FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (more than 1 out of 10 patients): - headache - flushing - swelling, particularly of the ankles and legs
Danish: Meget almindelige (mere end 1 ud af 10 patienter): - hovedpine - rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet.
English: Always take Nifedipine Pharmamatch retard exactly as your doctor has told you.
Danish: Nifedipine Pharmamatch retard bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
English: - The other ingredients are: carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b) and titanium dioxide (E171).
Danish: - De øvrige indholdsstoffer er: Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171).
English: Especially for prolonged-release products (Nifedipine Pharmamatch retard) elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
Danish: Specielt ved depotprodukter (Nifedipine Pharmamatch retard) skal udskillelsen være så komplet som muligt, inkl.
English: How to store Nifedipine Pharmamatch retard Further information
Danish: Hvordan De opbevarer Nifedipine Pharmamatch retard Yderligere oplysninger
English: Nifedipine Pharmamach retard tablets come in a calendar packing of 28 tablets (2 blisters of 14 tablets each).
Danish: Nifedipine Pharmamach retard tabletter leveres i en kalenderpakning med 28 tabletter (2 blisterpakninger med hver 14 tabletter).
English: Bioavailability is approximately
Danish: Biotilgængeligheden er ca. 40-60%.
English: Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b), titanium dioxide (E171)
Danish: Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b), titandioxid (E171)
English: Respiratory, thoracic and mediastinal disorders: - Very rare:
Danish: Lidelser i luftveje, thorax og mediastinum: - Meget sjældne:
English: Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E553b) and titanium dioxide (E171).
Danish: Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171).
English: - if you have a severe narrowing of the gastrointestinal tract.
Danish: - Hvis De har en alvorlig forsnævring i tarmsystemet.
English: angina upon abrupt withdrawal of nifedipine, increased frequency or worsening of angina, aggravation of myocardial ischemia including myocardial infarction, palpitations (tachycardia - accelerated pulse rate), congestive heart failure, hypotension, orthostatic hypotension.
Danish: angina ved pludselig seponering af nifedipin, øget hyppighed eller forværring af angina, aggravation af myokardial iskæmi inkl.
English: If necessary the dosage can be increased according to individual requirements up to a maximum of 90mg once-daily.
Danish: Om nødvendigt kan dosen øges i henhold til det individuelle behov, dog op til maks.
English: muscle cramps.
Danish: Muskelkramper.
English: Reproductive system and breast disorders: - Uncommon:
Danish: Forstyrrelser i reproduktion og lidelser i mammae: - Ualmindelige:
English: Studies in animals have shown reproductive toxicity, consisting of embryotoxicity and teratogenic effects at maternally toxic doses.
Danish: embryotoksicitet og teratogenisk effekt ved maternelt toksiske doser.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG III PRODUKTRESUME
English: Uncommon (more than 1 out of 1.000, but less than 1 out of 100 patients): - heart rhythm disturbances - increased sensitivity, particularly in arms and legs - eye reactions such as eye pain, temporary vision disturbances - finger twitching - fever in the first few days after start of therapy - transient increase in liver enzymes - oesophageal reflux - allergic liver infection - increased blood pressure in the portal vein in patients with alcoholic cirrhosis - degradation of the mucous membrane of the uterus (atrophic endometrium) - reduction in blood flow to the fingers and toes (digital blood flow reduction) in patients with
Danish: - trækninger i fingrene - feber de første par dage efter behandlingens start - forbigående forøgelse af leverenzymer - oesophageal reflux - allergisk leverinfektion - øget blodtryk i portalvenen hos patienter med alkoholinduceret cirrhose - degradering af livmoderens slimhinde (endometriatrofi) - nedsat blodgennemstrømning til fingre og tæer (reduktion af blodgennemstrømningen) hos patienter med Raynaud's syndrom
English: Nifedipine Pharmamatch 60 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Danish: Nifedipine Pharmamatch 60 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter).
English: Nifedipine Pharmamatch 30 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Danish: Nifedipine Pharmamatch 30 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter).
English: Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets contain 30 mg nifedipine per tablet.
Danish: Nifedipine Pharmamatch retard 30 mg, depottabletter indeholder 30 mg nifedipin pr. tablet.
English: Prolonged-release tablets.
Danish: Depottabletter.
English: Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets contain 60 mg nifedipine per tablet.
Danish: Nifedipine Pharmamatch retard 60 mg, depottabletter indeholder 60 mg nifedipin pr. tablet.
English: HOW TO TAKE NIFEDIPINE PHARMAMATCH RETARD
Danish: HVORDAN DE TAGER NIFEDIPINE PHARMAMATCH RETARD
English: - giddiness - light headedness - feeling of pressure in the head.
Danish: hovedpine, svimmelhed, ørhed, følelsen af tryk i hovedet.
English: Blood and lymphatic system disorders: - Very rare:
Danish: Lidelser i blod og lymfe: - Meget sjældne:
English: HOW TO STORE NIFEDIPINE PHARMAMATCH RETARD
Danish: HVORDAN DE OPBEVARER NIFEDIPINE PHARMAMATCH RETARD
English: BEFORE YOU TAKE NIFEDIPINE PHARMAMATCH
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE NIFEDIPINE PHARMAMATCH
English: How to take
Danish: Hvordan De tager lægemidlet
English: 4.2 Posology and method of administration For oral administration.
Danish: 4.2 Dosering og indgivelsesmåde
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine.
Danish: LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin.
English: colouring aid
Danish: FORTEGNELSE OVER HJÆLPESTOFFER
English: It is not known if a pharmacological effect in the infant can occur because of this; however, it is recommended to cease breast feeding as a precautionary measure.
Danish: Der savnes oplysninger om en farmakologisk effekt hos spædbarnet pga. dette.
English: NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine.
Danish: LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin.
English: Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine
Danish: Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin
English: It is not known if this can lead to an effect in the infant.
Danish: Der savnes oplysninger om risiko for det ammende barn.
English: Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine
Danish: Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin
English: 6.5 Nature and contents of container
Danish: 6.5 Emballage
English: Important information about some of the ingredients of Nifedipine Pharmamatch retard
Danish: Vigtige oplysninger om visse af indholdsstofferne i Nifedipine Pharmamatch retard Nifedipine Pharmamatch retard indeholder lactose.
English: The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.
Danish: Dosen kan øges i henhold til det individuelle behov, dog op til maks.
English: General disorders and administration site conditions: - Very common: headache, giddiness, light headedness, feeling of pressure in the head.
Danish: - rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet.
English: Nifedipine Pharmamatch retard contains lactose.
Danish: Nifedipine Pharmamatch retard.
English: RVG 31823 - Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) RVG 31823 - Nifedipine Pharmamatch retard 60 mg, depottabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: ETIKETTERING OG INDLÆGSSEDDEL
English: Cardiovascular disorders: - Very common: peripheral oedema, flushing (facial reddening).
Danish: myokardial infarkt, palpitationer (tachykardia - accelereret puls),
English: The recommended dose is 350 mg once every 3 weeks.
Danish: Den anbefalede dosis er 350 mg én gang hver tredje uge.
English: However, the study involved a small number of patients and additional data are required.
Danish: Studiet omfattede imidlertid et lille antal patienter, og der er behov for yderligere data.
English: Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Danish: Yderligere information om Libtayo findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/libtayo.
English: It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
Danish: Det anvendes hos patienter, der ikke kan gennemgå en operation eller en behandling med stråling for at helbrede deres sygdom.
English: Libtayo has been given ‘conditional authorisation'.
Danish: Libtayo har fået en "betinget godkendelse".
English: As for the medicine's safety, its side effects are manageable and similar to those seen in other cancer treatments of this type.
Danish: Hvad angår lægemidlets sikkerhed, er bivirkningerne håndterbare og svarer til dem, der ses ved andre kræftbehandlinger af denne type.
English: In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Danish: I et hovedstudie, hvori der indgik i alt 193 patienter, blev kræften mindre hos ca. 39 % af de patienter med metastatisk sygdom, som fik 350 mg Libtayo hver 3. uge i ca. et år.
English: The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Danish: Virksomheden vil også undersøge, om lægemidlet virker anderledes, afhængigt af niveauet af PD-L1, som produceres af kræftcellerne.
English: The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Libtayo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: As for all medicines, data on the use of Libtayo are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Libtayo løbende overvåget.
English: Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
Danish: Behandlingen kan fortsætte, så længe sygdommen er stabil, og patienten kan tolerere bivirkningerne.
English: Libtayo contains the active substance cemiplimab.
Danish: Libtayo indeholder det aktive stof cemiplimab.
English: Other information about Libtayo
Danish: Andre oplysninger om Libtayo
English: Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer.
Danish: Behandling med Libtayo skal indledes og overvåges af en læge med erfaring i behandling af kræft.
English: For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Libtayo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Libtayo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Libtayo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Libtayo?
English: Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping Libtayo.
Danish: Libtayo er forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet, og de kan være alvorlige, selv om de fleste bivirkninger ophører efter en passende behandling, eller ved at ophøre med brug af Libtayo.
English: Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Danish: Libtayo gives som en infusion (drop) i en vene i løbet af 30 minutter.
English: Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Danish: Svære reaktioner, herunder Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (livstruende reaktioner med influenzalignende symptomer og smertefuld udsæt, der påvirker huden, munden, øjnene og kønsdelene), er indberettet med Libtayo.
English: Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Danish: Hos patienter med lokalt fremskreden sygdom, som fik Libtayo hver 2. uge (i en dosis på 3 mg/kg legemsvægt) i ca. 2 år, var kræften blevet mindre hos 44 % af dem.
English: What is Libtayo and what is it used for?
Danish: Hvad er Libtayo, og hvad anvendes det til?
English: The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Danish: De mest almindelige immunitetsrelaterede virkninger (som kan forekomme hos op til 1 ud af 10 personer) var hypothyreoidisme (en underaktiv skjoldbruskkirtel med træthed, vægtforøgelse og hud- og hårforandring), pneumonitis (betændelse i lungerne, som forårsager åndenød og hoste), hudreaktioner, hyperthyreoidisme (en overaktiv skjoldbruskkirtel, der kan forårsage hyperaktivitet, svedafsondring, vægttab og tørst) og betændelse i leveren.
English: The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
Danish: Virksomheden, der markedsfører Libtayo, skal udlevere en vejledning og et patientkort til patienterne med oplysninger om tegn og symptomer på immunrelaterede bivirkninger ved lægemidlet samt anvisninger om at kontakte deres læge, hvis de oplever symptomer.
English: An overview of Libtayo and why it is authorised in the EU
Danish: En oversigt over Libtayo, og hvorfor det er godkendt i EU
English: Why is Libtayo authorised in the EU?
Danish: Hvorfor blev Libtayo godkendt i EU?
English: Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Danish: Kræftceller kan producere proteiner (PD-L1 og PD-L2), der binder sig til denne receptor og afbryder T-cellernes aktivitet, så de ikke kan angribe kræften.
English: Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
Danish: Libtayo er et kræftlægemiddel, der anvendes alene til behandling af voksne med hudkræft, kaldet kutant planocellulært karcinom, når kræften er lokalt fremskreden (har spredt sig i nærheden) eller metastatisk (har bredt sig til andre dele af kroppen).
English: Since Libtayo has been given conditional authorisation, the company that markets Libtayo will provide data from an ongoing study on the effectiveness and safety of the medicine for cutaneous squamous cell carcinoma.
Danish: Eftersom Libtayo har fået en betinget godkendelse, vil virksomheden, der markedsfører Libtayo, fremlægge data fra et igangværende studie af lægemidlets virkning og sikkerhed ved behandling af kutant planocellulært karcinom.
English: What information is still awaited for Libtayo?
Danish: Hvilke oplysninger afventes der stadig for Libtayo?
English: The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Danish: Det aktive stof i Libtayo, cemiplimab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til en receptor kaldet PD-1, som findes på bestemte celler i immunsystemet kaldet T-celler.
English: What are the risks associated with Libtayo?
Danish: Hvilke risici er der forbundet med Libtayo?
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at virksomheden er blevet pålagt at fremskaffe mere viden om lægemidlet.
English: For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Libtayo fremgår af indlægssedlen.
English: Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread.
Danish: Libtayo er effektivt til behandling af kutant planocellulært karcinom, en kræftform med få behandlingsmuligheder, når den har spredt sig.
English: Libtayo is effective at treating cutaneous squamous cell carcinoma in many patients.
Danish: Libtayo er effektivt til behandling af kutant planocellulært karcinom hos mange patienter.
English: How does Libtayo work?
Danish: Hvordan virker Libtayo?
English: By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Danish: Ved at binde sig til receptoren forhindrer cemiplimab PD-L1 og PD-L2 i at slukke for T-cellerne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Libtayo.
English: How is Libtayo used?
Danish: Hvordan anvendes Libtayo?
English: What benefits of Libtayo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Libtayo?
English: SERETIDE DISKUS and associated names (See Annex I)
Danish: SERETIDE DISKUS og tilknyttede navne (se bilag I)
English: In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
Danish: I proceduren for gensidig anerkendelse er Sverige referencemedlemsstaten, og Østrig, Belgien, Danmark, Finland, Frankrig, Grækenland, Tyskland, Italien, Irland, Luxembourg, Nederlandene, Portugal, Spanien og Det Forenede Kongerige er de berørte medlemsstater.
English: In several EU Member States Seretide Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
Danish: Seretide Diskus og tilknyttede navne er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: 4 July 2006 EMEA/306065/2006
Danish: 4. juli 2006 EMEA/306065/2006
English: Seretide Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Danish: Seretide Diskus og tilknyttede navne (se bilag I) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, og er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2-agonist.
English: This summary was last updated on 12/04/2011.
Danish: Dette sammendrag blev sidst ajourført den 12/04/2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Veraflox to Bayer Animal Health GmbH on 12/04/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Veraflox til Bayer Animal Health GmbH den 12/04/2011.
English: Do not eat, drink or smoke while handling Veraflox products.
Danish: Der må ikke spises, drikkes eller ryges, mens Veraflox håndteres.
English: Other information about Veraflox:
Danish: Andre oplysninger om Veraflox:
English: The studies showed that Veraflox was at least as effective as the comparator medicines in all indications.
Danish: Undersøgelserne viste, at Veraflox var mindst lige så effektivt som sammenligningslægemidlerne ved alle indikationer.
English: The dose and duration of treatment depend on the species of the animal being treated and its body weight, the nature and severity of the infection, and the animal's response to the treatment.
Danish: Dosis og behandlingens varighed afhænger af, hvilken dyreart der bliver behandlet, dyrets legemsvægt, infektionens type og sværhedsgrad samt af, hvordan dyret reagerer på behandlingen.
English: Veraflox 15 mg tablets can be used in both cats and dogs.
Danish: Veraflox 15-mg-tabletter kan anvendes til både katte og hunde.
English: In case of contact, rinse immediately with plenty of water.
Danish: Hvis en sådan kontakt forekommer, skylles der straks med rigelige mængder vand.