natgillin/translations-raw huggingface dataset:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yescarta have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Yescarta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Serious side effects, particularly cytokine release syndrome, can occur; however these are manageable if appropriate measures are in place (see below). 
Lahko se pojavijo resni neželeni učinki, zlasti sindrom sproščanja citokinov, vendar so ob ustreznih ukrepih (glejte v nadaljevanju) obvladljivi.
Of the patients who joined the study, 47% had a complete response (which means they had no signs of the cancer left) and 66% had at least a partial response after treatment with Yescarta. 
Pri 47 % bolnikov, ki so se pridružili študiji, je prišlo do popolnega odziva (kar pomeni, da niso več imeli znakov raka), pri 66 odstotkih bolnikov pa je po zdravljenju z zdravilom Yescarta prišlo do vsaj delnega odziva.
The company that markets Yescarta must ensure that hospitals where Yescarta is given have appropriate expertise, facilities and training. 
Podjetje, ki trži zdravilo Yescarta, mora zagotoviti, da je v bolnišnicah, v katerih se daje to zdravilo, na voljo ustrezna oprema ter ima osebje ustrezno strokovno znanje in izkušnje in je ustrezno usposobljeno.
These results were better than those from studies of patients receiving standard cancer treatments, where around 7% of patients had a complete response and around 26% had at least a partial response. 
Ti izidi so bili boljši kot izidi študij pri bolnikih, ki so prejemali standardna zdravila proti raku, saj je do popolnega odziva prišlo pri 7 % teh bolnikov, do vsaj delnega odziva pa pri 26 % bolnikov.
What are the risks associated with Yescarta? 
Kakšna tveganja so povezana z zdravilom Yescarta?
Yescarta is for adult patients whose blood cancer has returned or has stopped responding to previous treatment. 
Zdravilo Yescarta je namenjeno odraslim bolnikom, pri katerih se je krvni rak ponovil ali se je prenehal odzivati na predhodno zdravljenje.
When Yescarta is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body. 
Po dajanju zdravila Yescarta bolniku se spremenjene celice T pritrdijo na rakave celice in jih uničijo, s tem pa pripomorejo k odstranjevanju raka iz telesa.
A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below). 
Na voljo morata biti zdravilo tocilizumab in nujna medicinska oprema za primer, da bi se pri bolniku pojavil resen neželeni učinek, imenovan sindrom sproščanja citokinov (glejte oddelek o tveganjih v nadaljevanju).
A main study of 111 patients with DLBCL and PMBCL that was not responding to previous treatment or had returned showed that Yescarta is effective at clearing the cancer in many patients. 
Glavna študija pri 111 bolnikih z difuznim velikoceličnim B-limfomom ali primarnim mediastinalnim velikoceličnim B-limfomom, ki se nista odzvala na predhodno zdravljenje ali sta se ponovila, je pokazala, da zdravilo Yescarta pri številnih bolnikih učinkovito odstrani raka.
Yescarta contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR). 
Zdravilo Yescarta vsebuje bolnikove lastne celice T (vrsto belih krvnih celic), ki so bile v laboratoriju gensko spremenjene tako, da tvorijo beljakovino, imenovano himerni antigenski receptor (CAR).
For the full list of side effects and restrictions with Yescarta, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Yescarta glejte navodilo za uporabo.
Yescarta is a type of advanced therapy medicine called a ‘gene therapy product'. 
Zdravilo Yescarta spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
The blood cancers that Yescarta is used to treat are rare, and Yescarta was designated an ‘orphan medicine' (a medicine used in rare diseases) for DLBCL on 16 December 2014 and for PMBCL on 9 October 2015. 
Obliki krvnega raka, za kateri se uporablja zdravilo Yescarta, sta redki, zato je bilo zdravilo Yescarta 16. decembra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje difuznega velikoceličnega B-limfoma in 9. oktobra 2015 kot „zdravilo sirota“ za zdravljenje primarnega mediastinalnega velikoceličnega B-limfoma.
Yescarta is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory. 
Zdravilo Yescarta se pripravi iz bolnikovih lastnih belih krvnih celic, pridobljenih iz krvi in gensko spremenjenih v laboratoriju.
It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion. 
Pred prejemom zdravila Yescarta je treba bolnika kratkotrajno zdraviti s kemoterapijo, da se iz krvi odstranijo obstoječe bele krvne celice, tik pred infuzijo pa bolnik prejme še paracetamol in antihistaminik za zmanjšanje tveganja reakcije na infuzijo.
• primary mediastinal large B-cell lymphoma (PMBCL). 
• primarnega mediastinalnega velikoceličnega B-limfoma.
Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells). 
Zdravilo Yescarta vsebuje učinkovino aksicabtagen ciloleucel (ta vsebuje gensko spremenjene bele krvne celice).
• diffuse large B-cell lymphoma (DLBCL); 
• difuznega velikoceličnega B-limfoma;
A main study showed that Yescarta is effective at clearing the cancer in many patients with DLBCL and PMBCL that was not responding to previous treatment or had returned. 
Glavna študija je pokazala, da zdravilo Yescarta učinkovito odstrani raka pri številnih bolnikih z difuznim velikoceličnim B-limfomom ali primarnim mediastinalnim velikoceličnim B-limfomom, ki se nista odzvala na predhodno zdravljenje ali sta se ponovila.
How is Yescarta used? 
Kako se zdravilo Yescarta uporablja?
How does Yescarta work? 
Kako zdravilo Yescarta deluje?
Two other studies have shown similar results. 
Dve drugi študiji sta dali podobne rezultate.
Please consult your doctor if you plan to become pregnant. 
Prosimo, posvetujte se s svojim zdravnikom, če načrtujete nosečnost.
Do not increase or decrease the amount of medicine without your doctor's approval. 
Ne povečujte ali zmanjšujte količine zdravila brez odobritve svojega zdravnika.
The potential risk for humans is unknown. 
Potencialno tveganje za človeka pa ni znano.
It is important to take the dose as close to every 6 hours as possible. 
Pomembno je jemati odmerke kar se da točno vsakih 6 ur.
Approximately 35% of patients can be expected to experience adverse reactions. 
Pri približno 35 % bolnikov lahko pričakujemo pojav neželenih učinkov.
Your or your child's doctor will arrange for the blood tests to be done. 
Vaš ali otrokov zdravnik bo odredil izvajanje krvnih testov.
PACKAGE LEAFLET: INFORMATION FOR THE USER 
NAVODILO ZA UPORABO: INFORMACIJEZA UPORABNIKA
In all studies, patient response was better when treatment was started at an early age with good renal function. 
V vseh študijah je bil odgovor bolnikov boljši, kadar se je zdravljenje začelo v zgodnji starosti, ob ustrezno dobrem delovanju ledvic.
If a dose of medicine is missed, it should be taken as soon as possible. 
Če je bil odmerek zdravila izpuščen, ga je treba vzeti kakor hitro je to mogoče.
CYSTAGON may cause some people to become drowsy or less vigilant than they are normally. 
CYSTAGON lahko pri nekaterih ljudeh povzroči, da postanejo zaspani ali manj pozorni kot običajno.
Very common: Anorexia 
Zelo pogosto: anoreksija
No interaction studies have been performed 
Študij medsebojnega delovanja niso izvedli.
Do not add to acidic drinks e.g. orange juice. 
Ne dodajajte zdravila kislim pijačam, npr. pomarančnemu soku.
black ink on hard capsules containing E172 
črnilo na trdi kapsuli, ki vsebuje E172.
Different organs are affected at different ages. 
Prizadetost različnih organov se pokaže v različnih starostih bolnika.
Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately. 
Če pride do prevelikega odmerjanja, je treba uvesti ustrezno respiratorno in kardiovaskularno podporno zdravljenje.
When these effects appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance. 
Kadar se ti učinki pojavijo ob uvedbi zdravljenja s cisteaminom, lahko začasna prekinitev in ponovno postopno uvajanje terapije učinkovito izboljša toleranco.
- Your or your child's medical treatment may include, in addition to CYSTAGON, one or more supplements to replace important electrolytes lost through the kidneys. 
- Vaše ali otrokovo zdravljenje lahko vključuje poleg CYSTAGONa še enega ali več dodatkov za nadomeščanje pomembnih elektrolitov, ki se izgubljajo skozi ledvice.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriouness 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Consult the doctor for complete directions. 
Za podrobnejša navodila se posvetujte z zdravnikom.
It is important to take or give these supplements exactly as instructed. 
Važno je, da se ti dodatki dajejo oz. jemljejo točno po navodilih.
No information is available for patients with severe renal insufficiency. 
Ni na razpolago podatkov za bolnike s hudo okvaro ledvic.
The principal efficacy measurements were serum creatinine and calculated creatinine clearance and growth (height). 
Glavna merila učinkovitosti so bila: serumski kreatinin, izračunani očistek kreatinina in rast (višina).
Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3). 
V študijah na živalih je bila ugotovljena reproduktivna toksičnost vključno s teratogenezo (glejte poglavje 5.3).
If you use more CYSTAGON than you should: 
Če ste uporabili večji odmerek zdravila CYSTAGON, kot bi smeli:
CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food. 
CYSTAGON je treba jemati 4-krat na dan, vsakih 6 ur, po možnosti takoj po jedi ali med jedjo.
CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells. 
CYSTAGON je zdravilo, ki reagira s cistinom in tako znižuje njegovo raven znotraj celic.
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.