FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Dasselta - if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Danish: Tag ikke Dasselta - hvis du er allergisk over for desloratadin eller et af de øvrige indholdsstoffer i Dasselta (angivet i punkt 6) eller over for loratadin.
English: Blister (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box.
Danish: Blisterpakning (OPA/alu/PVC//alu): 7, 10, 20, 30, 50, 90 og 100 filmovertrukne tabletter i en æske.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Dasselta, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: No serious side effects are expected with accidental overdose.
Danish: Ved fejlagtig overdosis forventes ingen alvorlige bivirkninger.
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: Use caution when taking Dasselta with alcohol.
Danish: Du skal udvise forsigtighed, hvis du tager Dasselta sammen med alkohol.
English: What Dasselta is Dasselta contains desloratadine which is an antihistamine.
Danish: Hvad Dasselta er Dassleta indeholder desloratadin, som er et antihistamin.
English: As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Danish: For en sikkerheds skyld bør desloratadin undgås under graviditet.
English: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour and aggression.
Danish: Andre bivirkninger, der blev rapporteret i perioden efter markedsføring hos pædiatriske patienter med frekvensen ”Ikke kendt”, var forlænget QT-interval, arytmi, bradykardi, unormal adfærd og aggression.
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: Desloratadin var effektivt til at lindre generne ved sæsonbetinget allergisk rhinitis, vist ved den totale score i rhino-konjunktivitis livskvalitetsspørgeskemaet.
English: What you need to know before you take Dasselta
Danish: Det skal du vide, før du begynder at tage Dasselta
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Hvorvidt amningen skal fortsættes eller om behandlingen med desloratadin skal seponeres/undlades skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling.
English: Excipient with known effect: Each film-coated tablet contains 16.15 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 16,15 mg lactose (som monohydrat).
English: As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as nonresponsive to antihistamines was excluded.
Danish: Som i andre antihistaminstudier ved kronisk idiopatisk urticaria blev de få patienter, der var identificeret som ikke-responderende på antihistaminer, ekskluderet.
English: After oral administration, desloratadine selectively blocks peripheral histamine H1receptors because the substance is excluded from entry to the central nervous system.
Danish: Efter peroral indgift blokerer desloratadin selektivt perifere histamin H1receptorer, fordi stoffet hindres i at trænge ind i centralnervesystemet.
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, frarådes det at beskæftige sig med aktiviteter, der kræver mental årvågenhed, for eksempel køre bil og betjene maskiner indtil din reaktion på dette lægemiddel er fastlagt.
English: During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Danish: Under markedsføringen af desloratadin er der rapporteret meget sjældne tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, kløende udslæt) blevet rapporteret meget sjældent.
English: 7 film-coated tablets 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets for tablet container: 250 film-coated tablets
Danish: 7 filmovertrukne tabletter 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter tabletbeholder: 250 filmovertrukne tabletter
English: ), titanium dioxide (E171) and indigo carmine (E132).
Danish: ), titandioxide (E171) og indigocarmin (E132).
English: Common (the following may affect up to 1 in 10 people): - fatigue, - dry mouth, - headache.
Danish: Almindelige: følgende kan forekomme hos op til 1 ud af 10 personer - træthed - mundtørhed - hovedpine
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Danish: Desloratadin, givet i en enkelt daglig dosis på 7,5 mg, påvirkede ikke den psykomotoriske præstationsevne i kliniske studier.
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Danish: Forhøjede leverenzymer, forhøjet bilirubin, hepatitis Gulsot
English: Metabolism and nutritional disorders
Danish: Metabolisme og ernæring Ikke kendt
English: Tablet container (HDPE, volume 60 ml), PP closure with desiccant: 250 film-coated tablets, in a box.
Danish: Tabletbeholder (HDPE, volumen 60 ml), PP-låg med tørremiddel: 250 filmovertrukne tabletter i en æske.
English: Lactose monohydrate Talc (E553b)
Danish: Lactosemonohydrat Talcum (E553b)
English: When Dasselta should be used
Danish: Hvornår Dasselta skal bruges
English: Each film-coated tablet contains 5 mg desloratadine.
Danish: Hver filmovertrukken tablet indeholder 5 mg desloratadin.
English: Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet container of 250 film-coated tablets.
Danish: Dasselta fås i æsker med 7, 10, 20, 30, 50, 90 og 100 filmovertrukne tabletter i blisterkort og i en plast-tabletbeholder med 250 filmovertrukne tabletter.
English: 250 film-coated tablets
Danish: 250 filmovertrukne tabletter
English: Dasselta relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Danish: Dasselta lindrer symptomer forbundet med allergisk snue (irritation af vævet i de nasale passager forårsaget af allergi, for eksempel høfeber eller støvmideallergi) hos voksne og unge i alderen 12 år og derover.
English: What Dasselta contains - The active substance is desloratadine.
Danish: Dasselta indeholder: - Aktivt stof: desloratadin.
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 Dasselta på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Excipient: lactose monohydrate.
Danish: Hjælpestof: lactosemonohydrat.
English: Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
Danish: Lyseblå, runde, filmovertrukne tabletter med skrå kanter (diameter: 6,5 mm, tykkelse: 2,3 - 3,5 mm).
English: Dasselta is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Danish: Dasselta anvendes også til at lindre symptomerne i forbindelse med nældefeber (en hudlidelse forårsaget af allergi).
English: How Dasselta works
Danish: Sådan virker Dasselta
English: Not known: frequency cannot be estimated from the available data - unusual weakness, - yellowing of the skin and/or eyes, - increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium, - changes in the way the heart beats,
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data - usædvanlig mathedsfølelse, - huden og/eller øjnene får en gullig farve, - øget hudfølsomhed over for sollys, selv i overskyet vejr, og over for ultraviolet (UV) lys, f.eks.
English: If you take more Dasselta than you should
Danish: Hvis du har taget for mange Dasselta
English: 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 desloratadine were reported in 3 % of patients in excess of those treated with placebo.
Danish: Opsummering af sikkerhedsprofilen I kliniske studier ved en række indikationer omfattende allergisk rhinitis og kronisk idiopatisk urticaria, ved den anbefalede dosis på 5 mg daglig, blev bivirkninger med desloratadin rapporteret hos 3 % flere patienter end hos dem, der behandledes med placebo.
English: Lactose monohydrate Titanium dioxide (E171) Indigo carmine (E132)
Danish: Lactosemonohydrat Titandioxid (E171) Indigocarmin (E132)
English: Dasselta contains lactose
Danish: Dasselta indeholder lactose
English: During the marketing of desloratadine-containing products, the following side effects were reported as:
Danish: Voksne Efter markedsføring af desloratadin er følgende bivirkninger blevet rapporteret:
English: In clinical studies with desloratadine, the following side effects were reported as:
Danish: I kliniske studier med Dasselta er følgende bivirkninger blevet rapporteret som:
English: What Dasselta looks like and contents of the pack Light blue, round, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).
Danish: Udseende og pakningsstørrelser Lyseblå, runde, filmovertrukne tabletter med skrå kanter (diameter: 6,5 mm, tykkelse: 2,3-3,5 mm).
English: In patients with allergic rhinitis, desloratadine was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Danish: Hos patienter med allergisk rhinitis lindrede desloratadin effektivt symptomer såsom nysen, næseflåd og - kløe, samt øjenkløe, tåreflåd og rødme og kløe i ganen.
English: Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1), - urticaria (see section 5.1).
Danish: Dasselta er indiceret hos voksne og unge i alderen 12 år og derover til lindring af symptomer i forbindelse med: - allergisk rhinitis (se pkt.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Dasselta til dig personligt.
English: Tablet core:
Danish: tabletbeholder:
English: Dasselta 5 mg film-coated tablets Desloratadine
Danish: Dasselta 5 mg filmovertrukne tabletter Desloratadin
English: - The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose«.)
Danish: - Øvrige indholdsstoffer i tabletkernen: mikrocrystallinsk cellulose (E460), hypromellose (E464), saltsyre (E507), natriumhydroxid (E524), majsstivelse, lactosemonohydrat (se pkt.
English: In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
Danish: I et klinisk farmakologisk studie, i hvilket desloratadin blev indgivet i en dosering på 45 mg daglig (ni gange den terapeutiske dosis) i ti dage, sås ingen forlængelse af QTc-intervallet.
English: film-coated tablet for blister:
Danish: Filmovertrukken tablet blisterpakning:
English: Dasselta 5 mg film-coated tablets
Danish: Dasselta 5 mg filmovertrukne tabletter
English: In a clinical pharmacology trial desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Danish: I et klinisk farmakologisk studie forstærkede desloratadin tabletter indtaget sammen med alkohol ikke alkohols præstationshæmmende virkninger (se pkt.
English: Other medicines and Dasselta
Danish: Brug af anden medicin sammen med Dasselta
English: Microcrystalline cellulose (E460) Hypromellose (E464) Hydrochloric acid (E507) Sodium hydroxide (E524) Maize starch
Danish: Microcrystallinsk cellulose (E460) Hypromellose (E464) Saltsyre (E507)
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Ikke kendt
English: - The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose«.
Danish: - Øvrige indholdsstoffer I filovertrækket: hypromellose (E464), macrogol, lactosemonohydrat (se pkt.
English: Dasselta contains lactose.
Danish: Dasselta indeholder lactose.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to loratadine.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).
Danish: Dasselta bør anvendes med forsigtighed til patienter med svær nyreinsufficiens (se pkt.
English: Manufacturers KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Danish: Fremstiller KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
English: Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials.
Danish: Vurderet på baggrund af kliniske studier påvirker Dasselta ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Talk to your doctor or pharmacist before taking Dasselta: - if you have poor kidney function.
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: If you are pregnant or nursing a baby, taking Dasselta is not recommended.
Danish: Det frarådes, at du tager Dasselta, hvis du er gravid, eller hvis du ammer dit spædbarn.
English: How to store Dasselta
Danish: Sådan skal du tage Dasselta
English: What Dasselta is and what it is used for What you need to know before you take Dasselta How to take Dasselta
Danish: Det skal du vide, før du begynder at tage Dasselta Sådan skal du tage Dasselta Bivirkninger
English: There is a possibility that this may lead to hypermagnesaemia.
Danish: Der er en mulighed for, at dette kan føre til hypermagnesiæmi.
English: Use with caution in patients with renal insufficiency.
Danish: Skal anvendes med forsigtighed til patienter med nyreinsufficiens.
English: Section 4.4 Special warnings and precautions for use Renal [This wording should be inserted]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Renal [Denne ordlyd skal indsættes]
English: Hypermagnesaemia
Danish: Hypermagnesiæmi
English: [This wording should be inserted at the top of the SmPC] This medicinal product is subject to additional monitoring.
Danish: [Denne ordlyd skal indsættes øverst i SPC'et] Dette lægemiddel er underlagt supplerende overvågning.
English: This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
Danish: Dette er især vigtigt for patienter med øget risiko for udvikling af hypermagnesiæmi, herunder patienter med nedsat nyrefunktion, patienter, der får anden medicin, der kan medføre risiko for udvikling af hypermagnesiæmi, eller patienter, der får magnesium fra andre kilder, inklusive nyfødte, hvor moderen har fået magnesium den sidste tid før fødslen.
English: Elevated levels of Magnesium in blood
Danish: Forhøjet magnesiumindhold i blodet
English: As signs of hypermagnesaemia may not be detected, monitoring of magnesium levels is advised at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient.
Danish: Da tegnene på hypermagnesiæmi ikke nødvendig opdages, anbefales monitorering af magnesium ved baseline og derefter med passende intervaller i overensstemmelse med rutinemæssig klinisk praksis og den enkelte patients behov.
English: Annex IV Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag IV Ændringer til relevante punkter i produktresumeet og indlægssedlen
English: As these signs may be difficult to detect, your child´s blood values may be monitored by their doctor, in particular if your child has risk factors for elevated levels of magnesium in blood, including impaired renal function.
Danish: Da disse tegn kan være svære at opdage, bør dit barns blodværdier overvåges af lægen, især hvis dit barn har risiko for forhøjet magnesiumindhold, herunder nedsat nyrefunktion.
English: Fluid and electrolyte status including magnesium (see Hypermagnesaemia) should be closely monitored in these patients.
Danish: Væskebalance og elektrolytter, herunder magnesium (se hypermagnesiæmi) skal monitoreres nøje hos disse patienter.
English: Summary of Product Characteristics of Numeta G16%E, and associated names
Danish: Produktresumé for Numeta G16 og tilknyttede navne
English: The signs of this could include weakness, slow reflexes, nausea, vomiting, low calcium levels in blood, breathing difficulties, low blood pressure and irregular heartbeat.
Danish: Tegnene herpå kan være svaghed, langsomme reflekser, kvalme, opkastning, lavt calciumindhold i blodet, åndedrætsbesvær, lavt blodtryk og uregelmæssig hjerterytme (puls).
English: The signs of hypermagnesaemia include generalised weakness, hypo-reflexia, nausea, vomiting, hypocalcaemia, respiratory failure, hypotension and arrhythmias.
Danish: Tegnene på hypermagnesiæmi inkluderer generel svaghed, hyporefleksi, kvalme, opkastning, hypokalcæmi, respirationssvigt, hypotension og arytmier.
English: [This wording should be inserted at the end of the section]
Danish: [Denne ordlyd skal indsættes til sidst i punktet]
English: Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Danish: Alvorlige forstyrrelser i væske- og elektrolytbalancen, tilstande med alvorlig væske-overload og alvorlige metaboliske lidelser skal korrigeres, før infusionen påbegyndes (se pkt.
English: If serum magnesium levels are elevated (above reference range normal values) the infusion of <Invented Name> should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Danish: Hvis serum-magnesium er forhøjet (ovennævnte referenceområde er normalværdier), bør infusion af Numeta G16E stoppes, eller infusionshastigheden bør nedsættes i henhold til, hvad der skønnes klinisk hensigtsmæssigt og sikkert.
English: If blood magnesium levels are elevated, the infusion will be stopped or reduced.
Danish: Hvis magnesiumindholdet er forhøjet, vil lægen stoppe infusionen eller nedsætte infusionshastigheden.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i <afsnit><punkt> 4, hvordan <De> <du> indberetter bivirkninger.
English: The amendments to the Summary of Product Characteristics, labelling and package leaflet may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate
Danish: Det kan efterfølgende være nødvendigt, at myndighederne, i samarbejde med referencestaten, opdaterer ændringerne til produktresume, mærkning og indlægsseddel, hvis det er hensigtsmæssigt.
English: The amount of magnesium in <Invented Name>, may cause elevated levels of magnesium in blood.
Danish: Mængden af magnesium i Numeta G16E kan medføre forhøjet magnesiumindhold i blodet.
English: [The wording below should be added to this section]
Danish: [Denne ordlyd skal tilføjes dette afsnit]
English: <Invented Name> provides 0.3 mmol/kg/d of magnesium when administered at maximum dose (see section 4.2).
Danish: Når Numeta G16E administreres ved maksimumdosis, tilføres 0,3 mmol magnesium/kg/døgn (se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: <De> <Du> eller <Deres> <dine> pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i
English: Annex V Conditions to the marketing authorisations
Danish: Appendiks V*.
English: It is used for the treatment of adults and children over the age of two years with:
Danish: Det anvendes til behandling af voksne og børn over 2 år med:
English: The tablets are to be taken at least one hour before or after a meal.
Danish: Tabletterne skal tages mindst én time før eller efter et måltid.
English: (patients with a normal white blood cell count);
Danish: (patienter med et normalt antal hvide blodlegemer)
English: The dose may be increased or decreased according to how the patient responds.
Danish: Dosen kan øges eller sættes ned afhængigt af, hvordan patienten reagerer.
English: Patients need to receive an initial higher dose (loading dose) on the first day of treatment.
Danish: Patienter skal have en højere begyndelsesdosis på behandlingens første dag.
English: The aim of the loading dose is to attain effective blood levels quickly.
Danish: Formålet med begyndelsesdosen er hurtigt at opnå et stabilt blodniveau.
English: The full EPAR for Voriconazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Voriconazole Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Voriconazole Accord is available as tablets (50 mg or 200 mg).
Danish: Voriconazole Accord fås som tabletter (50 mg eller 200 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Accord on 16 May 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Voriconazole Accord den 16. maj 2013.
English: Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risks.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Vfend.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes.
Danish: Det virker ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellemembranerne.
English: This is a summary of the European public assessment report (EPAR) for Voriconazole Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Voriconazole Accord.