natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with Simponi in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Simponi za eno ali več skupin pediatrične populacije z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB.
• Pri bolnikih, zdravljenih z zdravilom Simponi, so poročali o primerih TB, v redkih primerih celo pri bolnikih, ki so prejemali zdravila za zdravljenje TB.
The prescribed volume of injection should be selected according to patient's height and weight as shown in Table 1.
Predpisano količino za injiciranje je treba izbrati glede na bolnikovo telesno višino in telesno maso, kot je prikazano v preglednici 1.
• Melanoma (a type of skin cancer)
• melanom (vrsta kožnega raka),
Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Izberite dve različni mesti za injiciranje (npr. ena injekcija v desno stegno in druga injekcija v levo stegno) in si injicirajte injekciji eno za drugo.
Mean change in SPARCC
Povprečna sprememba seštevka SPARCC
Turn plunger until the dose line for your prescribed dose lines up with the dose selection notch.
Obračajte bat, dokler ni črta odmerka za vaš predpisani odmerek poravnana z zarezo za izbiro odmerka.
baseline = week 0 “n” reflects enrolled patients
izhodišče = teden 0 “n”: število vključenih bolnikov
It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any vaccine.
Pomembno je, da otrokovim zdravnikom in drugim zdravstvenim delavcem poveste za vašo uporabo zdravila Simponi, da bodo lahko presodili, kdaj sme vaš otrok prejeti katero koli cepivo.
Physicians global assessment of disease (VAS
Splošna ocena aktivnosti bolezni s strani zdravnika (VAS
Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
To zdravilo zavrzite, če ga ne uporabite do novega datuma izteka roka uporabnosti ali datuma izteka roka uporabnosti, natisnjenega na škatli, kar nastopi prej.
7% 15% p = 0.021 NA
7 % 15 % p = 0,021 NA NA
Week 24 28% 60%*
24. teden 28 % 60 %*
At week 16, patients entered an open label period in which all patients received Simponi 50 mg administered subcutaneously every 4 weeks through week 48 with efficacy assessments performed through week 52 and safety follow-up through week 60.
V 16. tednu so bolniki vstopili v obdobje odprtega zdravljenja, v katerem so vsi bolniki prejemali 50 mg zdravila Simponi subkutano vsake 4 tedne do 48. tedna z ocenjevanjem učinkovitosti do 52. tedna in spremljanjem varnosti do 60. tedna.
The orange needle guard will lock, and you will not receive the full dose.
Oranžen ščitnik igle se bo zaklenil in ne boste prejeli celotnega odmerka.
Efficacy evaluation in the study extension was based on changes in corticosteroid use, Physician's Global Assessment (PGA) of disease activity, and improvement in quality of life as measured by Inflammatory Bowel Disease Questionnaire (IBDQ).
Ocena učinkovitosti v podaljšanju študije je temeljila na spremembah glede uporabe kortikosteroidov, zdravnikovi splošni oceni (Physician's Global Assessment - PGA) aktivnosti bolezni ter izboljšanju kakovosti življenja, merjenim z vprašalnikom IBDQ (Inflammatory Bowel Disease Questionnaire).
If multiple injections are required, the injections should be administered at different sites on the body.
Če je potrebnih več injekcij, jih je treba dati na različna mesta na telesu.
Some of these reactions occurred after the first administration of golimumab.
Nekatere od teh reakcij so nastopile že po prvi uporabi golimumaba.
• You may cover the injection site with a small adhesive bandage, if necessary.
• Mesto injiciranja lahko prekrijete z majhnim samolepilnim obližem, če je potrebno.
The use of Simponi in pregnant women is not recommended.
Uporaba zdravila Simponi pri nosečnicah ni priporočljiva.
GO-FORWARD Active RA despite MTX
GO-FORWARD aktiven RA kljub prejemanju metotreksata
* Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
* Humano monoklonsko protitelo IgG1κ, ki ga izdelujejo v celični liniji mišjega hibridoma s pomočjo tehnologije rekombinantne DNA.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of golimumab, and in accordance with local recommendations.
V primeru diagnoze neaktivne ("latentne") tuberkuloze je pred uvedbo golimumaba potrebno začeti zdravljenje latentne tuberkuloze s protituberkulozno terapijo, ter v skladu z lokalnimi priporočili.
In both the AT and OSI populations, the improvements in signs and symptoms, spinal mobility, physical function, quality of life, and productivity observed at week 16 among patients treated with Simponi 50 mg continued in those remaining in the study at week 52.
Pri obeh populacijah, AT in OSI, so se izboljšanja znakov in simptomov, gibljivosti hrbtenice, telesne funkcije, kakovosti življenja in produktivnosti, ki so jih opazili v 16. tednu pri bolnikih, ki so se zdravili z zdravilom Simponi 50 mg, nadaljevala tudi pri tistih, ki so ostali v študiji v 52. tednu.
• When you are ready to inject, hold the body of the pre-filled syringe with one hand.
• Ko ste pripravljeni za injiciranje zdravila, držite trup napolnjene injekcijske brizge z eno roko.
At week 48, children entered a long-term extension.
V 48. tednu so otroke vključili v dolgoročno podaljšano študijo.
However, population pharmacokinetic analysis indicated that concomitant use of NSAIDs, oral corticosteroids or sulfasalazine did not influence the apparent clearance of golimumab.
Vendar je analiza populacijske farmakokinetike pokazala, da sočasna uporaba nesteroidnih antirevmatikov, peroralnih kortikosteroidov ali sulfasalazina ni vplivala na navidezni očistek golimumaba.
In general these elevations were asymptomatic and the abnormalities decreased or resolved with either continuation or discontinuation of golimumab or modification of concomitant medicinal products.
Na splošno so bila ta zvišanja asimptomatična in nenormalne vrednosti so se zmanjšale ali vrnile na normalo bodisi ob nadaljnjem zdravljenju, po ukinitvi golimumaba ali po spremembi sočasno predpisanih zdravil.
• Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.
• Zdravljenje z zaviralci TNF, kot je zdravilo Simponi, lahko pri bolnikih, ki so nosilci tega virusa, povzroči reaktivacijo HBV, kar je lahko v nekaterih primerih življenjsko nevarno.
Latex sensitivity
Občutljivost za lateks
If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
V primeru suma na latentno tuberkulozo se je treba posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
Storage information Store in refrigerator at 2° to 8°C.
Informacije o shranjevanju Shranjujte v hladilniku pri temperaturi od 2 do 8 °C.
Where golimumab use is described by dose, the median duration of follow-up varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may have switched between doses.
Kjer je uporaba golimumaba opredeljena z odmerkom, je mediano trajanje spremljanja bolnikov spremenljivo (približno 2 leti za odmerek 50 mg in približno 3 leta za odmerek 100 mg), saj so bolniki morda prehajali med odmerki.
Simponi belongs to a group of medicines called ‘TNF blockers'.
Zdravilo Simponi spada v skupino zdravil, imenovanih "zaviralci TNF".
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following golimumab administration.
V okviru izkušenj v obdobju trženja so poročali o resnih sistemskih preobčutljivostnih reakcijah (vključno z anafilaktično reakcijo) po uporabi golimumaba.
Do not administer a second dose without speaking to your doctor.
Ne smete si dati drugega odmerka, ne da bi se posvetovali z zdravnikom.
If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy.
Če ste zdravilo Simponi prejemali v času nosečnosti, lahko pri vašem dojenčku obstaja večje tveganje, da dobi takšno okužbo še približno šest mesecev po tem, ko ste v nosečnosti prejeli zadnji odmerek tega zdravila.
Previous treatment with an anti-TNF agent was not allowed.
Prejšnje zdravljenje z zaviralci TNF pa ni bilo več dovoljeno.
• Store in a refrigerator (2°C-8°C).
• Shranjujte v hladilniku (2 °C - 8 °C).
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
Ženske v rodni dobi morajo uporabljati ustrezno kontracepcijo za preprečevanje nosečnosti, in sicer še vsaj 6 mesecev po zadnjem zdravljenju z golimumabom.
Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage.
Ko se zdravilo Simponi enkrat shranjuje na sobni temperaturi, se ga ne sme vrniti nazaj v hladilnik.
• Pain and discolouration in the fingers or toes
• bolečine in obarvanje prstov na rokah ali nogah,
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Pri tistih bolnikih, ki imajo pozitiven izvid na okužbo z virusom HBV, je priporočljiv posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
• Depression
• depresija,
The primary endpoint, the proportion of children who were ACR Ped 30 responders at week 16 and who did not experience a flare between week 16 and week 48, was not achieved.
Primarni opazovani dogodek, opredeljen kot delež otrok z odzivom ACR Ped 30 v 16. tednu ter brez ponovnega zagona bolezni med 16. in 48. tednom, ni bil dosežen.
The presence of antibodies to golimumab may increase the risk of injection site reactions.
Prisotnost protiteles proti golimumabu lahko poveča tveganje za reakcije na mestu injiciranja.
ACR 50 Week 14 10% 35%*
ACR 50 14. teden 10 % 35 %*
Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn.
Ker je golimumab zaviralec TNF, bi lahko njegova uporaba v času nosečnosti vplivala na normalen imunski odziv pri novorojenčku.
*: Observed with other TNF-blocking agents.
*: Opaženo pri drugih zaviralcih TNF.
Responders, % of patients ASAS 20
Odzivni, % bolnikov ASAS 20
1.1 Prior to Simponi treatment:
1.1 Pred zdravljenjem z zdravilom Simponi:
Do not warm the pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
Napolnjene injekcijske brizge ne smete segrevati na noben drug način (na primer v mikrovalovni pečici ali v vroči vodi).
Height (cm)
Telesna višina (cm)
The next dose should be administered based on the following guidance:
Pri naslednjem odmerku je treba upoštevati naslednja navodila:
Neoplasms, benign, malignant and unspecified
Benigne, maligne in neopredeljene novotvorbe
What you need to know before you use Simponi
Kaj morate vedeti, preden boste uporabili zdravilo Simponi
If this happens, do not ride bicycles, drive or use any tools or machines.
Če se vam to zgodi, ne vozite kolesa, ne upravljajte vozil in orodij ali strojev.
Keep pushing the pre-filled pen against the skin for approximately 5 seconds.
Napolnjen injekcijski peresnik še naprej pritiskajte na kožo približno 5 sekund.
• If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in se zdravite z zdravilom Simponi, vas mora zdravnik skrbno spremljati.
• Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
• Pri bolnikih s hudim revmatoidnim artritisom in drugimi vnetnimi boleznimi, ki imajo bolezen že dolgo, je tveganje za pojav limfoma lahko večje od povprečja.
In addition, levels of TNF- were reduced in RA and AS patients and levels of IL-8 were reduced in PsA patients.
Poleg tega so bile koncentracije TNF- zmanjšane pri bolnikih z RA in AS, koncentracije IL-8 pa so bile zmanjšane pri bolnikih s PsA.
• A reminder to patients to show the Patient Reminder Card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Simponi.
• Opomnik za bolnike, da morajo pokazati opozorilno kartico za bolnika vsem zdravstvenim delavcem, ki sodelujejo pri zdravljenju (tudi v nujnih stanjih) ter sporočilo za zdravstvene delavce, da bolnik uporablja zdravilo Simponi.
Lymphoma and leukaemia
Limfom in levkemija
In GO-BEFORE, major clinical response, defined as the maintenance of an ACR 70 response over a continuous 6-month period, was measured.
V študiji GO-BEFORE so merili velik klinični odziv, ki je bil opredeljen kot ohranjanje odziva ACR 70 skozi neprekinjeno obdobje 6 mesecev.
Week 24 14% 37%* Week 52 NA NA NA
24. teden 14 % 37 %* 52. teden NA NA
Colon dysplasia/carcinoma
Displazija/karcinom kolona
Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Golimumab je humano monoklonsko protitelo, ki z veliko afiniteto tvori stabilne komplekse tako s topnimi kot s transmembranskimi bioaktivnimi oblikami človeškega TNF-α, kar preprečuje vezavo TNF-α na njegove receptorje.
Ask your doctor to record the type and date of the last screening(s) for TB below: Test _______________
Zdravnika prosite, naj na spodnje črte vpiše vrsto in datum zadnjega presejalnega testiranja na TB:
Simponi is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group.
Zdravilo Simponi ni priporočljivo za otroke, mlajše od 2 let, s poliartikularnim juvenilnim idiopatskim artritisom, ker zdravilo pri tej skupini ni bilo raziskano.
If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away.
Če ste bivali ali potovali na območjih, kjer so pogoste okužbe s posebno vrsto gliv, ki lahko prizadenejo pljuča ali druge dele telesa (histoplazmoza, kokcidioidomikoza ali blastomikoza), morate o tem nemudoma obvestiti zdravnika.
Terminal half-life value was estimated to be approximately 12  3 days in healthy subjects and similar values were observed in patients with RA, PsA, AS, or UC.
Vrednost končne razpolovne dobe zdravila so ocenili na približno 12 ± 3 dni pri zdravih preiskovancih, podobne vrednosti pa so dobili tudi pri bolnikih z RA, PsA, AS ali UK.
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
• zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa pri odraslih, ki predhodno niso bili zdravljeni z MTX.
• If you use Simponi or other TNF blockers, your risk for developing lymphoma or another cancer may increase.
• Med uporabo zdravila Simponi ali drugih zaviralcev TNF se pri vas lahko poveča tveganje za nastanek limfoma ali druge vrste raka.
Potential for medication errors
Možnost napak pri zdravljenju
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB06
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB06
Blood disease
Bolezni krvi
Week 14 Week 24
14. teden 24. teden
The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Relativno pomanjkanje TNF, ki ga povzroči zdravljenje z zaviralci TNF, lahko vodi do sprožitve avtoimunskega procesa.
• Check the expiration date and the security seal
• Preverite datum izteka roka uporabnosti in varnostni pečat.
• 1 Alcohol swab
• 1 alkoholni zloženec
In patients with newly diagnosed dysplasia treated with golimumab, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.
Pri bolnikih z novo diagnosticirano displazijo, zdravljenih z golimumabom, je treba skrbno pregledati tveganja in koristi za posameznega bolnika in razmisliti, ali naj se zdravljenje nadaljuje.
• You should not receive certain (live) vaccines while using Simponi.
• Med uporabo zdravila Simponi ne smete dobiti določenih (živih) cepiv.
Simponi, in combination with methotrexate (MTX), is indicated for:
Revmatoidni artritis (RA) Zdravilo Simponi v kombinaciji z metotreksatom (MTX) je indicirano za:
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Vse bolnike z ulceroznim kolitisom, ki imajo večje tveganje za displazijo ali karcinom kolona (npr. bolnike z dolgotrajnim ulceroznim kolitisom ali primarnim sklerozirajočim holangitisom) ali imajo anamnezo displazije ali karcinoma kolona, je treba pred zdravljenjem in med potekom bolezni v rednih intervalih spremljati glede displazije.
• Back of upper arms (if a caregiver is giving you the injection) Choose a different site within your preferred area for each injection.
• zadnjo stran nadlakti (če vam injekcijo daje oseba, ki skrbi za vas) Za vsako injiciranje izberite drugo mesto na izbranem predelu za injiciranje.
Side effects of which the frequency is not known: • A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)
Neželeni učinki neznane pogostnosti: • redka vrsta krvnega raka, ki prizadene predvsem mlade ljudi (jetrnovranični T-celični limfom).
The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Kombiniranje golimumaba z drugimi biološkimi zdravili za zdravljenje enakih bolezni, kot jih zdravimo z golimumabom, vključno z anakinro in abataceptom, ni priporočljivo (glejte poglavje 4.4).
Your doctor will also give you a Patient Reminder Card, which contains important safety information you need to be aware of before and during your treatment with Simponi.
Zdravnik vam bo dal opozorilno kartico za bolnika, ki vsebuje pomembne podatke o varnosti, s katerimi morate biti seznanjeni pred in med zdravljenjem z zdravilom Simponi.
Among patients who entered the study extension, the proportion of subjects who remained corticosteroid free was generally maintained through week 216.
Med bolniki, ki so bili vključeni v podaljšano študijo, se je delež tistih, ki niso uporabljali kortikosteroidov, v splošnem ohranil do 216. tedna.
If you have hearing problem, count 15 seconds from the time you first press the button and then lift the pre-filled pen from the injection site.
Če imate težave s sluhom in ne slišite drugega ‘klika', štejte 15 sekund od prvega pritiska na gumb in potem dvignite napolnjeni injekcijski peresnik z mesta injiciranja.
Other medicines and Simponi
Druga zdravila in zdravilo Simponi
In GO-AFTER, the percentage of patients achieving an ACR 20 response was greater for patients receiving Simponi than for patients receiving placebo regardless of the reason reported for discontinuation of one or more prior anti-TNF therapies.
V študiji GO-AFTER je bil odstotek bolnikov, ki so dosegli odziv ACR 20, večji pri bolnikih, ki so prejemali zdravilo Simponi kot pri tistih, ki so prejemali placebo, ne glede na prijavljen razlog za ukinitev enega ali več prej uporabljenih zaviralcev TNF.
However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Pri starejših je potrebna previdnost pri zdravljenju, še posebej glede pojava okužb.
The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professional(s) treating the patient about ongoing treatment with the product.
Kartica je namenjena beleženju datumov in rezultatov določenih preiskav kot tudi lažji izmenjavi posebnih informacij glede trenutnega zdravljenja z zdravilom med bolnikom in zdravstvenim(i) delavcem(i), ki sodeluje(jo) pri zdravljenju bolnika.
Liver enzyme elevations
Zvišanje jetrnih encimov
CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
ŠKATLA ZA VEČKRATNO PAKIRANJE S 3 ZAVOJČKI (VKLJUČNO Z MODRIM OKENCEM)
Among patients who received Simponi maintenance treatment, the improvement in quality of life as measured by IBDQ was maintained through week 54.
Med bolniki, ki so prejemali vzdrževalno zdravljenje z zdravilom Simponi, se je izboljšanje kakovosti življenja, merjeno z IBDQ, ohranilo do 54. tedna.
Check the window - a yellow indicator confirms proper administration (see figure 9)
Poglejte v okence - rumeni kazalnik potrdi pravilno uporabo napolnjenega injekcijskega peresnika (glejte sliko 9)
In patients who develop HBV reactivation, golimumab should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, pri katerih pride do reaktivacije HBV, je treba golimumab ukiniti in jim uvesti učinkovito protivirusno terapijo ob ustreznem podpornem zdravljenju.
• If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection.
• če ste prejeli zdravilo Simponi med nosečnostjo, lahko pri dojenčku obstaja večje tveganje za okužbo.
A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).
Študija vpliva na plodnost pri miših z uporabo analognega protitelesa, ki selektivno zavira funkcionalno delovanje mišjega TNFα, ni pokazala nobenih pomembnih učinkov na plodnost (glejte poglavje 5.3).
The following additional side effects have been observed with Simponi: Very common side effects (may affect more than 1 in 10 people):
Pri uporabi zdravila Simponi so opažali naslednje dodatne neželene učinke: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Within the designated system organ classes, the ARs are listed under headings of frequency and 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 (< 1/10,000); not known (cannot be estimated from the available data).
Neželeni učinki za navedene organske sisteme so podani po posameznih kategorijah pogostnosti v skladu z naslednjim dogovorom: 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), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother's last golimumab injection during pregnancy (see sections 4.4 and 4.5).
Dajanje živih cepiv dojenčkom, ki so bili izpostavljeni golimumabu in utero, ni priporočljivo še 6 mesecev po zadnji injekciji golimumaba, ki jo je mati prejela v času nosečnosti (glejte poglavji 4.4 in 4.5).