FrancophonIA/ELRC3.0 huggingface dataset:
English: CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
Danish: CHMP konkluderede, at colistimethatnatrium ved cystisk fibrose også kan gives ved inhalation eller med nebulisator til patienter med vedvarende (kroniske) infektioner med bakterien Pseudomonas aeruginosa.
English: On 23 October 2014 the European Medicines Agency (EMA) completed a review of the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
Danish: Den 23. oktober 2014 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af sikkerheden og virkningen af lægemidler, der indeholder antibiotikaene colistin eller colistimethatnatrium (også kaldet polymyxiner).
English: The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited.
Danish: CHMP konkluderede, at colistimethatnatrium til injektion eller infusion (drop) bør være forbeholdt alvorlige infektioner med følsomme bakterier hos patienter med få andre behandlingsmuligheder.
English: • Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Danish: • Der bør udvises stor forsigtighed ved intravenøs indgift af colistimethatnatrium sammen med andre potentielt nefrotoksiske eller neurotoksiske lægemidler.
English: Research currently underway may provide further information on pharmacodynamics and pharmacokinetics of these medicines to improve the evidence-base behind any dose recommendations.
Danish: Den igangværende forskning kan tænkes at tilføre yderligere viden om farmakodynamikken og farmakokinetikken af disse lægemidler.
English: A parallel review is currently underway, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Danish: Sideløbende pågår en gennemgang, der ser nærmere på præparaternes kvalitet og den anvendte metode til måling og testning af colistimethatnatriums styrke.
English: Polymyxins are a group of antibiotics that includes colistin and colistimethate sodium (a ‘prodrug' that is converted to colistin in the body), which have been available in the EU since the 1960s for the treatment of susceptible infections.
Danish: Polymyxiner er en gruppe antibiotika, der dels omfatter colistin, dels colistimethatnatrium, som er et lægemiddelforstadium (“prodrug”), der i kroppen omdannes til colistin.
English: Products taken by mouth (which mainly contain colistin and are not absorbed into the body in significant amounts but act locally on the gut) and those applied externally were not covered in this review.
Danish: Gennemgangen omfattede ikke præparater til indtagelse gennem munden (disse indeholder hovedsagelig colistin og optages ikke i nævneværdige mængder i kroppen, men virker lokalt i tarmen).
English: • When given by inhalation, colistimethate sodium solutions may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis.
Danish: • Ved cystisk fibrose hos voksne og børn kan colistimethatnatrium gives ved inhalation til behandling af kroniske lungeinfektioner med Pseudomonas aeruginosa.
English: Colistimethate sodium may also be inhaled as a liquid vapour to treat lung infection in patients with cystic fibrosis.
Danish: Hos patienter med cystisk fibrose kan colistimethatnatrium desuden anvendes som inhalationsdamp til behandling af lungeinfektioner.
English: This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Renvela i 2009 ("informeret samtykke").
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Danish: • voksne og børn fra 6 år og opefter med kronisk (langvarig) nyresygdom.
English: • adult patients on dialysis (a technique to remove unwanted substances from the blood);
Danish: • voksne patienter i dialyse (en teknik, hvor man fjerner uønskede stoffer fra blodet)
English: Sevelamer carbonate Winthrop received a marketing authorisation valid throughout the EU on 15 January 2015.
Danish: Sevelamer carbonate Winthrop fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015.
English: Further information on Sevelamer carbonate Winthrop can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Danish: Yderligere information om Sevelamer carbonate Winthrop findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
English: The dose to take depends on the patient's level of blood phosphate and, for children, their height and weight.
Danish: Dosen afhænger af patientens niveau af fosfat i blodet og for børns vedkommende af højde og vægt.
English: Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.
Danish: Sevelamer carbonate Winthrop fås som tabletter (800 mg) og som pulver (800 mg og 2,4 g), som skal tages tre gange om dagen sammen med et måltid.
English: 1 Previously known as Sevelamer carbonate Zentiva.
Danish: 1 Tidligere kendt som Sevelamer carbonate Zentiva.
English: The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Danish: De hyppigste bivirkninger ved Sevelamer carbonate Winthrop (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning, smerter i den øvre del af maven og forstoppelse.
English: The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop'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 Sevelamer carbonate Winthrop opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.
Danish: Når lægemidlet tages med et måltid, binder det sig i tarmen til fosfat fra maden og forhindrer dermed fosfatet i at blive optaget i kroppen, hvilket reducerer fosfatniveauet i blodet.
English: As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Sevelamer carbonate Winthrop løbende overvåget.
English: In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Danish: I et tredje hovedstudie hos 49 voksne, som ikke var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet fra 2,0 mmol/l til 1,6 mmol/l.
English: For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Sevelamer carbonate Winthrop, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.
Danish: I to hovedstudier hos 110 voksne med nyresygdom, som var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet til ca. 1,5-1,6 mmol/l (hvilket er inden for eller tæt på normalområdet), og det var lige så effektivt som et andet godkendt lægemiddel, Renagel.
English: Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.
Danish: Sevelamer carbonate Winthrop må ikke tages på tom mave, og patienterne bør overholde den ordinerede kostplan.
English: Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Sevelamer carbonate Winthrop vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It contains the active substance sevelamer carbonate.
Danish: Det indeholder det aktive stof sevelamercarbonat.
English: Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Danish: Sevelamer carbonate Winthrop bør anvendes sammen med andre behandlinger, som f.eks. tilskud af calcium og D-vitamin, for at forebygge knoglesygdom.
English: The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder.
Danish: Det aktive stof i Sevelamer carbonate Winthrop, sevelamercarbonat, er en fosfatbinder.
English: An overview of Sevelamer carbonate Winthrop and why it is authorised in the EU
Danish: En oversigt over Sevelamer carbonate Winthrop, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Winthrop?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sevelamer carbonate Winthrop?
English: (sevelamer carbonate)
Danish: (sevelamercarbonat)
English: Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Danish: Sevelamer carbonate Winthrop er et lægemiddel, der anvendes til regulering af hyperfosfatæmi (forhøjet niveau af fosfat i blodet) hos:
English: Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Danish: Sevelamer carbonate Winthrop må ikke anvendes hos personer med lavt fosfatindhold i blodet eller tarmobstruktion (en blokering af tarmen).
English: Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Danish: Studier har vist, at Sevelamer carbonate Winthrop er effektivt til at sænke niveauet af fosfat i blodet hos patienter med hyperfosfatæmi, og bivirkningerne anses for håndterbare.
English: What is Sevelamer carbonate Winthrop and what is it used for?
Danish: Hvad er Sevelamer carbonate Winthrop, og hvad anvendes det til?
English: Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
Danish: Hos børn, der fik Sevelamer carbonate Winthrop, sås et større fald i fosfor (0,87 mg/dl) end hos børn, der fik placebo (en uvirksom behandling), hvor der sås en stigning i fosfor på 0,04 mg/dl.
English: Other information about Sevelamer carbonate Winthrop
Danish: Andre oplysninger om Sevelamer carbonate Winthrop
English: Why is Sevelamer carbonate Winthrop approved?
Danish: Hvorfor blev Sevelamer carbonate Winthrop godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop.
English: What are the risks associated with Sevelamer carbonate Winthrop?
Danish: Hvilke risici er der forbundet med Sevelamer carbonate Winthrop?
English: For the full list of side effects of Sevelamer carbonate Winthrop, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Sevelamer carbonate Winthrop fremgår af indlægssedlen.
English: Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
Danish: Det er i studier påvist, at Sevelamer carbonate Winthrop er effektivt til at sænke niveauet af fosfat i blodet hos patienter med hyperfosfatæmi.
English: How is Sevelamer carbonate Winthrop used?
Danish: Hvordan anvendes Sevelamer carbonate Winthrop?
English: How does Sevelamer carbonate Winthrop work?
Danish: Hvordan virker Sevelamer carbonate Winthrop?
English: What benefits of Sevelamer carbonate Winthrop have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Sevelamer carbonate Winthrop?
English: Effect is unknown.
Danish: Virkningen er ukendt.
English: ATC code: J05AR17.
Danish: ATC-kode: J05AR17.
English: None of the changes was considered clinically relevant.
Danish: Ingen af ændringerne blev vurderet at være klinisk relevante.
English: Date of first authorisation: 21 April 2016
Danish: Dato for første markedsføringstilladelse: 21 april 2016
English: Descovy contains two active substances:
Danish: Descovy indeholder to aktive stoffer:
English: Effects on medicinal product levels.
Danish: Virkning på lægemiddelniveauer.
English: • Use effective contraception while taking Descovy.
Danish: • Anvend effektiv prævention, mens De tager Descovy.
English: Keep the tablet bottle with you so that you can show what you have taken.
Danish: Tag beholderen med, så De kan vise, hvad De har taget.
English: Descovy therefore reduces the amount of HIV in your body.
Danish: Descovy nedsætter derfor mængden af hiv i Deres krop.
English: As a result, the amounts of Descovy or other medicines in your blood may change.
Danish: Som et resultat heraf kan mængden af Descovy eller anden medicin i Deres blod ændres.
English: Adults: one tablet each day, with or without food
Danish: Voksne: en tablet om dagen sammen med eller uden mad
English: 5 Study conducted with Descovy.
Danish: 5 Studiet blev udført med Descovy.
English: If you have taken Descovy during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Descovy under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Table 2: Interactions between the individual components of Descovy and other medicinal products
Danish: Tabel 2: Interaktion mellem Descovys individuelle komponenter og andre lægemidler
English: • antiviral medicines used to treat HIV:
Danish: • antivirale lægemidler, der anvendes til at behandle hiv:
English: Therefore, the same problems may be seen if Descovy is administered with a third nucleoside analogue.
Danish: Derfor er det muligt, at de samme problemer vil ses, når Descovy administreres sammen med en tredje nukleosidanalog.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og beholderen efter ”EXP”.
English: • Your doctor may not prescribe Descovy to you if the virus has a K65R mutation.
Danish: • Det kan være, at Deres læge ikke ordinerer Descovy til Dem, hvis Deres virus har en K65Rmutation.
English: There are no data on fertility from the use of Descovy in humans.
Danish: Der foreligger ingen data om fertilitet fra anvendelsen af Descovy til mennesker.
English: Patients were stratified by the class of the third agent in their prior treatment regimen.
Danish: Patienterne blev stratificeret ved klassen for det tredje stof i deres tidligere behandlingsregime.
English: The adverse reactions in Table 3 are listed by system organ class and frequency.
Danish: Bivirkningerne i tabel 3 er opstillet pr. systemorganklasse og hyppighed.
English: You should not take Descovy with medicines containing:
Danish: De må ikke tage Descovy sammen med lægemidler, der indeholder:
English: The use of Descovy in children aged 11 years or under has not yet been studied.
Danish: Anvendelsen af Descovy til børn i alderen 11 år eller derunder er ikke undersøgt endnu.
English: Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af overdosering med Descovy består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: If you have both HIV infection and hepatitis B, it is very important not to stop taking Descovy without talking to your doctor first.
Danish: Hvis De har både hiv-infektion og hepatitis B, er det meget vigtigt ikke at ophøre med at tage Descovy uden først at konsultere Deres læge.
English: While taking Descovy you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Descovy, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: It is recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk.
Danish: Det anbefales, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: Descovy can cause dizziness.
Danish: Descovy kan forårsage svimmelhed.
English: Recommendation concerning co-administration with Descovy
Danish: Anbefalinger vedrørende samtidig administration med Descovy
English: Although kidney problems have not been observed with Descovy, there is a possibility that you may experience kidney problems when taking Descovy over a long period of time.
Danish: Selvom der ikke er blevet observeret nyreproblemer med Descovy, er der en mulighed for, at De kan opleve nyreproblemer, når De tager Descovy over længere tid.
English: If Descovy is stopped for any reason, speak to your doctor before you restart taking Descovy tablets.
Danish: Hvis Descovy stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Descovy tabletter.
English: If you are on dialysis, take your daily dose of Descovy following completion of dialysis.
Danish: Hvis De er i dialyse, skal De tage Deres daglige dosis Descovy, efter De har fuldført Deres dialyse.
English: (ng/mL)
Danish: (ng•t/ml)
English: It is not an inhibitor or inducer of CYP3A in vivo.
Danish: Det er ikke en hæmmer eller inducer af CYP3A in vivo.
English: Stopping Descovy can seriously affect how well future treatment works.
Danish: Descovy, kan det i alvorlig grad påvirke hvor godt fremtidig behandling virker.
English: Patients should be informed that dizziness has been reported during treatment with Descovy.
Danish: Patienter bør informeres om, at svimmelhed er blevet indberettet under behandling med Descovy.
English: Descovy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Descovy bør kun anvendes under graviditet, hvis den potentielle fordel berettiger den potentielle risiko for fosteret.
English: There are no adequate and well-controlled studies of Descovy or its components in pregnant women.
Danish: Der er ingen tilstrækkelige og velkontrollerede studier af Descovy eller Descovy-indholdsstoffer hos gravide kvinder.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>.
English: No emergent resistance to E/C/F/TAF was detected through Week 48.
Danish: Der blev ikke detekteret nogen fremkomst af resistens over for E/C/F/TAF til og med uge 48.
English: If you have hepatitis B liver problems may become worse after you stop taking Descovy.
Danish: Hvis De har hepatitis B kan leverproblemerne blive værre, efter De holder op med at tage Descovy.
English: You must remain under the care of your doctor while taking Descovy.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Descovy.
English: Do not stop taking Descovy without talking to your doctor: see section 3, Do not stop taking Descovy.
Danish: Hold ikke op med at tage Descovy uden at tale med lægen: se punkt 3, Hold ikke op med at tage Descovy.
English: Interactions between the components of Descovy and potential co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem Descovy-komponenterne og mulige samtidigt administrerede lægemidler ses i tabel 2 (stigning er angivet som ”↑”, fald som ”↓”, ingen ændring som ”↔”).
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på, at leversygdommen forværres hos sådanne patienter, skal seponering overvejes eller at foretage et ophold i behandlingen.
English: The film-coated tablet should not be chewed, crushed, or split.
Danish: Den filmovertrukne tablet må ikke tygges, knuses eller deles.
English: • Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection.
Danish: • Autoimmunsygdomme (når immunsystemet angriber sundt kropsvæv) kan også opstå, efter De begynder at tage lægemidler mod hiv-infektion.
English: If you take more than the recommended dose of Descovy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Danish: Hvis De tager mere end den anbefalede dosis Descovy, kan De have større risiko for at få bivirkninger fra denne medicin (se punkt 4, Bivirkninger).
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Danish: De 50 % effektive koncentrationsværdier (EC50) for emtricitabin var i intervallet fra 0,0013 til 0,64 µM.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug; antivirale midler til behandling af hiv-infektioner, kombinationer.
English: There are no efficacy and safety studies conducted in treatment-naïve patients with Descovy.
Danish: Der er ikke udført studier af virkning og sikkerhed hos behandlingsnaive patienter med Descovy.
English: Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Danish: Denne medicin må ikke gives til børn i alderen 11 år eller derunder eller børn, som vejer under 35 kg.
English: Descovy should be taken orally, once daily with or without food (see section 5.2).
Danish: Descovy skal tages oralt, én gang dagligt, sammen med eller uden mad (se pkt.
English: Talk to your doctor before taking Descovy: • If you have liver problems or have suffered liver disease, including hepatitis.
Danish: Kontakt lægen, før De tager Descovy: • Hvis De har leverproblemer, eller hvis De tidligere har lidt af en leversygdom, herunder hepatitis (gulsot).
English: Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity
Danish: Vær opmærksom på symptomer på infektion eller andre symptomer, såsom: muskelsvaghed svaghed, der begynder i hænder og fødder og bevæger sig op mod selve kroppen hjertebanken, rysten eller hyperaktivitet.