natgillin/translations-raw huggingface dataset:
Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section
Zdravnik mora potrditi ustrezno odpornost pri bolnikih, preden začnejo zdravljenje z zdravilom TYSABRI (glejte tudi poglavje 4.4).
This includes:
UPORABNO DO:
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
V obdobju trženja zdravila so poročali o spontanih hudih neželenih reakcijah okvare jeter.
TYSABRI contains sodium
Zdravilo TYSABRI vsebuje natrij.
- Keep this leaflet and the Patient Alert Card. You may need to read them again.
- Navodilo in opozorilno kartico za bolnika shranite.
virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Virus JC lahko povzroči tudi bolezen, imenovano JCV GCN (JCV nevropatija zrnatih celic), o kateri so poročali pri nekaterih bolnikih, zdravljenih z zdravilom TYSABRI.
• Reminder to read the package leaflet carefully before starting Tysabri
• Navodilo, da je treba pred začetkom jemanja zdravila Tysabri skrbno prebrati navodilo za uporabo.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a higher risk of PML.
Pri bolnikih z vsemi tremi dejavniki tveganja za PML (tj. so pozitivni na protitelesa proti JCV, so se več kot dve leti zdravili z zdravilom TYSABRI in so jih predhodno zdravili z imunosupresivi) obstaja večje tveganje za razvoj PML.
Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
1 leto pred vključitvijo vsaj en klinični recidiv in po lestvici prizadetosti EDSS (Kurtzke Expanded Disability Status Scale) med 0 in 5 točkami.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ml (0,9 %)
• Prescriber name, signature and date
• ime, podpis zdravnika, ki predpisuje zdravilo, in datum.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
o Management of PML o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
o Bolnike je treba seznaniti s koristmi in tveganji zdravila TYSABRI ter jim posredovati naslednje:
o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
o Tveganje PML narašča s trajanjem zdravljenja in zdravljenje, ki traja dlje kot
Talk to your doctor before using TYSABRI.
Pred začetkom uporabe zdravila TYSABRI se posvetujte z zdravnikom.
Caution regarding potential concomitant immune effects is required when switching patients from teriflunomide to TYSABRI.
Pri prehajanju bolnikov s teriflunomida na zdravilo TYSABRI je potrebna previdnost glede možnih sočasnih imunskih učinkov.
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
43,5 % bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila
• Keep alert card with the them after discontinuation • Reporting of side effects
• Po prekinitvi zdravljenja morajo imeti pri sebi opozorilno kartico.
• Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
• porumenelost kože ali beločnice
In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML (i.e. the risk is greater in those with a high antibody index compared to those with a low index).
JCV (indeks) povezana s stopnjo tveganja za razvoj PML (tako je tveganje večje pri bolnikih z visokim indeksom protiteles v primerjavi z bolniki z nizkim indeksom).
Your doctor may switch you directly from another medicine for MS to TYSABRI if there are no signs of abnormalities caused by your previous treatment.
Če ni nobenih bolezenskih znakov, ki bi jih povzročilo vaše predhodno zdravljenje, vam lahko zdravnik drugo zdravilo za MS neposredno zamenja z zdravilom TYSABRI.
Hepatic events
Farmakodinamični učinki
Discussion of PML in TYSABRI Treated Patients
V opazovalnih študijah v obdobju trženja zdravila so pri bolnikih, zdravljenih z zdravilom Tysabri,
Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including:
Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro.
The interim analysis showed a lower risk of PML in patients treated with EID (hazard ratio = 0.06 95% CI of hazard ratio = 0.01- 0.22).
PIO (razmerje tveganja= 0,06; 95-% IZ razmerja tveganja = 0,01-0,22).
In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
1,5 na bolnika-leto, tako pri bolnikih zdravljenih z natalizumabom, kot pri bolnikih, zdravljenih s placebom.
1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
≥ 106,3- ≤ 108,3 CFU živih bakterij Bordetella bronchiseptica, sev B-C2, na odmerek
Vial (type I glass) in plastic box
Viala (steklo tip I) In plastična škatla
Vial (type I glass) in carton box
Viala (steklo tip I) in zloženka
Pack size l t o r
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja o č
Invented nameStrength Pharmaceutical Form
Izmišljeno ime Jakost
The results of these pre-specified analyses are as follows:
Rezultati teh vnaprej določenih analiz so naslednji:
• you are pregnant.
• če ste noseči.
Summarised below are PFS results:
Spodaj so povzeti rezultati PFS:
• epidemiological studies/non-interventional or observational studies,
• v epidemioloških študijah/neinterventnih ali opazovalnih študijah ali,
Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Overall survival (final analysis)***
Celokupno preživetje (končna analiza)***
Observed in paediatric population only.
Opaženo samo pri pediatrični populaciji.
Interferon alfa-2a 9 MIU 3x/week.
a interferon alfa-2a 9 mio 3x/teden.
• spontaneous reporting,
• pri spontanem poročanju,
Further details on the study and the results are provided below.
Dodatne podrobnosti o preskušanju in rezultati so navedeni spodaj.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018
Datum prve odobritve: 15. januar 2018
Blinded independent review (protocol-defined primary analysis).
Slepi neodvisni pregled (primarna analiza, določena s protokolom).
• loss of appetite,
• izgubo apetita,
• abnormal urine test (protein in the urine),
• nenormalen urinski test (beljakovine v seču),
Patients older than 65 years have an increased risk of experiencing the following side effects:
Pri bolnikih, starejših od 65 let, je večje tveganje za naslednje neželene učinke:
• or through an evaluation of individual case reports.
• s presojo poročil posameznih primerov.
** Primary analysis at clinical cut-off 31 January 2006.
** Primarna analiza kliničnih podatkov zbranih do 31. januarja 2006.
MVASI may also cause changes in laboratory tests carried out by your doctor.
Zdravilo MVASI lahko povzroči tudi spremembe rezultatov laboratorijskih testov, ki jih izvaja vaš zdravnik.
Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
• your doctor will decide when you should be given your next dose of MVASI.
• bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
• lack of energy,
• pomanjkanje energije,
Elderly patients: No dose adjustment is required in the elderly.
Starejši bolniki: za starejše bolnike prilagajanje odmerka ni potrebno.
• any severe bleeding.
• kakršna koli huda krvavitev.
Subject to a p-value boundary of 0.0116.
Odvisna od meje p-vrednosti, ki je 0,0116.
• you may develop a severe migraine.
• lahko dobite hudo migreno.
*** The final analysis of overall survival was performed when 266 deaths, which account for 73.7% of enrolled patients, were observed.
*** Končna analiza celokupnega preživetja je bila opravljena, ko je nastopilo 266 smrti, kar je predstavljalo 73,7 % vključenih bolnic.
Kaplan-Meier estimates.
Ocena po metodi Kaplan-Meier.
• post-authorisation safety studies,
• v varnostnih študijah po pridobitvi dovoljenja za promet,
Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason.
Posvetujte se s svojim zdravnikom, če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje krvi iz kakršnih koli razlogov.
Based on a substudy from NSABP C-08 with 295 patients.
Na podlagi podštudije NSABP C-08 z 295 bolnicami.
Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Hudi neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti), vključujejo:
However two of the randomised patients discontinued the study before receiving any study treatment.
Dva izmed randomiziranih bolnikov sta bila iz študije izključena, preden sta prejela katero koli zdravljenje, uporabljeno v študiji.
• if you undergo surgery.
• če boste operirani.
Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Ocene tumorjev in vrednotenje odzivov so določili raziskovalci z uporabo kriterijev GOG RECIST (revidiranih smernic RECIST (verzija 1.1).
• problems with the eyes (including increased production of tears),
• težave z očmi (vključno s povečanim solzenjem),
Final analysis
Končna analiza.
Name and address of the manufacturer of the biological active substance Amgen Inc
Ime in naslov izdelovalca biološke učinkovine Amgen Inc
• abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
• nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot navadno,
Approximate 95% CI for difference of two rates using Hauck-Anderson method.
Približni 95-% interval zaupanja za razliko dveh deležev z uporabo Hauck-Andersonove metode.
MVASI use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Uporaba zdravila MVASI ni priporočena pri otrocih in mladostnikih, mlajših od 18 let, ker varnosti in koristi zdravila pri tej populaciji niso dokazali.
Please discuss with your doctor if you noticed this previously.
Pogovorite se s svojim zdravnikom, če ste to že kdaj opazili.
The adverse reactions listed in this section fall into the following frequency categories: 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).
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: 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), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
With or without gross residual disease.
Z ali brez preostanka bolezni.
Do not stop treatment with MVASI unless you have discussed this with your doctor.
Ne prenehajte zdravljenja z zdravilom MVASI, ne da bi se o tem pogovorili s svojim zdravnikom.
There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly diagnosed high-grade glioma.
Na voljo ni dovolj podatkov, da bi določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje malignosti.
The incidence varied between 10% (4/40) and 20%
Incidenca se je gibala med 10 % (4/40) in 20 % (3/15).
p-value (Chi-squared test)
Vrednost p (test hi-kvadrat)
Before initiating MVASI, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila MVASI je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
There are no clinical trial data on the use of bevacizumab in pregnant women.
Iz kliničnih preskušanj ni podatkov o uporabi bevacizumaba pri nosečnicah.
It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
Redko je prišlo do prekinitve zdravljenja z bevacizumabom ali hospitalizacije.
• Bleeding in the eye.
• krvavitev v očesu.
After cycle 1, the medicinal product could be delivered as a 1-hour infusion.
Po prvem ciklusu se lahko zdravilo daje kot 1-urna infuzija.
Please talk to your doctor since blood clots can lead to heart attack and stroke.
Posvetujte se s svojim zdravnikom, saj lahko krvni strdki privedejo do srčnega napada in kapi.
MVASI has not been shown to reduce your ability to drive or to use any tools or machines.
Za zdravilo MVASI se ni izkazalo, da bi zmanjšalo vašo sposobnost za vožnjo ali uporabo orodij oziroma strojev.
EU/1/17/1246/002
EU/1/17/1246/001 EU/1/17/1246/002
It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease.
Pomembno je, da vaš zdravnik ve, če ste kdaj prejeli antracikline (na primer doksorubicin, specifično vrsto kemoterapije, ki jo uporabljajo pri zdravljenju nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen.
When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur:
Kadar bevacizumab injiciramo neposredno v oko (neodobrena uporaba), se lahko pojavijo naslednji neželeni učinki:
Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Posvetujte se s svojim zdravnikom, če imate rak v metastatski obliki, ki je prizadel vaše možgane.
Bevacizumab has no or negligible influence on the ability to drive and use machines.
Bevacizumab nima oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• blood clot in the arteries which can lead to a stroke or a heart attack,
• krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada,
Key efficacy results for the superiority analysis (ITT population, trial NO16966)
Ključni rezultati učinkovitosti za analizo superiornosti (populacija, ki so jo nameravali zdraviti; preskušanje NO16966)
The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Varnost in učinkovitost sočasnega zdravljenja z radioterapijo in bevacizumabom nista bili ugotovljeni.
Duration of response Median time (months)
Trajanje odgovora Mediana časa (meseci)
For additional information refer below within section “Description of selected serious adverse reactions”.
Za nadaljnje informacije glejte spodnje podpoglavje ”Opis določenih resnih neželenih učinkov”.
Patients included in analysis
Število bolnikov, vključenih v analizo delež
Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014; vse vrednosti p so napisane samo za deskriptivne namene.
• The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
• tveganje za pojav krvnih strdkov v arterijah (tip krvne žile) je lahko povečano, če ste starejši od 65 let, imate sladkorno bolezen ali če ste v preteklosti že imeli krvne strdke v arterijah.
The median age of patients was 61.0 (range: 25-84) years.
Mediana starosti bolnic je bila 61,0 let (razpon: 25 do 84 let).
These clinically significant reactions have therefore been included in table 2 within the column entitled “Frequency not known”.
Te klinično pomembne neželene učinke so zato v preglednici 2 razvrstili v kolono »Neznana pogostnost«.
• It is possible that MVASI can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
• možno je, da lahko zdravilo MVASI povzroči preobčutljivost in/ali reakcije, povezane z infundiranjem (reakcije, povezane z injiciranjem zdravila).
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
• A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with MVASI treatment.
• redek neželen učinek, povezan z živci, imenovan sindrom posteriorne reverzibilne encefalopatije (PRES), povezujejo z zdravljenjem z zdravilom MVASI.
The incidence of adverse events, including grade ≥ 3 adverse events and serious adverse events, was similar between the two treatment arms.
Incidenca neželenih učinkov, vključno z neželenimi učinki stopnje ≥ 3 in resnimi neželenimi učinki, je bila pri obeh zdravljenih skupinah podobna.
In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
V večini primerov je bila hipertenzija ustrezno uravnana s standardnimi antihipertenzivnimi zdravili, ki so bila primerna za posameznega bolnika v dani situaciji.
Other medicines and MVASI
Druga zdravila in zdravilo MVASI
If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Če boste operirani, če je od večje operacije minilo manj kot 28 dni, ali če se vaša rana po operaciji še ni zacelila, tega zdravila ne smete prejeti.
Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Kombinacija zdravila MVASI z drugim zdravilom, imenovanim sunitinib malat (predpisanem za zdravljenje raka ledvic in prebavil), lahko povzroči hude neželene učinke.
Exploratory analysis; OS updated analysis at clinical cut-off on 28 October 2015, approx. 45% patient had died and OS is therefore considered immature.
Eksplorativna analiza; analiza celokupnega preživetja, posodobljena s kliničnimi podatki, zajetimi do 28. oktobra 2015; približno 45 % bolnikov je umrlo in zato oceno celokupnega preživetja ocenjujemo kot nezrelo.
In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in table 6 for trial NO16966.
V skupini, ki je prejemala kemoterapijo, so pri zdravljenju po shemi FOLFOX-4 uporabljali enake odmerke in sheme, kot je prikazano v preglednici 6 za preskušanje NO16966.
The median age was 60.0 years in the CP arm and 59.0 years in the CPB arm.
Mediana starost je bila 60,0 let v skupini CP in 59,0 let v skupini CPB.
Overall survival - Follow-up analysis7 Median (months)1
Celokupno preživetje - analiza po spremljanju7 Mediana (meseci)1
What MVASI is and what it is used for
Kaj je zdravilo MVASI in za kaj ga uporabljamo
MVASI is not approved for use in patients under the age of 18 years.
Zdravilo MVASI ni odobreno za uporabo pri bolnikih, mlajših od 18 let.
Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 mL of red blood) should not be treated with bevacizumab.
Bolnike, ki so nedavno imeli krvavitev v pljučih/hemoptizo (> 2,5 ml rdeče krvi), z bevacizumabom ne smemo zdraviti.
However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR = 0.91).
Vendar pa povečanje primarnega končnega cilja - celokupnega preživetja - za 2 meseca ni bilo signifikantno (razmerje ogroženosti = 0,91).
The secondary endpoint of overall survival was not mature.
Sekundarni cilj študije, celokupno preživetje, ni bilo zrelo.
Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Očistek bevacizumaba je bil približno 30 % hitrejši pri bolnikih z nizkimi vrednostmi serumskega albumina in 7 % hitrejši pri bolnikih z visokim tumorskim bremenom v primerjavi s tipičnim bolnikom s srednjimi vrednostmi albumina in tumorskega bremena.
Objective response rate**
Objektivni odgovor**
* Primary analysis was performed with a data cut-off date of 14 November 2011.
* Primarna analiza je bila pripravljena s podatki, zajetimi do 14. novembra 2011.
log-rank test (stratified).
Test log-rang (stratificirani).
The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Dodatek bevacizumaba k zdravljenju po shemi FOLFOX-4 je statistično značilno podaljšal preživetje.
MVASI therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Zdravljenje z zdravilom MVASI je treba pri bolnikih, pri katerih se razvije nekrotizirajoči fasciits, nemudoma prekiniti in takoj začeti z ustreznim zdravljenjem.
Investigator assessment*
Ocena raziskovalca*
Additional endpoints included objective response, duration of response, overall survival and safety.
Ostali cilji so vključevali objektiven odgovor, trajanje odgovora, celokupno preživetje in varnost.
MVASI may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Zdravilo MVASI lahko poškoduje nerojenega otroka, ker lahko zaustavi tvorbo novih krvnih žil.
Pulmonary embolism,
pljučna embolija,
• if you have problems with wound healing following surgery,
• če imate težave s celjenjem ran po operaciji,
• MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
• zdravilo MVASI lahko povzroči okužbe in zmanjša število vaših nevtrofilcev (vrsta krvnih celic, ki so pomembne za zaščito pred bakterijami).
In an exploratory analysis, the extent of bevacizumab benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
V eksplorativni analizi so ugotovili, da je bila korist bevacizumaba glede celokupnega preživetja manj izražena v podskupini bolnikov, ki ni imela adenokarcinoma.
If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Če imate stanje, ki povzroča trebušno vnetje (npr. divertikulitis, želodčno razjedo, s kemoterapijo povezan kolitis), se o tem pogovorite s svojim zdravnikom.
• feeling weak and having no energy,
• občutek šibkosti in pomanjkanja energije,