natgillin/translations-raw huggingface dataset:
4. 4).
6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Serum- ALAT - og HBV DNA- niveauer bør følges regelmæssigt efter seponering af behandlingen for at kunne påvise et eventuelt sent virologisk tilbagefald.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
- Hos HBeAg- negative patienter uden levercirrose bør behandlingen administreres mindst indtil
- In HBeAg negative patients without cirrhosis, treatment should be administered at least until
HBs- serokonversion, eller indtil der er tegn på manglende virkning.
HBs seroconversion or there is evidence of loss of efficacy.
5. 2).
Viread is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
4. 4).
No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Tenofovir udskilles via nyrerne og eksponeringen over for tenofovir øges hos patienter med nyredysfunktion.
Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction.
Der er begrænsede data om sikkerhed og virkning af tenofovirdisoproxilfumarat hos patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/ min), og langtidssikkerhedsdata er ikke blevet evalueret for let nedsat nyrefunktion (kreatinclearance < 50- 80 ml/ min).
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/ min) and long term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/ min).
Tenofovirdisoproxilfumarat bør derfor kun bruges til patienter med nedsat nyrefunktion, hvis de potentielle fordele ved behandlingen anses for at veje tungere end de potentielle risici.
Therefore, in patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Det anbefales at justere dosisintervallet hos patienter med en kreatinclearance på < 50 ml/ min.
Dose interval adjustments are recommended for patients with creatinine clearance < 50 ml/ min.
Let nedsat nyrefunktion (kreatininclearance 50- 80 ml/ min):
Mild renal impairment (creatinine clearance 50-80 ml/ min):
Begrænsede data fra kliniske undersøgelser understøtter én daglig dosis med tenofovirdisoproxilfumarat hos patienter med let nedsat nyrefunktion.
Limited data from clinical studies support once daily dosing of tenofovir disoproxil fumarate in patients with mild renal impairment.
Moderat nedsat nyrefunktion (kreatininclearance 30- 49 ml/ min):
Moderate renal impairment (creatinine clearance 30-49 ml/ min):
Dette er baseret på modellering af farmakokinetiske data for enkeltdosis hos patienter uden HIV - eller HBV- infektion men med forskellige grader af nedsat nyrefunktion, herunder end- stage renal sygdom, hvor det er nødvendigt med dialyse, og er ikke blevet bekræftet i kliniske undersøgelser.
Administration of 245 mg tenofovir disoproxil (as fumarate) every 48 hours is recommended based on modelling of single-dose pharmacokinetic data in non-HIV 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.
4. 4 og 5. 2).
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see sections 4.4 and 5.2).
Svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) og hæmodialyse- patienter:
Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
Brug til denne patientgruppe frarådes derfor.
Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Hvis der ikke findes nogen alternativ behandling, kan de følgende forlængede dosisintervaller anvendes:
If no alternative treatment is available, prolonged dose intervals may be used as follows:
Svært nedsat nyrefunktion:
Severe renal impairment:
245 mg tenofovirdisoproxil (som fumarat) kan administreres hver 72. - 96. time (dosering to gange ugentlig).
245 mg tenofovir disoproxil (as fumarate) may be administered every 72-96 hours (dosing twice a week).
Hæmodialyse- patienter:
Haemodialysis patients:
245 mg tenofovirdisoproxil (som fumarat) kan administreres hver 7. dag efter afslutning af en hæmodialyse- session *.
245 mg tenofovir disoproxil (as fumarate) may be administered every 7 days following completion of a haemodialysis session*.
Disse dosisintervaljusteringer er ikke blevet bekræftet i kliniske undersøgelser.
These dose adjustments have not been confirmed in clinical studies.
Simuleringer antyder, at det forlængede dosisinterval ikke er optimalt, og at det kan resultere i øget toksicitet og mulig
Simulations suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
4. 4 og 5. 2).
Therefore clinical response to treatment and renal function should be closely monitored (see sections 4.4 and 5.2).
4 timers varighed eller efter 12 timers kumulativ hæmodialyse.
3 * Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
Der kan ikke gives nogle dosisanbefalinger til ikke- hæmodialyse- patienter med kreatininclearance < 10 ml/ min.
No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance < 10 ml/ min.
4. 4 og 5. 2).
No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
4. 4).
If Viread is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Tenofovirdisoproxilfumarat er hverken blevet undersøgt hos patienter under 18 år eller hos patienter over 65 år.
Tenofovir disoproxil fumarate has not been studied in patients under the age of 18 or in patients over the age of 65.
Der skal derfor udvises forsigtighed ved behandling af ældre patienter med tenofovirdisoproxilfumarat, da det er mere sandsynligt, at ældre patienter har nedsat nyrefunktion (se nedenfor).
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir disoproxil fumarate (see below).
Alle HBV- inficerede patienter bør tilbydes HIV- antistoftest før start af behandlingen med tenofovirdisoproxilfumarat (se Samtidig infektion med HIV- 1 og hepatitis B nedenfor).
HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxil fumarate therapy (see below Co-infection with HIV-1 and hepatitis B).
Patienterne skal underrettes om, at det ikke er påvist, at tenofovirdisoproxilfumarat forebygger risikoen for overførsel af HIV eller HBV til andre ved seksuel kontakt eller kontaminering af blod.
Patients must be advised that tenofovir disoproxil fumarate has not been proven to prevent the risk of transmission of HIV or HBV to others through sexual contact or contamination with blood.
Viread indeholder lactosemonohydrat.
Viread contains lactose monohydrate.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase Deficiency) eller glukose/ galaktosemalabsorption.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Samtidig indgivelse af andre lægemidler:
Co-administration of other medicinal products:
- Viread bør ikke tages sammen med andre lægemidler, der indeholder
- Viread should not be administered with any other medicinal products containing tenofovir
tenofovirdisoproxilfumarat (Truvada eller Atripla).
disoproxil fumarate (Truvada or Atripla).
- Viread bør heller ikke tages samtidig med adefovirdipivoxil.
- Viread should also not be administered concurrently with adefovir dipivoxil.
Samtidig
- Co-administration of tenofovir disoproxil fumarate and didanosine is not recommended.
Der er rapporteret om sjældne tilfælde af pancreatitis og laktatacidose, og nogle af disse var fatale.
Rare cases of pancreatitis and lactic acidosis, sometimes fatal, have been reported.
En reduceret dosis på 250 mg didanosin, der administreres samtidig med tenofovirdisoproxilfumarat, er blevet sat i forbindelse med rapporter om høj forekomst af manglende virologisk effekt i flere testede kombinationer til behandling af HIV- 1- infektion.
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Trestofsbehandling med nukleosider/ nukleotider:
Triple therapy with nucleosides/ nucleotides:
Hos HIV- patienter er der rapporteret om høj forekomst af manglende virologisk effekt og om resistensudvikling, begge på et tidligt tidspunkt, når tenofovirdisoproxilfumarat blev kombineret med lamivudin og abacavir eller med lamivudin og didanosin, der blev indgivet en gang dagligt.
There have been reports of a high rate of virological failure and of emergence of resistance at early stage in HIV patients when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
4 Nyrefunktion:
Renal function:
Tenofovirs renale sikkerhed er kun blevet undersøgt i et meget begrænset omfang hos patienter med nedsat nyrefunktion (CrCl < 80 ml/ min).
4 Renal safety with tenofovir has only been studied to a very limited degree in patients with impaired renal function (CrCl < 80 ml/ min).
Desuden skal nyrefunktionen (kreatininclearance og serumfosfat) også overvåges hver fjerde uge i løbet af det første år og derefter hver tredje måned.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with tenofovir disoproxil fumarate and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year, and then every three months.
Patienter med en kreatininclearance < 50 ml/ min, herunder hæmodialysepatienter:
Patients with creatinine clearance < 50 ml/ min, including haemodialysis patients:
Det frarådes at bruge tenofovir hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min).
In patients with severe renal impairment (creatinine clearance < 30 ml/ min) use of tenofovir is not recommended.
4. 2 og 5. 2).
If no alternative treatment is available, the dosing interval must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
4. 8, proksimal tubulopati).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Det bør også overvejes at afbryde behandlingen med tenofovirdisoproxilfumarat hos patienter med kreatininclearance på under < 50 ml/ min eller fald i serumfosfat til < 1, 0 mg/ dl (0, 32 mmol/ l).
Consideration should also be given to interrupting treatment with tenofovir disoproxil fumarate in patients with creatinine clearance decreased to < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Brug af tenofovirdisoproxilfumarat bør undgås med samtidig eller nylig brug af et nefrotoksisk lægemiddel (f. eks. aminoglycosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin- 2).
Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product (e. g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2).
Nyrefunktionen bør overvåges en gang om ugen, hvis samtidig brug af tenofovirdisoproxilfumarat og nefrotoksiske lægemidler er uundgåelig.
If concomitant use of tenofovir disoproxil fumarate and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Tenofovirdisoproxilfumarat er ikke klinisk vurderet hos patienter, der får lægemidler, som secerneres via det samme renale system, herunder transportproteinerne human organic anion transporter (hOAT) 1 og 3 eller MRP 4 (f. eks. cidofovir, et lægemiddel, der er kendt for at virke nefrotoksisk).
Tenofovir disoproxil fumarate has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e. g. cidofovir, a known nephrotoxic medicinal product).
Farmakokinetikken hos disse lægemidler, som secerneres af det samme renale system, herunder transportproteinerne (hOAT) 1 og 3 eller MRP 4, kan derfor forandre sig, hvis de indgives samtidig.
Consequently, the pharmacokinetics of these medicinal products which are secreted by the same renal pathway including transport proteins hOAT 1 and 3 or MRP 4 might be modified if they are co-administered.
4. 5).
Unless clearly necessary, concomitant use of these medicinal products which are secreted by the same renal pathway is not recommended, but if such use is unavoidable, renal function should be monitored weekly (see section 4.5).
I en 144- ugers kontrolleret, klinisk undersøgelse med HIV- inficerede patienter, som sammenlignede tenofovirdisoproxilfumarat med stavudin i kombination med lamivudin og efavirenz hos antiretroviral- naive patienter, sås små reduktioner i knoglemineraltætheden i hoften og rygraden hos begge behandlingsgrupper.
In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Reduktionerne i knoglemineraltætheden i rygraden og ændringerne i knoglebiomarkører fra baseline var i uge 144 signifikant større i gruppen, der blev behandlet med tenofovirdisoproxilfumarat.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
5 Leversygdom:
Liver disease:
Sikkerheden af tenofovir hos patienter med dekompenseret leversygdom undersøges i øjeblikket.
The safety of tenofovir in patients with decompensated liver disease is being studied.
På nuværende tidspunkt er sikkerheden hos denne patientpopulation ikke blevet grundigt evalueret.
At present the safety in this patient population has not been thoroughly evaluated.
Der er ingen tilgængelige data for sikkerhed og virkning hos levertransplanterede patienter.
No safety and efficacy data are available in liver transplant patients.
Forværring af hepatitis:
5 Exacerbations of hepatitis:
Opblussen under behandlingen:
Flares on treatment:
Spontan forværring af kronisk hepatitis B er relativt almindeligt og karakteriseret af forbigående stigninger i serum- ALAT.
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
Efter opstart af antiviral behandling kan serum- ALAT stige hos nogle patienter, når serum- HBV- DNA- niveauerne falder (se pkt.
After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Hos tenofovir- behandlede patienter optrådte forværringen under behandlingen typisk efter 4- 8 uger.
Among tenofovir-treated patients on-treatment exacerbations typically occurred after 4-8 weeks of therapy.
Hos patienter med kompenseret leversygdom er disse stigninger i serum- ALAT generelt hverken ledsaget af en stigning i serum- bilirubinkoncentrationen eller af hepatisk dekompensation.
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Patienter med levercirrose kan have større risiko for hepatisk dekompensation efter forværring af hepatitis og skal derfor overvåges nøje under behandlingen.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Opblussen efter seponering af behandlingen:
Flares after treatment discontinuation:
Akut forværring af hepatitis er også blevet rapporteret hos patienter efter seponering af hepatitis B- behandlingen.
Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
En forværring efter behandlingen er normalt forbundet med stigning i HBV- DNA, og størstedelen af tilfældene forekommer at være selvbegrænsende.
Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Der er imidlertid blevet rapporteret om alvorlige forværringer, herunder dødsfald.
However, severe exacerbations, including fatalities, have been reported.
Leverfunktionen bør overvåges i regelmæssige intervaller, både med klinisk kontrol og laboratoriekontroller, i mindst 6 måneder efter seponering af hepatitis B- behandlingen.
Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
En opblussen af levesygdommen er særdeles alvorlig og nogle gange fatal hos patienter med dekompenseret leversygdom.
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Der findes ingen data om virkningen af tenofovir hos patienter med samtidig infektion med hepatitis C - eller D- virus.
There are no data on the efficacy of tenofovir in patients co-infected with hepatitis C or D virus.
Samtidig infektion med HIV- 1 og hepatitis B:
Co-infection with HIV-1 and hepatitis B:
På grund af risikoen for udvikling af HIV- resistens skal tenofovirdisoproxilfumarat kun anvendes som en del af en passende, antiretroviral kombinationsbehandling hos patienter med samtidig HIV/ HBV- infektion.
Due to the risk of development of HIV resistance, tenofovir disoproxil fumarate should only be used as part of an appropriate antiretroviral combination regimen in HIV/ HBV co-infected patients.
Hos patienter med tidligere tilfælde af leverdysfunktion herunder kronisk aktiv hepatitis er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling og disse patienter bør overvåges i henhold til standardprocedurer.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Det skal imidlertid bemærkes, at stigninger i ALAT kan være en del af HBV- clearance under behandling med tenofovir, se Forværring af hepatitis ovenfor.
However, it should be noted that increases of ALT can be part of HBV clearance during therapy with tenofovir, see above Exacerbations of hepatitis.
De prækliniske og kliniske data antyder, at risikoen for forekomst af laktatacidose, en lægemiddelgruppeeffekt af nukleosidanaloger, er lav for tenofovirdisoproxilfumarat.
The preclinical and clinical data suggest that the risk of occurrence of lactic acidosis, a class effect of nucleoside analogues, is low for tenofovir disoproxil fumarate.
Da tenofovir strukturelt er relateret til nukleosidanaloger, kan denne risiko dog ikke udelukkes.
However, as tenofovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Blandt de tidlige symptomer (symptomatisk hyperlaktatæmi) er godartede fordøjelsessymptomer (kvalme, opkastning og mavesmerter), uspecifik utilpashed, appetitløshed, vægttab, symptomer i åndedrætsorganer (hurtig og/ eller dyb vejrtrækning) eller neurologiske symptomer (herunder motorisk svaghed).
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Behandling med nukleosidanaloger bør seponeres i tilfælde af symptomatisk hyperlaktatæmi og metabolisk acidose/ laktatacidose, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
6 Der bør udvises forsigtighed ved indgivelse af nukleosidanaloger til en patient (især overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom og steatosis hepatis (herunder visse lægemidler og alkohol).
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Lipodystrophia (lipoatrophia/ lipomatose):
Lipodystrophy (lipoatrophy/ lipomatosis):
Hos HIV- inficerede patienter er antiretroviral kombinationsbehandling blevet forbundet med omfordeling af legemsfedt (lipodystrophia).
In HIV infected patients, combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy).
De langsigtede konsekvenser af disse hændelser er p. t. ikke kendte.
The long-term consequences 6 of these events are currently unknown.
En hypotese om forbindelsen mellem visceral lipomatose og proteasehæmmere samt lipoatrophia og nukleosid reverse transkriptasehæmmere er blevet opstillet.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
En højere risiko for lipodystrophia er blevet forbundet med individuelle faktorer som f. eks. højere alder, og med lægemiddelrelaterede faktorer som f. eks. længere varighed af antiretroviral behandling og associeret metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Tenofovir er strukturelt relateret til nukleosidanaloger, og derfor kan risikoen for lipodystrophia ikke udelukkes.
Tenofovir is structurally related to nucleoside analogues hence the risk of lipodystrophy cannot be excluded.
144- ugers kliniske data fra antiretroviral- naive, HIV- inficerede patienter tyder imidlertid på, at risikoen for lipodystrophia var lavere med tenofovirdisoproxilfumarat end med stavudin ved indgivelse sammen med lamivudin og efavirenz.
However, 144-week clinical data from antiretroviral-naïve HIV infected patients indicate that the risk of lipodystrophy was lower with tenofovir disoproxil fumarate than with stavudine when administered with lamivudine and efavirenz.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis jiroveci pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis jiroveci pneumonia.
På basis af resultaterne af in vitro- forsøg og tenofovirs kendte eliminationsvej er potentialet for CYP450- medierede interaktioner, hvor tenofovir er involveret sammen med andre lægemidler, lav.
Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.