FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum.
Croatian: Nakon vađenja bočice (ili bočica) iz hladnjaka, Strensiq se mora upotrijebiti unutar najviše 3 sata.
English: Among those 97 patients, 55 (56.7%) also showed the presence of neutralizing antibodies at some time point post-baseline.
Croatian: Od tih 97 bolesnika, u njih 55 (56,7%) pokazala se u nekoj vremenskoj točki poslije početka ispitivanja i prisutnost neutralizirajućih protutijela.
English: • This total dose can be given either as an injection of 1 mg/kg asfotase alfa 6 times per week or as 2 mg/kg asfotase alfa 3 times per week depending on the recommendation of your doctor.
Croatian: • Ovu ukupnu dozu možete primati ili kao injekciju 1 mg/kg asfotaze alfa 6 puta na tjedan ili kao 2 mg/kg asfotaze alfa 3 puta na tjedan, ovisno o preporuci Vašeg liječnika.
English: Do not rub the injection site after injection.
Croatian: Nakon davanja injekcije nemojte trljati mjesto primjene injekcije.
English: Twenty five percent (15 out of 60) of the overall patient population was adult (>18 years) at baseline.
Croatian: Od sveukupne populacije bolesnika 25% (15 bolesnika od 60) bili su odrasli (u dobi od > 18 godina) na početku.
English: Any unused medicinal product or waste material should be disposed of immediately.
Croatian: Sav neiskorišteni lijek ili otpadni materijal valja odmah zbrinuti.
English: The pharmacokinetic variables characterized by population pharmacokinetic analysis represent the overall hypophosphatasia patient population with age range from 1 day to 66 years, subcutaneous doses of up to 28 mg/kg/week and a range of disease onset cohorts.
Croatian: Farmakokinetičke varijable opisane analizom populacijske farmakokinetike predstavljaju sveukupnu populaciju bolesnika s hipofosfatazijom s rasponom dobi od 1 dana do 66 godina, supkutano primijenjenim dozama do 28 mg/kg na tjedan i rasponom oblika bolesti po skupinama.
English: Administration of asfotase alfa will interfere with routine measurement of serum alkaline phosphatase by hospital laboratories resulting in serum alkaline phosphatase activity measurements of several thousand units per litre.
Croatian: Primjena asfotaze alfa interferirat će s rutinskim mjerenjem serumske razine alkalne fosfataze kakvo se provodi u bolničkim laboratorijima, što će rezultirati izmjerenom serumskom razinom aktivnosti alkalne fosfataze od nekoliko tisuća po litri.
English: What Strensiq contains
Croatian: Što Strensiq sadrži
English: The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia.
Croatian: Djelatna tvar u Strensiqu može zamijeniti enzim (alkalna fosfataza) koji nedostaje u hipofosfataziji.
English: As in adults, the recommended dosage of Strensiq in children and adolescents is 6 mg of asfotase alfa per kg weekly.
Croatian: Kao i u odraslih, preporučena doza Strensiqa u djece i adolescenata iznosi 6 mg asfotaze alfa po kilogramu tjelesne težine na tjedan.
English: It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.
Croatian: Preporučuje se praćenje razina paratireoidnog hormona i kalcija u serumu u bolesnika liječenih asfotazom alfa.
English: Step 5: Disposing of supplies
Croatian: 5. korak: zbrinjavanje pribora
English: 4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.
Croatian: Za 4 bolesnika nije bilo moguće procijeniti jer nije bilo dovoljno podataka, a za 1 se bolesnika nije moglo pouzdano odrediti.
English: Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8).
Croatian: Reakcije preosjetljivosti, uključujući znakove i simptome u skladu s anafilaksijom, zabilježene su u bolesnika liječenih asfotazom alfa (vidjeti dio 4.8).
English: Driving and using machines This medicine is not expected to have any effect on the ability to drive or use machines.
Croatian: Ne očekuje se da ovaj lijek utječe na sposobnost upravljanja vozilima ili rukovanja strojevima.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti/EXP”.
English: The reactions occurred within minutes after taking asfotase alfa, and can occur in patients who were taking asfotase alfa for more than one year.
Croatian: Reakcije su se događale unutar nekoliko minuta nakon primjene asfotaze alfa, a mogu se pojaviti i u bolesnika koji se liječe asfotazom alfa dulje od jedne godine.
English: The model identified body weight to affect asfotase alfa clearance and volume of distribution parameters.
Croatian: Model je pokazao da tjelesna težina utječe na parametre klirensa i volumena distribucije asfotaze alfa.
English: Following repeated subcutaneous administration to pregnant mice in the therapeutic dose range (>0.5 mg/kg), asfotase alfa levels were quantifiable in fetuses at all doses tested, suggesting cross-placental transport of asfotase alfa.
Croatian: Nakon ponavljane supkutane primjene skotnim ženkama miša u terapijskom rasponu doza (> 0,5 mg/kg), razine asfotaze alfa bilo je moguće kvantificirati u fetusima za sve testirane doze, što upućuje na prijenos asfotaze alfa kroz posteljicu.
English: • Hypersensitivity reactions have been observed in patients treated with Strensiq, including a description of sign and symptoms
Croatian: • u bolesnika liječenih Strensiqom opažene su reakcije preosjetljivosti, uključujući opis znakova i simptoma
English: Clear, colourless to slightly yellow, aqueous solution; pH 7.4.
Croatian: Bistra, bezbojna do blago žuta vodena otopina, kiselosti pH 7,4.
English: What benefits of Strensiq have been shown in clinical studies Strensiq has shown benefits for patients' mineralization of the skeleton and growth.
Croatian: Koje su se koristi Strensiqa pokazale u kliničkim ispitivanjima Strensiq se u bolesnika pokazao korisnim za mineralizaciju kostura i rast.
English: How to inject Strensiq:
Croatian: Kako ubrizgati Strensiq:
English: 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.
Croatian: Bolesnici su podvrgnuti biopsiji u području grebena bočne kosti ili kao ispitanici u kontrolnoj skupini ili prije, te poslije izlaganja asfotazi alfa: - kontrolna skupina, standardna skrb (5 procjenjivih bolesnika): prosječno (SD) vrijeme do mineralizacije bilo je 226 (248) dana na početku i 304 (211) dana u 24. tjednu - skupina koja je primala 0,3 mg/kg asfotaze alfa na dan (4 procjenjiva bolesnika): prosječno (SD) vrijeme do mineralizacije bilo je 1236 (1468) dana na početku i 328 (200) dana u 48. tjednu - skupina koja je primala 0,5 mg/kg asfotaze alfa na dan (5 procjenjivih bolesnika): prosječno (SD) vrijeme do mineralizacije bilo je 257 (146) dana na početku i 130 (142) dana u 48. tjednu.
English: The onset of hypophosphatasia was under 6 months in 4 patients, between 6 months and 17 years in 14 patients, and over 18 years in one patient.
Croatian: Početak hipofosfatazije zabilježen je u 4 bolesnika prije dobi od 6 mjeseci, u 14 bolesnika u dobi između 6 mjeseci i 17 godina te u 1 bolesnika u dobi iznad 18 godina.
English: 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.
Croatian: Ektopične kalcifikacije i reakcije na mjestu primjene injekcije opažene su u majmuna kada im je asfotaza alfa bila primjenjivana supkutano u dozama do 10 mg/kg na dan tijekom 26 tjedana.
English: These have been generally assessed as non-serious, mild to moderate in severity and self-limiting.
Croatian: Za te se reakcije obično ustanovi da nisu ozbiljne, da su blage do umjerene težine i samoograničavajuće.
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Croatian: Ako niste sigurni na što se odnose niže navedene nuspojave, zamolite liječnika da
English: What you need to know before you use Strensiq Do not use Strensiq
Croatian: Što morate znati prije nego počnete primjenjivati Strensiq
English: Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase.
Croatian: Asfotaza alfa sadrži katalitičku domenu tkivno nespecifične alkalne fosfataze.
English: Injection reaction
Croatian: Reakcije na injekciju
English: After the 3 mg/kg for 1.08 hours intravenous infusion, the median time (Tmax) ranged between 1.25 to 1.50 hours, and the mean (SD) Cmax ranged between 42694 (8443) and 46890 (6635) U/L over the studied cohorts.
Croatian: Nakon intravenske infuzije 3 mg/kg tijekom 1,08 sati, medijan vremena (Tmax) kretao se između 1,25 do 1,50 sati, a prosjek (SD) vrijednosti Cmax između 42694 (8443) i 46890 (6635) U/L u ispitivanim kohortama.
English: Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease (see section 5.1).
Croatian: Strensiq je kao dugoročna enzimska nadomjesna terapija indiciran u bolesnika s hipofosfatazijom nastalom u pedijatrijskoj dobi za liječenje koštanih manifestacija bolesti (vidjeti dio 5.1).
English: Hypophosphatasia is associated with multiple bone manifestations including rickets / osteomalacia, altered calcium and phosphate metabolism, impaired growth and mobility, respiratory compromise that may require ventilation, and vitamin B6-responsive seizures.
Croatian: Hipofosfatazija je povezana s višestrukim koštanim manifestacijama uključujući rahitis / osteomalaciju, promijenjeni metabolizam kalcija i fosfata, zaostali rast i narušenu pokretljivost, te s ugroženim disanjem što može zahtijevati mehaničku ventilaciju i napadajima koji su osjetljivi na vitamin B6.
English: Severe or potentially life-threatening hypersensitivity is a contraindication to re-challenge, if hypersensitivity is not controllable (see section 4.3).
Croatian: Teška ili potencijalno životno ugrožavajuća preosjetljivost kontraindikacija je za ponovno uvođenje lijeka ako se preosjetljivost ne može držati pod kontrolom (vidjeti dio 4.3).
English: Important information about some of the ingredients of Strensiq This medicine contains less than 1 mmol sodium (23 mg) per vial, which means it is essentially ‘sodiumfree'.
Croatian: Važna informacija o nekim sastojcima Strensiqa Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable (see section 4.4).
Croatian: Teška ili životno ugrožavajuća preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari, ako se preosjetljivost ne može držati pod kontrolom (vidjeti dio 4.4).
English: 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:
Croatian: U 10 bolesnika iz skupine liječene prema protokolu (isključeni su oni bolesnici koji su primili peroralno vitamin D između početka ispitivanja i 24. tjedna), koji su podvrgnuti biopsiji u području grebena bočne kosti prije i poslije primjene asfotaze alfa:
English: What is Strensiq
Croatian: Što je Strensiq
English: Patients have problems with bone growth and strength, which can lead to broken bones, bone pain, and difficulty walking, as well as difficulties with breathing and a risk of seizures (fits).
Croatian: Bolesnici imaju teškoće s rastom i čvrstoćom kostiju što može dovesti do lomova kostiju, bola u kostima i otežanog hodanja, a također i do otežanog disanja i rizika od pojave napadaja.
English: Hypophosphatasia is a rare, severe, and potentially fatal, genetic disorder caused by loss-of-function mutation(s) in the gene encoding tissue non-specific alkaline phosphatase.
Croatian: Hipofosfatazija je rijetki, teški i potencijalno smrtonosni genetski poremećaj prouzročen mutacijom/mutacijama povezanima s gubitkom funkcije u genu za kodiranje tkivno nespecifične alkalne fosfataze.
English: 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.
Croatian: Nakon supkutane primjene, procijenjena apsolutna bioraspoloživost iznosila je 0,602 (95% CI: 0,567; 0,638) ili 60,2%, a brzina apsorpcije 0,572 (95% CI: 0,338; 0,967) na dan ili 57,2%.
English: All patients began the study on a dose of asfotase alfa 6 mg/kg per week.
Croatian: Svi bolesnici započeli su ispitivanje s dozom asfotaze alfa od 6 mg/kg tjedno.
English: • Information on reporting side effect
Croatian: • informacije o prijavljivanju nuspojava
English: 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]).
Croatian: Sažetak sigurnosnog profila Suportivni podaci o sigurnosti odražavaju izloženost u 112 bolesnika s hipofosfatazijom perinatalnog/infantilnog (n = 89), juvenilnog nastupa (n = 22) i nastupa u odrasloj dobi (n = 1) ( dob pri uključivanju iznosila je 1 dan do 66,5 godina) liječenih asfotazom alfa, uz trajanje liječenja u rasponu od 1 dana do 391,9 tjedana [7,5 godina]).
English: For those patients who received asfotase alfa: 11/13 patients displayed persistent apparent catch-up heightgain as shown by movement over time to a higher percentile on CDC growth charts.
Croatian: U bolesnika koji su primali asfotazu alfa: 11/13 bolesnika pokazalo je ustrajni očiti zamah rasta prikazan na dijagramima rasta CDC-a kao kretanje prema višim percentilima tijekom vremena.
English: 1/13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement.
Croatian: Za 1/13 bolesnika nije se pokazao očiti zamah rasta, a za 1 bolesnika nije bilo dovoljno podataka da se omogući prosudba.
English: Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.
Croatian: Neki bolesnici za koje je potvrđeno da su pozitivni na protutijela protiv lijeka imali su reakcije na mjestu primjene injekcije i/ili preosjetljivost, međutim, između bolesnika koji su bili uvijek pozitivni na protutijela protiv lijeka i onih koji su bili uvijek negativni, nije ustanovljen dosljedan trend u učestalosti tih reakcija tijekom vremena.
English: 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.
Croatian: Prijavljeno je i nekoliko slučajeva anafilaktoidne reakcije / reakcije preosjetljivosti, koje su bile povezane sa znakovima i simptomima otežanog disanja, osjećaja gušenja, periorbitalnog edema i omaglice.
English: Strensiq is for subcutaneous use only.
Croatian: Strensiq je samo za supkutanu primjenu.
English: The treating physician should inform the testing lab that the patient is treated with medication affecting the ALP levels.
Croatian: Nadležni liječnik mora obavijestiti laboratorij koji provodi testove o tome da se bolesnik liječi lijekom koji utječe na razine alkalne fosfataze.
English: If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.
Croatian: Ako je u kliničkim laboratorijskim uzorcima prisutna asfotaza alfa, u dobivenim se vrijednostima mogu pojaviti odstupanja.
English: The reactions have occurred within minutes after subcutaneous administration of Strensiq and can occur in patients on treatment for more than 1 year.
Croatian: Reakcije su se javljale nekoliko minuta nakon supkutane primjene Strensiqa, a mogu se pojaviti u bolesnika koji se liječe dulje od 1 godine.
English: Table 1: Adverse Reactions Reported in clinical trials in hypophosphatasia patients (age 1 day to 66 years, treatment duration range from 1 day to 391 weeks [7.5 years])
Croatian: Tablica 1: Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika s hipofosfatazijom (u dobi od 1 dana do 66 godina, s rasponom trajanja liječenja od 1 dana do 391 tjedna
English: For handling of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rukovanju lijekom prije primjene vidjeti dio 6.6.
English: 69 patients completed the studies, and 11 discontinued.
Croatian: Ispitivanja je završilo 69 bolesnika, a prekinulo 11 bolesnika.
English: After the 2 mg/kg weekly subcutaneous administration in Cohort 2 the mean (SD) AUCτ was 138595 (6958) and 136109 (41875) following the first and the third dose, respectively.
Croatian: Nakon supkutane primjene od 2 mg/kg na tjedan u kohorti 2, prosjek (SD) AUCτ-a bio je 138595 (6958) nakon prve doze i 136109 (41875) nakon treće doze.
English: The most common adverse reactions observed were injection site reactions and injection-associated adverse reactions.
Croatian: Najčešće opažene nuspojave bile su reakcije na mjestu primjene injekcije i nuspojave povezane s injekcijom.
English: 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.
Croatian: Ventilacijska potpora Ispitivanja ENB-002-08/ENB-003-08 (11 bolesnika) i ENB-010/10 (69 bolesnika) bila su nerandomizirana, nekontrolirana ispitivanja otvorenog tipa, provedena na bolesnicima u dobi od 0,1 do 312 tjedana na početku.
English: There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis.
Croatian: Nema dovoljno podataka da bi se ustanovio uzročno-posljedični odnos između izloženosti Strensiqu i napredovanja kraniosinostoze.
English: 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.
Croatian: U trenutku uključivanja u ispitivanje ispitanici su imali između 6 i 12 godina, na kraju ispitivanja imali su između 10 i 18 godina, a 9 bolesnika navršilo je tijekom ispitivanja između 13 i 17 godina.
English: For the time period of observation of historical controls: 1/16 patients displayed apparent catch-up heightgain, 12/16 patients did not display apparent catch-up height-gain and data were inconclusive in 3/16 patients.
Croatian: U razdoblju praćenja kontrolnih bolesnika čiji su podaci bili prikupljeni u prošlosti: 1/16 bolesnika pokazala je očiti zamah rasta, 12/16 bolesnika nije pokazalo očiti zamah rasta, a podaci za 3/16 bolesnika nisu omogućili zaključak.
English: The central and peripheral volumes of distribution estimates for a patient with body weight of 70 kg (and 95% CI) were 5.66 (2.76, 11.6) L and 44.8 (33.2, 60.5) L, respectively.
Croatian: Procjene za centralni i periferni volumen distribucije u bolesnika tjelesne težine od 70 kg (i 95% CI) bile su 5,66 l (2,76; 11,6), odnosno 44,8 l (33,2; 60,5).
English: Pull the plunger back to draw air into the syringe equal to your dose.
Croatian: 7. Povucite klip prema natrag da biste u štrcaljku uvukli zrak u količini koja odgovara Vašoj dozi.
English: Before removing the needle from the vial, check the syringe for air bubbles.
Croatian: Prije nego što izvučete iglu iz bočice, provjerite ima li u štrcaljki mjehurića zraka.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Croatian: Otopina za injekciju (injekcija).
English: If it is the case, multiple injections should be done at different sites.
Croatian: Ako je potrebna veća količina, potrebno je primijeniti nekoliko injekcija na različita mjesta na tijelu.
English: 40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively.
Croatian: Među bolesnicima, njih 40/69 i 32/69 nije pokazalo očiti zamah u dobivanju na visini odnosno povećanju težine.
English: 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).
Croatian: Primjena asfotaze alfa može rezultirati lokalnim reakcijama na mjestu primjene injekcije (uključujući, između ostalih, eritem, osip, promjenu boje kože, pruritus, bol, papulu, nodul, atrofiju) definiranim kao bilo koji povezani štetni događaj koji se pojavi tijekom injiciranja ili do kraja dana kada je injekcija primljena (vidjeti dio 4.8).
English: In adult patients with pediatric-onset HPP, the pharmacokinetics of asfotase alfa at doses of 0.5, 2 and 3 mg/kg administered three times per week was consistent with those observed in pediatric patients with pediatric-onset HPP, and thus supported the approved dose of 6 mg/kg per week in treating adult patients with pediatric-onset HPP.
Croatian: U odraslih bolesnika s hipofosfatazijom koja je nastupila u dječjoj dobi, farmakokinetika asfotaze alfa primijenjene tri puta tjedno u dozama od 0,5, 2 i 3 mg/kg bila je u skladu s onom opaženom u pedijatrijskih bolesnika s hipofosfatazijom dječjeg oblika, što je potkrijepilo odobrenu dozu od 6 mg/kg tjedno za liječenje odraslih bolesnika s hipofosfatazijom koja je nastupila u dječjoj dobi.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane redoslijedom prema manjoj ozbiljnosti.
English: One patient withdrew from the trial due to injection site hypersensitivity.
Croatian: Jedan bolesnik prekinuo je sudjelovanje u kliničkom ispitivanju zbog reakcije preosjetljivosti na mjestu primjene injekcije.
English: OTHER 80 mg/0.8 ml
Croatian: DRUGO 80 mg/0,8 ml
English: 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.
Croatian: Preporučeni režim doziranja asfotaze alfa iznosi 2 mg po kg tjelesne težine primijenjeno supkutano tri puta na tjedan ili režim doziranja od 1 mg po kg tjelesne težine primijenjeno supkutano šest puta na tjedan.
English: Pharmacokinetics of asfotase alfa were evaluated in a 1-month, multicenter, open-label, dose-escalating, study in adults with hypophosphatasia.
Croatian: Farmakokinetika asfotaze alfa procijenjena je u 1-mjesečnom, multicentričnom ispitivanju otvorenog tipa s povećanjem doze u odraslih osoba s hipofosfatazijom.
English: Contusion (bruise)
Croatian: • modrica (kontuzija)
English: • The development of blood proteins against Strensiq, also called anti-drug antibodies, may occur during the treatment.
Croatian: • Tijekom liječenja u krvi se mogu razviti proteini protiv Strensiqa, koji se nazivaju i protutijela protiv lijeka.
English: The patients were randomly assigned to treatment group for the primary treatment period.
Croatian: U terapijsku skupinu primarnog perioda liječenja bolesnici su raspoređeni nasumično.