natgillin/translations-raw huggingface dataset:
Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in rabbits following delivery of the implant to the posterior segment of the eye. 
Izpostavitev deksametazonu pri zdravem/nezdravljenem očesu prek kontralateralne difuzije so opazovali pri kuncih po vstavitvi vsadka v posteriorni del očesa.
The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been established. 
Varnost in učinkovitost zdravila OZURDEX pri pediatrični populaciji z uveitisom še nista bili dokazani.
• Vision loss caused by a blockage of veins in the eye. 
• Izguba vida pri odraslih, ki jo povzroča zamašenost ven v očesu.
This can lead to swelling of the clear layer in the front of the eye and cause blurred vision. 
To lahko povzroči otekanje prozorne plasti v sprednjem delu očesa in zamegljen vid.
Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%). 
O krvavitvah v steklovino so poročali pri večjem deležu bolnikov, ki so bili zdravljeni z zdravilom OZURDEX in so prejemali antikoagulante (11 %), v primerjavi s tistimi, ki niso prejemali antikoagulantov (6 %).
Contents of the pack and other information What OZURDEX contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo OZURDEX
With the bevel of the needle up away from the sclera, advance the needle about 1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the silicone sleeve is against the conjunctiva. 
Medtem ko poševni del igle držite stran od beločnice, jo potisnite približno 1 mm v beločnico, potem pa spremenite smer proti središču očesa v vitrealno votlino in potiskajte, dokler silikonski tulec ne pride v stik z očesno veznico.
What OZURDEX is and what it is used for 
Kaj je zdravilo OZURDEX in za kaj ga uporabljamo
A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 diabetes. 
V študijah 3. faze so preučevali omejeno število oseb s sladkorno boleznijo tipa 1 in odziv teh oseb na zdravilo OZURDEX ni bil bistveno drugačen od odziva pri osebah s sladkorno boleznijo tipa 2.
Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical studies in up to 56% of patients. 
Med kliničnimi študijami je antitrombotike, kot je klopidogrel, v neki fazi uporabljalo do 56 % bolnikov.
The incidence of all observed cataract types (i.e. cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract lenticular, cataract) was 68% in OZURDEX treated patients with a phakic study eye across the 3 year studies. 
Incidenca vseh opaženih vrst katarakte (tj. kortikalne katarakte, diabetične katarakte, jedrne katarakte, subkapsularne katarakte, katarakte leče in katarakte) v triletnih preizkušanjih je bila pri bolnikih s fakično lečo na preiskovanem očesu, zdravljenih z zdravilom OZURDEX, 68 %.
OZURDEX should not be used during pregnancy or breast-feeding unless your doctor thinks it is clearly necessary. 
se ne sme uporabljati med nosečnostjo ali v obdobju dojenja, razen če zdravnik meni, da je to nujno potrebno.
What you need to know before you are given OZURDEX You must not be given OZURDEX 
Kaj morate vedeti, preden boste prejeli zdravilo OZURDEX Zdravila OZURDEX ne smete prejeti:
Dexamethasone is ultimately metabolised to lipid and water soluble metabolites that can be excreted in bile and urine. 
Deksametazon se na koncu presnovi v lipid in vodotopne presnovke, ki se lahko izločijo z žolčem in urinom.
• Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1. 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Retreatment may be performed after approximately 6 months if the patient experiences decreased vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular oedema. 
Ponovno zdravljenje se lahko izvede po približno šestih mesecih, če se bolniku poslabša vid in/ali odebeli mrežnica zaradi ponavljajočega ali poslabšanega stanja diabetičnega makularnega edema.
Increased pressure in the eye, clouding of the lens (cataract), bleeding on the surface of the eye* 
zvišan tlak v očesu, motnost očesne leče (katarakta), krvavitev na površini očesa*
4) Depress the actuator button slowly until you hear a click. 
4) Počasi potiskajte sprožilni gumb, dokler ne zaslišite klika.
In DME, anti-coagulant therapy was used in 8% of patients. 
Pri DME je zdravljenje z antikoagulanti prejemalo 8 % bolnikov.
Occasionally the injection of OZURDEX may cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. 
Občasno lahko injiciranje zdravila OZURDEX povzroči vnetje v očesu, bolečino ali rdečino v očesu ali odstop oz. raztrganino mrežnice.
vaccinia, varicella, mycobacterial infections, and fungal diseases. 
norice, mikobakterijske okužbe in glivične bolezni.
Do not twist or flex the tab. 
Zavihka ne obračajte ali upogibajte.
The needle is protected by a cap and the lever by a safety tab. 
Igla je zaščitena s pokrovčkom, vzvod pa z varnostnim jezičkom.
The proportion of patients achieving the primary efficacy measure of ≥ 15 letter improvement from baseline in BCVA following injection of a single implant is shown in Table 5. 
Delež bolnikov, ki so dosegli primarno merilo za učinkovitost, izboljšanje za ≥ 15 črk od izhodiščne vrednosti pri BCVA po injiciranju enega vsadka, je prikazan v tabeli 5.
Therefore, regular monitoring of IOP, irrespective of baseline IOP, is required and any elevation should be managed appropriately post-injection as needed. 
Zato je potrebno redno spremljanje očesnega tlaka ne glede na njegovo izhodiščno vrednost, vsako zvišanje po injiciranju pa je treba ustrezno obravnavati.
OZURDEX works by reducing this inflammation. 
Zdravilo OZURDEX deluje tako, da zmanjša tako vnetje.
Description of selected adverse reactions Diabetic Macular Oedema 
Opis izbranih neželenih učinkov Diabetični makularni edem
Patients treated with OZURDEX who have experienced an initial response and in the physician's opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment. 
Pri bolnikih, zdravljenih z zdravilom OZURDEX, ki so se odzvali na prvo zdravljenje in za katere zdravnik meni, da bi jim ponovno zdravljenje koristilo, ne da bi bili pri tem izpostavljeni znatnemu tveganju, se lahko izvede ponovno zdravljenje.
• Aphakic eyes with ruptured posterior lens capsule. 
• Afakično oko z raztrgano posteriorno kapsulo leče.
During the initial treatment period, 0.7 % (3/421) of the patients who received OZURDEX required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2 % (1/423) with sham. 
Med začetnim obdobjem zdravljenja je 0,7 % (3/421) bolnikov, ki so prejeli zdravilo OZURDEX, potrebovalo laserske ali kirurške posege za obravnavo zvišanega očesnega tlaka v preiskovanem očesu v primerjavi z 0,2 % (1/423) v skupini, ki so prejeli placebo.
OZURDEX was numerically superior to sham in preventing vision loss as shown by a lower of proportion of patients experiencing deterioration of vision of ≥ 15 letters in the OZURDEX group throughout the 6-month assessment period. 
Zdravilo OZURDEX je bilo pri preprečevanju izgube vida numerično boljše kot placebo, kar se kaže z manjšim deležem bolnikov, pri katerih se je pojavilo poslabšanje vida za ≥ 15 črk v skupini, ki je prejela zdravilo OZURDEX, v celotnem šestmesečnem obdobju ocenjevanja.
This leaflet was last revised in MM/YYY 
Navodilo je bilo nazadnje revidiranoMM/LLL
Pooled Studies 206207-010 and 
Zbrani študiji 206207-010 in
In addition, patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs. 
Poleg tega je treba bolnike po injiciranju spremljati, da se lahko uvede zgodnje zdravljenje, če se pojavi okužba ali zvišan očesni tlak.
Statistical superiority was achieved at week 3 and maintained up to and including week 26 (p < 0.001) as shown in Table 6. 
3. tednu in je trajala do vključno 26. tedna (p < 0,001), kot je prikazano v tabeli 6.
The adverse reaction profile for BRVO patients was similar to that observed for CRVO patients although the overall incidence of adverse reactions was higher for the subgroup of patients with CRVO. 
Profil neželenih učinkov bolnikov z BRVO je bil podoben profilu bolnikov s CRVO, čeprav je bila skupna incidenca neželenih učinkov večja pri podskupini bolnikov s CRVO.
The primary and key secondary endpoints for the pooled analysis for patients with any prior treatment are presented in Table 4. 
Primarni in ključni sekundarni končni rezultati analize zbranih podatkov za bolnike, ki so bili predhodno zdravljeni, so predstavljeni v tabeli 4.
This blockage leads to a build up of fluid causing swelling in the area of the retina (the light-sensitive layer at the back of the eye) called the macula. 
Ta zamašenost povzroča kopičenje tekočine, zaradi česar se pojavi otekanje v območju mrežnice (plasti v ozadju očesa, občutljive za svetlobo), imenovanem makula.
After OZURDEX treatment you may experience some reduced vision for a short time. 
Po zdravljenju z zdravilom OZURDEX se lahko pojavi kratkotrajno poslabšanje vida.
All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or without a history of vitrectomy, are at risk of implant migration into the anterior chamber. 
Pri bolnikih z raztrgano posteriorno kapsulo leče, na primer bolnikih s posteriorno lečo (na primer zaradi operacije katarakte), in/ali bolnikih z odprtino šarenice proti steklovini (npr. zaradi iridektomije) z vitrektomijo v anamnezi ali brez nje, obstaja tveganje, da se vsadek premakne v sprednji prekat.
Ninety-five percent of the plasma dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL). 
Petindevetdeset odstotkov vrednosti koncentracij deksametazona v plazmi za skupino z odmerkom 350 µg in 86 % za skupino z odmerkom 700 µg je bilo pod spodnjo mejo za kvantifikacijo (0,05 ng/ml).
Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. 
Potem mošnjiček iz folije odprite na sterilnem polju in aplikator nežno položite na sterilni pladenj.
• Inflammation of the back of the eye. 
• Zdravljenje vnetja očesnega ozadja.
For instructions on the administration of the intravitreal implant, see section 6.6 
Navodila za uporabo intravitrealnega vsadka so v poglavju 6.6.
Your doctor will ask you to use antibiotic eye drops daily for 3 days before and after each injection to prevent any eye infection. 
Zdravnik vam bo pred injiciranjem in po njem predpisal 3 dni vsakodnevne uporabe antibiotičnih kapljic za oko, da se prepreči kakršna koli očesna okužba.
The efficacy of OZURDEX was assessed in two multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,267 patients who were randomized to receive treatment with dexamethasone 350 µg or 700 µg implants or sham (studies 206207-008 and 206207-009). 
Učinkovitost zdravila OZURDEX so ocenili v dveh multicentričnih, dvojno slepih, randomiziranih, s placebom nadzorovanih vzporednih študijah z istim načrtom, ki sta vključili skupno 1267 bolnikov, naključno izbranih za prejem vsadkov s 350 µg ali 700 µg deksametazona ali za placebo (študiji 206207-008 in 206207-009).
There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women. 
O uporabi intravitrealnega deksametazona pri nosečnicah ni zadostnih podatkov.
Fertility There are no fertility data available. 
Ni podatkov o učinkih na plodnost.
Mean IOP in the study eye at baseline was the same in both treatment groups (15.3 mmHg). 
Povprečni očesni tlak v preiskovanem očesu je bil na začetku enak pri obeh zdravljenih skupinah (15,3 mmHg).
The primary and key secondary endpoints for the pooled analysis for pseudophakic patients are presented in Table 3. 
Primarni in ključni sekundarni končni rezultati analize zbranih podatkov za bolnike, ki imajo psevdofakijo, so predstavljeni v tabeli 3.
A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation. 
Pri skupno 4 bolnikih (1 %) zdravljenih z zdravilom OZURDEX, so bili na preiskovanem očesu izvedeni postopki za zdravljenje zvišanega očesnega tlaka.
Patients who had a BCVA score of <84 OR retinal thickness > 250 microns by optical coherence tomography OCT and in the investigator's opinion treatment would not put the patient at risk; were eligible to receive an OZURDEX treatment in an open label extension. 
Bolniki, pri katerih je bil rezultat BCVA < 84 ALI debelina mrežnice > 250 mikronov, ki so jo izmerili z optično koherenčno tomografijo, in pri katerih po mnenju raziskovalca zdravljenje ne bi pomenilo tveganja, so izpolnjevali merila za prejem zdravljenja z zdravilom OZURDEX v odprtem podaljšanju študije.
Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment. 
Intravitrealna injiciranja, tudi tista z zdravilom OZURDEX, so lahko povezana z endoftalmitisom, intraokularnim vnetjem, zvišanim očesnim tlakom in odstopom mrežnice.
The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention: 
Neželeni učinki, ki jih povezujejo z zdravljenjem z zdravilom OZURDEX, iz kliničnih preskušanj 3. faze (DME, BRVO/CRVO in uveitis) in iz spontanega poročanja, so navedeni v spodnji tabeli glede na organske sisteme po MedDRA in skladno z naslednjim dogovorom:
OZURDEX is indicated for the treatment of adult patients with: 
Zdravilo OZURDEX je indicirano za zdravljenje odraslih bolnikov z:
Patients who experience deterioration in vision, which is not slowed by OZURDEX, should not be retreated. 
Bolnikov, pri katerih se pojavi poslabšanje vida, ki ga zdravilo OZURDEX ne ustavi, ne smete ponovno zdraviti.
• visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy 
• okvaro vida zaradi diabetičnega makularnega edema (DME), ki imajo psevdofakijo ali se slabše odzivajo ali niso primerni za zdravljenje brez kortikosteroidov;
In a 6-month monkey study following a single intravitreal injection of OZURDEX the dexamethasone vitreous humour Cmax was 100 ng/mL at day 42 post-injection and 5.57 ng/mL at day 91. 
V šestmesečni študiji pri opicah, ki so jim dali eno intravitrealno injiciranje zdravila OZURDEX, je bila koncentracija Cmax deksametazona v steklovini 100 ng/ml na 42. dan po injiciranju in 5,57 ng/ml na 91. dan. Deksametazon je bilo v steklovini mogoče zaznati šest mesecev po injiciranju.
The injection of OZURDEX into both eyes at the same time has not been studied and is not recommended. 
Sočasno injiciranje zdravila OZURDEX v obe očesi niso preučevali, zato se ne priporoča.
One hundred percent of the plasma dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL). 
Sto odstotkov vrednosti koncentracij deksametazona v plazmi za skupino z odmerkom 350 µg in 90 % za skupino z odmerkom 700 µg je bilo pod spodnjo mejo za kvantifikacijo (0,05 ng/ml).
Day 30 
30. dan
In the non-infectious uveitis study, 1 patient out of the 62 phakic patients underwent cataract surgery after a single injection. 
V študiji nenalezljivega uveitisa je bil pri enem od 62 bolnikov s fakično lečo opravljen kirurški poseg zaradi katarakte po enem injiciranju.
PHARMACEUTICAL PARTICULARS 6.6 Special precautions for disposal and other handling 
FARMACEVTSKI PODATKI 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Patients were eligible for retreatment based upon central subfield retinal thickness >175 microns by optical coherence tomography (OCT) or upon investigators interpretation of the OCT for any evidence of residual retinal edema consisting of intraretinal cysts or any regions of increased retinal thickening within or outside of the central subfield. 
O ponovnem zdravljenju bolnikov se je odločalo na podlagi, če je bila debelina centralnega podpolja očesne mrežnice, izmerjena z optično koherenčno tomografijo (OKT), >175 mikronov, ali pa če so raziskovalci pri OKT opazili znake ostankov retinalnega edema v obliki intraretinalnih cist ali območij povečane zadebelitve mrežnice znotraj ali zunaj centralnega podpolja.
In the majority of patients who have not yet had an operation for cataract, a clouding of the eye's natural lens (a cataract) may occur after repeated treatment with OZURDEX. 
Pri večini bolnikov, ki še niso bili operirani za sivo mreno, lahko po večkratnem zdravljenju z zdravilom OZURDEX pride do motnosti naravne leče očesa (katarakta).
The cumulative response rates were higher throughout the open label phase in those patients receiving two consecutive OZURDEX injections compared with those patients who had not received an OZURDEX injection in the initial phase. 
Hitrosti kumulativnega odziva so bile v celotni odprti fazi večje pri bolnikih, ki so prejeli dve zaporedni injiciranji zdravila OZURDEX, kot pri bolnikih, ki v začetni fazi niso prejeli injiciranja zdravila
2) Allow the applicator to meet the sclera at an oblique angle with the bevel of the needle facing up, away from the sclera. 
2) Aplikator naj bo v poševnem položaju glede na beločnico, medtem ko poševni del igle držite stran od beločnice.
Other medicines and OZURDEX 
Druga zdravila in zdravilo OZURDEX
Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior to dosing and on days 1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone. 
Koncentracije v plazmi so ugotavljali pri podskupini bolnikov v dveh ključnih študijah DME pred odmerjanjem ter na 1., 7. in 21. dan ter 1,5 in 3 mesece po intraviteralnem injiciranju enega intravitrealnega vsadka, ki je vseboval 350 µg ali 700 µg deksametazona.
Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting oedema, fibrin deposition, capillary leakage, and phagocytic migration of the inflammatory response. 
Pokazali so, da deksametazon, močan kortikosteroid, zavira vnetje, tako da preprečuje edem, odlaganje fibrina, kapilarno puščanje in migracijo fagocitov pri vnetnem odzivu.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where OZURDEX is marketed, at launch and after launch all ophthalmological clinics where OZURDEX is expected to be used are provided with an up-to-date patient information pack. 
Imetnik dovoljenja za promet zdravilom mora po dogovoru s pristojnimi nacionalnimi organi v vseh državah članicah, kjer se zdravilo OZURDEX trži, zagotoviti, da bodo vse oftalmološke ustanove, za katere se pričakuje, da bodo uporabljale zdravilo OZURDEX, pred prihodom na trg in po njem,
The applicator and a packet of drying material are sealed in a foil pouch which is inside a carton. 
Aplikator in zavojček sušilnega sredstva sta zatesnjena v mošnjičku iz folije, ki je v škatli.
What OZURDEX looks like and contents of the pack 
Izgled zdravila OZURDEX in vsebina pakiranja
The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place by a sleeve (silicone). 
Aplikator je sestavljen iz bata (iz nerjavnega jekla) v igli, kjer vsadek na mestu drži tulec (iz silikona).
A total of 229 patients were randomised to receive dexamethasone 350 µg or 700 µg implants or sham. 
Skupno 229 bolnikov so naključno razporedili v skupine za zdravljenje z vsadki s 350 µg ali 700 µg deksametazona ali s placebom.
The clinical efficacy of OZURDEX has been assessed in a single, multicentre, masked, randomised study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with uveitis. 
Klinično učinkovitost zdravila OZURDEX so ocenili v enojni, multicentrični, slepi, randomizirani študiji za zdravljenje nenalezljivega vnetja posteriornega dela očesa pri bolnikih z uveitisom.
Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and has locked flush with the applicator surface. 
Preden izvlečete aplikator iz očesa, se prepričajte, da je sprožilni gumb popolnoma pritisnjen in je poravnan v zaklenjenem položaju s površino aplikatorja.
The most frequently reported adverse reactions across the entire study period in the study eye of patients who received OZURDEX were cataract and elevated IOP (see below). 
Neželena učinka, o katerih so v celotnem obdobju preizkušanja poročali najpogosteje, za preiskovano oko pri bolnikih, ki so prejemali zdravilo OZURDEX, sta bila katarakta in zvišan očesni tlak (glejte spodaj).
One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator. 
En sterilni vsadek s podaljšanim sproščanjem v obliki paličice, ki vsebuje 700 mikrogramov deksametazona v igli (iz nerjavnega jekla) aplikatorja za enkratno uporabo.
Sham N = 261 P-value 
N = 261 p vrednost
There is no experience of using OZURDEX in pregnant women or during breast-feeding. 
Pri uporabi zdravila OZURDEX pri nosečnicah in doječih materah ni izkušenj.
The most frequently reported adverse reactions in the study eye of patients who received OZURDEX were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%). 
Neželeni učinki za preiskovano oko pri bolnikih, ki so prejemali zdravilo OZURDEX, o katerih so poročali najpogosteje, so bili krvavitev očesne veznice (30,3 %), zvišan očesni tlak (25,0 %) in katarakta (11,8 %).
Whereas, delaying treatment for 6 months results in a lower proportion of responders at all time points in the open label phase when compared with those receiving a second OZURDEX injection. 
Zamik zdravljenja za šest mesecev povzroči manjši delež bolnikov z odzivom na vseh časovnih točkah odprte faze v primerjavi z bolniki, ki so prejeli drugo injiciranje zdravila OZURDEX.
Discontinuation due to lack of efficacy was lower in the OZURDEX group compared to sham (7% vs 24%). 
Prekinitev sodelovanja zaradi neučinkovitosti je bilo manj v skupini, ki je prejela zdravilo OZURDEX, kot v skupini, ki je prejela placebo (7 % in 24 %).
Clinical efficacy and safety Diabetic Macular Oedema 
Klinična varnost in učinkovitost Diabetični makularni edem
Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections. 
Uporaba kortikosteroidov, vključno z zdravilom OZURDEX, lahko povzroči nastanek katarakt (vključno s posteriornimi subkapsularnimi kataraktami), zvišan očesni tlak, glavkom, ki ga povzročajo steroidi, in sekundarne očesne okužbe.
The active substance in OZURDEX is dexamethasone. 
Zdravilna učinkovina v zdravilu OZURDEX je deksametazon.