natgillin/translations-raw huggingface dataset:
7 transdermal patches (sachet: paper/PET/alu/PAN) 
7 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
• Uneven heartbeat and poor control of movements Other side effects seen with Exelon transdermal patches and which may occur with the oral solution: 
Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev Exelon in bi se lahko pojavili tudi pri uporabi peroralne raztopine:
84 transdermal patches (sachet: paper/PET/alu/PAN) 
84 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
60 transdermal patches (sachet: paper/PET/alu/PAN) 
60 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
90 transdermal patches (sachet: paper/PET/alu/PAN) 
90 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
30 transdermal patches (sachet: paper/PET/alu/PAN) 
30 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase 
In vitro kaže ta presnovek zelo majhno stopnjo zaviranja holinesteraze (< 10 %).
Baseline 265 27.5 271 25.8 Week 48 Value 
Povprečje ob izhodišču  SD 27,0  10,3 Povprečna sprememba po 24 tednih  SD
(picture 8). 
(slika 8).
Each box contains: 
Vsaka škatla vsebuje:
Monitoring is required. 
Potrebno je spremljanje.
Date of first authorisation: 19 January 2017 10. 
Datum prve odobritve: 19 januar 2017
You can usually carry on taking the drops, unless the effects are serious. 
Običajno lahko nadaljujete z uporabo kapljic, razen če so učinki resni.
OCT-1 study 
Študija OCT-1
• Repeat the step 3 for the other eye. 
• Ponovite 3. korak za drugo oko.
The treatment should not be stopped. 
Zdravljenja ne smemo prekiniti.
If a drop misses your eye Try again. 
Če kapljica zgreši oko Poskusite znova.
19 patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old. 
19 bolnikov je bilo mlajših od 6 let, 21 bolnikov je bilo starih od 6 do 12 let, 29 bolnikov pa od 12 do 18 let.
• You must throw away the dropper bottle 7 days after you first opened it even if it is not empty. 
• Kapalno steklenico morate zavreči 7 dni po tem, ko ste jo prvič odprli, čeprav ni prazna.
Frequencies are defined as: 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), not known (cannot be estimated from the available data). 
Pogostnost je opredeljena kot: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The majority of these adverse reactions are transient and most are mild or moderate. 
Večina teh neželenih učinkov je prehodnih in blagih ali zmernih.
It will facilitate the use of the drops. 
To bo olajšalo uporabo kapljic.
Do not drive or use machines until your vision is clear. 
Ne vozite in ne uporabljajte strojev, dokler vaš vid ni oster.
Frequency, type and severity of adverse reactions in children are the same as in adults. 
Pogostost, vrsta in resnost neželenih učinkov pri otrocih so enake kot pri odraslih.
Before first opening: store in a refrigerator. 
Pred prvim odprtjem: shranjujte v hladilniku.
Therefore, oral cysteamine should not be used during pregnancy, particularly during the first trimester, unless clearly necessary. 
Zato peroralnega cisteamina ne smemo uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno.
• Make sure that you do not lose the small white cap (picture 5) that comes on the top of the dropper. 
• Pazite, da ne izgubite majhne bele zaporke (slika 5), ki se namesti na vrh kapalke.
The mean IVCM total score was calculated for 11 patients. 
Povprečna skupna ocena IVCM je bila izračunana za 11 bolnikov.
Temporary (in average less than 1 minute) blurred vision or other visual disturbances may affect the ability to drive or use machines. 
Začasno (v povprečju manj kot 1 minuto), zamegljen vid ali druge motnje vida vplivajo na sposobnost vožnje ali upravljanja s stroji.
Each carton box contains 1 vial and 1 dropper applicator. 
Vsaka kartonska škatla vsebuje 1 vialo in 1 kapalni aplikator.
The recommended interval between each instillation is 4 hours. 
Priporočeni časovni presledek med vsakim vkapanjem je 4 ure.
Clinical data on safety and efficacy were collected during the 2 clinical trials (OCT-1 and CHOC studies). 
Klinični podatki o varnosti in učinkovitosti so bili zbrani v 2 kliničnih preskušanjih (študiji OCT-1 in CHOC).
CHOC study 
Študija CHOC
Photophobia tended to improve over time. 
S časom se je izboljšala tudi fotofobija.
After first opening: 7 days. 
Po prvem odprtju: 7 dni.
If you wear soft contact lenses 
Če nosite mehke kontaktne leče
Therefore talk to your doctor before stopping this treatment. 
Zato se pred prenehanjem zdravljenja posvetujte z zdravnikom.
• Get the dropper bottle and a mirror. 
• Vzemite kapalno steklenico in ogledalo.
Do not use Cystadrops If you are allergic to cysteamine or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Cystadrops, če ste alergični na cisteamin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The efficacy and safety results are similar in both paediatric and adult populations. 
Rezultati učinkovitosti in varnosti so podobni pri otrocih in odraslih.
None of the patients discontinued treatment over the 5 year follow-up. 
Po več kot 5 letih spremljanja nobeden od bolnikov ni prekinil zdravljenja.
Do not stop using Cystadrops without speaking to your doctor. 
Ne prenehajte z uporabo zdravila Cystadrops brez posveta z zdravnikom.
• Keep Cystadrops at room temperature (it will facilitate the use of the dropper). 
• Zdravilo Cystadrops hranite pri sobni temperaturi (to bo olajšalo uporabo kapalke).
This study assessed the safety and efficacy of Cystadrops during 5 years. 
V tej študiji so ocenili varnost in učinkovitost zdravila Cystadrops v 5 letih.
The patient should be told to discard the dropper bottle after 7 days of use. 
Bolniku je treba svetovati, da zavrže kapalno steklenico po 7 dneh uporabe.
Do not remove the dropper from the vial. 
Kapalke ne odstranite z viale.
Dose adaptation was performed following ocular examination. 
Odmerek je bil prilagojen po očesnem pregledu.
15 patients were exposed to Cystadrops. 
Zdravilu Cystadrops je bilo izpostavljenih 15 bolnikov.
• Hold the dropper bottle, pointing down, between your thumb and fingers. 
• Kapalno steklenico držite obrnjeno navzdol med palcem in prsti.
• 1 dropper applicator. 
• 1 kapalni aplikator.
Only use the drops in your eyes (ocular use). 
Kapljice uporabljajte samo za oči (okularna uporaba).
The drop will go in here (picture 6). 
Vanj bo padla kapljica (slika 6).
Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see section 5.1). 
Zdravilo Cystadrops se lahko uporablja pri pediatričnih bolnikih, starejših od 2 let, v enakem odmerku kot pri odraslih (glejte poglavje 5.1).
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.The expiry date refers to the last day of that month. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/m2/day. 
To pri podganah pomeni 0,6 g/m2/dan, kar je malo manj kot polovica priporočenega kliničnega vzdrževalnega odmerka cisteamina, tj. 1,30 g/m2/dan.
There are no adequate data from the use of cysteamine in pregnant women. 
Ni zadostnih podatkov o uporabi cisteamina pri nosečnicah.
The following side effects were reported: 
Poročali so o naslednjih neželenih učinkih:
After 30 days of treatment and at a median frequency of 4 instillations per day, an average 30% decrease in the IVCM total score was observed. 
Po 30 dneh zdravljenja z mediano pogostnosti 4 vkapanj na dan so ugotovili povprečno zmanjšanje skupne ocene IVCM za 30 %.
• Check the opening date that you wrote down on the carton box. 
• Preverite datum odprtja, ki ste ga zapisali na škatlo.
If you use Cystadrops with another eye medicine Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine. 
Če uporabljate zdravilo Cystadrops z drugim zdravilom za oči Pazite, da med uporabo zdravila Cystadrops in drugega zdravila za oči preteče vsaj 10 minut.
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: