FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) se mora pred prihodom zdravila na trg v vsaki državi članici dogovoriti za izobraževalni program z nacionalnim pristojnim organom.
English: The safety findings observed in study TG-MV-009 were consistent with the known safety profile for JETREA.
Slovenian: Varnostne ugotovitve, ki so jih opazili v študiji TG-MV-009 so bile skladne z znanim varnostnim profilom zdravila JETREA.
English: Elderly The elderly population has been studied in clinical studies.
Slovenian: Starejši bolniki Dajanje zdravila starejši populaciji so preučili v kliničnih študijah.
English: Patients should be monitored appropriately (see section 4.8 and 5.3).
Slovenian: Bolnike je treba primerno spremljati (glejte poglavji 4.8 in 5.3).
English: The medicinal product should be diluted and used immediately.
Slovenian: Zdravilo je treba razredčiti in takoj uporabiti.
English: There is no relevant use of Jetrea in children and adolescents below 18 years old.
Slovenian: Zdravilo Jetrea ni primerno za uporabo pri otrocih in mladostnikih, starih do 18 let.
English: Jetrea should not be used during pregnancy or breast-feeding unless your doctor/ophthalmologist thinks it is clearly necessary.
Slovenian: Zdravila Jetrea ne uporabljajte med nosečnostjo ali dojenjem, razen če vaš zdravnik/oftalmolog meni, da je to nujno potrebno.
English: % VMA Resolution
Slovenian: % odprav VMA
English: To prepare Jetrea for intravitreal injection, adhere to the following instructions: 1.
Slovenian: Za pripravo zdravila Jetrea v obliki intravitrealne injekcije upoštevajte naslednja navodila: 1.
English: Store in a freezer.
Slovenian: Shranjujte v zamrzovalniku.
English: Administration in close temporal association with other medicinal products in the same eye may affect the activity of both medicinal products and is therefore not recommended.
Slovenian: Dajanje v tesnem časovnem zaporedju z drugimi zdravili v isto oko lahko vpliva na delovanje obeh zdravil, zato se odsvetuje.
English: When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or α2-macroglobulin.
Slovenian: Pri intravenski uporabi okriplazmin vstopi v katabolično pot endogene beljakovine, prek katere se hitro inaktivira zaradi interakcije z zaviralcem proteaze α2-antiplazminom ali α2-makroglobulinom.
English: Ocriplasmin is a proteolytic enzyme with serine protease activity which could be present in the eye for several days after intravitreal injection (see section 5.2).
Slovenian: Okriplazmin je proteolitični encim z aktivnostjo serinske proteaze, ki je lahko v očesu prisotna še nekaj dni po intravitrealnem injiciranju (glejte poglavje 5.2).
English: The safety and efficacy of ocriplasmin in paediatric subjects scheduled for vitrectomy was investigated in study TG-MV-009.
Slovenian: Varnost in učinkovitost okriplazmina pri pediatričnih bolnikih, načrtovanih za vitrektomijo, sta bili raziskani v študiji TG-MV-009.
English: It remains unclear if this haemorrhage is related to the injection procedure itself or administration of ocriplasmin.
Slovenian: Ni jasno, ali je krvavitev povezana s samim postopkom injiciranja ali dajanjem okriplazmina.
English: During the studies, vitrectomy could be performed at the discretion of the Investigator.
Slovenian: V času študij je bila lahko izvedena vitrektomija, če je raziskovalec tako presodil.
English: The median time to resolution was 22 days.
Slovenian: Mediani čas do izginotja spremembe je bil 22 dni.
English: From a microbiological point of view, the medicinal product must be used immediately after opening.
Slovenian: Z mikrobiološkega vidika morate zdravilo uporabiti takoj po odprtju.
English: - if you are allergic to ocriplasmin or any of the other ingredients of this medicine (listed in section 6); - if you have (or suspect you may have) an infection in or around your eye.
Slovenian: - če ste alergični na okriplazmin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate okužbo v očesu ali okoli njega ali v primeru suma na okužbo teh predelov.
English: The unopened vial in the original carton protected from light may be stored in a refrigerator (2 °C to 8 °C) for up to 1 week.
Slovenian: Neodprta viala, shranjena v originalni škatli, zaščitena pred svetlobo je lahko shranjena v hladilniku (2 °C - 8 °C) do 1 tedna.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/ophthalmologist for advice before being given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom/oftalmologom, preden dobite to zdravilo.
English: After thawing, unopened vial may be stored for up to 1 week in a refrigerator.
Slovenian: Po odmrznitvi lahko neodprto vialo shranjujete do 1 tedna v hladilniku.
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre of the vitreous cavity avoiding the horizontal meridian.
Slovenian: Injekcijsko iglo je treba vstaviti 3,5-4,0 mm posteriorno glede na limbus in jo usmeriti proti središču steklovinskega prostora, pri čemer se je treba izogniti horizontalnemu meridianu.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where JETREA will be marketed, at launch and after launch, all healthcare professionals who are expected to use JETREA are provided with the following items:
Slovenian: MAH mora po diskusiji in dogovoru z nacionalnim pristojnim organom v vsaki državi članici, kjer bo zdravilo JETREA na trgu, ob prihodu in po prihodu na trg, zagotoviti preskrbo vseh zdravnikov, ki bodo predvidoma uprabljali zdravilo JETREA, z naslednjimi materiali:
English: This information will be taken into account to evaluate if and when Jetrea can be injected into the same eye.
Slovenian: To informacijo je treba upoštevati pri ocenitvi, ali se zdravilo Jetrea lahko injicira v isto oko in kdaj.
English: The inactive ocriplasmin/α2-antiplasmin complex is cleared from the circulation with a half-life (t1/2) of several hours.
Slovenian: Inaktivirani kompleks okriplazmina/α2-antiplazmina se izloči iz obtoka z razpolovnim časom (t1/2)
English: There are no clinical data on concomitant use of ocriplasmin with VEGF-inhibitors (vascular endothelial growth factor) and therefore it is not recommended.
Slovenian: Kliničnih podatkov o sočasni uporabi okriplazmina in zaviralcev VEGF (vaskularnega endotelijskega rastnega dejavnika) ni in zato ta ni priporočljiva.
English: Other medicines and Jetrea
Slovenian: Druga zdravila in zdravilo Jetrea
English: Visual symptoms perceived in the contralateral eye or bilaterally have also been reported.
Slovenian: Poročali so tudi o simptomih, povezanih z vidom, ki so jih opazili v kontralateralnem očesu ali bilateralno.
English: Do not use this needle for the intravitreal injection.
Slovenian: Igle ne uporabite za intravitrealno injiciranje.
English: What Jetrea is and what it is used for
Slovenian: Kaj je zdravilo Jetrea in za kaj ga uporabljamo
English: Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions' section.
Slovenian: Podatki o prenehanju določenih učinkov, kot so kromatopsija in spremembe ERG, so podani v ustreznem odstavku poglavja Opis izbranih neželenih učinkov.
English: Only a clear, colourless solution without visible particles should be used.
Slovenian: Uporabite lahko le bistro in brezbarvno raztopino brez vidnih delcev.
English: Based on the results of this study, the use of JETREA as an adjunct to vitrectomy in children, to facilitate vitreous separation and removal, is not recommended.
Slovenian: Na osnovi rezultatov te študije ne priporočamo uporabe zdravila JETREA kot dodatka vitrektomiji pri otrocih za pospešitev ločitve in odstranitve steklovine.
English: Your doctor/ophthalmologist will monitor you and take corrective measures if needed.
Slovenian: Vaš zdravnik ali oftalmolog vas bo spremljal in po potrebi uvedel korektivne ukrepe.
English: Disinfect the top of the vial with an alcohol wipe (Figure 2).
Slovenian: Vrh viale razkužite z alkoholnim robčkom (slika 2).
English: What Jetrea is and what it is used for What you need to know before you are given Jetrea How Jetrea is given
Slovenian: Kaj je zdravilo Jetrea in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Jetrea Kako se daje zdravilo Jetrea
English: Disinfect the top of the vial with an alcohol wipe.
Slovenian: Vrh viale razkužite z alkoholnim robčkom.
English: Monitoring for increases in IOP may consist of a check for perfusion of the optic nerve head immediately after the injection and tonometry within 30 minutes following the injection.
Slovenian: Spremljanje zvišanja očesnega tlaka lahko vključuje preverjanje perfuzije glave vidnega živca takoj po injiciranju in tonometrijo v roku 30 minut po injiciranju.
English: The clinical data on the effects of JETREA overdose are limited.
Slovenian: Klinični podatki o učinkih prevelikega odmerka zdravila JETREA so omejeni.
English: You will not be given Jetrea into both eyes at the same time.
Slovenian: Zdravila Jetrea ne boste prejeli sočasno v obe očesi.
English: Your doctor/ophthalmologist will also give you a local anaesthetic to prevent any pain from the injection.
Slovenian: Vaš zdravnik/oftalmolog vam bo dal tudi lokalni anestetik, da prepreči bolečino zaradi injekcije.
English: The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT).
Slovenian: Diagnoza vitreomakularne trakcije (VMT) mora obsegati celovito klinično sliko, ki vključuje bolnikove težave v preteklosti, klinični pregled in preiskavo z uporabo splošno sprejetih diagnostičnih metod, kot je optična koherentna tomografija (OCT).
English: Patients should be monitored appropriately (see section 4.8).
Slovenian: Bolnike je treba primerno spremljati (glejte poglavje 4.8).
English: After the injection, your doctor/ophthalmologist will monitor your vision.
Slovenian: Po injiciranju bo vaš zdravnik/oftalmolog spremljal vaš vid.
English: On the day of the injection, your doctor/ophthalmologist will use antimicrobial eye drops and clean your eye and eyelid carefully to prevent infection.
Slovenian: Na dan injiciranja bo vaš zdravnik/oftalmolog uporabil antimikrobne kapljice za oko in vaše oko ter očesno veko skrbno očistil, da prepreči okužbo.
English: From a microbiological point of view, the medicinal product must be used immediately after opening/dilution.
Slovenian: Z mikrobiološkega vidika morate zdravilo uporabiti takoj po odprtju/redčenju.
English: Contents of the pack and other information What Jetrea contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Jetrea
English: What you need to know before you are given Jetrea You must not be given Jetrea
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Jetrea Zdravila Jetrea ne smete prejeti
English: JETREA should be used during pregnancy only if the clinical benefit outweighs the potential risks.
Slovenian: Uporaba zdravila JETREA med nosečnostjo je dovoljena le, če so klinične koristi večje od možnih tveganj.
English: Based on the proteolytic activity of ocriplasmin, preclinical and clinical findings, the potential for lens subluxation or phacodonesis cannot be ruled out.
Slovenian: Na podlagi proteolitične aktivnosti okriplazmina in predkliničnih ter kliničnih izsledkov možnosti subluksacije leče ali fakodoneze ni mogoče izključiti.
English: Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, TG-MV-007 and integrated data)
Slovenian: Slika 1: Delež bolnikov z odpravo vitreomakularne adhezije do 180. dne (6. meseca) (TG-MV-006, TG-MV-007 in integrirani podatki)
English: The clinical efficacy and safety of JETREA for the treatment of vitreomacular traction (VMT) was assessed in 3 double-masked studies.
Slovenian: Klinično učinkovitost in varnost zdravila JETREA pri zdravljenju vitreomakularne trakcije (VMT) so ocenili v 3 dvojno slepih študijah.
English: A total of 652 patients (JETREA 464, placebo 188) were randomised in these 2 studies.
Slovenian: 652 bolnikov (JETREA 464, placebo 188) je bilo randomiziranih v ti dve študiji).
English: To prepare JETREA for intravitreal injection, adhere to the following instructions: Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Slovenian: Za pripravo zdravila JETREA v obliki intravitrealne injekcije upoštevajte naslednja navodila: Vialo vzemite iz zamrzovalnika in pustite, da se odtaja pri sobni temperaturi (kar traja približno 2 minuti).
English: Your doctor/ophthalmologist will decide if treatment with Jetrea is right for you.
Slovenian: Vaš zdravnik/oftalmolog se bo odločil, ali je zdravljenje z zdravilom Jetrea za vas primerno.
English: At the end of this period the product must be used or discarded.
Slovenian: Po tem času morate zdravilo uporabiti ali zavreči.
English: This effect appeared to be dose-related and was observed in all animals administered intravitreal ocriplasmin more than once.
Slovenian: Izgleda, da je ta učinek odvisen od odmerka, saj so ga opazili pri vseh živalih, ki so jim dali okriplazmin intravitrealno več kot enkrat.
English: Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, while no inflammation or ERG changes were observed in minipigs.
Slovenian: Okriplazmin je induciral vnetni odziv in prehodne spremembe ERG pri kuncih in opicah, pri pritlikavih prašičih pa niso opazili vnetja ali sprememb ERG.
English: The use of Jetrea is therefore not recommended in this patient group.
Slovenian: Uporabe zdravila Jetrea zato ne priporočamo v tej starostni skupini.
English: Electroretinographic (ERG) changes (a- and b-wave amplitude decrease) have been reported as a very common adverse reaction in patients injected with JETREA; in the majority of cases visual impairment and chromatopsia were also reported.
Slovenian: O elektroretinografskih spremembah (ERG) (zmanjšanje amplitude vala a in b) so poročali kot o zelo pogostem neželenem učinku pri bolnikih, ki so jim injicirali zdravilo JETREA; v večini primerov so poročali tudi o okvari vida in kromatopsiji.
English: VMT can cause symptoms such as distorted or decreased vision.
Slovenian: Vitreomakularna trakcija lahko povzroči simptome, kot so popačen ali slabši vid.
English: • What are the steps following treatment with Jetrea
Slovenian: • Kakšni so koraki po zdravljenju z zdravilom Jetrea
English: Intravenous administration of 10 mg/kg was generally well tolerated in both rat and dog whether administered as single dose or as repeated dose.
Slovenian: Podgane in psi so intravensko dajanje 10 mg/kg na splošno dobro prenašali ali v obliki enega odmerka ali ponavljajočih se odmerkov.
English: Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA).
Slovenian: Okriplazmin ima proteolitično aktivnost proti beljakovinskim sestavinam steklovine in vitreoretinalnim povezavam (npr. lamininu, fibronektinu in kolagenu) ter pomaga razbiti beljakovinski matriks, odgovoren za nenormalno vitreomakularno adhezijo (VMA).
English: The safety and efficacy of JETREA administered to both eyes concurrently has not been studied.
Slovenian: Varnosti in učinkovitosti zdravila JETREA, danega v obe očesi hkrati, niso preučili.
English: In monkeys, after administration of 125 µg/eye (68 µg/mL vitreous) the ERG was fully recovered by Day 55.
Slovenian: Pri opicah se je po odmerku 125 µg/oko (68 µg/ml steklovine) ERG povsem popravil do 55. dne.
English: The concentrate is clear and colourless.
Slovenian: Koncentrat je bister in brezbarven.
English: A single intravitreal injection of 0.175 mg (above the recommended dose), or placebo, was injected in the mid-vitreous of 24 eyes of children aged 0 to 16 years, 30 to 60 minutes prior to the planned start of vitrectomy.
Slovenian: Enkratna intravitrealna injekcija 0,175 mg (v odmerku, ki je večji od priporočenega) ali placebo sta bila injicirana v osrednji del steklovine 24 oči otrok, starih od 0 do 16 let, 30 do 60 minut pred načrtovanim začetkom vitrektomije.
English: JETREA should be used during breast-feeding only if the clinical benefit outweighs the potential risks.
Slovenian: Uporaba zdravila JETREA med dojenjem je dovoljena le, če so klinične koristi večje od možnih tveganj.
English: The following table summarises the adverse reactions reported in the treated eye in clinical studies and/or from post-marketing experience.
Slovenian: V naslednji preglednici so povzeti neželeni učinki, o katerih so pri zdravljenem očesu poročali v kliničnih študijah in/ali v obdobju trženja.
English: One case of lens subluxation/phacodonesis was reported in clinical studies in adults and appears to have been possibly related to treatment with JETREA.
Slovenian: Subluksacija leče/fakodoneza O enem primeru subluksacije leče/fakodoneze so poročali v kliničnih študijah pri odraslih in kaže, da je lahko povezan z zdravljenjem z zdravilom JETREA.
English: The most common reason for performing vitrectomy was FTMH (in 24.8% JETREA treated patients and 23.3 % sham patients).
Slovenian: Najpogostejši razlog za izvedbo vitrektomije je bil FTMH (pri 24,8 % bolnikov, zdravljenih z zdravilom JETREA, in pri 23,3 % bolnikov z navideznim zdravljenjem).
English: These include optical coherence tomography (OCT), ophthalmoscopy (foveal reflex), colour vision test (Roth 28-hue) and full-field ERG.
Slovenian: Med te preiskave sodijo optična koherentna tomografija (OCT), oftalmoskopija (fovealni refleks), testiranje barvnega vida (Rothovo z 28 barvami) in ERG celotnega vidnega polja.
English: Repeated administration in the same eye is not recommended.
Slovenian: Ponovnega dajanja v isto oko ne priporočamo.
English: The patient had a decrease in BCVA of 21 ETDRS letters from baseline that returned to within 9 letters of baseline at the end of the study.
Slovenian: Bolnik je imel poslabšanje BCVA za 21 ETDRS črk glede na izhodišče, ki se je ob koncu študije vrnila na 9 črk od izhodišča.
English: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgium
Slovenian: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgija
English: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIUM
Slovenian: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIJA
English: Ethnicity Experience is limited in groups other than Caucasians.
Slovenian: Izkušnje pri etničnih skupinah, ki niso belci, so omejene.
English: The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA system organ class and frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: razumno mogoča, so navedeni po organskih sistemih MedDRA in pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: It is unknown whether JETREA is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo JETREA izloča v materino mleko.
English: Repeated administration of JETREA in the same eye has not been adequately studied and is therefore not recommended.
Slovenian: Ponavljajoče dajanje Ponavljajoče dajanje zdravila JETREA v isto oko ni zadosti preučeno, zato ga ne priporočamo.
English: Days Post-Injection
Slovenian: št. dni po injiciranju
English: Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Any persistence or progression of macular hole should be treated according to usual practice.
Slovenian: Morebitno trdovratno navzočnost ali napredovanje foramna makule je treba zdraviti v skladu z običajno prakso.
English: Tell your doctor/ophthalmologist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika/oftalmologa, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Inform your doctor/ophthalmologist if you have had an injection of a medicine into the eye recently.
Slovenian: Obvestite svojega zdravnika/oftalmologa, če ste pred kratkim v oko prejeli injekcijo zdravila.
English: If you have any further questions on the use of this medicine, ask your doctor/ophthalmologist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom/oftalmologom.
English: In study TG-MV-014, a sub-set of 40 patients receiving JETREA systematically underwent ERG testing; the ERG changes which had developed in 16 out of 40 patients resolved in the majority of patients (13 out of 16).
Slovenian: V študiji TG-MV-014 so pri podskupini 40 bolnikov, ki so prejemali zdravilo JETREA, opravili sistematično testiranje ERG; spremembe ERG, ki so se pojavile pri 16 od 40 bolnikov, so izzvenele pri večini bolnikov (pri 13 od 16).
English: In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start concentration 2-4 hours after injection and below the lower level of quantification at 7 days.
Slovenian: V klinični študiji pri bolnikih, načrtovanih za vitrektomijo, ki so prejeli 0,125 mg zdravila JETREA (kar ustreza teoretični začetni koncentraciji 29 µg/ml steklovine), je bila srednja aktivnost okriplazmina 9 % teoretične začetne koncentracije 2-4 ure po injiciranju, 7. dan pa pod spodnjo ravnijo merljivosti.
English: Lens subluxation was observed in the 3 species at ocriplasmin concentrations at or above 41 µg/mL vitreous, a concentration above the intended clinical concentration of 29 µg/mL.
Slovenian: Subluksacijo leče so opazili pri 3 vrstah pri koncentracijah okriplazmina 41 µg/ml steklovine ali več, kar je koncentracija nad predvideno klinično koncentracijo 29 µg/ml.
English: The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA > 1500 microns (see section 5.1).
Slovenian: Učinek okriplazmina (zlasti pri induciranju odprave vitreomakularne adhezije ali povzročitvi popolnega posteriornega odstopa steklovine [PVD - Posterior Vitreous Detachment]) je manjši pri bolnikih z epiretinalno membrano (ERM) ali premerom vitreomakularne adhezije >1500 mikronov (glejte poglavje 5.1).
English: However, chemical and physical in-use stability of unopened product in the original carton protected from light has been demonstrated for up to 8 hours when stored below 25 °C.
Slovenian: Kemijska in fizikalna stabilnost neodprtega zdravila med uporabo je dokazana do 8 ur, če je zdravilo shranjeno v originalni škatli, zaščiteno pred svetlobo in pri temperaturi do 25 °C.
English: See section 4.4 for instructions on post-injection monitoring.
Slovenian: Glejte poglavje 4.4 za navodila za spremljanje po injiciranju.