natgillin/translations-raw huggingface dataset:
Efter af virksomheden havde fremlagt de supplerende oplysninger, der var blevet anmodet om, blev godkendelsen ændret fra ” under særlige omstændigheder” til ” normal ” godkendelse den 16. december 2008.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 16 December 2008.
Andre oplysninger om Prezista:
2/ 3 Other information about Prezista:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prezista til Janssen- Cilag International NV den 12. februar 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Prezista to Janssen-Cilag International NV on 12 February 2007.
Den fuldstændige EPAR for Prezista findes her.
The full EPAR for Prezista can be found here.
Dette sammendrag blev sidst ajourført i 01- 2009
This summary was last updated in 01-2009.
EU- nummer EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
EU Number EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
Særnavn Prezista Prezista Prezista
Invented name Prezista Prezista Prezista
Styrke 300 mg 600 mg 400 mg
Strength 300 mg 600 mg 400 mg
Lægemiddelform Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use Oral use
Emballage Flaske (HDPE) Flaske (HDPE) Flaske (HDPE)
Packaging bottle (HDPE) bottle (HDPE) bottle (HDPE)
Paknings- størrelse 120 tabletter 60 tabletter 60 tabletter
Package size 120 tablets 60 tablets 60 tablets
PREZISTA 300 mg filmovertrukne tabletter.
PREZISTA 300 mg film-coated tablets.
Hver tablet indeholder 1, 375 mg Sunset yellow FCF (E110).
Each tablet contains 1.375 mg sunset yellow FCF (E110).
Orange, oval tablet med "300MG" præget på den ene side og "TMC114" præget på den anden side.
Orange oval shaped tablet, debossed with “ 300MG” on one side and “ TMC114” on the other side.
PREZISTA, administreret sammen med 100 mg ritonavir, er indiceret i kombination med andre antiretrovirale lægemidler til behandling af human immundefekt virus (HIV- 1) - infektion hos voksne patienter, som tidligere har været i behandling, inklusiv patienter der tidligere har været i omfattende behandling.
PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.
I forbindelse med beslutningen om at påbegynde behandling med PREZISTA, administreret sammen med 100 mg ritonavir, skal man nøje overveje den enkelte patients behandlingsanamnese og de mutationsmønstre, der er forbundet med forskellige midler.
In deciding to initiate treatment with PREZISTA co-administered with 100 mg ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Genotype - og fænotypebestemmelse (hvor det er muligt) og behandlingsanamnese skal være vejledende for brugen af PREZISTA.
Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
Behandlingen skal påbegyndes af en læge, der har erfaring med håndtering af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
PREZISTA skal altid gives peroralt med 100 mg ritonavir som en farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler.
PREZISTA must always be given orally with 100 mg ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Man skal derfor læse produktresuméet for ritonavir og de andre antiretrovirale lægemidler inden påbegyndelse af behandling med PREZISTA.
The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with PREZISTA.
Den anbefalede dosis af PREZISTA er 600 mg to gange dagligt (x 2) indtaget sammen med ritonavir 100 mg, dvs. også to gange dagligt.
The recommended dosage of PREZISTA is 600 mg twice daily (b. i. d.) taken with ritonavir 100 mg b. i. d. and with food.
4. 4, 4. 5 og 5. 2).
The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
PREZISTA bør ikke anvendes til børn og unge, da der ikke foreligger data om sikkerhed, virkning og farmakokinetik.
PREZISTA is not recommended for use in children and adolescents because there are no data on safety, efficacy and pharmacokinetics.
4. 4 og 5. 2).
Limited information is available in this population (see sections 4.4 and 5.2).
Dog skal PREZISTA anvendes med forsigtighed til disse patienter.
No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, PREZISTA should be used with caution in these patients.
4. 3, 4. 4 og 5. 2).
Therefore, PREZISTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
4. 4 og 5. 2).
No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
2 Hvis en patient bliver opmærksom på, at en dosis PREZISTA og/ eller ritonavir er blevet glemt inden for 6 timer efter det tidspunkt, hvor den normalt tages, skal patienten instrueres i at tage den ordinerede dosis PREZISTA og ritonavir med mad så hurtigt som muligt.
2 In case a dose of PREZISTA and/ or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible.
Hvis patienten bliver opmærksom på den glemte dosis mere end 6 timer efter det tidspunkt, hvor den normalt tages, må den glemte dosis ikke tages, og patienten skal genoptage den sædvanlige doseringsplan.
If this was noticed later than 6 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
12 timer.
This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Patienter med svær (Child- Pugh klasse C) nedsat leverfunktion.
Patients with severe (Child-Pugh Class C) hepatic impairment.
4. 5).
Combination of rifampicin with PREZISTA with concomitant low dose ritonavir is contraindicated (see section 4.5).
4. 5).
The combination product lopinavir/ ritonavir should not be used with PREZISTA because co-administration causes large decreases in darunavir concentrations, which may in turn significantly decrease the darunavir therapeutic effect (see section 4.5).
4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking PREZISTA due to the risk of decreased plasma concentrations and reduced clinical effects of darunavir (see section 4.5).
Samtidig administration af PREZISTA, med 100 mg ritonavir, og aktive stoffer, der er meget afhængige af CYP3A for eliminering, og for hvilke forhøjede plasmakoncentrationer er forbundet med alvorlige og/ eller livstruende hændelser, er kontraindiceret.
Co-administration of PREZISTA with 100 mg ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/ or life-threatening events is contraindicated.
4. 5).
These active substances include e. g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e. g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ hypnotics (triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)) and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
Patienterne skal oplyses om, at den aktuelle antiretrovirale behandling ikke helbreder HIV, og at det ikke er bevist, at den forebygger overførsel af HIV til andre via blod eller seksuel kontakt.
Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact.
Der skal derfor stadig tages de rette forholdsregler.
Appropriate precautions should continue to be employed.
5. 2).
PREZISTA should only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see section 5.2).
4. 2 påvirkede ikke koncentrationen af darunavir i signifikant grad og anbefales ikke.
Increasing the dose of ritonavir from that recommended in section 4.2 did not significantly affect darunavir concentrations and is not recommended.
4. 2 og 5. 2).
As limited information is available on the use of PREZISTA in patients aged 65 and over, caution should be exercised in the administration of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Darunavir binder sig hovedsageligt til α1- syre- glycoprotein.
Darunavir binds predominantly to α 1-acid glycoprotein.
Denne proteinbinding er koncentrationsafhængig som er indikativ for mætning af binding.
This protein binding is concentration dependent indicative for saturation of binding.
Derfor kan man ikke udelukke en proteinfortrængning af lægemidler, der i udstrakt grad binder sig til α1- syre- glycoprotein.
Therefore, protein displacement of medicinal products highly bound to α 1-acid glycoprotein cannot be ruled out.
Alvorlige hududslæt, der kan ledsages af feber og/ eller forøgelser af transaminaser, er forekommet hos 0, 5% af PREZISTA- behandlede patienter.
Severe skin rash, which may be accompanied with fever and/ or elevations of transaminases, has occurred in 0.5% of patients treated with PREZISTA.
Erythema multiforme og Stevens- Johnsons syndrom er
Erythema multiforme and Stevens-Johnson
3 sjældent (< 0, 1%) observeret.
3 Syndrome have been rarely (< 0.1%) observed.
Behandling med PREZISTA skal seponeres, hvis sådanne tilstande udvikler sig.
Treatment with PREZISTA should be discontinued if such a condition develops.
Darunavir indeholder en sulfonamid- del.
Darunavir contains a sulphonamide moiety.
Patienter med co- eksisterende tilstande Nedsat leverfunktion Sikkerheden og virkningen af PREZISTA er ikke blevet fastslået hos patienter med alvorlige, underliggende leversygdomme, og PREZISTA er derfor kontraindiceret til patienter med svært nedsat leverfunktion.
Patients with coexisting conditions Hepatic impairment The safety and efficacy of PREZISTA have not been established in patients with severe underlying liver disorders and PREZISTA is therefore contraindicated in patients with severe hepatic impairment.
4. 2, 4. 3 og 5. 2).
Due to an increase in the unbound darunavir plasma concentrations, PREZISTA should be used with caution in patients with mild or moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Patienter med kronisk hepatitis B eller C, der får antiretroviral kombinationsbehandling, har en forhøjet risiko for alvorlige og potentielt dødelige hepatiske uønskede hændelser.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der til de relevante produktresuméer for disse lægemidler.
In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Patienter med præeksisterende leverdysfunktion, herunder kronisk hepatitis, har en øget forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling, og de skal monitoreres i henhold til standardpraksis.
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Hvis der er tegn på forværring af leversygdommen hos disse patienter, skal man overveje at afbryde eller seponere behandlingen.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Nedsat nyrefunktion Der gælder ingen særlige sikkerhedsregler eller dosisjusteringer for patienter med nedsat nyrefunktion.
Renal impairment No special precautions or dose adjustments are required in patients with renal impairment.
4. 2 og 5. 2).
Therefore, no special precautions or dose adjustments are required in these patients (see sections 4.2 and 5.2).
Patienter med hæmofili Der har været rapporter om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthron hos patienter med type A - og B- hæmofili, der behandles med PI' er.
Haemophiliac patients There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
I over halvdelen af de rapporterede tilfælde fortsatte behandlingen med PI' er eller blev genoptaget, hvis den havde været afbrudt.
In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
Patienter med hæmofili skal derfor oplyses om muligheden for øget blødningstendens.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Diabetes mellitus/ hyperglykæmi Der er rapporter om nyligt opstået diabetes mellitus, hyperglykæmi eller forværring af eksisterende diabetes mellitus hos patienter, der får antiretroviral behandling, herunder PI' er.
Diabetes mellitus/ Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy, including PIs.
Hos nogle af disse patienter var hyperglykæmien alvorlig og i nogle tilfælde også forbundet med ketoacidose.
In some of these patients the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Mange patienter havde andre medicinske tilstande, hvoraf nogle krævede behandling med lægemidler, der har været forbundet med udvikling af diabetes mellitus eller hyperglykæmi.
Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Omfordeling af fedt og metaboliske forstyrrelser Antiretroviral kombinationsbehandling er blevet forbundet med omfordeling af kropsfedt (lipodystrofi) hos HIV- inficerede patienter.
Fat redistribution and metabolic disorders Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
Man kender ikke på nuværende tidspunkt de langsigtede konsekvenser af disse hændelser.
The long-term consequences of these events are currently unknown.
Der foreligger kun ufuldstændige oplysninger om mekanismen.
Knowledge about the mechanism is incomplete.
Man har opstillet en hypotese om en forbindelse mellem visceral lipomatose og PI' er og lipoatrofi og NRTI' er.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
En højere risiko for lipodystrofi er blevet forbundet med individuelle faktorer såsom stigende alder og med lægemiddelrelaterede faktorer såsom længere varighed af antiretroviral behandling og tilknyttede metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Det bør overvejes at måle fastende serumlipider og blodglukose.
Consideration should be given to measurement of fasting serum lipids and blood glucose.
Osteonekrose
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been
4 Selvom ætiologien anses for at være multifaktoriel (herunder kortikosteroidbehandling, alkoholforbrug, alvorlig immunsuppression, højt BMI), er der rapporteret tilfælde af osteonekrose, især hos patienter med fremskreden HIV- sygdom og/ eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
4 reported particularly in patients with advanced HIV disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Immunreaktiveringssyndrom Hos HIV- inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
Immune reactivation syndrome In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/ eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jiroveci (tidligere kendt som Pneumocystis carinii).
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Derudover er der observeret reaktivering af herpes simplex og herpes zoster i kliniske forsøg med PREZISTA, co- administreret med 100 mg ritonavir.
In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with PREZISTA co-administered with 100 mg ritonavir.
Interaktioner med lægemidler Adskillige af interaktionsstudierne er blevet udført med en lavere dosis af darunavir end rekommanderet.
Interactions with medicinal products Several of the interaction studies have been performed at lower than recommended doses of darunavir.
Effekten på co- administreret medicin er derfor muligvis undervurderet, og klinisk sikkerhedsmonitorering kan være indiceret.
The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
4. 5.
For full information on interactions with other medicinal products see section 4.5.
PREZISTA- tabletter indeholder Sunset yellow FCF (E110), som kan forårsage en allergisk reaktion.
PREZISTA tablets contain sunset yellow FCF (E110) which may cause an allergic reaction.
Darunavir og ritonavir er begge hæmmere af CYP3A4- isoformen.
Darunavir and ritonavir are both inhibitors of the CYP3A4 isoform.
Co- administration af darunavir og ritonavir med lægemidler, der især metaboliseres af CYP3A4, kan forårsage øget systemisk eksponering for sådanne lægemidler, hvilket kan øge eller forlænge både den terapeutiske virkning og bivirkninger.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP3A4 may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
PREZISTA, co- administreret med 100 mg ritonavir, må ikke kombineres med lægemidler, der er meget afhængige af CYP3A4 i forbindelse med clearance, og for hvilke øget systemisk eksponering er forbundet med alvorlige og/ eller livstruende hændelser (snævert terapeutisk indeks).
PREZISTA co-administered with 100 mg ritonavir must not be combined with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/ or life-threatening events (narrow therapeutic index).
4. 3).
These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
14- fold stigning i den systemiske eksponering for darunavir ved administration af en peroral enkeltdosis darunavir på 600 mg i kombination med ritonavir 100 mg x 2.
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg b. i. d.
4. 4 og 5. 2).
Therefore, PREZISTA must only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Dette kan skyldes tilstedeværelsen af lav- dosis ritonavir.
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of PREZISTA/ rtv, which may be attributed to the presence of low dose ritonavir.
Co- administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2D6 (såsom flecainid, propafenon, metoprolol), kan resultere i en øget plasmakoncentration af disse lægemidler, hvilket kan øge eller forlænge deres terapeutiske effekt og bivirkninger.
Co-administration of darunavir and ritonavir and medicinal products which are primarily metabolised by CYP2D6 (such as flecainide, propafenone, metoprolol) may result in increased plasma concentrations of these medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Co- administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C9 (såsom warfarin) og CYP2C19 (såsom methadon) kan resultere i nedsat systemisk eksponering af disse lægemidler, hvilket kan nedsætte eller forkorte deres terapeutiske effekt.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Selvom effekten på CYP2C8 kun er blevet undersøgt in vitro, kan co- administration af darunavir og ritonavir og lægemidler, som primært metaboliseres af CYP2C8 (såsom paclitaxel, rosiglitazon, repaglinid), resultere i nedsat systemisk eksponering af disse lægemidler, hvilken kan nedsætte eller forkorte deres terapeutiske effekt.
Although the effect on CYP2C8 has only been studied in vitro, co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 (such as paclitaxel, rosiglitazone, repaglinide) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
5 Lægemidler, der påvirker eksponeringen for darunavir/ ritonavir Darunavir og ritonavir metaboliseres via CYP3A.
5 Medicinal products that affect darunavir/ ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Lægemidler, der inducerer CYP3A- aktivitet, ville forventes at øge clearance af darunavir og ritonavir, hvilket medfører en lavere plasmakoncentration af darunavir og ritonavir (f. eks. rifampicin, perikon, lopinavir).
Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e. g. rifampicin, St John’ s wort, lopinavir).