FrancophonIA/ELRC3.0 huggingface dataset:
English: Please discuss with you doctor or nurse the best sites for you.
Slovenian: Pogovorite se z zdravnikom ali medicinsko sestro o tem, kateri predeli so za vas najprimernejši.
English: The educational programme is aimed to provide instruction to patients and carers for proper administration techniques to address the risks of medication errors and injection site and injection associated reactions, including hypersensitivity.
Slovenian: Cilj izobraževalnega programa je zagotoviti navodila glede pravilnih tehnik uporabe zdravila bolnikom in njihovim skrbnikom, ki bodo odgovorila tudi na vprašanja o tveganju napak pri uporabi zdravila in o reakcijah na mestu injiciranja ter o reakcijah, povezanih z injiciranjem, vključno s preobčutljivostjo.
English: Nephrocalcinosis occurred in 51.6% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
Slovenian: Nefrokalcinoza se je pojavila pri 51,6 % bolnikov med rojstvom in starostjo 5 let v študiji naravnega poteka bolezni pri bolnikih z nezdravljeno hipofosfatazijo z infantilnim nastopom.
English: 2 ml or 3 ml vial (Type I glass) with a stopper (butyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
Slovenian: 2-mililitrska ali 3-mililitrska viala (steklo tipa I) z zamaškom (butilna guma) in tesnilom (aluminij) z dvižno zaporko (polipropilen).
English: One patient withdrew from the trial due to injection site hypersensitivity.
Slovenian: En bolnik se je umaknil iz kliničnega preskušanja zaradi preobčutljivosti na mestu injiciranja.
English: If you use more Strensiq than you should
Slovenian: Če ste uporabili večji odmerek zdravila Strensiq, kot bi smeli
English: Serum parathyroid hormone concentration may increase in hypophosphatasia patients administered asfotase alfa, most notably during the first 12 weeks of treatment.
Slovenian: Koncentracije obščitničnega hormona se lahko pri bolnikih s hipofosfatazijo, ki dobijo asfotazo alfa, povečajo, najbolj opazno v prvih 12 tednih zdravljenja.
English: Pharmacokinetics of asfotase alfa were evaluated in a 1-month, multicenter, open-label, dose-escalating, study in adults with hypophosphatasia.
Slovenian: Farmakokinetiko asfotaze alfa so ocenili v 1-mesečni, multicentrični, odprti študiji z večanjem odmerka pri odraslih s hipofosfatazijo.
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).
Slovenian: Zdravilo Strensiq je indicirano za dolgotrajno encimsko nadomestno zdravljenje pri bolnikih s pediatričnim nastopom hipofosfatazije za zdravljenje manifestacij te bolezni na kosteh (glejte poglavje 5.1).
English: Among those 97 patients, 55 (56.7%) also showed the presence of neutralizing antibodies at some time point post-baseline.
Slovenian: 97 bolniki se je pri 55 (56,7 %) pokazala v neki časovni točki po izhodišču tudi prisotnost nevtralizirajočih protiteles.
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.
Slovenian: Po ponavljajočem subkutanem dajanju zdravila brejim mišim v terapevtskem območju odmerkov (> 0,5 mg/kg) je bilo mogoče ravni asfotaze alfa pri zarodkih določiti za vse testirane odmerke, kar nakazuje na prehajanje asfotaze alfa skozi posteljico.
English: Severe or potentially life-threatening hypersensitivity is a contraindication to re-challenge, if hypersensitivity is not controllable (see section 4.3).
Slovenian: Resna ali življenje ogrožajoča preobčutljivost je kontraindikacija za ponovno uporabo zdravila, če preobčutljivosti ni mogoče obvladati (glejte poglavje 4.3).
English: Adverse reactions with asfotase alfa are listed by system organ class and preferred term using MedDRA frequency 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).
Slovenian: Neželeni učinki z asfotazo alfa so našteti glede na organski sistem in posamezen izraz, upoštevajoč MedDRA konvencijo za pogostnost: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki
English: As in adults, the recommended dosage of Strensiq in children and adolescents is 6 mg of asfotase alfa per kg weekly.
Slovenian: Kot pri odraslih je priporočeni odmerek zdravila Strensiq pri otrocih in mladostnikih 6 mg asfotaze alfa na kg na teden.
English: The model identified body weight to affect asfotase alfa clearance and volume of distribution parameters.
Slovenian: Z modelom je bilo ugotovljeno, da telesna masa vpliva na parametre očistka asfotaze alfa in volumna porazdelitve.
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).
Slovenian: Huda ali življenje ogrožajoča preobčutljivost na učinkovino ali katero koli pomožno snov, če preobčutljivosti ni mogoče obvladati (glejte poglavje 4.4.
English: Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase.
Slovenian: Asfotaza alfa vsebuje katalitično domeno tkivno nespecifične alkalne fosfataze.
English: Clear, colourless to slightly yellow, aqueous solution; pH 7.4.
Slovenian: Bistra, brezbarvna do rahlo rumenkasta vodna raztopina s pH 7,4.
English: • The development of blood proteins against Strensiq, also called anti-drug antibodies, may occur during the treatment.
Slovenian: • Med zdravljenjem se lahko razvijejo krvne beljakovine proti zdravilu Strensiq, ki se imenujejo tudi protitelesa proti zdravilu.
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.
Slovenian: • V študijah so pri bolnikih, ki so uporabljali zdravilo Strensiq, in pri tistih, ki ga niso, poročali o nekaterih neželenih učinkih, povezanih z očesom, ki so verjetno povezani s hipofosfatazijo.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: There was no evidence of ectopic calcification observed in any other tissues examined.
Slovenian: Na drugih pregledanih tkivih niso opazili dokazov ektopične kalcifikacije.
English: • Hypersensitivity reactions have been observed in patients treated with Strensiq, including a description of sign and symptoms
Slovenian: • pri bolnikih, zdravljenih z zdravilom Strensiq, so opazili preobčutljivostne reakcije, vključno z opisom znakov in simptomov,
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.
Slovenian: Dajanje asfotaze alfa bo vplivalo na rutinske meritve alkalne fosfataze v serumu, ki jih opravljajo bolnišnični laboratoriji, in povzročijo meritve aktivnosti alkalne fosfataze več tisoč enot na liter.
English: Trans-iliac crest bone biopsies were obtained by standard procedure.
Slovenian: Biopsije transčrevničnega grebena so odvzeli s standardnim postopkom.
English: There are insufficient data to establish a causal relationship between exposure to Strensiq and ectopic calcification.
Slovenian: Ni dovolj podatkov za dokaz vzročne povezave med izpostavljenostjo zdravilu Strensiq in ektopično kalcifikacijo.
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.
Slovenian: Hipofosfatazija je redka, huda in potencialno smrtna prirojena bolezen, ki jo povzroči mutacija/-e gena z izgubo funkcije, ki kodira tkivno nespecifično alkalno fosfatazo.
English: Based on the results of population pharmacokinetic analysis it was concluded that asfotase alfa exhibits linear pharmacokinetic up to subcutaneous doses of 28 mg/kg/week.
Slovenian: Na podlagi rezultatov populacijske farmakokinetične analize so sklepali, da je farmakokinetika asfotaze alfa linearna do subkutanih odmerkov 28 mg/kg/teden.
English: • If you are treated with Strensiq, you may experience a reaction at the injection site (pain, nodule, rash, discoloration) during the injection of the medicine or during the hours following the injection.
Slovenian: • Če se zdravite z zdravilom Strensiq, boste morda imeli reakcijo na mestu injiciranja (bolečino, zatrdlino, izpuščaj, obarvanje) med injiciranjem zdravila ali v urah, ki sledijo injiciranju.
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.
Slovenian: Skupaj 24 od 69 (35 %) bolnikov je pokazalo navidezno dohitevanje pridobivanja telesne višine, 32 od 69 (46 %) bolnikov pa je pokazalo navidezno dohitevanje pridobivanja telesne mase, kot kaže gibanje v času proti naslednjemu percentilu na rastnih shemah CDC.
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).
Slovenian: O lokalizirani lipodistrofiji, vključno z lipoatrofijo in lipohipertrofijo, na mestu injiciranja so pri bolnikih, zdravljenih z zdravilom STRENSIQ v kliničnih preskušanjih, poročali po več mesecih (glejte poglavje 4.8).
English: Elderly There is no evidence for special considerations when Strensiq is administered to elderly patients.
Slovenian: Ni dokazov o tem, da bi bila pri dajanju zdravila Strensiq starejšim bolnikom potrebna posebna previdnost.
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.
Slovenian: med odmernim intervalom (AUCτ) 66.034 (19.241) po prvem oz. 40.444 (N = 1) e*h/l po tretjem odmerku.
English: Any unused solution in the vial should be discarded.
Slovenian: Morebitno neuporabljeno raztopino v viali je treba zavreči.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Read section 4 carefully to know what side effects can occur before using this medicine
Slovenian: Pred uporabo tega zdravila natančno preberite poglavje 4, da boste vedeli, kateri neželeni učinki se lahko pojavijo.
English: If it is the case, multiple injections should be done at different sites.
Slovenian: Če presega, dajte več injekcij na različnih mestih.
English: A few case reports of anaphylactoid/hypersensitivity reaction have been received in the clinical trial setting.
Slovenian: Prejeli so nekaj poročil o primerih anafilaktoidnih/preobčutljivostnih reakcij v okviru kliničnih preskušanj.
English: • Information on reporting side effect
Slovenian: • informacije o poročanju neželenih učinkov.
English: Not all pack sizes may be marketed in your country.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: Subcutaneous use.
Slovenian: subkutana uporaba
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB13
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi, oznaka ATC:
English: Serum Parathyroid Hormone and Calcium
Slovenian: Ravni obščitničnega hormona in kalcija v serumu
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. the product is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
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.
Slovenian: • Če si zdravilo injicirate sami, vam bo zdravnik, farmacevt ali medicinska sestra pokazal, kako si zdravilo pripravite in injicirate.
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.
Slovenian: Po intravenski infuziji 3 mg/kg v 1,08-ure je bil razpon medianega časa (Tmax) od 1,25 do 1,50 ure, srednja vrednost (SD) Cmax pa je bila v proučevanih kohortah v območju med 42.694 (8.443) in 46.890 (6.635) e/l.
English: If you suspect that you have been accidently administered a higher dose of Strensiq than prescribed, please contact your doctor for advice.
Slovenian: Če sumite, da ste prejeli večji odmerek zdravila Strensiq, kot vam je bil predpisan, se za nasvet obrnite na zdravnika.
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.
Slovenian: Asfotaza alfa, humana rekombinantna tkivno nespecifična alkalna fosfataza-Fc-deka-aspartatni fuzijski protein z encimsko aktivnostjo spodbuja mineralizacijo skeleta pri bolnikih s hipofosfatazijo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1015/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1015/003
English: Remove the needle from the vial and place back the protective cap over the needle.
Slovenian: Odstranite iglo iz viale in spet namestite zaščitni pokrovček na iglo.
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.
Slovenian: Usposobljeni radiologi so ocenjevali rentgenske posnetke zapestij in kolen bolnikov pred izhodiščem in po izhodišču in ugotavljali naslednje znake: navidezna fizna razširitev, metafizni izbruh, nepravilnosti začasne cone kalcifikacije, metafizne radiotransparence, metadiafizna skleroza, osteopenija, "popcorn" kalcifikacije v metadiafizi, demineralizacija distalne metafize, transverzen subfizni trak transparence in pasovi radiotransparence.
English: Ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis as manifestations of hypophosphatasia are documented in published literature.
Slovenian: Očesna (veznična in roženična) kalcifikacija in nefrokalcinoza kot manifestaciji hipofosfatazije sta dokumentirani v objavljenih virih.
English: Step 4: Injecting Strensiq
Slovenian: 4. korak: Injiciranje zdravila Strensiq
English: Table 1 gives the adverse reactions observed from clinical trials.
Slovenian: V preglednici 1 so navedeni neželeni učinki, ki so jih opazili v kliničnih preskušanjih.
English: Any unused medicinal product or waste material should be disposed of immediately.
Slovenian: Morebitno neuporabljeno zdravilo ali odpadni material takoj zavrzite.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: raztopina za injiciranje (injekcija)
English: Your doctor will provide dietary advice as necessary.
Slovenian: Zdravnik vam bo po potrebi svetoval glede prehrane.
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.
Slovenian: 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.
English: 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.
Slovenian: 726 aminokislin, sestavljen iz (i) katalitične domene humane, tkivno nespecifične alkalne fosfataze, (ii) domene Fc humanega imunoglobulina G1 in (iii) deka-aspartat peptidne domene.
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 (CDC), USA.
Slovenian: 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.
English: At study completion patients had received a median of over 76 months (6.3 years) of treatment (1 to 79 months).
Slovenian: Ob zaključku študije so bolniki prejeli mediano več kot 76 mesecev (6,3 leta) zdravljenja (1 do 79 mesecev).
English: Strensiq is a medicine used to treat the inherited disease hypophosphatasia.
Slovenian: Zdravilo Strensiq se uporablja za zdravljenje dedne bolezni hipofosfatazije.
English: • Patients receiving asfotase alfa have had allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis.
Slovenian: 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.
English: Nineteen patients were enrolled, 14 completed, and 5 discontinued.
Slovenian: Vključenih je bilo 19 bolnikov, 14 bolnikov je študijo zaključilo, 5 bolnikov pa prekinilo.
English: There are insufficient data from the use of asfotase alfa in pregnant women.
Slovenian: Podatkov o uporabi asfotaze alfa pri nosečnicah ni dovolj.
English: Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles.
Slovenian: Držite brizgo z iglo navzgor in s prstom potrkajte po valju brizge, da boste odstranili morebitne zračne mehurčke.
English: • The maximum volume per injection should not exceed 1 ml.
Slovenian: • Največji volumen na injekcijo ne sme preseči 1 ml.
English: 5/11 subjects displayed apparent catch-up height-gain.
Slovenian: Pri 5 od 11 oseb se je pokazalo navidezno dohitevanje v pridobivanju višine.
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.
Slovenian: Injekcijsko iglo odstranite, izpustite kožno gubo in na mesto injiciranja za nekaj sekund nežno položite kosem vate ali gazo.
English: Step 3: Placing the needle for injection on the syringe 1.
Slovenian: 3. korak: Pritrditev igle za injiciranje na brizgo
English: The extrinsic factors affecting asfotase alfa pharmacokinetic exposures were formulation specific activity and total sialic acid content.
Slovenian: Ekstrinzični dejavniki, ki so vplivali na farmakokinetično izpostavljenost asfotazi alfa, so bili aktivnost, specifična za zdravilo, in skupna vsebnost sialne kisline.
English: No interaction studies have been performed with asfotase alfa.
Slovenian: Študij medsebojnega delovanja z asfotazo alfa niso izvedli.
English: Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum.
Slovenian: Potem, ko viale vzamete iz hladilnika, morate zdravilo Strensiq porabiti najkasneje v 3 urah.
English: These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness.
Slovenian: Ti simptomi so vključevali težave z dihanjem, občutek dušenja, periorbitalni edem in omotičnost.
English: Pull the plunger back to draw air into the syringe equal to your dose.
Slovenian: Povlecite bat nazaj, da boste posrkali v brizgo toliko zraka, kolikor ustreza vašemu odmerku.
English: Ireland
Slovenian: Francija
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.
Slovenian: Uporabo zdravila Strensiq vam bo razložil zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi boleznimi ali boleznimi, povezanimi s kostmi.
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.
Slovenian: 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.
English: All patients began the study on a dose of asfotase alfa 6 mg/kg per week.
Slovenian: Vsi bolniki so začeli študijo z odmerkom 6 mg/kg asfotaze alfa na teden.
English: If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.
Slovenian: Če je v vzorcih za klinične laboratorije prisotna asfotaza alfa, to lahko povzroči nepravilne rezultate.
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.
Slovenian: 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.
English: - Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24
Slovenian: - srednja vrednost (SD) osteoidne debeline je bila 12,8 (3,5) µm ob izhodišču in 9,5 (5,1) µm v
English: Before removing the needle from the vial, check the syringe for air bubbles.
Slovenian: Preden odstranite iglo iz viale, se prepričajte, da v brizgi ni zračnih mehurčkov.
English: Step 2: Withdrawing Strensiq solution from the vial
Slovenian: 2. korak: Odvzem raztopine zdravila Strensiq iz viale
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.
Slovenian: 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.
English: Study ENB-010-10
Slovenian: Študija ENB-010-10
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.
Slovenian: 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.
English: Patients who experienced anaphalaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness.
Slovenian: Bolniki, ki so imeli podobne simptome kot pri anafilaksiji, so imeli težave z dihanjem, občutek dušenja, navzeo, oteklino okrog oči in omotico.
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.
Slovenian: • 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.