FrancophonIA/ELRC3.0 huggingface dataset:
English: Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula.
Slovenian: Lucentis je zdravilo za zdravljenje odraslih z določenimi težavami z vidom, ki jih povzročajo poškodbe mrežnice (na svetlobo občutljive plasti v zadnjem delu očesa), zlasti pa njenega osrednjega dela, imenovanega makula ali rumena pega.
English: Lucentis is available as a solution for injection in prefilled syringes or vials, for single use.
Slovenian: Zdravilo Lucentis je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah ali vialah za enkratno uporabo.
English: The main measure of effectiveness in both was the change in vision using a standard eye test with a letter chart.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bila sprememba vida, ocenjena na podlagi standardnega testa vida na črkovni tabeli.
English: The company that makes Lucentis will provide information packs to patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.
Slovenian: Podjetje, ki izdeluje zdravilo Lucentis, bo bolnikom zagotovilo komplet navodil, ki bodo vsebovala informacije o pripravi na zdravljenje ter nasvete za prepoznavanje hudih neželenih učinkov in stanj, ko morajo poiskati nujno zdravniško pomoč.
English: How does Lucentis work?
Slovenian: Kako zdravilo Lucentis deluje?
English: Lucentis was more effective at improving vision than its comparison treatments.
Slovenian: Zdravilo Lucentis je bilo učinkovitejše pri izboljšanju vida kot primerjalna zdravljenja.
English: • macular oedema (swelling of the macula) caused by diabetes;
Slovenian: • makularnega edema (otekanja makule), ki ga povzroča sladkorna bolezen,
English: Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.
Slovenian: Zdravilo Lucentis je bilo učinkovitejše od navideznih injekcij: bolniki, ki so šest mesecev prejemali zdravilo Lucentis v odmerku 0,5 mg, so lahko v prvi študiji videli 11 črk več , v drugi študiji pa 14 črk več kot bolniki, ki so prejemali navidezne injekcije.
English: For macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection.
Slovenian: Pri makularnem edemu zaradi zapore mrežničnih ven so zdravilo Lucentis proučevali v dveh glavnih študijah, ki sta vključevali 789 bolnikov in v katerih so zdravilo Lucentis primerjali z navideznimi injekcijami.
English: One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness).
Slovenian: V prvi študiji so zdravilo Lucentis primerjali s fotodinamično terapijo z verteporfinom pri 277 bolnikih s horoidalno neovaskularizacijo, povezano s patološko kratkovidnostjo (hudo obliko kratkovidnosti).
English: Choroidal neovascularisation
Slovenian: Horoidalna neovaskularizacija
English: The first study compared Lucentis with a sham injection.
Slovenian: V prvi študiji so zdravilo Lucentis primerjali z navideznimi injekcijami.
English: By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
Slovenian: Ranibizumab z zaviranjem tega dejavnika zmanjšuje rast krvnih žil ter nadzoruje iztekanje tekočine in krvi iz njih in otekanje.
English: The patients cannot tell whether they received Lucentis or the sham procedure.
Slovenian: Bolniki pri tem ne vedo, ali so prejeli zdravilo Lucentis ali le navidezno injekcijo.
English: In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own.
Slovenian: V drugi študiji so bolniki, ki so prejemali zdravilo Lucentis, bodisi kot samostojno zdravilo bodisi kot dodatek k laserski fotokoagulaciji, po enem letu videli povprečno pet črk več kot bolniki, ki so bili zdravljeni le z lasersko fotokoagulacijo.
English: How is Lucentis used?
Slovenian: Kako se zdravilo Lucentis uporablja?
English: Treatment with Lucentis is started with one injection every month, with regular checks of the patient's vision and the appearance of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity; the monitoring and treatment intervals should then be determined by the treating doctor depending on the patient's condition and response.
Slovenian: Zdravljenje z zdravilom Lucentis se začne z eno injekcijo na mesec, čemur sledijo redni pregledi bolnikovega vida in videza zadnjega dela očesa, dokler se ne doseže ustrezno dober vid in/ali odpravijo znaki bolezni.
English: For choroidal neovascularisation other than that associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year.
Slovenian: V okviru horoidalne neovaskularizacije, ki ni povezana z vlažno obliko starostne degeneracije makule, so zdravilo Lucentis proučevali v dveh glavnih študijah, od katerih je vsaka trajala leto dni.
English: In the first study, lasting one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections.
Slovenian: V prvi študiji, ki je trajala eno leto, so bolniki, ki so prejemali zdravilo Lucentis, videli okoli šest črk več kot tisti, ki so prejemali navidezne injekcije.
English: Lucentis must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.
Slovenian: Zdravila Lucentis ne smejo uporabljati bolniki, ki utegnejo imeti vneto oko ali področje okoli očesa, ali bolniki s hudim vnetjem znotraj očesa.
English: The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD).
Slovenian: V tretji študiji so zdravilo Lucentis primerjali s fotodinamično terapijo z verteporfinom (PDT), tj. drugo vrsto zdravljenja starostne degeneracije makule.
English: The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own.
Slovenian: V drugi študiji so zdravilo Lucentis, injicirano bodisi kot samostojno zdravilo bodisi kot dodatek k laserski fotokoagulaciji (zdravljenju makularnega edema zaradi sladkorne bolezni z uporabo laserja), primerjali z lasersko fotokoagulacijo kot samostojnim zdravljenjem.
English: It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.
Slovenian: Predpisovanje in izdaja zdravila Lucentis je le na recept, injicirati pa ga mora specialist oftalmolog, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: After 2 months of treatment, patients given Lucentis could see around 10 letters more on average than those given sham treatment.
Slovenian: Po dveh mesecih zdravljenja so lahko bolniki, ki so prejemali zdravilo Lucentis, v povprečju videli okoli deset črk več kot tisti, ki so prejemali navidezne injekcije.
English: Macular oedema due to occlusion of retinal veins
Slovenian: Makularni edem zaradi zapore mrežničnih ven
English: • macular oedema caused by occlusion (blockage) of the veins behind the retina.
Slovenian: • makularnega edema, ki ga povzroča okluzija (zapora) ven za mrežnico.
English: On average over the first 3 months of treatment, patients given Lucentis could see around 8 to 9 letters more than those receiving verteporfin PDT.
Slovenian: V povprečju so lahko v prvih treh mesecih bolniki, ki so prejemali zdravilo Lucentis, videli od osem do devet črk več kot tisti, ki so prejemali fotodinamično terapijo z verteporfinom.
English: For the full list of all side effects of Lucentis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lucentis, glejte navodilo za uporabo.
English: The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.
Slovenian: Poleg tega je v študiji, v kateri so injekcije dajali manj pogosto, in sicer prve tri mesece vsak mesec, nato pa vsake tri mesece, vid bolnikov, ki so prejemali zdravilo Lucentis, ostal boljši kot vid bolnikov, ki so prejemali navidezne injekcije.
English: Diabetic macular oedema
Slovenian: Makularni edem zaradi sladkorne bolezni
English: This summary was last updated in 11-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2009.
English: Ref.: EMEA/634501/2009 EMEA/H/C/1066
Slovenian: : EMEA/649375/2009 EMEA/H/C/1066
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; pink: 2 mg).
Slovenian: Na voljo je v obliki okroglih tablet (belih: 0,5 mg; rumenih: 1 mg; rožnatih: 2 mg).
English: Repaglinide Krka is taken before meals, normally up to 15 minutes before each main meal.
Slovenian: Zdravilo Repaglinid Krka se jemlje pred obroki, po navadi največ 15 minut pred vsakim glavnim obrokom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Krka to Krka, d.d., Novo mesto on 4 November 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Repaglinide Krka, veljavno po vsej Evropski uniji, odobrila družbi Krka, d.d., Novo mesto, dne 4. novembra 2009.
English: Repaglinide Krka repaglinide
Slovenian: Repaglinide Krka repaglinid
English: Repaglinide Krka is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Slovenian: Uporaba zdravila Repaglinide Krka pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: This means that Repaglinide Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
English: What are the benefit and risk of Repaglinide Krka?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Repaglinide Krka?
English: Repaglinide Krka is a ‘generic medicine'.
Slovenian: Repaglinid Krka je „generično zdravilo“.
English: Other information about Repaglinide Krka:
Slovenian: Druge informacije o zdravilu Repaglinide Krka:
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Slovenian: Uporablja se skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni mogoče nadzorovati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Krka has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repaglinide Krka primerljivo raven kakovosti kot zdravilo NovoNorm ter da mu je biološko enakovredno.
English: The Committee recommended that Repaglinide Krka be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Repaglinide Krka odobri dovoljenje za promet.
English: Because Repaglinide Krka is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Slovenian: Ker je zdravilo Repaglinide Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Repaglinide Krka is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Repaglinid Krka se uporablja pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina).
English: Repaglinide Krka can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Slovenian: Zdravilo Repaglinide Krka se lahko uporabi tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so ravni glukoze v krvi po navadi dobro nadzorovane z dieto, vendar doživljajo obdobja prehodne izgube nadzora.
English: Because Repaglinide Krka is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Slovenian: Ker je zdravilo Repaglinide Krka generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu NovoNorm.
English: Repaglinide Krka is a medicine that contains the active substance repaglinide.
Slovenian: Repaglinid Krka je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
English: Repaglinide Krka helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Slovenian: Zdravilo Repaglinide Krka spodbuja trebušno slinavko, da med obroki tvori več insulina, zato se uporablja za nadzor sladkorne bolezni tipa 2.
English: Why has Repaglinide Krka been approved?
Slovenian: Zakaj je bilo zdravilo Repaglinide Krka odobreno?
English: The full EPAR for Repaglinide Krka can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Repaglinide Krka je na voljo tukaj.
English: What is Repaglinide Krka?
Slovenian: Kaj je zdravilo Repaglinid Krka?
English: What is Repaglinide Krka used for?
Slovenian: Za kaj se zdravilo Repaglinid Krka uporablja?
English: How has Repaglinide Krka been studied?
Slovenian: Kako je bilo zdravilo Repaglinide Krka raziskano?
English: How is Repaglinide Krka used?
Slovenian: Kako se zdravilo Repaglinide Krka uporablja?
English: D - 133 42 Berlin, Germany Telephone: +49 30 468-1111
Slovenian: D 13342 Berlin, Nemčija Telefon: +49 30 468-1111
English: Before you receive Gadograf, tell your doctor if any of these applies to you.
Slovenian: Preden vam dajo zdravilo Gadograf, obvestite zdravnika, če karkoli od naštetega velja za vas.
English: Tell your doctor if you are pregnant or could be pregnant, since Gadograf should not be used during pregnancy unless it is considered absolutely necessary.
Slovenian: Povejte zdravniku, če ste noseči ali bi lahko bili noseči, ker se zdravilo Gadograf med nosečnostjo ne sme uporabljati, razen če je nujno.
English: - If you are younger than 18, use of Gadograf is not recommended.
Slovenian: - Če ste mlajši od 18 let, uporaba zdravila Gadograf ni priporočena.
English: The passage of Gadograf into breast milk has not been investigated in humans so far.
Slovenian: Prehajanja zdravila Gadograf v materino mleko pri ljudeh doslej ni bilo raziskano.
English: Gadograf should not be used in patients with uncorrected hypokalemia.
Slovenian: Zdravilo Gadograf se ne sme uporabljati pri bolnikih z nekorigirano hipokaliemijo.
English: If you have any further questions, please ask your doctor or the person giving you Gadograf (the radiologist) or the hospital/MRI-centre personnel.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom ali osebo, ki vam daje zdravilo Gadograf (radiologom), ali z bolnišničnim osebjem/osebjem oddelka za magnetnoresonančno slikanje.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravil ne smete odvreči v odpadne vode ali gospodinjske odpadke.
English: In patients with severe cardiovascular disease Gadograf should only be administered after careful risk benefit assessment because only limited data are available so far.
Slovenian: Pri bolnikih s hudimi kardiovaskularnimi boleznimi se lahko zdravilo Gadograf uporablja samo po skrbni oceni razmerja tveganja in koristi, ker so za zdaj na voljo le omejeni podatki.
English: A label extension to the indication “Contrastenhanced Magnetic resonance angiography” (CE-MRA) followed in November 2003.
Slovenian: Razširitev označevanja na indikacijo „izboljšanje kontrasta pri magnetno resonančni angiografiji“ (CE-MRA) je sledila novembra 2003.
English: Gadograf 1.0 mmol/ml (INN gadobutrol) was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” (MRI) in Germany in January 2000 and subsequently in July 2001 in Spain via the mutual recognition procedure.
Slovenian: Gadograf 1,0 mmol/ml (INN gadobutrol) je bil januarja 2000 v Nemčiji odobren za „izboljšanje kontrasta pri magnetnem resonančnem slikanju možganov in hrbtenice“, po postopku medsebojnega priznavanja pa nato julija 2001 v Španiji.
English: T1 -weighted scanning sequences are particularly suitable for contrast-enhanced examinations.
Slovenian: T1 - obtežena zaporedja so zlasti primerna za kontrastne preiskave.
English: In particularly severe cases, it is advisable to remove Gadograf from the body by extracorporeal haemodialysis: For removal of the agent from the body, at least 3 dialysis sessions within 5 days of the injection should be performed.
Slovenian: V posebno hudih primerih se priporoča odstranjevanje zdravila Gadograf iz telesa z zunajtelesno hemodializo: za odstranjevanje zdravila iz telesa je treba v petih dneh od injiciranja opraviti vsaj tri dialize.
English: The actual dosage of Gadograf that is right for you will depend on your body weight and on the region of examination:
Slovenian: Dejanski odmerek zdravila Gadograf, ki je primeren za vas, bo odvisen od vaše telesne mase in mesta preiskave.
English: Tissue enhancement generally lasts up to 45 minutes after injection of Gadograf.
Slovenian: Povečanje kontrasta tkiva traja na splošno do 45 minut po injiciranju zdravila Gadograf.
English: Like all medicines, Gadograf can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Gadograf neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If you receive more GADOGRAF than you should have received:
Slovenian: Če ste prejeli večji odmerek zdravila GADOGRAF, kot bi smeli:
English: Average specificity in a patientbased analysis was 52% and in a lesion-based analysis 82%.
Slovenian: Povprečna specifičnost je bila pri analizi na temelju števila bolnikov 52 %, pri analizi na temelju števila lezij pa 82 %.
English: the Committee considered the referral made under Article 36(1) of Directive 2001/83/EC, as amended for Gadograf detailed in Annex I;
Slovenian: Ob upoštevanju, da je Odbor upošteval napotitveni postopek v skladu s členom 36(1) Direktive 2001/83/ES, kot je bila spremenjena, za zdravilo Gadograf in z njim povezana imena, ki so navedena v Dodatku I;
English: Further information regarding the use of Gadograf is given in section 3 of the leaflet.
Slovenian: Dodatne informacije o uporabi zdravila Gadograf so v poglavju 3 tega navodila za uporabo.
English: Gadograf should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Gadograf ne smete uporabljati med nosečnostjo, razen če je nujno.
English: Hypersensitivity reactions, as have been reported for other contrast media containing gadolinium, have also been observed after administration of Gadograf.
Slovenian: Preobčutljivostne reakcije, o katerih so poročali pri uporabi drugih kontrastnih sredstev, ki vsebujejo gadolinij, so opazili tudi po uporabi zdravila Gadograf.
English: Further information regarding the administration and handling of Gadograf is given at the end of the leaflet.
Slovenian: Dodatne informacije o uporabi zdravila Gadograf in ravnanju z njim so na koncu teh navodil.
English: Side effects which have been observed in clinical trials before the approval of Gadograf: Uncommon
Slovenian: Neželeni učinki, ki so jih opazili v kliničnih preskušanjih pred odobritvijo uporabe zdravila Gadograf: Občasni
English: Gadograf should be used with special care in patients - with known congenital long QT syndrome or a family history of congenital long QT syndrome - with known previous arrhythmias after taking medicinal products that prolong cardiac repolarisation - who are currently taking a medicinal product that is known to prolong cardiac repolarisation e.g. a Class III antiarrhythmic (e.g. amiodarone, sotalol).
Slovenian: Zdravilo Gadograf je treba uporabljati posebno previdno pri bolnikih: - z znanim sindromom prirojenega dolgega intervala QT ali družinsko anamnezo sindroma prirojenega dolgega intervala QT; - z aritmijami, ki so se v preteklosti pojavile po jemanju zdravil, ki podaljšajo repolarizacijo srca; - ki trenutno jemljejo zdravila, za katera je znano, da podaljšujejo repolarizacijo srca, npr. antiaritmike III skupine (npr. amiodaron, sotalol).
English: Optimal opacification is observed during arterial first pass for CE-MRA and within a period of about 15 minutes after injection of Gadograf for CNS indications (time depending on type of lesion/tissue).
Slovenian: Opacifikacija za slikanje CE-MRA je optimalna med prvim arterijskim prehodom, za indikacije pri slikanju CŽS pa v obdobju približno 15 minut po injiciranju zdravila Gadograf (čas je odvisen od vrste lezije/tkiva).
English: Gadograf was the first paramagnetic contrast agent developed in a 1.0 molar solution thus requiring a smaller application volume in a higher dosage.
Slovenian: Gadograf je prvo paramagnetno kontrastno sredstvo s koncentracijo 1,0 mol, kar omogoča manjši aplikacijski volumen pri višjih odmerkih.
English: Moreover, the wording of the indication should also reflect the clinical context for which Gadograf has demonstrated to have the same diagnostic accuracy than its comparator, that is to correctly localise at least one malignant lesion of liver or kidney in an individual patient using combined pre- and post-contrast MR images.
Slovenian: Poleg tega mora besedilo indikacije odražati tudi klinični kontekst, v katerem je bila za Gadograf dokazana enaka diagnostična natančnost kot za primerjalno zdravilo, kar pomeni pravilno lokalizacijo najmanj ene maligne lezije v jetrih ali ledvicah pri posameznem bolniku na osnovi kombiniranja kontrastiranih MRI slik pred in potem.
English: Gadograf This leaflet was last approved in {MM/YYYY}.
Slovenian: Gadograf Navodilo je bilo odobreno {MM/LLLL}.
English: WHAT GADOGRAF IS AND WHAT IT IS USED FOR
Slovenian: Kaj je zdravilo GADOGRAF in za kaj ga uporabljamo 2.
English: While injecting Gadograf into veins with a small lumen there is the possibility of adverse effects such as reddening and swelling.
Slovenian: Pri injiciranju zdravila Gadograf v vene z majhno svetlino obstaja možnost neželenih učinkov, kot sta pordelost in otekanje.
English: Additional side effects which have been reported after the approval of Gadograf:
Slovenian: Drugi neželeni učinki, o katerih so poročali po odobritvi uporabe zdravila Gadograf:
English: A single injection of 0.1 millilitre Gadograf per kg body weight is generally sufficient (this means for a person weighing 70 kg the dose would be 7 millilitres).
Slovenian: Na splošno zadostuje enkratno injiciranje 0,1 mililitra zdravila Gadograf na kg telesne mase (to pomeni, da bi bil za osebo, ki tehta 70 kg, odmerek 7 mililitrov).
English: Schering Deutchland GmbH
Slovenian: Schering Deutchland GmbH Max-Dohrn-Strasse 10
English: The possibility that Gadograf may cause torsade de pointes arrhythmias in an individual patient cannot be excluded (see section 5.3 Preclinical safety data).
Slovenian: Možnosti, da lahko zdravilo Gadograf pri posameznih bolnikih povzroči aritmije torsade de pointes, ni mogoče izključiti (glejte poglavje 5.3 Predklinični podatki o varnosti).