FrancophonIA/ELRC3.0 huggingface dataset:
English: raltegravir, zidovudine); - anti-tuberculosis medicine (bedaquiline and delamanid); - antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults (e.g.
Danish: − antivirale midler, som bruges til at behandle kronisk hepatitis C-virus-infektion hos voksne
English: Pour the powder into the cup a. Tear open the sachet.
Danish: Hæld pulveret i koppen a. Riv brevet op. b. Hæl ALT pulveret ned i blande-koppen.
English: 100 q12h
Danish: 100 mg hver 12. time
English: ↑ 7.2-fold
Danish: ↑ 7,2 gange
English: Antifungal
Danish: Anafylaksi
English: What you need to know before you or your child takes Norvir.
Danish: Se også punkt 2 Det skal du vide, før du eller dit barn begynder at tage Norvir.
English: Numbness, tingling, or a “pins and needles” sensation may occur if you take too much Norvir.
Danish: Hvis du tager for meget Norvir, kan der forekomme en sovende eller prikkende fornemmelse eller andre unormale følefornemmelser i huden.
English: ↑ 16-fold
Danish: Ritonavir ↔ ↔
English: 200 q12h
Danish: 200 mg hver 12. time
English: 750, single
Danish: 750 mg, enkeltdosis
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists.
Danish: Ritonavir doseret som en farmakokinetisk forstærker eller som et antiretroviralt stof hæmmer CYP3A4 og forventes som følge heraf at øge plasmakoncentrationerne af kalciumantagonister.
English: Adverse reactions associated with the use of ritonavir as a pharmacokinetic enhancer are dependent on the specific co-administered PI. For information on adverse reactions refer to the SPC of the specific co-administered PI.
Danish: Konkrete anbefalinger vedrørende brugen af ritonavir som en farmakokinetisk forstærker til patienter med nedsat leverfunktion afhænger af den proteasehæmmer, det gives sammen med. Produktresuméet for den proteasehæmmer, der gives sammen med ritonavir, bør gennemgås med hensyn til konkrete oplysninger om dosering til denne patientgruppe.
English: 50, single dose 200 q12h ↑ 2.4-fold An increase in the incidence in trazodone-related adverse reactions was noted when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Danish: En øget forekomst af trazodon-relaterede bivirkninger er registreret ved indgift sammen med ritonavir doseret som et antiretroviralt stof eller som en farmakokinetisk forstærker.
English: Zidovudine 200 q8h
Danish: Zidovudin 200 mg hver 8. time
English: 6.25 mg Powder for solution for injection Intravenous use
Danish: Kepivance 6.25 mg Pulver til injektionsvæske, opløsning Intravenøs anvendelse Hætteglas (glas)
English: 6 vials l t o r
Danish: 6 Hætteglas t r
English: Kepivance
Danish: Indhold
English: Semglee is used once a day at the same time each day.
Danish: Semglee gives én gang dagligt på samme tidspunkt hver dag.
English: Further information on Semglee can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Semglee findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Semglee is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Semglee i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: As for all medicines, data on the use of Semglee is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Semglee løbende overvåget.
English: An overview of Semglee and why it is authorised in the EU
Danish: En oversigt over Semglee og hvorfor det er godkendt i EU
English: What is Semglee and what is it used for?
Danish: Hvad er Semglee, og hvad anvendes det til?
English: Other information about Semglee
Danish: Andre oplysninger om Semglee
English: The reference medicine for Semglee is Lantus.
Danish: Referencelægemidlet for Semglee er Lantus.
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Danish: Diabetes er en sygdom, hvor blodsukkerniveauet er forhøjet, enten fordi kroppen ikke kan producere insulin (type 1-diabetes), eller fordi kroppen ikke producerer nok insulin eller ikke kan anvende insulinet effektivt (type 2-diabetes).
English: What measures are being taken to ensure the safe and effective use of Semglee?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Semglee?
English: Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Semglee vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Danish: Når blodsukkeret reguleres, mindskes symptomerne på diabetes, og komplikationer undgås.
English: Why is Semglee authorised in the EU?
Danish: Hvorfor blev Semglee godkendt i EU?
English: However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects.
Danish: Der er dog gennemført en understøttende undersøgelse hos 558 patienter med type 1diabetes, som viste, at Semglee og Lantus havde samme virkninger.
English: Semglee is a medicine used to treat diabetes in patients from 2 years of age.
Danish: Semglee er et lægemiddel, der anvendes til at behandle diabetes hos patienter fra toårsalderen.
English: Semglee is a ‘biosimilar medicine'.
Danish: Semglee er et "biosimilært" lægemiddel.
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Danish: Det gives som en indsprøjtning under huden i maven, låret eller overarmen.
English: Semglee (insulin glargine) EMA/57790/2018
Danish: Semglee (insulin glargin) EMA/57790/2018
English: Semglee (insulin glargine)
Danish: Semglee (insulin glargin)
English: What are the risks associated with Semglee?
Danish: Hvilke risici er der forbundet med Semglee?
English: Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Danish: Insulin glargin, det aktive stof i Semglee, kommer ind i blodbanen efter injektionen, men langsommere end humant insulin, og det virker derfor i længere tid.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Semglees og Lantus' kvalitet, sikkerhed og virkning svarer til hinanden.
English: The dose of Semglee is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Danish: Semglee-dosen fastsættes individuelt for den enkelte patient og afhænger af patientens blodsukkerniveau og behandling med andre insulinlægemidler.
English: Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine in Semglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Danish: Omfattende laboratorieundersøgelser, hvor Semglee er blevet sammenlignet med Lantus, har vist, at Semglees insulin glargin i meget høj grad ligner det aktive stof i Lantus, hvad angår kemisk opbygning, renhed og biologisk aktivitet.
English: The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Danish: Den hyppigste bivirkning ved Semglee (som optræder hos mere end 1 ud af 10 patienter) er for lavt blodsukker (hypoglykæmi).
English: Semglee is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Danish: Semglee er et erstatningsinsulin, der fungerer på samme måde som kroppens eget insulin og hjælper glukosen (sukkeret) med at komme ind i cellerne fra blodet.
English: Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Danish: Semglee er et biosimilært lægemiddel, og derfor har det ikke været nødvendigt at gennemføre undersøgelser af dets virkning og sikkerhed, da dette er veldokumenteret for det aktive stof, insulin glargin.
English: For the full list of side effects and restrictions with Semglee, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Semglee fremgår af indlægssedlen.
English: Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose.
Danish: En række andre undersøgelser har vist, at Semglee absorberes i kroppen på samme måde som referencelægemidlet (Lantus), og at det kan anses for at virke på samme måde på blodsukkeret.
English: Therefore, the Agency's view was that, as for Lantus, the benefit of Semglee outweighs the identified risk and it can be authorised in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Semglee opvejer de identificerede risici som for Lantus, og anbefalede, at Semglee godkendes til anvendelse i EU.
English: Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus.
Danish: Fortsat behandling med enten Semglee eller Lantus i 24 uger indikerede en sammenlignelig kontrol af HbA1c med begge lægemidler, idet niveauforandringen gennemsnitligt var 0,14 % hos patienter, der fik Semglee, og 0,11 % hos dem, der fik Lantus.
English: How is Semglee used?
Danish: Hvordan anvendes Semglee?
English: Semglee is available in pre-filled disposable pens and can only be obtained with a prescription.
Danish: Semglee leveres som fyldte penne til engangsbrug, som kun udleveres efter recept.
English: For more information about using Semglee, see the package leaflet or contact your doctor or pharmacist.
Danish: Patienterne kan give sig selv indsprøjtningerne med Semglee, når de er blevet oplært i det. For mere information om brug af Semglee, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Semglee can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.
Danish: Type 2-diabetikere kan også anvende Semglee sammen med diabeteslægemidler, der tages gennem munden.
English: What benefits of Semglee have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Semglee?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Semglee have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Semglee.
English: How does Semglee work?
Danish: Hvordan virker Semglee?
English: • Important tips to keep in mind
Danish: • Vigtige tips at huske
English: Symptoms may disappear completely or partly.
Danish: Symptomerne kan helt eller delvist forsvinde igen.
English: Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013
Danish: Dato for første markedsføringstilladelse: 20. maj 2008 Dato for seneste fornyelse: 20. maj 2013
English: You will need the medicine:
Danish: Du skal bruge medicinen:
English: This is called a Rotation Cycle.
Danish: Dette kaldes en rotationscyklus.
English: - If you have ever had an allergic reaction to latex.
Danish: - Hvis du nogensinde har haft en allergisk reaktion over for latex.
English: Follow-up of patients is continuing in order to provide additional data.
Danish: Opfølgningen af patienterne fortsætter for at tilvejebringe yderligere data.
English: 1 - Wash your hands thoroughly with soap and water before beginning this process.
Danish: 1 - Vask hænderne grundigt med vand og sæbe, før du går i gang med denne proces.
English: Let the skin air-dry.
Danish: Lad huden lufttørre.
English: Component of a 3-month multipack.
Danish: Delpakning af 3måneders multipakning.
English: Experience with exposure during the second and third trimesters is very limited.
Danish: Erfaringer med eksponering under det andet og tredje trisemester er meget begrænsede.
English: This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
Danish: Det gør det nemmere at huske og nemmere at planlægge et tidsrum uden afbrydelser.
English: Advice on which areas to choose is given in the first part of this Annex.
Danish: Råd om, hvilke områder du kan vælge imellem, findes i bilagets første del.
English: - medicines which affect the production of blood cells.
Danish: Medicin, der påvirker produktionen af blodceller.
English: The injection site must be changed regularly.
Danish: Indsprøjtningsstedet skal ændres regelmæssigt.
English: 60% (53) of these patients returned to negative status based on the last available assessment within the 5-year period.
Danish: 60 % (53) af disse patienter vendte tilbage til negativ status baseret på den sidste tilgængelige vurdering inden for 5-års perioden.
English: Patients and investigators remained blinded to the initial treatment allocation.
Danish: Patienter og investigatorer forblev blindede indtil allokation af initialbehandlingen.
English: - Never re-use syringes or needles.
Danish: - Genbrug aldrig sprøjter eller kanyler.
English: Extavia with food and drink
Danish: Brug af Extavia sammen med mad og drikke
English: The most common side effects are:
Danish: De hyppigste bivirkninger er:
English: - Try to give yourself the injection at the same time each day.
Danish: - Forsøg at tage indsprøjtningen på samme tid hver dag.
English: • Getting off to a good start!
Danish: • Kom godt i gang!
English: The reconstituted product should be inspected visually before use.
Danish: Det rekonstituerede produkt skal undersøges visuelt før brug.
English: Start with your first injection (or your last injection if you are not a new Extavia user).
Danish: Begynd med din første indsprøjtning (eller din seneste indsprøjtning, hvis du ikke er ny Extaviabruger).
English: If you have already been using Extavia start with the area that has not been used during the last rotation cycle (i.e. the past 16 days).
Danish: Hvis du allerede har taget Extavia, skal du starte med det område, der ikke har været i brug under den seneste rotationscyklus (dvs. de sidste 16 dage).
English: How Extavia helps fight your disease
Danish: Hvordan hjælper Extavia med at bekæmpe din sygdom?
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for en opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: At the present time, it is not known for how long the patient should be treated.
Danish: På nuværende tidspunkt vides det ikke, hvor lang tid patienten skal behandles.
English: This study consisted of two phases, a placebocontrolled phase followed by a pre-planned follow-up phase.
Danish: Dette studie bestod af to faser: en placebokontrolleret fase efterfulgt af en planlagt opfølgningsfase.
English: Do not inject a double dose to make up for a forgotten individual dose.
Danish: Du må ikke indsprøjte en dobbeltdosis som erstatning for den glemte dosis.
English: Your doctor will closely monitor you during treatment.
Danish: Din læge vil følge dig tæt under behandlingen.
English: Extavia has been shown to cut down the number of attacks and make them less severe.
Danish: Extavia har vist sige at mindske antallet af anfald og gøre dem mindre alvorlige.
English: If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Danish: Hvis du har glemt en indsprøjtning på det rigtige tidspunkt, skal du tage den, så snart du kommer i tanke om det, og så tage den næste indsprøjtning 48 timer senere.
English: 10 - Hold the vial between your thumb and fingers.
Danish: 10 - Hold hætteglasset mellem tommelfingeren og de øvrige fingre.
English: Push the plunger to the 1 ml mark (or to the volume prescribed by your doctor).
Danish: Skub stemplet ind til 1 ml-mærket (eller til den mængde, din læge har ordineret).
English: This is often associated with an increase in certain blood fats (triglycerides).
Danish: Dette er ofte forbundet med en stigning af visse fedtstoffer i blodet (triglycerider).
English: Human albumin Mannitol (E421)
Danish: Humant albumin Mannitol (E421)
English: Some analyses suggest that this effect might be more pronounced in patients with higher titre levels of neutralising activity.
Danish: Nogle analyser antyder, at denne virkning kan være mere udtalt hos patienter med højere titreringsniveauer af neutraliserende aktivitet.
English: Extavia itself does not affect the heart directly.
Danish: Extavia har i sig selv ingen direkte indvirkning på hjertet.
English: The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status.
Danish: Beslutningen om at fortsætte eller seponere behandlingen bør baseres på klinisk sygdomsaktivitet frem for neutraliserende aktivitetsstatus.
English: Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Danish: Interferoner har en molekylvægt, der varierer fra 15,000 til 21,000 Dalton.
English: This is a disorder of the immune system where an abnormal protein is found in the blood.
Danish: Dette er en defekt i immunsystemet, hvor et unormalt protein er til stede i blodet.
English: PART I: STEP BY STEP INSTRUCTIONS
Danish: DEL I: INSTRUKTIONER TRIN FOR TRIN
English: These may be symptoms of a serious allergic reaction, which may become life threatening.
Danish: Dette kan være symptom på en alvorlig allergisk reaktion, der kan udvikle sig til en livstruende tilstand.
English: Put the vial on the table.
Danish: Sæt hætteglasset på bordet.
English: If you are especially sensitive, this might influence your ability to drive or use machines.
Danish: Hvis du er særligt følsom, kan det påvirke din evne til at køre bil eller betjene maskiner.
English: - If you have monoclonal gammopathy.
Danish: - Hvis du har monoklonal gammopati.
English: * produced by genetic engineering from strain of Escherichia coli.
Danish: * Produceret med genteknologi fra Escherichia coli-stammen.
English: Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event.
Danish: Der sås også signifikant effekt hos patienter med mindre dissemineret og mindre aktiv sygdom på tidspunktet for første hændelse.
English: Extavia may cause serious side effects.
Danish: Extavia kan give alvorlige bivirkninger.
English: - Always use a sterile (aseptic) technique as described in here.
Danish: - Brug altid en steril (aseptisk) teknik, som beskrevet nedenfor.
English: If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Danish: Hvis nogle af områderne er for vanskelige at nå, kan du eventuelt bede et familiemedlem eller en ven om at hjælpe med disse indsprøjtninger.
English: Moreover, an autoinjector was used by the majority of patients throughout the study.
Danish: Desuden anvendte størstedelen af patienterne en autoinjektor under studiet.
English: Other things to consider when using Extavia:
Danish: Andre ting der skal overvejes ved brug af Extavia:
English: Powder: Human albumin, mannitol.
Danish: Pulver: Humant albumin, mannitol.
English: Extavia is indicated for the treatment of:
Danish: Extavia er indiceret til behandling af:
English: If this occurs and a relationship to Extavia is suspected, treatment should be discontinued.
Danish: Hvis dette opstår, og der er mistanke om en forbindelse til Extavia, bør behandlingen seponeres.
English: This will either be done by your doctor or nurse or by yourself after you have been carefully trained.
Danish: Dette gøres enten af din læge, sygeplejerske eller dig, efter at du har fået en omhyggelig instruktion.
English: The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Extavia in the third year of the study.
Danish: Der blev observeret en fortsat behandlingseffekt, selv om størstedelen af patienterne fra placebogruppen blev behandlet med Extavia i det tredje studieår.
English: ► Tell your doctor, if any of the above applies to you.
Danish: ► Kontakt din læge, hvis noget af det ovenstående gælder for dig.
English: An example of a medication record is also included (see Annex Part III).
Danish: Der finder du også et eksempel på en behandlingskalender (se bilag DEL III).
English: You should inject this medicine into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 mm to 12 mm under the skin).
Danish: Du skal sprøjte dette lægemiddel ind i fedtlaget mellem huden og musklen (subkutant - dvs. ca. 8 mm til 12 mm under huden).
English: If clinically needed, the use of Extavia may be considered during pregnancy.
Danish: Hvis klinisk nødvendigt kan anvendelse af Extavia under graviditet overvejes.
English: - Prepare each dose only when you are ready for an injection.
Danish: - Klargør først hver dosis, når du er klar til indsprøjtningen.
English: 2 - Use an alcohol swab to clean the skin at the injection site.
Danish: 2 - Brug en spritserviet til at rengøre huden på indsprøjtningsstedet.
English: Injection site reactions and necroses were observed less frequently in this study than in the other pivotal studies.
Danish: Reaktioner på injektionsstedet samt nekrose blev observeret mindre hyppigt i dette studie end i de andre pivotale studier.
English: - During treatment with Extavia your body may produce substances called neutralising antibodies, which may react with Extavia.
Danish: - Under behandling med Extavia kan din krop producere stoffer, som kaldes neutraliserende antistoffer, som kan reagere mod Extavia.
English: Your doctor or nurse can tell you more about this.
Danish: Det kan din læge eller sygeplejersken fortælle dig mere om.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC Code: L03AB08
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, interferoner, ATC-kode: L03AB08
English: 11 - Examine the solution carefully.
Danish: 11 - Undersøg nøje opløsningen.
English: Extavia may cause side effects in the central nervous system (see section 4 “Possible side effects”).
Danish: Extavia kan forårsage bivirkninger i centralnervesystemet (se afsnit 4 ”Bivirkninger”).
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Danish: Den mest relevante MedDRA-term er anvendt til at beskrive en bestemt reaktion og dens synonyme og relaterede tilstande.
English: Detailed instructions for self-injection of Extavia under the skin are provided in the Annex at the back of this leaflet.
Danish: Detaljeret information om selvindsprøjtning af Extavia under huden findes i bilaget bagerst i denne vejledning.