natgillin/translations-raw huggingface dataset:
Nervous system symptoms may include memory lapse; speech and communication difficulties; a change in your mood or behaviour; confusion or inability to control your muscles; weakness on one side of the body; vision changes; or headache.
Simptomi živčanog sustava mogu uključivati gubitak pamćenja; poteškoće u govoru i komunikaciji; promjenu raspoloženja ili ponašanja; smetenost ili nemogućnost kontroliranja mišića; slabost na jednoj strani tijela; promjene vida; ili glavobolju.
If any serious allergic or anaphylactic reaction occurs, belatacept therapy should be discontinued immediately and appropriate therapy initiated (see section 4.4).
Ako nastupi neka ozbiljna alergijska ili anafilaktička reakcija, potrebno je odmah prekinuti terapiju belataceptom i uvesti odgovarajuće liječenje (vidjeti dio 4.4).
Within the belatacept clinical program, there were 2 patients diagnosed with PML.
U sklopu kliničkog programa za belatacept u 2 bolesnika je dijagnosticiran PML.
Following administration, it is recommended that the intravenous line be flushed with infusion fluid to ensure administration of the complete dose.
Nakon primjene, preporučuje se isprati intravensku liniju infuzijskom tekućinom kako bi se osigurala primjena potpune doze.
To minimise foam formation, gently swirl and invert the vial for at least 30 seconds or until the powder is completely dissolved.
Da bi se smanjilo stvaranje pjene, nježno kružnim pokretima promućkajte i okrećite sadržaj bočice najmanje 30 sekundi ili dok se prašak potpuno ne otopi.
More detailed information on the benefits, risks, and precautions for usage of NULOJIX are described in the Summary of Product Characteristics (SmPC) for health care professionals and a package leaflet (PL) for patients.
Detaljnije informacije o koristima, rizicima i mjerama opreza kod primjene lijeka NULOJIX navedene su u Sažetku opisa svojstava lijeka za zdravstvene radnike i Uputi o lijeku za bolesnike.
Skin changes may include unexpected bruising or bleeding; brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other; a change in the size and colour of a mole; or a new skin lesion or bump.
Promjene na koži mogu uključivati neočekivane modrice ili krvarenje; smeđe ili crne kožne lezije nepravilnih rubova ili jedan dio lezije ne izgleda kao drugi dio; promjenu veličine i boje madeža; ili novu kožnu leziju ili čvorić.
Although some foam may remain on the surface of the reconstituted solution, a sufficient excess of belatacept is included in each vial to account for withdrawal losses.
Iako može zaostati nešto pjene na površini rekonstituirane otopine, u svakoj se bočici nalazi dovoljna količina belatacepta da nadoknadi gubitak zbog izvlačenja.
Uncommon abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased
Manje često abnormalni snovi, promjene raspoloženja, nedostatak pozornosti/hiperaktivni poremećaj, pojačan libido
Pack sizes: 1 vial and 1 syringe or 2 vials and 2 syringes.
Veličina pakiranja: 1 bočica i 1 štrcaljka ili 2 bočice i 2 štrcaljke.
There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
Autoimuni proces Teoretski bi liječenje belataceptom moglo povećati rizik od autoimunih procesa (vidjeti dio 4.8).
No evidence of lymphomas or preneoplastic morphologic changes was observed in either study.
Niti u jednom ispitivanju nije dokazana pojava limfoma ili preneoplastičkih morfoloških promjena.
In Study 1, one additional case of PTLD was reported in the ciclosporin group, in a patient who was EBV seropositive at the time of transplant.
U Ispitivanju 1 prijavljen je jedan dodatan slučaj PTLD-a u skupini liječenoj ciklosporinom, u bolesnika koji je u trenutku presađivanja bio seropozitivan na EBV.
Transplant recipients who are EBV seronegative or serostatus unknown should not receive belatacept (see section 4.3).
Primatelji presatka koji su seronegativni na EBV ili čiji serološki status nije poznat ne smiju primati belatacept (vidjeti dio 4.3).
To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Da bi se procijenila prisutnost neutralizirajućih protutijela, napravio se in vitro test kojim su ispitani uzorci 29 bolesnika u kojih je potvrđeno aktivno vezanje za modificiranu regiju molekule antigena 4 povezanog s citotoksičnim T limfocitima (CTLA-4); pokazalo se da 8 (27,6%) bolesnika ima neutralizirajuća protutijela.
In clinical studies with belatacept, 2 cases of PML were reported in patients receiving belatacept at doses higher than the recommended regimen.
U kliničkim ispitivanjima belatacepta zabilježena su 2 slučaja PML-a u bolesnika koji su primali belatacept u dozama višima od preporučenog režima.
Elderly patients demonstrated consistency with the overall study population for safety and efficacy as assessed by patient and graft survival, renal function, and acute rejection.
Djelotvornost i sigurnost primjene u starijih bolesnika pokazala se sukladnom onoj u ukupne ispitivane populacije na temelju preživljenja bolesnika i presatka, funkcije bubrega i akutnog odbacivanja.
Method of administration NULOJIX is for intravenous use only.
Način primjene NULOJIX je namijenjen samo za intravensku primjenu..
Of the 1209 randomized and transplanted patients in the two Phase 3 studies (see section 5.1), 761 patients continued after Year 3 in a long-term extension period for up to an additional 4 years and continued to receive the study drug according to their original treatment assignment.
Od 1209 randomiziranih bolesnika s presatkom iz dva ispitivanja faze 3 (vidjeti dio 5.1), 761 bolesnik je nakon 3. godine uključen u dugoročan produžetak ispitivanja u trajanju od najviše 4 dodatne godine, tijekom kojega je nastavio primati ispitivani lijek koji mu je izvorno dodijeljen.
No dose adjustment is recommended in patients with renal impairment or undergoing dialysis (see section 5.2).
Ne preporučuje se prilagođivati dozu u bolesnika s oštećenjem funkcije bubrega ili bolesnika na dijalizi (vidjeti dio 5.2).
In addition to EBV seronegative status, other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy, which was more commonly used to treat acute rejection in belatacept-treated patients in Phase 3 clinical studies (see section 5.1).
Uz seronegativni status na EBV, ostali poznati čimbenici rizika za PTLD uključuju citomegalovirusnu (CMV) infekciju i terapiju koja smanjuje broj T-stanica, a koja se češće koristila za liječenje akutnog odbacivanja presatka u bolesnika liječenih belataceptom u kliničkim ispitivanjima Faze III (vidjeti dio 5.1).
When reconstitution and dilution are performed under aseptic conditions, the NULOJIX infusion should be started immediately or must be completed within 24 hours of reconstitution of the powder.
Kad se rekonstitucija i razrjeđivanje provode u aseptičkim uvjetima, infuziju lijeka NULOJIX treba započeti odmah ili se mora završiti u roku od 24 sata od rekonstitucije praška.
These belatacept dosing regimens differed from those studied in renal transplant recipients (see section 5.1).
Ovi režimi s belataceptom razlikovali su se od onih koji su se ispitivali u primatelja bubrežnog presatka (vidjeti dio 5.1).
Any disease of the brain causing headache, fever, hallucinations, confusion, abnormal speech and body movement
Bilo koja bolest mozga koja uzrokuje glavobolju, vrućicu, halucinacije, smetenost, poremećaj govora i kretanja
Post-transplant lymphoproliferative disorder
Posttransplantacijska limfoproliferativna bolest
Therefore, preclinical studies conducted with abatacept have been used to support the safety of belatacept in addition to the studies conducted with belatacept.
Stoga su neklinička ispitivanja provedena s abataceptom, uz ispitivanja provedena s belataceptom, upotrijebljena kao potpora sigurnosti belatacepta.
If any serious allergic or anaphylactic reaction occurs, NULOJIX therapy should be discontinued immediately and appropriate therapy initiated.
Ako nastupi ozbiljna alergijska ili anafilaktička reakcija, terapiju lijekom NULOJIX treba odmah prekinuti i uvesti odgovarajuće liječenje.
In rats, belatacept had no undesirable effects on male or female fertility (see section 5.3).
Belatacept nije imao neželjene učinke na plodnost mužjaka i ženki štakora (vidjeti dio 5.3).
At a given dose of MMF, MPA exposure is approximately 40% higher with belatacept coadministration than with ciclosporin coadministration.
Pri danoj dozi MMF-a, izloženost MPA-u približno je 40% viša kod istodobne primjene belatacepta nego kod istodobne primjene ciklosporina.
Women should not breast-feed while on treatment with a belatacept-based regimen.
Žene ne smiju dojiti za vrijeme liječenja belataceptom.
Remove the flip off seal from the vial and wipe the top with an alcohol swab.
Uklonite aluminijsku zaštitnu kapicu s bočice i obrišite gornju površinu vatom natopljenom alkoholom.
* See section “Description of selected adverse reactions”.
“Opis odabranih nuspojava”.
In postmarketing experience, use of belatacept in conjunction with basiliximab induction, mycophenolate mofetil and corticosteroid taper to 5 mg/day by Week 6 post-transplant was associated with an increased rate of acute rejection, particularly Grade III rejection.
Nakon stavljanja lijeka u promet, primjena belatacepta u kombinaciji s uvodnom terapijom baziliksimabom te mofetilmikofenolatom i dozom kortikosteroida smanjenom na 5 mg/dan do 6. tjedna nakon presađivanja bila je povezana s povećanom stopom akutnog odbacivanja, osobito odbacivanja stupnja III.
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development at doses up to 16-fold and 19-fold a human 10 mg/kg dose based on AUC.
Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na embrionalni/fetalni razvoj pri dozama koje su, na temelju AUC, 16 i 19 puta veće od doze od 10 mg/kg koja se primjenjuje u ljudi.
EBV seronegative patients receiving immunosuppressants are at a particularly increased risk for PTLD (see sections 4.3 and 4.4).
Bolesnici seronegativni na EBV koji su primali imunosupresive imali su osobito povišen rizik od PTLD-a (vidjeti dijelove 4.3 i 4.4).
There is no data available in patients with hepatic impairment.
Nema dostupnih podataka o bolesnicima s oštećenjem funkcije jetre.
No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
Abatacept nije pokazao mutagenost ili klastogenost u bateriji in vitro ispitivanja.
Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
Posttransplantacijska limfoproliferativna bolest (PTLD) U ispitivanjima Faze II i III (3 ispitivanja), incidencija PTLD-a bila je viša u bolesnika liječenih belataceptom nego u bolesnika liječenih ciklosporinom (vidjeti dio 4.8).
Pain when passing urine, blood in the urine
Bol pri mokrenju, krv u mokraći
Every 4 weeks (± 3 days) starting at end of week 16 after transplantation
Svaka 4 tjedna (± 3 dana) počevši od kraja 16. tjedna nakon presađivanja organa
In a single Phase 2 clinical study in de novo liver transplant patients, an increase in the number of deaths was observed in 2 of 3 belatacept-containing regimens studied.
U jednom kliničkom ispitivanju Faze II u de novo bolesnika s presađenom jetrom opažen je povećan broj smrti u 2 od 3 režima u sklopu kojih se primjenjivao belatacept.
Practical details on the reconstitution of vials
Praktični detalji o rekonstituciji otopine za infuziju
The use of live vaccines should be avoided (see section 4.4).
Primjenu živih cjepiva treba izbjegavati (vidjeti dio 4.4).
In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept.
U kliničkom je ispitivanju nakon početne primjene belatacepta bilo opaženo približno 90% zasićenosti CD86 receptora na površini stanica koje predočuju antigene u perifernoj krvi.
In general, these events occurred early and the majority resulted in graft loss.
Tromboza presatka općenito bi rano nastupila i uglavnom rezultirala gubitkom presatka.
It is unknown whether belatacept is excreted in human milk (see section 5.3).
Nije poznato izlučuje li se belatacept u majčino mlijeko (vidjeti dio 5.3).
In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
U kliničkim ispitivanjima, primatelji presađenog organa liječeni betalaceptom s EBV seronegativnim statusom imali su povišen rizik od PTLD-a u usporedbi s onima koji su bili seropozitivni na EBV (7,7% ili 7/91 seronegativnih nasuprot 0,7% ili 6/810 seropozitivnih).
Serious infections Serious infections can happen with NULOJIX treatment and can lead to death.
Ozbiljne infekcije Za vrijeme liječenja lijekom NULOJIX mogu se razviti ozbiljne infekcije i dovesti do smrti.
Abnormal swelling of the brain, increased pressure inside the skull and brain, seizure, weakness causing loss of movement on one side of the body, loss of the covering around nerves, inability of muscles to move in the face
Abnormalno oticanje mozga, povišen tlak u lubanji i mozgu, epileptički napadaji, slabost koja uzrokuje gubitak pokreta na jednoj strani tijela, gubitak ovojnice oko živaca, nesposobnost pomicanja mišića lica
Study 1 excluded (1) recipients undergoing a first transplant whose current PRA were ≥50%; (2) recipients undergoing a retransplantation whose current PRA were ≥30%; (3) recipients when previous graft loss was due to acute rejection and in case of a positive T-cell lymphocytotoxic cross match.
U ispitivanje 1 nisu bili uključeni (1) primatelji koji su prvi puta podvrgnuti presađivanju i čiji je trenutni PRA bio ≥ 50%; (2) primatelji podvrgnuti ponovnom presađivanju čiji je trenutni PRA bio ≥ 30%; (3) primatelji u kojih je prethodni gubitak presatka bio posljedica akutnog odbacivanja te primatelji s pozitivnim nalazom na limfocitotoksičnost T-stanica u testu križne reakcije.
Allergic reactions related to belatacept use have been reported in the clinical studies.
Alergijske reakcije povezane s primjenom belatacepta zabilježene su u kliničkim ispitivanjima.
In addition to PTLD, patients receiving immunosuppressive regimens, including belatacept, are at increased risk of malignancies, including skin cancer (see section 4.8).
Uz PTLD, bolesnici koji primaju imunosupresivnu terapiju, uključujući belatacept, imaju povišen rizik od zloćudnih bolesti, uključujući rak kože (vidjeti dio 4.8).
This medicinal product contains 0.65 mmol or 15 mg sodium per vial.
Ovaj lijek sadrži 0,65 mmol ili 15 mg natrija po bočici.
As an increased risk of PML and of other infections has been associated with high levels of overall immunosuppression, the recommended doses of belatacept and concomitant immunosuppressives, including MMF or MPA, should not be exceeded (see section 4.5).
Kako je povećan rizik od PML-a i drugih infekcija povezan s visokim razinama ukupne imunosupresije, belatacept i istovremeno primjenjivani imunosupresivi, uključujući MMF ili MPA, ne smiju se davati u dozama koje su veće od preporučenih (vidjeti dio 4.5).
Do not use NULOJIX if you notice any particles or discolouration in the reconstituted or diluted solution.
NULOJIX se ne smije upotrijebiti ako primijetite čestice ili promjenu boje pripremljene ili razrijeđene otopine.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i kutiji iza „Rok valjanosti“ ili kratice EXP.
The use of live vaccines should be avoided (see section 4.5).
Primjenu živih cjepiva treba izbjegavati (vidjeti dio 4.5).
For Studies 1 and 2 at Years 1 and 3, belatacept was associated with 6 to 9 mmHg lower mean systolic blood pressure, approximately 2 to 4 mmHg lower mean diastolic blood pressure, and less use of antihypertensive medicinal products than ciclosporin.
Ispitivanjima 1 i 2 u 1. i 3. godini belatacept je, u usporedbi s ciklosporinom, bio povezan sa 6 do 9 mm Hg nižim prosječnim sistoličkim krvnim tlakom, približno 2 do 4 mm Hg nižim prosječnim dijastoličkim krvnim tlakom te manjom uporabom antihipertenzivnih lijekova.
Abnormal collection of fluid
Abnormalno nakupljanje tekućine.
The solution for infusion may be stored for a maximum of 4 hours of the total 24 hours below 25°C.
Otopina za infuziju može se čuvati najviše 4 sata od ukupno 24 sata na temperaturi ispod 25°C.
Number of vials required equals the belatacept dose in mg divided by 250 rounded up to the next full number of vials.
Broj potrebnih bočica jednak je dozi belatacepta u mg podijeljenoj s 250 zaokruženo na sljedeći cijeli broj bočica.
During clinical studies, there was no dose modification of belatacept for a change in body weight of less than 10%.
Doza belatacepta se za vrijeme kliničkih ispitivanja nije prilagođivala u slučaju promjene tjelesne težine manje od 10%.
Physicians should consider PTLD in the differential diagnosis in patients with new or worsening neurologic, cognitive or behavioural signs or symptoms.
Liječnici trebaju uzeti u obzir PTLD u sklopu diferencijalne dijagnoze u bolesnika s novim ili pogoršavajućim neurološkim, kognitivnim ili bihevioralnim znakovima ili simptomima.
Constipation, diarrhoea, nausea, vomiting, abdominal pain High blood pressure, low blood pressure
Zatvor, proljev, mučnina, povraćanje, bol u trbuhu Visok krvni tlak, niski krvni tlak
Acute rejection (AR) occurred more frequently with belatacept versus ciclosporin in Study 1 and with similar frequency with belatacept versus ciclosporin in Study 2.
Akutno odbacivanje bilo je češće uz belatacept nego uz ciklosporin u Ispitivanju 1, dok je u Ispitivanju 2 bilo jednako često uz belatacept i ciklosporin.
At Month 1, 4, and 6 post-transplant, the mean (range) trough concentrations of belatacept were 22.7 (11.1-45.2), 7.6 (2.1-18.0), and 4.0 (1.5-6.6) μg/ml, respectively.
U 1., 4. odnosno 6. mjesecu nakon presađivanja, prosječne (raspon) najniže koncentracije belatacepta bile su 22,7 (11,1-45,2), 7,6 (2,1-18,0) odnosno 4,0 (1,5-6,6) μg/ml.
Volume of the reconstituted solution required (ml) equals total belatacept dose in mg divided by 25.
Volumen rekonstituirane potrebne otopine (ml) jednak je ukupnoj dozi belatacepta u mg podijeljenoj s 25.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001-002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/694/001-002
MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/694/001
A single, randomised, multi-center, controlled Phase 2 trial of belatacept in de novo orthotopic liver transplant recipients was conducted.
Provedeno je jedno randomizirano, multicentrično, kontrolirano ispitivanje belatacepta Faze II u de novo primatelja ortotopičnog presatka jetre.
Physicians should consider PML in the differential diagnosis in patients with new or worsening neurologic, cognitive or behavioural signs or symptoms.
Liječnici trebaju uključiti PML u diferencijalnu dijagnozu u bolesnika s pojavom novih ili pogoršanjem postojećih neuroloških, kognitivnih ili bihevioralnih znakova ili simptoma.
Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 4.2).
Ukupna doza belatacepta u mg jednaka je tjelesnoj težini bolesnika u kg pomnoženoj s dozom belatacepta u mg/kg (5 ili 10 mg/kg, vidjeti dio 4.2).
Cases of PTLD varied by serostatus.
2. Slučajevi PTLD-a razlikovali su se prema serološkom statusu.
This medicine contains 0.65 mmol (or 15 mg) sodium per vial which corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of three vials.
Ovaj lijek sadrži 0,65 mmol (ili 15 mg) natrija po bočici, što odgovara 1,95 mmol (ili 45 mg) natrija po maksimalnoj dozi od tri bočice.
Uncommon acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular
Manje često akutni koronarni sindrom, atrioventrikularni blok drugog stupnja, bolest aortalne valvule, supraventrikularna aritmija
Poor blood flow to the heart, blocked heart beats, abnormal aorta heart valve, abnormal rapid heart rate
Slab dotok krvi u srce, blokirani otkucaji srca, abnormalni aortalni srčani zalistak, abnormalno ubrzan rad srca
The other case of PML was reported in a liver transplant recipient in a Phase 2 trial who received 6 months of treatment with an augmented belatacept MI regimen, MMF at doses higher than the recommended dose and corticosteroids (see section 4.4).
Drugi slučaj PML-a bio je zabilježen u primatelja presatka jetre u ispitivanju Faze II koji je 6 mjeseci primao pojačani MI režim belatacepta, MMF u dozama višima od preporučene i kortikosteroide (vidjeti dio 4.4).
Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients with 4 to 6 human leukocyte antigen (HLA) mismatches (see sections 4.4 and 5.1)
Postupno smanjivanje doze kortikosteroida u bolesnika koji primaju belatacept treba provoditi uz oprez, osobito u bolesnika s 4 do 6 nepodudarnih humanih leukocitnih antigena (HLA) (vidjeti dijelove 4.4 i 5.1).
Remove the syringe and needle after 10.5 ml of reconstitution fluid has been added to the vial.
Izvadite iglu i štrcaljku nakon što ste u bočicu dodali 10,5 ml otapala za rekonstituciju.
In a six-month and one-year toxicity study in cynomolgus monkeys with belatacept and abatacept, respectively, no significant toxicity was observed.
U ispitivanju toksičnosti belatacepta u trajanju od 6 mjeseci i abatacepta u trajanju od 1 godine u makaki majmuna nije bila primijećena značajna toksičnost.
Dose modification of NULOJIX is not recommended for a change in body weight of less than
Ne preporučuje se prilagođivati dozu lijeka NULOJIX kod promjene tjelesne težine manje od
Burning sensation
Osjećaj žarenja
Patients on controlled sodium diet
Bolesnici na dijeti s kontroliranim unosom natrija
In the 3 studies (one Phase 2 and two Phase 3 studies, Study 1 and Study 2), the cumulative frequency of PTLD was higher in belatacept treated patients at the recommended dosing regimen (LI) (1.3%; 6/472) than in the ciclosporin group (0.6%; 3/476), and was highest in the belatacept MI group (1.7%; 8/477).
U 3 ispitivanja (jednom ispitivanju Faze II i dva ispitivanja Faze III, Ispitivanju 1 i Ispitivanju 2), kumulativna učestalost PTLD-a bila je viša u bolesnika liječenih belataceptom u preporučenom režimu doziranja (LI) (1,3%; 6/472) nego u bolesnika liječenih ciklosporinom (0,6%; 3/476), a najviša je bila u skupini liječenoj belataceptom prema MI režimu (1,7%; 8/477).
Minimal systemic accumulation of belatacept occurred upon multiple infusions of 5 or 10 mg/kg doses in renal transplant patients every 4 weeks.
Sistemsko nakupljanje belatacepta bilo je minimalno nakon višestrukih infuzija doza od 5 ili 10 mg/kg svaka 4 tjedna u bolesnika s bubrežnim presatkom.
See leaflet for shelf-life after reconstitution and dilution.
Pogledajte Uputu o lijeku za rok valjanosti nakon rekonstitucije i razrjeđivanja.