FrancophonIA/ELRC3.0 huggingface dataset:
English: Study NGF0212 enrolled a total of 174 patients (mean age 61±16 years, range 18-95 years), who have been exposed to OXERVATE and vehicle without the L-methionine excipient; 156 patients were assessed independently for efficacy, comparing two different dosages of the medicinal product with 20 and 10 µg/ml cenegermin to vehicle (52 patients per arm).
Slovenian: V študijo NGF0212 je bilo vključenih skupno 174 bolnikov (povprečna starost 61 ± 16 let, razpon 18-95 let), ki so bili izpostavljeni zdravilu OXERVATE in vehiklu brez pomožne snovi L-metionina; učinkovitost je bila neodvisno ocenjena pri 156 bolnikih s primerjavo dveh različnih odmerkov zdravila z 20 µg/ml oziroma 10 µg/ml cenegermina in vehikla (52 bolnikov v vsakem kraku).
English: Study NGF0214 Study NGF0212
Slovenian: Študija NGF0214 Študija NGF0212
English: Other medicines and OXERVATE
Slovenian: Druga zdravila in zdravilo OXERVATE
English: How to store OXERVATE Contents of the pack and other information
Slovenian: Shranjevanje zdravila OXERVATE Vsebina pakiranja in dodatne informacije
English: You can give the missed dose 2 hours after your last scheduled dose of the day, provided this is still within 12 hours from first opening the daily vial.
Slovenian: Pozabljeni odmerek lahko uporabite 2 uri po zadnjem odmerku na urniku zdravljenja za tisti dan, če je to še vedno največ 12 ur po prvem odprtju viale za tisti dan.
English: If eye ointment, gel or other viscous eye drops are used, they should be administered 15 minutes following OXERVATE treatment (see also section 4.5).
Slovenian: V primeru uporabe mazila ali gela za oko ali drugih viskoznih kapljic za oko je treba te dati 15 minut po zdravljenju z zdravilom OXERVATE (glejte tudi poglavje 4.5).
English: The vial and any remaining solution must be discarded at the end of the day, and no later than 12 hours from the time the vial adapter was connected (irrespective of whether any residual solution remains in the vial).
Slovenian: Vialo in vse morebitne preostanke raztopine je treba zavreči konec vsakega dne, in to najpozneje 12 ur od takrat, ko je bil pritrjen nastavek za vialo (ne glede na to, ali je v viali ostalo kaj raztopine).
English: The weekly carton contains 7 vials of OXERVATE (1 vial per day of the week).
Slovenian: Tedenska škatla vsebuje 7 vial zdravila OXERVATE (1 viala za vsak dan v tednu).
English: • Check the pipette to ensure it contains the eye drops, solution.
Slovenian: • Preglejte pipeto in se prepričajte, da je v njej raztopina kapljic za oko.
English: The missed dose can be administered later, within the 12 hours shelf-life of the daily vial.
Slovenian: Izpuščeni odmerek je mogoče dati pozneje, v času 12-urnega roka uporabnosti dnevne viale.
English: As a precautionary measure, it is preferable to avoid the use of OXERVATE during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila OXERVATE bolje izogibati.
English: To control that six doses have been taken every day, the patient should be advised to use the weekly dose recording card provided with the delivery system.
Slovenian: Za zagotovitev tega, da bo vsak dan uporabljenih šest odmerkov, je treba bolniku svetovati, naj uporablja tedensko kartico za evidentiranje odmerjanja, priloženo sistemu za dostavo zdravila.
English: After cleaning, the valve should be allowed to dry for approximately one minute.
Slovenian: Po čiščenju je treba počakati približno eno minuto, da se ventil posuši.
English: Unopened vial
Slovenian: Odprta viala
English: No dose adjustment is required in patients 65 years of age and older.
Slovenian: Pri bolnikih, starih 65 let in več, prilagoditev odmerka ni potrebna.
English: Hepatic and renal impairment:
Slovenian: Okvara jeter in ledvic:
English: 12) Hold the pipette, pointing down, between the middle finger and thumb, tilt the head back and position the pipette above the affected eye.
Slovenian: 12) Pipeto držite obrnjeno navzdol med sredincem in palcem, nagnite glavo nazaj in pomaknite pipeto nad prizadeto oko.
English: The recommended dose is 1 drop in the affected eye 6 times a day at 2-hourly intervals, starting in the morning (i.e. 6 drops per day within 12 hours).
Slovenian: Priporočeni odmerek je 1 kapljica v prizadeto oko, 6-krat na dan v 2-urnih razmikih, z začetkom zjutraj (torej 6 kapljic na dan v času 12 ur).
English: Pharmacist: Store in a freezer until dispensing.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Farmacevt: Shranjujte v zamrzovalniku do izročitve.
English: The medicinal product has not been studied in patients with hepatic or renal impairment.
Slovenian: Uporabe tega zdravila pri bolnikih z okvaro jeter ali ledvic niso proučevali.
English: 1 ml OXERVATE solution in sterile, preservative-free multi-dose Type I glass vials, closed with a rubber stopper and an aluminium overseal with a polypropylene flip-off cap, presented in cardboard cartons.
Slovenian: 1 ml raztopine zdravila OXERVATE brez konzervansov v sterilnih večodmernih vialah iz stekla tipa I, zaprtih z gumijastim zamaškom in aluminijastim prekrivnim tesnilom s polipropilensko zaporko „flip-off“, pakiranih v kartonske škatle.
English: Extra adapter (1), pipettes (3) and wipes (3) will also be provided as spares.
Slovenian: Kor rezervni deli so priloženi tudi dodatni nastavek (1), pipete (3) in robčki (3).
English: Each opened vial can be stored in the fridge or below 25 °C, but must be used within 12 hours.
Slovenian: Odprto vialo je mogoče shraniti v hladilniku ali pri temperaturi do 25 °C, vendar jo je treba uporabiti v 12 urah.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Once opened, the product must be stored below 25 °C and used within 12 hours at 25 °C.
Slovenian: Po odprtju zdravilo shranjujte pri temperaturi do 25 °C in ga uporabite v 12 urah pri temperaturi 25 °C.
English: • Remove the plastic flip-off cap from the vial (picture 1).
Slovenian: • Z viale odstranite plastično zaporko „flip-off“ (slika 1).
English: 7 vial adapters (i.e. 1 per day), 42 pipettes (i.e. 6 per day) and 42 disinfectant wipes (i.e. 6 per day) sufficient to administer the medicinal product for one week will be provided separately, together with a dose recording card.
Slovenian: Bolnik ločeno prejme 7 nastavkov za vialo (t. j. 1 nastavek za vsak dan), 42 pipet (t. j. 6 pipet za vsak dan) in 42 razkužilnih robčkov (t. j. 6 robčkov za vsak dan), ki zadoščajo za enotedensko dajanje zdravila, skupaj s kartico za evidentiranje odmerjanja.
English: Gently push the plunger in until a single drop is dropped into the conjunctival fornix (picture 7).
Slovenian: Nežno potiskajte bat, dokler v forniks veznice ne kane ena kapljica raztopine (slika 7).
English: On that card the patient should track the date of the first use of the weekly supply, the time of the vial opening (i.e. when the vial adapter is connected to the vial), and the time of daily ocular instillations occurring over the week.
Slovenian: Na to kartico naj bolnik zapiše datum prve uporabe tedenske zaloge zdravila, čas odprtja viale (torej čas, ob katerem je bil nastavek za vialo nameščen na vialo) ter čas dnevnih dajanj zdravila skozi ves teden.
English: • redness of the conjunctiva (mucous membrane that covers the front of the eye and lines the inside of the eyelids);
Slovenian: • rdečina veznice (sluznice, ki prekriva sprednji del očesa in notranjost vek),
English: On that card you should write down the date of the first use of the weekly supply, the time of the vial opening (i.e. when you connect the vial adapter to the vial) and track each time you use an eye drop of this medicine, over the week.
Slovenian: Na to kartico zapišite datum prve uporabe tedenske zaloge zdravila in čas odprtja viale (torej čas, ob katerem ste na vialo namestili nastavek za vialo), nato pa ves teden vpišite čas vsakič, ko uporabite kapljico tega zdravila.
English: An eye infection should be treated before use of OXERVATE.
Slovenian: Okužbo očesa je treba zdraviti pred uporabo zdravila OXERVATE.
English: Store the weekly carton containing 7 vials of OXERVATE in the fridge (2-8 °C).
Slovenian: Tedensko škatlo s 7 vialami zdravila OXERVATE shranjujte v hladilniku (2-8 °C).
English: Very common (may affect more than 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 oseb)
English: 9) Turn the vial upside-down with the pipette connected and gently pull the pipette plunger outwards until it stops, to draw the solution into the pipette (ensure that the plunger has reached the stop point).
Slovenian: 9) Vialo z nameščeno pipeto obrnite z zgornjim delom navzdol in nežno izvlecite bat, dokler se ne ustavi, ter tako povlecite raztopino v pipeto (prepričajte se, da je bat pipete dosegel točko zaustavitve).
English: Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues.
Slovenian: Receptorji za živčni rastni dejavnik so izraženi v anteriornem segmentu očesa (roženica, veznica, šarenica, ciliarno telesce in očesna leča), solzni žlezi in intraokularnih tkivih v posteriornem segmentu.
English: A topical overdose of cenegermin may be flushed from the eye(s) with lukewarm water.
Slovenian: Topikalni prevelik odmerek cenegermina je mogoče izprati iz očesa/oči z mlačno vodo.
English: Extra adapter (1), pipettes (3) and wipes (3) are included as spares.
Slovenian: Kor rezervni deli so priloženi dodatni nastavek (1), pipete (3) in robčki (3).
English: If you get an eye infection whilst using OXERVATE, you should stop your treatment and consult your doctor for advice straightaway.
Slovenian: Če se pri vas pojavi okužba očesa med uporabo zdravila OXERVATE, morate takoj prenehati z zdravljenjem in se posvetovati z zdravnikom.
English: • Holding the pipette, pointing down, between your middle finger and thumb, tilt your head back and position the pipette above your affected eye.
Slovenian: • Pipeto držite obrnjeno navzdol med sredincem in palcem, nagnite glavo nazaj in pomaknite pipeto nad prizadeto oko.
English: The lesion or ulcer in your eye will worsen and could lead to infections or impaired vision.
Slovenian: Če ste prenehali uporabljati zdravilo OXERVATE Lezija ali razjeda v vašem očesu se bo poslabšala, kar lahko privede do okužb ali okvare vida.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 oseb)
English: If you use more than you should, flush the affected eye with lukewarm water.
Slovenian: Če ste uporabili večji odmerek zdravila OXERVATE, kot bi smeli Če ste uporabili več zdravila, kot bi smeli, izplaknite prizadeto oko z mlačno vodo.
English: There are no data on the effects of cenegermin on human fertility.
Slovenian: Podatkov o vplivu cenegermina na sposobnost razmnoževanja pri človeku ni.
English: How to use OXERVATE
Slovenian: Kako uporabljati zdravilo OXERVATE
English: What you need to know before you use OXERVATE Do not use OXERVATE:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo OXERVATE
English: The vial can be stored in the fridge or below 25 °C throughout the day, but should not be frozen.
Slovenian: Vialo je mogoče čez dan shraniti nazaj v hladilnik ali pri temperaturi do 25 °C, ne sme pa se je zamrzniti.
English: • After each use throughout the day, place the vial back in the fridge (or keep it below 25 °C) for the rest of the day, with the vial adapter still connected.
Slovenian: • Čez dan po vsaki uporabi shranite vialo nazaj v hladilnik (ali pa jo shranite pri temperaturi do 25 °C), pri čemer mora nastavek za vialo ostati pritrjen.
English: Treatment with OXERVATE may cause you mild to moderate eye discomfort such as eye pain.
Slovenian: Zdravljenje z zdravilom OXERVATE lahko povzroči blago do zmerno neugodje v očesu, kot je bolečina v očesu.
English: Eye inflammation, eyelid pain, foreign body sensation in the eye, lacrimation increased, blepharitis, conjunctival hyperaemia, photophobia, eye irritation Uncommon Corneal neovascularization
Slovenian: Očesne bolezni zelo pogosti bolečina v očesu pogosti vnetje očesa, bolečina v veki, občutek tujka v očesu, povečano solzenje, blefaritis, hiperemija veznice, fotofobija, razdraženost očesa občasni neovaskularizacija roženice
English: To control that six doses have been taken at the end of each treatment day, you should use the weekly dose recording card provided with the delivery system.
Slovenian: Za zagotovitev tega, da boste vsak dan zdravljenja uporabili šest odmerkov, uporabljajte tedensko kartico za evidentiranje odmerjanja, priloženo sistemu za dostavo zdravila.
English: What OXERVATE is and what it is used for What you need to know before you use OXERVATE How to use OXERVATE
Slovenian: Kaj je zdravilo OXERVATE in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo OXERVATE Kako uporabljati zdravilo OXERVATE Možni neželeni učinki
English: Each vial contains 1 ml eye drops, solution.
Slovenian: Ena viala vsebuje 1 ml raztopine kapljic za oko.
English: Should an eye infection occur, OXERVATE should be suspended until infection resolution (see section 4.2).
Slovenian: Če pride do okužbe očesa, je treba do ozdravljenja okužbe prekiniti zdravljenje z zdravilom OXERVATE (glejte poglavje 4.2).
English: If you experience a severe eye reaction seek medical advice from your doctor.
Slovenian: Če se pri vas pojavi huda reakcija v očesu, se posvetujte z zdravnikom.
English: If more than one topical ophthalmic product is being used, the eye drops must be administered at least 15 minutes apart, to avoid diluting the other product.
Slovenian: Ob uporabi več kot enega topikalnega oftalmološkega zdravila je treba kapljice za oko dati vsaj 15 minut pred dajanjem drugega zdravila ali vsaj 15 minut po njem, da preprečimo razredčenje drugega zdravila.
English: The recommended dose is one drop of OXERVATE in the conjunctival sac of the affected eye(s), 6 times a day at 2 hourly intervals, starting from the morning and within 12 hours.
Slovenian: Priporočeni odmerek je ena kapljica zdravila OXERVATE v veznično vrečko prizadetega očesa (prizadetih očesih), 6-krat na dan v razmiku 2 ur, z začetkom zjutraj in zaključkom v času 12 ur.
English: Pack size: 7 multi-dose vials.
Slovenian: Velikost pakiranja: 7 večodmernih vial.
English: Eye drops, solution (eye drops).
Slovenian: Kapljice za oko, raztopina (kapljice za oko).
English: You should wait at least 15 minutes before or after using OXERVATE if you use any other eye drops.
Slovenian: Pred uporabo zdravila OXERVATE ali po njej morate počakati vsaj 15 minut, če uporabljate katere koli druge kapljice za oko.
English: Excipients: trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine, water for injections, hydrochloric acid, sodium hydroxide, nitrogen.
Slovenian: Pomožne snovi: trehaloza dihidrat, manitol, brezvodni dinatrijev hidrogenfosfat, natrijev dihidrogenfosfat dihidrat, hidroksipropilmetilceluloza, polietilenglikol 6000, L-metionin, voda za injekcije, klorovodikova kislina, natrijev hidroksid, dušik.
English: 15) Throughout the day, the vial can either be placed back in the fridge after each use or stored below 25 °C (with the vial adapter still connected).
Slovenian: 15) Prek dneva je vialo mogoče shraniti nazaj v hladilnik po vsaki uporabi ali pa jo shraniti pri temperaturi do 25 °C (nastavek za vialo mora ostati pritrjen).
English: Other topical ophthalmic products may be used during treatment with OXERVATE when used 15 minutes apart, with the exception of agents known to inhibit epithelial healing (e.g. corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives) (see sections 4.2 and 4.4).
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Med zdravljenjem z zdravilom OXERVATE je mogoče uporabljati druga topikalna oftalmološka zdravila, če je presledek med uporabo 15 minut, z izjemo zdravil, za katera je znano, da zavirajo celjenje epitelija (npr. kortikosteroidi ali kapljice za oko, ki vsebujejo konzervanse, kot so benzalkonijev klorid, polikvaternij-1, benzododecinijev bromid, cetrimid in drugi kvaterni amonijevi derivati) (glejte poglavji 4.2 in 4.4).
English: Cenegermin administered by eye drops is mostly eliminated with the tear secretion.
Slovenian: Cenegermin, dan v obliki kapljic za oko, se v glavnem izloča prek izločanja solz.
English: • pain in the eyelid;
Slovenian: • bolečina v veki,
English: The percentage of patients experiencing complete corneal clearing (grade 0 on the modified Oxford scale), the least squares mean change in best corrected distance visual acuity score (Early Treatment Diabetic Retinopathy Study letters) from baseline and any improvement in corneal sensitivity as measured in millimetres by Cochet-Bonnet aesthesiometry (difference compared to baseline >0) was also measured after 8 weeks of treatment in both studies, and summarized in the table below.
Slovenian: Po 8 tednih zdravljenja v obeh študijah so izmerili tudi odstotek bolnikov, pri katerih je prišlo do popolne zbistritve roženice (ocena 0 po modificirani Oxfordski lestvici), povprečno spremembo najmanjših kvadratov ocene največje korigirane ostrine vida na daljavo (optotipi ETDRS) glede na izhodišče in kakršno koli izboljšanje občutljivosti roženice, merjeno v milimetrih z esteziometrijo po Cochet-Bonnet (razlika v primerjavi z izhodiščem >0), ki so povzeti v spodnji preglednici.
English: OXERVATE is intended to allow the healing of the cornea.
Slovenian: Zdravilo OXERVATE je namenjeno temu, da omogoči celjenje roženice.
English: Nonclinical data reveal no hazard for humans based on conventional studies of safety pharmacology (central nervous system), single-dose toxicity, repeat-dose toxicity and toxicity to reproduction, embryo-foetal development, pre- and post-natal development using ocular (eye drop), intravenous, and/or subcutaneous administration.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti (centralni živčni sistem), toksičnosti pri enkratnih odmerkih, toksičnosti pri ponavljajočih odmerkih, vpliva na sposobnost razmnoževanja, embrio-fetalnega, prenatalnega in postnatalnega razvoja pri okularnem (kapljice za oko), intravenskem in/ali subkutanem dajanju ne kažejo posebnega tveganja za človeka.
English: An individual pipette should be used per application.
Slovenian: Za vsako dajanje zdravila je treba uporabiti novo pipeto.
English: Pack size: 7 multi-dose vials per carton
Slovenian: Velikost pakiranja: 7 večodmernih vial na škatlo
English: Gently push the pipette plunger in until a single drop is instilled into the conjunctival fornix.
Slovenian: Nežno pritiskajte bat pipete, dokler v forniks veznice ne kane ena kapljica raztopine.
English: Adults:
Slovenian: Odrasli bolniki:
English: 1 ml of OXERVATE contains 20 micrograms of cenegermin.
Slovenian: 1 ml zdravila OXERVATE vsebuje 20 mikrogramov cenegermina.
English: 1) With clean freshly-washed hands, place the vial on a steady flat surface and remove the plastic flip-off cap. 2) Peel-off the back of the vial adapter blister pack.
Slovenian: 1) S sveže umitimi rokami položite vialo na ravno površino in snemite plastično zaporko „flipoff“.
English: To withdraw and administer each dose of OXERVATE solution, the steps below should be followed:
Slovenian: Za odvzem in dajanje posameznega odmerka raztopine zdravila OXERVATE sledite naslednjim korakom:
English: Ensure the plunger has reached the stop point
Slovenian: Prepričajte se, da je bat pipete dosegel točko zaustavitve (slika 6).
English: • If a drop misses your eye, try again, using a new pipette and wipe.
Slovenian: • Če kapljica ne pade v vaše oko, uporabite novo pipeto in robček ter ponovite zgornje korake.
English: OXERVATE vials
Slovenian: Viale zdravila OXERVATE
English: • inflammation of the eyelid with itching and redness;
Slovenian: • okužba roženice z gnojenjem in otekanjem.
English: Pharmacy:
Slovenian: Lekarna:
English: Use of ophthalmic topical agents known to inhibit epithelial healing, including corticosteroids or eye drops containing preservatives such as benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide and other quaternary ammonium derivatives, should be avoided during treatment of neurotrophic keratitis, as they could interfere with corneal healing (see section 4.5).
Slovenian: Med zdravljenjem nevrotrofičnega keratitisa se je treba izogibati uporabi oftalmoloških topikalnih zdravil, za katera je znano, da zavirajo celjenje epitelija, vključno s kortikosteroidi ali kapljicami za oko, ki vsebujejo konzervanse, kot so benzalkonijev klorid, polikvaternij-1, benzododecinijev bromid, cetrimid in drugi kvaterni amonijevi derivati, saj lahko vplivajo na celjenje roženice (glejte poglavje 4.5).
English: After the vial adapter is connected to the vial, it can be stored in the fridge or below 25 °C.
Slovenian: Po tem, ko na vialo namestite nastavek, jo lahko shranite v hladilniku ali pri temperaturi do 25 °C.
English: • Without removing the vial adapter from its blister pack, connect it to the vial by firmly pushing it down until it snaps into place over the neck of the vial.
Slovenian: • Ne da bi odstranili nastavek za vialo iz pretisnega omota, ga namestite na vialo, in sicer tako, da odločno potisnete nastavek za vialo naravnost navzdol, tako da zdrsne preko vratu viale.
English: If eye ointment, gel or other viscous eye drops are used, OXERVATE should be administered first.
Slovenian: Če se uporabljajo mazilo ali gel za oko ali druge viskozne kapljice za oko, je treba zdravilo OXERVATE dati pred njimi.
English: Discard the used vial at the end of the day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.
Slovenian: Uporabljeno vialo zavrzite (tudi če je v njej še zmeraj nekaj tekočine) ob koncu dneva, v vsakem primeru pa najpozneje 12 ur po tem, ko ste nanjo namestili nastavek za vialo.
English: The following adverse reactions listed below were observed in clinical studies in patients suffering from neurotrophic keratitis, treated with OXERVATE 20 μg/ml.
Slovenian: V kliničnih študijah so pri bolnikih z nevrotrofičnim keratitisom, zdravljenih z zdravilom OXERVATE 20 μg/ml, opazili naslednje neželene učinke.
English: 13) Immediately discard the used pipette and wipe after instillation.
Slovenian: 13) Po dajanju zdravila takoj zavrzite uporabljeno pipeto in robček.
English: Discard the used vial at the end of each day (even if there is still some liquid left in it), and in any case no later than 12 hours from the time you connected the vial adapter to it.
Slovenian: Uporabljeno vialo zavrzite (tudi če je v njej še zmeraj nekaj tekočine) ob koncu vsakega dne, v vsakem primeru pa najpozneje 12 ur po tem, ko ste nanjo namestili nastavek za vialo.
English: • Turn the vial upside-down (with the pipette still connected) and gently pull the plunger until it stops, to draw the solution into the pipette.
Slovenian: • Vialo (z nameščeno pipeto) obrnite z zgornjim delom navzdol in nežno izvlecite bat, dokler se ne ustavi, ter tako povlecite raztopino v pipeto.
English: The patient will receive a weekly carton including 7 vials of OXERVATE in an insulated pack.
Slovenian: Bolnik prejme tedensko škatlo s 7 vialami zdravila OXERVATE v izoliranem paketu.
English: 4) Remove and discard the vial adapter blister pack.
Slovenian: 4) Odstranite in zavrzite pretisni omot nastavka za vialo.
English: 5) Take an individual disinfectant wipe and gently clean the surface of the valve on the luer lock connector of the vial adapter.
Slovenian: 5) Vzemite en razkužilni robček in nežno obrišite površino ventila na priključku luer lock na nastavku za vialo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - VIALA