FrancophonIA/ELRC3.0 huggingface dataset:
English: Since at the pharmacy this medicine is stored in a freezer, in case treatment is started right away after receiving the weekly carton, you will have to wait until the first vial is thawed (this could take up to 30 minutes).
Slovenian: Ker je to zdravilo v lekarni shranjeno v zamrzovalniku, morate v primeru, da z zdravljenjem začnete takoj po prejemu tedenske škatle, najprej počakati, da se prva viala odtali (to lahko traja do 30 minut).
English: In case of concomitant use with contact lenses, see section 4.4.
Slovenian: V primeru sočasne uporabe s kontaktnimi lečami glejte poglavje 4.4.
English: • With your head still tilted back, blink a few times so that the medicine covers the surface of your eye.
Slovenian: • Glavo držite nagnjeno nazaj in nekajkrat pomežiknite, da bo zdravilo prekrilo površino očesa.
English: The administration instructions above (steps 5 to 15) should be repeated every 2 hours (six times per day) using a new disinfectant wipe and a new pipette each time.
Slovenian: Zgornji postopek dajanja zdravila (koraki 5 do 15) je treba ponoviti vsaki 2 uri (šestkrat na dan), pri čemer je treba vsakič uporabiti nov razkužilni robček in novo pipeto.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the medicinal product in one or more subsets of the paediatric population in neurotrophic keratitis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s tem zdravilom za eno ali več podskupin pediatrične populacije z nevrotrofičnim keratitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: There are no data from the use of cenegermin in pregnant women.
Slovenian: Podatkov o uporabi cenegermina pri nosečnicah ni.
English: You will receive an insulated container containing a weekly carton of OXERVATE and a separate delivery system (composed of medical devices intended for withdrawing and administering the medicine).
Slovenian: Prejeli boste izoliran vsebnik s tedensko škatlo zdravila OXERVATE in ločen sistem za dostavo zdravila (sestavljen iz medicinskih pripomočkov, namenjenih odvzemu in dajanju zdravila).
English: OXERVATE Vehicle (p value)
Slovenian: vehikel (vrednost p)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: Risk of corneal melting or impending perforation
Slovenian: Tveganje za topljenje roženice ali grozečo perforacijo
English: Systemic exposure to cenegermin is negligible or does not occur.
Slovenian: Sistemska izpostavljenost cenegerminu je zanemarljiva ali neobstoječa.
English: To withdraw and administer each dose of this medicine, follow the steps below:
Slovenian: Za odvzem in dajanje vsakega odmerka tega zdravila sledite naslednjim korakom:
English: Patient: Store in a refrigerator for a maximum of 7 days.
Slovenian: Bolnik: Shranjujte v hladilniku do največ 7 dni.
English: Eye infections
Slovenian: Okužbe očesa
English: Animal studies with cenegermin do not indicate direct or indirect harmful effects with respect to reproductive toxicity when administered subcutaneously (see section 5.3).
Slovenian: Študije s cenegerminom na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja ob subkutani uporabi (glejte poglavje 5.3).
English: Treatment should be initiated and supervised by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Slovenian: Zdravljenje mora uvesti in nadzorovati oftalmolog ali zdravstveni delavec, usposobljen za področje oftalmologije.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this 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 tega zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If a dose is missed, treatment should be continued as normal, at the next scheduled administration.
Slovenian: V primeru izpuščenega odmerka je treba zdravljenje nadaljevati kot običajno, ob naslednjem načrtovanem dajanju zdravila.
English: Do not put in any more drops until it is time for your next regular dose.
Slovenian: V oko ne dajajte kapljic, dokler ni čas za naslednji odmerek.
English: At the ocular doses, cenegermin is not distributed throughout body tissues as there is no systemic absorption above the natural baseline levels.
Slovenian: Pri okularnih odmerkih se cenegermin ne porazdeli po telesnih tkivih, saj ni sistemske absorpcije nad naravnimi izhodiščnimi ravnmi.
English: In both studies patients received OXERVATE or vehicle 6 times daily in the affected eye(s) for 8 weeks, and underwent a follow-up period.
Slovenian: V obeh študijah so bolniki 8 tednov prejemali zdravilo OXERVATE ali vehikel 6-krat na dan v prizadeto oko oziroma prizadeti očesi, nato pa so vstopili v obdobje spremljanja.
English: Remove the weekly carton of OXERVATE from the insulated container and store it in a fridge as soon as you can (and in any case no later than 5 hours from when you receive the medicine from your pharmacist).
Slovenian: Tedensko škatlo z zdravilom OXERVATE vzemite iz izoliranega vsebnika in jo shranite v hladilnik, takoj ko lahko (in v vsakem primeru v največ 5 urah po tem, ko ste zdravilo prevzeli v lekarni).
English: Treatment should be continued for eight weeks.
Slovenian: Zdravljenje je treba nadaljevati osem tednov.
English: What OXERVATE is and what it is used for
Slovenian: Kaj je zdravilo OXERVATE in za kaj ga uporabljamo
English: It is supplied in multi-dose glass vials.
Slovenian: Na voljo je v steklenih večodmernih vialah.
English: Each pipette should be discarded immediately after using, even if there is still some liquid left in it.
Slovenian: Vsako pipeto je treba zavreči takoj po uporabi, tudi če je v njej še vedno nekaj tekočine.
English: Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.
Slovenian: Navodila za uporabo Natančno sledite tem navodilom in se posvetujte z zdravnikom ali farmacevtom, če česa ne razumete.
English: Results after 8 weeks of treatment
Slovenian: Rezultati po 8 tednih zdravljenja
English: Avoid touching the surface of the adapter.
Slovenian: Izogibajte se dotikanja površine nastavka.
English: An individual multi-dose vial of OXERVATE should be taken from the refrigerator at the same time each morning bearing in mind the 12 hour treatment schedule.
Slovenian: Posamezno večodmerno vialo zdravila OXERVATE je treba vzeti iz hladilnika vsako jutro ob istem času, skladno z 12-urnim urnikom zdravljenja.
English: Patients considered completely healed at the end of 8 weeks of treatment with OXERVATE did not tend to have recurrences within the 12 months follow-up period of study NGF0212.
Slovenian: Pri bolnikih, ki so po koncu 8 tednov zdravljenja z zdravilom OXERVATE veljali za popolnoma ozdravljene, običajno ni prišlo do ponovitve v 12-mesečnem obdobju spremljanja v študiji NGF0212.
English: OXERVATE contains cenegermin, a recombinant form of human nerve growth factor.
Slovenian: Zdravilo OXERVATE vsebuje cenegermin, rekombinantno obliko humanega živčnega rastnega dejavnika.
English: Patients should be instructed to remove contact lenses before applying OXERVATE and to wait 15 minutes after instillation of the dose before reinsertion, because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion.
Slovenian: Bolnikom je treba svetovati, da pred nanosom zdravila OXERVATE odstranijo kontaktne leče in da po nanosu odmerka počakajo 15 minut, preden jih ponovno vstavijo, saj bi lahko prisotnost kontaktne leče (terapevtske ali korekcijske) teoretično omejila porazdelitev cenegermina po površini roženične lezije.
English: If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Slovenian: Če ob vkapavanju pride do zamegljenega vida, mora bolnik počakati, da se mu vid zbistri, preden vozi ali upravlja stroje.
English: If you forget to use OXERVATE
Slovenian: Če ste pozabili uporabiti zdravilo OXERVATE
English: • Immediately discard the used pipette after use, even if there is still some liquid left in it.
Slovenian: • Takoj po uporabi zavrzite uporabljeno pipeto, tudi če je v njej še vedno nekaj tekočine.
English: If the pipette is empty, keep the vial with the connected pipette upside-down, push the plunger all the way in and pull it out again.
Slovenian: Če je pipeta prazna, držite vialo z nameščeno pipeto z zgornjim delom navzdol, potisnite bat povsem navznoter in ga nato ponovno izvlecite.
English: The vials are contained in a weekly cardboard carton containing 7 vials.
Slovenian: Viale so spravljene v tedenski kartonski škatli, ki vsebuje 7 vial.
English: OXERVATE should only be administered using the associated delivery system (vial adapter and pipettes), according to the instructions presented in section 6.6.
Slovenian: Zdravilo OXERVATE je treba dajati izključno prek ustreznega sistema za dostavo (nastavek za vialo in pipete), skladno z navodili, podanimi v poglavju 6.6.
English: To ensure accurate dosing every 2 hours, you could set an alarm as a reminder for dosing.
Slovenian: Za zagotovitev pravilnega odmerjanja vsaki 2 uri si lahko nastavite alarm kot opomnik za odmerjanje.
English: 7 vial adapters, 42 pipettes, 42 disinfectant wipes and a dose recording card are provided separately from the vials.
Slovenian: 7 nastavkov za viale, 42 pipet, 42 razkužilnih robčkov in kartica za evidentiranje odmerkov so na voljo ločeno od vial.
English: The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
Slovenian: Zdravljenje s cenegerminom, danim v obliki kapljic za oko, je namenjeno omogočanju obnovitve celovitosti roženice.
English: Eye reactions
Slovenian: Očesne reakcije
English: The weekly carton containing the vials must be stored in a freezer (-20 °C ±5 °C).
Slovenian: Tedensko škatlo z vialami je treba shranjevati v zamrzovalniku (-20 °C ± 5 °C).
English: The efficacy and safety of OXERVATE were evaluated in two multicentre, randomised, doublemasked, vehicle-controlled clinical studies (NGF0212 and NGF0214) in patients with moderate (persisted epithelial defect) or severe (corneal ulcer) neurotropic keratitis refractory to non-surgical treatments.
Slovenian: Učinkovitost in varnost zdravila OXERVATE so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih, z vehiklom kontroliranih kliničnih študijah (NGF0212 in NGF0214) pri bolnikih z zmernim (perzistenten defekt epitela) ali hudim (razjeda roženice) nevrotrofičnim keratitisom, neodzivnim na nekirurško zdravljenje.
English: Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Slovenian: Zdravljenje zmernega (perzistenten defekt epitela) ali hudega (razjeda na roženici) nevrotrofičnega keratitisa pri odraslih.
English: OXERVATE should be used with caution in patients with ocular cancer.
Slovenian: Zdravilo OXERVATE je treba pri bolnikih z rakom očesa uporabljati previdno.
English: This is a disease affecting the cornea (the transparent layer in the front part of the eye) which causes defects on the outer surface of the cornea that do not heal naturally or corneal ulcers.
Slovenian: To je bolezen, ki prizadene roženico (prozorni sloj na sprednjem delu očesa) in povzroči defekte na zunanji površini roženice, ki se ne zacelijo naravno, ali razjede na roženici.
English: This will help to avoid one eye drop diluting the other eye drop.
Slovenian: Na ta način pomagate preprečiti, da bi kapljice za oko razredčile druge kapljice za oko.
English: The patient will also receive separately vial adapters, pipettes and disinfectant wipes.
Slovenian: Bolnik bo ločeno prejel tudi nastavke za viale, pipete in razkužilne robčke.
English: Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors.
Slovenian: Živčni rastni dejavnik je endogena beljakovina, ki sodeluje pri diferenciaciji in vzdrževanju nevronov in deluje prek specifičnih receptorjev živčnega rastnega dejavnika z visoko afiniteto (tj. TrkA) in nizko afiniteto (tj. p75NTR).
English: 10) Check the pipette and confirm that it contains some of the solution.
Slovenian: 10) Preglejte pipeto in se prepričajte, da je v njej nekaj raztopine.
English: Specifically, more than 80 % of the 31 patients who were healed after initial OXERVATE 20 µg/ml treatment and for whom a response was available, remained completely healed at the end of the 12 months follow up period.
Slovenian: Konkretno je bilo po koncu 12-mesečnega obdobja spremljanja več kot 80 % od 31 bolnikov, ki so ozdraveli po začetnem zdravljenju z zdravilom OXERVATE 20 µg/ml in za katere je bil na voljo podatek o odzivu, še vedno povsem ozdravljenih.
English: You should continue your treatment for 8 weeks.
Slovenian: Zdravljenje morate nadaljevati 8 tednov.
English: The patient will receive a weekly carton containing 7 multi-dose vials of OXERVATE, which should be stored in a refrigerator until the day of use.
Slovenian: Bolnik prejme tedensko škatlo s 7 večodmernimi vialami zdravila OXERVATE, ki jo je treba shraniti v hladilniku do dneva uporabe.
English: As systemic absorption of cenegermin after use of the medicinal product is negligible or not detectable, no drug interactions are anticipated.
Slovenian: Ker je sistemska absorpcija cenegermina po uporabi tega zdravila zanemarljiva ali nezaznavna, medsebojno delovanje z drugimi zdravili ni pričakovano.
English: The multi-dose vial of OXERVATE is now ready for use (1 drop in the affected eye every 2 hours six times a day).
Slovenian: Večodmerna viala zdravila OXERVATE je sedaj pripravljena za uporabo (1 kapljica v prizadeto oko vsaki 2 uri, šestkrat na dan).
English: Continue with your next dose as scheduled.
Slovenian: Nadaljujte z naslednjim odmerkom, skladno z vašim urnikom zdravljenja.
English: Discard any remaining solution at the end of each day.
Slovenian: Ob koncu vsakega dne zavrzite vse morebitne preostanke raztopine.
English: To ensure accurate dosing every 2 hours, the patient should be advised to set an alarm as a reminder for dosing.
Slovenian: Za zagotovitev pravilnega odmerjanja vsaki 2 uri je treba bolniku svetovati, da si nastavi alarm kot opomnik za odmerjanje.
English: After eye drop administration, cenegermin is distributed particularly in the anterior portion of the eye, although a study with radiolabelled cenegermin in rats has shown that it also reaches the retina and other posterior parts of the eye at doses significantly higher than those administered by eye drops in humans to treat neurotrophic keratitis.
Slovenian: Po dajanju kapljic za oko se cenegermin porazdeli zlasti v anteriornem predelu očesa, vendar pa je študija z radiološko označenim cenegerminom na podganah pokazala, da doseže tudi mrežnico in druge posteriorne dele očesa pri odmerkih, znatno večjih ob tistih, ki se dajejo v obliki kapljic za oko pri ljudeh za zdravljenje nevrotrofičnega keratitisa.
English: The most commonly reported adverse reactions in patients suffering from neurotrophic keratitis and treated with OXERVATE during clinical studies include eye pain (11.1 %), eye inflammation (8.3 %), which may include anterior chamber inflammation and hyphaema; lacrimation increased (5.6 %), with symptoms such as eye discharge; eyelid pain (5.6 %) and foreign body sensation in the eye (5.6 %).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih z nevrotrofičnim keratitisom, zdravljenih z zdravilom OXERVATE v kliničnih študijah, vključujejo bolečino v očesu (11,1 %), vnetje očesa (8,3 %), ki lahko vključuje vnetje sprednjega prekata in hifemo, povečano solzenje (5,6 %) s simptomi, kot je izcedek iz očesa, bolečino v veki (5,6 %) in občutek tujka v očesu (5,6 %).
English: • Take a pipette (dropper) and remove it from its protective packaging.
Slovenian: • Vzemite pipeto (kapalko) in jo odstranite iz zaščitne ovojnine.
English: After this period of time the vial contents should be discarded irrespective of whether some residual product remains in the vial.
Slovenian: Po tem času je treba vsebino viale zavreči, ne glede na to, ali je v njej še kaj zdravila.
English: Take an individual vial of this medicine from the fridge in the morning (always at the same time each morning), and prepare it in the following way:
Slovenian: Zjutraj (vedno ob istem času) vzemite posamezno vialo tega zdravila iz hladilnika in jo pripravite na naslednji način:
English: 8) Ensure that the pipette plunger is pushed all the way down.
Slovenian: 8) Prepričajte se, da je bat pipete potisnjen povsem navzdol.
English: • If you wear contact lenses, take them out before using the drops.
Slovenian: • Če nosite kontaktne leče, jih pred uporabo kapljic odstranite iz oči.
English: - if you are allergic to cenegermin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila OXERVATE: - če ste alergični na cenegermin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Only use this medicine in your affected eye(s).
Slovenian: Opozorila in previdnostni ukrepi To zdravilo uporabljajte samo v prizadetem očesu (prizadetih očesih).
English: Ocular administered cenegermin is mainly eliminated by tear secretion and the remainder mostly biotransformed by local tissue proteases.
Slovenian: Okularno dan cenegermin se v glavnem izloča prek izločanja solz, preostanek pa večinoma biotransformirajo proteaze lokalnih tkiv.
English: In general, the systemic absorption of OXERVATE is negligible.
Slovenian: Na splošno je sistemska absorpcija zdravila OXERVATE zanemarljiva.
English: Once the vial adapter has been connected correctly, it should not be removed from the vial.
Slovenian: Ko je nastavek za vialo pravilno nameščen, ga ne smete več odstraniti z viale.
English: Do not use more than 6 drops each day in the affected eye(s).
Slovenian: V prizadetem očesu ne uporabite več kot 6 kapljic zdravila na dan.
English: Study NGF0214 enrolled 48 patients (mean age 65±14 years, range 33-94 years) treated with OXERVATE 20 µg/ml or vehicle (24 patients per arm).
Slovenian: V študijo NGF0214 je bilo vključenih 48 bolnikov (povprečna starost 65 ± 14 let, razpon 33-94 let), ki so bili zdravljeni z zdravilom OXERVATE 20 µg/ml ali vehiklom (24 bolnikov v vsakem kraku).
English: Adverse drug reactions are presented below according to MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Neželeni učinki so spodaj navedeni po organskih sistemih po MedDRA (raven organskega sistema in prednostnega izraza).
English: If you also use an eye ointment or gel or an eye drop with a thick consistency, you should use OXERVATE first, and then wait at least 15 minutes before using the other medicine.
Slovenian: Če uporabljajte tudi mazilo ali gel za oko ali zelo goste kapljice za oko, morate najprej uporabiti zdravilo OXERVATE, nato pa počakati vsaj 15 minut, preden uporabite drugo zdravilo.
English: It is not known whether cenegermin is excreted in human milk.
Slovenian: Ni znano, ali se cenegermin izloča v materino mleko.
English: Talk to your doctor before breast-feeding your baby, as a decision must be made whether to stop breast-feeding or to avoid or stop OXERVATE therapy.
Slovenian: Pred dojenjem otroka se posvetujte z zdravnikom, saj se je treba odločiti med prenehanjem dojenja in izogibanjem ali prekinitvijo zdravljenja z zdravilom OXERVATE.
English: Study NGF0214
Slovenian: Študija NGF0214
English: 7 multi-dose vials
Slovenian: 7 večodmernih vial
English: Study NGF0212
Slovenian: Študija NGF0212
English: An individual multi-dose vial of OXERVATE is to be removed from the fridge for use over the course of a single day.
Slovenian: Posamezno večodmerno vialo zdravila OXERVATE je treba za uporabo odstraniti iz hladilnika in porabiti v enem dnevu.
English: Patients with an eye infection should be treated before starting therapy with OXERVATE (see section 4.4).
Slovenian: Bolnike z očesno okužbo je treba zdraviti pred uvedbo zdravljenja z zdravilom OXERVATE (glejte poglavje 4.4).
English: • Ensure that the pipette plunger is pushed all the way down.
Slovenian: • Prepričajte se, da je bat pipete potisnjen povsem navzdol.
English: Patient:
Slovenian: Bolnik:
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V BRAILLOVI PISAVI oxervate
English: The table below summarizes the results for complete corneal healing of the persistent epithelial defect or corneal ulcer (the primary endpoint, defined as the greatest diameter of corneal fluorescein staining <0.5 mm) after 4 and 8 weeks of treatment for patients who received OXERVATE 20 µg/ml or vehicle in the two studies.
Slovenian: V spodnji preglednici so povzeti rezultati za popolno zaceljenje roženice pri vztrajnem defektu epitelija ali razjedi roženice (primarni opazovani dogodek, opredeljen kot največji premer obarvanja roženice pri fluoresceinskem preizkusu < 0,5 mm) po 4 in 8 tednih zdravljenja pri bolnikih, ki so prejemali zdravilo OXERVATE 20 µg/ml ali vehikel v obeh študijah.
English: Cenegermin is mostly removed from the eye with the tear production and through the naso-lacrimal duct; the minor portion that is absorbed occurs mostly in the conjunctiva and peri-orbital tissue and to a minor extent through the cornea following ocular administration.
Slovenian: Cenegermin se v glavnem izloča iz očesa s tvorbo solz in prek nosno-solznega kanala; manjši del, ki se absorbira, se po okularni uporabi v glavnem pojavlja v vezničnem in obzrkelnem tkivu ter v manjši meri prek roženice.
English: It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before starting therapy with OXERVATE as cenegermin should not be used in patients requiring immediate surgery.
Slovenian: Pred začetkom zdravljenja z zdravilom OXERVATE je pomembno oceniti tveganje za topljenje roženice ali grozečo perforacijo ter potrebo po nujnem kirurškem ali drugem posegu, saj se cenegermina ne sme uporabljati pri bolnikih, ki potrebujejo takojšen kirurški poseg.
English: 14) If a mistake is made and a drop is not instilled into the eye, repeat the steps described above using a new pipette and wipe.
Slovenian: 14) Če pride do napake in kapljica ne kane v oko, uporabite novo pipeto in robček ter ponovite zgornje korake.
English: Patients should be advised not to instil more than one drop in the affected eye(s) during any administration.
Slovenian: Bolnikom je treba svetovati, naj v prizadeto oko ne kanejo več kot eno kapljico zdravila ob posameznem dajanju.
English: 6) Take a pipette and remove it from the protective packaging.
Slovenian: 6) Vzemite pipeto in jo odstranite iz zaščitne ovojnine.
English: OXERVATE is used to treat adults with moderate or severe ‘neurotrophic keratitis'.
Slovenian: Zdravilo OXERVATE se uporablja za zdravljenje odraslih z zmernim ali hudim nevrotrofičnim keratitisom.
English: This medicinal product should only be used with specific vial adapters and disposable devices (pipettes) that will be provided separately from the weekly OXERVATE carton.
Slovenian: To zdravilo je treba uporabljati izključno s specifičnimi nastavki za vialo in pripomočki za enkratno uporabo (pipetami), ki jih bolnik prejme ločeno od tedenske škatle z zdravilom OXERVATE.