natgillin/translations-raw huggingface dataset:
However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013. 
Vendar države članice niso mogle doseči soglasja, zato je španska regulativna agencija za zdravila 31. oktobra 2013 zadevo napotila na odbor CHMP v arbitražo.
This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Germany and the Netherlands). 
To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Španija) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Belgiji, Nemčiji in na Nizozemskem).
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has been shown. 
Na podlagi ocene trenutno razpoložljivih podatkov in interne znanstvene razprave je odbor CHMP zaključil, da je bila biološka enakovrednost z referenčnim zdravilom dokazana.
Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months. 
Tibolon je vrsta učinkovine za hormonsko nadomestno zdravljenje (HNZ), ki se uporablja za lajšanje simptomov menopavze (kot so na primer navali vročine) pri ženskah, pri katerih je od zadnje naravne menstruacije minilo najmanj 12 mesecev.
On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Tibolona Aristo and Tibocina. 
Evropska agencija za zdravila je dne 19. decembra 2013 zaključila arbitražni postopek, potem ko so države članice Evropske unije (EU) izrazile nestrinjanje glede odobritve zdravil Tibolona Aristo in Tibocina.
This means that storage conditions could potentially have been inadequate leading to the degradation of the active substance, making the samples inadequate for testing. 
To pomeni, da so bili morda pogoji shranjevanja neustrezni, kar bi lahko povzročilo degradacijo zdravilne učinkovine, to pa bi pomenilo, da vzorci niso bili primerni za preskušanje.
Germany considered that these data were not reliable because of failings in the way the study samples were identified and registered and the cold storage and transport of the samples were recorded. 
Nemčija je predvsem menila, da omenjeni podatki niso zanesljivi zaradi pomanjkljivosti v načinu identifikacije in registracije preiskovanih vzorcev ter dokumentiranja njihovega shranjevanja v hladilnici in prenosa.
The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study. 
Družba je predložila dodatne dokaze o tem, da so bili preiskovani vzorci ves čas shranjeni pri ustreznih temperaturnih pogojih, kar so potrdile tudi koncentracije, ki so jih zabeležili v študiji biološke enakovrednosti.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks, and the marketing authorisations can be granted in Spain and in the following Member States of the EU: Belgium, Germany and the Netherlands. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje v okviru agencije, je zaključil, da so koristi zdravil Tibolona Aristo in Tibocina večje od z njima povezanih tveganj in da se dovoljenji za promet lahko odobrita v Španiji in naslednjih državah članicah EU: v Belgiji, Nemčiji in na Nizozemskem.
The grounds for the referral were objections raised by Germany about the data submitted to show that Tibolona Aristo and Tibocina were ‘bioequivalent' to the reference medicine, Liviella. 
Podlaga za napotitev so bili pomisleki Nemčije glede predloženih podatkov, ki naj bi dokazovali, da sta zdravili Tibolona Aristo in Tibocina „biološko enakovredni“ referenčnemu zdravilu Liviella.
Tibolona Aristo and Tibocina are generic medicines based on a ‘reference medicine', Liviella, which is authorised in Germany. 
Zdravili Tibolona Aristo in Tibocina sta generični zdravili, ki temeljita na „referenčnem zdravilu“, imenovanem Liviella, ki je že odobreno v Nemčiji.
The CHMP therefore concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks and recommended that the marketing authorisations be granted in the concerned Member States. 
Odbor CHMP je zato zaključil, da so koristi zdravil Tibolona Aristo in Tibocina večje od z njima povezanih tveganj, in priporočil, da se odobri dovoljenje za promet s tema zdraviloma v zadevnih državah članicah.
Why were Tibolona Aristo and Tibocina reviewed? 
Zakaj sta bili zdravili Tibolona Aristo in Tibocina pregledani?
What are Tibolona Aristo and Tibocina? 
Kaj sta zdravili Tibolona Aristo in Tibocina?
Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure. 
Družba Aristo Pharma GmbH je španski regulativni agenciji za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravili Tibolona Aristo in Tibocina.
Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg). 
Tibolona Aristo in Tibocina sta zdravili, ki vsebujeta zdravilno učinkovino tibolon.
Patients should be monitored for at least one hour after the first infusion for any reactions. 
Bolnike je treba spremljati najmanj eno uro po prvi infuziji zaradi morebitnih reakcij.
If a reaction occurs, the infusion should be stopped and patients should receive appropriate treatment. 
Če pride do reakcije, je treba infuzijo prekiniti in bolnikom zagotoviti ustrezno zdravljenje.
Further information on Trogarzo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trogarzo. 
Nadaljnje informacije o zdravilu Trogarzo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/trogarzoema.europa.eu/medicines/human/EPAR/tro garzo.
What measures are being taken to ensure the safe and effective use of Trogarzo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trogarzo?
Treatment is started with a single infusion of 2,000 mg followed by 800 mg every 2 weeks; if treatment is interrupted, it should be restarted in the same way. 
Zdravljenje se začne z enkratnim infundiranjem v jakosti 2 000 mg, čemur sledi 800-miligramski odmerek vsaka dva tedna; če se zdravljenje prekine, je treba ponovno začeti na enak način.
The European Medicines Agency therefore decided that Trogarzo's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Trogarzo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Overall, the safety profile of Trogarzo was considered to be acceptable. 
Na splošno se je varnostni profil zdravila Trogarzo štel za sprejemljivega.
Although the studies submitted were small and did not include a direct comparison with other medicines, the results indicate that adding Trogarzo to other medicines could control the virus in these patients. 
Čeprav so bile predložene študije majhne in ne vključujejo neposredne primerjave z drugimi zdravili, rezultati kažejo, da bi lahko dodajanje zdravila Trogarzo drugim zdravilom omogočilo nadzor nad virusom pri teh bolnikih.
Other information about Trogarzo 
Druge informacije o zdravilu Trogarzo
In patients with multi-drug resistant HIV, treatment options are limited and there is therefore an unmet medical need in this group. 
Pri bolnikih z multirezistentnim virusom HIV so možnosti zdravljenja omejene, zato v tej skupini obstaja neizpolnjena zdravstvena potreba.
As for all medicines, data on the use of Trogarzo are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Trogarzo stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trogarzo have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Trogarzo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Trogarzo are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Trogarzo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Trogarzo have been shown in studies? 
Kakšne koristi zdravila Trogarzo so se pokazale v študijah?
The most common side effects with Trogarzo (which may affect up to 1 in 10 patients) are rash, diarrhoea, dizziness, headache, nausea (feeling sick), vomiting and tiredness. 
Najpogostejši neželeni učinki zdravila Trogarzo (ki se lahko pojavijo pri največ 1 bolniku od 10) so izpuščaj, driska, omotica, glavobol, navzeja (siljenje na bruhanje), bruhanje in utrujenost.
Why is Trogarzo authorised in the EU? 
Zakaj je bilo zdravilo Trogarzo odobreno v EU?
For more information about using Trogarzo, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Trogarzo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Trogarzo and why it is authorised in the EU 
Pregled zdravila Trogarzo in zakaj je odobreno v EU
What are the risks associated with Trogarzo? 
Kakšna tveganja so povezana z zdravilom Trogarzo?
Treatment should be started and monitored by a doctor who is experienced in the treatment of HIV infection. 
Zdravljenje lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
The company that markets Trogarzo will carry out a study to confirm the benefits of treatment with Trogarzo in patients with multi-drug resistant HIV infection. 
Podjetje, ki trži zdravilo Trogarzo, bo izvedlo študijo za potrditev koristi zdravljenja s tem zdravilom pri bolnikih z multirezistentno okužbo z virusom HIV.
What is Trogarzo and what is it used for? 
Kaj je zdravilo Trogarzo in za kaj se uporablja?
Trogarzo is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi-drug resistant HIV). 
Daje se skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, kadar nobena od standardnih kombinacij ne deluje za nadzor nad okužbo, ker je virus odporen proti njim (multirezistentni virus HIV).
Similar effects were seen in a second main study with 113 adults, where 44% of patients who had maintenance doses of Trogarzo added to standard treatment had undetectable HIV levels after 25 weeks. 
Podobni učinki so bili opaženi v drugi glavni študiji s 113 odraslimi, saj je imelo po 25 tednih 44 % bolnikov, pri katerih so k standardnemu zdravljenju dodajali vzdrževalne odmerke zdravila Trogarzo, nezaznavne ravni virusa HIV.
By attaching to CD4, ibalizumab prevents the virus from entering the T-cells and reproducing, thereby slowing down the spread of infection. 
Ibalizumab z vezavo na receptorje CD4 preprečuje, da bi virus vstopil v celice T in se razmnoževal, zaradi česar upočasni širjenje okužbe.
Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Trogarzo je zdravilo za zdravljenje odraslih bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Trogarzo does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Trogarzo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
Trogarzo is available as a solution for infusion (drip) into a vein. 
Zdravilo Trogarzo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
In a main study that included 40 adults with multi-drug resistant HIV whose HIV treatment was failing, levels of HIV virus in the blood were undetectable (fewer than 50 copies/ml) in 43% of patients after 25 weeks of combining standard treatment with Trogarzo. 
V glavni študiji, v katero je bilo vključenih 40 odraslih z multirezistentnim virusom HIV, katerih zdravljenje okužbe s tem virusom HIV je bilo neuspešno, so bile po 25 tednih kombiniranega standardnega zdravljenja z zdravilom Trogarzo ravni virusa HIV v krvi nezaznavne (manj kot 50 kopij/ml) pri 43 % bolnikov.
For the full list of side effects and restrictions with Trogarzo, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trogarzo glejte navodilo za uporabo.
How does Trogarzo work? 
Kako zdravilo Trogarzo deluje?
The active substance in Trogarzo, ibalizumab, is a monoclonal antibody (a type of protein) designed to attach to CD4, a receptor (target) found on the surface of immune cells called T cells. 
Učinkovina v zdravilu Trograzo, ibalizumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na CD4, tj. receptor (prijemališče) na površini imunskih celic, imenovanih celice T. Celice T so glavno prijemališče za virus HIV, ki ga uporabi kot gostitelja za razmnoževanje.
How is Trogarzo used? 
Kako se zdravilo Trogarzo uporablja?
Trogarzo taken with other HIV medicines was shown to be effective at reducing viral load (blood levels of HIV virus) in patients with multi-drug resistant HIV, that is, where standard HIV combination treatments have failed to suppress levels of HIV in the blood sufficiently. 
Dokazano je bilo, da je zdravilo Trogarzo, ki se jemlje skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, učinkovito pri zniževanju virusnega bremena (ravni virusa HIV v krvi) pri bolnikih z multirezistentnim virusom HIV.
Some of these reactions may be serious or life-threatening. 
Nekatere od teh reakcij so lahko resne ali življenjsko nevarne.
• Your doctor will want to closely monitor your heart. 
• Zdravnik bo skrbno spremljal vaše srce.
Some of these patients have been under 50 years of age. 
Nekateri od teh bolnikov so bili tudi mlajši od 50 let.
If you are 65 or older, you have a greater risk. 
Če ste stari 65 let ali več, je to tveganje večje.
EXP EXP, if not refrigerated ___________________ 
EXP EXP izven hladilnika___________________
These children must be 6 years of age or older. 
Otroci morajo biti stari 6 let ali starejši.
Adults (≥ 18 years) 
Odrasli bolniki (≥ 18 let)
PASI 75 response** 
Odziv PASI 75**
Efficacy has been demonstrated with or without concomitant use of methotrexate. 
Učinkovitost so dokazali z ali brez sočasne uporabe metotreksata.
Other special considerations are discussed below. 
Druge posebnosti so obravnavane v nadaljevanju.
The median CDAI score was 180. 
Mediana vrednost rezultata po CDAI je bila 180.
• Improve your physical function. 
• izboljšanje telesne sposobnosti.
• Depression, problems sleeping 
• depresija, težave s spanjem
The information above also applies to children and adolescents. 
Otroci in mladostniki Zgoraj navedene informacije veljajo tudi za otroke in mladostnike.
Allow the reconstituted solution to stand for 5 minutes. 
Rekonstituirana raztopina naj stoji 5 minut.
This type of cancer has usually resulted in death. 
Ta vrsta raka je bila običajno smrtna.
Nearly 50% of reported deaths have been associated with infection. 
Skoraj 50 % poročanih primerov smrtnega izida je bilo povezanih z okužbo.
Check that the solution is colourless to light yellow and opalescent. 
Preverite, ali je raztopina brezbarvna do svetlo rumena in opalescentna.
In particular, tell your doctor if you are using any of the following medicines: 
Še posebej povejte zdravniku, če uporabljate katero od naslednjih zdravil:
The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear. 
Morebitni prispevek izpostavljenosti infliksimabu in/ali resnost obstoječe bolezni pri teh izidih ostajata nejasna.
• Blood test result showing ‘antibodies' against your own body. 
• rezultati krvnih preiskav, ki kažejo "protitelesa" proti lastnemu telesu
List of other medicines: 
Seznam ostalih zdravil:
(% of patients) 
(% bolnikov)
• Eye problems, including red eyes and infections 
• težave z očmi, vključno z rdečimi očmi in okužbami
Radiographic changes were assessed in IMPACT 2. 
Spremembe na rentgenskih slikah so ocenjevali v študiji IMPACT2.
The median duration of response was 12 weeks. 
Mediano trajanje odziva je bilo 12 tednov.
Fistula Response (%) Complete fistula response (%) 
Odziv fistule (%) Popoln odziv fistule (%)
No serious infusion reactions were reported. 
Resnih infuzijskih reakcij ni bilo.
In addition: 
Poleg tega še:
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening 
• huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko življenjsko nevarna
Pregnancy and Vaccinations 
Nosečnost in cepljenja
Telephone number doctor: 
Telefonska številka zdravnika:
Reduction in CDAI ≥ 25% and ≥ 70 points. 
Zmanjšanje CDAI na ≥ 25 % oziroma ≥ 70 točk.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established. 
Dodatno so poročali o zlomu kosti (6,8 %), vendar vzročna povezava ni bila dokazana.
For more information see section on Pregnancy and breast-feeding. 
Za več informacij glejte poglavje o Nosečnosti in dojenju.
These infections are caused by specific types of fungi that can affect the lungs or other parts of your body. 
Te okužbe povzročajo posebne vrste gliv, ki lahko prizadenejo pljuča ali druge dele telesa.
The median terminal half-life at these doses ranged from 8 to 9.5 days. 
Mediani končni razpolovni čas po teh odmerkih je znašal od 8 do 9,5 dni.
It is important that you and your doctor record the brand name and batch number of your medicine. 
Pomembno je, da si vi in zdravnik zabeležita ime in številko serije vašega zdravila.
• The table below shows how often you will usually have this medicine after your first dose. 
• V spodnji preglednici je prikazano, kako pogosto boste običajno prejemali to zdravilo po prvem odmerku.
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. 
Priporočljivo je periodično pregledovanje kože, predvsem pa za tiste bolnike z dejavniki tveganja za kožnega raka.
• In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding. 
• Pri nekaterih bolnikih, ki prejemajo zdravilo Remicade, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
(anaphylactic shock) 
(anafilaktični šok)
Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed. 
Poleg tega so opazili tudi zmanjšanje uporabe kortikosteroidov in izboljšanje kakovosti življenja.
• in combination with methotrexate 
• v kombinaciji z metotreksatom
Serious infections were reported in 12% (7/60) of all treated patients. 
O resnih okužbah so poročali pri 12 % (7/60) vseh zdravljenih bolnikov.
If acute infusion reactions occur, the infusion must be interrupted immediately. 
Če se pojavi akutna z infuzijo povezana reakcija, morate infuzijo takoj prekiniti.
In ASPIRE, more than 90% of patients had at least two evaluable X-rays. 
V študiji ASPIRE je imelo več kot 90 % bolnikov najmanj dve uporabni rentgenski sliki.
Instructions for use and handling - storage conditions 
Navodila za uporabo in ravnanje z zdravilom - pogoji shranjevanja
An allergic reaction could happen within 2 hours of your injection or later. 
Alergijska reakcija lahko nastopi v času 2 ur po injekciji pa tudi kasneje.
* including bovine tuberculosis (disseminated BCG infection), see section 4.4 
* vključno z bovino tuberkulozo (razsejano okužbo BCG), glejte poglavje 4.4
• Medicines that affect your immune system. 
• Zdravila, ki vplivajo na vaš imunski sistem
All infusion reactions were mild or moderate in intensity. 
Vse infuzijske reakcije so bile blage ali zmerne.
This evaluation should include colonoscopy and biopsies per local recommendations. 
Med te teste sodijo na primer kolonoskopija in biopsije, v skladu z lokalnimi priporočili.
Use of live vaccines can result in clinical infections, including disseminated infections. 
Uporaba živih cepiv lahko povzroči klinične okužbe, vključno z razsejanimi okužbami.
Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26. 
Bolniki z oceno PGA ≥ 3 so lahko prejeli dodatno infuzijo iste terapije v 26. tednu.
Talk to your doctor if you are on a low salt diet. 
Posvetujte se z zdravnikom, če ste na dieti z zmanjšanim vnosom soli.
ACR response (% of patients) 
Odziv ACR (% bolnikov)
Week 26 All randomised patients 
26. teden vsi randomizirani bolniki
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2 IMPACT 
Preglednica 9 Učinki na ACR in PASI v študijah IMPACT in IMPACT 2 IMPACT
These medicines may cause side effects. 
Ta zdravila lahko povzročijo neželene učinke.
• Lack of interest or emotion 
• pomanjkanje interesa ali čustev
The patient reminder card shall contain the following key messages: 
Opozorilna kartica za bolnika mora vsebovati naslednja pomembna sporočila:
A low proportion of the infusion reactions was serious allergic reactions. 
Majhen odstotek z infuzijo povezanih reakcij so predstavljale hude alergijske reakcije.
Write the new expiry date on the carton including day/month/year. 
Na škatlo napišite novi rok uporabnosti, ki vključuje dan/mesec/leto.
There was no difference between groups in the number of late responders thereafter. 
Potem ni bilo več nobene razlike med skupinama glede števila bolnikov s poznim odzivom.
Date of latest renewal: 2 July 2009. 
Datum prve odobritve: 13. avgust 1999 Datum zadnjega podaljšanja: 2. julij 2009
Janssen Biotech Inc., 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, United States of America 
Janssen Biotech Inc. 200 Great Valley Parkway Malvern, Pennsylvania 19355-1307, Združene države Amerike
If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again. 
Če ste prekinili zdravljenje z zdravilom Remicade za več kot 16 tednov, obstaja večje tveganje za pojav alergijskih reakcij ob ponovni uvedbi zdravljenja.
Discuss the use of contraception during this time with your doctor. 
Glede uporabe kontracepcije med tem časom se posvetujte z zdravnikom.
All patients had a history of heavy smoking. 
Vsi bolniki so imeli v anamnezi močno kajenje.
The available clinical experience is limited. 
Na voljo je malo kliničnih izkušenj.
The interval between the last maintenance dose and the first re-induction dose ranged from 35-231 days. 
Časovni razmik med zadnjim vzdrževalnim odmerkom zdravila in prvim odmerkom pri ponovni uporabi uvodne sheme je bil od 35 do 231 dni.
Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period. 
Ker lahko izločanje infliksimaba traja do šest mesecev, morate bolnika spremljati ves ta čas.
It is used in adults for the following inflammatory diseases: 
Uporablja se za zdravljenje naslednjih vnetnih bolezni pri odraslih:
After reconstitution and dilution: 
Po rekonstituciji in redčenju:
• Cancer in children and adults 
• rak pri otrocih in odraslih