natgillin/translations-raw huggingface dataset:
Heraf havde 185 (98, 9%) env- gener specifikke substitutioner i området af gp41 aminosyrerne 36- 45.
Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41.
Den geometriske ændring i middelværdi varierede fra 15, 2 gange for V38M til 41, 6 gange for V38A.
The geometric mean changes ranged from 15.2 fold for V38M to 41.6 fold for V38A.
Der er ikke påvist sammenhæng mellem substitutionerne og in vivo- effekten af enfuvirtid.
The relationship of these substitutions to in vivo effectiveness of enfuvirtide has not been established.
Fald i viral følsomhed var korreleret til graden af præbehandlingsresistens over for optimal baggrund.
Decrease in viral sensitivity was correlated to the degree of pre-treatment resistance to background therapy.
(Se tabel 5)
(See Table 5)
På grund af det nye virale angrebspunkt er enfuvirtid lige aktivt in vitro over for wild - type laboratorieisolater som kliniske isolater samt over for isolater, som er resistente over for en, to eller tre andre klasser af antiretrovirale lægemidler (nukleosid reverse transkriptasehæmmere, non - nukleosid reverse transkriptasehæmmere og proteasehæmmere).
Due to its novel viral target enfuvirtide is equally active in vitro against both wild- type laboratory and clinical isolates and those with resistance to 1, 2 or 3 other classes of antiretrovirals (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors).
Omvendt forventes det ikke, at mutationer i gp41 aminosyrerne 36- 45, som forårsager resistens over for enfuvirtid, vil forårsage resistens over for andre antiretrovirale lægemiddelgrupper.
Conversely, mutations in aa 36-45 of gp41 which give resistance to enfuvirtide would not be expected to give cross resistance to other classes of antiretrovirals.
Studier af patienter, som tidligere har været i behandling med antiretrovirale lægemidler:
Studies in Antiretroviral Experienced Patients:
Fuzeons kliniske aktivitet (i kombination med andre antiretrovirale stoffer) på plasma- hiv- RNA - koncentrationer og CD4- tal er undersøgt i to randomiserede, kontrollerede multicenterstudier (TORO 1 og TORO 2) af 48 ugers varighed.
The clinical activity of Fuzeon (in combination with other antiretroviral agents) on plasma HIV RNA levels and CD4 counts have been investigated in two randomised, multicentre, controlled studies (TORO 1 and TORO 2) of Fuzeon of 48 weeks duration.
Intent- to- treat- populationen omfattede 995 patienter.
995 patients comprised the intent-to-treat population.
Fuzeon + OB og OB.
Patient demographics include a median baseline HIV-1 RNA of 5.2 log10 copies/ ml and 5.1 log10 copies/ ml and median baseline CD4 cell count of 88 cells/ mm3 and 97 cells/ mm3 for Fuzeon + OB and OB, respectively.
Ved uge 48 havde 30, 4% patienter i Fuzeon + OB- gruppen en viral belastning < 400 kopier/ ml sammenlignet med 12% af patienterne i OB- gruppen.
The proportion of patients achieving viral load of < 400 copies/ ml at week 48 was 30.4% among patients on the Fuzeon+OB regimen compared to 12% among patients receiving OB regimen only.
Middelstigningen i CD4- celletallet var større hos patienter i Fuzeon + OB- gruppen end i OB- gruppen (se tabel 4).
(see Table 4)
Tabel 4:
8 Table 4
Endepunkter for den randomiserede behandling efter 48 uger (TORO 1 og TORO 2
Outcomes of Randomised Treatment at Week 48 (Pooled Studies TORO 1 and TORO 2, ITT)
Fuzeon +
Fuzeon +
OB OB
OB OB
Behandlings -
Treatment
forskel
(N=334)
Konfidens - interval
Difference Confidence Interval
hiv- 1- RNA Log ændring fra baseline (log10 kopier/ ml) *
HIV-1 RNA Log Change from baseline (log10 copies/ ml)*
- 1, 48 - 0, 63
-1.48
LSM - 0, 85
-0.63
- 1, 073; - <, 0001 0, 628
LSM -1.073, - < .0001 -0.85 0.628
CD4+ celletal Ændring fra baseline
CD4+ cell count Change from baseline (cells/ mm3)#
+91 +45
+91
LSM 46, 4
+45
25, 1; 67, 8 <, 0001
LSM 25.1, 67.8 < .0001 46.4
Hiv- RNA > 1 log under baseline **
HIV RNA > 1 log below Baseline**
Odds Ratio 3, 02
Odds Ratio 2.16, 4.20 < .0001 3.02
Hiv- RNA < 400 kopier/ ml **
HIV RNA < 400 copies/ ml**
40
40 (12.0%) Odds Ratio 2.36, 5.06 < .0001 3.45
Hiv- RNA < 50 kopier/ ml **
HIV RNA < 50 copies/ ml
26
26 (7.8%) Odds Ratio 1.76, 4.37 < .0001 2.77
Stoppet pga. bivirkninger/ tilstødende † sygdom/ laboratorietal
Discontinued due to adverse reactions/ intercurrent † illness/ labs
Stoppet pga. reaktioner på † injektionsstedet
Discontinued due to injection † site reactions
Stoppet pga. andre årsager † φ§
Discontinued due to other †φ § reasons
* Baseret på resultaterne af sammenlagte data fra TORO 1 og TORO 2 for ITT- population, viral belastning ved uge 48 for patienter som ikke kom til follow- up, afbrød behandlingen eller fik virologisk svigt erstattet med deres sidste observation (LOCF). # Seneste værdi fremført. ** M- H- test:
* Based on results from pooled data of TORO 1 and TORO 2 on ITT population, week 48 viral load for subjects who were lost to follow-up, discontinued therapy, or had virological failure replaced by their last observation (LOCF). # Last value carried forward. ** M-H test:
Behandlingsstop eller virologisk svigt betragtes som behandlingssvigt. † Procenter baseret på sikkerhedspopulationen Fuzeon+baggrundsbehandling (N=663) og baggrundsbehandling (N=334).
Discontinuations or virological failure considered as failures. † Percentages based on safety population Fuzeon+background (N=663) and background (N=334).
Nævner for patienter som ikke skifter:
Denominator for non-switch patients:
N=112. φ I henhold til investigators skøn. § Inkluderer tabt for follow- up, afvisning af behandling og andre årsager.
N=112. φ As per the judgment of the investigator. § Includes discontinuations from loss to follow-up, treatment refusal, and other reasons.
Behandling med Fuzeon + OB viste i alle subgrupper flere patienter, som opnåede < 400 kopier/ ml (eller < 50 kopier/ ml) baseret på CD4 ved baseline, hiv- 1- RNA ved baseline, antal tidligere antiretrovirale lægemidler (ARL) eller antal aktive ARL i OB- gruppen.
Fuzeon+OB therapy was associated with a higher proportion of patients reaching < 400 copies/ ml (or < 50 copies/ ml) across all subgroups based on baseline CD4, baseline HIV-1 RNA, number of prior antiretrovirals (ARVs) or number of active ARVs in the OB regimen.
Uanset behandling havde patienter med CD4 > 100 celler/ mm3 ved baseline, hiv- 1- RNA < 5, 0 log10 kopier/ ml ved baseline, ≤ 10 tidligere ARL, og/ eller andre aktive ARL i deres OB- regime dog større chance for at opnå hiv- 1 - RNA < 400 kopier/ ml (eller < 50 kopier/ ml).
However, subjects with baseline CD4 > 100 cells/ mm3, baseline HIV-1 RNA < 5.0 log10 copies/ ml, ≤ 10 prior ARVs, and/ or other active ARVs in their OB regimen were more likely to achieve a HIV-1 RNA of < 400 copies/ ml (or < 50 copies/ ml) on either treatment.
(Se tabel 5)
(see Table 5)
Tabel 5:
9 Table 5
Patienter som opnåede < 400 kopier/ ml og < 50 kopier/ ml ved uge 48 iht. subgruppe (sammenlagte data fra TORO 1 og TORO 2, ITT) Subgruppe
Proportion of Patients achieving < 400 copies/ ml and < 50 copies/ ml at Week 48 by subgroup (pooled TORO 1 and TORO 2, ITT)
hiv- 1- RNA < 400 kopier/ ml
Subgroups
hiv- 1- RNA < 50 kopier/ ml
HIV-1 RNA < 400 copies/ ml HIV-1 RNA < 50 copies/ ml
OB Fuzeon + OB
Fuzeon + OB OB Fuzeon + OB
OB
OB
(N=334) 90
(N=334) 90 mg bid (N=661)
(N=334)
(N=334)
BL hiv- 1- RNA < 5, 0 log101 kopier/ ml BL hiv- 1- RNA ≥ 5, 0 log101 kopier/ ml
BL HIV-1 RNA < 5.0 log101 copies/ ml BL HIV-1 RNA ≥ 5.0 log101 copies/ ml
118/ 269 (43, 9%) 83/ 392 (21, 2%)
118/ 269 (43.9%) 83/ 392 (21.2%)
77/ 269 (28, 6%) 44/ 392 (11, 2%)
26/ 144 77/ 269 (18.1%) (28.6%) 14/ 190 44/ 392 (7.4%) (11.2%)
18/ 144 (12, 5%) 8/ 190 (4, 2%)
18/ 144 (12.5%) 8/ 190 (4.2%)
Total tidligere ARL ≤ 101 Total tidligere ARL > 101
Total prior ARVs ≤ 101 Total prior ARVs > 101
100/ 215 (46, 5%) 101/ 446 (22, 6%)
100/ 215 (46.5%) 101/ 446 (22.6%)
64/ 215 (29, 8%) 57/ 446 (12, 8%)
29/ 120 64/ 215 (24.2%) (29.8%) 11/ 214 57/ 446 (5.1%) (12.8%)
19/ 120 (15, 8%) 7/ 214 (3, 3%)
19/ 120 (15.8%) 7/ 214 (3.3%)
0 aktive ARL i
0 Active ARVs in
9/ 112
9/ 112
0/ 53
0/ 53
4/ 112
4/ 112
1 aktivt ARL i
background1,2 1 Active ARV in
56/ 194
(8.0%) 56/ 194
7/ 95
(0%) 7/ 95
34/ 194
(3.5%) 34/ 194
3/ 95
(0%) 3/ 95
≥ 2 aktive ARL i baggrundsbehandlin - gen, 2 1
background1,2 ≥ 2 Active ARVs in
130/ 344 (37, 8%)
(28.9%) 130/ 344
32/ 183 (17, 5%)
(7.4%) 32/ 183
77/ 334 (22, 4%)
(17.5%) 77/ 334
22/ 183 (12, 0%)
(3.2%) 22/ 183
Behandlingsstop eller virologisk svigt betragtes som behandlingssvigt.
Discontinuations or virological failures considered as failures.
2 Baseret på GSS- score.
2 Based on GSS score.
Enfuvirtids farmakokinetiske egenskaber er undersøgt hos hiv- 1- smittede voksne og børn.
The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients.
Den absolutte biotilgængelighed efter subkutan administration af 90 mg enfuvirtid i abdomen var 84, 3 ± 15, 5%.
The absolute bioavailability after subcutaneous administration of enfuvirtide 90 mg in the abdomen was 84.3 ± 15.5%.
Den subkutane absorption af enfuvirtid er proportional med den administrerede dosis i dosisintervallet 45 til 180 mg.
Mean (± SD) Cmax was 4.59 ± 1.5 μ g/ ml, AUC was 55.8 ± 12.1 μ g*hr/ ml The subcutaneous absorption of enfuvirtide is proportional to the administered dose over the 45 to 180 mg dose range.
Den subkutane absorption efter en dosis på 90 mg dose er sammenlignelig og uafhængig af om den injiceres i abdomen, lår eller arm.
Subcutaneous absorption at the 90 mg dose is comparable when injected into abdomen, thigh or arm.
I fire separate studier (N= 9 til 12) spændte middel steady state trough- plasmakoncentrationerne fra 2, 6 til 3, 4 μg/ ml.
In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 μ g/ ml.
Steady state- distributionsvolumen efter intravenøs administration af en 90 mg dosis enfuvirtid var 5, 5 ± 1, 1 l.
The steady state volume of distribution with intravenous administration of a 90 mg dose of enfuvirtide was 5.5 ± 1.1 l.
92% af enfuvirtid bindes til plasmaproteiner i hiv- inficeret plasma over en plasmakoncentrationsspændvidde fra 2 til 10 μg/ ml.
Enfuvirtide is 92% bound to plasma proteins in HIV infected plasma over a plasma concentration range of 2 to 10 μ g/ ml.
Det bindes fortrinsvis til albumin og i mindre udstrækning til α- 1 glykoproteinsyre.
It is bound predominantly to albumin and to a lower extent to α -1 acid glycoprotein.
I in vitro- studier blev enfuvirtid ikke erstattet fra sine bindingssteder af andre lægemidler, og enfuvirtid erstattede heller ikke andre lægemidler fra deres bindingssteder.
In in vitro studies, enfuvirtide was not displaced from its binding sites by other medicinal products, nor did enfuvirtide displace other medicinal products from their binding sites.
Hos hiv- patienter er enfuvirtid- niveauer i cerebrospinalvæsken blevet rapporteret som ubetydelige.
In HIV patients, enfuvirtide levels in the cerebrospinal fluid have been reported to be negligible.
Som peptid forventes enfuvirtid at blive nedbrudt til de aminosyrer, som det består af, med efterfølgende genanvendelse i kroppen.
As a peptide, enfuvirtide is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.
Humane mikrosomale in vitro- studier og in vivo- studier tyder på, at enfuvirtid ikke hæmmer CYP450- enzymer.
In vitro human microsomal studies and in in vivo studies indicate that enfuvirtide is not an inhibitor of CYP450 enzymes.
I humane in vitro mikrosomale og hepatocyt - studier, resulterer hydrolyse af amidgruppen i den C- terminale aminosyre, phenylalanin, i en deamineret metabolit, og dannelsen af denne metabolit er ikke NADPH- afhængig.
In in vitro human microsomal and hepatocyte studies, hydrolysis of the amide group of the C-terminus amino acid, phenylalanine results in a deamidated metabolite and the formation of this metabolite is not NADPH dependent.
Denne metabolit findes i humant plasma efter administration af enfuvirtid, og den har en AUC, som spænder fra 2, 4 til 15% af enfuvirtids AUC.
This metabolite is detected in human plasma following administration of enfuvirtide, with an AUC ranging from 2.4 to 15% of the enfuvirtide AUC.
Enfuvirtid- clearance efter intravenøs administration af 90 mg var 1, 4 ± 0, 28 l/ time, og eliminationshalveringstiden var 3, 2 ± 0, 42 timer.
Clearance of enfuvirtide after intravenous administration 90 mg was 1.4 ± 0.28 l/ h and the elimination half-life was 3.2 ± 0.42 h.
Efter en subkutan dosis på 90 mg enfuvirtid var enfuvirtids halveringstid 3, 8 ± 0, 6 timer.
Following a 90 mg subcutaneous dose of enfuvirtide the
Leverinsufficiens:
Hepatic Insufficiency:
Enfuvirtids farmakokinetik er ikke undersøgt hos patienter med leverinsufficiens.
The pharmacokinetics of enfuvirtide have not been studied in patients with hepatic impairment.
Analyser af plasmakoncentrationsdata fra patienter i kliniske studier tyder på, at enfuvirtids clearance ikke påvirkes klinisk relevant hos patienter med mild til moderat nyreinsufficiens.
Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is not affected to any clinically relevant extent in patients with mild to moderate renal impairment.
I et studie, hvor patienter med nyreinsufficiens blev sammenlignet med patienter med normal nyrefunktion, var enfuvirtids AUC i gennemsnit øget med 43- 62% hos patienter med svær nyreinsufficiens eller hos patienter med nyresygdom i slutfasen.
In a renal impairment study AUC of enfuvirtide was increased on average by 43-62% in patients with severe or end stage renal disease compared to patients with normal renal function.
Hæmodialyse ændrede ikke signifikant på enfuvirtid- clearance.
Hemodialysis did not significantly alter enfuvirtide clearance.
Mindre end 13% af dosis blev fjernet med hæmodialyse.
Less than 13% of the dose was removed during hemodialysis.
10 Ældre:
Elderly:
Enfuvirtids farmakokinetik er ikke formelt undersøgt hos ældre patienter over 65 år.
The pharmacokinetics of enfuvirtide have not been formally studied in elderly patients over 65 years of age.
Køn og vægt:
Gender and Weight:
Analyser af plasmakoncentrationsdata fra patienter i kliniske studier tyder på, at enfuvirtid- clearance er 20% lavere hos kvinder end hos mænd, uanset vægt, og øges med stigende legemsvægt, uanset køn (20% højere hos en patient, der vejer 100 kg og 20% lavere hos en patient, der vejer 40 kg, sammenlignet med en patient, der vejer 70 kg).
Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is 20% lower in females than males irrespective of weight and is increased with increased body weight irrespective of gender (20% higher in a 100 kg and 20% lower in a 40 kg body weight patient relative to a 70 kg reference patient).
Analyser af plasmakoncentrationsdata fra patienter i kliniske studier tyder på, at der ikke er forskel på enfuvirtid- clearance hos afro- amerikanere sammenlignet med kaukasere.
Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide was not different in Afro-Americans compared to Caucasians.
Enfuvirtids farmakokinetik er undersøgt hos 37 børn.
The pharmacokinetics of enfuvirtide have been studied in 37 paediatric patients.
En dosis på 2 mg/ kg to gange daglig (maksimalt 90 mg to gange daglig) resulterede i enfuvirtid- plasmakoncentrationer, som svarede til plasmakoncentrationerne hos voksne patienter, der fik 90 mg to gange daglig.
A dose of 2 mg/ kg bid (maximum 90 mg bid) provided enfuvirtide plasma concentrations similar to those obtained in adult patients receiving 90 mg bid dosage.
Hos 25 børn i alderen 5 til 16 år, som fik 2 mg/ kg to gange daglig i overarmen, på lårets forside eller i abdomen, var middel- AUC i steady- state 54, 3 ± 23, 5 μg* time/ ml, Cmax var 6, 14 ± 2, 48 μg/ ml og Ctrough var 2, 93 ± 1, 55 μg/ ml.
In 25 paediatric patients ranging in age from 5 to 16 years and receiving the 2 mg/ kg bid dose into the upper arm, anterior thigh or abdomen, the mean steady-state AUC was 54.3 ± 23.5 μ g*h/ ml, Cmax was 6.14 ± 2.48 μ g/ ml, and Ctrough was 2.93 ± 1.55 μ g/ ml.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
Long-term animal carcinogenicity studies have not been performed.
Forsøg med marsvin tyder på, at enfuvirtid potentielt kan udløse en forsinket kontaktoverfølsomhedsreaktion.
Studies in guinea pigs indicated a potential for enfuvirtide to produce delayed contact hypersensitivity.
Der blev observeret en nedsat produktion af IFN- γ i en rottemodel til måling af resistens over for influenzainfektion.
In a rat model on the resistance to influenza infection, an impairment of IFN-γ production was observed.
Resistensen over for influenza - og streptokokinfektion hos rotterne blev kun svagt kompromitteret.
The resistance to influenza and streptococcal infection in rats was only weakly compromised.
Pulver Natriumcarbonat Mannitol Natriumhydroxid Saltsyre
Powder Sodium carbonate Mannitol Sodium hydroxide Hydrochloric Acid
Solvens Vand til injektionsvæsker
11 Solvent Water for Injections
Pulver 3 år
Powder 3 years
Solvens 3 år
Solvent 3 years
11 Opbevaring efter rekonstituering Efter rekonstituering:
Shelf life after reconstitution After reconstitution:
Der er vist kemisk og fysisk stabilitet i 48 timer ved 5°C, når det beskyttes mod lys.
Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C when protected from light.
De må normalt ikke overskride 24 timer ved 2°C til 8°C, medmindre rekonstituering har fundet sted under kontrollerede og validerede aseptiske betingelser.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Pulver Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
Powder Keep the vial in the outer carton in order to protect from light.
Pulver Hætteglas:
Powder Vial:
3 ml hætteglas, farveløst glas, type 1 Lukke:
3 ml vial, colourless glass type 1 Closure:
Forsegling:
Seal:
latexfri gummilukke aluminiumsforsegling med aftagelig beskyttelseshætte
lyophilisate stopper, rubber (latex free) aluminum seal with flip-off cap
Hætteglas:
Closure:
Forsegling
Seal:
latexfri gummilukke aluminiumsforsegling med aftagelig beskyttelseshætte
2 ml vial, colourless glass type 1 rubber stopper (latex free) aluminum seal with flip-off cap
Pakning 1 60 hætteglas pulver til injektionsvæske, opløsning 60 hætteglas solvens 60 3 ml sprøjter 60 1 ml sprøjter 180 spritservietter
Pack 1 60 vials powder for solution for injection 60 vials solvent 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs
Pakning 2 60 hætteglas pulver til injektionsvæske, opløsning 60 hætteglas solvens
12 Pack 2 60 vials powder for solution for injection 60 vials solvent
Fuzeon må kun rekonstitueres med 1, 1 ml vand til injektionsvæsker.
Fuzeon must only be reconstituted with 1.1 ml of Water for Injections.
Man må aldrig ryste eller vende hætteglasset op og ned for at blande – dette vil forårsage skumdannelse.
After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve.
Når pulveret er begyndt at opløses, kan patienten sætte hætteglasset til side, indtil pulveret er helt opløst, hvilket kan tage op til 45 minutter.
The powder may take up to 45 minutes to dissolve into solution.
Før opløsningen trækkes op til administration, skal hætteglas undersøges visuelt for at sikre, at indholdet er fuldstændig opløst, og at opløsningen er klar og uden
Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter.
Hætteglasset med solvens indeholder 2 ml med vand til injektionsvæsker, hvoraf 1, 1 ml skal anvendes til rekonstituering af pulveret.
The solvent vials contain 2 ml Water for Injections, of which 1.1 ml must be withdrawn for the reconstitution of the powder.
1 ml af den rekonstituerede opløsning skal injiceres subkutant i overarmen, abdomen eller lårets forside.
1 ml of the reconstituted solution should be injected subcutaneously in the upper arm, abdomen or anterior thigh.
Et hætteglas må kun bruges en gang og ikke anvendt opløsning skal bortskaffes.
A vial is suitable for single use only; unused portions must be discarded.
Dato for seneste fornyelse af tilladelsen:
Date of last renewal:
27. maj 2003 DD- MM- ÅÅ
27 May 2003 DD-MM-YY
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu
Detailed information on this medicinal product is available on the web site of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Fuzeon 90 mg/ ml, pulver til injektionsvæske, opløsning
Fuzeon 90 mg/ ml powder for solution for injection
Proteasehæmmere, non- nukleosid reverse transkriptasehæmmere og nucleosid reverse transkriptasehæmmere, eller som ikke har tolereret tidligere antiretrovirale regimer.
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non- nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
5. 1)
(see section 5.1).
Beslutningen om en ny behandling af patienter, som ikke har responderet på antiretroviral behandling, bør træffes efter omhyggelige overvejelser om tidligere behandling af den enkelte patient og resistensmønster associeret med forskellige lægemidler.
In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given treatment history of the individual patient and the patterns of mutations associated with different drugs.
5. 1)
(See sections 4.4 and 5.1).
Fuzeon skal ordineres af læger med erfaring i behandling af hiv- infektion.
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
I kliniske forsøg, blev doseringsregimet, som er anvist i tabel 1 nedenfor, anvendt:
In clinical trials the dosage regimen in Table 1 below was used:
14 Tabel 1:
15 Table 1:
Dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens, inklusive dialysepatienter.
No dose adjustment is required for patients with renal impairment including those receiving dialysis.
4. 4 og 5. 2).
No data are available to establish a dose recommendation for patients with hepatic impairment (See sections 4.4 and 5.2).
Hypersensitivitetsreaktioner er lejlighedsvis blevet relateret til behandlingen med enfuvirtid, og i sjældne tilfælde er hypersensitivitetsreaktionerne dukket op igen ved provokationsforsøg.
Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on re-challenge.
De omfatter udslæt, feber, kvalme og opkastning, kulderystelser, stivhed, lavt blodtryk og forhøjede serum - levertransaminaser i forskellige kombinationer og muligvis primært immunkompleksreaktioner, respiratorisk distress og glomerulonefritis.
Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
15 og C, som behandles med antiretroviral terapi har en forhøjet risiko for alvorlige og potentielt dødelige leverbivirkninger.
16 antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.