FrancophonIA/ELRC3.0 huggingface dataset:
English: Protopic is available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).
Danish: Protopic findes i to styrker (Protopic 0,03% og Protopic 0,1% salve).
English: Do not apply the ointment to infected lesions.
Danish: Du må ikke smøre salve på betændt, beskadiget hud.
English: Cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
Danish: kutane (f.eks. kutan T-celle lymfom) og andre typer lymfomer hos patienter, som bruger tacrolimussalve (se pkt 4.8).
English: Median mEASI Percentage Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician's Global Evaluation § higher values = greater improvement
Danish: Procent fald i median mEASI (Primær parameter)§ Bedring ≥ 90% i lægens samlede vurdering § højere værdi = større bedring
English: Protopic ointment should not be used during pregnancy unless clearly necessary.
Danish: Protopic salve bør kun anvendes til gravide på tvingende indikation.
English: Protopic 0.1 % ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
Danish: Du skal påsmøre Protopic 0,1% salve en gang dagligt to gange om ugen (f.eks. mandag og torsdag) på de områder af kroppen, som sædvanligvis er angrebet af eksem.
English: • The active substance is tacrolimus monohydrate.
Danish: - Aktive stof: Tacrolimusmonohydrat.
English: An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 0.03% ointment if the clinical condition allows.
Danish: Hvis den kliniske tilstand tillader det, bør man forsøge at reducere applikationsfrekvensen eller benytte den svagere Protopic 0,03% salve.
English: Tacrolimus 0.1% Twice weekly (N=80)
Danish: Tacrolimus 0,1% To gange ugentlig (N=80)
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Protopic til dig personligt.
English: • Apply Protopic as a thin layer to affected areas of your skin.
Danish: • Påsmør Protopic i et tyndt lag på de angrebne hudområder.
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the clinical trial.
Danish: Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af behandlingsgrupperne.
English: Butylhydroxytoluene (E321) 15 micrograms/g ointment.
Danish: Hjælpestof, som behandleren skal være opmærksom på Butylhydroxytoluen (E321) 15 mikrogram/g salve.
English: Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Danish: Protopic 0,1% salve benyttes til at behandle moderat til svær atopisk dermatitis (eksem) hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider.
English: Tacrolimus 0.03% Twice daily (N=210)
Danish: Tacrolimus 0,03% To gange om dagen (N=210)
English: Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis.
Danish: Du skal påsmøre Protopic salve en gang daglig to gange om ugen (f.eks. mandag og torsdag) på de områder af kroppen, som sædvanligvis er angrebet af eksem.
English: Tacrolimus 0.03% Once daily (N=207)
Danish: Tacrolimus 0,03% En gang om dagen (N=207)
English: Hard paraffin
Danish: Paraffin
English: Improvement ≥ 90% in Physician's
Danish: Bedring ≥ 90% i lægens samlede 15,7%
English: In vitro, in Langerhans cells isolated from normal human skin, tacrolimus reduced the stimulatory activity towards T cells.
Danish: In vitro reducerer tacrolimus den stimulerende effekt på T-celler i Langerhans celler isoleret fra normal human hud.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan påvirke mellem 1 og 10 ud af 100 behandlede):
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Danish: Ved atopisk dermatitis ses inflammation af huden (kløe, rødme og tørhed) på grund af en overreaktion af hudens immunsystem.
English: Package leaflet: Information for the user Protopic 0.1% ointment tacrolimus monohydrate
Danish: Indlægsseddel: Information til brugeren Protopic 0,1% salve tacrolimusmonohydrat
English: Package leaflet: Information for the user Protopic 0.03% ointment tacrolimus monohydrate
Danish: Indlægsseddel: Information til brugeren Protopic 0,03% salve tacrolimusmonohydrat
English: Metabolism of tacrolimus by human skin was not detectable.
Danish: Der er ikke tegn på, at tacrolimus metaboliseres af human hud.
English: • facial flushing or skin irritation after drinking alcohol is also common
Danish: • ansigtsrødme eller hudirritation efter indtagelse af alkohol
English: Ointment A white to slightly yellowish ointment.
Danish: Salve Hvid til svagt gullig salve.
English: improvement in mEASI (Primary Endpoint)§§
Danish: Responsrate på ≥ 60% bedring i mEASI (Primær parameter)§§
English: Application site oedema*
Danish: Ødem på applikationsstedet*
English: 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate)
Danish: 1 g salve indeholder: 0,3 mg tacrolimus (som monohydrat),
English: 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate)
Danish: 1 g salve indeholder: 1,0 mg tacrolimus (som monohydrat),
English: 1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Danish: 1 g Protopic 0,03% salve indeholder 0,3 mg tacrolimus som tacrolimusmonohydrat (0,03%).
English: Application site rash
Danish: Kløe på applikationsstedet
English: 1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Danish: 1 g Protopic 0,1% salve indeholder 1,0 mg tacrolimus som tacrolimusmonohydrat (0,1%).
English: Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares.
Danish: For at forhindre eksemudbrud bør Protopic salve påsmøres en gang dagligt to gange om ugen (f.eks. mandag og torsdag) på de områder, som sædvanligvis er afficeret af atopisk dermatitis.
English: One gram of Protopic 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Danish: Et gram af Protopic 0,1% salve indeholder 1,0 mg tacrolimus (som tacrolimusmonohydrat).
English: One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Danish: Et gram af Protopic 0,03% salve indeholder 0,3 mg tacrolimus (som tacrolimusmonohydrat).
English: • redness
Danish: • udslæt
English: LEO Pharma S.p.A. Tel: +39 06 52625500
Danish: Tel: +39 06 52625500
English: The review of the child`s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.
Danish: Behandlingen bør seponeres for at evaluere sygdomsforløbet og for at vurdere behovet for fortsat behandling.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PROTOPIC 0,1% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
English: What Protopic is and what it is used for What you need to know before you use Protopic How to use Protopic
Danish: Det skal du vide, før du begynder at bruge Protopic Sådan skal du bruge Protopic Bivirkninger
English: Protopic 0.1% ointment tacrolimus monohydrate
Danish: Protopic 0,1% salve tacrolimusmonohydrat
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.1% OINTMENT (30 g, 60 g TUBE)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PROTOPIC 0,1% SALVE (30 g, 60 g TUBE)
English: Treat each affected region of your skin until the eczema has gone away.
Danish: Alle angrebne hudområder skal behandles indtil eksemen er forsvunden.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPIC 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PROTOPIC 0,03% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
English: Protopic 0.1% ointment
Danish: Protopic 0,1% salve
English: Protopic 0.03% ointment
Danish: Protopic 0,03% salve
English: Protopic 0.03% ointment tacrolimus monohydrate
Danish: Protopic 0,03% salve tacrolimusmonohydrat
English: Flare treatment
Danish: Behandling af eksemudbrud
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPIC 0.03% OINTMENT (30 g, 60 g TUBE)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PROTOPIC 0,03% SALVE (30 g, 60 g TUBE)
English: General disorders and administration site conditions
Danish: Almindelige symptomer og reaktioner på applikationsstedet
English: Protopic 0.03% ointment tacrolimus monohydrate Cutaneous use
Danish: Protopic 0,03% salve tacrolimusmonohydrat Kutan anvendelse
English: Only Protopic 0.03 % ointment should be used in children from the age of 2 to 16 years.
Danish: Børn fra 2 til 16 år bør kun anvende Prototopic 0,03% salve.
English: Protopic 0.1% ointment tacrolimus monohydrate Cutaneous use
Danish: Protopic 0,1% salve tacrolimusmonohydrat Kutan anvendelse
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been reported (see section 4.8) Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Danish: kutane (f.eks. kutan T-celle lymfom) og andre typer lymfomer og hudcancere hos patienter behandlet med tacrolimussalve (se pkt.
English: What Protopic looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Breast-feeding
Danish: Teratogenicitet
English: Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Danish: Behandling af moderat til svær atopisk dermatitis hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider.
English: • Risk Management Plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP) Ikke relevant
English: Adults and adolescents (12 years of age and over)
Danish: Voksne og unge (i alderen 12 år og derover)
English: Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Danish: Lindring af disse symptomer varer en hel dag og hjælper dig med at genoptage dine normale daglige aktiviteter og søvn.
English: Very rare: the following may affect up to 1 in 10,000 people ● severe allergic reactions
Danish: Meget sjældne: følgende kan forekomme hos op til 1 ud af 10.000 personer ● alvorlige allergiske reaktioner
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret således: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Adults and adolescents 12 years of age and over The recommended dose is one tablet once a day with water, with or without food.
Danish: Voksne og unge i alderen 12 år og derover Den sædvanlige dosis er en tablet en gang dagligt sammen med vand, med eller uden mad.
English: Desloratadine effectively controlled symptoms for 24 hours.
Danish: Desloratadine regulerede effektivt symptomerne i 24 timer.
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Danish: Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er endnu blevet identificeret, og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
English: For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.
Danish: For nældefeber kan varigheden af behandling variere fra patient til patient, og du skal derfor følge din læges instruktioner.
English: If you forget to take Desloratadine ratiopharm If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Danish: Hvis du har glemt at tage Desloratadine ratiopharm Hvis du glemmer at tage din medicin til tiden, så tag den snarest muligt og vend derefter tilbage til din sædvanlige medicineringsplan.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow the tablet whole with water.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Slug tabletten hel med vand.
English: Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG United Kingdom
Danish: Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Storbritannien
English: Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine ratiopharm.
Danish: Med hensyn til varigheden af behandlingen, vil din læge bestemme hvilken type allergisk snue, du lider af, og vil fastsætte, hvor længe du skal tage Desloratadine ratiopharm.
English: Desloratadine ratiopharm with food, drink and alcohol Desloratadine ratiopharm may be taken with or without a meal.
Danish: Brug af Desloratadine ratiopharm sammen med mad, drikke og alkohol Desloratadine ratiopharm kan tages med eller uden mad.
English: Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Danish: Behandling med desloratadin reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire-points skala, der anvendtes for at vurdere disse parametre.
English: EU/1/11/746/001 - Cartons of 7 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/002 - Cartons of 10 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/003 - Cartons of 14 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/004 - Cartons of 15 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/005 - Cartons of 20 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/006 - Cartons of 30 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/007 - Cartons of 40 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/008 - Cartons of 50 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/009 - Cartons of 60 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/010 - Cartons of 90 film-coated tablets in PVC/PVdC/aluminium blisters EU/1/11/746/011 - Cartons of 100 film-coated tablets in PVC/PVdC/aluminium blisters
Danish: EU/1/11/746/001 - Kartoner med 7 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/002 - Kartoner med 10 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/003 - Kartoner med 14 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/004 - Kartoner med 15 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/005 - Kartoner med 20 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/006 - Kartoner med 30 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/007 - Kartoner med 40 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/008 - Kartoner med 50 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/009 - Kartoner med 60 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/010 - Kartoner med 90 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters EU/1/11/746/011 - Kartoner med 100 filmovertrukne tabletter i PVC/PVdC/aluminiumsblisters
English: The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Danish: De hyppigste bivirkninger, rapporteret oftere end ved placebo var træthed (1,2 %), mundtørhed (0,8 %) og hovedpine (0,6 %).
English: Date of latest renewal: 8 August 2016
Danish: Dato for første markedsføringstilladelse: 13. januar 2012 Dato for seneste fornyelse: 8. august 2016
English: 305 74770 Opava-Komárov Czech Republic
Danish: 305 74770 Opava-Komárov Tjekkiet
English: In adolescents, headache was the most commonly reported side effect.
Danish: Hovedpine var den mest almindelige rapporterede bivirkning hos unge.
English: Round, biconvex, blue film-coated tablets.
Danish: Runde, bikonvekse, blå filmovertrukne tabletter.
English: Pack sizes of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets.
Danish: Pakninger med 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 og 100 filmovertrukne tabletter.
English: The efficacy of desloratadine tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
Danish: Virkningen af desloratadin-tabletter er ikke blevet tydeligt vist i studier med unge patienter mellem 12 og 17 år.
English: PHARMACEUTICAL FORM Film-coated tablet.
Danish: LÆGEMIDDELFORM Filmovertrukket tablet
English: ● restlessness with increased
Danish: ● rastløshed med øget
English: Non-clinical data 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: De prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Desloratadine ratiopharm 5 mg film-coated tablets are supplied in PVC/PVdC/aluminium blister packs of 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 and 100 film-coated tablets.
Danish: Desloratadine ratiopharm 5 mg filmovertrukne tabletter leveres i PVC/PVdC/aluminiumsblisterpakninger med 7, 10, 14, 15, 20, 30, 40, 50, 60, 90 og 100 filmovertrukne tabletter.
English: 305, 74770 Opava-Komarov Czech Republic
Danish: 305 74770 Opava-Komarov Tjekkiet
English: ● hallucinations
Danish: ● hallucinationer
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Danish: I to placebokontrollerede seks-ugers studier hos patienter med kronisk idiopatisk urticaria var desloratadin effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
English: 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 30 film-coated tablets 40 film-coated tablets 50 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 10 filmovertrukne tabletter 14 filmovertrukne tabletter 15 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 40 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity.
Danish: Desloratadin er en ikke-sederende, langtidsvirkende histaminantagonist med selektiv perifer H1receptorantagonist aktivitet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg desloratadine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 5 mg desloratadin.
English: Maximum desloratadine concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Danish: Maksimumkoncentration af desloratadin var omkring 3 gange højere efter cirka 7 timer med en halveringstid for den terminale fase på cirka 89 timer.
English: Adults During the marketing of Desloratadine ratiopharm, the following side effects were reported as:
Danish: Voksne Efter markedsføring af Desloratadine ratiopharm er følgende bivirkninger blevet rapporteret:
English: Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Danish: Desloratadine var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: In another study, grapefruit juice had no effect on the disposition of desloratadine.
Danish: I et separat studie havde grapefrugtjuice ingen indflydelse på metaboliseringen af desloratadin.
English: ● increased appetite
Danish: ● øget appetit
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Danish: Manglende karcinogenicitet blev vist i studier med desloratadin og loratadin.
English: In clinical studies with desloratadine, the following side effects were reported as:
Danish: I kliniske studier med desloratadin er følgende bivirkninger blevet rapporteret:
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany info@ratiopharm.de
Danish: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland info@ratiopharm.de
English: ● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to
Danish: ● øget hudfølsomhed over for sollys, selv i overskyet vejr, og over for ultraviolet (UV) lys, f.eks. UVlys i et solarium
English: Film-coating: polyvinyl alcohol (part. hydrolysed), titanium dioxide (E171), macrogol/PEG 3350, talc and indigo carmine aluminium lake (E132).
Danish: Tabletovertræk: polyvinylalkohol (delvist hydrolyseret), titandioxid (E171), macrogol/PEG 3350, talcum, indigocarmin aluminium lake (E132).
English: Use caution when taking Desloratadine ratiopharm with alcohol.
Danish: Du skal udvise forsigtighed, hvis du tager Desloratadine ratiopharm sammen med alkohol.
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Danish: Desloratadine, givet i en enkelt daglig dosis på 7,5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske studier.
English: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table.
Danish: Frekvenserne af de bivirkninger, der er rapporteret i kliniske studier ud over placebo, og andre bivirkninger, der er rapporteret efter markedsføring, fremgår af nedenstående tabel.
English: The safety and efficacy of Desloratadine ratiopharm 5 mg film-coated tablets in children below the age of 12 years have not been established.
Danish: Sikkerhed og virkning af Desloratadine ratiopharm 5 mg filmovertrukne tabletter hos børn under 12år er ikke klarlagt.
English: Other medicines and Desloratadine ratiopharm There are no known interactions of Desloratadine ratiopharm with other medicines.
Danish: Brug af anden medicin sammen med Desloratadine ratiopharm Der er ingen kendte interaktioner mellem Desloratadine ratiopharm og andre lægemidler.
English: Desloratadine ratiopharm is an antiallergy medicine that does not make you drowsy.
Danish: Desloratadine ratiopharm er et lægemiddel mod allergi, som ikke gør dig døsig.
English: Taking Desloratadine ratiopharm is not recommended if you are pregnant or nursing a baby.
Danish: Det frarådes, at du tager Desloratadine ratiopharm, hvis du er gravid, eller hvis du ammer dit spædbarn.