FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure.
Slovenian: Pred izvedbo intravitrealnega posega je treba pozorno preveriti bolnikovo anamnezo glede preobčutljivostnih reakcij.
English: In BRIGHTER, ranibizumab 0.5 mg with adjunctive laser therapy demonstrated non-inferiority versus ranibizumab monotherapy from baseline to Month 24 (95% CI -2.8, 1.4).
Slovenian: V študiji BRIGHTER je bilo zdravljenje z 0,5 mg ranibizumaba z dodatnim laserskim zdravljenjem neinferiorno v primerjavi z zdravljenjem z ranibizumabom v monoterapiji v času od izhodišča do konca 24. meseca (95-odstotni IZ: -2,8, 1,4).
English: In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with Lucentis was not affected by concomitant treatment with thiazolidinediones.
Slovenian: V kliničnih študijah zdravljenja okvare vida zaradi DME pri bolnikih, ki so prejemali zdravilo Lucentis, sočasno zdravljenje s tiazolidindioni ni vplivalo na rezultat ostrine vida ali centralne debeline fovealnega dela mrežnice.
English: Proportion of patients who gained: ≥15 letters, or reached ≥84 letters in BCVA 53.3%
Slovenian: delež bolnikov z izboljšanjem za ≥15 črk ali doseženo BCVA ≥84 črk
English: Figure 5 Mean change from baseline BCVA over time to Month 6 and Month 12 (BRAVO)
Slovenian: Slika 5 Časovni potek povprečne spremembe BCVA od izhodiščne vrednosti v 6 in v 12 mesecih (študija BRAVO)
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure,
Slovenian: • ključni znaki in simptomi resnih neželenih dogodkov, med drugim zvišanega intraokularnega tlaka, intraokularnega vnetja, odstopa mrežnice, raztrganine mrežnice in infekcijskega endoftalmitisa
English: Non-visual side effects include: Anxiety, nausea.
Slovenian: Neželeni učinki, ki niso povezani z očmi, vključujejo: tesnobo, slabost.
English: Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.
Slovenian: Neželeni učinki pri bolnikih iz teh poročil so bili zvišan intraokularni tlak, prehodna slepota, zmanjšana ostrina vida, edem roženice, bolečine v roženici in bolečine v očesu.
English: Note: Do not wipe the injection needle.
Slovenian: Pozor: Injekcijske igle ne brišite.
English: The doctor will monitor the condition of your baby's eye(s) and, depending on how your baby responds to the treatment, will decide if and when further treatment is needed.
Slovenian: Glede na otrokov odziv na zdravljenje se bo odločil, ali otrok potrebuje nadaljnje zdravljenje in kdaj ga potrebuje.
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Slovenian: Po intravitrealni uporabi zaviralcev VEGF obstaja teoretično tveganje za arterijske trombembolične dogodke, vključno z možgansko kapjo in miokardnim infarktom.
English: Prepare
Slovenian: Pripravite potrebno
English: The estimated difference between ranibizumab and laser was 29.9% (95% CI: [20.0, 39.7]).
Slovenian: Ocenjena razlika med zdravljenjem z ranibizumabom oziroma laserjem je bila 29,9 % (95-odstotni IZ: [20,0; 39,7]).
English: Rhegmatogenous retinal detachment or macular holes
Slovenian: Regmatogeni odstop mrežnice ali foramen makule
English: Sham (n=59)
Slovenian: placebo (n=59)
English: Also, while a consistent effect was observed in subjects with subfoveal and juxtafoveal lesions, there are insufficient data to conclude on the effect of Lucentis in PM subjects with extrafoveal lesions.
Slovenian: Pri bolnikih s subfovealnimi in jukstafovealnimi lezijami so dosledno opažali učinek zdravila, pri bolnikih z ekstrafovealnimi lezijami pa ni dovolj podatkov, na podlagi katerih bi lahko sklepali o učinkovitosti zdravila Lucentis pri bolnikih z degenerativno kratkovidnostjo.
English: Mean change in visual acuity at Month 6
Slovenian: povprečna sprememba ostrine vida po 6 mesecih a
English: Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, all of which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, pathologic myopia and CNV or to visual impairment caused by either diabetic macular oedema or macular oedema secondary to RVO.
Slovenian: Vezava VEGF-A na njegove receptorje povzroča proliferacijo endotelijskih celic in neovaskularizacijo, pa tudi povečano žilno permeabilnost, kar vse prispeva k razvoju neovaskularne oblike starostne degeneracije makule, degenerativne kratokovidnosti in CNV ali k okvari vida zaradi diabetičnega makularnega edema ali zaradi makularnega edema pri zapori mrežnične vene.
English: Hold the syringe upright.
Slovenian: Brizgo držite obrnjeno navzgor.
English: Cases of accidental overdose have been reported from the clinical studies in wet AMD and postmarketing data.
Slovenian: Iz kliničnih študij vlažne oblike SDM in postmarketinških izkušenj so poročali o primerih nehotenega prevelikega odmerjanja.
English: Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper and one blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents.
Slovenian: Pakiranje vsebuje eno stekleno vialo ranibizumaba s klorbutilnim gumijastim zamaškom in eno topo iglo s filtrom (18G x 1½″, 1,2 mm x 40 mm, 5 mikrometrov) za aspiriranje vsebine viale.
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Slovenian: Injekcijsko iglo je treba uvesti 3,5-4,0 mm posteriorno od limbusa v steklovinski prostor, se pri tem izogniti horizontalnemu meridianu in jo usmeriti proti središču zrkla.
English: If you have any further questions on the use of this medicine, ask your baby's doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z otrokovim zdravnikom.
English: Treatment of visual impairment due to CNV secondary to PM The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV in PM have been assessed based on the 12-month data of the double-masked, controlled pivotal study F2301 (RADIANCE).
Slovenian: Zdravljenje okvare vida zaradi CNV, do katere pride zaradi degenerativne kratkovidnosti Klinično varnost in učinkovitost zdravila Lucentis so pri bolnikih z okvaro vida zaradi CNV pri degenerativni kratkovidnosti ocenjevali na osnovi 12-mesečnih podatkov iz dvojno prikrite kontrolirane ključne študije F2301 (RADIANCE).
English: Lucentis is administered as a single injection into your eye by your eye doctor under a local anaesthetic.
Slovenian: Zdravilo Lucentis vam bo vaš očesni zdravnik dal v oko v obliki posamezne injekcije ob uporabi lokalne anestezije.
English: What Lucentis is
Slovenian: Kaj je zdravilo Lucentis
English: Figure 4 Mean change in visual acuity from baseline over time in study D2301 (RESTORE)
Slovenian: Slika 4 Časovni potek povprečne spremembe ostrine vida od izhodišča v študiji D2301 (RESTORE)
English: This provides a suitable amount to deliver a single dose of 0.02 ml containing 0.2 mg ranibizumab.
Slovenian: Ta količina zadošča za injiciranje enkratnega odmerka 0,02 ml, ki vsebuje 0,2 mg ranibizumaba.
English: Each ml contains 10 mg ranibizumab.
Slovenian: Vsak ml vsebuje 10 mg ranibizumaba.
English: Visual side effects include: Inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.
Slovenian: Neželeni učinki, ki se pojavijo na očeh, vključujejo: vnetje in krvavitev v sprednjem delu očesa, gnojni mehurček na očesu, spremembe v osrednjem delu očesne površine, bolečino ali draženje na mestu injiciranja, nenormalne zaznave v očesu in draženje veke.
English: Each vial contains 2.3 mg ranibizumab in 0.23 ml solution.
Slovenian: Ena viala vsebuje 2,3 mg ranibizumaba v 0,23 ml raztopine.
English: Figure 6 Mean change from baseline BCVA over time to Month 6 and Month 12 (CRUISE)
Slovenian: Slika 6 Časovni potek povprečne spremembe BCVA od izhodiščne vrednosti v 6 in v 12 mesecih (študija CRUISE)
English: When initiating ranibizumab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Slovenian: Pri uvajanju ranibizumaba bolnikom z navedenimi dejavniki tveganja za raztrganje pigmentnega epitelija mrežnice je potrebna previdnost.
English: The vial is for single use only.
Slovenian: Viala je namenjena samo za enkratno uporabo.
English: • a retinal break;
Slovenian: • raztrganje mrežnice;
English: What Lucentis contains - The active substance is ranibizumab.
Slovenian: Kaj vsebuje zdravilo Lucentis - Učinkovina je ranibizumab.
English: Lucentis is indicated in adults for:
Slovenian: Zdravilo Lucentis je indicirano pri nedonošenčkih:
English: Following monthly intravitreal administration of Lucentis to patients with neovascular AMD, serum concentrations of ranibizumab were generally low, with maximum levels (Cmax) generally below the ranibizumab concentration necessary to inhibit the biological activity of VEGF by 50% (11-27 ng/ml, as assessed in an in vitro cellular proliferation assay).
Slovenian: Najvišja koncentracija (Cmax) je bila večinoma nižja od tiste koncentracije ranibizumaba, ki je potrebna za zaviranje biološke aktivnosti VEGF za 50 % (11-27 ng/ml po oceni testa celične proliferacije in vitro).
English: Outcome measures at Month 12 compared to baseline in study D2301 (RESTORE)
Slovenian: Merila izida po 12 mesecih v primerjavi z izhodiščno vrednostjo v študiji D2301 (RESTORE)
English: Vial-only pack
Slovenian: ŠKATLA VIALA
English: Ask your doctor or pharmacist for advice before Lucentis treatment.
Slovenian: Pred zdravljenjem z zdravilom Lucentis se posvetujte z zdravnikom ali farmacevtom.
English: For treatment of preterm infants use the low volume high accuracy syringe provided together with an injection needle (30G x ½″) in the VISISURE kit.
Slovenian: Za zdravljenje nedonošenčkov uporabite brizgo z majhnim volumnom in visoko natančnostjo, ki je skupaj z injekcijsko iglo (30G x ½″) priložena v kompletu VISISURE.
English: Nervous system disorders Very common
Slovenian: Bolezni živčevja zelo pogosti glavobol
English: Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis.
Slovenian: V 60 minutah po injiciranju zdravila Lucentis so opažali prehodno zvišan intraokularni tlak (IOT).
English: A transient increase in post-dose intraocular pressure was observed following intravitreal injections, irrespective of dose.
Slovenian: Po intravitrealnih injekcijah so opažali prehodno, od velikosti odmerka neodvisno zvišanje intraokularnega tlaka po odmerjanju.
English: CRUISE
Slovenian: študija CRUISE
English: The injection volume of 0.02 ml is then delivered.
Slovenian: Nato se injicira 0,02 ml vsebine.
English: The effect in terms of visual improvement was observed in all patients treated with 0.5 mg ranibizumab monotherapy regardless of their disease duration in both BRIGHTER and CRYSTAL.
Slovenian: Učinek v smislu izboljšanja vida so tako v študiji BRIGHTER kot v študiji CRYSTAL opažali pri vseh bolnikih, ki so prejemali 0,5 mg ranibizumaba v monoterapiji, ne glede na trajanje bolezni.
English: Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.
Slovenian: Pred samo injekcijo je treba razkužiti kožo okrog očesa, veko in površino očesa ter bolniku aplicirati ustrezno anestezijo in širokospektralni lokalni antibiotik, v skladu z nacionalno prakso.
English: Patients with active or suspected ocular or periocular infections.
Slovenian: Bolniki z aktivno okužbo očesa, okolice očesa ali s sumom na okužbo teh predelov.
English: Lucentis and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of Lucentis and verteporfin.
Slovenian: Zdravilo Lucentis in fotodinamična terapija z verteporfinom pri horoidalni neovaskularizaciji, do katere pride zaradi degenerativne kratkovidnosti S sočasno uporabo zdravila Lucentis in verteporfina ni nobenih izkušenj.
English: The injection needle should be inserted into the eye 1.0 to 2.0 mm posterior to the limbus, with the needle pointing towards the optic nerve.
Slovenian: Injekcijsko iglo je treba uvesti v oko 1,0-2,0 mm posteriorno od limbusa in jo usmeriti proti očesnemu živcu.
English: Clear, colourless to pale yellow aqueous solution.
Slovenian: Raztopina je bistra, brezbarvna do bledo rumena vodna raztopina.
English: The sterility of the pre-filled syringe cannot be guaranteed unless the tray remains sealed.
Slovenian: Sterilnosti napolnjene injekcijske brizge ni mogoče zagotoviti, če pretisni omot ne ostane neprodušno zaprt.
English: Prior ranibizumab 0.5 mg + laser n=83
Slovenian: predhodna uporaba ranibizumaba 0,5 mg + laserja n=83
English: To prepare Lucentis for intravitreal administration to adults, please adhere to the following instructions:
Slovenian: Pri pripravi zdravila Lucentis za intravitrealno aplikacijo odraslim upoštevajte naslednja navodila:
English: This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)).
Slovenian: Do takega otekanja lahko pride zaradi sladkorne bolezni (bolezen imenujemo diabetični makularni edem (DME)) ali zaradi zapore mrežničnih ven (bolezen imenujemo zapora mrežnične vene).
English: In preterm infants, the injection needle should be inserted into the eye 1.0 to 2.0 mm posterior to the limbus, with the needle pointing towards the optic nerve.
Slovenian: Pri nedonošenčkih je treba injekcijsko iglo uvesti v oko 1,0-2,0 mm posteriorno od limbusa in jo usmeriti proti očesnemu živcu.
English: The most serious side effects in adults are described below:
Slovenian: Spodaj so navedeni najbolj resni neželeni učinki pri odraslih:
English: Psychiatric disorders Common
Slovenian: Psihiatrične motnje pogosti tesnoba
English: ≥3-step worsening n (%)
Slovenian: poslabšanje ≥3 stopnje n (%)
English: Categorised change from baseline
Slovenian: Kategorija spremembe od izhodišča
English: Occasionally, an infection in the internal portion of the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur after Lucentis treatment.
Slovenian: Včasih pride po zdravljenju z zdravilom Lucentis do okužbe notranjega dela očesa, bolečine ali rdečine (vnetja), odstopa ali raztrganine ene od plasti na zadnji strani očesa (odstop ali raztrganina mrežnice in odstop ali raztrganina pigmentnega epitelija mrežnice), ali do zamotnitve leče (sive mrene).
English: Non-visual side effects include: Urinary tract infection, low red blood cells count (with symptoms such as tiredness, breathlessness, dizziness, pale skin), anxiety, cough, nausea, allergic reactions like rash, hives, itching and skin reddening.
Slovenian: Neželeni učinki, ki niso povezani z očmi, vključujejo: okužbo sečil, nizko število rdečih krvnih celic (s simptomi, kot so utrujenost, zadihanost, omotičnost, bledica), tesnobo, kašelj, slabost, alergijske reakcije, na primer izpuščaj, koprivnico, srbenje in rdečino kože.
English: Prior ranibizumab 0.5 mg n=83
Slovenian: predhodna uporaba ranibizumaba 0,5 mg n=83
English: Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Slovenian: Zdravilo Lucentis sme aplicirati samo specialist oftalmolog, ki ima izkušnje z intravitrealnimi injekcijami.
English: These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by: - Growth of leaky, abnormal blood vessels.
Slovenian: Okvaro mrežnice lahko povzroča: - rast nenormalnih prepustnih krvnih žil.
English: The most frequently reported ocular adverse reactions following injection of Lucentis are: eye pain, ocular hyperaemia, increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye and eye pruritus.
Slovenian: Neželeni učinki, ki se pojavijo na očeh, o katerih so po injekciji zdravila Lucentis najbolj pogosto poročali, so: bolečine v očesu, očesna hiperemija, zvišan intraokularni tlak, vitritis, odstop steklovine, krvavitev v mrežnici, motnje vida, delci v steklovini, veznična krvavitev, draženje očesa, občutek tujka v očeh, močnejše solzenje, vnetje veke, suho oko in srbenje v očesu.
English: In adults the injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Slovenian: Pri odraslih je treba injekcijsko iglo uvesti 3,5-4,0 mm posteriorno od limbusa v steklovinski prostor, usmeriti jo je treba proti središču zrkla, pri tem pa se je treba izogniti horizontalnemu meridianu.
English: The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total.
Slovenian: Vsebina napolnjene injekcijske brizge presega priporočeni odmerek 0,5 mg. Volumen, ki ga je mogoče iztisniti iz napolnjene injekcijske brizge (0,1 ml), ni namenjen uporabi v celoti.
English: Lucentis 10 mg/ml solution for injection
Slovenian: Lucentis 10 mg/ml raztopina za injiciranje
English: Non-visual side effects include: Sore throat, nasal congestion and runny nose, low red blood cell counts (with symptoms such as tiredness, breathlessness, pale skin), cough, urinary tract infection, allergic reactions like rash and skin reddening.
Slovenian: Neželeni učinki, ki niso povezani z očmi, vključujejo: boleče grlo oziroma žrelo, zamašen nos, izcedek iz nosu, nizko število rdečih krvnih celic (s simptomi, kot so utrujenost, zadihanost, bledica), kašelj, okužbo sečil, alergijske reakcije, na primer izpuščaj in rdečino kože.
English: If you are considering stopping Lucentis treatment for your baby, please go to your next appointment and discuss this with your baby's doctor.
Slovenian: Preden prekinete zdravljenje z zdravilom Lucentis Če razmišljate o prekinitvi zdravljenja z zdravilom Lucentis pri vašem otroku, kljub temu pojdite k zdravniku, kot ste dogovorjeni, in se o tem pogovorite z otrokovim zdravnikom.
English: However, subjects with a baseline BCVA >73 letters and macular oedema with central retinal thickness <300 µm did not appear to benefit from treatment with ranibizumab compared to laser photocoagulation.
Slovenian: Po 12 mesecih je bil učinek v večini podskupin enak, vendar kaže, da bolnikom, ki so imeli začetno BCVA >73 črk in makularni edem s centralno debelino mrežnice <300 m, zdravljenje z ranibizumabom ni koristilo tako kot laserska fotokoagulacija.
English: BRIGHTER
Slovenian: študija BRIGHTER
English: At year 1 in the ranibizumab-treated group in Protocol S, ≥2-step improvement in DRSS was consistent in eyes without DME (39.9%) and with baseline DME (48.8%).
Slovenian: V skupini bolnikov, ki so v študiji Protocol S prejemali ranibizumab, je bil po 1 letu delež izboljšanja ocene DRSS za ≥2 stopnji pri očeh brez DME ob izhodišču (39,9 %) podoben kot pri očeh z DME ob izhodišču (48,8 %).
English: This provides a suitable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.
Slovenian: Ta količina zadošča za injiciranje enkratnega odmerka 0,05 ml, ki vsebuje 0,5 mg ranibizumaba.
English: If you are considering stopping Lucentis treatment, please go to your next appointment and discuss this with your doctor.
Slovenian: Preden prekinete zdravljenje z zdravilom Lucentis Če razmišljate o prekinitvi zdravljenja z zdravilom Lucentis, kljub temu pojdite k zdravniku, kot ste dogovorjeni, in se o tem pogovorite z zdravnikom.
English: 95% CI Comparison Odds ratio (OR)
Slovenian: primerjava razmerje obetov (OR)
English: Group I Ranibizumab 0.5 mg “vision stability” (n=105)
Slovenian: skupina I ranibizumab 0,5 mg “stabilnost vida”
English: Common serious side effects (may affect up to 1 in 10 people): Detachment or tear of the layer in the back of the eye (retinal detachment or tear) progressing to a temporary loss of sight, or a clouding of the lens (cataract).
Slovenian: Pogosti resni neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): odstop ali raztrganje plasti na očesnem ozadju (odstop ali raztrganina mrežnice), ki napreduje do začasne izgube vida, ali zamotnitev leče (siva mrena ali katarakta).
English: Figure 2 Mean change from baseline BCVA over time to Month 12 (RADIANCE)
Slovenian: Slika 2 Časovni potek povprečne spremembe BCVA od izhodiščne vrednosti v 12 mesecih (študija RADIANCE)
English: After 6 months, patients in the sham-control arms switched to 0.5 mg ranibizumab.
Slovenian: Po 6. mesecu so bolniki v skupini s placebom prešli na zdravljenje z ranibizumabom v odmerku 0,5 mg.
English: To prepare Lucentis for intravitreal administration to preterm infants please adhere to the instructions for use in the VISISURE kit.
Slovenian: Pri pripravi zdravila Lucentis za intravitrealno aplikacijo nedonošenčkom upoštevajte navodila za uporabo v kompletu VISISURE.
English: Assemble a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm) onto a 1 ml syringe using aseptic technique.
Slovenian: 5-mikrometrsko iglo s filtrom (18G x 1½″, 1,2 mm x 40 mm, 5 µm) aseptično namestite na 1-mililitrsko brizgo.
English: Note: The dose must be set to 0.05 ml.
Slovenian: Opozorilo: Nastaviti morate odmerek 0,05 ml.
English: (letters) (SD) Gain of ≥15 letters in BCVA at Month 24 (%) Mean number of injections (SD) (months 0-23)
Slovenian: (črke) (standardna deviacija) izboljšanje za ≥15 črk BCVA po 24 mesecih povprečno število injekcij (standardna deviacija) (od začetka do konca 23. meseca)
English: Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections in preterm infants.
Slovenian: Zdravilo Lucentis sme aplicirati samo specialist oftalmolog, ki ima izkušnje z intravitrealnimi injekcijami pri nedonošenčkih.
English: Following intravitreal administration of Lucentis to preterm infants with ROP at a dose of 0.2 mg (per eye), serum ranibizumab concentrations were higher than those observed in neovascular AMD adult patients receiving 0.5 mg in one eye. Based on a population pharmacokinetic analysis, the differences in Cmax and AUCinf were approximately 16-fold and 12-fold higher, respectively.
Slovenian: Po intravitrealnem odmerjanju zdravila Lucentis nedonošenčkom z ROP v odmerku 0,2 mg (na posamezno oko) so bile koncentracije ranibizumaba v serumu višje kot pri odraslih bolnikih z neovaskularno obliko SDM, ki so prejeli 0,5 mg v eno oko.
English: To prepare Lucentis for intravitreal administration, please adhere to the instructions for use:
Slovenian: Pri pripravi zdravila Lucentis za intravitrealno aplikacijo upoštevajte navodila za uporabo:
English: You must not receive Lucentis - If you are allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Lucentis ne smete dobiti - če ste alergični na ranibizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate okužbo v očesu ali okoli njega, - če vas oko boli ali je rdeče (hudo vnetje v očesu).
English: Statistically significant patient-reported benefits in subscales related to near and distance activity were observed with ranibizumab treatment over the control group as measured by the NEI VFQ-25.
Slovenian: Pri zdravljenju z ranibizumabom so opažali statistično značilno večje koristi na podlestvicah dejavnosti, ki so povezane z gledanjem na blizu in na daleč, kot v kontrolni skupini, pri čemer so svoje funkcije vida ocenjevali bolniki sami s pomočjo vprašalnika NEI VFQ-25.