FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy.
Slovenian: Zato je treba ob neobičajnih trebušnih simptomih ali spremembah trebušnih simptomov preventivno obiskati zdravnika, da se izključi možnost fibrozirajoče kolonopatije.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism product, ATC code: A16AA04.
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, oznaka ATC: A16AA04.
English: 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.
Slovenian: 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.
English: Your doctor will routinely monitor your blood counts and liver function.
Slovenian: Zdravnik bo redno spremljal vašo krvno sliko in delovanje jeter.
English: * measured using the mixed leukocyte assay
Slovenian: * izmerjeno z uporabo testa mešanih levkocitov
English: 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.
Slovenian: 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.
English: A white plastic bottle contains 250 capsules.
Slovenian: Bela plastenka vsebuje 250 kapsul.
English: If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary.
Slovenian: Če se razvijejo simptomi osrednjega živčevja, je treba bolnika natančno pregledati in ustrezno prilagoditi odmerek.
English: The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI.
Slovenian: Drugi neželeni učinki, našteti v nadaljevanju, so navedeni z oceno pogostnosti, s katero se lahko pojavijo pri uporabi zdravila PROCYSBI.
English: Very common side effects (may affect more than 1 in 10 people): diarrhoea fever sensation of sleep
Slovenian: Zelo pogosti neželeni učinki (ki lahko prizadenejo več kot 1 bolnika od 10 bolnikov): driska povišana telesna temperatura občutek zaspanosti
English: • The need to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
Slovenian: •potrebo po rednem spremljanju kože in rentgenskem slikanju kosti, kadar je to potrebno;
English: 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.
Slovenian: 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.
English: Treatment may be restarted at a lower dose under close supervision, and then slowly titrated to the appropriate therapeutic dose (see sections 4.2).
Slovenian: 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).
English: Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function.
Slovenian: Cisteamin so občasno povezali z reverzibilno levkopenijo in nenormalnim delovanjem jeter.
English: The estimated glomerular filtration rate (eGFR) did not change for the study population over time.
Slovenian: Ocenjena hitrost glomerulne filtracije (eGFR) je pri proučevani populaciji ves čas ostala enaka.
English: Recommended dose in mg Every 12 hours*
Slovenian: Telesna masa v kilogramih Priporočeni odmerek v mg vsakih 12 ur*
English: Ask your pharmacist how to throw away the medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: CYP2A6 and CYP3A4 were not involved in the metabolism of cysteamine bitartrate under the experimental conditions.
Slovenian: Encima CYP2A6 in CYP3A4 v eksperimentalnih pogojih nista sodelovala pri presnavljanju cisteaminijevega bitartrata.
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Slovenian: V študijah na živalih je bila ugotovljena reproduktivna toksičnost, vključno s teratogenezo (glejte poglavje 5.3).
English: 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.
Slovenian: 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.
English: • 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).
Slovenian: • 2. možnost/skodelica: 5 minut rahlo mešajte v skodelici ali 5 minut nežno stresajte v pokriti skodelici (npr. v otroški steklenički).
English: The targeted maintenance dose is 1.3 g/m2/day, in two divided doses, given every 12 hours.
Slovenian: Ciljni vzdrževalni odmerek je 1,3 g/m2/dan, ki se ga daje v dveh deljenih odmerkih v razmiku 12 ur.
English: 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).
Slovenian: 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).
English: These include skin striae (which are like stretch marks), bone injuries (such as fractures), bone deformities, and joint problems.
Slovenian: Te vključujejo kožne strije (podobne strijam zaradi raztezanja kože), poškodbe kosti (na primer zlomi), deformacije kosti in težave s sklepi.
English: Per -Protocol (PP) Population (N=39) Immediate-release cysteamine bitartrate
Slovenian: Populacija po protokolu (Per Protocol - PP, N = 39) Cisteaminijev bitartrat s takojšnjim sproščanjem PROCYSBI
English: • 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.
Slovenian: • 1. možnost/brizga: rahlo mešajte 5 minut in nato mešanico zrn cisteamina in kislega sadnega soka ali vode potegnite v brizgo za odmerjanje;
English: Duration of treatment Treatment with PROCYSBI should continue life-long, as instructed by your doctor.
Slovenian: Trajanje zdravljenja Zdravljenje z zdravilom PROCYSBI mora trajati vse življenje po navodilih zdravnika.
English: -0.21 ± 0.14; -0.48 to 0.06; <0.001
Slovenian: −0,21 ± 0,14; −0,48 do 0,06; < 0,001
English: 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.
Slovenian: Kapsule za jutranji ali večerni odmerek je treba odpreti in vsebino stresti na približno 100 gramov jabolčne čežane ali jagodnega želeja.
English: What you need to know before you take PROCYSBI
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PROCYSBI
English: Patients on dialysis or post-transplantation
Slovenian: Bolniki na dializi ali po presaditvi ledvic
English: Sprinkling on food
Slovenian: Stresanje na hrano
English: High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Slovenian: Veliki odmerki cisteamina, bodisi peroralni ali parenteralni, povzročajo razjede na dvanajstniku pri podganah in miših, ne pa tudi pri opicah.
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Slovenian: Zmanjšanje plodnosti pri podganah so opazili pri 375 mg/kg/dan, tj. pri odmerku, pri katerem je prišlo do zastoja v porastu telesne mase.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: If several doses of the supplements are missed or weakness or drowsiness develops, call your doctor for instructions.
Slovenian: Če ste izpustili več odmerkov dodatkov ali če se pojavi oslabelost ali zaspanost, pokličite zdravnika in ga vprašajte za nasvet;
English: Bicarbonate should be administered at least one hour before or one hour after PROCYSBI to avoid potential earlier release of cysteamine.
Slovenian: Bikarbonat je treba uporabiti vsaj eno uro pred ali eno uro po zaužitju zdravila PROCYSBI, da se prepreči morebitno prehitro sproščanje cisteamina.
English: Food intake two hours after administration did not affect the absorption of PROCYSBI.
Slovenian: Uživanje hrane dve uri po uporabi zdravila PROCYSBI ni vplivalo na njegovo absorpcijo.
English: PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults.
Slovenian: Zdravilo PROCYSBI vsebuje učinkovino cisteamin (imenovan tudi merkaptamin) in se uporablja za zdravljenje nefropatske cistinoze pri otrocih in odraslih.
English: Marketing Authorisation Holder Chiesi Farmaceutici S.p.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom Chiesi Farmaceutici S.p.A.
English: If skin or bone abnormalities appear, the dose of cysteamine should be reduced or stopped.
Slovenian: Če se pojavijo spremembe na koži ali kosteh, je treba zmanjšati odmerek cisteamina ali prekiniti zdravljenje.
English: ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Therefore, blood counts and liver function should be monitored.
Slovenian: Zato je treba spremljati krvno sliko in delovanje jeter.
English: No specific antidote is known.
Slovenian: Specifično protisredstvo ni znano.
English: If you forget to take PROCYSBI
Slovenian: Če ste pozabili vzeti zdravilo PROCYSBI
English: Leukopenia and abnormal liver function
Slovenian: Levkopenija in nenormalno delovanje jeter
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: The in vitro plasma protein binding of cysteamine, primarily to albumin, is approximately 54% and independent of plasma drug concentration over the therapeutic range.
Slovenian: 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.
English: Therefore, healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories.
Slovenian: Zato morajo zdravstveni delavci upoštevati terapevtske ciljne vrednosti specifičnih testov, ki jih zagotovijo posamezni testni laboratoriji.
English: • The need for monitoring of white blood cell cystine levels, full blood count and liver function.
Slovenian: •potrebo po spremljanju koncentracij cistina v belih krvnih celicah, krvne slike in delovanja jeter;
English: 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).
Slovenian: 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).
English: Patients should try to consistently avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing.
Slovenian: Bolniki naj se poskušajo dosledno izogniti obrokom in mlečnim izdelkom najmanj 1 uro pred in 1 uro po uporabi zdravila PROCYSBI.
English: Uncommon: Nephrotic syndrome Very common: Lethargy, pyrexia
Slovenian: Občasni: nefrotski sindrom Zelo pogosti: letargija, pireksija
English: Other medicines and PROCYSBI
Slovenian: Druga zdravila in zdravilo PROCYSBI
English: 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.
Slovenian: 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.
English: In genotoxicity studies published for cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported.
Slovenian: V objavljenih študijah genotoksičnosti cisteamina so poročali o pojavu kromosomskih aberacij pri gojenih vrstah evkariontskih celic.
English: 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.
Slovenian: 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.
English: Do not crush or chew capsules or capsule contents.
Slovenian: Kapsul ali vsebine kapsul ne zdrobite ali žvečite.
English: • 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.
Slovenian: • 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;
English: 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).
Slovenian: Otrokom, mlajšim od 6 let, ne smete dajati celih kapsul cisteamina, saj obstaja nevarnost zadušitve (glejte poglavje 3 Kako jemati zdravilo PROCYSBI - Način uporabe).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: For children and patients who have problems to swallow, please refer to section 3 How to take PROCYSBIMethod of administration.
Slovenian: Za otroke in bolnike, ki imajo težave s požiranjem, glejte poglavje 3 Kako jemati zdravilo PROCYSBI - Način uporabe.
English: The cap is child resistant and has a foil seal.
Slovenian: Pokrovček je varen za otroke in ima zaščitno folijo.
English: The targeted maintenance dose is 1.3 g/m2/day.
Slovenian: Ciljni vzdrževalni odmerek je 1,3 g/m2/dan.
English: PROCYSBI treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.
Slovenian: Zdravljenje z zdravilom PROCYSBI se sme uvesti le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem cistinoze.
English: In-use shelf life: 30 days.
Slovenian: 24 mesecev Rok uporabnosti po odprtju: 30 dni.
English: Effects on fertility have been seen in animal studies (see section 5.3).
Slovenian: V študijah na živalih so opazili vpliv na plodnost (glejte poglavje 5.3).
English: Newly diagnosed adult patients should be started on 1/6 to 1/4 of the targeted maintenance dose of PROCYSBI.
Slovenian: 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.
English: Uncommon: Nervousness, hallucination Common: Headache, encephalopathy
Slovenian: Občasni: živčnost, halucinacije Pogosti: glavobol, encefalopatija
English: 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).
Slovenian: 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).
English: For the immediate-release formulation of cysteamine bitartrate, approximately 35% of patients can be expected to experience adverse reactions.
Slovenian: Pri farmacevtski obliki cisteaminijevega bitartrata s takojšnjim sproščanjem je neželene učinke mogoče pričakovati pri približno 35 % bolnikov.
English: 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
Slovenian: 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.
English: If such symptoms develop, tell your doctor who will adjust your dose.
Slovenian: Če opazite omenjene simptome, se posvetujte z zdravnikom, ki bo prilagodil odmerek.
English: •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
Slovenian: •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.
English: Discard 30 days after opening the foil seal.
Slovenian: Zavrzite 30 dni po odprtju zaščitne folije.
English: Total daily dose should be divided by two and administered every 12 hours.
Slovenian: Skupni dnevni odmerek je treba razdeliti na dva dela, ki se ju jemlje vsakih 12 ur.
English: Cysteamine bitartrate is not an inhibitor of OAT1, OAT3 and OCT2.
Slovenian: Cisteaminijev bitartrat ni zaviralec OAT1, OAT3 in OCT2.
English: The total usual dose should not exceed 1.95 g/m2/day.
Slovenian: Običajni skupni odmerek ne sme preseči 1,95 g/m2/dan.
English: In some patients, the skin lesions on elbows regressed after immediate-release cysteamine dose reduction (see section 4.4).
Slovenian: Pri nekaterih bolnikih so se kožne lezije na komolcih po zmanjšanju odmerka cisteamina s takojšnjim sproščanjem izboljšale (glejte poglavje 4.4).
English: The pharmacokinetics of cysteamine bitartrate has not been studied in special populations.
Slovenian: Farmakokinetike cisteaminijevega bitartrata pri posebnih skupinah bolnikov niso proučevali.
English: 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).
Slovenian: Otrokom, mlajšim od približno 6 let, ne smete dajati celih kapsul zdravila PROCYSBI zaradi tveganja aspiracije (glejte poglavje 4.2).
English: 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.
Slovenian: Občasne izkušnje kažejo, da bolniki na dializi slabše prenašajo nekatere oblike cisteamina (tj. nekatere oblike pri njih povzročajo več neželenih učinkov kot druge).
English: High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Slovenian: Veliki odmerki cisteamina zmanjšujejo sposobnost samic, da v obdobju laktacije prehranjujejo svoje mladiče.
English: PROCYSBI 75 mg hard capsule EU/1/13/861/002
Slovenian: PROCYSBI 75 mg trda kapsula EU/1/13/861/002