natgillin/translations-raw huggingface dataset:
Graviditet bør undgås hos kvinder, der er i behandling med efavirenz.
Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Rotteundersøgelser har vist, at efavirenz udskilles i mælk i langt højere koncentrationer, end det er set i maternal plasma.
88 Lactation: studies in rats have demonstrated that efavirenz is excreted in milk reaching concentrations much higher than those in maternal plasma.
4. 4).
The most notableadverse reactions associated with efavirenz are rash and nervous system symptoms (see section 4.4).
Langtidssikkerhedsprofilen for regimer, der indeholder efavirenz, blev evalueret i en kontrolleret undersøgelse (006), hvor patienter behandledes med enten efavirenz + zidovudin + lamivudin (n = 412, medianvarighed 180 uger), eller efavirenz + indinavir (n = 415, medianvarighed 102 uger) eller indinavir + zidovudin + lamivudin (n = 401, medianvarighed 76 uger).
The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Svære udslæt optrådte hos mindre end 1% af de efavirenzbehandlede patienter, og 1, 7% ophørte med behandlingen på grund af udslæt.
Severe rash occurred in less than 1% of patients treated with efavirenz, and 1.7% discontinued therapy because of rash.
Udslættene er for det meste milde til moderate, makulopapuløse huderuptioner, der optræder inden for de første 2 uger efter påbegyndelsen af efavirenzbehandling.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
100 genoptages hos patienter, der afbryder behandlingen på grund af udslæt.
Efavirenz can be reinitiated in patients interrupting therapy because of rash.
Nitten patienter, der ophørte med nevirapin på grund af udslæt, er blevet behandlet med efavirenz.
Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
Ni af disse patienter udviklede mildt til moderat udslæt, mens de fik behandling med efavirenz, og 2 ophørte på grund af udslæt.
Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Der har, ligeledes efter markedsføring, været indberetninger om selvmord, vrangforestillinger og psykotisk opførsel.
There have also been post-marketing reports of death by suicide, delusions and psychosis-like behaviour.
5. 2).
Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Ikke almindelig
90 Ear and labyrinth disorders uncommon
Mave- tarmkanalen Almindelig
Gastrointestinal disorders
Hud og subkutane væv Meget almindelig
very common
Lipodystrofi og metaboliske abnormaliteter:
Lipodystrophy and metabolic abnormalities:
Kombinationsbehandling med antiretrovirale lægemidler er hos patienter med HIV associeret med omfordeling af kropsfedt (lipodystrofi), herunder tab af
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Der sås forhøjelser af aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) til mere end 5 gange den øvre grænse for normalområdet (ULN) hos 3% af 1. 008 patienter, der blev behandlet med 600 mg efavirenz (5- 8% efter langtidsbehandling i Undersøgelse 006).
Liver enzymes: elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients
Hos børn var bivirkningerne generelt de samme som hos voksne patienter.
Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Diarré sås hos 19 (32%) born I aldermen aged 3 – 8 years, som fik efavirenz oral opløsning sammen med nelfinavir (20 – 30 mg/ kg 3 gange om dagen) og en eller flere NRTI’ ere.
Diarrhoea occurred in six of nineteen (32%) children, aged 3 – 8 years, who took efavirenz oral solution in combination with nelfinavir (20 – 30 mg/ kg given three times a day) and one or more NRTIs.
4. 9 Overdosering
92 4.9 Overdose
Efavirenz er en NNRTIer af HIV- 1.
Efavirenz is a NNRTI of HIV-1.
Den frie koncentration af efavirenz, der er nødvendig for 90– 95% hæmning af vildtype - eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0, 46 til 6, 8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag - / monocytkulturer.
Antiviral activity: the free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.
Der blev også observeret substitutioner på RT - positionerne 98, 100, 101, 108, 138, 188, 190 eller 225, men med lavere frekvenser og ofte kun i
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Mønstret for aminosyresubstitutioner i RT, der er forbundet med resistens over for efavirenz, var uafhængigt af de andre antivirale medikamenter, der anvendtes i kombination med efavirenz.
The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medications used in combination with efavirenz.
Ved cellekultur viste krydsresistensprofiler for efavirenz, nevirapin og delavirdin, at K103N- substitutionen giver tab af følsomhed over for alle tre NNRTI’ ere.
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
To ud af tre undersøgte delavirdinresistente, kliniske isolater var krydsresistente over for efavirenz og indeholdt K103N- substitutionen.
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Virale isolater, der er indhentet fra PBMCer fra patienter inkluderet i kliniske efavirenzundersøgelser, som viste tegn på behandlingssvigt (reboundfænomen af virus i blodet) blev vurderet med henblik på følsomhed over for NNRTI’ ere.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Man fandt, at 5 af disse NNRTI- resistente isolaterhavde K103N - eller en valin- til- isoleucin- substitution på position 108 (V108I) i RT.
Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT.
Tre af de testede efavirenz- behandlingssvigtisolater forblev følsomme over for efavirenz ved cellekultur og var også følsomme over for nevirapin og delavirdin.
Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Potentialet for krydsresistens mellem efavirenz og PI' ere er lille på grund af de forskellige enzymmål, der er involverede.
93 The potential for cross resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Efavirenz er ikke undersøgt i kontrollerede undersøgelser med patienter med fremskreden HIV- sygdom, det vil sige CD4 tal < 50 celler/ mm3 eller med PI - eller NNRTI- behandlede patienter.
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/ mm3, or in PI or NNRTI-experienced patients.
I disse undersøgelser var efavirenzdosis 600 mg en gang dagligt; indinavirdosis på 1. 000 mg hver 8. time blev anvenddt i kombination med efavirenz, og 800 mg hver 8. time blev anvendt uden efavirenz. ´Nelfinavirdosis var 750 mg 3 gange daglig.
The dose of nelfinavir was 750 mg given three times a day.
Undersøgelse 006, en randomiseret, ublindet undersøgelse, sammenlignede efavirenz + zidovudin + lamivudin eller efavirenz + indinavir med indinavir + zidovudin + lamivudin omfattede hos 1. 266 patienter, som ikke tidligere var behandlet med efavirenz, lamivudin, NNRTI’ ere eller PI´ere.
Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
105 Tabel 3:
Table 3:
EFV + IDV
ZDV + 3TC EFV + IDV IDV +
54% (47%, 61%)
%, 73%) 54%%, 61%) 45%
48% (41%, 55%)
%, 69%) 48%%, 55%) 40%
177 (11, 3)
(11.8) 177 (11.3) 153
IDV + ZDV + 3TC a
ZDV + 3TC a
45% 38%, 52%)
(38
40% (34%, 47%)
(34
153 (12, 3)
(12.3)
Standard afvigelse på middelværdi d EFV, efavirenz; ZDV, zidovudin, 3TC, lamivudin; IDV, indinavir.
NC = F, noncompleter = failure. b C. I., confidence interval. c S. E. M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Effektresultater for undersøgelserne ACTG 364 og 020 kan ses i tabel 4.
94 Efficacy results for studies ACTG 364 and 020 are found in Table 4.
NC = F, ikke fuldførte = afsluttet b EFT, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nucleoside reverse transkriptasehæmmer; NFV, nelfinavir c C. I., konfidensinterval for antal patienter med respons d S. E. M., Standard afvigelse på middelværdi --- Ikke udført
NC = F, noncompleter = failure. b EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir. c C. I., confidence interval for proportion of patients in response. d S. E. M., standard error of the mean. ---, not performed.
ACTG 382 er en igangværende ukontrolleret undersøgelse af 57 NRTI - behandlede, pædiatriske patienter (3 - 16 år), som beskriver farmakokinetik, antiviral aktivitet og sikkerhed af efavirenz i kombination med nelfinavir (20 - 30 mg/ kg indgivet 3 gange om dagen) og et eller flere NRTI’ ere.
ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/ kg given three times a day) and one or more NRTIs.
106 procentdel af patienter med plasma HIV- RNA < 400 koPI' er/ ml efter 48 uger var 60% (95%, C. I.
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ ml at 48 weeks was 60% (95%, C. I.
Hos 35 patienter, der fik efavirenz 600 mg 1 gang dagligt, var det gennemsnitlige steady- state Cmax 12, 9 ± 3, 7 μM (29%) [gennemsnit ± S. D.
In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μ M (29%) [mean ± S. D.
Hos ikke- inficerede voksne frivillige var Cmax og AUC for en 240 mg dosis STOCRIN oral opløsning henholdsvis 78% og 97% af de værdier, der blev målt, når STOCRIN blev givet som 200 mg hårde kapsler.
In uninfected adult volunteers, the Cmax and AUC of a 240 mg dose of STOCRIN oral solution were 78% and 97%, respectively, of the values measured when STOCRIN was given as a 200 mg hard capsule.
AUC og Cmax 240 mg efavirenz oral opløsning hos ikke- inficerede voksne frivillige blev forøget med henholdsvis 30% og 43%, når dosen blev givet sammen med henholdsvis et måltid med stort fedtindhold og under faste.
95 Effect of food: the AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30% and 43% respectively, when given with a high-fat meal, relative to fasted conditions.
107 Hos den enkelte patient med svær leverinsufficiens (Child Pugh grad C), der blev undersøgt, blev halveringstiden fordoblet, hvilket indikerer et potentiale for en langt større grad af akkumulering.
In the single patient studied with severe hepatic impairment (Child Pugh Grade C), half life was doubled indicating a potential for a much greater degree of accumulation.
En dosis ækvivalent med 600 mg efavirenz blev givet som hårde kapsler (dosis justeret ud fra beregnet legemsstørrelse på basis af vægt) til 49 pædiatriske patienter.
Paediatric pharmacokinetics: the equivalent of a 600 mg dose of efavirenz was given as hard capsules (dose adjusted from calculated body size based on weight) to 49 paediatric patients.
Efavirenz ’ farmakokinetik hos pædiatriske patienter svarede til den hos voksne.
The pharmacokinetics of efavirenz in paediatric patients were similar to adults.
Steady- state Cmax var 14, 1 μM, steady- state Cmin 5, 6 μM og AUC 216 μM⋅t.
Steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
Hos 17 pædiatriske patienter, som fik en test oral opløsning svarende til den formulering, der markedsføres og justeret på basis af legemsstørrelse til at svare til en 600 mg kapsel dosis til voksne, var steady- state Cmax 11, 8 μM, steady- state Cmin var 5, 2 μM og AUC var 188 μM⋅t.
In 17 paediatric patients receiving an investigational oral solution similar to the commercial formulation adjusted on the basis of body size to be equivalent to an adult 600 mg capsule dose, the steady-state Cmax was 11.8 μ M, steady state Cmin was 5.2 μ M, and AUC was 188 μ M·h.
I en subgruppe med 6 regimen- kompliante børn i aldersgruppen 3 - 5 år, var det gennemsnitlige AUC 147 μM· t, hvilket var 23% lavere end forventet.
In the subset of 6 children aged 3 – 5 who were compliant with their drug regimen, the mean AUC was 147 μ M·h, which was 23% lower than expected.
Køn, race, ældre:
Gender, race, elderly:
Der er set misdannelser hos 3 ud af 20 fostre/ nyfødte fra efavirenzbehandlede cynomolgusaber, der fik indgivet en dosis der resulterede i efavirenzkoncentrationer i plasma lig dem set hos mennesker.
Anencephaly and unilateral anophthalmia
Anencefali og unilateral anophthalmia med sekundær forstørrelse af tungen sås hos ét foster, microphthalmia hos et andet foster og ganespalte hos et tredje foster.
96 with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus, and cleft palate was observed in a third foetus.
Carcinogenicitetsundersøgelser har vist øget incidens af hepatiske og pulmonære tunorer hos hunmus, men ikke hos hanmus.
Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Carcinogenicitetsundersøgelser på hanmus samt han - og hunrotter var negative.
Carcinogenicity studies in male mice, male and female rats were negative.
Triglycerider, middelkædelængde Benzoesyre (E210) Jordbær/ mintsmag
Medium chain triglycerides Benzoic acid (E210) Strawberry/ mint flavour
108 6. 3 Opbevaringstid
6.3 Shelf life
Efter anbrud:
After first opening:
HDPE- flasker med børnesikret polypropylenlåg indeholdende180 ml oral opløsning.
HDPE bottles with a child-resistant polypropylene closure containing 180 ml of oral solution.
En oral sprøjte med adapter til at sætte i flaskens hals følger kartonen.
An oral syringe with a push-in bottle-neck adapter is included in the carton.
Ingen særlige forkoldsregler.
No special requirements.
EU/ 1/ 99/ 111/ 005 – flaske
EU/ 1/ 99/ 111/ 005 - bottle
109 1.
98 1.
Hver filmovertrukken tablet indeholder 249, 6 mg lactosemonohydrat.
Excipient: each film-coated tablet contains 249.6 mg of lactose monohydrate.
Mørkegule, kapselformede, præget med “ 225 ” på den ene side.
Dark yellow, capsule-shaped, debossed with “ 225 ” on one side.
Den anbefalede dosis af STOCRIN i kombination med en PI' er og/ eller NRTI' ere til patienter i alderen 3– 17 år er beskrevet i tabel 1.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
STOCRIN tabletter må kun gives til børn, der med sikkerhed er i stand til at synke tabletter.
STOCRIN tablets must only be administered to children who are able to reliably swallow tablets.
STOCRIN bør ikke anvendes til børn
STOCRIN is not
5. 1 og 5. 2).
99 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
13 til < 15 15 til < 20 20 til < 25
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
200 250 300
STOCRIN Dose (mg )∗ 200 250 300 350 400 600
* STOCRIN findes som 50 mg, 200 mg og 600 mg filmovertrukne tabletter.
∗ STOCRIN 50 mg, 200 mg and 600 mg film-coated tablets are available.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
100 4.4 Special warnings and precautions for use
111 Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat, bør ikke administreres samtidigt.
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
Der er set krampeanfald hos patienter i efavirenzbehandling, disse patienter havde sædvanligvis krampeanfald i anamnesen.
101 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
5. 2) og kan føre til øget bivirkningshyppighed (se pkt.
Effect of food: the administration of STOCRIN with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Hos patienter, der er behandlet med andre lægemidler, der sættes i forbindelse med levertoksicitet, anbefales monitorering af leverenzymer.
102 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Andre kemiske forbindelser, som er substrater af CYP3A4, kan muligvis få reducerede plasmakoncentrationer, når de administreres sammen med efavirenz.
Other compounds that are substrates of CYP3A4 may have decreased plasma concentrations when co-administered with efavirenz.
Optagelsen af efavirenz kan også ændres ved samtidigt indtag af medicin eller mad (fx grapefrugtjuice), som påvirker CYP3A4 - aktivitet.
Efavirenz exposure may also be altered when given with medicinal products or food (for example, grapefruit juice) which affect CYP3A4 activity.
114 Tabel 2:
103 Table 2:
efavirenz og atazanavir/ ritonavir anbefales ikke.
Co-administration of efavirenz with atazanavir/ ritonavir is not recommended.
115
Indinavir:
Lægemidler i henhold til
104 Medicinal product by therapeutic
Sammen med efavirenz bør en øgning af dosis for lopinavir/ ritonavir blød kapsel eller
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses by 33% should be considered
oral opløsning på 33% overvejes (4 kapsler/ ~ 6, 5 ml to gange dagligt i stedet for 3 kapsler/ 5 ml to gange
Caution is warranted
117
Effects on drug levels
Når efavirenz gives i et regime sammen med ritonavir i lav dosis, bør muligheden for stigning i incidensen af efavirenz - associerede bivirkninger overvejes på grund af eventuel farmakodynamisk interaktion.
When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Maraviroc/ efavirenz (100 mg to gange dagligt/ 600 mg én gang dagligt)
Maraviroc/ Efavirenz (100 mg twice daily/ 600 mg once daily) Integrase strand transfer inhibitor
Intergrase hæmmer af genoverførelse Raltegravir/ efavirenz (400 mg enkeltdoser / -)
Raltegravir/ Efavirenz (400 mg single dose/ -) NRTIs and NNRTIs
118
No dosage adjustment is necessary for either medicinal product.
Lægemidler i henhold til
106 Medicinal product by therapeutic
Hverken aluminium - / magnesiumhydroxidantacida eller famotidin ændrede absorptionen af efavirenz.
108 Medicinal product by therapeutic
121
co-administration with efavirenz
Lægemidler i henhold til
109 Medicinal product by therapeutic
123
No dosage adjustment is necessary for efavirenz.
Lægemidler i henhold til
110 Medicinal product by therapeutic
Ethinylestradiol/ efavirenz (50 µg enkeltdosis/ 400 mg én gang dagligt)
111
IMMUNOSUPPRESIVA Immunosuppressiva metaboliseres via CYP3A4 (fx cyclosporin, tac - rolimus, sirolimus) / efavirenz OPIOIDER
Immunosuppressants metabolized by CYP3A4 (e. g., cyclosporine, tacrolimus, sirolimus)/ Efavirenz OPIOIDS
126 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Graviditet bør undgås hos kvinder, der er i behandling med efavirenz.
112 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
127 Udslættene er for det meste milde til moderate, makulopapuløse huderuptioner, der optræder inden for de første 2 uger efter påbegyndelsen af efavirenzbehandling.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Erfaring med efavirenz hos patienter, som er ophørt med andre antiretrovirale lægemidler af NNRTI- gruppen, er begrænset.
113 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
I kliniske, kontrollerede undersøgelser med patienter, som fik 600 mg efavirenz sammen med andre antiretrovirale lægemidler, var de ofte rapporterede bivirkninger bl. a. følgende; Svimmelhed, søvnløshed, somnolens, nedsat koncentrationsevne og unormal drømmeaktivitet.
Nervous system symptoms: in clinical controlled trials, frequently reported adverse reactions in patients receiving 600 mg efavirenz with other antiretroviral agents included, but were not limited to: dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
19, 4% af patienterne oplevede symptomer fra nervesystemet af moderat til svær intensitet sammenlignet med 9, 0% af de patienter, der fik kontrolregimer.
Nervous system symptoms of moderate-to-severe intensity were experienced by 19.4% of patients compared to 9.0% of patients receiving control regimens.
Symptomer fra nervesystemet debuterer sædvanligvis i løbet af de første 1 – 2 behandlingsdage og forsvinder i reglen efter de første 2 – 4 uger.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
I en klinisk undersøgelse varierede den månedlige prevalens af symptomer af mindst moderat sværhedsgrad fra nervesystemet mellem uge 4 og 48, mellem 5 – 9% hos patienter i behandlingsregimer med efavirenz og mellem 3 – 5% hos patienterne, som fik kontrolbehandling.
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
128 Moderate eller mere alvorlige bivirkninger, hvor der mindst er en mulig forbindelse til behandlingsregimet (baseret på investigator tilskrivning), som er rapporteret i kliniske undersøgelser for efavirenz i anbefalede doser i kombinationsbehandling (n = 1. 008) er anført nedenfor.
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Nervesystemet Almindelig
114 Nervous system disorders common
Træthed
common
Immunsystemet
fatigue
Ikke almindelig
Immune system disorders uncommon
Lever og galdeveje Ikke almindelig
Hepatobiliary disorders
Det reproduktive system og mammae
Reproductive system and breast disorders uncommon
Ikke almindelig
gynaecomastia
Gynækomasti
Psychiatric disorders
Psykiske forstyrrelser Almindelig
common