natgillin/translations-raw huggingface dataset:
• Information on placing the patient into recovery position and administering the second dose, if required, in this position
• informacijo o tem, da je treba bolnika namestiti v stabilno lego na boku in mu v tem položaju dati drugi odmerek, če je potrebno
Do not prime or test the Nyxoid nasal spray before use as it contains only one dose of naloxone and cannot be reused.
Pred uporabo iz vsebnika ne iztiskajte zraka oziroma ga ne preskušajte, saj vsebuje samo en odmerek naloksona in ga ni mogoče ponovno uporabiti.
Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3).
Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja samo pri odmerkih, ki so bili toksični za mater (glejte poglavje 5.3).
Onset of action following intranasal administration can reasonably be expected to occur in each individual before the tmax is reached.
Zato je razumno pričakovati, da bo po intranazalnem dajanju pri vseh posameznikih mogoče opaziti začetek delovanja zdravila, še preden bo dosežena tmax.
Contents of the pack and other information What Nyxoid contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nyxoid
Patients or any other person who might be in a position to administer Nyxoid must be instructed in its proper use and the importance of seeking medical assistance.
Bolniki ali druge osebe, ki bodo morda morale dati zdravilo Nyxoid, morajo biti poučene o pravilni uporabi zdravila in pomenu klicanja medicinske pomoči.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
• Changes in behaviour including violent behaviour, nervousness, anxiety, excitement,
• spremembe v vedenju, vključno z agresivnim vedenjem, živčnost, tesnobnost, vznemirjenost,
Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.
Znaki in simptomi sindroma odtegnitve zdravila vključujejo nemir, razdražljivost, hiperestezijo, slabost (navzea), bruhanje, bolečine v prebavilih, mišične krče, disforijo, nespečnost, anksioznost, hiperhidrozo, piloerekcijo, tahikardijo, povišan krvni tlak, zehanje, pireksijo.
The principal metabolites are naloxone-3-glucuronide, 6-beta-naloxol and its glucuronide.
Glavni presnovki so nalokson-3-glukuronid, 6-beta-naloksol in njegovi glukuronidi.
However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible.
Ker pa biološka razpoložljivost naloksona pri peroralni uporabi skoraj ni prisotna, je verjetnost, da bo zdravilo vplivalo na dojenega otroka, zanemarljiva.
Reversal of buprenorphine-induced respiratory depression may be incomplete.
Nevtralizacija z buprenorfinom izzvane respiratorne depresije je lahko nepopolna.
• The patient/carer information card
• Informacijsko kartico za bolnika/negovalca
Your baby could suffer from sudden opioid withdrawal syndrome, which could be life-threatening if not treated.
Pri vašem otroku se lahko pojavi sindrom nenadne opioidne odtegnitve, ki je lahko življenjsko nevaren, če ni zdravljen.
It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone.
Ni znano, ali se nalokson izloča v materino mleko, in ni bilo ugotovljeno, ali nalokson vpliva na dojene otroke.
• A brief introduction on Nyxoid
• Kratek uvod o zdravilu Nyxoid
Therefore, the prescriber should take appropriate steps to ensure that the patient and/or any other person who might be in a position to administer Nyxoid thoroughly understands the indications and use of Nyxoid.
Zato mora zdravnik, ki predpiše zdravilo, z ustreznimi koraki zagotoviti, da bolnik in/ali druga oseba, ki bo zdravilo Nyxoid morda morala dati drugi osebi, v celoti razume indikacije zdravila Nyxoid in njegovo uporabo.
Naloxone had no effect on fertility and reproduction in the rat or on early embryonic development of the rat and rabbit.
Nalokson ni imel nobenega učinka na plodnost in razmnoževanje pri podganah ali na zgodnji razvoj zarodka pri podganah in kuncih.
• It should be available as o A link for online access in the HPD and PIC o Memory stick for HCP use to train, if WiFi not accessible
• na voljo naj bo kot o povezava za spletni dostop v HPD in informacijski kartici za bolnika o ključek USB, ki ga zdravstveni delavec uporablja za vadbo, če WiFi ni na voljo
After taking this medicine, you must not drive, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours, since the effects of opioids may recur.
Ko vzamete to zdravilo, najmanj 24 ur po prejetju zdravila ne smete voziti, upravljati s stroji ali opravljati zahtevnih telesnih in umskih aktivnosti, saj se opioidni učinek lahko pojavi znova.
Detailed instructions on how to use Nyxoid are provided in the Package Leaflet and a Quick Start Guide is printed on the back of each blister.
Podrobna navodila o uporabi zdravila Nyxoid so na voljo v Navodilih za uporabo in Kratkih navodilih, ki so natisnjena na zadnji strani vsakega pretisnega omota.
The Video should include:
Videoposnetek naju vključuje:
CAMBRIDGE, CB4 0GW,
CAMBRIDGE, CB4 0GW, Velika Britanija
Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8).
O hipertenziji, srčnih aritmijah, pljučnem edemu in srčnem zastoju so pogosteje poročali pri pooperativnem dajanju naloksona (glejte poglavji 4.4 in 4.8).
Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.
Preverite, ali so prisotni znaki prekomernega odmerjanja, npr.: neodzivnost na dotik ali zvoke, počasno neenakomerno dihanje ali odsotnost dihanja, smrčanje, sopenje ali goltanje, modri ali vijolični nohti na rokah ali ustnicah.
The signs and symptoms of an opioid overdose can return after this nasal spray is given.
Znaki in simptomi prekomernega odmerka opioidov se lahko po odmerjanju tega pršila za nos povrnejo.
After 2-3 mins, use 2nd spray.
Po 2-3 minutah uporabite drugo pršilo.
Nyxoid works for a short time only to reverse the effects of opioids while you wait for emergency medical attention.
Zdravilo Nyxoid kratkoročno nevtralizira učinke opioidov za obdobje, ko čakate na nujno medicinsko pomoč.
Following an IV dose of 125 µg, 38% of the dose was recovered in the urine within 6 hours in healthy volunteers compared with 25% of the dose being recovered in opioid-dependent patients in the same time period.
dajanju 125-µg odmerka se je v šestih urah pri zdravih prostovoljcih z urinom izločilo 38 % odmerka, pri bolnikih, ki so zasvojeni z opioidi, pa se je v istem obdobju z urinom izločilo 25 % odmerka.
Each spray contains only one dose.
En vsebnik za pršilo vsebuje samo en odmerek.
However, reversal of respiratory depression caused by buprenorphine is limited.
Nevtralizacija respiratorne depresije, ki je posledica buprenorfina, je omejena.
Naloxone was not mutagenic in the bacterial reverse mutation assay, but was positive in mouse lymphoma assay and was clastogenic in vitro, however, naloxone was not clastogenic in vivo.
Nalokson ni bil mutagen pri preskusu reverzne mutacije pri bakterijah, vendar je bil v preskusu na celicah mišjega limfoma in vitro klastogen, in vivo pa ni bil klastogen.
Naloxone does not possess the "agonistic" or morphine-like properties characteristic of other opioid antagonists.
Nalokson nima »agonističnih« lastnosti ali morfiju podobnih lastnosti, ki so značilne za druge opioidne antagoniste.
Hypersensitivity, Anaphylactic shock
preobčutljivost, anafilaktični šok
Not better?
Ne opazite izboljšanja?
• Details of what information needs to be shared when training the patient/carer o how to manage a known or suspected opioid overdosed and how to properly administer Nyxoid o how to minimise the occurrence and severity of the following risks associated with Nyxoid: reappearance of respiratory depression, precipitation of acute opioid withdrawal effect and lack of efficacy due to medication error
• Eznam izobraževalnih gradiv, vključenih v izobraževalni program • Podrobnosti o informacijah, ki jih je treba deliti pri izobraževanju bolnika/negovalca o kako ravnati pri znanem prevelikem odmerjanju opioida ali sumu nanj in kako pravilno dati zdravilo Nyxoid o kako zmanjšati pojav in resnost naslednjih tveganj, povezanih z zdravilom Nyxoid: ponovni pojav respiratorne depresije, povzročitev akutnega opioidnega odtegnitvenega učinka in neučinkovitost zaradi napake pri odmerjanju
Nasal use.
Za nazalno uporabo.
In patients who are unconscious and not breathing normally additional life-saving support should be given if possible.
Če bolnik izgubi zavest in če njegovo dihanje ni normalno, lahko bolniku nudite dodatne postopke oživljanja, če je to možno.
ADRs are listed below by system organ class and frequency.
Spodnji neželeni učinki zdravila so navedeni po organskem sistemu in pogostnosti.
• breathing problems
• težave z dihanjem,
In the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Zdravilo v odsotnosti opioidov ali agonističnih učinkov drugih opioidnih antagonistov ne kaže skoraj nobenih farmakoloških učinkov.
If the patient is no better within 2-3 minutes, a second dose can be given.
Če bolnik v 2 do 3 minutah ne občuti izboljšanja, mu lahko daste drugi odmerek.
If the patient does not respond, the second dose should be administered after 2-3 minutes.
Če se bolnik ne odzove, mu je treba po 2 do 3 minutah dati drugi odmerek.
It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses.
Ta učinek naj bi bil rezultat krivulje odziva na odmerek buprenorfina, ki ima obliko loka, pri katerem se analgezija s povečevanjem odmerka zmanjšuje.
After a period of 72 hours, 65% of the injected dose was recovered in urine in the healthy volunteers compared with 68% of the dose in opiate-dependent patients.
Po 72 urah se je pri zdravih prostovoljcih z urinom izločilo 65 % injiciranega odmerka, pri bolnikih, ki so zasvojeni z opioidi, pa 68 % odmerka.
Naloxone is rapidly metabolized in the liver and excreted in the urine.
Nalokson se hitro presnovi v jetrih in se izloči z urinom.
The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience.
Pri uporabi zdravila Nyxoid in/ali drugih zdravil, ki vsebujejo nalokson, so v kliničnih študijah in postmarketinških izkušnjah poročali o naslednjih neželenih učinkih.
Uncommon Arrhythmia, Bradycardia Very rare
Občasni aritmija, bradikardija
Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine.
Nalokson začasno nevtralizira učinek opioidov, kot so heroin, metadon, fentanil, oksikodon, buprenorfin in morfij.
This may necessitate repeat doses of naloxone - though the need for repeat naloxone doses is dependent on the quantity, type and route of administration of the opioid agonist that is being treated.
Zato bodo morda potrebni ponovni odmerki naloksona, vendar je ponovljeno odmerjanje naloksona odvisno od količine, vrste in načina dajanja opioidnega agonista, ki ga želimo nevtralizirati.
What Nyxoid is and what it is used for What you need to know before you receive Nyxoid How Nyxoid is to be given Possible side effects
Kaj je zdravilo Nyxoid in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Nyxoid Kako se daje zdravilo Nyxoid
Nyxoid is not for use in children or adolescents under 14 years.
Zdravilo Nyxoid ni namenjeno za uporabo pri otrocih ali mladostnikih, mlajših od 14. leta.
Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered.
Pri bolnikih, ki opioide prejemajo za lajšanje kronične bolečine, se lahko po dajanju zdravila Nyxoid pojavijo bolečine in simptomi opioidne odtegnitve.
Naloxone is therefore not teratogenic in rats or rabbits.
Nalokson zato pri podganah ali kuncih nima teratogenega učinka.
Vomiting Uncommon Diarrhoea, Dry mouth
Občasni diareja, suha usta
Do not prime or test before use.
Ne preskušajte pred uporabo
Do not use this medicine after the expiry date which is stated on the carton, blister pack and the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
If you are given Nyxoid while you are pregnant or breast-feeding, your baby should be closely monitored.
Če prejmete zdravilo Nyxoid v nosečnosti ali ko dojite, morajo vašega dojenčka skrbno nadzorovati.
Further doses (if available) should be administered in alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergency services.
Dodatne odmerke (če je to ustrezno) je treba bolniku dati v nosnice in ga nato nadzorovati, dokler ne prispe nujna pomoč.
• Information on how to use the nasal spray to correctly administer Nyxoid
• informacijo o tem, kako uporabljati nazalno pršilo za pravilno dajanje zdravila Nyxoid
In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress.
Pri nosečnicah, zdravljenih z zdravilom Nyxoidom, je potrebno spremljanje fetusa zaradi znakov stiske.
Cardiac fibrillation, Cardiac arrest
Zelo redki srčna fibrilacija, srčni zastoj
The side effects below may happen with this medicine.
Pri tem zdravilu se lahko pojavijo spodnji neželeni učinki.
Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects.
Intranazalna absorpcija in učinkovitost naloksona se lahko spremenita pri bolnikih, ki imajo poškodovano nosno sluznico in defekte pretina.
• Being sick (vomiting)
• slabost (bruhanje)
Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
Pršilo za nos primite tako, da palec položite na dno bata, kazalec in sredinec pa na vsako stran razpršilne šobe.
In peri-post natal rat studies, naloxone produced increased pup deaths in the immediate post-partum period at the high doses that also caused significant maternal toxicity in rats (e.g. bodyweight loss, convulsions).
V perinatalnih in postnatalnih študijah pri podganah je nalokson v obdobju takoj po rojstvu v večjih odmerkih, ki so privedli tudi do bistveno povečane toksičnosti pri materah (npr. izguba telesne mase, konvulzije), povzročil večjo incidenco smrti pri mladičih.
Receiving Nyxoid can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome (see section 4.8).
Ob prejemu zdravila Nyxoid se lahko učinek opioida hitro nevtralizira, kar lahko privede do akutnega odtegnitvenega sindroma (glejte poglavje 4.8).
• Unpleasant or uncomfortable mood
• slabo počutje ali razpoloženje
Intranasal administration of naloxone has demonstrated naloxone to be rapidly absorbed, as evidenced by very early appearance (as early as 1 minute after administration) of the active substance in systemic circulation.
Nalokson se je pri intranazalnem dajanju hitro absorbiral, kar dokazuje zelo hitra prisotnost učinkovine v sistemskem obtoku (že 1 minuto po dajanju).
Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous (IV) injection, when IV access is not immediately available.
Zdravilo Nyxoid ne more nadomestiti nujne medicinske oskrbe in se lahko uporabi namesto intravenskega injiciranja (i.v.
A study demonstrated mean absolute bioavailability of 47% and mean half-lives of 1.4 h from intranasal doses of 2 mg.
Študija z intranazalnimi odmerki 2 mg je pokazala, da absolutna biološka razpoložljivost zdravila v povprečju znaša 47 % in da ima zdravilo povprečni razpolovni čas 1,4 ure.
In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4).
Pri nosečnicah, ki so zasvojene z opioidi, lahko dajanje naloksona privede do simptomov odtegnitve pri novorojenčkih (glejte poglavje 4.4).
Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.
Bolnike, ki so nalokson prejeli za nevtralizacijo opioidnih učinkov, je treba opozoriti, da najmanj 24 ur po prejetju zdravila ne smejo voziti, upravljati s stroji ali opravljati zahtevnih telesnih in umskih aktivnosti, ker se opioidni učinek lahko znova pojavi.
This medicine contains naloxone in 0.1 ml of a clear, colourless to pale yellow solution in a pre-filled nasal spray, solution in a single dose container.
To zdravilo vsebuje 0,1 ml bistre, brezbarvne do bledo rumene raztopine naloksona v napolnjenem pršilniku za nos, raztopina v enoodmernem vsebniku.
Spray into one nostril.
Šobo pripomočka nežno vstavite v eno nosnico.
Stay with the patient and continue to watch for an improvement until the emergency services arrive who will give further treatment.
Ostanite z bolnikom, dokler ne prispe nujna medicinska pomoč, ki mu bo nudila nadaljnje zdravljenje, in opazujte, ali se pri bolniku pojavi izboljšanje.
The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution.
Stično ovojnino sestavlja viala iz stekla tipa I s silikoniziranim zamaškom iz klorobutila, ki vsebuje 0,1 ml raztopine.
• Rapid breathing
• hitro dihanje
How to store Nyxoid
Kako dajati zdravilo Nyxoid
The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency very common).
Najpogostejši neželeni učinek zdravila, o katerem so poročali pri dajanju naloksona, je slabost (zelo pogosti).
• Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers will have access to the video (either through the PIC or memory stick) and are encouraged to read the quick starting guide (QSG) and package leaflet included in the medicinal product outer carton.
• Navodila, da mora zdravstveni delavec bolniku/negovalcu izročiti informacijsko kartico za bolnika in zagotoviti, da imata bolnik/negovalec dostop do videoposnetka (s pomočjo informacijske kartice za bolnika ali ključek USB) in ju spodbuditi, da prebereta kratka navodila in navodilo za uporabo, priložena v škatli zdravila.
Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting.
Zdravilo Nyxoid je namenjeno za uporabo kot del postopka oživljanja pri domnevnih žrtvah prekomernega odmerjanja, pri katerih obstaja možnost zlorabe opioidnih mamil oziroma suma nanjo, najpogosteje v nemedicinskih okoljih.
Nyxoid is packed in a carton containing 2 nasal sprays individually sealed in blisters.
Zdravilo Nyxoid je pakirano v škatli z dvema pršiloma za nos, ki sta posamično pakirana v pretisni omot.
Receiving Nyxoid close to giving birth Tell your midwife or doctor if you have received Nyxoid close to or during labour.
Odmerjanje zdravila Nyxoid tik pred porodom Babici ali zdravniku povejte, če ste zdravilo Nyxoid prejeli tik pred porodom ali med porodom.
Tilt head back.
Glavo nagnite nazaj.
There are no data available on the excretion of naloxone following intranasal administration, however, the disposition of labelled naloxone following IV administration was studied in healthy volunteers and opioid-dependent patients.
Podatkov o izločanju naloksona po intranazalnem dajanju ni na voljo, vendar so pri zdravih prostovoljcih in bolnikih, ki so zasvojeni z opioidi, preučevali porazdelitev označenega naloksona po intravenskem dajanju.
Lay in recovery position.
Položite osebo v stabilni bočni položaj.
• Steps detailing management of a patient which are aligned with information in PIC and package leaflet
• korake, ki podrobno opisujejo obravnavo bolnika, in so v skladu z informacijami na informacijski kartici za bolnika in navodilom za uporabo
Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding.
Pri dajanju naloksona doječi materi je potrebna previdnost, vendar z dojenjem ni treba prenehati.
• Tremor
Občasni tremor
Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis Very rare
Bolezni kože in podkožja Občasni hiperhidroza
What Nyxoid looks like and contents of the pack
Izgled zdravila Nyxoid in vsebina pakiranja
This medicine contains the active substance naloxone.
To zdravilo vsebuje učinkovino nalokson.
Support the back of the neck and allow the head to tilt back.
Bolniku podprite vrat, da bo njegova glava nagnjena nekoliko nazaj.
This leaflet was last revised in.
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
Conditions to look out for
Stanja, na katera morate biti pozorni
• Life-threatening irregular heartbeat, heart attack
• življenjsko nevaren nepravilen srčni utrip, srčna kap
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Zdravilo Nyxoid je namenjeno za takojšnjo uporabo kot nujno zdravljenje ob prevelikem odmerku opioida ali sumu nanj, ki se kaže v obliki respiratorne depresije in/ali depresije centralnega živčnega sistema v bolnišničnem okolju ali zunaj njega.
Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability.
Dojene otroke mater, ki so prejemale zdravilo Nyxoid, je treba spremljati zaradi znakov sedacije ali razdražljivosti.
As the duration of action of some opioid agonists may be longer than that of naloxone, the effects of the opioid agonist may return as the effects of naloxone disappear.
Ker je lahko trajanje delovanja pri nekaterih opioidnih agonistih daljše kot pri naloksonu, se lahko po koncu učinkovanja naloksona učinki opioidnih agonistov pojavijo znova.
• Reference to the QSG on the back of the product immediate packaging
• sklicevanje na hitra navodila na hrbtni strani stične ovojnine zdravila
- The other ingredients are trisodium citrate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and purified water.
- Druge sestavine zdravila so trinatrijev citrat dihidrat, natrijev klorid, klorovodikova kislina, natrijev hidroksid in prečiščena voda.
Nyxoid contains only one dose and therefore it must not be primed or tested prior to administration.
Zdravilo Nyxoid vsebuje le en odmerek, zato pred uporabo iz njega ne iztiskajte zraka in ga ne preskušajte.
A study investigating intranasal naloxone at doses of 1, 2, 4 mg (MR903-1501) shows that the median (range) tmax associated with intranasal administration of naloxone was 15 (10, 60) minutes for
Študija, ki preiskuje intranazalno dajanje naloksona v odmerkih 1 mg, 2 mg in 4 mg (MR903-1501), kaže, da je z intranazalnim dajanjem povezana mediana (razpon) tmax 15(10, 60) minut za 1-mg, 30 (8, 60) minut za 2-mg in 15 (10, 60) minut za 4-mg intranazalne odmerke.
• HCP Guidance Document with training delivery instructions
• Dokument s smernicami za zdravstvene delavce z navodili za vadbo uporabe zdravila
Reproductive and developmental toxicity
Škodljiv vpliv na sposobnost razmnoževanja in razvoj