natgillin/translations-raw huggingface dataset:
De almindeligste bivirkninger af Aerinaze (der ses hos mellem 1 og 10 patienter ud af hver 100) er hjertebanken, mundtørhed, svimmelhed, rastløshed, ondt i halsen, appetitløshed, forstoppelse, hoved - pine, træthed, søvnbesvær, søvnighed, søvnforstyrrelser og nervøsitet.
The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Aerinaze bør ikke anvendes hos patienter, der muligvis er overfølsomme (allergiske) over for deslora - tadin, pseudoephedrin, andre af indholdsstofferne, adrenerge stoffer eller loratadin (et andet lægemid - del til behandling af allergi).
Aerinaze should not be used in people who may be hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Det bør heller ikke anvendes hos patienter, der er i behandling med mo - noaminoxidasehæmmere (MAO- hæmmere) (f. eks. visse lægemidler mod depression) eller er holdt op med at tage sådanne lægemidler inden for de seneste to uger.
It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks.
Aerinaze bør desuden ikke anvendes hos patienter med snævervinklet glaukom (grøn stær, forhøjet tryk i øjet), vandladningsbesvær, hjerte - karsygdomme, herunder for højt blodtryk, for stor produktion af skjoldbruskkirtelhormon, tidligere hjerneblødning eller forhøjet risiko for hjerneblødning.
Aerinaze should also not be taken by people who have narrow- angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Aerinaze opve - jer risiciene til behandling af symptomerne ved sæsonbundet høfeber ledsaget af stoppet næse.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze’ s benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Udval - get anbefalede udstedelse af markedsføringstilladelse for Aerinaze.
The Committee recommended that Aerinaze be given marketing authorisation.
Andre oplysninger om Aerinaze:
Other information about Aerinaze:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aerinaze til SP Europe den 30. juli 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze to SP Europe on 30 July 2007.
Den fuldstændige EPAR om Aerinaze findes her.
The full EPAR for Aerinaze can be found here.
Dette sammendrag blev sidst ajourført i 06- 2007.
This summary was last updated in 06-2007.
2, 5 mg / 120 mg
Invented name
Oral brug
Strength
EU/ 1/ 07/ 399/ 003
Pharmaceutical Form
Blister (PCTFE/ PVC/ Alu)
Route of Administration
7 tabletter
Packaging
10 tabletter
Package size
Tablet med modificeret udløsning
Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet
Tablet med modificeret udløsning
Oral use Oral use Oral use Oral use Oral use Oral use
Blister (PCTFE/ PVC/ Alu)
Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu) Blister (PCTFE/ PVC/ Alu)
20 tabletter
2 tablets 4 tablets 7 tablets 10 tablets 14 tablets 20 tablets
∗ 2, 5 mg desloratadin/ 120 mg pseudoephedrin sulfat
∗ 2.5 mg desloratadine/ 120 mg pseudoephedrine sulphate
Aerinaze 2, 5 mg/ 120 mg tabletter med modificeret udløsning.
Aerinaze 2.5mg/ 120 mg modified-release tablets
Hver tablet indeholder 2, 5 mg desloratadin og 120 mg pseudoephedrin (som sulfat).
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine (as sulphate).
Blå og hvid oval tablet i to lag med ” D12 ” præget på det blå lag.
Blue and white bilayer oval tablet with “ D12” branded to blue layer.
Symptomatisk behandling af sæsonbetinget allergisk rhinitis ledsaget af tilstoppet næse.
Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Voksne og unge ≥ 12 år:
Adults and adolescents 12 years of age and over:
Anbefalet Aerinaze- dosis er 1 tablet 2 gange daglig.
The recommended dose of Aerinaze is one tablet twice a day.
Tabletten kan tages med et helt glas vand men skal sluges hel (uden at knuse, dele eller tygge den).
The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
5. 1).
Aerinaze should not be used in children below the age of 12 years due to a lack of data on safety and efficacy (see section 5.1).
Behandlingsvarigheden bør holdes så kort som muligt og bør ikke fortsættes, efter at symptomerne er forsvundet.
The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
Det anbefales at begrænse behandlingen til omkring 10 dage, da pseudoephedrins aktivitet kan mindskes med tiden ved kronisk administration.
It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, over for adrenergika eller over for loratadin.
Hypersensitivity to the active substance, to any of the excipients, to adrenergic agents or to loratadine.
Da Aerinaze indeholder pseudoephedrin er det også kontraindiceret til patienter, der behandles med monoaminoxidase- hæmmere (MAO- hæmmere) og i de efterfølgende 2 uger efter seponering af sådan behandling.
As Aerinaze contains pseudoephedrine, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Aerinaze er også kontraindiceret hos patienter med: • snævervinkel glaukom, • urinretention, • kardiovaskulære lidelser såsom iskæmisk hjertelidelse, takyarytmi og svær hypertension, • hyperthyreoidism, • tidligere hæmoragisk apopleksi eller risikofaktorer der øger risikoen for hæmoragisk apopleksi.
Aerinaze is also contraindicated in patients with: • narrow-angle glaucoma, • urinary retention, • cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension, • hyperthyroidism,
Dette skyldes den alfa- mimetiske virkning af pseudoephedrin, i kombination med andre vasokontriktorer som bromocriptin, pergolid, lisurid, cabergolin, ergotamin, dihydroergotamin eller andre dekongestanter brugt til næsen enten peroralt eller nasalt (phenylpropanolamin, phenylephrin, ephedrin, oxymetazolin, naphazolin...).
This is due to the alpha-mimetic activity of pseudoephedrine in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…).
2 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
4. 2).
Do not exceed the recommended dosage and the duration of treatment (see section 4.2).
Patienter i alderen 60 år eller ældre oplever sandsynligvis bivirkninger af sympatomimetika, såsom pseudoephedrin.
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine.
Sikkerhed og virkning af kombinationspræparatet er ikke undersøgt i denne patientgruppe, og der er utilstrækkelige data til at give fyldestgørende dosisrekommandationer.
The safety and efficacy of the combination have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Kombinationspræparatet bør derfor anvendes med forsigtighed til patienter over 60 år.
Therefore the combination product should be used with caution in patients above 60 years of age.
Nedsat nyre - eller leverfunktion:
Renal or hepatic impairment:
Sikkerhed og virkning af Aerinaze er ikke fastslået for patienter med nedsat nyre - eller leverfunktion, og der er utiltrækkelige data til at give fyldestgørende dosisrekommandationer.
The safety and efficacy of Aerinaze has not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Kombinationspræparatet bør ikke bruges til patienter med nedsat nyre - og leverfunktion.
The combination product is not recommended for use in patients with impaired renal or hepatic function.
4. 2).
Aerinaze should not be used in children below the age of 12 years (see section 4.2).
Patienter bør oplyses om, at behandlingen bør afbrydes i tilfælde af hypertension, takykardi, palpitationer eller hjertearytmier, kvalme eller andre neurologiske tegn (såsom hovedpine eller forværret hovedpine).
Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache or increased headache).
Sympatomimetika kan forårsage stimulering af centralnervesystemet med kramper eller kardiovaskulært kollaps med hypotension.
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
4. 9).
These effects may be more likely to occur in children, elderly patients, or in cases of overdose (see section 4.9).
Der skal udvises forsigtighed med følgende patientgrupper: • patienter behandlet med digoxin • patienter med hjertearytmier • patienter med hypertension • patienter med tidligere myokardieinfarkt, diabetes mellitus, blærehalsobstruktion eller bronkospasme.
Caution should be exercised in the following patient groups: • Patients receiving digitalis • Patients with cardiac arrhythmias • Patients with hypertension • Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm.
Der skal også udvises forsigtighed med patienter i behandling med andre sympatomimetika.
Caution should also be exercised in patients being treated with other sympathomimetics.
Disse inkluderer: • decongestanter • anorexogenika eller amfetaminlignende psykostimulanter • antihypertensiva • tricykliske antidepressiva og andre antihistaminer.
These include: • decongestants • anorexogenics or amphetamine-type psychostimulants • antihypertensive agents • tricyclic antidepressants and other antihistamines.
Der skal udvises forsigtighed med migrænepatienter, som bliver behandlet med sekalealkaloid vasokonstriktorer.
Caution should be exercised in patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors.
Der kan opstå akut hypertension i forbindelse med operation, hvis der anvendes flygtig halogeneret anæstesi under behandling med indirekte sympatomimetika.
3 Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Sportsudøvere bør oplyses om, at behandling med pseudoephedrin kan føre til positiv dopingtest.
Athletes should be informed that treatment with pseudoephedrine could lead to positive doping tests.
Aerinaze bør seponeres mindst 48 timer før hudtests, da antihistaminer måske forhindrer eller nedsætter ellers positive hudreationer.
The administration of Aerinaze should be discontinued at least 48 hours before skin tests since antihistamines maybe prevent or reduce other wise positive reaction to dermal reactivity index.
3 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Der er imidlertid ikke observeret klinisk relevante interaktioner eller ændringer i desloratadin- plasmakoncentrationer i kliniske undersøgelser, hvor desloratadin blev administreret samtidig med erythromycin eller ketoconazol.
However, no clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered.
Risiko for vasokonstriktion og øget blodtryk.
Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood pressure.
Samtidig administration med sympatomimetika kan forårsage kritiske hypertensionsreaktioner.
Concurrent administration with sympathomimetic medicines may result in critical hypertension reactions.
Følgende kombinationer bør undgås: • bromocriptin • cabergolin • lisurid, pergolid: risiko for vasokonstriktion og øget blodtryk.
The following combinations are not recommended: • bromocriptine • cabergoline • lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Andre vasokonstriktorer, som blev brugt som nasaldekongestanter ved peroral eller nasal brug (phenylpropanolamin, phenylephrin, ephedrin, oxymetazolin, naphazolin...): risiko for vasokonstriktion.
Other vasoconstrictors used as nasal decongestant, by oral or nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…): risk of vasoconstriction.
Sympatomimetika reducerer den antihypertensive virkning af α- methyldopa, mecamylamin, reserpin, veratrum alkaloider og guanethidin.
Sympathomimetic medicines reduce the antihypertensive effect of α -methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine.
I en klinisk farmakologiundersøgelse hvor desloratadin og alkohol blev taget sammen, øgede desloratadin imidlertid ikke alkohols negative virkning på præstationsevnen.
However, in a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Ved administration alene eller med alkohol sås der ingen signifikante forskelle i de psykomotoriske testresultater mellem desloratadin og placebogrupperne.
No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Derfor kan visse interaktioner med andre lægemidler ikke udelukkes fuldstændigt.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded.
In vitro - undersøgelser har ligeledes vist, at lægemidlet ikke hæmmer CYP2D6 og hverken er et substrat eller en hæmmer af P- glycoprotein.
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Hverken desloratadin eller kombinationen af loratadin og pseudoephedrin var teratogent i dyreforsøg.
Neither desloratadine nor the combination of loratadine and pseudoephedrine were teratogenic in animal studies.
Erfaring fra et stort antal eksponerede graviditeter hos mennesker viser imidlertid ingen stigning i misdannelser sammenlignet med incidensen i den almindelige population.
The safe use of Aerinaze during pregnancy has not been established; however experience from a large number of exposed pregnancies in humans does not reveal any increase in the frequency of malformations as compared to the incidence in the general population.
Da undersøgelser med dyrereproduktion ikke altid er prediktive for respons hos mennesker og p. g. a. pseudoephedrins vasokonstriktive egenskaber, bør Aerinaze ikke anvendes ved graviditet.
4 Because animal reproduction studies are not always predictive of human response, and due to the vasoconstrictive properties of pseudoephedrine, Aerinaze should not be used during pregnancy.
Både desloratadin og pseudoephedrin udskilles i modermælken.
Desloratadine and pseudoephedrine are both excreted in breast milk.
Der er rapporteret nedsat produktion af modermælk hos ammende kvinder med pseudoephedrin.
Decreased milk production in nursing mothers has been reported with pseudoephedrine.
Aerinaze bør derfor ikke anvendes under amning.
Therefore Aerinaze should not be used in breast-feeding women.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner med Aerinaze.
No studies on the effects on the ability to drive and use machines have been performed with Aerinaze.
Der sås ingen nedsættelse af evnen til at føre motorkøretøj i kliniske undersøgelser med desloratadin.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine.
Patienterne bør imidlertid oplyses om, at der ganske sjældent kan opleves døsighed, hvilket kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
4 Det forventes ikke, at pseudoephedrinsulfat nedsætter den psykomotoriske evne.
It is not expected that pseudoephedrine sulphate impairs psychomotor performance.
Insomni (8, 9%), mundtørhed (7, 2%) og hovedpine (3, 1%).
In clinical trials involving 414 adults the most frequent of adverse events reported were insomnia (8.9%), dry mouth (7.2%) and headache (3.1%).
Disse og andre bivirkninger, som blev rapporteret under de kliniske undersøgelser, er nævnt i følgende tabel.
These and other undesirable effects reported during the clinical trials are listed in the following table.
Bivirkninger set under kliniske undersøgelser med Aerinaze Meget almindelige (≥ 1/ 10); almindelige (≥ 1/ 100, < 1/ 10); ikke almindelige (≥ 1/ 1. 000, < 1/ 100); sjældne (≥ 1/ 10. 000, < 1/ 1. 000); meget sjældne (< 1/ 10. 000)
Adverse reactions reported during clinical trials for Aerinaze very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000)
Hjerte Almindelig:
Cardiac disorders Common:
Takykardi Palpitationer, præmature sammentrækninger af atrierne
Tachycardia Palpitation, premature atrial contractions
Hyperkinesi, opblussen, hedeture, forvirring
Mouth dry, dizziness, psychomotor hyperactivity Hyperkinesia, flushing, hot flushes, confusion
Luftveje, throrax og mediastinum
Respiratory, thoracic and mediastinal disorders
Sløret syn, tørre øjne
Blurred vision, dry eyes
Pharyngitis Rhinitis, sinuitis, epistaxi, nasal irritation, rhinorré, tør hals, hyposmi
Pharyngitis Rhinitis, sinusitis, epistaxis, nasal irritation, rhinorrhea, dry throat, hyposmia
Anoreksi, konstipation Dyspepsi, kvalme, abdominalsmerte, gastroenteritis, unormal afføring
Anorexia, constipation Dyspepsia, nausea, abdominal pain, gastroenteritis, stool abnormal
Dysuri, vandladningslidelser, ændret vandladningsfrekvens
Dysuria, micturition disorder, altered micturition frequency
Tørst, glycosuri, hyperglycemi
Thirst, glycosuria, hyperglycemia
Almindelige:
5 General disorders and administration site conditions Common:
Hovedpine, træthed Forværret hovedpine, rigor
Headache, fatigue Headache aggravated, rigors
Øgede leverenzymer
Increased hepatic enzymes
Agitation, ængstelse, irritabilitet
Insomnia, somnolence, sleep disorder, nervousness Agitation, anxiety, irritability
Andre bivirkninger, som er rapporteret meget sjældent for desloratadin efter markedføring, er nævnt i tabel 2.
Other adverse reactions reported very rarely for desloratadine during the post-marketing period are listed in Table 2.
Bivirkninger rapporteret efter markedsføring af desloratadin
Adverse reactions reported during the post-marketing period for desloratadine
5 Psykiske forstyrrelser Nervesystemet
Psychiatric disorders Nervous system disorders
Hallucinationer Svimmelhed, somnolens, søvnløshed, psykomotorisk hyperaktivitet, anfald
Hallucinations Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Hjerte Mave- tarmkanalen
Cardiac disorders Gastrointestinal disorders
Takykardi, palpitationer Abdominalsmerte, kvalme, opkastning, dyspepsi, diarre
Tachycardia, palpitations Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Øgede leverenzymer, øget bilirubin, hepatitis
Elevations of liver enzymes, increased bilirubin, hepatitis
Knogler, led, musker og bindevæv Almene symptomer og reaktioner på administrationsstedet
Musculoskeletal and connective tissue disorders General disorders
Myalgi Hypersensitivitetsreaktioner (såsom anafylakse, angioødem, dyspnø, pruritus, udslæt og urticaria)
Myalgia Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Symptomerne kan variere fra CNS- depression (sedation, apnø, nedsat mental parathed, cyanose, koma, kadiovaskulært kollaps) til CNS- stimulering (søvnløshed, hallucination, tremor, kramper) med muligt fatalt forløb.
Symptoms may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome.
CNS- stimulation er især sandsynlig hos børn, ligesom atropinlignende symptomer (tør mund, fikserede og udvidede pupiller, rødmen, hypertermi og gastrointestinale symptomer).
CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms).
I tilfælde af overdosering skal symptomatisk og støttende behandling startes øjeblikkeligt og vedligeholdes så længe som nødvendigt.
In the event of overdose, start symptomatic and supportive treatment immediately and maintain it for as long as necessary.
Foretag maveskylning med fysiologisk saltvand hos børn.
Perform gastric lavage with physiologic saline solution, particularly in children.
Fjern så meget som muligt af den administrerede mængde før den næste skylning.
Remove as much as possible of the amount administered before the next instillation.
Patienten skal fortsat overvåges medicinsk efter akut behandling.
After emergency treatment, continue to monitor the patient medically.
Behandling af pseudoephedrin- overdosering er symptomatisk og støttende.
Treatment of the pseudoephedrine overdose is symptomatic and supportive.
Hypertension kan kontrolleres med et adrenoceptorblokkerende middel, og takykardi med et beta- blokkende middel.
Hypertension can be controlled with an adrenoceptor-blocking agent and tachycardia with a
Antihistaminer – H1 antagonist, ATC- kode:
Antihistamines – H1 antagonist, ATC code:
Nasale decongestanter til systemisk brug, ATC- kode:
Nasal decongestants for systemic use group, ATC code:
Aerinaze- tabletters farmakodynamik er direkte relateret til indholdsstofferne.
The pharmacodynamics of Aerinaze tablets are directly related to that of its components.
Desloratadin er en ikke- sederende, langtidsvirkende histaminantagonist med selektiv perifer H1 receptorantagonist- aktivitet.
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Efter peroral administration blokkerer desloratadin selektivt perifere histamin H1 - receptorer, fordi stoffet ekskluderes fra adgang til centralnervesystemet.
After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Desloratadin har vist antiallergiske egenskaber i in vitro- undersøgelser.
Desloratadine has demonstrated antiallergic properties from in vitro studies.