natgillin/translations-raw huggingface dataset:
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
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.