natgillin/translations-raw huggingface dataset:
3) Redirect towards the centre of the eye into the vitreous cavity.
3) Spremenite smer proti središču očesa v vitrealno votlino.
A total of 47.3 % of patients experienced at least one adverse reaction.
Skupno 47,3 % bolnikov je imelo vsaj en neželeni učinek.
Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Dal vam bo tudi lokalni anestetik, da zmanjša ali prepreči kakršno koli bolečino, ki se lahko pojavi med injiciranjem.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
* indicates adverse reactions considered to be related to the intravitreal injection procedure (the frequency of these adverse reactions is proportional to the number of treatments given).
* označuje neželene učinke, ki so verjetno povezani s postopkom intravitralnega injiciranja (pogostnost teh neželenih učinkov je sorazmerna s številom izvedenih zdravljenj)
Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the maximum dose for human indicating little relevance to clinical use.
Učinke v nekliničnih študijah so opazili samo pri odmerkih, ki so zadostno presegli največji odmerek pri človeku, kar kaže na majhen pomen za klinično uporabo.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit:risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
1) Hold the long axis of the applicator parallel to the limbus.
1) Dolgo os aplikatorja držite vzporedno z limbusom.
Swelling of the macula may lead to damage which affects your central vision which is used for tasks like reading.
Otekanje makule lahko povzroči poškodbo, ki prizadene osrednji vid, ki se uporablja za opravila, kot je branje.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na pooblaščenega predstavnika imetnika dovoljenja za promet z zdravilom:
If this continues for a long time and is left untreated, it may require tissue transplantation.
Če to traja dlje časa in se ne zdravi, je pozneje morda potrebna presaditev tkiva.
The implant is approximately 0.46 mm in diameter and 6 mm in length.
Premer vsadka je približno 0,46 mm, dolžina pa 6 mm.
• When to seek urgent attention from their health care provider
• v katerih primerih je treba poiskati nujno zdravniško pomoč.
No treatment is required since spontaneous resolution occurs.
Zdravljenje ni potrebno, ker spontano pride do izboljšanja.
The overall incidence of cataracts was higher after 1 year compared to the initial 6 months.
Skupna incidenca katarakte je bila večja po enem letu kot po prvih šestih mesecih.
*These side effects may be caused by the injection procedure and not the OZURDEX implant itself.
*Te neželene učinke lahko povzroči postopek injiciranja in ne sam vsadek zdravila OZURDEX.
Only 1 patient out of 368 required cataract surgery during the first treatment and 3 patients out of 302 during the second treatment.
Samo eden od 368 bolnikov je potreboval kirurški poseg zaradi katarakte med prvim zdravljenjem in trije od 302 bolnikov med drugim zdravljenjem.
Peak usage (33%) occurred during the first 12 months and remained similar from year to year.
Najpogosteje (33 %) so bila uporabljena v prvih 12 mesecih, v naslednjih letih pa je odstotek uporabe ostal podoben.
Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.
Zdi se, da koncentracija deksametazona v plazmi ni povezana s starostjo, telesno maso ali spolom bolnikov.
A total of 95% of patients completed the 26-week study.
Skupno je 26-tedensko študijo zaključilo 95 % bolnikov.
One carton contains one applicator with one implant which will be used once and thrown away.
Ena škatla vsebuje en aplikator z enim vsadkom, ki se ga uporabi enkrat in potem zavrže.
Patients received up to 7 treatments at intervals no more frequently than approximately every 6 months.
7 zdravljenj v razmikih, ki niso bili pogostješi od približno 6 mesecev.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH AND OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
The primary and key secondary endpoints for studies 206207-010 and 011 are presented in Table 2.
Primarni in ključni sekundarni končni rezultati študij 206207-010 in 011 so predstavljeni v tabeli 2.
Before the injection, your doctor will clean your eye and eyelid.
Pred injiciranjem bo zdravnik očistil oko in veko.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, discuss this with your doctor before OZURDEX treatment.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo OZURDEX.
There is only very limited information on repeat dosing intervals less than 6 months (see section 5.1).
Podatki o ponovnem odmerjanju v presledku, krajšem od 6 mesecev, so zelo omejeni (glejte poglavje 5.1).
A total of 54 % of patients experienced at least one adverse reaction.
Skupno 54 % bolnikov je imelo vsaj en neželeni učinek.
Additionally, corticosteroids prevent the release of prostaglandins, some of which have been identified as mediators of cystoid macular oedema.
Poleg tega kortikosteroidi preprečujejo sproščanje prostaglandinov, od katerih so za nekatere pokazali, da so mediatorji za cistoidni makularni edem.
OZURDEX may have a moderate influence on the ability to drive and use machines.
Zdravilo OZURDEX lahko zmerno vpliva na sposobnost vožnje in upravljanja s stroji.
These patients should be closely monitored to allow for early diagnosis and management of device migration.
Take bolnike je treba skrbno spremljati, da se omogoči zgodnja diagnoza in obvladovanje morebitnega premika pripomočka.
Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child.
Dolgotrajno sistemsko zdravljenje z glukokortikoidi med nosečnostjo poveča tveganje upočasnjene rasti v maternici in adrenalne insuficience pri novorojenčku.
Statistical superiority was maintained up to and including week 26 (p ≤ 0.014) as shown in Table 6.
Statistična superiornost je bila izkazana do vključno 26. tedna (p ≤ 0,014), kot je prikazano v tabeli 6.
You may hear a ‘click' during the injection of OZURDEX; this is normal.
lahko zaslišite »klik« - to je normalno.
Your doctor should not inject OZURDEX into both eyes at the same time.
Zdravnik vam zdravila OZURDEX ne sme sočasno injicirati v obe očesi.
The vision improvement in the DEX700 group was confounded by cataract formation.
Izboljšanje vida v skupini DEX 700 je preprečil nastanek katarakte.
The proportion of responders at each time point was always greater after the second treatment compared with the first treatment.
Delež bolnikov z odzivom je bil na vsaki časovni točki večji po drugem zdravljenju kot pri prvem.
On the day of the injection, your doctor may use antibiotic eye drops to prevent infection.
Na dan injiciranja bo zdravnik morda uporabil antibiotične kapljice za oko, da prepreči okužbo.
Systemic absorption is minimal and no interactions are anticipated.
Sistemska absorpcija je minimalna, zato se ne pričakuje medsebojno delovanje z drugimi zdravili.
This will create a shelved scleral path.
To bo ustvarilo stopničasto pot v beločnico.
Detailed instructions for your doctor on how to carry out the OZURDEX injection are provided in the medicine carton.
Podrobna navodila za zdravnika o tem, kako injicirati zdravilo OZURDEX, so priložene v škatli zdravila.
If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used.
Če je tesnilo mošnjička iz folije, ki vsebuje aplikator, poškodovano, aplikatorja ne smete uporabiti.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o vsebini končnega izobraževalnega gradiva.
1 implant
1 vsadek
Of the patients who were treated in the open label phase, 98% received an OZURDEX injection between 5 and 7 months after the initial treatment.
Od bolnikov, ki so jih zdravili v odprti fazi, jih je 98 % prejelo injekcijo zdravila OZURDEX od 5 do 7 mesecev po prvem zdravljenju.
Following the intravitreal injection patients should continue to be treated with a broad spectrum antimicrobial.
Po intravitrealnem injiciranju je treba pri bolnikih nadaljevati zdravljenje s širokospektralnim antibiotikom.
5) Withdraw the applicator in the same direction that you used to enter the vitreous.
5) Aplikator odstranite v isti smeri, kot je bila smer njegovega uvajanja v steklovino.
OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal products.
Zdravilo OZURDEX je treba previdno uporabljati pri bolnikih, ki jemljejo antikoagulante ali antitrombotike.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL NAME OF THE MEDICINAL PRODUCT
INFORMACIJE ZA ZDRAVSTVENE DELAVCE IME ZDRAVILA
Advance the needle until you enter the vitreous cavity.
Iglo potiskajte, dokler ta ne vstopi v vitrealno votlino.
For information concerning the current safety experience of repeat administrations beyond 2 implants in posterior segment non-infectious uveitis and Retinal Vein Occlusion, see section 4.8.
Za informacije o trenutnih izkušnjah glede varnosti večkratne uporabe več kot dveh vsadkov pri nenalezljivem uveitisu posteriornega dela očesa in okluziji retinalne vene glejte poglavje 4.8.
Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection.
Spremljanje lahko vključuje preverjanje perfuzije papile vidnega živca takoj po injiciranju, tonometrijo 30 minut po injiciranju in biomikroskopijo od dva do sedem dni po injiciranju.
There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 7 implants.
Na področju zdravljenja DME zaenkrat ni izkušenj o učinkovitosti ali varnosti večkratnega odmerjanja pri več kot 7 vsadkih.
Vascular Endothelial Growth Factor (VEGF) is a cytokine which is expressed at increased concentrations in the setting of macular oedema.
Vaskularni endotelijski rastni faktor (VEGF) je citokin, ki je v povečani koncentraciji izražen na mestu makularnega edema.
Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician's opinion may benefit from retreatment without being exposed to significant risk (see section 5.1).
O ponovnem odmerjanjuje treba razmisliti, kadar se bolnik odzove na zdravljenje, nato pa se mu ostrina vida zmanjša, pri tem pa ponovno zdravljenje po mnenju zdravnika lahko koristi bolniku, ne da bi bil ta izpostavljen znatnemu tveganju (glejte poglavje 5.1).
• Vision loss due to diabetic macular oedema (DME), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment.
• Okvara vida zaradi diabetičnega makularnega edema (DME), če ste že imeli kirurški poseg zaradi katarakte ali se niste odzvali oziroma niste primerni za druge vrste zdravljenja.
What OZURDEX is and what it is used for What you need to know before you are given OZURDEX How OZURDEX is used
Kaj je zdravilo OZURDEX in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo OZURDEX Kako uporabljati zdravilo OZURDEX
Remove the foil pouch from the carton and examine for damage (see section 6.6).
Iz škatle vzemite mošnjiček iz folije in preglejte morebitne poškodbe na njem (glejte poglavje 6.6).
If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Če pride do prevelikega odmerjanja, je treba spremljati očesni tlak in ga zdraviti, če lečeči zdravnik meni, da je to potrebno.
If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Če se pri bolniku pojavijo simptomi, kot so zamegljen vid ali druge motnje vida, jih upoštevajte za ovrednotenje možnih vzrokov, ki lahko vključujejo katarakto, glavkom ali redke bolezni, kot je centralna serozna horioretinopatija (CSCR - central serous chorioretinopathy), o katerih so poročali po sistemski in topični uporabi kortikosteroidov.
Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
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).
The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
Postopek intravitrealnega injiciranja je treba opraviti pri nadzorovanih aseptičnih pogojih, ki vključujejo uporabo sterilnih rokavic, sterilnega pregrinjala in sterilnega očesnega spekuluma (ali drugega ustreznega instrumenta).
The adverse reaction profile of 341 patients analysed following a second injection of OZURDEX, was similar to that following the first injection.
Profil neželenih učinkov 341 bolnikov, analiziran po drugem injiciranju zdravila OZURDEX, je bil podoben kot po prvem injiciranju.
This is consistent with results from rabbit and monkey ocular metabolism studies.
To je skladno z rezultati študij očesne presnove pri kuncih in opicah.
Visualisation is possible in the large majority of cases.
V veliki večini primerov je vsadek viden.
If the effect of this injection wears off and your doctor recommends it, another implant may then be injected into your eye.
Če učinek injiciranja preneha, vam bodo, če to priporoči zdravnik, v oko injicirali še drugi vsadek.
Corticosteroids have been shown to inhibit the expression of VEGF.
Pokazali so, da kortikosteroidi zavirajo ekspresijo faktorja VEGF.
Escape therapy was permitted at the investigators discretion at any stage but led to subsequent withdrawal from the studies.
Dodatno zdravljenje je bilo dovoljeno na kateri koli stopnji na odločitev raziskovalca, vendar pa je bilo treba posledično bolnika nato izločiti iz študije.
This inflammation leads to a decrease of vision and/or the presence of floaters in the eye, (black dots or wispy lines that move across the field of vision).
Tako vnetje povzroči poslabšanje vida in/ali pojav plavajočih motnjav v očesu (črne pike ali koprenaste črte, ki se premikajo po vidnem polju).
• Key signs and symptoms of serious adverse events including: worsening of vision after the injection; pain or discomfort in or around the eye, redness of the eye which continues to get worse; increase in floaters or spots in the vision; discharge from the eye
• ključne znake in simptome resnih neželenih učinkov, vključno z naslednjimi: poslabšanje vida po injiciranju; bolečina ali neugodje v očesu ali okoli njega; pordelost očesa, ki se slabša; povečanje števila plavajočih motnjav ali pik v vidu; izcedek iz očesa,
Elevations of IOP either did not require treatment or were managed with the temporary use of topical IOP-lowering medicinal products.
Zvišanje očesnega tlaka ni zahtevalo zdravljenja ali pa se je obravnavalo z začasno uporabo lokalnih zdravil za nižanje IOP.
Remove the needle in the same direction as used to enter the vitreous.
Iglo odstranite v isti smeri, kot ste jo uporabili za uvajanje v steklovino.
OZURDEX works by reducing this swelling of the macular which helps to lessen or prevent more damage to the macula.
Zdravilo OZURDEX deluje tako, da zmanjša oteklino makule, kar pomaga zmanjšati ali preprečiti poškodbo makule.
The recommended dose is one implant to be given by injection into your eye.
Priporočeni odmerek je en vsadek, ki se injicira v oko.
Therefore, although the systemic exposure of dexamethasone would be expected to be very low after local, intraocular treatment, OZURDEX is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Čeprav se pričakuje, da bo sistemska izpostavitev deksametazonu po lokalnem, intraokularnem zdravljenju z zdravilom OZURDEX zelo majhna, se ne priporoča med nosečnostjo, razen če morebitna korist upraviči morebitno tveganje za plod.
This could be attributable to the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or Non-steroidal anti-inflammatory medications.
To lahko pripišemo postopku injiciranja v steklovino ali sočasni uporabi lokalnih in/ali sistemskih kortikosteroidov ali nesteroidnih protivnetnih zdravil.
Please tell your doctor immediately if you develop increased eye pain or increased discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased vision or increased sensitivity to light after your injection.
Takoj obvestite zdravnika, če se pri vas razvije večja bolečina v očesu ali povečano neugodje,poslabšanje rdečice v očesu, utripanje svetlobe in nenadno povečanje plavajočih pik, delno zamegljen vid, slabši vid ali povečana občutljivost za svetlobo po injiciranju.
No dose adjustment is required for elderly patients.
Pri starejših bolnikih ni potrebno prilagajanje odmerka.
The use of OZURDEX in children and adolescents has not been studied and is therefore not recommended.
Uporabe zdravila OZURDEX niso preučevali pri otrocih in mladostnikih, zato se pri njih ne priporoča.
Before the injection, the periocular skin, eyelid and ocular surface should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should be administered.
Pred injiciranjem je treba razkužiti kožo okoli oči, veko in površino očesa (na primer z nanosom kapljic 5-odstotne raztopine povidonjodida na očesno veznico, kot je bilo to narejeno med kliničnimi preskušanji za odobritev zdravila OZURDEX) ter uporabiti zadostno lokalno anestezijo.
The incidence of increased IOP (24.9 %) was similar to that seen following the first injection and likewise returned to baseline by open-label day 180.
Incidenca zvišanega očesnega tlaka (24,9 %) je bila podobna kot incidenca po prvem injiciranju in se je vrnila na izhodiščno vrednost do 180. dneva odprte faze.
The rate and magnitude of IOP elevation following OZURDEX treatment did not increase upon repeated injection of OZURDEX.
Stopnja in obseg zvišanja očesnega tlaka po zdravljenju z zdravilom OZURDEX se nista povečali po večkratnem injiciranju zdravila OZURDEX.
Push the tip about 1 mm into the sclera, keeping it parallel to the limbus.
Konico potisnite približno 1 mm v beločnico vzporedno z limbusom.
Hold the applicator in one hand and pull the safety tab straight off the applicator.
Z eno roko primite aplikator in z njega naravnost povlecite varnostni zavihek.
Patients who experience and retain improved vision should not be retreated.
Bolnikov, pri katerih pride do izboljšanega vida in se ta vzdržuje, ne smete ponovno zdraviti.
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.