FrancophonIA/ELRC3.0 huggingface dataset:
English: In 374 patients from the two efficacy studies, plasma concentrations of ciclosporin were measured before administration and after 6 months (SICCANOVE study and SANSIKA study) and 12 months of treatment (SANSIKA study).
Slovenian: Pri 374 bolnikih iz dveh študij učinkovitosti so koncentracije ciklosporina v plazmi izmerili pred dajanjem in po 6. mesecih (študija SICCANOVE in študija SANSIKA) in po 12. mesecih zdravljenja (študija SANSIKA).
English: Three patients had values above the upper limit of quantification (5 ng/mL) however they were already taking oral ciclosporin at a stable dose, which was allowed by the studies' protocol.
Slovenian: Trije bolniki so imeli vrednosti nad zgornjo mejo kvantifikacije (5 ng/ml), vendar so že jemali stabilni odmerek peroralnega ciklosporina, kar je protokol študij dopuščal.
English: If you stop using IKERVIS without speaking to your doctor, the inflammation of the transparent front part of your eye (known as keratitis) will not be controlled and could lead to impaired vision.
Slovenian: Če ste prenehali uporabljati zdravilo IKERVIS, ne da bi se pogovorili z zdravnikom, vnetje prosojnega sprednjega dela očesa (znanega kot keratitis) ni pod nadzorom in lahko povzroči okvaro vida.
English: This study was an open-label, non-randomized, one-arm, 24-month study extension of the Sansika Study.
Slovenian: Ta študija je bila odprt, nerandomiziran, 24-mesečni podaljšek študije Sansika z enim krakom.
English: There is no data on the effects of IKERVIS on human fertility.
Slovenian: Ni podatkov o vplivu zdravila IKERVIS na plodnost pri ljudeh.
English: The primary endpoint was the proportion of patients achieving by Month 6 at least a twograde improvement in keratitis (CFS) and a 30% improvement in symptoms, measured with the Ocular Surface Disease Index (OSDI).
Slovenian: Primarni opazovani dogodek je bil delež bolnikov, ki je do 6. meseca doseglo izboljšanje keratitisa (CFS) za vsaj dve stopnji in 30 % izboljšanje simptomov, izmerjeno z indeksom bolezni očesne površine (OSDI - Ocular Surface Disease Index).
English: Ciclosporin has been shown to inhibit the production and/or release of pro-inflammatory cytokines, including interleukin 2 (IL-2) or T-cell growth factor (TCGF).
Slovenian: Pokazalo se je, da ciklosporin zavira nastajanje in/ali sproščanje provnetnih citokinov, vključno z interlevkinom 2 (IL-2) ali T-celičnim rastnim faktorjem (TCGF -Tcell growth factor).
English: Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of proinflammatory cytokines such as IL-2.
Slovenian: Inaktivacija kalcinevrina, ki jo povzroči ciklosporin, zavira defosforilacijo transkripcijskega faktorja NF-AT in preprečuje translokacijo NF-AT v jedro, s čimer zavira sproščanje provnetnih citokinov, kot je IL-2.
English: IKERVIS eye drops should be used at least 15 minutes after any other eye drops are used.
Slovenian: Zdravilo IKERVIS kapljice za oko morate uporabiti vsaj 15 minut po uporabi drugih kapljic za oko.
English: In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year.
Slovenian: V petih kliničnih študijah, v katerih je bilo vključenih 532 bolnikov, ki so prejemali zdravilo IKERVIS, in 398 bolnikov, ki je prejemalo vehikel zdravila IKERVIS (kontrolna skupina), so zdravilo IKERVIS dajali do enega leta vsaj enkrat na dan v obe očesi.
English: poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Slovenian: poloksamer 188, natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
English: Ciclosporin appears to block the resting lymphocytes in the G0 or G1 phase of the cell cycle.
Slovenian: Kaže, da ciklosporin zavira mirujoče limfocite v fazi celičnega cikla G0 ali G1.
English: After opening of the aluminium pouches, the single-dose containers should be kept in the pouches in order to protect from light and avoid evaporation.
Slovenian: Po odprtju aluminijastih vrečic shranjujte enoodmerne vsebnike v mošnjičkih za zagotavljanje zaščite pred svetlobo in preprečevanje izhlapevanja.
English: In both studies, no significant improvement of symptoms was observed for IKERVIS compared to vehicle after 6 months of treatment, whether using a visual analogue scale or the OSDI.
Slovenian: V obeh študijah po 6 mesecih zdravljenja niso opazili značilnega izboljšanja za zdravilo IKERVIS v primerjavi z vehiklom, bodisi z uporabo vizualne analogne lestvice ali OSDI.
English: If you use more IKERVIS than you should, rinse your eye with water.
Slovenian: Če ste uporabili večji odmerek zdravila IKERVIS, kot bi smeli, oko izperite z vodo.
English: IKERVIS should be administered last (see section 4.4).
Slovenian: Zdravilo IKERVIS je treba dati nazadnje (glejte poglavje 4.4).
English: The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular and mild to moderate in severity.
Slovenian: Večina neželenih učinkov, o katerih so poročali v kliničnih študijah z uporabo zdravila IKERVIS, je bila na očesu, po resnosti pa so bili blagi do zmerni.
English: • Open the aluminium pouch, which contains 5 single-dose containers.
Slovenian: • Odprite aluminijasti mošnjiček, ki vsebuje 5 enoodmernih vsebnikov.
English: Precautions to be taken before administering the medicinal product Patients should be instructed to first wash their hands.
Slovenian: Bolnikom je treba naročiti, naj si najprej umijejo roke.
English: No significant changes have been observed in the other secondary endpoints (TBUT, lissamine green staining and Schirmer test, NEI-VFQ and EQ-5D) over the course of the extension study.
Slovenian: Značilnih sprememb v drugih sekundarnih opazovanih dogodkih (TBUT, obarvanje z lisamin zeleno in Schirmerjev test, NEI-VFQ in EQ-5D) v podaljšanju študije.
English: There is insufficient information on the effects of ciclosporin in newborns/infants.
Slovenian: Podatki o učinku ciklosporina na dojene novorojence/otroke so nezadostni.
English: Mechanism of action and pharmacodynamic effects Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties.
Slovenian: Ciklosporin (znan tudi kot ciklosporin A) je ciklični polipeptidni imunomodulator z imunosupresivnimi lastnostmi.
English: Prior to administration, the single-dose container should be gently shaken.
Slovenian: Pred dajanjem je treba enoodmerni vsebnik nežno pretresti.
English: Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception.
Slovenian: Ženske v rodni dobi/kontracepcija pri ženskah Zdravila IKERVIS ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: A reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen-DR (HLADR) expression (an exploratory endpoint), was observed at Month 6 in favour of IKERVIS (p=0.021).
Slovenian: Zmanjšanje vnetja očesne površine, ocenjene s izraženostjo humanega levkocitnega antigena-DR (HLA-DR) (končni raziskovalni opazovani dogodek), v 6. mesecu opazili v korist zdravila IKERVIS (p = 0,021).
English: Santen Tél: +33 (0) 1 70 75 26 84
Slovenian: Tél: +33 (0) 1 70 75 26 84
English: Contact lenses can further damage the transparent front part of the eye (cornea).
Slovenian: Kontaktne leče lahko dodatno poškodujejo prosojni sprednji del očesa (roženico).
English: The efficacy and safety of IKERVIS were evaluated in two randomised, double-masked, vehiclecontrolled clinical studies in adult patients with dry eye disease (keratoconjunctivitis sicca) who met the International Dry Eye Workshop (DEWS) criteria.
Slovenian: Učinkovitost in varnost zdravila IKERVIS so ocenili v dveh randomiziranih, dvojno slepih, z vehiklom nadzorovanih kliničnih študijah pri odraslih bolnikih s sindromom suhega očesa (suhi keratitis), ki so izpolnjevali kriterije Mednarodne delavnice o suhem očesu (DEWS - International Dry Eye Workshop).
English: - if you are allergic to ciclosporin or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: NE uporabljajte zdravila IKERVIS - če ste alergični na ciklosporin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies.
Slovenian: Zdravila za očesne bolezni, ki vplivajo na imunski sistem, vključno s ciklosporinom, lahko vplivajo na obrambo gostitelja pred lokalnimi okužbami in malignostmi.
English: They are ranked according to system organ class and classified according to 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), or not known (cannot be estimated from the available data).
Slovenian: Razvrščene so po organskih sistemih po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100);
English: Pregnancy There is no data from the use of IKERVIS in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi zdravila IKERVIS pri nosečnicah ni.
English: 30 single-dose containers 90 single-dose containers
Slovenian: 30 enoodmernih vsebnikov 90 enoodmernih vsebnikov
English: In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator's global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.
Slovenian: Poleg tega niso opazili izboljšanja sekundarnih opazovanih dogodkov z zdravilom IKERVIS v primerjavi z vehiklom v 6. mesecu, vključno z rezultatom očesnega nelagodja, Schirmerjevim testom, sočasno uporabo umetnih solz, raziskovalčevo globalno oceno učinkovitosti, določanjem časa do pojava solz, barvanjem z lisamin zelenim barvilom, rezultatom kakovosti življenja in osmolarnosti solz.
English: IKERVIS treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Slovenian: Zdravljenje z zdravilom IKERVIS mora uvesti oftalmolog ali zdravstveni delavec, usposobljen za oftalmološko delo.
English: Percentage of patients who experienced a severe keratitis recurrence was 35% and 48% in patients treated 12 months and 6 months with IKERVIS respectively in the SANSIKA study.
Slovenian: Odstotek bolnikov, ki so imeli ponovni pojav hudega keratitisa, je bil 35 % bolnikov, zdravljenih z zdravilom IKERVIS 12 mesecev, in 48 % bolnikov, zdravljenih z zdravilom IKERVIS 6 mesecev v študiji SANSIKA.
English: What IKERVIS looks like and contents of the pack
Slovenian: Izgled zdravila IKERVIS in vsebina pakiranja
English: In patients with dry eye disease, a condition that may be considered to have an inflammatory immunological mechanism, following ocular administration, ciclosporin is passively absorbed into Tlymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase.
Slovenian: Pri bolnikih s sindromom suhega očesa, stanja, za katerega se meni, da ima vnetni imunološki mehanizem, se ciklosporin po dajanju v oko pasivno absorbira v infiltrate T-limfocitov v roženici in veznici in inaktivira kalcinevrin.
English: The following adverse reactions listed below were observed in clinical studies.
Slovenian: Spodaj naštete neželene učinke so opazili v kliničnih študijah.
English: Talk to your doctor if you are using eye drops containing steroids with IKERVIS as these might increase the risk of side effects.
Slovenian: Zdravniku povejte, če z zdravilom IKERVIS uporabljate kapljice za oko, ki vsebujejo steroide, saj lahko povečajo tveganje za neželene učinke.
English: How to use IKERVIS
Slovenian: Kako uporabljati zdravilo IKERVIS
English: IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye).
Slovenian: Zdravilo IKERVIS se uporablja za zdravljenje odraslih s hudim keratitisom (vnetje roženice, prosojne plasti na sprednjem delu očesa).
English: Two patients had values above the upper limit of quantification, however they were also on oral ciclosporin at a stable dose since their inclusion in the study.
Slovenian: Dva bolnika sta imela vrednosti nad zgornjo mejo kvantifikacije, vendar sta že jemala stabilni odmerek peroralnega ciklosporina od vključitve v študijo.
English: The effect of IKERVIS has not been studied in patients with hepatic or renal impairment.
Slovenian: Učinka zdravila IKERVIS niso preučili pri bolnikih z okvaro jeter ali ledvic.
English: Do not use more than one drop each day in the affected eye(s).
Slovenian: Ne uporabite več kot eno kapljico enkrat na dan za vsako prizadeto oko.
English: Any opened individual single-dose container with any remaining emulsion should be discarded immediately after use.
Slovenian: Vsak posamezni odprt enoodmerni vsebnik z morebitnim preostankom emulzije zavrzite takoj po uporabi.
English: If this happens, wait until your vision clears before you drive or use machines.
Slovenian: da se vam vid zbistri, preden vozite ali upravljate stroje.
English: Formal pharmacokinetic studies have not been conducted in humans with IKERVIS.
Slovenian: Formalnih farmakokinetičnih študij z zdravilom IKERVIS pri ljudeh niso izvajali.
English: Blood concentrations of IKERVIS were measured using a specific high-pressure liquid chromatography-mass spectrometry assay.
Slovenian: Koncentracije zdravila IKERVIS v krvi so izmerili s specifičnim testom visokotlačne tekočinske kromatografije in masne spektrometrije.
English: Each single-dose container contains 0.3 mL eye drops, emulsion.
Slovenian: Vsak enoodmerni vsebnik vsebuje 0,3 ml kapljic za oko, emulzije.
English: - The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol,
Slovenian: - Druge sestavine zdravila so srednjeverižni trigliceridi, cetalkonijev klorid, glicerol, tiloksapol,
English: There is no relevant use of IKERVIS in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Slovenian: Zdravilo IKERVIS ni primerno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let, za zdravljenje hudega keratitisa pri bolnikih s sindromom suhega očesa, ki se kljub zdravljenju z umetnimi solzami ne izboljša.
English: If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 15 minutes apart.
Slovenian: V primeru uporabe več kot enega topikalnega očesnega zdravila mora med uporabo vsakega posameznega zdravila miniti vsaj 15 minut.
English: Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).
Slovenian: Zato je pri dajanju kortikosteroidov skupaj z zdravilom IKERVIS potrebna previdnost (glejte poglavje 4.5).
English: One pouch contains five single-dose containers.
Slovenian: Ena mošnjiček vsebuje pet enoodmernih vsebnikov.
English: Instillation site pain was a frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials.
Slovenian: O bolečini na mestu vkapanja so pogosto poročali kot o lokalnem neželenem učinki, povezanem z uporabo zdravila IKERVIS med kliničnimi preskušanji.
English: Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
Slovenian: Sočasno dajanje z drugimi zdravili, ki vplivajo na imunski sistem Sočasno dajanje zdravila IKERVIS s kapljicami za oko, ki vsebujejo kortikosteroide, lahko okrepi učinke ciklosporina na imunski sistem (glejte poglavje 4.4).
English: Discomfort, itching or irritation in or around the eye including feeling that there is something in the eye.
Slovenian: Nelagodje, srbenje ali draženje v očesu ali okoli njega, vključno z občukom tujka v očesu.
English: It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Slovenian: Na voljo je v enoodmernih vsebnikih iz polietilena nizke gostote (LDPE, low-density polyethylene).
English: • Twist off the cap (picture 1).
Slovenian: • Pokrovček odtrgajte z zavijanjem (slika 1).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, fototoksičnosti in fotoalergičnosti, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).
Slovenian: Zdravljenje hudega keratitisa pri odraslih bolnikih s sindromom suhega očesa, ki se kljub zdravljenju z umetnimi solzami ne izboljša (glejte poglavje 5.1).
English: Effects in non-clinical studies were observed only with systemic administration or at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke opazili samo pri sistematskem dajanju ali pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: • If you wear contact lenses, take them out at bedtime before using the drops; you can reinsert them when you wake up.
Slovenian: • Če nosite kontaktne leče, jih zvečer pred spanjem odstranite in nato uporabite kapljice; ko zjutraj vstanete, si ponovno vstavite leče.
English: • The remaining single-dose containers should be kept in the aluminium pouch.
Slovenian: • Preostale enoodmerne vsebnike shranjujte v aluminijastem mošnjičku.
English: IKERVIS is supplied in 0.3 mL single-dose, low-density polyethylene (LDPE) containers presented in a sealed laminate aluminium pouch.
Slovenian: Zdravilo IKERVIS je na voljo v 0,3 ml enoodmernih vsebnikih iz polietilena nizke gostote (LDPE), vstavljenih v zaprte mošnjičke iz aluminijevega laminata.
English: Patients randomised to the vehicle group were switched to IKERVIS after 6 months.
Slovenian: Bolniki, randomizirani v skupino z vehiklom so po 6 mesecih prešli v skupino z zdravilom IKERVIS.
English: EXCELVISION Rue de la Lombardière ZI la Lombardière
Slovenian: Izdelovalec EXCELVISION Rue de la Lombardière ZI la Lombardière F-07100 Annonay
English: The recommended dose is one drop of IKERVIS once daily to be applied to the affected eye(s) at bedtime.
Slovenian: Priporočeni odmerek je ena kapljica zdravila IKERVIS enkrat na dan v prizadeto oko (očesi) pred spanjem.
English: However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk.
Slovenian: Vendar pa ni verjetno, da bi bile v materinem mleku prisotne zadostne količine ciklosporina iz kapljic za oko v terapevtskih odmerkih.
English: Uncommon Keratitis bacterial, herpes zoster ophthalmic.
Slovenian: Infekcijske in parazitske bolezni občasni bakterijski keratitis, očesni herpes zoster
English: Ocular or peri-ocular malignancies or premalignant conditions Active or suspected ocular or peri-ocular infection.
Slovenian: Aktivna okužba očesa ali periokularna okužba ali sum nanjo.
English: Following oral administration, ciclosporin is excreted in breast milk.
Slovenian: Ciklosporin se po peroralnem dajanju izloča v materino mleko.
English: IKERVIS should not be used in children and adolescents below 18 years old.
Slovenian: Otroci in mladostniki, stari manj kot 18 let, ne smejo uporabljati zdravila IKERVIS.
English: Santen UK Limited Tel: + 44 (0) 845 075 4863
Slovenian: United Kingdom Santen UK Limited Tel: +44 (0) 845 075 4863
English: The severity of keratitis, assessed using CFS, improved significantly from baseline at Month 6 with IKERVIS compared to vehicle (mean change from baseline was -1.764 with IKERVIS vs. -1.418 with vehicle, p=0.037).
Slovenian: Resnost keratitisa, ocenjenega s pomočjo CFS, se je značilno izboljšala v 6. mesecu od izhodišča z zdravilom IKERVIS v primerjavi z vehiklom (povprečna sprememba od izhodišča je bila -1,764 z zdravilom IKERVIS v primerjavi z -1,418 z vehiklom, p = 0,037).
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA18.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje očesnih bolezni, druga zdravila za zdravljenje očesnih bolezni, oznaka ATC: S01XA18.
English: The single-dose containers are wrapped in a sealed aluminium pouch.
Slovenian: Enoodmerni vsebnik je vstavljen v zaprt aluminijast mošnjiček.
English: What you need to know before you use IKERVIS Do NOT use IKERVIS
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo IKERVIS
English: Patients with renal or hepatic impairment
Slovenian: Bolniki z okvarjenim delovanjem ledvic ali jeter
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section
Slovenian: Pri živalih, ki so jim intravensko dajali ciklosporin, niso poročali o vplivu na plodnost (glejte poglavje 5.3).
English: Co-administration of Ikervis with eye drops containing corticosteroids may potentiate the effects of Ikervis on the immune system.
Slovenian: Sočasno dajanje zdravila IKERVIS s kapljicami za oko, ki vsebujejo kortiosteroide, lahko okrepi učinek zdravila IKERVIS na imunski sistem.
English: The mean change from baseline in ocular discomfort score (assessed using a Visual Analogic Scale) was -12.82 with IKERVIS and -11.21 with vehicle (p=0.808).
Slovenian: Povprečna sprememba rezultata očesnega nelagodja od izhodišča (ocenjena z uporabo vizualne analogne lestvice) je bila -12,82 za zdravilo IKERVIS in -11,21 za vehikel (p = 0,808).
English: It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.
Slovenian: Pokazalo se je, da podaljša preživetje alogenskih presadkov pri živalih in značilno izboljša preživetje presadka pri vseh vrstah presaditev čvrstih organov pri ljudeh.
English: Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja po sistemskem dajanju ciklosporina ob izpostavljenostih, ki so veliko večje kot je največja izpostavljenost pri ljudeh, kar kaže, da podatek za klinično uporabo zdravila IKERVIS ni pomemben.
English: IKERVIS has moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo IKERVIS ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.