natgillin/translations-raw huggingface dataset:
Any unused medicinal product or waste material should be disposed of immediately. 
Morebitno neuporabljeno zdravilo ali odpadni material takoj zavrzite.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
PHARMACEUTICAL FORM Solution for injection (injection). 
raztopina za injiciranje (injekcija)
Your doctor will provide dietary advice as necessary. 
Zdravnik vam bo po potrebi svetoval glede prehrane.
A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital edema and dizziness. 
Prejeli so tudi nekaj poročil o primerih anafilaktoidnih/preobčutljivostnih reakcij, ki so bile povezane z znaki in simptomi oteženega dihanja, občutkom dušenja, periorbitalnim edemom in omotico.
Asfotase alfa is a soluble glycoprotein comprised of two identical polypeptide chains, each with a length of 726 amino acids made from (i) the catalytic domain of human tissue-nonspecific alkaline phosphatase, (ii) the human immunoglobulin G1 Fc domain and (iii) a deca-aspartate peptide domain. 
726 aminokislin, sestavljen iz (i) katalitične domene humane, tkivno nespecifične alkalne fosfataze, (ii) domene Fc humanega imunoglobulina G1 in (iii) deka-aspartat peptidne domene.
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 (CDC), USA. 
Telesno višino, telesno maso in obseg glave so vnašali v krivulje rasti (serije percentilnih krivulj, ki ponazarjajo porazdelitev), ki so na voljo v Centrih za obvladovanje in preprečevanje bolezni (Centers for Disease Control and Prevention - CDC), ZDA.
At study completion patients had received a median of over 76 months (6.3 years) of treatment (1 to 79 months). 
Ob zaključku študije so bolniki prejeli mediano več kot 76 mesecev (6,3 leta) zdravljenja (1 do 79 mesecev).
Strensiq is a medicine used to treat the inherited disease hypophosphatasia. 
Zdravilo Strensiq se uporablja za zdravljenje dedne bolezni hipofosfatazije.
• Patients receiving asfotase alfa have had allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis. 
Opozorila in previdnostni ukrepi • Bolniki, ki so prejemali asfotazo alfa, so imeli alergijske reakcije, vključno z življenje ogrožajočimi alergijskimi reakcijami, zaradi katerih je bilo potrebno podobno zdravljenje kot pri anafilaksiji.
Nineteen patients were enrolled, 14 completed, and 5 discontinued. 
Vključenih je bilo 19 bolnikov, 14 bolnikov je študijo zaključilo, 5 bolnikov pa prekinilo.
There are insufficient data from the use of asfotase alfa in pregnant women. 
Podatkov o uporabi asfotaze alfa pri nosečnicah ni dovolj.
Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles. 
Držite brizgo z iglo navzgor in s prstom potrkajte po valju brizge, da boste odstranili morebitne zračne mehurčke.
• The maximum volume per injection should not exceed 1 ml. 
• Največji volumen na injekcijo ne sme preseči 1 ml.
5/11 subjects displayed apparent catch-up height-gain. 
Pri 5 od 11 oseb se je pokazalo navidezno dohitevanje v pridobivanju višine.
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. 
Injekcijsko iglo odstranite, izpustite kožno gubo in na mesto injiciranja za nekaj sekund nežno položite kosem vate ali gazo.
Step 3: Placing the needle for injection on the syringe 1. 
3. korak: Pritrditev igle za injiciranje na brizgo
The extrinsic factors affecting asfotase alfa pharmacokinetic exposures were formulation specific activity and total sialic acid content. 
Ekstrinzični dejavniki, ki so vplivali na farmakokinetično izpostavljenost asfotazi alfa, so bili aktivnost, specifična za zdravilo, in skupna vsebnost sialne kisline.
No interaction studies have been performed with asfotase alfa. 
Študij medsebojnega delovanja z asfotazo alfa niso izvedli.
Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum. 
Potem, ko viale vzamete iz hladilnika, morate zdravilo Strensiq porabiti najkasneje v 3 urah.
These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness. 
Ti simptomi so vključevali težave z dihanjem, občutek dušenja, periorbitalni edem in omotičnost.
Pull the plunger back to draw air into the syringe equal to your dose. 
Povlecite bat nazaj, da boste posrkali v brizgo toliko zraka, kolikor ustreza vašemu odmerku.
Ireland 
Francija
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. 
Uporabo zdravila Strensiq vam bo razložil zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi boleznimi ali boleznimi, povezanimi s kostmi.
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. 
Rast Višina, telesna masa in obseg glave so bili izrisani na tablicah rasti (serije percentilnih krivulj, ki ponazarjajo porazdelitev), in so na voljo pri Centrih za nadzor in preprečevanje bolezni (Centers for Disease Control and Prevention) v ZDA.
All patients began the study on a dose of asfotase alfa 6 mg/kg per week. 
Vsi bolniki so začeli študijo z odmerkom 6 mg/kg asfotaze alfa na teden.
If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported. 
Če je v vzorcih za klinične laboratorije prisotna asfotaza alfa, to lahko povzroči nepravilne rezultate.
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. 
Namestite iglo večjega notranjega premera (npr. 25G) na prazno brizgo in medtem, ko je zaščitni pokrovček na igli, iglo pritisnite navzdol na brizgo in jo zasukajte v smeri urnega kazalca, da bo čvrsto pritrjena.
- Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24 
- srednja vrednost (SD) osteoidne debeline je bila 12,8 (3,5) µm ob izhodišču in 9,5 (5,1) µm v
Before removing the needle from the vial, check the syringe for air bubbles. 
Preden odstranite iglo iz viale, se prepričajte, da v brizgi ni zračnih mehurčkov.
Step 2: Withdrawing Strensiq solution from the vial 
2. korak: Odvzem raztopine zdravila Strensiq iz viale
Ectopic calcifications and injection site reactions were observed in monkeys when asfotase alfa was administered subcutaneously at daily doses up to 10 mg/kg through 26 weeks. 
Pri opicah so opazili ektopične kalcifikacije in reakcije na mestu injiciranja, ko so jim 26 tednov asfotazo alfa dajali subkutano v dnevnih odmerkih do 10 mg/kg.
Study ENB-010-10 
Študija ENB-010-10
Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered subcutaneously six times per week. 
Odmerjanje Priporočeni režim odmerjanja asfotaze alfa je 2 mg/kg telesne mase subkutano trikrat na teden ali režim odmerjanja 1 mg/kg telesne mase subkutano šestkrat na teden.
Patients who experienced anaphalaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness. 
Bolniki, ki so imeli podobne simptome kot pri anafilaksiji, so imeli težave z dihanjem, občutek dušenja, navzeo, oteklino okrog oči in omotico.
• 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. 
• V kliničnih študijah na dojenčkih s hipofosfatazijo so pri otrocih, starih manj kot 5 let, poročali o zgodnjem zraščanju kosti lobanje pri uporabi zdravila Strensiq in brez nje.
• Risk management plan (RMP) The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis. 
Ni dovolj podatkov za dokaz vzročne povezave med izpostavljenostjo zdravilu Strensiq in napredovanjem kraniosinostoze.
Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered. 
Dajanje zdravila Strensiq je treba prekiniti pri bolnikih, ki doživijo hude reakcije na mestu injiciranja, in uvesti ustrezno zdravljenje z zdravili.
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. 
Ko bodo vsi mehurčki na vrhu brizge, previdno potisnite bat in iztisnite mehurčke iz brizge nazaj v vialo.
Bone biopsy 
Biopsija kosti
These have been generally assessed as non-serious, mild to moderate in severity and self-limiting. 
Običajno so bile ocenjene kot neresne, blage do zmerne po resnosti in so izzvenele brez zdravljenja.
The volume per injection should not exceed 1 ml. 
Volumen na injekcijo ne sme preseči 1 ml.
Study ENB-009-10 was an open-label, randomised study. 
Študija ENB-009-10 je bila odprta, randomizirana študija.
It contains the active substance asfotase alfa. 
Vsebuje učinkovino asfotazo alfa.
12 vials of 0.8 mL 
12 vial z 0,8 ml
For management of adverse reactions, see sections 4.4 and 4.8. 
Za obravnavo neželenih učinkov glejte poglavji 4.4 in
The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia. 
Učinkovina v zdravilu Strensiq lahko pri hipofosfataziji nadomesti manjkajoči encim (alkalno fosfatazo).
Holding the syringe and vial, insert the needle through the sterile rubber seal and into the vial. 
Medtem ko držite brizgo in vialo, zabodite iglo skozi sterilno gumijasto zaporko v vialo.
The absolute bioavailability and absorption rate following subcutaneous administration were estimated to be 0.602 (95% CI: 0.567, 0.638) or 60.2% and 0.572 (95%CI: 0.338, 0.967)/day or 57.2%, respectively. 
0,567; 0,638) oz. 60,2 %, in hitrost absorpcije po subkutanem dajanju pa 0,572 (95-odstotni IZ: 0,338; 0,967)/dan oziroma 57,2 %.
1/13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement. 
13 bolnikov ni kazal opaznega dohitevanja v pridobivanju višine in za 1 bolnika ni bilo dovolj podatkov, da bi bila možna ocena.
What benefits of Strensiq have been shown in clinical studies Strensiq has shown benefits for patients' mineralization of the skeleton and growth. 
Pokazalo se je, da zdravilo Strensiq bolnikom koristi pri mineralizaciji skeleta in rasti.
OTHER 80 mg/0.8 ml 
DRUGI PODATKI 80 mg/0,8 ml
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. 
Asfotaza alfa je humana rekombinantna tkivno nespecifična alkalna fosfataza-Fc-deka-aspartatni fuzijski protein, izražena v liniji ovarijskih celic kitajskega hrčka, pridobljeni z genskim inženiringom.
Infection of skin at injection site (injection site cellulitis) Reduced levels of calcium in the blood (hypocalcaemia) Kidney stones (nephrolithiasis) 
brazgotina večja nagnjenost k modricam vročinski valovi okužba kože na mestu injiciranja (celulitis na mestu injiciranja) znižana raven kalcija v krvi (hipokalciemija) ledvični kamni (nefrolitiaza)
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. 
Kohorta 2 (n = 3) je prvi teden intravensko dobivala asfotazo alfa 3 mg/kg, nato pa so sledili 3 odmerki po 2 mg/kg subkutano v tedenskih intervalih od 2. do 4. tedna.
The mean age at sign/symptom onset was 1.49 months. 
Povprečna starost ob nastopu znakov/simptomov je bila
Choose an injection site (thighs, abdomen, arms (deltoids), buttocks). 
Izberite mesto injiciranja (stegna, trebuh, roke (deltoidne mišice), zadnjica).
Ventilation support In studies ENB-002-08/ENB-003-08 (11 patients) and ENB-010-10 (69 patients), both open-label, nonrandomised, non-controlled studies of patients aged 0.1 to 312 weeks at baseline. 
Ventilacijska podpora V študijah ENB-002-08/ENB-003-08 (11 bolnikov) in ENB-010-10 (69 bolnikov), obe odprti,
• Self-injection guide for patients 
• Vodnik za samoinjiciranje za bolnike,
Control visually that the volume contained into the syringe is correct. 
S prostim očesom preverite, ali je količina v injekcijski brizgi pravilna.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction and development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih ali vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Study ENB-006-09/ENB-008-10 
Študija ENB-006-09/ENB-008-10
Very common: may affect more than 1 in 10 people Reactions at the injection site during the injection of the medicine or during the hours following the injection (which can lead to redness, discolorations, itching, pain, fatty lumps or decreased fatty tissue on the surface of the skin, skin hypopigmentation, and/or swelling) Fever (pyrexia), irritability 
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov reakcije na mestu injiciranja med injiciranjem zdravila ali v urah, ki sledijo injiciranju (povzročijo lahko rdečino, obarvanje, srbenje, bolečino, maščobne zatrdline ali pomanjkanje maščobnega tkiva na površini kože, kožno hipopigmentacijo in/ali oteklino)
While continuing to hold the skin, push the syringe plunger to inject the medicine slowly, and steadily all the way in. 5. 
Medtem ko držite kožo, potisnite bat injekcijske brizge in si počasi in enakomerno injicirajte zdravilo.
Dose to be injected 
ki se injicira
Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8). 
Dajanje asfotaze alfa lahko povzroči lokalne reakcije na mestu injiciranja (med drugim lahko vključujejo eritem, izpuščaj, obarvanje, pruritus, bolečino, papule, vozliče, atrofijo), opredeljene kot kateri koli z injiciranjem povezani neželeni učinek, ki je nastopil med injiciranjem ali do konca dneva injiciranja
At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of 
V 48. tednu je 50 od 69 bolnikov (72,5 %) v celotni skupini za analizo doseglo rezultate ≥ 2 na lestvici radiografskega globalnega vtisa sprememb (Radiographic Global Impression of Change) in so jih obravnavali kot bolnike, ki so se klinično pomembno odzvali na zdravljenje.
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. 
Zdravilo Strensiq je na voljo v obliki bistre in brezbarvne do rahlo rumenkaste vodne raztopine za injiciranje v vialah, ki vsebujejo 0,3 ml, 0,45 ml, 0,7 ml in 1 ml raztopine.
There is insufficient information on the excretion of asfotase alfa in human milk. 
Dojenje Ni dovolj podatkov o izločanju asfotaze alfa v materino mleko.
Study ENB-009-10 
Študija ENB-009-10
Please collect your syringes, vials and needle in a sharps container. 
Injekcijske brizge, viale in igle odlagajte v vsebnik za ostre odpadke.
The reactions have occurred within minutes after subcutaneous administration of Strensiq and can occur in patients on treatment for more than 1 year. 
Do teh reakcij je prišlo v času nekaj minut po subkutanem dajanju zdravila Strensiq, pojavijo pa se lahko tudi pri bolnikih, ki prejemajo zdravilo več kot
Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study. 
Študija ENB-002-08/ENB-003-08 Študija ENB-002-08/ENB-003-08 je bila odprta, nerandomizirana, nekontrolirana študija.
Talk to your doctor if you notice any change in the shape of your infant's head. 
Če opazite kakršne koli spremembe oblike dojenčkove glave, se posvetujte z zdravnikom.
If you forget to use Strensiq Do not inject a double dose to make up for a forgotten dose and contact your doctor for advice. 
Ne injicirajte dvojnega odmerka, če ste pozabili injicirati prejšnji odmerek, in za nasvet vprašajte zdravnika.
The maximum volume of medicinal product per injection should not exceed 1 ml. 
Največja količina zdravila na injekcijo ne sme preseči 1 ml.
For 10 patients in the per-protocol set (excludes those patients who received oral vitamin D between baseline and week 24) who underwent biopsy of the trans-iliac bone crest before and after receiving asfotase alfa: 
(izključeni so bolniki, ki so prejemali peroralni vitamin D med izhodiščem in 24. tednom), ki so imeli biopsijo transčrevničnega grebena, preden so prejeli asfotazo alfa, in po tem:
Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics. 
Zaradi razlik v encimskih značilnostih se aktivnost asfotaze alfa ne sme razlagati enako kot meritev aktivnosti alkalne fosfataze v serumu.
Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders. 
Zdravljenje mora uvesti zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi ali kostnimi boleznimi.
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 0.8 ml of solution. 
Zdravilo Strensiq je na voljo v obliki bistre in brezbarvne do rahlo rumenkaste vodne raztopine za injiciranje v vialah, ki vsebujejo po 0,8 ml raztopine.
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 
2- Posamezni izrazi, obravnavani kot preobčutljivost, so predstavljeni v spodnjem poglavju.
How to use Strensiq 
Kako uporabljati zdravilo Strensiq
Strensiq should be administered using sterile disposable syringes and injection needles. 
Zdravilo Strensiq je treba dati s sterilno injekcijsko brizgo in injekcijsko iglo za enkratno uporabo.
29 of 80 patients required ventilation support at baseline: ∙ 16 patients required invasive ventilation support (intubation or tracheostomy) at baseline (one had a brief period of non-invasive ventilation at baseline before transfer). 
∙ 16 bolnikov je potrebovalo invazivno ventilacijsko podporo (intubacija ali traheostomija) ob izhodišču (eden je imel kratko obdobje neinvazivne ventilacije ob izhodišču pred transferjem);
Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypaesthesia. 
Druge preobčutljivostne reakcije so vključevale bruhanje, navzeo, zvišano telesno temperaturo, glavobol, pordevanje, razdražljivost, mrzlico, kožni eritem, izpuščaj, pruritus in oralno hipestezijo.
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. 
Če se v brizgi pojavijo zračni mehurčki, držite brizgo z iglo navzgor in previdno potrkajte po valju brizge, da se bodo mehurčki dvignili navzgor.
In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis and occurrence of Arnold-Chiari malformation, have been reported in hypophosphatasia patients < 5 years of age. 
V kliničnih študijah z asfotazo alfa so kot o neželenih učinkih poročali o kraniosinostozi (povezani z povečanim intrakranialnim tlakom), vključno s poslabšanjem obstoječe kraniosinostoze in pojavom
Remove the larger bore needle pushing down and turning counterclockwise. 
Odstranite iglo večjega notranjega premera, tako da jo potisnete navzdol in jo zasukate v obratni smeri urnega kazalca.
Contents of the pack and other information 
Shranjevanje zdravila Strensiq Vsebina pakiranja in dodatne informacije
With the needle in the solution, pull the plunger to withdraw the correct dose into the syringe. 
Z iglo v raztopini povlecite bat nazaj, da boste v brizgo izvlekli pravilni odmerek.
Injection reaction 
Reakcije na injiciranje
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. 
Namestite iglo manjšega notranjega premera (npr. 27 ali 29G) na napolnjeno brizgo in medtem,
Supportive safety data reflect exposure in 112 patients with perinatal/infantile (n=89), juvenile-onset (n = 22), adult onset (n = 1) HPP (age at enrollment from 1 day to 66.5 years) treated with asfotase alfa, with a treatment duration range from 1 day to 391.9 weeks [7.5 years]). 
z juvenilnim začetkom (n=22) in HPP z začetkom v odrasli dobi (n=1) (starost ob vključitvi v študijo je bila od 1 dneva do 66,5 let), ki so prejemali asfotazo alfa, zdravljenje pa je trajalo od 1 dne do 391,9 tednov [7,5 let].
After the 1 mg/kg weekly subcutaneous administration in Cohort 1 the mean 
Po subkutanem dajanju 1 mg/kg na teden v kohorti 1 je bila srednja (SD) vrednost AUC
Patients underwent biopsy of the trans-iliac bone crest either as part of a control group or before and after exposure to asfotase alfa: - Control group, standard of care (5 evaluable patients): mean (SD) mineralisation lag-time was 226 (248) days at baseline and 304 (211) days at week 24 - 0.3 mg/kg/day asfotase alfa group (4 evaluable patients): mean (SD) mineralisation lag-time was 1236 (1468) days at baseline and 328 (200) days at week 48 - 0.5 mg/kg/day asfotase alfa group (5 evaluable patients): mean (SD) mineralisation lag-time was 257 (146) days at baseline and 130 (142) days at week 48 After approximately 48 weeks all patients were adjusted to the recommended dose 1.0 mg/kg/day. 
- kontrolna skupina, standardna oskrba (5 bolnikov, ki jih je bilo možno oceniti): srdnja vrednost (SD) časa zakasnitve mineralizacije je bila 226 (248) dni ob izhodišču in 304 (211) dni v 24. tednu; - skupina z 0,3 mg/kg/dan asfotaze alfa (4 bolniki, ki jih je bilo možno oceniti): srednja vrednost (SD) časa zakasnitve mineralizacije je bila 1236 (1468) dni ob izhodišču in 328 (200) dni v
No trends in adverse events based on antibody status were observed in clinical trials. 
V kliničnih preskušanjih niso opazili trendov neželenih učinkov na podlagi statusa protiteles.
Age at inclusion in the study was between 6 and 12 years old and was between 10 and 18 years old at completion, with 9 patients who became between 13 and 17 years old during the study. 
Pri vključitvi v študijo je bila starost bolnikov med 6 in 12 leti, ob zaključku pa med 10 in 18 leti.