FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions seen with desloratadine
Danish: Bivirkninger set med desloratadin
English: Tablet core: poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, lactose monohydrate (see section 2 “Desloratadine ratiopharm contains lactose”), talc,
Danish: Tabletkerne: poloxamer type 188, citronsyremonohydrat, mikrokrystallinsk cellulose, majsstivelse, natriumcroscarmellose, lactosemonohydrat (se punkt 2 ”Desloratadine ratiopharm indeholder lactose”), talcum.
English: ● pounding or irregular heartbeat
Danish: ● hjertebanken eller uregelmæssig
English: 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.
Danish: 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.
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: 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: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Desloratadine ratiopharm 5 mg film-coated tablets 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 Desloratadine ratiopharm 5 mg filmovertrukne tabletter skal seponeres/undlades skal vurderes ud fra afvejning af barnets fordele ved amning og kvindens fordele ved behandling..
English: Indigo carmine aluminium lake (E132) 6.2 Incompatibilities
Danish: Indigocarmin aluminium lake (E132).
English: In a multiple dose clinical trial, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed.
Danish: I et flerdosis klinisk studie, i hvilket op til 20 mg desloratadin blev indgivet daglig i 14 dage, blev der ikke observeret nogle statistisk eller klinisk relevante kardiovaskulære virkninger.
English: Desloratadine ratiopharm is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Danish: Desloratadine ratiopharm anvendes også til at lindre symptomerne i forbindelse med nældefeber (en hudlidelse forårsaget af allergi).
English: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash and urticaria) Asthenia
Danish: Overfølsomhedsreaktioner (såsom anafylaksi, angioødem, dyspnø, kløe, udslæt og urticaria) Asteni
English: During the marketing of Desloratadine ratiopharm, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Danish: Under markedsføringen af Desloratadine ratiopharm er der rapporteret meget sjældne tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, nældefeber og hævelse).
English: What Desloratadine ratiopharm is Desloratadine ratiopharm contains desloratadine which is an antihistamine.
Danish: Hvad Desloratadine ratiopharm er Desloratadine ratiopharm indeholder desloratadin, som er et antihistamin.
English: Each tablet contains 14.25 mg of lactose (as monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 14,25 mg lactose (som monohydrat).
English: Fertility There are no data available on male and female fertility.
Danish: Fertilitet Der foreligger ingen data vedrørende fertiliteten hos hanner og hunner.
English: When Desloratadine ratiopharm should be used Desloratadine ratiopharm 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: Desloratadine ratiopharm lindrer symptomer forbundet med allergisk snue (inflammation af næsepassager forårsaget af allergi, for eksempel høfeber eller støvmideallergi) hos voksne og unge i alderen 12 år og derover.
English: Croscarmellose sodium Lactose monohydrate Talc
Danish: Natriumcroscarmellose Lactosemonohydrat Talcum.
English: ● weight increased
Danish: ● Vægtforøgelse
English: In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Danish: Ved vedvarende allergisk rhinitis (tilstedeværelse af symptomer i 4 dage eller mere per uge og i mere end 4 uger) kan fortsat behandling foreslås til patienterne under perioder med allergeneksponering.
English: There is no data available on male/female fertility.
Danish: Der er ingen information tilgængelig om virkningen på frugtbarheden hos mænd og kvinder.
English: In the multiple-dose study, steady state was reached after Day 11, and compared to healthy subjects the exposure to desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in subjects with severe CRI.
Danish: I flerdosisstudiet blev steady state nået efter dag 11, og eksponeringen for desloratadin var ~1,5 gange højere hos patienter med let til moderat CRI og ~2,5 gange højere hos patienter med svær CRI sammenlignet med raske personer.
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: Desloratadine ratiopharm 5 mg film-coated tablets 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: Desloratadine ratiopharm 5 mg filmovertrukne tabletter er indiceret hos voksne og unge i alderen 12 år og derover til symptomlindring i forbindelse med: - allergisk rhinitis (se pkt.
English: What you need to know before you take Desloratadine ratiopharm Do not take Desloratadine ratiopharm - if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Danish: Tag ikke Desloratadine ratiopharm - hvis du er allergisk over for desloratadin eller et af de øvrige indholdsstoffer i Desloratadine ratiopharm (angivet i punkt 6) eller over for loratadin.
English: Desloratadine ratiopharm tablets contains lactose.
Danish: Desloratadine ratiopharm-tabletter indeholder lactose.
English: If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your doctor will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Danish: Hvis din allergiske snue er forbigående (tilstedeværelse af symptomer i mindre end 4 dage per uge eller i mindre end 4 uger), vil din læge anbefale dig en behandlingsplan, som vil afhænge af vurderingen af din sygdomshistorie.
English: 6.5 Nature and contents of container PVC/PVdC/aluminium blister:
Danish: 6.5 Emballagetype og pakningsstørrelser Pvc/PVdC-aluminiumblisters.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg desloratadine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 5 mg desloratadin.
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: If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your doctor may recommend you a longer term treatment.
Danish: Hvis din allergiske snue er vedvarende (tilstedeværelse af symptomer i 4 dage eller mere per uge og i mere end 4 uger), vil din læge måske anbefale dig en længerevarende behandling.
English: Teva Nederland B.V. Tel.: +31 (0) 800 0228400
Danish: Tel.: +31 (0) 800 0228400
English: What Desloratadine ratiopharm contains - The active substance is desloratadine 5 mg. - The other ingredients are:
Danish: - Aktivt stof: desloratadin 5 mg - Øvrige indholdsstoffer:
English: Talk to your doctor, pharmacist or nurse before taking Desloratadine ratiopharm:
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Desloratadine ratiopharm: - hvis du har dårlig nyrefunktion.
English: The recommended dose of Desloratadine ratiopharm 5 mg film-coated tablets is one tablet once a day.
Danish: Den anbefalede dosis Desloratadine ratiopharm 5 mg filmovertrukne tabletter en tablet en gang daglig.
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, over for et eller flere af hjælpestofferne anført i pkt.
English: INFORMATION IN BRAILLE Desloratadine ratiopharm 5 mg 17.
Danish: INFORMATION I BRAILLESKRIFT Desloratadine ratiopharm 5 mg
English: As a precautionary measure, it is preferable to avoid the use of Desloratadine ratiopharm 5 mg film-coated tablets during pregnancy.
Danish: For en sikkerheds skyld bør Desloratadine ratiopharm 5 mg filmovertrukne tabletter undgås under graviditeten.
English: Desloratadine ratiopharm contains lactose
Danish: Desloratadine ratiopharm indeholder lactose
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 January 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Polyvinyl alcohol (part. hydrolysed) Titanium dioxide (E171) Macrogol/PEG 3350
Danish: Polyvinylalkohol (delvist hydrolyseret) Titandioxid (E171)
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 studier, var der ingen overhyppighed af døsighed sammenlignet med placebo ved den anbefalede dosis på 5 mg daglig.
English: If you stop taking Desloratadine ratiopharm If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du holder op med at tage Desloratadine ratiopharm Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget du er i tvivl om.
English: How to take Desloratadine ratiopharm
Danish: Sådan skal du tage Desloratadine ratiopharm
English: ● liver inflammation ● abnormal liver function tests body movement
Danish: ● unormale prøver for leverfunktion
English: In the case of severe renal insufficiency, Desloratadine ratiopharm 5 mg film-coated tablets should be used with caution (see section 5.2).
Danish: Desloratadine ratiopharm 5 mg filmovertrukne tabletter bør anvendes med forsigtighed til patienter med svær nyreinsufficiens (se pkt.
English: Poloxamer type 188 Citric acid monohydrate Microcrystalline cellulose Maize starch
Danish: Citronsyremonohydrat Mikrokrystallinsk cellulose Majsstivelse
English: Desloratadine ratiopharm 5 mg film-coated tablets desloratadine
Danish: Desloratadine ratiopharm 5 mg filmovertrukne tabletter desloratadin
English: ● muscle pain
Danish: ● muskelsmerter
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 desloratadin ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: NAME OF THE MEDICINAL PRODUCT Desloratadine ratiopharm 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Desloratadine ratiopharm 5 mg filmovertrukne tabletter
English: What Desloratadine ratiopharm is and what it is used for What you need to know before you take Desloratadine ratiopharm How to take Desloratadine ratiopharm Possible side effects
Danish: Det skal du vide, før du begynder at tage Desloratadine ratiopharm Sådan skal du tage Desloratadine ratiopharm Bivirkninger
English: ● fast heartbeat
Danish: ● hurtig hjerterytme (puls)
English: NAME OF THE MEDICINAL PRODUCT Desloratadine ratiopharm 5 mg film-coated tablets Desloratadine
Danish: LÆGEMIDLETS NAVN Desloratadine ratiopharm 5 mg filmovertrukket tablet Desloratadin
English: No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Danish: I kliniske studier med desloratadin tabletter, hvor erythromycin eller ketoconazol blev givet samtidigt, blev der ikke observeret klinisk relevante interaktioner (se pkt.
English: ● upset stomach
Danish: ● mavesmerter hjerterytme
English: • if you have medical or familial history of seizures.
Danish: - hvis du tidligere har haft krampeanfald eller nogen i familien har haft det.
English: How to store Desloratadine ratiopharm
Danish: Sådan virker Desloratadine ratiopharm
English: How Desloratadine ratiopharm works
Danish: Hvornår Desloratadine ratiopharm skal bruges
English: ● drowsiness
Danish: ● svimmelhed
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Danish: Indehaver af markedsføringstilladelsen ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Tyskland info@ratiopharm.de
English: If you take more Desloratadine ratiopharm than you should
Danish: Tag udelukkende Desloratadine ratiopharm således, som det er ordineret til dig.
English: Most of them occurred during the first months of treatment.
Danish: De fleste af disse tilfælde opstod i løbet af de første måneder af behandlingen.
English: In such cases doubling of the daily dose may be necessary.
Danish: I disse tilfælde kan en fordobling af den daglige dosis være nødvendig.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten.
English: Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Afterwards gynaecological examination should be repeated at least once a year.
Danish: Efterfølgende gynækologisk undersøgelse bør gentages mindst én gang om året.
English: No information is available concerning polymorphic metabolism.
Danish: Der er ingen information tilgængelig vedrørende en polymorf metabolisme.
English: The basal disposition parameters (CL and V) could not be estimated due to the lack of intravenous study.
Danish: De basale dispositionsparametre (CL og V) kunne ikke estimeres grundet manglende intravenøse studier.
English: There is no specific antidote and the treatment is symptomatic.
Danish: Der er intet specifikt antidot og behandlingen er symptomatisk.
English: Enterohepatic circulation can be expected.
Danish: Enterohepatisk cirkulation kan forventes.
English: Food intake has no effect on the extent of absorption but may delay the peak concentrations by 1.5 - 2 hours.
Danish: Fødeindtagelse påvirker ikke den totale absorption, men kan forsinke peakkoncentrationen med 1,5-2 timer.
English: If you miss one dose take the next tablet as usual and continue treatment as recommended.
Danish: Hvis du glemmer en dosis, skal du tage den næste tablet som sædvanligt og fortsætte behandlingen, som anbefalet.
English: Owing to the slow elimination, steady-state concentrations in serum are reached in 4 to 6 weeks.
Danish: På grund af langsom elimination, opnås steady state koncentration i serum efter 4 til 6 uger.
English: The serum concentration curve can be described by a biexponential equation.
Danish: Serum koncentrationskurven kan beskrives af en biexponentiel ligning.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for indsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: System organ class
Danish: Systemorganklasser
English: These results strongly suggest an important dose-dependent effect.
Danish: Disse resultater antyder kraftigt en vigtig dosisrelateret virkning.
English: SN: {number}
Danish: SN: {nummer} [serienummer]
English: Toremifene can be taken with or without food.
Danish: Toremifen kan tages sammen med eller uden mad.
English: Your doctor will conduct regular medical check-ups.
Danish: Din læge vil kontrollere dig regelmæssigt.
English: See section 2 Warnings and precautions.
Danish: Se punkt 2 ”Advarsler og forsigtighedsregler).
English: There is a risk of increased endometrial changes including hyperplasia, polyps and cancer.
Danish: Der er en risiko for øget endometriale forandringer, bl.a. hyperplasi, polypper og cancer.
English: The half-life of the first (distribution) phase is 4 (range 2 - 12) hours, and of the second (elimination) phase 5 (range 210) days.
Danish: Halveringstiden for første (distributions-) fase er 4 (variation 2-12) timer og for anden eliminationsfase 5 (variation 2-10) dage.
English: The following information regarding QT-prolongation is of special importance (for contraindications see section 4.3).
Danish: Den følgende information angående QT-forlængelse er af særlig vigtighed (om kontraindikationer se pkt.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: {nummer} [produktkode]
English: Symptoms of overdose may be dizziness and headache.
Danish: Symptomer på en overdosis kan være svimmelhed og hovedpine.
English: Patients with non-compensated cardiac insufficiency or severe angina pectoris should be closely monitored.
Danish: Patienter med ikke kompenseret hjerteinsufficiens eller svær angina pectoris bør følges tæt.
English: Pharmacotherapeutic group: Anti-estrogens, ATC code: L02BA02
Danish: Farmakoterapeutisk klassifikation: Antiøstrogener, ATC kode: L02BA02
English: - if you experience an abnormal heart rhythm whilst taking Fareston.
Danish: - hvis du oplever en unormal hjerterytme, mens du tager Fareston.
English: Fareston can be taken with or without food.
Danish: Fareston kan tages sammen med eller uden mad.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1996
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN/ FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14. februar 1996 Dato for seneste fornyelse: 2. februar 2006
English: Although they have theoretically interesting hormonal effects, their concentrations during toremifene treatment are too low to have any major biological importance.
Danish: Skønt de har teoretisk interessante hormonale effekter, er deres koncentration ved toremifen behandling for lav til at udøve nogen biologisk effekt.
English: There are no adequate data from the use of Fareston in pregnant women.
Danish: Der foreligger ikke tilstrækkelig data om brugen af Fareston hos gravide kvinder.
English: It is bound to plasma proteins even more extensively than toremifene, the protein bound fraction being > 99.9%.
Danish: Den er bundet til plasmaproteiner i højere grad end toremifen, idet den proteinbundne fraktion er >99,9 %.
English: The usual dose is one 60 mg tablet taken orally, once daily.
Danish: Den sædvanlige dosis er én 60 mg tablet indtaget oralt, én gang dagligt.
English: If you have missed several doses, please inform your doctor and follow his instructions.
Danish: Hvis du har glemt flere doser, skal du informere din læge og følge lægens instruktioner.
English: About 10% of the administered dose is eliminated via urine as metabolites.
Danish: Ca. 10 % af den indgivne dosis udskilles som metabolitter i urinen.
English: This may be due to the underlying mechanism/estrogenic stimulation (see also section 4.4).
Danish: Dette kan skyldes den underliggende mekanisme/østrogene stimulation (se også pkt
English: Clinical anti-tumour efficacy and serum concentrations have no positive correlation at the recommended daily dose of 60 mg.
Danish: Klinisk antitumoreffekt og serumkoncentrationer har ingen positiv korrelation ved anbefalet daglig dosis på 60 mg.
English: Toremifene has not shown any genotoxicity and has not been found to be carcinogenic in rats.
Danish: Toremifen har ikke vist nogen genotoksicitet og er ikke fundet karcinogent hos rotter.
English: Regarding the 20 mg group, this effect is significant as well, according to ICH guidelines, with upper confidence interval of 10 - 12 ms.
Danish: Med hensyn til gruppen der fik 20 mg, er denne virkning ligeledes signifikant i henhold til ICH guidelines med et øvre konfidensinterval på 10 - 12 msek.
English: The recommended dose is 60 mg daily.
Danish: Den anbefalede dosis er 60 mg dagligt.
English: Toremifene binds extensively (> 99.5%) to serum proteins, mainly to albumin.
Danish: Toremifen er extensivt bundet til serumproteiner (>99,5 %), hovedsageligt til albumin.
English: This is because Fareston can affect your heart by delaying the conduction of electrical signals within your heart (prolongation of QT-interval).
Danish: Dette skyldes, at Fareston kan påvirke dit hjerte ved at forsinke overledningen af de elektriske signaler i dit hjerte (forlængelse af QT-intervallet)
English: Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Danish: Ældre patienter kan ligeledes være mere følsomme for lægemiddelassocierede påvirkninger af QT-intervallet.
English: Fareston is not recommended for patients with estrogen receptor negative tumours.
Danish: Fareston anbefales ikke til patienter med østrogenreceptornegative tumorer.
English: It is also to be noted that the Cmax observed in the monkeys (1800 ng/ml) is two-fold compared to the mean Cmax observed in humans at a daily dose of 60 mg.
Danish: Det skal også bemærkes, at Cmax, som er observeret hos aber (1800 ng/ml) er dobbelt så stor sammenlignet med den gennemsnitlige Cmax, der er set hos mennesker ved en daglig dosis på 60 mg.
English: The dose of some of these may have to be adjusted while you are on Fareston.
Danish: Dosis af noget af denne medicin skal måske reguleres, mens du tager Fareston.
English: The acute toxicity of toremifene is low with LD-50 in rats and mice of more than 2000 mg/kg.
Danish: Toremifens akutte toksicitet er lav, LD-50 er således hos rotter og mus mere end 2000 mg/kg.
English: If you are admitted to the hospital or if you are prescribed a new medicine, please tell your doctor that you are taking Fareston.
Danish: Hvis du bliver indlagt på hospitalet, eller hvis du får ordineret en ny slags medicin, skal du fortælle lægen, at du er i behandling med Fareston.
English: In vivo, high plasma concentrations in monkeys caused a 24% prolongation in QTc, which is in line with QTc findings in humans.
Danish: In vivo medførte høje plasmakoncentrationer hos aber en forlængelse af QTc på 24 %, hvilket er i overensstemmelse med QTc-fund hos mennesker.