FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaisalantie 4/ Vaisalavägen 4 FI-02130 Espoo/ Esbo Puh/Tel: +358 20 720 9550
Danish: Vaisalantie 4/ Vaisalavägen 4 FIN-02130 Espoo/ Esbo Puh/Tel: +358 20 720 9550
English: An allergic reaction may also include a rash, itching, or swelling of the face, lips, throat or tongue.
Danish: En allergisk reaktion kan også omfatte udslæt, kløe eller hævelser i ansigt, læber, hals eller tunge.
English: Concomitant use of zaleplon with these drugs may increase the risk of next day drowsiness, including impaired driving ability (see section 4.7).
Danish: Samtidig brug af zaleplon og disse lægemiddelstoffer kan øge risikoen for sløvhed den efterfølgende dag, inklusiv nedsat evne til at føre motorkøretøj (se pkt.
English: Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Danish: Samtidig indgivelse af Sonata og CYP3A4 fremmere som f.eks. rifampicin, carbamazepin og phenobarbiton kan resultere i en reduktion af zaleplons virkning.
English: anorexia
Danish: Anoreksi
English: Frequencies are defined as
Danish: Hyppighed ikke fastslået
English: Immune system disorders Very rare:
Danish: Immunsystemet Meget sjælden ikke kendt
English: It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness.
Danish: Det kan forekomme sammen med andre reaktioner, herunder humørsvingninger, angst eller søvnforstyrrelser og hvileløshed.
English: Reproductive system and breast disorders Common:
Danish: Det reproduktive system og mammae: Almindelig
English: In a fertility and reproductive performance study in rats, mortality and decreased fertility were observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis).
Danish: I et fertilitets- og reproduktionsevnestudie med rotter, blev mortalitet og nedsat fertilitet observeret hos hanner og hunner ved en oral zaleplon dosis på 100 mg/kg/dag (svarende til 49 gange den maksimale anbefalede humane dosis på 20 mg baseret på mg/m2).
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.
Danish: • Der er en risiko for, at De vil gå i søvne, herunder også at De spiser eller kører bil, mens De ikke er helt vågen, og ikke bagefter har nogen erindring om det.
English: As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
Danish: Ligesom med andre benzodiazepiner eller benzodiazepin-lignende midler, udgør overdosering ikke en trussel mod livet, med mindre de kombineres med andre midler, som virker beroligende på centralnervesystemet (herunder alkohol).
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3.
Danish: Eftersom clearance er reduceret, bør patienter med mild til moderat leverinsufficiens behandles med Sonata 5 mg. Ved alvorlig nedsat leverfunktion se pkt.
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)
Danish: Meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: What Sonata contains
Danish: Sonata indeholder
English: The dose of zaleplon should be reduced in patients with mild to moderate hepatic impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment.
Danish: Zaleplon dosis bør reduceres hos patienter med mild til moderat leverinsufficiens, og zaleplon anbefales ikke til behandling af patienter med svær leverinsufficiens.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Do not take Sonata
Danish: Tag ikke Sonata:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke Sonata efter den udløbsdato, der står på pakningen.
English: Insomnia may represent an underlying physical or psychiatric disorder.
Danish: Søvnløshed kan skyldes en underliggende fysisk eller psykisk lidelse.
English: They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Danish: De kan skyldes den aktive substans, være opstået spontant eller være et resultat af en underliggende psykisk eller fysisk lidelse.
English: Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Danish: Overdosering med benzodiazepiner eller benzodiazepin-lignende stoffer manifesterer sig sædvanligvis ved forskellige grader af CNS-depression fra sløvhed til koma.
English: Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Danish: Benzodiazepiner og benzodiazepin-lignende midler er ikke indiceret til behandling af patienter med alvorlig leverinsufficiens, eftersom de kan fremskynde encefalopati (se pkt.
English: The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea.
Danish: Størstedelen af de indberettede bivirkninger er Amnesi, paræstesi, somnolens og dysmenoré.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/ .
English: If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Danish: Hvis De på nogen måde er i tvivl, om De lider af ovennævnte tilstande, skal De spørge Deres læge.
English: Memory and psychomotor impairment
Danish: Hukommelses- og psykomotorisk svækkelse
English: If you forget to take Sonata
Danish: Hvis De glemmer at tage Sonata
English: Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5).
Danish: Yderligere, kan samtidig indtag af zaleplon og alkohol og andre CNS depressiva øge risikoen (se pkt.
English: Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Danish: Benzodiazepiner og benzodiazepin-lignende midler kan fremkalde anterograd amnesi og psykomotorisk svækkelse.
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased.
Danish: Hvis søvnperioden er utilstrækkelig, vil sandsynligheden for forringet opmærksomhed være forøget (se pkt.
English: Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations.
Danish: Samtidig indgivelse af Sonata og en 800 mg enkeltdosis erythromycin, en kraftigt selektiv CYP3A4 inhibitor gav en beskeden stigning på 34% i plasmakoncentrationen af zaleplon.
English: Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Danish: Derudover omdannes zaleplon af CYP3A4 og danner desethylzaleplon, som yderligere omdannes af aldehydoxidase og danner 5-oxo-desethylzaleplon.
English: depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
Danish: Depersonalisation, hallucinationer, depression, forvirring, apati
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.
Danish: Oral administration af zaleplon i doser op til 20 mg/kg/dag til rotter i 104 på hinanden følgende uger medførte ikke lægemiddel-relateret tumorgenicitet.
English: Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Danish: Der kan forekomme et vist tab af benzodiazepiners og benzodiazepin-lignende midlers hypnotikumvirkning efter gentagen brug i et par uger.
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).
Danish: I et studie af embryoføtal udvikling medførte oral administration af zaleplon i doser op til 100 mg/kg/dag og 50 mg/kg/dag til henholdsvis drægtige rotter og kaniner ingen evidens for teratogenicitet (svarende til 49- (for rotter) og 48- (for kaniner) gange den maksimale anbefalede humane dosis baseret på mg/m2).
English: These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Danish: Dette kan være hovedpine, muskelsmerter, ekstrem angst, spænding, rastløshed, forvirring og irritabilitet.
English: hyperacusis
Danish: Hyperakusis
English: In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of ≥7 mg/kg/day that did not elicit maternal toxicity.
Danish: I et studie af præ- og postnataludvikling hos rotter, blev der observeret øget forekomst af dødfødsel og postnatal mortalitet, samt nedsat vækst og langsommere fysisk udvikling hos afkommet, hvor moderen var behandlet med doser på ≥7 mg/kg/dag, en dosis som ikke fremkaldte maternal toksicitet.
English: Psychosis
Danish: Psykose
English: Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”.
Danish: Sonata 10 mg hårde kapsler, som indeholder et lyst blåt pulver, har en hvid kapseltop og hvid kapselunderdel med lysrødt tryk ”10 mg”.
English: INFORMATION IN BRAILLE Sonata 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Sonata 10 mg
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”.
Danish: Sonata 5 mg hårde kapsler, som indeholder et lyseblåt pulver, har en lysbrun kapseltop og en hvid kapselunderdel med guldtryk ”5 mg”.
English: If you have any further questions, please consult your doctor or pharmacist.
Danish: Hvis De har yderligere spørgsmål, bedes De kontakte Deres læge eller apoteket.
English: Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Danish: Allerede eksisterende depression kan blive afsløret ved brug af benzodiazepiner eller benzodiazepinlignende midler.
English: Ear and labyrinth disorders Uncommon:
Danish: Øre og labyrint Ikke almindelig
English: Common (1/100 to <1/10)
Danish: Ikke almindelig (≥1/1.000 til <1/100)
English: nausea
Danish: Kvalme
English: Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Danish: Zaleplon omsættes primært ved hjælp af aldehydoxidase og danner 5-oxo-zaleplon.
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Danish: Amnesi, paræstesi, somnolens Ataksi/svigt af koordination, svimmelhed, opmærksomhedsforstyrrelse, parosmi, taleforstyrrelser (artikulationsforstyrrelse, sløret tale), hypæstesi
English: asthenia, malaise
Danish: Asteni, utilpashed
English: INFORMATION IN BRAILLE Sonata 5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Sonata 5 mg
English: However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
Danish: Imidlertid er en additiv farmakodynamisk virkning mulig, da begge stoffer har virkning på centralnervesystemet.
English: Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Danish: Samtidig indgivelse af Sonata og medicin, som vides at påvirke CYP3A4, forventes at resultere i ændringer i plasmakoncentrationen af zaleplon (se pkt.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaveren af markedsføringstilladelsen og fremstiller
English: These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Danish: Disse reaktioner kan være forårsaget af det aktive stof, opstået spontant eller som følge af fysisk eller psykisk lidelse.
English: If you stop taking Sonata
Danish: Hvis De holder op med at tage Sonata
English: Rebound insomnia and anxiety
Danish: Rediciv søvnløshed og angst
English: Meda Pharma S.p.A. Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
Danish: Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed overfor det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
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.
Danish: både aldehyd oxidase og CYP3A4, bevirkede en 85% stigning i plasmakoncentrationen af zaleplon, fordi det hæmmede både de primære (aldehyd oxidase) og de sekundære (CYP3A4) enzymer, som er ansvarlige for metaboliseringen af zaleplon.
English: General disorders and administration site conditions Uncommon:
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
English: If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
Danish: Hvis De har taget en overdosis, kan De blive meget døsig meget hurtigt.
English: Skin and subcutaneous tissue disorders Uncommon:
Danish: Hud og subkutane væv Ikke almindelig Hyppighed ikke fastslået
English: Do not go unaccompanied to seek medical help.
Danish: Tag æsken med. Søg ikke lægehjælp uden en ledsager er med.
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.
Danish: Forstærkelse af den beroligende virkning på centralnervesystemet kan forekomme i tilfælde med samtidig brug af antipsykotika (neuroleptika), hypnotika, anxiolytika/beroligende midler, antidepressionsmidler, narkotiske analgetika, antiepileptiske medikamenter, anæstetika og beroligende antihistaminer.
English: Solvang 8
Danish: Krijgsman 20
English: If you experience these events, contact your doctor immediately.
Danish: Hvis De oplever dette, skal De straks kontakte Deres læge.
English: Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient.
Danish: Man skal være opmærksom på at luftvejene er frie, ofte er understøttelse af ventilation og hæmodynamik tilstrækkelig.
English: An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting.
Danish: En allergisk reaktion kan omfatte udslæt, kløe, åndedrætsbesvær eller hævelser i ansigt, læber, hals eller tunge, eller kvalme og opkastning.
English: Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
Danish: Hvis der er udviklet fysisk afhængig, vil et pludselig ophør med behandlingen medføre abstinenssymptomer.
English: anaphylactic/anaphylactoid reactions
Danish: Anafylaktiske/anafylaktoide reaktioner
English: The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Danish: 4.2), og bør ikke overstige to uger.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE SONATA 10 MG KAPSLER - PAKNINGSSTØRRELSE 7, 10 OG 14 KAPSLER
English: Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”.
Danish: Kapslernes skal er hård, uigennemsigtig hvid og lys brun med styrken “5 mg”.
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).
Danish: Denne type medicin omfatter: midler som bruges i behandlingen af mentale lidelser (antipsykotika, hypnotika, angstdæmpende og beroligende midler, antidepressiva), lægemidler til smertestillende behandling (narkotiske smertestillende midler), lægemidler til behandling af kramper/krampeanfald (antiepileptisk medicin), bedøvende midler og lægemidler til behandling af allergi (beroligende antihistaminer).
English: In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Danish: I mere alvorlige tilfælde kan symptomerne være ataksi, hypotoni, hypotension, respirations depression, i sjældne tilfælde koma og i meget sjældne tilfælde død.
English: If you experience any of these events, contact your doctor immediately.
Danish: Hvis De oplever noget af dette, skal De straks kontakte Deres læge.
English: Suomi/Finland
Danish: Suomi/Finland Meda Oy
English: Combination with other CNS-acting compounds should be taken into account.
Danish: Der skal tages hensyn til kombination med andre stoffer, som har indvirkning på centralnervesystemet.
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.
Danish: mg/kg/dag) zaleplon til mus i 65 eller 104 på hinanden følgende uger, fremkaldte en statistisk signifikant øget forekomst af benigne men ikke maligne levertumorer.
English: Capsules have an opaque white hard shell with the strength “10 mg”.
Danish: Kapslernes skal er hård, uigennemsigtig hvid med styrken “10 mg”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
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).
Danish: Ikke almindelige bivirkninger inkluderer: svimmelhed, svaghed, nedsat koordination af bevægelser, vaklen og/eller fald (ataksi), nedsat koncentration, sløvhed, hvileløshed, depression, ophidselse, irritabilitet, forvirring, unormal tænkning og opførsel (udadvendthed som ikke synes at passe til personen, nedsat hæmning, aggressivitet, raseri, vrangforestillinger, depersonalisation, psykose), mareridt, hallucinationer, dobbeltsyn eller andre synsproblemer, øget følsomhed over for støj (hyperakusis), lugtforstyrrelser (parosmi), taleforstyrrelser, inkl.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE SONATA 5 MG - PAKNINGSSTØRELSE 7, 10 OG 14 KAPSLER
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.
Danish: På grund af den øgede risiko for bevidst overdosering hos patienter med depression generelt bør mængden af lægemiddel, inkl.
English: Keep this leaflet.
Danish: - Gem indlægsseddlen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 10 mg zaleplon.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 5 mg zaleplon.
English: Psychiatric disorders Uncommon:
Danish: Psykiske forstyrrelser Ikke almindelig
English: Nervous system disorders Common:
Danish: Nervesystemet Almindelig Ikke almindelig
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Danish: Almindelige bivirkninger: døsighed, hukommelsesbesvær, snurrende fornemmelser, f.eks. i arme og ben (paræstesi), smertefuld menstruation.
English: Česká republika MEDA Pharma s.r.o.
Danish: MEDA Pharma s.r.o.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/102/001-003
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/99/102/004-006
English: Uncommon:
Danish: Ikke almindelig
English: Meda Pharma SIA Vienības gatve 109 LV-1058 Riga, Latvia Tel.: +371 67616137
Danish: LV-1058 Riga, Latvia Tel.: +371 67616137
English: Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Danish: Sonata er fremstillet således, at hvis indholdet af kapslen opløses i væske, vil væsken skifte farve og blive uklar.
English: The active substance in each Sonata hard capsule is zaleplon 10 mg.
Danish: Det aktive indholdsstof i hver Sonata hårde kapsel er 10 mg zaleplon.
English: Sleep apnoea syndrome
Danish: Søvnapnø syndrom
English: The active substance in each Sonata hard capsule is zaleplon 5 mg.
Danish: Det aktive indholdsstof i hver Sonata hårde kapsel er 5 mg zaleplon.
English: The sedative effect may be enhanced when the product is used in combination with alcohol which may affect the ability to drive or use machines the next day (see section 4.7).
Danish: Dette kan have indvirkning på evnen til at føre motorkøretøj eller betjene maskiner den efterfølgende dag (se pkt.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering
English: Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
Danish: Trykfarverne på kapslen indeholder følgende (guldfarve SB-3002): shellac, ammoniumhydroxid, gul jernoxid (E172).
English: How to take Sonata
Danish: SÅDAN SKAL DE TAGE SONATA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS SONATA 5 MG KAPSLER