FrancophonIA/ELRC3.0 huggingface dataset:
English: These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Slovenian: Pravimo jim mišični relaksanti, mednje pa sodita na primer rokuronijev bromid in vekuronijev bromid.
English: Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted.
Slovenian: Sugamadeks se ne presnavlja v jetrih in se ne izloča z jetri, zato niso bile opravljene študije pri bolnikih z jetrno okvaro.
English: Renal impairment and age:
Slovenian: Ledvična okvara in starost:
English: Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
Slovenian: Takojšnje prekinitve blokade pri otrocih in mladostnikih niso proučevali in zato uporabe zdravila ne priporočamo, dokler ne bo na voljo več podatkov.
English: Talk to your doctor if your progesterone levels need to be tested on the same day you receive Bridion.
Slovenian: Posvetujte se z zdravnikom, če morate na preiskave za določanje hormona progesterona na isti dan, ko prejmete zdravilo Bridion.
English: As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular blockade.
Slovenian: Kot je to običajna praksa za obdobje po anesteziji po živčnomišični blokadi, je takoj po operaciji priporočljivo spremljanje bolnika glede neželenih učinkov, vključno s ponovitvijo živčnomišične blokade.
English: The effects with sugammadex on human fertility have not been investigated.
Slovenian: Vpliva sugamadeksa na plodnost pri ljudeh niso raziskovali.
English: In post-marketing data and in one dedicated clinical trial in patients with a history of pulmonary complications, bronchospasm was reported as a possibly related adverse event.
Slovenian: V obdobju trženja in v enem namenskem kliničnem preskušanju pri bolnikih z anamnezo o pljučnih zapletih so poročali o bronhospazmu kot o možnem z zdravilom povezanem neželenem učinku.
English: Solution for injection 10 vials
Slovenian: raztopina za injiciranje 10 vial
English: 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium
Slovenian: 0,6 mg/kg rokuronija ali 0,1 mg/kg vekuronija
English: No recurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fusidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days.
Slovenian: V pooperativni fazi ni pričakovati ponovitve živčnomišične blokade, ker fusidno kislino infundiramo v času več ur in se kumulira v krvi 2 do 3 dni.
English: 96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex.
Slovenian: 96 % odmerka se izloči s sečem, od tega najmanj 95 % v nespremenjeni obliki.
English: When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of recurrence of neuromuscular blockade.
Slovenian: Pri uporabi zdravil, ki okrepijo živčnomišično blokado, v po-operativnem obdobju morate biti posebej pozorni na možnost ponovitve živčnomišične blokade.
English: → If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill's package leaflet.
Slovenian: → Če vzamete tabletko isti dan, kot prejmete zdravilo Bridion, upoštevajte navodila za ravnanje v primeru izpuščenega odmerka, ki so podana v priloženem navodilu za uporabo tabletk.
English: In case hepatic impairment is accompanied by coagulopathy see the information on the effect on haemostasis.
Slovenian: V primeru jetrne okvare s spremljajočo koagulopatijo glejte podatke o vplivu na hemostazo.
English: The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill.
Slovenian: Količina progestogena, ki se izgubi pri uporabi zdravila Bridion, je približno enaka, kot če bolnica pozabi vzeti eno peroralno kontracepcijsko tabletko.
English: Volume of distribution at steady state (L)
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja (l)
English: It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Slovenian: Na voljo je v dveh velikostih pakiranja, ki vsebujeta bodisi 10 vial po 2 ml ali 10 vial po 5 ml raztopine za injiciranje.
English: For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 mL/min): the dose recommendations are the same as for adults without renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro (očistek kreatinina ≥ 30 in < 80 ml/min) so priporočeni odmerki enaki kot za vse odrasle bolnike brez ledvične okvare.
English: Pharmacodynamic effects:
Slovenian: Farmakodinamični učinki:
English: The use of fusidic acid in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9.
Slovenian: Uporaba fusidne kisline v predoperativni fazi lahko povzroči določeno zakasnitev pri vračanju razmerja T4/T1 na vrednost 0,9.
English: For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
Slovenian: Pri uporabi toremifena, ki ima sorazmerno veliko vezavno afiniteto do sugamadeksa in je lahko prisoten v sorazmerno visokih plazemskih koncentracijah, bi lahko prišlo do delnega izpodrivanja vekuronija ali rokuronija iz kompleksa s sugamadeksom.
English: Interactions potentially affecting the efficacy of sugammadex (displacement interactions):
Slovenian: Interakcije, ki bi lahko vplivale na učinkovitost sugamadeksa (interakcije zaradi izpodrivanja zdravila):
English: Bridion can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
Slovenian: Zdravilo Bridion se lahko injicira v intravensko linijo tekoče infuzije z naslednjimi intravenskimi raztopinami: raztopino natrijevega klorida 9 mg/ml (0,9 %), raztopino glukoze 50 mg/ml (5 %), raztopino natrijevega klorida 4,5 mg/ml (0,45 %) in raztopino glukoze 25 mg/ml (2,5 %), raztopino Ringerjevega laktata, Ringerjevo raztopino ter raztopino glukoze 50 mg/ml (5 %) v raztopini natrijevega klorida 9 mg/ml (0,9 %).
English: In adult anaesthetized patients with normal renal function the elimination half-life (t1/2) of sugammadex is about 2 hours and the estimated plasma clearance is about 88 mL/min.
Slovenian: Pri odraslih anesteziranih bolnikih z normalnim delovanjem ledvic je razpolovni čas (t1/2) izločanja sugamadeksa približno 2 uri, njegov očistek iz plazme pa je ocenjen na približno 88 ml/min.
English: After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C.
Slovenian: Dokazano je bilo, da je zdravilo po prvem odprtju in po redčenju kemično in fizikalno stabilno med uporabo 48 ur pri temperaturi med 2 °C in 25 °C.
English: The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.
Slovenian: Začetek delovanja depolarizirajočega mišičnega relaksanta je lahko počasnejši od pričakovanega, saj je lahko precejšnji delež postsinaptičnih nikotinskih receptorjev še vedno zaseden z mišičnim relaksantom.
English: A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
Slovenian: Podatki iz podatkovne baze z majhnim številom podatkov kažejo, da je profil varnosti sugamadeksa pri pediatričnih bolnikih (do odmerka 4 mg/kg) podoben kot pri odraslih.
English: In a pharmacokinetic study comparing patients with severe renal impairment to patients with normal renal function, sugammadex levels in plasma were similar during the first hour after dosing, and thereafter the levels decreased faster in the control group.
Slovenian: V farmakokinetični študiji, kjer so primerjali bolnike s hudo ledvično okvaro ter bolnike z normalnim delovanjem ledvic, so bile v prvi uri po odmerjanju plazemske koncentracije sugamadeksa podobne, nato pa so se vrednosti hitreje znižale v kontrolni skupini.
English: Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
Slovenian: Pri dajanju sugamadeksa zdravim prostovoljcem se je povečalo ledvično izločanje rokuronija v obliki kompleksa.
English: Excipient(s) with known effect Each mL contains up to 9.7 mg sodium (see section 4.4).
Slovenian: Pomožna(e) snov(i) z znanim učinkom: En ml vsebuje do 9,7 mg natrija (glejte poglavje 4.4).
English: In the Pooled Phase 1 database, AEs considered common (≥ 1/100 to < 1/10) or very common (≥ 1/10) and more frequent among subjects treated with sugammadex than in the placebo group, include dysgeusia (10.1%), headache (6.7%), nausea (5.6%), urticaria (1.7%), pruritus (1.7%), dizziness (1.6%), vomiting (1.2%) and abdominal pain (1.0%).
Slovenian: V podatkovni bazi združenih podatkov iz I. faze so med neželene učinke, ki veljajo za pogoste (≥ 1/100 do < 1/10) ali zelo pogoste (≥ 1/10) in bolj pogoste pri osebah, zdravljenih s sugamadeksom, kot v skupini na placebu, vključeni: disgevzija (10,1 %), glavobol (6,7 %), navzea (5,6 %), urtikarija (1,7 %), pruritus (1,7 %), omotica (1,6 %), bruhanje (1,2 %) in bolečine v trebuhu (1,0 %).
English: After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes.
Slovenian: Po dajanju sugamadeksa pri ponovnem pojavu T2 po blokadi živčnomišičnega prenosa z rokuronijem znaša mediana vrednost časa do povrnitve razmerja T4/T1 na 0,9 pri odraslih (starih od 18 do 64 let) 2,2 minuti, pri starostnikih (starih od 65 do 74 let) 2,6 minut in pri zelo starih bolnikih (starih 75 let ali več) 3,6 minut.
English: Sugammadex has no effects on fracture repair and remodelling of bone.
Slovenian: Sugamadeks nima vpliva na celjenje zloma in obnavljanje kosti.
English: Intravenous administration of fusidic acid:
Slovenian: Intravenska uporaba fusidne kisline:
English: Elimination half-life (hr)
Slovenian: Razpolovni čas izločanja (h)
English: Sugammadex is rapidly cleared in preclinical species, although residual sugammadex was observed in bone and teeth of juvenile rats.
Slovenian: Pri vrstah iz predkliničnih raziskav se sugamadeks izloča hitro, vendar so ostanke sugamadeksa opazili v kosteh in zobeh mladih podgan.
English: Re-administration of rocuronium or vecuronium after immediate reversal (16 mg/kg sugammadex): For the very rare cases where this might be required, a waiting time of 24 hours is suggested.
Slovenian: Ponovna uporaba rokuronija ali vekuronija po takojšnji prekinitvi blokade (16 mg/kg sugamadeksa): V zelo redkih primerih, kjer bi to lahko bilo potrebno, priporočamo časovni presledek 24 ur.
English: Bridion is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
Slovenian: Zdravilo Bridion je selektivni vezalec mišičnih relaksantov, saj deluje le s specifičnimi mišičnimi relaksanti, rokuronijevim bromidom ali vekuronijevim bromidom.
English: Bridion contains sodium Tell your anaesthetist if you are on a controlled salt diet.
Slovenian: Zdravilo Bridion vsebuje natrij Povejte anesteziologu, če ste na dieti z omejeno količino soli.
English: Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Slovenian: Ker pa mišični relaksanti sprostijo tudi dihalne mišice, potrebuje bolnik med operacijo in po njej pomoč pri dihanju (umetno predihavanje) tako dolgo, dokler ni spet zmožen dihati samostojno.
English: Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events.
Slovenian: Simptomi, povezani s temi reakcijami, so lahko: zardevanje, urtikarija, eritematozni izpuščaj, (huda) hipotenzija, tahikardija, otekanje jezika, otekanje žrela, bronhospazem in učinki, povezani z obstrukcijo pljuč.
English: It does this by combining with the rocuronium bromide or vecuronium bromide in your body.
Slovenian: Zdravilo to doseže z vezavo rokuronijevega bromida ali vekuronijevega bromida v vašem telesu.
English: • if you have liver disease or have had it in the past.
Slovenian: • če imate ali ste imeli kdaj v preteklosti bolezni jeter,
English: For paediatric patients Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see section 6.3).
Slovenian: Za pediatrične bolnike lahko zdravilo Bridion redčimo z raztopino natrijevega klorida 9 mg/ml (0,9 %) do koncentracije 10 mg/ml (glejte poglavje 6.3).
English: Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Slovenian: Sicer je na voljo malo podatkov o prekinitvi blokade živčnomišičnega prenosa, dosežene s pankuronijem, vendar svetujemo, da v tem primeru ne uporabite sugamadeksa.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sugammadex therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s sugamadeksom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Interactions due to the lasting effect of rocuronium or vecuronium:
Slovenian: Interakcije zaradi podaljšanega učinka rokuronija ali vekuronija:
English: In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).
Slovenian: V primeru, da opazite ponovitev živčnomišične blokade, bo bolnik lahko potreboval umetno predihavanje in ponovno uporabo sugamadeksa (glejte poglavje 4.2).
English: Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Bridion to the mother.
Slovenian: Vaš anesteziolog vam bo pomagal pri odločitvi med prenehanjem dojenja ali prekinitvijo zdravljenja s sugamadeksom, ob upoštevanju prednosti dojenja za otroka in prednosti zdravila Bridion za mater.
English: Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
Slovenian: Čeprav je čas popuščanja živčnomišične blokade pri starostnikih daljši, veljajo zanje enaka priporočila za odmerjanje kot za vse odrasle bolnike (glejte poglavje 4.4).
English: There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
Slovenian: Ni podatkov, na podlagi katerih bi lahko priporočili uporabo sugamadeksa za takojšnjo prekinitev z vekuronijem povzročene živčnomišične blokade.
English: The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri kirurških bolnikih so bili kašelj, zapleti v dihalnih poteh pri anesteziji, zapleti pri anesteziji, s posegom povezana hipotenzija in s posegom povezan zaplet (pogosti (≥ 1/100 do < 1/10)).
English: Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/mL (peak plasma level following 8 mg/kg bolus injection).
Slovenian: Motnje te preiskave opažamo pri plazemski koncentraciji sugamadeksa 100 mikrogramov/ml (največja plazemska koncentracija po bolusni injekciji odmerka 8 mg/kg).
English: Each mL solution contains up to 9.7 mg sodium.
Slovenian: En ml raztopine vsebuje do 9,7 mg natrija.
English: In one study, sugammadex was administered following rocuronium induced blockade at 1-2 PTCs (4 mg/kg; N=68); in the other study, sugammadex was administered at reappearance of T2 (2 mg/kg; N=30).
Slovenian: V eni študiji so sugamadeks dajali po blokadi, povzročeni z rokuronijem, pri PTCs 1-2 (4 mg/kg; N=68), v drugi študiji pa so sugamadeks dajali pri ponovnem pojavu T2 (2 mg/kg; N=30).
English: Frequencies
Slovenian: Pogostnost
English: A summary of sugammadex pharmacokinetic parameters stratified by age and renal function is presented below:
Slovenian: Povzetek farmakokinetičnih parametrov sugamadeksa glede na starost in delovanje ledvic je prikazan v spodnji preglednici:
English: Based on the clinical data-base (N=3,519) and on a specific study in 1184 patients undergoing hip fracture/major joint replacement surgery there was no clinically relevant effect of sugammadex 4 mg/kg alone or in combination with anticoagulants on the incidence of peri- or post-operative bleeding complications.
Slovenian: Po podatkih iz klinične podatkovne baze (N=3.519) in iz študije pri 1.184 bolnikih z operacijo zaradi zloma kolka/zamenjave večjega sklepa pri uporabi sugamadeksa samega v odmerku 4 mg/kg ali v kombinaciji z antikoagulanti ni bilo nobenega klinično pomembnega učinka na incidenco perioperativnih ali postoperativnih hemoragičnih zapletov.
English: There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
Slovenian: O zvečani pogostnosti ali resnosti preobčutljivosti po večkratnem odmerjanju sugamadeksa ni bilo nobenega dokaza.
English: Conditions associated with prolonged circulation time such as cardiovascular disease, old age (see section 4.2 for the time to recovery in elderly), or oedematous state (e.g., severe hepatic impairment) may be associated with longer recovery times.
Slovenian: Stanja, ki so povezana s podaljšanjem cirkulacijskega časa, kot so bolezni srca in ožilja, starost (za čas popuščanja živčnomišične blokade pri starostnikih glejte poglavje 4.2) ali edematozna stanja (npr. huda jetrna okvara), so lahko povezana z upočasnjenim popuščanjem blokade.
English: Additional information on special populations
Slovenian: Dodatne informacije za posebne skupine bolnikov
English: Caution should be exercised when considering the use of sugammadex in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy (see section 4.4).
Slovenian: Previdnost je potrebna pri odločitvi glede uporabe sugamadeksa pri bolnikih s hudo jetrno okvaro ali z jetrno okvaro s spremljajočo koagulopatijo (glejte poglavje 4.4).
English: The following adverse reactions were reported in placebo controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1,078 subject exposures to sugammadex versus 544 to placebo): [Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)]
Slovenian: V s placebom nadzorovanih kliničnih preskušanjih, kjer so osebe prejele anestezijo in/ali živčnomišične relaksante (1.078 oseb je prejelo sugamadeks, 544 pa placebo) so poročali o naslednjih neželenih učinkih: [zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/.000), zelo redki (< 1/10.000)]
English: 2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
Slovenian: Viale z 2 ml ali 5 ml raztopine iz stekla tipa I, zaprte z zamaškom iz klorobutilne gume in zgubano aluminijasto zaporko z odmično ploščico.
English: If you have any further questions on the use of this medicine, ask your anaesthetist or other doctor.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z anesteziologom ali z drugim zdravnikom.
English: Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
Slovenian: Poročali so o fizikalni nezdružljivosti zdravila z verapamilom, ondansetronom in ranitidinom.
English: Immediate reversal of rocuronium-induced blockade:
Slovenian: Takojšnja prekinitev z rokuronijem povzročene blokade:
English: Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations.
Slovenian: Sugamadeksa ne smete uporabljati za prekinitev blokade živčnomišičnega prenosa, dosežene z drugimi steroidnimi mišičnimi relaksanti in ne rokuronijem ali vekuronijem, ker ni podatkov o varnosti in učinkovitosti v teh primerih.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: 1.2 mg/kg rocuronium
Slovenian: 1,2 mg/kg rokuronija
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso omenjeni v tem navodilu.
English: Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Slovenian: Drugih primerov rutinske prekinitve živčnomišične blokade niso proučevali, zato v njih uporabe zdravila ne priporočamo, dokler ne bo na voljo več podatkov.
English: When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
Slovenian: Pri namerni prekinitvi blokade živčnomišičnega prenosa med anestezijo so v kliničnih preskušanjih občasno opazili znake plitve anestezije (premikanje bolnika, kašelj, grimase in sesanje dihalne cevke).
English: Reports of suspected hypersensitivity were adjudicated by a blinded committee.
Slovenian: Poročila domnevne preobčutljivosti je ocenjevala komisija, ki ni imela podatkov o zdravljenju (blinded committee).
English: Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required.
Slovenian: Tudi če živčnomišična blokada že popolnoma popusti, lahko druga zdravila, ki jih uporabljamo v času pred operacijo ali po njej, oslabijo dihalno funkcijo in bolnik kljub temu še vedno potrebuje umetno predihavanje.
English: This is important as Bridion is removed from your body by the kidneys.
Slovenian: Bridion odstranjuje iz telesa skozi ledvice,
English: EXP After first opening and dilution, store at 2-8°C and use within 24 hours.
Slovenian: EXP Po prvem odprtju in razredčitvi shranjujte pri temperaturi 2 - 8 °C in uporabite v 24 urah.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential, and toxicity to reproduction, local tolerance or compatibility with blood.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja ter lokalnega prenašanja zdravila ali njegove združljivosti s krvjo ne kažejo posebnega tveganja za človeka.