What is the translation of " LUCENTISA " in English?

• lucentis

Examples of using Lucentisa in Croatian and their translations into English

Ako se propusti doza Lucentisa.
If a dose of Lucentis is missed.

Tijekom primjene Lucentisa dojenje se ne preporučuje.
Breast-feeding is not recommended during the use of Lucentis.

Postoji potencijal za imunogenost Lucentisa.
There is a potential for immunogenicity with Lucentis.

Preporučena doza Lucentisa iznosi 0, 5 mg u obliku jednokratne intravitrealne injekcije.
The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.

Za informacije o pripremi Lucentisa vidjeti dio 6.6.
For information on preparation of Lucentis, see section 6.6.

Navedeni medicinski proizvodi nisu uključeni u pakovanje Lucentisa.
These medical devices are not included within the Lucentis pack.

Primjena Lucentisa u djece i adolescenata nije ispitana te se stoga ne preporučuje.
The use of Lucentis in children and adolescents has not been studied and is therefore not recommended.

Liječenje započinje jednom injekcijom Lucentisa mjesečno.
The treatment is started with one injection of Lucentis per month.

Ne postoje iskustva s primjenom Lucentisa u trudnica; stoga nisu poznati mogući rizici.
There is no experience of using Lucentis in pregnant women; therefore the potential risks are unknown.

Informacija da se mora izbaciti višak volumena iz napunjene štrcaljke prije injiciranja Lucentisa kako ne bi došlo do predoziranja.
The need to expel excess volume of the pre-filled syringe before injecting Lucentis to avoid overdose.

Djelotvornost i sigurnost Lucentisa procjenjivana je u okviru tri randomizirana, kontrolirana ispitivanja u trajanju od najmanje 12 mjeseci.
The efficacy and safety of Lucentis have been assessed in three randomised, controlled studies of at least 12 months duration.

Nema iskustava s istodobnom primjenom Lucentisa i Visudynea.
There is no experience of concomitant administration of Lucentis and Visudyne.

Nuspojave povezane s primjenom Lucentisa uzrokovane su ili samim lijekom ili postupkom davanja injekcije i pretežno se javljaju u oku.
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.

Za zajedničku primjenu fotodinamske terapije(PDT) verteporfinom i Lucentisa kod vlažnog AMD-a i PM-a, vidjeti dio 5.1.
For the adjunctive use of verteporfin photodynamic therapy(PDT) and Lucentis in wet AMD and PM, see section 5.1.

Podaci o primjeni Lucentisa u oba oka(uključujući primjenu u istom danu) su ograničeni i ne ukazuju na povećani rizik od sistemskih štetnih događaja u usporedbi s primjenom u jedno oko.
Limited data on bilateral use of Lucentis(including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.

Za zajedničku primjenu laserske fotokoagulacije i Lucentisa kod DME-a i BRVO-a, vidjeti dijelove 4.2 i 5.1.
For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1.

Klinička sigurnost i djelotvornost Lucentisa u bolesnika s oštećenjem vida uzrokovanim CNV-om kod PM-a ocijenjene su na temelju 12-mjesečnih podataka iz dvostruko maskiranog, kontroliranog ključnog ispitivanja F2301 RADIANCE.
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.

Oštećenje jetre: nisu provedena formalna ispitivanja farmakokinetike Lucentisa u bolesnika s oštećenjem jetre.
Hepatic impairment: No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with hepatic impairment.

U bolesnika s PM-om postoje ograničeni podaci o učinku Lucentisa u bolesnika koji su se prethodno neuspješno podvrgnuli verteporfin fotodinamskoj terapiji(vPDT) terapiji.
In patients with PM, there are limited data on the effect of Lucentis in patients who have previously undergone unsuccessful verteporfin photodynamic therapy(vPDT) treatment.

Bolesnici s oštećenjem bubrega: nisu provedena formalna ispitivanja farmakokinetike Lucentisa u bolesnika s oštećenjem bubrega.
Patients with renal impairment: No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with renal impairment.

Nema dovoljno podataka da bi se donio zaključak o učinku Lucentisa u bolesnika s RVO-om u kojih je došlo do ireverzibilnog gubitka vidne funkcije zbog ishemije.
There are insufficient data to conclude on the effect of Lucentis in patients with RVO presenting irreversible ischaemic visual function loss.

Kod vlažnog AMD-a te poremećaja vida nastalog zbog DME-a, makularnog edema posljedičnog RVO-u ili CNV-a posljedičnog PM-u, preporučena doza Lucentisa iznosi 0, 5 mg u obliku jednokratne intravitrealne injekcije.
In wet AMD and in visual impairment due to DME, to macular oedema secondary to RVO or to CNV secondary to PM, the recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.

To je postupak koji je sličan davanju injekcije Lucentisa, ali bez Lucentisa i igle, kod kojeg se štrcaljka pritišće na površinu oka ali se ne daje injekcija.
This is a procedure that is similar to a Lucentis injection, but with no Lucentis and no needle, in which the syringe is pressed against the surface of the eye but no actual injection is carried out.

Također, iako je dosljedan učinak uočen u ispitanika s lezijama ispod fovee ili uz nju, nema dovoljno podataka da bi se mogao donijeti zaključak o učinku Lucentisa u ispitanika s PM-om i lezijama izvan fovee.
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.

Nuspojave koje su se pojavile nakon primjene Lucentisa u kliničkim ispitivanjima sažete su u tablici u nastavku.
The adverse reactions experienced following administration of Lucentis in clinical trials are summarised in the table below.

U ispitivanju FVF2598g(MARINA), 716 bolesnika s minimalno klasičnim ili okultnim lezijama bez klasične komponente randomizirani su u omjeru 1:1:1 da bi primili mjesečne injekcije Lucentisa u dozi od 0, 3 mg, Lucentisa u dozi od 0, 5 mg ili prividno dane injekcije.
In study FVF2598g(MARINA), 716 patients with minimally classic or occult with no classic lesions were randomised in a 1:1:1 ratio to receive monthly injections of Lucentis 0.3 mg, Lucentis 0.5 mg or sham.

Većina nuspojava uočenih nakon primjene Lucentisa povezana je s postupkom primjene intravitrealne injekcije.
The majority of adverse reactions reported following administration of Lucentis are related to the intravitreal injection procedure.

Nakon mjesečnih intravitrealnih primjena Lucentisa u bolesnika s neovaskularnim AMD-om, koncentracije ranibizumaba u serumu bile su općenito niske, a maksimalne razine(Cmax) bile su općenito ispod koncentracije ranibizumaba nužne za inhibiciju 50% biološke aktivnosti VEGF-a 11-27 ng/ml, procijenjeno testom stanične proliferacije in vitro.
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.

Podaci iz dvaju ispitivanja(MONT BLANC, BPD952A2308 i DENALI, BPD952A2309) provedenih nakon dobivanja odobrenja potvrdili su djelotvornost Lucentisa, ali nisu pokazali dodatni učinak kombinirane primjene verteporfina(Visudyne PDT) i Lucentisa u usporedbi s monoterapijom Lucentisom..
Data from two studies(MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin(Visudyne PDT) and Lucentis compared to Lucentis monotherapy.

Primjena intravitrealnih injekcija, uključujući primjenu Lucentisa, bila je povezana s pojavom endoftalmitisa, intraokularne upale, regmatogene ablacije mrežnice, razderotine mrežnice i jatrogene traumatske katarakte vidjeti dio 4.8.
Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract see section 4.8.