natgillin/translations-raw huggingface dataset:
It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems. 
Pomembno je, da zdravniku poveste, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
EU/1/17/1216/006 
EU/1/17/1216/005 EU/1/17/1216/006
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems. 
Pomembno je, da poveste zdravniku, če dobite znake okužbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1) 
brazgotinjenje redki multiformni eritem sindrom Stevens-Johnson angioedem kožni vaskulitis lihenoidna reakcija neznana poslabšanje simptomov dermatomiozitisa
• You might get infections more easily while you are receiving Imraldi treatment. 
• Med zdravljenjem z zdravilom Imraldi se lahko poveča dovzetnost za okužbe.
If this dose does not work well enough, your doctor may increase the dose to 40 mg every week or 80 mg every other week. 
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
OTHER 
Znova
Injection site care 
Shranjevanje injekcijskega peresnika
No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis. 
ki so bili med preskušanjem adalimumaba izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
Imraldi 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. 
En 0,8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba.
If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. 
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
There is no relevant use of adalimumab in children aged less than 4 years for this indication. 
Uporaba adalimumaba pri bolnikih, starih manj kot 4 leta, za to indikacijo ni primerna.
Adverse Reaction alopecia1), pruritus 
Zdravljenje placebo adalimumab Δ anonimizirano
• autoantibodies present in the blood; 
• avtoprotitelesa prisotna v krvi; • nizke krvne vrednosti za kalij.
Solution for injection (injection). 
raztopina za injiciranje (injekcija) bistra, brezbarvna raztopina
Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom,
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 
• 40 mg v 0. tednu in 20 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
Uncommon Inflammation 
Neželeni učinki pogostnost
In Psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15). 
V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do
How to inject with your vial 1) Setting up 
Kako injicirati z vialo
Continued therapy should be reconsidered in a patient not responding within this time period. 
Pri bolniku, ki se v tem času ne odzove na zdravljenje, je treba ponovno razmisliti o nadaljevanju zdravljenja.
• numbness; 
• omrtvelost;
Adalimumab 40 mg eow 
Adalimumab 80/40 mg
GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome 
Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, 
Žilne bolezni pogosti hipertenzija, zardevanje, hematom občasni aortna anevrizma,
Skin Pain b 
≥ 30 % zmanjšanje bolečine na koži b
DO NOT set the syringe down at any time. 
Brizge nikoli NE ODLOŽITE.
• low blood potasium. 
• nizke krvne vrednosti za kalij.
Impaired healing 
Zdravljenje prek
Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease. 
a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
• With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place. 
• Medtem ko je adapter za vialo še v prozorni ovojnini, ga namestite na pokrovček viale.
• liver failure; 
• izpadanje las;
Your single-dose pre-filled syringe 
otekanje oči občasni diplopija
Very common Abdominal pain, nausea and vomiting 
Bolezni prebavil zelo pogosti bolečine v trebuhu, navzea in bruhanje pogosti gastrointestinalna krvavitev, dispepsija,
The recommended Imraldi dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). 
160 mg na 1. dan (aplicirano v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (aplicirano v obliki dveh 40 mg injiciranj v enem dnevu).
Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI. 
-56,2a a p <0,001, adalimumab v primerjavi s placebom Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi s placebom.
Combino Pharm Portugal, Unipessoal, Lda. 
Portugalska Combino Pharm Portugal, Unipessoal, Lda.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
Priloga I Seznam imen, farmacevtskih oblik, jakosti, poti uporabe zdravil in imetnikov dovoljenja za promet z zdravili v državah članicah
Mylan SAS 117, allée des Parcs 69800 Saint-Priest France 
Francija Mylan SAS 117, allée des Parcs 69800 Saint-Priest France
Parenteral use 
Parenteralna uporaba
GUERBET B.P. 
Španija GUERBET B.P.
Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia Bulgaria 
Bolgarija Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia
Lek farmacevtska družba d.d., 
Slovenija Lek farmacevtska družba d.d.,
49, avenue Georges Pompidou 
Francija SANDOZ 49, avenue Georges Pompidou
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria 
Poljska Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France 
Poljska VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
Lek Pharmaceuticals d.d. 
Estonija Lek Pharmaceuticals d.d.
IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier 
Francija IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier 69003 Lyon France
G.E.S. 
Španija G.E.S.
Sweden Orion Corporation, Orionintie 1, 
Švedska Orion Corporation, Orionintie 1,
Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary 
Madžarska Sanofi-Aventis Zrt Tó utca 1-5,
Oral use Intravenous use 
Oralna uporaba Intravenska uporaba
Denmark Orion Corporation, Orionintie 1, 
Danska Orion Corporation, Orionintie 1,
Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex 
Nemčija Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany
Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 
Portugalska Farmoz - Sociedade Técnico Medicinal, S.A.
Rua João de Deus, 19 2700-487 Amadora Portugal 
2700-487 Amadora Portugal
Intramuscular use 
Intramuskularna uporaba
Concentrate for suspension for infusion 
Koncentrat za suspenzijo za infundiranje
Intravenous use intramuscular use 
Intravenska uporaba intramuskularna uporaba
Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje 
Karboksimaltoza Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom 
Francija Pharmaki Generics Ltd 5 Bourlet Close
92931 Paris La Défense Cedex 
Francija TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Iron(III) isomaltoside complex 
Kompleks železovega (III) izomaltozida
Ferric carboxymaltose complex 
Kompleks železove karboksimaltoze
FERINJECT 50 mg fer/ml 
FERINJECT 50 mg fer/ml 50 mg/ml
FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML 
INJECTION/CONCENTRA TE FOR SOLUTION FOR INFUSION 20MG/ML
Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid 
Španija Laboratorios Normon S.A. Ronda de Valdecarrizo 6
Ferric carboxymaltose 
Železova karboksimaltoza
Germany Medice Arzneimittel Pütter GmbH & Co KG 
Nemčija Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
69003 Lyon 
28760 Tres Cantos
Concentrate for solution for injection 
Koncentrat za raztopino za injiciranje
Solution for perfusion 
Raztopina za perfundiranje
Poland 
Belgija
Iceland VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Islandija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Sodium ferric gluconate complex 
Kompleks natrijevega železovega glukonata
Metamorfosi Attikis 14452 Greece 
Athens 14564 Greece
Iron (III) hydroxide dextran complex 
Kompleks železovega (III) hidroksid dekstrana
Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Romunija VIFOR France SA 7-13 Boulevard Paul Emile Victor
FRANCE 
Madrid
Denmark Fresenius Medical Care Nephrologica Deutschland GmbH 
Danska Fresenius Medical Care Nephrologica Deutschland GmbH
Sweden Fresenius Medical Care Nephrologica Deutschland GmbH 
Švedska Fresenius Medical Care Nephrologica Deutschland GmbH
Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Švedska VIFOR France SA 7-13 Boulevard Paul Emile Victor
Germany Fresenius Medical Care Nephrologica Deutschland GmbH 
Nemčija Fresenius Medical Care Nephrologica Deutschland GmbH
Germany VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Nemčija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Lithuania VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Slovenija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Denmark VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Danska VIFOR France SA 7-13 Boulevard Paul Emile Victor
Lithuania Fresenius Medical Care Nephrologica Deutschland GmbH 
Slovenija Fresenius Medical Care Nephrologica Deutschland GmbH
Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor 
Francija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Finland Fresenius Medical Care Nephrologica Deutschland GmbH 
Španija Fresenius Medical Care Nephrologica Deutschland GmbH
Solution for injection Solution for infusion 
Raztopina za injiciranje
FERROLOGIC 20 MG/ML 
FERROLOGIC 20 MG/ML 20 mg/ml
Do not exceed 10mg per 24 hours. 
Ne prekoračite odmerka 10 mg na 24 ur.
Do not take another dose during the same night. 
Isto noč ne smete vzeti še enega odmerka.
The randomized trials only showed convincing evidence of efficacy of 10mg zolpidem. 
Randomizirana preskušanja so prinesla prepričljive dokaze le o učinkovitosti 10 mg zolpidema.
In some patients, a lower dose of 5mg could be effective. 
Pri nekaterih bolnikih je lahko učinkovit nižji odmerek 5 mg.
The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate. 
Spremembe povzetka glavnih značilnosti zdravila in navodila na uporabo bodo morda v nadaljevanju morali posodobiti pristojni nacionalni organi v stiku z referenčno državo članico, če bo treba.
Other medicines and [Invented name] 
Druga zdravila in zdravilo [Izmišljeno ime]
The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg. 
Uporabiti je treba najmanjši učinkoviti dnevni odmerek zolpidema, ki ne sme preseči 10 mg.
4.7 Effects on ability to drive and use machines [The currently approved text should be deleted and replaced by the following] 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji [Trenutno odobreno besedilo je treba izbrisati in ga nadomestiti z naslednjim.]
• Your quick decision-making may be longer 
• imate podaljšan čas hitrega odločanja,
Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night. 
Zolpidem je treba vzeti v enem zaužitju tik pred spanjem in se ga v isti noči ne sme uporabiti ponovno.
• just before bedtime 
• tik pred spanjem.
Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem. 
Bolnike je treba opozoriti, naj med jemanjem zolpidema ne uživajo alkohola ali drugih psihoaktivnih snovi.
The recommended dose per 24 hours is 10 mg of [Invented Name]. 
Priporočeni odmerek na 24 ur je 10 mg zdravila [Izmišljeno ime].
• as a single intake, 
• v enem zaužitju,
[Invented Name] should be taken: 
Zdravilo [Izmišljeno ime] je treba vzeti:
A lower dose may be prescribed to some patients. 
Nekaterim bolnikom lahko zdravnik predpiše nižji odmerek.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets 
Priloga III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8). 
Za zmanjšanje tveganja mora bolnik poskrbeti, da bo lahko neprekinjeno spal 8 ur (glejte poglavje
4.2 Posology and method of administration [Replaces current sentence ‘The recommended daily dose for adults is 10 mg] The treatment should be taken in a single intake and not be re-administered during the same night. 
4.2 Odmerjanje in način uporabe [Nadomesti trenutni stavek: "Priporočeni dnevni odmerek za odrasle je 10 mg."] Zdravilo je treba vzeti v enem zaužitju in se ga v isti noči ne sme uporabiti ponovno.
• You may feel drowsy, sleepy, dizzy or confused 
• občutite dremavost, zaspanost, omotico ali zmedenost,
• zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7); 
• če je zolpidem uporabljen manj kot 8 ur pred izvajanjem dejavnosti, ki zahtevajo duševno zbranost (glejte poglavje 4.7),
• Medicines for some mental health problems (antipsychotics) 
• zdravili za nekatere težave z duševnim zdravjem (antipsihotiki),
Package Leaflet What you need to know before you are given [Invented Name] [The wording below should be inserted in this section under the following headings] Warnings and precautions Next-day psychomotor impairment (see also Driving and using machines) The day after taking [Invented Name], the risk of psychomotor impairment, including impaired driving ability may be increased if: 
Navodilo za uporabo Kaj morate vedeti, preden boste dobili zdravilo [Izmišljeno ime] [Spodnje besedilo je treba vstaviti v to poglavje pod naslednjimi naslovi] Opozorila in previdnostni ukrepi Psihomotorična prizadetost naslednji dan (glejte tudi Upravljanje vozil in strojev) Na dan po uporabi zdravila [Izmišljeno ime] je lahko tveganje za psihomotorično prizadetost, vključno s prizadeto zmožnostjo za upravljanje vozil, večje:
• Medicines used for anesthesia 
• zdravili, ki se uporabljajo za anestezijo,
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see section 4.8). 
Voznike vozil in upravljalce strojev je treba opozoriti, da (tako kot z drugimi hipnotiki) obstaja možno tveganje za zaspanost, podaljšan reakcijski čas, omotičnost, zaspanost, zamegljen/dvojni vid in zmanjšano pozornost in prizadeto upravljanje vozil v jutru po uporabi zdravila (glejte poglavje 4.8).
• Medicines for epilepsy 
• zdravili za epilepsijo,
• Medicines for depressions 
• zdravili za depresijo,
[Invented name] has major influence on the ability to drive and use machines. 
Zdravilo [Izmišljeno ime] močno vpliva na sposobnost upravljanja vozil in strojev.
• You take a higher dose than the recommended dose 
• če vzamete odmerek, ki je večji od priporočenega,
Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. 
Depresivni učinek na osrednje živčevje se lahko poveča v primeru sočasne uporabe z antipsihotiki (nevroleptiki), hipnotiki, anksiolitiki/sedativi, antidepresivi, narkotičnimi analgetiki, antiepileptiki, anestetiki in sedativnimi antihistaminiki.
• Medicines for moderate to severe pain (narcotic analgesics) 
• zdravili za zmerne do hude bolečine (narkotični analgetiki),
Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine. 
Opisani so bili tudi posamezni primeri vidnih halucinacij pri bolnikih, ki so jemali zolpidem z antidepresivi, vključno bupropionom, dezipraminom, fluoksetinom, sertralinom in venlafaksinom.
Do not drink alcohol or take other psychoactive substances while you are taking [Invented Name], as it can increase the above listed effects 
Med uporabo zdravila [Izmišljeno ime] ne pijte alkohola in ne jemljite drugih psihoaktivnih snovi, ker to lahko poveča omenjene učinke
When zolpidem was administrated with ranitidine or cimetidine, no significant pharmacokinetic interactions were observed. 
Med uporabo zolpidema z ranitidinom ali cimetidinom niso opazili pomembnih farmakokinetičnih medsebojnjih delovanj.
• You take this medicine less than 8 hours before performing activities that require your alertness 
• če to zdravilo vzamete manj kot 8 ur pred izvajanjem dejavnosti, ki zahtevajo zbranost,
• Medicines to calm or reduce anxiety 
• zdravili za pomiritev ali zmanjšanje tesnobnosti,
In a randomized double-blind trial in 462 non-elderly healthy volunteers with transient insomnia, zolpidem 10mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5mg zolpidem this was 3 minutes. 
V randomiziranem, dvojno slepem preskušanju pri 462 zdravih prostovoljcih s prehodno nespečnostjo, ki niso bili starostniki, je 10 mg zolpidema v primerjavi s placebom skrajšalo povprečni čas do tedaj, ko je oseba zaspala, za 10 minut, s 5 mg zolpidema pa je bilo to skrajšanje 3 minute.
Other drugs [When present in the current SmPC, the following sentence should be modified to remove reference to cimetidine] 
Druga zdravila [Če je ta stavek vključen v trenutnem povzetku glavnih značilnosti zdravila, ga je treba spremeniti tako, da se odstrani navedba cimetidina.]
In a randomized double-blind trial in 114 non-elderly patients with chronic insomnia, zolpidem 10mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5mg zolpidem this was 15 minutes. 
V randomiziranem, dvojno slepem preskušanju pri 114 bolnikih s kronično nespečnostjo, ki niso bili starostniki, je 10 mg zolpidema v primerjavi s placebom skrajšalo povprečni čas do tedaj, ko je bolnik zaspal, za 30 minut, s 5 mg zolpidema pa je bilo to skrajšanje 15 minut.
• a dose higher than the recommended dose is taken; 
• če je uporabljen večji odmerek od priporočenega,
• You take zolpidem while you are already taking another central nervous system depressants or another medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances Take the single intake immediately at bedtime. 
• če vzamete zolpidem medtem, ko že jemljete kakšen drug zaviralec osrednjega živčevja ali druga zdravila, ki zvišajo koncentracijo zolpidema v krvi, ali če pijete alkohol ali uporabljate prepovedane droge.
4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section under the following headings] 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [Spodnje besedilo je treba vstaviti v to poglavje pod naslednjimi naslovi]
The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. 
Priporočeni dnevni odmerek za odrasle je 10 mg in ga je treba vzeti tik pred spanjem.
Furthermore, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours (see section 4.4 and 4.5). 
Poleg tega sočasna uporaba zolpidema z alkoholom in drugimi zaviralci osrednjega živčevja poveča tveganje za takšno vedenje (glejte poglavji 4.4 in 4.5).
In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights. 
Da bi to tveganje čim bolj zmanjšali, je med uporabo zolpidema in upravljanjem vozil ali strojev oziroma delom na višini priporočljivo vsaj 8-urno obdobje počitka.
• Your vision may be blurred or double 
• imate zamegljen vid ali dvojen vid,
4.4 Special warnings and precautions for use [The wording below should be inserted in this section] 
4.4 Posebna opozorila in previdnostni ukrepi [Spodnje besedilo je treba vnesti v to poglavje]
Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness. 
Poskrbite, da bo od uporabe tega zdravila do izvajanja dejavnosti, ki zahtevajo zbranost, minilo vsaj 8 ur.
Next-day psychomotor impairment The risk of next-day psychomotor impairment, including impaired driving ability, is increased if: 
Psihomotorična prizadetost naslednji dan Tveganje za psihomotorično prizadetost naslednji dan, vključno s prizadeto zmožnostjo za upravljanje vozil, se poveča:
Combination with CNS depressants 
Kombinacija z zaviralci osrednjega živčevja
How to take [product name] [The wording below should be inserted in this section] 
Kako jemati zdravilo [ime zdravila] [Spodnje besedilo je treba vnesti v to poglavje]
Therefore, concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability (see section 4.4 and section 4.7). 
Zato lahko sočasna uporaba zolpidema in teh zdravil poveča zaspanost in psihomotorično prizadetost naslednji dan, vključno s prizadeto zmožnostjo za upravljanje vozil (glejte poglavji 4.4 in 4.7).
• zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5). 
• če je zolpidem uporabljen sočasno z drugimi zaviralci osrednjega živčevja ali drugimi zdravili, ki povečajo koncentracijo zolpidema v krvi, ali z alkoholom ali prepovedanimi drogami (glejte poglavje 4.5).
• Medicines for sleep problems (hypnotics) 
• zdravili za težave s spanjem (uspavala),
Co- administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended. 
Sočasna uporaba fluvoksamina lahko poveča koncentracijo zolpidema v krvi in zato ni priporočljiva.
5.1 Pharmacodynamic properties [The wording below should be inserted in this section] 
5.1 Farmakodinamične lastnosti [Spodnje besedilo je treba vnesti v to poglavje]
[Invented Name] has major influence on the ability to drive and use machines such as “sleep driving”. 
Zdravilo [Izmišljeno ime] močno vpliva na sposobnost upravljanja vozil in strojev, povzroča na primer "speče šofiranje".
On the day after taking [Invented Name] (as other hypnotic medicines), you should be aware that: 
Vedeti morate, da lahko na dan po uporabi zdravila [Izmišljeno ime] (tako kot v primeru drugih uspaval):