FrancophonIA/ELRC3.0 huggingface dataset:
English: These occur most often up to several hours after ingesting the product.
Slovenian: Le-te se največkrat pojavijo več ur po zaužitju zdravila.
English: Alcohol and medicinal product abuse
Slovenian: Zloraba alkohola in zdravila
English: As with sleep-driving, patients usually do not remember these events.
Slovenian: Podobno kot pri vožnji v polsnu se bolniki teh aktivnosti navadno ne spominjajo.
English: Al. Jana Pawła II nr 15
Slovenian: Al. Jana Pawla II/15
English: Sonata will help you to sleep.
Slovenian: Zdravilo Sonata vam bo pomagalo zaspati.
English: Sonata with food, drink and alcohol
Slovenian: Zdravilo Sonata skupaj s hrano, pijačo in alkoholom
English: Swallow the capsule(s) with a small glass of water.
Slovenian: Kapsulo/kapsule pogoltnite z majhnim kozarcem vode.
English: • if you have myasthenia gravis (very weak or tired muscles).
Slovenian: • če imate miastenijo gravis (zelo šibke ali utrujene mišice).
English: The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Slovenian: Zdravljenje mora biti čim krajše (glejte poglavje 4.2), ne več od dveh tednov.
English: Some patients have required medical therapy in the emergency department.
Slovenian: Pri nekaterih bolnikih je bilo potrebno zdravljenje na urgentnem oddelku.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. marec 1999
English: Specific patient groups
Slovenian: Specifične skupine bolnikov
English: At least 71% of the orally-administered dose is absorbed.
Slovenian: Absorbira se najmanj 71% peroralno zaužitega odmerka.
English: The extent of exposure to zaleplon was similar among all groups.
Slovenian: Izpostavljenost zaleplonu je bila v vseh skupinah podobna.
English: See also below under Depression and Psychiatric and “paradoxical” reactions
Slovenian: Glejte tudi spodaj pod Depresija in Psihiatrične in »paradoksne« reakcije.
English: For adults, the recommended dose is 10 mg.
Slovenian: Priporočeni odmerek za odrasle je 10 mg.
English: • if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na zaleplon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Slovenian: Če imate težave s spanjem tudi potem, ko ste porabili kapsule, ponovno obiščite svojega zdravnika.
English: This includes medicines that can be bought without a prescription.
Slovenian: To velja tudi za zdravila, ki se dobijo brez recepta.
English: These reactions are more likely to occur in the elderly.
Slovenian: Verjetnost za pojav teh reakcij je večja pri starejših osebah.
English: Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).
Slovenian: Med zdravljenjem z zdravilom Sonata nikoli ne pijte alkohola (glejte odstavek »Opozorila in previdnostni ukrepi«).
English: Children and adolescents (under 18 years of age)
Slovenian: Otroci in mladostniki (mlajši od 18 let)
English: The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep.
Slovenian: Običajni odmerek za odrasle je 10 mg tik pred spanjem ali če ste že šli v posteljo in ne morete zaspati.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razporejeni po padajoči resnosti.
English: In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
Slovenian: V te študije so bili vključeni bolniki s primarno (psihofiziološko) nespečnostjo.
English: To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Sonata (see section 4.7).
Slovenian: Za zmanjšanje tveganja bolniki ne bi smeli opravljati aktivnosti, ki zahtevajo psihomotorično koordinacijo do 4 ure ali več po zaužitju zdravila Sonata (glej poglavje 4.7).
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased.
Slovenian: V primeru nezadostnega spanja se poveča možnost zmanjšane budnosti.
English: Treatment should be as short as possible with a maximum duration of two weeks.
Slovenian: Zdravljenje mora biti čim krajše in lahko traja največ dva tedna.
English: Myasthenia gravis
Slovenian: Miastenija gravis
English: It is important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety should such symptoms develop when the medicinal product is discontinued.
Slovenian: Pomembno je, da so bolniki seznanjeni z možnostjo pojava ponovnih simptomov in tako zmanjšate tesnobo, če bi se takšni simptomi pojavili ob prenehanju jemanja zdravila.
English: • Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
Slovenian: • Zdravila Sonata ali drugih uspaval ne jemljite dlje, kot vam je predpisal vaš zdravnik.
English: It may be useful to inform the patient when treatment is started that it will be of limited duration.
Slovenian: Morda je dobro, da bolniku ob začetku zdravljenja poveste, da bo zdravljenje časovno omejeno.
English: Induced vomiting is not recommended.
Slovenian: Izzivanje bruhanja ni priporočeno.
English: Reproduction toxicity
Slovenian: Reproduktivna toksičnost
English: Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
Slovenian: Anterogradna amnezija se lahko pojavi pri uporabi priporočenih terapevtskih odmerkov, tveganje pa se poveča pri večjih odmerkih.
English: Psychiatric and “paradoxical” reactions
Slovenian: Psihiatrične in »paradoksne« reakcije
English: It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Slovenian: Indicirano je le, kadar je motnja huda in osebo onesposobi ali ji povzroča izjemno neugodje.
English: They are packed in blisters.
Slovenian: Pakirane so v pretisnih omotih.
English: When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Slovenian: Kadar zdravilo Sonata jemljete z drugimi zdravili, ki učinkujejo na možgane, vas lahko kombinacija naredi bolj zaspane, kot bi vas smela.
English: Respiratory insufficiency
Slovenian: Respiratorna insuficienca
English: Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on Sonata to assess its safety during pregnancy and breastfeeding.
Slovenian: Čeprav študije na živalih niso pokazale teratogenih ali embriotoksičnih učinkov, za zdravilo Sonata ni na voljo dovolj kliničnih podatkov, da bi lahko ocenili njegovo varnost v času nosečnosti in dojenja.
English: The risk of dependence increases with dose and duration of treatment and is greater with patients having a history of alcohol and medicinal product abuse.
Slovenian: Tveganje za pojav odvisnosti se povečuje z odmerkom in trajanjem zdravljenja in je večje pri bolnikih, ki imajo v anamnezi zlorabo alkohola in zdravil.
English: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines the next day.
Slovenian: Sedacija, amnezija, slabša koncentracija in slabša mišična funkcija lahko neugodno vplivajo na sposobnost vožnje in upravljanja s stroji naslednji dan.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: Concomitant intake with alcohol is not recommended.
Slovenian: Sočasno uporaba z alkoholom ni priporočljiva.
English: • If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them.
Slovenian: • Če jemljete katero koli zdravilo, ki spada v skupino uspaval, vključno z zdravilom Sonata, obstaja nevarnost, da se razvije odvisnost.
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Slovenian: Meda AB Pipers väg 2A S-170 09 Solna Švedska
English: Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and other hypnotics.
Slovenian: Zaleplon je pirazolopirimidinski hipnotik, ki se strukturno razlikuje od benzodiazepinov in drugih hipnotikov.
English: The total daily dose of Sonata should not exceed 10 mg in any patient.
Slovenian: Celotni dnevni odmerek zdravila Sonata pri nobenem bolniku ne sme presegati 10 mg.
English: Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Sonata.
Slovenian: Rezultati iz 2 in 4-tedenskih raziskav kažejo, da se pri nobenem odmerku zdravila Sonata ni razvila farmakološka toleranca.
English: If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Slovenian: Če opazite katerega od spodaj navedenih ali kakršnokoli drugo spremembo glede svojega zdravja, o tem čim prej obvestite svojega zdravnika.
English: You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete cimetidin (zdravilo za želodec) ali eritromicin
English: This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata').
Slovenian: Vse to je lahko še slabše, če ste po zaužitju zdravila spali manj kot 7 do 8 ur, če že jemljete druge zaviralce osrednjega živčevja ali če uživate alkohol (glejte odstavek »Druga zdravila in zdravilo Sonata«).
English: Tolerance
Slovenian: Toleranca
English: This medicinal product does not require any special temperature storage conditions.
Slovenian: Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
English: Other medicines and Sonata
Slovenian: Druga zdravila in zdravilo Sonata
English: Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Slovenian: Farmakoterapevtska skupina: benzodiazepinom sorodna zdravila, oznaka ATC: N05CF03
English: 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.
Slovenian: 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.
English: Treatment of Sonata overdose is largely supportive.
Slovenian: Zdravljenje prevelikega odmerjanja zdravila Sonata je predvsem podporno.
English: Children and adolescents under 18 years of age must not take Sonata.
Slovenian: Otroci in mladostniki, mlajši od 18 let, ne smejo jemati zdravila Sonata.
English: In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
Slovenian: V zelo redkih primerih so poročali o nekaterih resnih alergičnih reakcijah, npr. o težavah z dihanjem, ki lahko zahtevajo takojšnjo zdravniško oskrbo.
English: The elimination half-life of zaleplon is approximately 1 hour.
Slovenian: Razpolovna doba izločanja zaleplona je približno 1 ura.
English: Depression
Slovenian: Depresija
English: Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Slovenian: Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
English: Follow-up studies indicated that impaired fertility was due to an effect on the female.
Slovenian: Študije nadaljnjega spremljanja so pokazale, da je bila zmanjšana plodnost posledica učinka na samice.
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7 trdih kapsul
English: Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations are reached in approximately 1 hour.
Slovenian: Zaleplon se hitro in skoraj v celoti absorbira po peroralnem zaužitju, največjo koncentracijo pa doseže po približno 1 uri.
English: visual impairment, diplopia
Slovenian: motnja vida, diplopija
English: What Sonata is and what it is used for What you need to know before you take Sonata How to take Sonata
Slovenian: Kaj je zdravilo Sonata in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sonata Kako jemati zdravilo Sonata
English: 51063 Cologne Germany
Slovenian: 51063 Köln
English: Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Slovenian: Izločanje Zaleplon se izloča v obliki neaktivnih presnovkov, predvsem s sečem (71%) in blatu (17%).
English: • There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event.
Slovenian: • 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.
English: Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Slovenian: Zdravilo Sonata ni vplivalo na farmakokinetični in farmakodinamični profil digoksina in varfarina, dveh učinkovin z ozkim terapevtskim indeksom.
English: The value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined.
Slovenian: Vrednost prisilne dialize ali hemodialize pri zdravljenju prevelikega odmerjanja ni bila ugotovljena.
English: Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Slovenian: Zdravilo Sonata lahko povzroči omotico, izgubo koncentracije ali spomina ali mišično šibkost.
English: In severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after ingestion.
Slovenian: V hujših primerih sta lahko koristna uporaba aktivnega oglja ali izpiranje želodca, če se ju opravi kmalu po zaužitju.
English: Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day.
Slovenian: Uživanje alkohola med zdravljenjem z zdravilom Sonata lahko prav tako povzroči zaspanost naslednji dan.
English: • If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.
Slovenian: • Če nespečnost traja še naprej ali se poslabša po kratkotrajnem zdravljenju z zdravilom Sonata, se posvetujte s svojim zdravnikom.
English: • Use with extreme caution if you have ever been addicted to medicines or alcohol.
Slovenian: • Zdravilo Sonata uporabljajte še posebej previdno, če ste bili kdaj odvisni od zdravil ali alkohola.
English: Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Sonata at recommended doses in humans.
Slovenian: Na splošno izsledki predkliničnih študij ne kažejo nobenih bistvenih nevarnosti pri uporabi zdravila Sonata v priporočenih odmerkih za ljudi.
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenja za promet z zdravilom.
English: What Sonata is and what it is used for
Slovenian: Kaj je zdravilo Sonata in za kaj ga uporabljamo
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness.
Slovenian: Ob prenehanju zdravljenja se vam lahko povrne prvotna nespečnost ter lahko občutite simptome, kot so spremembe razpoloženja, tesnoba in nemir.
English: Zaleplon's pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Slovenian: Farmakokinetični profil zaleplona kaže hitro absorpcijo in eliminacijo zdravila (glejte poglavje 5.2).
English: depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
Slovenian: depersonalizacija, halucinacije, depresija, zmedenost, apatija somnambulizem
English: Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.
Slovenian: Poročali so o povečanju koncentracije transaminaz (skupina jetrnih encimov, ki se nahajajo v krvi), kar je lahko znak motenj v delovanju jeter.
English: 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.
Slovenian: 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.
English: A routine dosage adjustment of Sonata is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Slovenian: Rutinska prilagoditev odmerka zdravila Sonata ni potrebna, vendar morate bolnike opozoriti na možnost okrepitve uspavalnih učinkov.
English: The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Slovenian: Oksidativni presnovki zdravila se presnavljajo naprej s konjugacijo prek glukuronidacije.
English: No adverse effects on embryofetal development were observed in rabbits.
Slovenian: Neželenih učinkov na embriofetalni razvoj pri kuncih niso opazili.
English: Dependence
Slovenian: Odvisnost
English: Use of Sonata is not recommended during pregnancy.
Slovenian: Odsvetujemo uporabo zdravila Sonata v času nosečnosti.
English: In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Slovenian: Poleg tega ibuprofen kot primer učinkovine, ki spremenijo ledvično izločanje zdravila, ni pokazal nobenih interakcij z zdravilom Sonata.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcije glukoze/galaktoze ne smejo jemati tega zdravila.
English: If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Slovenian: Če angioedem prizadene jezik, glotis ali larinks, lahko nastopi obstrukcija zračnih poti, ki se lahko konča s smrtjo.
English: 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.
Slovenian: 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.
English: Amnestic effects may be associated with inappropriate behaviour (see section 4.4).
Slovenian: Učinki v smislu amnezije so združeni s pojavom neprimernega vedenja (glejte poglavje 4.4).
English: Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Slovenian: Zaleplon je lipofilna snov s porazdelitvenim volumnom okoli 1,4 ± 0,3 l/kg po intravenskem odmerku.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: Caution is recommended for patients performing skilled tasks.
Slovenian: Previdnost je priporočena pri bolnikih, ki opravljajo zahtevna opravila.
English: Patients should be advised not to take a second dose within a single night.
Slovenian: Bolnikom odsvetujte, da bi vzeli drugi odmerek v isti noči.
English: The in vitro plasma protein binding is approximately 60%, suggesting little risk of active substance interaction due to protein binding.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Slovenian: Temu se običajno lahko izognete tako, da po zaužitju kapsule Sonata počivate vsaj 4 ure.
English: • if you have severe breathing or chest problems.
Slovenian: • če imate hude težave z dihanjem ali prsnim košem.
English: Each pack contains 7, 10 or 14 hard capsules.
Slovenian: Eno pakiranje vsebuje 7, 10 ali 14 trdih kapsul.
English: anorexia
Slovenian: anoreksija
English: 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.
Slovenian: 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.
English: Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Slovenian: Zdravilo Sonata je indicirano za zdravljenje bolnikov z nespečnostjo, ki težko zaspijo.