natgillin/translations-raw huggingface dataset:
NN: [kun på den ydre emballage]
NN: [outer packaging only]
Tenofovir omdannes derefter af konstitutivt eksprimerede celleenzymer til den aktive metabolit, tenofovirdiphosphat, en obligat kædeblokker.
Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes.
6.2 Uforligeligheder Ikke relevant.
6.2 Incompatibilities
Gennemsnitlig (SD) BMD Zresultat a for hele kroppen Gennemsnitlig (SD) ændring af BMD Z-resultat a for hele kroppen fra baseline
Whole body mean (SD) BMD Z-scorea Whole body mean (SD) change from baseline BMD Z-scorea
Tenofovirdisoproxil bør ikke administreres samtidig med adefovirdipivoxil (se pkt.
Tenofovir disoproxil should not be administered concurrently with adefovir dipivoxil (see section 4.4).
10 mg adefovirdipivoxil n = 90
Adefovir dipivoxil 10 mg n = 90
Opblussen under behandlingen: Spontan eksacerbation af kronisk hepatitis B er relativt almindeligt og karakteriseret af forbigående stigninger i serum-ALAT.
Flares on treatment: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients (see section 4.8).
426 HBeAg-negative (GS-US-174-0102, n = 250) og HBeAg-positive (GS-US-174-0103, n = 176) patienter, der initialt blev randomiseret til behandling med dobbelt-blind tenofovirdisoproxil og derefter skiftede til open-label-behandling med tenofovirdisoproxil, blev undersøgt for genotype-ændringer i HBV-polymerase i forhold til baseline.
Clinical resistance Four hundred and twenty-six HBeAg negative (GS-US-174-0102, n = 250) and HBeAg positive (GS-US-174-0103, n = 176) patients initially randomised to double-blind tenofovir disoproxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Hos patienter i behandling med tenofovirdisoproxil med risikofaktorer for renal dysfunktion er der blevet rapporteret tilfælde af akut nyresvigt efter påbegyndelse af højdosisbehandling med non-steroide antiinflammatoriske midler (NSAID'er) og behandling med flere NSAID'er.
Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
• fald i blodets kaliumniveau
• decreases in potassium in the blood,
141 voksne forsøgspersoner blev randomiseret til en behandlingsarm med tenofovirdisoproxil, og 139 voksne forsøgspersoner blev randomiseret til en behandlingsarm med emtricitabin plus tenofovirdisoproxil.
One hundred forty-one and 139 adult subjects were randomised to a tenofovir disoproxil and emtricitabine plus tenofovir disoproxil treatment arm, respectively.
De viste tal er kumulative procentdele baseret på en Kaplan Meier-analyse, som inkluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovirdisoproxil (KM-ITT).
g Figures presented are cumulative percentages based upon a Kaplan Meier analysis including data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-ITT).
+ Raltegravir (400 mg b.i.d) + Emtricitabin/tenofovirdisoprox il (200 mg/245 mg q.d.)
+ Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Tab af HBsAg/ serokonversion n k n n a Baseret på Long Term Evaluation algoritme (LTE-analyse) - Patienter, som afbrød studiet på et vilkårligt tidspunkt før uge 384 pga. et protokoldefineret endepunkt, såvel som dem, der fuldførte uge 384, inkluderes i nævneren.
11l a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384
4.4, 4.8 og 5.1).
- decompensated liver disease (see sections 4.4, 4.8 and 5.1).
NRTIer Didanosin
NRTIs Didanosine
Følgende bivirkninger er meget almindelige (kan opstå hos mere end 1 ud af 10 personer):
The following side effects are very common (may affect more than 1 in 10 people):
245 mg tenofovirdisoproxil og stavudin gruppen).
245 mg and stavudine groups, respectively).
De viste tal er kumulative procenter baseret på en Kaplan Meier-analyse, som ekskluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovirdisoproxil (KM-tenofovirdisoproxil).
l Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Der blev ikke identificeret aminosyresubstitutioner forbundet med tenofovirdisoproxil-resistens hos nogen forsøgspersoner.
No amino acid substitutions associated with tenofovir disoproxil resistance were detected in any subject.
- Tenofovir disoproxil Zentiva bør ikke tages samtidigt med adefovirdipivoxil.
- Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
hovedpine
headache
n De viste tal er kumulative procenter baseret på en Kaplan Meier-analyse, som ekskluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovirdisoproxil (KM-tenofovirdisoproxil).
n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Samtidig administration af tenofovirdisoproxil 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.
Co-administration of tenofovir disoproxil 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).
Til de mange risikofaktorer for udvikling af denne sygdom hører blandt andre: Varigheden af kombinationsbehandlingen, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar, samt (over)vægt (højere Body Mass Index (BMI)).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
10 mg adefovirdipivoxil n = 125
Adefovir dipivoxil 10 mg n = 125
Tenofovirdisoproxil Metabolisme og ernæring:
Tenofovir disoproxil Metabolism and nutrition disorders: Very common:
Følgende bivirkninger er sjældne (kan opstå hos op til 1 ud af 1.000 personer):
The following side effects are rare (may affect up to 1 in 1,000 people):
Ved behandlingsintentionsanalyse (manglende data og skift i antiretroviral behandling (ART) blev betragtet som svigt) var procentdelen af patienter med hiv 1-RNA under 400 kopier/ml og 50 kopier/ml i uge 48 af behandlingen henholdsvis 80 % og 76 % i 245 mg tenofovirdisoproxil behandlingsarmen, sammenlignet med 84 % og 80 % i stavudin behandlingsarmen.
By intent to treat analysis (missing data and switch in antiretroviral therapy (ART) considered as failure), the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml at 48 weeks of treatment was 80% and 76% respectively in the tenofovir disoproxil 245 mg arm, compared to 84% and 80% in the stavudine arm. At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mg arm, compared to 64% and 63% in the stavudine arm.
Brug sammen med visse antivirale lægemidler mod hepatitis C Det er vist, at samtidig administration af tenofovirdisoproxil og ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir øger plasmakoncentrationen af tenofovir, især ved brug af et hiv-regime, der indeholder tenofovirdisoproxil og en farmakokinetisk booster (ritonavir eller cobicistat).
Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Tenofovir disoproxil Zentiva indeholder lactosemonohydrat.
Tenofovir disoproxil Zentiva contains lactose monohydrate.
200 mg emtricitabin/ 245 mg tenofovirdisoproxil (n = 45)
Emtricitabine 200 mg/ tenofovir disoproxil 245 mg (n = 45)
Samtidig administration af tenofovirdisoproxil og didanosin kan ikke anbefales (se pkt.
Co-administration of tenofovir disoproxil and didanosine is not recommended (see section
Påvirkning af nyrer og knogler hos den pædiatriske population Der er usikkerheder i forbindelse med virkningen af langvarig behandling på knogle- og nyretoksicitet.
There are uncertainties associated with the long-term effects of bone and renal toxicity.
* p-værdi versus adefovirdipivoxil < 0,05. a Komplet respons defineret som HBV-DNA-niveauer < 400 kopier/ml og en forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore.
*p-value versus adefovir dipivoxil < 0.05, a Complete response defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay, d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Hold øje med tegn på betændelse eller infektion i tiden lige efter, du begynder at tage
Look out for signs of inflammation or infection soon after you start taking Tenofovir disoproxil Zentiva.
Hvis der er mistanke om nyreabnormiteter, eller disse påvises, skal konsultation med en nefrolog foretages for at overveje at seponere behandlingen med tenofovirdisoproxil.
If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of tenofovir disoproxil treatment.
Der er rapporteret akut hepatitis-eksacerbationer, både under behandling og efter seponering af hepatitis B-behandling (se pkt.
Acute exacerbation of hepatitis has been reported in patients on treatment as well as in patients who have discontinued hepatitis B therapy (see section 4.4).
Tenofovir disoproxil Zentiva bør ikke tages samtidigt med adefovirdipivoxil.
Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Samtidig administration af tenofovirdisoproxil og didanosin resulterer i en 4060 % stigning i systemisk eksponering for didanosin, hvilket kan øge risikoen for didanosinrelaterede bivirkninger.
Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Såfremt der forekommer overdosering, skal patienten monitoreres for tegn på toksicitet (se pkt.
If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary.
Lopinavir/ritonavir (400 b.i.d./100 b.i.d./245 q.d.)
Lopinavir/Ritonavir (400 mg b.i.d./100 mg b.i.d.)
Kør ikke bil eller motorcykel, lad være med at cykle og lad være med at arbejde med værktøj eller maskiner, hvis du bliver svimmel, når du tager Tenofovir disoproxil Zentiva.
If you feel dizzy while taking Tenofovir disoproxil Zentiva, do not drive or ride a bicycle and do not use any tools or machines.
Der er rapporteret sjældne tilfælde af pancreatitis og laktatacidose, og nogle af disse tilfælde var letale (se pkt.
Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported (see section 4.4).
Samtidig administration af tenofovirdisoproxil og didanosin resulterer i en 40-60 % stigning i systemisk eksponering for didanosin, hvilket kan øge risikoen for didanosin-relaterede bivirkninger (se pkt.
Co-administration of tenofovir disoproxil and didanosine 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).
Etiket til tabletbeholder og ydre pakning
Bottle label and outer carton
Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos behandlingsnaive og behandlingserfarne forsøgspersoner, hvor 76 % (38/50) behandlingsnaive og 80 % (8/10)
Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/ml (69 IU/ml) at Week 48.
Dette er baseret på modellering af farmakokinetiske data for enkeltdosis hos hiv-negative patienter eller patienter uden HBV-infektion men med forskellige grader af nedsat nyrefunktion, herunder nyresygdom i slutstadiet, hvor det er nødvendigt med dialyse, og er ikke blevet bekræftet i kliniske studier.
Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV-negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Følgende bivirkninger er ikke almindelige (kan opstå hos op til 1 ud af 100 personer):
The following side effects are uncommon (may affect up to 1 in 100 people):
Tenofovirdisoproxil Knogler, led, muskler og bindevæv: Ikke almindelig:
Musculoskeletal and connective tissue disorders: Uncommon:
Titandioxid
Titanium dioxide Triacetin
Lægemidler, som udskilles gennem nyrerne
Renally eliminated medicinal products
Svært nedsat nyrefunktion: 245 mg tenofovirdisoproxil kan administreres hver 72.
Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72 - 96 hours (dosing twice a week).
• problemer med bugspytkirtlen
• pancreas problems.
245 mg tenofovirdisoproxil n = 176
Tenofovir disoproxil 245 mg n = 176
Gennemsnitlig stigning (%) i BMD for hele kroppen
Whole body BMD mean % increase
Gennemsnitlig (SD) BMD Zresultata for columna lumbalis Gennemsnitlig (SD) ændring i BMD Z-resultata for columna lumbalis fra baseline
Lumbar spine mean (SD) change from baseline BMD Z-scorea NA
o 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 336 uger open-label.
o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
e 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 96 uger open-label.
e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Data vedrørende knoglemineraltæthed (BMD) fra studiet GS-US-174-0115 er opsummeret i tabel 8:
Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Gennemsnitlig (SD) BMD Z-resultata for hele kroppen
Whole body mean (SD) BMD Z-scorea
var sammenlignelig mellem behandlingsgruppen med tenofovirdisoproxil og behandlingsgruppen med stavudin eller zidovudin.
The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Mindst 4 % fald i BMD for columna lumbalis
Lumbar spine BMD at least 4% decrease
Hver filmovertrukket tablet indeholder tenofovirdisoproxilphosphat (svarende til 245 mg tenofovirdisoproxil).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tenofovir disoproxil phosphate (equivalent to 245 mg of tenofovir disoproxil).
kopier/ml, serum-ALAT > 1,5 x ULN) i gruppen, der blev behandlet med tenofovirdisoproxil, og 0 % (0/32) af patienterne i placebogruppen HBV-DNA < 400 kopier/ml.
At week 72, 96% (27/28) of immuneactive patients (HBV DNA ≥ 105 copies/ml, serum ALT > 1.5 x ULN) in the tenofovir disoproxil treatment group and 0% (0/32) of patients in the placebo group had HBV DNA < 400 copies/ml.
Da Tenofovir disoproxil Zentiva kan foråsage nyreskader, anbefales monitorering af nyrefunktionen (se pkt.
As Tenofovir disoproxil Zentiva may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
c 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af op til 192 uger open-label.
c 48 weeks double-blind tenofovir disoproxil followed by up to 192 weeks open-label.
Nedsat leverfunktion Justering af dosis er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Sådan skal du tage Tenofovir disoproxil Zentiva
How to take Tenofovir disoproxil Zentiva
Følgende bivirkninger er almindelige (kan opstå hos op til 1 ud af 10 personer):
The following side effects are common (may affect up to 1 in 10 people):
p 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 336 uger open-label tenofovirdisoproxil.
p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
b 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 48 uger open-label.
b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
• beskadigelse af celler i nyrerne (de tubulære celler)
• pain in the tummy (abdomen) caused by inflammation of the pancreas, • damage to kidney tubule cells.
Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders.
Det frarådes at bruge tenofovirdisoproxil hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), og hos patienter med behov for hæmodialyse.
In patients with severe renal impairment (creatinine clearance < 30 ml/min) and in patients who require haemodialysis use of tenofovir disoproxil is not recommended.
Påvirkning af knogler
Bone effects
g 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 144 uger open-label.
g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
FREMSTILLERENS BATCHNUMMER Lot:
BATCH NUMBER
I studierne GS-US-174-0102 og GS-US-174-0103 skiftede patienterne uden behandlingsafbrydelse til open-label-behandling med tenofovirdisoproxil efter at have fået dobbeltblind-behandling i 48 uger
In studies GS-US-174-0102 and GS-US-174-0103, after receiving double-blind treatment for 48 weeks (either tenofovir disoproxil 245 mg or adefovir dipivoxil 10 mg), patients rolled over with no interruption in treatment to open-label tenofovir disoproxil.
Hvis du har særlige problemer med at synke, kan du knuse tabletten med spidsen af en ske og opløse den i ca. 100 ml (et halvt glas) vand, appelsinjuice eller druesaft.
Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately.
10 mg adefovirdipivoxil skift til 245 mg tenofovirdisoproxil n = 125
Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125
f 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 96 uger open-label tenofovirdisoproxil.
f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil .
Serologi (%) Tab af HBeAg/ serokonversion Tab af HBsAg/ serokonversion g g l l l g g l l l a
Serology (%)HBeAg loss/seroconversionHBsAg loss/seroconversion n/a n/a
Tenofovirdi soproxiltenofovirdis oproxil
Tenofovir disoproxiltenofovir disoproxil
c 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 48 uger open-label tenofovirdisoproxil.
c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil .
245 mg tenofovirdisoproxil n = 250
Tenofovir disoproxil 245 mg n = 250
48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 240 uger open-label.
l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir/voxil aprevir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxil aprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Det skal du vide, før du begynder at tage Tenofovir disoproxil Zentiva Sådan skal du tage Tenofovir disoproxil Zentiva Bivirkninger
What Tenofovir disoproxil Zentiva is and what it is used for What you need to know before you take Tenofovir disoproxil Zentiva How to take Tenofovir disoproxil Zentiva Possible side effects
Tenofovir disoproxil Zentiva 245 mg filmovertrukne tabletter Tenofovirdisoproxil
NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets Tenofovir disoproxil
AUC: ↔ Cmax: ↑ 47 % Cmin: ↑ 47 %
AUC: ↔ Cmax: ↑ 47%
Didanosin Samtidig administration af tenofovirdisoproxil og didanosin anbefales ikke (se pkt.
Didanosine Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
10 mg adefovirdipivoxil skift til 245 mg tenofovirdisoproxil n = 90
Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Der foreligger ingen data for dosisanbefalinger (se pkt.
No data are available to make dose recommendations (see sections 4.2 and 4.4).
Behandling
asthenia
• unge i alderen 12 til under 18 år, som allerede er blevet behandlet med anden hiv-medicin, der ikke længere er helt effektivt på grund af udvikling af resistens, eller der forårsagede bivirkninger.
medicines which are no longer fully effective due to development of resistance, or have caused side effects.
• hovedpine • mavesmerter
• stomach pain,
Mindst 6 % fald i BMD for columna lumbalis b
Lumbar spine BMD at least 6% decreaseb
Seponering af behandlingen frarådes hos voksne patienter med dekompenseret leversygdom eller levercirrose.
In adult patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Den forøgede tenofovir-eksponering kan forstærke effekten af bivirkninger ved tenofovirdisoproxil, herunder nyresygdomme.
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Gennemsnitlig (SD) BMD Z-resultata for columna lumbalis
Lumbar spine mean (SD) BMD Z-scorea
Sofosbuvir: AUC: ↔ Cmax: ↓ 19 %
Sofosbuvir: AUC: ↓ 27%
h 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 144 uger open-label.
h 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Gennemsnitlig (SD) ændring i BMD Zresultata for hele kroppen fra baseline
Whole body mean (SD) change from baseline
laktatacidose
fatigue
j 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 192 uger open-label.
j 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 144 uger open-label tenofovirdisoproxil.
i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil .
• afgang af tarmluft (flatulens)
• flatulence.
48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 240 uger open-label tenofovirdisoproxil.
n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil .
Meget almindelig: diarré, opkastning, kvalme Almindelig:
diarrhoea, vomiting, nausea
245 mg tenofovirdisoproxil (n = 45)
Tenofovir disoproxil 245 mg (n = 45)
Darunavir/ritonavir (300/100 b.i.d./245 q.d.)
Darunavir/Ritonavir (300 mg/100 mg b.i.d.)
hypokaliæmi
hypokalaemia1
+ Emtricitabin/rilpivirin/tenofovi rdisoproxil (200 mg/25 mg/245 mg q.d.)
+ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
48 uger dobbeltblind adefovirdipivoxil, efterfulgt af op til 192 uger open-label tenofovirdisoproxil.
d 48 weeks double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil .
Meget almindelig: svimmelhed Almindelig:
Gastrointestinal disorders: Very common:
resultata for columna lumbalis fra baseline NA
Mean change from baseline in CPT score