natgillin/translations-raw huggingface dataset:
Rivastigmine Hexal is also used to treat mild to moderately severe dementia in patients with Parkinson's disease. 
Zdravilo se lahko uporablja tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
The active substance in Rivastigmine Hexal, rivastigmine, is an antidementia medicine. 
Zdravilna učinkovina zdravila Rivastigmine Hexal, rivastigmin, je zdravilo proti demenci.
For the global score, patients taking Rivastigmine Hexal had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo. 
Kar zadeva rezultat celostne ocene simptomov, je pri bolnikih, ki so jemali zdravilo Rivastigmine Hexal, prišlo do povečanja simptomov za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
For the full list of all side effects reported with Rivastigmine Hexal, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rivastigmine Hexal, glejte navodilo za uporabo.
In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day. 
Pri bolnikih, ki prenašajo navedeni odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler ni dosežen stalni odmerek 3 do 6 mg dvakrat na dan. Za dosego največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar ta ne sme preseči 6 mg dvakrat na dan.
The types of side effects seen with Rivastigmine Hexal depend on the type of dementia it is being used to treat. 
Vrste neželenih učinkov, opaženih pri zdravilu Rivastigmine Hexal, so odvisne od vrste demence, ki se zdravi.
What is the risk associated with Rivastigmine Hexal? 
Kakšna tveganja so povezana z zdravilom Rivastigmine Hexal?
Why has Rivastigmine Hexal been approved? 
Zakaj je bilo zdravilo Rivastigmine Hexal odobreno?
What is Rivastigmine Hexal used for? 
Za kaj se zdravilo Rivastigmine Hexal uporablja?
How has Rivastigmine Hexal been studied? 
Kako je bilo zdravilo Rivastigmine Hexal raziskano?
What is Rivastigmine Hexal? 
Kaj je zdravilo Rivastigmine Hexal?
How is Rivastigmine Hexal used? 
Kako se zdravilo Rivastigmine Hexal uporablja?
How does Rivastigmine Hexal work? 
Kako zdravilo Rivastigmine Hexal deluje?
What measures are being taken to ensure the safe and effective use of Ciambra? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ciambra?
Ciambra is a cancer medicine used to treat two types of lung cancer: 
Ciambra je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
Other information about Ciambra 
Druge informacije o zdravilu Ciambra
The full EPAR and risk management plan summary for Ciambra 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) in povzetek načrta obvladovanja tveganj za zdravilo Ciambra sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Committee recommended that Ciambra be approved for use in the EU. 
Priporočil je, da se zdravilo Ciambra odobri za uporabo v EU.
For more information on generic medicines, see the question-and-answer document here. 
Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj
This means that Ciambra is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
Because Ciambra is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Ciambra generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ciambra has been shown to be comparable to Alimta. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Ciambra primerljivo z zdravilom Alimta.
What are the benefits and risks of Ciambra? 
Kakšne so koristi in tveganja, povezani z zdravilom Ciambra?
Ciambra is a ‘generic medicine'. 
Zdravilo Ciambra je „generično zdravilo“.
A risk management plan has been developed to ensure that Ciambra is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ciambra je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Ciambra. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ciambra.
It is not intended to provide practical advice on how to use Ciambra. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Ciambra and what is it used for? 
Kaj je zdravilo Ciambra in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ciambra, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ciambra in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Why is Ciambra approved? 
Zakaj je bilo zdravilo Ciambra odobreno?
For practical information about using Ciambra, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ciambra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Ciambra. 
Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Ciambra jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
For more information about treatment with Ciambra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ciambra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When Ciambra is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose. 
Kadar se zdravilo Ciambra daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem vzeti tudi antiemetično zdravilo (za preprečevanje bruhanja) in zaužiti tekočino (za preprečevanje dehidracije).
The active substance in Ciambra, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'. 
Zdravilna učinkovina zdravila Ciambra, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
Ciambra is available as a powder that is made up into a solution for infusion (drip) into a vein. 
Zdravilo Ciambra je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
How does Ciambra work? 
Kako zdravilo Ciambra deluje?
Ciambra contains the active substance pemetrexed. 
Zdravilo Ciambra vsebuje zdravilno učinkovino pemetreksed.
How has Ciambra been studied? 
Kako je bilo zdravilo Ciambra raziskano?
How is Ciambra used? 
Kako se zdravilo Ciambra uporablja?
No additional studies were needed as Ciambra is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta. 
Ker je zdravilo Ciambra generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
400 mg Powder for concentrate for solution for infusion 
400 mg prašek za koncentrat za raztopino za infundiranje intravenska uporaba stekleni viali
• men who are at an increased risk of fractures; 
• moških s povečanim tveganjem za zlom;
Movymia must not be used during pregnancy or breastfeeding. 
Ne sme se uporabljati med nosečnostjo in dojenjem.
This means that Movymia is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU). 
To pomeni, da je zelo podobno biološkemu zdravilu (t.i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
What measures are being taken to ensure the safe and effective use of Movymia? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Movymia?
The full EPAR for Movymia 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 Movymia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This was considered sufficient to conclude that Movymia will behave in the same way in terms of effectiveness and safety. 
To je zadostovalo za zaključek, da se bo zdravilo Movymia z vidika učinkovitosti in varnosti vedlo na enak način.
It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine. 
Poleg tega poveča absorpcijo kalcija iz hrane in preprečuje izgubo velike količine kalcija z urinom.
Patients may inject themselves once they have been trained. 
Bolniki si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni.
This is a summary of the European public assessment report (EPAR) for Movymia. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Movymia.
• men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid). 
• moških in ženskah, ki imajo povečano tveganje za zlome zaradi dolgotrajnega zdravljenja z glukokortikoidi (vrsto steroida).
The most common side effect with Movymia (seen in more than 1 patient in 10) is pain in the arms or legs. 
Najpogostejši neželeni učinek zdravila Movymia (opažen pri več kot 1 bolniku od 10) so bolečine v rokah ali nogah.
A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body. 
Študija na 54 zdravih ženskah je pokazala, da so enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročili podobno raven učinkovine teriparatid v telesu.
What benefits of Movymia have been shown in studies? 
Kakšne koristi je zdravilo Movymia izkazalo v študijah?
It is not intended to provide practical advice on how to use Movymia. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Movymia? 
Kakšna tveganja so povezana z zdravilom Movymia?
Movymia must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease. 
Zdravilo Movymia se ne sme uporabljati pri bolnikih, ki imajo druga obolenja kosti, kot so Pagetova bolezen, kostni rak ali metastaze v kosteh (rak, ki se je razširil na kosti), bolnikih, ki so bili na obsevanju okostja, ali bolnikih, ki imajo hiperkalciemijo (visoke ravni kalcija v krvi), tistih z nepojasnjeno visokimi ravnmi alkalne fosfataze (vrste encima) ali hudim obolenjem ledvic.
Thus, as for Forsteo, the benefit outweighs the identified risks and the Committee recommended that Movymia be given marketing authorisation. 
Tako njegove koristi enako kot pri zdravilu Forsteo odtehtajo znana tveganja, zato je Odbor priporočil, da se za zdravilo Movymia izda dovoljenje za promet.
The two-year course of Movymia should be given only once during a patient's lifetime. 
Dveletno zdravljenje z zdravilom Movymia se sme pri bolniku uporabiti le enkrat v življenju.
What is Movymia and what is it used for? 
Kaj je zdravilo Movymia in za kaj se uporablja?
Other information about Movymia 
Druge informacije o zdravilu Movymia
• women who have been through the menopause. 
• ženskah po menopavzi.
For more information about treatment with Movymia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Movymia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Movymia approved? 
Zakaj je bilo zdravilo Movymia odobreno?
Movymia is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in: 
Zdravilo Movymia se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Movymia have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Movymia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In these patients, Movymia has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip; 
Pri teh bolnicah je bilo dokazano, da zdravilo Movymia znatno zmanjšuje pojavnost zlomov vretenc (hrbtenice) in nevretenčnih zlomov (zlomov kosti), ne pa tudi zlomov kolka;
Because Movymia is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not need to be repeated for Movymia. 
Zdravilo Movymia je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti teriparatida, izvedenih z zdravilom Forsteo, z zdravilom Movymia ni treba ponavljati.
Gradually, the bones become less dense and more likely to break. 
Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive.
The reference medicine for Movymia is Forsteo. 
Referenčno zdravilo za zdravilo Movymia je zdravilo Forsteo.
It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells). 
Deluje enako kot hormon in vzpodbuja tvorbo kostnine tako, da deluje na osteoblaste (celice, ki tvorijo kostnino).
For practical information about using Movymia, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Movymia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Movymia can be used for up to two years. 
Bolniki morajo jemati tudi dodatek kalcija in vitamina D, če ju ne dobivajo dovolj s prehrano.
Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women. 
Osteoporoza lahko pri moških in ženskah nastane tudi kot neželeni učinek zdravljenja z glukokortikoidi.
The active substance in Movymia, teriparatide, is identical to part of the human parathyroid hormone. 
Zdravilna učinkovina v zdravilu Movymia, teriparatid, je enaka delu humanega paratiroidnega hormona.
Movymia is a ‘biosimilar medicine'. 
Zdravilo Movymia je „podobno biološko zdravilo“.
Further, Movymia and Forsteo produced similar effects on calcium levels in the blood. 
Poleg tega sta imeli zdravili Movymia in Forsteo podoben učinek na raven kalcija v telesu.
For the full list of all side effects reported with Movymia, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Movymia, glejte navodilo za uporabo.
Movymia contains the active substance teriparatide. 
Zdravilo Movymia vsebuje zdravilno učinkovino teriparatid.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Movymia has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je obravnaval podatke, ki so dokazovali, da je zdravilo Movymia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu
Laboratory studies comparing Movymia with Forsteo have shown that the active substance in Movymia is highly similar to that in Forsteo in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Movymia primerjali z zdravilom Forsteo, so pokazale, da je zdravilo Movymia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Forsteo.
How is Movymia used? 
Kako se zdravilo Movymia uporablja?
How does Movymia work? 
Kako zdravilo Movymia deluje?
Movymia is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system. 
Zdravilo Movymia je na voljo v obliki raztopine za injiciranje v vložkih (vsebujejo 600 mikrogramov teriparatida), namenjenih za uporabo s sistemom ServoPen Fix. Priporočeni odmerek je 20 mikrogramov zdravila Movymia, ki se daje enkrat dnevno z injiciranjem pod kožo v stegno ali trebuh.
The product information was amended accordingly. 
Informacije o zdravilu so bile zato ustrezno spremenjene.
It was however acknowledged that in some patients a lower dose of 5mg could be effective. 
Vendar so potrdili, da bi bil lahko pri nekaterih bolnikih učinkovit tudi manjši 5-miligramski odmerek.
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations 
Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili
However, on a population level, the randomised trials only showed convincing evidence of efficacy of the 10mg dose of zolpidem. 
Vendar so randomizirana preskušanja na ravni populacije pokazala prepričljive dokaze le o učinkovitosti 10-miligramskega odmerka zolpidema.
The currently recommended daily dose in the elderly and in patients with hepatic impairment is 5mg, and this dose recommendation remains unchanged in the product information. 
Trenutno priporočeni dnevni odmerek pri starejših bolnikih ter bolnikih z jetrno okvaro je 5 mg in ostaja nespremenjen v informacijah o zdravilu.
The PRAC therefore agreed that the recommended daily dose of zolpidem should not be reduced for adults. 
Odbor PRAC se je zato strinjal, da se priporočeni dnevni odmerek zolpidema pri odraslih ne bi smel zmanjšati.
Therefore in July 2013, AIFA requested the PRAC to give a recommendation under Article 31 of Directive 2001/83/EC on whether marketing authorisation of these products should be maintained, varied, suspended, or withdrawn. 
Julija 2013 je zato agencija AIFA zaprosila odbor PRAC za priporočilo v skladu s členom 31 Direktive 2001/83/ES, ali naj se dovoljenje za promet s temi zdravili ohrani, spremeni, začasno umakne ali ukine.
Grounds for the PRAC recommendation 
Podlaga za priporočilo odbora PRAC
Based on evidence from the literature, it was considered necessary to amend and harmonise the ‘Interaction with other medicinal products' section of the product information. 
Na podlagi dokazov iz literature so menili, da je v informacijah o zdravilu treba spremeniti in uskladiti poglavje „Medsebojno delovanje z drugimi zdravili“.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for zolpidem-containing medicinal products; 
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo zolpidem;
• The PRAC also reviewed the available data on the efficacy of zolpidem in order to determine whether amendments to the posology would help to minimise the risks but agreed that the available efficacy data do not provide robust evidence that a lower dose would be effective on a population level; 
• odbor PRAC je prav tako pregledal razpoložljive podatke o učinkovitosti zolpidema, da bi ugotovil, ali bi lahko spremembe odmerjanja pomagale zmanjšati ta tveganja, vendar je ugotovil, da razpoložljivi podatki o učinkovitosti ne vsebujejo trdnih dokazov, da bi bil lahko manjši odmerek učinkovit na ravni populacije;
Some studies showed an association between impaired driving performance on the next morning and middle of the night intake of zolpidem. 
Nekatere študije so pokazale povezavo med poslabšano sposobnostjo vožnje naslednje jutro in zaužitjem zolpidema sredi noči.
It was therefore considered by the PRAC that the dosing recommendation should include instructions that Zolpidem is to be taken in a single intake immediately at bedtime and should not be re-administered during the same night. 
Odbor PRAC je zato menil, da morajo priporočila za odmerjanje vključevati navodila, da se sme enkratni odmerek zolpidema zaužiti tik pred spanjem in se ne sme ponovno vzeti v isti noči.
Finally and in view of further minimising the risks of impaired driving and somnambulism, a potential lowering of the recommended dose for adults was discussed by the PRAC. 
Na koncu je odbor PRAC zaradi dodatnega zmanjšanja tveganja poslabšane sposobnosti vožnje in somnambulizma razpravljal še o morebitnem zmanjšanju priporočenega odmerka za odrasle.
In February 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed the results of the search in EudraVigilance (EV) of cases of impaired driving ability as well as road traffic accidents associated with zolpidem, performed by the Italian Competent Authority (AIFA). 
Februarja 2013 je Odbor za oceno tveganja na področju farmakovigilance (PRAC) razpravljal o rezultatih iskanja primerov poslabšane sposobnosti vožnje in prometnih nesreč, povezanih z zolpidemom, v zbirki EudraVigilance (EV), ki ga je izvedel italijanski pristojni organ (AIFA).
The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of zolpidem containing medicinal products for which the amendments to the product information are set out in annex III. 
Usklajevalna skupina CMDh je po proučitvi priporočila odbora PRAC z dne 6. marca 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe dovoljenj za promet z zdravili, ki vsebujejo zolpidem, za katera so spremembe informacij o zdravilu navedene v Prilogi III.
The analysis of the submitted individual case reports of driving ability and somnambulism showed that whatever the age and gender category, most of the cases of impaired driving were reported at a 10mg daily dose for both events. 
Analiza predloženih poročil o posameznih primerih poslabšane sposobnosti vožnje in somnambulizma je pokazala, da so o največ primerih poslabšane sposobnosti vožnje in somnambulizma poročali pri dnevnem odmerku 10 mg ne glede na starost in spol.
Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs. 
Ker lahko učinek zolpidema traja vsaj 8 ur in zaradi zgoraj navedenih dejavnikov tveganja, je odbor PRAC prav tako priporočil vključitev opozoril, ki navajajo, da je tveganje poslabšane sposobnosti vožnje povečano, če se zolpidem zaužije manj kot 8 ur pred opravljanjem dejavnosti, ki zahtevajo umsko pozornost, če se vzame večji odmerek zolpidema od priporočenega in/ali če se vzame sočasno z drugimi zdravili, ki povzročajo depresijo osrednjega živčevja, in/ali alkoholom ali prepovedanimi drogami.