natgillin/translations-raw huggingface dataset:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.
Odmerek CYSTAGONa, ki ga predpišejo vam ali vašemu otroku, bo odvisen od starosti in telesne teže vas samih ali vašega otroka.
However if it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Vendar pa, v primeru, da manjka do naslednjega odmerka manj kot dve uri, izpuščeni odmerek preskočite in nadaljujte z jemanjem po ustaljenem urniku.
Patients on dialysis or post-transplantation:
Bolniki na dializi ali po presaditvi ledvic:
Uncommon: Nervousness, hallucination
Občasno: živčnost, halucinacije
However, growth velocity did not increase enough to allow patients to catch up the normal for their age.
Vendar pa se hitrost rasti ni povečala do te mere, da bi bolniki uspeli dohiteti za svojo starost primerne vrednosti.
Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help your or your child's doctor correctly adjust the doses of these supplements.
Redni krvni oz. urinski testi za merjenje pomembnih elektrolitov v telesu so potrebni tudi zato, ker pomagajo vašemu oz. otrokovemu zdravniku pravilno prilagoditi odmerke teh dodatkov.
In order for CYSTAGON to work correctly, you must do the following: - Follow your doctor's directions exactly.
Da bi CYSTAGON deloval pravilno, morate upoštevati naslednje: - Natančno upoštevajte zdravnikova navodila.
In any case the usual dose should not exceed 1.95 g/m2/day.
Običajni odmerek v nobenem primeru ne sme preseči 1,95 g/m2/dan.
Therefore, CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Torej se CYSTAGON ne sme uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno.
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek!
If any skin or bone abnormalities appear, please inform your doctor immediately.
Če se pojavijo kakršnekoli nenormalnosti kože ali kosti, prosimo, da nemudoma obvestite svojega zdravnika.
Starting doses should be 1/4 to 1/6 of the expected maintenance dose, increased gradually over 46 weeks to avoid intolerance.
Začetni odmerki znašajo 1/4 do 1/6 pričakovanega vzdrževalnega odmerka, povečujejo pa se postopoma skozi 4 do 6 tednov, da ne bi prišlo do neprenašanja.
Your doctor could require a regular physical and X-ray examination for the skin and the bones to control the effects of the medicinal product.
Zdravnik bo mogoče potreboval redne telesne preglede in rentgenske preiskave kože in kosti, da bo lahko kontroliral učinke zdravila.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
WHAT CYSTAGON IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CYSTAGON IN ZA KAJ GA UPORABLJAMO
If you forget to take CYSTAGON:
Če ste pozabili vzeti zdravilo CYSTAGON:
Date of latest renewal: 23 June 2007
Datum zadnjega podaljšanja: 23. junij 2007
Self-examination of the skin by the patient or the parents should also be advised.
Bolniku ali staršem je treba priporočiti tudi samopregledovanje kože.
This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/ m2/day.
To odgovarja pri podganah 0,6 g/m2/dan, kar je manj kot polovica priporočanega kliničnega vzdrževalnega odmerka cisteamina, tj. 1,30 g/m2/dan.
The effect on pregnancy of untreated cystinosis is also unknown.
Vpliv nezdravljene cistinoze na nosečnost tudi ni znan.
Uncommon: Leukopenia
Občasno: levkopenija
The mixed disulfide is then exported from the lysosomes by an intact lysine transport system.
Mešani disulfid se nato prenaša iz lizosomov preko intaktnega sistema za transport lizina.
CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi syndrome as well as vitamin D and thyroid hormones.
CYSTAGON se lahko daje skupaj s terapijo za nadomeščanje elektrolitov in mineralov, ki je potrebna za obvladovanje Fanconijevega sindroma, kot tudi z vitaminom D in ščitničnimi hormoni.
When starting therapy, you or your child should not engage in potentially hazardous activities until the effects of the drug are well known.
Ob uvedbi terapije se vi ali vaš otrok ne smete ukvarjati s potencialno nevarnimi dejavnostmi, dokler učinki zdravila niso povsem znani.
The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
Poročali so o naslednjih neželenih učinkih: zelo pogostih (pojavijo se pri najmanj 1 od 10 bolnikov), pogostih (pojavijo se pri najmanj 1 od 100 bolnikov), občasnih (pojavijo se pri najmanj 1 od 1.000 bolnikov), redkih (pojavijo se pri najmanj 1 od 10.000 bolnikov), zelo redkih (pojavijo se pri najmanj 1 od 100.000 bolnikov).
There are no adequate data from the use of cysteamine bitartrate in pregnant women.
Ni ustreznih podatkov o uporabi cisteaminijevega bitartrata pri nosečnicah.
Experience suggests that foods such as milk, potatoes and other starch based products seem to be appropriate for mixing with the powder.
Po izkušnjah sodeč so mleko, krompir in druge jedi na osnovi škroba primerni za mešanje s praškom.
Very limited data suggest that cysteamine pharmacokinetic parameters may not be significantly modified in patients with mild to moderate renal insufficiency.
Zelo omejeni podatki kažejo, da se farmakokinetični parametri za cisteamin pri bolnikih z blago do zmerno okvaro ledvic ne morejo bistveno spreminjati.
Make sure you know how you or your child reacts to this medicine before doing anything that could be dangerous if not alert.
Ugotovite, kako vi ali vaš otrok reagira na to zdravilo, preden se lotite česa takega, kar bi ob zmanjšani pozornosti lahko bilo nevarno.
Uncommon: Nephrotic syndrome
Občasno: nefrotski sindrom
For children up to age 12 years, the dose will be based on the body size (surface area), the usual dose being 1.30 g/m2 of body surface area per day.
Pri otrocih do 12. leta starosti bo odmerek temeljil na velikosti telesa (površini), običajni odmerek je 1,30 g/m2 telesne površine na dan.
In contrast to phosphocysteamine, CYSTAGON does not contain phosphate.
V nasprotju s fosfocisteaminom CYSTAGON ne vsebuje fosfata.
The plasma protein binding in patients at steady state is similar: 53.1 % ( 3.6) and 51.1 % ( 4.5) at 1.5 and 6 hours post-dose, respectively.
Vezava na plazemske proteine pri bolnikih v stanju dinamičnega ravnovesja je podobna: 53,1 % ( 3,6) in 51,1 % ( 4,5) 1,5 in 6 ur po odmerku.
Self examination of your or your child's skin is recommended.
Priporočamo samopregledovanje vaše kože ali kože vašega otroka.
Among cysteamine patients, glomerular function was maintained over time.
Pri bolnikih, ki so prejemali cisteamin, je bila glomerularna funkcija ves čas ohranjena.
Patients on treatment maintained growth as compared to untreated patients.
Zdravljeni bolniki so v primerjavi z nezdravljenimi še naprej rasli.
CYSTAGON is contraindicated in patients who have developed hypersensitivity to penicillamine.
CYSTAGON je kontraindiciran pri bolnikih, ki so razvili preobčutljivost za penicilamin.
In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate ( sd) for the terminal half-life of elimination was 4.8 ( 1.8) hours.
V 24-urni farmakokinetični študiji pri 24 zdravih prostovoljcih je bila povprečna ( sd) končna razpolovna doba izločanja 4,8 ( 1,8) h.
Pharmacotherapeutic group: Alimentary tract and metabolism product, ATC code: A16AA04.
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, oznaka ATC: A16AA04.
Indomethacin and CYSTAGON have been used simultaneously in some patients.
Pri nekaterih bolnikih sta bila sočasno uporabljena indometacin in CYSTAGON.
The use of doses higher than 1.95g/m2/day is not recommended (see sections 4.2 and 4.8).
Uporabe odmerkov, večjih od 1,95 g/m2/dan, ne priporočajo (glejte poglavji 4.2 in 4.8).
Take special care with CYSTAGON - When your or your child's disorder has been confirmed by leucocyte cystine measurements, the therapy with CYSTAGON must be started as soon as possible.
Bodite posebno pozorni pri uporabi zdravila CYSTAGON - Ko vašo bolezen ali bolezen vašega otroka potrdijo z meritvami cistina v levkocitih, se mora zdravljenje z zdravilom CYSTAGON začeti čimprej.
In cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
V nekaj primerih, pri katerih so opravili histopatološko preiskavo kože, so rezultati kazali na angioendoteliomatozo.
Like all medicines, CYSTAGON can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo CYSTAGON neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If any similar skin or bone abnormalities appear, it is recommended to decrease the dose of CYSTAGON.
Če se pojavijo kakšne podobne nenormalnosti kože ali kosti, priporočamo, da zmanjšate odmerek zdravila CYSTAGON.
- Regular blood tests to measure the amount of cystine inside white blood cells are necessary to help determine the correct dose of CYSTAGON.
- Redni pregledi krvi z merjenjem količine cistina v belih krvničkah so potrebni za lažje določanje pravilnega odmerka CYSTAGONa.
- Hard capsules should not be given to children under approximately six years of age because they may not be able to swallow them and they may choke.
- Do približno 6. leta starosti otrokom ne smete dajati trdih kapsul, ker jih morda ne bodo mogli pogoltniti in se lahko zadušijo.
HOW TO USE CYSTAGON
KAKO UPORABLJATI CYSTAGON
Treatment with CYSTAGON should continue indefinitely, as instructed by your doctor.
Zdravljenje s CYSTAGONom je treba nadaljevati neprekinjeno, tako kot vam je naročil vaš zdravnik.
The WBC levels should be measured 5 to 6 hours after dosing and should be checked frequently when initiating therapy (e.g. monthly) and every 3-4 months when on a stable dose.
Koncentracijo v L je treba določati 5 do 6 ur po odmerjanju ter jo v začetnem obdobju zdravljenja pogosto preverjati (npr. enkrat mesečno), ob že ustaljenem odmerjanju pa vsake 3 - 4 mesece.
Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
Digestive tolerance of cysteamine is improved when the medicinal product is taken just after or with food.
Toleranca prebavil za cisteamin se izboljša, če bolnik zdravilo jemlje neposredno po jedi ali med jedjo.
CYSTAGON should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.6 and section 5.3), as it is teratogenic in animals.
CYSTAGON se ne sme uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno (glejte poglavje 4.6 ter poglavje 5.3), ker se je pri živalih izkazal kot teratogen.
At this dose, weight gain and survival of the offspring during lactation was also reduced.
Pri tem odmerku se je zmanjšal tudi prirastek telesne mase in preživetje mladičev v obdobju laktacije.
The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m2/day.
Maksimalni odmerek CYSTAGONa v kliničnih študijah je znašal 1,95 g/m2/dan.
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.
Cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
V 6 mesecih od začetka terapije poročajo o primerih nefrotskega sindroma, kjer je po ukinitvi terapije prišlo do progresivnega izboljšanja.
CYSTAGON is prescribed to manage this rare inherited disorder.
CYSTAGON se predpisuje za zdravljenje te redke dedne bolezni.
Intact CYSTAGON hard capsules should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Otrokom, mlajšim od 6 let, ne smete dajati celih trdih kapsul CYSTAGONa zaradi tveganja aspiracije (glejte poglavje 4.2).
If several doses of the supplements are missed or weakness or drowsiness develops, call the doctor for instructions.
Če ste izpustili več odmerkov dodatkov ali se pojavi oslabelost ali zaspanost, pokličite zdravnika in ga vprašajte za nasvet.
No carcinogenic studies have been conducted with CYSTAGON.
Študij kancerogenosti CYSTAGONa niso izvajali.
The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4).
Uporabe odmerkov, večjih od 1,95 g/m2/dan, ne priporočajo (glejte poglavje 4.4).
CYSTAGON may cause some drowsiness.
CYSTAGON lahko povzroča zaspanost.
However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), breast-feeding is contra-indicated in women taking CYSTAGON.
Vendar pa je - glede na rezultate študij na živalih pri doječih materah in novorojenih mladičih (glejte poglavje 5.3) - dojenje pri ženskah, ki jemljejo CYSTAGON, kontraindicirano.
Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to 1/10) and uncommon (≥1/1,000 to 1/100).
Pogostnost je opredeljena kot: zelo pogosto ((≥ 1/10); pogosto (≥1/100 to 1/10) in občasno (≥1/1,000 to 1/100).
It is therefore recommended to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
Zato priporočajo redno spremljanje kože in po potrebi rentgensko slikanje kosti.
Since some of these side effects are serious, ask your or your child's doctor to explain their warning signs.
Ker so nekateri od teh neželenih učinkov resni, se o njihovih opozorilnih znakih posvetujte s svojim ali otrokovim zdravnikom.
4.1 Therapeutic indication
KLINIČNI PODATKI 4.1 Terapevtske indikacije
Common: Liver function tests abnormal
Pogosto: nenormalni jetrni funkcijski testi
For children under approximately six years of age, the hard capsule may be opened and the contents sprinkled on food (e.g. milk, potatoes or starch based foods) or mixed in formula.
Pri otrocih, mlajših od 6 let, lahko trde kapsule odprete in vsebino stresete na obrok hrane (npr. mleko, krompir ali močnate jedi) ali primešate nadomestnemu mleku.
Reproduction studies showed embryofoetotoxic 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 poimplantacijske izgube) pri podganah v odmerku 100 mg/kg/dan in pri kuncih, ki so dobivali cisteamin, v odmerku 50 mg/kg/dan.
In children who are at risk of aspiration, aged approximately 6 years and under, the hard capsules should be opened and the content sprinkled on food.
Pri otrocih do 6. leta starosti, pri katerih obstaja nevarnost aspiracije, je treba trde kapsule odpreti in vsebino stresti na obrok pripravljene hrane.
Monitoring of blood cell count is recommended on a regular basis.
Priporočljivo je redno kontroliranje krvne slike.
Cysteamine mechanism of action by interfering with the cross-linking of collagen fibers has been postulated (see section 4.4).
Postulirali so cisteaminski mehanizem delovanja z oviranjem nastajanja prečnih vezi med kolagenskimi vlakni (glejte poglavje 4.4).
A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Zmanjšanje fertilnosti pri podganah so opazili pri 375 mg/kg/dan, tj. pri odmerku, pri katerem je prišlo do zastoja v porastu telesne mase.
Cystinosis is a metabolic disease called ‘nephropathic cystinosis' which is characterized by 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 presnovna bolezen, ki se imenuje ‘nefropatska cistinoza' in za katero je značilno nenormalno kopičenje aminokisline cistina v različnih telesnih organih, npr. ledvicah, očeh, mišicah, trebušni slinavki in možganih.
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 nabiranje cistina v nekaterih celicah (npr. levkocitih, mišičnih in jetrnih celicah) pri bolnikih s cistinozo in, če se zdravljenje začne dovolj zgodaj, zavira nastanek ledvične odpovedi.
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Visoki odmerki cisteamina, bodisi peroralni ali parenteralni, povzročajo razjede na dvanajstniku pri podganah in miših, ne pa tudi pri opicah.
• For children up to age 12 years, CYSTAGON dosing should be on the basis of body surface area (g/m 2/day).
• Pri otrocih do 12. leta starosti je treba CYSTAGON odmerjati na podlagi telesne površine (g/m2/dan).
For patients over age 12 and over 50 kg weight, the usual dose is 2g/day.
Pri bolnikih, starejših od 12 let in težjih od 50 kg, je običajni odmerek 2 g/dan.
- In contrast to phosphocysteamine, another active substance close to cysteamine bitartrate, CYSTAGON does not contain phosphate.
- V nasprotju s fosfocisteaminom, ki je druga zdravilna učinkovina, sorodna cisteaminijevemu bitartratu, CYSTAGON ne vsebuje fosfata.
The decrease in leucocyte cystine levels is correlated to the cysteamine plasma concentration over the six hours following the administration of CYSTAGON.
Zmanjšanje koncentracije cistina v levkocitih je sorazmerno s plazemskimi koncentracijami cisteamina v šestih urah po aplikaciji CYSTAGONa.
An earlier study treated 94 children with nephropathic cystinosis with increasing doses of cysteamine to attain white cell cystine levels of less than 2 nmol hemicystine/mg protein 5 to 6 hours post-dose, and compared their outcome with an historical control group of 17 children treated with placebo.
V eni od zgodnejših študij je bilo 94 otrok z nefropatsko cistinozo zdravljenih z naraščajočimi odmerki cisteamina, da bi dosegli padec koncentracije cistina v levkocitih pod vrednost 2 nmol hemicistina/mg beljakovin 5 do 6 ur po odmerku, dobljene rezultate pa so primerjali z arhivsko kontrolno skupino 17 otrok, ki so prejemali placebo.
CYSTAGON treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis.
Zdravljenje s CYSTAGONom se sme uvesti le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem cistinoze.
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 4 bolnikih se je izločanje cisteamina v nespremenjeni obliki gibalo med 0,3 % in 1,7 % celotnega dnevnega odmerka; večina cisteamina se izloča v obliki sulfata.
Renal tubular function was not affected by treatment.
Zdravljenje ni prizadelo tubularne funkcije ledvic.
Gastrointestinal disorders
Občasno: gastrointestinalne razjede
Placebo treated patients, in contrast, experienced a gradual rise in serum creatinine.
Nasprotno pa se je pri bolnikih, ki so prejemali placebo, serumski kreatinin začel postopno zviševati.
Genotoxicity studies have been performed: although in published studies using cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported, specific studies with cysteamine bitartrate did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test.
Opravljene so bile študije genotoksičnosti: Čeprav v objavljenih študijah cisteamina poročajo o pojavu kromosomskih aberacij pri gojenih vrstah eukariotskih celic, v posebnih študijah s cisteaminijevim bitartratom Amesov test ni potrdil mutagenega učinka, enako kot tudi test mikrojeder pri miših ni potrdil klastogenosti.
Do not use after the expiry date which is stated on the label.
Zdravila CYSTAGON ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
The recommended dose is 1.30 g/m 2/day of the free base divided four times daily.
Priporočeni odmerek je 1,30 g/m2/dan proste baze, porazdeljeno v 4 odmerke na dan.
Most patients will already be receiving phosphate supplements and the dose of these may need to be altered when CYSTAGON is substituted for phosphocysteamine.
Večina bolnikov bo že prejemala fosfatne dodatke in bo zato morda potrebno ob nadomestitvi fosfocisteamina s CYSTAGONom njihovo odmerjanje ustrezno spremeniti.
The in vitro plasma protein binding of cysteamine, which is mostly to albumin, is independent of plasma drug concentration over the therapeutic range, with a mean ( sd) value of 54.1 % ( 1.5).
In vitro vezava cisteamina na plazemske proteine, pretežno na albumin, ni odvisna od koncentracije zdravila v plazmi v terapevtskem razponu, s povprečno vrednostjo ( sd) 54,1 % ( 1,5).
In some patients, the skin lesions on elbows regressed after CYSTAGON dose reduction.
Pri nekaterih bolnikih so kožne lezije na komolcih po zmanjšanju odmerka zdravila CYSTAGON regredirale.
A closer monitoring of the leucocyte cystine levels is recommended in these patients.
Pri teh bolnikih je priporočljivo še bolj skrbno spremljati koncentracijo cistina v levkocitih.
- Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
- Občasno: kožne strije, kožne lezije (trde bulice na komolcih), ohlapni sklepi, bolečine v spodnjih udih, zlomi kosti, skolioza (deformacija hrbtenice), deformacije in krhkost kosti, sprememba barve las, težke alergijske reakcije, zaspanost, krči, živčnost, halucinacije, padec števila belih krvničk, razjeda prebavnega trakta, ki se kaže kot krvavitev iz prebavil, ter prizadetost ledvic, ki je razvidna iz oteklih okončin in porasta telesne mase.
Bottles of 100 or 500 hard capsules.
Steklenice, ki vsebujejo po 100 ali 500 trdih kapsul.
High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Visoki odmerki cisteamina zmanjšujejo sposobnost samic, da v obdobju laktacije prehranjujejo svoje mladiče.
In some cases, these skin lesions were associated with vascular proliferation, skin striae and bone lesions first seen during an X-ray examination.
V nekaterih primerih so bile te kožne lezije povezane z vaskularno proliferacijo, kožnimi strijami in lezijami kosti, ki so jih najprej opazili pri rentgenskem slikanju.
Do not use CYSTAGON - if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of Cystagon.
Ne uporabljajte zdravila CYSTAGON: - če ste sami ali če je vaš otrok alergičen na (preobčutljiv za) cisteaminijev bitartrat ali penicilamin ali katerokoli drugo sestavino zdravila CYSTAGON; - če ste noseči, to je še posebno pomembno v prvem trimesečju; - če dojite.