natgillin/translations-raw huggingface dataset:
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Aripiprazole Sandoz contains the active substance aripiprazole and is a ‘generic' and a ‘hybrid' medicine.
Zdravilo Aripiprazole Sandoz vsebuje zdravilno učinkovino aripiprazol in je „generično“ in „hibridno“ zdravilo.
Aripiprazole Sandoz is used in patients aged 15 years or over;
Zdravilo Aripiprazole Sandoz se uporablja pri bolnikih, starih 15 let ali več;
Other information about Aripiprazole Sandoz
Druge informacije o zdravilu Aripiprazole Sandoz
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Za zdravljenje maničnih epizod pri bipolarni motnji pri odraslih je priporočeni začetni odmerek 15 mg peroralno enkrat na dan, ki se jemlje samostojno ali v kombinaciji z drugimi zdravili.
Aripiprazole Sandoz is available as tablets and can only be obtained with a prescription.
Zdravilo Aripiprazole Sandoz je na voljo v obliki tablet in se izdaja le na recept.
The active substance in Aripiprazole Sandoz, aripiprazole, is an antipsychotic medicine.
Zdravilna učinkovina v zdravilu Aripiprazole Sandoz, aripiprazol, je antipsihotik.
The company carried out ‘bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Družba je izvedla študije biološke enakovrednosti, s katerimi je pokazala, da je zdravilo Aripiprazole Sandoz biološko enakovredno referenčnemu zdravilu Abilify.
What is Aripiprazole Sandoz and what is it used for?
Kaj je zdravilo Aripiprazole Sandoz in za kaj se uporablja?
Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Zdravilo Aripiprazole Sandoz se uporablja tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih, starih 13 let ali več, v obdobju do 12 tednov.
Why is Aripiprazole Sandoz approved?
Zakaj je bilo zdravilo Aripiprazole Sandoz odobreno?
How has Aripiprazole Sandoz been studied?
Kako je bilo zdravilo Aripiprazole Sandoz raziskano?
How is Aripiprazole Sandoz used?
Kako se zdravilo Aripiprazole Sandoz uporablja?
How does Aripiprazole Sandoz work?
Kako zdravilo Aripiprazole Sandoz deluje?
It is not intended to provide practical advice on how to use Aripiprazole Sandoz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Then carry on as normal, sticking to your usual injection day.
Nato pa nadaljujte kot normalno z injiciranjem na vaš običajni dan.
Clicking Clicking Stops
Klikanje Klikanje preneha
No risk factors or alternative aetiology have been reported in any of these cases.
V nobenem od teh primerov niso poročali o dejavnikih tveganja ali alternativni etiologiji.
• Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
• neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
Chronic administration of daclizumab beta at all doses increased the incidence of skin findings (compared to those observed in control animals).
Kronično dajanje daklizumaba beta pri vseh odmerkih je povečalo incidenco izsledkov na koži (v primerjavi z opaženimi pri kontrolnih živalih).
Four new serious cases of colitis confirmed by health-care professionals have been received during this period.
V tem obdobju so poročali o štirih novih resnih primerih kolitisa, ki so jih potrdili zdravstveni delavci.
Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Farmakokinetika daklizumaba beta je dobro opisana v dvoprostornem modelu z absorpcijo in izločanjem prvega reda.
• The liquid is cloudy or contains floating
• je tekočina motna ali vsebuje plavajoče
In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab beta on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Raziskovalne študije in vitro kažejo, da agregati celic mikroglije ne nastajajo kot neposredni učinek daklizumaba beta na mikroglijske celice, temveč so verjetno posledica povečanja biološke uporabnosti lokalnega IL-2.
Daclizumab beta was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Daklizumab beta so odkrili v mleku 11/14 opic v laktaciji v ravneh, ki so bile < 0,122 % ravni v serumu matere, brez neželenih učinkov pri potomcih.
Choose an injection site and wipe the skin
Izberite mesto injiciranja in kožo obrišite z
Daclizumab beta had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Daklizumab beta nima vpliva na perinatalni in postnatalni razvoj potomcev od rojstva do 6 mesecev starosti.
Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab beta in milk (for details see section 5.3).
Razpoložljivi toksikološki podatki pri doječih opicah cynomolgus kažejo na izločanje daklizumaba beta v mleko (za podrobnosti glejte poglavje 5.3).
Based on the cross-study population pharmacokinetic analysis, daclizumab beta pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Na podlagi medštudijske analize populacijske farmakokinetike na farmakokinetiko daklizumaba beta nista vplivala starost (razpon: 18 do 66 let; n = 1670) ali spol (n = 567 moških in 1103 žensk).
Do not inject into an area of the body
Ne injicirajte v predel telesa, kjer je
• The need to screen for hepatitis B and C prior to treatment initiation and to recommend patients who test positive for HBV or HCV infection to consult with a physician with expertise in the
• potrebi presejanja za hepatitis B in C pred začetkom zdravljenja in o potrebi, da se bolniki, ki imajo pozitiven test na okužbo s HBV ali HCV, posvetujejo z zdravnikom, izkušenim v
• If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can.
• Če izpustite odmerek in sta od pozabljenega odmerka minila manj kot 2 tedna, si ga injicirajte takoj, ko lahko.
There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
Izpostavljenost bolnikov, starih več kot 55 let, v kliničnih študijah z daklizumabom beta je bila omejena.
• The recommendation not to initiate treatment in patients with autoimmune disorders (other than
• priporočilu, naj se zdravljenje ne uvaja pri bolnikih z avtoimunskimi boleznimi (razen multiple
This small volume of distribution indicates that daclizumab beta is primarily confined to the vascular and interstitial spaces.
Ta majhen volumen porazdelitve kaže, da je daklizumab beta primarno omejen na ožilje in intersticijski prostor.
Section 4.8 of the SmPC has been reviewed to add the adverse reaction sarcoidosis with a frequency uncommon and the adverse reaction colitis with a frequency common.
Poglavje 4.8 SmPC-ja je bilo revidirano z dodatkom neželenega učinka sarkoidoza s pogostnostjo občasni in neželenega učinka kolitis s pogostnostjo pogosti.
In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab beta) antibodies at week 4 and approximately every 3 months thereafter.
V študiji DECIDE (glejte poglavje 5.1) so pri bolnikih testirali prisotnost protiteles proti zdravilu (daklizumab beta) v 4. tednu, nato pa približno vsake 3 mesece.
What Zinbryta is and what it is used for What you need to know before you use Zinbryta
Kaj je zdravilo Zinbryta in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta
Do not use the pen if it has been dropped or is visibly damaged.
Napolnjenega injekcijskega peresnika ne uporabljajte, če pade ali je vidno poškodovan.
Do not share the pen with anyone else to avoid giving an infection to them or getting an
Napolnjenega injekcijskega peresnika ne delite z nikomer, da ne bi od koga dobili infekcije ali da ne bi kdo dobil infekcije od vas.
Following subcutaneous administration of daclizumab beta, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Po subkutanem dajanju daklizumaba beta je bil razpon mediane časa za doseganje največje koncentracije v serumu (tmax) od 5 do 7 dni.
The absolute bioavailability of daclizumab beta 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Absolutna biološka uporabnost daklizumaba beta 150 mg, apliciranega subkutano, je bila približno 90 % na podlagi medštudijske analize populacijske farmakokinetike subkutanega in intravenskega odmerjanja.
Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
V skladu z rezultati posamičnih študij je medštudijska analiza populacijske farmakokinetike pokazala, da je izpostavljenost daklizumabu beta več kot sorazmerna z odmerkom pri subkutanem odmerku 50 mg do 100 mg, in da je sorazmerna z odmerkom v razponu subkutanega odmerka 100 mg do 300 mg.
Quickly insert the needle straight into the skin fold until the needle is fully
Iglo hitro vbodite naravnost v kožno gubo tako, da je igla povsem pod kožo.
These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and subacute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe.
Ti izsledki (suhe, rdeče izbočene kožne zaplate, v primerjavi s kontrolo, kar mikroskopsko korelira z akantozo/hiperkeratozo in subakutnim do kroničnim vnetjem) so bili opisani pretežno kot blagi do zmerni, en primer pa je bil ocenjen kot resen.
Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Daklizumab beta je humanizirano monoklonsko protitelo IgG1, ki se veže na CD25 (IL-2Rα) in prepreči vezavo IL-2 na CD25.
Daclizumab beta did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Daklizumab beta ni vplival na sposobnost razmnoževanja pri samicah in samcih opic vrste cynomolgus (AUC pri samicah in samcih do 85- oz. 100-krat večji, kot je izpostavljenost pri kliničnih odmerkih).
• Immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis)
• imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza)
• If you see blood at your injection site, wipe it off with the gauze pad and apply an
• Če na mestu injiciranja vidite kri, jo obrišite z gazo in namestite lepljiv povoj ali
Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab beta binding only to human or primate CD25.
Predklinične študije so izvedli na opicah vrste cynomolgus zaradi specifičnosti vrste pri vezavi daklizumaba beta samo na CD25 pri ljudeh ali primatih.
On the basis of the scientific conclusions for daclizumab beta the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing daclizumab beta is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za daklizumab beta odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) daklizumab beta, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
You b. c.
Videti b. c.
Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab beta is 0.212 L/day with a terminal half-life value of approximately 21 days.
Na podlagi medštudijske analize populacijske farmakokinetike je očistek daklizumaba beta 0,212 l/dan z vrednostjo končnega razpolovnega časa približno 21 dni.
In two 9 month studies conducted in cynomolgus monkeys daclizumab beta was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
V dveh 9-mesečnih študijah, izvedenih na opicah vrste cynomolgus, so daklizumab beta subkutano dajali dvakrat tedensko v odmerkih od 10 do 200 mg/kg.
As an IgG1 monoclonal antibody, daclizumab beta is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Kot monoklonsko protitelo IgG1 se pričakuje, da se daklizumab beta katabolično presnovi na peptide in aminokisline na enak način kot endogeni IgG.
Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology.
Daklizumab beta se pridobiva iz celične kulture sesalcev (NS0) s tehnologijo rekombinantne DNA.
Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab beta clearance.
Na podlagi medštudijske analize populacijske farmakokinetike je bila telesna masa vzrok za manj kot 40 % variabilnost med bolniki pri očistku daklizumaba beta.
Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab beta is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Na podlagi medštudijske analize populacijske farmakokinetike je volumen porazdelitve v stanju dinamičnega ravnovesja daklizumaba beta 6,34 l pri bolniku s telesno maso 68 kg (približno mediana ocenjenih bolnikov).
1.0 point improvement p=0.0008
izboljšanje za 1,0 točko p=0,0008
There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab beta.
Med razvojem protiteles proti zdravilu ali nevtralizirajočih protiteles in kliničnim odzivom, neželenimi učinki ali farmakodinamičnim profilom daklizumaba beta ni bilo očitne korelacije.
• Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to
• Zdravilo je priporočljivo shranjevati v nadzorovanem hladilniku med 2 °C in 8 °C v zaprti originalni škatli za zagotovitev zaščite pred svetlobo.
Within the studied regimens of daclizumab beta 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab beta exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Znotraj preučevanih režimov subkutanega odmerjanja daklizumaba beta 150 mg in 300 mg vsake 4 tedne pri bolnikih z multiplo sklerozo ni bilo jasnega razmerja med izpostavljenostjo daklizumabu beta in opazovanimi dogodki klinične učinkovitosti (ARR, lezije T2 in lezije, vidne z gadolinijem), ali izbranimi opazovanimi dogodki varnosti (resne okužbe, zmerni ali resni kožni neželeni učinki in vrednosti AST/ALT > 5-kratna ULN).
Cumulatively, 24 cases of colitis have been retrieved from clinical trials.
Kumulativno so v kliničnih preskušanjih ugotovili 24 primerov kolitisa.
At steady state, daclizumab beta mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentration-time curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
V stanju dinamičnega ravnovesja so bile vrednosti povprečne največje koncentracije v serumu (cmax), najmanjše koncentracije v serumu (cmin) in površina pod časovno krivuljo koncentracije v serumu v intervalu odmerjanja (AUCtau) daklizumaba beta približno 30 mikrogramov/ml, 15 mikrogramov/ml in 640 dan*mikrogramov/ml, s približno 40-odstotno variabilnostjo med bolniki (% CV).
Carcinogenicity studies with daclizumab beta have not been conducted.
Študij kancerogenosti z daklizumabom beta niso izvajali.
Daclizumab beta modulates IL-2 signalling by blocking CD25dependent, high-affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Daklizumab beta modulira sporočanje IL-2 z zaviranjem od CD25 odvisnega sporočanja receptorjev IL-2 z visoko afiniteto, kar povzroči višje ravni razpoložljivega IL-2 za sporočanje prek receptorjev IL-2 z zmerno afiniteto.
• Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain
• bolniki z 2 ali več recidivi v 1 letu in z 1 ali več lezij, vidno z gadolinijem, pri MR slikanju
Potential adverse reactions beyond this level are expected to be consistent with the safety profile for daclizumab beta in MS patients.
Pričakuje se, da bodo možni neželeni učinki nad to ravnijo v skladu z varnostnim profilom za daklizumab beta pri bolnikih z multiplo sklerozo.
In patients with neutralising antibodies, daclizumab beta clearance was increased on average by 19% (see section 5.2).
Pri bolnikih z nevtralizirajočimi protitelesi se je očistek daklizumaba beta povprečno povečal za 19 % (glejte poglavje 5.2).
Twelve cases of sarcoidosis confirmed by health-care professionals were reported from clinical trials cumulatively.
Kumulativno so v kliničnih preskušanjih poročali o dvanajstih primerih sarkoidoze, ki so jih potrdili zdravstveni delavci.
Daclizumab beta clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Očistek daklizumaba beta pri bolnikih, pri katerih se razvijejo nevtralizirajoča protitelesa, je bil povprečno 19 % večji (glejte poglavje 4.8
Following subcutaneous administration of daclizumab beta 150 mg every 4 weeks, steady-state serum daclizumab beta concentrations were achieved by the 4th dose and daclizumab beta accumulated to a level approximately 2.5-fold compared to a single dose.
Po subkutani uporabi daklizumaba beta 150 mg vsake 4 tedne je bilo stanje dinamičnega ravnovesja koncentracij daklizumaba beta v serumu doseženo do 4. odmerka; daklizumab beta se je akumuliral do ravni, ki je bila približno 2,5-kratnik v primerjavi z enkratnim odmerkom.
There is also a plausible mechanism of action for the development of sarcoidosis due to the immunomodulatory effects of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Obstaja tudi verjeten mehanizem delovanja za razvoj sarkoidoze zaradi imunomodulacijskih učinkov daklizumaba beta in vpletenosti daklizumaba beta v nastanek drugih imunsko posredovanih učinkov.
• Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form;
o pogovora med zdravnikom in bolnikom o tveganju za resne in potencialno smrtne poškodbe jeter in nepredvidljivi naravi takih reakcij in možnosti zamenjave zdravila v primeru, ko je raven AST ali ALT >3-krat ULN; o da bolnik razume posredovane informacije o tveganju;
Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
natrijev sukcinat, sukcinska kislina, natrijev klorid, polisorbat 80, voda za injekcije raztopina za injiciranje
Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window.
injiciranja, dokler zvok klikanja ne preneha injiciranje z mesta injiciranja, dokler zvok klikanja ne preneha in v oknu za stanje injiciranja ne zagledate zelenih kljukic.
Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Ključni učinek te modulacije poti IL-2, ki je morda povezan s terapevtskimi učinki daklizumaba beta pri multipli sklerozi, vključuje selektivni antagonizem odzivov aktiviranih celic T in ekspanzijo imunoregulacijskih naravnih celic ubijalk CD56bright, za katere se je pokazalo, da selektivno zmanjšujejo aktivirane celice T. Ti imunomodulirajoči učinki daklizumaba beta skupaj naj bi zmanjševali patologijo osrednjega živčnega sistema pri multipli sklerozi in s tem zmanjševali pojavnost recidivov in napredovanje bolezni.
Do not use Zinbryta - if you have previously had a serious allergic reaction to any form of daclizumab, or any of the other ingredients of this medicine listed in section 6.
Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta Ne uporabljajte zdravila Zinbryta - če ste že prej imeli resne alergijske reakcije na katero koli obliko daklizumaba ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Elimination As an IgG1 monoclonal antibody, daclizumab beta is not expected to undergo renal elimination.
Izločanje Kot monoklonsko protitelo IgG1 se ne pričakuje, da bi se daklizumab beta izločal skozi ledvice.
There is a plausible mechanism of action for the development of this colitis due to immunomodulatory properties of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Obstaja verjeten mehanizem delovanja za razvoj tega kolitisa zaradi imunomodulacijskih lastnosti daklizumaba beta in vpletenosti daklizumaba beta v nastanek drugih imunsko posredovanih učinkov.
• Check that the Zinbryta medicine is colourless or slightly yellow (See Figure syringe if the liquid is cloudy, or has
• Preverite, da je zdravilo Zinbryta brezbarvno ali rumenkasto (glejte sliko E).
The causal relationship between daclizumab beta and sarcoidosis is considered possible.
Vzročna povezava med daklizumabom beta in sarkoidozo velja za možno.
• Patients who had failed to respond to a full and adequate course (at least 1 year) of prior DMT treatment, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2 hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years.
DMT, ki so imeli vsaj 1 recidiv v prejšnjem letu med zdravljenjem, in vsaj 9 hiperintenzivnih lezij T2 na MR slikanju glave ali vsaj 1 lezijo, vidno z gadolinijem, ali ki so imeli nespremenjeno ali povečano stopnjo recidivov v prejšnjem letu v primerjavi s prejšnjima
• increases in body temperature (fever)
• zvišana telesna temperatura
Daclizumab beta is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Ne pričakuje se, da bi se daklizumab beta presnavljal z jetrnimi encimi, kot so izoencimi CYP (glejte poglavje 4.5).
The active substance in Zinbryta is daclizumab beta.
Učinkovina zdravila Zinbryta je daklizumab beta.
Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6.
raztopina za injiciranje (injekcija) Brezbarvna do rumenkasta, bistra do nekoliko motna tekočina s pH 6.
Daclizumab beta is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Ne pričakuje se, da bi se daklizumab beta izločal skozi ledvice ali presnavljal z jetrnimi encimi (glejte poglavje 4.2).