FrancophonIA/ELRC3.0 huggingface dataset:
English: Transport medium (Dulbecco's Modified Eagles Medium supplemented with L-glutamine).
Croatian: Transportna podloga (Eagleova podloga modificirana po Dulbeccu obogaćena L-glutaminom).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije ruptura šavova manje često
English: Adverse reactions reported in patients implanted with Holoclar are provided in the table.
Croatian: Nuspojave zabilježene u bolesnika kojima je implantiran Holoclar navedene su u tablici.
English: System / organ class
Croatian: Klasifikacija sustava / organa Nuspojava
English: • Uneven eyelids
Croatian: • nejednake vjeđe
English: Any shaking, inverting or other mechanical stress of the Holoclar container should be avoided.
Croatian: Treba izbjegavati bilo kakvo protresanje, preokretanje ili drugi mehanički pritisak na spremnik s
English: • Bleeding from the eye lid skin
Croatian: • krvarenje iz kože vjeđa
English: Most side effects are mild and disappear in the weeks after surgery.
Croatian: Većina nuspojava je blaga i povlači se unutar nekoliko tjedana od kirurškog zahvata.
English: Eye-drops containing benzalkonium chloride, and/or other preservatives, must be avoided.
Croatian: Moraju se izbjegavati kapi za oči koje sadrže benzalkonijev klorid i/ili druge konzervanse.
English: The excess of insert is trimmed and the edge covered with the conjunctiva applying 2 or 3 stitches (sutures) of vicryl or silk 8/0 in order to form a physical seal of the lesion and to secure the implant.
Croatian: Višak umetka se podreže i rub pokrije spojnicom te se načini 2 do 3 šava (suture) koncem Vicryl ili koncem od svile 8/0 kako bi se fizički zatvorila rana i učvrstio implantat.
English: Moderate to severe LSCD was defined according to an invasion of at least two quadrants of the corneal surface by superficial neo vessels.
Croatian: Umjeren do težak LSCD definiran je sukladno urastanju novonastalih površinskih krvnih žila na najmanje dva kvadranta površine rožnice.
English: During the corneal repair process, the administered stem cells are intended to partially multiply, differentiate and migrate to regenerate corneal epithelium, as well as maintaining a reservoir of stem cells that can continually regenerate the corneal epithelium.
Croatian: Tijekom procesa obnavljanja rožnice primijenjene matične stanice trebale bi se djelomično umnožiti, diferencirati i migrirati kako bi obnovile epitel rožnice, a također i služiti kao zaliha matičnih stanica koje mogu kontinuirano obnavljati epitel rožnice.
English: • Inability for your eye to sense pain (anaesthesia of the cornea or conjunctiva or hypoaesthia)
Croatian: • gubitak osjeta za bol u oku (anestezija ili hipoestezija rožnice ili spojnice)
English: Name and address of the manufacturer of the biological active substance Holostem Terapie Avanzate S.R.L.
Croatian: PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača biološke djelatne tvari Holostem Terapie Avanzate S.R.L.
English: Breast-feeding As a precautionary measure, Holoclar is not recommended for implant during breast-feeding.
Croatian: Kao mjera opreza, implantacija Holoclara se ne preporučuje tijekom dojenja.
English: Following the biopsy, an appropriate regimen of prophylaxis with an antibiotic treatment must be given.
Croatian: Nakon biopsije mora se provesti odgovarajuće profilaktičko antibiotsko liječenje.
English: Other medicines and Holoclar Some eye-drops contain a preservative called ‘benzalkonium chloride'.
Croatian: Neke kapi za oči sadrže konzervans pod nazivom ‘benzalkonijev klorid'
English: Final CSR December
Croatian: Završno izvješće kliničkog ispitivanja prosinac
English: Marketing Authorisation Holder Chiesi Farmaceutici S.p.A.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Chiesi Farmaceutici S.p.A.
English: Transport medium (Dulbecco's Modified Eagles Medium supplemented with L-glutamine) Fibrin support.
Croatian: Transportna podloga (Eagleova podloga modificirana po Dulbeccu obogaćena L-glutaminom) Fibrinski nosač.
English: Each container contains 3.8 cm2 of autologous human corneal epithelium attached on a fibrin support and covered with transport medium.
Croatian: Svaki spremnik sadrži 3,8 cm2 autolognog epitela ljudske rožnice pričvršćenog na fibrinski nosač i prekrivenog transportnom podlogom.
English: The eye is subjected to ocular surface lavage with sterile balanced salt solution for eye irrigation followed by detachment of the conjunctiva from the limbus to expose the sample collection site of the cornea.
Croatian: Površina oka ispere se sterilnom fiziološkom otopinom pogodnom za irigaciju oka, a zatim se spojnica odvoji od limbusa kako bi se pristupilo mjestu uzimanja uzorka rožnice.
English: The eyelids are kept closed over the insert with a steri-strip band.
Croatian: Preko umetka vjeđe treba držati zatvorene ljepljivom trakom (Steri strip).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC BAG (TERTIARY)
Croatian: PLASTIČNA VREĆICA (TERCIJARNA AMBALAŽA)
English: • Severe dry eye.
Croatian: • težak oblik suhog oka.
English: Chiesi Farmaceutici SPA, Via Palermo 26/A, 43122, Parma,
Croatian: Chiesi Farmaceutici SPA, Via Palermo 26/A,
English: Transparent, circular sheet.
Croatian: Prozirni okrugli listić.
English: Each container contains 3.8 cm2 of autologous human corneal epithelium attached to a fibrin support and immersed in transport medium.
Croatian: Svaki spremnik sadrži 3,8 cm2 autolognog epitela ljudske rožnice pričvršćenog na fibrinski nosač i uronjenog u transportnu podlogu.
English: • Infection of the cornea
Croatian: • infekcija rožnice
English: OTHER M.A.H: CHIESI FARMACEUTICI S.P.A
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: CHIESI FARMACEUTICI S.P.A
English: Warnings and precautions Talk to your surgeon before you are given Holoclar.
Croatian: Upozorenja i mjere opreza Obratite se svom kirurgu prije nego
English: Please read the package leaflets for the individual medicines you are given for further information on these medicines.
Croatian: Za dodatne informacije o pojedinim lijekovima koji Vam se daju, molimo da pročitate njihove upute o lijeku.
English: This biopsy will then be used to make
Croatian: Taj će se bioptat koristiti za pripremu Holoclara.
English: Patients with a known hypersensitivity to mice or foetal bovine serum must not be treated (see section 4.3).
Croatian: Bolesnike s poznatom preosjetljivošću na miševe ili fetalni goveđi serum ne smije se liječiti
English: Conventional pharmacodynamic studies for Holoclar have not been performed Clinical efficacy and safety
Croatian: Konvencionalna farmakodinamička ispitivanja za Holoclar nisu provedena.
English: Ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Croatian: Ex vivo umnožene autologne epitelne stanice ljudske rožnice koje sadrže matične stanice.
English: The product is implanted locally.
Croatian: Ovaj lijek je za lokalnu implantaciju.
English: Fifty-seven patients underwent a keratoplasty after the use of the product with a success rate of 42.1% (N=24) one year after the corneal transplantation (i.e. with a stable corneal epithelium without significant recurrence of neovascularisation).
Croatian: 42,1% (N=24) (tj. sa stabilnim epitelom rožnice bez značajnog recidiva neovaskularizacije) godinu dana nakon transplantacije rožnice.
English: Educational material for healthcare professionals to provide training on the appropriate use of the product and to minimise risks, addressing the key elements of: - Patient selection - Traceability of patients and use of identifiers - Biopsy, implant and follow up care - Contraindicated use of eye drops containing benzalkonium chloride - Risk of glaucoma and blepharitis - Encouraging enrolment in the registry - Reporting suspected side effects
Croatian: - odabir bolesnika - sljedivost bolesnika i uporaba identifikatora - biopsija, implantacija i njega nakon zahvata - kontraindicirana primjena kapi za oko koje sadrže benzalkonijev klorid - rizik od glaukoma i blefaritisa - poticanje upisivanja u registar - prijavljivanje sumnje na nuspojavu
English: How Holoclar is given
Croatian: Vam se da Holoclar Kako se daje Holoclar
English: Kidney and liver problems Please talk with your surgeon before the start of treatment if you have liver or kidney disease.
Croatian: Ako imate bolest jetre ili bubrega, molimo da o tome obavijestite Vašeg kirurga prije početka liječenja.
English: The recommended dose of Holoclar is 79,000 - 316,000 cells/cm², corresponding to 1 cm² of product/cm² of defect.
Croatian: Preporučena doza Holoclara je 79 000 - 316 000 stanica/cm², što odgovara 1 cm² lijeka/cm² oštećenja.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA SERIJA:
English: The sealed bag is put in a non-sterile, thermally insulated box for organ transportation with a temperature monitor.
Croatian: Zapečaćena vrećica spremljena je u nesterilnu termoizolacijsku kutiju za transport organa s prikazom temperature.
English: Syncope vasovagal
Croatian: spojnica rožnica limbus
English: For information on the preparation and handling of Holoclar, please refer to section 6.6.
Croatian: Za uputu o pripremi i rukovanju Holoclarom vidjeti dio 6.6. 4.3 Kontraindikacije
English: The biopsy is placed in the sterile test tube supplied containing transport medium.
Croatian: Bioptat se spremi u isporučenu sterilnu epruvetu s transportnom podlogom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SCREW-CAP CONTAINER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE SPREMNIK ZATVOREN NAVOJNIM ZATVARAČEM
English: Data on the use of Holoclar in patients with hepatic and renal impairment are not available.
Croatian: Oštećenje jetre i bubrega Podaci o primjeni Holoclara u bolesnika s oštećenjem jetre i bubrega nisu dostupni.
English: Next, the insert is fitted under the undermined conjunctiva.
Croatian: Zatim se umetak postavi pod odignutu spojnicu.
English: What you need to know before you are given Holoclar
Croatian: Što morate znati prije nego
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva potkožno krvarenje manje često
English: The most serious adverse reactions are corneal perforation and ulcerative keratitis, which may occur within the 3 months from Holoclar implantation and are related to the corneal epithelial instability, and syncope vasovagal occurring in the first day after surgery due to eye pain.
Croatian: mjeseca od implantacije Holoclara i povezane su s nestabilnošću epitela rožnice, te vazovagalna sinkopa koja se može javiti prvi dan nakon operacije zbog bola u oku.
English: Ask your surgeon if you have any further questions about the treatment with Holoclar.
Croatian: Ako imate dodatnih pitanja o liječenju Holoclarom, obratite se svom kirurgu.
English: Each batch is shipped in a temperature-controlled thermally insulated box for organ transplant.
Croatian: Svaka serija se otprema u termoizolacijskoj kutiji za transport organa s kontrolom temperature.
English: The topical corticosteroid can be maintained in case of persistent ocular inflammation.
Croatian: U slučaju da upala oka i dalje traje može se nastaviti s topikalnim kortikosteroidima.
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA19 Mechanism of action and pharmacodynamic effects The mechanism of action of Holoclar is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns.
Croatian: Mehanizam djelovanja i farmakodinamički učinci Mehanizam djelovanja Holoclara je nadomještanje epitela rožnice i izgubljenih limbalnih matičnih stanica u bolesnika u kojih je limbus uništen opeklinama oka.
English: Educational material for patients and/or carers to address the following key elements: - Contraindicated use of eye drops containing benzalkonium chloride - Side effects of post-transplant treatment with antibiotics and corticosteroids - Inform patients of the registry - Reporting suspected side effects
Croatian: Edukacijski materijal za bolesnike i/ili njegovatelje koji sadrži sljedeće ključne elemente: - kontraindicirana primjena kapi za oko koje sadrže benzalkonijev klorid
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent
Croatian: NAZIV LIJEKA Holoclar 79 000 - 316 000 stanica/cm2 ekvivalent živoga tkiva
English: General disorders and administration site conditions Metaplasia of the implant
Croatian: Opći poremećaji i reakcije na mjestu primjene metaplazija implantata manje često
English: What Holoclar looks like and contents of the pack Holoclar is a layer of cells for implantation into your eye.
Croatian: Holoclar je sloj stanica za implantaciju u Vaše oko.
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent.
Croatian: NAZIV LIJEKA Holoclar 79 000 - 316 000 stanica/cm2 ekvivalent živoga tkiva.
English: Hepatic and renal impairment
Croatian: Klinička djelotvornost i sigurnost
English: Reports of glaucoma included adverse reactions of intraocular pressure.
Croatian: Intraokularni tlak koji je nastao kao nuspojava bio je uključen u prijave glaukoma.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING ZIPPED SEALABLE BAG
Croatian: ZAPEČAĆENA VREĆICA SA ZIP ZATVARAČEM
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava vazovagalna sinkopa manje često
English: Suture rupture
Croatian: Prijavljivanje nuspojava
English: If you get any side effects, talk to your surgeon.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti kirurga.
English: Conjunctival haemorrhage, eye haemorrhage, corneal epithelium defect, eye pain, glaucoma/intraocular pressure increased, ulcerative keratitis
Croatian: Poremećaji oka blefaritis vrlo često krvarenje spojnice, krvarenje oka, oštećenje epitela rožnice, bol u oku, glaukom/povišen intraokularni tlak, ulcerozni keratitis često adhezija spojnice, hiperemija spojnice, edem rožnice, perforacija rožnice, iritacija oka, fotofobija manje često
English: Package leaflet: Information for the patient
Croatian: - obavještavanje bolesnika o registru - prijavljivanje sumnje na nuspojavu
English: Blepharitis
Croatian: • upala vjeđa (blefaritis)
English: Conjunctival adhesion, conjunctival hyperaemia, corneal oedema, corneal
Croatian: Farmakoterapijska skupina: Oftalmologici, ostali oftalmologici, ATK oznaka: S01XA19
English: For autologous use only.
Croatian: Samo za jednokratnu primjenu.
English: Infections and infestations
Croatian: Infekcije i infestacije infekcija rožnice manje često
English: In small children this can be 4 to 6 times per day.
Croatian: Kod male djece to može biti 4 do 6 puta na dan.
English: You should take a dose as soon as possible with your next meal.
Croatian: Dozu trebate uzeti što je prije moguće s Vašim idućim obrokom.
English: Your doctor will tell you the amount of granules you should take.
Croatian: Vaš će Vam liječnik reći koju količinu granula morate uzeti.
English: If you mix them with food, it is important that you take it immediately.
Croatian: Ako ih miješate s hranom, važno je da hranu odmah pojedete.
English: Make sure that there are at least 3 hours between two doses.
Croatian: Pazite da između doza protekne najmanje 3 sata.
English: The patient recovered within 48 hours after symptomatic treatment.
Croatian: Bolesnik se oporavio za 48 sati uz simptomatsku terapiju.
English: You will need to take this medicine and to follow a diet throughout your life.
Croatian: Ovaj ćete lijek morati uzimati i provoditi dijetu cijeli život.
English: Date of first authorisation: 31 July 2013 Date of latest renewal: 23 March 2018
Croatian: Datum posljednje obnove odobrenja: 23. ožujka 2018.
English: The safety and efficacy of doses in excess of 20 g/day have not been established.
Croatian: Sigurnost i djelotvornost doza iznad 20 g/dan još nisu ustanovljene.
English: Content of clinically important electrolytes
Croatian: Sadržaj klinički važnih elektrolita
English: If you take more PHEBURANE than you should
Croatian: Ako uzmete više PHEBURANEA nego što ste trebali
English: You should take PHEBURANE with each meal or feeding.
Croatian: PHEBURANE morate uzimati sa svakim obrokom ili hranjenjem.
English: It is important that the diagnosis is made early and treatment is initiated immediately to improve the survival and the clinical outcome.
Croatian: Važno je da se rano postavi dijagnoza i odmah započne liječenje kako bi se poboljšalo preživljenje i klinički ishod bolesti.
English: The total daily dose should be divided into equal amounts and given with each meal or feeding (e.g. 4-6 times per day in small children).
Croatian: Ukupnu dnevnu dozu treba podijeliti u jednake obroke i davati sa svakim obrokom hrane ili kod svakog hranjenja (npr. kod male djece 4-6 puta na dan).
English: After the first opening, to be used within 45 days.
Croatian: Nakon prvog otvaranja iskoristiti unutar 45 dana.
English: The effect of food on absorption is unknown.
Croatian: Utjecaj hrane na apsorpciju nije poznat.
English: Common depression, irritability
Croatian: Često depresija, razdražljivost
English: The elimination half-life was estimated to be 0.8 hours.
Croatian: Poluvrijeme eliminacije procijenjeno je na 0,8 sati.
English: Talk to your doctor or pharmacist if you need 3 or more grams daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Croatian: Obratite se svom liječniku ili ljekarniku ako Vam je potrebno 3 ili više grama dnevno kroz duže vrijeme, osobito ako vam je preporučena prehrana s niskim udjelom soli (natrija).
English: Talk to your doctor for the details.
Croatian: Upitajte svog liječnika za više pojedinosti.
English: Adverse reactions mainly involved the reproductive and gastrointestinal system.
Croatian: Nuspojave prvenstveno uključuju reproduktivni i gastrointestinalni sustav.
English: If you are sexually active and your period stops altogether, do not assume that this is caused by PHEBURANE.
Croatian: Ako ste spolno aktivni i potpuno izgubite menstruaciju, nemojte smatrati da je tome razlog PHEBURANE.
English: If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see ‘Pregnancy and breast-feeding' section above) or by menopause.
Croatian: Ako se to dogodi molimo porazgovarajte sa svojim liječnikom jer gubitak menstruacije može biti uzrokovan trudnoćom (pogledajte odlomak "Trudnoća i dojenje" gore) ili menopauzom.
English: Plasma glutamine should be maintained at levels less than 1,000 μmol/L.
Croatian: Razinu glutamina u plazmi treba održavati ispod 1000 μmol/l.
English: You must follow this diet carefully.
Croatian: Ove se dijete morate pažljivo pridržavati.
English: These medicines may change the effect of PHEBURANE and you will need more frequent blood tests.
Croatian: Ovi lijekovi mogu promijeniti djelovanje PHEBURANE pa će Vam stoga biti potrebne češće pretrage krvi.
English: Very common amenorrhea, irregular menstruation
Croatian: Vrlo često amenoreja, nepravilne menstruacije
English: This should be particularly taken into account for those on a low salt diet.
Croatian: To treba posebno uzeti u obzir kod osoba podvrgnutih prehrani s niskim udjelom soli.
English: This will keep the granules from producing any taste.
Croatian: Ovo će spriječiti da granule promijene okus hrane.
English: After the first opening, PHEBURANE can be used within 45 days.
Croatian: Nakon prvog otvaranja PHEBURANE se može koristiti unutar 45 dana.
English: Take the correct amount as prescribed by your doctor.
Croatian: Uzmite točno onu količinu koju Vam je propisao liječnik.
English: • are pregnant.
Croatian: • Trudnoća.
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Croatian: Većina ispitivanih bolesnika imala je IQ u rasponu od prosječnog do nisko prosječnog/graničnog stupnja mentalne retardacije.
English: Lucane Pharma 172 rue de Charonne 75011 Paris France
Croatian: 172 rue de Charonne 75011 Paris Francuska
English: Distribution The volume of distribution of phenylbutyrate is 0.2 l/kg.
Croatian: Distribucija Volumen distribucije fenilbutirata je 0,2 l/kg.
English: • Pour granules directly into the spoon as shown by the picture (on the outer carton and at the end of/page 2 of this leaflet)
Croatian: Istresite granule izravno u žlicu kako je to prikazano na slici (na vanjskoj kutiji i na kraju odnosno stranici 2 ove upute).
English: Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Croatian: Povlačenje od ranije postojećih neuroloških poremećaja liječenjem nije vjerojatno, a pogoršanje neurološkog statusa može se nastaviti u nekih bolesnika.
English: If this happens you will develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion and will need to get urgent medical help.
Croatian: Ako se to dogodi kod Vas će se javiti simptomi poput osjećaja mučnine, povraćanja, smetenosti i bit će Vam potrebna hitna medicinska pomoć.
English: If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.
Croatian: Ako primijetite bilo koji od ovih simptoma odmah se obratite svom liječniku ili u najbližu hitnu pomoć radi potpornog liječenja.
English: In the event of an overdose, the treatment should be discontinued and supportive measures be instituted.
Croatian: U slučaju predoziranja, liječenje treba prekinuti i uvesti mjere potporne terapije.
English: What PHEBURANE is and what it is used for 2.
Croatian: Što je PHEBURANE i za što se koristi 2.
English: If you need laboratory tests, it is important to remind your doctor that you are taking PHEBURANE, since sodium phenylbutyrate may interfere with certain laboratory test results (such as blood electrolytes or protein, or liver function tests)
Croatian: Ako morate učiniti laboratorijske pretrage, važno je podsjetiti svog liječnika da uzimate PHEBURANE, budući da natrijev fenilbutirat može utjecati na rezultate određenih laboratorijskih pretraga (poput razine elektrolita ili proteina u krvi, ili jetrenih funkcionalnih testova).
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Croatian: Jedan slučaj predoziranja dogodio se kod 5-mjesečnog dojenčeta nehotičnom dozom od 10 g (1370 mg/kg).
English: Other medicines and PHEBURANE
Croatian: Drugi lijekovi i PHEBURANE
English: Phenylacetate is also hydrolysed by esterases in liver and blood.
Croatian: Fenilacetat se također hidrolizira pomoću esteraza u jetri i krvi.
English: Haemodialysis or peritoneal dialysis may be beneficial.
Croatian: Hemodijaliza i peritonejska dijaliza mogu biti od koristi.
English: She recovered following dose reduction except for recurrent pancreatitis episodes that eventually prompted treatment discontinuation.
Croatian: Oporavila se nakon snižavanja doze osim epizoda recidivirajućeg pankreatitisa koji je uzrokovao prekid liječenja.
English: If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, dok uzimate PHEBURANE morate koristiti pouzdanu metodu kontracepcije.
English: The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Croatian: Poluvrijeme eliminacije procijenjeno je na 1,3 odnosno 2,4 sata.
English: <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: It is indicated in all patients with neonatal-onset disease (complete enzyme deficiencies, presenting within the first 28 days of life).
Croatian: Indiciran je u svih bolesnika u kojih se znakovi bolesti pojavljuju u neonatalnoj dobi (potpuni nedostatak enzima, koji se pojavljuje unutar prvih 28 dana života).