FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: 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
Slovenian: 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
English: There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis.
Slovenian: Ni dovolj podatkov za dokaz vzročne povezave med izpostavljenostjo zdravilu Strensiq in napredovanjem kraniosinostoze.
English: Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.
Slovenian: Dajanje zdravila Strensiq je treba prekiniti pri bolnikih, ki doživijo hude reakcije na mestu injiciranja, in uvesti ustrezno zdravljenje z zdravili.
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.
Slovenian: Ko bodo vsi mehurčki na vrhu brizge, previdno potisnite bat in iztisnite mehurčke iz brizge nazaj v vialo.
English: Bone biopsy
Slovenian: Biopsija kosti
English: These have been generally assessed as non-serious, mild to moderate in severity and self-limiting.
Slovenian: Običajno so bile ocenjene kot neresne, blage do zmerne po resnosti in so izzvenele brez zdravljenja.
English: The volume per injection should not exceed 1 ml.
Slovenian: Volumen na injekcijo ne sme preseči 1 ml.
English: Study ENB-009-10 was an open-label, randomised study.
Slovenian: Študija ENB-009-10 je bila odprta, randomizirana študija.
English: It contains the active substance asfotase alfa.
Slovenian: Vsebuje učinkovino asfotazo alfa.
English: 12 vials of 0.8 mL
Slovenian: 12 vial z 0,8 ml
English: For management of adverse reactions, see sections 4.4 and 4.8.
Slovenian: Za obravnavo neželenih učinkov glejte poglavji 4.4 in
English: The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia.
Slovenian: Učinkovina v zdravilu Strensiq lahko pri hipofosfataziji nadomesti manjkajoči encim (alkalno fosfatazo).
English: Holding the syringe and vial, insert the needle through the sterile rubber seal and into the vial.
Slovenian: Medtem ko držite brizgo in vialo, zabodite iglo skozi sterilno gumijasto zaporko v vialo.
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.
Slovenian: 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 %.
English: Hypophosphatasia
Slovenian: Hipofosfatazija
English: 1/13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement.
Slovenian: 13 bolnikov ni kazal opaznega dohitevanja v pridobivanju višine in za 1 bolnika ni bilo dovolj podatkov, da bi bila možna ocena.
English: What benefits of Strensiq have been shown in clinical studies Strensiq has shown benefits for patients' mineralization of the skeleton and growth.
Slovenian: Pokazalo se je, da zdravilo Strensiq bolnikom koristi pri mineralizaciji skeleta in rasti.
English: OTHER 80 mg/0.8 ml
Slovenian: DRUGI PODATKI 80 mg/0,8 ml
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.
Slovenian: 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.
English: Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection asfotase alfa
Slovenian: 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: Infection of skin at injection site (injection site cellulitis) Reduced levels of calcium in the blood (hypocalcaemia) Kidney stones (nephrolithiasis)
Slovenian: 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)
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.
Slovenian: 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.
English: The mean age at sign/symptom onset was 1.49 months.
Slovenian: Povprečna starost ob nastopu znakov/simptomov je bila
English: Choose an injection site (thighs, abdomen, arms (deltoids), buttocks).
Slovenian: Izberite mesto injiciranja (stegna, trebuh, roke (deltoidne mišice), zadnjica).
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.
Slovenian: Ventilacijska podpora V študijah ENB-002-08/ENB-003-08 (11 bolnikov) in ENB-010-10 (69 bolnikov), obe odprti,
English: • Self-injection guide for patients
Slovenian: • Vodnik za samoinjiciranje za bolnike,
English: Control visually that the volume contained into the syringe is correct.
Slovenian: S prostim očesom preverite, ali je količina v injekcijski brizgi pravilna.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction and development.
Slovenian: 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.
English: Study ENB-006-09/ENB-008-10
Slovenian: Študija ENB-006-09/ENB-008-10
English: 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
Slovenian: 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)
English: While continuing to hold the skin, push the syringe plunger to inject the medicine slowly, and steadily all the way in. 5.
Slovenian: Medtem ko držite kožo, potisnite bat injekcijske brizge in si počasi in enakomerno injicirajte zdravilo.
English: Dose to be injected
Slovenian: ki se injicira
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).
Slovenian: 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
English: At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of
Slovenian: 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.
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.
Slovenian: 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.
English: There is insufficient information on the excretion of asfotase alfa in human milk.
Slovenian: Dojenje Ni dovolj podatkov o izločanju asfotaze alfa v materino mleko.
English: Study ENB-009-10
Slovenian: Študija ENB-009-10
English: Please collect your syringes, vials and needle in a sharps container.
Slovenian: Injekcijske brizge, viale in igle odlagajte v vsebnik za ostre odpadke.
English: The reactions have occurred within minutes after subcutaneous administration of Strensiq and can occur in patients on treatment for more than 1 year.
Slovenian: 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
English: Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.
Slovenian: Študija ENB-002-08/ENB-003-08 Študija ENB-002-08/ENB-003-08 je bila odprta, nerandomizirana, nekontrolirana študija.
English: Talk to your doctor if you notice any change in the shape of your infant's head.
Slovenian: Če opazite kakršne koli spremembe oblike dojenčkove glave, se posvetujte z zdravnikom.
English: 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.
Slovenian: Ne injicirajte dvojnega odmerka, če ste pozabili injicirati prejšnji odmerek, in za nasvet vprašajte zdravnika.
English: The maximum volume of medicinal product per injection should not exceed 1 ml.
Slovenian: Največja količina zdravila na injekcijo ne sme preseči 1 ml.
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:
Slovenian: (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:
English: Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.
Slovenian: Zaradi razlik v encimskih značilnostih se aktivnost asfotaze alfa ne sme razlagati enako kot meritev aktivnosti alkalne fosfataze v serumu.
English: Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.
Slovenian: Zdravljenje mora uvesti zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi ali kostnimi boleznimi.
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 0.8 ml of solution.
Slovenian: 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.
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
Slovenian: 2- Posamezni izrazi, obravnavani kot preobčutljivost, so predstavljeni v spodnjem poglavju.
English: How to use Strensiq
Slovenian: Kako uporabljati zdravilo Strensiq
English: Strensiq should be administered using sterile disposable syringes and injection needles.
Slovenian: Zdravilo Strensiq je treba dati s sterilno injekcijsko brizgo in injekcijsko iglo za enkratno uporabo.
English: 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).
Slovenian: ∙ 16 bolnikov je potrebovalo invazivno ventilacijsko podporo (intubacija ali traheostomija) ob izhodišču (eden je imel kratko obdobje neinvazivne ventilacije ob izhodišču pred transferjem);
English: Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypaesthesia.
Slovenian: Druge preobčutljivostne reakcije so vključevale bruhanje, navzeo, zvišano telesno temperaturo, glavobol, pordevanje, razdražljivost, mrzlico, kožni eritem, izpuščaj, pruritus in oralno hipestezijo.
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.
Slovenian: Če se v brizgi pojavijo zračni mehurčki, držite brizgo z iglo navzgor in previdno potrkajte po valju brizge, da se bodo mehurčki dvignili navzgor.
English: 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.
Slovenian: 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
English: Remove the larger bore needle pushing down and turning counterclockwise.
Slovenian: Odstranite iglo večjega notranjega premera, tako da jo potisnete navzdol in jo zasukate v obratni smeri urnega kazalca.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Strensiq Vsebina pakiranja in dodatne informacije
English: With the needle in the solution, pull the plunger to withdraw the correct dose into the syringe.
Slovenian: Z iglo v raztopini povlecite bat nazaj, da boste v brizgo izvlekli pravilni odmerek.
English: Injection reaction
Slovenian: Reakcije na injiciranje
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.
Slovenian: Namestite iglo manjšega notranjega premera (npr. 27 ali 29G) na napolnjeno brizgo in medtem,
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]).
Slovenian: 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].
English: After the 1 mg/kg weekly subcutaneous administration in Cohort 1 the mean
Slovenian: Po subkutanem dajanju 1 mg/kg na teden v kohorti 1 je bila srednja (SD) vrednost AUC
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.
Slovenian: - 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
English: No trends in adverse events based on antibody status were observed in clinical trials.
Slovenian: V kliničnih preskušanjih niso opazili trendov neželenih učinkov na podlagi statusa protiteles.
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.
Slovenian: Pri vključitvi v študijo je bila starost bolnikov med 6 in 12 leti, ob zaključku pa med 10 in 18 leti.
English: Remove the protective plastic from the syringe to be used.
Slovenian: odstranite zaščitno plastiko.
English: Ophthalmology examination and renal ultrasounds are recommended at baseline and periodically in hypophosphatasia patients.
Slovenian: Pri bolnikih s hipofosfatazijo se zato priporočajo očesni pregledi v izhodišču in nato periodično in ultrazvok ledvic.
English: - Mean (SD) mineralisation lag-time was 93 (70) days at baseline and 119 (225) days at week 24
Slovenian: - srednja vrednost (SD) časa zakasnitve mineralizacije je bila 93 (70) dni ob izhodišču in
English: Onset of hypophosphatasia was under 6 months in all patients.
Slovenian: Pri vseh bolnikih je hipofosfatazija nastopila pri manj kot
English: The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and water for injections.
Slovenian: Druge sestavine zdravila so natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat in voda za injekcije.
English: In asfotase alfa clinical studies ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis have been reported in patients with hypophosphatasia.
Slovenian: V kliničnih študijah z asfotazo alfa so pri bolnikih s hipofosfatazijo poročali o očesnih (vezničnih in roženičnih) kalcifikacijah in nefrokalcinozi.
English: Study ENB-006-09/ENB-008-10 was an open-label, randomised study.
Slovenian: Študija ENB-006-09/ENB-008-10 je bila odprta, randomizirana študija.
English: - 7 patients were weaned off invasive ventilation (time on ventilation from 12 to 168 weeks), 4 patients were off any ventilation support, and 3 patients were on noninvasive ventilation support.
Slovenian: 168 tednov), 4 bolniki so bili brez ventilacijske podpore, 3 bolniki pa so bili na neinvazivni ventilacijski podpori.
English: 9 out of 10 patients achieved a RGI-C score ≥2, only 1 with RGI-C <2.
Slovenian: Pet od 7 bolnikov je doseglo oceno RGI-C ≥ 2,
English: This is important to rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, or deltoid.
Slovenian: Za zmanjšanje tveganja lipodistrofije je pomembno, da izmenjujete predel injiciranja: predel trebuha, stegna in nadlakta.
English: Prior to launch of Strensiq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila Strensiq na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa,
English: Periodic monitoring (including fundoscopy for signs of papilloedema) and prompt intervention for increased intracranial pressure is recommended in hypophosphatasia patients below 5 years of age.
Slovenian: Pri bolnikih s hipofosfatazijo, starih manj kot 5 let, se priporoča obdobno spremljanje (vključno s fundoskopijo za znake papiloedema) in hitro ukrepanje pri zvečanem intrakranialnem tlaku.
English: If injecting 6 x per week
Slovenian: Ob injiciranju 6 x na teden
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
Slovenian: Napolnjeni volumni vial so: 0,3 ml, 0,45 ml, 0,7 ml in 1,0 ml
English: Craniosynostosis
Slovenian: Kraniosinostoza
English: What Strensiq is and what it is used for
Slovenian: Kaj je zdravilo Strensiq in za kaj ga uporabljamo Kaj je zdravilo Strensiq
English: Refer to the dosing chart below for more details.
Slovenian: Za več podrobnosti glejte preglednico za odmerjanje.
English: Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z asfotazo alfa, so poročali o preobčutljivostnih reakcijah, vključno z znaki in simptomi, skladnimi z anafilaksijo (glejte poglavje 4.8).
English: For storage conditions before administration of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja pred dajanjem zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
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.
Slovenian: 9 od 10 bolnikov je doseglo oceno RGI-C ≥ 2, samo eden z oceno RGI-C - 2 bolnika sta potrebovala invazivno ventilacijsko podporo in 1 bolnik je nadaljeval z neinvazivno ventilacijsko podporo, vsi 3 bolniki so umrli in vsi so imeli oceno RGI-C < 2.
English: Each vial contains 40 mg of asfotase alfa (40 mg/1 ml).
Slovenian: Ena viala vsebuje 40 mg asfotaze alfa (40 mg/1 ml).
English: Dose - and time-dependent acute injection reactions that were transient and self-limiting were noted in rats at intravenous use doses of 1 to 180 mg/kg.
Slovenian: Pri podganah so pri intravenski uporabi odmerkov od 1 do 180 mg/kg opazili akutne reakcije na injiciranje, odvisne od odmerka in časa, ki so bile prehodne in so izzvenele same od sebe.
English: If injecting 3 x per week
Slovenian: Ob injiciranju 3 x na teden
English: Any unused solution should be discarded.
Slovenian: Neporabljeni ostanek raztopine je treba zavreči.
English: Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika, farmacevta ali medicinske sestre.
English: The central and peripheral clearance estimates for a patient with body weight of 70 kg (and 95% CI) were 15.8 (13.2, 18.9) L/day and 51.9 (44.0, 61.2) L/day, respectively.
Slovenian: Za bolnika s telesno maso 70 kg (in 95-odstotnim IZ) je bila ocena centralnega volumna porazdelitve 5,66 (2,76; 11,6) l in perifernega volumna porazdelitve 44,8 (33,2; 60,5) l. Za bolnika s telesno maso 70 kg (in 95-odstotnim IZ) je bila ocena centralnega očistka 15,8 (13,2; 18,9) l/dan in perifernega očistka 51,9 (44,0; 61;2) l/dan.
English: There is no experience with overdose of asfotase alfa.
Slovenian: S prevelikim odmerjanjem asfotaze alfa ni izkušenj.
English: Dispose the needle with the protective cap in your sharps container.
Slovenian: Iglo z nameščenim zaščitnim pokrovčkom vred zavrzite v vsebnik za ostre odpadke.