natgillin/translations-raw huggingface dataset:
If you forget to take a dose of Plavix, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time. 
Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
EU/1/10/651/009 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters (calendar pack) 
EU/1/10/651/009 škatla z 28x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih (koledarsko pakiranje) EU/1/10/651/010 škatla s 30x1 filmsko obloženo tableto v OPA/Al/PVC - Al perforiranih enoodmernih pretisnih omotih
Recent ischaemic stroke 
Kounisov sindrom
• Periodic Safety Update Reports 
Nadaljnja presnova vmesnega presnovka
Renal impairment 
• Jetrna okvara
NMS can cause death. 
NMS lahko povzroči smrt.
These are diseases characterised by symptoms such as: 
Te bolezni zaznamujejo simptomi, kot so:
Date of first authorisation: 20 February 2013 Date of latest renewal: 
Datum prve odobritve: 20. februarja 2013 Datum zadnjega podaljšanja:
• recreational (illegal) drugs 
• rekreativne (nezakonite) droge;
For the main results, see the table below. 
Za glavne rezultate glejte spodnjo tabelo.
These symptoms can temporally worsen or can even arise after discontinuation of treatment. 
Ti simptomi se lahko začasno poslabšajo ali se pojavijo celo po prekinitvi zdravljenja.
• At the request of the European Medicines Agency; 
na zahtevo Evropske agencije za zdravila;
• are an older person with dementia (loss of memory and other mental abilities). 
• ste starejša oseba z demenco (izguba spomina in drugih umskih sposobnosti).
Additional measures include oxygen and intravenous fluids. 
Dodatni ukrepi vključujejo kisik in intravenske tekočine.
The treatment of overdosage is essentially symptomatic and supportive. 
Zdravljenje prevelikega odmerjanja je v osnovi simptomatsko in podporno.
The terminal elimination half-life (T½) ranged from 6 to 8 hours. 
Končni eliminacijski razpolovni čas (T½) je segal od 6 do 8 ur.
• Introductory statement on the purpose of the educational material 
• uvodna izjava o namenu izobraževalnega materiala,
Inclusion in Study 004-301 required a diagnosis of schizophrenia. 
Vključitev v študijo 004-301 je zahtevala diagnozo shizofrenije.
The device exterior may become warm during use. 
Med uporabo se lahko zunanjost naprave segreje.
• Mention of contra-indications and related warnings 
• navedba kontraindikacij in povezanih opozoril,
Key elements to be included in the educational materials: 
Ključni elementi, ki morajo biti vključeni v izobraževalni material: Splošno:
• medicines to treat Parkinson's disease 
• zdravila za zdravljenje Parkinsonove bolezni;
Common: dry mouth 
Pogosti: suha usta
Typically, this will occur within 25 minutes of use. 
Običajno do tega pride v 25 minutah po uporabi.
Such medicinal products may modify efficacy and safety of ADASUVE in an irregular manner. 
Taka zdravila lahko spremenijo učinkovitost in varnost zdravila ADASUVE na nepravilen način.
Read all instructions before use. 
Pred uporabo preberite vsa navodila.
No more than two doses should be administered. 
Več kot dveh odmerkov se ne sme dati.
Treatment N 
Zdravljenje N
Healthcare professionals should ensure the patient will use the inhaler properly. 
Zdravstveni delavec mora zagotoviti, da bo bolnik pravilno uporabljal inhalator.
• have or had low or high blood pressure 
• imate ali ste imeli nizek ali visok krvni tlak;
Intoxication or physical disease (delirium) 
Zastrupitev ali fizična bolezen (delirij)
Loxapine is 96.6% bound to human plasma proteins. 
Loksapin se 96,6 % veže na človeške plazemske beljakovine.
Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings. 
Pregled podskupin populacije (starost, rasa in spol) ni pokazal nikakršne diferencialne odzivnosti na podlagi razvrstitve v podskupine.
In the event of accidental overdosage, signs and symptoms will depend on the number of units taken and individual patient tolerance. 
V primeru nenamernega prevelikega odmerjanja so znaki in simptomi odvisni od števila vzetih enot in tolerance posameznega bolnika.
Instruct the patient to: 
Bolniku dajte napotke, da mora:
Study Patients 
Študija Bolniki
• Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE. 
• Nevroleptični maligni sindrom (NMS) je niz simptomov, ki se lahko pojavijo, če jemljete antipsihotike, vključno z zdravilom ADASUVE.
Pharmacotherapeutic group: psycholeptics, antipsychotics; ATC code: N05AH01 
Farmakoterapevtska skupina: psiholeptiki, antipsihotiki; oznaka ATC: N05AH01
It is known that in humans, long-term treatment with antipsychotics may lead to loss of libido and amenorrhoea. 
Znano je, da dolgotrajno zdravljenje z antipsihotiki pri ljudeh lahko vodi v izgubo libida in amenorejo.
• if you are allergic to loxapine or amoxapine; 
• če ste alergični na loksapin ali amoksapin;
• The indicator light automatically turns off again when the medicine is inhaled. 
• Signalna lučka samodejno znova ugasne, ko je zdravilo inhalirano.
The adverse reactions listed below are categorized using the following convention: 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). 
Spodaj našteti neželeni učinki so razvrščeni v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1000 do < 1/100); redki (≥ 1/10.000 do < 1/1000); zelo redki
Consequently, monitoring of new-borns should be considered. 
Posledično je treba razmisliti o nadzoru novorojenčkov.
Also talk to your doctor if you have any of the following side effects that could also happen with other forms of this medicine: 
Z zdravnikom se posvetujte tudi, če imate katerega koli od naslednjih neželenih učinkov, ki se lahko pojavijo tudi pri drugih oblikah tega zdravila:
Inclusion in Study 004-302 required a diagnosis of bipolar disorder (current episode manic or mixed). 
Vključitev v študijo 004-302 je zahtevala diagnozo bipolarne motnje (prisotna manična ali mešana epizoda).
A majority of the patients in both Phase 3 studies were smokers with about 82% of the patients with schizophrenia and 74% of the patients with bipolar disorder currently smoking. 
Večina bolnikov v obeh študijah faze 3 je bilo kadilcev, pri čemer je trenutno kadilo približno 82 % bolnikov s shizofrenijo in 74 % bolnikov z bipolarno motnjo.
Very common: sedation/somnolence 
Zelo pogosti: sedacija/zaspanost
• worsening agitation or confusion, especially combined with fever or muscle stiffness (rare occurrence). 
• poslabšanje agitacije ali zmedenosti, še posebej v kombinaciji z vročino ali okorelostjo mišic (redek pojav).
Children and adolescents ADASUVE is not for use in children and adolescents under 18 years. 
Otroci in mladostniki Zdravilo ADASUVE ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
In female rats, reproductive effects have been observed (see section 5.3). 
Pri podganjih samicah so opazovali učinke na razmnoževanje (glejte poglavje 5.3).
Loxapine excretion occurs mainly in the first 24 hours. 
Do izločanja loksapina pride večinoma v prvih 24 urah.
Tell your doctor if you are using or have recently used or might use any other medicines, including: 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo, tudi:
Similar changes, e.g., gynecomastia, are known in humans, but only after long-term administration of medicines causing hyperprolactinaemia. 
Podobne spremembe, npr. ginekomastija, so znane pri ljudeh, a le po dolgotrajnem dajanju zdravil, ki povzročajo hiperprolaktinemijo.
Pharmacokinetics in special patient populations 
Farmakokinetika v posebnih populacijah bolnikov
The inhaler is then ready for use. 
Inhalator je takrat pripravljen za uporabo.
Use within 15 minutes after removing the tab (or until the green light turns off) to prevent automatic deactivation of the inhaler. 
Ko odstranite jeziček, morate inhalator uporabiti v 15 minutah (ali dokler zelena lučka ne ugasne), da preprečite samodejno deaktivacijo inhalatorja.
ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. 
Zdravilo ADASUVE se med nosečnostjo lahko uporablja le, če možne koristi upravičijo možno tveganje za zarodek.
Do not open pouch until ready to use. 
Vrečke ne odpirajte, dokler niste pripravljeni na uporabo zdravila.
Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited. 
Zato je tveganje za presnovna medsebojna delovanja, ki bi jih povzročil učinek na posamezno izoobliko, omejeno.
People with this condition may also feel depressed, guilty, anxious or tense. 
Osebe s to boleznijo imajo lahko tudi občutke potrtosti, krivde, tesnobnosti ali napetosti;
• medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.” 
• zdravila, kot so fluvoksamin, propranolol in enoksacin ter druga zdravila, ki zavirajo določen jetrni encim, imenovan “CYP450 1A2”;
Changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species, associated with calming effects and suppression of aggressive behaviour. 
Spremembe ravni razdražljivosti inhibitornih kortikalnih območij so opazili pri več živalskih vrstah, in so bile povezane s pomirjevalnimi učinki in supresijo agresivnega vedenja.
The mean age of randomized patients was 43.1 years in Study 004-301 and 40.8 years in Study 004-302: young adults (18-25 years old) were scarcely (7.3%) represented in either trial. 
Povprečna starost randomiziranih bolnikov je bila 43,1 let v študiji 004-301 in 40,8 let v študiji 004-302: mlajši odrasli (18−25 let) so bili v obeh študijah skromno (7,3 %) zastopani.
About 35% of the patients with schizophrenia were taking concomitant antipsychotics at the time of dosing while approximately 13% of the patients with bipolar disorder were taking these drugs. 
Približno 35 % bolnikov s shizofrenijo je v času odmerjanja sočasno jemalo antipsihotike, medtem ko je ta zdravila jemalo približno 13 % bolnikov z bipolarno motnjo.
This product is packaged in a sealed pouch and should remain in the pouch until ready to use 
Izdelek je pakiran v zapečateno vrečko in mora ostati v vrečki do uporabe.
If you get any of the following side effects, talk to your doctor immediately and stop taking the medicine: 
Če opazite katerega koli od naslednjih neželenih učinkov, se takoj posvetujete z zdravnikom in prenehajte jemati zdravilo:
At therapeutic concentrations, however, it is not expected to inhibit P-gp-mediated transport of other medicinal products in a clinically significant manner. 
Kljub temu ni pričakovati, da bi zdravilo v terapevtskih koncentracijah zaviralo transport drugih zdravil prek P-gp na klinično pomemben način.
Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors, and its interaction with these systems may influence the spectrum of its pharmacological effects. 
Loksapin se veže na noradrenergične, histaminske in holinergične receptorje, njegovo medsebojno delovanje s temi sistemi pa lahko vpliva na spekter njegovih farmakoloških učinkov.
Rescue medication (intramuscular lorazepam) was given if medically required. 
Olajševalno zdravilo (intramuskularni odmerek lorazepama) je bilo dano, če je bilo medicinsko nujno.
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items: 
Imetnik dovoljenja za promet bo zagotovil, da bodo po razpravah in v soglasju z nacionalnimi pristojnimi organi v vsaki državi članici, kjer se bo zdravilo ADASUVE tržilo, ob uvedbi na trg in po uvedbi na trg vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo ADASUVE, prejeli informativni paket, ki bo vseboval naslednje:
• (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. 
• (shizofrenija) slišanje, videnje ali občutenje stvari, ki jih dejansko ni, sumničavost, zmotna prepričanja, nepovezano govorjenje in vedenje ter čustvena praznost.
The potential risk of QTc prolongation due to interaction with medicinal products known to prolong QTc interval is unknown. 
Morebitno tveganje za podaljšanje intervala QTc zaradi medsebojnega delovanja z zdravili, za katera je znano, da podaljšajo interval QTc, ni znano.
Higher doses of lorazepam have not been studied. 
Večjih odmerkov lorazepama niso proučevali.
The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established. 
Varnost in učinkovitost zdravila ADASUVE pri bolnikih, ki so starejši od 65, nista bili dokazani.
IMPORTANT: Check that the green light turns off after the patient inhales. 
POMEMBNO: Preverite, da zelena lučka ugasne, ko bolnik vdihne.
ADASUVE has major influence on the ability to drive and use machines. 
Zdravilo ADASUVE ima velik vpliv na sposobnost vožnje in upravljanja strojev.
A population pharmacokinetic analysis that compared exposures in smokers versus non-smokers indicated that smoking, which induces CYP1A2, had a minimal effect on the exposure to ADASUVE. 
Farmakokinetična analiza populacij, ki je primerjala izpostavljenosti pri kadilcih v primerjavi z nekadilci, je pokazala, da ima kajenje, ki inducira CYP1A2, minimalen učinek na izpostavljenost zdravilu ADASUVE.
A lower dose of 4.5 mg may be given if the 9.1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate. 
Mogoče je dati nižji odmerek 4,5 mg, če odmerka 9,1 mg bolnik pred tem ni dobro prenašal ali če se zdravnik odloči, da je nižji odmerek primernejši.
Store in the original pouch until ready for use in order to protect from light and moisture. 
Shranjujte v originalni vrečki do uporabe, za zagotovitev zaščite pred svetlobo in vlago.
The extent of the excretion of loxapine or its metabolites in human milk is not known. 
Obseg izločanja loksapina ali njegovih metabolitov v materino mleko ni znan.
Clinical studies with both atypical and conventional antipsychotic medicinal products have demonstrated that elderly patients with dementia-related psychosis are at an increased risk of death compared to placebo. 
Klinične študije tako z atipičnimi kot s konvencionalnimi antipsihotiki so pokazale, da pri starejših bolnikih s psihozo, povezano z demenco, obstaja povečano tveganje za smrt v primerjavi s placebom.
The medicinal product has been delivered when the green light turns off. 
Zdravilo je bilo dovedeno, ko zelena lučka ugasne.
You will use ADASUVE under the supervision of a doctor or nurse. 
Zdravilo ADASUVE boste uporabljali pod nadzorom zdravnika ali medicinske sestre.
The safety and efficacy of ADASUVE has not been evaluated in patients with agitation due to intoxication or physical disease (delirium). 
Varnost in učinkovitost zdravila ADASUVE nista bili preučeni pri bolnikih z agitacijo zaradi zastrupitve ali fizične bolezni (delirija).
Women in the schizophrenia trial were scarcely represented (26.5%), and about half of the patients were male (49.7%) in Study 004-302. 
Ženske so bile skromno zastopane v študiji s shizofrenijo (26,5 %) in približno polovica bolnikov (49,7 %) v študiji 004-302 je bila moškega spola.
Before treatment with ADASUVE, tell your doctor or nurse if you: 
Pred začetkom zdravljenja z zdravilom ADASUVE povejte zdravniku ali medicinski sestri, če:
These can be associated with a severe condition called neuroleptic malignant syndrome (NMS) 
To je lahko povezano z resnim stanjem, ki se imenuje nevroleptični maligni sindrom (NMS).
Do not use ADASUVE if you notice an open or torn pouch or any signs of physical damage to the medicine. 
Ne uporabljajte zdravila ADASUVE, če opazite, da je vrečka odprta ali pretrgana ali kakršne koli znake fizične poškodbe zdravila.
Very common (may affect more than 1 in 10 people): bad taste in the mouth or sleepiness. 
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): slab okus v ustih ali zaspanost.
After the doctor or nurse has prepared ADASUVE for you to use, you will be asked to take the device in your hand, exhale and then put the mouthpiece in your mouth, inhale the medicine through the device and then hold your breath briefly. 
Ko vam zdravnik ali medicinska sestra pripravita zdravilo ADASUVE za uporabo, vas bosta prosila, da primete pripomoček v roko, izdihnete in nato vstavite ustnik v usta, vdihnete zdravilo skozi pripomoček, nato pa za kratek čas zadržite dih.
Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE. 
Zdi se, da klinično pomembno podaljšanje intervala QT ni povezano z enkratnimi ali ponavljajočimi odmerki zdravila ADASUVE.
• Administration of a maximum of 2 doses 
• dajanje največ dveh odmerkov,
Most of these events occurred within 25 minutes of dosing, were mild to moderate in severity, and could be relieved with an inhaled bronchodilator. 
Do večine teh dogodkov je prišlo v 25 minutah po odmerjanju in so bili po izraženosti blagi do zmerni ter jih je bilo mogoče olajšati z inhaliranim bronhodilatatorjem.
PEC Change 
Sprememba PEC
The white inhaler (housing) is molded from a medical-grade polycarbonate. 
Beli inhalator (ohišje) je oblikovan iz polikarbonata medicinske kakovosti.
Patients should receive regular treatment immediately after control of acute agitation symptoms. 
Bolniki morajo takoj po obvladanju akutnih simptomov agitacije prejeti redno zdravljenje.
Not all pack-sized may be marketed. 
Na trgu morda ni vseh navedenih pakiranj.
The effects of the combination on sedation appeared to be additive. 
Učinki te kombinacije zdravil na sedacijo so se izkazali za aditivne.
ADASUVE works by blocking certain chemicals in the brain (neurotransmitters) such as dopamine and serotonin thus causing calming effects and relieving aggressive behaviour. 
Zdravilo ADASUVE deluje tako, da blokira določene kemične snovi v možganih (nevrotransmiterje), kot sta dopamin in serotonin, ter tako povzroči pomirjevalne učinke in olajša agresivno vedenje.
• have or had urinary retention (incomplete emptying of the bladder) 
• imate ali ste imeli zastajanje urina (nepopolno praznjenje mehurja);
• if you have symptoms of wheezing or shortness of breath; 
• če imate simptome sopenja ali kratke sape;
In vitro studies indicated that loxapine was not a substrate for P-glycoprotein (P-gp), but does inhibit P-gp. 
In vitro študije so pokazale, da loksapin ni substrat za P-glikoprotein (P-gp), vendar pa zavira P-gp.
ADASUVE should only be administered in a hospital-setting under the supervision of a healthcare professional. 
Zdravilo ADASUVE se sme dajati le v bolnišničnem okolju pod nadzorom zdravstvenega delavca.
Animal studies following oral administration suggest an initial preferential distribution in the lungs, brain, spleen, heart and kidney. 
Študije na živalih po peroralnem dajanju so pokazale začetno preferenčno porazdelitev v pljuča, možgane, vranico, srce in ledvice.
• Addtional risk minimisation measures 
• Dodatni ukrepi za zmanjševanje tveganj
What ADASUVE is and what it is used for 2. 
Kaj je zdravilo ADASUVE in za kaj ga uporabljamo 2.
Do not use in patients with asthma or COPD or acute respiratory symptoms 
Ne uporabljajte pri bolnikih z astmo ali KOPB ali z akutnimi simptomi motenj dihanja.
The use of loxapine in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products) has not been evaluated. 
Uporaba loksapina pri bolnikih, ki so se zastrupili z alkoholom ali z drugim zdravilom (bodisi predpisanim ali nedovoljenim zdravilom), ni bila ocenjena.
The efficacy of loxapine is proposed to be mediated through high affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors. 
Za učinkovitost loksapina se predpostavlja, da poteka prek visokoafinitetnega antagonizma receptorjev dopamina D2 in receptorjev serotonina 5-HT2A.
Demographics 
Demografski podatki
Do not use ADASUVE after the expiry date which is stated on the product label. 
Ne uporabljajte zdravila ADASUVE po datumu izteka roka uporabnosti, ki je naveden na ovojnini zdravila.
Hold Breath. 
Potegnite jeziček.
White device with a mouthpiece on one end and a pull-tab protruding from the other end. 
Bel pripomoček z ustnikom na eni strani in z jezičkom na poteg, ki sega z drugega konca.
A second dose can be given after 2 hours, if necessary. 
Po potrebi je drugi odmerek mogoče dati po 2 urah.
Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics. 
Ekstrapiramidni simptomi (vključno z akutno distonijo) so znani razredni učinki antipsihotikov.
Concomitant use of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin, enoxacin, propranolol and refecoxib) should be avoided, if possible. 
Če je mogoče, se je treba sočasni uporabi inhibitorjev CYP1A2 (kot so fluvoksamin, ciprofloksacin, enoksacin, propranolol in refekoksib) izogibati.
Consequently, patients receiving ADASUVE should be observed as appropriate following dosing. 
Zato je bolnike, ki prejemajo zdravilo ADASUVE, po odmerjanju treba ustrezno opazovati.
• medicines to treat a breathing problem 
• zdravila za zdravljenje težav z dihanjem;
EU/1/13/823/001 (5 single-dose inhalers) EU/1/13/823/003 (1 single-dose inhaler) 
EU/1/13/823/001 (5 inhalatorjev z enkratnim odmerkom) EU/1/13/823/003 (1 inhalator z enkratnim odmerkom)
What you need to know before you use ADASUVE 3. 
Kaj morate vedeti, preden boste uporabili zdravilo ADASUVE 3.
If you use more ADASUVE than you should 
Če ste uporabili večji odmerek zdravila ADASUVE, kot bi smeli
• light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence); 
• vrtoglavico ali omedlevico, saj lahko to pomeni, da zdravilo znižuje krvni tlak (občasni pojav);
The safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established. 
Varnost in učinkovitost zdravila ADASUVE pri otrocih (mlajših od 18 let) nista bili dokazani.
Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (Tmax) by 2 minutes. 
Dajanje zdravila ADASUVE je povzročilo hitro absorpcijo loksapina z medianim časom najvišje plazemske koncentracije (Tmax) za 2 minuti.
Hypersensitivity to the active substance, or to amoxapine. 
Preobčutljivost na učinkovino ali na amoksapin.
• if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”). 
• če imate težave s pljuči, kot je astma ali kronična obstrukcijska pljučna bolezen (ki jo je zdravnik morda imenoval “KOPB”).
Once the pull-tab is removed, a green light turns on, indicating the product is ready for use (Note: the product must be used within 15 minutes of pulling the tab). 
Ko odstranite jeziček na poteg, se prižge zelena lučka, kar pomeni, da je zdravilo pripravljeno za uporabo (opomba: ko potegnete za jeziček, morate zdravilo uporabiti v 15 minutah).
EU/1/13/823/002 (5 single-dose inhalers) EU/1/13/823/004 (1 single-dose inhaler) 
EU/1/13/823/002 (5 inhalatorjev z enkratnim odmerkom) EU/1/13/823/004 (1 inhalator z enkratnim odmerkom)
If benzodiazepine therapy is deemed necessary in addition to loxapine, patients should be monitored for excessive sedation and for orthostatic hypotension. 
Če se zdravljenje z benzodiazepini smatra za nujno potrebno poleg loksapina, je treba bolnike spremljati glede prekomerne sedacije in ortostatske hipotenzije.