natgillin/translations-raw huggingface dataset:
The active substance in Irbesartan Teva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Zdravilna učinkovina v zdravilu Irbesartan Teva, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine. 
Ker je zdravilo Irbesartan Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Irbesartan Teva is a medicine that contains the active substance irbesartan. 
Irbesartan Teva je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk. 
Zaradi tega je CHMP menil, da koristi, tako kot pri zdravilu Aprovel, odtehtajo znana tveganja.
Irbesartan Teva is taken by mouth, with or without food. 
Zdravilo Irbesartan Teva se zaužije peroralno, s hrano ali brez nje.
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age. 
Pri bolnikih na hemodializi (postopku čiščenja krvi) ali pri bolnikih, starejših od 75 let, se lahko uporabi začetni odmerek 75 mg.
The Committee recommended that Irbesartan Teva be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Irbesartan Teva odobri dovoljenje za promet.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. 
Irbesartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar povzroči razširitev krvnih žil.
Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel. 
Ker je zdravilo Irbesartan Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Aprovel.
In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension. 
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Irbesartan Teva uvede poleg drugih načinov zdravljenja hipertenzije.
Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). 
Zdravilo Irbesartan Teva se uporablja tudi za zdravljenje ledvičnega obolenja pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 (ki je neodvisna od insulina).
Why has Irbesartan Teva been approved? 
Zakaj je bilo zdravilo Irbesartan Teva odobreno?
The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B.V.
The full EPAR for Irbesartan Teva can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Teva je na voljo tukaj.
How has Irbesartan Teva been studied? 
Kako je bilo zdravilo Irbesartan Teva raziskano?
How is Irbesartan Teva used? 
Kako se zdravilo Irbesartan Teva uporablja?
What is Irbesartan Teva used for? 
Za kaj se zdravilo Irbesartan Teva uporablja?
How does Irbesartan Teva work? 
Kako zdravilo Irbesartan Teva deluje?
What is Irbesartan Teva? 
Kaj je zdravilo Irbesartan Teva?
It can be taken at any time of day. 
Vzame se lahko kadar koli podnevi.
This summary was last updated in 06-2012. 
Povzetek je bil nazadnje posodobljen 06-2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn on 24 February 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Fablyn , veljavno po vsej Evropski uniji, odobrila dne 24. februarja 2009.
It must not be used in women with unexplained bleeding from the womb. 
Ne sme se uporabljati pri ženskah z nepojasnjeno krvavitvijo iz maternice.
The recommended dose of Fablyn is one tablet once a day. 
Priporočeni odmerek zdravila Fablyn je ena tableta enkrat dnevno.
Fablyn lasofoxifene 
Fablyn lasofoksifen
Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective. 
Izidi z 250-mikrogramskim odmerkom so prav tako pokazali, da je 500-mikrogramski odmerek učinkovitejši.
The full EPAR for Fablyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fablyn je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Fablyn. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fablyn.
Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744). 
V petih letih se je nov zlom hrbtenice pojavil pri 6 % žensk, ki so jemale zdravilo Fablyn 500 mikrogramov (155 od 2 748), medtem ko je do novega zloma prišlo pri 9 % tistih, ki so jemale placebo (255 od 2 744).
The effects of Fablyn were first tested in experimental models before being studied in humans. 
Učinki zdravila Fablyn so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main measure of effectiveness was the number of women who had a new fracture in the spine as seen on X-rays. 
Glavno merilo učinkovitosti je bilo število žensk z novim zlomom hrbtenice, kar je bilo ugotovljeno z rentgenskim slikanjem.
What measures are being taken to ensure the safe use of Fablyn? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Fablyn?
The programme will include information about the risk of venous thromboembolism, changes in the womb that may occur when taking the medicine, and the need to investigate unexplained bleeding from the womb. 
Program bo vključeval podatke o tveganju za nastanek venske trombembolije, spremembah v maternici, ki se lahko pojavijo pri jemanju zdravila in potrebi po preiskavi nepojasnjenega krvavenja iz maternice.
The study also looked at existing spine fractures that got worse, new fractures in other parts of the body and the density of bones throughout the body. 
V študiji so proučevali tudi obstoječe zlome hrbtenice, katerih stanje se je poslabšalo, nove zlome v drugih delih telesa in gostoto kosti v celem telesu.
The company that makes Fablyn will make sure that an educational programme is available in all Member States for all healthcare workers who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine. 
Družba, ki izdeluje zdravilo Fablyn, bo zagotovila, da bo izobraževalni program na voljo v vseh državah članicah za vse zdravstvene delavce, ki bodo predpisovali zdravilo Fablyn ali napotili ženske, ki jemljejo zdravilo, na ultrazvočno slikanje medenice.
For more information about treatment with Fablyn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Fablyn preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Fablyn's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Fablyn večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Fablyn was more effective than placebo at reducing the number of new fractures. 
Zdravilo Fablyn je bilo pri zmanjšanju števila novih zlomov učinkovitejše od placeba.
Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breastfeeding. 
Zdravilo Fablyn je namenjeno le ženskam po menopavzi, zato ga ne smejo uporabljati ženske, ki bi lahko zanosile, nosečnice ali ženske, ki dojijo.
Other information about Fablyn 
Druge informacije o zdravilu Fablyn
It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye). 
Ne sme se uporabljati pri bolnicah, ki so imele težave zaradi venske trombembolije, vključno z globoko vensko trombozo (DTV), pljučno embolijo (krvnim strdkom v pljučih) in trombozo ven mrežnice (krvnim strdkom v zadnjem delu očesa).
What benefit has Fablyn shown during the studies? 
Kakšne koristi je zdravilo Fablyn izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fablyn. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Fablyn, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Fablyn must not be used in people who are hypersensitive (allergic) to lasofoxifene or any of the other ingredients. 
Zdravila Fablyn ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) lasofoksifen ali katere koli druge sestavine zdravila.
The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps. 
Najpogostejši neželeni učinek zdravila Fablyn (opažen pri več kot 1 od 10 bolnic) so mišični krči.
It is used in women who are at risk of fracture (broken bones). 
Uporablja se pri ženskah, pri katerih obstaja tveganje za zlom kosti.
When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels. 
Zdravnik mora, preden predpiše zdravilo Fablyn ali druga zdravljenja, ugotoviti prisotnost kakršnih koli znakov menopavze pri bolnici ter presoditi morebitne učinke zdravljenja na maternico, prsi, srce in krvne žile.
The active substance in Fablyn, lasofoxifene, is a selective oestrogen receptor modulator (SERM). 
Zdravilna učinkovina zdravila Fablyn, lasofoksifen, je selektivni modulator estrogenskih receptorjev (SERM).
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Fablyn is intended for long-term use. 
Bolnice lahko po potrebi jemljejo tudi dodatek kalcija in vitamina D, če ju ne dobijo dovolj s prehrano.
What is the risk associated with Fablyn? 
Kakšna tveganja so povezana z zdravilom Fablyn?
Lasofoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. 
Lasofoksifen deluje kot agonist receptorjev estrogena (snov, ki stimulira receptorje za estrogen) v nekaterih telesnih tkivih.
Fablyn is a medicine that contains the active substance lasofoxifene. 
Fablyn je zdravilo, ki vsebuje zdravilno učinkovino lasofoksifen.
Lasofoxifene has the same effect as oestrogen in the bone. 
Lasofoksifen učinkuje na kost enako kot estrogen.
For the full list of all side effects reported with Fablyn, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fablyn, glejte navodilo za uporabo.
Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause). 
Zdravilo Fablyn se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi.
Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients. 
Zdravilo Fablyn ni zmanjšalo števila zlomov kolka v tolikšni meri, da bi bilo to za bolnice pomembno.
Why has Fablyn been approved? 
Zakaj je bilo zdravilo Fablyn odobreno?
Fablyn has been shown to reduce fractures in the spine and elsewhere in the body, but not in the hip. 
Zdravilo Fablyn se je izkazalo kot učinkovito pri zmanjšanju števila zlomov hrbtenice in drugih kosti v telesu, vendar ne zlomov kolka.
Fewer women taking the higher dose had a fracture outside the spine and there were greater increases in bone density. 
Pri ženskah, ki so jemale večje odmerke, so bili zlomi drugih kosti v telesu redkejši, bolj pa se je povečala tudi kostna gostota.
Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years. 
V eni glavni študiji, v katero je bilo vključenih skoraj 9 000 žensk v obdobju po menopavzi, starih od 60 do 80 let, so primerjali dva odmerka zdravila Fablyn (250 in 500 mikrogramov enkrat dnevno) s placebom (zdravilom brez zdravilne učinkovine).
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture. 
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko upade količina ženskega hormona estrogena.
What is Fablyn used for? 
Za kaj se zdravilo Fablyn uporablja?
How has Fablyn been studied? 
Kako je bilo zdravilo Fablyn raziskano?
How does Fablyn work? 
Kako zdravilo Fablyn deluje?
What is Fablyn? 
Kaj je zdravilo Fablyn?
How is Fablyn used? 
Kako se zdravilo Fablyn uporablja?
Fablyn should be used with caution in women with severe liver or kidney problems. 
Pri bolnicah z resnimi obolenji jeter ali ledvic je treba zdravilo Fablyn uporabljati previdno.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Zinnat 250 mgGranulat 
Zinnat 250 mgGranulat zrnca
980 Great West Road Brentford, Middlesex, TW8 9GS 
GlaxoSmithKline Export Ltd 980 Great West Road Brentford, Middlesex, TW8 9GS
Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN, 
Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN, UNITED KINGDOM
Zinnat 250 mg apvalkotās tabletes 250mg Film-coated Tablets 
Zinnat 250 mg apvalkotās tabletes 250 mg
Zinnat 500 mg apvalkotās tabletes 500mg Film-coated Tablets 
Zinnat 500 mg apvalkotās tabletes 500 mg
Oraxim250 mg Granules for Oral Suspension 
Oraxim250 mg zrnca za peroralno suspenzijo
500mg Granules for Oral Suspension 
500 mg zrnca za peroralno suspenzijo
1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest. 
Člen 31 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev v interesu Skupnosti.
London, 14 June 2010 Doc. 
London, 14. junija 2010 Ref. dok.
Because of this, a number of Member States have carried out safety reviews of this combination, but these have led to different conclusions. 
Posledično so številne države članice opravile varnostne preglede te kombinacije, vendar so prišle do različnih zaključkov.
The Committee recommended that the withdrawals and suspensions should be gradual in line with national recommendations. 
Odbor je priporočil, da morajo biti umiki in zadržanja postopni in v skladu z nacionalnimi priporočili.
However, there were insufficient data on their effectiveness. 
Vendar pa obstoječi podatki niso zadostovali za potrditev njegove učinkovitosti.
The review was carried out under an ‘Article 31' referral1. 
Pregled je bil opravljen v skladu z napotitvenim postopkom1 iz člena 31.
Medicines containing dextropropoxyphene on its own are authorised in 10 Member States (Belgium, Denmark, Finland, France, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden) and medicines containing dextropropoxyphene combined with paracetamol (sometimes with caffeine) are authorised in six Member States (Belgium, Cyprus, France, Luxembourg, Malta and Portugal) as well as Norway. 
Zdravila, ki vsebujejo dekstropropoksifen samostojno, so odobrena v 10 državah članicah (Belgija, Danska, Finska, Francija, Grčija, Italija, Luksemburg, Nizozemska, Španija in Švedska); zdravila, ki vsebujejo dekstropropoksifen v kombinaciji s paracetamolom (včasih s kofeinom), pa so odobrena v šestih državah članicah (Belgija, Ciper, Francija, Luksemburg, Malta in Portugalska) ter na Norveškem.
In the United Kingdom and Sweden, the marketing authorisations for these medicines were withdrawn from 2005. 
V Združenem kraljestvu in na Švedskem so bila dovoljenja za promet s temi zdravili umaknjena leta 2005.
Proposed activities to reduce this risk, such as including further warnings or restrictions, or limiting the size of packs, were not considered to be adequate to protect public health. 
O predlaganih aktivnostih za zmanjšanje tega tveganja, npr. uvedba dodatnih opozoril ali omejitev, ali omejitev velikosti pakiranja, pa meni, da niso ustrezne za zaščito javnega zdravja.
What happened during the re-examination? 
Kaj se je dogajalo med ponovno presojo?
This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small. 
To pomeni, da je razlika med odmerkom, potrebnim za zdravljenje bolnika, in odmerkom, ki lahko bolniku škoduje, majhna.
Quite often, the patients had taken medicines prescribed for someone else. 
Zelo pogosto so bolniki jemali zdravila, ki so bila predpisana za drugega bolnika.
It will be the responsibility of each Member State to set the timeframe for this withdrawal and assess the need for other activities such as recommendations for prescribers and patients on safe and effective pain relief. 
Posamezna država članica bo pristojna za določitev časovnega okvira za ta umik in za oceno potrebe po dodatnih ukrepih, kot so priporočila za zdravnike, ki predpisujejo zdravilo, in bolnike v zvezi z varnim in učinkovitim lajšanjem bolečin.
To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee recommended that the withdrawal of the medicines from the market be carried out gradually. 
Za zagotovitev, da imajo zdravniki, ki predpisujejo zdravilo, dovolj časa za določitev najustreznejših zdravil za posameznega bolnika, je Odbor priporočil postopen umik zdravil s trga.
Therefore, the Committee recommended that the marketing authorisations for these medicines be withdrawn across the EU. 
Odbor je zato priporočil umik dovoljenj za promet s temi zdravili v EU.
The Committee also reviewed data from published literature including analyses comparing the results of different studies (meta-analyses) in short-term pain relief. 
Odbor je pregledal tudi podatke iz objavljene literature, vključno z analizami primerjav rezultatov različnih študij (metaanalize) pri kratkotrajnem lajšanju bolečin.
On 25 June 2009, the European Medicines Agency completed a review of the safety and effectiveness of dextropropoxyphene-containing medicines. 
Evropska agencija za zdravila je dne 25. junija 2009 zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo dekstropropoksifen.
What were the conclusions of CHMP after the initial review? 
Kakšni so bili zaključki CHMP po začetnem pregledu?
Dextropropoxyphene is a painkiller that is used to treat short- and long-term (chronic) pain. 
Dekstropropoksifen je zdravilo proti bolečinam, ki se uporablja za zdravljenje kratkotrajnih in dolgotrajnih (kroničnih) bolečin.
The CHMP also considered the views received from patient organisations. 
CHMP je upošteval tudi pobude, ki jih je prejel od bolniških organizacij.
Questions and answers on the withdrawal of the marketing authorisations for medicines containing dextropropoxyphene 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravili, ki vsebujejo dekstropropoksifen
On 21 October 2009, the Committee confirmed its original recommendation that the marketing authorisations for the non-parenteral (tablets, capsules and suppositories) forms of dextropropoxyphene-containing medicines should be withdrawn. 
Dne 21. oktobra 2009 je Odbor potrdil svoje prvotno priporočilo, da je treba umakniti dovoljenja za promet z neparenteralnimi oblikami (tablete, kapsule in svečke) zdravil, ki vsebujejo dekstropropoksifen.
The Committee acknowledged that it is important that patients continue to receive adequate pain relief, and that it is necessary to allow for those who currently take dextropropoxyphene-containing medicines to be transferred to alternative treatments. 
Odbor priznava, da je pomembno, da bolniki še naprej prejemajo ustrezno zdravilo za lajšanje bolečin, in da je nujno potrebno, da se bolnikom, ki trenutno prejemajo zdravila, vsebujoča dekstropropoksifen, omogoči prehod na alternativna zdravila.
In November 2007, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of combination products containing dextropropoxyphene and paracetamol and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU. 
Novembra 2007 je Evropska komisija pozvala CHMP, naj izvede celotno oceno razmerja med koristmi in tveganji za zdravila, ki vsebujejo kombinacijo dekstropropoksifena in paracetamola, ter naj izda mnenje, ali se dovoljenja za promet s temi zdravili v EU ohranijo, spremenijo, zadržijo ali umaknejo.
It is a weak opioid (opioids are medicines related to morphine) that relieves pain by acting on receptors in the brain and spinal cord. 
Je šibek opioid (opioidi so zdravila, podobna morfinu), ki lajša bolečine z delovanjem na receptorje v možganih in hrbtenjači.
However, for the parenteral form (solution for injection), the CHMP recommended that the marketing authorisations be suspended until further data are available. 
Za parenteralno obliko (raztopina za injiciranje) je CHMP priporočil zadržanje dovoljenj za promet, dokler niso na voljo nadaljnji podatki.
Patients may easily take too much dextropropoxyphene and risk a fatal overdose, as dextropropoxyphene can be rapidly fatal. 
Zelo lahko se zgodi, da bolniki vzamejo preveč dekstropropoksifena in tvegajo prekomeren odmerek s smrtnim izidom, saj lahko dekstropropoksifen hitro privede do smrti.
In light of differences between Member States in terms of the number of fatal overdoses reported, the Committee also sought data from other sources available in Member States, including case reports of fatal overdose, data from poison centres, data from coroners' services, hospital statistics, national mortality statistics, and toxicology data from forensic services, from both published and unpublished research. 
Zaradi razlik med državami članicami v številu primerov prekomernega odmerjanja s smrtnim izidom, o katerih so poročali, je Odbor pridobil podatke tudi iz drugih razpoložljivih virov v državah članicah, vključno s poročili o posameznih primerih prekomernega odmerjanja s smrtnim izidom, podatki centrov za zastrupitve, podatki mrliškopreglednih služb, statistikami bolnišnic, nacionalnimi statistikami umrljivosti ter toksikološkimi podatki forenzičnih služb, tako iz objavljenih kot tudi iz neobjavljenih raziskav.
Because the Committee was also concerned about the safety of medicines containing only dextropropoxyphene, in March 2009, the assessment was widened, in agreement with the Commission, to include all dextropropoxyphene-containing medicines, either on its own or in combination. 
Ker je imel Odbor pomisleke tudi glede varnosti zdravil, ki vsebujejo samo dekstropropoksifen, je bila marca 2009 ocena po dogovoru s Komisijo razširjena, tako da je vključevala vsa zdravila, vsebujoča dekstropropoksifen, bodisi samostojno bodisi v kombinaciji.