natgillin/translations-raw huggingface dataset:
Kontakt lægen eller apoteket, hvis du får en bivirkning over for Aerinaze som fortsætter, er ubehagelig, eller som du mener er alvorlig.
Contact a doctor or pharmacist if you have any reaction at all to Aerinaze that continues, is bothersome or that you think is serious.
Hurtig hjerterytme, rastløshed med øgede kropsbevægelser, tør mund, svimmelhed, ondt i halsen, nedsat appetit, forstoppelse, sukker i urinen, øget blodsukker, tørst, træthed, hovedpine, søvnbesvær, nervøsitet og døsighed.
Common (at least 1 in 100 patients) side effects associated with Aerinaze include: fast heartbeat, restlessness with increased body movement, dry mouth, dizziness, sore throat, decreased appetite, constipation, sugar in urine, increased sugar in blood, thirst, tiredness, headache, trouble sleeping, nervousness, and drowsiness.
Hamrende eller uregelmæssig hjertebanken, øgede kropsbevægelser, opblussen, hedeture, forvirring, sløret syn, tøre øjne, næseblod, irriteret næse, betændelse i næsen, løbende næse, bihulebetændelse, tør hals, mavepine, maveinfluenza, kvalme, unormal afføring, smertefuld eller besvær ved vandladning, vandladningsproblemer, ændret vandladningshyppighed, kløe, kuldegysninger, nedsat lugtesans, unormale leverfunktionstests, uro, ængstelse og irritabilitet.
Uncommon (at least 1 in 1,000 patients) side effects include: pounding or irregular heart beat, increased body movement, flushing, hot flushes, confusion, blurry vision, dry eyes, nose bleeds, irritated nose, inflammation of the nose, runny nose, inflammation of the sinus, dry throat, stomach pain, stomach flu, nausea, abnormal stool, painful or difficult urination, problems urinating, changes in frequency of urination, itching, chills, decreased sense of smell, abnormal liver function tests, agitation, anxiety, and irritability.
Ved markedsføringen af desloratadin blev der set meget sjældne tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, nældefeber og opsvulmen) og udslæt.
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Der er også set meget sjældne tilfælde af hjertebanken, hurtig hjertebanken, mavepine, kvalme, opkastning, oprørt mave, diarré, hallucinationer, svimmelhed, døsighed, vanskelighed ved at sove, muskelsmerter, anfald, rastløshed med øgede kropsbevægelser, leverbetændelse og unormale leverfunktionstests.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, hallucinations, dizziness, drowsiness, inability to sleep, muscle pain, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
SÅDAN OPBEVARER DU AERINAZE
HOW TO STORE AERINAZE
Brug ikke Aerinaze efter den udløbsdato, der står på blisterpakningen.
Do not use Aerinaze after the expiry date which is stated on the blister.
Aerinaze indeholder:
What Aerinaze contains
- Aktive stoffer: desloratadin og pseudoephedrin (som sulfat)
- The active substances are desloratadine and pseudoephedrine (as sulphate)
- 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).
Inaktive indholdsstoffer i det blå lag til umiddelbar udløsning: majsstivelse,
- Inactive ingredients in the blue, immediate-release layer: maize starch, microcrystalline
mikrokrystallinsk cellulose, edetatdinatrium, citronsyre, stearinsyre og farvestof (Indigo Carmin E132 Aluminium lake).
cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132 Aluminum lake).
Inaktive indholdsstoffer i det hvide lag til modificeret udløsning: hypromellose 2208,
- Inactive ingredients in the white, sustained-release layer: hypromellose 2208, microcrystalline
mikrokrystallinsk cellulose, povidon K30, silicadioxid og magnesiumstearat.
cellulose, povidone K30, silicon dioxide and magnesium stearate.
Aerinazes udseende og pakningstørrelse
What Aerinaze looks like and contents of the pack
Aerinaze er en blå og hvid oval tolagstablet med ” D12 ” præget i det blå lag.
Aerinaze is a blue and white oval bi-layer tablet with “ D12” branded on the blue layer.
Aerinaze- tabletter er pakket som 2, 4, 7, 10, 14 eller 20 tabletter i blister bestående af laminat blisterfilm og folielåg.
Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate blister film and foil lidding.
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Belgien
SP Europe Rue de Stalle 73 B-1180 Bruxelles Belgium.
Industriepark 30 B- 2220 Heist- op- den- Berg Belgien
Industriepark 30 B-2220 Heist-op-den-Berg Belgium.
Hvis du vil have yderligere oplysninger om Aerinaze, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
21 Deutschland Thomas- Dehler- Straße 27 D- 81737 München Tel: + 49 - (0) 89 627 31- 0
Deutschland Thomas-Dehler-Straße 27 D-81737 München Tel: + 49-(0)89 627 31-0
22 Lietuva Kęstučio g.
Lietuva Kę stuč io g.
Du kan finde yderligere information om Aerinaze på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP’ s anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR)
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Det leveres som 5 mg tabletter, som 5 mg oralt lyofilisat (dispergible, dvs. letopløselige tabletter), som 2, 5 mg og 5 mg smeltetabletter (tabletter, der opløses i munden), som 0, 5 mg/ ml syrup og som 0, 5 mg/ ml oral opløsning.
It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ ml syrup and a 0.5 mg/ ml oral solution.
Aerius anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f. eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
Aerius is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Dosis for børn afhænger af barnets alder.
The dose in children depends on their age.
For børn mellem 1 og 5 år er dosis 1, 25 mg en gang dagligt taget som 2, 5 ml sirup eller som oral opløsning.
For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
For børn mellem 6 og 11 år er dosis 2, 5 mg en gang dagligt taget enten som 5 ml sirup eller oral opløsning eller som en 2, 5 mg smeltetablet.
For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Aerius kan tages med eller uden et måltid.
Aerius can be taken with or without food.
Aerius blev undersøgt i 8 undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
Aerius has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Effekten af Aerius blev målt ved at se på ændringen i symptomerne (næseflåd, kløe, nysen, tilstopning) før og efter 2 eller 4 ugers behandling.
The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Effekten blev målt ved at se på ændringen i symptomerne (kløe, antallet og størrelsen af nældefeberen, interferens med søvn og funktion i dagtimerne) før og efter 6 ugers behandling.
The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
I alle undersøgelserne blev Aerius ’ effekt sammenlignet med virkningen af placebo (uvirksom behandling).
In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).
Der blev fremlagt resultater af supplerende undersøgelser for at vise, at syrup, oral opløsning, og smeltetabletter behandles af kroppen på samme måde som tabletter, og for at vise, at de kan anvendes sikkert til børn.
Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Til allergisk rhinitis førte en 2- ugers behandling med Aerius 5 mg, hvis man ser på resultaterne af alle undersøgelserne taget under et, til et gennemsnitligt fald i symptomscoren på mellem - 25 til - 32% sammenlignet med et fald på 12 til 26% hos patienter, som fik placebo.
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
I de to undersøgelser af urticaria var faldet i symptomscoren efter 6 ugers behandling med Aerius 58% og 67% sammenlignet med 40% og 33% for patienter behandlet med placebo.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Hos voksne og unge var de mest almindelige bivirkninger træthed (1, 2%), tørhed i munden (0, 8%) og hovedpine (0, 6%).
In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%).
Hos børn under 2 - årsalderen var de hyppigste bivirkninger diarre (3, 7%), feber (2, 3%) og søvnløshed (vanskeligt ved at falde i søvn 2, 3%).
In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Den fuldstændige liste over alle de indberettede bivirkninger ved Aerius fremgår af indlægssedlen.
For the full list of all side effects reported with Aerius, see the Package Leaflet.
Aerius må ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
Aerius should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Aerius er større end risiciene til lindring af de symptomer, der er forbundet med allergisk rhinitis eller urticaria.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerius’ s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Aerius.
The Committee recommended that Aerius be given marketing authorisation.
Andre oplysninger om Aerius:
Other information about Aerius:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aerius til SP Europe den 15. januar 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for Aerius to SP Europe on 15 January 2001.
Markedsføringstilladelsen blev fornyet den 15. januar 2006.
The marketing authorisation was renewed on 15 January 2006.
Den fuldstændige EPAR for Aerius findes her.
The full EPAR for Aerius is available here.
Dette sammendrag blev sidst ajourført i 04- 2008.
This summary was last updated in 04-2008.
Særnavn Aerius
EU Number
Styrke 5 mg
Invented name
EU/ 1/ 00/ 160/ 002
Pharmaceutical Form
Filmovertrukne tabletter
Route of Administration
Oral anvendelse
Packaging
2 tabletter
Content
EU/ 1/ 00/ 160/ 003
Package size
Aerius
EU/ 1/ 00/ 160/ 001 EU/ 1/ 00/ 160/ 002 EU/ 1/ 00/ 160/ 003 EU/ 1/ 00/ 160/ 004 EU/ 1/ 00/ 160/ 005 EU/ 1/ 00/ 160/ 006 EU/ 1/ 00/ 160/ 007 EU/ 1/ 00/ 160/ 008 EU/ 1/ 00/ 160/ 009 EU/ 1/ 00/ 160/ 010 EU/ 1/ 00/ 160/ 011 EU/ 1/ 00/ 160/ 012 EU/ 1/ 00/ 160/ 013
Filmovertrukne tabletter
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
blister (Aclar/ PVC, alu)
5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
3 tabletter
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
blister (Aclar/ PVC, alu)
blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu)
Aerius
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 100 tablets
5 mg
EU/ 1/ 00/ 160/ 014 EU/ 1/ 00/ 160/ 015 EU/ 1/ 00/ 160/ 016 EU/ 1/ 00/ 160/ 017 EU/ 1/ 00/ 160/ 018 EU/ 1/ 00/ 160/ 019 EU/ 1/ 00/ 160/ 020 EU/ 1/ 00/ 160/ 021 EU/ 1/ 00/ 160/ 022 EU/ 1/ 00/ 160/ 023 EU/ 1/ 00/ 160/ 024 EU/ 1/ 00/ 160/ 025 EU/ 1/ 00/ 160/ 026 EU/ 1/ 00/ 160/ 027 EU/ 1/ 00/ 160/ 028 EU/ 1/ 00/ 160/ 029 EU/ 1/ 00/ 160/ 030 EU/ 1/ 00/ 160/ 031 EU/ 1/ 00/ 160/ 032
Filmovertrukne tabletter
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
Oral anvendelse
0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
EU/ 1/ 00/ 160/ 006
Syrup Syrup Syrup Syrup Syrup Syrup Syrup Syrup Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate
Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
EU/ 1/ 00/ 160/ 007
bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
Filmovertrukne tabletter
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
Oral anvendelse
1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 2 3 5 7 10 14 15 20 21 30
EU/ 1/ 00/ 160/ 008
EU/ 1/ 00/ 160/ 033 EU/ 1/ 00/ 160/ 034
Oral anvendelse
Oral lyophilisate Oral lyophilisate
blister (Aclar/ PVC, alu)
blister (PVC/ Alu) blister (PVC/ Alu)
20 tabletter
50 100
EU/ 1/ 00/ 160/ 010
EU/ 1/ 00/ 160/ 035
5 mg
0.5 mg/ ml
Aerius
Syrup
blister (Aclar/ PVC, alu)
bottle (glass)
Aerius
150 ml
Filmovertrukne tabletter
1 bottle with 1 oral syringe
Oral anvendelse
EU/ 1/ 00/ 160/ 036 EU/ 1/ 00/ 160/ 037 EU/ 1/ 00/ 160/ 038 EU/ 1/ 00/ 160/ 039 EU/ 1/ 00/ 160/ 040 EU/ 1/ 00/ 160/ 041 EU/ 1/ 00/ 160/ 042 EU/ 1/ 00/ 160/ 043 EU/ 1/ 00/ 160/ 044 EU/ 1/ 00/ 160/ 045 EU/ 1/ 00/ 160/ 046 EU/ 1/ 00/ 160/ 047 EU/ 1/ 00/ 160/ 048 EU/ 1/ 00/ 160/ 049 EU/ 1/ 00/ 160/ 050 EU/ 1/ 00/ 160/ 051 EU/ 1/ 00/ 160/ 052 EU/ 1/ 00/ 160/ 053 EU/ 1/ 00/ 160/ 054 EU/ 1/ 00/ 160/ 055 EU/ 1/ 00/ 160/ 056 EU/ 1/ 00/ 160/ 057 EU/ 1/ 00/ 160/ 058 EU/ 1/ 00/ 160/ 059 EU/ 1/ 00/ 160/ 060
blister (Aclar/ PVC, alu)
Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius Aerius
50 tabletter
5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
EU/ 1/ 00/ 160/ 013
Film-coated tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Aerius
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
5 mg
blister (Aclar/ PVC, alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu)
Filmovertrukne tabletter
90 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets
EU/ 1/ 00/ 160/ 014
EU/ 1/ 00/ 160/ 061
Syrup
Oral solution
flaske (glas)
bottle (glass) + spoon (plastic)
1 flaske med 1 måleske
1 bottle
EU/ 1/ 00/ 160/ 015
EU/ 1/ 00/ 160/ 062
EU/ 1/ 00/ 160/ 016
EU/ 1/ 00/ 160/ 063
1/ 3 EU/ 1/ 00/ 160/ 017
EU/ 1/ 00/ 160/ 064
EU/ 1/ 00/ 160/ 018
EU/ 1/ 00/ 160/ 065
EU/ 1/ 00/ 160/ 019
EU/ 1/ 00/ 160/ 066
EU/ 1/ 00/ 160/ 020
EU/ 1/ 00/ 160/ 067
EU/ 1/ 00/ 160/ 021
EU/ 1/ 00/ 160/ 068
EU/ 1/ 00/ 160/ 035
EU/ 1/ 00/ 160/ 069
flaske (glas)
bottle (glass) + syringe (plastic)
1 flaske med 1 oral sprøjte
1 bottle
Aerius er indiceret til symptomlindring i forbindelse med:
Aerius is indicated for the relief of symptoms associated with:
5. 1)
- allergic rhinitis (see section 5.1)
5. 1)
- urticaria (see section 5.1)
5. 1).
Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Der er begrænset erfaring med klinisk effekt ved brug af desloratadin til unge mellem 12 og 17 år (se afsnit 4. 8 og 5. 1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Intermitterende allergisk rhinitis (tilstedeværelse af symptomer i mindre end 4 dage per uge eller i mindre end 4 uger) bør behandles i overensstemmelse med vurderingen af patientens sygdomshistorie, og behandlingen kan afbrydes efter symptomerne er forsvundet og genoptages efter deres tilbagevenden.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’ s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne eller loratadin.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Effekt og sikkerhed af Aerius- tabletter til børn under 12 år er ikke undersøgt.
Efficacy and safety of Aerius tablets in children under 12 years of age have not been established.
5. 2).
In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
2 4. 5 Interaktion med andre lægemidler og andre former for interaktion
2 4.5 Interaction with other medicinal products and other forms of interaction
5. 1).
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
5. 1).
In a clinical pharmacology trial Aerius taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Desloratidin var ikke teratogent i dyreforsøg.
Desloratadine was not teratogenic in animal studies.
Sikkerheden ved brug af lægemidlet under graviditet er ikke dokumenteret.
The safe use of the medicinal product during pregnancy has not been established.
Brug af Aerius under graviditet kan derfor ikke anbefales.
The use of Aerius during pregnancy is therefore not recommended.
Desloratadin udskilles i modermælk; anvendelse af Aerius anbefales derfor ikke hos ammende kvinder.
Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breast- feeding women.
I kliniske undersøgelser, der bedømte evnen til at køre, forekom ingen forringelse hos patienter, der modtog desloratadin.
In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine.
Dog bør patienter informeres om, at nogle mennesker meget sjældent kan opleve døsighed, hvilket kan have indflydelse på deres evne til at køre 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.
I kliniske undersøgelser ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med Aerius rapporteret hos 3% flere patienter end hos dem, der behandledes med placebo.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Aerius were reported in 3% of patients in excess of those treated with placebo.
De hyppigste bivirkninger, rapporteret oftere end ved placebo var træthed (1, 2%), mundtørhed (0, 8%) og hovedpine (0, 6%).
The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
I en klinisk undersøgelse med 578 unge patienter mellem 12 og 17 år var hovedpine den mest almindelige bivirkning.
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9% of patients treated with desloratadine and 6.9% of patients receiving placebo.
Den opstod hos 5, 9% af de patienter, som blev behandlet med deloratadin, og 6, 9% af de patienter, som fik placebo.
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.