FrancophonIA/ELRC3.0 huggingface dataset:
English: The magnitude of this relative risk is similar to that found in previous studies of desogestrel/gestodene OCs when compared with LNG-OCs.
Slovenian: Obseg tega relativnega tveganja je podoben obsegu, opaženem v prejšnjih študijah peroralnih kontracepcijskih sredstev z dezogestrelom/gestodenom v primerjavi s peroralnimi kontracepcijskimi sredstvi, ki vsebujejo levonorgestrel.
English: With the submission of the responses to the CHMP list of questions, the MAH changed the request for the indication and reverted to the indication as follows: “Treatment of moderate acne vulgaris only in women seeking oral contraception”.
Slovenian: Ob predložitvi odgovorov na seznam vprašanj odbora CHMP je imetnik dovoljenja za promet spremenil zahtevo za indikacijo in tako obnovil besedilo indikacije: „Zdravljenje zmernih vulgarnih aken samo pri ženskah, ki potrebujejo peroralno kontracepcijo.“ Odbor CHMP je presodil vse razpoložljive podatke glede na zadnje uporabljeno besedilo indikacije.
English: The CHMP was requested to give its opinion on whether the overall risk-benefit profile for Ethinylestradiol-Drospirenone 24+4 in the proposed indication was considered acceptable, particularly in light of the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)COCs, and initiated the procedure in July 2011.
Slovenian: Odbora CHMP sta zaprosili za mnenje, ali splošni profil med koristmi in tveganji zdravila Ethinylestradiol-Drospirenone 24+4 pri predlagani indikaciji velja za sprejemljivega, zlasti ob upoštevanju znanega večjega tveganja za venske trombembolične dogodke pri uporabi kombiniranih peroralnih kontracepcijskih sredstev z drospirenonom v primerjavi s kombiniranimi peroralnimi kontracepcijskimi sredstvi, ki vsebujejo levonorgestrel (LNG).
English: The CHMP noted that other treatment options are available for the treatment of acne alone.
Slovenian: Omenil je tudi, da so na voljo druga zdravila, namenjena samo zdravljenju aken,
English: With regard to breast cancer risk, published data showed that the current use of combined OCs is associated with a relative risk (RR) of 1.24 (95 % confidence interval 1.15-1.33).
Slovenian: V zvezi s tveganjem za raka dojke so objavljeni podatki pokazali, da je trenutna uporaba kombiniranih peroralnih kontracepcijskih sredstev povezana z relativnim tveganjem (RT) 1,24 (95-odstotni interval zaupanja 1,15-1,33).
English: Therefore, it remains of concern the potential for unnecessary exposure to EE/DRSP for prolonged periods for the acne indication alone and that the proposed activities for risk minimisation are insufficient to ensure use of EE/DRSP for the acne indication only by women seeking oral contraception.
Slovenian: Zato ostaja skrb vzbujajoče, da bodo morda bolnice dalj časa po nepotrebnem izpostavljene kombinaciji etinilestradiola in drospirenona samo zaradi indikacije aken ter da predlagane dejavnosti za obvladovanje tveganja niso dovolj, da bi zagotovile uporabo etinilestradiola in drospirenona za indikacijo aken samo pri ženskah, ki potrebujejo peroralno kontracepcijo.
English: This is an important factor which needs to be considered when selecting an oral contraceptive and may preclude EE/DRSP-COCs to be regarded as a first choice for contraception, in clinical practice.
Slovenian: To je pomemben dejavnik, ki ga je treba upoštevati pri izbiri peroralnega kontracepcijskega sredstva ter ki lahko prepreči, da bi kombinirana peroralna kontracepcijska sredstva z etinilestradiolom in drospirenonom v klinični praksi veljala za prvo izbiro pri kontracepciji.
English: • The Committee considered the known safety profile of EE/DRSP in particular the higher risk associated with VTE in comparison to other available OCs.
Slovenian: • Odbor je upošteval znani varnostni profil kombinacije etinilestradiola in drospirenona, zlasti večje tveganje, povezano z venskimi trombemboličnimi dogodki, v primerjavi z drugimi peroralnimi kontracepcijskimi sredstvi, ki so na voljo na trgu;
English: The most recent review by the Pharmacovigilance Working Party (PhVWP) concluded in January 2012, confirmed that DRSP-containing OCs are associated with a higher VTE risk than levonorgestrel-containing COCs and that the risk may be similar to that for desogestrel/gestodenecontaining COCs.
Slovenian: Na podlagi najnovejšega pregleda, ki ga je Delovna skupina za farmakovigilanco (PhVWP) zaključila januarja 2012, je bilo potrjeno, da so peroralna kontracepcijska sredstva z vsebnostjo drospirenona povezana z večjim tveganjem za venske trombembolične dogodke kot kombinirana peroralna kontracepcijska sredstva z vsebnostjo levonorgestrela ter da je tveganje morda podobno kot pri kombiniranih peroralnih kontracepcijskih sredstvih z vsebnostjo dezogestrela in gestodena.
English: The CHMP considered the MAH proposed measures for risk minimisation not sufficient to ensure the safe and effective use of EE/DRSP in the specific applied clinical situation.
Slovenian: Odbor CHMP je menil, da ukrepi za obvladovanje tveganja, ki jih je predlagal imetnik dovoljenja za promet, v praksi ne zadoščajo za zagotovitev varne in učinkovite uporabe etinilestradiola/drospirenona v teh specifičnih kliničnih okoliščinah.
English: The safety profile of EE/DRSP - COCs in the approved indication is well known.
Slovenian: Varnostni profil kombiniranih peroralnih kontracepcijskih sredstev, ki vsebujejo etinilestradiol in drospirenon, za odobreno indikacijo je dobro znan.
English: In this regard, a recent safety review performed in January 2012 by the Pharmacovigilance working party, confirmed that DRSP-containing OCs are associated with a higher VTE risk than levonorgestrel-containing OCs and that the risk may be similar to that for desogestrel/gestodenecontaining OCs.
Slovenian: V zvezi s tem je najnovejša analiza varnosti, ki jo je januarja 2012 opravila Delovna skupina za farmakovigilanco, potrdila, da so peroralna kontracepcijska sredstva z vsebnostjo drospirenona povezana z večjim tveganjem za venske trombembolične dogodke kot peroralna kontracepcijska sredstva z vsebnostjo levonorgestrela, ter da je tveganje morda podobno kot pri peroralnih kontracepcijskih sredstvih z vsebnostjo dezogestrela in gestodena.
English: a) the known greater risk of venous thromboembolic events (VTE) for DRSP-COCs in comparison with levonorgestrel (LNG)-COCs;
Slovenian: a) znanega večjega tveganja za venske trombembolične dogodke pri uporabi kombiniranih peroralnih kontracepcijskih sredstev z drospirenonom v primerjavi s kombiniranimi peroralnimi kontracepcijskimi sredstvi z levonorgestrelom;
English: With regard to the VTE risk associated with EE/DRSP-COCs, the EURAS study (European led study) could not exclude a small difference in VTE risk between drospirenone and other combined OCs.
Slovenian: Študija EURAS (študija pod evropskim vodstvom) v zvezi s tveganjem za venske trombembolične dogodke, povezanim s kombiniranimi peroralnimi kontracepcijskimi sredstvi z etinilestradiolom in drospirenonom, ni mogla izključiti majhne razlike v venskih trombemboličnih dogodkih med drospirenonom in drugimi kombiniranimi peroralnimi kontracepcijskimi sredstvi.
English: Moreover, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Slovenian: Poleg tega je tveganje za raka dojke večje pri ženskah, ki so začele uporabljati peroralno kontracepcijo pred 20. letom, v primerjavi s tistimi, ki so začele pozneje, RT = 1,22 (95odstotni interval zaupanja 1,17-1,26; Lancet 1996).
English: Overall, the safety profile of EE/DRSP oral contraceptives is known and associated with serious adverse events (i.e. VTE and breast cancer).
Slovenian: Na splošno je varnostni profil peroralnih kontracepcijskih sredstev z etinilestradiolom in drospirenonom znan ter povezan z resnimi neželenimi učinki (venskimi trombemboličnimi dogodki in rakom dojke).
English: This is an important factor when prescribing an oral contraceptive and may preclude EE/DRSP-COCs to be regarded as a first choice for contraception, in clinical practice.
Slovenian: To je pomemben dejavnik pri predpisovanju peroralnih kontracepcijskih sredstev, ki lahko prepreči, da bi kombinirana peroralna kontracepcijska sredstva z vsebnostjo etinilestradiola in drospirenona v klinični praksi veljala za prvo izbiro pri kontracepciji.
English: The CHMP considered the MAH proposed measures for risk minimisation to ensure the safe use of EE/DRSP COCs and to limit possible off-label use following authorisation of the applied indication.
Slovenian: Odbor CHMP je pretehtal ukrepe za obvladovanje tveganja, ki jih je predlagal imetnik dovoljenja za promet, s katerimi naj bi zagotovili varno uporabo kombiniranih peroralnih kontracepcijskih sredstev z etinilestradiolom/drospirenonom in omejili morebitno izjemno uporabo po odobritvi zadevne indikacije.
English: The treatment with EE/DRSP is associated with venous thromboembolic events (VTE) and with breast cancer risks.
Slovenian: Zdravljenje z etinilestradiolom in drospirenonom je povezano z venskimi trombemboličnimi dogodki in rakom dojke.
English: The VTE associated risk is higher for EE/DRSP oral contraceptives when compared to other combined oral contraceptives.
Slovenian: Tveganje za venske trombembolične dogodke je pri peroralnih kontracepcijskih sredstvih z etinilestradiolom in drospirenonom večje v primerjavi z drugimi kombiniranimi peroralnimi kontracepcijskimi sredstvi.
English: The MAH submitted a risk minimisation program to ensure the safe use of EE/DRSP COCs and to limit possible off-label use following authorisation of the applied indication.
Slovenian: Imetnik dovoljenja za promet je predložil program za obvladovanje tveganja, ki naj bi zagotovil varno uporabo kombiniranih peroralnih kontracepcijskih sredstev, ki vsebujejo etinilestradiol in drospirenon, ter omejil morebitno izjemno uporabo po odobritvi zadevne indikacije.
English: Moreover, when data were analysed by age at first use, women who started OC use before age 20 had a higher risk of breast cancer than those starting later, RR = 1.22 (95 % confidence interval 1.17-1.26; Lancet 1996).
Slovenian: Ko so podatke analizirali glede na starost ob prvi uporabi, se je izkazalo, da je tveganje za raka dojke večje pri ženskah, ki so začele uporabljati peroralno kontracepcijo pred 20. letom, v primerjavi s tistimi, ki so jo začele uporabljati pozneje, RT = 1,22 (95-odstotni interval zaupanja 1,171,26; Lancet 1996).
English: Furthermore the MAH failed to show that once the need for oral contraception seizes to exist, the patients will be switched to other acne treatments.
Slovenian: Poleg tega imetnik dovoljenja za promet ni dokazal, da bodo bolnice prešle na zdravljenje z drugim zdravilom proti aknam, ko ne bodo več potrebovale peroralne kontracepcije.
English: Indeed, the prescriber will verify the need for a treatment for acne at the start of the prescribing period.
Slovenian: Tako bo zdravnik, ki predpisuje zdravilo, pred začetkom njegovega predpisovanja preveril, ali je potrebno zdravljenje aken, imetnik dovoljenja za promet pa ni predložil prepričljivih predlogov, kako bi bilo to mogoče zagotoviti tudi med zdravljenjem.
English: ¾ The specific indication approved.
Slovenian: ¾ Odobrena specifična indikacija.
English: • infection with tuberculosis, herpes, hepatitis, HIV
Slovenian: • okužba s tuberkulozo, herpesom, hepatitisom, HIV
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA,
English: ¾ The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Slovenian: ¾ Pomanjkanje kliničnih podatkov, ki bi podpirali kombinacijo s teofilinom, zato takšna kombinacija ni priporočljiva.
English: ¾ The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Slovenian: ¾ Potencialno tveganje za maligne tumorje in pomanjkanje izkušenj pri bolnikih z anamnezo raka v preteklosti.
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Slovenian: Daliresp je kontraindiciran pri bolnikih z zmerno ali hudo okvaro jeter (Child Pugh B ali C).
English: • Copies of the patient card to be given to patients before they receive Daliresp
Slovenian: • Kopije kartic za bolnike, ki naj bi jih bolniki prejeli pred začetkom jemanja zdravila Daliresp
English: Daliresp is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Slovenian: Daliresp ni priporočljiv za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
English: ¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
Slovenian: ¾ Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Daliresp se pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
English: ¾ The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Slovenian: ¾ Potencialno tveganje za srce: zdravilo Daliresp ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
English: Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Slovenian: Zdravila Daliresp se ne sme uvajati oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
English: ¾ The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Slovenian: ¾ Tveganje za zmanjšanje telesne mase pri podhranjenih bolnikih, potreba po spremljanju telesne mase ob vsakem obisku in potreba po prekinitvi zdravljenja v primeru nepojasnjenega ali klinično zaskrbljujočega zmanjšanja telesne mase.
English: The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Slovenian: Dejstvo, da zdravilo Daliresp ni indicirano za zdravljenje bolnikov s KOPB, razen tistih, ki ustrezajo odobreni indikaciji, ni primeren za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
English: That patients should tell their doctor if they develop symptoms indicative of:
Slovenian: Da morajo obvestiti svojega zdravnika, če opazijo simptome, ki so značilni za:
English: ¾ The need to inform patients about the risks of Daliresp and the precautions for safe use.
Slovenian: ¾ Obveznost informiranja bolnikov o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daliresp are provided with an Educational pack.
Slovenian: • Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli ob uvajanju vsi zdravniki, ki bodo predpisovali zdravilo Daliresp, na razpolago izobraževalno gradivo.
English: ¾ The limited or missing information in patients with liver impairment.
Slovenian: ¾ Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
English: ¾ The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Slovenian: ¾ Potencialno tveganje za okužbe: zdravila Daliresp se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
English: ¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Slovenian: ¾ Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daliresp in potencialno tveganje za samomor.
English: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Slovenian: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo zdravila Daliresp
English: That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Slovenian: Da zdravilo Daliresp lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na kartico za bolnike.
English: ¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
Slovenian: ¾ Pri določenih populacijah lahko pride do povečane izpostavljenosti in povečanega tveganja za trajno intoleranco: o Posebne populacije s povečano inhibicijo PDE4, npr. temnopolte ženske nekadilke.
English: on 29 November 2010.
Slovenian: dne 29. novembra 2010.
English: This summary was last updated in 10-2010.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2010.
English: This may help to protect against the disease caused by the virus.
Slovenian: To lahko pripomore k zaščiti pred boleznijo, ki jo ta virus povzroča.
English: It contains parts of influenza (flu) viruses that have been inactivated.
Slovenian: Vsebuje dele virusov influence (gripe), ki so bili inaktivirani.
English: This vaccine contains some parts of the H5N1 virus.
Slovenian: To cepivo vsebuje nekatere delce virusa H5N1.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Slovenian: Vendar pa bo med pandemijo cepljenje takih bolnikov morda vseeno upravičeno, če bo na voljo oprema za oživljanje.
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Slovenian: V prvi študiji je 21 dni po drugi injekciji okoli 90 % ljudi, mlajših od 60 let, in okoli 80 % ljudi, starejših od 60 let, imelo tako raven protiteles, ki bi jih zaščitila pred sevom H5N1.
English: The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
English: The vaccine is given by injection into the shoulder muscle in two single doses, at least three weeks apart.
Slovenian: Cepivo se daje z injiciranjem v ramensko mišico z dvema posameznima odmerkoma v časovnem presledku vsaj treh tednov.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot „tujek“ in začne proti njim tvoriti protitelesa.
English: The vaccine has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Slovenian: Cepivo je bilo razvito za zagotavljanje zaščite pred tem sevom, tako da ga je mogoče uporabiti pred pandemijo gripe ali med njo.
English: The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
Slovenian: V teh študijah so proučevali sposobnost cepiva, da sproži nastajanje protiteles („imunogenost“) v skladu z merili CHMP za prepandemska cepiva.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Slovenian: V skladu z merili, ki jih je določil CHMP, je prepandemsko cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Slovenian: To je posebna vrsta cepiva za zaščito pred novim sevom gripe, ki lahko povzroči pandemijo gripe v prihodnosti.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Slovenian: Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev H5N1 virusa.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Do pandemije gripe pride, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (oziroma pred njim niso zaščiteni).
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Slovenian: Zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ne smejo prejeti bolniki, ki so kdaj imeli anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva, vključno s katero koli snovjo, ki je v cepivu v sledeh (zelo majhne količine), kot so jajčne ali kokošje beljakovine, ovalbumin (beljakovina v jajčnem beljaku), kanamicin ali neomicinsulfat (antibiotika), formaldehid in cetiltrimetilamonijev bromid.
English: The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da bo sev H5N1 influence v prihodnosti verjetno povzročil pandemijo.
English: The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (opaženi pri več kot 1 bolniku izmed 10) so glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja (otekanje, bolečina, zatrdlina in rdečina) in utrujenost.