FrancophonIA/ELRC3.0 huggingface dataset:
English: A direct relationship to Macugen or any of the various treatments administered as part of the injection preparation procedure, or to other factors has not been established in these cases.
Slovenian: Direktna povezava z zdravilom Macugen, drugimi zdravljenji, ki se uporabljajo pri postopku priprave na injiciranje, ali z drugimi faktorji v teh primerih ni bila dokazana.
English: Please read section 2.
Slovenian: Preberite 2. poglavje.
English: A decrease in creatinine clearance down to 20 ml/min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Slovenian: Zmanjšanje očistka kreatinina do 20 ml/min lahko spremlja do 2,3-kratno povečanje AUC pegaptaniba.
English: Other medicines and Macugen
Slovenian: Druga zdravila in zdravilo Macugen
English: Caution should be exercised when treating such patients (see section 4.8, heading ‘Product-class-related adverse reactions').
Slovenian: Pri zdravljenju takih bolnikov je potrebna previdnost (glejte poglavje 4.8, pod naslovom „Na skupino zdravil vezani neželeni učinki“).
English: In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Slovenian: Pri miših, podganah, kuncih, psih in opicah se pegaptanib porazdeli predvsem v plazemski volumen in se po intravenski uporabi ne porazdeli izdatno v periferna tkiva.
English: • Macugen is not recommended during breastfeeding as it is not known whether Macugen passes into human milk.
Slovenian: • Uporaba zdravila Macugen med dojenjem ni priporočljiva, ker ni znano, ali zdravilo Macugen prehaja v materino mleko.
English: If you are affected, do not drive or use machines until this resolves.
Slovenian: Če se to zgodi, ne upravljajte vozil in strojev, dokler ne mine.
English: Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF) EOP 1004
Slovenian: Povzetek povprečne spremembe VA od začetka do tedna 6, 12, 54 in 102 (zadnje izvedeno opazovanje) EOP 1003
English: A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Slovenian: Skupaj je bilo zdravljenih 1.190 bolnikov (892 jih je dobivalo zdravilo Macugen in 298 placebo (kontrolno snov)); mediana starost je bila 77 let.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih občasni
English: Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Slovenian: Opažali so zmanjšanje telesne mase (5 %) in minimalno zamudo pri osifikaciji falang sprednjih tac, a le pri izpostavljenostih, ki so bile na podlagi AUC več kot 300-krat večje, kot so pričakovane pri človeku.
English: The safety and efficacy of Macugen beyond two years has not been demonstrated.
Slovenian: Varnost in učinkovitost zdravila Macugen pri terapiji, daljši od dveh let, nista bili dokazani.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Macugen treatment.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se pred zdravljenjem z zdravilom Macugen posvetujte z zdravnikom.
English: All injections of Macugen will be administered by your doctor.
Slovenian: Vse injekcije zdravila Macugen vam bo dal zdravnik.
English: At this point, the remaining content of the syringe should be injected.
Slovenian: Preostalo vsebino injekcijske brizge se sedaj lahko injicira.
English: After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Slovenian: Po vsakem injiciranju vam bo zdravnik morda naročil, da za zaščito pred okužbo uporabite antibiotične kapljice za oko (ali kakšno drugo vrsto antibiotičnega zdravila).
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Macugen is marketed, at launch and after launch all ophthalmological clinics where Macugen is expected to be used are provided with an updated physician information pack containing the following elements:
Slovenian: Imetnik dovoljenja za promet mora po razpravah in v dogovoru s pristojnimi nacionalnimi organi v vsaki državi članici, kjer se zdravilo Macugen trži, zagotoviti, da bodo ob in po prihodu zdravila na trg trg vse oftalmološke klinike, kjer se bo zdravilo Macugen predvidoma uporabljajo, prejele posodobljeno gradivo za zdravnike, ki vključuje naslednje elemente:
English: Moreover patients should be closely monitored for vitreous haemorrhage and endophthalmitis in the two weeks following the injection.
Slovenian: Poleg tega je treba bolnike dva tedna po injekciji natančno nadzirati glede krvavitve v steklovino in endoftalmitisa.
English: Cases of serious allergic reaction, including anaphylactic reaction and angioedema of which symptoms are described below, has been reported soon after the injection.
Slovenian: Poročali so o primerih resne alergične reakcije, vključno z anafilaktično reakcijo in angioedemom, katere simptomi so opisani spodaj in ki se je pojavila kmalu po injiciranju.
English: Macugen should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Slovenian: Zdravilo Macugen se med nosečnostjo ne sme uporabljati, razen če možna korist zdravljenja odtehta možno tveganje za še nerojenega otroka.
English: The safety and efficacy of Macugen in children under 18 years has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Macugen pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure.
Slovenian: Večina neželenih učinkov, o katerih so poročali po aplikaciji zdravila Macugen, je povezanih s postopkom intraviteralnega injiciranja.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet mora pred prihodom zdravila na trg v vsaki državi članici s pristojnimi nacionalnimi organi dogovoriti končno izobraževalno gradivo.
English: Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Slovenian: Bolniki v vseh krakih študije so v prvem letu dobili povprečno 8,4-8,6 odmerkov od skupno možnih 9.
English: The pouch must not be opened until the patient has been prepared for injection.
Slovenian: Vrečke ne smete odpreti, dokler bolnik ni pripravljen za injiciranje.
English: (Actual air bubble formation may vary)
Slovenian: (Dejanska prisotnost zračnih mehurčkov lahko variira.)
English: The two trials enrolled patients, including all neovascular AMD lesion subtypes (25% predominantly classic, 39% occult with no classic and 36% minimally classic), lesion sizes up to 12 disc areas, of which up to 50% could be comprised of subretinal haemorrhage and/or up to 25% fibrotic scar or atrophic damage.
Slovenian: Preskušanji sta vključevali bolnike z vsemi podvrstami lezij neovaskularne AMD (25 % pretežno klasičnih, 39 % prikritih brez klasičnih in 36 % osnovnih klasičnih), velikostjo lezij do 12 površin diskusa, od katerih jih je bilo lahko do 50 % zapletenih s podmrežnično krvavitvijo in/ali do 25 % s fibrotičnim brazgotinjenjem ali atrofično okvaro.
English: This disease leads to vision loss resulting from damage to the central part of the retina (called the macula), at the back of the eye.
Slovenian: Ta bolezen, ki povzroči izgubljanje vida, nastane zaradi okvare osrednjega dela mrežnice (imenujemo ga makula), ki leži na zadnji strani očesa.
English: Psychiatric disorders Uncommon nightmare, depression
Slovenian: Psihiatrične motnje občasni nočna mora, depresija
English: Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
Slovenian: Zgodnji klinični študiji pri bolnikih, ki so dobili zdravilo Macugen samo in v kombinaciji s fotodinamično terapijo, nista pokazali očitnih razlik v plazemski farmakokinetiki pegaptaniba.
English: To prevent contamination, the syringe should not be removed from the pouch until the patient has been prepared for injection.
Slovenian: Da bi preprečili kontaminacijo, injekcijske brizge ne smete vzeti iz vrečke, dokler bolnik ni pripravljen na injiciranje.
English: The systemic exposure is expected to be within a well tolerated range in patients with hepatic impairment, as a 10 fold higher dose (3 mg/eye) was well tolerated.
Slovenian: Po pričakovanju naj bi bila sistemska izpostavljenost pri bolnikih z okvaro jeter v območju, ki ga bolniki dobro prenesejo, saj so dobro prenašali do 10-krat večji odmerek (3 mg/oko).
English: Immune system disorders Not known anaphylactic reaction*
Slovenian: Bolezni imunskega sistema neznana anafilaktična reakcija*
English: • palpitations, high blood pressure, dilatation of the aorta (the main blood vessel)
Slovenian: • razbijanje srca, visok krvni tlak, razširitev aorte (glavne telesne krvne žile)
English: There are no studies on the carcinogenic potential of pegaptanib.
Slovenian: Študij o kancerogenosti pegaptaniba ni.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: A post marketing observational study has also reported on a small risk of slow sustained increase in intraocular pressure (see section 4.8).
Slovenian: V opazovalni študiji v obdobju trženja zdravila so prav tako poročali o majhnem tveganju za počasno ter vztrajno zvišanje očesnega tlaka (glejte poglavje 4.8).
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Slovenian: Postopek injiciranja moramo opraviti v aseptičnih pogojih, kar vključuje kirurško dezinfekcijo rok, uporabo sterilnih rokavic, sterilnega pokritja in sterilnega spekuluma za veke (ali drugega ustreznega instrumenta) ter dosegljivost sterilne paracenteze (če je potrebno).
English: It tells you what to do if you have any of these symptoms.
Slovenian: V njem boste našli napotke za ravnanje v primeru, če se pojavi kateri izmed teh simptomov.
English: In animals that received doses of pegaptanib up to 0.5 mg/eye to both eyes, plasma concentrations were 0.03% to 0.15% of those in the vitreous humour.
Slovenian: Pri živalih, ki so dobile pegaptanib v odmerkih do 0,5 mg/oko v obe očesi, je koncentracija v plazmi znašala 0,03-0,15 % tiste v steklovini.
English: Drug interaction studies have not been conducted with Macugen.
Slovenian: Študij medsebojnega delovanja z zdravilom Macugen niso izvedli.
English: • elevation of the liver enzymes, abrasion.
Slovenian: • zvišanje jetrnih encimov, abrazija
English: Cases of serious increase in intraocular pressure have been reported when the excess volume in the pre-filled syringe was not expelled before injection.
Slovenian: Poročali so o primerih resnega zvišanja očesnega tlaka, kadar pred injiciranjem iz napolnjene injekcijske brizge ni bil odstranjen odvečni volumen.
English: For additional information regarding sodium content of Macugen, see section
Slovenian: Za dodatne informacije o vsebnosti natrija v zdravilu Macugen glejte poglavje 2.
English: Patients who were re-randomized to discontinue pegaptanib after one year, lost visual acuity during the second year.
Slovenian: Bolnikom, ki so bili ob ponovni randomizaciji po enem letu razvrščeni za prekinitev zdravljenja s pegaptanibom, se je ostrina vida v drugem letu zmanjšala.
English: Dose adjustments are not recommended in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni priporočena (glejte poglavje 5.2).
English: In some patients the pressure inside the treated eye may increase for a short period directly after the injection.
Slovenian: Pri nekaterih bolnikih se lahko za krajši čas neposredno po injiciranju zviša tlak v zdravljenem očesu.
English: Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
Slovenian: V primeru prevelikega odmerjanja je treba spremljati očesni tlak in uvesti primerno zdravljenje, če zdravnik presodi, da je to potrebno.
English: Pegaptanib sodium has not been adequately studied in patients with creatinine clearance below 20 ml/min.
Slovenian: Natrijev pegaptanib ni ustrezno raziskan pri bolnikih z očistkom kreatinina pod 20 ml/min.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite navodilo!
English: Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision.
Slovenian: Zdravniku morate takoj povedati, če opazite katerega od naslednjih simptomov: bolečino ali močnejše nelagodje v očesu, poslabšanje pordelosti oči, zamegljen ali poslabšan vid, večjo občutljivost za svetlobo, številnejše drobne delce v vidnem polju.
English: CAUTION: Since the pre-filled syringe contains more medicinal product volume (250-270 microlitres) than the recommended dose (90 microlitres), a part of the volume contained in the syringe has to be discarded prior to the administration.
Slovenian: OPOZORILO: Ker napolnjena injekcijska brizga vsebuje večji volumen zdravila (250-270 mikrolitrov) od priporočenega odmerka (90 mikrolitrov), je treba del volumna v injekcijski brizgi zavreči pred aplikacijo zdravila.
English: The rate of absorption from the eye is the rate-limiting step in the disposition of pegaptanib in animals and is likely to be in humans.
Slovenian: Hitrost absorpcije iz očesa je stopnja, ki omejuje hitrost izločanja pegaptaniba pri živalih; verjetno je tako tudi pri človeku.
English: - The active substance is pegaptanib.
Slovenian: - Zdravilna učinkovina je pegaptanib.
English: Pegaptanib 0.3 mg showed treatment benefit regardless of baseline lesion subtype, lesion size and visual acuity as well as age, gender, iris pigmentation and prior and/or baseline PDT usage.
Slovenian: Zdravljenje s pegaptanibom v odmerku 0,3 mg je koristilo ne glede na vrsto izhodiščne lezije, velikost lezije ali ostrino vida in prav tako ne glede na starost, spol, pigmentacijo šarenice ter predhodno in/ali izhodiščno PDT.
English: After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy.
Slovenian: Če pri bolniku po 2 zaporednih prejetih injekcijah zdravila Macugen na pregledu v 12. tednu ni opazne koristi zdravljenja (izguba ostrine vida za manj kot 15 črk), je treba razmisliti o prekinitvi ali začasni prekinitvi zdravljenja z zdravilom Macugen.
English: If the solution appears cloudy, particles are observed or if there is evidence of damage to the syringe, or if the plastic clip is missing or not attached to the syringe, that Macugen dose should not be used.
Slovenian: Če je raztopina motna, so v njej vidni delci ali je injekcijska brizga poškodovana ali če plastičnega zatiča ni oziroma ni pritrjen na brizgo, tega odmerka zdravila Macugen ne smete uporabiti.
English: The medicine is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients.
Slovenian: Zdravilo uporabljamo za zdravljenje vseh vrst nenormalne rasti žil pri odraslih bolnikih z AMD.
English: N Mean change in VA Week
Slovenian: N Povprečna sprememba VA v tednu
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: Expel excess volume before injecting.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA OPOZORILO: Pred injiciranjem odstranite odvečni volumen.
English: The mean area under the plasma concentration-time curve (AUC) is about 25 g·hr/ml at this dose.
Slovenian: Ob tem odmerku je povprečna površina pod krivuljo plazemske koncentracije po času (AUC) približno 25 g∙h/ml.
English: VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
Slovenian: VEGF165 je izooblika VEGF, ki je vpletena predvsem v patološko neovaskularizacijo v očesu.
English: Pharmacotherapeutic group: Ophthalmologicals, Ocular vascular disorder agents, ATC Code S01LA03.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje očesno žilnih bolezni, oznaka ATC: S01LA03
English: It is not known whether Macugen is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Macugen pri človeku izloča v materino mleko.
English: Pegaptanib is metabolised by endo- and exonucleases.
Slovenian: Pegaptanib presnavljajo endo- in eksonukleaze.
English: In animal studies no effects on male or female fertility in mice were observed.
Slovenian: Pri študijah na živalih niso opazili nobenih vplivov na plodnost mišjih samcev ali samic.
English: Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults (see section 5.1).
Slovenian: Zdravilo Macugen je indicirano za zdravljenje neovaskularne (vlažne) starostne degeneracije makule (AMD - age-related macular degeneration) pri odraslih (glejte poglavje 5.1).
English: Patients were randomised to receive sham or 0.3 mg, 1 mg or 3 mg pegaptanib administered as intravitreal injections every 6 weeks for 48 weeks.
Slovenian: Bolniki so bili randomizirani na prejemanje kontrolne snovi (placebo) ali 0,3 mg, 1 mg ali 3 mg pegaptaniba v intravitrealnih injekcijah vsakih 6 tednov v obdobju 48 tednov.
English: Important information about some of the ingredients of Macugen This medicine contains less than 1 mmol sodium (23 mg) per 90 microlitre dose, i.e. essentially ‘sodium-free' (see section 6).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Macugen To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 90-mikrolitrski odmerek, kar v bistvu pomeni „brez natrija“ (glejte poglavje 6).
English: What is in this leaflet What Macugen is and what it is used for What you need to know before you are given Macugen How you will be given Macugen Possible side effects How to store Macugen Contents of the pack and other information
Slovenian: Kaj je zdravilo Macugen in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Macugen Kako boste prejeli zdravilo Macugen Možni neželeni učinki
English: Method of administration For intravitreal injection use only.
Slovenian: Način uporabe Samo za intravitrealno uporabo.
English: Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.
Slovenian: Presnova pegaptaniba poteka z nukleazami, zato interakcije z zdravili prek citokroma P450 niso verjetne.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose: 0.3 mg/90 µl
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Enkratni odmerek: 0,3 mg/90 µl
English: Macugen is for single use only.
Slovenian: Zdravilo Macugen je namenjeno samo za enkratno uporabo.
English: If you have been given more Macugen than you should have In the case excess Macugen volume is injected, serious increase in intraocular pressure may occur.
Slovenian: Če ste prejeli večji odmerek zdravila Macugen, kot bi smeli V primeru, da vam je bil injiciran presežni volumen zdravila Macugen, se lahko pojavi zvišanje očesnega tlaka.
English: Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
Slovenian: Pegaptanib so pri bolnikih z neovaskularno AMD raziskali v dveh kontroliranih, dvojno slepih in enako zasnovanih randomiziranih študijah (EOP1003, EOP1004).
English: Therefore, the perfusion of the optic nerve head should be verified and elevation of intraocular pressure should be managed appropriately post injection.
Slovenian: Zato je treba preverjati perfundiranost glave vidnega živca, zvišanje očesnega tlaka pa po injiciranju ustrezno obvladovati.
English: • nightmare, depression, deafness, vertigo
Slovenian: • nočne more, depresija, naglušnost, vrtoglavica
English: Your doctor may monitor this after each injection.
Slovenian: Zdravnik bo morda tlak v očesu nadziral po vsakem injiciranju.
English: The solution to be injected should reach room temperature (below 25°C) before injecting.
Slovenian: Injekcijska raztopina mora biti pred injiciranjem segreta na sobno temperaturo (do 25 °C).
English: Whenever you'll experience vision disturbances, eye discomfort/pain, eye redness or nausea and vomiting, immediately refer to your doctor and tell about your symptoms.
Slovenian: Če se pri vas pojavijo motnje vida, neugodje/bolečina v očesu, rdečina očesa ali siljenje na bruhanje in bruhanje, se takoj posvetujte z zdravnikom in mu povejte, kakšni so vaši simptomi.
English: • Intravitreal injection procedure video
Slovenian: • Video s prikazom postopka intravitrealnega injiciranja
English: Mean change in VA Week
Slovenian: Povprečna sprememba VA v tednu
English: Patients should be instructed to report any symptoms suggestive of these conditions without delay (see section 4.4).
Slovenian: Bolnikom je treba naročiti, naj nemudoma povedo za vsak simptom, ki bi lahko nakazoval ti dve stanji (glejte poglavje 4.4).
English: No human data on the effect of Macugen on fertility are available.
Slovenian: Podatkov o vplivu zdravila Macugen na plodnost pri človeku ni na voljo.
English: Injection of the entire volume of the pre-filled syringe could result in serious adverse events; therefore, the excess volume must be expelled before injection (see sections 4.8 and 6.6).
Slovenian: Injiciranje celotnega volumna napolnjene injekcijske brizge lahko povzroči resne neželene učinke, zato je treba pred injiciranjem odvečni volumen odstraniti (glejte poglavji 4.8 in 6.6).
English: If you are allergic to pegaptanib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Macugen ne smete prejeti: - če ste alergični na pegaptanib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: • disturbance in your eye's reaction to the light (pupillary reflex impaired)
Slovenian: • moteno odzivanje očesa na svetlobo (okvara zeničnega refleksa)
English: Each pre-filled syringe contains approximately 0.25-0.27 ml of solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje približno 0,25-0,27 ml raztopine.
English: Twenty-four hours after intravitreous administration of a radiolabeled dose of pegaptanib to both eyes of rabbits, radioactivity was mainly distributed in vitreous humour, retina and aqueous humour.
Slovenian: Štiriindvajset ur po aplikaciji radioaktivno označenega odmerka pegaptaniba v steklovino obeh očes pri kuncih se je radioaktivnost porazdelila predvsem v steklovini, mrežnici in prekatni vodki.
English: Pegaptanib has not been studied in pregnant women.
Slovenian: Pri nosečnicah pegaptaniba niso preučevali.
English: • decreased pressure inside the eye
Slovenian: • znižan tlak v očesu