FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety for suckling puppies or kittens has not been sufficiently established, therefore Comfortis should only be used in breeding, pregnant or lactating dogs or cats if the veterinary surgeon has specifically recommended it.
Croatian: Budući da u dostatnoj mjeri nije utvrđena sigurnost za psiće i mačiće koji sišu, proizvod se smije upotrijebiti u pasa i mačaka za vrijeme rasploda, graviditeta i laktacije samo u skladu s izričitom preporukom veterinara.
English: How has Comfortis been studied?
Croatian: Kako se Comfortis ispitivao?
English: How does Comfortis work?
Croatian: Na koji način Comfortis djeluje?
English: For a full list of all side effects reported with Comfortis, see the package leaflet.
Croatian: Potpuni popis nuspojava prijavljenih s VMP-om Comfortis dostupan je u uputama o lijeku.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 28. kolovoz 2015
English: Final study report expected in July 2019
Croatian: Završno izvješće o ispitivanju očekuje se u srpanj 2019
English: Aseptic technique should be used.
Croatian: Treba koristiti aseptičnu tehniku.
English: Each infusion will take approximately 1 to 2 hours.
Croatian: Svaka infuzija trajat će otprilike 1 do 2 sata.
English: Children and adults
Croatian: Djeca i odrasli
English: The educational material should contain:
Croatian: Edukacijski materijal mora sadržavati:
English: The Guide for healthcare professionals shall contain the following key elements:
Croatian: Vodič za zdravstvene radnike sadržavat će sljedeće ključne elemente:
English: Two patients were positive at only a single time point.
Croatian: Dva bolesnika bila su pozitivna samo u jednoj vremenskoj točki ispitivanja.
English: Unopened vials: 2 years.
Croatian: Neotvorene bočice: 2 godine.
English: If you have any further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku.
English: Store in a refrigerator (2°C to 8°C).
Croatian: Čuvati u hladnjaku (2 °C do 8 °C).
English: Elderly population (≥ 65 years old)
Croatian: Starija populacija (≥65 godina starosti)
English: What KANUMA is and what it is used for
Croatian: Što je KANUMA i za što se koristi
English: This is known as an infusion reaction which can sometimes be severe, and may include an allergic reaction.
Croatian: To je poznato kao infuzijska reakcija koja ponekad može biti teška i može uključivati alergijsku reakciju.
English: This medicine is an enzyme replacement therapy.
Croatian: Taj lijek je enzimska nadomjesna terapija.
English: Based on the limited data currently available the development of ADA seems to occur more frequently in infants.'
Croatian: Na temelju trenutno dostupnih ograničenih podataka čini se da se razvoj ADA češće javlja u dojenčadi.
English: In the absence of more clinical data, this dose is not recommended.
Croatian: Zbog nedostatka više kliničkih podataka ova se doza ne preporučuje.
English: 12-17 years old N=23
Croatian: 12-17 godina starosti n=23
English: The majority of reactions occurred during or within 4 hours of the completion of the infusion.
Croatian: Većina reakcija javila se tijekom ili unutar 4 sata od završetka infuzije.
English: The dose you or your child receives is based on your or your child's body weight.
Croatian: Doza koju ćete primiti Vi ili Vaše dijete temelji se na Vašoj tjelesnoj težini ili tjelesnoj težini Vašeg djeteta.
English: The vials should not be left outside the refrigerator longer than 24 hours prior to dilution for infusion.
Croatian: Bočice se ne smiju ostaviti izvan hladnjaka duže od 24 sata prije razrjeđivanja za infuziju.
English: c. The vials should not be shaken.
Croatian: c. Bočice se ne smiju tresti.
English: Body temperature increased b,c
Croatian: Povišena tjelesna temperatura b,c
English: The age range at study entry was 1-6 months.
Croatian: Raspon dobi pri ulasku u ispitivanje bio je 1-6 mjeseci.
English: The infusion period may be extended in the event of dose escalation.
Croatian: Trajanje infuzije može se produžiti u slučaju povećanja doze.
English: Store in a refrigerator Do not freeze.
Croatian: Čuvati u hladnjaku Ne zamrzavati.
English: Pre-treatment with antipyretics and/or antihistamines may prevent subsequent reactions in those cases where symptomatic treatment was required.
Croatian: Premedikacija antipireticima i/ili antihistaminicima može spriječiti kasnije reakcije u slučajevima u kojima je bilo potrebno simptomatsko liječenje.
English: Sebelipase alfa has not been investigated in patients 2 to 4 years of age or patients aged 65 years or older.
Croatian: Sebelipaza alfa nije ispitivana u bolesnika u dobi od 2 do 4 godine ili u bolesnika u dobi od 65 godina ili starijih.
English: The vials should not be frozen, heated or microwaved and should be protected from light.
Croatian: Bočice se ne smiju zamrzavati, grijati, ili zagrijavati u mikrovalnoj pećnici te trebaju biti zaštićene od svjetlosti.
English: * The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
Croatian: * Volumen infuzije treba se temeljiti na propisanoj dozi i pripremiti tako da konačna koncentracija sebelipaze alfa bude 0,1-1,5 mg/ml.
English: With continued treatment beyond 12 months of age, 1 additional patient died at age 15 months.
Croatian: Tijekom nastavka liječenja nakon dobi od 12 mjeseci, još je jedan bolesnik umro u dobi od 15 mjeseci.
English: KANUMA should be started at as young an age as possible and is intended for long-term use.
Croatian: Liječenje KANUMOM treba započeti u što je moguće ranijoj dobi i namijenjena je za dugotrajnu primjenu.
English: Total infusion volume (ml)
Croatian: Ukupan volumen infuzije (ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1033/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1033/001
English: The efficacy objectives are assessment of hepatic function overtime up to 3 years and survival at 12 months.
Croatian: Ciljevi djelotvornosti su procjena funkcije jetre tijekom razdoblja do tri godine i preživljenje u 12. mjesecu.
English: You should not be given KANUMA if you are pregnant unless clearly necessary.
Croatian: Ako ste trudni, ne biste trebali primati KANUMU osim ako to nije zaista neophodno.
English: What you need to know before KANUMA is given
Croatian: Što morate znati prije nego primite KANUMU
English: Posology It is important to initiate treatment as early as possible after diagnosis of LAL deficiency.
Croatian: Doziranje Važno je započeti liječenje što je ranije moguće nakon postavljanja dijagnoze nedostatka LAL-a.
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Croatian: Učestalost, vrsta i težina nuspojava u djece iste su kao u odraslih.
English: The MAH shall ensure that in each Member State where Kanuma is marketed, all healthcare professionals who are expected to use Kanuma have access to the educational material.
Croatian: Nositelj odobrenja osigurat će da u svakoj zemlji članici u kojoj je Kanuma na tržištu svi zdravstveni radnici za koje se očekuje da će primjenjivati Kanumu imaju pristup edukacijskom materijalu.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor if you or your child is on a controlled sodium diet.
Croatian: Recite svom liječniku ako ste Vi ili Vaše dijete na dijeti s kontroliranim unosom natrija.
English: This medicine may contain egg proteins.
Croatian: Ovaj lijek može sadržavati proteine jajeta.
English: Studies to evaluate the mutagenic and carcinogenic potential of sebelipase alfa have not been performed.
Croatian: Ispitivanja za procjenu mutagenog i kancerogenog potencijala sebelipaze alfa nisu provedena.
English: What KANUMA is and what it is used for What you need to know before you are given KANUMA How KANUMA is given
Croatian: Što je KANUMA i za što se koristi Što morate znati prije nego primite KANUMU Kako se KANUMA daje Moguće nuspojave
English: Patients also had rapidly progressive liver disease and severe hepatosplenomegaly.
Croatian: Bolesnici su također imali brzo progresivnu bolest jetre i tešku hepatosplenomegaliju.
English: Prior to launch of Kanuma in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational material including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije puštanja Kanume u promet u svakoj zemlji članici nositelj odobrenja mora postići dogovor s nacionalnim nadležnim tijelima oko sadržaja i oblika edukacijskih materijala, uključujući medije komunikacije, načine distribucije i sve druge aspekte programa.
English: These increases have generally occurred within the first 2 to 4 weeks and improved within a further 8 weeks of treatment.
Croatian: Općenito su se ti porasti javili unutar prva 2 do 4 tjedna, a do poboljšanja je došlo unutar sljedećih 8 tjedana liječenja.
English: This medicinal product may contain traces of egg proteins.
Croatian: Ovaj lijek može sadržavati tragove proteina jajeta.
English: In cases of severe infusion reactions and in cases of lack or loss of effect, patients should be tested for the presence of antibodies.
Croatian: U slučajevima teških infuzijskih reakcija i u slučajevima nedostatka ili gubitka učinka, u bolesnika treba provjeriti prisutnost protutijela.
English: KANUMA should be administered through a 0.2 μm filter (see section 6.6).
Croatian: KANUMA se treba davati kroz filter od 0,2 μm (vidjeti dio 6.6).
English: The total volume of the infusion should be administered over approximately 2 hours.
Croatian: Ukupan volumen infuzije treba primijeniti tijekom otprilike 2 sata.
English: The age range at randomisation was 4-58 years old (71% were < 18 years old).
Croatian: Raspon dobi pri randomizaciji bio je 4-58 godina (71% je bilo u dobi
English: Patients with known egg allergies were excluded from clinical studies (see section 4.3).
Croatian: Bolesnici s poznatom alergijom na jaja bili su isključeni iz kliničkih ispitivanja (vidjeti dio 4.3).
English: Following the first sebelipase alfa infusion, including the first infusion after a dose escalation, patients should be observed for 1 hour in order to monitor for any signs or symptoms of anaphylaxis or a severe hypersensitivity reaction.
Croatian: Nakon prve infuzije sebelipaze alfa, uključujući i prvu infuziju nakon povećanja doze, bolesnike je potrebno nadzirati tijekom 1 sata kako bi se uočili bilo kakvi znaci ili simptomi anafilaksije ili teške reakcije preosjetljivosti.
English: The age range of patients with biopsy evidence of cirrhosis was 4-21 years old.
Croatian: Raspon dobi bolesnika s cirozom dokazanom biopsijom bio je 4-21 godine.
English: Of the 32 patients who had a liver biopsy at study entry, 100% had fibrosis and 31% had cirrhosis.
Croatian: Od 32 bolesnika kojima je učinjena biopsija jetre pri ulasku u ispitivanje, 100% ih je imalo fibrozu, a 31% cirozu.
English: Children and adults with LAL deficiency
Croatian: Djeca i odrasli s nedostatkom LAL-a
English: From a microbiological point of view, the diluted solution should be used immediately.
Croatian: S mikrobiološke točke gledišta, razrijeđenu otopinu treba odmah primijeniti.
English: Infants (< 6 months of age)
Croatian: Dojenčad (< 6 mjeseci starosti)
English: • Information to healthcare professionals that it is the responsibility of the MAH to provide the test for the monitoring of ADA positive patients including the modalities for requesting the test.
Croatian: • Informaciju zdravstvenim radnicima da je odgovornost nositelja odobrenja osigurati test za nadzor bolesnika pozitivnih na ADA, uključujući i način potraživanja testa.
English: Sebelipase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Croatian: Sebelipaza alfa je protein i očekuje se njegova metabolička razgradnja hidrolizom peptida.
English: KANUMA should be administered by a trained healthcare professional who can manage medical emergencies.
Croatian: KANUMU treba primjenjivati obučen zdravstveni radnik koji može zbrinuti hitna medicinska stanja.
English: Improvement in growth occurs as a result of substrate reduction in the intestine.
Croatian: Do poboljšanja rasta dolazi zbog smanjenja supstrata u crijevu.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes; ATC code: not yet assigned
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, Enzimi; ATK oznaka: nije još dodijeljena
English: • Information on the ongoing LAL Deficiency Registry, including the importance of enrolling patients, also those not treated with Kanuma, and the modalities for participation.
Croatian: • Informaciju o pokrenutom Registru nedostatka LAL-a, uključujući važnost uključivanja bolesnika, također i onih koji se ne liječe Kanumom, te o načinima sudjelovanja.
English: These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of antiinflammatory medicines).
Croatian: Ti lijekovi mogu uključivati antihistaminike, lijekove za snižavanje temperature i/ili kortikosteroide (vrsta protuupalnih lijekova).
English: The medicine will be diluted before being given to you or your child.
Croatian: Lijek se mora razrijediti prije nego ga Vi ili Vaše dijete primite.
English: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom
Croatian: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA Ujedinjeno Kraljevstvo
English: If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).
Croatian: Ako ste Vi ili Vaše dijete alergični na jaja ili ste prije imali alergiju na jaja, recite to svom liječniku ili medicinskoj sestri (vidjeti Ne smijete primiti KANUMU).
English: Twenty-four patients were aged 411 years, 23 were aged 12-17 years, and 18 were aged ≥ 18 years (Table 4).
Croatian: Dvadeset i četiri bolesnika bila su u dobi od 4 do 11 godina, 23 su bila u dobi od 12 do 17 godina i 18 ih je bilo u dobi
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sebelipase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom sebelipaza alfa uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: b. It is recommended to allow KANUMA vials to reach a temperature between 15°C and 25°C prior to reconstitution to minimize the potential for the formation of sebelipase alfa protein particles in solution.
Croatian: b. Preporučuje se ostaviti bočice s KANUMOM da dosegnu temperaturu između 15 °C i 25 °C prije rekonstitucije kako bi se mogućnost stvaranja proteinskih čestica sebelipaze alfa u otopini svela na najmanju moguću mjeru.
English: In addition to liver disease, patients with LAL deficiency experience increased risk for cardiovascular disease and accelerated atherosclerosis.
Croatian: Osim bolesti jetre, bolesnici s nedostatkom LAL-a imaju povećan rizik za kardiovaskularnu bolest i ubrzanu aterosklerozu.
English: In clinical studies, doses of sebelipase alfa were explored up to 5 mg/kg once weekly and no specific signs or symptoms were identified following the higher doses.
Croatian: U kliničkim ispitivanjima istraživane su doze sebelipaze alfa do 5 mg/kg jednom tjedno i nisu zabilježeni posebni znakovi ili simptomi nakon viših doza.
English: The safety and efficacy of KANUMA in patients older than 65 years have not been evaluated and no alternative dose regimens can be recommended for these patients.
Croatian: Sigurnost i djelotvornost KANUME u bolesnika starijih od 65 godina nisu procijenjene i nije moguće dati preporuku o alternativnom režimu doziranja za ove bolesnike.
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Croatian: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francuska
English: The European Medicines Agency has deferred the obligation to submit the results of studies with KANUMA in one or more subsets of the paediatric population in LAL deficiency (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka KANUMA u jednoj ili više podskupina pedijatrijske populacije s nedostatkom LAL-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Table 4: Mean Population Pharmacokinetic Parameters
Croatian: Tablica 4: Srednje vrijednosti farmakokinetičkih parametara populacije
English: LAL deficiency registry
Croatian: Registar nedostatka LAL-a
English: The majority of patients (58%) had LDLcholesterol > 190 mg/dl at study entry, and 24% of patients with LDL-cholesterol > 190 mg/dl were on lipid lowering medicinal products.
Croatian: Većina bolesnika (58%) imala je LDL kolesterol > 190 mg/dl pri ulasku u ispitivanje, a 24% bolesnika s LDL kolesterolom > 190 mg/dl uzimalo je lijekove za snižavanje razine lipida.
English: Common side effects reported in children and adolescents (4 to 18 years old) and adults are: severe allergic reaction (anaphylactic reaction)
Croatian: Česte nuspojave zabilježene u djece i adolescenata(u dobi od4 do 18 godina) te odraslih su: teška alergijska reakcija (anafilaktička reakcija)
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika na dijeti s kontroliranim unosom natrija.
English: Table 3: Primary and secondary efficacy endpoints in LAL-CL02 Endpoint
Croatian: Tablica 3: Primarne i sekundarne ishodiza procjenu djelotvornosti u ispitivanju LAL-CL02
English: MedDRA preferred term
Croatian: MedDRA preporučeni izraz
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity in rats and monkeys, or fertility, embryo-foetal and peri- and postnatal development in rats and rabbits.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza u štakora i majmuna ili plodnosti, embriofetalnog, perinatalnog ili postnatalnog razvoja u štakora i kunića.
English: a. The number of vials to be diluted for infusion should be determined based on the patient's weight and prescribed dose.
Croatian: Potrebno je odrediti broj bočica koje treba razrijediti za infuziju na temelju težine bolesnika i propisane doze.
English: As a precautionary measure, it is preferable to avoid use of sebelipase alfa during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka sebelipaze alfa tijekom trudnoće.
English: You must not be given KANUMA: - if you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti KANUMU: ako ste Vi ili Vaše dijete imali životno ugrožavajuću alergijsku reakciju na sebelipazu alfa, koja se ne može zbrinuti kada Vi ili Vaše dijete ponovno primite lijek, ili alergijsku reakciju na jaje ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Most patients who developed ADA did so within the first 2 months of exposure.
Croatian: U većine bolesnika u kojih su se razvila ADA to se dogodilo unutar prva 2 mjeseca izloženosti.
English: Hyperaemia e, hypotension
Croatian: Hiperemija e, hipotenzija
English: For instructions on the preventive measures and monitoring of hypersensitivity reactions, see section 4.4.
Croatian: Za upute o preventivnim mjerama i nadziranju reakcija preosjetljivosti vidjeti dio 4.4.
English: Method of administration KANUMA is for intravenous use only.
Croatian: Način primjene KANUMA je namijenjena samo za intravensku primjenu.
English: From baseline to week 48, mean weight-for-age percentile improved from 12.74% to 29.83% and mean serum albumin levels increased from 26.7 g/l to 38.7 g/l.
Croatian: Od početka do 48. tjedna srednja vrijednost percentile težine u odnosu na dob poboljšala se s 12,74% na 29,83%; a srednja vrijednost razina serumskog albumina povećala se s 26,7 g/l na 38,7 g/l.
English: During the covariate analysis of the population pharmacokinetics model for sebelipase alfa, age, body weight, and sex were not found to have a significant influence on CL and Vc of sebelipase alfa.
Croatian: Tijekom kovarijantne analize modela populacijske farmakokinetike za sebelipazu alfa nije utvrđeno da su dob, tjelesna težina i spol značajno utjecali na CL i Vc sebelipaze alfa.
English: Following the occurrence of a hypersensitivity reaction, appropriate pre-treatment should be considered according to the standard of care (see section 4.4).
Croatian: Nakon pojave reakcije preosjetljivosti treba razmotriti odgovarajuću premedikaciju u skladu sa standardnom skrbi (vidjeti dio 4.4).
English: The absolute reduction in mean ALT level was -57.9 U/l (-53%) in the sebelipase alfa-treated group and -6.7 U/l (-6%) in the placebo group.
Croatian: Apsolutno smanjenje srednje vrijednosti razine ALT-a bilo je -57,9 U/l (-53%) u skupini liječenoj sebelipazom alfa i -6,7 U/l (-6%) skupini koja je primala placebo.
English: The association between the development of ADA to sebelipase alfa and reductions in treatment effect or the occurrence of adverse reactions has not been determined.
Croatian: Povezanost između razvoja ADA na sebelipazu alfa i smanjenja učinka liječenja ili pojave nuspojava nije utvrđena.
English: Side effects were seen while patients were being given the medicine or shortly after (infusion reactions).
Croatian: Nuspojave su uočene za vrijeme primanja lijeka ili kratko nakon toga (infuzijske reakcije).
English: Preparation of the sebelipase alfa infusion KANUMA should be prepared and used according to the following steps.
Croatian: Priprema infuzije sebelipaze alfa KANUMU treba pripremiti i primijeniti prema sljedećim uputama.
English: If interrupted, the infusion may be resumed at a slower rate with increases as tolerated.
Croatian: Ako se prekine, infuzija se može nastaviti manjom brzinom i ubrzati ovisno o podnošljivosti.
English: P-values are from Fisher's exact test for normalisation endpoints and Wilcoxon rank-sum test for all other endpoints.
Croatian: P-vrijednosti za ishode normalizacije dobivene su Fisherovim egzaktnim testom, a za sve ostale ishode Wilcoxonovim testom sume rangova.
English: Fifty-six of 84 patients (67%) who received sebelipase alfa during clinical studies (LAL-CL01/LALCL04, LAL-CL02 and LAL-CL03) were in the paediatric and adolescent age range (1 month up to 18 years).
Croatian: Pedeset i šest od 84 bolesnika (67%) koja su primala sebelipazu alfa tijekom kliničkih ispitivanja (LAL-CL01/LAL-CL04, LAL-CL02 i LAL-CL03) bili su pedijatrijske i adolescentske dobi (od 1 mjeseca do 18 godina).
English: If you or your child experiences symptoms like these, seek immediate medical attention.
Croatian: Ako Vi ili Vaše dijete osjetite simptome poput ovih, odmah potražite liječničku pomoć.
English: Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein.
Croatian: Vaš liječnik ili medicinska sestra dat će Vam KANUMU putem infuzije (drip) u venu.
English: LAL-CL02 was a multicentre, double-blind, placebo-controlled study in 66 children and adults with LAL deficiency.
Croatian: Ispitivanje LAL-CL02 bilo je multicentrično, dvostruko slijepo, placebom kontrolirano ispitivanje u 66 djece i odraslih s nedostatkom LAL-a.