FrancophonIA/ELRC3.0 huggingface dataset:
English: Nineteen patients were enrolled, 14 completed, and 5 discontinued.
Croatian: Uključeno je 19 bolesnika, 14 ih je završilo ispitivanje, a 5 je bolesnika prekinulo sudjelovanje.
English: Strensiq 40 mg/ml solution for injection EU/1/15/1015/001
Croatian: Strensiq 40 mg/ml otopina za injekciju EU/1/15/1015/001
English: Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.
Croatian: Liječenje treba započeti liječnik iskusan u liječenju bolesnika s metaboličkim ili koštanim poremećajima.
English: There are insufficient data from the use of asfotase alfa in pregnant women.
Croatian: Nema dovoljno podataka o primjeni asfotaze alfa u trudnica.
English: In the event that bubbles appear in the syringe, hold the syringe with the needle pointing upwards and gently tap the side of the syringe until the bubbles rise to the top.
Croatian: U slučaju da u štrcaljki opazite mjehuriće, držeći štrcaljku tako da je igla usmjerena prema gore lagano lupkajte prstom postrance po štrcaljki sve dok se mjehurići ne dignu do vrha.
English: Strensiq 100 mg/ml solution for injection EU/1/15/1015/003
Croatian: Strensiq 100 mg/ml otopina za injekciju EU/1/15/1015/003
English: • If you are injecting this medicine yourself, you will be shown how to prepare and inject the medicine by your doctor, pharmacist or nurse.
Croatian: • Ako ćete samoprimjenjivati ovaj lijek, liječnik, ljekarnik ili medicinska sestra će Vam pokazati kako ga pripremiti i ubrizgati.
English: Trained radiologists evaluated pre- and post-baseline x-rays of wrists and knees of patients for the following signs: apparent physeal widening, metaphyseal flaring, irregularity of provisional zone of calcification, metaphyseal radiolucencies, metadiaphyseal sclerosis, osteopenia, ‘popcorn' calcification in metadiaphysis, demineralization of distal metaphysis, transverse subphyseal band of lucency and tongues of radiolucency.
Croatian: Specijalizirani radiolozi pregledali su rendgenske snimke zapešća i koljena prije i poslije početka ispitivanja kako bi ustanovili postoje li sljedeći znakovi: očito epifizno proširenje, proširenje metafize, nepravilnost privremeno postojeće zone kalcifikacije, radiolucentne metafize, metadijafizealna skleroza, osteopenija, grubo zrnata (engl. popcorn) kalcifikacija u metadijafizi, demineralizacija distalne metafize, transverzalni subfizealni pojas prosvjetljenja i jezičci radiolucencije.
English: The study employed historical controls from the same centres as patients who received asfotase alfa and who had been subject to a similar protocol of clinical management.
Croatian: U ispitivanju su kao kontrola poslužili bolesnici čiji su podaci prikupljeni ranije u istim ispitivačkim centrima u kojima su bolesnici u ovom ispitivanju primali asfotazu alfa, i koji su bili podvrgnuti sličnom protokolu kliničkog liječenja (povijesne kontrole).
English: Remove the needle, release the skin fold and gently place a piece of cotton wool or gauze over the injection site for a few seconds.
Croatian: Izvadite iglu, opustite kožni nabor i blagim pritiskom držite komad vate ili gaze na mjestu uboda nekoliko sekunda.
English: This is important to rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, or deltoid.
Croatian: Kako bi se smanjio rizik od lipodistrofije, važno je izmjenjivati mjesta primjene injekcije između nekoliko predloženih: područje trbuha, bedra ili područje gornjeg dijela nadlaktice (deltoidno područje).
English: • Increase of parathyroid hormone concentration and low calcium levels have been reported in studies.
Croatian: • U ispitivanjima su zabilježeni porast koncentracije paratireoidnog hormona i niske razine kalcija.
English: 9 out of 10 patients achieved a RGI-C score ≥2, only 1 with RGI-C <2.
Croatian: Pet od 7 bolesnika postiglo je RGI-C ≥ 2.
English: 11 patients were enrolled in the initial study and 10 patients entered the extension study, with 9 patients completing the extension study.
Croatian: U inicijalno ispitivanje je bilo uključeno 11 bolesnika, od toga je 10 ispitanika nastavilo sudjelovati u produžetku ispitivanja, a 9 ih je i završilo produžetak ispitivanja.
English: Remove the needle from the vial and place back the protective cap over the needle.
Croatian: Izvucite iglu iz bočice i vratite na iglu zaštitnu kapicu.
English: 7/11 patients in the full analysis set achieved Radiographic Global Impression of Change scores of +2 at Week 24 compared to baseline radiographs.
Croatian: U cijeloj skupini za analizu, 7/11 bolesnika postiglo je rezultat na ljestvici za procjenu općeg radiografskog dojma promjene (RGI-C) od +2 u 24. tjednu u usporedbi s rendgenskim snimkama na početku.
English: Study ENB-010-10
Croatian: Ispitivanje ENB-010-10
English: There was no evidence of ectopic calcification observed in any other tissues examined.
Croatian: Ni u jednom drugom pregledanom tkivu nisu opaženi dokazi za ektopičnu kalcifikaciju.
English: Study ENB-006-09/ENB-008-10
Croatian: Ispitivanje ENB-006-09/ENB-008-10
English: Asfotase alfa, a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with hypophosphatasia.
Croatian: Asfotaza alfa, humani rekombinantni fuzijski protein sačinjen od tkivno nespecifične alkalne fosfataze-Fcdeka-aspartata s enzimskom aktivnosti, potiče mineralizaciju kostura u bolesnika s hipofosfatazijom.
English: Hot flush
Croatian: • navale vrućine
English: Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles.
Croatian: Držeći štrcaljku s iglom usmjerenom prema gore, lupkajte prstom po tijelu štrcaljke kako biste uklonili mjehuriće zraka.
English: Bone biopsy
Croatian: Biopsija kostiju
English: Hypophosphatasia
Croatian: Hipofosfatazija
English: Ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis as manifestations of hypophosphatasia are documented in published literature.
Croatian: Oftalmička kalcifikacija (konjunktive i korneje) te nefrokalcinoza kao manifestacije hipofosfatazije potkrijepljene su dokazima u objavljenoj literaturi.
English: Historical controls did not show change over time.
Croatian: U kontrolnih bolesnika čiji su podaci prikupljeni u prošlosti, nije se pokazalo da je s vremenom došlo do promjene.
English: Please collect your syringes, vials and needle in a sharps container.
Croatian: Molimo da upotrijebljene štrcaljke, bočice i iglu odložite u poseban spremnik za oštre predmete.
English: Control visually that the volume contained into the syringe is correct.
Croatian: Vizualno provjerite sadrži li štrcaljka točnu količinu.
English: Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection asfotase alfa
Croatian: Strensiq 40 mg/ml injekcija Strensiq 40 mg/ml injekcija Strensiq 40 mg/ml injekcija Strensiq 40 mg/ml injekcija asfotaza alfa s.c.
English: Onset of hypophosphatasia was under 6 months in all patients.
Croatian: Početak hipofosfatazije zabilježen je u svih bolesnika prije dobi od 6 mjeseci.
English: • Early fusion of the bones of the head in children below 5 years of age has been reported in clinical studies of infants with hypophosphatasia, with and without use of Strensiq.
Croatian: • U kliničkim ispitivanjima dojenčadi s hipofosfatazijom, zabilježeno je rano srastanje kostiju glave u djece mlađe od 5 godina, uz primjenu i bez primjene Strensiqa.
English: Refer to the dosing chart below for more details.
Croatian: Detaljnije o doziranju vidjeti u tablici ispod.
English: Once all the bubbles are at the top of the syringe, gently push on the plunger to force the bubbles out of the syringe and back into the vial.
Croatian: Kada su svi mjehurići pri vrhu štrcaljke, lagano potiskujte klip kako biste ih istisnuli iz štrcaljke natrag u bočicu.
English: Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.
Croatian: Primjenu Strensiqa treba prekinuti i započeti odgovarajuću medicinsku terapiju u svakog bolesnika s teškim reakcijama na injekciju.
English: How to use Strensiq will be explained to you by a doctor who is experienced in the management of patients with metabolic or bone related diseases.
Croatian: Kako se Strensiq primjenjuje objasnit će Vam liječnik s iskustvom u liječenju bolesnika s metaboličkim bolestima ili bolestima povezanim s kostima.
English: Strensiq should be administered using sterile disposable syringes and injection needles.
Croatian: Strensiq treba primijeniti upotrebom sterilnih štrcaljki i injekcijskih igala za jednokratnu uporabu.
English: Patients who experienced anaphalaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness.
Croatian: Bolesnici u kojih su se pojavili simptomi nalik anafilaksiji imali su otežano disanje, osjećaj gušenja, mučninu, oticanje oko očiju i omaglicu.
English: Push the plunger in completely to inject the air into the vial.
Croatian: Potisnite klip do kraja kako biste istisnuli zrak u bočicu.
English: At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of
Croatian: U 48. tjednu, 50/69 (72,5%) bolesnika iz cijele skupine za analizu postiglo je prema općem radiografskom dojmu promjene rezultate ≥ 2 i smatrali su se bolesnicima s odgovorom.
English: Disproportionate weight gain Patients may display disproportionate weight increase.
Croatian: U bolesnika se može pojaviti nesrazmjerno povećanje tjelesne težine.
English: - Mean (SD) osteoid volume / bone volume was 11.8 (5.9)% at baseline and 8.6 (7.2)% at week 24
Croatian: - prosječni (SD) volumen koštanog tkiva / volumen kosti bio je 11,8 (5,9)% na početku i 8,6 (7,2)% u
English: For storage conditions before administration of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja prije primjene lijeka vidjeti u dijelu 6.3.
English: Study ENB-009-10
Croatian: Ispitivanje ENB-009-10
English: Pull the cap straight off the needle.
Croatian: Povucite kapicu i uklonite je s igle.
English: There is insufficient information on the excretion of asfotase alfa in human milk.
Croatian: Nema dovoljno podataka o izlučivanju asfotaze alfa u majčino mlijeko.
English: If injecting 6 x per week
Croatian: Ako se primjenjuje 6 x tjedno
English: At study completion patients had received a median of over 60 months of treatment (24 to 68 months).
Croatian: Na završetku ispitivanja medijan trajanja liječenja bolesnika iznosio je više od 60 mjeseci (raspon od 24 do 68 mjeseci).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. the product is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Remove the protective cap from the Strensiq vial.
Croatian: 3. Uklonite zaštitnu kapicu s bočice Strensiqa.
English: Holding the syringe and vial, insert the needle through the sterile rubber seal and into the vial.
Croatian: Držeći štrcaljku i bočicu, umetnite iglu kroz sterilan gumeni čep u bočicu.
English: Place a smaller bore needle (e.g. 27 or 29G) on the filled syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight.
Croatian: Na napunjenu štrcaljku stavite iglu manjeg promjera (npr. 27 ili 29G) sa zaštitnom kapicom, pritisnite je na štrcaljku i pričvrstite zakretanjem u smjeru kazaljke na satu.
English: Serum parathyroid hormone concentration may increase in hypophosphatasia patients administered asfotase alfa, most notably during the first 12 weeks of treatment.
Croatian: U bolesnika s hipofosfatazijom koji su liječeni asfotazom alfa, razine paratireoidnog hormona u serumu mogu se povećati posebice tijekom prvih 12 tjedana liječenja.
English: Serum Parathyroid Hormone and Calcium
Croatian: Paratireoidni hormon i kalcij u serumu
English: These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness.
Croatian: Ti su simptomi uključivali otežano disanje, osjećaj gušenja, periorbitalni edem i omaglicu.
English: If injecting 3 x per week
Croatian: Ako se primjenjuje 3 x tjedno
English: Strensiq 40 mg/ml solution for injection Filled volumes of the vials are: 0.3 ml, 0.45 ml, 0.7 ml and 1.0 ml
Croatian: Strensiq 40 mg/ml otopina za injekciju Volumeni punjenja bočica su 0,3 ml, 0,45 ml, 0,7 ml i 1,0 ml.
English: Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypaesthesia.
Croatian: Ostale reakcije preosjetljivosti uključivale su povraćanje, mučninu, vrućicu, glavobolju, navale crvenila, iritabilnost, zimicu, eritem kože, osip, pruritus i oralnu hipoesteziju.
English: Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein that is expressed in an engineered Chinese hamster ovary cell line.
Croatian: Asfotaza alfa je ljudski rekombinantni fuzijski protein sačinjen od tkivno nespecifične alkalne fosfatazeFc-deka-aspartata, koji je eksprimiran u staničnoj liniji jajnika kineskog hrčka dobivenoj genetičkim inženjerstvom.
English: Choose an injection site (thighs, abdomen, arms (deltoids), buttocks).
Croatian: Izaberite mjesto za primjenu injekcije (bedra, trbuh, ruke (deltoidni mišić), stražnjicu).
English: - Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24
Croatian: - prosječna (SD) debljina koštanog tkiva bila je 12,8 (3,5) µm na početku i 9,5 (5,1) µm u 24. tjednu
English: No interaction studies have been performed with asfotase alfa.
Croatian: Nisu provedena ispitivanja interakcija za asfotazu alfa.
English: Growth
Croatian: Rast
English: Trans-iliac crest bone biopsies were obtained by standard procedure.
Croatian: Biopsije u području grebena bočne kosti učinjene su standardnim postupkom.
English: Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention, USA.
Croatian: Podaci za visinu, težinu i opseg glave bili su ucrtani u grafikone rasta (nizovi percentilnih krivulja koje prikazuju distribuciju) dostupne od američkih centara za kontrolu i sprječavanje bolesti (engl.
English: Injection recommendations
Croatian: Preporuke za davanje injekcije
English: Read section 4 carefully to know what side effects can occur before using this medicine
Croatian: Prije nego što primijenite ovaj lijek, pažljivo pročitajte dio 4 kako biste saznali koje se nuspojave mogu pojaviti.
English: Five out of 7 patients achieved an RGI-C score ≥2 - 5 patients continued with invasive ventilation support, 4 of them with RGI-C score <2 - 3 patients died whilst on ventilation support - 1 patient withdrew consent ∙ 13 patients required non-invasive ventilation support at baseline.
Croatian: - 5 bolesnika nastavilo je s invazivnom ventilacijskom potporom, s tim da su 4 bolesnika imala rezultat RGI-C < 2 - 3 su bolesnika umrla dok su bili na ventilacijskoj potpori - 1 bolesnik je povukao pristanak
English: Injection site reactions (including injection site atrophy, abscess, erythema, discolouration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticarial, calcification, warmth, haemorrhage,
Croatian: Reakcije na mjestu primjene injekcije (uključujući atrofiju, apsces, eritem, promjenu boje kože, bol, pruritus, makulu, oticanje, kontuziju, nastanak modrice, lipodistrofiju (lipoatrofiju ili lipohipertrofiju), induraciju, reakciju, nodul, osip, papulu, hematom, upalu, urtikariju, kalcifikaciju, toplinu, krvarenje,
English: • The maximum volume per injection should not exceed 1 ml.
Croatian: • Maksimalni volumen po injekciji ne smije prelaziti 1 ml.
English: Study ENB-009-10 was an open-label, randomised study.
Croatian: Ispitivanje ENB-009-10 bilo je randomizirano ispitivanje otvorenog tipa.
English: Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.
Croatian: Zbog razlika u karakteristikama enzima, rezultati aktivnosti asfotaze alfa ne smiju se tumačiti istom mjerom kao serumske razine aktivnosti alkalne fosfataze.
English: The improvement in rickets severity was maintained for at least 72 months of follow-up treatment (including at least 84 months in 4 patients), as measured by the RGI C.
Croatian: Prema rezultatima RGI-C-a dobivenim u daljnjem praćenju liječenja, poboljšanja težine rahitisa održala su se najmanje 72 mjeseca (uključujući najmanje 84 mjeseca u 4 bolesnika).
English: • In studies, some eye-related side-effects have been reported both in patients using Strensiq and those who were not, probably associated with hypophosphatasia.
Croatian: • U ispitivanjima su zabilježene neke nuspojave povezane s očima, vjerojatno povezane s hipofosfatazijom, i u bolesnika koji su primali Strensiq i u onih koji ga nisu primali.
English: Place a larger bore needle (e.g. 25G) on the empty syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight.
Croatian: Na praznu štrcaljku stavite iglu većeg promjera (npr. 25G) sa zaštitnom kapicom, pritisnite iglu na štrcaljku i pričvrstite je zakretanjem u smjeru kazaljki na satu.
English: Strensiq 100 mg/ml solution for injection (80 mg/0.8 ml) asfotase alfa
Croatian: Strensiq 100 mg/ml otopina za injekciju (80 mg/0,8 ml) asfotaza alfa
English: Tetracycline for bone-labelling was administered in two 3-day courses (separated by a 14-day interval) prior to acquisition of the bone biopsy.
Croatian: Prije provedbe biopsije kostiju, tetraciklin za obilježavanje kostiju primijenjen je u dva 3-dnevna ciklusa (odvojena razmakom od 14 dana).
English: Any unused solution in the vial should be discarded.
Croatian: Svu neiskorištenu otopinu u bočici treba baciti.
English: Therefore another type of test may need to be used if you are treated with Strensiq.
Croatian: Stoga, ako se liječite Strensiqom, pretrage može biti potrebno provoditi drugom vrstom testa.
English: A few case reports of anaphylactoid/hypersensitivity reaction have been received in the clinical trial setting.
Croatian: U kliničkim ispitivanjima prijavljeno je nekoliko slučajeva anafilaktoidne reakcije / reakcije preosjetljivosti.
English: 1- Preferred terms considered as injection site reactions are presented in section below 2- Preferred terms considered as hypersensitivity are presented in the section below
Croatian: 2 Preporučeni pojmovi koji se smatraju preosjetljivošću prikazani su u dijelu ispod.
English: Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis (see section 4.4).
Croatian: Reakcije preosjetljivosti uključuju eritem/crvenilo, pireksiju/vrućicu, osip, pruritus, iritabilnost, mučninu, povraćanje, bol, rigor/zimicu, oralnu hipoesteziju, glavobolju, navale crvenila, tahikardiju, kašalj te znakove i simptome u skladu s anafilaksijom (vidjeti dio 4.4).
English: A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts.
Croatian: Na temelju pomaka prema višim vrijednostima percentila tijekom vremena na grafikonima CDC-a, ukupno 24/69 (35%) bolesnika pokazalo je očiti zamah u dobivanju na visini, a 32/69 (46%) bolesnika pokazalo je očiti zamah u dobivanju na težini.
English: Cohort 2 (n=3) received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 2 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Croatian: Kohorta 2 (n = 3) primila je u prvom tjednu intravenski asfotazu alfa u dozi od 3 mg/kg, a zatim supkutano 3 doze od 2 mg/kg u tjednim intervalima od 2. do 4. tjedna.
English: At study completion patients had received a median of over 76 months (6.3 years) of treatment (1 to 79 months).
Croatian: Medijan trajanja liječenja bolesnika iznosio je na kraju ispitivanja više od 76 mjeseci (6,3 godine) (raspon od 1 do 79 mjeseci).
English: Remove the larger bore needle pushing down and turning counterclockwise.
Croatian: Uklonite iglu većeg promjera sa štrcaljke tako što ćete je potisnuti prema dolje i zakrenuti u smjeru suprotnom od kazaljke na satu.
English: With the needle in the solution, pull the plunger to withdraw the correct dose into the syringe.
Croatian: Dok se igla nalazi u otopini, povucite klip i u štrcaljku izvucite točnu dozu.
English: SC
Croatian: C.
English: 12 vials of 0.8 mL
Croatian: 12 bočica od 0,8 ml
English: (SD) AUC over the dosing interval (AUCτ) was 66034 (19241) and 40444 (N=1) U*h/L following the first and the third dose, respectively.
Croatian: Nakon supkutane primjene od 1 mg/kg na tjedan, prosjek (SD) AUC-a kroz interval doziranja (AUCτ) bio je u kohorti 1 66034 (19241) nakon prve doze i 40444 (N = 1) U*h/L nakon treće doze.
English: What Strensiq looks like and contents of the pack Strensiq is presented as a clear colourless to slightly yellow aqueous solution for injection in vials containing 0.3 ml, 0.45 ml, 0.7 ml and 1 ml of solution.
Croatian: Strensiq je bistra bezbojna do blago žuta vodena otopina za injekciju, a isporučuje se u bočicama koje sadrže 0,3 ml, 0,45 ml, 0,7 ml i 1 ml otopine.
English: Strensiq 40 mg/ml solution for injection (12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml) asfotase alfa
Croatian: Strensiq 40 mg/ml otopina za injekciju (12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml 40 mg/1 ml) asfotaza alfa
English: It contains the active substance asfotase alfa.
Croatian: Sadrži djelatnu tvar asfotazu alfa.
English: Your doctor will provide dietary advice as necessary.
Croatian: Ako bude potrebno, liječnik će Vam dati preporuke za prehranu.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Procjene za centralni i periferni klirens u bolesnika tjelesne težine od 70 kg (i 95% CI) bile su 15,8 l (13,2; 18,9) na dan, odnosno 51,9 l (44,0; 61,2) na dan.
English: Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials (see section 4.8).
Croatian: U bolesnika liječenih Strensiqom u kliničkim ispitivanjima, na mjestima primjene injekcije zabilježena je nakon nekoliko mjeseci lokalizirana lipodistrofija, uključujući lipoatrofiju i lipohipertrofiju (vidjeti dio 4.8).
English: Cohort 1 (n=3) of the study received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 1 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Croatian: Kohorta 1 (n = 3) u ispitivanju primila je u prvom tjednu intravenski asfotazu alfa u dozi od 3 mg/kg, a zatim supkutano 3 doze od 1 mg/kg u tjednim intervalima od 2. do 4. tjedna.
English: Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.
Croatian: Ispitivanje ENB-002-08/ENB-003-08 Ispitivanje ENB-002-08/ENB-003-08 bilo je nerandomizirano, nekontrolirano ispitivanje otvorenog tipa.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane često hipokalcijemija
English: The active substance is asfotase alfa.
Croatian: Djelatna tvar je asfotaza alfa.
English: 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
Croatian: DRUGO 12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml
English: Craniosynostosis
Croatian: Kraniosinostoza