FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not try and catch up on the doses you have missed.
Danish: Lad være med at tage de doser, som De har glemt.
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
English: It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly.
Danish: Det anbefales, at De ikke tager Sonata sammen med eller umiddelbart efter et stort måltid, da den kan virke langsommere.
English: Al. Jana Pawła II nr 15
Danish: Al. Jana Pawla II/15
English: Alcohol can increase the undesirable effects of any medicine taken to help you sleep.
Danish: Alkohol kan forøge de uønskede bivirkninger ved al medicin, som tages som hjælp til at sove.
English: Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Danish: Børn og unge Giv ikke dette lægemiddel til børn og unge under 18 år.
English: Each pack contains 7, 10 or 14 hard capsules.
Danish: Hver pakning indeholder 7, 10 eller 14 hårde kapsler.
English: hepatotoxicity (mostly described as transaminase increased)
Danish: Hepatotoksicitet (hovedsagelig beskrevet som forhøjede transaminaseniveauer)
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.
Danish: Den sædvanlige dosis for voksne er 10 mg lige før De går i seng, eller efter at De er gået i seng og har besvær med at falde i søvn.
English: It may be useful to inform the patient when treatment is started that it will be of limited duration.
Danish: Det kan ved behandlingens begyndelse være nyttigt at informere patienten om, at behandlingen vil være af begrænset varighed.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP er enig med PRACs videnskabelige konklusioner.
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Danish: Dette kan normalt undgås, hvis De ikke er aktiv i mindst 4 timer efter indtagelse af Sonata.
English: • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Danish: • Der er risiko for at opleve en bestemt type midlertidigt hukommelsestab (amnesi) og manglende koordinationsevne ved indtagelse af sovemedicin.
English: For adults, the recommended dose is 10 mg.
Danish: Den anbefalede dosis for voksne er 10 mg.
English: Duration of treatment
Danish: Behandlingens varighed
English: Sonata with food, drink and alcohol
Danish: Brug af Sonata sammen med mad, drikke og alkohol
English: Contact a doctor immediately and say how many capsules you have taken.
Danish: Fortæl lægen, hvor mange kapsler, De har taget.
English: If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Danish: Hvis De stadig har problemer med at sove, efter at De har indtaget alle kapsler, skal De kontakte lægen igen.
English: The total daily dose of Sonata should not exceed 10 mg in any patient.
Danish: Den totale daglige dosis af Sonata må ikke overstige 10 mg hos nogen som helst patient.
English: Patients should be advised not to drive or operate machinery until it is established that their performance is not impaired.
Danish: Patienter bør rådgives om ikke at føre motorkøretøj eller betjene maskiner før det er konstateret at deres evner ikke er forringet.
English: Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport af PSUR'en for zaleplon er CHMPs videnskabelige konklusion følgende:
English: At these doses, a significant reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent dogs.
Danish: Ved disse doser var der en signifikant reduktion i vægten af både prostata og testikler i et 3 måneders studie med præpubertale hunde.
English: In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Danish: Ved håndtering af overdosering af ethvert lægemiddel, bør man tage under overvejelse, at der kan være blevet indtaget flere forskellige midler.
English: Do not take any other medicines without asking your doctor or pharmacist first.
Danish: Tag ikke nogen anden medicin uden først at spørge lægen eller på apoteket.
English: You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Danish: De skal informere Deres læge eller apoteker, hvis De tager cimetidin (en mavemedicin) eller erythromycin (et antibiotikum).
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.
Danish: Det er vigtigt, at patienter er klar over muligheden for recidivfænomenet for derved at minimere ængstelsen, hvis sådanne symptomer forekommer, når behandlingen med produktet ophører.
English: Sonata has major influence on the ability to drive and use machines.
Danish: Sonata har stor indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: In mild cases patients should sleep under control of respiratory and circulatory function.
Danish: I lette tilfælde bør patienten sove under kontrol af respiration og cirkulation.
English: The in vitro plasma protein binding is approximately 60%, suggesting little risk of active substance interaction due to protein binding.
Danish: In vitro plasmaproteinbinding er ca. 60%, hvilket tyder på kun ringe risiko for interaktion med den aktive substans på grund af proteinbinding.
English: Treatment should be as short as possible with a maximum duration of two weeks.
Danish: Behandlingen bør være så kortvarig som mulig, og højest af to ugers varighed.
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Danish: Meda AB Pipers väg 2A S-170 09 Solna Sverige
English: • Never drink alcohol while you are being treated with Sonata.
Danish: • Drik aldrig alkohol mens De bliver behandlet med Sonata.
English: In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
Danish: I meget sjældne tilfælde er rapporteret om allergiske reaktioner, nogle alvorlige, nogle gange med besvær med at trække vejret, hvilket kan kræve øjeblikkelig lægelig behandling.
English: This decreased sleep latency was significantly different from that observed with placebo.
Danish: Dette fald i søvnlatenstid var signifikant forskelligt fra det, der blev observeret med placebo.
English: Children and adolescents (under 18 years of age)
Danish: Børn og unge (under 18 år)
English: Some patients have required medical therapy in the emergency department.
Danish: Nogle patienter har krævet medicinsk behandling på skadestuen.
English: Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Danish: Zaleplon udskilles i form af inaktive stofskifteprodukter, hovedsageligt i urinen (71%) og afføringen (17%).
English: Date of latest renewal: 12 March 2009
Danish: Dato for første markedsføringstilladelse: 12. marts 1999 Dato for seneste fornyelse: 12. marts 2009
English: Use of Sonata is not recommended during pregnancy.
Danish: Brug af Sonata under graviditet anbefales ikke.
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.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Sonata.
Danish: Resultater fra 2- og 4-ugers undersøgelser viste, at der ikke udvikledes nogen farmakologisk tolerance med nogen af Sonata-doserne.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Patients should be advised not to take a second dose within a single night.
Danish: Patienterne skal informeres om ikke at tage endnu en dosis samme nat.
English: This medicinal product does not require any special temperature storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Concomitant intake with alcohol is not recommended.
Danish: Samtidig indtagelse af alkohol anbefales ikke.
English: Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations are reached in approximately 1 hour.
Danish: Zaleplon absorberes hurtigt og næsten fuldstændigt efter oral indgivelse, og de højeste koncentrationer opnås i løbet af ca. en time.
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
Danish: Der er forskellige doser for mennesker, der er 65 år eller ældre, og dem der har milde til moderate leverproblemer: 65 år eller ældre: tag en 5 mg kapsel Milde til moderate leverproblemer: tag en 5 mg kapsel
English: • if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for zaleplon eller et af de øvrige indholdsstoffer i Sonata (angivet i afsnit 6).
English: A routine dosage adjustment of Sonata is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Danish: Rutinemæssig dosisjustering af Sonata betragtes ikke som nødvendig, men patienterne bør informeres om, at den sedative effekt kan forstærkes.
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.
Danish: Risikoen for afhængighed forøges med dosens størrelse og behandlingens varighed og er større hos patienter, som har en fortid med alkohol- og lægemiddelmisbrug.
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.
Danish: Der er rapporteret om forhøjede transaminaser (en gruppe leverenzymer, som findes naturligt i blodet), hvilket kan være tegn på leverproblemer.
English: The increased incidence of benign liver tumors in mice was likely an adaptive event.
Danish: Den øgede forekomst af benigne levertumorer hos mus var sandsynligvis et adaptivt tilfælde.
English: Talk to your doctor or pharmacist before taking Sonata.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Sonata.
English: They are packed in blisters.
Danish: Findes i blisterpakning.
English: It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Danish: Det er kun indiceret, hvis lidelsen er alvorlig, invaliderende eller udsætter personen for ekstrem lidelse.
English: • Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
Danish: • Brug ikke Sonata eller anden sovemedicin længere end Deres læge har sagt.
English: Some can cause drowsiness and should not be taken while taking Sonata.
Danish: Nogle af disse kan forårsage døsighed og bør ikke tages samtidig med Sonata.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne, arvelige problemer med galactoseintolerans, Lapp lactase-mangel eller glucose-galactose-malabsorption bør ikke anvende denne medicin
English: Capsule, hard.
Danish: Kapsler, hårde.
English: These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Danish: Disse hændelser kan forekomme hos såvel sedativahypnotika-naive som hos sedativa-hypnotika-erfarne personer.
English: Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Danish: Der skal udvises forsigtighed ved ordination af sedativ medicin til patienter med kronisk respirationsinsufficiens.
English: Therefore, caution is advisable in co-administering cimetidine and Sonata.
Danish: Derfor tilrådes forsigtighed ved samtidig indgivelse af cimetidin og Sonata.
English: • Do not use a second dose of Sonata within a single night.
Danish: • Tag ikke 2 doser Sonata inden for samme aften.
English: Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Danish: Sonata havde ikke indvirkning på de farmakokinetiske og farmakodynamiske profiler ved digoxin og warfarin, som er to stoffer med et snævert terapeutisk index.
English: Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
Danish: Anterograd amnesi kan forekomme ved anvendelse af anbefalet terapeutisk dosis, med stigende risiko ved højere dosering.
English: If affected do not drive or operate machinery.
Danish: Hvis De er påvirket, må De ikke føre motorkøretøj eller betjene maskiner.
English: Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Danish: Farmakoterapeutisk gruppe: Benzodiazepin-relaterede præparater, ATC kode N05CF03.
English: • If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.
Danish: • Hvis Deres søvnløshed fortsætter eller forværres efter kort behandlingsvarighed med Sonata skal De kontakte Deres læge.
English: Caution is recommended for patients performing skilled tasks.
Danish: Forsigtighed tilrådes for patienter, der udfører faglært arbejde.
English: Dependence
Danish: Afhængighed
English: There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose levels in humans have not been determined.
Danish: Der er begrænset klinisk erfaring med virkningerne af en akut overdosering med Sonata, og overdosisniveauer hos mennesker er ikke blevet fastlagt.
English: Children and adolescents under 18 years of age must not take Sonata.
Danish: Børn under 18 år må ikke tage Sonata.
English: Follow-up studies indicated that impaired fertility was due to an effect on the female.
Danish: Opfølgende studier indikerede, at nedsat fertilitet var forårsaget af en virkning på hunnen.
English: In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers.
Danish: Hos patienter med moderat insufficiens og patienter i dialyse var der en reduktion på ca. 23% af peak plasmakoncentrationen sammenlignet med raske frivillige.
English: The duration of treatment should usually vary from a few days to two weeks.
Danish: Behandlingens længde varierer normalt fra et par dage til to uger, med et maksimum på 4 uger.
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).
Danish: For at mindske risikoen, bør patienterne ikke foretage aktiviteter, som kræver psykomotorisk koordination før 4 eller flere timer efter indtagelse af Sonata (se pkt.
English: Hence, no dose adjustment is required in these patients.
Danish: Dermed er dosisjustering ikke nødvendigt hos disse patienter.
English: Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Sonata overdose.
Danish: Dyrestudier tyder på, at flumazenil er en antagonist i forhold til zaleplon og skal tages under overvejelse ved håndtering af Sonata overdosis.
English: 14 hard capsules
Danish: 14 hårde kapsler
English: In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in physiological dependence.
Danish: Ved narkotiske analgetika kan der forekomme forstærkelse af eufori, hvilket fører til en forøgelse af fysiologisk afhængighed.
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.
Danish: Advarsler forefindes allerede i zaleplon produktinformation men baseret på den tilgængelige information fandt PRAC det hensigtsmæssigt i forbindelse med denne procedure at forstærke ordlyden i produktresuméet og indlægssedlen for at sikre, at klar information er tilgængelig for patienter og sundhedspersonale vedrørende de potentielle alvorlige konsekvenser af næste dags psykomotoriske svækkelse.
English: The remainder of the urinary recovery consists of minor metabolites.
Danish: Resten af genfindingen i urinen består af mindre stofskifteprodukter.
English: Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding mothers.
Danish: Eftersom zaleplon udskilles i modermælk, bør Sonata ikke gives til ammende mødre.
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.
Danish: Skønt dyrestudier ikke har vist nogen teratogene eller embryotoksiske virkninger, findes der ikke tilstrækkelige kliniske data vedrørende Sonata til vurdering af dets sikkerhed under graviditet og amning.
English: Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Danish: Zaleplon er lipofilt med en distributionsvolumen på ca. 1,4±0,3 l/kg efter intravenøs indgivelse.
English: Zaleplon's pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Danish: Zaleplons farmakodynamiske profil viser hurtig absorption og elimination (se pkt.
English: In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Danish: Endvidere viste ibuprofen, som et eksempel på stoffer som ændrer nyreekskretion, ingen interaktion med Sonata.
English: The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Danish: De oxidative stofskifteprodukter omdannes yderligere ved konjugation via glukuronidation.
English: Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Danish: På grund af zaleplons korte halveringstid bør alternativ behandling overvejes, hvis patienter oplever at vågne tidligt om morgenen.
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.
Danish: Selvom der ikke var nogen signifikante fund i relation til zaleplon, blev et lille antal tilfælde rapporteret efter markedsføring dog hovedsageligt i kombination med andre CNS depressive midler og i doser større end 10 mg.
English: Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient.
Danish: Søvnløshed, som varer ved eller bliver værre efter en kortvarig behandling med zaleplon, kan indikere, at det er nødvendigt at revurdere patienten.
English: Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day.
Danish: Hvis De drikker alkohol samtidig med at De anvender Sonata, kan det medføre, at du føler dig døsig den efterfølgende dag.
English: 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.
Danish: Hvis produktet ordineres til en kvinde med potentiale for at blive gravid, bør hun informeres om at kontakte sin læge med henblik på behandlingsophør, hvis hun har til hensigt at blive gravid eller har mistanke om, at hun er gravid.
English: 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.
Danish: Syvoghalvtreds procent (57%) af dosen genfindes i urinen i form af 5-oxo-zaleplon og dets glukuronide stofskifteprodukt, og yderligere 9% genfindes som 5-oxodesethylzaleplon og dets glukuronide stofskifteprodukt.
English: The extent of exposure to zaleplon was similar among all groups.
Danish: Zaleplon eksponeringen var den samme i alle grupper.
English: 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
Danish: Begrundelser for at anbefale ændring af betingelserne for markedsføringstilladelsen På baggrund af de videnskabelige konklusioner for zaleplon er CHMP af den opfattelse, at benefit/risk forholdet for det lægemiddel, der indeholder zaleplon, er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkinger, som ikke er medtaget i denne indlægsseddel.
English: Sonata can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Danish: Sonata kan indtages umiddelbart inden patienten går i seng, eller efter at patienten er gået i seng og har besvær med at falde i søvn.
English: 10 hard capsules
Danish: 10 hårde kapsler
English: Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance.
Danish: Patienter, som udvikler angioødem efter behandling med zaleplon, bør ikke få den aktive substans igen.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis Deres læge har fortalt, at De ikke kan tåle visse sukkerstoffer, skal De kontakte lægen, før De tager denne medicin.
English: However, there is no clinical experience with the use of flumazenil as an antidote to a Sonata overdose.
Danish: Der er imidlertid ingen klinisk erfaring med brugen af flumazenil som modgift til en Sonata overdosis.
English: Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg.
Danish: Søvnlatenstiden i undersøgelser af ambulante patienter faldt i op til 4 uger hos ikke-ældre patienter med Sonata 10 mg.
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.
Danish: Disse egenskaber, i kombination med de undertype-selektive receptorbindende egenskaber med høj selektivitet og lav affinitet til benzodiazepin type I receptoren, er ansvarlige for Sonatas overordnede egenskaber.