FrancophonIA/ELRC3.0 huggingface dataset:
English: In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Slovenian: Pri zdravljenju prevelikega odmerjanja s katerim koli zdravilom morate upoštevati, da je bolnik lahko zaužil več zdravil naenkrat.
English: Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors.
Slovenian: Peroralno dajanje zaleplona mišim v obdobju 65 ali 104 zaporednih tednov v visokih odmerkih (≥100 mg/kg/dan) je privedlo do statistično značilnega povečanja pogostnosti benignih, ne pa tudi malignih tumorjev.
English: These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Slovenian: Le-ti vključujejo glavobole, bolečino v mišicah, izredno tesnobo, napetost, nemir, zmedenost in razdražljivost.
English: Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata.
Slovenian: Starejši bolniki so lahko občutljivi za učinke uspaval, zato je zanje priporočeni odmerek zdravila Sonata 5
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V. 4.9 Preveliko odmerjanje
English: Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Slovenian: Benzodiazepini in njim sorodne učinkovine niso priporočljive za primarno zdravljenje psihotičnih motenj.
English: Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Slovenian: Zaleplon se primarno presnavlja s pomočjo aldehidne oksidaze in tvori 5-okso-zaleplon.
English: Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines.
Slovenian: Povečanje centralne sedacije lahko nastopi v primerih sočasne uporabe z antipsihotiki (nevroleptiki), hipnotiki, anksiolitiki/sedativi, antidepresivnimi sredstvi, narkotičnimi analgetiki, antiepileptiki, anestetiki in sedativnimi antihistaminiki.
English: Extension beyond these periods should not take place without clinical re-evaluation of the patient.
Slovenian: Pred podaljšanjem tega roka morate bolnika ponovno klinično pregledati.
English: Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Slovenian: Zdravilo Sonata sodi v skupino zdravil, ki jih imenujemo benzodiazepinom sorodna zdravila oz. zdravila z uspavalnim delovanjem.
English: Contact a doctor immediately and say how many capsules you have taken.
Slovenian: Če ste vzeli večji odmerek zdravila Sonata, kot bi smeli Nemudoma pokličite zdravnika in mu povejte, koliko kapsul ste vzeli.
English: These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Slovenian: Te reakcije lahko povzroči zdravilna učinkovina, lahko so spontane ali pa so posledica prikrite psihične ali telesne motnje.
English: You should not take a second dose within a single night.
Slovenian: V isti noči ne smete vzeti drugega odmerka.
English: If you suffer from these symptoms, ask your doctor for advice.
Slovenian: Če imate te simptome, se posvetujte z zdravnikom.
English: Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za zaleplon, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents.
Slovenian: V obdobju spremljanja zdravila na tržišču so o odvisnosti, povezani z zaleplonom, poročali predvsem v kombinaciji z drugimi psihoaktivnimi snovmi.
English: Common (1/100 to <1/10)
Slovenian: Pogosti (≥1/100 do <1/10)
English: Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Slovenian: Poleg tega se zaleplon presnavlja s pomočjo encima CYP3A4 in tvori desetilzaleplon, ki se naprej presnovi s pomočjo aldehidne oksidaze in tvori 5-okso-desetilzaleplon.
English: Carcinogenicity
Slovenian: Kancerogenost
English: Meda Pharma S.p.A. Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
Slovenian: Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
English: Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Slovenian: Zaradi kratke razpolovne dobe zaleplona morate premisliti o uporabi drugega načina zdravljenja v primeru zgodnjega jutranjega zbujanja bolnika.
English: Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Slovenian: Jetrna okvara Zaleplon se presnavlja predvsem v jetrih in je podvržen pomembni predsistemski presnovi.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity (equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis).
Slovenian: Študije embriofetalnega razvoja po peroralni uporabi aleplona v odmerku do 100 mg/kg/dan in 50 mg/kg/dan, ki so ga prejele breje podgane oziroma kunci, niso pokazale teratogenosti (odmerek ustreza 49-kratniku (podgane) in 48-kratniku (kunci) MRHD, izračunano v mg/m2).
English: Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Slovenian: Benzodiazepini in njim podobne snovi lahko sprožijo anterogradno amnezijo in psihomotorične motnje.
English: They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Slovenian: Lahko jih sproži zdravilna učinkovina, lahko nastanejo spontano ali pa kot posledica prikrite psihične ali telesne motnje.
English: Zaleplon binds selectively to the benzodiazepine type I receptor.
Slovenian: Zaleplon se selektivno veže na benzodiazepinske receptorje tipa I.
English: Capsule, hard.
Slovenian: Trda kapsula.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA SONATA 10 MG - VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
English: How to take Sonata
Slovenian: Kako jemati zdravilo Sonata
English: INFORMATION IN BRAILLE Sonata 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Sonata 10 mg
English: Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance.
Slovenian: Bolniki, pri katerih se po zdravljenju z zaleplonom pojavi angioedem, te zdravilne učinkovine ne smejo več dobiti.
English: Do not try and catch up on the doses you have missed.
Slovenian: Ne poskušajte nadomestiti izpuščenih odmerkov.
English: No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
Slovenian: Pri bolnikih z blago do zmerno ledvično insuficienco ni potrebna prilagoditev odmerka, ker farmakokinetika zdravila Sonata pri teh bolnikih ni spremenjena.
English: INFORMATION IN BRAILLE Sonata 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Sonata 5 mg
English: 10 hard capsules
Slovenian: 10 trdih kapsul
English: dysmenorrhea
Slovenian: dismenoreja
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compound-related tumorigenicity.
Slovenian: Kancerogenost Peroralno dajanje zaleplona podganam v obdobju 104 zaporednih tednov v odmerkih do 20 mg/kg/dan ni povzročilo tumorogenih učinkov, povezanih s to spojino.
English: • Do not use a second dose of Sonata within a single night.
Slovenian: • Ne vzemite drugega odmerka v isti noči.
English: The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea.
Slovenian: 4.8 Neželeni učinki Najpogostejši neželeni učinki so amnezija, parestezija, somnolenca in dismenoreja.
English: • if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).
Slovenian: če med spanjem večkrat prenehate dihati za kratek čas).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA ZDRAVILO SONATA 5 MG - VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
English: Oral use
Slovenian: Peroralna uporaba
English: Complex behaviours such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics.
Slovenian: Pri bolnikih, ki jemljejo sedative/hipnotike, poročajo o oblikah kompleksnega vedenja, kakršna je “vožnja v polsnu” (tj., upravljanje motornega vozila v ne povsem budnem stanju po zaužitju sedativa-hipnotika in s poznejšo amnezijo za ta dogodek).
English: The remainder of the urinary recovery consists of minor metabolites.
Slovenian: Preostali del izločanja zdravila s sečem je v obliki manj pomembnih presnovkov.
English: What you need to know before you take Sonata
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sonata Ne jemljite zdravila Sonata
English: There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose levels in humans have not been determined.
Slovenian: Klinične izkušnje z učinki akutnega prevelikega odmerka zdravila Sonata so omejene.
English: Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon's metabolism.
Slovenian: Cimetidin, nespecifičen zmerni zaviralec nekaterih jetrnih encimov, vključno z aldehidno oksidazo in CYP3A4, je povzročil 85% povečanje koncentracije zaleplona v plazmi, ker je zaviral tako primarni encim
English: Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Slovenian: Občasni neželeni učinki: omotičnost, šibkost, zmanjšana koordinacija gibov, negotovost in/ali padci (ataksija), zmanjšana koncentracija, apatija, nemir, depresija, vznemirjenos, razdražljivost, zmedenost, nenormalno mišljenje in obnašanje (ekstrovertnost, ki se zdi pretirana, popustitev zavor, agresivnost, bes, prividi, depersonalizacija, psihoza), nočne more, halucinacije, dvojni vid ali druge motnje vida, povečana občutljivost za zvok (hiperakuzija), motnje voha (parosmija), motnje govora, vključno z nerazločnim izgovarjanjem,,otopelost, npr. v okončinah (hipoestezija), slabost, zmanjšan apetit, povečana občutljivost za svetlobo (sončno svetlobo, UV svetlobo), slabo počutje (občutek bolehnosti).
English: In a subsequent cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in utero and lactational exposure to zaleplon.
Slovenian: V nadaljnji t.i. cross-fostering študiji (v kateri so prenesli mladiče iz enega legla v drugega) se je zdelo, da so neželeni učinki na sposobnost za preživetje mladičev in njihovo rast posledica izpostavljenosti zaleplonu tako v maternici kot med laktacijo.
English: Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Slovenian: Obstoječa latentna depresija lahko postane vidna med uporabo benzodiazepinov ali njim sorodnih učinkovin.
English: Capsules have an opaque white hard shell with the strength “10 mg”.
Slovenian: Kapsule imajo neprozorno belo trdo ovojnico z jakostjo »10 mg«.
English: PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
Slovenian: Pretisni omoti iz PVC/PVDC in aluminija s po 7, 10 ali 14 kapsulami.
English: Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Slovenian: Uporaba benzodiazepinov in njim sorodnih učinkovin lahko privede do telesne in duševne odvisnosti.
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Slovenian: pogosti (pojavijo se lahko pri 1 do 10 bolnikov od 100 bolnikov) občasni (pojavijo se lahko pri 1 do 10 bolnikov od 1000 bolnikov) redki (pojavijo se lahko pri 1 do 10 bolnikov od 10.000 bolnikov) zelo redki (pojavijo se lahko pri manj kot 1 bolniku od 10.000 bolnikov)
English: Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”.
Slovenian: Kapsule imajo neprozorno belo in neprozorno svetlo rjavo trdo ovojnico z jakostjo »5 mg«.
English: Severe renal impairment is contraindicated (see section 4.3.
Slovenian: Pri hudi ledvični okvari je kontraindicirano (glejte poglavje
English: Pregnancy and breast-feeding
Slovenian: Nosečnost, dojenje in plodnost
English: These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines).
Slovenian: Med tovrstna zdravila sodijo: substance, ki se uporabljajo pri zdravljenju duševnih bolezni (antipsihotiki, hipnotiki, anksiolitiki/sedativi, antidepresivi), močna protibolečinska zdravila (narkotični analgetiki), zdravila za zdravljenje epileptičnih napadov oz. konvulzij (antiepileptična zdravila), anestetiki in zdravila za zdravljenje alergij (sedativni antihistaminiki).
English: The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis).
Slovenian: Odmerek brez učinka na poporodni razvoj je bil 1 mg/kg/dan (kar ustreza 0,5-kratniku MRHD, izračunano v mg/m2).
English: The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis).
Slovenian: Odmerek brez učinka na rast podganjih mladičev je bil 10 mg/kg (kar ustreza 5-kratniku MRHD, izračunano v mg/m2).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Meda AB
English: Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data)
Slovenian: Pogostnosti so definirane kot: Zelo pogosti (≥1/10) Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
English: Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
Slovenian: Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (zlato črnilo SB-3002): šelak, amonijev hidroksid, rumeni železov oksid (E172).
English: What Sonata contains
Slovenian: Kaj vsebuje zdravilo Sonata
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient.
Slovenian: Običajno zadošča skrb za prehodnost dihalnih poti in zagotavljanje podpore dihanju in hemodinamiki.
English: Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”.
Slovenian: Izgled zdravila Sonata in vsebina pakiranja Sonata 5 mg trde kapsule, ki vsebujejo svetlo moder prašek, imajo svetlo rjav pokrovček in belo telo z zlatim odtisom »5 mg«.
English: The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Slovenian: Druge sestavine so mikrokristalna celuloza, predgeliran škrob, silicijev dioksid, natrijev lavrilsulfat, magnezijev stearat, laktoza monohidrat, indigo karmin (E132), titanov dioksid (E171).
English: Talk to your doctor or pharmacist before taking Sonata.
Slovenian: Pred začetkom jemanja zdravila Sonata se posvetujte z zdravnikom ali farmacevtom.
English: Reproductive system and breast disorders Common:
Slovenian: Motnje reprodukcije in dojk Pogosto:
English: Zaleplon has not been adequately studied in patients with severe renal impairment.
Slovenian: Zaleplona niso ustrezno testirali pri bolnikih s hudo ledvično okvaro.
English: anaphylactic/anaphylactoid reactions
Slovenian: anafilaktične / anafilaktoidne reakcije
English: The majority of the faecal recovery consists of 5-oxo-zaleplon.
Slovenian: Večino količine zdravila, izločene v blato, sestavlja 5-okso-zaleplon.
English: Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
Slovenian: Če se razvije odvisnost, se lahko pri nenadni prekinitvi zdravljenja pojavijo odtegnitveni simptomi.
English: Česká republika MEDA Pharma s.r.o.
Slovenian: MEDA Pharma s.r.o.
English: In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro farmakokinetski profil zaleplona ni pomembno drugačen kot pri zdravih osebah, zato pri teh bolnikih odmerka ni treba prilagajati.
English: Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5).
Slovenian: To tveganje povečuje tudi sočasna uporaba zaleplona z alkoholom in drugimi zaviralci osrednjega živčevja (glejte poglavje 4.5).
English: If you experience these events, contact your doctor immediately.
Slovenian: Če se vam zgodi kaj takega, se nemudoma posvetujte z zdravnikom.
English: If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Slovenian: Če sumite, da imate morda katero izmed zgoraj navedenih bolezni, se posvetujte s svojim zdravnikom.
English: Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon.
Slovenian: Po zaužitju prvega ali kakšnega poznejšega odmerka sedativov/hipnotikov, vključno z zaleplonom, so poročali o primerih angioedema jezika, glotisa ali larinksa.
English: Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Slovenian: Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (rožnato črnilo SW-1105): šelak, titanov dioksid (E171), amonijev hidroksid, rdeči železov oksid (E172), rumeni železov oksid (E172).
English: Meda Pharma SIA Vienības gatve 109 LV-1058 Riga, Latvia Tel.: +371 67616137
Slovenian: LV-1058 Riga, Latvia Tel.: +371 67616137
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Slovenian: neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Pogosti neželeni učinki: dremavost/zaspanost, težave s spominom, občutki kot so mravljinci, npr. v okončinah (parestezije), boleča menstruacija.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/001-003
English: These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Slovenian: Ti dogodki se lahko pojavijo tako pri bolnikih, ki sedativa/hipnotika prej še nikoli niso vzeli, kot tudi pri tistih, ki ga že jemljejo.
English: In line with effects observed with other compounds binding to benzodiazepine receptors, reversible increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral administration of high multiples of the maximum human therapeutic dose.
Slovenian: Reverzibilno povečanje mase jeter in nadledvičnih žlez pri podganah in psih je bilo opaženo šele po večkratni peroralni uporabi visokih večkratnikov največjega terapevtskega odmerka za ljudi, kar je v skladu z učinki drugih zdravil, ki se vežejo na benzodiazepinske receptorje.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/99/102/004-006
English: If you have any further questions, please consult your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: S-170 73 Solna
Slovenian: S-170 09 Solna Švedska
English: This medicine has been prescribed for you.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Slovenian: Sočasno odmerjanje zdravila Sonata z zdravili, ki vplivajo na izoencim CYP3A4, lahko povzroči spremembe koncentracije zaleplona v plazmi (glejte poglavje 4.5).
English: Severe renal impairment
Slovenian: Huda ledvična okvara
English: Uncommon:
Slovenian: Pogosto:
English: Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Slovenian: V kontroliranih raziskavah za merjenje odstotka trajanja spanja v posameznih fazah spanja se je izkazalo, da zdravilo Sonata ohrani faze spanja.
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate.
Slovenian: Sestavine ovojnice kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172) in natrijev lavrilsulfat.
English: Psychiatric disorders Uncommon:
Slovenian: Psihiatrične motnje Občasno:
English: How to store Sonata
Slovenian: Shranjevanje zdravila Sonata