FrancophonIA/ELRC3.0 huggingface dataset:
English: Vomiting a,am
Danish: Svimmelhed a,am
English: Rasilamlo 300 mg/5 mg tablets
Danish: Rasilamlo 300 mg/5 mg tabletter Aliskiren/amlodipin
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.
English: Your doctor may need to change your dose and/or take other precautions if you are taking one of
Danish: Det kan være nødvendigt at din læge ændrer din dosis og/eller tager andre forholdsregler, hvis du bruger et af følgende lægemidler: - furosemid eller torasemid, er medicin, der tilhører gruppen kaldet diuretika og som bruges til at øge mængden af den urin, du producerer.
English: micturition disorder
Danish: Nedsat nyrefunktion
English: Rasilamlo 150 mg/5 mg tablets
Danish: Rasilamlo 150 mg/5 mg tabletter Aliskiren/amlodipin
English: What Rasilamlo looks like and contents of the pack Rasilamlo 150 mg/5 mg film-coated tablets are light yellow, convex, oval film-coated tablets, with “T2” debossed on one side and “NVR” on the other.
Danish: Rasilamlo 150 mg/5 mg filmovertrukne tabletter er lysegule, udadbuede, ovale filmovertrukne tabletter præget med ”T2” på den ene side og ”NVR” på den anden side.
English: Content (concentration)
Danish: Indhold (Koncentratio)
English: 40 mg Powder for solution for injection
Danish: 40 mg Pulver til injektionsvæske, opløsning
English: 40 mg
Danish: 40 mg hætteglas
English: It should be given up to 15 minutes before or just after a meal.
Danish: Apidra bør gives op til 15 minutter inden eller lige efter et måltid.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@ema.europa.eu http://www.ema.europa.eu
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: The European Commission granted a marketing authorisation valid throughout the European Union for Apidra to Sanofi-Aventis Deutschland GmbH on 27 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Apidra til Sanofi-Aventis Deutschland GmbH den 27. september 2004.
English: It must not be used in patients who already have hypoglycaemia.
Danish: Det må ikke anvendes hos patienter, der allerede har hypoglykæmi.
English: However, there was not enough information to show whether Apidra was effective in children aged below six years.
Danish: Der forelå dog ikke tilstrækkelige oplysninger til at påvise, om Apidra var effektivt hos børn under seks år.
English: Other information about Apidra:
Danish: Andre oplysninger om Apidra:
English: Apidra can also be injected into a vein, but this can only be done by a doctor or nurse.
Danish: Apidra kan også injiceres i en vene, men dette må kun foretages af en læge eller sygeplejerske.
English: Patients can inject Apidra under the skin themselves.
Danish: Patienten kan selv injicere Apidra under huden.
English: Apidra insulin glulisine EPAR summary for the public
Danish: Apidra insulin glulisin EPAR - sammendrag for offentligheden
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Apidra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at fordelene ved Apidra opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The full EPAR for Apidra can be found here.
Danish: Den fuldstændige EPAR for Apidra findes her.
English: The patient's blood glucose (sugar) levels should be regularly tested to find the lowest effective dose.
Danish: Patientens blodglukoseniveau (sukker) skal kontrolleres regelmæssigt for at fastsætte den effektive minimumsdosis.
English: Apidra doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels.
Danish: Det kan være nødvendigt at justere dosis af Apidra, når det gives sammen med visse andre lægemidler, der kan indvirke på blodglukoseniveauet.
English: The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Apidra (som ses hos flere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodglukoseniveau).
English: The active substance in Apidra, insulin glulisine, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glulisine.
Danish: Det aktive stof i Apidra, insulin glulisin, fremstilles via en metode, der er kendt som "rekombinant dna-teknologi": Det produceres af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere insulin glulisin.
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde blodglukosen under kontrol mindskes sukkersygesymptomerne og -komplikationerne.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at regulere blodsukkerniveauet.
English: What is the risk associated with Apidra?
Danish: Hvilken risiko er der forbundet med Apidra?
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet fungerer på samme måde som naturligt produceret insulin og hjælper glukosen til at trænge ind i cellerne fra blodet.
English: In type 2 diabetes (when the body is unable to use insulin effectively), Apidra has been studied in one study involving 878 adults.
Danish: Ved type 2-diabetes (hvor kroppen ikke kan udnytte insulin effektivt) så man på Apidra i en undersøgelse, som omfattede 878 voksne.
English: Apidra is given by injection under the skin in the abdominal wall (tummy), the thigh or the shoulder, or by continuous infusion using an insulin pump.
Danish: Apidra gives som injektion under huden i bugvæggen (maven), låret eller skulderen eller ved kontinuerlig infusion ved hjælp af en insulinpumpe.
English: Apidra, used in combination with a long-acting insulin, has been studied in type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children and adolescents aged between four and 17 years.
Danish: Apidra anvendt i kombination med langtidsvirkende insulin blev undersøgt hos patienter med type 1diabetes (hvor kroppen ikke kan producere insulin) i to undersøgelser, der omfattede i alt 1 549 voksne, og i en undersøgelse, der omfattede 572 børn og unge mellem fire og 17 år.
English: In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, and a decrease of 0.14% for insulin lispro.
Danish: I den første undersøgelse af voksne med type 1-diabetes var der efter seks 6 måneder et fald på 0,14 % (fra 7,60 % til 7,46 %) og et fald på 0,14 % for insulin lispro.
English: Blood glucose control with Apidra was at least as effective as that with the comparator insulins.
Danish: Reguleringen af blodglukosen med Apidra var mindst ligeså effektiv som med sammenligningsinsulinerne.
English: The main measure of effectiveness was the change in levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: Det primære effektmål var ændringen i blodets indhold af et stof kaldet glykosyleret hæmoglobin (HbA1c), som giver en indikation af, hvor godt blodglukosen er reguleret.
English: Insulin glulisine is very slightly different from human insulin.
Danish: Insulin glulisin adskiller sig en smule fra humant insulin.
English: Apidra should not be used in people who may be hypersensitive (allergic) to insulin glulisine or any of the other ingredients.
Danish: Apidra må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for insulin glulisin eller andre af indholdsstofferne.
English: The difference means that insulin glulisine acts more rapidly, and has a shorter duration of action than a short-acting human insulin.
Danish: Forskellen betyder, at insulin glulisin virker hurtigere og har en korterevarende virkning end kortvirkende humant insulin.
English: In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.
Danish: Hos voksne med type 2-diabetes var der et fald i HbA1c på 0,46 % efter seks måneder med Apidra sammenlignet med 0,30 % for almindeligt human insulin.
English: Apidra is used to treat patients aged six years or over with diabetes, when they need insulin.
Danish: Apidra anvendes til behandling af sukkersyge hos patienter fra 6-års-alderen, når de har behov for insulin.
English: Why has Apidra been approved?
Danish: Hvorfor blev Apidra godkendt?
English: In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro).
Danish: I alle fire undersøgelser blev Apidra sammenlignet med andre insulinpræparater eller insulinanaloger (almindeligt humant insulin eller insulin lispro).
English: It is supplied in vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).
Danish: Det leveres i hætteglas, cylinderampuller og fyldte engangspenne (OptiSet og SoloStar).
English: Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin.
Danish: Tilsvarende fald kunne observeres i den anden undersøgelse hos voksne, hvor Apidra blev sammenlignet med almindeligt humant insulin.
English: Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin).
Danish: Apidra er et kortvirkende insulinpræparat, som anvendes i kombination med middellangt- eller langtvirkende insuliner eller insulinanaloger (modificerede former for insulin).
English: It may also be used in combination with antidiabetes medicines taken by mouth.
Danish: Det kan også anvendes i kombination med orale lægemidler mod diabetes.
English: Apidra is a replacement insulin that is very similar to the insulin made by the body.
Danish: Apidra er en insulinerstatning, der er næsten identisk med det insulin, der produceres af kroppen.
English: For the full list of all side effects reported with Apidra, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Apidra fremgår af indlægssedlen.
English: Apidra is a solution for injection that contains the active substance insulin glulisine.
Danish: Apidra er en injektionsvæske, opløsning, der indeholder det aktive stof insulin glulisin.
English: What is Apidra?
Danish: Hvad er Apidra?
English: In all of the studies, the change in the level of HbA1c seen with Apidra was similar to that seen with the comparator insulins.
Danish: I alle undersøgelser svarede ændringen i HbA1c-niveauet, som blev set ved Apidra, til ændringen ved de insulinpræparater, det blev sammenlignet med.
English: In this study, Apidra was used in combination with an intermediate-acting insulin and antidiabetes medicines taken by mouth.
Danish: I denne undersøgelse blev Apidra anvendt i kombination med insulin med middellang virkningstid og orale lægemidler mod diabetes.
English: What is Apidra used for?
Danish: Hvad anvendes Apidra til?
English: In the study in children and adolescents, Apidra and insulin lispro produced similar changes in HbA1c after six months.
Danish: I undersøgelsen af børn og unge forekom der tilsvarende ændringer i HbA1c efter seks måneder med Apidra og insulin lispro.
English: What benefit has Apidra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Apidra?
English: How has Apidra been studied?
Danish: Hvordan blev Apidra undersøgt?
English: How is Apidra used?
Danish: Hvordan anvendes Apidra?
English: How does Apidra work?
Danish: Hvordan virker Apidra?
English: This does not constitute a sign of deterioration.
Danish: Dette er ikke et tegn på forringelse.
English: (4) Not statistically significant.
Danish: (4) Ikke statistisk signifikant
English: Type or cause of AOM
Danish: Type eller årsag til AOM
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, bør navnet og batchnummeret af det administrerede produkt registreres tydeligt.
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Danish: Hovedparten af disse reaktioner var af let til moderat sværhedsgrad og ikke langvarige.
English: Incidence per 100,000 person years
Danish: Incidens pr. 100.000 personår
English: The results were not statistically significant across all analyses in COMPAS.
Danish: Resultaterne var ikke statistisk signifikante på tværs af alle analyser i COMPAS.
English: Children above 5 years old
Danish: Børn over 5 år
English: These reactions will usually occur before leaving the doctor's surgery.
Danish: Disse reaktioner vil normalt forekomme, inden du forlader lægen.
English: Control vaccine N=10,201
Danish: Kontrolvaccine N=10.201
English: No direct cause-and-effect can be inferred from observational studies of this type.
Danish: Der kan ikke udledes direkte årsag-virkning-forhold fra observationsstudier af denne type.
English: If this applies to your child then the vaccination will be postponed until your child is feeling better.
Danish: Hvis dette er tilfældet, vil vaccinationen blive udsat, indtil dit barn har det bedre.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelen ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller udsættes.
English: Immunologic non-inferiority to 7-valent Prevenar
Danish: Immunologisk non-inferioritet over for 7-valent Prevenar
English: The following side effects may happen with this medicine:
Danish: Nedenstående bivirkninger kan forekomme med denne vaccine:
English: Efficacy and effectiveness in clinical trials
Danish: Virkning og effektivitet i kliniske studier
English: Remove the needle protector, which on occasion can be a little stiff.
Danish: Fjern beskyttelseshætten fra kanylen; den kan af og til være lidt stram.
English: For children above 5 years old safety and efficacy of the vaccine have not been established, therefore vaccination of these children is not recommended.
Danish: For børn over 5 år er sikkerhed og effekt af vaccinen ikke fastslået, og derfor er vaccination af disse børn ikke anbefalet.
English: Acute Otitis Media (AOM)
Danish: Akut otitis media (AOM)
English: Information on protection conferred by the vaccine
Danish: Information om den beskyttelse, som vaccinen giver
English: Use with other vaccines
Danish: Samtidig anvendelse med andre vacciner
English: However, taken together there was a trend for decrease in overall pneumococcal carriage.
Danish: Tilsammen resulterede det dog i en tendens til et fald i den samlede pneumokok-bærertilstand.
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Danish: Bakterier kan være årsag til 60-70 % af de kliniske tilfælde af AOM.
English: • You will be told when your child should come back for the next injections.
Danish: • Du vil få oplyst, hvornår dit barn skal komme og få de næste vaccinationer.
English: Synflorix should not be given if:
Danish: Synflorix må ikke gives hvis:
English: Results suggest comparable reactogenicity and safety profile of Synflorix between these high risk groups and healthy children.
Danish: Resultaterne tyder på sammenlignelig reaktogenicitet og sikkerhedsprofil for Synflorix imellem disse højrisiko-grupper og raske børn.
English: See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
Danish: 4.4 og 5.1 for oplysninger om beskyttelse mod specifikke pneumokokserotyper.
English: Antipyretic treatment should be initiated according to local treatment guidelines.
Danish: Antipyretisk behandling skal initieres i overensstemmelse med lokale retningslinjer.
English: The persistence of protection against B-CAP and C-CAP beyond the age of 36 months is currently not established.
Danish: Den vedvarende beskyttelse mod B-CAP og C-CAP hos børn over 36 måneder er ikke klarlagt i øjeblikket.
English: Synflorix was shown to be immunogenic and no new safety concerns were observed in this study.
Danish: Synflorix viste at være immunogen, og der blev ikke observeret nogle nye sikkerhedsmæssige bekymringer i dette studie.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: • your child has a severe infection with a high temperature (over 38 °C).
Danish: • dit barn har en alvorlig infektion med høj feber (over 38 °C).
English: The antibodies form a part of the immune system that will protect your child against these diseases.
Danish: Antistofferne er en del af kroppens immunforsvar, som beskytter dit barn mod disse sygdomme.
English: Furthermore, 19,466 children and 116 preterm infants received a booster dose of Synflorix in the second year of life.
Danish: Desuden har 19.466 børn og 116 præmature spædbørn fået en boosterdosis Synflorix i andet leveår.
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Danish: Hvis du har yderligere spørgsmål om brugen af denne vaccine, spørg din læge, apotekspersonalet eller sygeplejersken.
English: At least six months after the last injection, your child will receive an additional injection (booster).
Danish: Mindst 6 måneder efter den sidste indsprøjtning skal dit barn have yderligere en indsprøjtning (booster).
English: In addition, OPA GMTs were in same ranges for both groups.
Danish: Desuden var OPA GMTs i samme intervaller for begge grupper.
English: As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.
Danish: Som for andre vacciner kan det forventes, at patienter i immunsuppressiv behandling ikke med sikkerhed kan opnå tilstrækkeligt respons.
English: Effectiveness in post-marketing surveillance
Danish: Effektivitet i overvågning efter markedsføring
English: Human data on the use during pregnancy or breast-feeding and animal reproduction studies are not available.
Danish: Der foreligger ingen humane data vedrørende brug under graviditet eller amning, og der foreligger ingen dyrestudier vedrørende reproduktion.
English: Of these, 76, 96 and 49 infants, respectively, received a booster dose.
Danish: Ud af disse modtog henholdsvis 76, 96 og 49 spædbørn en booster dosis.
English: Vaccine efficacy results in children > 36 months of age suggest a waning of protection.
Danish: Effektresultater af vaccinen hos børn > 36 måneder indikerer aftagende beskyttelse.
English: (4) Individual serotypes for which statistical significance was reached in the effectiveness analysis controlling for confounding factors (no adjustment for multiplicity performed).
Danish: (4) Individuelle serotyper, for hvilke statistisk signifikans blev nået i effektivitetsanalysen, som kontrollerede for konfunderende faktorer (der blev ikke justeret for multiplicitet).
English: The proportion of subjects who received the booster dose in the ATP cohort was 92.3% in both analyses.
Danish: Andelen af personer i ATP-kohorten, som fik en boosterdosis, var 92,3 % i begge analyser.
English: For other vaccine serotypes, the number of AOM cases was too limited to allow any efficacy conclusion to be drawn.
Danish: For andre vaccineserotyper var antallet af rapporterede AOM-tilfælde for begrænset til at der kunne drages en konklusion om effektivitet.
English: Streptococcus pneumoniae and Non-Typeable Haemophilus influenzae (NTHi) are the most common causes of bacterial AOM worldwide.
Danish: Streptococcus pneumoniae og ikke-kapselbærende Haemophilus influenzae (NTHi) er de mest almindelige årsager til bakteriel AOM på verdensplan.
English: Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed.
Danish: De officielle retningslinjer for immunisering mod difteri, tetanus og Haemophilus influenzae type b bør også følges.
English: Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe fremlægges bivirkningerne i rækkefølge af faldende alvorlighed.
English: After NIP
Danish: Efter NIP
English: • This vaccine has been prescribed for your child only.
Danish: • Lægen har ordineret denne vaccine til dit barn personligt.
English: The vaccine efficacy against B-CAP observed at the interim analysis is presented below (table 2).
Danish: Vaccinens effekt mod B-CAP observeret i interimanalysen er anført nedenfor (tabel 2).
English: Before NIP
Danish: Før NIP
English: IPD due to individual serotypes(4) - 6B
Danish: IPD, som skyldes individuelle serotyper(4) - 6B
English: In both studies there were significant decrease of individual serotypes 6B and 19F.
Danish: I begge studier var der et signifikant fald af de individuelle serotyper 6B og 19F.
English: Table 3: Vaccine efficacy against AOM(1) in COMPAS
Danish: Tabel 3: Vaccine-effekt mod AOM(1) i COMPAS
English: Synflorix will only protect against infections caused by the bacteria for which the vaccine has been developed.
Danish: Synflorix beskytter kun mod infektioner som skyldes de bakterier, som vaccinen er udviklet til.
English: Table 5: Rates of IPD and the corresponding rate reductions in Finland IPD
Danish: Tabel 5: Hyppighed af IPD og den tilsvarende reduktion i forekomsten i Finland IPD
English: The immunisation schedules for Synflorix should be based on official recommendations.
Danish: Immuniseringsprogrammet for Synflorix skal baseres på officielle retningslinjer.
English: Allergic reactions (such as eczema, allergic dermatitis, atopic dermatitis)
Danish: Allergiske reaktioner (f.eks. eksem, allergisk dermatitis, atopisk dermatitis)
English: Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Danish: Akut otitis media (AOM) er en almindelig børnesygdom, med forskellig ætiologi.
English: • your child is allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6).
Danish: • dit barn er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6).
English: Synflorix does not provide protection against other microorganisms.
Danish: Synflorix giver ikke beskyttelse mod andre mikroorganismer.
English: Safety and immunogenicity data for Synflorix are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis (see section
Danish: Sikkerhedsog immungenicitetsdata for Synflorix er ikke tilgængelig for personer i andre specifikke immunkompromitterede grupper og vaccination skal overvejes på individuel basis (se pkt.
English: Pneumonia of different aetiologies is a leading cause of childhood morbidity and mortality globally.
Danish: Pneumoni med forskellig ætiologi er globalt set en af de væsentligste årsager til morbiditet og mortalitet i barndommen.
English: • Synflorix is a turbid white suspension.
Danish: • Synflorix er en uklar, hvid suspension.
English: The vaccine is a turbid white suspension.
Danish: Vaccinen er en uklar, hvid suspension.
English: Please speak to your doctor for information on the number and timing of injections for your child.
Danish: Tal med lægen omkring antal og tidsintervaller for de insprøjtninger dit barn skal have.
English: Table 4: Summary of effectiveness of Synflorix for IPD in Brazil Types of IPD(1)
Danish: Tabel 4: Sammendrag af Synflorix' effektivitet mod IPD i Brasilien Typer af IPD(1)