natgillin/translations-raw huggingface dataset:
If not used immediately, in-use storage times and conditions are the responsibility of user.
Če zdravilo ni uporabljeno takoj, so časi shranjevanja in pogoji med uporabo odgovornost uporabnika.
Then lift the pen away from your skin.
Potem dvignite peresnik proč od kože.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Nadaljnje ukrepanje mora potekati, kot je klinično indicirano ali kot priporoča nacionalni center za zastrupitve, kjer je ta na voljo.
The safety profile was similar to that seen in adults.
Varnostne značilnosti v teh študijah so bile podobne, kot so jih zabeležili pri odraslih.
Dispose of it (see Step 9), and start again with a new pen.
(glejte 9. korak) in začnite znova z novim peresnikom.
The reconstituted solution, if not used immediately must be:
Če rekonstituirana raztopina ni uporabljena takoj, jo je treba:
Yellow indicator (becomes visible when the injection is complete)
Rumeni indikator (postane viden, ko je injiciranje končano)
Administer once every four weeks.
Uporabite enkrat na štiri tedne.
Prepare 1.
Priprava 1.
These events were all non-serious, mild to moderate in intensity and the majority resolved within a few days.
Nobeden od teh učinkov ni bil resen, vsi so bili blagi do zmerni in večina je minila v nekaj dneh.
The safety and efficacy of mepolizumab in children less than 6 years old have not yet been established.
Varnost in učinkovitost mepolizumaba pri otrocih, mlajših od 6 let, še nista bili dokazani.
In adults, adolescents and children, this magnitude of reduction was observed within 4 weeks of treatment.
Pri odraslih, mladostnikih in otrocih so zmanjšanje v tolikšnem obsegu opažali v 4 tednih zdravljenja.
Wait 30 minutes
Počakajte 30
• Do not worry if you see a drop of liquid at the end of the needle.
• Ne skrbite, če opazite kapljico tekočine na koncu igle.
These reactions may be common (they can affect up to 1 in 10 people).
Te reakcije so lahko pogoste (pojavijo se lahko pri največ 1 od 10 oseb).
Your injection may take up to 15 seconds to complete.
Injiciranje lahko traja do 15 sekund, preden je dokončano.
• Alcohol wipe (not included)
• alkoholni robček (ni priložen)
Children less than 6 years old
Otroci, mlajši od 6 let
The following information is intended for healthcare professionals only: Step-by-step instructions for use and handling, reconstitution, and administration
Naslednje informacije so namenjene samo zdravstvenemu osebju: Podrobna navodila za uporabo, ravnanje, rekonstitucijo in dajanje
Children aged 6 to 11 years old
Otroci, stari od 6 do 11 let
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
V primeru prevelikega odmerjanja je treba bolnika zdraviti podporno in ga ustrezno kontrolirati, kot je potrebno.
• Do not store it above 30°C.
• Ne shranjujte na temperaturi nad 30 °C.
Check the medicine
Preverite zdravilo
- if you are allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na mepolizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Once complete, release the pinched skin.
• Ko je to dokončano, izpustite stisnjeno kožo.
This study did not include a littering or functional offspring assessment.
Ta študija ni vključila ocene legel ali funkcionalne ocene potomcev.
• Protected from sunlight
• zaščititi pred sončno svetlobo,
This medicinal product must not be mixed with other medicinal products.
Tega zdravila se ne sme mešati z drugimi zdravili.
Predefined categories included percent reductions ranging from 90-100% reduction, to no decrease in the prednisone dose from the end of the optimisation phase.
Opredeljene kategorije so obsegale odstotna zmanjšanja, ki so segala od zmanjšanja za 90-100 % do nobenega zmanjšanja odmerka prednizona od konca optimizacijske faze.
The mean number of exacerbations in the previous year was 3.6 and the mean predicted pre-bronchodilator FEV1 was 60%.
Povprečno število poslabšanj v preteklem letu je bilo 3,6 in povprečni predvideni FEV1 pred bronhodilatatorjem je bil 60 %.
Instructions for reconstitution for each vial
Navodila za rekonstitucijo vsake viale
• Inject straight after removing the needle cap, and always within 5 minutes.
• Injicirajte takoj po odstranitvi pokrovčka igle in vedno v največ 5 minutah.
Contents of the pack and other information 7.
Vsebina pakiranja in dodatne informacije 7.
This could cause a needle injury.
To lahko povzroči poškodbo z iglo.
Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C.
Kemična in fizikalna stabilnost rekonstituiranega zdravila sta dokazani za obdobje 8 ur, če je zdravilo shranjeno pri temperaturi do 30 °C.
Examinations for internal or skeletal malformations were not performed.
Pregledov za notranje malformacije ali malformacije okostja niso izvedli.
• swelling of eyelids, face, lips, tongue or mouth
• oteklost vek, obraza, ustnic, jezika ali ust,
Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body (see section 4, ‘Possible side effects').
Zdravila te vrste (monoklonska protitelesa) lahko ob injiciranju v telo povzročijo hude alergijske reakcije (glejte poglavje 4, "Možni neželeni učinki").
St. George's Respiratory Questionnaire (SGRQ) at week 32
Vprašalnik SGRQ (St. George's Respiratory Questionnaire) 32. teden
Local injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections.
Lokalne reakcije na mestu injiciranja so se pojavile predvsem na začetku zdravljenja in pri prvih 3 injekcijah; pri poznejših injiciranjih so bile redkejše.
If you are pregnant, if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
A total of 135 patients were enrolled: mean age was 50 years, 55% were female, and 48% had been receiving oral steroid therapy for at least 5 years.
Vključenih je bilo skupaj 135 bolnikov: povprečna starost je bila 50 let, 55 % je bilo žensk in 48 % jih je vsaj že 5 let jemalo peroralne kortikosteroide.
• Continue to hold the pen in place while you count to 5.
• Še naprej držite peresnik na mestu in preštejte do 5.
PRESS HERE TO OPEN
ZA ODPRTJE PRITISNITE TUKAJ
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Pogostnost neželenih učinkov je opredeljena upoštevaje naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Administration of Nucala to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Uporaba zdravila Nucala pri nosečnicah pride v poštev le, če je pričakovana korist za mater večja od možnega tveganja za plod.
No additional adverse reactions were identified.
Dodatnih neželenih učinkov niso ugotovili.
- If you are not sure, hold the pen down for another 15 seconds to make sure the injection is complete.
- Če niste prepričani, držite peresnik pritisnjen dodatnih 15 sekund; tako se boste prepričali, da je injiciranje dokončano.
Do not touch the yellow needle guard with your fingers.
Ne dotikajte se rumenega ščitnika igle s prsti.
After a treatment interruption of 8 weeks, 30 of these patients, received mepolizumab for a further 52 weeks.
tedenski prekinitvi zdravljenja je 30 od teh bolnikov prejemalo mepolizumab še nadaljnjih 52 tednov.
You may need to pull the needle cap quite firmly to remove it.
Pokrovček igle boste morda morali potegniti precej močno, da ga boste odstranili.
If you do not notice that you have missed a dose until it is already time for your next dose, then just inject the next dose as planned.
Če ugotovite, da ste pozabili uporabiti odmerek, šele tedaj, ko je že čas za naslednjega, injicirajte le naslednji odmerek po običajnem načrtu.
The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.
Potrebo po nadaljevanju zdravljenja je potrebno pretehtati vsaj enkrat na leto glede na zdravnikovo oceno izrazitosti bolnikove bolezni in doseženega nadzora nad poslabšanji.
They usually occur within minutes to hours after the injection, but sometimes symptoms can start up to several days later.
Po navadi se pojavijo v nekaj minutah do nekaj urah po injiciranju, včasih pa se simptomi razvijejo šele čez nekaj dni.
Press down
Potisnite dol
For examples of the associated manifestations reported and a description of the time to onset, see section 4.4.
Za primere opisanih spremljajočih manifestacij in za čas do njihovega pojava glejte poglavje 4.4.
MEA112997+MEA115588 <150 cells/µL
MEA112997+MEA115588 < 150 celic/µl n
Nucala is intended for long-term treatment.
Zdravilo Nucala je namenjeno za dolgotrajno zdravljenje.
The comparison between mepolizumab and placebo was statistically significant (p=0.008).
Primerjava med mepolizumabom in placebom je bila statistično značilna (p = 0,008).
If you are taking medicines called oral corticosteroids, Nucala can also help reduce the daily dose you need to control your asthma.
Če jemljete zdravila, imenovana peroralni kortikosteroidi, lahko zdravilo Nucala pomaga zmanjšati tudi njihov dnevni odmerek, potreben za nadzor astme.
The powder should be reconstituted prior to administration and the reconstituted solution should be used immediately.
Prašek je treba pred dajanjem rekonstituirati, rekonstituirano raztopino pa je treba uporabiti takoj.
This dosing regimen is considered acceptable due to the wide therapeutic index of mepolizumab.
Ta odmerna shema velja za sprejemljivo, saj ima mepolizumab širok terapevtski indeks.
Other side effects include: Very common side effects
Med drugimi neželenimi učinki so: Zelo pogosti neželeni učinki
Do not lift the pen until you are sure you have completed your injection.
Ne dvignite peresnika, dokler niste prepričani, da ste injiciranje dokončali.
Dose-ranging efficacy MEA112997 (DREAM) study
Študija učinkovitosti razpona odmerkov MEA112997 (DREAM)
The yellow needle guard will slide up into the pen.
Rumeni ščitnik igle bo zdrsnil navzgor v peresnik.
These reactions may occur for the first time after a long duration of treatment (see section 4.8).
Te reakcije se lahko prvič pojavijo po že dolgotrajnem zdravljenju (glejte poglavje
It is not known whether the ingredients of Nucala can pass into breast milk.
Ni znano, ali lahko sestavine zdravila Nucala prehajajo v materino mleko.
The absolute subcutaneous bioavailability appears complete compared to that observed in adults and adolescents of 76%.
Kaže, da je absolutna subkutana biološka uporabnost popolna v primerjavi s 76% biološko uporabnostjo, ki so jo opazili pri odraslih in mladostnikih.
7 days, when stored in the original carton.
vendar ne več kot 7 dni in pod pogojem, da je shranjena v originalni škatli.
• Insert the entire needle into the pinched skin at a 45° angle, as shown.
• Celotno iglo pod kotom 45 ° zabodite v stisnjeno kožo, kot je prikazano.
The potential for harm to a human fetus is unknown.
Možnost za poškodbo ploda pri človeku ni znana.
Slowly raise your thumb
Počasi dvignite palec
• Slowly lift your thumb up.
• Počasi dvignite palec.
These may affect up to 1 in 10 people:
Pojavijo se lahko pri največ 1 od 10 oseb:
• Discarded if not used within 8 hours of reconstitution
• zavreči, če ni uporabljena v 8 urah po rekonstituciji.
These medicines (especially ones called corticosteriods) must be stopped gradually, under the direct supervision of your doctor and dependant on your response to Nucala.
Ta zdravila (zlasti zdravila, imenovana kortikosteroidi) je treba opuščati postopoma, pod neposrednim nadzorstvom zdravnika in odvisno od vašega odziva na zdravilo Nucala.
Neutralising antibodies were detected in one adult subject.
Nevtralizacijska protitelesa so odkrili pri enem odraslem preiskovancu.
• Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
• Pomaknite palec na bat in položite druge prste na belo držalo za prste, kot je prikazano.
Subcutaneous use after reconstitution.
Subkutana uporaba po rekonstituciji.
These patients either remained uncontrolled (at least two severe exacerbations in the previous 12 months) on their current standard of care, including at least high doses of inhaled corticosteroids (ICS) plus an additional maintenance treatment(s), or were dependent on systemic corticosteroids.
Ti bolniki so bodisi ostali neurejeni (vsaj dve hudi poslabšanji v preteklih 12 mesecih) ob svojem trenutnem zdravljenju, ki je vključevalo vsaj visok odmerek inhalacijskega kortikosteroida (IKS), in eno ali več dodatnih vzdrževalnih zdravil, bodisi so bili odvisni od sistemskih kortikosteroidov.
• eczema (itchy red patches on the skin)
• ekcem (srbeče, rdeče zaplate na koži),
Concentrations of mepolizumab were about 1.2-2.4 times higher in infants than in mothers for several months post partum and did not affect the immune system of the infants.
Koncentracija mepolizumaba je bila pri mladičih več mesecev po rojstvu približno 1,2- do 2,4-krat višja kot pri materah in ni vplivala na imunski sistem mladičev.
Component of a multipack, can't be sold separately.
Del večkratnega pakiranja, ne prodaja se posamezno.
• Stored below 30°C, not frozen
• shranjevati pri temperaturi do 30 °C, nezamrznjeno,
The side effects caused by Nucala are usually mild to moderate but can occasionally be serious.
Neželeni učinki zdravila Nucala so po navadi blagi do zmerni, občasno pa so lahko resni.
In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
*** The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving mepolizumab 100 mg subcutaneously.
***V poročilih o sistemskih nealergijskih reakcijah, povezanih z dajanjem zdravila, so bile najpogosteje opisane manifestacije izpuščaj, zardevanje in mialgija; zabeležili so jih redko in pri <1 % bolnikov, ki so prejemali 100 mg mepolizumaba subkutano.
Secondary endpoints Frequency of exacerbations requiring hospitalisations/emergency room visits
Sekundarni opazovani dogodki Pogostnost poslabšanj, ki so zahtevala sprejem v bolnišnico/obisk v ambulanti za nujno pomoč
Adults and adolescents aged 12 years and over
Odrasli in mladostniki, stari 12 let ali več
This could activate the pen too soon and may cause a needle injury.
To lahko povzroči prezgodnje aktiviranje peresnika in lahko povzroči poškodbo z iglo.
There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
O uporabi mepolizumaba pri nosečnicah je podatkov malo (manj kot 300 izidov nosečnosti).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
• fever (high temperature)
• zvišana telesna temperatura (vročina),
Do not touch the plunger at this stage, as you can accidentally push liquid out and will not receive your full dose.
V tej fazi se ne dotikajte bata, saj lahko tako nehote iztisnete tekočino in tako ne boste dobili celotnega odmerka.
* Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo.
* Celotna pojavnost sistemskih reakcij, vključno s preobčutljivostjo, je bila podobna kot pri placebu.
Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom
Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT Velika Britanija
Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.
Med rekonstitucijo vialo pustite na sobni temperaturi in jo po 10 sekund vrtite s krožnimi gibi s 15-sekundnimi presledki, dokler se prašek ne raztopi.
Nucala can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines.
Zdravilo Nucala lahko zmanjša število napadov astme, če že jemljete ali vaš otrok že jemlje zdravila - na primer visokoodmerne inhalatorje - pa astme kljub temu nimate dobro urejene.
• You may notice a small drop of blood at the injection site.
• Na mestu injiciranja se lahko pojavi majhna kapljica krvi.
EDTA disodium dihydrate Water for injections
Dinatrijev edetat dihidrat Voda za injekcije
• Continue to hold the pen down until you hear the 2nd “click”, and the stopper and yellow indicator have stopped moving and fill the inspection window.
• Še naprej držite peresnik pritisnjen, dokler ne zaslišite drugega "klika" in dokler se zamašek in rumeni indikator ne nehata premikati ter napolnita okence za ogled.
The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Primarni opazovani dogodek je bilo odstotno zmanjšanje dnevnega odmerka PKS (20. do 24. teden) ob vzdrževanju urejenosti astme glede na opredeljene kategorije zmanjšanja odmerka (glejte preglednico 4).
The solution for injection can be stored between 2°C to 30°C for no more than 8 hours.
Raztopina za injiciranje je lahko shranjena pri temperaturi od 2 °C do 30 °C največ 8 ur.
In monkeys, mepolizumab had no effect on pregnancy or on embryonic/fetal and postnatal development (including immune function) of the offspring.
Pri opicah mepolizumab ni vplival na brejost, razvoj zarodkov/plodov ali postnatalni razvoj (vključno z imunskim delovanjem) mladičev.
Dispose 9.
Zavrzite 9.
• Gauze pad or cotton wool ball (not included) Do not perform the injection if you do not have all these.
• zloženec gaze ali kosem vate (nista priložena) Ne injicirajte zdravila, če nimate vsega tega.
The baseline mean prednisone equivalent dose was approximately 13 mg per day.
Izhodiščni povprečni prednizonu enakovredni odmerek je bil približno 13 mg na dan.
Nucala should not be used to treat acute asthma exacerbations.
Zdravila Nucala se ne sme uporabljati za zdravljenje akutnih poslabšanj astme.
The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
Med najpogostejšimi manifestacijami teh dogodkov so bile bolečine, eritem, oteklost, srbenje in pekoč občutek.
If appropriate, they will then provide training to show you or your caregiver the correct way to use Nucala.
Če je primerno, vam bosta zagotovila usposabljanje, na katerem se boste vi ali vaš negovalec naučili pravilno uporabiti zdravilo Nucala.
Any unused concentrate or solution remaining after 8 hours must be discarded.
Ves neporabljeni koncentrat oz. vso neporabljeno raztopino, ki ostane po 8 urah, je treba zavreči.
Pre-bronchodilator FEV1 (mL) at week 32
FEV1 pred bronhodilatatorjem (ml) 32. teden
• upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
• bolečine v zgornjem delu trebuha (bolečine v trebuhu ali nelagodje v zgornjem delu trebuha),
Mepolizumab inhibits the bioactivity of IL-5 with nanomolar potency by blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival of eosinophils.
Mepolizumab zavira bioaktivnost IL-5 z nanomolarno potenco tako, da blokira vezavo IL-5 na alfa-verigo IL-5 receptorskega kompleksa, izraženega na površini eozinofilnih celic; s tem zavre signalizacijo z IL-5 in zmanjša nastajanje in preživetje eozinofilcev.
Hold the pen in place to complete your injection
Držite peresnik na mestu, da boste dokončali injiciranje
Contents of the pack and other information What Nucala contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nucala
• Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown).
• Odstranite pokrovček igle z brizge tako, da ga odločno potegnete naravnost dol in iztegnete roko proč od konca igle (kot je prikazano).
Do not touch the needle.
Ne dotikajte se igle.
Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
Če je treba odmerke kortikosteroidov zmanjšati, mora biti zmanjšanje postopno in mora potekati pod nadzorstvom zdravnika.
These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days).
Po navadi se te reakcije pojavijo v nekaj urah po uporabi, v nekaterih primerih pa se lahko pojavijo pozno (tj.
As a precautionary measure, it is preferable to avoid the use of Nucala during pregnancy.
Iz previdnosti se je med nosečnostjo bolje izogniti uporabi zdravila Nucala.
Table 2 provides the results of the primary and secondary endpoints for patients treated with subcutaneous mepolizumab or placebo.
Preglednica 2 prikazuje rezultate primarnih in sekundarnih opazovanih dogodkov za bolnike, ki so dobivali mepolizumab subkutano ali placebo.
If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Če se bolnik okuži med zdravljenjem z zdravilom Nucala in se ne odzove na zdravljenje z antihelmintiki, pride v poštev začasno prenehanje zdravljenja.
Open-label extension studies in severe refractory eosinophilic asthma MEA115666 (COLUMBA), MEA115661 (COSMOS) and 201312 (COSMEX)
Odprte podaljšane študije pri težki trdovratni eozinofilni astmi MEA115666 (COLUMBA), MEA115661 (COSMOS) in 201312 (COSMEX)
Keep the skin pinched throughout your injection.
Kožo držite stisnjeno med celotnim injiciranjem.
Frequency of exacerbations requiring hospitalisation
Pogostnost poslabšanj, ki so zahtevala sprejem v bolnišnico
What Nucala is and what it is used for 2.
Kaj je zdravilo Nucala in za kaj ga uporabljamo 2.
• To start your injection, push the pen down all the way and keep it held down against your skin.
• Da boste začeli injiciranje, potisnite peresnik do konca dol in ga držite pritisnjenega na kožo.
Parasitic infections
Okužbe s paraziti
• Take the carton out of the refrigerator.
• Vzemite škatlo iz hladilnika.
There are limited pharmacokinetic data available in elderly patients (≥65 years old) across all clinical studies (N=90).
Farmakokinetičnih podatkov za starejše bolnike (≥ 65 let), je v vseh kliničnih študijah skupaj malo (N = 90).
For instructions on the reconstitution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
If you may have had a similar reaction to any injection or medicine,
Če ste morda kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo,
Ask your doctor or pharmacist for advice if necessary.
Če je treba, za nasvet prosite zdravnika ali farmacevta.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če postopek rekonstitucije preprečuje tveganje za mikrobno kontaminacijo.
These may affect up to 1 in 1,000 people: • severe allergic reactions (anaphylaxis)
Pojavijo se lahko pri največ 1 od 1.000 oseb: • hude alergijske reakcije (anafilaksija).