FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have been given more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or sleepiness, trouble breathing, low blood pressure, throat irritation or a bad taste in the mouth, muscle or eye movements you can't control.
Danish: Hvis man har fået for meget ADASUVE, kan det give et eller flere af følgende symptomer: ekstrem træthed eller søvnighed, vejrtrækningsbesvær, lavt blodtryk, irritation i halsen eller ubehagelig smag i munden eller ukontrollerede muskel- eller øjenbevægelser.
English: To deliver the medicinal product, the patient inhales through the mouthpiece with a steady deep breath.
Danish: Produktet administreres ved, at patienten inhalerer gennem mundstykket med en jævn, dyb indånding.
English: Marketing Authorisation Holder Ferrer Internacional, S.A.
Danish: Indehaver af markedsføringstilladelsen Ferrer Internacional, S.A.
English: In vitro studies indicate that loxapine and 8-OH-loxapine are not inducers of CYP1A2, 2B6 or 3A4 enzymes at clinically relevant concentrations.
Danish: In vitro studier indikerer, at loxapin og 8-OH-loxapin ikke inducerer CYP 1A2, 2B6 eller 3A4 ved klinisk relevante koncentrationer.
English: • have or had glaucoma (increased pressure in the eye)
Danish: • har eller har haft grøn stær (for højt væsketryk i øjet)
English: Inhale through the mouthpiece with a steady, deep breath.
Danish: Inhalér gennem mundstykket med en stabil, dyb indånding.
English: Extrapyramidal symptoms
Danish: Ekstrapyramidale symptomer.
English: In addition, in vitro studies indicate that loxapine and 8-OH loxapine are not inhibitors of UGT1A1, 1A3, 1A4, 2B7 and 2B15.
Danish: Herudover indikerer in vitro studier, at loxapin og 8-OHloxapin ikke hæmmer UGT1A, 1A3, 1A4, 2B7 og 2B15.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ADASUVE in the subset of the paediatric population from birth to less than 12 years of age for the treatment of schizophrenia and in the subset from birth to less than 10 years of age for the treatment of bipolar disorder (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ADASUVE i undergruppen af den pædiatriske population i alderen 0-12 år til behandling af skizofreni og i undergruppen i alderen 0-10 år til behandling af bipolar lidelse (se pkt.
English: The potential for loxapine and its metabolites (amoxapine, 7-OH-loxapine, 8-OH-loxapine, and loxapine-N-oxide) to inhibit CYP450 - mediated drug metabolism has been examined in vitro for CYPs 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Danish: Potentialet af loxapin og dets metabolitter (amoxapin, 7-OH-loxapin, 8-OH-loxapin, og loxapin-Noxid) til at hæmme CYP-medieret metabolisering af lægemidler er undersøgt in vitro for CYP 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: Common (may affect up to 1 in 10 people): dizziness, throat irritation, dry mouth or tiredness.
Danish: Almindelig (forekommer hos indtil 1 ud af 10 behandlede): svimmelhed, irritation i halsen eller træthed
English: The recommended initial dose of ADASUVE is 9.1 mg. As this dose cannot be reach with this presentation (ADASUVE 4.5 mg), the presentation ADASUVE 9.1 mg should be used initially.
Danish: Da denne dosis ikke kan opnås ved denne styrke (ADASUVE 4,5 mg) skal styrken ADASUVE 9,1 mg anvendes i starten.
English: Upon completion of the inhalation, the patient removes the mouthpiece from mouth and holds breath briefly.
Danish: Efter inhalation skal patienten tage mundstykket ud af munden og holde vejret et øjeblik.
English: The main metabolic pathways include hydroxylation to form 8-OH-loxapine and 7-OH-loxapine, N-oxidation to form loxapine N-oxide, and de-methylation to form amoxapine.
Danish: De vigtigste metaboliseringsveje er hydroxylering til 8-OH-loxapin og 7-OH-loxapin, N-oxidation til loxapin Noxid og demethylering til amoxapin.
English: Each inhaler is provided in a sealed, multilaminate aluminum foil pouch.
Danish: Hver inhalator leveres i en forseglet pose af flerlaget aluminiumfolie.
English: Caution should be exercised when ADASUVE is administered in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products known to prolong the QT interval.
Danish: Der bør udvises forsigtighed, når ADASUVE administreres til patienter med kendt kardiovaskulær sygdom eller familiær anamnese med QT-forlængelse og til patienter i samtidig behandling med andre lægemidler, der vides at forlænge QT-intervallet.
English: The mean plasma loxapine concentrations following administration of ADASUVE were linear over the clinical dose range.
Danish: Efter administration af ADASUVE var den gennemsnitlige plasmakoncentration af loxapin lineær i hele det kliniske dosisområde.
English: FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spain
Danish: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spanien
English: • ADASUVE may cause narrowing of the airways (bronchospasm) and may cause you to wheeze, cough, feel chest tightness or have shortness of breath.
Danish: • ADASUVE kan medføre forsnævring af luftvejene (bronkospasme), hvæsende vejrtrækning, hoste, trykken for brystet og stakåndethed.
English: Seizures have been reported in patients receiving oral loxapine at antipsychotic dose levels, and may occur in epileptic patients even with maintenance of routine anticonvulsant drug therapy (see section 4.5).
Danish: Ved oral behandling med loxapin i antipsykotiske doser er der beskrevet krampeanfald, som kan forekomme hos patienter med epilepsi, selv om de er i løbende behandling med krampestillende medicin (se pkt.
English: Respiratory, thoracic and mediastinal disorders Common: throat irritation
Danish: Luftveje, thorax og mediastinum Almindelig: halsirritation
English: MedDRA system organ classification Nervous system disorders
Danish: MedDRA systemorganklasse
English: 5 single-dose inhalers
Danish: 5 enkeltdosisinhalatorer
English: Tear open the foil pouch and remove the inhaler from the package.
Danish: Riv folieposen op og tag inhalatoren ud af pakningen.
English: Do not open pouch until ready to use.
Danish: Undgå at åbne posen, før produktet skal bruges.
English: Patients should be observed during the first hour after each dose for signs and symptoms of bronchospasm.
Danish: I den første time efter hver dosis skal patienterne observeres for tegn og symptomer på bronkospasme.
English: Hold breath Remove the mouthpiece from the mouth and hold breath briefly.
Danish: Hold vejret Tag mundstykket ud af munden og hold vejret et øjeblik.
English: Main results of the pivotal efficacy studies: comparisons between ADASUVE 4.5 mg, 9.1 mg, and placebo
Danish: Hovedresultaterne af de vigtigste kliniske undersøgelser af virkning: sammenligning mellem ADASUVE 4,5 mg og 9,1 mg
English: Note: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3 to 5.
Danish: Bemærk: Hvis den grønne lampe bliver ved med at lyse, efter at patienten har inhaleret, skal patienten gentage punkt 3 til 5.
English: Given the primary Central Nervous System (CNS) effects of loxapine, ADASUVE should be used with caution in patients with compromised respiration, such as hypovigilant patients or patients with CNS-depression due to alcohol or other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. (see section 4.5).
Danish: På grund af loxapins primære virkninger på CNS skal der udvises forsigtighed ved anvendelse af ADASUVE til patienter med kompromitteret respiration, såsom patienter med nedsat opmærksomhed eller med CNS-depression forårsaget af alkohol eller andre centralt virkende lægemidler, f.eks. anxiolytika, de fleste antipsykotika, hypnotika, opiater m.v. (se pkt.
English: Should bronchospasm occur after treatment with ADASUVE, it can be treated with a short-acting beta-agonist bronchodilator, e.g., salbutamol (see sections 4.2 and 4.8).
Danish: Ved bronkospasme efter behandlingen med ADASUVE kan der gives en korttidsvirkende bronkodilaterende beta-agonist, f.eks. salbutamol (se pkt.
English: Loxapine is a substrate for several CYP450 isozymes; in vitro studies demonstrated that 7-OHloxapine is formed mainly by CYPs 3A4 and 2D6, 8-OH-loxapine is formed mainly by CYP1A2, amoxapine is formed mainly by CYP3A4, 2C19, and 2C8, and loxapine N-oxide is formed by FMOs.
Danish: In vitro-undersøgelser viste, at 7-OH-loxapin hovedsagelig dannes af CYP 3A4, og 2D6, 8-OH-loxapin hovedsagelig dannes af CYP1A2, amoxapin hovedsagelig dannes af CYP-3A4, -2C19 og -2C8, og loxapin N-oxid dannes af FMO.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V .
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: • Caution to be exercised when ADASUVE is administered in patients with known cardiovascular disease or a family history of QT prolongation, and in cases of concomitant use with other medicial products known to prolong the QT interval
Danish: • nødvendigheden af forsigtighed ved administration af ADASUVE til patienter med kendt kardiovaskulær sygdom eller familiær anamnese med QT-forlængelse samt til patienter i samtidig behandling med andre lægemidler, der vides at forlænge QT-intervallet
English: NOTE: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3-5.
Danish: BEMÆRK: Hvis den grønne lampe bliver ved med at lyse efter at patienten har inhaleret, skal patienten gentage punkt 3-5.
English: Remove the mouthpiece from the mouth and hold breath briefly.
Danish: Tag mundstykket ud af munden og hold vejret et øjeblik.
English: Loxapine exposure in the first 2 hours after administration (AUC0-2h, a measure of early exposure that is relevant to the onset of therapeutic effect) was 25.6 ng*h/mL for the 4.5 mg dose and 66.7 ng*h/mL for the 9.1 mg dose in healthy subjects.
Danish: Hos raske forsøgspersoner var eksponeringen for loxapin i de første 2 timer efter administration (AUC0-2h, der er et mål for tidlig eksponering med relevans for indsættelse af terapeutisk virkning,) 25,6 ng*t/ml for 4,5 mg dosen og 66,7 ng*t/ml for 9,1 mg dosen.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling • Educational material for the healthcare professionals
Danish: • produktresumé, indlægsseddel og etikettering
English: Common: dizziness
Danish: Almindelig: svimmelhed
English: • if you have symptoms of wheezing or shortness of breath;
Danish: • hvis du har hvæsende vejrtrækning eller er stakåndet
English: However, in placebo-controlled clinical trials in subjects with mild-to-moderate persistent asthma or moderate-to-severe COPD, adverse reactions of bronchospasm were reported very commonly.
Danish: I de placebokontrollerede kliniske undersøgelser hos patienter med persisterende let til moderat astma eller moderat til svær KOL blev bronkospasme derimod indberettet som en meget almindelig bivirkning.
English: After the first dose, a second dose was administered at least 2 hours later if the agitation had not subsided sufficiently.
Danish: Hvis agitationen ikke var aftaget tilstrækkeligt efter den første dosis, blev der givet endnu en dosis mindst to timer senere.
English: Loxapine is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are either metabolised by cytochrome P450 (CYP450) isozymes or glucuronidated by human uridine 5'-diphosphoglucuronosyl transferases (UGTs).
Danish: Loxapin forventes ikke at medføre klinisk betydningsfulde farmakokinetiske interaktioner med lægemidler, der enten metaboliseres af CYP-isoenzymer eller glukuronideres af humant UDPglukuronyltransferase (UGT).
English: Female rats did not mate due to persistent diestrus after oral treatment with loxapine.
Danish: Hunrotter ville efter oral behandling med loxapin ikke parre sig som følge af vedvarende diestrus.
English: ADASUVE is used to treat acute symptoms of mild-to-moderate agitation that may occur in adult patients who have schizophrenia or bipolar disorder.
Danish: ADASUVE anvendes til at behandle akutte symptomer på let til moderat rastløs uro (agitation) hos voksne patienter med skizofreni eller bipolar (maniodepressiv) sygdom.
English: For ADASUVE, the order of metabolites observed in humans (based on systemic exposure) was 8-OH-loxapine >> loxapine N oxide > 7-OH-loxapine > amoxapine, with plasma levels of 8-OH-loxapine similar to the parent compound.
Danish: Rangordenen af metabolitterne hos mennesker (baseret på systemisk eksponering) var for ADASUVE 8-OH-loxapin >> loxapin N-oxid > 7-OH-loxapin > amoxapin, med plasmakoncentrationer af 8-OH-loxapin i samme størrelsesorden som moderstoffets.
English: Firmly pull the plastic tab from the rear of the inhaler.
Danish: Træk plastfligen på bagsiden af inhalatoren af med et fast greb.
English: - If you have any further questions, ask your doctor or nurse.
Danish: Er du i tvivl, så spørg lægen eller sygeplejersken.
English: In a supportive Phase 2 single dose study enrolling a total of 129 patients with schizophrenia and schizoaffective disorder the decrease in PEC change after 2 hours was -5.0 for placebo, -6.7 for ADASUVE 4.5 mg, and -8.6 (p<0.001) for ADASUVE 9.1 mg.
Danish: I en støttende fase 2-enkeltdosisundersøgelse med i alt 129 patienter med skizofreni og skizoaffektiv sygdom var ændringen i PEC efter to timer -5,0 for placebo, -6,7 for ADASUVE 4,5 mg og -8,6 (p<0,001) for ADASUVE 9,1 mg. Der blev givet redningsmedicin til henholdsvis 32,6 %, 11,1 % og 14,6 % af patienterne.
English: Pull tab.
Danish: (se pkt.
English: Caution is advised if loxapine is combined with other medicinal products known to lower the seizure threshold, e.g. phenothiazines or butyrophenones, clozapine, tricyclics or selective serotonine reuptake inhibitors (SSRIs), tramadol, mefloquine (see section 4.4).
Danish: Der bør udvises forsigtighed ved anvendelse af loxapin sammen med andre lægemidler, der vides at sænke krampetærsklen, f.eks. phenothiaziner eller butyrofenoner, clozapin, tricykliske antidepressiva eller selektive serotoningenoptagshæmmere (SSRI), tramadol og mefloqin (se pkt.
English: Change at 2 hr post dose
Danish: Ændring to timer efter dosering
English: The pharmacokinetic parameters of loxapine were determined in subjects on chronic, stable antipsychotic regimens following repeat administration of ADASUVE every 4 hours for a total of 3 doses (either 4.5 mg or 9.1 mg).
Danish: De farmakokinetiske parametre af loxapin blev bestemt efter gentagen administration af ADASUVE hver 4. time med i alt tre doser (på enten 4,5 mg eller 9,1 mg) hos patienter i kronisk, stabilt antipsykotisk behandlingsregimen.
English: How to use ADASUVE
Danish: Sådan skal du bruge ADASUVE
English: Three
Danish: Tre
English: PEC Responders
Danish: CGI-Irespondere
English: - If you get any side effects, talk to your doctor or nurse.
Danish: - Hvis du får bivirkninger, skal du sige det til lægen eller sygeplejersken.
English: In studies in agitated patients, bronchospasm was reported as an uncommon, but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator.
Danish: Bronkospasme blev derimod beskrevet som almindelig hos patienter med aktiv luftvejssygdom, hos hvem den ofte krævede behandling med en korttidsvirkende bronkodilaterende beta-agonist.
English: ADASUVE should be used with caution in patients who are intoxicated or delirious (see section 4.5).
Danish: Der bør udvises forsigtighed ved anvendelse af ADASUVE til berusede eller delirøse patienter (se pkt.
English: ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
Danish: Der bør udvises forsigtighed ved anvendelse af ADASUVE til patienter med ekstrapyramidale symptomer i anamnesen.
English: • already used ADASUVE and you developed symptoms of wheezing or shortness of breath
Danish: • tidligere har fået ADASUVE og har fået hvæsende vejrtrækning eller stakåndethed
English: irregular or fast heart rate or pulse.
Danish: Symptomerne kan bestå af høj feber, muskelstivhed og ujævn eller hurtig hjerterytme eller puls.
English: Tell your doctor if you are using or have recently used or might use any other medicines, including:
Danish: Brug af anden medicin sammen med ADASUVE Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig, herunder:
English: The recommended initial dose is 9.1 mg. After 2 hours, your doctor may prescribe a second dose after carefully considering your condition and your dose may be reduced to 4.5 mg if your doctor believes that this is a more appropriate dose to treat your condition.
Danish: Din dosis kan også blive sat ned til 4,5 mg, hvis lægen mener, at det er en bedre dosis til at behandle din tilstand.
English: Loxapine should be used with caution in patients with a history of convulsive disorders since it lowers the convulsive threshold.
Danish: Hos patienter med krampeanfald i anamnesen bør anvendelse af loxapin ske med forsigtighed, da det sænker krampetærsklen.
English: If you use more ADASUVE than you should
Danish: Hvis du har brugt for meget ADASUVE
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse FERRER INTERNACIONAL, S.A.
English: Angelini S.p.A. Tel: +39 06 780531
Danish: Tel: +39 06 780531
English: Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
Danish: Hver enkeltdosisinhalator indeholder 5 mg loxapin og afgiver 4,5 mg loxapin.
English: • have or had urinary retention (incomplete emptying of the bladder)
Danish: • har eller har haft tilbageholdelse af urinen
English: • medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
Danish: • medicin, der kan medføre kramperisiko (f.eks. clozapin, tricykliske antidepressiva eller selektive serotoningenoptagshæmmere [SSRI], tramadol, mefloqin)
English: What ADASUVE contains
Danish: ADASUVE indeholder:
English: • if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).
Danish: • hvis du har problemer med lungerne såsom astma eller kronisk obstruktiv lungesygdom (KOL)
English: Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Danish: Hver enkeltdosisinhalator indeholder 10 mg loxapin og afgiver 9,1 mg loxapin.
English: Inhalation powder, pre-dispensed
Danish: Inhalationspulver, afdelt
English: What ADASUVE looks like and contents of the pack ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Danish: ADASUVE 9,1 mg inhalationspulver, afdelt, består af en hvid engangsinhalator af plast, der indeholder en enkelt dosis af loxapin.
English: One
Danish: Én
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers.
Danish: ADASUVE 9,1 mg leveres i en karton med 1 eller 5 enkeltdosisinhalatorer.
English: Decreased agitation was evident 10 minutes after Dose 1, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, for both 4.5 mg and 9.1 mg doses in both schizophrenia and bipolar disorder patients.
Danish: Der var klart mindsket agitation 10 minutter efter dosis 1, som var det første vurderingstidspunkt, samt ved alle de efterfølgende vurderinger i den 24-timers vurderingsperiode.
English: 1 single dose inhaler
Danish: Én enkeltdosisinhalator
English: Each inhaler delivers 9.1 mg loxapine.
Danish: Hver inhalator afgiver 9,1 mg loxapin.
English: What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Danish: ADASUVE 4,5 mg inhalationspulver, afdelt, består af en hvid engangsinhalator af plast, der indeholder en enkelt dosis af loxapin.
English: Cardiovascular
Danish: Krampeanfald
English: Adrenaline should not be used since its use in a patient with partial adrenergic blockage may further lower the blood pressure (see sections 4.4 and 4.5).
Danish: Adrenalin bør ikke anvendes, da det kan forstærke eksisterende hypotension hos patienter med partiel adrenerg blokade (se pkt.
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers.
Danish: ADASUVE 4,5 mg leveres i en karton med 1 eller 5 enkeltdosisinhalatorer.
English: ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Danish: ADASUVE 9,1 mg, leveres i en karton á 1 eller 5 stk.
English: Common: dry mouth
Danish: Almindelig: mundtørhed
English: Inhale Inhale through the mouthpiece with a steady deep breath.
Danish: Inhalér Inhalér gennem mundstykket med en stabil, dyb indånding.
English: If you are concerned that you are given more ADASUVE than you feel necessary, tell your doctor or nurse of your concern.
Danish: Fortæl det til lægen eller sygeplejersken, hvis du er bekymret for, at du får mere ADASUVE, end du mener er nødvendigt.
English: DEVICE HOUSING
Danish: ANORDNINGENS HUS
English: Each inhaler delivers 4.5 mg loxapine.
Danish: Hver inhalator afgiver 4,5 mg loxapin.
English: ADASUVE 4.5 mg inhalation powder loxapine
Danish: ADASUVE 4,5 mg inhalationspulver loxapin
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed
Danish: ADASUVE 9,1 mg, inhalationspulver, afdelt
English: ADASUVE 9.1 mg inhalation powder loxapine
Danish: ADASUVE 9,1 mg inhalationspulver loxapin
English: ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Danish: ADASUVE 4,5 mg, leveres i en karton á 1 eller 5 stk.
English: Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.
Danish: Der var ingen forskelle i respons mellem undergrupper inddelt efter alder, race og køn.
English: • have or had seizures (convulsions)
Danish: • har eller har haft kramper
English: ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
Danish: ADASUVE 9,1 mg inhalationspulver, afdelt loxapin
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Danish: ADASUVE 4,5 mg inhalationspulver, afdelt loxapin
English: In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed.
Danish: Der blev meget ofte iagttaget bronkospasme i de placebokontrollerede kliniske undersøgelser hos patienter med astma eller KOL.
English: • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske opdaterede sikkerhedsberetninger
English: Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment.
Danish: ADASUVE er ikke blevet undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: Inhale.
Danish: Inhalér.
English: ADASUVE 4.5 mg inhalation powder, pre-dispensed
Danish: ADASUVE 4,5 mg, inhalationspulver, afdelt.
English: They will decide how much you need.
Danish: De vil vurdere hvor meget du har brug for.
English: This may cause bleeding.
Danish: Dette kan give blødning.
English: There is no known specific treatment in case of an overdose.
Danish: Der er ingen kendt specifik behandling i tilfælde af overdosering.
English: However, this finding is based on a very small sample (n=129 patients).
Danish: Dette resultat er dog baseret på et meget lille antal (n=129 patienter).
English: Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
Danish: Dato for første markedsføringstilladelse: 20. januar 2000 Dato for seneste fornyelse: 20. januar 2010
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: - Brug ikke dette lægemiddel efter udløbsdatoen, der er angivet på etiketten efter EXP.