natgillin/translations-raw huggingface dataset:
White blood cell (WBC) cystine concentration may for instance be measured by a number of different techniques such as specific WBC subsets (e.g., granulocyte assay) or the mixed leukocyte assay with each assay having different target values. 
Koncentracija cistina v belih krvnih celicah se na primer lahko izmeri s številnimi različnimi tehnikami, kot so testi specifičnih podskupin belih krvnih celic (npr. granulocitni test) ali test mešanih levkocitov, pri čemer ima vsak test drugačne ciljne vrednosti.
For patients who cannot swallow the whole capsule, the gastro-resistant hard capsule may be opened and the contents may be sprinkled on food (such as apple sauce or berry jelly) or mixed in with an acidic drink (such as orange juice or any acidic juice) or water. 
Za bolnike, ki ne morejo pogoltniti cele kapsule, lahko gastrorezistentno trdo kapsulo odprete in vsebino stresete na obrok hrane (na primer jabolčno čežano ali jagodni žele) ali vmešate v kislo pijačo (na primer pomarančni sok ali drug kisli sadni sok) ali vodo.
For children and patients who have problems to swallow, please refer to section 3 How to take PROCYSBIMethod of administration. 
Za otroke in bolnike, ki imajo težave s požiranjem, glejte poglavje 3 Kako jemati zdravilo PROCYSBI - Način uporabe.
The cap is child resistant and has a foil seal. 
Pokrovček je varen za otroke in ima zaščitno folijo.
The targeted maintenance dose is 1.3 g/m2/day. 
Ciljni vzdrževalni odmerek je 1,3 g/m2/dan.
PROCYSBI treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis. 
Zdravljenje z zdravilom PROCYSBI se sme uvesti le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem cistinoze.
In-use shelf life: 30 days. 
24 mesecev Rok uporabnosti po odprtju: 30 dni.
Effects on fertility have been seen in animal studies (see section 5.3). 
V študijah na živalih so opazili vpliv na plodnost (glejte poglavje 5.3).
Newly diagnosed adult patients should be started on 1/6 to 1/4 of the targeted maintenance dose of PROCYSBI. 
Odrasli bolniki z na novo diagnosticirano boleznijo Pri odraslih bolnikih z na novo diagnosticirano boleznijo je treba zdravljenje začeti z 1/6 do 1/4 ciljnega vzdrževalnega odmerka zdravila PROCYSBI.
Uncommon: Nervousness, hallucination Common: Headache, encephalopathy 
Občasni: živčnost, halucinacije Pogosti: glavobol, encefalopatija
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 (see section 4.6). 
Ob ugotovljeni ali načrtovani nosečnosti je treba ponovno skrbno pretehtati odločitev za zdravljenje, bolnico pa seznaniti z možnim tveganjem teratogenosti cisteamina (glejte poglavje 4.6).
For the immediate-release formulation of cysteamine bitartrate, approximately 35% of patients can be expected to experience adverse reactions. 
Pri farmacevtski obliki cisteaminijevega bitartrata s takojšnjim sproščanjem je neželene učinke mogoče pričakovati pri približno 35 % bolnikov.
Forty-three (43) patients were randomized; twenty-seven (27) children (ages 6 to 12 years old), fifteen (15) adolescents (ages 12 to 21 years old) and one (1) adult with cystinosis and with native kidney function based on an estimated Glomerular Filtration Rate (GFR) (corrected for body surface area) > 30 mL/minute/1.73 m2 
Randomizirali so triinštirideset (43) bolnikov; sedemindvajset (27) otrok (starih od 6 do 12 let), petnajst (15) mladostnikov (starih od 12 do 21 let) in enega (1) odraslega s cistinozo in nativno ledvično funkcijo glede na ocenjeno hitrost glomerulne filtracije (GFR) (popravljeno glede na površino telesa) > 30 ml/minuto/1,73 m2. Od teh triinštiridesetih (43) bolnikov sta dva (2) posameznika, brat in sestra, na koncu prvega obdobja navzkrižnega preskušanja prekinila zdravljenje zaradi predhodno načrtovane operacije enega (1) od njiju; študijo je dokončalo enainštirideset (41) bolnikov.
If such symptoms develop, tell your doctor who will adjust your dose. 
Če opazite omenjene simptome, se posvetujte z zdravnikom, ki bo prilagodil odmerek.
•The need to advise patients about: The method of administration and timing of medicine intake The need to contact the treating physician if they experience the following events: Problems or changes with their skin Upset in their normal bowel habit, Lethargy, somnolence depression, fits Any suspicion that they might be pregnant 
•potrebo po tem, da se bolnike seznani: z načinom dajanja in časovnim razporedom jemanja zdravila; s potrebo po posvetu z zdravnikom v primeru naslednjih dogodkov: težave s kožo ali spremembe na koži; spremembe glede na običajno odvajanje blata; letargija, zaspanost, depresija, krči; kakršen koli sum na nosečnost.
Discard 30 days after opening the foil seal. 
Zavrzite 30 dni po odprtju zaščitne folije.
Total daily dose should be divided by two and administered every 12 hours. 
Skupni dnevni odmerek je treba razdeliti na dva dela, ki se ju jemlje vsakih 12 ur.
Cysteamine bitartrate is not an inhibitor of OAT1, OAT3 and OCT2. 
Cisteaminijev bitartrat ni zaviralec OAT1, OAT3 in OCT2.
The total usual dose should not exceed 1.95 g/m2/day. 
Običajni skupni odmerek ne sme preseči 1,95 g/m2/dan.
In some patients, the skin lesions on elbows regressed after immediate-release cysteamine dose reduction (see section 4.4). 
Pri nekaterih bolnikih so se kožne lezije na komolcih po zmanjšanju odmerka cisteamina s takojšnjim sproščanjem izboljšale (glejte poglavje 4.4).
The pharmacokinetics of cysteamine bitartrate has not been studied in special populations. 
Farmakokinetike cisteaminijevega bitartrata pri posebnih skupinah bolnikov niso proučevali.
Intact capsules of PROCYSBI should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2). 
Otrokom, mlajšim od približno 6 let, ne smete dajati celih kapsul zdravila PROCYSBI zaradi tveganja aspiracije (glejte poglavje 4.2).
Experience has occasionally shown that some forms of cysteamine are less well tolerated (i.e. leading to more adverse events) when patients are on dialysis. 
Občasne izkušnje kažejo, da bolniki na dializi slabše prenašajo nekatere oblike cisteamina (tj. nekatere oblike pri njih povzročajo več neželenih učinkov kot druge).
High doses of cysteamine impair the ability of lactating mothers to feed their pups. 
Veliki odmerki cisteamina zmanjšujejo sposobnost samic, da v obdobju laktacije prehranjujejo svoje mladiče.
PROCYSBI 75 mg hard capsule EU/1/13/861/002 
PROCYSBI 75 mg trda kapsula EU/1/13/861/002
Severe allergic reaction (seen uncommonly): Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat. 
Poiščite nujno zdravniško pomoč, če opazite katerega koli od naslednjih znakov alergijske reakcije: koprivnica; oteženo dihanje; otekanje obraza, ustnic, jezika ali grla.
Two (2) patients were excluded from the per-protocol analysis because their WBC cystine level increased over 2 nmol hemicystine/mg protein during the immediate-release cysteamine treatment period. 
Dva (2) bolnika so izključili iz analize po protokolu, ker so se njune vrednosti cistina v belih krvnih celicah med zdravljenjem s cisteaminom s takojšnjim sproščanjem zvišale nad 2 nmol hemicistina/mg beljakovin.
It is not known if cysteamine is removed by haemodialysis. 
Ni znano, ali se cisteamin odstrani s hemodializo.
What PROCYSBI is and what it is used for What you need to know before you take PROCYSBI How to take PROCYSBI 
Kaj je zdravilo PROCYSBI in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo PROCYSBI Kako jemati zdravilo PROCYSBI Možni neželeni učinki
PROCYSBI 25 mg hard capsule EU/1/13/861/001 
PROCYSBI 25 mg trda kapsula EU/1/13/861/001
Each gastro-resistant hard capsule contains 25 mg or 75 mg of cysteamine. 
Ena gastrorezistentna trda kapsula vsebuje 25 mg ali 75 mg cisteamina.
Physicians should instruct patients to report any of the following symptoms: headache, tinnitus, dizziness, nausea, diplopia, blurred vision, loss of vision, pain behind the eye or pain with eye movement. 
Zdravniki morajo bolnikom naročiti, naj poročajo o katerem koli od naslednjih simptomov: glavobol, tinitus, omotica, navzea, diplopija, zamegljen vid, izguba vida, bolečina za očesom ali bolečina ob premikanju očesa.
It should be noted that therapeutic targets for cystine depletion are assay-specific and different assays have specific treatment targets. 
Treba je upoštevati, da so terapevtske ciljne vrednosti za znižanje cistina specifične za posamezni test in imajo različni testi specifične terapevtske ciljne vrednosti.
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) was first described in cystic fibrosis patients who were given high doses of pancreatic enzymes in the form of tablets with an enteric coating of methacrylic acid - ethyl acrylate copolymer (1:1), one of the excipients in PROCYSBI. 
Strikture ileocekalnega predela in debelega črevesa (fibrozirajoča kolonopatija) so najprej opazili pri bolnikih s cistično fibrozo, ki so prejemali velike odmerke encimov trebušne slinavke v tabletah z enterično oblogo iz kopolimera metakrilne kisline in etilakrilata (1:1), ki je ena od pomožnih snovi zdravila PROCYSBI.
Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumour on elbows) 
Občasni: spremembe barve las, kožne strije, nežna koža, ki se zlahka poškoduje (moluskoidni psevdotumor na komolcih)
Drink the mixture of cysteamine granules and acidic fruit juice or water. 
Popijte mešanico zrn cisteamina in kislega sadnega soka ali vode.
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 je treba ponovno skrbno pretehtati odločitev za zdravljenje, bolnico pa seznaniti z možnim tveganjem teratogenosti cisteamina.
Oral cysteamine has not been shown to prevent eye deposition of cystine crystals. 
Ni dokazano, da bi peroralna aplikacija cisteamina preprečevala nalaganje cistinskih kristalov v očesu.
Cysteamine participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis. 
Znotraj lizosomov sodeluje v reakciji izmenjave tiola in disulfida, pri kateri se cistin pretvori v cistein in mešani disulfid cisteina ter cisteamina, ki lahko zapustita lizosom pri bolnikih s cistinozo.
If any of the following side effects occur, please contact your doctor immediately. 
Če opazite katerega koli od naslednjih neželenih učinkov, se nemudoma posvetujte z zdravnikom.
Important information about some of the excipients of PROCYSBI This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree. 
Pomembne informacije o nekaterih pomožnih snoveh zdravila PROCYSBI Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da praktično ne vsebuje natrija.
Gently stir the contents into the soft food, creating a mixture of cysteamine granules and food. 
Na rahlo vmešajte vsebino v mehko hrano, tako da dobite mešanico zrn cisteamina in hrane.
Cysteamine may cause drowsiness. 
Cisteamin lahko povzroča zaspanost.
Cysteamine bitartrate can be administered with an acidic fruit juice or water. 
Cisteaminijev bitartrat se lahko vzame s kislim sadnim sokom ali vodo.
If it is within four hours of the next dose, skip the missed dose and go back to the regular dosing schedule. 
V primeru, da do naslednjega odmerka manjkajo manj kot štiri ure, izpuščeni odmerek preskočite in nadaljujte z jemanjem po ustaljenem urniku.
Therefore, where cysteamine ophthalmic solution is used for that purpose, its usage should continue. 
Kadar se v ta namen uporablja raztopina cisteamina za oči, je zato treba s to terapijo nadaljevati.
The determination of WBC cystine and/or plasma cysteamine must be obtained 12.5 hours after the evening dose the day before, and therefore 30 minutes after the following morning dose is given. 
Vrednosti cistina v belih krvnih celicah in/ali cisteamina v plazmi je treba izmeriti 12,5 ure po večernem odmerku prejšnji dan, tj. 30 minut po zaužitju naslednjega jutranjega odmerka.
Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day. 
Teratogene učinke so opazili pri podganah, ki so dobivale cisteamin v odmerkih 100 mg/kg/dan v obdobju organogeneze.
The mixture must be administered (drunk) within 30 minutes after preparation and must be refrigerated from the time of preparation to the time of administration. 
Pripravljeno mešanico je treba dati (popiti) v 30 minutah in jo je treba po pripravi do uporabe hraniti v hladilniku.
Capsule content microcrystalline cellulose methacrylic acid - ethyl acrylate copolymer (1:1) hypromellose talc triethyl citrate sodium lauryl sulphate 
Vsebina kapsule mikrokristalna celuloza kopolimer metakrilne kisline in etilakrilata (1:1) hipromeloza smukec trietilcitrat natrijev lavrilsulfat
In this study, the WBC cystine measured using the mixed leukocyte assay was always on average under optimal control at < 1 nmol hemicystine/mg protein. 
V tej študiji je bila koncentracija cistina v belih krvnih celicah, izmerjena z uporabo testa mešanih levkocitov, v povprečju ves čas pod optimalnim nadzorom pri < 1 nmol hemicistina/mg beljakovin.
Administration with food 
Jemanje s hrano
Transferring patients from immediate-release cysteamine bitartrate hard capsules Patients with cystinosis taking immediate-release cysteamine bitartrate may be transferred to a total daily dose of PROCYSBI equal to their previous total daily dose of immediate-release cysteamine bitartrate. 
Prehod bolnikov s trdih kapsul s takojšnjim sproščanjem, ki vsebujejo cisteaminijev bitartrat Bolniki s cistinozo, ki jemljejo cisteaminijev bitartrat s takojšnjim sproščanjem, lahko preidejo na skupni dnevni odmerek zdravila PROCYSBI, ki ustreza predhodnemu skupnemu dnevnemu odmerku cisteaminijevega bitartrata s takojšnjim sproščanjem.
To get the most benefit from this medicine, try to avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing. 
Za največji učinek zdravila se poskusite izogniti obrokom in mlečnim izdelkom najmanj 1 uro pred in 1 uro po zaužitju zdravila PROCYSBI.
PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 60 capsules 
FARMACEVTSKA OBLIKA IN VSEBINA gastrorezistentna trda kapsula 60 kapsul
Post-marketing experience with immediate-release cysteamine bitartrate Benign intracranial hypertension (or pseudotumor cerebri (PTC)) with papilledema; skin lesions, molluscoid pseudotumors, skin striae, skin fragility; joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture and scoliosis have been reported with immediate-release cysteamine bitartrate (see section 4.4). 
Izkušnje s cisteaminijevim bitartratom s takojšnjim sproščanjem v obdobju trženja Pri uporabi cisteaminijevega bitartrata s takojšnjim sproščanjem so poročali o benigni intrakranialni hipertenziji (cerebralnem psevdotumorju) s papiloedemom; kožnih lezijah, moluskoidnih psevdotumorjih, kožnih strijah, nežni koži, ki se zlahka poškoduje; hiperekstenziji sklepov, bolečinah v spodnjih udih, deformaciji genu valgum, osteopeniji, kompresijski frakturi in skoliozi (glejte poglavje 4.4).
However, if it is within 4 hours of the next dose, skip the missed dose and go back to the regular dosing schedule. 
Če do naslednjega odmerka manjkajo manj kot 4 ure, pa izpuščeni odmerek preskočite in nadaljujte z jemanjem po ustaljenem urniku.
In order for this medicine to work correctly, you must do the following: - Swallow the whole capsule with an acidic drink (such as orange juice or any acidic juice) or water. 
Da bi zdravilo delovalo pravilno, morate upoštevati naslednje: - pogoltnite celo kapsulo s kislo pijačo (na primer pomarančnim sokom ali katerim koli drugim kislim sokom) ali vodo.
Stomach and intestinal ulcers and bleeding can occur in patients receiving cysteamine (see section 4). 
Pri bolnikih, ki jemljejo cisteamin, se lahko pojavijo želodčne in črevesne razjede ter krvavitve (glejte poglavje 4).
Dose administration options are provided below: 
Odmerek se lahko daje na naslednje načine:
It cannot be excluded that cysteamine is a clinically relevant inducer of CYP enzymes, inhibitor of P-gp and BCRP at the intestinal level and inhibitor of liver uptake transporters (OATP1B1, OATP1B3 and OCT1). 
Ni izključeno, da je cisteamin klinično pomemben induktor encimov CYP, zaviralec P-glikoproteina in BCRP v črevesju ter zaviralec jetrnih privzemnih prenašalcev (OATP1B1, OATP1B3 in OCT1).
Experimental administration of the drug causes depletion of somatostatin in several animal species. 
Eksperimentalno dajanje zdravila je pri mnogih vrstah živali povzročilo znižanje vrednosti somatostatina.
Tell your doctor or nurse straight away if you notice any of the following side effects - you may need urgent medical treatment: 
Takoj se posvetujte z zdravnikom ali medicinsko sestro, če opazite katerega koli od naslednjih neželenih učinkov - morda boste potrebovali nujno zdravniško pomoč: hude alergijske reakcije (ki so jih opazili občasno).
Warnings and precautions Talk to your doctor or pharmacist before taking PROCYSBI. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila PROCYSBI se posvetujte z zdravnikom ali farmacevtom.
Your doctor will monitor you for benign intracranial hypertension (or pseudotumor cerebri (PTC)) and/or swelling of the optic nerve (papilledema) associated with cysteamine treatment. 
Zdravnik vas bo spremljal glede benigne intrakranialne hipertenzije (cerebralnega psevdotumorja) in/ali otekanja vidnega živca (papiloedem), ki sta povezana z uporabo cisteamina.
Indomethacin and cysteamine have been used simultaneously in some patients. 
Pri nekaterih bolnikih sta bila sočasno uporabljena indometacin in cisteamin.
Take the capsule with an acidic drink (such as orange juice or any acidic juice) or water. 
Kapsulo vzemite s kislo pijačo (na primer pomarančnim sokom ali katerim koli drugim kislim sokom) ali vodo.
No carcinogenic studies have been conducted with cysteamine bitartrate gastro-resistant hard capsules. 
Študij kancerogenosti z gastrorezistentnimi trdimi kapsulami cisteaminijevega bitartrata niso izvedli.
In vitro: Cysteamine bitartrate is a substrate of P-gp and OCT2, but not a substrate of BCRP, OATP1B1, OATP1B3, OAT1, OAT3 and OCT1. 
In vitro: cisteaminijev bitartrat je substrat P-glikoproteina in OCT2, ni pa substrat BCRP, OATP1B1, OATP1B3, OAT1, OAT3 in OCT1.
A pivotal phase 3 randomized, crossover PK and PD study (which was also the first ever randomized study with immediate-release cysteamine bitartrate) demonstrated that at steady-state, patients receiving PROCYSBI every 12 hours (Q12H) maintained a comparable depletion of WBC cystine levels compared to immediate-release cysteamine bitartrate every 6 hours (Q6H). 
V ključni randomizirani navzkrižni farmakokinetični in farmakodinamični študiji 3. faze (ki je bila hkrati sploh prva randomizirana študija s cisteaminijevim bitartratom s takojšnjim sproščanjem) so ugotovili, da so se pri bolnikih, ki so prejemali zdravilo PROCYSBI vsakih 12 ur (Q12H), v stanju dinamičnega ravnovesja vrednosti cistina v belih krvnih celicah zniževale podobno kot vrednosti cisteaminijevega bitartrata s takojšnjim sproščanjem, ki se daje na 6 ur (Q6H).
INFORMATION IN BRAILLE PROCYSBI 25 mg 
PODATKI V BRAILLOVI PISAVI PROCYSBI 25 mg
There have been reports of benign intracranial hypertension (or pseudotumor cerebri (PTC)) and/or papilledema associated with cysteamine bitartrate treatment that has resolved with the addition of diuretic therapy (post-marketing experience with the immediate-release cysteamine bitartrate). 
V povezavi z uporabo cisteaminijevega bitartrata so poročali o benigni intrakranialni hipertenziji (cerebralnem psevdotumorju) in/ali papiloedemu, ki sta se popravila z dodatnim zdravljenjem z diuretiki (izkušnje s cisteaminijevim bitartratom s takojšnjim sproščanjem v obdobju trženja).
Printing ink shellac povidone K-17 titanium dioxide (E171) 
Črnilo za tisk šelak povidon K-17 titanov dioksid (E171)
PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 250 capsules 
FARMACEVTSKA OBLIKA IN VSEBINA gastrorezistentna trda kapsula 250 kapsul
INFORMATION IN BRAILLE PROCYSBI 75 mg 
PODATKI V BRAILLOVI PISAVI PROCYSBI 75 mg
PROCYSBI may need to be temporarily stopped until the rash goes away. 
Morda boste morali začasno prekiniti jemanje zdravila PROCYSBI, dokler izpuščaj ne bo izginil.
Tell your doctor right away if you develop any of the following symptoms while taking PROCYSBI: headache, buzzing or "whooshing" sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye or pain with eye movement. 
Nemudoma se posvetujte z zdravnikom, če med jemanjem zdravila PROCYSBI opazite katerega koli od naslednjih simptomov: glavobol, zvonjenje oziroma »šumenje« v ušesih, omotica, siljenje na bruhanje, dvojni vid, zamegljen vid, izguba vida, bolečina za očesom ali bolečina ob premikanju očesa.
The maximum recommended dose of cysteamine is 1.95 g/m2/day. 
Največji priporočeni odmerek cisteamina je 1,95 g/m2/dan.
In vitro data suggests that cysteamine bitartrate is likely to be metabolized by multiple CYP enzymes, including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1. 
Podatki in vitro kažejo, da se cisteaminijev bitartrat verjetno presnavlja z različnimi encimi CYP, vključno s CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP2E1.
PROCYSBI is indicated for the treatment of proven nephropathic cystinosis. 
Zdravilo PROCYSBI je indicirano za zdravljenje dokazane nefropatske cistinoze.
A periodic eye examination is needed to identify this condition early and timely treatment should be provided when it occurs to prevent vision loss. 
Da bi preprečili izgubo vida, so potrebni redni pregledi oči za zgodnje odkrivanje te bolezni in pravočasno zdravljenje, če se bolezen pojavi.
Uncommon: Anaphylactic reaction Metabolism and nutrition disorders Very common: Anorexia Psychiatric disorders 
Presnovne in prehranske motnje Zelo pogosti: anoreksija Psihiatrične motnje
This may be followed by 250 mL of an acceptable acidic liquid - fruit juice (e.g., orange juice or any acidic fruit juice) or water. 
Nato lahko spijete 250 ml primerne kisle tekočine - sadnega soka (npr. pomarančni sok ali kateri koli kisli sadni sok) ali vode.
Co-administration of the proton pump inhibitor omeprazole and PROCYSBI in vivo showed no effects on cysteamine bitartrate exposure. 
Sočasna uporaba zaviralca protonske črpalke omeprazola in zdravila PROCYSBI in vivo ni pokazala vpliva na izpostavljenost cisteaminijevemu bitartratu.
Histology showed a membranous glomerulonephritis of the renal allograft in one case and hypersensitivity interstitial nephritis in the other. 
S histološko preiskavo je bil v enem primeru ugotovljen glomerulonefritis presajene ledvice, v drugem pa intersticijski nefritis, ki je bil posledica preobčutljivosti.
In clinical studies comparing PROCYSBI to the immediate-release cysteamine bitartrate, one third of the patients exhibited very common GI disorders (nausea, vomiting, abdominal pain). 
Izkušnje iz kliničnih študij z zdravilom PROCYSBI V kliničnih študijah, v katerih so primerjali zdravilo PROCYSBI s cisteaminijevim bitartratom s takojšnjim sproščanjem, so pri tretjini bolnikov opazili zelo pogoste bolezni prebavil (navzea, bruhanje, bolečine v trebuhu).
Your doctor may interrupt and change your dose if these occur. 
Če se to zgodi, lahko zdravnik prekine zdravljenje in spremeni odmerek.
The use of doses higher than 1.95 g/m2/day is not recommended. 
Uporaba odmerkov, večjih od 1,95 g/m2/dan, ni priporočljiva.
Common nervous system disorders (headache, somnolence and lethargy) and common general disorders (asthenia) were also seen. 
Zabeležili so tudi pogoste bolezni živčevja (glavobol, somnolenca in letargija) ter pogoste splošne težave (astenija).
Common: Liver function tests abnormal 
Pogosti: nenormalni testi delovanja jeter