multiple doses.
Slovenian: Viale niso namenjene za večkratno odmerjanje.
English: Continuing breast feeding or discontinuing Ablavar for a period of 24 hours after administration, should be at the discretion of the doctor and lactating mother.
Slovenian: Nadaljevanje dojenja ali prekinitev uporabe Ablavar za obdobje 24 ur po uporabi je v presoji zdravnika in doječe matere.
English: In a clinical trial it was shown that gadofosveset can effectively be removed from the body by dialysis using high flux filters.
Slovenian: V kliničnih preskušanjih so pokazali, da se lahko gadofosveset učinkovito odstrani iz telesa z dializo, pri kateri se uporabijo visokopretočni filtri.
English: Ablavar should not be used during pregnancy unless the clinical condition of the woman requires use of gadofosveset.
Slovenian: Ablavar ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva uporabo gadofosveseta.
English: The extended vascular imaging window for gadofosveset is attributed to enhanced relaxivity and extended residence in vascular space resulting from its plasma protein binding.
Slovenian: To podaljšano obdobje slikanja, ki ga omogoča gadofosveset, se pripisuje povečani relaksaciji žil in podaljšani prisotnosti v notranjosti žil zaradi vezave na plazemske beljakovine.
English: • When new information is received that may impact on the current Safety Specification,
Slovenian: • Kadar imetnik dovoljenja za promet z zdravilom prejeme nove informacije, ki lahko vplivajo na veljavne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjšanje
English: Use of Ablavar should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI) (see section 4.4).
Slovenian: Uporabi Ablavar se je treba izogniti pri bolnikih s hudo ledvično okvaro (hitrost glomerularne filtracije - GFR < 30 ml/min/1,73m2) in pri bolnikih v obdobju pred presaditvijo jeter, razen če je diagnostična informacija bistvenega pomena in je ni mogoče pridobiti z nekontrastnim magnetnoresonančnim slikanjem (MRI) (glejte poglavje 4.4).
English: Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.
Slovenian: Ablavar je indicirano za magnetnoresonančno angiografijo (CE-MRA) za vizualizacijo žil v trebuhu in okončinah samo pri odraslih bolnikih z znano ali domnevno vaskularno boleznijo.
English: The usual safety precautions for magnetic resonance imaging must be observed, e.g., exclusion of cardiac pacemakers and ferromagnetic implants.
Slovenian: Pri magnetnoresonančnem slikanju morate upoštevati običajne previdnostne ukrepe, npr. izključitev srčnega spodbujevalnika in feromagnetnih vsadkov.
English: The dose of this medicine varies depending on your weight.
Slovenian: Odmerek zdravilaje odvisen od vaše telesne mase.
English: This medicine is given as a rapid injection into a vein by a medical professional only.
Slovenian: Zdravilo lahko s hitrim injiciranjem v žilo odmeri samo zdravstveni profesionalec.
English: EXP After first opening use immediately.
Slovenian: EXP Uporabite takoj po prvem odpiranju.
English: Ablavar should not be used during pregnancy unless the clinical condition of the woman requires use of the medicinal product.
Slovenian: Ablavar ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva uporabo zdravila .
English: Any remaining solution not used in one examination must be discarded.
Slovenian: Raztopino, ki je pri pregledu ne uporabite, morate zavreči.
English: There are no studies on the effects on the ability to drive and use machines.
Slovenian: Ni študij, ki bi dokazale učinke zdravila na sposobnost vožnje in uporabe strojev.
English: After intravenous administration of 0.03 mmol/kg dose the mean half-life of the distribution phase (t1/2) was 0.48 ± 0.11 hours and the volume of distribution at steady state was 148 ± 16 ml/kg, roughly equivalent to that of extracellular fluid.
Slovenian: Po intravenski aplikaciji odmerka 0,03 mmol/kg je bila srednja vrednost razpolovnega časa porazdelitvene faze (t1/2α) 0,48 ± 0,11 ure, volumen porazdelitve v stanju dinamičnega ravnovesja pa 148 ± 16 ml/kg, kar približno ustreza vrednosti zunajcelične tekočine.
English: A slight decrease in faecal elimination of gadofosveset was seen for the hepatic impaired subjects (2.7%) compared to normal subjects (4.8%).
Slovenian: Pri osebah z oslabljenim delovanjem jeter so opazili rahlo zmanjšanje izločanja v blatu (2,7 %) v primerjavi z zdravimi osebami (4,8 %).
English: As the renal clearance of gadofosveset 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: PSURs The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo nadaljeval s predajanjem letnih poročil o varnosti zdravila PSUR, razen če CHMP določi drugače.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteku roka uporabnosti, ki je naveden na ovojnini.
English: Characteristics in patients
Slovenian: Lastnosti pri bolnikih
English: The results from various evaluations of plasma and urine samples indicated that gadofosveset does not undergo measurable metabolism.
Slovenian: Rezultati različnih ocen vzorcev plazme in urina so pokazali, da zaradi majhnega obsega presnove gadofosveseta le te ni mogoče izmeriti.
English: If a patient experiences these effects he/she should not drive or use machines
Slovenian: Če ime bolnik te težave, ne sme voziti avtomobila ali uporabljati strojev
English: Haemodialysis shortly after Ablavar administration may be useful at removing Ablavar from the body.
Slovenian: Hemodializa takoj po uporabi Ablavar je morda koristna pri odstranitvi Ablavar iz telesa.
English: The following is a list of side-effects observed in clinical trials:
Slovenian: Našteti so neželeni učinki, ki so jih opazili v kliničnih preskušanjih.
English: If necessary, this medicine can be removed from the body by haemodialysis using high-flux filters.
Slovenian: Če je treba, lahko Ablavar odstranijo iz telesa s hemodializo z uporabo visokopretočnih filtrov.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: OTHER SPECIAL WARNING(S), IF NECESSARY The peel-off tracking label included with the vials should have the dose recorded on it and be stuck onto patient record
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Na odlepljivo sledljivo oznako, priloženo vialam, je treba zabeležiti odmerek in jo prilepiti na bolnikovo kartoteko.
English: You will need special medical attention if allergy-like reactions occur.
Slovenian: Če se pojavi alergijska reakcija, boste potrebovali posebno zdravljenje.
English: In one subject with moderate hepatic impairment and abnormally low serum albumin, total clearance and half-life of gadofosveset was indicative of faster clearance compared to subjects with moderate hepatic impairment and normal serum albumin levels.
Slovenian: Pri eni osebi z zmerno okvarjenim delovanjem jeter in nenormalno nizko ravnijo albumina v serumu sta skupni očistek in razpolovni čas gadofosveseta kazala na hitrejši očistek kot pri osebah z zmerno okvarjenim delovanjem jeter in normalno koncentracijo albumina v serumu.
English: If you have any further questions on the use of this medicine, please consult your doctor, the radiologist or MRI-centre personnel.
Slovenian: Če imate še kakšno vprašanje glede uporabe tega zdravila, se posvetujte z zdravnikom, radiologom ali osebjem v oddelku za magnetnoresonančno slikanje.
English: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, UK
Slovenian: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, Velika Britanija
English: Ablavar is a clear, colourless to pale yellow liquid supplied in a rubber stoppered glass vial, with an aluminium seal, in individual cartons.
Slovenian: Ablavar je bistra, brezbarvna do svetlo rumena raztopina v stekleni viali z gumijastim pokrovom in aluminijastim tesnilom, zapakirana v posamezni škatli.
English: As there is a possibility that NSF may occur with Ablavar, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Slovenian: Ker obstaja možnost, da se NSF pojavi pri uporabi Ablavar, se mu je treba izogniti pri bolnikih s hudo ledvično okvaro in pri bolnikih v obdobju pred presaditvijo jeter, razen če je diagnostična informacija bistvenega pomena in je ni mogoče pridobiti z nekontrastnim magnetnoresonančnim slikanjem.
English: Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive this medicine.
Slovenian: Vaš zdravnik se bo z vami pogovoril, ali boste nadaljevali z dojenjem ali z njim prenehali za 24 ur po uporab Ablavar.
English: You must not be given Ablavar if you are allergic (hypersensitive) to gadofosveset or any of the other ingredients of this medicine (see section 6 of this leaflet).
Slovenian: Ablavar vam ne smejo dati, če ste alergični na (preobčutljivi za) gadofosveset ali katerokoli sestavino v zdravila .