natgillin/translations-raw huggingface dataset:
Women of child-bearing potential should be advised to use an adequate method of contraception during the course of treatment;
Ženama koje mogu zatrudnjeti mora se savjetovati da koriste odgovarajuću metodu kontracepcije tijekom liječenja;
Should overdosing occur, the respiratory and cardiovascular systems should be supported appropriately.
Ukoliko dođe do predoziranja, mora se omogućiti odgovarajuća potpora dišnog i srčanožilnog sustava.
This medicine may cause some drowsiness.
Ovaj lijek može uzrokovati omamljenost.
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.
Najmanje 1 sat prije i 1 sat poslije uzimanja lijeka PROCYSBI pokušajte izbjegavati obroke bogate mastima ili proteinima, kao i svaku hranu ili tekućinu koja može smanjiti kiselost u želucu, poput mlijeka ili jogurta.
Uncommon: Leukopenia
Manje često: Leukopenija
Newly diagnosed adult patients should be started on 1/6 to 1/4 of the targeted maintenance dose of PROCYSBI.
Novodijagnosticirani odrasli bolesnici moraju započeti s 1/6 do 1/4 ciljne doze održavanja lijeka PROCYSBI.
If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary.
Ako se razviju simptomi SŽS-a, bolesnik se mora pažljivo procijeniti i doza se mora po potrebi prilagoditi.
These tests must be obtained 12.5 hours after the evening dose the day before, and therefore 30 minutes after the following morning dose is given.
Te pretrage moraju se provesti 12,5 sati nakon večernje doze prethodnog dana i stoga 30 minuta nakon što se primijeni iduća jutarnja doza.
A white plastic bottle contains 250 capsules.
Bijela plastična boca sadrži 250 kapsula.
Cysteamine is the simplest stable aminothiol and a degradation product of the amino acid cysteine.
Cisteamin je najjednostavniji stabilni aminotiol i proizvod razgradnje aminokiseline cisteina.
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.
Eliminacija nepromijenjenog cisteamina urinom dokazana je u rasponu između 0,3% i 1,7% ukupne dnevne doze kod četiri ispitanika; glavnina cisteamina se izlučuje u obliku sulfata.
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
Četrdeset tri (43) ispitanika je nasumično raspodijeljeno u skupine; dvadeset sedmero (27) djece (starosti od 6 do 12 godina), petnaest (15) adolescenata (starosti od 12 do 21 godine) i jedan (1) odrasli s cistinozom i nativnom bubrežnom funkcijom na temelju procijenjene brzine glomerularne filtracije (GFR) (korigirane za površinu tijela) > 30 ml/minuti/1,73 m2.
In some cases, these skin lesions were associated with skin striae and bone lesions first seen during an X-ray examination.
U nekim slučajevima te su kožne lezije povezane sa strijama i lezijama kostiju koje su prvo uočene rendgenskim pregledom.
Patients should not engage in potentially hazardous activities until the effects of cysteamine on mental performance are known (see section 4.7).
Bolesnici ne smiju obavljati potencijalno opasne aktivnosti sve dok nisu poznati učinci cisteamina na mentalnu sposobnost (vidjeti dio 4.7).
Physicians should routinely monitor the skin and bones of patients receiving cysteamine.
Liječnici moraju rutinski pregledavati kožu i kosti bolesnika koji primaju cisteamin.
There is no adequate data from the use of cysteamine in pregnant women.
Ne postoje odgovarajući podaci o primjeni cisteamina u trudnica.
Of those forty-three (43) patients, two (2) siblings withdrew at the end of the first crossover period, due to a prior planned surgery in one (1) of them; forty-one (41) patients completed the protocol.
Od tih četrdeset tri (43) ispitanika, dva (2) srodnika su se povukla iz ispitivanja na kraju prvog ukriženog razdoblja, zbog prethodno planirane operacije kod jednog (1) od njih; četrdeset jedan (41) ispitanik je završio plan ispitivanja.
Cysteamine bitartrate should not be administered with food rich in fat or proteins, or with frozen food like ice-cream.
Cisteaminhidrogentartarat se ne smije primjenjivati uz hranu bogatu mastima ili proteinima, ili uz smrznutu hranu kao što je sladoled.
- Your medical treatment may include, in addition to cysteamine, one or more supplements to replace important electrolytes lost through the kidneys.
- Vaše liječenje može uključivati, uz cisteamin, jedan ili više nadomjestaka kako bi se nadomjestili važni elektroliti koji se gube kroz bubrege.
•Guidance on appropriate patient selection and dose titration.
• Smjernice o odgovarajućem odabiru bolesnika i titraciji doze.
Your doctor will routinely monitor your skin and bones and reduce or stop your treatment if needed (see section 4).
Vaš liječnik će rutinski pratiti Vašu kožu i kosti te po potrebi smanjiti dozu ili prekinuti liječenje (pogledajte dio 4.).
Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući teratogenezu (vidjeti dio 5.3).
When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known.
Na početku liječenja, bolesnici ne smiju obavljati potencijalno opasne aktivnosti sve dok nisu poznati učinci lijeka na pojedinca.
Since oral cysteamine doesn't prevent deposits of cystine crystals in the eye, you should continue taking cysteamine eye drops as prescribed by your doctor.
Kako oralni cisteamin ne sprečava odlaganje kristala cistina u oku, morate i dalje nastaviti uzimati cisteaminske kapi za oči kako Vam je propisao Vaš liječnik.
The in vitro plasma protein binding of cysteamine, primarily to albumin, is approximately 54% and independent of plasma drug concentration over the therapeutic range.
Vezanje cisteamina na proteine plazme in vitro, primarno na albumin, iznosi približno 54% i neovisno je koncentraciji lijeka u plazmi unutar terapijskog raspona.
PROCYSBI is a medicine that reacts with cystine to decrease its level within the cells.
PROCYSBI je lijek koji reagira s cistinom kako bi smanjio njegovu razinu unutar stanica.
An overdose of cysteamine may cause progressive lethargy.
Predoziranje cisteaminom može uzrokovati progresivnu letargiju.
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.
Ako planirate trudnoću ili zatrudnite, odmah potražite savjet svog liječnika o prekidu liječenja ovim lijekom jer nastavak može naškoditi nerođenom djetetu.
-0.21 ± 0.14; -0.48 to 0.06; <0.001
-0,21 ± 0,14; -0,48 do 0,06; <0,001
Co-administration with electrolyte and mineral replacement
Istovremena primjena s nadomjescima elektrolita i minerala
If you take more PROCYSBI than you should
Ako uzmete više lijeka PROCYSBI nego što ste trebali
Central nervous system symptoms: Some patients taking cysteamine have developed seizures, depression, and become too sleepy (excessive sleepiness).
Simptomi središnjeg živčanog sustava (SŽS): Neki bolesnici koji uzimaju cisteamin su razvili napadaje, depresiju i postali suviše pospani (pretjerana pospanost).
High doses of cysteamine impair the ability of lactating mothers to feed their pups.
Visoke doze cisteamina smanjuju sposobnost ženki koje doje da hrane svoje mladunce.
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).
Ako se razvije teški kožni osip kao što je erythema multiforme bullosa ili toksična epidermalna nekroliza, cisteamin se ne smije ponovno primjenjivati (vidjeti dio 4.8).
EXP Discard 30 days after opening the foil seal.
EXP Baciti 30 dana nakon otvaranja zaštitne folije.
Do not use this medicine after the expiry date, which is stated on the carton and the bottle label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na boci iza oznake „EXP“.
Food intake two hours after administration did not affect the absorption of PROCYSBI.
Uzimanje hrane dva sata nakon primjene nije utjecalo na apsorpciju lijeka PROCYSBI.
The targeted maintenance dose is 1.3 g/m2/day, in two divided doses, given every 12 hours.
Ciljna doza održavanja je 1,3 g/m2/dan, podijeljena u dvije doze koje se uzimaju svakih 12 sati.
• Hypersensitivity to penicillamine.
• Preosjetljivost na penicilamin.
• Hypersensitivity to the active substance, any form of cysteamine (mercaptamine), or to any of the excipients listed in section 6.1.
• Preosjetljivost na djelatnu tvar, bilo koji oblik cisteamina (merkaptamin) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Very common side effects (may affect more than 1 in 10 people): diarrhoea fever sensation of sleep
Vrlo česte nuspojave (mogu zahvatiti više od 1 na 10 osoba): proljev vrućica pospanost
Duration of treatment Treatment with PROCYSBI should continue life-long, as instructed by your doctor.
Trajanje liječenja Liječenje lijekom PROCYSBI mora se nastaviti cijeli život, kako Vas je uputio liječnik.
Other medicines and PROCYSBI
Drugi lijekovi i PROCYSBI
Per -Protocol (PP) Population (N=39) Immediate-release cysteamine bitartrate
Populacija prema planu (PP) ispitivanja (N=39) Trenutno oslobađanje cisteaminhidrogentartarat
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.
Četrdeset od četrdeset jednog (40/41) ispitanika koji su završili pivotalno ispitivanje faze 3 ušlo je u prospektivno ispitivanje s lijekom PROCYSBI koje je ostalo otvoreno sve dok im njihov liječnik nije mogao propisati PROCYSBI.
Total daily dose should be divided by two and administered every 12 hours.
Ukupnu dnevnu dozu treba podijeliti s dva i primijeniti svakih 12 sati.
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.
Doza od 1,95 g/m2/dan cisteaminhidrogentartarata s trenutnim oslobađanjem povezana je s povećanom stopom prekida liječenja uslijed intolerancije i povećane incidencije štetnih događaja.
Food intake reduces the absorption of PROCYSBI at 30 minutes pre-dose (approximately 35% decrease in exposure) and at 30 min post-dose (approximately 16 or 45% decrease in exposure for intact and open capsules respectively).
Uzimanje hrane smanjuje apsorpciju lijeka PROCYSBI u trenutku od 30 minuta prije doze (smanjenje izloženosti od približno 35%) i 30 minuta poslije doze (smanjenje od približno 16 ili 45% izloženosti za cjelovitu i otvorenu kapsulu, navedenim redom).
Leukopenia and abnormal liver function
Leukopenija i abnormalna funkcija jetre
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.
Cistinoza je bolest koja zahvaća način na koji tijelo radi, s abnormalnim nakupljanjem aminokiseline cistina u različitim organima u tijelu kao što su bubrezi, oči, mišići, gušterača i mozak.
Therefore, where cysteamine ophthalmic solution is used for that purpose, its usage should continue.
Stoga, kad se za to koristi oftalmološka otopina cisteamina, treba nastaviti s njezinom uporabom.
PROCYSBI 75 mg hard capsule EU/1/13/861/002
PROCYSBI 75 mg tvrda kapsula EU/1/13/861/002
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 September 2013
Datum prvog odobrenja: 6. rujna 2013.
• The risk of teratogenicity and relevant risk minimisation advice: Women of childbearing potential should be informed about the risk of teratogenicity; For women of child-bearing potential a negative pregnancy test should be confirmed before starting treatment;
• Rizik od teratogenosti i važne savjete za smanjenje rizika: Žene koje mogu zatrudnjeti moraju biti obaviještene o riziku od teratogenosti; Za žene koje mogu zatrudnjeti mora se prije početka liječenja potvrditi negativni rezultat testa za trudnoću.
• 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).
• Mogućnost 2 / Šalica: Lagano miješajte u šalici 5 minuta ili lagano protresite 5 minuta u poklopljenoj šalici (npr. bočici za djecu).
• The need for monitoring of white blood cell cystine levels, full blood count and liver function.
• Potrebu za praćenjem razina cistina u leukocitima, kompletne krvne slike i jetrene funkcije.
You will receive regular eye examinations to identify this condition as early treatment can prevent vision loss.
Imat ćete redovite očne preglede kako bi ustanovili to stanje jer rano liječenje može spriječiti gubitak vida.
It is important to take PROCYSBI in a consistent way over time.
Važno je dosljedno uzimati PROCYSBI kroz dulje vrijeme.
In genotoxicity studies published for cysteamine, induction of chromosome aberrations in cultured eukaryotic cell lines has been reported.
U objavljenim ispitivanjima genotoksičnosti cisteamina opisana je indukcija kromosomskih aberacija u kulturi eukariotskih staničnih linija.
If any of the following side effects occur, please contact your doctor immediately.
Ako se pojavi bilo koja od sljedećih nuspojava, odmah se javite svom liječniku.
Tell your doctor right away if you get stomach ache, nausea, vomiting, loss of appetite, or throw up blood.
Odmah javite svom liječniku ako osjetite bol u trbuhu, mučninu, povraćanje, gubitak apetita ili povraćate krv.
What you need to know before you take PROCYSBI
Što morate znati prije nego počnete uzimati PROCYSBI
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.
Prosipanje u sok od naranče ili bilo koji kiseli voćni sok ili vodu Kapsule za jutarnju ili večernju dozu moraju se otvoriti i sadržaj se mora prosuti u približno 100 do 150 ml kiselog voćnog soka ili vode.
These include skin striae (which are like stretch marks), bone injuries (such as fractures), bone deformities, and joint problems.
To uključuje strije (koje izgledaju kao oznake rastezanja), ozljede kostiju (kao što su prijelomi), deformitete kostiju i probleme sa zglobovima.
• The need to monitor regularly skin and to consider X-ray examinations of the bone as necessary.
• Potrebu za redovitim praćenjem kože i da se po potrebi razmotre rendgenske pretrage kostiju.
Treatment may be restarted at a lower dose under close supervision, and then slowly titrated to the appropriate therapeutic dose (see sections 4.2).
Liječenje se može ponovno uvesti nižom dozom pod strogim nadzorom i potom se postupno titrirati do odgovarajuće terapijske doze (vidjeti dio 4.2).
If skin or bone abnormalities appear, the dose of cysteamine should be reduced or stopped.
Ako se pojave abnormalnosti kože ili kostiju, doza cisteamina mora se smanjiti ili se liječenje mora prekinuti.
This is equivalent to 0.6 g/m2/day in the rat, which is slightly less than the recommended clinical maintenance dose of cysteamine, i.e. 1.3 g/m2/day.
To odgovara dozi od 0,6 g/m2/dan kod štakora, što je malo manje od preporučene kliničke doze održavanja, tj. 1,3 g/m2/dan cisteamina.
Abnormal liver function on blood tests.
Abnormalna jetrena funkcija u pretragama krvi.
Cysteamine has occasionally been associated with reversible leukopenia and abnormal liver function.
Cisteamin se ponekad povezuje s reverzibilnom leukopenijom i abnormalnim rezultatima jetrene funkcije.
If your doctor prescribes bicarbonate, do not take it at the same time as PROCYSBI; take bicarbonate at least one hour before or at least one hour after the medicine.
Ako Vam liječnik propiše bikarbonate, nemojte ih uzimati istovremeno s lijekom PROCYSBI; uzmite bikarbonate najmanje jedan sad prije ili jedan sat poslije uzimanja lijeka.
What PROCYSBI is and what it is used for What you need to know before you take PROCYSBI How to take PROCYSBI
Što je PROCYSBI i za što se koristi Što morate znati prije nego počnete uzimati PROCYSBI
Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes.
Nakupljanje cistina uzrokuje oštećenje bubrega i izlučivanje povećane količine glukoze, proteina i elektrolita.
Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Teratogeni učinci su opisani kod štakora kad se cisteamin primjenjivao tijekom razdoblja organogeneze pri dozi od 100 mg/kg/dan.
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.
Cisteamin se može primjenjivati zajedno s nadomjescima elektrolita (osim bikarbonata) i minerala koji su potrebni za liječenje Fanconijeva sindroma kao i uz vitamin D i hormone štitne žlijezde.
Cysteamine has minor or moderate influence on the ability to drive and use machines.
Cisteamin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
• 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.
• Mogućnost 1 / Štrcaljka: Lagano miješajte 5 minuta, potom usišite smjesu granula cisteamina i kiselog voćnog soka ili vode u štrcaljku za doziranje.
High doses of cysteamine, either by oral or parenteral routes, produce duodenal ulcers in rats and mice but not in monkeys.
Visoke doze cisteamina, bilo oralnim ili parenteralnim putem, dovode do vrijedova na dvanaesniku kod štakora i miševa, no ne i kod majmuna.
You or your doctor will arrange for these blood tests to be performed.
Vaš liječnik će dogovoriti provođenje tih pretraga krvi.
If you forget to take PROCYSBI
Ako ste zaboravili uzeti PROCYSBI
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.
Nositelj odobrenja mora prije distribucije edukativnog paketa s nacionalnim regulatornim tijelom dogovoriti sadržaj i oblik edukativnih materijala, zajedno s planom komunikacije.
A few cases of Ehlers-Danlos-like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Prijavljeno je nekoliko slučajeva nalik na Ehlers-Danlosov sindrom na laktovima kod djece koja su kronično liječena visokim dozama različitih preparata cisteamina (cisteamin klorhidrat ili cisteamin ili cisteaminhidrogentartarat) uglavnom iznad maksimalne doze od 1,95 g/m2/dan.
Stomach and intestinal (gastrointestinal) problems: Patients taking cysteamine have developed ulcers and bleeding.
Problemi sa želucem i crijevima (gastroinstestinalni problemi): Bolesnici koji uzimaju cisteamin su razvili vrijedove i krvarenje.
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).
Međutim zbog rezultata ispitivanja na životinjama kod ženki koje su dojile i novorođenih mladunaca (vidjeti dio 5.3), kod žena koje uzimaju PROCYSBI dojenje je kontraindicirano (vidjeti dio 4.3).
Experimental administration of the drug causes depletion of somatostatin in several animal species.
Eksperimentalna primjena lijeka dovodi do smanjenja somatostatina kod nekoliko životinjskih vrsta.
Pharmacotherapeutic group: Other alimentary tract and metabolism product, ATC code: A16AA04.
Farmakoterapijska skupina: Ostali lijekovi s djelovanjem na probavni sustav i metabolizam, ATK oznaka: A16AA04.
However, if it is within 4 hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Međutim, ako je to unutar četiri sata prije sljedeće doze, preskočite dozu koju ste propustili i vratite se na pravilni raspored uzimanja.
In the few cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
U nekoliko slučajeva provedeni su histopatološki pregledi kože i rezultati su ukazivali na angioendoteliomatozu.
PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults.
PROCYSBI sadrži djelatnu tvar cisteamin (poznat i kao merkaptamin) i uzima se za liječenje nefropatske cistinoze kod djece i odraslih.
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.
Cisteamin sudjeluje unutar lizosoma u reakciji razmjene tiol-disulfid pretvarajući cistin u cistein i cistein-cisteamin miješani disulfid, od kojih oba mogu napustiti lizosom kod bolesnika s cistinozom.
- 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.
Potrebne su redovite pretrage krvi kako bi se izmjerila razina cistina u bijelim krvnim stanicama i/ili koncentracija cisteamina u krvi kako bi se lakše odredila točna doza lijeka PROCYSBI.
Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help you or your doctor correctly adjust the doses of these supplements.
Potrebne su i redovite pretrage krvi i mokraće kako bi se izmjerile razine važnih elektrolita u tijelu kako bi Vaš liječnik lakše prilagodio točnu dozu tih nadomjestaka.
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).
U kliničkim ispitivanjima koja uspoređuju PROCYSBI s cisteaminhidrogentartaratom s trenutnim oslobađanjem, jedna trećina ispitanika je imala vrlo česte GI poremećaje (mučnina, povraćanje i bol u abdomenu).
Cysteamine bitartrate is not an inhibitor of OAT1, OAT3 and OCT2.
Cisteaminhidrogentartarat nije inhibitor OAT1, OAT3 i OCT2.
The pharmacokinetics of cysteamine bitartrate has not been studied in special populations.
Farmakokinetika cisteaminhidrogentartarata nije se ispitivala na posebnim populacijama.
Effects on fertility have been seen in animal studies (see section 5.3).
Učinci na plodnost su uočeni tijekom ispitivanja na životinjama (vidjeti dio 5.3).
Skin lesions, bone lesions, and joint problems: Treatment with high doses of cysteamine can cause skin lesions to develop.
Oštećenja kože, kostiju i problemi sa zglobovima: Liječenje visokim dozama cisteamina može dovesti do razvoja oštećenja kože.
A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Uočena je smanjena plodnost kod štakora pri dozi od 375 mg/kg/dan, pri dozi kod koje je usporeno dobivanje na težini.
If it is within four hours of the next dose, skip the missed dose and go back to the regular dosing schedule.
Ako je to unutar četiri sata prije sljedeće doze, preskočite dozu koju ste propustili i vratite se na pravilni raspored uzimanja.
The physician education pack should contain the Safety Checklist, the Summary of Product Characteristics and Package Leaflet.
Edukativni paket za liječnike mora sadržavati Popis za provjeru sigurnosti, Sažetak opisa svojstava lijeka i Uputu o lijeku.
The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI.
Druge nuspojave koje su popisane u nastavku navedene su s procjenom učestalosti kojom se mogu javiti uz PROCYSBI.