natgillin/translations-raw huggingface dataset:
Use of andexanet alfa in conjunction with other supportive measures Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate.
Uporaba andeksaneta alfa v povezavi z drugimi podpornimi ukrepi Andeksanet alfa se lahko uporablja v povezavi s standardnimi hemostatskimi podpornimi ukrepi, o katerih je treba razmisliti, kot je medicinsko primerno.
PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven.
Primerljivost FK z andeksanetom alfa v zdravilu Ondexxya (2. generacija) še ni bila dokazana.
Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Prašek v 20-ml viali (steklo tipa I) z zamaškom (butilna guma).
* Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
* Andeksanet alfa se izdeluje s tehnologijo rekombinantne DNA v ovarijskih celicah kitajskega hrčka
Among the healthy subjects studied, women experienced more adverse reactions (mainly infusion-related reactions) than men.
Med zdravimi osebami se je pri ženskah pojavilo več neželenih učinkov (večinoma reakcij, povezanih z infuzijo) kot pri moških.
Therefore, treatment monitoring should be based mainly on clinical parameters indicative of appropriate response (i.e., achievement of haemostasis), lack of efficacy (i.e., re-bleeding), and adverse events (i.e., thromboembolic events).
Zato mora spremljanje med zdravljenjem v glavnem temeljiti na kliničnih parametrih, ki kažejo na ustreznost odziva (npr. doseganje hemostaze), pomanjkanje učinkovitosti (npr. ponovna krvavitev) in neželene dogodke (npr. trombembolične dogodke).
Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, to povejte zdravniku.
Known allergic reaction to hamster proteins.
Znana alergijska reakcija na beljakovine hrčka.
To date, the occurrence of positive, non-neutralizing antibodies to andexanet alfa following treatment in patients in the ANNEXA-4 study (8.5% or 20/236 patients) has been similar to that observed in healthy subjects.
Do zdaj je bilo pojavljanje pozitivnih, ne-nevtralizirajočih protiteles proti andeksanetu alfa po zdravljenju pri bolnikih v študiji ANNEXA-4 (8,5 % bolnikov oziroma 20/236 bolnikov) podobno tistemu, ki so ga opazili pri zdravih osebah.
These markers were not measured in patients enrolled in the ANNEXA-4 study, but thromboembolic events have been observed (see section 5.1).
Teh označevalcev pri bolnikih, vključenih v študijo ANNEXA-4, niso merili, so pa opazili trombembolične dogodke (glejte poglavje 5.1).
Reduction in anti-FXa activity
Zmanjšanje aktivnosti proti FXa
Transient elevations of D-dimer and F1+2 fragments very common
Prehodno zvišanje vrednosti D-dimera in fragmentov F1 + 2
Your doctor may give you an antihistamine medicine to help with any side effects (see section 4).
Zdravnik vam bo morda dal antihistaminike za pomoč pri morebitnih neželenih učinkih (glejte poglavje 4).
A total of 33.3% of patients with thromboembolic events (12/36) experienced the thromboembolic event during the first three days.
Skupno 33,3 % bolnikov s trombemboličnim dogodkom (12/36 bolnikov) je imelo trombembolični dogodek v prvih treh dneh.
Anti-FXa activity correlates poorly to clinical efficacy and safety, making it unsuitable for dosing guidance (see section 4.4 and 5.1)
Aktivnost proti FXa šibko korelira s klinično učinkovitostjo in varnostjo, zaradi česar ni primerna smernica za odmerjanje (glejte poglavji 4.4 in 5.1).
The posology was confirmed in a study in patients with acute major bleeding.
Odmerjanje so potrdili v študiji pri bolnikih z večjo akutno krvavitvijo.
Use for edoxabanor enoxaparin-reversal is not recommended due to lack of data.
Uporaba za odpravo učinka edoksabana ali enoksaparina se zaradi pomanjkanja podatkov ne priporoča.
Andexanet alfa does not need to be brought to room temperature before reconstitution or administration to the patient.
Andeksaneta alfa ni treba ogreti na sobno temperaturo pred rekonstitucijo oziroma dajanjem bolniku.
It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.
Ni verjetno, da bi zdravilo Ondexxya vplivalo na učinek drugih zdravil ali da bi druga zdravila vplivala na zdravilo
Store in a refrigerator.
DRUGI PODATKI Shranjujte v hladilniku.
Clinical relevance in the target population (patients with uncontrolled or life-threatening bleeding who are anticoagulated due to high to very high risk of thrombosis) is unknown.
Klinični pomen za ciljno populacijo (bolnike z neobvladano ali smrtno nevarno krvavitvijo, ki prejemajo antikoagulantno terapijo zaradi velikega do zelo velikega tveganja za trombozo) ni znan.
In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included.
V študijo ANNEXA-4 so bili vključeni bolniki z intrakranialno krvavitvijo (GCS > 7 in volumen hematoma < 60 ml).
The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials.
Varnost andeksaneta alfa ni bila ocenjena pri bolnikih, ki so prejeli koncentrate protrombinskega kompleksa, rekombinantni faktor VIIa ali polno kri v času sedmih dni pred krvavitvijo, saj so bili izključeni iz kliničnih preskušanj.
Reduction in anti-FXa activity correlates with restoration of thrombin generation.
Zmanjšanje aktivnosti proti FXa korelira z obnovo tvorbe trombina.
The anti-FXa activity returned to the placebo levels and above approximately two hours after the end of a bolus or infusion dependent on dosage.
Aktivnost proti FXa se je vrnila na raven placeba in višje približno dve uri po koncu dajanja bolusa ali infundiranja, odvisno od odmerka.
The most common side effects associated with Ondexxya in clinical trials of healthy people were infusion-related reactions with usually mild symptoms such as flushing or feeling hot (very common side effects which may affect more than 1 in 10 people).
Najpogostejši neželeni učinki, ki so bili povezani z zdravilom Ondexxya v kliničnih preskušanjih pri zdravih ljudeh, so bile z infuzijo povezane reakcije, ki so ponavadi imele blage simptome, kot so pordevanje ali občutek vročine (zelo pogosta neželena učinka, ki se lahko pojavita pri več kot 1 bolniku od 10 bolnikov).
Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots.
Odprava učinkov zaviralca faktorja Xa z zdravilom Ondexxya lahko poveča tveganje za krvne strdke.
The reconstituted solution is a clear, colourless, or slightly yellow solution.
Rekonstituirana tekočina je bistra, brezbarvna ali bledo rumena raztopina.
All used syringes, needles, and vials, including any unused portion of reconstituted solution, should be disposed of in accordance with local requirements.
Vse uporabljene injekcijske brizge, igle in viale, vključno z vso neuporabljeno rekonstituirano raztopino, zavrzite v skladu z lokalnimi predpisi.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.2 Inkompatibilnosti Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
8 mg/min for 120 minutes (960 mg)
8 mg/min v trajanju 120 minut (960 mg)
In addition, independent pro-thrombotic effect of andexanet alfa cannot be ruled out.
Poleg tega ni mogoče izključiti neodvisnega protrombotičnega učinka andeksaneta alfa.
297/352 patients (84.4%) received the low-dose regimen of andexanet, while 55 patients (15.6%) received the high-dose regimen.
297/352 bolnikov (84,4 %) je prejelo shemo z majhnim odmerkom andeksaneta, 55 bolnikov (15,6 %) pa je prejelo shemo z velikim odmerkom andeksaneta.
Restarting antithrombotic therapy
Ponoven začetek antitrombotičnega zdravljenja
Biliary and/or faeces elimination of protein therapeutics is not a known route of protein elimination.
Izločanje beljakovinskih zdravil v žolč in/ali blato ni znana pot izločanja beljakovin.
Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity.
Andeksanet alfa je rekombinantna oblika humane beljakovine FXa, ki je bila spremenjena tako, da nima encimske aktivnosti FXa.
4 mg/min for 120 minutes (480 mg)
4 mg/min v trajanju 120 minut (480 mg)
For the most efficient reconstitution of the needed dose, and to minimise errors, inject each vial needed with 20 mL of water for injections before proceeding to the next step.
Da bo rekonstitucija potrebnega odmerka najučinkovitejša, možnost napak pa najmanjša, v vsako potrebno vialo vbrizgajte 20 ml vode za injekcije, preden nadaljujete z naslednjim korakom.
In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died.
V študiji ANNEXA-4 je od bolnikov v populaciji za oceno varnosti, ki so dokončali 30-dnevno spremljanje (N = 351), umrlo 54 bolnikov (15,4 %).
Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345).
Nenevtralizirajoča protitelesa proti andeksanetu alfa, ki so se pojavila v povezavi z zdravljenjem, so zaznali pri približno 10 % bolnikov (35/345).
The antiFXa activity thresholds for normalization of thrombin generation (defined by mean ETP and standard deviations) were estimated to be 44.2 ng/mL (within one standard deviation of normal ETP) based on pooled data from Studies 14-503 and 14-504, as indicated in the figure.
FXa za normalizacijo tvorbe trombina (opredeljene s povprečnim ETP in standardnimi odkloni) so bile ocenjene na 44,2 ng/ml (znotraj enega standardnega odklona od normalnega ETP) na podlagi združenih podatkov iz študij 14-503 in 14-504, kar je prikazano na sliki.
• if you are allergic to hamster proteins
• če ste alergični na beljakovine hrčka.
Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration.
Za aktivnost plazemskega TFPI so dokazali, da je bila zavrta 10 ur do 20 ur po dajanju andeksaneta alfa.
Total number of 200 mg vials needed
Skupno število potrebnih 200-mg vial
• stomach pain or discomfort
• bolečina ali neugodje v želodcu,
Thrombotic events have been reported following treatment with andexanet alfa (see sections 4.8 and 5.1).
Po zdravljenju z andeksanetom alfa so poročali o trombotičnih dogodkih (glejte poglavji 4.8 in 5.1).
In order to further confirm the efficacy and safety, the MAH should submit an updated PK/PD model using all previously incorporated data (from studies 11-501, 12-502, 14503, 14-504, and 14-506) as well as newly incorporated data from study 16-512 (PKPD study of Generation 2 andexanet versus Generation 1), study 16-508 (PK-PD study of andexanet in individuals of Japanese ethnicity), and study 14-505 (ANNEXA-4).
Za nadaljnjo potrditev učinkovitosti in varnosti mora imetnik dovoljenja za promet predložiti posodobljen model FK/FD, v katerem bodo uporabljeni vsi predhodno vključeni podatki (iz študij 11-501, 12-502, 14-503, 14-504 in 14-506) ter novo vključeni podatki iz študije 16-512 (študija FK-FD andeksaneta 2. generacije v primerjavi s 1. generacijo), študije 16-508 (študija FK-FD andeksaneta pri osebah japonske narodnosti) in študije 14-505 (ANNEXA-4).
This medicine is for hospital use only.
To zdravilo je namenjeno samo za uporabo v bolnišnici.
Studies to evaluate the mutagenic and carcinogenic potential of andexanet alfa have not been performed.
Študij za oceno mutagenega in karcinogenega potenciala andeksaneta alfa niso izvedli.
> 10 mg/ Unknown
> 10 mg/neznano
This medicine is unlikely to affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost vožnje in upravljanja strojev.
When andexanet alfa was administered as a bolus followed by a continuous infusion, the maximum decrease in unbound FXa inhibitors was rapid (within two minutes of the end of the bolus) and was sustained over the course of the infusion then gradually increased over time, reaching a maximum at approximately two hours following the end of infusion.
Ko so andeksanet alfa dali v obliki bolusa, ki mu je sledila kontinuirana infuzija, je bilo največje zmanjšanje nevezanih zaviralcev FXa zelo hitro doseženo (v dveh minutah po koncu bolusa) in se je ohranilo v celotnem času infuzije, nato pa sčasoma postopno zvišalo, pri čemer je bila največja vrednost dosežena približno dve uri po koncu infundiranja.
Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event.
Od 209 bolnikov, ki so pred trombotičnim dogodkom prejemali antikoagulacijsko zdravljenje, je 10 bolnikov (4,8 %) imelo trombembolični dogodek.
Reversal of the effects of other FXa inhibitors (e.g., fondaparinux, unfractionated heparin) with andexanet alfa has not been studied in humans.
Odprave učinkov drugih zaviralcev FXa (npr. fondaparinuksa, nefrakcioniranega heparina) z andeksanetom alfa pri ljudeh niso proučili.
Change in anti-FXa activity (ng/mL) in healthy subjects anticoagulated with apixaban (A) and rivaroxaban (B)
Sprememba aktivnosti proti FXa (ng/ml) pri zdravih osebah, ki so prejemale antikoagulacijsko zdravljenje z apiksabanom (A) in rivaroksabanom (B)
Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination.
Očistek (l/uro) andeksaneta alfa je 4,4 ± 1,2 l/uro, z majhnim ledvičnim izločanjem.
The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Serin aktivnega mesta je bil zamenjan z alaninom, zaradi česar molekula ne more cepiti in aktivirati protrombina, domena gama-karboksiglutaminske kisline (Gla) pa je bila odstranjena, da se odstrani sposobnost beljakovine za sestavljanje v kompleks protrombinaze in s tem tudi vsako antikoagulacijsko delovanje.
The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Najpogosteje opaženi neželeni učinki so bile blage ali zmerne reakcije, povezane z infuzijo (glejte preglednico 4), ki so zajemale simptome, kot so pordevanje, občutek vročine, kašelj, disgevzija in dispneja, ki so se pojavili od nekaj minut do nekaj ur po infundiranju.
For these patients, median anti-FXa activity at baseline was 149.7 ng/mL for patients taking apixaban, and 211.8 ng/mL for patients taking rivaroxaban.
Pri teh bolnikih je bila mediana aktivnost proti FXa ob izhodišču149,7 ng/ml pri bolnikih, ki so prejemali apiksaban, in 211,8 ng/ml pri bolnikih, ki so prejemali rivaroksaban.
Pro-coagulant factor treatments (e.g., 3- or 4-factor prothrombin complex concentrate (PCC)/activated PCC, recombinant factor VIIa, fresh frozen plasma) and whole blood should be avoided unless absolutely required, due to lack of data in combination with these treatments.
Zdravljenju s prokoagulacijskimi faktorji (npr. s koncentratom protrombinskega kompleksa s 3 ali 4 faktorji (PCC)/aktiviranim PCC, rekombinantnim faktorjem VIIa, sveže zmrznjeno plazmo) in polno krvjo se je treba zaradi pomanjkanja podatkov o tovrstnih kombinacijah izogniti, če ni nujno potrebno.
The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Varnosti in učinkovitosti pri bolnikih z okvaro jeter niso proučili (glejte poglavje 5.2).
Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated.
Okvara ledvic: Učinka okvare ledvic na ravni izpostavljenosti andeksanetu alfa niso ocenili.
No neutralising antibodies or antibodies to factor X or FXa were detected.
Nevtralizirajočih protiteles ali protiteles proti faktorju X ali FXa niso zaznali.
According to region, death rates were 22.1% (31/140) in patients recruited in the European Union and 10.9% (23/211) in patients recruited in North America.
Glede na regijo je bila stopnja smrtnosti za bolnike, vključene v Evropski uniji, 22,1 % (31/140) ter 10,9 % (23/211) za bolnike, vključene v Severni Ameriki.
Wipe the rubber stopper of each vial with an alcohol swab.
Gumijasti zamašek vsake viale obrišite z alkoholnim robčkom.
Factor Xa inhibitors are given to prevent clots in your blood vessels.
Zaviralci faktorja Xa se uporabljajo za preprečevanje strdkov v vaših krvnih žilah.
Thirty-six of 352 patients with complete 30-day safety follow up (10.3%) had thrombotic events, including venous thromboembolism (VTE), myocardial infarction (MI), and stroke.
Šestintrideset bolnikov od 352 bolnikov z zaključenim 30-dnevnim spremljanjem varnosti (10,3 %) je imelo trombotične dogodke, vključno z vensko trombembolijo (VTE), miokardnim infarktom (MI) in možgansko kapjo.
Ten of 36 (27.8%) patients had restarted antithrombotic therapy at the time of the event, and all 36 patients had been anticoagulated for a prior history of VTE and/or atrial fibrillation at the time of receiving andexanet alfa (see sections 4.4 and 5.1).
Deset bolnikov od 36 bolnikov (27,8 %) je v času dogodka že ponovno začelo prejemati antitrombotično zdravljenje, vseh 36 bolnikov pa je v času, ko so prejeli zdravljenje z andeksanetom alfa, že prejemalo antikoagulantno terapijo zaradi anamneze venske trombembolije in/ali atrijske fibrilacije (glejte poglavji 4.4 in 5.1).
Use aseptic technique during the reconstitution procedure.
Med postopkom rekonstitucije uporabljajte aseptično tehniko.
Non-cardiovascular deaths (n=27) included: respiratory failure (n=5), infection/sepsis (n=5), accident/trauma (n=2), cancer (n=1), and other/non-vascular cause (n=14).
Ne-srčno-žilne smrti (n = 27) so zajemale: dihalno odpoved (n = 5), okužbo/sepso (n = 5), nesrečo/travmo (n = 2), raka (n = 1) in druge/nežilne vzroke (n = 14).
Restoration of thrombin generation following administration was dose- and dose-regimen-dependent and did not correlate with anti-FXa-activity beyond approximately four hours (see below, “restoration of thrombin generation”).
Obnova tvorbe trombina po dajanju je bila odvisna od odmerka in sheme odmerjanja in po preteku približno štirih ur ni več korelirala z aktivnostjo proti FXa (glejte v nadaljevanju: »Obnova tvorbe trombina«).
Submission of the final CSR by 30 June
Predložitev končnega poročila klinične študije do 30. junija 2021
In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material (study 19-514).
Za nadaljnjo potrditev odmerjanja zdravila Ondexxya mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije primerjave farmakokinetike z materiali 1. generacije, 3. procesa, in materiali 2. generacije (študija 19-514).
The European Medicines Agency has deferred the obligation to submit the results of studies with andexanet alfa in one or more subsets of the paediatric population in treatment and prevention of FXa inhibitor-associated haemorrhages (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z andeksanetom alfa pri zdravljenju in preprečevanju krvavitev, povezanih z zaviralci FXa, za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If a syringe driver is used for administration, multiple syringes should be used to contain the final volume of reconstituted product.
Če se za aplikacijo uporablja črpalka za brizgo, je treba uporabiti več injekcijskih brizg, ki bodo vsebovale končni volumen rekonstituiranega zdravila.
For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations.
Pri osebah, zdravljenih z rivaroksabanom, je velik odmerek andeksaneta alfa (bolus in infuzija) povzročil povečano tvorbo trombina nad dvema standardnima odklonoma.
Last dose
Zadnji odmerek
Detailed instructions for your doctor or nurse on how to give Ondexxya are given at the end of this package leaflet (see ‘Handling instructions').
Podrobne informacije o dajanju zdravila Ondexxya, namenjene zdravniku ali medicinski sestri, so na koncu tega navodila za uporabo (glejte »Navodila za ravnanje z zdravilom«).
Insert the syringe needle through the centre of the rubber stopper.
Vstavite iglo skozi center gumijastega zamaška.
Pack size of four vials.
Velikost pakiranja: štiri viale.
If needed, the reconstituted solution once transferred into the IV bag can be stored for an additional eight hours at room temperature.
Po potrebi je mogoče rekonstituirano raztopino, ki je bila prenesena v vrečko za infuzijo, pri sobni temperaturi hraniti še dodatnih osem ur.
Push the plunger down to slowly inject the 20 mL of water for injections into the vial, directing the stream toward the inside wall of the vial to minimise foaming.
Potisnite bat injekcijske brizge, tako da v vialo počasi injicirate 20 ml vode za injekcije, pri čemer curek usmerite proti notranji steni viale, da kar najbolj zmanjšate penjenje.
Name and address of the manufacturer responsible for batch release Portola Netherlands B.V.
Ime in naslov izdelovalca, odgovornega za sproščanje serij Portola Netherlands B.V.
In both, Study 14-503 and Study 14-504, treatment with andexanet alfa also resulted in a statistically significant increase in thrombin generation in healthy subjects anticoagulated with apixaban or rivaroxaban versus placebo (p < 0.0001).
V obeh študijah, študiji 14-503 in študiji 14-504, je zdravljenje z andeksanetom alfa povzročilo tudi statistično značilno povečanje tvorbe trombina pri zdravih osebah, ki so prejemale antikoagulacijsko zdravljenje z apiksabanom in rivaroksabanom v primerjavi s placebom (p < 0,0001).
Laboratory parameters as antiFXa activity, endogenous thrombotic potential (ETP), or markers of thrombosis might not be reliable for guidance.
Laboratorijski parametri, kot so aktivnost proti FXa, endogeni trombinski potencial (ETP) ali označevalci tromboze, niso vedno zanesljivo vodilo.
For moderate symptoms, consideration may be given to a brief interruption or slowing of the infusion with resumption of the infusion after symptoms subside.
Pri zmernih simptomih je treba razmisliti o kratkotrajni prekinitvi ali upočasnitvi infundiranja in nadaljnjem infundiranju po umiritvi simptomov.
The two co-primary endpoints are: a) percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus until the end of the infusion, and; b) rate of good or excellent (compared to poor or none) haemostatic efficacy within 12 hours after infusion, as rated by an independent endpoint adjudication committee .
Soprimarna opazovana dogodka sta: a) odstotna sprememba aktivnosti proti FXa od izhodišča do nadirja od pet minut po koncu bolusa do konca infuzije in b) stopnja dobre ali odlične hemostatske učinkovitosti (v primerjavi s slabo ali nično) v 12 urah po infundiranju, ki jo je ocenila neodvisna komisija za presojo opazovanih dogodkov.
Contents of the pack and other information What Ondexxya contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ondexxya
Therefore, dose adjustment is not considered needed for patients with hepatic impairment.
Zato velja, da prilagoditev odmerka pri bolnikih z okvaro jeter ni potrebna.
Do not breast-feed your child while you are taking this medicine.
Med jemanjem tega zdravila ne smete dojiti.
What you need to know before you receive Ondexxya Do not use Ondexxya:
Kaj morate vedeti, preden boste dobili zdravilo Ondexxya Ne uporabite zdravila Ondexxya: