natgillin/translations-raw huggingface dataset:
After initiation of treatment with burosumab, fasting serum phosphate should be measured every 2 weeks for the first month of treatment, every 4 weeks for the following 2 months and thereafter as appropriate.
Po uvedbi zdravljenja z burosumabom je treba meriti serumske fosfate na tešče vsaka 2 tedna prvi mesec zdravljenja, vsake 4 tedne naslednja 2 meseca, po tistem pa, kot je primerno.
Patient's fasting serum phosphate level should be monitored due to the risk of hyperphosphatemia.
Bolnikovo koncentracijo serumskih fosfatov na tešče je treba spremljati zaradi tveganja hiperfosfatemije.
This conventional therapy was discontinued 2-4 weeks prior to burosumab initiation.
To konvencionalno zdravljenje so ukinili 2-4 tedne pred uvedbo burosumaba.
These changes were a consequence of higher than normal serum phosphate levels, which accelerated bone turnover and also led to periosteal hyperostosis and a decrease in bone strength in adult animals, but not in juvenile animals at the doses tested.
Te spremembe so bile posledica serumskih koncentracij fosfatov, višjih od normalnih, ki so pospešile premeno kostnine in povzročile tudi periostno hiperostozo in zmanjšanje čvrstosti kosti pri odraslih živalih, ne pa pri mladostniških živalih pri testiranih odmerkih.
Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection.
Lokalne reakcije (npr. urtikarija, eritem, izpuščaj, oteklina, modrica, bolečina, pruritus in hematom na mestu injiciranja) se pojavljajo na mestu injiciranja.
No specific fertility studies in animals with burosumab were conducted.
Posebnih študij plodnosti na živalih z burosumabom niso opravili.
This conventional therapy was discontinued 2-6 weeks prior burosumab initiation.
To konvencionalno terapijo so ukinili 2-6 tednov pred uvedbo burosumaba.
Serum burosumab and phosphate concentrations, as well as TmP/GFR, increased and decreased in parallel and reached maximum levels at approximately the same time point after each dose, supporting a direct PK-PD relationship.
Serumske koncentracije burosumaba in fosfatov, pa tudi TmP/GFR, so se vzporedno višale in nižale in dosegle maksimalne ravni v približno isti časovni točki po vsakem odmerku, kar podpira neposredno razmerje FK-FD.
Studies in animals have shown effects on male reproductive organs (see section 5.3).
Študije na živalih so pokazale učinke na moške reproduktivne organe (glejte poglavje 5.3).
Talk to your doctor before taking CRYSVITA if you are taking:
Posvetujte se z zdravnikom, preden začnete jemati zdravilo CRYSVITA, če jemljete:
Paediatric PK/PD
Pediatrična FK/FD
Patients received burosumab at a dose of 0.8 mg/kg every two weeks.
Bolniki so prejemali burosumab v odmerku 0,8 mg/kg vsaka dva tedna.
There are no clinical data available on the effect of burosumab on human fertility.
Kliničnih podatkov o učinku burosumaba na plodnost pri ljudeh ni.
Monitoring of plasma alkaline phosphatases, Calcium, PTH and creatinine is recommended every 6 months (every 3 months for children 1- 2 years) or as indicated.
Spremljanje plazemskih alkalnih fosfataz, kalcija, paratiroidnega hormona (PTH) in kreatinina je priporočljivo vsakih 6 mesecev (vsake 3 mesece za otroke, stare 1-2 leti) ali kot je indicirano.
Following subcutaneous administration, the time to reach maximum serum concentrations (Tmax) of burosumab is approximately 5-10 days.
Po subkutanem dajanju je čas za dosego najvišje serumske koncentracije (Tmax) burosumaba približno 5-10 dni.
No significant difference has been observed in paediatric patient pharmacokinetics or pharmacodynamics as compared with PK/PD in the adult population.
Pri farmakokinetiki in farmakodinamiki pediatričnih bolnikov niso opazili pomembnih razlik v primerjavi s FK/FD odrasle populacije.
Anti-drug antibodies (ADA) have been detected in a small percentage of patients receiving burosumab who had also tested positive for ADA prior to dosing; no adverse events or loss of efficacy was associated with these findings.
Protitelesa proti zdravilu (anti-drug antibodies - ADA) so odkrili pri majhnem odstotnem deležu bolnikov, ki so prejemali burosumab in pri katerih so bili rezultati preiskav ADA pred odmerjanjem pozitivni; s temi ugotovitvami neželeni učinki ali zmanjšanje učinkovitosti niso bili povezani.
Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mimic the effect of calcium on tissues by activating the calcium receptor).
Pri kombiniranju burosumaba s kalcimimetičnimi zdravili (tj. sredstvi, ki posnemajo učinek kalcija na tkiva, tako da aktivirajo receptor za kalcij) je potrebna previdnost.
The most common adverse drug reaction (ADR) reported in paediatric patients up to 64 weeks was injection site reactions (57%), headache (54%), pain in extremity (42%), vitamin D decreased (28%), rash (23%), toothache (19%), tooth abscess (14%), myalgia (14%), and dizziness (11%) (See section 4.4 and ‘Description of selected adverse reactions' below).
Najpogostejši neželeni učinki (adverse drug reaction - ADR), o katerih so poročali pri pediatričnih bolnikih, starih do 64 tednov, so bili reakcije na mestu injiciranja (57 %), glavobol (54 %), bolečina v okončinah (42 %), znižan vitamin D (28 %), izpuščaj (23 %), zobobol (19 %), zobni absces (14 %), mialgija (14 %) in omotica (11 %) (glejte poglavje 4.4 in ‘Opis izbranih neželenih učinkov' v nadaljevanju).
• you are taking any phosphate or vitamin D supplements
• če jemljete prehranska dopolnila s fosfati ali vitaminom D;
Monitoring for signs and symptoms of nephrocalcinosis, e.g. by renal ultrasonography, is recommended at the start of treatment and every 6 months for the first 12 months of treatment, and annually thereafter.
Spremljanje glede znakov in simptomov nefrokalcinoze, npr. z ultrasonografijo ledvic, je priporočljivo v začetku zdravljenja in vsakih 6 mesecev v prvem 12-mesečnem obdobju zdravljenja, nato pa enkrat na leto.
• severe swelling of eyelids, mouth or lips (angio-oedema)
• izrazite otekline očesnih vek, ust ali ustnic (angioedem),
In repeat-dose toxicology studies of up to 40 weeks duration in cynomolgus monkeys, mineralisation of the rete testis/seminiferous tubules was observed in male monkeys; however, no changes were observed in semen analysis.
V toksikoloških študijah s ponavljajočimi se odmerki pri opicah cinomolgus, ki so trajale do 40 tednov, so ugotovili mineralizacijo rete testis/seminifernih tubulov pri opičjih samcih; vendar pri analizi semena niso ugotovili nobenih sprememb.
The patient must have fasting serum phosphate below the reference range for age to restart burosumab at approximately half of the previous dose.
Bolnik mora imeti serumske fosfate na tešče pod referenčnim razponom za starost, da lahko spet začne prejemati burosumab v odmerku, ki je približno polovica prejšnjega odmerka.
a) The estimates of LS means and p-values are from the generalized estimation equation model accounting for baseline RSS, visits and regimen and its interaction.
a) Ocene povprečij in vrednosti p z metodo najmanjših kvadratov so iz modela generaliziranih ocenjevalnih enačb, ki utemeljujejo izhodiščno RSS, preglede in terapevtsko shemo in njihovo interakcijo.
It is not known if CRYSVITA passes into breast milk, and a risk to newborns or infants cannot be ruled out.
Ni znano, ali se zdravilo CRYSVITA izloča v materino mleko, in tveganja za dojene novorojence/otroke ne moremo izključiti.
Burosumab is composed solely of amino acids and carbohydrates as a native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Burosumab je kot nativen imunoglubulin sestavljen samo iz aminokislin in ogljikovih hidratov in ni verjetno, da bi se izločal preko mehanizmov presnove v jetrih.
CRYSVITA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravilo CRYSVITA ni priporočljivo v nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Burosumab must not be given to patients with severe or end stage renal disease (see section 4.3).
Burosumaba ne smemo dajati bolnikom s hudo boleznijo ledvic ali boleznijo ledvic v končnem stadiju (glejte poglavje 4.3).
Do not use CRYSVITA if:
Ne uporabljajte zdravila CRYSVITA:
In paediatric patients, the most frequent potential hypersensitivity events were rash (22%), injection site rash (6%), and urticaria (4%).
Pri pediatričnih bolnikih so bili najpogostnejši možni preobčutljivostni dogodki izpuščaj (22 %), izpuščaj na mestu injiciranja (6 %) in urtikarija (4 %).
Your doctor will check the phosphate level in your blood and urine and may also do a renal ultrasound during your treatment in order to reduce the risk of hyperphosphataemia (too much phosphate in the blood) and ectopic mineralisation (a build up of calcium in tissues such as the kidneys).
Zdravnik bo med zdravljenjem kontroliral raven fosfatov v vaši krvi in urinu in mogoče naredil tudi ultrazvok ledvic, s čimer bo zmanjšal tveganje hiperfosfatemije (preveč fosfatov v krvi) in ektopične mineralizacije (kopičenje kalcija v tkivih, na primer v ledvicah).
Patients with severe renal impairment or end stage renal disease.
Bolniki s hudo okvaro ledvic ali boleznijo ledvic v končnem stadiju.
Figure 1: Serum Phosphate Concentration (mmol/L) over Time in the Phase 2 Paediatric Study in Children 5-12 years Receiving Burosumab Every 2 Weeks (Q2W)
Slika 1: Serumska koncentracija fosfatov (mmol/l) v času v pediatrični študiji 2. faze pri otrocih, starih 5 do 12 let, ki so prejemali burosumab vsaka 2 tedna (Q2W)
• FGF23 lowers the amount of phosphate in the blood.
• FGF23 znižuje koncentracijo fosfatov v krvi.
The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so navedeni po organskih sistemih in pogostnosti, ki je opredeljena z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do
Burosumab did not promote abnormal bone development, as no changes in femur length or bone strength were noted in juvenile animals.
Burosumab ni pospešil abnormalnega razvoja kosti, ker pri mladostniških živalih niso opazili sprememb dolžine stegnenice ali čvrstosti kosti.
You may get skin reactions where the injection is given, see section 4 for more information.
Na mestu, kamor so vam dali injekcijo, lahko dobite kožne reakcije, za več informacij glejte poglavje 4.
The injection site reactions were generally mild in severity, occurred within 1 day of medicinal product administration, lasted approximately 1 to 3 days, required no treatment, and resolved in almost all instances.
Reakcije na mestu injiciranja so bile po izraženosti na splošno blage, pojavljale so se 1 dan po uporabi zdravila, trajale so približno 1 do 3 dni, ni jih bilo treba zdraviti in skoraj v vseh primerih so se pozdravile same od sebe.
RSS Total Score
Skupna ocena RSS
There is no experience with overdose of burosumab.
Izkušenj s prevelikim odmerjanjem burosumaba ni.
Tests and checks
Preiskave in kontrolne preiskave
If you are not sure, talk to your doctor before using CRYSVITA.
Če ste negotovi, se pred uporabo zdravila CRYSVITA pogovorite z zdravnikom.
By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1, 25 dihydroxy-Vitamin D.
Z zaviranjem FGF23 burosumab zvečuje tubulno reabsorpcijo fosfatov iz ledvic in zvišuje serumsko koncentracijo 1, 25 dihidroksi-vitamina D.
Hydrochloric acid, 10% (for pH adjustment) Water for injections
L-metionin klorovodikova kislina, 10 % (za prilagoditev pH) voda za injekcije
Twenty six of 52 patients received burosumab every 4 weeks (Q4W).
Šestindvajset od 52 bolnikov je prejemalo burosumab enkrat na 4 tedne (Q4W).
Do not shake before use.
Pred uporabo ne stresajte.
Ectopic mineralisation, as manifested by nephrocalcinosis, has been observed in patients with XLH treated with oral phosphorous and vitamin D analogues; these medicinal products should be stopped at least 1 week prior to initiating burosumab treatment (see section 4.2).
Ektopično mineralizacijo, ki se kaže z nefrokalcinozo, so ugotavljali pri bolnikih z na kromosom X vezano hipofosfatemijo (XLH), zdravljenih s peroralnim fosforjem in analogi vitamina D; ta zdravila se morajo ukiniti vsaj 1 teden pred uvedbo burosumaba (glejte poglavje 4.2).
Pharmacokinetic/pharmacodynamic relationship(s)
Farmakokinetično(-a)/farmakodinamično(-a) razmerje(-a)
The AUC for the change from baseline in serum phosphate, TmP/GFR and 1,25(OH)2D increased linearly with increasing burosumab AUC.
AUC za spremembo od izhodišča serumskih fosfatov, TmP/GFR in 1,25(OH)2D so se zvečevali linearno z naraščajočo AUC burosumaba.
Administration should be interrupted in any patient experiencing severe injection site reactions (see section 4.8) and appropriate medical therapy administered.
Dajanje zdravila je treba prekiniti pri vsakem bolniku, ki ima hude reakcije na mestu injiciranja (glejte poglavje 4.8), in uvesti primerno zdravljenje.
Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Pričakuje se, da bosta njegova presnova in izločanje v skladu s presnovnimi potmi imunoglobulinskega očistka, kar ima za posledico razgradnjo v majhne peptide in posamične aminske kisline.
What you need to know before you use CRYSVITA
Kaj morate vedeti, preden boste uporabili zdravilo CRYSVITA
The active substance is burosumab.
Učinkovina je burosumab.
There are no or limited amount of data from the use of burosumab in pregnant women.
Podatkov o uporabi burosumaba pri nosečnicah ni oziroma so omejeni.
Studies in rabbits and adult and juvenile cynomolgus monkeys demonstrated dose-dependent elevations of serum phosphate and 1,25 (OH)2D confirming the pharmacologic actions of burosumab in these species.
Študije na kuncih in odraslih in mladostniških opicah cinomolgus so pokazale od odmerka odvisna zvišanja serumskih fosfatov in 1,25 (OH)2D, ki so potrdila fiziološke učinke burosumaba pri teh živalskih vrstah.
What CRYSVITA is and what it is used for
Kaj je zdravilo CRYSVITA in za kaj ga uporabljamo
In a murine model of XLH, a significant reduction in the incidence of ectopic mineralisation was observed at equivalent levels of serum phosphate, suggesting that the risk of mineralisation is less in the presence of excess FGF23.
V mišjem modelu XLH so opazili značilno zmanjšanje incidence ektopične mineralizacije pri enakih ravneh serumskih fosfatov, kar kaže, da je tveganje mineralizacije manjše v prisotnosti čezmernega FGF23.
CRYSVITA is not recommended in pregnancy.
Zdravilo CRYSVITA v nosečnosti ni priporočljivo.
If fasting serum phosphate is below the reference range for age, the dose may be increased stepwise by 0.4 mg/kg up to a maximum dose of 2.0 mg/kg (maximum dose of 90 mg).
Če so serumski fosfati na tešče pod referenčnim razponom za starost, se lahko odmerek postopoma zveča po 0,4 mg/kg do največjega odmerka 2,0 mg/kg (največji odmerek 90 mg).
The burosumab dose was adjusted to target a fasting serum phosphorous concentration of 1.13 to 1.62 mmol/L.
Odmerek burosumaba so prilagodili tako, da je bil cilj koncentracija serumskega fosforja na tešče 1,13 do 1,62 mmol/l.
Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture.
Burosumab CRYSVITA je rekombinantno človeško monoklonsko IgG1 protitelo proti FGF23, izdelano s tehnologijo rekombinantne DNA v kulturi sesalskih celic ovarija kitajskega hrčka (Chinese hamster ovary - CHO).
Ectopic mineralisation of multiple tissues and organs (e.g. kidney, heart, lung, and aorta), and associated secondary consequences (e.g. nephrocalcinosis) in some cases, due to hyperphosphataemia, was observed in normal animals at doses of burosumab that resulted in serum phosphate concentrations in animals greater than approximately 2.58 mmol/L.
Ektopično mineralizacijo več tkiv in organov (npr. ledvic, srca, pljuč in aorte) in z njimi povezane sekundarne posledice (npr. nefrokalcinozo) v nekaterih primerih, zaradi hiperfosfatemije, so ugotavljali pri normalnih živalih pri odmerkih burosumaba, ki so povzročile serumske koncentracije burosumaba pri živalih, ki so presegale približno 2,58 mmol/l.
In Study UX023-CL201, the RSS was scored using a predefined scale looking at specific abnormalities in the wrists and knees.
V študiji UX023-CL201 so ocenjevali RSS z vnaprej opredeljeno lestvico z opazovanjem specifičnih abnormalnosti v zapestjih in kolenih.
The maximum dose is 90 mg. All doses should be rounded to the nearest 10 mg.
Vse odmerke je treba zaokrožiti na najbližjih 10 mg.
Bone changes were consistent with the pharmacology of burosumab and the role of phosphate in bone mineralization, metabolism and turnover.
Kostne spremembe so se skladale s farmakologijo burosumaba in z vlogo fosfatov v mineralizaciji, presnovi in premeni kosti.
Table 2: Rickets Response in Children 5-12 years Receiving Burosumab in Study UX023-CL201
Preglednica 2: Odziv rahitisa pri otrocih, starih 5-12 let, ki so v študiji UX023-CL201 prejemali burosumab
Bone effects seen in adult and juvenile monkeys included changes in bone metabolism markers, increases in thickness and density of cortical bone, increased density of total bone and thickening of long bone.
Učinki na kosti, ki so jih ugotovili pri odraslih in mladostniških opicah, so vključevale spremembe označevalcev kostne presnove, zvečanje debeline in gostote kortikalne kosti, zvečano gostoto kosti skupaj in zadebelitev dolgih kosti.
CRYSVITA attaches to FGF23 in the blood which stops FGF23 from working and increases the phosphate levels in the blood so that normal levels of phosphate can be achieved.
Zdravilo CRYSVITA se pripne na FGF23 v krvi, kar prepreči delovanje FGF23 in zviša raven fosfatov v krvi, tako da se lahko doseže normalna raven fosfatov.
These effects were consistent with an exaggerated response to the inhibition of normal FGF23 levels resulting in a supraphysiologic increase in serum phosphate beyond the upper limit of normal.
Ti učinki so se ujemali s pretiranim odzivom na inhibicijo normalnih koncentracij FGF23, ki so povzročile suprafiziološko zvišanje serumskih fosfatov čez zgornjo mejo normalnih vrednosti.
Each vial is for single use only.
Viala je namenjena samo za enkratno uporabo.
Burosumab absorption from subcutaneous injection sites to blood circulation is nearly complete.
Burosumab se skoraj popolnoma absorbira iz mest podkožnih injekcij v krvni obtok.
Shortening of the gestation period and associated increased incidence of premature births were observed in pregnant monkeys at doses of ≥ 0.3 mg/kg which corresponded to burosumab exposures that are ≥0.875- to 1.39-fold anticipated clinical levels.
Skrajšanje obdobja brejosti in s tem povezane zvečane pogostnosti prezgodnjih kotitev so opazili pri brejih opicah pri odmerkih ≥ 0,3 mg/kg, ki so ustrezali izpostavljenostim burosumabu, ki so ≥0,875- do 1,39-krat večje od napovedanih kliničnih ravni.
Burosumab clearance and volume of distribution are body weight dependent.
Očistek in porazdelitveni volumen burosumaba sta odvisna od telesne mase.
Burosumab should be administered using aseptic technique and sterile disposable syringes and injection needles.
Burosumab morate dajati z aseptično tehniko in sterilnimi brizgami in injekcijskimi iglami za enkratno uporabo.
Clear glass vial with butyl rubber stopper, and aluminium seal.
Viala iz prozornega stekla z zamaškom iz butilne gume in aluminijasto zaporko.
It is unknown whether burosumab/metabolites are excreted in human milk.
Ni znano, ali se burosumab/presnovki izločajo v materino mleko.
In XLH patients, the observed volume of distribution of burosumab approximates the volume of plasma, suggesting limited extravascular distribution.
Pri bolnikih z XLH je ugotovljeni porazdelitveni volumen burosumaba približno enak volumnu plazme, kar kaže na omejeno ekstravaskularno porazdelitev.
Adverse reactions reported in paediatric patients with XLH (N=65)
Preglednica 1: Neželeni učinki, o katerih so poročali pri pediatričnih bolnikih z XLH (N=65)
Pack size of one vial.
Velikost pakiranja je ena viala.
Increases in serum parathyroid hormone have been observed in some XLH patients during treatment with burosumab.
Zvišanje serumskega paratiroidnega hormona so ugotovili pri nekaterih bolnikih z XLH med zdravljenjem z busorumabom.
Burosumab displays time-invariant pharmacokinetics that is linear to dose over the subcutaneous dose range of 0.1 to 2.0 mg/kg.
Burosumab kaže časovno konstantno farmakokinetiko, ki je linearna odmerku v razponu subkutanih odmerkov od 0,1 do 2,0 mg/kg.
If fasting serum phosphate is above the reference range for age, the next dose should be withheld and the fasting serum phosphate reassessed within 4 weeks.
Če so serumski fosfati na tešče nad referenčnim razponom za starost, naslednjega odmerka ne smemo dati, serumske fosfate na tešče pa moramo spet določiti čez 4 tedne.
The peak serum concentration (Cmax) and area under the concentration-time curve (AUC) of serum burosumab is dose proportional over the dose range of 0.1-2.0 mg/kg.
Najvišja serumska koncentracija (Cmax) in površina pod krivuljo koncentracija-čas (AUC) serumskega burosumaba je sorazmerna odmerku v razponu odmerkov 0,1-2,0 mg/kg.
CRYSVITA is indicated for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
Zdravilo CRYSVITA je indicirano za zdravljenje s kromosomom X povezane hipofosfatemije (XLH) z rentgenskimi znaki bolezni kosti pri otrocih, starih 1 leto ali več, in mladostnikih z rastočim okostjem.
What CRYSVITA looks like and contents of the pack CRYSVITA comes as a clear to slightly opalescent, colourless to pale yellow/brown solution for injection in a small glass vial.
Izgled zdravila CRYSVITA in vsebina pakiranja Zdravilo CRYSVITA je na voljo kot bistra do rahlo opalescentna, brezbarvna do bledo rumenorjava raztopina za injiciranje v majhni stekleni viali.
The positive change in the RGI-C score reflects resolution of the x-ray appearance of rickets.
Pozitivna sprememba rezultata RGI-C odraža izboljšanje rentgenološke slike rahitisa.
Do not shake the vial before use.
Pred uporabo viale ne stresajte.
Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia (see section 4.3).
Sočasno dajanje burosumaba s peroralnim fosfatom in analogi vitamina D je kontraindicirano, ker lahko zveča tveganje hiperfosfatemije in hiperkalcemije (glejte poglavje 4.3).
The European Medicines Agency has deferred the obligation to submit the results of studies with CRYSVITA in one or more subsets of the paediatric population in treatment of X-linked hypophosphataemia.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij zdravljenja na kromosom X vezane hipofosfatemije z zdravilom CRYSVITA za eno ali več podskupin pediatrične populacije.
Fasting serum phosphate should also be measured 4 weeks after any dose adjustment.
Serumske fosfate na tešče je treba meriti tudi 4 tedne po kakršnem koli prilagajanju odmerka.
Excipients: L-histidine, D- sorbitol E420, polysorbate 80, L-methionine, hydrochloric acid, 10%, and water for injections.
Pomožne snovi: L-histidin, D-sorbitol E420, polisorbat 80, L-metionin, klorovodikova kislina, 10 %, in voda za injekcije.
Serum alkaline phosphatase activity
Aktivnost serumske alkalne fosfataze
Adverse reactions in non-clinical studies with normal animals were observed at exposures which resulted in serum phosphate concentration greater than normal limits.
Neželene učinke v nekliničnih študijah z normalnimi živalmi so opazili pri izpostavljenostih, ki so povzročile koncentracijo serumskih fosfatov, ki je bila višja od normalne zgornje meje.