FrancophonIA/ELRC3.0 huggingface dataset:
English: Toxicity observed following multiple doses of verteporfin without light was associated mainly with effects on the haematopoietic system.
Slovenian: Toksičnost, ki so jo opažali po večkratnih odmerkih verteporfina brez osvetlitve, je večinoma povezana z učinki na hematopoetski sistem.
English: Patients should not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help eliminate the medicinal product quickly through the skin by a process called photobleaching.
Slovenian: Bolniki naj ne bodo v temi in jih je treba spodbujati, da izpostavljajo kožo okolni svetlobi v zaprtih prostorih, ker bo to pomagalo hitro odstraniti zdravilo iz telesa skozi kožo s procesom, ki se imenuje fotobeljenje.
English: Studies in animals have shown teratogenic effects in one species (rat) (see section 5.3).
Slovenian: Študije na živalih so pokazale teratogene učinke pri eni živalski vrsti (podgana) (glejte poglavje 5.3).
English: Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD.
Slovenian: Verteporfin, imenovan tudi enokislinski derivat benzoporfirina (BPD-MA), je sestavljen iz mešanice enako aktivnih regioizomer BPD-MAC in BPD-MAD v razmerju 1:1.
English: However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion.
Slovenian: Če pa je zdravljenje drugega očesa potrebno, je treba drugo oko osvetliti takoj po koncu osvetljevanja prvega očesa, vendar najpozneje 20 minut od začetka infundiranja.
English: It produces cytotoxic agents only when activated by light in the presence of oxygen.
Slovenian: Iz njega nastajajo citotoksične spojine le takrat, ko se aktivira s svetlobo v prisotnosti kisika.
English: Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process.
Slovenian: Predhodno dajanje difenhidramina je te učinke ublažilo, kar kaže na možno vpletenost histamina v ta proces.
English: - Do not stay in the dark because exposure to normal indoor lighting will help your body to eliminate Visudyne more quickly.
Slovenian: - Ne zadržujte se v temi, ker bo izpostavljanje normalni svetlobi v zaprtih prostorih pomagalo telesu, da hitreje izloči zdravilo Visudyne.
English: To ensure treatment of poorly demarcated lesion borders, an additional margin of 500 µm should be added around the visible lesion.
Slovenian: Zdravljenje slabo omejenih meja lezije se zagotovi tako, da se okrog vidne lezije doda še pas, širok 500 µm.
English: Results indicate that, at 12 months, Visudyne was statistically superior to placebo in terms of the proportion of patients responding to the treatment.
Slovenian: Rezultati kažejo, da je bilo po 12 mesecih zdravilo Visudyne statistično boljše od placeba glede deleža bolnikov, ki so se odzvali na zdravljenje.
English: Free radical scavengers
Slovenian: Lovilci prostih radikalov
English: Singlet oxygen causes damage to biological structures within the diffusion range, leading to local vascular occlusion, cell damage and, under certain conditions, cell death.
Slovenian: Singlet kisik povzroča poškodbe bioloških struktur v dosegu difuzije, kar povzroči lokalno vaskularno okluzijo, celične okvare, v določenih razmerah pa tudi smrt celic.
English: The maximum spot size used for the first treatment in the clinical studies was 6,400 m.
Slovenian: V kliničnih študijah je bila največja velikost osvetljenega predela pri prvem zdravljenju 6.400 µm.
English: Partial recovery of vision was observed in some patients.
Slovenian: Pri nekaterih bolnikih so opažali delno ponovno izboljšanje vida.
English: Agents which increase verteporfin uptake in the vascular endothelium
Slovenian: Zdravila, ki povečujejo privzem verteporfina v vaskularnem endoteliju
English: Pregnancy and breast-feeding - There is very little experience of using Visudyne in pregnant women.
Slovenian: Nosečnost in dojenje - Izkušenj z uporabo zdravila Visudyne pri nosečnicah je zelo malo.
English: Single and repeated dose toxicity
Slovenian: Toksičnost posameznih in ponavljajočih se odmerkov
English: Combined excretion of verteporfin and BPD-DA in human urine was less than 1%, suggesting biliary excretion.
Slovenian: Kombinirano izločanje verteporfina in BPD-DA v človeškem urinu je bilo manjše od 1 %, kar kaže na izločanje z žolčem.
English: Photosensitivity reactions (in 2.2 % of patients and <1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
Slovenian: Fotosenzitivnostne reakcije (pri 2,2 % bolnikov in < 1 % ciklusov zdravljenja z zdravilom Visudyne) so se pojavljale v obliki sončnih opeklin po izpostavljanju sončni svetlobi, običajno v 24 urah po zdravljenju z zdravilom Visudyne.
English: What you need to know before you are given Visudyne
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Visudyne
English: If you are given more Visudyne than you should be Overdose of Visudyne may prolong the time during which you are sensitive to light and you may need to follow the protection instructions given in section 2 for longer than 48 hours.
Slovenian: Če ste dobili večji odmerek zdravila Visudyne, kot bi smeli Prevelik odmerek zdravila Visudyne lahko podaljša obdobje, v katerem boste preobčutljivi za svetlobo in morda boste morali več kot 48 ur upoštevati navodila za zaščito pred svetlobo iz poglavja 2.
English: Effects of gender At the intended dose, pharmacokinetic parameters are not significantly affected by gender.
Slovenian: Pri predvidenem odmerku spol ne vpliva bistveno na farmakokinetične parametre zdravila.
English: If this happens, the infusion needs to be stopped and the skin treated with cold compresses and thoroughly protected from light until the skin colour returns to normal.
Slovenian: V tem primeru je treba infundiranje prekiniti, kožo pa zdraviti s hladnimi obkladki in jo temeljito zaščititi pred svetlobo, dokler barva kože ne postane spet normalna.
English: BPD-DA is also a photosensitiser but its systemic exposure is low (5-10% of the verteporfin exposure, suggesting that most of the active substance is eliminated unchanged).
Slovenian: Tudi BPD-DA je fotosenzitizator, vendar gre pri njem za majhno sistemsko izpostavljenost (5-10 % izpostavljenosti verteporfinu, kar kaže na to, da se večina zdravilne učinkovine odstrani iz telesa v nespremenjeni obliki).
English: The primary efficacy parameter was the same as in TAP (see above), with an additional endpoint of month 24 defined.
Slovenian: Primarni parameter učinkovitosti je bil enak kot pri TAP (glejte zgoraj), z dodatnim rokom opazovanja po 24 mesecih.
English: Name and address of manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion.
Slovenian: Za zdravljenje lezij, večjih od največje velikosti osvetljenega predela, je treba svetlobo usmeriti na največji možni predel aktivne lezije.
English: - If you experience any eye problems after the treatment, such as a vision loss, talk to your doctor.
Slovenian: - Če opazite kakšne težave z očmi po zdravljenju, na primer slabšanje vida, obvestite svojega zdravnika.
English: In human plasma, 90% of verteporfin is associated with plasma lipoprotein fractions and approximately 6% are associated with albumin.
Slovenian: V človeški plazmi je 90 % verteporfina vezanega na frakcije plazemskih lipoproteinov in približno 6 % na albumine.
English: Half-life, however, was significantly increased by approximately 20%.
Slovenian: V nasprotju z njima pa je bil razpolovni čas pri teh bolnikih bistveno daljši, in sicer za približno 20 %.
English: The objective was to demonstrate the long-term efficacy and safety of photodynamic therapy with verteporfin in limiting the decrease in visual acuity in patients with subfoveal choroidal neovascularisation due to age-related macular degeneration.
Slovenian: Cilj je bil prikazati dolgoročno učinkovitost in varnost fotodinamične terapije z verteporfinom pri omejevanju zmanjševanja ostrine vida pri bolnikih s subfovealno horioidalno neovaskularizacijo zaradi starostne degeneracije makule.
English: The safety and efficacy of Visudyne in the paediatric population have not been established.
Slovenian: Varnost in učinkovitost zdravila Visudyne pri pediatrični populaciji nista bili dokazani.
English: In whole human blood, 90% of verteporfin is associated with plasma and 10 % associated with blood cells, of which very little was membrane associated.
Slovenian: V polni človeški krvi je 90 % verteporfina vezanega v plazmi, 10 % pa na krvne celice, od tega ga je zelo malo vezanega na membrane.
English: In the event of suspected heart attack, seek medical attention immediately.
Slovenian: Pri sumu na miokardni infarkt takoj poiščite zdravniško pomoč.
English: It is used as a light-activated medicinal product (photosensitiser).
Slovenian: Uporablja se kot zdravilo, ki se aktivira s svetlobo (fotosenzitizator).
English: In sedated or anaesthetised pigs, a Visudyne dose significantly higher than the recommended dose in patients given as a bolus injection caused severe haemodynamic effects including death, probably as a result of complement activation.
Slovenian: Pri sediranih ali anesteziranih prašičih je odmerek zdravila Visudyne, ki je bil bistveno večji od priporočenega odmerka za bolnike, dan v obliki bolusne injekcije, povzročil hude hemodinamske učinke, vključno s smrtjo, verjetno zaradi aktivacije komplementa.
English: Cmax after a 10-minute infusion of 6 and 12 mg/m body surface area in the target population is approximately 1.5 and 3.5 µg/ml, respectively.
Slovenian: Cmax po 10-minutnem infundiranju 6 oziroma 12 mg/m telesne površine v ciljni skupini je približno 1,5 oziroma 3,5 µg/ml.
English: Medicinal products which antagonise blood vessel occlusion
Slovenian: Zdravila, ki antagonizirajo okluzijo krvnih žil
English: Normal indoor lighting is safe.
Slovenian: Normalna svetloba v zaprtih prostorih je varna.
English: In vitro studies did not show any significant involvement of oxidative metabolism by cytochrome P450 enzymes.
Slovenian: Študije in vitro niso pokazale, da bi bila pomembno vpletena oksidativna presnova z encimi s citokromom P450.
English: The subgroup of patients with predominantly classic CNV lesions (N=243; Visudyne 159, placebo 84) were more likely to exhibit a larger treatment benefit.
Slovenian: Pri podskupini bolnikov, pri kateri so prevladovale klasične CNV lezije (N=243; Visudyne 159, placebo 84), je bila večja koristnost zdravljenja verjetnejša.
English: Caution should therefore be exercised when using Visudyne concomitantly with other photosensitising medicinal products (see “Photosensitivity and exposure to light” under section 4.4).
Slovenian: Iz tega razloga je pri sočasni uporabi zdravila Visudyne z drugimi zdravili, ki fotosenzitizirajo, potrebna previdnost (glejte podpoglavje “Fotosenzitivnost in izpostavljanje svetlobi” v poglavju 4.4).
English: Do not use normal sodium chloride solutions or other parenteral solutions.
Slovenian: Ne uporabljajte raztopine natrijevega klorida ali drugih parenteralnih raztopin.
English: Presence of occult CNV lesions (fluorescence not well demarcated on the angiogram) was allowed.
Slovenian: Dovoljena je bila prisotnost okultnih CNV lezij (slabo omejena fluorescenca na angiogramu).
English: The two regioisomers of verteporfin exhibit similar pharmacokinetic properties of distribution and elimination and thus both isomers are considered verteporfin as a whole from the pharmacokinetic perspective.
Slovenian: Dva regioizomera verteporfina imata podobne farmakokinetične lastnosti glede porazdelitve in izločanja, tako da s farmakokinetičnega vidika oba izomera skupaj predstavljata verteporfin.
English: Patients who experience a severe decrease of vision (equivalent to 4 lines or more) within one week after treatment should not be re-treated, at least until their vision has completely recovered to pretreatment level and the potential benefits and risks of subsequent treatment have been carefully considered by the treating physician.
Slovenian: Pri bolnikih, ki se jim v enem tednu po zdravljenju vid močno poslabša (ustrezno 4 vrstam ali več), se zdravljenja ne sme ponoviti vsaj toliko časa, dokler se jim vid ne izboljša na raven pred zdravljenjem in dokler zdravnik skrbno ne pretehta možnih koristi in tveganj nadaljnjega zdravljenja.
English: The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see “Method of administration”).
Slovenian: Druga stopnja je svetlobna aktivacija zdravila Visudyne 15 minut po začetku infundiranja (glejte podpoglavje “Način uporabe”).
English: If you have to go outdoors during daylight in the first 48 hours after treatment, you must protect your skin and eyes by wearing protective clothing and dark sunglasses.
Slovenian: Če morate iti na prosto čez dan v prvih 48 urah po zdravljenju, si morate zaščititi kožo in oči z zaščitnimi oblačili in temnimi sončnimi očali.
English: It will be administered by your doctor or nurse into a vein using a drip (intravenous infusion).
Slovenian: Zdravilo vam bosta dala zdravnik ali medicinska sestra, in sicer v veno s pomočjo infuzije (z intravensko infuzijo).
English: The renal excretion of verteporfin and its metabolite is minimal (<1% of the verteporfin dose) and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
Slovenian: Obseg izločanja verteporfina in njegovega presnovka preko ledvic je majhen (<1 % odmerka verteporfina), tako da pri bolnikih z okvaro ledvic klinično pomembne spremembe v izpostavljenosti verteporfinu niso zelo verjetne.
English: The reaction occurred mainly in patients with occult only (4.9 %) or minimally classic CNV lesions in patients with AMD and was not reported for placebo-treated patients.
Slovenian: To se je zgodilo zlasti pri bolnikih s samo okultnimi lezijami (4,9 %) ali pri bolnikih s starostno degeneracijo makule z minimalnimi klasičnimi horioidalnimi neovaskularnimi (CNV) lezijami, niso pa o tem poročali pri bolnikih, ki so prejeli placebo.
English: It is not known how the potential for DNA damage with PDT agents translates into human risk.
Slovenian: Ni znano, kaj navedeni potencial za okvaro DNA pri uporabi zdravil za fotodinamično terapijo pomeni za tveganje pri ljudeh.
English: In a study of patients with mild hepatic impairment (defined as having two abnormal hepatic function tests at enrolment), AUC and Cmax were not significantly different from the control group.
Slovenian: V študiji pri bolnikih z blago okvaro jeter (opredeljeno kot patološki izvid dveh jetrnih testov ob vključitvi v študijo) se vrednosti AUC in Cmax nista bistveno razlikovali od tistih pri kontrolni skupini.
English: On rare occasions the vasovagal and hypersensitivity reactions may be severe and potentially include seizures.
Slovenian: V redkih primerih so vazovagalne in preobčutljivostne reakcije lahko hude in lahko vključujejo krče.
English: Pharmacotherapeutic group: Ophthalmologicals, Antineovascularisation agents, ATC code: S01LA01
Slovenian: Farmakoterapevtska skupina: zdravila za očesne bolezni, zaviralci neovaskularizacije, oznaka ATC: S01LA01
English: Sunscreens offer no protection.
Slovenian: Zaščitni faktorji v kremah za sončenje ne nudijo nikakršne zaščite.
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 ljudi)
English: Age-related macular degeneration with predominantly classic subfoveal lesions
Slovenian: Starostna degeneracija makule s pretežno klasičnimi subfovealnimi lezijami
English: In patients followed from month 24 onwards and treated with uncontrolled, open-label Visudyne treatment as needed, long-term extension data suggest that month-24 vision outcomes may be sustained for up to 60 months.
Slovenian: Pri bolnikih, ki so jih od 24. meseca dalje spremljali v odprti nekontrolirani študiji in jih zdravili z zdravilom Visudyne po potrebi, pridobljeni podatki za dolgoročno podaljšanje terapije kažejo, da se izidi vida, doseženi v 24. mesecu, lahko vzdržujejo do 60. meseca.
English: Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.
Slovenian: Priporočamo uporabo standardnega filtra za infuzijske sisteme s hidrofilnimi membranami (na primer polietersulfon) in porami velikosti vsaj 1,2 μm.
English: If you come into direct contact with Visudyne, you must therefore wash it off thoroughly with water.
Slovenian: Če pridete v neposreden stik z zdravilom Visudyne, ga morate temeljito sprati z vodo.
English: When you are given an infusion of Visudyne, it is distributed within your body through the blood vessels, including the blood vessels at the back of the eye.
Slovenian: Ko dobite infuzijo zdravila Visudyne, se to razporedi po telesu tako, da potuje po krvnih žilah, med drugim tudi po krvnih žilah očesnega ozadja.
English: In such cases, the patient should prolong skin and eye protection from direct sunlight or bright indoor light for a period proportionate with the overdose given.
Slovenian: V takih primerih naj bolnik podaljša zaščito kože in oči pred neposredno sončno svetlobo ali močno umetno svetlobo za obdobje, sorazmerno prejetemu prevelikemu odmerku.
English: If patients have to go outdoors in daylight during the first 48 hours after treatment, they must protect their skin and eyes by wearing protective clothing and dark sunglasses.
Slovenian: Če morajo bolniki v prvih 48 urah po zdravljenju iti podnevi na prosto, si morajo zaščititi kožo in oči z zaščitnimi oblačili in temnimi sončnimi očali.
English: Protect the affected area thoroughly from bright direct light until swelling and discoloration have disappeared, and put cold compresses on the injection site.
Slovenian: Prizadeti predel mora biti temeljito zaščiten pred močno neposredno svetlobo, dokler oteklina in obarvanost ne izgineta, na mesto injiciranja pa je treba dati mrzle obkladke.
English: The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography.
Slovenian: Največja linearna dimenzija horioidalne neovaskularne lezije se oceni s fluoresceinsko angiografijo in fotografiranjem očesnega ozadja.
English: Verteporfin and its diacid metabolic are excreted in human milk in low amounts.
Slovenian: Verteporfin in njegov dvokislinski metabolit se izločata v materino mleko v majhnih količinah.
English: 5, infusion-related reaction primarily presented as back pain
Slovenian: 5, z infundiranjem povezana reakcija, ki se izraža predvsem kot bolečina v križu
English: Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
Slovenian: Imetnik dovoljenja za promet z zdravilom CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
English: Please tell your doctor if you are breastfeeding.
Slovenian: Povejte zdravniku, če dojite.
English: - If you have any liver problems or a blockage of your bile duct, please tell your doctor before starting Visudyne therapy.
Slovenian: - Če imate kakršnekoli težave z jetri ali zaporo odtoka žolča, povejte zdravniku še preden začnete zdravljenje z zdravilom Visudyne.
English: For the light activation of Visudyne, a diode laser generating non-thermal red light (wavelength 689 nm  3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens.
Slovenian: Za svetlobno aktivacijo zdravila Visudyne se uporablja diodni laser, ki daje hladno rdečo svetlobo (valovne dolžine 689 nm  3 nm), s pomočjo naprave iz optičnih vlaken, nameščene na špranjsko svetilko, in ustrezne kontaktne leče.
English: By itself, the clinically recommended dose of verteporfin is not cytotoxic.
Slovenian: Klinično priporočeni odmerek verteporfina sam po sebi ni citotoksičen.
English: A lower percentage of Visudyne patients had events leading to death (n=4 [1.8%] versus n=3 [2.6%]); no death was considered to be related to treatment.
Slovenian: Med bolniki z zdravilom Visudyne je pri manjšem deležu prišlo do dogodkov, ki so se končali s smrtjo (n=4 [1,8 %] proti n=3 [2,6 %]); nobene smrti niso povezovali z zdravljenjem.
English: Localised (skin) necrosis at the injection site following extravasation has also been reported.
Slovenian: Poročali so tudi o lokaliziranih (kožnih) nekrozah na mestu injiciranja po ekstravazaciji.
English: It should therefore not be administered to nursing mothers, or breastfeeding should be interrupted for 48 hours after administration.
Slovenian: Zato se verteporfina pri doječih materah ne sme uporabljati ali pa je treba dojenje prekiniti za 48 ur po uporabi zdravila.
English: 15 mg of powder for solution for infusion in a single-use glass vial (type I), sealed with bromobutyl stopper and aluminium flip-off cap.
Slovenian: 15 mg praška za raztopino za infundiranje v stekleni viali (tip I) za enkratno uporabo, zapečateni z bromobutilnim zamaškom in aluminijasto dvižno zaporko.
English: Patients who receive Visudyne will become photosensitive for 48 hours after the infusion.
Slovenian: Bolniki, ki prejmejo zdravilo Visudyne, postanejo po infundiranju za 48 ur fotosenzitivni.
English: However, photodynamic therapy (PDT) induces the formation of reactive oxygen species and has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross links which may result in chromosomal aberrations, sister chromatid exchanges (SCE) and mutations.
Slovenian: Vendar pa fotodinamična terapija (PDT) sproži nastajanje reaktivnih kisikovih zvrsti, poročali pa so tudi, da povzroča poškodbe DNA, vključno s prelomi verig DNA, z alkalno labilnimi mesti, z razgradnjo DNA in s križnimi povezavami DNA s proteini, kar lahko povzroča kromosomske aberacije, izmenjavo sestrskih kromatid (SCE, sister chromatid exchanges) in mutacije.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 ljudi)
English: Overdose of the medicinal product and/or light in the treated eye may result in non-selective nonperfusion of normal retinal vessels, with the possibility of severe vision decrease.
Slovenian: Prevelik odmerek zdravila in/ali svetlobe v zdravljenem očesu lahko povzroči neselektivno prekinitev perfuzije normalnih mrežničnih žil z možnostjo močnega poslabšanja vida.
English: Based on theoretical data and despite the lack of clinical evidence these agents might result in enhanced verteporfin tissue-uptake when used concurrently.
Slovenian: Po teoretičnih podatkih, a brez podpore kliničnih dokazov, bi ta zdravila pri sočasni uporabi lahko povečala privzem verteporfina v tkivo.
English: It is possible that concomitant use of other photosensitising medicinal products (e.g. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, hypoglycaemic medicinal products, thiazide diuretics, and griseofulvin) could increase the potential for photosensitivity reactions.
Slovenian: Možno je, da bi sočasna uporaba drugih zdravil, ki fotosenzitizirajo (na primer tetraciklinov, sulfonamidov, fenotiazinov, sulfoniluree, hipoglikemičnih zdravil, tiazidnih diuretikov in grizeofulvina), lahko povečala možnost nastanka fotosenzitivnostnih reakcij.
English: Carcinogenicity
Slovenian: Kancerogeno delovanje
English: When the laser light is shone into the eye, Visudyne is activated.
Slovenian: Ko z lasersko svetlobo posvetimo v oko, se zdravilo Visudyne aktivira.
English: In non-clinical studies, no impairment of fertility and no genotoxicity have been observed (see section 5.3).
Slovenian: V nekliničnih študijah niso opažali zmanjšane plodnosti ali genotoksičnih učinkov zdravila (glejte poglavje 5.3).
English: No studies have been conducted to evaluate the carcinogenic potential of verteporfin.
Slovenian: Študij za oceno kancerogenega delovanja verteporfina niso izvajali.