natgillin/translations-raw huggingface dataset:
Long-term safety and efficacy of TAKHZYRO for prophylaxis to prevent HAE attacks was evaluated in an open-label HELP study extension. 
Dolgoročno varnost in učinkovitost zdravila TAKHZYRO kot profilakse za preprečevanje napadov HAE so ocenili v odprtem podaljšku študije HELP.
e) Gently invert the vial 3 to 5 times to ensure the solution is mixed. 
e) Vialo nežno 3- do 5-krat obrnite in zagotovite, da je raztopina premešana.
With this condition your blood does not have enough of a protein called ‘C1 inhibitor', or C1 inhibitor does not work properly. 
Pri tej bolezni v krvi ni dovolj beljakovine, imenovane ‘zaviralec C1' ali pa zaviralec C1 ne deluje pravilno.
Afterwards, lanadelumab could be used during breast-feeding if clinically needed. 
Kasneje se lanadelumab lahko uporablja med dojenjem, če je to klinično potrebno.
% Reduction relative to placebo (95% CI) 
% zmanjšanje glede na placebo (95-% IZ)
If you have not had an attack for a long period, your doctor may change the dose to 300 mg every 4 weeks, especially if you have a low body weight. 
Če dolgo časa niste imeli napada, lahko zdravnik odmerek spremeni na 300 mg vsake 4 tedne, zlasti, če imate majhno telesno maso.
From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately. 
Z mikrobiološkega vidika je treba zdravilo porabiti takoj, razen če je bilo tveganje kontaminacije z mikrobi izključeno z načinom priprave.
It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the name and batch number of the medicine. 
Zelo priporočljivo je, da vsakič, ko uporabite odmerek zdravila TAKHZYRO, zabeležite ime in številko serije zdravila.
What hereditary angioedema (HAE) is 
Kaj je hereditarni angioedem (HAE)?
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja neporabljenega zdravila med uporabo odgovoren uporabnik.
Table 1 summarises adverse reactions observed in the HELP study that included 84 subjects with HAE, who received at least one dose of TAKHZYRO. 
V preglednici 1 so povzeti neželeni učinki, ki so jih opazili v študiji HELP, v katero je bilo vključenih 84 preiskovancev s HAE, ki so prejeli vsaj en odmerek zdravila TAKHZYRO.
Each TAKHZYRO vial is intended for single use only (see section 6.6). 
Vsaka viala zdravila TAKHZYRO je namenjena samo za enkratno uporabo (glejte poglavje 6.6).
The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. 
Raztopina ima pH vrednost približno 6,0 in osmolalnost približno 300 mOsm/kg.
In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated. 
V primeru hude preobčutljivostne reakcije je treba takoj prenehati z dajanjem zdravila TAKHZYRO in uvesti ustrezno zdravljenje.
Following SC administration, the time to maximum concentration is approximately 5 days. 
Po s.c. dajanju je največja koncentracija dosežena v približno 5 dneh.
The safety of TAKHZYRO was evaluated in a subgroup of 23 subjects aged 12 to <18 years old. 
Varnost zdravila TAKHZYRO so ocenili v podskupini s 23 preiskovanci, starimi od 12 do < 18 let.
In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. 
V primeru prebijajočega napada HAE je treba uvesti zdravljenje, prilagojeno posamezniku, z odobrenim rešilnim zdravilom.
Model-based treatment period HAE attack rate (attacks/4 weeks). 
Stopnja napadov HAE v obdobju zdravljenja na podlagi modela (napadi/4 tedne).
Lanadelumab is a fully human, monoclonal antibody (IgG1/ κ-light chain). 
Lanadelumab je povsem humano, monoklonsko protitelo (IgG1/κ-lahka veriga).
HAE is a condition which runs in families. 
HAE je bolezen, ki se pojavlja v družini.
• A doctor, pharmacist or nurse should show you how to prepare and inject TAKHZYRO properly before you use it for the first time. 
Zdravnik, farmacevt ali medicinska sestra vam bo pokazala, kako pravilno pripraviti in injicirati zdravilo TAKHZYRO, preden ga prvič uporabite.
• The area you choose for injection should be at least 5 cm away from any scars or your belly button (navel). 
• Predel, ki ga izberete za injiciranje, mora biti vsaj 5 cm proč od morebitnih brazgotin in popka.
The European Medicines Agency has deferred the obligation to submit the results of studies with TAKHZYRO in one or more subsets of the paediatric population in the prevention of hereditary angioedema attacks. 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom TAKHZYRO za eno ali več podskupin pediatrične populacije pri preprečevanju napadov hereditarnega angioedema.
This is so that you keep a record of the batches used. 
Na tak način vodite evidenco, katere serije ste uporabili.
Interference with coagulation test 
Vpliv na koagulacijske teste
If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6). 
če ste alergični na zdravilo TAKHZYRO ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Fear/Shame score 
Rezultat za strah/sram
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity (see section 5.3). 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja ali razvoja (glejte tudi poglavje 5.3).
The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE. 
Študija HELP je bila multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija z vzporednimi skupinami s 125 (115 odraslimi in 10 mladostniki) preiskovanci s simptomatičnim HAE tipa I ali II.
Release the skin fold and gently remove the needle. 
Spustite kožno gubo in nežno odstranite iglo.
Step 4: Select and prepare injection site a) Choose an injection site on your stomach 
4. korak: Izberite in pripravite mesto injiciranja a) Izberite mesto injiciranja na trebuhu
Lanadelumab has a mean (SD) total body clearance of 0.0297 L/h (0.0124) and a terminal elimination half-life of approximately 14 days. 
Lanadelumab ima povprečni (SD) skupni telesni očistek 0,0297 l/h (0,0124) in končno razpolovno dobo izločanja približno 14 dni.
There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity. 
Ni razpoložljivih kliničnih podatkov o uporabi lanadelumaba pri bolnikih s HAE z normalno aktivnostjo C1-INH.
Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes. 
Med temi reakcijami na mestu injiciranja jih je bilo 97 % blagih, 90 % pa jih je v 1 dnevu po nastanku izzvenelo, z mediano trajanja 6 minut.
No dedicated drug-drug interaction studies have been conducted. 
Namenskih študij medsebojnega delovanja med zdravili niso izvedli.
The percentage of subjects who were attack free is provided in Table 3. 
Odstotek preiskovancev, ki niso imeli napadov, je naveden v preglednici 3.
The cHMWK formation rate was maximally reduced by 53.7% with an IC50 of 5705 ng/ml. 
Stopnja nastajanja cHMWK se je zmanjšala za 53,7 %, vrednost IC50 pa je bila 5705 ng/ml.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before starting to use Takhzryo. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite zdravilo TAKHZYRO.
2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies. 
2,4 % (2/84) preiskovancev, zdravljenih z lanadelumabom, je bilo pozitivnih na nevtralizirajoča protitelesa.
HELP study 
Študija HELP
Do not use this medicine if you notice signs of deterioration such as particles in the vial or changed colour of the injection solution. 
Ne uporabljajte tega zdravila, če opazite znake kvarjenja, kot so delci v viali ali spremenjena barva raztopine za injiciranje.
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).