FrancophonIA/ELRC3.0 huggingface dataset:
English: Eye ointments should be used last.
Croatian: Mast za oko treba primijeniti posljednju.
English: • If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container.
Croatian: • Ako Vam je liječnik rekao da kapate u oba oka, ponovite gornji postupak s drugim okom,
English: Always use EMADINE exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: • If you use drops in both eyes, repeat the steps for your other eye.
Croatian: • Trebate li kapati oba oka, ponovite opisani postupak s drugim okom.
English: B. CONDITIONS OR RESTRICIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: How to use EMADINE (continued)
Croatian: Kako primjenjivati EMADINE (nastavak)
English: Discard any unused contents of a single use container immediately after use.
Croatian: Neiskorišteni sadržaj spremnika za jednokratnu primjenu baciti odmah nakon primjene.
English: If you are using other eye drops at the same time as EMADINE, follow the advice at the end of section 3 “How to use EMADINE”.
Croatian: Ako istodobno s EMADINE koristite i druge kapi za oko, pridržavajte se savjeta navedenog na kraju poglavlja 3 „Kako primjenjivati EMADINE“.
English: • Gently press on the base of the bottle to release one drop of EMADINE at a time.
Croatian: • Nježno pritisnite dno bočice tako da isteče po jedna kap lijeka EMADINE.
English: 6.5 Nature and content of container
Croatian: Vrsta i sadržaj spremnika
English: Nervous system disorders Uncommon headache, sinus headache, dysgeusia
Croatian: Poremećaji živčanog sustava Manje često glavobolja, sinusna glavobolja, disgeuzija
English: If you are worried, talk to your doctor or pharmacist.
Croatian: Budete li zabrinuti, obratite se svom liječniku ili ljekarniiku.
English: Five single-dose containers are then presented in a foil pouch.
Croatian: Pet jednodoznih spremnika nalazi se u vrećici od folije.
English: • Hold the long flat end of the container between your thumb and forefinger and open it by twisting off the other end (picture 2).
Croatian: • Palcem i kažiprstom uhvatite dugi, plosnati dio spremnika i otvorite ga zavrtanjem njegova drugog kraja (slika 2).
English: • EMADINE is not recommended for use in patients over 65 years of age, as it has not been studied in clinical trials in this age group.
Croatian: • EMADINE se ne preporučuje osobama starijim od 65 godina jer u toj dobnoj skupini lijek nije ispitan u kliničkim ispitivanjima.
English: EMADINE Ocular use
Croatian: EMADINE Za oko
English: • Do not use if the solution is cloudy or has bits in it.
Croatian: • Ne koristite ako je otopina mutna ili sadržava netopljive čestice.
English: Any unused solution should be discarded immediately after use.
Croatian: Svu neiskorištenu otopinu treba baciti odmah nakon primjene.
English: You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Croatian: Potrebno je ukloniti kontaktne leće prije primjene lijeka te pričekati najmanje 15 minuta prije ponovnog stavljanja leća.
English: • Put the bottle cap back on firmly immediately after use.
Croatian: • Odmah nakon uporabe vratite poklopac na bočicu i čvrsto ga zategnite.
English: EMADINE is supplied in low density polyethylene single-dose containers which contain 0.35 ml.
Croatian: EMADINE je dostupan u jednodoznim spremnicima od polietilena niske gustoće koji sadrže 0,35 ml.
English: • After cap is removed, if tamper evident snap collar is loose, remove before using product.
Croatian: • Nakon skidanja poklopca, ukoliko je zaštitni obruč za evidenciju otvaranja klimav, uklonite ga prije primjene lijeka.
English: In case of accidental ingestion of the content of a bottle of EMADINE, sedative effects may occur and the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
Croatian: U slučaju nehotične ingestije sadržaja bočice lijeka EMADINE, moguć je sedativni učinak i potrebno je imati na umu sposobnost emedastina da produži QT-interval te osigurati primjereno praćenje i zbrinjavanje.
English: 11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11 NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: In case of the deliberate ingestion of the contents of many unit doses of EMADINE, sedative effects may occur and the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
Croatian: U slučaju namjerne ingestije sadržaja mnogo pojedinačnih spremnika lijeka EMADINE, moguć je sedativni učinak i potrebno je imati na umu sposobnost emedastina da produži QT-interval, te osigurati primjereno praćenje i zbrinjavanje.
English: The 5-oxo analogues of 5-and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
Croatian: U malim se količinama kao metaboliti stvaraju i 5-okso analozi 5- i 6-hidroksiemedastina i N-oksid.
English: Write down the date you opened each bottle in the space below and in the space on the bottle label and box.
Croatian: U prostor niže, kao i u prostor na naljepnici bočice i kutiji upišite datum kada ste otvorili bočicu.
English: No human fertility data are available.
Croatian: Nema dostupnih podataka o učinku na plodnost kod čovjeka.
English: What you need to know before you use EMADINE
Croatian: Što morate znati prije nego počnete primjenjivati EMADINE Nemojte uzimati EMADINE
English: Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal
Croatian: Ponekad se dodaju male količine kloridne kiseline ili natrijeva hidorksida za održavanje normalne razine kiselosti (pH vrijednosti).
English: In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.
Croatian: Uz to, benzalkonijev klorid može nadražiti oko, a poznato je i da uzrokuje promjenu boje mekih kontaktnih leća.
English: 10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: 10 POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: 6 POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: EMADINE has not been studied in these patients and therefore, its use is not recommended in this population.
Croatian: EMADINE nije ispitan u tih bolesnika te se stoga njegovo davanje toj populaciji ne preporučuje.
English: Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels
Croatian: Ponekad se dodaju male količine kloridne kiseline ili natrijeva hidroksida za održavanje normalne razine kiselosti
English: Emedastine is principally metabolised by the liver.
Croatian: Emedastin se u načelu metabolizira u jetri.
English: After cap is removed, if tamper evident snap collar is loose, remove before using product.
Croatian: Nakon skidanja poklopca, ukoliko je zaštitni obruč za evidenciju otvaranja klimav, uklonite ga prije primjene lijeka.
English: • Make sure you have a mirror handy and wash your hands.
Croatian: • Imajte pri ruci zrcalo.
English: The following adverse reactions listed below were observed in clinical studies or with post marketing experience.
Croatian: Nuspojave prijavljene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet navedene su niže.
English: Preservative free.
Croatian: Ne sadržava konzervans.
English: Contains: benzalkonium chloride 0.1 mg/ml, trometamol, sodium chloride, hypromellose, hydrochloric acid/sodium hydroxide, purified water.
Croatian: Sadrži: benzalkonijev klorid 0,1 mg/ml, trometamol, natrijev klorid, hipromelozu, kloridnu kiselinu/natrijev hidroksid, pročišćenu vodu.
English: Emedastine difumarate was not genotoxic in a standard battery of in vitro and in vivo genotoxicity assays.
Croatian: Emedastin difumarat nije pokazao genotoksičnost u ispitivanjima kompletom standardnih testova genotoksičnosti in vitro i in vivo.
English: Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23-fold higher than those found in patients (7 ng/ml as compared with 0.3 ng/ml, i.e., the limit of detection for emedastine).
Croatian: NOEL odgovara razinama koje su 23 puta veće od onih nađenih u bolesnika (7 ng/ml u usporedbi s 0,3 ng/ml, što je donja granica osjetljivosti pri određivanju emedastina).
English: Discard any unused containers one week after first opening pouch.
Croatian: Nekorištene spremnike baciti tjedan dana nakon prvog otvaranja vrećice.
English: Uncommon corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia
Croatian: Manje često rožnični infiltrati, obojenje rožnice, zamućenje vida, nadražaj oka, suho oko, osjećaj stranog tijela u očima, pojačano suzenje, astenopija, hiperemija oka
English: In a study involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ml eye drops solution, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (0.3 ng/ml).
Croatian: U ispitivanju desetoro zdravih dobrovoljaca koji su uzimali EMADINE 0,5 mg/ml otopine kapi za oko dvaput na dan u oba oka tijekom 15 dana, koncentracije matične tvari u plazmi općenito su bile ispod donje granice testa kvantitativnog određivanja (0,3 ng/ml).
English: No serious ophthalmic or systemic adverse drug reactions were reported in the clinical trials.
Croatian: U kliničkim ispitivanjima nije bilo prijava ozbiljnih oftalmičkih ni sistemnih nuspojava.
English: The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily.
Croatian: Doza je po jedna kap EMADINE u zahvaćeno oko (oči) dvaput na dan.
English: Common side effects (may affect up to 1 in 10 people) • Effects in the eye: eye pain, itchy eye, eye redness
Croatian: Česte nuspojave (mogu se pojaviti u manje od 1 na 10 osoba) • Nuspojave na oku: bol u oku, svrbež oka, crvenilo oka
English: EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population.
Croatian: EMADINE nije ispitan u osoba starijih od 65 godina te se stoga njegova primjena u toj populaciji ne preporučuje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Jednodozni spremnik
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: Contains: trometamol, sodium chloride, hypromellose, hydrochloric acid, sodium hydroxide and purified water.
Croatian: Sadrži: trometamol, natrijev klorid, hipromelozu, kloridnu kiselinu, natrijev hidroksid i pročišćenu vodu.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove : www.ema.europa.eu.
English: EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
Croatian: EMADINE je dostupan u neprozirnim plastičnim DROP-TAINER bočicama od 5 ml i 10 ml.
English: If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with warm water.
Croatian: Ako ukapate više nego što ste trebali, temeljito isplahnite oko, po mogućnosti sterilnom fiziološkom otopinom ili, ako ju nemate, toplom vodom.
English: What EMADINE looks like and the contents of the pack EMADINE is a liquid (a solution) supplied in a pack containing a 5 ml or 10 ml plastic (DROP-TAINER) bottle with a screw cap. Not all pack sizes may be marketed.
Croatian: EMADINE je tekućina (otopina) dostupna u pakovanju koje sadržava plastičnu bočicu (DROPTAINER) od 5 ml ili 10 ml, sa zatvaračem s navojem.
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain.
Croatian: Camil Fabra 58 08320 El Masnou Barcelona Španjolska
English: - The other ingredients are trometamol; sodium chloride; hypromellose; purified water.
Croatian: - Drugi sastojci su trometamol; natrijev klorid; hipromeloza; pročišćena voda.
English: In a teratology study in rats, foetotoxic but not teratogenic effects were observed at the highest dose evaluated (140 mg/kg/day); no effects were observed at a lower level (40 mg/kg/day) which corresponds to an exposure well in excess of that produced by the therapeutic recommended dose.
Croatian: U ispitivanju teratogenosti u štakora, pri najvećoj je ispitivanoj dozi (140 mg/kg/dan) uočena fetotoksičnost, ali ne i teratogeni učinci.
English: What EMADINE contains - The active substance is emedastine 0.5 mg/ml as difumarate.
Croatian: Što EMADINE sadrži - Djelatna tvar je emedastin 0,5 mg/ml, kao difumarat.
English: No clinically significant local or systemic effects were observed in long-term topical ocular studies in rabbits.
Croatian: U ispitivanjima dugotrajne topikalne okularne primjene u kunića nisu zamijećeni klinički značajni lokalni ni sistemni učinci.
English: • Don't touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Croatian: • Vrhom spremnika ne dotičite oko ili vjeđu, okolna područja ni ostale površine.
English: • Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.
Croatian: • Tjedan dana nakon otvaranja vrećice bacite sve neiskorištene spremnike, bez obzira na to što su zatvoreni.
English: No reproductive toxicity was observed in a study in rabbits.
Croatian: U ispitivanju u kunića nije zamijećena reprodukcijska toksičnost.
English: Hydrochloric acid/sodium hydroxide (to adjust pH) Purified water
Croatian: Popis pomoćnih tvari trometamol natrijev klorid hipromeloza kloridna kiselina/natrijev hidroksid (za podešavanje pH) pročišćena voda
English: 1 ml of solution contains emedastine 0.5 mg (as difumarate).
Croatian: 1 ml otopine sadržava 0,5 mg emedastina (u obliku emedastindifumarata).
English: Mean peak plasma levels were approximately 1 ng/ml and 2 ng/ml for the 0.5 and 1.0 mg/ml treatments respectively.
Croatian: Srednje vrijednosti vršne koncentracije u plazmi iznosile su približno 1 ng/ml i 2 ng/ml pri dozama od, redom, 0,5 i 1,0 mg/ml.
English: EMADINE 0.5 mg/ml eye drops, solution S.A. Alcon-Couvreur N.V., Rijksweg 14,
Croatian: EMADINE 0,5mg/ml kapi za oko, otopina S.A. Alcon-Couvreur N.V.
English: • Throw away the container and any leftover solution at once.
Croatian: • Odmah bacite spremnik zajedno s preostalom otopinom.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nupojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Emedastine 0.5 mg/ml as difumarate
Croatian: Emedastin 0,5 mg/ml u obliku emedastindifumarata
English: Eye drops, solution.
Croatian: Kapi za oko, otopina.
English: Carton for 30 x 0.35 ml containers & carton of 60 x 0.35 ml containers
Croatian: KUTIJA S 30 SPREMNIKA X 0,35 ML I KUTIJA SA 60 SPREMNIKA X 0,35 ML
English: How to store EMADINE
Croatian: Kako čuvati EMADINE
English: • Hold the bottle, pointing down, between your thumb and middle finger.
Croatian: • Uhvatite bočicu palcem i srednjim prstom, držeći ju vrhom okrenutim dolje.
English: How to Store EMADINE
Croatian: Kako primjenjivati EMADINE
English: • Bring the container tip close to the eye. Use the mirror if it helps.
Croatian: Poslužite se zrcalom ako Vam to pomaže.
English: 5.3 Preclinical Safety Data
Croatian: Neklinički podaci o sigurnosti primjene
English: PHARMACOLOGICAL PROPERTIES
Croatian: Farmakodinamička svojstva
English: Tear open pouch at level of cut.
Croatian: • Primaknite vrh spremnika oku.
English: - The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose;
Croatian: - Drugi sastojci su benzalkonijev klorid, trometamol; natrijev klorid; hipromeloza; pročišćena voda.
English: • Bring the bottle tip close to the eye. Use the mirror if it helps.
Croatian: • Prinesite bočicu blizu oku.
English: 5.2 Pharmacokinetic properties
Croatian: Farmakokinetička svojstva
English: Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics.
Croatian: Farmakoterapijska skupina: dekongestivi i antialergici; ostali antialergici., ATK oznaka: S01G X 06
English: Put the others back in the foil wrapper.
Croatian: • Odvojeni spremnik stavite na stranu, ostale vratite u vrećicu.
English: Ocular corneal infiltrates
Croatian: Rožnični infiltrati
English: Common eye pain, eye pruritus, conjunctival hyperaemia
Croatian: Često bol u oku, svrbež oka, hiperemija konjunktive
English: 12 MARKETING AUTHORISATION NUMBERS
Croatian: 12 BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: What EMADINE looks like and the contents of the pack EMADINE is a liquid (a solution) supplied in single-dose plastic containers which contain 0.35 ml.
Croatian: EMADINE je tekućina (otopina) dostupna u plastičnim jednodoznim spremnicima od 0,35 ml.
English: Eye drops, solution
Croatian: Kapi za oko, otopina
English: Names and addresses of the manufacturers responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Hepatic and Renal impairment Use
Croatian: Oslabljena funkcija jetre i bubrega
English: Belgium.
Croatian: Belgija
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container.
Croatian: EMADINE 0,5 mg/ml kapi za oko, otopina, jednodozni spremnik.
English: EMADINE 0.5 mg/ml, eye drops, solution
Croatian: EMADINE 0,5 mg/ml, kapi za oko, otopina
English: • Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired eyes, eye irritation, blurred vision, corneal staining, dry eye.
Croatian: • Nuspojave na oku: poremećaj rožnice, poremećen osjet u očima, pojačano suzenje, umor očiju,
English: 1 ml of solution contains emedastine 0.5 mg (as difumarate)
Croatian: 1 ml otopine sadržava 0,5 mg emedastina (u obliku emedastindifumarata) Pomoćna tvar s poznatim učinkom
English: Novartis Farma - Produtos Farmacêuticos, S.A.
Croatian: Novartis Farma S.p.A.
English: 14 GENERAL CLASSIFICATION FOR SUPPLY
Croatian: 14 NAČIN IZDAVANJA LIJEKA
English: EMADINE 0.5 mg/ml eye drops, solution, single-dose container emedastine
Croatian: EMADINE 0,5mg/ml kapi za oko, otopina, jednodozni spremnik emedastin
English: EMADINE 0.5 mg/ml eye drops emedastine
Croatian: EMADINE 0,5 mg/ml kapi za oko emedastin
English: 6.6 Special precautions for disposal
Croatian: Posebne mjere za zbrinjavanje
English: Corneal limbal mononuclear cell infiltrates were noted in 1/4 male monkeys treated with 0.5 mg/ml and in 4/4 males and 1/4 females treated with 1.0 mg/ml.
Croatian: Infiltrati mononuklearnih stanica u limbusu rožnice bili su prisutni u 1/4 mužjaka koji su primali 0,5 mg/ml i u 1/4 ženki majmuna koje su primale 1,0 mg/ml.
English: Tel.: +48 22 375 4888
Croatian: Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
English: Scleral mononuclear cell infiltrates were present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated with 1.0 mg/ml.
Croatian: Infiltrati mononuklearnih stanica u bjeloočnici bili su prisutni u 1/4 mužjaka i u 1/4 ženki majmuna koji su primali 0,5 mg/ml, te u 2/4 mužjaka i 1/4 ženki majmuna koji su primali 1,0 mg/ml.
English: • Keep the single container out.
Croatian: služeći se istim spremnikom.
English: Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Croatian: Slovenská republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5439
English: Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Croatian: Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
English: This summary was last updated in 09-2013.
Croatian: Sažetak je posljednji put obnovljen 09-2013.
English: The body is able to remove this salt from the cells.
Croatian: Tijelo je u stanju eliminirati tu sol iz stanica.
English: The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs.
Croatian: Količina cistina u organima je stoga reducirana pa to ograničava oštećenje ovih organa.
English: Procysbi is available as gastroresistant capsules (25 and 75 mg).
Croatian: Procysbi je dostupan u obliku želučanootpornih kapsula (25 i 75 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Procysbi on 06.09.2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Procysbi vrijedi na prostoru Europske unije od 06.09.2013.
English: The recommended daily dose is calculated according to body surface area, as 1.30 g per m2 divided into 2 doses given every 12 hours.
Croatian: Preporučena dnevna doza računa se u skladu s površinom tijela, kao 1,30 g po m2 podijeljeno u dvije doze koje se daju svakih 12 sati.
English: Gastroresistant means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Croatian: Želučanootporne znači da sadržaj kapsula prolazi kroz želudac bez razgradnje dok ne dođe do crijeva.
English: A risk management plan has been developed to ensure that Procysbi is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Procysbi koristi što je sigurnije moguće.
English: This is a summary of the European public assessment report (EPAR) for Procysbi.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni (EPAR) za Procysbi.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Procysbi is available in a formulation that allows for a delayed release of the active substance in the body.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar ali Procysbi je dostupan u formulaciji koja omogućava odgođeno oslobađanje djelatne tvari u tijelu.
English: Levels were 0.51 nmol/mg with Procysbi, compared with 0.44 nmol/mg with Cystagon.
Croatian: Razine su bile 0,51 nmol/mg s lijekom Procysbi, u usporedbi s 0,44 nmol/mg s Cystagonom.
English: Procysbi mercaptamine
Croatian: Procysbi merkaptamin
English: Procysbi can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of cystinosis.
Croatian: Procysbi se može dobiti samo na recept, a liječenje treba započeti pod nadzorom liječnika koji ima iskustva u liječenju cistinoze.
English: Cystinosis is an inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Croatian: Cistinoza je nasljedna bolest u kojoj prekomjerna količina cistina, aminokiseline koja se prirodno nalazi u tijelu, nakuplja se unutar stanica, posebice u bubrezima i očima i oštećuje ih.
English: In addition, the company that markets Procysbi will provide educational material to all doctors expected to prescribe the medicine, containing important safety information including the risk that the medicine may be harmful to the unborn child.
Croatian: Osim toga, tvrtka koja stavlja Procysbi na tržište osigurati će dodatne edukacijske materijale svim liječnicima za koje se očekuje da će propisivati lijek, a koji sadrže važne sigurnosne informacije uključujući rizik da lijek može biti štetan za nerođeno dijete.
English: Procysbi is a ‘hybrid medicine'.
Croatian: Procysbi je „hibridni lijek”.