natgillin/translations-raw huggingface dataset:
Contact with soft contact lenses should be avoided.
Stik z mehkimi kontaktnimi lečami moramo preprečiti.
The safety and efficacy of Cystadrops in children aged less than 2 years has not been established.
Varnost in učinkovitost zdravila Cystadrops pri otrocih, mlajših od 2 let, nista dokazani.
This study was a randomised, controlled trial to assess the efficacy and the safety profile of Cystadrops following a period of 90 days of treatment at a dose regimen of 4 drops/eye/day.
Ta študija je bila randomizirano, kontrolirano preskušanje za oceno učinkovitosti in varnostnega profila zdravila Cystadrops v obdobju 90 dni zdravljenja pri shemi odmerjanja 4 kapljice/oko/dan.
Cystadrops may have a minor influence on the ability to drive and use machines.
Zdravilo Cystadrops ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Those instructions are also available as an animated movie on www.cystadrops.net ‘QR code to be included'
Ta navodila so na voljo tudi v obliki animiranega filma na naslovu www.cystadrops.net.
Move firmly the dropper bottle up and down to facilitate the filing of the dropper.
Kapalno steklenico odločno pomikajte gor in dol, da pospešite polnjenje kapalke.
Studies in animals have shown a reduction on fertility (see section 5.3).
Študije na živalih so pokazale zmanjšanje plodnosti (glejte poglavje 5.3).
• After using Cystadrops, press a finger into the corner of your eye by the nose (picture 7), then gently massage your upper eyelid to spread the eye drops over the eye.
• Po uporabi zdravila Cystadrops s prstom pritisnite na kot očesa ob nosu (slika 7) in nežno masirajte zgornjo veko, da kapljico razmažete po očesu.
The European Medicines Agency has deferred the obligation to submit the results of studies with Cystadrops in one or more subsets of the paediatric population in the treatment of corneal cystine crystal deposits in cystinosis patients (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Cystadrops za eno ali več podskupin pediatrične populacije za zdravljenje depozitov cistinskih kristalov v roženici pri bolnikih s cistinozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Two clinical trials were performed with Cystadrops: a single arm clinical trial on 8 children and adults (OCT-1 study) and a randomised, multi-centre, open label, active controlled phase III clinical trial (CHOC study) conducted on 32 patients.
Opravljeni sta bili dve klinični preskušanji z zdravilom Cystadrops: klinično preskušanje z eno skupino pri 8 otrocih in odraslih (študija OCT-1) in randomizirano, multicentrično, odprto, z zdravilno učinkovino nadzorovano klinično preskušanje faze III (študija CHOC) pri 32 bolnikih.
• Remove the green protective cap (picture 1).
• Snemite zeleno zaščitno ploščico (slika 1).
• Cystadrops can be used for up to 7 days from the time of opening.
• Zdravilo Cystadrops lahko uporabljate do 7 dni od dneva odprtja.
The effect on pregnancy of untreated cystinosis is also unknown.
Vpliv nezdravljene cistinoze na nosečnost ravno tako ni znan.
• Do not refrigerate.
• Ne shranjujte v hladilniku.
Reproduction studies showed embryofoetotoxic effects (resorptions and post-implantation losses) in rats at the 100 mg/kg/day dose level and in rabbits receiving cysteamine 50 mg/kg/day.
Študije reprodukcije so pokazale embriofetotoksične učinke (resorpcije in izgube po implantaciji) pri podganah pri odmerkih na ravni 100 mg/kg/dan in pri kuncih, ki so prejemali 50 mg cisteamina/kg/dan.
In total 15 paediatric patients were exposed to Cystadrops whereof 3 subjects (including one 2 year and one 3 year old subject) being less than 6 years of age.
Skupno je bilo zdravilu Cystadrops izpostavljenih 15 pediatričnih bolnikov, pri čemer so bili 3 preiskovanci (vključno z enim preiskovancem, starim 2 leti, in enim preiskovancem, starim 3 leta) mlajši od 6 let.
Very common side effects (may affect more than 1 in 10 people)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb):
Genotoxicity studies have been performed: induction of chromosome aberrations in cultured eukaryotic cell lines has been reported and specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Opravljene so bile študije genotoksičnosti: čeprav so poročali o pojavu kromosomskih aberacij pri gojenih evkariontskih celičnih linijah, v posebnih študijah s cisteaminom niso potrdili mutagenega učinka z Amesovim testom ali klastogenega učinka s testom mikrojeder pri miših.
Do not use a double dose to make up for a forgotten dose.
Ne uporabite dvojnega odmerka, če ste pozabili prejšnji odmerek.
• Place the dropper bottle into the carton box.
• Kapalno steklenico vložite v škatlo.
The patient should be advised to follow the instructions below for opening of the vial and attachement of the dropper applicator:
Bolniku je treba svetovati, da upošteva naslednja navodila za odprtje viale in namestitev kapalnega aplikatorja:
Take special care not to touch the tip of the dropper with your fingers.
Bodite posebej pozorni, da se s prsti ne dotaknete konice kapalke.
Patients should be instructed to remove contact lenses prior to the administration of the eye drops and wait at least 15 minutes before re-inserting contact lenses.
Bolnikom je treba svetovati, naj pred dajanjem kapljic za oko odstranijo kontaktne leče in počakajo najmanj 15 minut pred ponovno vstavitvijo kontaktnih leč.
• Remove the grey stopper (picture 3) from the vial.
• Snemite sivi zamašek (slika 3) iz viale.
Cystinosis is a rare hereditary disease in which the body is unable to remove excess cystine (an amino acid), causing cystine crystals to accumulate in various organs (such as kidney and eyes).
Cistinoza je redka dedna bolezen, pri kateri telo ne more odstraniti odvečnega cistina (aminokisline), kar privede do kopičenja cistinskih kristalov v različnih organih (kot so ledvice in oči).
If the patient misses an instillation, the patient should be told to continue the treatment with the next instillation.
Če bolnik zamudi vkapanje, naj nadaljuje zdravljenje z naslednjim vkapanjem.
What is cystinosis
Kaj je cistinoza
Pull down your eyelid with a clean finger, until there is a “pocket” between the eyelid and your eye.
S čistim prstom povlecite veko navzdol, da napravite „žep“ med veko in očesom.
A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Zmanjšanje plodnosti pri podganah so opazili pri 375 mg/kg/dan, tj. pri odmerku, pri katerem je prišlo do zastoja pri prirastku telesne mase.
• To avoid potential irritation, remove excess medicine around the eye with a moist tissue
• Da preprečite morebitno draženje, odstranite odvečno zdravilo okoli očesa z vlažnim robčkom
What Cystadrops is and what it is used for 2.
Kaj je zdravilo Cystadrops in za kaj ga uporabljamo 2.
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), women taking oral cysteamine should not breast-feed.
Vendar pa je glede na rezultate študij na živalih pri doječih samicah in novorojenih mladičih (glejte poglavje 5.3) dojenje pri ženskah, ki jemljejo peroralni cisteamin, kontraindicirano.
If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Ob ugotovljeni ali načrtovani nosečnosti moramo skrbno pretehtati odločitev za zdravljenje, bolnico pa seznaniti z možnim tveganjem teratogenosti cisteamina.
The dose could be decreased progressively (to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic examination (such as, corneal cystine crystal deposits, photophobia).
Odmerek lahko postopoma zmanjšujemo (do najmanjšega skupnega dnevnega odmerka 1 kapljica v vsako oko) glede na rezultate očesnega pregleda (kot so depoziti cistinskih kristalov v roženici, fotofobija).
The dose should not exceed 4 drops a day in each eye.
Odmerek ne sme preseči 4 kapljic na dan v vsako oko.
vial vial dropper dropper small white cap turn and push to attach small white cap
viala viala kapalka kapalka majhna bela zaporka obrnite in potisnite, da se nasadi majhna bela zaporka
• Wash your hands carefully in order to avoid contamination by bacteria of the content in the vial.
• Skrbno si umijte roke, da preprečite kontaminacijo vsebine viale z bakterijami.
• Replace the small white cap on the dropper immediately after use.
• Majhno belo zaporko takoj po uporabi znova namestite na kapalko.
When there is concomitant use of ocular and oral treatment with cysteamine the contribution to any systemic risk from ocular administration is considered negligible.
Pri sočasni uporabi okularnih in peroralnih zdravil s cisteaminom se prispevek okularne uporabe k sistemskemu tveganju šteje za zanemarljivega.
Systemic exposure following ocular administration is anticipated to be low.
Pričakuje se, da je sistemska izpostavljenost po okularni uporabi nizka.
• Wash your hands carefully in order to avoid microbiological contamination of the content in the vial.
• Skrbno si umijte roke, da preprečite kontaminacijo vsebine viale z mikroorganizmi.
Reported adverse reactions are listed below, by system organ class and by frequency (by patient).
V nadaljevanju so našteti neželeni učinki glede na organski sistem in pogostnost (pri bolnikih).
Benzalkonium chloride, which is commonly used as a preservative in ophtalmic products, has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Za benzalkonijev klorid, ki se običajno uporablja kot konzervans v očesnih zdravilih, obstajajo poročila, da povzroča punkcijsko keratopatijo in/ali toksično ulcerativno keratopatijo.
• Do not touch the opening of the vial after removing the grey stopper.
• Po odstranitvi sivega zamaška se ne dotikajte odprtine viale.
What you need to know before you use Cystadrops 3.
Kaj morate vedeti, preden boste uporabili zdravilo Cystadrops 3.
Treatment with Cystadrops should be initiated under the supervision of a physician experienced in the management of cystinosis.
Zdravljenje z zdravilom Cystadrops se sme uvesti le pod nadzorom zdravnika z izkušnjami z obravnavo cistinoze.
A mean decrease in corneal cystine crystal deposits of 30%, in comparison with baseline, was maintained over time with a median dosing regimen of 3 drops/eye/day (range 1-3 drops) for 7 of the 8 patients.
Povprečno zmanjšanje depozitov cistinskih kristalov v roženici za 30 % glede na izhodišče se je ohranilo skozi čas z mediano odmerjanja 3 kapljic/oko/dan (razpon od 1 do 3 kapljic) pri 7 od 8 bolnikov.
• Store below 25°C.
• Shranjujte pri temperaturi do 25 °C.
• abnormal sensation in eye, a feeling of something in the eye
• nenormalen občutek v očeh, občutek tujka v očesu,
In case of concomitant therapy with other topical ocular medicinal products, an interval of ten minutes should be allowed between successive applications.
Pri sočasnem zdravljenju z drugimi topičnimi okularnimi zdravili mora med zaporednimi uporabami preteči deset minut.
Step 1: Before using a vial for the first time
1. korak: Pred prvo uporabo viale
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the dropper bottle.
Da preprečimo kontaminacijo konice kapalke in raztopine, je treba paziti, da se s konico kapalke na kapalni steklenici ne dotaknemo vek, okolice ali drugih površin.
Do not put in any more drops until it is time for your next regular dose.
V oko do časa za naslednji redni odmerek ne dajajte več kapljic.
Pharmacotherapeutic group: Ophtalmologicals, other ophtalmologicals, ATC code: S01XA21.
Farmakoterapevtska skupina: zdravila za očesne bolezni, druga zdravila za očesne bolezni, oznaka ATC: S01XA21.
It is used to reduce the quantity of cystine crystals in the surface of the eye (cornea) in adults and children from 2 years of age with cystinosis.
Uporablja se za zmanjšanje količine cistinskih kristalov na površini očesa (roženici) pri odraslih in otrocih, starejših od 2 let, s cistinozo.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Če se po vkapanju pojavi zamegljen vid, mora bolnik pred vožnjo ali upravljanjem s stroji počakati, da se mu vid izostri.
• Immediately before using a vial for the first time, write the date of opening in the space provided on the carton box.
• Tik pred prvo uporabo viale napišite datum odprtja na predviden prostor na škatli.
No data on the effect of cysteamine on human fertility are available.
Podatki o učinku cisteamina na plodnost pri človeku niso na voljo.
Cystadrops must be used every day for the medicine to work properly.
Če ste prenehali uporabljati zdravilo Cystadrops Zdravilo Cystadrops morate uporabljati vsak dan, da zdravilo pravilno deluje.
The recommended dose is one drop in each eye, 4 times a day during waking hours.
Priporočeni odmerek je ena kapljica v vsako oko, 4-krat na dan v času budnosti.
Other medicines and Cystadrops Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Zdravilo Cystadrops je indicirano za zdravljenje depozitov cistinskih kristalov v roženici pri odraslih in otrocih od 2. leta starosti s cistinozo.
69 paediatric patients were followed through clinical trials and the French NPU programme.
V kliničnih preskušanjih in francoskem programu sočutne uporabe (NPU) so spremljali 69 pediatričnih bolnikov.
Accumulation of crystals in the eye can lead to increased sensitivity to light (photophobia), corneal deterioration (keratopathy) and loss of vision .
Kopičenje kristalov v očesu lahko povzroči povečano občutljivost za svetlobo (fotofobija), bolezen roženice (keratopatija) in izgubo vida.
The efficacy was assessed with In-Vivo Confocal Microscopy total score (IVCM score) by quantifying the cystine crystals in the 7 layers of the cornea.
Učinkovitost je bila ocenjena po lestvici s konfokalno mikroskopijo in vivo (IVCM - In-Vivo Confocal Microscopy), pri kateri se določa količina cistinskih kristalov v 7 plasteh roženice.
• The recommended dose is 1 drop in each eye, 4 times a day during waking hours.
• Priporočeni odmerek je 1 kapljica v vsako oko, 4-krat na dan v času budnosti.
Superiority of Cystadrops was also demonstrated for photophobia rated by the investigator compared to the control arm (cysteamine hydrochloride 0.10%) p< 0.048 95% CI (0.23; 1.14).
Superiornost zdravila Cystadrops so dokazali tudi za fotofobijo, kar je ocenil raziskovalec v primerjavi s kontrolno skupino (cisteaminijev klorid 0,10 %) z vrednostjo p < 0,048 in 95-odstotnim intervalom zaupanja od 0,23 do 1,14.
The IVCM total score was the primary efficacy endpoint.
Primarni opazovani dogodek je bila skupna ocena IVCM.
What you need to know before you use Cystadrops
Kaj morate vedeti, preden boste uporabili zdravilo Cystadrops
Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno s teratogenezo (glejte poglavje 5.3).
Preclinical data on oral cysteamine:
Predklinični podatki o peroralnem cisteaminu:
Warnings and precautions Talk to your doctor or pharmacist before using Cystadrops.
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Cystadrops se posvetujte z zdravnikom ali farmacevtom.
What Cystadrops looks like and contents of the pack Cystadrops is a clear and viscous eye drops solution.
Izgled zdravila Cystadrops in vsebina pakiranja Zdravilo Cystadrops je bistra in viskozna raztopina kapljic za oko.
• Remove the metal seal (picture 2).
• Snemite kovinsko objemno zaporko (slika 2).
Step 4: Storing the eye drops after use
4. korak: Shranjevanje kapljic za oko po uporabi
No carcinogenic studies have been conducted with cysteamine.
Študij kancerogenosti cisteamina niso opravili.
• Take the dropper out of its sachet, without touching the end intended to be attached to the vial, attach it (picture 4) to the vial and do not remove it.
• Iz vrečke vzemite kapalko in jo brez dotikanja konca, namenjenega namestitvi na vialo, nasadite (slika 4) na vialo in je ne odstranite.
- The other ingredients are benzalkonium chloride (see section 2 under ‘Cystadrops contains benzalkonium chloride'), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid and water for injections.
- Druge sestavine so benzalkonijev klorid (glejte poglavje 2 pod naslovom „Zdravilo Cystadrops vsebuje benzalkonijev klorid“), dinatrijev edetat, natrijev karmelozat, citronska kislina monohidrat, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Very common : instillation site discomfort (mainly sticky eyes and sticky eyelashes)
Zelo pogosti: nelagodje na mestu vkapanja (zlasti lepljive oči in lepljive trepalnice)
Cystadrops contains benzalkonium chloride which may cause eye irritation.
Zdravilo Cystadrops vsebuje benzalkonijev klorid, ki lahko povzroči draženje oči.
Human pharmacokinetic assessment following ocular administration of Cystadrops was not performed.
Ocena farmakokinetike pri človeku po okularni uporabi zdravila Cystadrops ni bila opravljena.
What Cystadrops is and what it is used for
Kaj je zdravilo Cystadrops in za kaj ga uporabljamo
In case of accidental ingestion, monitoring and symptomatic management of the patient should be implemented.
Ob nenamernem zaužitju uvedemo spremljanje in simptomatsko obravnavo bolnika.
How to use Cystadrops 4.
Kako uporabljati zdravilo Cystadrops 4.
To avoid sticky eyes in the morning, the patient should be advised to apply the last drop of the day at least 30 minutes before going to bed.
Bolniku je treba svetovati, da lahko prepreči jutranjo lepljivost oči z vkapanjem zadnje dnevne kapljice vsaj 30 minut pred spanjem.
Step 3: Using the eye drops
3. korak: Uporaba kapljic za oko
If you stop using Cystadrops, cystine crystals accumulation in the eye (cornea) may increase and lead to increased sensitity to light (photophobia), corneal deterioration (keratopathy) and loss of vision.
Če prenehate uporabljati zdravilo Cystadrops, lahko pride do kopičenja cistinskih kristalov v očesu (roženici), kar povzroči povečano občutljivost za svetlobo (fotofobija), bolezen roženice (keratopatija) in izgubo vida.
• The dose may be gradually decreased (to a minimum total daily dose of 1 drop in each eye) by your doctor based on eye examinations.
• Odmerek lahko zdravnik na osnovi očesnega pregleda postopoma zmanjšuje (do najmanjšega skupnega dnevnega odmerka 1 kapljice v vsako oko).
Experimental administration of the drug causes depletion of somatostatin in several animal species.
Eksperimentalno dajanje zdravila je pri mnogih živalskih vrstah povzročilo znižanje vrednosti somatostatina.
Systemic exposure of cysteamine following ocular administration is therefore lower than following oral administration.
Sistemska izpostavljenost cisteaminu pri okularni uporabi je zato manjša kot pri peroralni uporabi.
Common : instillation site pain
Pogosti: bolečina na mestu vkapanja
Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.
Po uporabi kapljic počakajte 15 minut, preden si leče vstavite nazaj.
Step 2: Before using the eye drops
2. korak: Pred uporabo kapljic za oko
Benzalkonium chloride (see leaflet for further information), disodium edetate, carmellose sodium, citric acid monohydrate, sodium hydroxide, hydrochloric acid, water for injections.
benzalkonijev klorid (glej navodilo za dodatne informacije), dinatrijev edetat, natrijev karmelozat, citronska kislina monohidrat, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
remove remove remove metal seal vial green protective cap grey stopper
snemite snemite snemite kovinska objemna zaporka viala zelena zaščitna ploščica sivi zamašek
However it should be considered that the recommended daily dose of cysteamine applied as eye drops is no more than approximately 0.4% of the highest recommended daily oral dose of cysteamine in any age group.
Vendar je treba upoštevati, da priporočeni dnevni odmerek cisteamina, uporabljen v obliki kapljic za oko, ni večji od približno 0,4 % največjega priporočenega peroralnega odmerka cisteamina v kateri koli starostni skupini.
5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.
5 ml raztopine v viali 10 ml iz rjavega stekla, zaprti z bromobutilnim zamaškom in zapečateni z aluminijasto zaporko, ki se odtrga.
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
• S kapalko se ne dotikajte očesa, veke, okolice ali drugih površin, ker lahko to privede do kontaminacije kapljic.
Superiority of Cystadrops was demonstrated compared to the control arm (cysteamine hydrochloride 0.10%) p<0.001 95% CI (2.11; 5.58).
Superiornost zdravila Cystadrops so dokazali v primerjavi s kontrolno skupino (cisteaminijev klorid 0,10 %) z vrednostjo p < 0,001 in 95-odstotnim intervalom zaupanja od 2,11 do 5,58.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Cysteamine reduces corneal cystine crystal accumulation acting as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides.
Cisteamin zmanjšuje kopičenje cistinskih kristalov v roženici, saj izplavlja cistin s pretvorbo cistina v cistein ter mešane disulfide cistein-cisteamin.
• Write down the date you opened the vial in the space on the carton.
• Zapišite datum, ko ste odprli vialo, v prostor na škatli.
• Take the dropper out of its sachet, without touching the end intended to be attached to the vial, and attach it (picture 4) to the vial.
• Iz vrečke vzemite kapalko in jo brez dotikanja konca, namenjenega namestitvi na vialo, nasadite (slika 4) na vialo.
• Unscrew the small white cap from the dropper.
• Odvijte majhno belo zaporko s kapalke.
Since the recommended total daily dose of cysteamine base is no more than approximately 0.4% of the highest recommended oral dose of cysteamine base in any age group, no interactions with orally administered medicinal products are anticipated.
Zaradi priporočila, da skupni dnevni odmerek cisteamina ni večji od približno 0,4 % največjega priporočenega peroralnega odmerka cisteamina v kateri koli starostni skupini, interakcij z zdravili za peroralno uporabo ne pričakujemo.
You may find that your vision is blurred for a few minutes just after using Cystadrops.
Vpliv na sposobnost upravljanja vozil in strojev Morda bo nekaj minut takoj po uporabi zdravila Cystadrops vaš vid zamegljen.
Therefore contact with soft contact lenses is to be avoided for15 minutes after having applied the eye drops.
Zato morate 15 minut po uporabi kapljic za oko preprečiti stik z mehkimi kontaktnimi lečami.
Common : abnormal sensation in eye, dry eye, foreign body sensation in eye, eyelid oedema, eyelid irritation, visual impairment, hordeolum
Pogosti: nenormalen občutek v očeh, suho oko, občutek tujka v očeh, edem vek, draženje vek, motnja vida, hordeol
To use the eye drops, please follow the instructions below carefully.
Za uporabo kapljic natančno upoštevajte navodila v nadaljevanju.
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 osebi od 10):
Cystadrops is an eye drops solution that contains the active substance cysteamine (also known as mercaptamine).
Zdravilo Cystadrops je raztopina za kapljice za oko, ki vsebuje učinkovino cisteamin (imenovano tudi merkaptamin).