natgillin/translations-raw huggingface dataset:
Prior to launch of Cyltezo in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom trženja zdravila Cyltezo se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načinom razdeljevanja in drugimi vidiki programa.
Adalimumab should only be used during pregnancy if clearly needed.
Adalimumab se med nosečnostjo lahko uporablja samo, če je brez dvoma
The European Medicines Agency has deferred the obligation to submit the results of the studies with adalimumab 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 adalimumabom za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
The conduct and results of these tests should be recorded on your patient alert card.
Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici za bolnike.
The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 %,
Ustrezni deleži bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
Adalimumab has not been studied in these patient populations.
Adalimumaba pri tej populaciji bolnikov niso preučili.
Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali pri njih ni bilo izboljšanja, so bili izključeni iz študij in so se šteli kot bolniki brez odgovora (“nonresponders”).
The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Bolniki v študijah HS-I in HS-II imajo po Hurleyevi razvrstitvi bolezen v stadiju II ali III z vsaj tremi abscesi ali vnetnimi noduli.
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Cyltezo.
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Cyltezo preiskal glede znakov in simptomov tuberkuloze.
If you received Cyltezo while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Če prejemate zdravilo Cyltezo med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
Your doctor may recommend temporary discontinuation of
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe
Clear to slightly opalescent solution.
Bistra do rahlo opalescentna raztopina.
• After proper training, the injection can be given by yourself or given by another person, for example, a
• Ko ste bili ustrezno poučeni, si lahko zdravilo injicirate sami ali vam ga injicira druga oseba, na
The Guide for healthcare professionals shall contain the following key elements:
Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
The impact of long-term treatment with Cyltezo on the development of autoimmune diseases is unknown.
Vpliv dolgoročnega zdravljenja z zdravilom Cyltezo na nastanek avtoimunskih bolezni ni znan.
If an alternate dose is required, other adalimumab products offering such an option should be used.
Če je potreben drugačen odmerek, je potrebno uporabiti druga zdravila z adalimumabom, ki ponujajo to možnost.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in
Patients may first be given other disease-modifying medicines, such as methotrexate.
Bolniki bodo morda najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
• Only use each pre-filled syringe for one injection.
• Vsako napolnjeno injekcijsko brizgo uporabite le za eno injiciranje.
Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 Paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Razpoložljivi podatki kažejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred
If you do not have all the supplies listed above, contact your pharmacist before proceeding.
Če nimate vseh zgoraj naštetih pripomočkov, se pred nadaljevanjem obrnite na farmacevta.
There is a window on each side of the pen through which you can see the Cyltezo solution inside the syringe.
Na vsaki strani peresnika je okence, skozi katerega vidite raztopino zdravila Cyltezo v brizgi.
You should not take Cyltezo with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Zdravila Cyltezo ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
It is important to tell your doctor if you have had or have a serious heart condition.
Pomembno je, da obvestite zdravnika, če ste imeli ali imate kakšno resno bolezen srca.
Treatment with Cyltezo can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Zdravljenje z zdravilom Cyltezo se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
You will inject into this raised area of • Before injecting, read steps 8 A-C to learn correct way to administer dose.
Injicirali boste v ta • Pred injiciranjem preberite točke od A do C v 8. koraku, da boste spoznali pravilen način za
The decision to stop using Cyltezo should be discussed with your doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Cyltezo, se morate posvetovati z zdravnikom.
A. Prepare to administer dose
A. Pripravite se na injiciranje odmerka
The potential risk with the combination of azathioprine or 6-mercaptopurine and Cyltezo should be carefully considered.
Potrebno je upoštevati možno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila Cyltezo.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Tarča adalimumaba je beljakovina imenovana tumorje nekrotizirajoči faktor (TNFα), ki je pri zgoraj navedenih vnetnih boleznih prisotna v večji koncentraciji.
Before initiation of therapy with Cyltezo, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Pred začetkom zdravljenja z zdravilom Cyltezo je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
• opportunistic infections (which include tuberculosis and other infections that occur when resistance to
• oportunistične okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni
• Do not touch this area again before injecting.
• Pred injiciranjem se tega mesta ne dotaknite znova.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Od 417 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 46 bolnikov neprimernih (npr. razvili so se sekundarni zapleti, ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is
Pri bolnikih, ki so pozitivni na okužbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okužb s hepatitisom B.
Some side effects observed with adalimumab may not have symptoms and may only be discovered through
Nekateri neželeni učinki, opaženi pri adalimumabu, nimajo simptomov in se jih lahko odkrije le pri
8) Before injecting, read steps A-C to learn correct way to administer dose.
8) Pred injiciranjem preberite točke od A do C, da boste spoznali pravilen način za dovajanje odmerka
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih, pri enaki ravni izpostavljenosti.
Percent of patients achieving PASI75 response was calculated as centre-adjusted rate
Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center.
• Cyltezo should only be used during a pregnancy if needed.
• Zdravilo Cyltezo se med nosečnostjo lahko uporablja samo, če je potrebno.
These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning).
Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije, druge oportunistične okužbe (nenavadne okužbe, povezane z oslabljenim imunskim sistemom) in sepso (zastrupitev krvi).
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Cyltezo (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Cyltezo posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediana časa do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA "zmerno" ali slabše) je bil približno 5 mesecev.
Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Med temi je bilo 109 oseb (63,7 %) po 10 letih v
After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Po korekciji za razlike v telesni masi se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
Then take your next dose as you would have on your originally scheduled day, had you not
Nato uporabite naslednji odmerek, kot bi ga uporabili po prvotnem urniku injiciranja, če ne bi pozabili
The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Koristi in tveganja nadaljevanja zdravljenja s 40 mg vsak teden ali 80 mg vsak drugi teden je treba ponovno natančno pretehtati pri bolniku z nezadostnim odzivom na zdravljenje po povečanju odmerka (glejte poglavje 5.1).
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Cyltezo.
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Cyltezo.
The MAH shall ensure that in each Member State where Cyltezo is marketed, all healthcare professionals who are expected to prescribe Cyltezo have are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, kjer se zdravilo Cyltezo trži, zagotoviti, da bodo vsi zdravstveni delavci, ki bodo zdravilo Cyltezo predpisovali, prejeli izobraževalno gradivo, ki ga sestavljata:
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni sklepov, ki se običajno najprej pojavi v otroštvu.
Patients on Cyltezo may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo zdravilo Cyltezo, lahko sočasno dobijo cepiva, razen živih cepiv.
• Do not select tender, bruised, or scarred areas.
• Ne izberite občutljivega, poškodovanega ali brazgotinastega predela.
In CD Study III, at week 4, 58 % (499/854) of patients were in clinical response and were assessed in the primary analysis.
V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
40 mg every other week in combination with methotrexate - Not applicable.
40 mg vsak drugi teden v kombinaciji z metotreksatom - Navedba smiselno ni potrebna.
Adalimumab is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Adalimumab se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Cyltezo treatment.
• Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Cyltezo.
o Press injection button once (you should hear a ‘click' that indicates the start of injection) and keep pen pressed firmly against skin while you slowly count to 10.
Gumb za injiicranje se bo odklenil in bo o Enkrat pritisnite gumb za injiciranje (zaslišali boste "klik", ki predstavlja začetek injiciranja) in peresnik držite močno pritisnjen na kožo, medtem ko počasi štejete do 10. o Med injiciranjem peresnika ne premikajte.
The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3 %/61.3 %/38.7 % and 83.3 %/73.3 %/36.7 %, respectively.
Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
Gather supplies onto clean, flat surface: a.
Pripomočke zberite na čisti, ravni površini:
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6 % versus 4.3 %, respectively [p = 0.014]).
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA "čisto" ali "skoraj čisto" za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0,014]).
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition
• imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje kot stanje,
The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7 %) was higher than for those under 65 years of age (1.5 %).
Pogostost resnih okužb je bila pri bolnikih starejših od 65 let, ki so prejemali adalimumab, večja (3,7 %) kot pri bolnikih mlajših od 65 let (1,5 %).
Week 26 Placebo-Controlled
26. teden Kontrolirana s placebom
Thus, it is not possible to administer Cyltezo to paediatric patients that require less than a full 40 mg dose.
Zato zdravila Cyltezo ni mogoče dajati pediatričnim bolnikom, ki potrebujejo odmerek, nižji od 40 mg.
Placebo/MTXAdalimumab/MTX (95 % Confidence Interval p-value
placebo/MTXadalimumab/MTX (95-% interval zaupanja vrednost p
Thus additional caution should be exercised in considering Cyltezo treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Cyltezo pri teh bolnikih (glejte poglavje 4.8).
The active ingredient in Cyltezo, adalimumab, is a monoclonal antibody.
Učinkovina v zdravilu Cyltezo, adalimumab, je monoklonsko protitelo.
If you take Cyltezo the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo Cyltezo, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Cyltezo treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cyltezo is indicated.
Zdravljenje z zdravilom Cyltezo mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Cyltezo indicirano.
Treatment with Cyltezo should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom Cyltezo se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
This evaluation should include colonoscopy and biopsies per
Takšna ocena mora vključevati kolonoskopijo in biopsije v skladu z lokalnimi priporočili.
• Hold pen straight up from injection site (at a 90 degree angle).
• Peresnik držite pravokotno na mesto injiciranja (pod kotom 90 stopinj).
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
• avtoimuni hepatitis (vnetje jeter, ki ga povzroči lastni imunski sistem);
• oedema (a build up of fluid in the body which causes the affected tissue to swell); • reduction in blood platelets which increases risk of bleeding or bruising;
• edem (nakopičenje tekočine v telesu, ki povzroči oteklino prizadetega tkiva); • zmanjšanje števila krvnih ploščic, kar poveča tveganje krvavitev ali podplutb;
• If you receive Cyltezo during your pregnancy, your baby may have a higher risk for getting an
• Če prejmete zdravilo Cyltezo med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček
Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 2, 2, 4 or 6 alcohol pads, respectively.
Eno pakiranje vsebuje 1, 2, 4 oz. 6 napolnjenih injekcijskih brizg za bolnikovo uporabo z 2, 2, 4 oz. 6 alkoholnimi zloženci.
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah III in V je bil dodaten primarni opazovani dogodek po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Preglednica 19: Študija pri psoriazi IV - rezultati učinkovitosti po 16, 26 in 52 tednih
Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Številke so bile v korist adalimumaba za večino podocen s statistično značilno povprečno razliko za splošni vid, očesno bolečino, vid na blizu, duševno zdravje in skupen rezultat v študiji UV I, ter za splošni vid in duševno zdravje v študiji UV II.
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult
Na splošno so bili neželeni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neželenim učinkom, opaženih pri odraslih bolnikih.
At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
• Always keep “sharps” container out of sight and reach of children.
• Vsebnik za ostre predmete vedno hranite zunaj dosega otrok.
The primary efficacy endpoint was the proportion of patients with no flare by week 68 of the study.
Primarni opazovani dogodek kot merilo učinkovitosti je bil delež bolnikov brez ponovnega zagona bolezni do 68. tedna študije.
Plunger should reach bottom of syringe.
Bat mora doseči dno
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Cyltezo in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot
O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Cyltezo razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
You should continue to inject Cyltezo for as long as your doctor has told you.
Nadaljevati morate z injiciranjem zdravila Cyltezo tako dolgo, kot vam je naročil zdravnik.
It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Cyltezo.
Za otroke je priporočljivo, da dobijo vsa cepiva, načrtovana za njihovo starost, pred začetkom zdravljenja z zdravilom Cyltezo, če je le mogoče.
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se izteče na zadnji dan
Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Med 250 osebami, ki so zaključile podaljšano odprto študijo, se je izboljšanje telesne funkcije ohranilo
People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rakom, ki prizadene limfatični sistem) in levkemijo (rak, ki prizadene kri in kostni mozeg).