natgillin/translations-raw huggingface dataset:
• Hiv-inficerede børn og unge i alderen 2 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
• HIV-1 infected children and adolescents aged 2 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Viread 245 mg filmovertrukne tabletter indeholder lactosemonohydrat.
Viread 245 mg film-coated tablets contain lactose monohydrate.
Hvis Viread 123 mg filmovertrukne tabletter seponeres hos patienter med samtidig hiv-infektion og hepatitis B-virus (HBV), skal disse patienter monitoreres tæt for tegn på eksacerbation af hepatitis (se pkt.
If Viread 123 mg film-coated tablets are discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Viread 204 mg tabletter anvendes til behandling af infektion med hiv (humant immundefektvirus).
Viread 204 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Viread 163 mg filmovertrukne tabletter er indiceret til behandling af kronisk hepatitis B hos pædiatriske patienter i alderen 6 til < 12 år, der vejer mellem 22 kg og under 28 kg med:
Viread 163 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:
Viread 163 mg filmovertrukne tabletter er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede, pædiatriske patienter med NRTI-resistens eller toksiciteter, der udelukker brugen af førstevalgsbehandling, i alderen 6 til < 12 år, der vejer mellem 22 kg og under 28 kg.
Viread 163 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.
Viread 163 mg filmovertrukne tabletter Tenofovirdisoproxil
Viread 163 mg film-coated tablets Tenofovir disoproxil
Kronisk hepatitis B: Steady-state tenofovir-eksponering hos HBV-inficerede unge patienter (i alderen 12 til <18 år) i behandling med en oral, daglig dosis tenofovirdisoproxil på 245 mg var sammenlignelig med eksponeringer opnået hos voksne i behandling med tenofovirdisoproxil 245 mg en gang dagligt.
Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg .
De må ikke holde op med at tage Viread, medmindre Deres læge har anbefalet det.
Don't stop taking Viread without your doctor's advice.
Blandt de patienter, som fik placebo i den dobbeltblinde periode, steg andelen af patienter med HBV-dna < 400 kopier/ml skarpt efter påbegyndelse af behandling med open-label tenofovirdisoproxil (PLB-tenofovirdisoproxil-gruppen): 74,1% (40/54) af patienterne i PLB-tenofovirdisoproxil-gruppen havde HBV-dna < 400 kopier/ml ved uge 192.
Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/mL rose sharply after they began treatment with open-label tenofovir disoproxil (PLB-tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Viread fås også som granulat til behandling af hiv 1-infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 2 til < 12 år og i reducerede tabletstyrker til behandling af hiv 1-infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 6 til < 12 år (se pkt.
Viread is also available as granules for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years and as reduced tablet strengths for the treatment of
Nyrer og urinveje: Ikke almindelig:
Tenofovir disoproxil Renal and urinary disorders: Uncommon:
Viread 245 mg filmovertrukne tabletter leveres i tabletbeholdere, der indeholder 30 tabletter.
Viread 245 mg film-coated tablets are supplied in bottles containing 30 tablets.
Viread 163 mg [kun på den ydre emballage
INFORMATION IN BRAILLE Viread 163 mg [Outer packaging only]
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.
svimmelhed Mave-tarm-kanalen: Meget almindelig:
Gastrointestinal disorders: Very common:
Indeholder lactosemonohydrat.
LIST OF EXCIPIENTS Contains lactose monohydrate.
Indlægsseddel: Information til brugeren Viread 163 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Viread 163 mg film-coated tablets
Viread 163 mg filmovertrukne tabletter indeholder lactosemonohydrat.
Viread 163 mg film-coated tablets contain lactose monohydrate.
Viread 123 mg filmovertrukne tabletter er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede, pædiatriske patienter med NRTI-resistens eller toksiciteter, der udelukker brugen af førstevalgsbehandling, i alderen 6 til < 12 år, der vejer mellem 17 kg og under 22 kg.
Viread 123 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.
Hvis Deres barn kaster op mindre end en time efter, at barnet har taget Viread, skal De give
If your child throws up less than 1 hour after taking Viread, give your child another tablet.
Vurderingen af bivirkninger med data fra kliniske studier med hiv 1-inficerede patienter er baseret på erfaringer fra to studier, hvor 653 behandlingserfarne voksne patienter fik behandling med tenofovirdisoproxil (n = 443) eller placebo (n = 210) i kombination med andre antiretrovirale lægemidler i 24 uger, og ligeledes fra et dobbeltblindt, sammenlignende, kontrolleret studie, hvor 600 behandlingsnaive voksne patienter fik behandling med 245 mg tenofovirdisoproxil (n = 299) eller stavudin (n = 301) i kombination med lamivudin og efavirenz i 144 uger.
Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced adult patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve adult patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Indlægsseddel: Information til brugeren Viread 123 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Viread 123 mg film-coated tablets
Data vedrørende knoglemineraltæthed (BMD) fra studiet GS-US-174-0144 er opsummeret i tabel 10:
Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 10:
Viread 163 mg filmovertrukne tabletter leveres i tabletbeholdere, der indeholder 30 tabletter.
Viread 163 mg film-coated tablets are supplied in bottles containing 30 tablets.
Viread 204 mg filmovertrukne tabletter Tenofovirdisoproxil
Viread 204 mg film-coated tablets Tenofovir disoproxil
Viread 123 mg tabletter anvendes til behandling af infektion med hiv (humant immundefektvirus).
Viread 123 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
• HBV-inficerede børn i alderen 6 til under 12 år, som vejer mellem 28 kg og under 35 kg
• HBV infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg
Viread 204 mg filmovertrukne tabletter indeholder lactosemonohydrat.
Viread 204 mg film-coated tablets contain lactose monohydrate.
• HBV-inficerede børn i alderen 6 til under 12 år, som vejer mellem 17 kg og under 22 kg
• HBV infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg
• børn i alderen 6 til under 12 år • som vejer mellem 28 kg og under 35 kg
• Children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg:
Viread 204 mg filmovertrukne tabletter leveres i tabletbeholdere, der indeholder 30 tabletter.
Viread 204 mg film-coated tablets are supplied in bottles containing 30 tablets.
Det skal De vide, før Deres barn begynder at tage Viread Giv ikke Viread
What you need to know before your child takes Viread
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.
Hver Viread-tablet indeholder 245 mg tenofovirdisoproxil (som fumarat).
Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Samtidig administration af tenofovirdisoproxil og didanosin anbefales ikke (se pkt.
Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Viread 123 mg filmovertrukne tabletter Tenofovirdisoproxil
Viread 123 mg film-coated tablets Tenofovir disoproxil
• kompenseret leversygdom og tegn på immunaktiv sygdom, dvs. aktiv viral replikation og vedvarende forhøjede ALAT-niveauer i serum eller histologisk tegn på moderat til svær inflammation og/eller fibrose.
• compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Se Produktresuméet for Viread 123 mg og 163 mg filmovertrukne tabletter for behandlingen af hiv 1-infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 6 til < 12 år, der vejer hhv. mellem 17 kg og < 22 kg og mellem 22 kg og < 28 kg.
Please refer to the Summaries of Product Characteristics for Viread 123 mg and 163 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 22 kg to < 28 kg, respectively.
Data vedrørende knoglemineraltæthed (BMD) fra studiet GS-US-174-0144 er opsummeret i tabel 9:
Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 9:
• kompenseret leversygdom og tegn på immunaktiv sygdom, dvs. aktiv viral replikation og vedvarende forhøjede ALAT-niveauer i serum eller histologiske tegn på moderat til svær inflammation og/eller fibrose.
• compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
• børn i alderen 6 til under 12 år • som vejer mellem 17 kg og under 22 kg
• Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:
Data vedrørende knoglemineraltæthed (BMD) fra studiet GS-US-174-0115 er opsummeret i tabel 9:
Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 9:
• HBV-inficerede børn i alderen 6 til under 12 år, som vejer mellem 22 kg og under 28 kg
• HBV infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg
BMD Z-resulta ta for columna lumbalis Gennemsnitlig (SD) ændring i BMD Zresultata for columna lumbalis fra baseline n/a n/a
Lumbar spine mean (SD) BMD Z-scorea Lumbar spine mean (SD) change from baseline BMD Z-score a
Deres barns læge, når barnet påbegynder behandlingen med Viread, hvis barnet har både HBV og hiv.
• Don't stop any anti-HIV medicines prescribed by your child's doctor when they start Viread if they have both HBV and HIV.
Se Produktresuméet for Viread 163 mg og 204 mg filmovertrukne tabletter til behandling af hiv 1-infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 6 til < 12 år, der vejer hhv. mellem 22 kg og < 28 kg og mellem 28 kg og < 35 kg.
Please refer to the Summaries of Product Characteristics for Viread 163 mg and 204 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 22 kg to < 28 kg and 28 kg to < 35 kg, respectively.
Tenofovir steady-state farmakokinetik blev evalueret hos 8 hiv 1-inficerede unge patienter (i alderen 12 til < 18 år) med kropsvægt ≥ 35 kg og hos 23 hiv 1-inficerede børn i alderen 2 til < 12 år (se tabel 10 nedenfor).
Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 10 below).
Kliniske studier, hiv 1: Vurderingen af bivirkninger med data fra kliniske studier med hiv 1-inficerede patienter er baseret på erfaringer fra to studier, hvor 653 behandlingserfarne voksne patienter fik behandling med tenofovirdisoproxil (n = 443) eller placebo (n = 210) i kombination med andre antiretrovirale lægemidler i 24 uger, og ligeledes fra et dobbeltblindt, sammenlignende, kontrolleret studie, hvor 600 behandlingsnaive voksne patienter fik behandling med 245 mg tenofovirdisoproxil (n = 299) eller stavudin (n = 301) i kombination med lamivudin og efavirenz i 144 uger.
HIV-1 clinical studies: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced adult patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve adult patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Viread 123 mg filmovertrukne tabletter indeholder lactosemonohydrat.
Viread 123 mg film-coated tablets contain lactose monohydrate.
Hver Viread-tablet indeholder 204 mg tenofovirdisoproxil (som fumarat).
Each Viread tablet contains 204 mg of tenofovir disoproxil (as fumarate).
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.
Deres barn vejer mere eller mindre end den tilladte vægt.
Contact your child's doctor if your child is outside the permitted weight.
l 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 240 uger open-label.
l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
udslæt
dizziness
96b 144e 192g 240i 288l 384o 96c 144f
96b 144e 192g 240i
Viread 204 mg tabletter anvendes også til behandling af kronisk hepatitis B, som er en infektion med HBV (hepatitis B-virus).
Viread 204 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Viread 163 mg tabletter anvendes også til behandling af kronisk hepatitis B, som er en infektion med HBV (hepatitis B-virus).
Viread 163 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Følgende bivirkninger er sjældne (kan opstå hos mellem 1 og 10 ud af 10.000 patienter):
The following side effects are rare (these can affect up to 1 in every 1,000 patients):
Det anbefales at justere den daglige dosis tenofovirdisoproxil 33 mg/g granulat hos patienter med moderat (kreatininclearance 30-49 ml/min) eller svært (kreatininclearance < 30 ml/min) nedsat nyrefunktion.
Adjustments of the daily dose of tenofovir disoproxil 33 mg/g granules are recommended in patients with moderate (creatinine clearance 30-49 ml/min) or severe (creatinine clearance < 30 ml/min) renal impairment 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.
Viread 123 mg filmovertrukne tabletter leveres i tabletbeholdere, der indeholder 30 tabletter.
Viread 123 mg film-coated tablets are supplied in bottles containing 30 tablets.
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.
I uge 144 var procentdelen af patienter med hiv 1-rna under 400 kopier/ml og 50 kopier/ml henholdsvis 71% og 68% i 245 mg tenofovirdisoproxil-armen sammenlignet med 64% og 63% i stavudinarmen.
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.
Efter en indledende reduktion på ca. -4,9 ml/min (ved anvendelse af Cockcroft-Gault-ligningen) eller -3,9 ml/min/1,73 m² (ved anvendelse af modification of diet in renal disease [MDRD]-ligningen) efter de første 4 ugers behandling var hastigheden af den årlige reduktion i nyrefunktionen efter baseline, der blev rapporteret hos patienter behandlet med tenofovirdisoproxil, -1,41 ml/min pr. år (ved anvendelse af Cockcroft-Gault-ligningen) og -0,74 ml/min/1,73 m² pr. år (ved anvendelse af MDRD-ligningen).
after the first 4 weeks of treatment, the rate of annual decline post baseline of renal function reported in tenofovir disoproxil treated patients was -1.41 ml/min per year (using Cockcroft-Gault equation) and -0.74 ml/min/1.73 m2 per year (using MDRD equation).
i 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 192 uger open-label.
i 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Den forøgede tenofovir-eksponering kan medføre forstærkede bivirkninger af tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
The increased exposure of tenofovir could potentiate tenofovirassociated adverse events, including renal disorders.
• børn i alderen 6 til under 12 år • som vejer mellem 22 kg og under 28 kg
• Children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg:
m 48 uger dobbeltblind tenofovirdisoproxil, efterfulgt af 240 uger open-label.
m 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Hver Viread-tablet indeholder 163 mg tenofovirdisoproxil (som fumarat).
Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Se Produktresuméet for Viread 123 mg og 204 mg filmovertrukne tabletter til behandling af hiv 1-infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 6 til < 12 år, der vejer hhv. mellem 17 kg og < 22 kg og mellem 28 kg og < 35 kg.
Please refer to the Summaries of Product Characteristics for Viread 123 mg and 204 mg film-coated tablets for the treatment of HIV-1 infect ion and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 28 kg to < 35 kg, respectively.
Viread 123 mg tabletter anvendes også til behandling af kronisk hepatitis B, som er en infektion med HBV (hepatitis B-virus).
Viread 123 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Det skal De vide, før Deres barn begynder at tage Viread Sådan skal Deres barn tage Viread Bivirkninger
What Viread is and what it is used for What you need to know before your child takes Viread How to take Viread
HBV-dnareduktion fra baselinec (log10 kopier/ml) HBV-dna (%) < 400 kopier/ml (< 69 IE/ml) ALAT (%) Normaliseret ALATd
(log10 copies/ml) HBV DNA (%) < 400 copies/ml (< 69 IU/ml) ALT (%) Normalised ALT
Kronisk hepatitis B: I studie GS-US-174-0115 blev 106 HBeAg-negative og HBeAg-positive patienter i alderen 12 til < 18 år med kronisk HBV-infektion [HBV-dna ≥ 105 kopier/ml, forhøjet serum-ALAT (≥ 2 x ULN) eller en anamnese med forhøjede serum-ALAT-niveauer i løbet af de seneste 24 måneder] behandlet med tenofovirdisoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger.
Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to < 18 years with chronic HBV infection [HBV DNA ≥ 105 copies/ml, elevated serum ALT
g De viste tal er kumulative procenter 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).
i 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.
10 mg adefovirdipivoxil skift til 245 mg tenofovirdisoproxil n = 125d
Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125d
h 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 144 uger open-label tenofovirdisoproxil.
h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
96b 144e 192h 240j 288m 384o 96c 144f
96b 144e 192h 240j
Hver Viread-tablet indeholder 123 mg tenofovirdisoproxil (som fumarat).
Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
m 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 240 uger open-label tenofovirdisoproxil.
m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Mindst 6% fald i BMD for columna lumbalisb n/a n/a
Lumbar spine BMD at least 6% decrease b
Cmax: ↑ 55% Cmin: ↑ 52%
AUC: ↑ 45% Cmax: ↑ 60%
n 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.
Ethylcellulose (E462) Hydroxypropylcellulose (E463) Mannitol (E421) Siliciumdioxid (E551)
(E421) and silicon dioxide (E551).
+ Emtricitabin/tenofovir disoproxil (200 mg/245 mg q.d.)
+ Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
• De må ikke amme, mens De er i behandling med Viread, fordi det aktive stof i denne medicin udskilles i mælken hos mennesker.
This is because the active substance in this medicine passes into human breast milk.
j 48 uger dobbeltblind adefovirdipivoxil, efterfulgt af 192 uger open-label tenofovirdisoproxil.
j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Knogler, led, muskler og bindevæv:
• breakdown of muscle, muscle pain or weakness
Kontakt lægen, før De tager dette lægemiddel, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Hver måleske giver ét gram granulat, som indeholder 33 mg tenofovirdisoproxil (som fumarat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).
Hiv 1: Tenofovir steady-state farmakokinetik blev evalueret hos 8 hiv 1-inficerede unge patienter (i alderen 12 til < 18 år) med kropsvægt ≥ 35 kg og hos 23 hiv 1-inficerede børn i alderen 2 til < 12 år (se tabel 11 nedenfor).
HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 11 below).
• afgang af tarmluft (flatulens)
• flatulence