natgillin/translations-raw huggingface dataset:
After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature.
Po redčenju z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje je treba zdravilo uporabiti takoj ali v 24 urah, če je shranjeno v hladilniku, ali v 6 urah, če je shranjeno pri sobni temperaturi.
At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated.
Vsaj 2 tedna pred začetkom zdravljenja z zdravilom Ultomiris vas bo zdravnik cepil proti meningokoknim okužbam, če niste bili cepljeni že prej ali če je vaše cepljenje zastaralo.
Nervous system disorders Headache
Bolezni živčevja glavobol,
Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy.
Posvetujte se z zdravnikom, preden se začnete zdraviti z zdravilom Ultomiris, da bi tako najmanj dva tedna pred začetkom zdravljenja zanesljivo prejeli cepivo proti bakteriji Neisseria meningitidis.
No specific test-article related reproductive toxicities were identified in these studies.
V teh študijah niso ugotovili specifične reproduktivne toksičnosti.
Study in PNH patients previously treated with eculizumab
Študija pri bolnikih s PNH, ki so se predhodno zdravili z ekulizumabom
Ravulizumab contains only natural occurring amino acids and has no known active metabolites.
Ravulizumab vsebuje samo aminokisline, ki se pojavljajo v naravi in nima znanih aktivnih presnovkov.
Key secondary endpoints included the percent change from baseline in LDH levels, change in quality of life (FACITFatigue), the proportion of patients with breakthrough haemolysis and proportion of patients with stabilized haemoglobin.
Ključni sekundarni opazovani dogodki so vključevali odstotno spremembo ravni LDH od izhodišča, spremembo v kvaliteti življenja (FACIT-utrujenost), delež bolnikov s prekinitveno hemolizo in delež bolnikov s stabiliziranim hemoglobinom.
Non-clinical data reveal no special hazard for humans based on nonclinical studies using a murine surrogate molecule, BB5.1, in mice.
Predklinični podatki ne kažejo posebnega tveganja za človeka na podlagi predkliničnih študij z mišjo nadomestno molekulo, BB5.1, na miših.
Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, polisorbat 80 in voda za injekcije.
Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francija
Discard any unused portion left in a vial as the medicinal product contains no preservatives.
• Zavrzite neuporabljeno zdravilo, ki ostane v viali, saj zdravilo ne vsebuje konzervansov.
Based on medical history.
Na podlagi anamneze.
Your doctor will discuss the possible side effects with you and explain the risks.
Vaš zdravnik vam bo razložil morebitne neželene učinke in tveganja.
The prepared solution should be administered immediately following preparation.
• Pripravljeno raztopino morate uporabiti takoj po pripravi.
Meningococcal infection/sepsis
Meningokokne okužbe/sepsa
Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ravulizumab or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Bolniki so bili cepljeni proti meningokokni okužbi pred začetkom ali ob začetku zdravljenja z ravulizumabom ali ekulizumabom, ali pa so bili profilaktično zdravljeni z ustreznimi antibiotiki, dokler od cepljenja nista minila 2 tedna.
Infections and infestations Upper respiratory tract infection, Nasopharyngitis
Infekcijske in parazitske bolezni okužbe zgornjih dihal, nazofaringitis,
Following ravulizumab treatment in both complement-inhibitor naïve patients and eculizumab-experienced patients with PNH in Phase 3 studies, immediate and complete inhibition of serum free C5 (concentration of < 0.5 µg/mL) was observed by the end of the first infusion and sustained throughout the entire 26-week treatment period in all patients.
Po zdravljenju z ravulizumabom so pri bolnikih s PNH v študijah 3. faze, ki še niso prejemali inhibitorjev komplementa, in pri bolnikih, ki so že prejemali ekulizumab, ugotovili takojšnjo in popolno inhibicijo prostega C5 v serumu (koncentracija < 0,5 µg/ml) ob koncu prve infuzije, ki je pri vseh bolnikih trajala celotno obdobje 26-tedenskega zdravljenja.
The MAH shall send annually to prescribers or pharmacists who prescribe/dispense ravulizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on ravulizumab.
Imetnik dovoljenja za promet z zdravilom mora zdravnikom, ki predpisujejo zdravilo, ali farmacevtom, ki izdajajo ravulizumab, pošiljati letne opomnike z namenom, da bo zdravnik, ki zdravilo predpisuje/farmacevt preveril, ali obstaja potreba po cepljenju/ponovnem cepljenju proti bakteriji Neisseria meningitidis bolnikov, ki se zdravijo z ravulizumabom.
If an adverse event occurs during the administration of Ultomiris, the infusion may be slowed or stopped at the discretion of the physician.
Če se med dajanjem zdravila Ultomiris pojavi neželen učinek, lahko zdravnik po lastni presoji infuzijo upočasni ali zaustavi.
PNH is a chronic disease and treatment with ravulizumab is recommended to continue for the patient's lifetime, unless the discontinuation of ravulizumab is clinically indicated (see section 4.4).
PNH je kronična bolezen, zato je priporočljivo zdravljenje z ravulizumabom nadaljevati vse bolnikovo življenje, razen če je ukinitev zdravljenja z ravulizumabom klinično indicirana (glejte poglavje 4.4).
For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses are administered once every 8 weeks, starting 2 weeks after loading dose administration, as shown in Table 1.
Bolnikom, ki prehajajo z zdravljenja z ekulizumabom na zdravljenje z ravulizumabom, je treba dati polnilni odmerek ravulizumaba 2 tedna po zadnji infuziji ekulizumaba, nato je treba dajati vzdrževalne odmerke enkrat na 8 tednov z začetkom 2 tedna po dajanju začetnega odmerka, kot kaže preglednica 1.
Note: The black triangle indicates the non-inferiority margins, and grey dot indicates point estimates.
Opomba: črni trikotnik kaže meje primerljivosti, sive pike pa so točkovne ocene.
Gently agitate the infusion bag containing the diluted Ultomiris solution to ensure thorough mixing of the medicinal product and diluent.
• Infuzijsko vrečko, ki vsebuje razredčeno raztopino zdravila Ultomiris, rahlo pretresite, da zagotovite temeljito mešanje zdravila in vehikla za redčenje.
Figure 2: Analysis of primary and secondary endpoints - full analysis set (eculizumabexperienced study)
Slika 2: Analiza primarnih in sekundarnih opazovanih dogodkov - celotna skupina bolnikov za analizo (študija s predhodnim zdravljenjem z ekulizumabom)
Ravulizumab was non-inferior compared to eculizumab for both coprimary endpoints, avoidance of pRBC transfusion per protocol-specified guidelines and LDH normalisation from day 29 to day 183, and for all 4 key secondary endpoints (Figure 1).
Ravulizumab je primerljiv z ekulizumabom za oba primarna opazovana dogodka, odsotnost potrebe za transfuzijo pRBC, po smernicah, določenih v protokolu, in normalizacijo LDH od 29. do 183. dne, in za vse 4 ključne sekundarne opazovane dogodke (slika 1).
Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1).
Zdravilo Ultomiris je indicirano za zdravljenje odraslih bolnikov s paroksizmalno nočno hemoglobinurijo (PNH): - pri bolnikih s hemolizo in kliničnim(-i) simptomom(-i) zelo aktivne bolezni; - pri bolnikih, ki so klinično stabilni, potem ko so se vsaj zadnjih 6 mesecev zdravili z ekulizumabom (glejte poglavje 5.1).
Instructions for proper use Ultomiris is given by infusion (drip) into a vein.
Navodila za pravilno uporabo Zdravilo Ultomiris se daje s kapalno infuzijo v veno.
Ultomiris must be diluted prior to administration by intravenous infusion over a minimal period of 1.7 to 2.4 hours depending of body weight, see Table 2 below.
Zdravilo Ultomiris je potrebno razredčiti pred uporabo v obliki intravenske infuzije, ki mora trajati najmanj 1,7 do 2,4 ure, odvisno od telesne mase.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Alexion Europe SAS
Imetnik dovoljenja za promet z zdravilom Alexion Europe SAS
Renal impairment No dose adjustment is required for patients with renal impairment, see section 5.2.
Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno, glejte poglavje 5.2.
Prepare Ultomiris as follows:
Zdravilo Ultomiris pripravite po sledečih navodilih: 1.
If you are allergic to ravulizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Ultomiris: če ste alergični na ravulizumab, beljakovine, pridobljene iz mišjih produktov, druga monoklonska protitelesa ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če niste bili cepljeni proti meningokokni okužbi; če imate meningokokno okužbo.
The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
• Razredčene raztopine ne smete segrevati v mikrovalovni pečici ali s katerim koli virom toplote,
As an immunoglobulin gamma (IgG) monoclonal antibody, ravulizumab is expected to be metabolized in the same manner as any endogenous IgG (degraded into small peptides and amino acids via catabolic pathways), and is subject to similar elimination.
Ravulizumab je monoklonsko protitelo vrste imunoglobulin gama (IgG), zato je pričakovano, da se bo presnavljal in izločal na enak način kot drugi endogeni IgG (razgraditev v majhne peptide in aminokisline po kataboličnih poteh).
The eculizumab-experienced study was a 26-week, multicentre, open-label, randomised, active-controlled Phase 3 study conducted in 195 patients with PNH who were clinically stable (LDH ≤ 1.5 x ULN) after having been treated with eculizumab for at least the past 6 months.
Študija s predhodnim zdravljenjem z ekulizumabom je bila 26-tedenska multicentrična, odprta, randomizirana, aktivno nadzorovana študija 3. faze, ki so jo opravili pri 195 bolnikih s PNH, ki so bili po zdravljenju z ekulizumabom najmanj zadnjih 6 mesecev klinično stabilni (LDH ≤ 1,5 x ZMN).
In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots.
Pri bolnikih s PNH je sistem komplementa preveč aktiven in napada telesu lastne rdeče krvničke, kar lahko povzroči zmanjšano število krvničk (anemija), utrujenost, težave v vsakdanjem življenju, bolečine, bolečine v trebuhu, temen urin, kratko sapo, oteženo požiranje, erektilno disfunkcijo in krvne strdke.
If you experience any of the following symptoms, you should immediately inform your doctor: headache with nausea or vomiting headache and fever headache with a stiff neck or stiff back fever fever and rash confusion muscle aches with flu-like symptoms eyes sensitive to light
Če se pojavi kateri od naslednjih simptomov, morate nemudoma obvestiti zdravnika: glavobol s slabostjo in bruhanjem; glavobol in zvišano telesno temperaturo; glavobol s trdim vratom ali trdim hrbtom; zvišana telesna temperatura; zvišana telesna temperatura in izpuščaj; zmedenost; bolečine v mišicah z gripi podobnimi simptomi; občutljivost oči za svetlobo.
Secondary endpoints included the proportion of patients with breakthrough haemolysis, quality-of-life (FACITFatigue), transfusion avoidance (TA), and proportion of patients with stabilised haemoglobin.
Sekundarni opazovani dogodki so vključevali delež bolnikov s prekinitveno hemolizo, kvaliteto življenja (FACIT-utrujenost), odsotnost potrebe za transfuzijo (transfusion avoidance - TA) in delež bolnikov s stabiliziranim hemoglobinom.
Table 5 presents the baseline characteristics of the PNH patients enrolled in the eculizumabexperienced study, with no apparent clinically meaningful differences observed between the treatment arms.
Preglednica 5 kaže izhodiščne značilnosti bolnikov s PNH, vključenih v študijo s predhodnim zdravljenjem z ekulizumabom, brez očitnih klinično pomembnih razlik med zdravljenima skupinama.
Refer to the administration reference tables below for minimum infusion duration.
Glejte referenčni preglednici za uporabo v nadaljevanju za najkrajši čas infuzije.
Table 5: Baseline characteristics in the eculizumab-experienced study Parameter
Preglednica 5: Izhodiščne značilnosti v študiji s predhodnim ekulizumabom
• The patient alert card shall contain the following key messages: o Signs and symptoms of meningococcal infection o Warning to seek immediate medical care if above are present o Statement that the patient is receiving ravulizumab o Contact details where a healthcare professional can receive further information
• Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila: o znake in simptome menigokokne okužbe; o opozorilo, naj bolnik nemudoma poišče zdravniško pomoč, če se zgoraj našteto pojavi; o izjavo, da bolnik prejema ravulizumab; o kontaktne podatke, kamor se lahko zdravstveni delavec obrne za dodatne informacije.
• Patient information pack
• paket z informacijami za bolnike.
Patients with any PNH conditions a prior to informed consent n (%)
PNH pred obveščenim pristankom n (%)
Human IgG are known to cross the human placental barrier, and thus ravulizumab may potentially cause terminal complement inhibition in the foetal circulation.
Znano je, da človeški IgG pri človeku prehaja skozi posteljično pregrado, zato bi lahko ravulizumab povzročal inhibicijo terminalnega komplementa v plodovem krvnem obtoku.
What Ultomiris is and what it is used for
Kaj je zdravilo Ultomiris in za kaj ga uporabljamo
Serious meningococcal infection
Resna meningokokna okužba
Ultomiris should only be administered via intravenous infusion.
• Zdravilo Ultomiris se sme aplicirati samo v obliki intravenske infuzije.
The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups within each of the Phase 3 studies.
12-mesečna anamneza transfuzij je bila v skupinah, ki so ju zdravili z ravulizumabom oziroma ekulizumabom, v obeh študijah 3. faze podobna.
If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Če ne morete biti cepljeni 2 tedna pred začetkom zdravljenja, vam bo zdravnik predpisal antibiotike za zmanjšanje tveganja okužbe do 2 tedna po cepljenju.
The complement-inhibitor naïve study was a 26-week, multicentre, open-label, randomised, active-controlled, Phase 3 study conducted in 246 patients who were naïve to complement inhibitor treatment prior to study entry.
Študija brez predhodnega zdravljenja z inhibitorji komplementa je bila 26-tedenska multicentrična, odprta, randomizirana, aktivno nadzorovana študija 3. faze, ki so jo izvedli pri 246 bolnikih, ki se pred vključitvijo v študijo še niso zdravili z inhibitorjem komplementa.
The mean (standard deviation [SD]) volume of distribution at steady state for patients with PNH on the studied weight-based dose regimen was 5.34 (0.92) L.
Povprečni (standardna deviacija ) volumen porazdelitve v stanju dinamičnega ravnovesja za bolnike s PNH na proučevani shemi odmerjanja na podlagi telesne mase je bil 5,34 (0,92) l. Biotransformacija in izločanje
Ravulizumab was non-inferior compared to eculizumab for the primary endpoint, percent change in LDH from baseline to day 183, and for all 4 key secondary endpoints (Figure 2).
Ravulizumab je bil primerljiv z ekulizumabom glede na primarni opazovani dogodek, odstotno spremembo LDH od izhodišča do 183. dne, in za vse štiri ključne sekundarne opazovane dogodke (slika 2).
Meningococcal infection*
meningokokne okužbe*
After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the final concentration of the solution is 5 mg/mL.
Po redčenju z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje je končna koncentracija raztopine 5 mg/ml.
Eligible patients to enter this trial had to demonstrate high disease activity, defined as LDH level ≥ 1.5 × upper limit of normal (ULN) at screening along with the presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening: fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), anaemia (haemoglobin < 10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell (pRBC) transfusion due to PNH.
Bolniki, primerni za vključitev v to študijo, so imeli visoko aktivnost bolezni, opredeljeno kot raven LDH ≥ 1,5 × zgornja meja normalnih vrednosti (ZMN) ob presejanju, skupaj s prisotnostjo enega ali več naslednjih znakov ali simptomov, povezanih s PNH, v 3 mesecih po presejanju: utrujenost, hemoglobinurija, bolečine v trebuhu, kratka sapa (dispneja), anemija (hemoglobin < 10 g/dl), anamneza pomembnega neželenega vaskularnega dogodka (vključno s trombozo), disfagija ali erektilna disfunkcija; ali anamneza transfuzije koncentriranih eritrocitov (packed red blood cell - pRBC) zaradi PNH.
Ultomiris contains sodium
Zdravilo Ultomiris vsebuje natrij
The patient information pack should contain: o Package leaflet o A patient guide o A patient alert card
Paket z informacijami za bolnike mora vsebovati: o navodilo za uporabo; o vodnik za bolnika; o opozorilno kartico za bolnika.
This medicinal product when diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection contains 2.65 g sodium per 720 mL at the maximal dose, equivalent to 133 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo po redčenju z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ob največjem odmerku vsebuje 2,65 g natrija na 720 ml, kar je enako 133 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
If patients with PNH discontinue treatment with ravulizumab, they should be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated LDH (lactate dehydrogenase) levels along with sudden decrease in PNH clone size or haemoglobin, or reappearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Če se bolniki s PNH prenehajo zdraviti z ravulizumabom, jih je treba skrbno spremljati glede znakov in simptomov resne intravaskularne hemolize, ki jo prepoznamo po zvišani ravni LDH (laktat dehidrogenaze) skupaj z nenadnim zmanjšanjem velikosti klona PNH ali hemoglobina, ali ponovnem pojavu simptomov, kot so utrujenost, hemoglobinurija, bolečine v trebuhu, kratka sapa (dispneja), pomemben neželen vaskularen dogodek (vključno s trombozo), disfagija ali erektilna disfunkcija.
For intravenous infusion only.
Samo za intravensko uporabo v obliki infuzije.
Weight-based dosing is proposed in section 4.2, Table
Predlagano odmerjanje na podlagi telesne mase kaže razpredelnica 1 v poglavju 4.2.
Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito metodo kontracepcije med zdravljenjem in do 8 mesecev po zdravljenju.
Vomiting, Nausea, Diarrhoea, Abdominal pain, Dyspepsia
Bolezni prebavil bruhanje, navzea, diareja, bolečina v trebuhu, dispepsija
If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice.
Če ste prejeli večji odmerek zdravila Ultomiris, kot bi smeli Če domnevate, da so vam pomotoma dali večji odmerek zdravila Ultomiris, kot vam je bil predpisan, se posvetujte z zdravnikom.
How to store Ultomiris 6.
Shranjevanje zdravila Ultomiris 6.
Patients who initiate ravulizumab treatment less than 2 weeks after receiving a meningococcal vaccine, must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Bolnike, ki se začnejo zdraviti z ravulizumabom prej kot 2 tedna po prejemu meningokoknega cepiva, je potrebno zdraviti z ustreznimi profilaktičnimi antibiotiki še 2 tedna po cepljenju.
This medicine when diluted with sodium chloride 9 mg/mL (0.9%) solution for injection for IV administration contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose.
To zdravilo po razredčitvi z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje vsebuje 2,65 g natrija (glavna sestavina kuhinjske/namizne soli) v 720 ml pri največjem odmerku.
The doses to be administered are based on the patient's body weight, as shown in Table 1.
Odmerki so odvisni od telesne mase bolnika, kot je navedeno v preglednici 1.
3- Administration
3- Uporaba
If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Če niste cepljeni vsaj 2 tedna pred začetkom zdravljenja z zdravilom ULTOMIRIS, vam bo vaš zdravnik predpisal antibiotike za zmanjševanje tveganja okužbe, dokler ne mineta 2 tedna po cepljenju.
Ultomiris should not be shaken.
Zdravila Ultomiris ne smete stresati.
Over the studied dose and regimen range, ravulizumab exhibited dose proportional and time linear pharmacokinetics (PK).
V raziskanem razponu odmerkov in shem kaže ravulizumab farmakokinetiko (FK), ki je proporcionalna odmerku in linearna v času.
Ultomiris volume (mL)
Volumen zdravila Ultomiris (ml)
The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Izračunani volumen zdravila odvzemite iz ustreznega števila vial in ga razredčite v infuzijski vrečki z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje kot vehiklom za redčenje.
Do not administer Ultomiris as an intravenous push or bolus injection.
• Zdravila Ultomiris ne smete dajati v obliki hitre intravenske ali bolusne injekcije.
Table 4 presents the baseline characteristics of the PNH patients enrolled in the complement-inhibitor naïve study, with no apparent clinically meaningful differences observed between the treatment arms.
Preglednica 4 kaže izhodiščne značilnosti bolnikov s PNH, vključenih v študijo brez predhodnega inhibitorja komplementa, brez očitnih klinično pomembnih razlik med zdravljenima skupinama.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
1- How is Ultomiris supplied?
1- V kakšni obliki je zdravilo Ultomiris na voljo?
Body weight range (kg)
Razpon telesne mase (kg)
Ultomiris 300 mg concentrate for solution for infusion ravulizumab
Ultomiris 300 mg koncentrat za raztopino za infundiranje ravulizumab
No dose adjustment is required for patients with PNH aged 65 years and over.
Za bolnike s PNH, stare 65 let ali več, prilagajanje odmerka ni potrebno.
Number of patients with packed red blood cell (pRBC) transfusions within 12 months prior to first dose n (%)
Število bolnikov s transfuzijami koncentriranih eritrocitov (pRBC) v 12 mesecih pred prvim odmerkom n (%)