natgillin/translations-raw huggingface dataset:
The median (range) age of the study population was 42 (12 to 73) years with 88 female subjects (70%).
Mediana (razpon) starosti študijske populacije je bila 42 (od 12 do 73) let, 88 (70 %) preiskovancev je bilo žensk.
Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%), see section 4.4.
Opazili so preobčutljivostne reakcije (blag in zmeren pruritus, nelagodje in mravljinčenje v jeziku) (1,2 %), glejte poglavje 4.4.
TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 6 cartons, each carton containing 1 vial.
Zdravilo TAKHZYRO je na voljo kot enojno pakiranje, ki vsebuje eno 2 ml vialo, in kot skupno pakiranje, ki vsebuje 2 ali 6 škatel; vsaka škatla vsebuje 1 vialo.
Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC05
Farmakoterapevtska skupina: Druga krvna zdravila, zdravila za zdravljenje hereditarnega angioedema, oznaka ATC: B06AC05.
Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects.
Zdravljenje z lanadelumabom je bilo povezano z razvojem protiteles proti zdravilu, ki so se pojavili med zdravljenjem, pri 11,9 % (10/84) preiskovancev.
Accordingly, in a population pharmacokinetic analysis, renal impairment (estimated GFR: 60 to 89 ml/min/1.73 m
Vskladu s tem v populacijski farmakokinetični analizi ledvična okvara (ocenjena vrednost GFR: od 60 do 89 ml/min/1,73 m
In addition to the vial, each TAKHZYRO pack also contains:
Poleg viale vsebuje eno pakiranje zdravila TAKHZYRO tudi:
Lanadelumab is not expected to interact directly with DNA or other chromosomal material, as it is made up entirely of naturally occurring amino acids and contains no inorganic or synthetic linkers or other nonprotein portions; therefore no genotoxicity evaluation has been conducted.
Ne pričakuje se, da bi lanadelumab neposredno vplival na DNA ali drug kromosomski material, saj je v celoti sestavljen iz naravnih aminokislin, ki se pojavljajo v naravi, in ne vsebuje anorganskih ali sintetičnih povezovalcev ali drugih nebeljakovinskih delov; ocene genotoksičnosti zato niso izvedli.
d) Remove the vial from the packaging.
d) Vialo odstranite iz pakiranja.
This leads to too much ‘plasma kallikrein', which in turn produces higher levels of ‘bradykinin' in your bloodstream.
To povzroči preveliko količino ‘plazemskega kalikreina', zaradi katerega nastajajo visoke ravni ‘bradikinina' v krvnem obtoku.
• Use each vial of TAKHZYRO only once.
Vsako vialo zdravila TAKHZYRO uporabite le enkrat.
TAKHZYRO is not known to affect other medicines or be affected by other medicines.
Ni znano, da bi zdravilo TAKHZYRO vplivalo na druga zdravila oz. ali da bi druga zdravila vplivala nanj.
Do not use the blunt tip vial access needle to inject TAKHZYRO as this may cause pain and bleeding.
Ne uporabljajte igle s topo konico za dostop do viale, da bi injicirali zdravilo TAKHZYRO, saj si lahko s tem povzročite bolečino ali krvavitev.
The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system.
Reagenti, ki se uporabljajo v laboratorijskem testu aPTČ, povzročijo intrinzično koagulacijo zaradi aktiviranja plazemskega kalikreina v kontaktnem sistemu.
Do not inject yourself or someone else until you have been trained to inject the medicine.
Zdravila si ne injicirajte sami in naj vam ga ne injicira kdo drug, dokler se ustrezno ne podučite o injiciranju zdravila.
Pharmacokinetics of lanadelumab showed linear dose-exposure response with doses up to 400 mg and reproducible exposure following subcutaneous administration up to 12 months.
Farmakokinetika lanadelumaba je pokazala linearni odziv glede na izpostavljenost z odmerki do 400 mg in ponovljivo izpostavljenost po subkutanem dajanju do 12 mesecev.
Solution for injection 1 vial of 2 ml component of a multipack, can't be sold separately.
1 viala z 2 ml kot del skupnega pakiranja, ni mogoče prodati ločeno.
Discard the vial with any unused contents.
Vialo z neporabljeno vsebino zavrzite.
If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, tight chest, wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.
Če imate hudo alergijsko reakcijo na zdravilo TAKHZYRO s simptomi, kot so izpuščaj, stiskanje v prsih, piskajoče dihanje ali hiter srčni utrip, to takoj povejte zdravniku, farmacevtu ali medicinski sestri.
TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4)
Zdravilo TAKHZYRO ni namenjeno za zdravljenje akutnih napadov HAE (glejte poglavje 4.4)
Your treatment will be started and managed under the supervision of a doctor experienced in the care of patients with HAE.
Zdravljenje se začne in vodi pod nadzorom zdravnika z izkušnjami v zdravljenju bolnikov s HAE.
The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established.
Varnost in učinkovitost zdravila TAKHZYRO pri otrocih, starih manj kot 12 let, nista bili dokazani.
e) Push the plunger slowly until all the medicine has been injected.
e) Počasi pritiskajte na bat, dokler ne vbrizgate vsega zdravila.
[moderate, N=9]) had no effect on the clearance or volume of distribution of lanadelumab.
[zmerna, N = 9]) ni vplivala na očistek ali porazdelitveni volumen lanadelumaba.
There is limited information on the safety of TAKHZYRO use during pregnancy and breast-feeding.
Informacije o varnosti zdravila TAKHZYRO med nosečnostjo in dojenjem so omejene.
Before use, each vial should be visually inspected for appearance.
Pred uporabo vizualno preverite videz vsake viale.
This medicine has negligible influence on the ability to drive or use machines.
To zdravilo ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
As IgG monoclonal antibodies are mainly eliminated via intracellular catabolism, renal impairment or hepatic impairment is not expected to influence clearance of lanadelumab.
Ker se monoklonska protitelesa IgG pretežno izločajo prek znotrajceličnega katabolizma, ni pričakovati, da bi okvara ledvic ali jeter vplivala na očistek lanadelumaba.
Although body weight was identified as an important covariate describing the variability of clearance, a 300 mg q2wks dose regimen provided sufficient exposure for the indication (see section 5.1).
Čeprav je bila telesna masa opredeljena kot pomembna spremenljivka, ki opisuje variabilnost očistka, je bila izpostavljenost v režimu odmerjanja 300 mg vsaka dva tedna zadostna za indikacijo (glejte poglavje 5.1).
HELP study extension
Podaljšek študije HELP
The recommended starting dose is 300 mg every 2 weeks.
Priporočeni začetni odmerek je 300 mg vsaka 2 tedna.
Nutrition score Note: AE-QoL= Angioedema Quality of Life; LS=least squares; SD=standard deviation.
Opomba: AE-QoL= vprašalnik kakovosti življenja pri angioedemu; LS = metoda najmanjših kvadratov; SD = standardni odklon.
During the study run-in period, the mean attack rate was 3.7 attacks/month with 52% (65/125) of subjects experiencing ≥3 attacks/month.
V uvajalnem obdobju študije je bila povprečna stopnja napadov 3,7 napada/mesec, pri čemer je 52 % (65/125) preiskovancev imelo ≥ 3 napade/mesec.
Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay.
Lanadelumab lahko podaljša aktivirani parcialni tromboplastinski čas (aPTČ) zaradi interakcije lanadelumaba s testom za določanje aPTT.
None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events.
Nobeno podaljšanje aPTČ pri bolnikih, zdravljenih z zdravilom TAKHZYRO, ni bilo povezano z neželenimi nenormalnimi krvavitvami.
• The outer area of the upper arm is not recommended if you are injecting yourself.
• Injiciranje v zunanji predel nadlakti ni priporočljivo, če si zdravilo injicirate sami.
Do not use the vial if the cap covering the stopper is missing.
Viale ne uporabite, če manjka zaporka, ki prekriva zamašek.
LS mean change (SD) from baseline at week 26
Povprečna sprememba LS (SD) od izhodišča v 26. tednu
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Zdravilo TAKHZYRO je indicirano za rutinsko preprečevanje ponavljajočih se napadov hereditarnega angioedema (HAE) pri bolnikih, starih 12 let in več.
Results are from a Poisson regression model accounting for over dispersion with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and the logarithm of time in days each subject was observed during the treatment period as an offset variable in the model.
Rezultati so iz Poissonovega regresijskega modela ob upoštevanju prevelike razpršenosti s fiksnim učinkom za skupino zdravljenja (kategorično) in normalizirano izhodiščno stopnjo napadov (neprekinjeno), in logaritem časa v dnevih, ko so vsakega preiskovanca v obdobju zdravljenja opazovali, kot prosta spremenljivka v modelu.
d) Gently pinch about 3 cm of skin at your cleaned injection site and insert the needle.
d) Nežno stisnite približno 3 cm kože na očiščenem mestu injiciranja v kožno gubo in vstavite iglo.
A history of laryngeal angioedema attacks was reported in 65% (81/125) of subjects and 56% (70/125) were on prior long term prophylaxis (LTP).
O laringealnih napadih angioedema v anamnezi so poročali pri 65 % (81/125) preiskovancev; 56 % (70/125) jih je bilo pred tem na dolgoročni profilaksi.
Very common
zelo pogosti
The site of SC injection (thigh, arm, or abdomen) and self-administration did not affect the absorption of lanadelumab.
Mesto s.c. injiciranja (stegno, roka ali trebuh) in samoinjiciranje nista vplivala na absorpcijo lanadelumaba.
Lanadelumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Lanadelumab je terapevtsko monoklonsko protitelo, za katerega se ne pričakuje, da bi se vezalo na beljakovine v plazmi.
All TAKHZYRO treatment groups observed an improvement in Angioedema Quality of Life Questionnaire (AE-QoL) total and domain (functioning, fatigue/mood, fear/shame, and nutrition) scores compared to the placebo group; the largest improvement was observed in the functioning score as shown in Table 4.
V vseh skupinah, zdravljenih z zdravilom TAKHZYRO, so opazili izboljšanje po vprašalniku o kakovosti življenja za angioedem (AE-QoL, Angioedema Quality of Life Questionnaire) v skupnem seštevku in po domenah (funkcioniranje, utrujenost/razpoloženje, strah/sram in prehranjevanje) v primerjavi s skupino s placebom; največje izboljšanje so opazili v rezultatu funkcioniranja, kot prikazuje preglednica 4.
In a population pharmacokinetic analysis, after correcting for body weight, no influence of gender or age (12 to 75 years) was apparent on the clearance or volume of distribution of lanadelumab.
V populacijski farmakokinetični analizi, po korekciji za telesno maso, niso opazili vpliva spola ali starosti (od 12 do 75 let) na očistek ali porazdelitveni volumen lanadelumaba.
Carcinogenicity has not been evaluated in animals as based on the weight of evidence approach, lanadelumab is considered to have a low risk for carcinogenicity.
Kancerogenosti pri živalih niso ocenili, saj na podlagi pristopa teže dokazov kaže, da ima lanadelumab majhno tveganje za kancerogenost.
TAKHZYRO is not intended for treatment of acute HAE attacks.
Zdravilo TAKHZYRO ni namenjeno za zdravljenje akutnih napadov HAE.
b) Clean your work area and wash your hands before preparing your dose.
b) Pred pripravo odmerka očistite delovno površino in si umijte roke.
If not administered immediately after preparation, the syringe may be stored in the refrigerator (2C to 8C), protected from light and administered within 8 hours.
Če se zdravilo ne aplicira takoj po pripravi, je mogoče injekcijsko brizgo shraniti v hladilniku (od 2 °C do 8 °C), zaščiteno pred svetlobo, in ga dati v 8 urah.
The effects of lanadelumab on fertility were evaluated in sexually mature cynomolgus monkeys.
Učinek lanadelumaba na plodnost so ocenili pri spolno zrelih opicah cynomolgus.
g) Remove the plastic cap from the vial.
g) Z viale odstranite plastično zaporko.
The absolute bioavailability of lanadelumab after subcutaneous administration has not been determined.
Absolutna biološka uporabnost lanadelumaba po subkutanem dajanju ni bila ugotovljena.
Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.
Na podlagi značilnosti lanadelumaba se farmakokinetične interakcije s sočasno uporabljenimi zdravili ne pričakujejo.
• The injection can be given either by yourself or a caregiver.
Injekcijo si lahko daste sami ali vam jo da negovalec.
Solution for injection 1 vial of 2 ml
raztopina za injiciranje 1 viala z 2 ml
No dedicated studies have been conducted to evaluate the pharmacokinetics of lanadelumab in special patient populations including gender, age, pregnant women or the presence of renal or hepatic impairment.
Namenskih študij za oceno farmakokinetike lanadelumaba pri posebnih populacijah bolnikov, vključno s spolom, starostjo, nosečnicami ali prisotnostjo okvare ledvic ali jeter, niso izvedli.
If you miss a dose of TAKHZYRO, inject your dose as soon as possible but there must be at least 10 days between each dose.
Če izpustite odmerek zdravila TAKHZYRO, si morate odmerek čim prej injicirati, vendar mora biti med enim in drugim odmerkom vsaj 10-dnevni interval.
In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
Pri bolnikih, ki so med zdravljenjem stabilni brez napadov, je možno razmisliti o zmanjšanju odmerka 300 mg lanadelumaba vsake 4 tedne, zlasti pri bolnikih z majhno telesno maso.
d) Remove large air bubbles by gently tapping on the syringe with your fingers until the bubbles rise to the top of the syringe.
d) Velike zračne mehurčke odstranite tako, da s prsti nežno krcate po injekcijski brizgi, dokler se mehurčki ne dvignejo na vrh injekcijske brizge.
Tell your doctor, pharmacist or nurse if you take too much TAKHZYRO.
Zdravniku, farmacevtu ali medicinski sestri povejte, če ste uporabili prevelik odmerek zdravila TAKHZYRO.
The percentage of patients who were attack free for the last 16-weeks (Day 70 to Day 182) of the study was 77% in the 300 mg q2wks group, compared to 3% of patients in the placebo group.
Odstotek bolnikov, ki v zadnjih 16 tednih (dan 70 do dan 182) študije niso imeli napadov, je bil za skupino, ki je prejemala 300 mg vsak drugi teden, 77 %, v primerjavi s 3 % bolnikov v skupini s placebom.
MULTIPACK INNER CARTON (NO BLUE-BOX)
NOTRANJA ŠKATLA ZA SKUPNO PAKIRANJE (BREZ MODREGA OKENCA (BLUEBOX))
c) Gather your TAKHZYRO and supplies and place them on your well-lit work surface.
c) Zdravilo TAKHZYRO in potrebščine položite na dobro osvetljeno površino.
AE-QoL Total score
Skupni rezultat po AE-QoL
Treatment period (Day 0 to Day 182, 26 weeks) n Attack free
Obdobje zdravljenja (od 0. do 182. dneva, 26. tednov)
Do not use TAKHZYRO:
Ne uporabljajte zdravila TAKHZYRO:
Do not return TAKHZYRO to refrigerated storage after storage at room temperature.
Zdravila TAKHZYRO po obdobju shranjevanja pri sobni temperaturi ne shranjujte več v hladilniku.
The PK-PD relationship between TAKHZYRO and cHMWK is described by an indirect exposureresponse pharmacological model.
Razmerje med farmakokinetiko in farmakodinamiko med zdravilom TAKHZYRO in cHMWK je opisano s posrednim farmakološkim modelom razmerja med izpostavljenostjo in odzivom.
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms (see section 5.2).
Injiciranje je treba omejiti na priporočena mesta injiciranja: trebuh, stegna in zunanji del nadlakti (glejte poglavje 5.2).
The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising.
Najpogostejši (52,4 %) neželeni učinek, ki so ga opazili v povezavi z zdravilom TAKHZYRO, je bila reakcija na mestu injiciranja, vključno z bolečino na mestu injiciranja, eritemom na mestu injiciranja in modrico na mestu injiciranja.
The rate ratio is ratio of the model-based treatment period HAE attack rates.
Razmerje pojavnosti je razmerje stopenj napadov HAE v obdobju zdravljenja na podlagi modela.
b) Clean your injection site with an alcohol wipe and allow the skin to dry completely.
b) Mesto injiciranja očistite z alkoholnim zložencem in počakajte, da se koža popolnoma osuši.
Important: Inject TAKHZYRO within 2 hours of preparing the dosing syringe at room temperature.
Pomembno: Zdravilo TAKHZYRO si injicirajte v 2 urah po pripravi injekcijske brizge za dajanje zdravila, shranjene na sobni temperaturi.
In the ePPND study in pregnant cynomolgus monkeys administered once weekly doses of 10 or 50 mg/kg (highest dose tested), there were no lanadelumab-related effects on pregnancy and parturition, embryo-foetal development, survival, growth, and/or postnatal development of offspring.
V študiji ePPND pri brejih opicah cynomolgus, ki so jim enkrat na teden dajali odmerek 10 ali 50 mg/kg (največji testirani odmerek), niso opazili z lanadelumabom povezanih učinkov na brejost in kotenje, embriofetalni razvoj , preživetje, rast in/ali razvoj mladičev po rojstvu.
Fatigue/Mood score
Rezultat za utrujenost/razpoloženje
A total of 212 adult and adolescent subjects with symptomatic type I or II HAE received at least one dose of lanadelumab in this study, including 109 subjects who entered as rollover subjects from the HELP study and 103 new or non-rollover subjects (including 19 subjects from Phase1b study) who had an historical baseline attack rate of ≥1 attack per 12 weeks Subjects were allowed to initiate self-administration after receiving the first 2 doses from a health care professional in clinic and completing appropriate training.
Skupaj 212 odraslih preiskovancev in mladostnikov s simptomatskim HAE tipa I ali II je v tej študiji prejelo vsaj en odmerek lanadelumaba, vključno s 109 preiskovanci, ki so nadaljevali kot preiskovanci iz študije HELP, in 103 novimi preiskovanci oz. preiskovanci, ki niso prišli iz predhodne študije (vključno z 19 preiskovanci iz študije faze 1b), in so imeli izhodiščno stopnjo napadov v anamnezi ≥ 1 napad na 12 tednov.
Clean the vial rubber stopper with an alcohol wipe and allow it to dry.
Gumijasti zamašek viale očistite z alkoholnim zložencem in počakajte, da se osuši.
TAKHZYRO is a medicine used in adults, and adolescents aged 12 years and older to prevent angioedema attacks, in patients with HAE.
Zdravilo TAKHZYRO se uporablja pri odraslih in mladostnikih, starih 12 let in več, za preprečevanje napadov angioedema pri bolnikih s HAE.
The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
Razvoj protiteles proti zdravilu, vključno z nevtralizirajočimi protitelesi proti zdravilu TAKHZYRO, ni neželeno vplival na farmakokinetični in farmakodinamični profil ali klinični odziv.
Increased plasma kallikrein activity leads to angioedema attacks in patients with HAE through the proteolysis of high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin.
Povečana aktivnost plazemskega kalikreina povzroči angioedemske napade pri bolnikih s HAE zaradi proteolize visokomolekularnega kininogena (HMWK), s katero nastaneta odcepljeni HMWK (cHMWK) in bradikinin.
a) Take the vial out of the refrigerator 15 minutes before use to allow it to reach room temperature (15°C to 25°C) before preparing an injection.
1. korak: Pripravite vialo zdravila TAKHZYRO a) Vialo vzemite iz hladilnika 15 minut pred uporabo in jo pustite, da se ogreje na sobno temperaturo (od 15 °C do 25 °C), preden pripravite injekcijo.
Hypersensitivity reactions have been observed.
Opazili so preobčutljivostne reakcije.
Select and prepare injection site
Izberite in pripravite mesto injiciranja.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
Obvestite zdravnika ali medicinsko sestro, če opazite katerega od naslednjih neželenih učinkov:
TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein.
Zdravilo TAKHZYRO je vrsta beljakovine, ki zavira aktivnost plazemskega kalikreina.
Do not shake the vial as this can cause foaming.
Viale ne stresajte, saj lahko to povzroči penjenje.
(abdomen), thigh, or upper arm.
(abdomnu), stegnu ali nadlakti.
TAKHZYRO has negligible influence on the ability to drive or use machines.
Zdravilo TAKHZYRO ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and water for injections - see section 2 “TAKHZYRO contains sodium” What TAKHZYRO looks like and contents of the pack
Druge sestavine so natrijev hidrogenfosfat dihidrat, citronska kislina monohidrat, histidin, natrijev klorid, polisorbat 80, voda za injekcije - glejte poglavje 2 »Zdravilo TAKHZYRO vsebuje natrij«.
The solution is colourless to slightly yellow, appearing either clear or slightly opalescent.
Raztopina je brezbarvna do rahlo rumenkasta ter bistrega ali nekoliko opalescentnega videza.
All TAKHZYRO treatment arms produced statistically significant reductions in the mean HAE attack rate compared to placebo across all primary and secondary endpoints in the Intent-to-Treat population (ITT) (Table 2).
Vsi kraki zdravljenja z zdravilom TAKHZYRO so pokazali statistično značilno zmanjšanje povprečne stopnje napadov HAE v primerjavi s placebom glede vseh primarnih in sekundarnih opazovanih dogodkov v populaciji z namenom zdravljenja (ITT, Intent-to-Treat) (preglednica 2).
It is unknown whether lanadelumab is excreted in human milk.
Ni znano, ali se lanadelumab izloča v materino mleko pri človeku.
TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a glass vial.
Zdravilo TAKHZYRO je na voljo kot bistra, brezbarvna do rahlo rumenkasta raztopina za injiciranje v stekleni viali.
Renal impairment is not expected to affect exposure to lanadelumab or the safety profile.
Ne pričakuje se, da bi ledvična okvara vplivala na izpostavljenost lanadelumabu ali na njegov varnostni profil.
Do not choose an area that is bruised, swollen, or painful.
Ne izberite predela z modrico, oteklino ali bolečega predela.
Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Z aseptično tehniko izvlecite predpisani odmerek zdravila TAKHZYRO iz viale v injekcijsko brizgo z iglo velikosti 18G.
2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.
2 ml raztopine v viali (steklo tipa I) z zamaškom iz butilne gume in aluminijastim tesnilom z vijolično dvižno zaporko.
The percentage of patients who achieved a clinically meaningful improvement in AE-QoL total score was 65% (Odds ratio vs placebo, [95% CI]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), and 81% (7.2 [2.2, 23.4]), in TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, and 300 mg q2 wks groups, respectively, compared to 37% of patients in the placebo group.
Odstotek bolnikov, ki so dosegli klinično pomembno izboljšanje v skupnem seštevku AE-QoL, je bil 65 % (razmerje obetov v primerjavi s placebom, [95-% IZ] = 3,2 [1,1; 9,2]), 63 % (2,9 [1,1; 8;1]) oz. 81 % (7,2 [2,2; 23,4]) za skupine z zdravilom TAKHZYRO 150 mg vsake štiri tedne, 300 mg vsake štiri tedne oz. 300 mg vsaka 2 tedna, v primerjavi s 37 % bolnikov v skupini s placebom.
Do not remove the vial rubber stopper.
Ne odstranite gumijastega zamaška z viale.
If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as possible ensuring at least 10 days between doses.
Če bolnik izpusti odmerek zdravila TAKHZYRO, mu je treba naročiti, naj si odmerek da čim prej, pri čemer pa mora med dvema odmerkoma preteči vsaj 10 dni.