natgillin/translations-raw huggingface dataset:
The mixture should then be administered via gastrostomy tube, nasogastric tube or gastrostomy-jejunostomy tube. 
Mešanico je nato treba dati po gastrostomi, nazogastrični sondi ali gastrojejuno anastomozi.
WBC cystine is monitored in these patients to determine adequacy of dosing, levels being measured 30 minutes after dosing when treated with PROCYSBI. 
Pri teh bolnikih je treba spremljati vrednosti cistina v belih krvnih celicah, da se določi ustrezen odmerek, pri čemer se koncentracija izmeri 30 minut po zaužitju zdravila PROCYSBI.
- Regular blood tests to measure the amount of cystine inside white blood cells and/or the concentration of cysteamine in the blood are necessary to help determine the correct dose of PROCYSBI. 
- za določitev ustreznega odmerka zdravila PROCYSBI so potrebni redni krvni testi, s katerimi se izmeri količino cistina v belih krvnih celicah in/ali koncentracijo cisteamina v krvi.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree.” 
Zdravilo PROCYSBI vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4). 
Uporaba odmerkov, večjih od 1,95 g/m2/dan, ni priporočljiva (glejte poglavje 4.4).
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe PROCYSBI prior to the launch. 
Imetnik dovoljenja za promet z zdravilom mora, preden da zdravilo v promet, pripraviti izobraževalni paket za vse zdravnike, za katere se pričakuje, da bodo predpisovali zdravilo PROCYSBI.
This medicinal product can be administered by swallowing the intact capsules as well as sprinkling the capsule contents (enteric coated beads) on food or delivery through a gastric feeding tube. 
To zdravilo se lahko pogoltne kot cele kapsule ali pa se vsebina kapsule (zrnca z gastrorezistentno oblogo) posipa po hrani ali vnese z gastrično sondo za hranjenje.
The mixture must be eaten within 2 hours after preparation and must be refrigerated from the time of preparation to the time of administration. 
Pripravljeno mešanico je treba pojesti v 2 urah in jo je treba po pripravi do uporabe hraniti v hladilniku.
Capsule shell gelatin titanium dioxide (E171) indigo carmine (E132) 
Ovojnica kapsule želatina titanov dioksid (E171) indigotin (E132)
Patients with poor tolerability 
Bolniki, ki slabo prenašajo zdravilo
Abnormal liver function or reduced white blood cell count (leukopenia) can occur with use of cysteamine. 
Pri uporabi cisteamina se lahko pojavi nenormalno delovanje jeter ali zmanjšanje števila belih krvnih celic (levkopenija).
The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.2). 
Uporaba odmerkov, večjih od 1,95 g/m2/dan, ni priporočljiva (glejte poglavje 4.2).
Cysteamine bitartrate is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in vitro. 
Cisteaminijev bitartrat in vitro ne zavira encimov CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4.
Each bottle contains three plastic cylinders used for additional moisture and air protection. 
Vsaka plastenka vsebuje tri plastične valjčke, ki zagotavljajo dodatno zaščito pred vlago in zrakom.
Central nervous system symptoms: Some patients taking cysteamine have developed seizures, depression, and become too sleepy (excessive sleepiness). 
Zdravnik vas bo spremljal v zvezi s tem; simptomi osrednjega živčevja: pri nekaterih bolnikih, ki so jemali cisteamin, so se pojavili epileptični napadi ali depresija ali pa so postali preveč zaspani (pretirana zaspanost).
Common side effects: unpleasant breath and body odour heartburn tiredness 
Pogosti neželeni učinki: neprijeten zadah iz ust in telesni vonj zgaga utrujenost
Individuals with cystinosis have elevations of WBC cystine above 2 nmol hemicystine/mg protein. 
Posamezniki s cistinozo imajo vrednosti cistina v belih krvnih celicah višje od 2 nmol hemicistina/mg beljakovin.
Serious skin lesions can occur in patients treated with high doses of cysteamine. 
Pri bolnikih, ki jemljejo velike odmerke cisteamina, se lahko pojavijo resne kožne lezije.
Uncommon: Gastrointestinal ulcer Common: Skin odour abnormal, rash 
Občasni: gastrointestinalne razjede Pogosti: nenormalen vonj kože, izpuščaj
Patients with poorer tolerability still receive significant benefit if white blood cell cystine levels are below 2 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay). 
Bolniki, ki slabo prenašajo zdravilo, imajo od njega še vedno pomembne koristi, če so vrednosti cistina v belih krvnih celicah pod 2 nmol hemicistina/mg beljakovin (izmerjeno z uporabo testa mešanih levkocitov).
Each bottle contains two plastic cylinders used for additional moisture and air protection. 
Vsaka plastenka vsebuje dva plastična valjčka, ki zagotavljata dodatno zaščito pred vlago in zrakom.
QUALITATIVE AND QUANTITATIVE COMPOSITION PROCYSBI 25 mg hard capsule 
KAKOVOSTNA IN KOLIČINSKA SESTAVA PROCYSBI 25 mg trda kapsula
How to take PROCYSBI 
Kako jemati zdravilo PROCYSBI
If you are allergic to cysteamine (also known as mercaptamine) or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila PROCYSBI: če ste alergični na cisteamin (imenovan tudi merkaptamin) ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če ste alergični na penicilamin; če dojite.
In cases of patients with kidney transplants, anti-rejection treatments have been used with cysteamine. 
Pri bolnikih s presajenimi ledvicami so se skupaj s cisteaminom uporabljala tudi zdravila za preprečevanje zavrnitvene reakcije.
The targeted maintenance dose of 1.3 g/m2/day can be approximated according to the following table, which takes surface area as well as weight into consideration. 
Pediatrična populacija z na novo diagnosticirano boleznijo Odmerek, ki približno ustreza ciljnemu vzdrževalnemu odmerku 1,3 g/m2/dan, je mogoče določiti s pomočjo spodnje preglednice, kjer sta upoštevani tako površina kot telesna masa.
400 mL white HDPE bottle containing 250 capsules with one 2-in-1 desiccant cylinder and two oxygen absorber cylinders, with a child resistant polypropylene closure. 
400 ml bela plastenka iz polietilena visoke gostote, ki vsebuje 250 kapsul, skupaj z enim sušilnim valjčkom 2 v 1 in dvema valjčkoma za absorpcijo kisika, ter ima polipropilensko zaporko, varno za otroke.
Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit. 
Za dosego maksimalnega učinka je treba zdravljenje s cisteaminom uvesti takoj po potrditvi diagnoze cistinoze.
Uncommon: Somnolence, convulsions Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis 
Organski sistem MedDRA Pogostnost: neželeni učinek Zelo pogosti: bruhanje, slabost, driska Pogosti: bolečine v trebuhu, ustni zadah, dispepsija, gastroenteritis
The other ingredients are: o In the capsules: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer 
Druge sestavine zdravila so: o v kapsulah: mikrokristalna celuloza, kopolimer metakrilne kisline in etilakrilata (1:1),
Normal individuals and persons heterozygous for cystinosis have white blood cell cystine levels of < 0.2 and usually below 1 nmol hemicystine/mg protein, respectively, when measured using the mixed leukocyte assay. 
Pri zdravih posameznikih je koncentracija cistina v belih krvnih celicah < 0,2, pri osebah, heterozigotnih za cistinozo, pa je običajno nižja od 1 nmol hemicistina/mg beljakovin, izmerjeno z uporabo testa mešanih levkocitov.
It is important to dose PROCYSBI in relation to food intake in a consistent and reproducible way over time (see section 5.2) In paediatric patients who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food or liquid listed below. 
Pri pediatričnih bolnikih do približno 6. leta starosti, pri katerih obstaja nevarnost aspiracije, je treba trde kapsule odpreti in vsebino stresti na spodaj navedeno hrano ali tekočino.
Frequency: adverse reaction 
Občasni: anafilaktična reakcija
The mixture must be administered within 2 hours after preparation and may be refrigerated from the time of preparation to the time of administration. 
Pripravljeno mešanico je treba dati v 2 urah in se jo lahko po pripravi do uporabe hrani v hladilniku.
There have been reports of serious skin lesions in patients treated with high doses of immediaterelease cysteamine bitartrate or other cysteamine salts that have responded to cysteamine dose reduction. 
Pri bolnikih, zdravljenih z velikimi odmerki cisteaminijevega bitartrata s takojšnjim sproščanjem ali drugimi cisteaminovimi solmi, so poročali o resnih kožnih lezijah, ki so se izboljšale po zmanjšanju odmerka cisteamina.
The adverse reactions profile for healthy subjects was similar to the adverse reactions profile in patients relative to GI disorders (diarrhoea and abdominal pain). 
Profil neželenih učinkov, povezanih z boleznimi prebavil (driska in bolečine v trebuhu), pri zdravih posameznikih je bil podoben kot pri bolnikih.
Bone disorders reported were genu valgum, leg pain and hyperextensive joints, osteopenia, compression fractures, and scoliosis. 
Kostne bolezni, o katerih so poročali, so bile genu valgum, bolečine v spodnjih udih in hiperekstenzija sklepov, osteopenija, kompresijske frakture in skolioza.
What PROCYSBI contains 
Kaj vsebuje zdravilo PROCYSBI
Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis. 
Občasni: hiperekstenzija sklepov, bolečine v spodnjih udih, genu valgum, osteopenija, kompresijska fraktura, skolioza
What PROCYSBI looks like and contents of the pack PROCYSBI 25 mg is presented as blue gastro-resistant hard capsules. 
Izgled zdravila PROCYSBI in vsebina pakiranja Zdravilo PROCYSBI 25 mg je na voljo v obliki modrih gastrorezistentnih trdih kapsul.
50 mL white HDPE bottle containing 60 capsules with one 2-in-1 desiccant cylinder and one oxygen absorber cylinder, with a child resistant polypropylene closure. 
50 ml bela plastenka iz polietilena visoke gostote, ki vsebuje 60 kapsul, skupaj z enim sušilnim valjčkom 2 v 1 in enim valjčkom za absorpcijo kisika, ter ima polipropilensko zaporko, varno za otroke.
A few cases of Ehlers-Danlos-like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day. 
Pri otrocih, kronično zdravljenih z velikimi odmerki različnih oblik cisteamina (cisteaminijev klorhidrat ali cistamin ali cisteaminijev bitartrat), večinoma večjimi od maksimalnega odmerka 1,95 g/m2/dan, so poročali o nekaj primerih sindroma, podobnega Ehlers-Danlosovemu, na komolcih.
The dose should be raised if there is adequate tolerance and the WBC cystine level remains > 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay). 
Odmerek je treba povečati, če je prenašanje primerno dobro in koncentracija cistina v belih krvnih celicah vztraja pri vrednosti > 1 nmol hemicistina/mg beljakovin (izmerjeno z uporabo testa mešanih levkocitov).
The cysteamine dose can be increased to a maximum of 1.95 g/m2/day to achieve this level. 
Za zagotovitev te vrednosti se lahko odmerek cisteamina poveča do največ 1,95 g/m2/dan.
Patients should not engage in potentially hazardous activities until the effects of cysteamine on mental performance are known (see section 4.7). 
Dokler se ne ugotovi, kakšni so vplivi cisteamina na bolnikove umske sposobnosti, se mora ta izogniti dejavnostim, ki bi lahko bile nevarne (glejte poglavje 4.7).
• The risk of teratogenicity and relevant risk minimisation advice: Women of childbearing potential should be informed about the risk of teratogenicity; For women of child-bearing potential a negative pregnancy test should be confirmed before starting treatment; 
ženske v rodni dobi je treba seznaniti s tveganjem za teratogenost; ženske v rodni dobi morajo pred začetkom zdravljenja opraviti test nosečnosti, ki mora biti negativen; ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo primerno kontracepcijsko metodo; ženske v rodni dobi je treba opozoriti, da morajo v primeru zanositve v času zdravljenja o tem obvestiti svojega zdravnika;
bone fragility hair discolouration fits nervousness hallucination effect on the kidney manifested by swelling of the extremities and weight gain 
Občasni neželeni učinki: bolečine v spodnjih udih skolioza (deformacija hrbtenice) krhkost kosti sprememba barve las krči živčnost halucinacije prizadetost ledvic, ki je razvidna iz oteklih okončin in porasta telesne mase
The target values provided in the SmPC are obtained from using the mixed leucocyte assay. 
Ciljne vrednosti, ki so navedene v povzetku glavnih značilnosti zdravila, so bile pridobljene s pomočjo testa mešanih levkocitov.
Specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test. A bacterial reverse mutation assay study (“Ames test”) was performed with the cysteamine bitartrate used for PROCYSBI and cysteamine bitartrate did not show any mutagenic effects in this test. 
Opravljen je bil bakterijski test povratnih mutacij (»Amesov test«) s cisteaminijevim bitartratom, ki se uporablja za zdravilo PROCYSBI, v katerem cisteaminijev bitartrat ni pokazal mutagenega učinka.
Cysteamine therapy must be initiated promptly once the diagnosis is confirmed (i.e., increased WBC cystine) to achieve maximum benefit. 
Za zagotovitev maksimalnega učinka je treba zdravljenje s cisteaminom uvesti takoj po potrditvi diagnoze (tj. povišana koncentracija cistina v belih krvnih celicah).
For example the therapeutic goal is to maintain a WBC cysteine level < 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay), 30 min after dosing For patients adherent to a stable dose of PROCYSBI, and who do not have easy access to an adequate facility for measuring their WBC cystine, the goal of therapy should be to maintain plasma cysteamine concentration > 0.1 mg/L, 30 min after dosing. 
Pri bolnikih, ki jemljejo stalen odmerek zdravila PROCYSBI in ki ne morejo preprosto dostopati do primerne zdravstvene ustanove, kjer bi jim izmerili cistin v belih krvnih celicah, je cilj zdravljenja ohraniti koncentracijo cisteamina v plazmi > 0,1 mg/l 30 minut po zaužitju odmerka.
The cylinders may be discarded with the bottle after use. 
Po uporabi lahko valjčke odvržete skupaj s plastenko.
Patients being transferred from immediate-release cysteamine bitartrate to PROCYSBI should have their WBC cystine levels measured in 2 weeks, and thereafter every 3 months to assess optimal dose as described above. 
Za določitev omenjenega optimalnega odmerka je treba bolnikom, ki preidejo s cisteaminijevega bitartrata s takojšnjim sproščanjem na zdravilo PROCYSBI, izmeriti vrednosti cistina v belih krvnih celicah po 2 tednih in nato še vsake 3 mesece.
Healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories when making decisions regarding diagnosis and PROCYSBI dosing for cystinosis patients. 
Pri bolnikih s cistinozo morajo zdravstveni delavci pri odločanju glede diagnoze in odmerjanja zdravila PROCYSBI upoštevati terapevtske ciljne vrednosti specifičnega testa, ki jih zagotovijo posamezni testni laboratoriji.
Skin lesions, bone lesions, and joint problems: Treatment with high doses of cysteamine can cause skin lesions to develop. 
Občasni neželeni učinki (ki lahko prizadenejo največ 1 bolnika od 100 bolnikov): kožne lezije, kostne lezije in težave s sklepi: zdravljenje z velikimi odmerki cisteamina lahko povzroči razvoj kožnih lezij.
Administration of cysteamine in neonate rats induced cataracts. 
Cisteamin je pri novorojenih podganah povzročil nastanek sive mrene.
Azoospermia has been reported in male cystinosis patients. 
Pri moških bolnikih s cistinozo so poročali o azoospermiji.
Symptoms such as seizures, tiredness, sleepiness, depression, and brain disorders (encephalopathy) can occur with cysteamine. 
Pri uporabi cisteamina se lahko pojavijo simptomi, kot so epileptični napadi, utrujenost, zaspanost, depresija in bolezni možganov (encefalopatija).
PROCYSBI 75 mg hard capsule 
PROCYSBI 75 mg trda kapsula
Common: Asthenia 
Pogosti: oslabelost
0.08 ± 0.03; 0.01 to 0.15; <0.0001 All Evaluable Patients (ITT) Population (N=41) Immediate-release cysteamine bitartrate 
0,08 ± 0,03; 0,01 do 0,15; < 0,0001
The active substance is cysteamine (as mercaptamine bitartrate). 
Učinkovina je cisteamin (v obliki merkaptaminijevega bitartrata).
These mainly involve the gastrointestinal and central nervous systems. 
Neželeni učinki običajno prizadenejo prebavila in osrednje živčevje.
Please keep the three cylinders in each bottle during the use of the bottle. 
Med uporabo naj vsi trije valjčki ostanejo v posamezni plastenki.
If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after taking PROCYSBI. 
Če to ni mogoče, lahko v eni uri pred in po jemanju zdravila PROCYSBI pojeste majhno količino (približno 100 gramov) hrane (po možnosti ogljikove hidrate, npr. kruh, testenine, sadje).
GI ulceration and bleeding have been reported in patients receiving immediate-release cysteamine bitartrate. 
Pri bolnikih, ki so prejemali cisteaminijev bitartrat s takojšnjim sproščanjem, so poročali o razjedah in krvavitvah v prebavilih.
PROCYSBI 25 mg hard capsule 
PROCYSBI 25 mg trda kapsula
PROCYSBI 75 mg is presented as blue gastro-resistant hard capsules. 
Zdravilo PROCYSBI 75 mg je na voljo v obliki modrih gastrorezistentnih trdih kapsul.
Stomach and intestinal (gastrointestinal) problems: Patients taking cysteamine have developed ulcers and bleeding. 
Če opazite te simptome, se posvetujte z zdravnikom; želodčne in črevesne (prebavne) težave: pri bolnikih, ki so jemali cisteamin, so se pojavile razjede in krvavitve.
* Higher dose may be required to achieve target WBC cystine concentration. 
* Za doseganje ciljne koncentracije cistina v belih krvnih celicah bo morda potreben večji odmerek.
CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine. 
S cisteaminom so povezani simptomi osrednjega živčevja, kot so epileptični napadi, letargija, somnolenca, depresija in encefalopatija.
Single doses of the drug inhibit prolactin secretion in animals. 
Enkratni odmerki zdravila pri živalih zavirajo izločanje prolaktina.
Please keep the two cylinders in each bottle during the use of the bottle. 
Med uporabo naj oba valjčka ostaneta v posamezni plastenki.
Patients with renal impairment Dose adjustment is not normally required; however, WBC cystine levels should be monitored. 
Prilagajanje odmerka običajno ni potrebno; treba pa je spremljati koncentracije cistina v belih krvnih celicah.
A closer monitoring of the WBC cystine levels is recommended in these patients. 
Pri teh bolnikih je priporočljivo še skrbneje spremljati koncentracije cistina v belih krvnih celicah.
Nervous system disorders 
Osrednje živčevje
Light blue size 0 hard capsules imprinted “75 mg” in white ink and a dark blue cap imprinted with “PRO” in white ink. 
Svetlomodre trde kapsule velikosti 0 z odtisnjeno belo oznako »75 mg« in temnomoder pokrovček, na katerem je z belim črnilom odtisnjen logotip družbe Raptor.
Each hard capsule contains 25 mg of cysteamine (as mercaptamine bitartrate). 
Ena trda kapsula vsebuje 25 mg cisteamina (v obliki merkaptaminijevega bitartrata).
Each hard capsule contains 75 mg of cysteamine (as mercaptamine bitartrate). 
Ena trda kapsula vsebuje 75 mg cisteamina (v obliki merkaptaminijevega bitartrata).
Light blue size 3 hard capsules imprinted “25 mg” in white ink and a light blue cap imprinted with “PRO” in white ink. 
Svetlomodre trde kapsule velikosti 3 z odtisnjeno belo oznako »25 mg« in svetlomoder pokrovček, na katerem je z belim črnilom odtisnjen logotip družbe Raptor.
Other intestinal symptoms including nausea, vomiting, anorexia and stomach ache can occur with cysteamine. 
Pri uporabi cisteamina se lahko pojavijo tudi drugi prebavni simptomi, ki vključujejo siljenje na bruhanje, bruhanje, anoreksijo in bolečine v želodcu.
Cysteamine excretion in human milk is unknown. 
Ni znano, ali se cisteamin izloča v materino mleko.
You should contact your doctor or the hospital emergency department immediately if you have taken more PROCYSBI than you should. 
Če ste vzeli večji odmerek zdravila PROCYSBI, kot bi smeli Če ste vzeli večji odmerek zdravila PROCYSBI, kot bi smeli, se nemudoma posvetujte z zdravnikom ali urgentnim oddelkom bolnišnice.
GI tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine. 
Prebavni simptomi, ki so jih povezali s cisteaminom, vključujejo navzeo, bruhanje, anoreksijo in bolečine v trebuhu.
Administering through feeding tubes 
Dajanje zdravila po sondi za hranjenje
If fasting during this period is not possible, it is acceptable to eat only a small amount ( 100 grams) of food (preferentially carbohydrates) during the hour before and after PROCYSBI administration. 
Če to ni mogoče, lahko v uri pred in po uporabi zdravila PROCYSBI zaužijejo majhno količino hrane ( 100 gramov in po možnosti ogljikove hidrate).
How to store PROCYSBI 
Shranjevanje zdravila PROCYSBI
If the rash is severe, your doctor may discontinue cysteamine treatment. 
V primeru hudih izpuščajev lahko zdravnik prekine zdravljenje s cisteaminom; krvni testi kažejo nenormalno delovanje jeter.
Please keep the cylinders in each bottle during the use of the bottle. 
Med uporabo naj valjčki ostanejo v posamezni plastenki.
PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules 
PROCYSBI 25 mg gastrorezistentne trde kapsule PROCYSBI 75 mg gastrorezistentne trde kapsule
The Safety Checklist should highlight the following: 
V varnostnem kontrolnem seznamu mora biti izpostavljeno naslednje: • tveganje za teratogenost in pomembni ukrepi za zmanjšanje tveganja:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/002 
EU/1/13/861/002
o In the capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132). 
hipromeloza, smukec, trietilcitrat, natrijev lavrilsulfat; o v ovoju kapsul: želatina, titanov dioksid (E171), indigotin (E132); o v črnilu za tisk: šelak, povidon (K-17), titanov dioksid (E171).
The dark blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “75 mg” in white ink. 
Na temnomodrem pokrovčku je z belim črnilom odtisnjen logotip družbe Raptor, na svetlomodrem osrednjem delu pa je odtisnjena bela oznaka »75 mg«.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/861/001 
EU/1/13/861/001
The light blue cap is imprinted with “PRO” in white ink and the light blue body is imprinted with “25 mg” in white ink. 
Na svetlomodrem pokrovčku je z belim črnilom odtisnjen logotip družbe Raptor, na svetlomodrem osrednjem delu pa je odtisnjena bela oznaka »25 mg«.
NAME OF THE MEDICINAL PRODUCT PROCYSBI 75 mg gastro-resistant hard capsules cysteamine 
PROCYSBI 75 mg gastrorezistentne trde kapsule cisteamin
NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules cysteamine 
PROCYSBI 25 mg gastrorezistentne trde kapsule cisteamin
Treatment effect (LS mean ± SE; 95.8% CI; p-value) 
Vrednost cistina v belih krvnih celicah (povprečje najmanjših kvadratov ± SN) v nmol hemicistina/mg beljakovin* Učinek zdravljenja (povprečje najmanjših kvadratov ± SN; 95,8-odstotni IZ; p-vrednost)
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 25 mg of cysteamine (as mercaptamine bitartrate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 25 mg cisteamina (v obliki merkaptaminijevega bitartrata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 75 mg of cysteamine (as mercaptamine bitartrate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 75 mg cisteamina (v obliki merkaptaminijevega bitartrata).