FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxturna is a concentrate for solution for subretinal injection that requires thawing and dilution prior to administration.
Slovenian: Zdravilo Luxturna je sterilna koncentrirana raztopina za subretinalno injiciranje, ki ga je treba pred apliciranjem odmrzniti in razredčiti.
English: • Cataract (clouding of the lens)
Slovenian: • siva mrena (zamotnitev leče)
English: Follow the steps below to administer Luxturna to patients:
Slovenian: Za apliciranje zdravila Luxturna bolnikom upoštevajte naslednja navodila:
English: For dilution, draw 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent.
Slovenian: Za razredčitev potegnite 0,3 ml odmrznjenega koncentrata v 1-mililitrsko brizgo in ga dodajte v 10-mililitrsko sterilno vialo, v kateri je vehikel.
English: XY2
Slovenian: XL2
English: The monocular MLMT change score significantly improved in the treatment group and was similar to the binocular MLMT results (see Table 4).
Slovenian: V skupini zdravljenih preiskovancev je bila sprememba ocene pri testu MLMT pri gledanju z enim samim očesom statistično značilno večja in je bila približno tolikšna kot pri rezultatih testa MLMT pri gledanju z obema očesoma (glejte preglednico 4).
English: VIAL LABEL (SOLVENT)
Slovenian: NALEPKA NA VIALI (VEHIKEL)
English: Luxturna is used for the treatment of adults and children with vision loss due to inherited retinal dystrophy caused by mutations in the RPE65 gene.
Slovenian: Zdravilo Luxturna uporabljamo za zdravljenje odraslih in otrok z izgubo vida zaradi dedne distrofije (propadanja) mrežnice, ki jo povzročijo mutacije gena RPE65.
English: It is recommended that patients/caregivers wear gloves for dressing changes and waste disposal, especially in case of underlying pregnancy, breast-feeding and immunodeficiency of caregivers.
Slovenian: Pri prevezovanju oči in odstranjevanju odpadkov je bolnikom oziroma njihovim negovalcem priporočena uporaba zaščitnih rokavic, zlasti v času nosečnosti ali dojenja ter v primeru imunske pomanjkljivosti pri negovalcih.
English: Do not drive or use heavy machines until your vision has recovered.
Slovenian: Dokler se vam vid ne povrne, ne smete voziti ali upravljati težkih strojev.
English: Clinical pharmacokinetics and shedding
Slovenian: Klinična farmakokinetika in izločanje s solzami
English: What Luxturna contains The active substance is voretigene neparvovec.
Slovenian: Kaj vsebuje zdravilo Luxturna Učinkovina je voretigen neparvovek.
English: No pharmacokinetic studies with voretigene neparvovec have been conducted in special populations.
Slovenian: Pri posebnih skupinah bolnikov niso opravili farmakokinetičnih študij z voretigen neparvovekom.
English: Talk to your doctor before resuming these activities.
Slovenian: Preden spet začnete s temi dejavnostmi, se posvetujte z zdravnikom.
English: Y1
Slovenian: L1
English: • All spills of voretigene neparvovec must be treated with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Slovenian: • Če se voretigen neparvovek polije, ga je treba pobrisati z virucidnim sredstvom, kot je 1-odstotni natrijev hipoklorit, in krpo iz vpojnega materiala.
English: Luxturna should be inspected visually prior to administration.
Slovenian: Zdravilo Luxturna je treba pred odmerjanjem vizualno pregledati.
English: • Supine head positioning is initiated immediately in the post-operative period and upon discharge should be maintained by the patient for 24 hours.
Slovenian: • Po posegu je treba bolniku takoj pravilno namestiti glavo v ležečem položaju, bolnik pa mora v takem položaju ostati še 24 ur po odpustu.
English: vg will be delivered into the subretinal space in a total volume of 0.3 mL per eye.
Slovenian: vg v subretinalni prostor v skupnem volumnu 0,3 ml v vsako oko.
English: • You should avoid swimming because of an increased risk of infection in the eye.
Slovenian: • zaradi povečanega tveganja za okužbo očesa ne smete plavati.
English: 1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
Slovenian: 1,7 ml ekstraktabilnega volumna vehikla v 2-mililitrski viali iz cikličnega olefinskega polimera s klorobutilnim gumijastim zamaškom, zatesnjenim z aluminijasto snemno (flip-off) zaporko.
English: Patients should be instructed to avoid air travel or other travel to high elevations until the air bubble formed as a result of administration of Luxturna has completely dissipated from the eye. A time period of up to one week or more following injection may be required before dissipation of the air bubble; this should be verified on ophthalmic examination.
Slovenian: Bolnikom je treba naročiti, da ne smejo potovati z zračnimi prevoznimi sredstvi ali kako drugače potovati v kraje z visoko nadmorsko višino, dokler se zračni mehurček, ki nastane zaradi injiciranja zdravila Luxturna, povsem ne porazgubi oziroma resorbira iz očesa.
English: The product-filled syringes should then be transferred in a designated transport container to the surgical suite.
Slovenian: Obe brizgi z zdravilom je treba nato do operacijske sobe prenesti v posebnem transportnem vsebniku.
English: Difference (95% CI) (Intervention-Control) -1.89 (-3.03, -0.75), p=0.002 Full-field light sensitivity testing - Averaged across both eyes (ITT) Difference (95% CI) (Intervention-Control): -2.11 (-3.19, -1.04), p<0.001
Slovenian: Testiranje občutljivosti celotnega vidnega polja na svetlobo - povprečna vrednost za obe očesi (populacija ITT) razlika med intervencijsko in kontrolno skupino (95-odstotni IZ): -2,11 (-3,19, -1,04), p<0,001
English: - Treat all Luxturna spills with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Slovenian: - Če se zdravilo Luxturna polije, ga je treba pobrisati z virucidnim sredstvom, kot je 1-odstotni natrijev hipoklorit, in krpo iz vpojnega materiala.
English: • Under direct visualisation, the tip of the subretinal injection cannula is placed in contact with the retinal surface.
Slovenian: • Ob neposredni vizualizaciji je treba vrh kanile za subretinalno injiciranje namestiti tako, da se dotika površine mrežnice.
English: • Connect the syringe containing the diluted product to the extension tube and subretinal injection cannula.
Slovenian: • Brizgo z razredčenim zdravilom spojite s cevnim podaljškom in kanilo za subretinalno injiciranje.
English: Retinal tear, dellen, macular hole, eye inflammation, eye irritation, eye pain, maculopathy, choroidal haemorrhage, conjunctival cyst, eye disorder, eye swelling, foreign body sensation in eyes, macular degeneration, endophthalmitis, retinal detachment, retinal disorder, retinal haemorrhage
Slovenian: Očesne bolezni zelo pogosti veznična hiperemija, katarakta pogosti raztrganina mrežnice, tanjšanje roženične strome, foramen makule, vnetje v očesu, draženje očesa, bolečine v očesu, makulopatija, krvavitev v žilnici, veznična cista, okvara očesa, otekanje očesa, občutek tujka v očeh, degeneracija makule, endoftalmitis, odstop mrežnice, okvara mrežnice, krvavitev v mrežnici
English: Figure 2 Change in MLMT score using binocular vision versus time before / after exposure to voretigene neparvovec
Slovenian: Slika 2 Spremembe ocene pri testu MLMT pri gledanju z obema očesoma: razlika med oceno pred izpostavljenostjo voretigen neparvoveku in po njej
English: Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into each sterile 1 mL syringe.
Slovenian: Brizge za injiciranje pripravite tako, da v vsako od dveh sterilnih 1-mililitrskih brizg potegnete 0,8 ml razredčene raztopine.
English: Patients should avoid swimming because of an increased risk of infection in the eye.
Slovenian: Zaradi povečanega tveganja za okužbo očesa bolniki ne smejo plavati.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
Slovenian: Bolnikom je treba naročiti, naj takoj obvestijo zdravnika, če opazijo kakršne koli simptome, ki bi kazali na endoftalmitis ali odstop mrežnice; bolnike je treba v takih primerih ustrezno zdraviti.
English: Excipients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, poloxamer 188, water for injections.
Slovenian: Pomožne snovi: natrijev klorid, natrijev dihidrogenfosfat monohidrat, dinatrijev hidrogenfosfat dihidrat, poloksamer 188, voda za injekcije.
English: After thawing and dilution
Slovenian: Po odmrznitvi in redčenju
English: Gently invert the 10 mL glass vial at least five times for proper mixing.
Slovenian: 10-mililitrsko stekleno vialo najmanj petkrat nežno obrnite na glavo, da se vsebina ustrezno premeša.
English: Prednisone (or equivalent) 0.5 mg/kg/day (maximum of 20 mg/day)
Slovenian: nato 5 dni prednizon (ali ekvivalent) 0,5 mg/kg/dan (največ 20 mg/dan)
English: Nausea, vomiting, abdominal pain upper, lip pain Skin and subcutaneous disorders Common
Slovenian: Bolezni prebavil pogosti navzea, bruhanje, bolečine v zgornjem delu trebuha, bolečine v ustnicah Bolezni kože in podkožja pogosti izpuščaj, otekanje obraza
English: Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into a sterile 1 mL syringe.
Slovenian: Brizgo za injiciranje pripravite tako, da v sterilno 1-mililitrsko brizgo potegnete 0,8 ml razredčene raztopine.
English: Temporary visual disturbances, such as blurred vision and photophobia, may occur during the weeks that follow the treatment.
Slovenian: V obdobju nekaj tednov po zdravljenju se lahko pojavijo prehodne motnje vida, kot sta zamegljen vid in fotofobija.
English: The highest levels of vector DNA sequences were detected in intraocular fluids (anterior chamber fluid and vitreous) of vector-injected eyes.
Slovenian: V očeh, v katere so injicirali vektorje, so najvišjo koncentracijo segmentov vektorske DNA izmerili v intraokularnih tekočinah (v tekočini sprednjega očesnega prekata in v steklovini).
English: Figure 1 Tip of the subretinal injection cannula placed within recommended injection site (surgeon's view)
Slovenian: Slika 1 Vrh kanile za subretinalno injiciranje nastavljen v mejah priporočenega mesta injiciranja (pogled kirurga)
English: For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja odmrznjenega in razredčenega zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: In 13/29 (45%) subjects receiving bilateral administrations, Luxturna vector DNA sequences were detected in tear samples; most of these subjects were negative after the day 1 post-injection visit, however, four of these subjects had positive tear samples beyond the first day, one subject up to day 14 post-second eye injection.
Slovenian: Pri večini teh preiskovancev so bili po obisku, 1 dan po injiciranju, vzorci negativni, pri štirih od teh preiskovancev pa so bili vzorci solza pozitivni več kot en dan po injiciranju: pri enem bolniku do 14. dne po injiciranju v drugo oko.
English: vector genomes of voretigene neparvovec.
Slovenian: vektorskih genomov voretigen neparvoveka.
English: Y3
Slovenian: L3
English: What Luxturna looks like and contents of the pack Luxturna is a clear, colourless concentrate for solution for subretinal injection, supplied in a clear plastic vial.
Slovenian: Zdravilo Luxturna je bister brezbarven koncentrat za raztopino za subretinalno injiciranje in je na voljo v prozorni plastični viali.
English: The product is slowly injected through the extension tube and subretinal injection cannula to eliminate any air bubbles.
Slovenian: Zdravilo je treba skozi cevni podaljšek in kanilo za subretinalno injiciranje injicirati počasi, da se v sistemu ne bi pojavili zračni mehurčki.
English: Figure 1B Tip of the subretinal injection cannula placed within the recommended site of injection (surgeon's view)
Slovenian: Slika 1B Vrh kanile za subretinalno injiciranje nastavljen v mejah priporočenega mesta injiciranja (pogled kirurga)
English: Patients should avoid strenuous physical activity because of an increased risk of injury to the eye.
Slovenian: Zaradi povečanega tveganja za poškodbo očesa se morajo bolniki izogibati napornim telesnim dejavnostim.
English: The back-up syringe may not be retained.
Slovenian: Rezervne brizge se ne sme shraniti za kasnejšo uporabo.
English: Figure 1A Subretinal injection cannula introduced via pars plana
Slovenian: Slika 1A Kanila za subretinalno injiciranje, vstavljena skozi pars plana trokar za vitrektomijo kanila za subretinalno injiciranje priporočeni predel injiciranja
English: Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec (see section 6.6).
Slovenian: Pri pripravljanju in apliciranju voretigen neparvoveka je treba uporabljati osebno zaščitno opremo (kar vključuje laboratorijsko haljo, zaščitna očala in rokavice) (glejte poglavje 6.6).
English: • Detachment of the retina
Slovenian: • odstop mrežnice
English: If particulates, cloudiness, or discoloration are visible, the single-dose vial must not be used.
Slovenian: Če so v njem vidni delci ali če je zdravilo motno ali obarvano, se viale za enkratno odmerjanje ne sme uporabiti.
English: There is reduced vision in the days after surgery that usually improves; tell your doctor if vision does not return.
Slovenian: Nekaj dni po posegu je vid slabši, nato pa se običajno spet izboljša.
English: • Deposits under the retina
Slovenian: • odlaganje depozitov (skupkov snovi) pod mrežnico
English: A cataract is clouding of the natural lens inside the eye that can make it harder to see clearly.
Slovenian: Katarakta je zamotnitev leče, ki je naravno prisotna v očesu.
English: Y2
Slovenian: L2
English: Psychiatric disorders Common
Slovenian: Psihiatrične motnje pogosti anksioznost
English: Each dose of diluted solution contains 1.5 x 10
Slovenian: En odmerek razredčene raztopine vsebuje 1,5 x 10
English: Electrocardiogram T wave inversion Injury, poisoning and procedural complications Common
Slovenian: Preiskave zelo pogosti zvišanje intraokularnega tlaka pogosti inverzija T vala v elektrokardiogramu Poškodbe in zastrupitve in zapleti pri posegih pogosti zapleti endotrahealne intubacije, dehiscenca rane
English: Prednisone (or equivalent) 0.5 mg/kg every other day (maximum of 20 mg/day)
Slovenian: nato 5 dni po en odmerek vsak drugi dan prednizon (ali ekvivalent) 0,5 mg/kg vsak drugi dan (največ 20 mg/dan)
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.29 (0.21), mean (SE).
Slovenian: Ob izhodišču je bila povprečna vrednost vidne ostrine prvega očesa pri teh preiskovancih 1,29 (v enotah logMAR) s standardno napako 0,21.
English: The following adverse reactions have been observed with the administration procedure:
Slovenian: V povezavi s postopkom apliciranja zdravila so opažali naslednje neželene učinke:
English: Gently invert the vial at least five times for proper mixing.
Slovenian: Vialo najmanj petkrat nežno obrnite na glavo, da se vsebina ustrezno premeša.
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.18 (0.14), mean (SE).
Slovenian: Ob izhodišču je bila povprečna vrednost vidne ostrine prvega očesa pri teh preiskovancih 1,18 (v enotah logMAR) s standardno napako 0,14.
English: Solvent for Luxturna
Slovenian: vehikel za zdravilo Luxturna
English: • Increased pressure in the eye
Slovenian: • zvišan očesni tlak
English: • You and your caregiver, especially if pregnant, breast-feeding or with a suppressed immune system, should wear gloves during dressing changes and when disposing of the dressings and other waste material.
Slovenian: • morata tako vi kot vaš negovalec uporabljati zaščitne rokavice pri prevezovanju očesa in odstranjevanju odpadnega obvezilnega materiala ter drugih odpadkov, zlasti v primeru nosečnosti, dojenja ali imunske pomanjkljivosti.
English: • Accidental exposure to voretigene neparvovec, including contact with skin, eyes and mucous membranes, is to be avoided.
Slovenian: • Paziti je treba, da ne pride do nenamerne izpostavljenosti voretigen neparvoveku, kar vključuje stik zdravila s kožo, očmi in sluznicami.
English: vg voretigene neparvovec in each eye. Each dose will be delivered into the subretinal space in a total volume of 0.3 mL.
Slovenian: Vsak odmerek je treba injicirati v subretinalni prostor v skupnem volumnu 0,3 ml.
English: Gently invert the vials five times to mix the contents.
Slovenian: Vsako vialo petkrat nežno obrnite na glavo, da se vsebina v njih premeša.
English: The following side effects may happen with Luxturna:
Slovenian: Zaradi zdravila Luxturna lahko pride do naslednjih neželenih učinkov:
English: Full-field light sensitivity testing - First assigned eye (ITT) Intervention, N = 21
Slovenian: Testiranje občutljivosti celotnega vidnega polja na svetlobo - prvo izbrano oko (populacija ITT)
English: Precaution to be taken before manipulating or administering the product Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec.
Slovenian: Previdnostni ukrepi, potrebni pred rokovanjem z zdravilom ali dajanjem zdravila Pri pripravljanju in apliciranju voretigen neparvoveka je treba uporabljati osebno zaščitno opremo (kar vključuje laboratorijsko haljo, zaščitna očala in rokavice).
English: Please talk to your doctor before beginning to engage in strenuous physical activity after receiving Luxturna.
Slovenian: V obdobju po prejemu zdravila Luxturna se morate posvetovati z zdravnikom, preden se lotite naporne telesne dejavnosti.
English: The safety and efficacy of voretigene neparvovec in patients ≥65 years old have not been established.
Slovenian: Varnost in učinkovitost voretigen neparvoveka pri bolnikih, ki so stari 65 let ali več, nista bili dokazani, vendar prilagajanje odmerjanja pri starejših bolnikih ni potrebno.
English: The other ingredients of the concentrate are sodium chloride (see end of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate dihydrate (for pH adjustment), poloxamer 188 and water for injections.
Slovenian: - Druge sestavine koncentrata so natrijev klorid (glejte na koncu poglavja 2), natrijev dihidrogenfosfat monohidrat (za uravnavanje pH), dinatrijev hidrogenfosfat dihidrat (za uravnavanje pH), poloksamer 188 in voda za injekcije.
English: Transfer 2.7 mL of solvent taken from the two thawed vials and dispense into a sterile 10 mL empty glass vial using a 3 mL syringe.
Slovenian: 2,7 ml vehikla, ki ga vzamete iz dveh odmrznjenih vial, s pomočjo 3-mililitrske brizge prenesite v prazno sterilno stekleno 10-mililitrsko vialo.
English: How Luxturna is given to you
Slovenian: Kako prejmete zdravilo Luxturna
English: vector genomes/mL concentrate and solvent for solution for injection voretigene neparvovec
Slovenian: vektorskih genomov/ml koncentrat in vehikel za raztopino za injiciranje voretigen neparvovek
English: Inspect for any visual particulates or any anomalies.
Slovenian: Zdravilo vizualno preglejte in bodite pozorni na morebitno vsebnost vidnih delcev in kakršne koli druge nepravilnosti.
English: Following the administration, patients should be instructed to report any symptoms suggestive of retinal detachment or endophthalmitis without delay and should be managed appropriately.
Slovenian: Po apliciranju zdravila je treba bolnikom naročiti, naj takoj obvestijo zdravnika, če opazijo kakršne koli simptome, ki bi kazali na odstop mrežnice ali endoftalmitis.
English: The solvent contains sodium chloride (see end of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate dihydrate (for pH adjustment), poloxamer 188 and water for injections.
Slovenian: Vehikel vsebuje natrijev klorid (glejte na koncu poglavja 2), natrijev dihidrogenfosfat monohidrat (za uravnavanje pH), dinatrijev hidrogenfosfat dihidrat (za uravnavanje pH), poloksamer 188 in vodo za injekcije.
English: vector genomes/mL concentrate and solvent for solution for injection
Slovenian: vektorskih genomov/ml koncentrat in vehikel za raztopino za injiciranje
English: Transfer 2.7 mL of the solvent taken from the two thawed vials and dispense into a sterile 10 mL glass vial using a 3 mL syringe.
Slovenian: 2,7 ml vehikla, ki ga vzamete iz dveh odmrznjenih vial, s pomočjo 3-mililitrske brizge prenesite v sterilno stekleno 10-mililitrsko vialo
English: Concentrate and solvent for solution for injection
Slovenian: koncentrat in vehikel za raztopino za injiciranje
English: Administration Follow the steps below to administer voretigene neparvovec to patients:
Slovenian: Odmerjanje Za apliciranje voretigen neparvoveka bolnikom upoštevajte naslednja navodila:
English: Please talk to your doctor before going to swim after receiving treatment with Luxturna.
Slovenian: V obdobju po prejemu zdravila Luxturna se morate posvetovati z zdravnikom, preden greste na plavanje.
English: vg in a deliverable volume of 0.3 mL.
Slovenian: vg v 0,3 ml, to je volumen, ki ga je mogoče aplicirati.
English: o Inform healthcare professionals that the patient has received gene therapy, and the importance of reporting adverse events.
Slovenian: • bolnikovo kartico: o na kateri je poudarjen pomen kontrolnih obiskov in bolnikovega obveščanja zdravnika o neželenih učinkih; o z informacijami, ki zdravstvene delavce seznanjajo z dejstvom, da je bolnik prejel gensko zdravilo, in poudarjajo pomen poročanja o neželenih dogodkih; o s kontaktnimi podatki za poročanje o neželenih dogodkih.
English: Thaw one single-dose vial of concentrate and two vials of solvent at room temperature.
Slovenian: Na sobni temperaturi odmrznite eno vialo za enkratno odmerjanje, ki vsebuje koncentrat, in dve viali za enkratno odmerjanje, ki vsebujeta vehikel.
English: Patients may experience temporary visual disturbances after receiving subretinal injection of Luxturna.
Slovenian: Po prejemu subretinalne injekcije zdravila Luxturna lahko pri bolnikih pride do prehodnih motenj vida.
English: vector genomes/mL concentrate for solution for injection voretigene neparvovec
Slovenian: vektorskih genomov/ml koncentrat za raztopino za injiciranje voretigen neparvovek subretinalna uporaba
English: There were three non-serious adverse reactions of retinal deposits in three of 41 (7%) subjects that were considered to be related to voretigene neparvovec.
Slovenian: Pri treh od 41 oseb (7 %) je prišlo do treh neželenih učinkov, ki niso bili opredeljeni kot resni, ocenjeni pa so bili kot vzročno povezani z voretigen neparvovekom, in sicer je šlo za prisotnost mrežničnih depozitov.
English: Endotracheal intubation complication, wound dehiscence
Slovenian: Bolezni živčevja pogosti glavobol, omotičnost
English: There is an additional risk of cataract if the lens inside the eye is damaged by the needle used to inject the medicine into the back of the eye.
Slovenian: Če igla, skozi katero zdravnik injicira zdravilo v zadajšnji del očesa, poškoduje lečo v očesu, je tveganje za razvoj katarakte še večje.
English: This ability depends on the subject's visual acuity, visual field and the extent of nyctalopia (decreased ability to perceive and/or see in dim light), each of which are functions specifically affected by the retinal disease associated with RPE65 mutations.
Slovenian: Ta sposobnost je odvisna od posameznih vidnih funkcij preiskovanca, in sicer od ostrine vida, obsega vidnega polja in stopnje niktalopije (zmanjšane zmožnosti zaznavanja svetlobe in/ali vida pri šibki svetlobi).
English: Accidental exposure must be avoided.
Slovenian: Paziti je treba, da ne pride do nenamerne izpostavljenosti zdravilu.
English: - Accidental exposure to voretigene neparvovec, including contact with skin, eyes and mucous membranes, is to be avoided.
Slovenian: - Paziti je treba, da ne pride do nenamerne izpostavljenosti voretigen neparvoveku, kar vključuje stik zdravila s kožo, očmi in sluznicami.