natgillin/translations-raw huggingface dataset:
In this study 277 patients were randomised in a 2:2:1 ratio to the following arms:
V tej študiji so 277 bolnikov randomizirali v razmerju 2:2:1 v naslednje skupine:
The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date patient information pack.
Imetnik dovoljenja za promet z zdravilom mora po usklajevanju in pridobitvi soglasja pristojnih nacionalnih oblasti v vsaki državi članici, v kateri se zdravilo Lucentis trži, zagotoviti, da bo v času prihoda zdravila na trg in po njem vsem oftalmološkim klinikam, na katerih je mogoče pričakovati uporabo zdravila Lucentis, priskrbel najnovejši komplet navodil za bolnika.
Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.
Pri obojestranskem intravitrealnem apliciranju ranibizumaba opicam javanski makak v odmerkih med 0,25 mg/oko in 2,0 mg/oko na 2 tedna v obdobju do 26 tednov je prišlo do od velikosti odmerka odvisnih učinkov na očeh.
Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in foetal serum, suggesting that the anti-ranibizumab antibody acted as (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer.
Ne glede na to so opisali primer z visoko koncentracijo ranibizumaba v materinem serumu in prisotnostjo ranibizumaba v plodovem serumu, kar kaže, da so protitelesa proti ranibizumabu delovala kot prenašalni protein (z Fc regijo) za ranibizumab, s čimer so zmanjšala izločanje ranibizumaba iz materinega seruma in omogočila prehajanje preko posteljice.
The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of:
Apliciranje odmerka je treba odložiti vsaj do naslednjega dogovorjenega datuma za zdravljenje v naslednjih primerih:
Treatment success, as measured by the absence of active ROP and absence of unfavourable structural outcomes in both eyes 24 weeks after the first study treatment, was highest with ranibizumab 0.2 mg (80%) compared to laser therapy (66.2%) (see Table 10).
Uspešnost zdravljenja, opredeljena kot odsotnost aktivne retinopatije nedonošenčkov (ROP) in odsotnost neugodnih strukturnih sprememb v obeh očesih 24 tednov po prvem študijskem zdravljenju, je bila največja v skupini z 0,2 mg ranibizumaba (80 %) v primerjavi s skupino z lasersko terapijo (66,2 %) (glejte preglednico 10).
In all groups, ranibizumab was administered monthly until BCVA was stable for at least three consecutive monthly assessments.
V vseh skupinah so ranibizumab odmerjali enkrat mesečno, dokler BCVA ni bila stabilna pri najmanj treh zaporednih mesečnih določanjih ostrine vida.
- Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding).
- Zdravniku povejte, če ste imeli že kdaj prej katero od očesnih bolezni ali ste si zdravili oči oziroma ste imeli kdaj možgansko kap ali prehodne znake možganske kapi (šibkost ali ohromelost okončin ali obraza, oteženo govorjenje ali razumevanje).
Your baby's doctor will advise you and decide how long your baby should be treated with Lucentis.
Otrokov zdravnik vam bo svetoval in določil, kako dolgo bi se moral vaš otrok zdraviti z zdravilom Lucentis.
Additional side effects that have been observed with Lucentis in adults are listed below.
Dodatni neželeni učinki, ki so jih opažali pri uporabi zdravila Lucentis pri odraslih, so navedeni spodaj.
All injections will be administered by the eye doctor.
Vsa injiciranja bo opravil očesni zdravnik.
In both studies, a rapid and statistically significant decrease from baseline in central retinal subfield thickness was observed at Month 1.
V obeh študijah so po 1 mesecu opažali hitro in statistično značilno zmanjšanje debeline centralnega dela mrežnice glede na izhodišče.
Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1.
Razpoložljivi podatki za mladoletne bolnike, ki so stari od 12 do 17 let in imajo okvaro vida zaradi CNV, so navedeni v poglavju 5.1.
In Group II, which is the recommended posology (see section 4.2), 50.9% of patients required 1 or 2 injections, 34.5% required 3 to 5 injections and 14.7% required 6 to 12 injections over the 12-month study period.
V 12-mesečnem študijskem obdobju je v skupini II, v kateri so bolniki prejemali zdravilo v skladu s priporočeno shemo (glejte poglavje 4,2), 50,9 % bolnikov potrebovalo 1 ali 2 injekciji, 34,5 % jih je potrebovalo 3 do 5 injekcij, 14,7 % pa jih je potrebovalo 6 do 12 injekcij.
All injections will be administered by your eye doctor.
Vsa injiciranja bo opravil vaš očesni zdravnik.
Lucentis can be used for people of 65 years of age and over without dose adjustment.
Starostniki (stari 65 let ali več) Zdravilo Lucentis se lahko uporablja pri ljudeh, starih 65 let ali več, brez prilagajanja odmerka.
It is unknown whether Lucentis is excreted in human milk.
Ni znano, ali se zdravilo Lucentis izloča v materino mleko.
Table 7 DRSS improvement or worsening of ≥2 or ≥3 steps at year 1 in Protocol S (LOCF Method)
Preglednica 7 Izboljšanje ali poslabšanje ocene DRSS za ≥2 ali ≥3 stopnje po 1 letu v študiji Protocol S po metodi prenosa zadnje ocene naprej (LOCF - Last Observation Carried Forward)
Patients were treated with ranibizumab 0.5 mg pro re nata (PRN) in the same eye as the core study (D2301 RESTORE).
Bolniki so prejemali 0,5 mg ranibizumaba po shemi odmerjanja pro re nata (PRN, po potrebi) v isto oko kot v osnovni študiji z oznako D2301 (RESTORE).
In pregnant monkeys, intravitreal ranibizumab treatment resulting in maximal systemic exposures 0.9-7-fold a worst case clinical exposure did not elicit developmental toxicity or teratogenicity, and had no effect on weight or structure of the placenta, although, based on its pharmacological effect ranibizumab should be regarded as potentially teratogenic and embryo-/foetotoxic.
Pri brejih opicah intravitrealno zdravljenje z ranibizumabom pri izpostavljenosti, ki je bila 0,9 do 7-krat večja od največje klinične sistemske izpostavljenosti, ni škodljivo vplivalo na razvoj, ni bilo teratogeno in ni vplivalo na težo ali zgradbo posteljice, čeprav bi morali ranibizumab glede na njegovo farmakološko delovanje šteti med potencialno teratogena zdravila in zdravila s škodljivim delovanjem na zarodek oziroma plod.
The primary endpoint was the mean visual acuity change at year 2.
Primarni cilj opazovanja je bila povprečna sprememba ostrine vida po 2 letih.
Intravitreal use
intravitrealna uporaba
Bilateral treatment
Obojestransko zdravljenje
The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic.
Po aplikaciji v oko je sistemska izpostavljenost ranibizumabu majhna, vendar je zaradi njegovega mehanizma delovanja treba ranibizumab obravnavati kot potencialno teratogen in toksičen za zarodek/plod.
Adverse reactions established for adult indications are considered applicable to preterm infants with ROP, though not all were observed in the RAINBOW trial.
Načeloma velja, da se neželeni učinki, ki so jih opažali pri zdravljenju v okviru indikacij za odrasle, nanašajo tudi na nedonošenčke z ROP, čeprav v študiji RAINBOW niso opažali vseh.
Lucentis is used in babies born prematurely to treat retinopathy of prematurity (ROP), a disease causing vision impairment due to damage to the back of the eye (the retina) caused by abnormal growth of blood vessels.
Zdravilo Lucentis se uporablja pri prezgodaj rojenih otrocih za zdravljenje retinopatije nedonošenčkov (ROP), to je bolezni, ki povzroča okvaro vida zaradi poškodbe zadnjega dela očesa (mrežnice), do katere pride zaradi nenormalne rasti krvnih žil.
These medical devices are not included within the Lucentis pack.
Navedeni medicinski pripomočki niso priloženi pakiranju zdravila Lucentis.
The pre-filled syringe has a plunger rod and a finger grip, and is packed in a sealed tray.
Napolnjena injekcijska brizga ima bat in držalo za prste, pakirana pa je v neprodušno zaprt pretisni omot.
Intraocularly, there were dose-dependent increases in anterior chamber flare and cells with a peak 2 days after injection.
Intraokularno je prišlo do od velikosti odmerka odvisnega povečanja vnetja in števila celic v sprednjem prekatu z vrhom 2 dni po injiciranju.
In a population pharmacokinetic analysis of neovascular AMD patients, 68% (136 of 200) of patients had renal impairment (46.5% mild [50-80 ml/min], 20% moderate [30-50 ml/min], and 1.5% severe [<30 ml/min]).
Pri analizi populacijske farmakokinetike pri bolnikih z neovaskularno SDM je imelo okvaro ledvic 68 % (136 od 200) bolnikov (46,5 % blago [50-80 ml/min], 20 % zmerno [30-50 ml/min] in 1,5 % hudo [<30 ml/min]).
The key outcome measures are summarised in Table 6.
Glavna merila izidov so prikazana v preglednici 6.
The side effects associated with the administration of Lucentis are either due to the medicine itself or the injection procedure and mostly affect the eye.
Do neželenih učinkov pri dajanju zdravila Lucentis lahko pride bodisi zaradi samega zdravila ali pa zaradi postopka injiciranja in večinoma prizadenejo oko.
Blood and lymphatic system disorders Common
Bolezni krvi in limfatičnega sistema pogosti anemija
Table 1 Outcomes at Month 12 and Month 24 in study FVF2598g (MARINA) and FVF2587g (ANCHOR)
Preglednica 1 Izid po 12 in po 24 mesecih v študijah FVF2598g (MARINA) in FVF2587g (ANCHOR)
• sham injection at baseline, followed by an individualised treatment regimen driven by disease activity.
• ali injekcije placeba ob izhodišču, nato po individualiziranem režimu odmerjanja na podlagi kriterijev aktivnosti bolezni.
In this study 178 adult patients were randomised in a 2:1 ratio to receive:
V tej študiji so 178 odraslih bolnikov v razmerju 2:1 randomizirali tako, da so prejemali bodisi:
Table 2 Outcomes at Month 3 and 12 (RADIANCE)
Preglednica 2 Izidi zdravljenja po 3 in 12 mesecih (študija RADIANCE)
For ranibizumab no clinical data on exposed pregnancies are available.
O uporabi ranibizumaba v nosečnosti ni na voljo kliničnih podatkov.
Check syringe 3.
Namestite iglo 7.
VIAL + FILTER NEEDLE
ŠKATLA VIALA + IGLA S FILTROM
The pre-filled syringe is sterile.
Napolnjena injekcijska brizga je sterilna.
The vial and filter needle are for single use only.
Viala in igla s filtrom sta namenjeni samo za enkratno uporabo.
Verteporfin PDT (n=143)
PDT z verteporfinom (n=143)
Table 3 Outcomes at Month 2 (MINERVA)
Preglednica 3 Izidi zdravljenja po koncu 2. meseca (študija MINERVA)
Limited data from sham subjects who later received ranibizumab suggested that early initiation of treatment may be associated with better preservation of visual acuity.
Podatki omejenega obsega pri bolnikih s placebom, ki so kasneje prejemali ranibizumab, nakazujejo, da je zgodnji začetek zdravljenja lahko povezan z boljšim ohranjanjem ostrine vida.
There is only limited experience in the treatment of subjects with DME due to type I diabetes.
Izkušenj z zdravljenjem ljudi z DME zaradi sladkorne bolezni tipa 1 je malo.
In the sham arm 7 out of 59 patients did not receive any treatment with ranibizumab in the study eye during the 12-month period.
V skupini s placebom 7 od 59 bolnikov ni prejelo nobene injekcije z ranibizumabom v študijsko oko v 12-mesečnem obdobju.
Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.
Razpoložljivi podatki za mladoletne bolnike, ki so stari od 12 do 17 let in imajo okvaro vida zaradi CNV, so navedeni v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
In RVO patients, 48.2% (253 of 525) had renal impairment (36.4% mild, 9.5% moderate and 2.3% severe).
Med bolniki z zaporo mrežnične vene je imelo okvaro ledvic 48,2 % (253 od 525) bolnikov (36,4 % blago, 9,5 % zmerno in 2,3 % hudo).
Sustained IOP increases have also been identified (see section 4.8).
Ugotavljali so tudi vztrajno zvišan intraokularni tlak (glejte poglavje 4.8).
For the intravitreal injection, a 30G x ½″ sterile injection needle should be used.
Za intravitrealno injiciranje je treba uporabiti sterilno injekcijsko iglo 30G x ½″.
Prior to launch in each Member State the MAH shall agree the final educational material with the National Competent Authority.
V vsaki državi članici mora imetnik dovoljenja za promet pred prihodom zdravila na trg pridobiti soglasje pristojnih nacionalnih oblasti za končno različico izobraževalnega gradiva.
Any component with packaging showing signs of damage or tampering must not be used.
Katere koli komponente, na kateri so vidne poškodbe ali spremembe ovojnine, ne smete uporabiti.
Before withdrawal, the outer part of the rubber stopper of the vial should be disinfected.
Pred aspiriranjem zdravila iz viale je treba dezinficirati zunanji del gumijastega zamaška na viali.
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A).
Ranibizumab je fragment humaniziranega monoklonskega protitelesa proti humanemu vaskularnemu endotelijskemu rastnemu dejavniku A (VEGF-A).
Intravitreal injection-related reactions
Reakcije na intravitrealno injiciranje
Table 9 Outcomes at Months 6 and 24 (BRIGHTER and CRYSTAL)
Preglednica 9 Izidi zdravljenja po 6 in 24 mesecih (študiji BRIGHTER in CRYSTAL)
The number of scheduled treatment visits after the initial 3 injections, was 13 and 20 for the TE and PRN regimens, respectively.
Pri shemi “Zdravi in podaljšaj” je bilo število dogovorjenih obiskov po začetnih 3 injekcijah 13, pri shemi odmerjanja pro re nata pa 20.
The most frequently reported side effects are described below:
Neželeni učinki, o katerih so najbolj pogosto poročali, so navedeni spodaj:
Table 4 Treatment effect overall and across baseline aetiology subgroups
Preglednica 4 Učinek zdravljenja v celotni zdravljeni skupini in po posameznih podskupinah glede na osnovno etiologijo bolezni
Table 8 Outcomes at Month 6 and 12 (BRAVO and CRUISE)
Preglednica 8 Izidi zdravljenja po 6 in 12 mesecih (študiji BRAVO in CRUISE)
Proper aseptic injection techniques must always be used when administering Lucentis.
Pri aplikaciji zdravila Lucentis je vedno potrebno uporabiti ustrezne aseptične tehnike injiciranja.
- There is no experience of using Lucentis in pregnant women.
- Z uporabo zdravila Lucentis v nosečnosti ni nobenih izkušenj.
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Ena viala (steklo tipa I) z zamaškom (klorbutilna guma), ki vsebuje 0,23 ml sterilne raztopine.
Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients with neovascular AMD treated with the 0.5 mg dose, the average vitreous elimination half-life of ranibizumab is approximately 9 days.
Na osnovi analize populacijske farmakokinetike in izločanja ranibizumaba iz seruma pri bolnikih z neovaskularno obliko SDM, zdravljenih z odmerkom 0,5 mg, je povprečen razpolovni čas izločanja ranibizumaba iz steklovine približno 9 dni.
The clinical safety and efficacy of Lucentis in patients with PDR have been assessed in Protocol S which evaluated the treatment with ranibizumab 0.5 mg intravitreal injections compared with panretinal photocoagulation (PRP).
Klinično varnost in učinkovitost zdravila Lucentis so pri bolnikih s PDR ocenjevali v študiji Protocol S, v kateri so vrednotili zdravljenje z intravitrealnimi injekcijami 0,5 mg ranibizumaba v primerjavi s panretinalno fotokoagulacijo (PRFK).
Please tell the doctor immediately if your baby develops signs such as eye pain or worsening eye redness.
Zdravnika obvestite takoj, če pri vašem otroku opazite znake, kot so bolečina ali vedno bolj pordelo oko.
Most patients (78%) in the clinical study received one injection per eye.
V klinični študiji je večina bolnikov (78 %) prejela po eno injekcijo na oko.
Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml for adults and 0.02 ml for preterm infants), a portion of the volume contained in the vial must be discarded prior to administration.
Količina zdravila, ki ga vsebuje viala (0,23 ml), je večja od priporočenega odmerka (0,05 ml za odrasle in 0,02 ml za nedonošenčke), zato je treba del celotne količine zdravila iz viale pred odmerjanjem zavreči.
In this study, the mean visual acuity change at year 2 was +2.7 letters in the ranibizumab group compared to -0.7 letters in the PRP group.
V tej študiji je bila po 2 letih povprečna sprememba vidne ostrine v skupini z ranibizumabom +2,7 črke v primerjavi z -0,7 črke v skupini s PRFK.
Peel the lid off the syringe tray and, using aseptic technique, carefully remove the syringe.
Odlepite prekrivno folijo pretisnega omota z brizgo in iz njega z aseptično tehniko previdno vzemite brizgo.
The safety and efficacy of Lucentis in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila Lucentis pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
Rhegmatogenous retinal detachment or macular holes in adults
Regmatogeni odstop mrežnice ali foramen makule pri odraslih
- Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe label after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na napolnjeni injekcijski brizgi poleg oznak Uporabno do/EXP.
Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Potegnite vso tekočino iz viale tako, da je viala v pokončnem položaju in nekoliko nagnjena, da laže aspirirate tekočino v celoti.
Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye.
Občasni resni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): slepota, okužba zrkla (endoftalmitis) z vnetjem v notranjosti očesa.
It is important to identify and treat such an infection or retinal detachment as soon as possible.
Tako okužbo ali odstop mrežnice je pomembno odkriti in zdraviti čimprej.
Odds ratio is calculated by using Cochran-Mantel-Haenszel test with ROP zone at baseline (zone I and II; per CRF) as stratum factor.
Razmerje obetov je izračunano s Cochran-Mantel-Haenszelovim testom s predelom prizadetosti z ROP ob izhodišču (predel I oziroma II; po podatkih v študijski mapi bolnikaCRF) kot dejavnikom stratifikacije.
Prior laser n=74
predhodna uporaba laserja n=74
After injection any unused product must be discarded.
Po injiciranju je treba neuporabljeno zdravilo zavreči.
Key outcome measures are summarised in Table 1 and Figure 1.
Glavna merila izidov so prikazana v preglednici 1 in na sliki 1.
Group II Ranibizumab 0.5 mg “disease activity” (n=116)
skupina II ranibizumab 0,5 mg “aktivnost bolezni” (n=116)
The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Pred izvedbo intravitrealnega posega je treba pozorno preveriti bolnikovo anamnezo glede preobčutljivostnih reakcij (glejte poglavje 4.4).
The long-term safety profile of ranibizumab observed in the 24-month extension study is consistent with the known Lucentis safety profile.
Dolgoročni varnostni profil ranibizumaba, ki so ga opažali v 24-mesečnem podaljšanju študije, se ujema z znanim varnostnim profilom zdravila Lucentis.
DRSS was also assessed in three separate active-controlled phase III DME studies (ranibizumab 0.5 mg PRN vs laser) that included a total of 875 patients, of whom approximately 75% were of Asian origin.
Oceno izraženosti diabetične retinopatije (DRSS - diabetic retinopathy severity score) so določali tudi v treh ločenih aktivno kontroliranih študijah DME faze III (0,5 mg ranibizumaba po shemi odmerjanja pro re nata v primerjavi z laserskim zdravljenjem): v te študije je bilo vključenih skupno 875 bolnikov, od katerih jih je bilo približno 75 % azijskega porekla.
Note: The plunger rod is not attached to the rubber stopper - this is to prevent air being drawn into the syringe.
Opozorilo: Bat ni pritrjen na gumijasto tesnilo, zato da v brizgo ne morete potegniti zraka.
In this study, 225 patients were randomised in a 1:1:1 ratio to receive intravitreal ranibizumab 0.2 mg (n=74), 0.1 mg (n=77), or laser therapy (n=74).
V tej študiji so 225 bolnikov randomizirali v razmerju 1:1:1 tako, da so prejemali bodisi intravitrealni 0,2 mg ranibizumab(n=74), 0,1 mg (n=77) ali lasersko terapijo (n=74).
Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment.
Glede na vaš odziv na zdravljenje se bo odločil, ali potrebujete nadaljnje zdravljenje in kdaj ga potrebujete.
How Lucentis works
Kako zdravilo Lucentis deluje
Children and adolescents (below 18 years of age) The use of Lucentis in children and adolescents has not been established and is therefore not recommended.
Otroci in mladostniki (stari manj kot 18 let) Uporabe zdravila Lucentis pri otrocih in mladostnikih niso dokazali in zato ni priporočljiva.
Any vial showing signs of damage or tampering must not be used.
Viale, na kateri so vidne poškodbe ali spremembe ovojnine, ne smete uporabiti.
• How to prepare for Lucentis treatment
• kako se pripraviti na zdravljenje z zdravilom Lucentis
Attach a 30G x ½″ sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 4).
Na brizgo čvrsto namestite sterilno injekcijsko iglo 30G x ½″, tako da jo trdno privijete na nastavek Luer lock (glejte sliko 4).
A total of 88 eyes (22.3%) had baseline DME: 42 (22.0%) and 46 (22.7%) eyes in the ranibizumab and PRP groups, respectively.
Skupno 88 oči (22,3 %) je imelo ob izhodišču DME: 42 (22,0 %) v skupini z ranibizumabom in 46 (22,7 %) v skupini s PRFK.
A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
V kliničnih preskušanjih z zdravilom Lucentis so pri bolnikih s SDM, DME, PDR, RVO in CNV opažali nizko stopnjo incidence arterijskih trombemboličnih dogodkov, vendar večjih razlik med skupinami bolnikov, zdravljenih z ranibizumabom, in kontrolnimi skupinami ni bilo.
Other side effects in adults are described below:
Drugi neželeni učinki pri odraslih so navedeni spodaj:
The study compared ranibizumab 0.5 mg intravitreal injections to standard treatment with PRP.
V študiji so primerjali zdravljenje z intravitrealnimi injekcijami 0,5 mg ranibizumaba s standardnim zdravljenjem s PRFK.
From Month 14 of the study, sham-treated patients were allowed to receive ranibizumab and from Month 19, more frequent treatments were possible.
Od 14. meseca dalje so bolnikom, ki so prejemali placebo, dovolili prehod na zdravljenje z ranibizumabom, od 19. meseca dalje pa so bolniki lahko pogosteje prejemali zdravilo.
The safety and efficacy of Lucentis in children and adolescents below 18 years of age for indications other than retinopathy of prematurity have not been established.
Varnost in učinkovitost zdravila Lucentis pri otrocih in mladostnikih, starih manj kot 18 let, za indikacije, ki niso retinopatija nedonošenčkov, nista bili dokazani.
The long-term safety profile of ranibizumab observed in the 24-month studies is consistent with the known Lucentis safety profile.
Dolgoročni varnostni profil ranibizumaba, ki so ga opažali v obeh 24-mesečnih študijah, se ujema z znanim varnostnim profilom zdravila Lucentis.