FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4).
Danish: Hver filmovertrukket tablet indeholder 1,2 mg lactosemonohydrat (se pkt.
English: Pack of 50 x 1 film-coated tablet (unit dose).
Danish: Pakning med 50 x 1 filmovertrukne tabletter (enkeltdosispakning).
English: < 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: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Hungary or
Danish: Ungarn eller
English: What you need to know before you take Desloratadine Teva Do not take Desloratadine Teva
Danish: Det skal du vide, før du begynder at tage Desloratadine Teva Tag ikke Desloratadine Teva
English: 50 x 1 film-coated tablet (unit dose) 60 film-coated tablets
Danish: 50 x 1 filmovertrukne tabletter (enkeltdosis-pakning) 60 filmovertrukne tabletter
English: Very rare: the following may affect up to 1 in 10,000 people
Danish: Meget sjælden: følgende kan forekomme hos op til 1 ud af 10.000 personer ● alvorlige allergiske reaktioner ● udslæt
English: 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).
Danish: Der er begrænset erfaring med klinisk virkning ved brug af desloratadin til unge mellem 12 og 17 år (se pkt.
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: EU/1/11/732/013 50 x 1 film-coated tablet (unit dose) EU/1/11/732/014 105 film-coated tablets
Danish: EU/1/11/732/013 50 x 1 filmovertrukket tablet (enhedsdosis) EU/1/11/732/014 105 filmovertrukne tabletter
English: Each film-coated tablet contains 5 mg desloratadine.
Danish: Hver filmovertrukket tablet indeholder 5 mg desloratadin.
English: When Desloratadine Teva should be used
Danish: Hvornår Desloratadin Teva skal bruges
English: If you stop taking Desloratadine Teva
Danish: Hvis du holder op med at tage Desloraradine Teva
English: Desloratadine Teva contains lactose.
Danish: Desloratadine Teva indeholder lactose.
English: Desloratadine Teva 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 Teva er indiceret hos voksne og unge i alderen 12 år og derover til symptomlindring i forbindelse med: - allergisk rhinitis (se pkt.
English: Other medicines and Desloratadine Teva
Danish: Brug af anden medicin sammen med Desloratadine Teva
English: OPA/Alu/PVC - Aluminium perforated unit dose blisters.
Danish: OPA/Alu/pvc-aluminiumenhedsdosisblisterpakninger.
English: If you forget to take Desloratadine Teva
Danish: Hvis du har glemt at bruge Desloratadine Teva
English: Contents of the pack and other information What Desloratadine Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Desloratadine Teva indeholder:
English: Desloratadine Teva 5 mg film-coated tablets Desloratadine
Danish: Desloratadine Teva 5 mg filmovertrukne tabletter Desloratadin
English: As a precautionary measure, it is preferable to avoid the use of Desloratadine Teva 5 mg film-coated tablets during pregnancy.
Danish: For en sikkerheds skyld bør Desloratadine Teva 5 mg filmovertrukne tabletter undgås under graviditet.
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: Desloratadine Teva 5 mg film-coated tablets
Danish: Desloratadine Teva 5 mg filmovertrukne tabletter
English: ● pounding or irregular heartbeat
Danish: ● mavesmerter uregelmæssig hjerterytme
English: Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine Teva 5 mg film-coated tablets is one tablet once a day.
Danish: Den anbefalede dosis af Desloratadine Teva 5 mg filmovertrukne tabletter er en tablet en gang daglig.
English: Desloratadine Teva contains lactose
Danish: Desloratadine Teva indeholder lactose
English: In the case of severe renal insufficiency, Desloratadine Teva 5 mg film-coated tablets should be used with caution (see section 5.2).
Danish: Desloratadine Teva 5 mg filmovertrukne tabletter bør anvendes med forsigtighed til patienter med svær nyreinsufficiens (se pkt.
English: Desloratadine Teva 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 Teva anvendes også til at lindre symptomerne i forbindelse med nældefeber (en hudlidelse forårsaget af allergi) hos voksne og unge i alderen 12 år og derover.
English: 105 film-coated tablets
Danish: 105 filmovertrukne tabletter
English: What Desloratadine Teva is and what it is used for What Desloratadine Teva is
Danish: Virkning og anvendelse Hvad Desloratadine Teva er
English: ● fast heartbeat
Danish: ● langsomme hjerteslag
English: 21 film-coated tablets
Danish: 21 filmovertrukne tabletter
English: How to take Desloratadine Teva
Danish: Sådan skal du tage Desloratadine Teva
English: Talk to your doctor or pharmacist before taking Desloratadine Teva
Danish: Men kontakt straks lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager flere Desloratadine Teva, end du har fået besked på.
English: EU/1/11/732/011 90 film-coated tablets
Danish: EU/1/11/732/011 90 filmovertrukne tabletter
English: How Desloratadine Teva works
Danish: Sådan virker Desloratadine Teva
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom or
Danish: East Sussex, BN22 9AG Storbritannien eller
English: ● upset stomach
Danish: ● mavebesvær
English: EU/1/11/732/012 100 film-coated tablets
Danish: EU/1/11/732/012 100 filmovertrukne tabletter
English: EU/1/11/732/010 60 film-coated tablets
Danish: EU/1/11/732/010 60 filmovertrukne tabletter
English: Printing ink
Danish: Trykfarve:
English: EU/1/11/732/006 28 film-coated tablets
Danish: EU/1/11/732/006 28 filmovertrukne tabletter
English: What Desloratadine Teva is and what it is used for What you need to know before you take Desloratadine Teva How to take Desloratadine Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Desloratadine Teva Sådan skal du tage Desloratadine Teva Bivirkninger
English: EU/1/11/732/007 30 film-coated tablets
Danish: EU/1/11/732/007 30 filmovertrukne tabletter
English: EU/1/11/732/008 40 film-coated tablets
Danish: EU/1/11/732/008 40 filmovertrukne tabletter
English: EU/1/11/732/009 50 film-coated tablets
Danish: EU/1/11/732/009 50 filmovertrukne tabletter
English: EU/1/11/732/004 20 film-coated tablets
Danish: EU/1/11/732/004 20 filmovertrukne tabletter
English: Desloratadine Teva is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Danish: Desloratadine Teva lindrer symptomer forbundet med allergisk snue (inflammation af næsepassager forårsaget af allergi, for eksempel høfeber eller støvmideallergi).
English: EU/1/11/732/002 10 film-coated tablets
Danish: EU/1/11/732/002 10 filmovertrukne tabletter
English: EU/1/11/732/005 21 film-coated tablets
Danish: EU/1/11/732/005 21 filmovertrukne tabletter
English: EU/1/11/732/003 14 film-coated tablets
Danish: EU/1/11/732/003 14 filmovertrukne tabletter
English: Silica colloidal anhydrous
Danish: Kolloid vandfri silica.
English: EU/1/11/732/001 7 film-coated tablets
Danish: EU/1/11/732/001 7 filmovertrukne tabletter
English: D.
Danish: SN:
English: Gastrointestinal disorders
Danish: ● unormale prøver for leverfunktion
English: DK-7171 Uldum Denmark
Danish: DK-7171 Uldum Danmark
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (European Medicines Agency) http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (European Medicines Agency) http://www.ema.europa.eu/.
English: Dispose of in accordance with local requirements.
Danish: Kasseres i overensstemmelse med de lokale bestemmelser.
English: More than 97% of meloxicam is bound to plasma proteins.
Danish: Mere end 97% af meloxicam er bundet til plasmaproteiner.
English: Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Danish: Ca. 75% af den indgivne dosis elimineres via fæces og den resterende del med urinen.
English: Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Flexicam må ikke gives samtidig med andre NSAID-præparater eller glucocortikosteroider.
English: Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip-off aluminium violet seal.
Danish: Farveløse hætteglas à 10 ml, lukket med en grå EPDM gummiprop og forseglet med en violet flip-af
English: Flexicam 5 mg/ml solution for injection for dogs and cats
Danish: Flexicam 5 mg/ml injektionsvæske, opløsning til hund og kat
English: Do not use after the expiry date stated on the carton and the vial after EXP. Shelf-life after first opening the container: 28 days.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken og flasken efter EXP. Opbevaringstid efter første åbning af beholderen: 28 dage.
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Danish: Efter subkutan administration er meloxicam fuldstændigt biotilgængeligt, og maksimale gennemsnitlige plasmakoncentrationer på 0,73 g/ml hos hunde og 1,1 g/ml hos katte opnåedes henholdsvis ca. 2,5 og 1,5 time efter administration.
English: 1 ml of solution for injection contains 5 mg of meloxicam.
Danish: 1 ml injektionsvæske indeholder 5 mg/ml meloxicam.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller
English: MARKETING AUTHORISATION NUMBER
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER
English: To be supplied only on veterinary prescription.
Danish: Kun til dyr- må kun udleveres efter veterinærrecept.
English: The safety of the veterinary medicinal product has not been established during pregnancy and
Danish: Veterinærlægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider
English: Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Danish: Hund: Lindring af betændelse og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
Danish: Undgå behandling af dehydrerede, hypovolæmiske eller hypotensive dyr, idet der foreligger en potentiel risiko for toksisk påvirkning af
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
Danish: INDEHAVERE AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR
English: Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Danish: Reduktion af post-operative smerter (over en periode på 24 timer): enkelt intravenøs eller subkutan injektion før indgrebet, for eksempel ved indledning af anæstesi.
English: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Danish: Reduktion af post-operative smerter efter ovariehysterektomi og mindre omfattende bløddelskirurgi: enkelt subkutan injektion af en dosis før indgrebet, for eksempel ved indledning af anæstesi.
English: Pack sizes: Single 10 ml injection vial.
Danish: Pakningsstørrelser: 10 ml hætteglas.
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Danish: Typiske NSAID-bivirkninger så som appetitløshed, opkastning, diarré, fækal okkult blødning og apati er af og til set.
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
Danish: Der er kun dokumenteret sikkerhed for post-operativ smertelindring hos katte efter anæstesi med thiopental/halothan.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
Danish: A. INDEHAVERE AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Danish: Der er kun dokumenteret sikkerhed for post-operativ smertelindring hos katte efter anæstesi med
English: When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Danish: Svækkelse af nyrefunktionen kan ikke udelukkes ved samtidig administration af
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glybera on 25 October 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Glybera den 25. oktober 2012.
English: Patients must also not use oral contraceptives.
Danish: Patienterne må heller ikke bruge oral svangerskabsforebyggelse.
English: The amount of the medicine to inject and the number of injections depend on the patient's weight.
Danish: Den injicerede mængde af lægemidlet og antallet af injektioner afhænger af patientens vægt.
English: This is a summary of the European public assessment report (EPAR) for Glybera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Glybera.
English: Patients will also be provided with a patient alert card.
Danish: Patienterne vil desuden få udleveret et patientinformationskort.
English: The CHMP therefore recommended that the medicine be granted marketing authorisation.
Danish: CHMP anbefalede derfor udstedelse af markedsføringstilladelse.
English: This is a type of medicine that works by delivering genes into the body.
Danish: Denne type lægemiddel virker ved at tilføre gener til kroppen.
English: Glybera alipogene tiparvovec
Danish: Glybera alipogentiparvovec
English: Other information about Glybera
Danish: Andre oplysninger om Glybera
English: The majority of patients who received Glybera also received immunosuppressive treatment.
Danish: Størstedelen af de patienter, der fik Glybera, fik desuden immunundertrykkende behandling.
English: The medicine will only be supplied to doctors who have received the appropriate educational materials and will only be used to treat patients participating in the registry.
Danish: Lægemidlet må kun udleveres til læger, der har fået passende oplysningsmateriale, og må kun anvendes til behandling af patienter, der er optaget i registret.
English: This is a subgroup of severely affected patients with a high unmet medical need.
Danish: Der er tale om en undergruppe af svært ramte patienter med et stort uopfyldt behandlingsbehov.
English: One patient was diagnosed with pulmonary embolism (clots in blood vessels supplying the lungs) seven weeks after treatment.
Danish: Én patient fik diagnosen lungeemboli (blodpropper i de kar, der forsyner lungerne) syv uger efter behandlingen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glybera.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Glybera skal anvendes.
English: Because the number of patients with lipoprotein lipase deficiency is low, the disease is considered ‘rare', and Glybera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 March 2004.
Danish: Da antallet af patienter med lipoproteinlipase-mangel er lavt, betragtes sygdommen som "sjælden", og Glybera blev udpeget som "lægemiddel til sjældne sygdomme" den 8. marts 2004.
English: A risk management plan has been developed to ensure that Glybera is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Glybera anvendes så sikkert som muligt.
English: The most common side effect reported with Glybera was pain in the legs following the injections, which occurred in a third of patients.
Danish: Den hyppigste bivirkning, der blev indberettet med Glybera, var smerter i benene efter injektionerne, hvilket forekom hos en tredjedel af patienterne.
English: Given the small number of patients treated, these side effects do not provide a complete picture of the frequency and nature of the side effects of Glybera.
Danish: På baggrund af det lille antal behandlede patienter giver disse bivirkninger ikke et fuldstændigt billede af hyppigheden og arten af bivirkningerne af Glybera.
English: Glybera has been authorised under ‘exceptional circumstances' as it has not been possible to obtain complete information about the medicine, because of the rarity of the disease.
Danish: Glybera er godkendt under "særlige omstændigheder" da det som følge af sygdommens sjældenhed ikke har været muligt at undersøge lægemidlet fuldstændigt.
English: The full EPAR for Glybera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Glybera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, the company has put in place a restricted access programme to ensure that Glybera is used appropriately when the diagnosis is confirmed.
Danish: Ydermere har virksomheden iværksat et program for begrænset adgang for at sikre, at Glybera anvendes korrekt, når diagnosen er bekræftet.
English: For three days before Glybera treatment and for twelve weeks after, patients are given immunosuppressive treatment to reduce the reaction of the body's immune system against the medicine.
Danish: I tre dage før behandlingen med Glybera og i tolv dage efter behandlingen gives immunundertrykkende behandling for at dæmpe immunsystemets reaktion mod lægemidlet.
English: The modified viral material used in Glybera does not cause infections and cannot make copies of itself.
Danish: Det modificerede virusmateriale, der anvendes i Glybera, kan ikke give infektioner og kan ikke formere sig.
English: Glybera is a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Glybera er et lægemiddel til avanceret terapi, som kaldes et "genterapiprodukt".
English: What measures are being taken to ensure the safe and effective use of Glybera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Glybera?
English: Under the terms of the authorisation, the company is required to provide further data on fat levels in the blood after meals and on the immune response to Glybera in new patients.
Danish: I henhold til vilkårene for godkendelsen skal virksomheden forelægge yderligere data om fedtindholdet i blodet efter måltiderne og om immunresponsen på Glybera hos nye patienter.
English: For more information about treatment with Glybera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Glybera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Anticoagulant medicines, which can increase bleeding, must not be used from the week before Glybera treatment to one day after.
Danish: Blodfortyndende (antikoagulerende) lægemidler kan øge blødningstendensen og må ikke anvendes i tidsrummet fra én uge før behandlingen med Glybera til én dag efter behandlingen.
English: Other common side effects reported include headache, tiredness, hyperthermia (high body temperature), contusion (bruising) and increased levels of the enzyme creatine kinase in the blood (a measure of damage to muscle tissue).
Danish: Andre almindelige indberettede bivirkninger er hovedpine, træthed, hypertermi (høj kropstemperatur), blå mærker (kontusioner) og et forhøjet niveau af enzymet kreatininkinase i blodet (en markør for muskelskader).
English: After careful consideration of all the evidence and the circumstances of the disease, including its extreme rarity, the CHMP concluded that the results from studies showed that the benefits of Glybera outweigh its risks in patients with severe or multiple pancreatitis attacks despite following a low-fat diet.
Danish: Efter nøje gennemgang af al dokumentationen og omstændighederne omkring sygdommen, herunder dens ekstreme sjældenhed, konkluderede CHMP, at undersøgelserne viste, at fordelene ved Glybera er større end risiciene hos patienter, der får svære eller gentagne anfald af pankreatitis, uanset at de følger en fedtfattig diæt.
English: Glybera is a medicine that contains the active substance alipogene tiparvovec.
Danish: Glybera er et lægemiddel, der indeholder det aktive stof alipogentiparvovec.
English: There was also a reduction in the number of pancreatitis attacks in some patients, as well as fewer hospital admissions and stays in intensive care units.
Danish: Desuden var der færre anfald af pankreatitis hos nogle af patienterne og færre indlæggelser og ophold på intensivafdelinger.
English: Patients with this disease need to be on a strict low-fat diet and are prone to recurring attacks of pancreatitis, which is a severe and life-threatening complication.
Danish: Patienter med sygdommen er nødt til at følge en streng fedtfattig diæt og har tendens til gentagne anfald af pankreatitis, som er en svær og livstruende komplikation.
English: When injected into the muscles, it corrects the lipoprotein lipase deficiency by enabling the muscle cells to produce the enzyme.
Danish: Når det injiceres i musklerne, korrigerer det lipoproteinlipase-manglen ved at sætte muskelcellerne i stand til at producere enzymet.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Glybera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Glybera findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.