FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral administration of pseudoephedrine sulphate at the recommended dose can cause other sympathomimetic effects, such as increased blood pressure, tachycardia or manifestations of central nervous system excitation.
Danish: Oral administration af pseudoephedrinsulfat ved den anbefalede dosis kan forårsage anden sympatomimetisk virkning, såsom øget blodtryk, takykardi eller manifestationer af spænding i centralnervesystemet.
English: The safety and efficacy of Aerinaze have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Danish: Aerinazes sikkerhed og virkning i denne population er ikke klarlagt, og data er utilstrækkelige til at give fyldestgørende dosisrekommandationer.
English: Pharmacotherapeutic group: Nasal preparations, nasal decongestants for systemic use, ATC code: R01BA52.
Danish: Farmakoterapeutisk klassifikation: Nasale præparater og dekongestanter til systemisk brug, ATCkode: R01BA52.
English: The blister consists of clear polychlorotrifluorethylene/polyvinyl chloride (PCTFE/PVC) film, sealed with a vinyl heat seal coated aluminium foil.
Danish: Blisterarket består af klar polychlortrifluorethylen/polyvinyl chlorid (PCTFE/PVC) film, forseglet med en varmeforsegling af vinyl betrukket med aluminiumsfolie.
English: Fertility There are no data available on male and female fertility.
Danish: Fertilitet Der er ingen tilgængelige data for fertiliteten hos mænd og kvinder.
English: In clinical trials involving 414 adults the most frequent of adverse reactions reported were insomnia (8.9 %), dry mouth (7.2 %) and headache (3.1 %).
Danish: De mest almindelige bivirkninger, der er set i kliniske undersøgelser med 414 voksne er: Insomni (8,9 %), mundtørhed (7,2 %) og hovedpine (3,1 %).
English: 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).
Danish: Patienterne bør oplyses om, at behandlingen skal afbrydes i tilfælde af hypertension, takykardi, palpitationer eller hjertearytmier, kvalme eller andre neurologiske tegn (såsom hovedpine eller forværret hovedpine).
English: However, non-clinical data with desloratadine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Præ-kliniske data med desloratadin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: What you need to know before you take Aerinaze
Danish: Det skal du vide, før du begynder at tage Aerinaze
English: EU/1/07/399/001 2 modified-release tablets EU/1/07/399/002 4 modified-release tablets EU/1/07/399/003 7 modified-release tablets EU/1/07/399/004 10 modified-release tablets EU/1/07/399/005 14 modified-release tablets EU/1/07/399/006 20 modified-release tablets
Danish: EU/1/07/399/001 2 tabletter med modificeret udløsning EU/1/07/399/002 4 tabletter med modificeret udløsning EU/1/07/399/003 7 tabletter med modificeret udløsning EU/1/07/399/004 10 tabletter med modificeret udløsning EU/1/07/399/005 14 tabletter med modificeret udløsning EU/1/07/399/006 20 tabletter med modificeret udløsning
English: Swallow the tablet whole; do not crush, break or chew the tablet before swallowing.
Danish: Slug tabletten hel; tabletten må ikke knuses, deles eller tygges, før den sluges.
English: After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Danish: Efter peroral administration blokkerer desloratadin selektivt perifere histamin H1- receptorer, fordi stoffet ekskluderes fra adgang til centralnervesystemet.
English: Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine sulphate.
Danish: Det er sandsynligt, at patienter i alderen 60 år eller ældre vil opleve bivirkninger af sympatomimetika, såsom pseudoephedrinsulfat.
English: Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på den ydre karton og blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The active substance is excreted in breast milk of breast-feeding women.
Danish: Den aktive substans udskilles i human mælk hos ammende kvinder.
English: Headache, fatigue, dry mouth
Danish: Hovedpine, træthed, tør mund
English: During reproductive toxicity studies, the combination of loratadine/pseudoephedrine sulphate was not teratogenic when administered orally to rats at doses up to 150 mg/kg/day and rabbits at doses up to 120 mg/kg/day.
Danish: Reproduktionstoksicitetsundersøgelser har vist, at kombinationen af loratadin/pseudoephedrinsulfat ikke var teratogen, når kombinationen blev administreret peroralt til rotter i doser på op til 150 mg/kg/dag og til kaniner i doser på op til 120 mg/kg/dag.
English: The safety and efficacy of Aerinaze in children below the age of 12 years have not been established.
Danish: Aerinazes sikkerhed og virkning hos børn under 12 år er ikke klarlagt.
English: Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Danish: Sundhedspersonalet kan overveje at seponere desloratadin hos patienter, der oplever et krampeanfald under behandlingen.
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1receptor antagonist activity.
Danish: Desloratadin er en ikke-sederende, langtidsvirkende histaminantagonist med selektiv perifer H1 receptorantagonist-aktivitet.
English: Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Danish: Aerinaze er indiceret til voksne og unge i alderen 12 år og ældre til symptomatisk behandling af sæsonbetinget allergisk rhinitis ledsaget af tilstoppet næse.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Danish: Manglende karcinogent potentiale er vist i undersøgelser med desloratadin og loratadin.
English: Alcohol use should be avoided during Aerinaze treatment.
Danish: Brug af alkohol bør undgås under behandling med Aerinaze.
English: These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Danish: Disse inkluderer hæmning af frigørelsen af proinflammatoriske cytokiner, såsom IL-4, IL-6, IL-8 og IL-13 fra humane mastceller/baseofile, så vel som hæmning af dannelsen af adhæsionsmolekylet P-selektin på endothelieceller.
English: • irritated nose
Danish: • irriteret næse
English: A component interaction study demonstrated that the exposure (Cmax and AUC) of pseudoephedrine sulphate following administration of pseudoephedrine sulphate alone was bioequivalent to pseudoephedrine sulphate exposure following administration of the Aerinaze tablet.
Danish: Et komponent-interaktionsstudie viste, at eksponeringen (Cmax og AUC) af pseudoephedrinsulfat, når det blev administreret alene, var bioækvivalent med pseudoephedrinsulfat-eksponering efter administration af Aerinaze-tablet.
English: In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Danish: I en enkeltdosis-undersøgelse med voksne påvirkede desloratadin 5 mg ikke standardmålene for evnen til at flyve, inklusive fremhævelse af subjektiv søvnighed, eller opgaver relaterede til flyvning.
English: • cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension,
Danish: • kardiovaskulære lidelser såsom iskæmisk hjertelidelse, takyarytmi og svær hypertension,
English: As Aerinaze contains pseudoephedrine sulphate, 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.
Danish: Da Aerinaze indeholder pseudoephedrinsulfat er det også kontraindiceret til patienter, der behandles med monoaminoxidase-hæmmere (MAO-hæmmere) og i de efterfølgende 2 uger efter seponering af sådan behandling.
English: Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.
Danish: Men da reaktionen på alle lægemidler varierer fra person til person, bør patienterne rådes til ikke at indlade sig på aktiviteter, der kræver mental skarphed, såsom at køre bil eller betjene maskiner, indtil deres eget respons på lægemidlet er etableret.
English: • increased body movement
Danish: • øget kropsbevægelse
English: QT prolongation
Danish: Forlænget QT-interval
English: • lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Danish: • lisurid, pergolid: risiko for vasokonstriktion og øget blodtryk
English: In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Danish: I kontrollerede kliniske undersøgelser ved den anbefalede dosis på 5 mg daglig sås der ingen øget hyppighed af somnolens sammenlignet med placebo.
English: (bronchospasm) - if you have problems with your liver, kidney, or bladder.
Danish: (bronkospasme) - hvis du har problemer med lever, nyrer eller blære.
English: Distribution Pseudoephedrine sulphate is presumed to cross the placenta and the haematoencephalic barrier.
Danish: Distribution Pseudoephedrinsulfat formodes at krydse placenta og blod-hjernebarrieren.
English: Pseudoephedrine sulphate (d-isoephedrine sulphate) is a sympathomimetic agent with mostly mimetic activity in comparison with the -activity.
Danish: Pseudoephedrinsulfat (d-isoephedrinsulfat) er et sympatomimetisk stof med hovedsageligt α-mimetisk aktivitet sammenlignet med β-aktivitet.
English: Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Danish: Selvom de fleste mennesker ikke oplever døsighed, bør man ikke indlade sig på aktiviteter, der kræver mental skarphed såsom at køre bil eller betjene maskiner indtil din reaktion på dette lægemiddel er etableret.
English: B-2220 Heist-op-den-Berg Belgium.
Danish: B-2220 Heist-op-den-Berg Belgien
English: It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine sulphate may diminish.
Danish: Det anbefales at begrænse behandlingen til omkring 10 dage, da pseudoephedrinsulfats virkning kan mindskes med tiden ved kronisk administration.
English: Pseudoephedrine sulphate Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.
Danish: Pseudoephedrinsulfat Antacida øger absorptionshastigheden af pseudoephedrinsulfat, kaolin nedsætter den.
English: Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Danish: Der kan opstå akut hypertension i forbindelse med operation, hvis der anvendes flygtig halogeneret anæstesi under behandling med indirekte sympatomimetika.
English: Uncommon: the following may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger: følgende kan berøre op til 1 ud af 100 personer
English: Gastric lavage with physiologic saline solution may be performed, particularly in children.
Danish: Maveskylning med fysiologisk saltvand kan foretages, især hos børn.
English: • restlessness with increased body movement
Danish: • rastløshed med øget kropsbevægelse
English: Sympathomimetic medicines reduce the antihypertensive effect of α-methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine.
Danish: Sympatomimetika reducerer den antihypertensive virkning af α-methyldopa, mecamylamin, reserpin, veratrum alkaloider og guanethidin.
English: Dizziness, psychomotor hyperactivity
Danish: Svimmelhed, psykomotorisk hyperaktivitet
English: Aerinaze is supplied in blisters comprised of laminate blister film and foil lidding.
Danish: Aerinaze leveres i blisterkort af laminatblisterfilm og folielåg.
English: 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.
Danish: Der er ikke observeret klinisk relevante interaktioner eller ændringer i desloratadinplasmakoncentrationerne i kliniske undersøgelser, hvor desloratadin blev administreret samtidig med erythromycin eller ketoconazol.
English: Gastrointestinal and genitourinary effects
Danish: Gastrointestinale og urogenitale virkninger
English: Thirst, glycosuria, hyperglycaemia
Danish: Tørst, glukosuri, hyperglykæmi
English: Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment.
Danish: Desloratadin skal administreres med forsigtighed hos patienter med krampeanfald i anamnesen eller i familien og især hos små børn, der er mere tilbøjelige til at få nye krampeanfald under behandling med desloratadin.
English: Hypertension can be controlled with an adrenoceptor-blocking agent and tachycardia with a beta-blocking agent.
Danish: Hypertension kan kontrolleres med et adrenoceptorblokkerende middel, og takykardi med et beta-blokkende middel.
English: Insomnia, somnolence, sleep disorder, nervousness
Danish: Insomni, somnolens, søvnforstyrrelser, nervøsitet
English: • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
Danish: • tidligere hæmoragisk apopleksi eller risikofaktorer der øger risikoen for hæmoragisk apopleksi.
English: Do not crush, break or chew.
Danish: Må ikke knuses, brækkes eller tygges.
English: There is insufficient information on the effects of desloratadine and pseudoephedrine sulphate in newborns/infants.
Danish: Der er utilstrækkelig information om virkningen af desloratadin og pseudoephedrinsulfat hos nyfødte/spædbørn.
English: Aerinaze is not recommended for use in patients with impaired renal or hepatic function.
Danish: Aerinaze bør ikke anvendes til patienter med nedsat nyre- eller leverfunktion.
English: The combination of loratadine/pseudoephedrine sulphate used in acute and multiple-dose studies, exhibited a low order of toxicity.
Danish: Kombinationen af loratadin/pseudoephedrinsulfat i akutte og multipeldosis-undersøgelser viste lav toksicitet.
English: No interaction studies have been performed with the combination of desloratadine and pseudoephedrine sulphate.
Danish: Der er ikke udført interaktionsstudier med kombinationen af desloratadin og pseudoephedrinsulfat.
English: Adverse reactions seen with Aerinaze
Danish: Bivirkninger set med Aerinaze
English: 2 modified-release tablets 4 modified-release tablets 7 modified-release tablets 10 modified-release tablets 14 modified-release tablets 20 modified-release tablets
Danish: 2 tabletter med modificeret udløsning 4 tabletter med modificeret udløsning 7 tabletter med modificeret udløsning 10 tabletter med modificeret udløsning 14 tabletter med modificeret udløsning 20 tabletter med modificeret udløsning
English: Food had no effect on the bioavailability (Cmax and AUC) of desloratadine or pseudoephedrine sulphate.
Danish: Mad har ingen effekt på biotilgængeligheden (Cmax og AUC) for deloratadin eller pseudoephedrinsulfat.
English: CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms).
Danish: CNS-stimulation er især sandsynlig hos børn, ligesom atropinlignende symptomer (tør mund, fikserede og udvidede pupiller, rødmen, hypertermi og gastrointestinale symptomer).
English: Dihydroergotamine, ergotamine, methylergometrine: risk of vasoconstriction and increase in blood pressure.
Danish: Dihydroergotamin, ergotamin, methylergometrin: risiko for vasokonstriktion og øget blodtryk.
English: Modified-release tablet.
Danish: Tabletter med modificeret udløsning.
English: Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an antihistamine and pseudoephedrine sulphate which is a decongestant.
Danish: Aerinaze-tabletter indeholder en kombination af to aktive indholdsstoffer, desloratadin, der er et antihistamin, og pseudoefedrinsulfat, der er et dekongestant.
English: Cases of severe skin reactions, including signs and symptoms such as fever, reddening of the skin, or many small pimples, have been reported with pseudoephedrine-containing products.
Danish: Tilfælde af alvorlige hudreaktioner, inklusive tegn og symptomer såsom feber, rødme i huden eller mange små bumser (pustler), er indberettet med pseudoephedrin-holdige lægemidler.
English: Pack sizes of 2, 4, 7, 10, 14 and 20 tablets.
Danish: Pakningstørrelser af 2, 4, 7, 10, 14 og 20 tabletter.
English: Concurrent administration with other sympathomimetics (decongestants, anorexogenics or amphetamine-type psychostimulants, antihypertensive medicinal products, tricyclic antidepressants and other antihistamines) may result in critical hypertension reactions (see section 4.4).
Danish: Samtidig administration med andre sympatomimetika (dekongestanter, anoreksika eller amfetaminlignende psykostimulanter , antihypertensiva, tricykliske antidepressiva og andre antihistaminer) kan forårsage kritiske hypertensionsreaktioner (se pkt.
English: The administration of Aerinaze should be discontinued at least 48 hours before skin tests since antihistamines maybe prevent or reduce otherwise positive reaction to dermal reactivity index.
Danish: Aerinaze bør seponeres mindst 48 timer før hudtests, da antihistaminer måske forhindrer eller nedsætter ellers positive hudreationer.
English: Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate blister film and foil lidding.
Danish: Aerinaze-tabletter er pakket som 2, 4, 7, 10, 14 eller 20 tabletter i perforeret enkeltdosisblister bestående af laminat blisterfilm og folielåg.
English: • severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling)
Danish: • svære allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, udslæt og hævelse)
English: Weight increased
Danish: Vægtforøgelse
English: • decreased appetite • constipation
Danish: • nedsat appetit • forstoppelse
English: Pseudoephedrine sulphate provides a nasal decongestant effect after oral administration due to its vasoconstrictive action.
Danish: Pseudoephedrinsulfat giver en nasal dekongestant virkning efter peroral administration p.g.a. dets vasokonstriktive virkning.
English: However, in a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Danish: I en klinisk farmakologisk undersøgelse, hvor desloratadin og alkohol blev taget sammen, øgede desloratadin imidlertid ikke alkohols negative indvirkning på præstationsevnen.
English: Aerinaze is not recommended for use in children below the age of 12 years.
Danish: Aerinaze bør ikke anvendes til børn under 12 år.
English: - Desloratadine and Pseudoephedrine sulphate:
Danish: • Desloratadin og pseudoephedrinsulfat:
English: One of the active ingredients in Aerinaze, pseudoephedrine sulphate, has the potential to be abused and large doses of pseudoephedrine sulphate can be toxic.
Danish: Et af de aktive stoffer i Aerinaze, pseudoephedrinsulfat, kan misbruges, og store doser pseudoephedrinsulfat kan være giftigt.
English: • inflammation of the sinus
Danish: • betændelse i sinus
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a component of Aerinaze.
Danish: Nedsat mælkeproduktion hos ammende mødre er blevet set med pseudoephedrinsulfat, som er en bestanddel af Aerinaze.
English: Central nervous system effects
Danish: Virkninger i centralnervesystemet
English: Other symptoms may include: headache, anxiety, micturition difficulty, muscle weakness and tenseness, euphoria, excitement, respiratory failure, cardiac arrhythmias, tachycardia, palpitations, thirst, perspiration, nausea, vomiting, precordial pain, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension.
Danish: Andre symptomer kan være: hovedpine, angst, vandladningsbesvær, muskelsvaghed og ømhed, eufori, spænding, vejrtrækningsstop, hjertearytmier, takykardi, palpitationer, tørst, svedtendens, kvalme, opkastning, precordial smerte, svimmelhed, tinnitus, ataksi, sløret syn og hypertension eller hypotension.
English: The safety and efficacy of Aerinaze have not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Danish: Aerinazes sikkerhed og virkning hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt, og data er utilstrækkelige til at give fyldestgørende dosisrekommandationer.
English: Depression may follow rapid withdrawal.
Danish: Hastig afvænning kan medføre depression.
English: • trouble sleeping
Danish: • søvnproblemer
English: Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood pressure.
Danish: Reversible eller irreversible MAO-hæmmere kan forårsage: Risiko for vasokonstriktion og øget blodtryk.
English: • Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm
Danish: • patienter med tidligere myokardieinfarkt, diabetes mellitus, blærehalsobstruktion eller bronkospasme
English: Its elimination half-life in humans, at an approximate urinary pH of 6, ranges from 5 to 8 hours.
Danish: Eliminationshalveringstiden i mennesker varierer fra 5 til 8 timer ved en pH i urinen på ca. 6.
English: Hypersensitivity (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Danish: Meget sjælden Overfølsomhed (såsom anafylaksi, angioødem, dyspnø, pruritus, udslæt og urticaria)
English: Athletes should be informed that treatment with pseudoephedrine sulphate could lead to positive doping tests.
Danish: Interferens med serologiske tests Sportsudøvere bør oplyses om, at behandling med pseudoephedrinsulfat kan føre til positiv dopingtest.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Aerinaze på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Aerinaze is a blue and white oval bilayer modified-release tablet with “D12” debossed in the blue layer.
Danish: Aerinaze er en blå og hvid oval tolagstablet med ”D12” præget i det blå lag.
English: Other vasoconstrictors used as nasal decongestant, by oral or nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…): risk of vasoconstriction.
Danish: Andre vasokonstriktorer anvendt som nasaldekongestanter ved oral eller nasal brug (phenylpropanolamin, phenylephrin, ephedrin, oxymetazolin, naphazolin ...): risiko for vasokonstriktion.