FrancophonIA/ELRC3.0 huggingface dataset:
English: Osteonecrosis: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Osteonekrose: Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig CART er der rapporteret om tilfælde af osteonekrose.
English: Atripla, your doctor may need to adjust your dose of the calcium channel blocker.
Danish: kan Deres læge finde det nødvendigt at ændre Deres dosis af calciumblokkeren.
English: In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Danish: I et studie med hiv-inficerede stofmisbrugere, resulterede samtidig administration af efavirenz og methadon i et fald i methadons plasmakoncentrationer og abstinenssymptomer.
English: Cmin: ↓ 8% (↑ 14 to ↓ 25)
Danish: Cmin: ↓ 8% (↑ 14 til ↓ 25)
English: Other interactions Interactions between Atripla or its individual component(s) and other medicinal products are listed in
Danish: Interaktioner mellem Atripla eller dets individuelle komponent(er) og andre lægemidler ses i tabel 1
English: 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 are available.
Danish: Hvis seponering af behandling med en af komponenterne i Atripla er indiceret, eller hvis dosismodificering er påkrævet, er separate efavirenz-, emtricitabin- og tenofovirdisoproxil-præparater tilgængelige.
English: In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/ml (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/ml (29%) of tenofovir.
Danish: Hos patienter med nyresygdom i slutstadiet (ESRD), hvor hæmodialyse var påkrævet, øgedes emtricitabin-eksponeringen mellem dialysebehandlingerne væsentligt i løbet af 72 timer til 53 µg·t/ml (19%), og tenofovir-eksponeringen øgedes i løbet af 48 timer til 42.857 ng·t/ml (29%).
English: If you think you may have lactic acidosis, contact your doctor immediately.
Danish: Hvis De tror, De kan have laktatacidose, skal De straks kontakte lægen.
English: Dose adjustment: If Atripla is co-administered with rifampicin to patients weighing 50 kg or more, an additional 200 mg/day (800 mg total) of efavirenz may be considered (see section 4.5).
Danish: Dosisjustering: Hvis Atripla gives samtidigt med rifampicin til patienter, der vejer 50 kg eller derover, kan det overvejes at give yderligere 200 mg efavirenz/dag (800 mg i alt) (se pkt.
English: When the two strata were analysed separately, response rates in the stratum with prior PI-treatment were numerically lower for patients switched to Atripla [92.4% versus 94.0% for the PVR (sensitivity analysis) for Atripla and SBR patients respectively; a difference (95%CI) of -1.6% (-10.0%, 6.7%).
Danish: Når de to strata blev analyseret separat, var responsraterne i det stratum med tidligere proteasehæmmer-behandling numerisk lavere for de patienter, der skiftede til Atripla [92,4% versus 94,0% for PVR (sensitivitetsanalyse) for henholdsvis Atripla- og SBR-patienter (SBR, stayed on their baseline regimen); en forskel (95% CI) på -1,6% (-10,0%; 6,7%)].
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP isozymes with efavirenz.
Danish: Reduktion eller øgning af phenytoins plasmakoncentrationer, phenobarbital og andre krampestillende lægemidler, som er substrater for CYP-isozymer, er mulig med efavirenz.
English: The separate pharmaceutical forms of efavirenz, emtricitabine and tenofovir disoproxil were used to determine the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil, administered separately in HIV infected patients.
Danish: De separate farmaceutiske former af efavirenz, emtricitabin og tenofovirdisoproxil blev anvendt til at bestemme farmakokinetikken af efavirenz, emtricitabin og tenofovirdisoproxil, når disse blev givet separat til hiv-inficerede patienter.
English: Patients with HIV and hepatitis B (HBV) or C virus (HCV) co-infection Patients with chronic hepatitis B or C and treated with CART are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med hiv, som samtidigt er inficerede med hepatitis B- (HBV) eller C-(HVC)virus Hos patienter med kronisk hepatitis B eller C, som behandles med CART, er der en øget risiko for svære og potentielt fatale, hepatiske bivirkninger.
English: How to take Atripla
Danish: Sådan skal De tage Atripla
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Danish: Den inducerende virkning af perikon kan vare ved i mindst 2 uger efter seponering (se pkt.
English: 8.9% (-7.7% to 25.6%)
Danish: 8,9% (-7,7% til 25,6%)
English: AUC0-last
Danish: AUC0-t
English: Plasma trough concentrations of boceprevir were decreased when administered with efavirenz, a component of Atripla.
Danish: Dal-plasmakoncentrationen af boceprevir blev reduceret, når det blev administreret sammen med efavirenz, et aktivt stof i Atripla.
English: In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
Danish: Den kliniske betydning af denne reduktion må forventes at være begrænset hos virologisk supprimerede patienter (se pkt.
English: Concomitant administration of atovaquone/proguanil with Atripla should be avoided.
Danish: Samtidig administration af atovaquon/proguanil og Atripla bør undgås.
English: Therefore co-administration of atazanavir/ritonavir and Atripla is not recommended (see Table 1).
Danish: Samtidig administration af atazanavir/ritonavir og Atripla derfor frarådes (se tabel 1).
English: Elderly Atripla should be administered with caution to elderly patients (see section 4.4).
Danish: Ældre Atripla bør administreres med forsigtighed til ældre patienter (se pkt.
English: Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose.
Danish: Der er set ikke-vedvarende krampeanfald hos nogle aber, der fik efavirenz i ≥ 1 år ved doser, der gav plasma AUC-værdier 4-13 gange højere end hos mennesker, der fik den anbefalede dosis.
English: Limited clinical experience in patients co-infected with HIV and HBV suggests that treatment with emtricitabine or tenofovir disoproxil in antiretroviral combination therapy to control HIV infection also results in a reduction in HBV DNA (3 log10 reduction or 4 to 5 log10 reduction, respectively) (see section 4.4).
Danish: Patienter som samtidigt er inficerede med hiv og HBV Begrænset klinisk erfaring hos patienter, der samtidigt er inficerede med hiv og HBV, tyder på, at behandling med emtricitabin eller tenofovirdisoproxil i antiretroviral kombinationsbehandling til kontrol af hiv-infektion også resulterer i reduktion af HBV-dna (henholdsvis 3 log10 reduktion eller 45 log10 reduktion) (se pkt.
English: Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Danish: Atripla er en fastdosis-kombination af efavirenz, emtricitabin og tenofovirdisoproxilfumarat.
English: Dose adjustment of buprenorphine may not be necessary when co-administered with Atripla.
Danish: Justering af buprenorphindosis er muligvis ikke nødvendig, når det administreres samtidigt med Atripla.
English: Uncommon hypercholesterolaemia3
Danish: Hyperkolesterolæmi3
English: (h)
Danish: (t)
English: Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Danish: Samtidig administration med naturlægemidler, som indeholder perikon (Hypericum perforatum) på grund af risiko for reduktion i plasmakoncentrationerne samt reduceret klinisk virkning af efavirenz (se pkt.
English: Magnesium stearate (E572) Microcrystalline cellulose (E460) Sodium laurilsulfate
Danish: Croscarmellosenatrium Hydroxypropylcellulose Magnesiumstearat (E572) Mikrokrystallinsk cellulose (E460)
English: Co-administration of Atripla with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir.
Danish: Samtidig administration af Atripla med elbasvir/grazoprevir er kontraindiceret, da det kan medføre tab af det virologiske respons på elbasvir/grazoprevir.
English: They may occur more frequently when Atripla is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Danish: De kan forekomme hyppigere, hvis Atripla indtages sammen med et måltid, muligvis pga. øget plasmakoncentration for efavirenz (se pkt.
English: Adverse reactions associated with the use of Atripla: Treatment-emergent adverse reactions considered possibly or probably related to Atripla reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of Atripla, include:
Danish: Bivirkninger som er forbundet med anvendelse af Atripla: Bivirkninger [rapporteret i studie AI266073 (over 48 uger, n=203)], som opstod under behandlingen, og som blev anset for muligvis eller sandsynligvis at være relateret til Atripla, og som ikke er blevet relateret til et af de aktive stoffer i Atripla, omfatter:
English: 0% (-2.4% to 4.2%)
Danish: 0% (-2,4% til 4,2%)
English: This effect is due to induction of CYP3A4 or P-gp by efavirenz and may result in loss of therapeutic effect of elbasvir/grazoprevir (see section 4.5).
Danish: Denne virkning skyldes efavirenz' induktion af CYP3A4 eller P-gp og kan medføre, at den terapeutiske virkning af elbasvir/grazoprevir forsvinder (se pkt.
English: No data are currently available from clinical studies with Atripla in treatment-naïve patients or in heavily pretreated patients.
Danish: Der er p.t. ingen tilgængelige data fra kliniske studier med Atripla til behandlingsnaive patienter eller til patienter, der tidligere har været i massiv behandling.
English: Due to similarities with emtricitabine, Atripla should not be administered concomitantly with other cytidine analogues, such as lamivudine.
Danish: På grund af ligheder med emtricitabin bør Atripla ikke administreres samtidigt med andre cytidinanaloger, såsom lamivudin.
English: • damage to kidney tubules
Danish: • Beskadigelse af de tubulære celler i nyrerne
English: Atripla should be avoided in patients with HIV-1 harbouring the K65R, M184V/I or K103N mutation (see sections 4.1 and 5.1).
Danish: Atripla bør undgås til patienter inficeret med hiv-1, som har K65R-, M184V/I- eller K102Nmutationer (se pkt.
English: When co-administered with Atripla, sertraline dose increases should be guided by clinical response.
Danish: Når sertralin administreres samtidigt med Atripla, bør øgning af sertralindosis styres af klinisk respons.
English: (CYP2B6 induction)
Danish: (CYP2B6-induktion)
English: • increases in creatinine in the blood
Danish: • Forhøjet kreatinin i blodet
English: hyperglycaemia, hypertriglyceridaemia
Danish: Hyperglykæmi, hypertriglyceridæmi
English: The adverse reactions from clinical study and post-marketing experience with Atripla and the individual components of Atripla in antiretroviral combination therapy are listed in Table 2 below by body system organ class, frequency and the component(s) of Atripla to which the adverse reactions are attributable.
Danish: I tabel 2 nedenfor ses bivirkningerne fra kliniske studier samt erfaring efter markedsføringen med Atripla og de aktive stoffer i Atripla inddelt i systemorganklasse, frekvens og Atripla-komponent(er), som bivirkningerne kan tilskrives.
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz
Danish: * p-værdi < 0,05, Fishers eksakte test, som sammenligner efavirenz + emtricitabin + tenofovirdisoproxil-gruppen med efavirenz + lamivudin/zidovudin-gruppen blandt alle patienter.
English: Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz (see sections 4.3 and 4.4).
Danish: Patienterne bør monitoreres omhyggeligt for bivirkninger, især symptomer fra nervesystemet, der er relateret til efavirenz (se pkt.
English: Stevens-Johnson syndrome, erythema multiforme3, severe rash angioedema4
Danish: Stevens-Johnsons syndrom, erythema multiforme3, svært udslæt (< 1%)
English: No clinically significant pharmacokinetic interaction.
Danish: Ingen klinisk signifikant farmakokinetisk interaktion
English: Since Atripla is a fixeddose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered.
Danish: Da Atripla er et fast-dosis kombinationsprodukt, kan efavirenzdosis ikke ændres; voriconazol og Atripla må derfor ikke administreres samtidigt.
English: Interaction with didanosine: Co-administration of Atripla and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Danish: Interaktion med didanosin: Samtidig administration af Atripla og didanosin anbefales ikke, da det resulterer i en stigning i systemisk eksponering for didanosin på 40-60%, hvilket kan øge risikoen for didanosinrelaterede bivirkninger (se pkt.
English: Co-administration of standard doses of efavirenz and voriconazole is contraindicated (see section 4.3).
Danish: Samtidig administration af standarddoser af efavirenz og voriconazol er kontraindiceret (se pkt.
English: Also, Atripla should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Danish: De bør heller ikke tage Atripla sammen med anden medicin, der indeholder efavirenz (medmindre Deres læge anbefaler det), emtricitabin, tenofovirdisoproxil, tenofoviralafenamid, lamivudin eller adefovirdipivoxil.
English: Rash: In clinical trials of efavirenz, rashes were usually mild-to-moderate maculopapular skin eruptions that occurred within the first two weeks of initiating therapy with efavirenz.
Danish: Udslæt: I kliniske studier af efavirenz var udslættene for det meste lette til moderate, makulopapuløse huderuptioner, der optrådte inden for de første 2 uger efter påbegyndelse af efavirenzbehandling.
English: The mean (%CV) tenofovir exposure increased from 2,185 ng•h/ml (12%) in patients with normal renal function, to 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) and 15,985 ng•h/ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Danish: Gennemsnitlig (%CV) tenofovir-eksponering øgedes fra 2.185 ng·t/ml (12%) hos patienter med normal nyrefunktion til henholdsvis 3.064 ng·t/ml (30%), 6.009 ng·t/ml (42%) og 15.985 ng·t/ml (45%) hos patienter med let, moderat og svær nedsat nyrefunktion.
English: Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil.
Danish: Svimmelhed er også set i kliniske studier med emtricitabin og tenofovirdisoproxil.
English: Liver enzyme monitoring should be considered for all patients independent of pre-existing hepatic dysfunction or other risk factors.
Danish: Monitorering af leverenzymer bør overvejes hos alle patienter, uanset om der er leverdysfunktion eller andre risikofaktorer i anamnesen.
English: • allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
Danish: • Allergisk reaktion (overfølsomhed) som kan medføre alvorlige hudreaktioner (Stevens
English: Efavirenz+ emtricitabine+ tenofovir disoproxil (N=244)
Danish: Efavirenz+ emtricitabin+ tenofovirdisoproxil (N=244)
English: Driving and using machines Atripla may cause dizziness, impaired concentration and drowsiness.
Danish: Trafik- og arbejdssikkerhed Atripla kan give svimmelhed, nedsat koncentrationsevne og døsighed.
English: If the patient vomits within 1 hour of taking Atripla, another tablet should be taken.
Danish: Hvis patienten kaster op inden for 1 time efter at have taget Atripla, skal der tages en ny tablet.
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.2).
Danish: Det forudses, at tenofovir-eksponeringen (AUC) vil være ca. 30% lavere efter administration af Atripla på tom mave sammenlignet med tenofovirdisoproxil, når denne tages som individuel komponent sammen med mad (se pkt.
English: 4-hydroxy atorvastatin:
Danish: 4-hydroxyatorvastatin:
English: Atripla 600 mg/200 mg/245 mg film-coated tablets
Danish: Atripla 600 mg/200 mg/245 mg filmovertrukne tabletter.
English: 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).
Danish: Hvis behandling med Atripla seponeres hos patienter, der har både hiv og HBV, bør disse patienter monitoreres tæt for tegn på forværring af hepatitis (se pkt.
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, Antivirale lægemidler til behandling af hiv-infektioner, kombinationer.
English: The mean (%CV) emtricitabine exposure increased from 12 µg•h/ml (25%) in subjects with normal renal function to 20 µg•h/ml (6%), 25 µg•h/ml (23%) and 34 µg•h/ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Danish: Gennemsnitlig (%CV) emtricitabin-eksponering øgedes fra 12 µg·t/ml (25%) hos patienter med normal nyrefunktion til henholdsvis 20 µg·t/ml (6%), 25 µg·t/ml (23%) og 34 µg·t/ml (6%) hos patienter med let, moderat og svær nedsat nyrefunktion.
English: Tenofovir disoproxil (n=45)
Danish: Tenofovirdisoproxil (n=45)
English: Rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have also been reported.
Danish: Der er i sjældne tilfælde rapporteret nedsat nyrefunktion, nyresvigt og ikke almindeligt forekommende tilfælde af proksimal renal tubulopati (herunder Fanconis syndrom), som nogle gange kan medføre knogleabnormiteter (i sjældne tilfælde medvirkende årsag til frakturer).
English: • rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Danish: • Udslæt (inklusive røde pletter eller skjolder, nogle gange med blærer og hævelse af huden), som kan være en allergisk reaktion
English: 2-hydroxy atorvastatin:
Danish: 2-hydroxyatorvastatin:
English: No dose adjustment of rifampicin is recommended when given with Atripla.
Danish: Justering af rifampicindosis frarådes, når dette gives sammen med Atripla.
English: Higher tenofovir concentrations could potentiate tenofovir-associated adverse events, including renal disorders.
Danish: Højere tenofovirkoncentrationer kunne forstærke tenofovir-associerede bivirkninger, inklusive nyrelidelser.
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Danish: Samtidig brug af Ginkgo biloba-ekstrakt frarådes (se pkt.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil in clinical practice (see section 4.8).
Danish: Der er rapporteret nyresvigt, nedsat nyrefunktion, forhøjet kreatinin, hypofosfatæmi og proksimal tubulopati (herunder Fanconis syndrom) ved klinisk anvendelse af tenofovirdisoproxil (se pkt.
English: Atripla must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Danish: Atripla må ikke administreres sammen med terfenadin, astemizol, cisaprid, midazolam, triazolam, pimozid, bepridil eller ergotalkaloider (f.eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin), da hæmning af disses metabolisme kan føre til alvorlige livstruende hændelser (se pkt.
English: Paroxetine:
Danish: Paroxetin:
English: Reference: single dose of a 600 mg efavirenz tablet, 200 mg emtricitabine capsule and 300 mg tenofovir disoproxil tablet taken under fasted conditions.
Danish: Reference: Enkeltdosis 600 mg efavirenztablet, 200 mg emtricitabinkapsel og 300 mg tenofovirdisoproxiltablet taget under faste.
English: When your supply of Atripla starts to run low, get more from your doctor or pharmacist.
Danish: Når Deres Atripla er ved at slippe op, skal De hente mere hos Deres læge eller på apoteket.
English: - triazole antifungal agents - certain antimalarial agents
Danish: Triazol-svampemidler Visse midler mod malaria
English: In a 144-week open-label randomised clinical study (GS-01-934) antiretroviral treatment-naïve HIV-1 infected patients received either a once-daily regimen of efavirenz, emtricitabine and tenofovir disoproxil or a fixed combination of lamivudine and zidovudine (Combivir) administered twice daily and efavirenz once daily (please refer to the Summary of Product Characteristics for Truvada).
Danish: I et 144-ugers åbent, randomiseret, klinisk studie (GS-01-934), hvor antiretroviralt-behandlingsnaive hiv-1-inficerede patienter enten fik et efavirenzregime en gang dagligt, emtricitabin og tenofovirdisoproxil eller en fast kombination af lamivudin og zidovudin (Combivir), som blev givet to gange dagligt og efavirenz en gang dagligt (se produktresuméet for Truvada).
English: The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Danish: Bivirkningsprofilen for efavirenz, emtricitabin og tenofovirdisoproxil hos patienter, som samtidigt var inficerede med hiv+HBV eller hiv+HCV, lignede den, der observeredes hos patienter, som kun var inficerede med hiv.
English: The pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil after co-administration of the separate pharmaceutical forms or as Atripla have not been studied in HIV infected patients with renal impairment.
Danish: Farmakokinetikken af efavirenz, emtricitabin og tenofovirdisoproxil efter samtidig administration af de enkelte lægemiddelformer eller som Atripla er ikke blevet undersøgt hos hiv-inficerede patienter med nedsat nyrefunktion.
English: No clinically significant effect on efavirenz pharmacokinetics.
Danish: Ingen klinisk signifikant virkning på farmakokinetikken af efavirenz.
English: - if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Danish: Hvis De tager anden medicin, som indeholder efavirenz, emtricitabin, tenofovirdisoproxil, tenofoviralafenamid, lamivudin eller adefovirdipivoxil.
English: Atripla should not be administered concomitantly with adefovir dipivoxil or with medicinal products containing tenofovir alafenamide.
Danish: Atripla må ikke administreres samtidigt med adefovirdipivoxil eller med lægemidler, som indeholder tenofoviralafenamid.
English: BOTTLE AND CARTON LABELLING
Danish: MÆRKNING PÅ BEHOLDER OG KARTON
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Danish: En pålidelig kontraceptiv barrieremetode skal anvendes sammen med hormonkontraceptiva (se pkt.