natgillin/translations-raw huggingface dataset:
Patients should be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Bolnikom je treba naročiti, da sporočijo, če se intenzivnost intraokularnega vnetja stopnjuje, kar bi bil lahko klinični znak, ki ga je mogoče pripisati tvorbi intraokularnih protiteles.
Lucentis has not been studied in patients who have previously received intravitreal injections.
3 Zdravila Lucentis niso preučevali pri bolnikih, ki so predhodno prejemali intravitrealne injekcije.
3 Lucentis should not be administered concurrently with other anti-VEGF agents (systemic or ocular).
Zdravila Lucentis se ne sme aplicirati sočasno z drugimi učinkovinami, ki delujejo proti VEGF (sistemskimi ali očesnimi).
The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: a decrease in best-corrected visual acuity (BCVA) of ≥ 30 letters compared with the last assessment of visual acuity; an intraocular pressure of ≥ 30 mmHg; a retinal break; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥ 50%, of the total lesion area; performed or planned intraocular surgery within the previous or next 28 days.
Apliciranje odmerka je treba odložiti vsaj do naslednjega dogovorjenega datuma za zdravljenje v naslednjih primerih: poslabšanje najboljše vidne ostrine s korekcijo (BCVA, best- corrected visual acuity) za ≥30 črk v primerjavi z zadnjim določanjem vidne ostrine; intraokularni tlak ≥30 mmHg; raztrganje mrežnice; krvavitev pod mrežnico, ki zajema center fovee, ali če velikost krvavitve obsega ≥50% celotne prizadete površine; izvedena ali načrtovana intraokularna operacija v predhodnih ali sledečih 28 dneh.
No formal interaction studies have been performed.
Formalnih študij medsebojnega delovanja z drugimi zdravili niso izvajali.
For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis, see section 5.1.
Glede skupnega zdravljenja s fotodinamično terapijo (PDT) z verteporfinom in z zdravilom Lucentis glejte poglavje 5. 1.
Pregnancy There are no data from the use of ranibizumab in pregnant women.
Nosečnost Ni podatkov o uporabi ranibizumaba pri nosečnicah.
There are no animal studies.
Študij na živalih ni.
The systemic exposure to ranibizumab is expected to be very 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 pričakovana le majhna sistemska izpostavljenost ranibizumabu, vendar je zaradi njegovega mehanizma delovanja treba ranibizumab obravnavati kot potencialno teratogen in toksičen za zarodek/ plod.
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment.
Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
Lactation It is not known whether Lucentis is excreted in human milk.
Dojenje Ni znano, ali se Lucentis izloča v materino mleko.
The Lucentis treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
Postopek zdravljenja z zdravilom Lucentis lahko povzroči začasne motnje vida, ki lahko motijo sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
A total of 1,315 patients constituted the safety population in the three phase III studies with 24 months exposure to Lucentis and 440 patients were treated with the recommended dose of 0.5 mg.
V treh študijah faze III s 24- mesečno izpostavljenostjo zdravilu Lucentis je skupino za vrednotenje varnosti zdravila sestavljalo skupno 1. 315 bolnikov, 440 bolnikov je bilo zdravljenih s priporočenim odmerkom 0, 5 mg.
Serious adverse events related to the injection procedure included endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4).
Resni neželeni dogodki, povezani s postopkom injiciranja, so vključevali endoftalmitis, regmatogeni odstop mrežnice, raztrganino mrežnice in iatrogeno travmatsko katarakto (glejte poglavje 4. 4).
Other serious ocular events observed among Lucentis-treated patients included intraocular inflammation and increased intraocular pressure (see section 4.4).
Drugi resni očesni dogodki, ki so jih opažali pri bolnikih, zdravljenih z zdravilom Lucentis, so
The adverse events listed below occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis 0.5 mg than in those receiving control treatment (sham or verteporfin PDT) in the three controlled phase III studies FVF2598g (MARINA), FVF2587g
4 vključevali intraokularno vnetje in zvišan intraokularni tlak (glejte poglavje 4. 4).
4 (ANCHOR) and FVF3192g (PIER).
FVF2598g (MARINA), FVF2587g (ANCHOR) in FVF3192g (PIER).
These were therefore considered potential adverse drug reactions.
Zato ti dogodki sodijo med potencialne neželene učinke zdravila.
The safety data described below also include all adverse events (in at least 0.5 percentage points of patients) suspected to be at least potentially related to the injection procedure or medicinal product in the 440 patients of the combined 0.5 mg treatment groups.
Spodaj opisani podatki vključujejo vse neželene dogodke (do katerih je prišlo pri vsaj 0, 5 odstotnih točkah bolnikov), ki bi bili lahko vsaj potencialno povezani s postopkom injiciranja ali z zdravilom, pri 440 bolnikih iz vseh skupin, zdravljenih z 0, 5 mg.
The adverse events are listed by 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), not known (cannot be estimated from the available data).
Neželeni dogodki so razvrščeni po organskih sistemih 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).
Investigations Very common
Preiskave zelo pogosti
Eye disorders Very common
Očesne bolezni zelo pogosti
Respiratory, thoracic and mediastinal disorders Common
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja pogosti
Musculoskeletal and connective tissue disorders Very common
Bolezni mišično- skeletnega sistema in
Arthralgia
vezivnega tkiva
Nasopharyngitis
artralgija
Hypersensitivity 5
5 Infekcijske in parazitske bolezni zelo pogosti
Product-class-related adverse reactions:
Na skupino zdravil vezani neželeni učinki:
However, there was no consistent pattern among the different haemorrhages.
V študijah faze III je bila pogostnost vseh krvavitev (razen očesnih), ki sicer sodijo med neželene dogodke, ki bi lahko bili povezani s sistemskim zaviranjem VEGF (vascular endothelial growth factor - rastnega dejavnika za žilni endotelij), nekoliko povečana pri bolnikih, ki so prejemali ranibizumab, vendar pri pojavljanju različnih krvavitev ni bilo nobenega pravila.
There is a theoretical risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Po intravitrealni uporabi zaviralcev VEGF obstaja teoretično tveganje za arterijske trombembolične dogodke.
A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials and there were no major differences between the treatment groups.
V kliničnih preskušanjih z zdravilom Lucentis so opažali nizko stopnjo incidence arterijskih trombemboličnih dogodkov, vendar večjih razlik med posameznimi študijskimi skupinami ni bilo.
Cases of accidental overdose have been reported from the clinical studies and post-marketing data.
Iz kliničnih študij in postmarketinških izkušenj so poročali o primerih nehotenega prevelikega odmerjanja.
Antineovascularisation agents, ATC code:
Farmakoterapevtska skupina: zaviralci neovaskularizacije, oznaka ATC:
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 rastnemu dejavniku za žilni endotelij A (human vascular endothelial growth factor A, VEGF- A).
VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Z visoko afiniteto se veže na izooblike VEGF- A (npr. VEGF110, VEGF121 in VEGF165) in tako preprečuje vezavo VEGF- A na njegove receptorje VEGFR- 1 in VEGFR- 2.
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.
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.
The clinical safety and efficacy of Lucentis have been assessed in three randomised, double-masked, sham- or active-controlled studies in patients with neovascular AMD.
Klinično varnost in učinkovitost zdravila Lucentis so ocenjevali v treh randomiziranih, dvojno slepih študijah s placebom ali z aktivnimi kontrolami pri bolnikih z neovaskularno obliko SDM.
A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Skupno so v te študije vključili 1. 323 bolnikov (879 aktivnih in 444 kontrol).
In study FVF2598g (MARINA), patients with minimally classic or occult with no classic choroidal neovascularisation (CNV) received monthly intravitreal injections of Lucentis 0.3 mg or 0.5 mg or sham injections.
V študiji FVF2598g (MARINA) so bolniki z minimalno stopnjo klasične horoidalne neovaskularizacije (CNV - choroidal neovascularisation) ali z okultno obliko brez klasične CNV prejemali intravitrealne injekcije zdravila Lucentis 0, 3 mg oziroma 0, 5 mg ali placebo injekcije.
Data are available up to the end of month 24.
Podatki so dostopni za obdobja tudi do konca 24. meseca.
In study FVF2587g (ANCHOR), patients with predominantly classic CNV lesions received either:
V študiji FVF2587g (ANCHOR) so bolniki, ki so imeli predvsem klasične CNV lezije, prejemali bodisi:
1) monthly intravitreal injections of Lucentis 0.3 mg and sham PDT; 2) monthly intravitreal injections of Lucentis 0.5 mg and sham PDT; or 3) sham intravitreal injections and active verteporfin PDT.
1) mesečno intravitrealno injekcijo zdravila Lucentis 0, 3 mg in placebo fotodinamično terapijo (PDT); 2) mesečno intravitrealno injekcijo zdravila Lucentis 0, 5 mg in placebo PDT; ali 3) placebo intravitrealno injekcijo in aktivno PDT z verteporfinom.
Sham or active verteporfin PDT was given with the initial Lucentis injection and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage.
Skupno je
In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at 12 months compared with baseline.
V obeh raziskavah je bil primarni cilj opazovanja delež bolnikov, ki so ohranili vid, kar je bilo opredeljeno kot poslabšanje vidne ostrine za manj kot 15 črk od izhodišča v 12 mesecih.
Almost all Lucentis-treated patients (approximately 95%) maintained their visual acuity.
Skoraj vsi bolniki, ki so prejemali Lucentis (približno 95%), so ohranili svojo ostrino vida.
34-40% of Lucentis- treated patients experienced a clinically significant improvement in vision, defined as gaining 15 or more letters at 12 months.
Pri 34- 40% bolnikov zdravljenih z zdravilom Lucentis je prišlo do klinično pomembnega izboljšanja vida, kar je bilo opredeljeno kot izboljšanje za 15 ali več črk v 12 mesecih.
The size of the lesion did not significantly affect the results.
Velikost okvare ni pomembno vplivala na izid.
In general, patients with poor visual acuity (< 20/ 200) at the onset of treatment experienced a benefit of treatment.
Bolnikom s slabo vidno ostrino (< 20/ 200) ob začetku zdravljenja je zdravljenje večinoma koristilo.
However, neovascular AMD that has evolved into lesions characterised by subretinal fibrosis and
Vendar pa je malo verjetno, da bi se na zdravilo Lucentis odzvala neovaskularna oblika SDM, ki se je razvila do lezij, za katere sta značilni subretinalna fibroza in napredovala področna atrofija.
Detailed results are shown in the tables below.
Podrobni izsledki so prikazani v spodnji preglednici.
Outcomes at month 12 and month 24 in study FVF2598g (MARINA)
Izidi po 12 in po 24 mesecih v študiji FVF2598g (MARINA)
Month
meseci placebo (n=238)
Loss of < 15 letters in visual acuity (%)a (maintenance of vision)
poslabšanje vidne ostrine za < 15 črk (%) a (ohranitev vida)
Month 12 Month 24
po 12 mesecih po 24 mesecih
Gain of ≥ 15 letters in visual acuity (%)a
izboljšanje vidne ostrine za ≥15 črk (%) a
Mean change in visual acuity (letters) (SD)a a p < 0.01
povprečna sprememba vidne ostrine (črke) (SD) a a p < 0, 01
Outcomes at month 12 and month 24 in study FVF2587g (ANCHOR)
Izid po 12 in po 24 mesecih v študiji FVF2587g (ANCHOR)
Verteporfin PDT (n=143)
meseci PDT z verteporfinom (n=143)
7 Figure 1
7 Slika 1
Mean change in visual acuity from baseline to month 24 in study FVF2598g (MARINA) and study FVF2587g (ANCHOR)
Povprečna sprememba vidne ostrine v 24 mesecih od izhodišča v študijah FVF2598g (MARINA) in FVF2587g (ANCHOR)
Study FVF2598g (MARINA) Mean change in visual acuity ± SE
študija FVF2598g (MARINA) povp. sprememba vidne ostrine ±SE
15 10 +6.6 5 (letters)
15 10 +6, 6 5 (črke)
12 14 16 18 20 22 24 Month
12 14 16 18 20 22 24 meseci
Study FVF2587g (ANCHOR) 15 Mean change in visual acuity ± SE
študija FVF2587g (ANCHOR) povp. sprememba vidne ostrine ±SE
+10.7 10 5 (letters)
15 +10, 7 10 5 (črke)
MARINA LUCENTIS 0.5 mg (n=240) Sham (n=238)
MARINA LUCENTIS 0, 5 mg (n=240) placebo (n=238)
ANCHOR LUCENTIS 0.5 mg (n=140) Verteporfin PDT (n=143)
ANCHOR LUCENTIS 0, 5 mg (n=140) PDT z verteporfinom (n=143)
Patients in the group treated with Lucentis had minimal observable CNV lesion growth, on average.
Bolniki v skupini z zdravilom Lucentis so imeli v povprečju najmanjšo opazno rast CNV lezij.
At month 12, the mean change in the total area of the CNV lesion was 0.1-0.3 DA for Lucentis versus 2.3-2.6 DA for the control arms.
Po 12 mesecih je bila povprečna sprememba skupne površine CNV lezij 0, 1- 0, 3 velikosti papile (DA – disc area) pri zdravilu Lucentis v primerjavi z 2, 3- 2, 6 DA za kontrolne krake.
Results from both trials indicated that continued ranibizumab-treatment may also be of benefit in patients who lost ≥ 15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Rezultati obeh študij so pokazali, da lahko nadaljnje zdravljenje z ranibizumabom koristi tudi bolnikom, pri katerih je v prvem letu zdravljenja prišlo do poslabšanja najboljše vidne ostrine s korekcijo (BCVA, best- corrected visual acuity) za ≥15 črk.
The use of Lucentis beyond 24 months has not been studied.
Uporabe zdravila Lucentis v obdobju daljšem od 24 mesecev, niso proučevali.
Study FVF3192g (PIER) was a randomised, double-masked, sham-controlled, two-year study designed to assess the safety and efficacy of Lucentis in patients with neovascular AMD (79% of the patients had minimally classic or occult AMD, 21% had a predominantly classic CNV component).
Študija FVF3192g (PIER) je bila randomizirana, dvojno slepa, s placebom kontrolirana dvoletna študija namenjena ocenjevanju varnosti in učinkovitosti zdravila Lucentis pri bolnikih z neovaskularno obliko SDM (79% bolnikov je imelo minimalno klasično ali okultno SDM, 21% pa jih je imelo predominantno klasično CNV).
Patients received Lucentis 0.3 mg or 0.5 mg intravitreal injections or sham injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months.
Bolniki so prejemali intravitrealne injekcije zdravila Lucentis 0, 3 mg
A total of 184 patients were enrolled in this study (Lucentis 0.3 mg, 60; Lucentis 0.5 mg, 61; sham, 63); 107 (88%) of
63).
8 ranibizumab-treated patients completed 24 months of this study.
107 (88%) bolnikov, ki so prejemali ranibizumab, je zaključilo 24 mesecev v tej študiji.
From month 14 of the study, sham- treated patients were allowed to cross over 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.
Patients treated with Lucentis in PIER received a mean of 10 total treatments out of possible 13 from day 0 to month 24.
Bolniki, ki so prejemali Lucentis v študiji PIER, so od dneva 0 do vključno 24. meseca od skupno 13 prejeli v povprečju 10 krogov zdravljenja v celoti.
In PIER, the primary efficacy endpoint was mean change in visual acuity at 12 months compared with baseline.
V študiji PIER je bil primarni cilj opazovanja povprečna sprememba vidne ostrine od izhodišča po 12 mesecih.
After an initial increase in visual acuity (following monthly dosing), on average, patients dosed once every three months with Lucentis lost visual acuity, returning to baseline at month 12.
V povprečju se je vidna ostrina pri bolnikih ob enkrat mesečnem odmerjanju zdravila Lucentis sprva izboljšala, kasneje ob odmerjanju enkrat na tri mesece poslabšala in se po 12 mesecih vrnila na izhodiščno raven.
This effect was essentially maintained at month 24 (see Figure 2).
Ta učinek je 24 mesecev po začetku študije ostal v glavnem ohranjen (glejte sliko 2).
In PIER, most Lucentis-treated patients (82%) maintained their visual acuity at month 24.
V študiji PIER je večina bolnikov, zdravljenih z zdravilom Lucentis (82%) po 24 mesecih ohranila svojo vidno ostrino.
Data from a limited number of subjects that crossed over to receive ranibizumab after more than a year of sham-treatment suggested that early initiation of treatment may be associated with a better preservation of visual acuity than if treatment was initiated when the disease had reached a more advanced stage.
Podatki omejenega števila bolnikov, ki so po več kot enem letu prejemanja placeba prešli na zdravljenje z ranibizumabom, nakazujejo, da je zgodnji začetek zdravljenja lahko povezan z boljšim ohranjanjem vidne ostrine v primerjavi z začetkom zdravljenja na stopnji bolj napredovale bolezni.
Mean change in visual acuity from baseline to month 24 in study FVF3192g (PIER)
Povprečna sprememba vidne ostrine od izhodišča po 24 mesecih v študiji FVF3192g (PIER)
Mean change from baseline in visual acuity ± SE (letters)
povp. sprememba vidne ostrine od izhodiščne ± SE (črke)
Study FVF3192g (PIER)
Študija FVF3192g (PIER)
Month
meseci
Sham (n=63)
placebo (n=63)
Data from an open label study (PROTECT) in 32 patients followed for 9 months in which the safety of same-day administration of verteporfin PDT and Lucentis 0.5 mg was evaluated showed that the incidence of intraocular inflammation following the initial treatment was 6.3% (2 of 32 patients).
Podatki iz odprte študije (PROTECT) z 32 bolniki, ki so jih spremljali 9 mesecev, v kateri so ocenjevali varnost izvedbe PDT z verteporfinom in apliciranja zdravila Lucentis 0, 5 mg v istem dnevu, so pokazali 6, 3- odstotno incidenco intraokularnega vnetja po začetnem zdravljenju (pri 2 od 32 bolnikov).
In study MARINA, the differences versus sham treatment had further increased at 24 months (p < 0.0001 for all three subscales).
Tako v študiji MARINA kot v študiji ANCHOR se je izboljšanje vidne ostrine, opaženo po 12 mesecih z zdravilom Lucentis 0, 5 mg, odražalo v koristih, ki so jih bolniki ocenjevali na treh podlestvicah vprašalnika National Eye Institute Visual Function Questionnaire (VFQ- 25): dejavnosti, ki so povezane z gledanjem na blizu, dejavnosti, ki so povezane z gledanjem na daleč, in za slabovidne specifična odvisnost od drugih.
In the ANCHOR study, the treatment effect of ranibizumab over verteporfin PDT was essentially maintained for the three VFQ-25 scores after 24 months.
Ti parametri so bili vnaprej določeni sekundarni cilji opazovanja za
9 5.2 Pharmacokinetic properties
9 oceno učinkovitosti.
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).
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).
Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/ eye.
Cmax je bila sorazmerna odmerku v obsegu odmerkov med 0, 05 do 1, 0 mg/ oko.
Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients 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, zdravljenih z odmerkom 0, 5 mg, je povprečen razpolovni čas izločanja ranibizumaba iz steklovine približno 9 dni.
Upon monthly intravitreal administration of Lucentis 0.5 mg/ eye, serum ranibizumab Cmax, attained approximately 1 day after dosing, is predicted to generally range between 0.79 and 2.90 ng/ ml, and Cmin is predicted to generally range between 0.07 and 0.49 ng/ ml.
Cmin je pričakovana večinoma v obsegu od 0, 07 do 0, 49 ng/ ml.
Serum ranibizumab concentrations are predicted to be approximately 90,000-fold lower than vitreal ranibizumab concentrations.
Pričakovane koncentracije ranibizumaba v serumu so približno 90. 000- krat manjše od koncentracij ranibizumaba v steklovini.
No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with renal impairment.
Formalnih študij za preverjanje farmakokinetike zdravila Lucentis pri bolnikih z okvaro ledvic niso opravili.
Sixty-eight percent (136 of 200) of patients in a population pharmacokinetic analysis had renal impairment (46.5% mild [50-80 ml/ min], 20% moderate [30-50 ml/ min], and 1.5% severe [< 30 ml/ min]).
68% (136 od 200) bolnikov v okviru analize populacijske farmakokinetike je imelo okvaro ledvic (46, 5% blago [50- 80 ml/ min], 20% zmerno [30- 50 ml/ min] in 1, 5% hudo [< 30 ml/ min]).
No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with hepatic impairment.
Formalnih študij za preverjanje farmakokinetike zdravila Lucentis pri bolnikih z okvaro jeter niso opravili.
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.
Intraocularly, there were dose-dependent increases in anterior chamber flare and cells with a peak 2 days after injection.
Inraokularno je prišlo do od velikosti odmerka odvisnega povečanja vnetja in števila celic v sprednjem prekatu z vrhom 2 dni po injiciranju.
In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
V 26- tedenski študiji je intenzivnost vnetja v steklovini naraščala s številom injekcij.
No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.
10 Podatki o kancerogenosti, mutagenosti ali o vplivu na sposobnost razmnoževanja in na razvoj niso na voljo.
α ,α -trehalose dihydrate Histidine hydrochloride, monohydrate Histidine Polysorbate 20 Water for injections
α, α- trehaloza dihidrat histidinijev klorid monohidrat histidin polisorbat 20 voda za injekcije