FrancophonIA/ELRC3.0 huggingface dataset:
English: Adlumiz was expected to be used to treat anorexia (loss of appetite), cachexia (a form of muscle wasting with significant weight loss) or unintended weight loss in patients with a type of lung cancer called non-small cell lung cancer.
Danish: Adlumiz skulle anvendes til behandling af anoreksi (appetitløshed), kakeksi (muskelsvækkelse og ekstrem afmagring) eller uønsket vægttab hos patienter med såkaldt ikke-småcellet lungekræft.
English: Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) EMA/599030/2017
Danish: EMA/599030/2017
English: 7 ml (50 mg/ml) 1 vial
Danish: Hætteglas 7 ml (50 mg/ml) 1 hætteglas
English: EU/1/19/1376/001
Danish: EU/1/19/1376/001 LIBTAYO 350 mg Infusionsvæske, koncentrat til opløsning
English: The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain.
Danish: Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Estland, Grækenland, Portugal og Spanien.
English: London, 22 August 2007 EMEA/CHMP/248862/2007
Danish: London, den 22. august 2007 EMEA/CHMP/248862/2007
English: Cefuroximaxetil and associated names
Danish: Cefuroximaxetil og tilknyttede navne
English: Spain referred the reasons for disagreement to the EMEA on 25 September 2006.
Danish: Spanien fremsendte begrundelserne for uenigheden til EMEA den 25. september 2006.
English: The repeat-use Mutual Recognition Procedure started on 17 May 2006.
Danish: Gentagen brug af den gensidige anerkendelsesprocedure indledtes den 17. maj 2006.
English: The arbitration procedure started on 18 October 2006 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 18. oktober 2006 med vedtagelsen af en liste med spørgsmål.
English: An opinion was adopted by consensus on 26 April 2007.
Danish: Der blev vedtaget en udtalelse ved konsensus den 26. april 2007.
English: The final opinion was converted into a Decision by the European Commission on 22 August 2007.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 22. august 2007.
English: The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas.
Danish: Rapportøren var dr. Frits Lekkerkerker, og medrapportøren var dr. Gonzalo Calvo Rojas.
English: The Marketing Authorisation Holder provided written explanations on 15 January 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. januar 2007.
English: Significant difference was identified with regard to the indication “uncomplicated gonorrhoea: urethritis and cervicitis”.
Danish: Der blev identificeret betydelige forskelle med hensyn til indikationen “ukompliceret gonorré: uretritis og cervicitis”.
English: During their April 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections raised by Spain could be agreed and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På mødet i april 2007 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at de indsigelser, der var rejst af Spanien, kunne godkendes, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel skulle ændres.
English: International Non-Proprietary Name (INN): cefuroxime (as axetil)
Danish: Internationalt fællesnavn (INN): cefuroxim (som axetil)
English: This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and riskbenefit balance for this sought indication and this was considered to be a serious public health concern.
Danish: Dette vedrører sikkerheden og virkningen af cefuroximaxetil ved ukompliceret gonorré og risk/benefit-forholdet for den ansøgte indikation, hvilket blev anset for at udgøre et alvorligt problem for folkesundheden.
English: Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments.
Danish: De eksisterende markedsføringstilladelser skulle ændres, og ikke-færdigbehandlede ansøgninger om markedsføringstilladelse skulle godkendes med disse ændringer.
English: - upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis - acute bronchitis, acute exacerbations of chronic bronchitis - lower uncomplicated urinary tract infections: cystitis - skin and soft tissue infections: furunculosis, pyoderma and impetigo - uncomplicated gonorrhoea: urethritis and cervicitis - treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age.
Danish: - øvre luftvejsinfektioner: akut otitis media, sinusitis, tonsillitis og pharyngitis - akut bronkitis, akutte eksacerbationer af kronisk bronkitis - ukomplicerede urinvejsinfektioner: cystitis - hud- og bløddelsinfektioner: furunkulose, pyoderma og impetigo - ukompliceret gonorré: uretritis og cervicitis - behandling af tidlige stadier af Lyme-sygdom (stadium I) og efterfølgende forebyggelse af sene komplikationer hos voksne og børn over 12 år.
English: Sandoz B.V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004.
Danish: indgav ansøgninger om gensidig anerkendelse af Cefuroximaxetil og tilknyttede navne, 125 mg, 250 mg og 500 mg overtrukne tabletter, på grundlag af den markedsføringstilladelse, som Nederlandene udstedte den 1. oktober 2004.
English: Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin (βlactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
Danish: Cefuroximaxetil og tilknyttede navne, 125 mg, 250 mg og 500 mg overtrukne tabletter, er et cephalosporin (gruppen af β-lactam-antibiotika), indiceret til behandling af lette til moderate/svære infektioner, som skyldes mikroorganismer, der er følsomme over for cefuroxim, f.eks.:
English: This might happen:
Danish: Dette kan ske:
English: This soon goes away.
Danish: Dette forsvinder hurtigt.
English: Follow their advice carefully.
Danish: Følg deres instruktioner nøje.
English: This medicine is prescribed for you personally and you should not pass it on to others.
Danish: Dette lægemiddel er ordineret til Dem personligt, og De bør ikke give det videre til andre.
English: • If you eat too little or miss a meal
Danish: • Hvis De spiser for lidt eller springer et måltid over
English: Dosage is individual and determined by the physician in accordance with the needs of the patient.
Danish: Dosering er individuel og bestemmes af lægen i overensstemmelse med patientens behov.
English: Trials have indicated a t½ of about 13-15 hours.
Danish: Forsøg har indikeret en t½ på ca. 13 - 15 timer.
English: This leaflet is a general guide.
Danish: Denne indlægsseddel er en generel vejledning.
English: Methyl parahydroxybenzoate
Danish: Methylparahydroxybenzoat Natriumacetat
English: The advisability of driving should be considered in these circumstances.
Danish: Det bør overvejes, om bilkørsel er tilrådeligt under disse omstændigheder.
English: • An infection or a fever
Danish: • Hvis De har en infektion eller har feber
English: However, the Ultratard dosage may need to be adjusted.
Danish: Imidlertid skal Ultratard-dosis måske justeres.
English: Treatment of diabetes mellitus.
Danish: Behandling af diabetes mellitus.
English: After first opening: 6 weeks.
Danish: Efter ibrugtagning: 6 uger.
English: Vision problems.
Danish: Synsproblemer.
English: MARKETING AUTHORISATION NUMBERS EU/0/00/000/000
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/0/00/000/000
English: Signs of allergy.
Danish: Symptomer på allergi.
English: Like all medicines, Ultratard can have side effects.
Danish: Som alle andre lægemidler kan Ultratard have bivirkninger.
English: Read all of this leaflet carefully before you start using your insulin.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden De begynder at anvende Deres insulin.
English: Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Danish: Glukose skal også gives intravenøst, hvis patienten ikke responderer på glukagon inden for 10 - 15 minutter.
English: Changes at the injection site.
Danish: Forandringer på injektionsstedet.
English: The listings below are all based on post-marketing experience and is subject to underreporting and should be interpreted in that light.
Danish: Nedenstående liste er baseret på post-marketing erfaring og repræsenterer en underrapportering og bør fortolkes under hensyntagen hertil.
English: If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Danish: Hvis De ikke reagerer på glukagonbehandlingen, skal De behandles på hospitalet.
English: Common side effects (up to 10%)
Danish: Almindelige bivirkninger (op til 10%)
English: From clinical investigations it is known that major hypoglycaemia, defined as need for assistance in treatment, occurs in approximately 20% of well-controlled patients.
Danish: Kliniske undersøgelser viser, at svær hypoglykæmi, defineret som behov for hjælp under behandlingen, optræder hos ca. 20% af velkontrollerede patienter.
English: Rare side effects (up to 0.1%)
Danish: Sjældne bivirkninger (op til 0,1%)
English: Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
Danish: Justering af dosis kan også blive nødvendig, hvis patienter ændrer fysisk aktivitet eller deres kost.
English: If an adjustment is needed when switching the patients to Ultratard, it may occur with the first dose or during the first several weeks or months.
Danish: Hvis en justering er nødvendig ved skift til Ultratard, kan det vise sig ved første dosis eller inden for de første adskillige uger eller måneder.
English: These reactions are usually transitory and normally they disappear during continued treatment.
Danish: Disse reaktioner er for det meste forbigående og forsvinder normalt ved fortsat behandling.
English: Generalised hypersensitivity reactions are potentially life threatening.
Danish: Generelle overfølsomhedsreaktioner kan være livstruende.
English: The physician must therefore take possible interactions into account and should always ask their patients about any medicinal products they take.
Danish: Lægen bør derfor altid overveje mulige interaktioner og altid spørge sine patienter, om de anvender andre lægemidler.
English: Pharmacotherapeutic group: antidiabetic agent ATC code: A10A E01.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika.ATC-kode: A10A E01.
English: This means that it will start to lower your blood sugar about 4 hours after you take it, and the effect will last for approximately 28 hours.
Danish: Det betyder, at det begynder at nedsætte blodsukkeret ca. 4 timer efter injektion, og at virkningen holder i ca. 28 timer.
English: These symptoms are usually of transitory nature.
Danish: Disse symptomer er normalt af forbigående karakter.
English: Onset of action is within 4 hours, reaches a maximum effect within 8-24 hours and the entire time of duration is approximately 28-32 hours.
Danish: Virkningen indtræder inden for 4 timer, maksimal virkning opnås 8 - 24 timer senere, og virkningsvarigheden er ca. 28 - 32 timer.
English: • Having forgotten to take your insulin
Danish: • Hvis De har glemt at tage Deres insulin
English: • Repeatedly taking less insulin than you need
Danish: • Hvis De gentagne gange tager mindre insulin, end De har brug for
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Insulin human, rDNA (fremstillet ved rekombinant DNA-teknologi i Saccharomyces cerevisiae).
English: If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or pharmacist.
Danish: Hvis De bemærker nogen form for bivirkninger, også selv om de ikke er nævnt i denne indlægsseddel, bør De oplyse Deres læge eller apotek herom.
English: Do not use Ultratard after the expiry date stated on the label and the carton.
Danish: Ultratard må ikke anvendes efter den udløbsdato, der er angivet på etiketten og kartonen.
English: You should always measure your blood glucose regularly.
Danish: De bør måle blodsukkeret jævnligt.
English: • If you take too much insulin
Danish: • Hvis De tager for meget insulin
English: The pharmacokinetics of insulins is therefore affected by significant intra- and inter-individual variation.
Danish: Insulins farmakokinetiske egenskaber påvirkes derfor af betydelige intra- og interpatient variationer.
English: During use: use within 6 weeks
Danish: Når præparatet er taget i brug: bruges inden 6 uger
English: Alcohol may intensify and prolong the hypoglycaemic effect of insulin.
Danish: Alkohol kan intensivere og forlænge den hypoglykæmiske effekt af insulin.
English: Ultratard contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Danish: Ultratard indeholder methylparahydroxybenzoat, som kan forårsage allergiske reaktioner (eventuelt forsinkede).
English: 6.6 Instructions for use and handling
Danish: 6.6 Instruktioner vedrørende anvendelse og håndtering
English: If you have further questions, please ask your doctor, diabetes nurse or pharmacist.
Danish: Hvis De har yderligere spørgsmål bedes De kontakte Deres læge, diabetessygeplejerske eller apotek.
English: Blood glucose monitoring is therefore recommended.
Danish: Det anbefales derfor at monitorere blodglukose.
English: The maximum plasma concentration of the insulins is reached within 2-18 hours after subcutaneous administration.
Danish: Absorption Maksimal plasmakoncentration for insulintyperne opnås 2 - 18 timer efter subkutan administration.
English: Insulin preparations, which have been frozen, must not be used.
Danish: Insulinpræparater, som har været frosne, må ikke anvendes.
English: See also the warning in 2 Before you use Ultratard.
Danish: Se også advarslen i 2 Hvad De skal gøre, før De begynder at tage Ultratard.
English: Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Danish: En konsekvens af dette er, at tidsaktionsprofilen for et insulinpræparat bestemmes udelukkende ved dets absorptionskarakteristika.
English: Usually the first symptoms of hyperglycaemia set in gradually, over a period of hours or days.
Danish: De første symptomer på hyperglykæmi kommer normalt gradvist over en periode på timer eller dage.
English: Protect from excessive heat and sunlight.
Danish: Beskyttes mod direkte varme og sollys.
English: The active substance is insulin human made by recombinant biotechnology.
Danish: Det aktive stof er humant insulin fremstillet ved rekombinant bioteknologi.
English: Use the injection technique advised by your doctor or diabetes nurse
Danish: Anvend den injektionsteknik, Deres læge eller diabetessygeplejerske har anbefalet
English: It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice.
Danish: Det anbefales derfor, at diabetespatienten konstant bærer nogle sukkerknalder, slik, småkager eller sukkerholdig frugtjuice på sig.
English: You may have a very rare serious allergic reaction to Ultratard or one of its ingredients (called a systemic allergic reaction).
Danish: De kan have fået en meget sjælden, alvorlig allergisk reaktion på Ultratard eller et af de øvrige indholdsstoffer (også kaldet systemisk allergisk reaktion).
English: The following substances may reduce insulin requirement:
Danish: Følgende lægemidler kan reducere behovet for insulin:
English: Always mix fast acting and long acting insulin in this order.
Danish: Bland altid hurtigtvirkende og langtidsvirkende insulin i denne rækkefølge.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Danish: Patienter bør informeres om at tage forholdsregler for at undgå hypoglykæmi, når de kører bil.
English: In order to be able to take action immediately, patients should carry glucose with them at all times.
Danish: For at kunne reagere hurtigt bør patienter altid medbringe glukose.
English: Based on post-marketing experience adverse drug reactions including hypoglycaemia have been reported rarely (>1/10,000 <1/1,000).
Danish: Post-marketing erfaring viser, at bivirkninger, herunder hypoglykæmi, er rapporteret i sjældne tilfælde (>1/10.000<1/1.000).
English: A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Danish: Nogle få patienter, som har oplevet hypoglykæmiske reaktioner efter skift fra animalsk insulin, har rapporteret, at de tidlige advarselssymptomer på hypoglykæmi var mindre udtalte eller forskellige fra dem, som de havde oplevet med deres tidligere insulin.
English: Metabolism and nutrition disorders
Danish: Metabolisme- og ernæringsforstyrrelser
English: The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg.
Danish: Gennemsnitsområdet for totalt dagligt insulinbehov for type 1 diabetikere i vedligeholdelsesbehandling ligger mellem 0,5 og 1,0 IE/kg.
English: After delivery, insulin requirements return rapidly to pre-pregnancy values.
Danish: Efter fødslen vil insulinbehovet hurtigt vende tilbage til før-graviditetsbehov.
English: In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals.
Danish: Ved intensiv insulinbehandling kan suspensionerne anvendes som basal insulin (injektion aften og/eller morgen) med hurtigtvirkende insulin til måltiderne.
English: You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Danish: De kan genvinde bevidstheden hurtigere, hvis De får en injektion af hormonet glukagon af en person, der er instrueret i, hvordan det anvendes.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Novo Nordisk A/S
English: Do not use Ultratard ► If the protective cap is loose or missing.
Danish: De bør ikke anvende Ultratard ► Hvis beskyttelseskapslen er løs eller mangler.
English: Using glucagon
Danish: Anvendelse af glukagon
English: Some people are allergic to the ingredient methyl parahydroxy benzoate.
Danish: Nogle mennesker er allergiske over for indholdsstoffet methylparahydroxybenzoat.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Prækliniske data viste ingen særlig risiko for mennesker baseret på konventionelle studier af farmakologisk sikkerhed, gentagen dosis-toxicitet, genotoxicitet, karcinogent potentiale, reproduktionstoxicitet.
English: These may be signs of a very serious condition called diabetic ketoacidosis.
Danish: Disse symptomer kan betyde, at De har en alvorlig tilstand kaldet diabetisk ketoacidose.
English: Intensified control in the treatment of pregnant women with diabetes is therefore recommended throughout pregnancy and when contemplating pregnancy.
Danish: Intensiveret kontrol anbefales derfor i hele forløbet af graviditeten, og hvis graviditet påtænkes.
English: • Check you have the right dose
Danish: • Kontrollér, at dosis er korrekt
English: After an injection of glucagon, the patient should be monitored in a hospital in order to find the reason for this severe hypoglycaemia and prevent other similar episodes.
Danish: Efter en glukagoninjektion bør patienten monitoreres på hospital for at finde årsagen til den svære hypoglykæmi og forhindre lignende episoder.
English: Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4 Special warnings and special precautions for use).
Danish: Dosisjustering kan også blive nødvendig, hvis patienter skifter fra et insulinpræparat til et andet (se 4.4, Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.
Danish: Når De påbegynder insulinbehandling, kan De opleve synsforstyrrelser, men denne reaktion forsvinder normalt.
English: Ultratard is for injection under the skin (subcutaneously).
Danish: Ultratard er beregnet til injektion under huden (subkutant).
English: In pre-pubertal children it usually varies from 0.7to 1.0 IU/kg.
Danish: Hos præpubertale børn vil det ofte variere mellem 0,7 og 1,0 IE/kg.
English: Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
Danish: Initialdosis for type 2 diabetikere er ofte lavere, f.eks. 0,3 - 0,6 IE/kg/dag.
English: Never inject your insulin directly into a vein or muscle.
Danish: Insulin må aldrig injiceres direkte i en vene eller muskel.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Danish: • Svær hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glukagon (0,5 - 1 mg) indgivet intramuskulært eller subkutant af en instrueret person eller med glukose indgivet intravenøst af en medicinsk uddannet person.
English: • Inject the insulin under the skin.
Danish: • Injicér insulinet under huden.
English: Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement.
Danish: Dosisjustering Anden sygdom, især infektioner og tilstande med feber, vil normalt øge patientens insulinbehov.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: • Mild hypoglykæmi kan behandles med oral indtagelse af glukose eller sukkerholdige produkter.
English: Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), species (animal, human or analogue insulin) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a change in dosage.
Danish: Ændringer i styrke, mærke (fremstiller), type (hurtigtvirkende, bifasisk, langtidsvirkende insulin osv.), art (animalsk insulin, humant insulin eller insulinanalog) og/eller fremstillingsmetode (rekombinant DNA i modsætning til insulin af animalsk oprindelse) kan medføre et behov for ændring af dosis.
English: The suspension consists of crystalline particles.
Danish: Suspensionen indeholder krystallinske partikler.
English: Change in blood glucose
Danish: Ændringer i blodglukose
English: The suspension for injection comes as a white, cloudy suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).
Danish: Injektionsvæske, suspension leveres som en hvid, uklar suspension i pakninger med 1 eller 5 hætteglas a 10 ml (ikke alle pakningsstørrelser er nødvendigvis markedsført).
English: Octreotide/lanreotide may both decrease and increase insulin requirement.
Danish: Octreotid/lanreotid kan både reducere og forøge insulinbehovet.
English: Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.
Danish: Insulinsuspensioner bør ikke anvendes, medmindre de er ensartet hvide og uklare efter opblanding.