natgillin/translations-raw huggingface dataset:
Your doctor will routinely monitor your skin and bones and reduce or stop your treatment if needed (see section 4). 
Vaš zdravnik bo redno spremljal vašo kožo in kosti ter po potrebi zmanjšal odmerek ali prekinil zdravljenje (glejte poglavje 4).
Therefore, cysteamine bitartrate should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.4). 
Zato cisteaminijevega bitartrata ne smete uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno (glejte poglavje 4.4).
The effect on pregnancy of untreated cystinosis is also unknown. 
Vpliv nezdravljene cistinoze na nosečnost prav tako ni znan.
• Hypersensitivity to the active substance, any form of cysteamine (mercaptamine), or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino, katero koli obliko cisteamina (merkaptamina) ali katero koli pomožno snov, navedeno v poglavju 6.1.
When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known. 
Ob uvedbi terapije se bolniki ne bi smeli ukvarjati s potencialno nevarnimi dejavnostmi, vse dokler ni pojasnjen učinek, ki ga ima zdravilo na posameznega bolnika.
Do not use this medicine if you are breastfeeding (see section 2 under “Do not use PROCYSBI”). 
Zdravila ne smete uporabljati, če dojite (glejte poglavje 2 pod »Ne jemljite zdravila PROCYSBI«).
Cysteamine is the simplest stable aminothiol and a degradation product of the amino acid cysteine. 
Cisteamin je najpreprostejši stabilni aminotiol ter produkt razgradnje aminokisline cisteina.
• Hypersensitivity to penicillamine. 
• Preobčutljivost na penicilamin.
This is a condition where there is high pressure in the fluid around the brain. 
To je bolezen, za katero je značilen visok tlak v tekočini, ki obdaja možgane.
Measurement timing: PROCYSBI should be administered every 12 hours. 
Čas merjenja: zdravilo PROCYSBI je treba dajati vsakih 12 ur.
Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious GI toxicity and what steps to take if they occur. 
Zdravniki morajo biti pozorni na znake razjed in krvavitev ter morajo bolnike in/ali njihove skrbnike poučiti o znakih in simptomih resne gastrointestinalne toksičnosti ter o tem, kaj storiti, če jih opazijo.
In the few cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis. 
V tistih nekaj primerih, pri katerih so opravili histopatološko preiskavo kože, so rezultati kazali na angioendoteliomatozo.
A white plastic bottle contains 60 capsules. 
Bela plastenka vsebuje 60 kapsul.
At this dose, weight gain and survival of the offspring during lactation was also reduced. 
Pri tem odmerku sta se zmanjšala tudi prirastek telesne mase in preživetje mladičev v obdobju laktacije.
Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation. 
Poročali so o dveh primerih nefrotskega sindroma, ki se je pojavil v 6 mesecih po začetku zdravljenja in se je po prekinitvi zdravljenja postopoma izboljšal.
When starting therapy, you should not drive, use machines, or engage in other dangerous activities until you know how the medicine affects you. 
Na začetku zdravljenja ne smete upravljati vozil in strojev ali se ukvarjati z nevarnimi dejavnostmi, dokler ne veste, kako zdravilo vpliva na vas.
Cysteamine bitartrate should not be administered with food rich in fat or proteins, or with frozen food like ice-cream. 
Cisteaminijevega bitartrata se ne sme jemati skupaj s hrano, bogato z maščobami ali beljakovinami, ali z zamrznjeno hrano, kot je sladoled.
One patient subsequently died of acute cerebral ischemia with marked vasculopathy. 
En bolnik je pozneje umrl zaradi akutne možganske ishemije z izrazito vaskulopatijo.
EXP Discard 30 days after opening the foil seal. 
EXP Zavrzite 30 dni po odprtju zaščitne folije.
The physician education pack should contain the Safety Checklist, the Summary of Product Characteristics and Package Leaflet. 
Izobraževalni paket za zdravnike mora vsebovati varnostni kontrolni seznam, povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The relative bioavailability is about 125% as compared to immediate-release cysteamine. 
Relativna biološka uporabnost je v primerjavi s cisteaminom s takojšnjim sproščanjem približno 125-odstotna.
What PROCYSBI is and what it is used for 
Kaj je zdravilo PROCYSBI in za kaj ga uporabljamo
Thirty-nine (39) patients were included in the final primary per protocol efficacy analysis. 
V končno primarno analizo učinkovitosti po protokolu so vključili devetintrideset (39) bolnikov.
If a dose is missed, it should be taken as soon as possible. 
Če je bil odmerek izpuščen, ga je treba vzeti, kakor hitro je to mogoče.
If your doctor prescribes bicarbonate, do not take it at the same time as PROCYSBI; take bicarbonate at least one hour before or at least one hour after the medicine. 
Če vam zdravnik predpiše bikarbonat, ga ne smete jemati sočasno z zdravilom PROCYSBI; bikarbonat vzemite vsaj eno uro pred ali vsaj eno uro po zaužitju zdravila.
If you missed a dose of medicine, you should take it as soon as possible. 
Če ste izpustili odmerek zdravila, ga vzemite, kakor hitro je to mogoče.
Co-administration with electrolyte and mineral replacement 
Sočasna uporaba s terapijami za nadomeščanje elektrolitov in mineralov
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 September 2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 06. september 2013 Datum zadnjega podaljšanja: 26 Julij 2018
It is important to take PROCYSBI in a consistent way over time. 
Pomembno je, da zdravilo PROCYSBI jemljete dalj časa na dosleden način.
Since oral cysteamine doesn't prevent deposits of cystine crystals in the eye, you should continue taking cysteamine eye drops as prescribed by your doctor. 
Ker peroralna uporaba cisteamina ne preprečuje nalaganja cistinskih kristalov v očesu, morate še naprej uporabljati kapljice za oko s cisteaminom, ki vam jih je predpisal zdravnik.
Your doctor will monitor you with eye examinations to find and treat this problem early. 
Zdravnik bo opravljal preglede oči, namenjene odkrivanju in zgodnjemu zdravljenju teh težav.
This is equivalent to 0.6 g/m2/day in the rat, which is slightly less than the recommended clinical maintenance dose of cysteamine, i.e. 1.3 g/m2/day. 
To pri podganah pomeni 0,6 g/m2/dan, kar je malo manj kot polovica priporočenega kliničnega vzdrževalnega odmerka cisteamina, tj. 1,3 g/m2/dan.
You will receive regular eye examinations to identify this condition as early treatment can prevent vision loss. 
Imeli boste redne preglede oči za odkrivanje te bolezni, saj lahko zgodnje zdravljenje prepreči izgubo vida.
Food intake reduces the absorption of PROCYSBI at 30 minutes pre-dose (approximately 35% decrease in exposure) and at 30 min post-dose (approximately 16 or 45% decrease in exposure for intact and open capsules respectively). 
Hrana zmanjša absorpcijo zdravila PROCYSBI, če se jo zaužije 30 minut pred odmerkom (približno 35 % manjša izpostavljenost) ali 30 minut po odmerku zdravila (približno 16 oziroma 45 % manjša izpostavljenost pri celih oziroma odprtih kapsulah).
An overdose of cysteamine may cause progressive lethargy. 
Preveliko odmerjanje cisteamina lahko povzroči progresivno letargijo.
These tests must be obtained 12.5 hours after the evening dose the day before, and therefore 30 minutes after the following morning dose is given. 
Teste je treba opraviti 12,5 ure po večernem odmerku prejšnji dan, tj. 30 minut po zaužitju naslednjega jutranjega odmerka.
Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes. 
Kopičenje cistina povzroča ledvično okvaro in izločanje čezmernih količin glukoze, beljakovin in elektrolitov.
Sprinkling in orange juice or any acidic fruit juice or water Capsules for either the morning or evening dose should be opened and the contents sprinkled into 100 to 150 mL of acidic fruit juice or water. 
Stresanje v pomarančni sok ali kateri koli kisel sadni sok ali vodo Kapsule za jutranji ali večerni odmerek je treba odpreti in vsebino stresti v 100 do 150 ml kislega sadnega soka ali vode.
If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, cysteamine should not be re-administered (see sections 4.8). 
Če se razvije hud kožni izpuščaj, na primer bulozni multiformni eritem ali toksična epidermalna nekroliza, se cisteamina ne sme ponovno uporabiti (glejte poglavje 4.8).
For at least 1 hour before and 1 hour after taking PROCYSBI try to avoid meals, which are rich in fat or proteins as well as any food or liquid that could decrease the acidity in your stomach, like milk or yogurt. 
Vsaj 1 uro preden vzamete zdravilo PROCYSBI in 1 uro po tem se poskušajte izogibati obrokom, ki so bogati z maščobami ali beljakovinami, ter hrani ali pijači, ki bi lahko zmanjšala kislost v želodcu, na primer mleko ali jogurt.
As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy. 
Zato je treba ob neobičajnih trebušnih simptomih ali spremembah trebušnih simptomov preventivno obiskati zdravnika, da se izključi možnost fibrozirajoče kolonopatije.
Pharmacotherapeutic group: Other alimentary tract and metabolism product, ATC code: A16AA04. 
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, oznaka ATC: A16AA04.
Cysteamine can be administered with electrolyte (except bicarbonate) and mineral replacements necessary for management of Fanconi syndrome as well as vitamin D and thyroid hormone. 
Cisteamin se lahko uporablja skupaj s terapijo za nadomeščanje elektrolitov (razen z bikarbonati) in mineralov, ki je potrebna za obvladovanje Fanconijevega sindroma, ter tudi z vitaminom D in ščitničnimi hormoni.
Your doctor will routinely monitor your blood counts and liver function. 
Zdravnik bo redno spremljal vašo krvno sliko in delovanje jeter.
* measured using the mixed leukocyte assay 
* izmerjeno z uporabo testa mešanih levkocitov
Reproduction studies showed embryo-foetotoxic 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 v odmerku 100 mg/kg/dan in pri kuncih, ki so dobivali cisteamin v odmerku 50 mg/kg/dan.
A white plastic bottle contains 250 capsules. 
Bela plastenka vsebuje 250 kapsul.
If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary. 
Če se razvijejo simptomi osrednjega živčevja, je treba bolnika natančno pregledati in ustrezno prilagoditi odmerek.
The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI. 
Drugi neželeni učinki, našteti v nadaljevanju, so navedeni z oceno pogostnosti, s katero se lahko pojavijo pri uporabi zdravila PROCYSBI.
Very common side effects (may affect more than 1 in 10 people): diarrhoea fever sensation of sleep 
Zelo pogosti neželeni učinki (ki lahko prizadenejo več kot 1 bolnika od 10 bolnikov): driska povišana telesna temperatura občutek zaspanosti
• The need to monitor regularly skin and to consider X-ray examinations of the bone as necessary. 
•potrebo po rednem spremljanju kože in rentgenskem slikanju kosti, kadar je to potrebno;
The elimination of unchanged cysteamine in the urine has been shown to range between 0.3% and 1.7% of the total daily dose in four patients; the bulk of cysteamine is excreted as sulphate. 
Pri štirih bolnikih se je izločanje cisteamina v nespremenjeni obliki z urinom gibalo med 0,3 % in 1,7 % celotnega dnevnega odmerka; večina cisteamina se izloča v obliki sulfata.
Treatment may be restarted at a lower dose under close supervision, and then slowly titrated to the appropriate therapeutic dose (see sections 4.2). 
Zdravljenje se lahko ponovno uvede pod strogim nadzorom in pri manjšem odmerku, ki se ga nato počasi prilagodi na primeren terapevtski odmerek (glejte poglavje 4.2).
Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function. 
Cisteamin so občasno povezali z reverzibilno levkopenijo in nenormalnim delovanjem jeter.
The estimated glomerular filtration rate (eGFR) did not change for the study population over time. 
Ocenjena hitrost glomerulne filtracije (eGFR) je pri proučevani populaciji ves čas ostala enaka.
Recommended dose in mg Every 12 hours* 
Telesna masa v kilogramih Priporočeni odmerek v mg vsakih 12 ur*
Ask your pharmacist how to throw away the medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
CYP2A6 and CYP3A4 were not involved in the metabolism of cysteamine bitartrate under the experimental conditions. 
Encima CYP2A6 in CYP3A4 v eksperimentalnih pogojih nista sodelovala pri presnavljanju cisteaminijevega bitartrata.
Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3). 
V študijah na živalih je bila ugotovljena reproduktivna toksičnost, vključno s teratogenezo (glejte poglavje 5.3).
Forty of forty-one (40/41) patients who completed the pivotal phase 3 study were entered in a prospective study with PROCYSBI that stayed open as long as PROCYSBI could not be prescribed by their treating physician. 
Štirideset od enainštiridesetih (40/41) bolnikov, ki so zaključili ključno študijo 3. faze, je nato sodelovalo v prospektivni študiji z zdravilom PROCYSBI, ki je bila odprta, dokler jim zdravila ni lahko predpisal njihov zdravnik.
• Option 2 / Cup: Mix gently for 5 minutes in a cup or shake gently for 5 minutes in a covered cup (e.g., “sippy” cup). 
• 2. možnost/skodelica: 5 minut rahlo mešajte v skodelici ali 5 minut nežno stresajte v pokriti skodelici (npr. v otroški steklenički).
The targeted maintenance dose is 1.3 g/m2/day, in two divided doses, given every 12 hours. 
Ciljni vzdrževalni odmerek je 1,3 g/m2/dan, ki se ga daje v dveh deljenih odmerkih v razmiku 12 ur.
However, due to the results of animal studies in breast-feeding females and neonates (see section 5.3), breast-feeding is contra-indicated in women taking PROCYSBI (see section 4.3). 
Vendar pa je glede na rezultate študij na živalih pri doječih samicah in novorojenih mladičih (glejte poglavje 5.3) dojenje pri ženskah, ki jemljejo zdravilo PROCYSBI, kontraindicirano (glejte poglavje 4.3).
These include skin striae (which are like stretch marks), bone injuries (such as fractures), bone deformities, and joint problems. 
Te vključujejo kožne strije (podobne strijam zaradi raztezanja kože), poškodbe kosti (na primer zlomi), deformacije kosti in težave s sklepi.
Per -Protocol (PP) Population (N=39) Immediate-release cysteamine bitartrate 
Populacija po protokolu (Per Protocol - PP, N = 39) Cisteaminijev bitartrat s takojšnjim sproščanjem PROCYSBI
• Option 1 / Syringe: Mix gently for 5 minutes, then aspirate the mixture of cysteamine granules and acidic fruit juice or water into a dosing syringe. 
• 1. možnost/brizga: rahlo mešajte 5 minut in nato mešanico zrn cisteamina in kislega sadnega soka ali vode potegnite v brizgo za odmerjanje;
Duration of treatment Treatment with PROCYSBI should continue life-long, as instructed by your doctor. 
Trajanje zdravljenja Zdravljenje z zdravilom PROCYSBI mora trajati vse življenje po navodilih zdravnika.
-0.21 ± 0.14; -0.48 to 0.06; <0.001 
−0,21 ± 0,14; −0,48 do 0,06; < 0,001
Capsules for either the morning or evening dose should be opened and the contents sprinkled onto approximately 100 grams of apple sauce or berry jelly. 
Kapsule za jutranji ali večerni odmerek je treba odpreti in vsebino stresti na približno 100 gramov jabolčne čežane ali jagodnega želeja.
What you need to know before you take PROCYSBI 
Kaj morate vedeti, preden boste vzeli zdravilo PROCYSBI
Patients on dialysis or post-transplantation 
Bolniki na dializi ali po presaditvi ledvic
Sprinkling on food 
Stresanje na hrano
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys. 
Veliki odmerki cisteamina, bodisi peroralni ali parenteralni, povzročajo razjede na dvanajstniku pri podganah in miših, ne pa tudi pri opicah.
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 v porastu telesne mase.
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack. 
Imetnik dovoljenja za promet z zdravilom se mora pred razdelitvijo izobraževalnega paketa o vsebini in obliki izobraževalnega gradiva, skupaj z načrtom sporočanja, dogovoriti z nacionalnim pristojnim organom.
Cystinosis is a disease affecting how the body functions, with an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain. 
Cistinoza je bolezen, ki prizadene delovanje telesa in za katero je značilno nenormalno kopičenje aminokisline cistina v različnih telesnih organih, npr. ledvicah, očeh, mišicah, trebušni slinavki in možganih.
The dose of 1.95 g/m2/day of immediate-release cysteamine bitartrate has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events. 
Odmerek cisteaminijevega bitartrata s takojšnjim sproščanjem 1,95 g/m2/dan je povezan z višjo stopnjo prekinitve zdravljenja zaradi nezmožnosti prenašanja zdravila in povečano pojavnostjo neželenih učinkov.
If several doses of the supplements are missed or weakness or drowsiness develops, call your doctor for instructions. 
Če ste izpustili več odmerkov dodatkov ali če se pojavi oslabelost ali zaspanost, pokličite zdravnika in ga vprašajte za nasvet;
Bicarbonate should be administered at least one hour before or one hour after PROCYSBI to avoid potential earlier release of cysteamine. 
Bikarbonat je treba uporabiti vsaj eno uro pred ali eno uro po zaužitju zdravila PROCYSBI, da se prepreči morebitno prehitro sproščanje cisteamina.
Food intake two hours after administration did not affect the absorption of PROCYSBI. 
Uživanje hrane dve uri po uporabi zdravila PROCYSBI ni vplivalo na njegovo absorpcijo.
PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults. 
Zdravilo PROCYSBI vsebuje učinkovino cisteamin (imenovan tudi merkaptamin) in se uporablja za zdravljenje nefropatske cistinoze pri otrocih in odraslih.
Marketing Authorisation Holder Chiesi Farmaceutici S.p.A. 
Imetnik dovoljenja za promet z zdravilom Chiesi Farmaceutici S.p.A.
If skin or bone abnormalities appear, the dose of cysteamine should be reduced or stopped. 
Če se pojavijo spremembe na koži ali kosteh, je treba zmanjšati odmerek cisteamina ali prekiniti zdravljenje.
ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS 
PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Therefore, blood counts and liver function should be monitored. 
Zato je treba spremljati krvno sliko in delovanje jeter.
No specific antidote is known. 
Specifično protisredstvo ni znano.
If you forget to take PROCYSBI 
Če ste pozabili vzeti zdravilo PROCYSBI
Leukopenia and abnormal liver function 
Levkopenija in nenormalno delovanje jeter
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
The in vitro plasma protein binding of cysteamine, primarily to albumin, is approximately 54% and independent of plasma drug concentration over the therapeutic range. 
In vitro se na beljakovine v plazmi, zlasti na albumin, veže približno 54 % cisteamina ne glede na to, ali so koncentracije zdravila v plazmi nad terapevtsko ravnijo.
Therefore, healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories. 
Zato morajo zdravstveni delavci upoštevati terapevtske ciljne vrednosti specifičnih testov, ki jih zagotovijo posamezni testni laboratoriji.
• The need for monitoring of white blood cell cystine levels, full blood count and liver function. 
•potrebo po spremljanju koncentracij cistina v belih krvnih celicah, krvne slike in delovanja jeter;
If cysteamine is initially poorly tolerated due to gastrointestinal (GI) tract symptoms or transient skin rashes, therapy should be temporarily stopped, then re-instituted at a lower dose and gradually increased to the appropriate dose (see section 4.4). 
Če bolnik na začetku slabo prenaša cisteamin zaradi gastrointestinalnih simptomov ali prehodnih kožnih izpuščajev, je treba zdravljenje začasno prekiniti in ga nato ponovno uvesti pri manjšem odmerku, ki ga je treba postopoma povečevati do ustreznega odmerka (glejte poglavje 4.4).
Patients should try to consistently avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing. 
Bolniki naj se poskušajo dosledno izogniti obrokom in mlečnim izdelkom najmanj 1 uro pred in 1 uro po uporabi zdravila PROCYSBI.
Uncommon: Nephrotic syndrome Very common: Lethargy, pyrexia 
Občasni: nefrotski sindrom Zelo pogosti: letargija, pireksija
Other medicines and PROCYSBI 
Druga zdravila in zdravilo PROCYSBI
Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure. 
Cisteamin zmanjšuje kopičenje cistina v nekaterih celicah (npr. levkocitih, mišičnih in jetrnih celicah) pri bolnikih z nefropatsko cistinozo in, če se zdravljenje začne dovolj zgodaj, zavira nastanek ledvične odpovedi.
In genotoxicity studies published for cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported. 
V objavljenih študijah genotoksičnosti cisteamina so poročali o pojavu kromosomskih aberacij pri gojenih vrstah evkariontskih celic.
If you are a woman planning a pregnancy or become pregnant, seek immediate advice from your doctor about stopping therapy with this medicine as continued treatment may be harmful to the unborn baby. 
Če načrtujete zanositev ali če zanosite, se nemudoma posvetujte z zdravnikom, ki vam bo svetoval glede prekinitve zdravljenja, saj bi lahko nadaljnje zdravljenje škodilo nerojenemu otroku.
Do not crush or chew capsules or capsule contents. 
Kapsul ali vsebine kapsul ne zdrobite ali žvečite.
• The risk of fibrosing colonopathy and relevant risk minimisation advice: Patients should be informed about the potential risk of fibrosing colonopathy; Patients should be advised of the signs and symptoms of fibrosing colonopathy and to alert the treating physician if they develop any. 
• tveganje za fibrozirajočo kolonopatijo in pomembni ukrepi za zmanjšanje tveganja: bolnike je treba seznaniti z možnim tveganjem za fibrozirajočo kolonopatijo; bolnike je treba poučiti o znakih in simptomih fibrozirajoče kolonopatije, o katerih morajo poročati svojemu zdravniku, če jih opazijo;
Whole cysteamine capsules should not be given to children under the age of 6 years due to the risk of choking (refer to section 3 How to take PROCYSBI - Method of administration). 
Otrokom, mlajšim od 6 let, ne smete dajati celih kapsul cisteamina, saj obstaja nevarnost zadušitve (glejte poglavje 3 Kako jemati zdravilo PROCYSBI - Način uporabe).