natgillin/translations-raw huggingface dataset:
Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.
Informacije o zdravilni učinkovini zaleplon že vsebujejo opozorila, vendar je PRAC na podlagi razpoložljivih podatkov menil, da je v okviru tega postopka razumno, da se poudari besedilo v SmPC in PIL ter tako zagotovi, da so bolnikom in zdravstvenim delavcem na voljo jasne informacije glede tveganja za pojav resnih motenj psihomotoričnih sposobnosti naslednji dan.
Treatment of Sonata overdose is largely supportive.
Zdravljenje prevelikega odmerjanja zdravila Sonata je predvsem podporno.
Children and adolescents under 18 years of age must not take Sonata.
Otroci in mladostniki, mlajši od 18 let, ne smejo jemati zdravila Sonata.
In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
V zelo redkih primerih so poročali o nekaterih resnih alergičnih reakcijah, npr. o težavah z dihanjem, ki lahko zahtevajo takojšnjo zdravniško oskrbo.
The elimination half-life of zaleplon is approximately 1 hour.
Razpolovna doba izločanja zaleplona je približno 1 ura.
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
Follow-up studies indicated that impaired fertility was due to an effect on the female.
Študije nadaljnjega spremljanja so pokazale, da je bila zmanjšana plodnost posledica učinka na samice.
PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
FARMACEVTSKA OBLIKA IN VSEBINA 7 trdih kapsul
Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations are reached in approximately 1 hour.
Zaleplon se hitro in skoraj v celoti absorbira po peroralnem zaužitju, največjo koncentracijo pa doseže po približno 1 uri.
visual impairment, diplopia
motnja vida, diplopija
What Sonata is and what it is used for What you need to know before you take Sonata How to take Sonata
Kaj je zdravilo Sonata in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sonata Kako jemati zdravilo Sonata
Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Izločanje Zaleplon se izloča v obliki neaktivnih presnovkov, predvsem s sečem (71%) in blatu (17%).
• There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event.
• Možno je, da se bo pri vas pojavil somnambulizem (mesečnost), vključno z uživanjem hrane ali vožnjo avtomobila, tačas ko ne boste povsem budni, tega pa se pozneje ne boste spominjali.
Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Zdravilo Sonata ni vplivalo na farmakokinetični in farmakodinamični profil digoksina in varfarina, dveh učinkovin z ozkim terapevtskim indeksom.
The value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined.
Vrednost prisilne dialize ali hemodialize pri zdravljenju prevelikega odmerjanja ni bila ugotovljena.
Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Zdravilo Sonata lahko povzroči omotico, izgubo koncentracije ali spomina ali mišično šibkost.
In severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after ingestion.
V hujših primerih sta lahko koristna uporaba aktivnega oglja ali izpiranje želodca, če se ju opravi kmalu po zaužitju.
Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day.
Uživanje alkohola med zdravljenjem z zdravilom Sonata lahko prav tako povzroči zaspanost naslednji dan.
• If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.
• Če nespečnost traja še naprej ali se poslabša po kratkotrajnem zdravljenju z zdravilom Sonata, se posvetujte s svojim zdravnikom.
• Use with extreme caution if you have ever been addicted to medicines or alcohol.
• Zdravilo Sonata uporabljajte še posebej previdno, če ste bili kdaj odvisni od zdravil ali alkohola.
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Sonata at recommended doses in humans.
Na splošno izsledki predkliničnih študij ne kažejo nobenih bistvenih nevarnosti pri uporabi zdravila Sonata v priporočenih odmerkih za ljudi.
The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
What Sonata is and what it is used for
Kaj je zdravilo Sonata in za kaj ga uporabljamo
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness.
Ob prenehanju zdravljenja se vam lahko povrne prvotna nespečnost ter lahko občutite simptome, kot so spremembe razpoloženja, tesnoba in nemir.
Zaleplon's pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Farmakokinetični profil zaleplona kaže hitro absorpcijo in eliminacijo zdravila (glejte poglavje 5.2).
depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
depersonalizacija, halucinacije, depresija, zmedenost, apatija somnambulizem
Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.
Poročali so o povečanju koncentracije transaminaz (skupina jetrnih encimov, ki se nahajajo v krvi), kar je lahko znak motenj v delovanju jeter.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Sonata.
Skupaj s selektivnostjo vezave na poseben podtip receptorjev, veliko selektivnostjo in majhno afiniteto za benzodiazepinski receptor tipa I so te lastnosti odgovorne za splošne značilnosti zdravila Sonata.
A routine dosage adjustment of Sonata is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Rutinska prilagoditev odmerka zdravila Sonata ni potrebna, vendar morate bolnike opozoriti na možnost okrepitve uspavalnih učinkov.
The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Oksidativni presnovki zdravila se presnavljajo naprej s konjugacijo prek glukuronidacije.
No adverse effects on embryofetal development were observed in rabbits.
Neželenih učinkov na embriofetalni razvoj pri kuncih niso opazili.
Dependence
Odvisnost
Use of Sonata is not recommended during pregnancy.
Odsvetujemo uporabo zdravila Sonata v času nosečnosti.
In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Poleg tega ibuprofen kot primer učinkovine, ki spremenijo ledvično izločanje zdravila, ni pokazal nobenih interakcij z zdravilom Sonata.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcije glukoze/galaktoze ne smejo jemati tega zdravila.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Če angioedem prizadene jezik, glotis ali larinks, lahko nastopi obstrukcija zračnih poti, ki se lahko konča s smrtjo.
Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.
Čeprav se takšne oblike vedenja, kot je vožnja v polsnu, lahko pojavijo, če bolnik vzame samo sedativ/hipnotik v terapevtskih odmerkih, se zdi, da uživanje alkohola in drugih depresorjev centralnega živčnega sistema (CŽS) skupaj s sedativi/hipnotiki zveča nevarnost takšnih oblik vedenja, isto pa velja za prekoračitev največjega priporočenega odmerka zdravila.
Amnestic effects may be associated with inappropriate behaviour (see section 4.4).
Učinki v smislu amnezije so združeni s pojavom neprimernega vedenja (glejte poglavje 4.4).
Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Zaleplon je lipofilna snov s porazdelitvenim volumnom okoli 1,4 ± 0,3 l/kg po intravenskem odmerku.
Sonata's efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
Učinkovitost zdravila Sonata je bila dokazana tako v študijah v spalnih laboratorijih z uporabo meritev spanja pri objektivni polisomnografiji (PSG) in v ambulantnih študijah z vprašalniki, v katerih so bolniki ocenjevali svoje spanje.
While there were no significant findings in relation to zaleplon, a small number of cases have been reported in the post-marketing setting, although mostly in combination with other CNS depressant agents and at doses greater than 10mg.
V zvezi z zaleplonom sicer ni bilo pomembnejših ugotovitev, poročali pa so o majhnem številu primerov v obdobju po prihodu zdravila na trg, čeprav večinoma v kombinaciji z drugimi zdravili za zaviranje CŽS in v odmerkih, večjih od 10mg.
There are different doses for people who are 65 or older, and those who have mild to moderate liver problems: 65 or older: Take one 5 mg capsule Mild to moderate liver problems: Take one 5 mg capsule
Za osebe, ki so stare 65 let in več in za tiste z rahlimi do zmernimi težavami z jetri so odmerki različni: Osebe stare 65 let ali starejše: vzemite eno 5 mg kapsulo Osebe z rahlimi do zmernimi težavami z jetri: vzemite eno 5 mg kapsulo
Caution is recommended for patients performing skilled tasks.
Previdnost je priporočena pri bolnikih, ki opravljajo zahtevna opravila.
Patients should be advised not to take a second dose within a single night.
Bolnikom odsvetujte, da bi vzeli drugi odmerek v isti noči.
The in vitro plasma protein binding is approximately 60%, suggesting little risk of active substance interaction due to protein binding.
In vitro vezava na plazemske beljakovine znaša približno 60%, kar pomeni majhno tveganje za pojav medsebojnega delovanja zdravilne učinkovine z drugimi zdravili zaradi vezave na beljakovine.
Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Pri novorojenčkih mater, ki so kronično jemale benzodiazepine in snovi, podobne benzodiazepinom, v zadnji fazi nosečnosti, se je lahko pojavila telesna odvisnost od zdravila in pri njih obstaja tveganje pojava odtegnitvenih simptomov v postnatalnem obdobju.
This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Temu se običajno lahko izognete tako, da po zaužitju kapsule Sonata počivate vsaj 4 ure.
• if you have severe breathing or chest problems.
• če imate hude težave z dihanjem ali prsnim košem.
Each pack contains 7, 10 or 14 hard capsules.
Eno pakiranje vsebuje 7, 10 ali 14 trdih kapsul.
Also, because of the increased risk for intentional overdose in patients with depression in general, the quantity of a medicinal product, including zaleplon, prescribed for such patients should be kept to the necessary minimum.
Prav tako je treba zaradi povečanega tveganja namernega prevelikega odmerjanja zdravila pri bolnikih z depresijo na splošno količino predpisanega zdravila, vključno z zaleplonom, zmanjšati na potrebni minimum.
Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Zdravilo Sonata je indicirano za zdravljenje bolnikov z nespečnostjo, ki težko zaspijo.
Additionally, there was no pharmacokinetic interaction between zaleplon and venlafaxine (extended release).
Poleg tega ni bilo farmakokinetičnih interakcij med zaleplonom in venlafaksinom (s podaljšanim sproščanjem).
However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
Ker pa obe spojini vplivata na centralni živčni sistem, lahko pride do aditivnega farmakodinamičnega učinka.
Memory and psychomotor impairment
Spomin in psihomotorične motnje
A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment.
Prehodni sindrom, pri katerem se simptomi, ki so privedli do zdravljenja z benzodiazepinom ali njemu podobnim zdravilom, pojavijo v okrepljeni obliki po prenehanju zdravljenja.
Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “sleep-driving” episode.
Zaradi tveganja za bolnika in okolico je pri bolnikih, ki poročajo o epizodi »vožnje v polsnu«, priporočljivo zaleplon ukiniti.
Immune system disorders Very rare:
Bolezni imunskega sistema Zelo redko:
Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Zdravilo Sonata ni indicirano za zdravljenje bolnikov s hudo ledvično okvaro, ker pri takih bolnikih niso bile opravljene ustrezne študije.
However, there is no clinical experience with the use of flumazenil as an antidote to a Sonata overdose.
Vendar pa ni kliničnih izkušenj z uporabo flumazenila kot antidota pri prevelikem odmerjanju zdravila Sonata.
Some can cause drowsiness and should not be taken while taking Sonata.
Nekatera zdravila lahko povzročijo zaspanost in jih ne smete jemati skupaj z zdravilom Sonata.
It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly.
Odsvetujemo zaužitje zdravila Sonata skupaj z večjim obrokom ali takoj po zaužitju večjega obroka, saj lahko v tem primeru zdravilo deluje počasneje.
In Sonata studies using objective PSG measures, Sonata 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
V študijah z zdravilom Sonata z uporabo objektivnih PSG meril je bilo zdravilo Sonata 10 mg boljše od placeba za zmanjšanje spalne latence in podaljšanje dolžine spanja v prvi polovici noči.
The CHMP agrees with the scientific conclusions made by the PRAC.
Odbor CHMP se strinja z znanstvenimi zaključki Odbora za oceno tveganja na področju farmakovigilance (PRAC).
Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
Benzodiazepine in njim podobne snovi morate uporabljati zelo previdno pri bolnikih, ki imajo v anamnezi zlorabo alkohola ali zdravila.
Sonata contains lactose.
Zdravilo Sonata vsebuje laktozo.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
If the medicinal product is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Če je zdravilo predpisano ženski v rodni dobi, jo morate opozoriti, naj obišče zdravnika, če namerava zanositi ali je noseča.
An allergic reaction may also include a rash, itching, or swelling of the face, lips, throat or tongue.
Alergijska reakcija lahko vključuje tudi izpuščaj, srbenje ali otekanje obraza, ustnic, žrela ali jezika.
LIST OF EXCIPIENTS Also contains: lactose monohydrate See leaflet for further information.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: laktozo monohidrat Za nadaljnje informacije glejte navodilo za uporabo.
All of zaleplon's metabolites are inactive in both animal behavioural models and in vitro activity assays.
Vsi presnovki zaleplona so neaktivni tako v živalskih vedenjskih modelih kot pri in vitro določanju aktivnosti.
Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3).
Uporaba zdravila Sonata je kontraindicirana pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje
Marketing Authorisation holder: Meda AB
Imetnik dovoljenja za promet: Meda AB
In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers.
Pri bolnikih z zmerno ledvično okvaro in pri tistih na dializi so v primerjavi z zdravimi prostovoljci zaznali približno 23% zmanjšanje največje plazemske koncentracije.
Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted.
Zato je bil PRAC glede na razpoložljive podatke v zvezi z vplivom na sposobnost vožnje in miselno zbranost, ki se pojavi naslednji dan, mnenja, da so spremembe informacij o zdravilu upravičene.
If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Če zaradi nujnih zdravstvenih razlogov zdravilo predpišete v velikih odmerkih v pozni fazi nosečnosti ali med porodom, lahko pričakujete učinke na novorojenčku, kot so podhladitev, hipotonija in zmerno poslabšanje dihanja zaradi farmakoloških učinkov zdravilne učinkovine.
In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 10 mg compared with placebo in 2-week studies.
Pri starostnikih se je spalna latenca pogosto bistveno zmanjšala pri uporabi zdravila Sonata 5 mg in dosledno zmanjšala pri uporabi zdravila Sonata 10 mg v primerjavi s placebom v 2-tedenskih raziskavah.
Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for zaleplon the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing zaleplon is favourable subject to the proposed changes to the product information
Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za zaleplon odbor CHMP meni, da je je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino zaleplon, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness.
Lahko ga spremljajo tudi druge reakcije, med drugim spremembe razpoloženja, tesnoba, motnje spanja in nemir.
Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Prevelik odmerek benzodiazepinov ali snovi, podobnih benzodiazepinom, se običajno odraža z različnimi stopnjami depresije osrednjega živčevja, od zaspanosti do kome.
Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding mothers.
Ker se zaleplon izloča v materino mleko, se zdravilo Sonata ne sme dajati doječim materam.
In mild cases patients should sleep under control of respiratory and circulatory function.
V blagih primerih je treba pri bolnikih med spanjem nadzorovati delovanje dihal in obtočil.
Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting.
Nekateri bolniki, ki so jemali sedative/hipnotike, so imeli še dodatne simptome, na primer dispneo, zaporo žrela ali navzeo in bruhanje.
Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient.
Nespečnost, ki je trdovratna ali se poslabša po kratkem zdravljenju z zaleplonom, lahko pomeni, da morate bolnika ponovno pregledati.
Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Jetrna okvara Benzodiazepini in njim podobne snovi niso indicirani za zdravljenje bolnikov s hudo jetrno insuficienco, saj lahko povzročijo encefalopatijo (glejte poglavje 4.2).
Frequency not known:
Pogostnost neznana:
Literature articles regarding next day effects on driving and mental alertness were published during the reporting period which examined these effects with zaleplon and other agents of the class.
Članki v zvezi z vplivom na sposobnost vožnje in miselno zbranost, ki se pojavi naslednji dan, so bili v literaturi objavljeni v obdobju poročanja, v katerem so preučevali te učinke pri zdravilni učinkovini zaleplon in drugih zdravilnih učinkovinah iz tega razreda.
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide metabolite.
57% odmerka najdemo v seču v obliki 5-okso-zaleplona in njegovega glukuronidnega presnovka, dodatnih 9% pa kot 5okso-desetilzaleplona in njegovega glukuronidnega presnovka.
Sonata has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will change colour and become cloudy.
Zdravilo Sonata je zasnovano tako, da tekočina, v kateri se vsebina kapsule raztopi, spremeni barvo in postane motna.
Manufacturer:
Izdelovalec
Sonata can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Zdravilo Sonata lahko bolnik vzame tik preden gre v posteljo ali potem, ko je že v postelji in ne more zaspati.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The increased incidence of benign liver tumors in mice was likely an adaptive event.
Povečana incidenca benignih jetrnih tumorjev je bila verjetno posledica prilagoditvene reakcije.
• Never drink alcohol while you are being treated with Sonata.
• Med zdravljenjem z zdravilom Sonata nikoli ne pijte alkohola.
Symptoms of overdose
Simptomi prevelikega odmerjanja
Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Sočasno dajanje zdravila Sonata skupaj z induktorji CYP3A4, kot so rifampicin, karbamazepin in fenobarbiton, lahko povzroči zmanjšanje učinkovitosti zaleplona.
Very common (1/10)
Zelo redki (<1/10.000)
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg.
Spalna latenca se je v ambulantnih študijah zmanjšala za čas do 4 tednov pri nestarostnikih, ki so prejemali zdravilo Sonata 10 mg.
Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known.
Poročali so, da je difenhidramin šibak zaviralec aldehid oksidaze v jetrih podgan, njegovi zaviralni učinki v človeških jetrih pa niso znani.