FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: I et efterfølgende kryds-foster studie synes de negative virkninger på afkommets levedygtighed og vækst at være et resultat af eksponering for zaleplon både in utero og under laktation.
English: Zaleplon binds selectively to the benzodiazepine type I receptor.
Danish: Zaleplon bindes selektivt til benzodiazepin type I receptoren.
English: Carcinogenicity
Danish: Karcinogenicitet
English: As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata.
Danish: Da administrationen efter et måltid forsinker tiden indtil maksimal plasmakoncentration med cirka 2 timer, skal mad ikke indtages sammen med eller lige før man tager Sonata.
English: Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Danish: Zaleplon metaboliseres primært i leveren og undergår signifikant præsystemisk metabolisme.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller der er ansvarlig for batchfrigivelse
English: Treatment of Sonata overdose is largely supportive.
Danish: Behandling af overdosering med Sonata er primært understøttende.
English: If you suffer from these symptoms, ask your doctor for advice.
Danish: Hvis De lider af disse symptomer, kan De spørge lægen til råds.
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.
Danish: Sonatas virkning er påvist både undersøgelser i søvnlaboratorier, hvor der benyttedes objektive polysomnografiske (PSG) mål for søvnen, og i undersøgelser med ambulante patienter, hvor man brugte patientspørgeskemaer til at vurdere søvnen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Meda AB
English: When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Danish: Hvis Sonata tages sammen med anden medicin, som påvirker hjernen, kan denne kombination få Dem til føle Dem mere døsig end ellers.
English: There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents.
Danish: Der er efter markedsføring rapporteret om afhængighed i forbindelse med zaleplon, hovedsagelig i kombination med andre psykofarmaka.
English: Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects.
Danish: Følgelig blev den oral clearance af zaleplon reduceret med 70% og 87% hos henholdsvis kompenserede og dekompenserede cirrhotiske patienter, medførende markante stigninger i gennemsnitlig Cmax og AUC (op til fire og syv gange hos henholdsvis kompenserede og dekompenserede patienter) i forhold til raske individer.
English: Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “sleep-driving” episode.
Danish: På grund af risikoen for patient og samfund anbefales seponering af zaleplon hos patienter, som rapporterer en episode med kørsel i medicinpåvirket tilstand.
English: Symptoms of overdose
Danish: Symptomer på overdosering
English: Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day.
Danish: Zaleplons plasmakoncentrationer blev forøget lineært med dosis, og zaleplon viste ingen tegn på akkumulering efter indgivelse af op til 30 mg pr. dag.
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)
Danish: Frekvensen af bivirkninger som er angivet nedenfor inddeles i følgende kategorier: Meget almindelige bivirkninger (det sker hos flere end l ud af 10 patienter) Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 patienter) Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 1.000 patienter) Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 10.000 patienter) Meget sjældne bivirkninger (det sker hos færre end 1 ud af 10.000 patienter) Bivirkninger, hvor hyppigheden ikke er kendt
English: BATCH NUMBER Lot
Danish: BATCHNUMMER Lot no:
English: Sonata contains lactose.
Danish: Sonata indeholder lactose.
English: Abuse of benzodiazepines and benzodiazepine-like active substances has been reported.
Danish: Der har været rapporteret misbrug af benzodiazepiner og benzodiazepin-lignende aktive substanser.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: 51063 Cologne Germany
Danish: 51063 Köln
English: There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug.
Danish: Der er ikke farmakokinetisk interaktion mellem zaleplon og diphenhydramin efter en enkelt administration af hvert stof (henholdsvis 10 mg og 50 mg).
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 hårde kapsler
English: photosensitivity reaction angioedema
Danish: Lysfølsomhedsreaktion Angioødem
English: Additionally, there was no pharmacokinetic interaction between zaleplon and venlafaxine (extended release).
Danish: Der var heller ingen farmakokinetisk interaktion mellem zaleplon og venlafaxin (depot).
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.
Danish: I overensstemmelse med de virkninger, der er set ved andre stoffer, som binder til benzodiazepinreceptorer, blev reversibel øget vægt af lever og binyrer i rotter og hunde, kun observeret i forbindelse med gentagen oral administration af doser mange gange højere end den maksimale anbefalede humane dosis.
English: • if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).
Danish: • Hvis De lider af søvnapnøsyndrom (under søvn holder op med at trække vejret i korte perioder)
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.
Danish: Spædbørn, som fødes af mødre, der har taget benzodiazepiner og benzodiazepin-lignende midler kronisk i de sene stadier af graviditeten, kan have udviklet fysisk afhængighed, og kan løbe en vis risiko for at udvikle abstinenser i efterfødselsperioden.
English: Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Danish: Sonata kan gøre Dem døsig, give koncentrations- eller hukommelsesbesvær og svække Deres muskler.
English: In patients with mild to moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced clearance, and the dose will therefore need to be modified in these patients.
Danish: Hos patienter med mild til moderat leverinsufficiens er biotilgængeligheden af zaleplon forøget på grund af nedsat clearance, og dosis skal derfor modificeres til disse patienter.
English: All of zaleplon's metabolites are inactive in both animal behavioural models and in vitro activity assays.
Danish: Alle zaleplons stofskifteprodukter er inaktive i både dyreadfærdsmodeller og in vitro-aktivitetsbestemmelser.
English: If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Danish: Hvis angioødem omfatter tunge, glottis eller larynx, kan luftvejene blokeres, hvilket kan være fatalt.
English: Metabolism and nutrition disorders Uncommon:
Danish: Metabolisme og ernæring Ikke almindelig
English: Zaleplon has not been adequately studied in patients with severe renal impairment.
Danish: Zaleplon er ikke tilstrækkeligt undersøgt hos patienter med alvorlig nyreinsufficiens.
English: 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.
Danish: Hvis produktet af tvingende medicinske årsager indgives i høje doser i den sene graviditetsfase eller under fødsel, kan der forventes påvirkning af den nyfødte som f.eks. hypotermi, hypotoni og moderat nedsættelse af åndedrættet på grund af stoffets farmakologiske virkning.
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.
Danish: Kompleks adfærd, såsom ”kørsel i medicinpåvirket tilstand” (dvs. kørsel, mens personen ikke er helt vågen efter indtagelse af et sedativum-hypnotikum, med amnesi for hændelsen) er rapporteret hos patienter, som tager sedativa-hypnotika.
English: Repeated dose toxicity
Danish: Toksicitet efter gentagen dosering
English: Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Danish: Sonata er ikke indiceret til at behandle patienter med alvorligt nedsat nyrefunktion, da der ikke foreligger tilstrækkelige studier med disse patienter.
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.
Danish: Selvom adfærd som kørsel i medicinpåvirket tilstand kan forekomme alene ved et sedativum-hypnotikum ved terapeutiske doser, synes brugen af alkohol og andre centralnervesystem (CNS)-depressiva sammen med sedativahypnotika at øge risikoen for sådan adfærd.
English: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known.
Danish: Diphenhydramin er rapporteret som værende en svag hæmmer af aldehyd oxidase i rotte lever, men det vides ikke, om det har en hæmmende virkning i leveren hos mennesker.
English: The value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined.
Danish: Værdien af dialyse eller hæmodialyse i behandling af overdosering er ikke undersøgt.
English: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines the next day.
Danish: Den beroligende virkning, hukommelsestab, forringet koncentration og forringet muskelfunktion kan have en negativ indvirkning på evnen til at føre motorkøretøj eller betjene maskiner den efterfølgende dag.
English: 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.
Danish: I undersøgelser med Sonata, hvor man brugte objektive PSG mål, var Sonata 10 mg overlegen i forhold til placebo til at reducere søvnlatenstiden og øge varigheden af søvnen i løbet af første halvdel af natten.
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').
Danish: Dette kan forværres, hvis De har sovet mindre end 7-8 timer, efter De har taget medicinen, eller hvis De samtidig tager et andet lægemiddel der virker på centralnervesystemet, eller hvis de drikker alkohol (se ”Brug af anden medicin sammen med Sonata”) .
English: Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3).
Danish: Børn: Sonata er kontraindiceret til børn og unge under 18 år (se pkt.
English: • if you have severe kidney or liver problems.
Danish: • Hvis De har alvorlig nyre- eller leverproblemer
English: You should not take a second dose within a single night.
Danish: De må ikke tage endnu en dosis samme nat.
English: Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Danish: Benzodiazepiner og benzodiazepin-lignende midler bør ikke anvendes alene til behandling af depression eller angst forbundet med depression (dette kan fremskynde selvmord hos sådanne patienter).
English: 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.
Danish: Et forbigående syndrom, hvor de symptomer, som førte til behandlingen med benzodiazepin eller et benzodiazepin-lignende middel, kommer igen i forværret form, kan forekomme ved behandlingsophør.
English: Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).
Danish: Drik aldrig alkohol mens De er i behandling med Sonata (se ”Advarsler og forsigtighedsregler”).
English: Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see section 4.4).
Danish: Brug (selv ved terapeutiske doser) kan føre til udvikling af fysisk afhængighed: Terapiophør kan medføre abstinens- eller recidivfænomener (se 4.4).
English: No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
Danish: Der kræves ingen justering af dosering hos patienter med mild til moderat nyreinsufficiens, eftersom Sonatas farmakokinetik ikke ændres hos sådanne patienter.
English: Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately
Danish: Zaleplon gennemgår også præsystemisk metabolisme, resulterende i en absolut biotilgængelighed på ca. 30%.
English: LIST OF EXCIPIENTS Also contains: lactose monohydrate See leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: lactosemonohydrat Se indlægsseddel for mere information
English: Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting.
Danish: Nogle patienter, som tager sedativa-hypnotika, har haft yderligere symptomer, såsom dyspnø, øvre luftvejsobstruktion eller kvalme og opkastning.
English: Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Danish: Anden kompleks adfærd (såsom tilberedning og indtagelse af mad, telefonopkald eller samleje) er rapporteret hos patienter, som ikke er helt vågne efter indtagelse af et sedativum-hypnotikum.
English: Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
Danish: Benzodiazepiner og benzodiazepin-lignende midler skal anvendes med yderste forsigtighed hos patienter, som har en fortid med alkohol- og lægemiddelmisbrug.
English: 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.
Danish: Hos ældre patienter faldt søvnlatenstiden ofte signifikant med Sonata 5 mg og faldt konsekvent med Sonata 10 mg sammenlignet med 2-ugers undersøgelser med placebo.
English: Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and other hypnotics.
Danish: Zaleplon er et pyrazolopyrimidinhypnotikum, som har en anden struktur end benzodiazepiner og andre hypnotika.
English: Pre-and postnatal growth of rats was reduced at the maternally toxic dose of 100 mg/kg/day.
Danish: Hos rotter var præ- og postnatal vækst reduceret ved den maternale toksiske dosis på 100 mg/kg/dag.
English: Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy and breast-feeding.
Danish: De bør ikke tage Sonata i disse tilfælde, fordi der er ikke tilstrækkelige kliniske data tilrådighed til at vurdere sikkerheden ved Sonata under graviditet og ved amning.
English: Oral use
Danish: Til oral indtagelse
English: In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
Danish: Hos patienter med mild til moderat nedsat nyrefunktion, er den farmakokinetiske profil af zaleplon ikke signifikant forskellig fra den for raske personer.
English: PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
Danish: PVC/PVDC aluminium blisterpakninger med 7, 10 og 14 kapsler.
English: The elimination half-life of zaleplon is approximately 1 hour.
Danish: Eliminationshalveringstid for zaleplon er ca. 1 time.
English: Other medicines and Sonata
Danish: Brug af anden medicin sammen med Sonata
English: Одрин 71-75, ет.2, ап 7
Danish: Одрин 71-75, ет.2, ап 7 1303 София
English: Induced vomiting is not recommended.
Danish: Fremkaldelse af opkastning anbefales ikke.
English: The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/min) and moderate (20 to 39 ml/min) renal impairment, and in patients on dialysis.
Danish: Farmakokinetikken efter en enkelt dosis zaleplon blev undersøgt hos patienter med mild (kreatinin clearance 40 til 89 ml/min) og moderat (20 til 39 ml/min) nyreinsufficiens, og hos patienter i dialyse.
English: • if you have severe breathing or chest problems.
Danish: • Hvis De har alvorlige vejrtræknings- eller brystproblemer
English: Respiratory insufficiency
Danish: Respirationsinsufficiens
English: Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Derfor er dosisjustering ikke nødvendig hos patienter med mild til moderat nyreinsufficiens.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Danish: Sonata tilhører en gruppe stoffer, som kaldes benzodiazepin-lignende lægemidler, som består af produkter med narkotiske virkninger.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Sonata kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Danish: Benzodiazepiner og benzodiazepin-lignende midler anbefales ikke til primær behandling af psykotiske sygdomme.
English: Severe respiratory insufficiency
Danish: Alvorlig respirationsinsufficiens
English: On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness.
Danish: Når behandlingen stoppes, kan Deres oprindelige søvnløshed vende tilbage, og De kan opleve symptomer som f.eks. humørsvingninger, angst og søvnløshed.
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.
Danish: Der er rapporteret tilfælde af angioødem omfattende tunge, glottis eller larynx hos patienter efter indtagelse af den første eller efterfølgende doser sedativahypnotika, herunder zaleplon.
English: Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Danish: Der er rapporteret alvorlige anafylaktiske/anafylaktoide reaktioner i forbindelse med brugen af sedativa-hypnotika, herunder zaleplon.
English: Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose.
Danish: Kromaturin (blå-grøn farvning af urinen) er blevet rapporteret i forbindelse med zaleplon overdosering.
English: 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.
Danish: I løbet af rapporteringsperioden blev litteraturartikler publiceret vedrørende næste dags virkninger på evnen til at køre bil og på den mentale årvågenhed, som undersøgte disse virkninger med zaleplon og andre lægemiddelstoffer af samme type.
English: In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Danish: I alvorlige tilfælde kan følgende symptomer forekomme: Uvirkelighed, depersonalisation, hyperacusis, følelsesløshed og snurren i ekstremiteter, overfølsomhed overfor lys, støj og fysisk kontakt, hallucinationer eller epileptiske anfald.
English: Scientific conclusions and grounds recommending the variation to the terms of the Marketing
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for
English: Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test).
Danish: Samtidig indgivelse af en enkelt dosis zaleplon 10 mg og venlafaxin (depot) 75 mg eller 150 mg dagligt gav ingen interaktion på hukommelse (umiddelbar og forsinket hukommelse af ord) eller psykomotorisk optræden (talsymbol substitutionsprøve).
English: Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Danish: Brug af benzodiazepiner og benzodiazepin-lignende midler kan føre til fysisk og psykisk afhængighed.
English: Amnestic effects may be associated with inappropriate behaviour (see section 4.4).
Danish: Hukommelsestabsvirkninger kan være forbundet med upassende adfærd (se 4.4).
English: dysmenorrhea
Danish: Dysmenoré
English: What you need to know before you take Sonata
Danish: DET SKAL DE VIDE FØR DE BEGYNDER AT TAGE SONATA
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller amer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager Sonata.
English: See also below under Amnesia Eye disorders
Danish: Se også nedenfor under hukommelsestab Øjne
English: Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Danish: Behandling med Sonata er indiceret til at fremkalde søvn hos patienter, som lider af søvnløshed og har svært ved at falde i søvn.
English: The majority of the faecal recovery consists of 5-oxo-zaleplon.
Danish: Størstedelen af genfindingen i afføringen består af 5-oxo-zaleplon.