natgillin/translations-raw huggingface dataset:
• Øvrige indholdsstoffer: natriumchlorid, vand til injektionsvæsker, saltsyre/ natriumhydroxid
• The other ingredients are sodium chloride, water for injections, hydrochloric acid/ sodium hydroxide
Udseende og pakningsstørrelser Atriance opløsning til infusion er en klar, farveløs opløsning.
What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Hætteglas af klart glas med en latex- fri gummiprop og forseglet med en aluminiumhætte.
It is provided in clear glass vials with a non-latex containing rubber stopper and sealed with an aluminium cap.
Indehaver af markedsføringstilladelsen Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Storbritannien.
Marketing Authorisation Holder Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Fremstiller Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations):
Manufacturer Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations):
Harmire Road, Barnard Castle, County Durham DL12 8DT, Storbritannien.
Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom.
Hvis du vil have yderligere oplysninger om Atriance, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Denne indlægsseddel blev senest godkendt
This leaflet was last approved in.
Atriance er godkendt under ” særlige omstændigheder ”.
This medicine has been authorised under “ exceptional circumstances”.
Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for Atriance fordi det drejer sig om en sjælden sygdom.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Det europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende Atriance, og denne indlægsseddel vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Du kan finde yderligere information om Atriance på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
33 Følgende oplysninger er tiltænkt læger og sundhedspersonale:
33 The following information is intended for medical or healthcare professionals only:
Opbevaring af Atriance infusionsvæske
Storage of Atriance solution for infusion
• Personalet skal være uddannet i at håndtere og overføre lægemidlet. • Gravide medarbejdere bør ikke arbejde med dette lægemiddel. • Personale, der hånterer dette lægemiddel, bør bære beskyttelsesdragt inklusiv maske, briller og handsker. • Alt udstyr brugt til administration eller rengøring inklusiv handsker, bør anbringes i en højrisiko- affaldssæk til forbrænding ved høj temperatur.
• Staff should be trained in how to handle and transfer the medicinal product. • Pregnant staff should be excluded from working with this medicinal product. • Personnel handling this medicinal product during handling/ transfer should wear protective clothing including mask, goggles and gloves. • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Flydende affaldsmateriale kan skylles ud i vasken med rigelige mængder vand. • Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder af vand.
Liquid waste may be flushed with large amounts of water. • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Atripla er et lægemiddel, der indeholder tre aktive stoffer: efavirenz (600 mg), emtricitabin (200 mg) og tenofovirdisoproxil (245 mg).
Atripla is a medicine containing three active substances: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Det fås som lyserøde kapselformede tabletter.
It is available as pink, capsule-shaped tablets.
Atripla er et antiviralt lægemiddel.
Atripla is an antiviral medicine.
Det anvendes til behandling af voksne, der er smittet med humant immundefektvirus type 1 (hiv- 1), som er en virus, der forårsager erhvervet immundefekt syndrom (aids).
It is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Det anvendes kun til patienter, hvis koncentration af hiv i blodet (virusbelastning) har været under 50 kopier/ ml i mere end tre måneder med deres nuværende hiv- behandlingskombination.
It is only used in patients whose levels of HIV in the blood (viral loads) have been below 50 copies/ ml for more than three months on their current HIV treatment combination.
Det må ikke anvendes til patienter, hos hvem tidligere hiv- behandlingskombinationer ikke har virket eller er ophørt med at virke.
It must not be used in patients in whom any previous HIV treatment combinations have failed to work or have stopped working.
Det skal være påvist, at patienterne ikke er smittet med hiv, der sandsynligvis ikke ville have responderet på et eller flere af de tre aktive stoffer i Atripla, inden de påbegyndte deres første hiv- behandlingskombination.
Patients must be known not to have been infected with HIV that was unlikely to respond to any of the three active substances in Atripla before they started their first HIV treatment combination.
Behandling med Atripla skal startes af en læge med erfaring i behandling af hiv- infektion.
Treatment with Atripla should be started by a doctor who has experience in the management of HIV infection.
Atripla skal anvendes med forsigtighed til ældre patienter.
Atripla should be used with caution in elderly patients.
Atripla anbefales ikke til patienter, der har moderate eller alvorlige problemer med nyrerne.
Atripla is not recommended for patients who have moderate or severe problems with their kidneys.
Patienter med leverproblemer skal observeres nøje for bivirkninger.
Patients who have problems with their liver should be monitored closely for side effects.
Atripla må ikke tages samtidig med andre lægemidler, der indeholder efavirenz, emtricitabin eller tenofovirdisoproxil, eller lamivudin (andet antiviralt lægemiddel).
Atripla should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Hvordan virker Atripla?
Reproduction is authorised provided the source is acknowledged. tenofovir in the body.
Både nukleoside og nukleotide revers transkriptasehæmmere betegnes som NRTI' er.
Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Det kurerer ikke hiv- infektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og udviklingen af infektioner og sygdomme, der er forbundet med aids.
It does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Efavirenz har været godkendt som Sustiva og Stocrin siden 1999, emtricitabin har været godkendt som Emtriva siden 2003, og tenofovirdisoproxil har været godkendt som Viread siden 2002.
All three active substances are already available in the European Union (EU): efavirenz has been approved as Sustiva and Stocrin since 1999, emtricitabine has been approved as Emtriva since 2003, and tenofovir disoproxil has been approved as Viread since 2002.
Hovedundersøgelsen af Atripla omfattede 300 patienter, hvis hiv- infektion allerede var under effektiv behandling med forskellige kombinationer af antivirale lægemidler.
The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines.
Undersøgelsen sammenlignede virkningen af at skifte til Atripla- tabletter, indtaget på tom mave, med virkningen af at fortsætte den effektive hiv- behandlingskombination.
The study compared the effectiveness of switching to Atripla tablets, taken on an empty stomach, with that of remaining on the successful HIV treatment combination.
Det primære effektmål var andelen af patienter, hvis virusbelastning var under 200 kopier/ ml efter 48 uger.
The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ ml after 48 weeks.
Virksomheden undersøgte også, hvordan den kombinerede tablet blev absorberet i kroppen sammenlignet med de separate lægemidler.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Efter 48 uger havde 89% af de patienter, der fik Atripla (181 ud af 203), og 88% af de patienter, der fortsatte med den tidligere behandling (85 ud af 97), en virusbelastning på mindre end 200 kopier/ ml.
After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ ml.
Den mest almindelige bivirkning ved Atripla (som ses hos flere end 1 ud af 10 patienter) er svimmelhed.
The most common side effect with Atripla (seen in more than 1 patient in 10) is dizziness.
Den fuldstændige liste over de indberettede bivirkninger ved Atripla fremgår af indlægssedlen.
For the full list of all side effects reported with Atripla, see the Package Leaflet.
Atripla må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for efavirenz, emtricitabin, tenofovirdisoproxil eller et eller flere af de øvrige indholdsstoffer.
Atripla should not be used in people who may be hypersensitive (allergic) to efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients.
Det må ikke anvendes til patienter med alvorlig leversygdom, eller som tager et eller flere af følgende lægemidler: • terfenadin, astemizol (anvendes ofte til at behandle symptomer på allergi – disse lægemidler kan muligvis fås uden recept) • cisaprid (anvendes mod visse maveproblemer) • midazolam, triazolam (anvendes mod angst og søvnbesvær) • pimozid (anvendes til behandling af psykiske sygdomme) • bepridil (anvendes mod angina) • ergotalkaloider, f. eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin (anvendes mod migræne) • perikon (urtemedicin mod depression) • voriconazol (mod svampeinfektioner).
It must not be used in patients with severe liver disease or who are taking any of the following medicines: • terfenadine, astemizole (commonly used to treat allergy symptoms – these medicines may be available without prescription); • cisapride (used to relieve certain stomach problems); • midazolam, triazolam (used to relieve anxiety or difficulty sleeping); • pimozide (used to treat mental illnesses); • bepridil (used to treat angina); • ergot alkaloids such as ergotamine, dihydroergotamine, ergonovine and methylergonovine (used to treat migraine headache); • St John’ s wort (a herbal preparation used to treat depression); • voriconazole (used to treat fungal infections).
Ligesom med andre lægemidler mod hiv kan der ved brug af Atripla være en øget risiko for, at patienterne får lipodystrofi (forandringer i fordelingen af kropsfedt), knoglenekrose (knoglevævsdød) eller immunreaktiveringssyndrom (symptomer på infektion, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Atripla may be at increased risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Patienter med leverproblemer (herunder hepatitis B - eller C- infektion) kan have øget risiko for leverbeskadigelse, når de tager Atripla.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Atripla.
Som andre lægemidler, der indeholder NRTI' er, kan Atripla også forårsage mælkesyreacidose (en ophobning af mælkesyre i kroppen).
As with other medicines containing NRTIs, Atripla may also cause lactic acidosis (a build-up of lactic acid in the body).
2/ 3 Hvorfor blev Atripla godkendt?
Why has Atripla been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at Atripla skal tages på tom mave for at forhindre visse bivirkninger, men at dette kan resultere i en lav tenofovirkoncentration i blodet.
The Committee for Medicinal Products for Human Use (CHMP) noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood.
Udvalget konkluderede således, at Atripla kunne være en passende behandling med én tablet én gang om dagen, hvis det blev anvendt til at opretholde en lav virusbelastning hos patienter, der allerede fik hiv- behandling, men der foreligger ikke tilstrækkelig information om virkningerne hos patienter, der ikke tidligere har været behandlet.
Therefore, the Committee concluded that Atripla could be a convenient ‘ one-tablet once-a- day’ treatment when used to maintain low viral loads in patients already taking HIV treatment, but 2/ 3 there is not enough information to be certain about its effects in patients who have not been treated before.
Udvalget besluttede derfor, at fordelene ved Atripla er større end risiciene til behandling af hiv- 1- infektion hos voksne med virologisk suppression til hiv- 1 RNA - koncentrationer under 50 kopier/ ml, som er i antiretroviral kombinationsbehandling og har været det i mere end tre måneder.
Therefore, the Committee decided that Atripla’ s benefits are greater than its risks for the treatment of HIV-1 infection in adults with virologic suppression to HIV-1 ribonucleic acid (RNA) levels of less than 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
Udvalget bemærkede, at påvisning af Atriplas gavnlige effekt primært er baseret på 48 ugers data fra en undersøgelse, hvor patienter med stabil suppression af hiv i hiv- kombinationsbehandling skiftede til Atripla.
The Committee noted that the demonstration of Atripla’ s benefit is based mainly on 48-week data from a study in patients with stable suppression of HIV on an HIV treatment combination who then switched to Atripla.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Atripla.
The Committee recommended that Atripla be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Atripla?
Which measures are being taken to ensure the safe use of Atripla?
Den virksomhed, som fremstiller Atripla, skal sikre, at lægemidlet anvendes på en sikker måde på baggrund af betænkelighederne ved de mulige virkninger af tenofovirdisoproxil på nyrerne.
The company that makes Atripla will make sure that the medicine is used safely, bearing in mind concerns over possible effects of tenofovir disoproxil on the kidneys.
Andre oplysninger om Atripla:
Other information about Atripla:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Atripla til Bristol- Myers Squibb And Gilead Sciences Limited den 13. december 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Atripla to Bristol-Myers Squibb And Gilead Sciences Limited on 13 December 2007.
Den fuldstændige EPAR for Atripla findes her.
The full EPAR for Atripla can be found here.
EU- nummer.
Invented name Atripla
EU/ 1/ 07/ 430/ 001 EU/ 1/ 07/ 430/ 002
EU/ 1/ 07/ 430/ 002
Særnavn Atripla Atripla
Atripla
Styrke 600 mg/ 200 mg/ 245 mg * 600 mg/ 200 mg/ 245 mg *
600 mg/ 200 mg/ 245 mg *
Lægemiddelform Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet
Administrationsvej Oral anvendelse Oral anvendelse
Oral use
Emballage Flaske (HDPE/ alu) Flaske (HDPE/ alu)
Bottle (HDPE/ alu)
Pakningsstørrelse 30 filmovertrukne tabletter 3 x 30 filmovertrukne tabletter
3 x 30 film-coated tablets
Atripla 600 mg/ 200 mg/ 245 mg filmovertrukne tabletter.
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets
Hver filmovertrukken tablet indeholder 1 mmol (23, 6 mg) natrium.
Each film-coated tablet contains 1 mmol (23.6 mg) of sodium.
Lyserød, kapselformet, filmovertrukken tablet med "123" præget på den ene side; den anden side er glat.
Pink, capsule shaped, film-coated tablet, debossed with “ 123” on one side, plain on the other side.
Atripla er en fastdosis- kombination af efavirenz, emtricitabin og tenofovirdisoproxilfumarat.
Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Atripla er indiceret til behandling af human immundefekt virus- 1 (HIV- 1) - infektion hos voksne med virologisk suppression til HIV- 1 RNA- koncentrationer < 50 kopier/ ml, som er i antiretroviral kombinationsbehandling og har været det i mere end 3 måneder.
It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
4. 4 og 5. 1).
Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1).
5. 1).
The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see section 5.1).
Der findes for tiden ingen data fra kliniske undersøgelser med Atripla til behandlingsnaive patienter eller patienter, som tidligere har fået massiv behandling.
No data are currently available from clinical studies with Atripla in treatment-naïve or in heavily pretreated patients.
Behandlingen bør initieres af en læge, der har erfaring med behandling af human immundefekt virus (HIV) - infektion.
Therapy should be initiated by a physician experienced in the management of human immunodeficiency virus (HIV) infection.
Den anbefalede dosis af Atripla er én tablet peroralt én gang dagligt.
Posology Adults: the recommended dose of Atripla is one tablet taken orally once daily.
Indgivelsesmåde Atripla bør sluges hel sammen med vand.
Method of administration It is recommended that Atripla be swallowed whole with water.
2 Atripla bør tages på tom mave, da mad kan øge efavirenz- eksponeringen og kan føre til øget bivirkningsfrekvens (se pkt.
It is recommended that Atripla be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8).
4. 8).
2 In order to improve the tolerability to efavirenz with respect to undesirable effects on the nervous system, bedtime dosing is recommended (see section 4.8).
(se pkt.
It is anticipated that tenofovir exposure will be approximately 35% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil fumarate when taken with food (see section 5.2).
Den kliniske betydning af denne reduktion må forventes at være begrænset hos virologisk suprimerede patienter (se pkt.
In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
Yderligere data om den kliniske translation af fald i farmakokinetisk eksponering afventes.
Further data on the clinical translation of the decrease in pharmacokinetic exposure is awaited.
Atripla bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Atripla is not recommended for use in children below 18 years of age due to lack of data on safety and efficacy.
Antallet af ældre patienter, der er vurderet i kliniske undersøgelser af komponenterne i Atripla, er ikke tilstrækkeligt til at afgøre, om de responderer anderledes end yngre patienter.
Elderly: insufficient numbers of elderly patients have been evaluated in clinical studies of the components of Atripla to determine whether they respond differently than younger patients.
Forsigtighed tilrådes ved ordination til ældre, i betragtning af deres højere frekvens af nyre - eller leverinsufficiens.
Caution should be exercised when prescribing Atripla to the elderly, keeping in mind the greater frequency of decreased hepatic or renal function in these patients.
4. 5).
Dose adjustment: if Atripla is co-administered with rifampicin, an additional 200 mg/ day (800 mg total) of efavirenz is recommended (see section 4.5).
Atripla bør ikke gives til patienter med moderat eller svær nyreinsufficiens (kreatinin- clearance < 50 ml/ min).
Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/ min).
4. 4 og 5. 2).
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
Atriplas farmakokinetik er ikke undersøgt hos patienter med leverinsufficiens.
Hepatic impairment: the pharmacokinetics of Atripla have not been studied in patients with hepatic impairment.
4. 3, 4. 4 og 5. 2).
Patients with mild-to-moderate liver disease (Child-Pugh-Turcotte (CPT), Grade A or B) may be treated with the normal recommended dose of Atripla (see sections 4.3, 4.4 and 5.2).
4. 3 og 4. 4).
Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz (see sections 4.3 and 4.4).
4. 4).
If Atripla is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Det er vigtigt at tage Atripla efter en regelmæssig doseringsplan for ikke at glemme doser.
It is important to take Atripla on a regular dosing schedule to avoid missing doses.
Patienterne bør informeres om, at hvis de glemmer at tage Atripla, skal de tage den glemte dosis med det samme, medmindre der er mindre end 12 timer til næste dags dosis.
Patients should be told that if they forget to take Atripla, they should take the missed dose right away, unless it is less than 12 hours until the next day’ s dose.
I dette tilfælde skal patienterne ikke tage den glemte dosis men tage næste dosis til sædvanlig tid.
In this case, patients should be told not to take the missed dose and to take their next dose at the usual time.
Hvis seponering af en af komponenterne i Atripla er indiceret, eller hvis dosismodificering er nødvendig, er separate præparater med efavirenz, emtricitabin og tenofovirdisoproxilfumarat tilgængelige.
Where discontinuation of therapy with one of the components of Atripla is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil fumarate are available.
Se venligst produktresuméet for disse lægemidler.
Please refer to the Summary of Product Characteristics for these medicinal products.
5. 2) samt tenofovirs og emtricitabins lange intracellulære halveringstid tages med i overvejelserne.
If therapy with Atripla is discontinued, consideration should be given to the long half-life of efavirenz (see section 5.2) and long intracellular half-lives of tenofovir and emtricitabine.
På grund af den individuelle variabilitet i disse parametre samt risikoen for resistensudvikling, bør rekommendationerne for HIV- behandling konsulteres, idet årsagen til seponering også tages med i overvejelserne.
Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
5. 2).
Atripla must not be used in patients with severe hepatic impairment (CPT Grade C) (see section 5.2).